WO2023171441A1 - Electrocardiograph - Google Patents

Electrocardiograph Download PDF

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Publication number
WO2023171441A1
WO2023171441A1 PCT/JP2023/006967 JP2023006967W WO2023171441A1 WO 2023171441 A1 WO2023171441 A1 WO 2023171441A1 JP 2023006967 W JP2023006967 W JP 2023006967W WO 2023171441 A1 WO2023171441 A1 WO 2023171441A1
Authority
WO
WIPO (PCT)
Prior art keywords
main body
base member
device main
adhesive sheet
electrocardiograph
Prior art date
Application number
PCT/JP2023/006967
Other languages
French (fr)
Japanese (ja)
Inventor
智之 内田
賢治 土肥
肇 池田
文彦 吉井
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Publication of WO2023171441A1 publication Critical patent/WO2023171441A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/251Means for maintaining electrode contact with the body
    • A61B5/257Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/271Arrangements of electrodes with cords, cables or leads, e.g. single leads or patient cord assemblies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282Holders for multiple electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332Portable devices specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/333Recording apparatus specially adapted therefor

Definitions

  • the present invention relates to an electrocardiograph that is attached to a human body and transmits and/or records electrocardiogram information.
  • Patent Document 1 proposes an electrocardiogram recording device that can record electrocardiogram information.
  • an electrocardiograph includes measurement electrodes for measuring electrocardiogram information, an electric circuit for controlling the device, a battery such as a battery housed inside, and lead wires for electrically connecting these. It is equipped with Conventional electrocardiographs require, for example, improvements in the stability of conduction at electrical connections, improvements in waterproof performance against water and sweat, reduction in the feeling of wearing by making them smaller and lighter, and the need to replace batteries. There was a need for improvements in properties such as improved elasticity and improved adhesion to the surface of the human body to prevent unintentional peeling from the human body.
  • the problem to be solved by the present invention is to provide a novel electrocardiograph that can reduce or eliminate at least one of the problems of electrocardiographs of conventional structure and improve its characteristics. It is in.
  • the first aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, the base member having a bottom wall fixed to the adhesive sheet, and the device main body attached to the base member based on a fitting action to the device main body.
  • a fitting peripheral wall is provided to hold the base member in an overlapping state, and a connector portion is provided between the base member and the main body of the device, and the connector portion is comprised of contacts that are electrically connected by contact in the mutual overlapping direction.
  • the plurality of measurement electrodes are electrically connected to the electric circuit on the device main body side through the connector portion, and the contacts on the base member side and the contacts on the device main body side are connected in the connector portion.
  • the device is equipped with a biasing member that urges the two to contact each other in the stacking direction.
  • the device main body is removable from the base member, and the contact point on the base member side and the contact point on the device main body side are urged in the overlapping direction by the biasing member. contact with.
  • the assembly structure of the base member and the device main body using the fitting peripheral wall makes it easy to improve the waterproof performance between the base member where electrical contacts are arranged and the device main body.
  • the biasing member is provided on at least one of the base member side and the device main body side of the connector portion, and the biasing member is provided on the base member side of the connector portion. It is constituted by an elastic member that biases the contact point on the device main body side and the contact point on the device main body side in the overlapping direction.
  • the biasing member is constituted by the elastic member, and the elastic restoring force in the elastic member is biased in a state where the contact point on the base side member side and the contact point on the device main body side are overlapped. It can be used as a biasing force.
  • the assembly structure between the base member and the device main body can be made lighter and smaller than, for example, when using a mechanical electrical connector. This reduces the feeling of wearing.
  • a contact support portion protruding from the inner surface of the bottom wall toward the connector portion is provided on the inner surface of the bottom wall of the base member. It is provided.
  • the contact support portion is provided on the inner surface of the bottom wall of the base member, the base member and the device main body can be brought closer to each other by the amount of the contact support portion, and the contact point on the base member side and the device body can be brought closer to each other by the contact support portion. It is also possible to make contact with the contact point on the main body side with a larger urging force. For example, in combination with the second aspect, the restoring force in the elastic member can be used more efficiently as an urging force between the contacts.
  • a fourth aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, in which an electric circuit board and a power supply battery are housed and assembled in the device main body, and a battery holder portion for positioning the battery is attached to the electric circuit. It is provided on the inner surface of the casing of the main body of the device on which the substrates are stacked.
  • the battery holder portion for positioning the battery is provided on the inner surface of the casing of the device main body, the battery holder portion can be formed more easily than, for example, when the battery holder portion is provided on the electric circuit board. As a result, the structure can be simplified and the battery can be easily attached and detached.
  • the battery is constituted by a button battery, and the casing of the device main body has a bottom member and a lid member overlapped with each other.
  • a housing space for the electric circuit board and the button battery is formed between the overlapping surfaces, and the battery holder portion is provided on the inner surface of one of the bottom member and the lid member.
  • the electric circuit board is superimposed on the button battery arranged in the battery holder part, and the bottom member and the lid member are fixed to each other, so that the electric circuit board is provided on the electric circuit board.
  • the contacts of both poles are held in contact with the button battery, and the electric circuit board and the button battery are removed from the housing by opening the bottom member and the lid member. It is considered possible.
  • the casing of the device main body is configured to include a bottom member and a lid member, and the electric circuit board and the button battery are housed between the bottom member and the lid member, and the bottom member
  • the electric circuit board and button battery can be taken out by opening the lid member. Therefore, by removing the device body from the base member and opening the bottom member and lid member, the electric circuit board and button battery can be easily replaced.
  • a sixth aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, wherein the adhesive sheet is provided with three of the measurement electrodes, and the device is set to be offset toward the bottom in the vertical direction at approximately the center in the left-right direction of the adhesive sheet.
  • the respective centers of the first and second measurement electrodes on the left and right are positioned diagonally upward from the center of the attachment site of the main body, and the third measurement electrode is positioned diagonally upward from the center of the attachment site of the device body.
  • the position is set above from .
  • the adhesive sheet is provided with three measurement electrodes, and the center of the device body is provided below the center of each measurement electrode. Therefore, the center of gravity of the electrocardiograph can be biased downward on the adhesive surface of the adhesive sheet that spreads over the entire area around the three measurement electrodes, for example, the center of gravity of the electrocardiograph can be positioned higher. Compared to the case where the electrocardiograph is attached, the state in which the electrocardiograph is attached can be stabilized, and unintended peeling of the adhesive sheet from the skin of the human body can be suppressed.
  • a seventh aspect of the electrocardiograph according to the sixth aspect is that the adhesive sheet has a curved shape in which an upper peripheral edge portion has a smaller radius of curvature than a lower peripheral edge portion. , the shortest position from the center of the attachment part of the device main body to the outer edge of the adhesive sheet is set below the device main body, and the position where the horizontal width dimension of the adhesive sheet is maximum The center of the attachment site of the device body is set to be biased downward.
  • the adhesive sheet is worn in a state where the vertical direction is approximately vertical when the human body is standing upright, the adhesive surface of the adhesive sheet is positioned above the main body of the device. Since the device body is provided in a form that spreads out so as to hang the device body, it is possible to further improve the stable adhesion state of the device body by the adhesive sheet.
  • An eighth aspect is an electrocardiograph that is attached to a patient's body to transmit and/or record electrocardiogram information, which includes an adhesive sheet that is attached to the skin of the human body, and an adhesive sheet provided on the adhesive sheet.
  • a plurality of measurement electrodes are superimposed on the skin of a human body, a base member is provided on the outer surface of the adhesive sheet, and the adhesive sheet is removably attached to the base member, and electrocardiogram information based on the detected potential by the measurement electrodes is provided.
  • a lead-off detection mechanism is provided to detect the occurrence of abnormality in electrical conductivity detected by the lead-off detection mechanism.
  • the measurement electrode may be peeled off from the skin, or the lead wire connecting the device body and the measurement electrode may be severed.
  • the occurrence of an abnormality in electrical continuity is detected by a lead-off detection mechanism.
  • the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism is notified to the patient wearing the electrocardiograph by the notification means, the moment the patient confirms that an abnormality has occurred, The abnormality can be corrected by reattaching the measurement electrode or going to a medical institution.
  • the electrocardiograph according to this embodiment since the electrocardiograph according to this embodiment is worn for a long period of time, for example, several days to several weeks, and measurements are taken, the abnormality can be resolved more quickly by allowing the patient to confirm the occurrence of the abnormality. It is also possible to shorten the period during which measurements are not possible, avoid delays in diagnosis due to re-measurement, and reduce the burden on patients associated with wearing an electrocardiograph for a longer period of time. .
  • FIG. 2 is an explanatory diagram for explaining the lighting state of the LED lamps constituting the lead-off detection mechanism in the electrocardiograph shown in FIG. 1, in which (a) both the first lighting area and the second lighting area are lit; (b) is a diagram showing a state in which only the second lighting area is lit; An exploded perspective view showing the internal structure of the device main body that constitutes the electrocardiograph shown in Figure 1.
  • FIG. 1 and 2 show an electrocardiograph 10 as one embodiment of the present invention.
  • This electrocardiograph 10 is attached to a patient's body A as shown in FIG. 7, which will be described later, and transmits electrocardiogram information to the outside of the device or records it inside the device over a long period of time, for example, several days or weeks. It is.
  • the direction in which the electrocardiograph 10 is attached to the human body A is not limited, but in the following description, the up-down direction refers to the up-down direction in FIG. 1, and the left-right direction refers to the left-right direction in FIG.
  • the front-rear direction refers to the up-down direction (sheet thickness direction) in FIG.
  • the electrocardiograph 10 includes an adhesive sheet 12 that is adhered to the skin a of the human body A (see FIG. 7), and an adhesive sheet 12 that is provided on the rear surface (back side) of the adhesive sheet 12 and that is attached to the skin a of the human body A (see FIG. 7).
  • the device includes a plurality of measurement electrodes 14 that are electrically connected to each other, a base member 16 provided on the front surface (outer surface serving as the front surface) of the adhesive sheet 12, and a device main body 18 that is removably attached to the base member 16. I'm here.
  • the shape of the adhesive sheet 12 is not limited, in this embodiment, the shape is generally larger in the horizontal direction than in the vertical direction in a plan view (front view) shown in FIG. It has an elliptical shape, and in particular in this embodiment, the upper peripheral edge portion is curved with a smaller radius of curvature than the lower peripheral edge portion, resulting in an approximately rice ball shape (triangular shape with rounded corners). ing. Furthermore, a thin annular protection sheet 22 that extends around each measurement electrode 14 is adhered to the rear surface of the adhesive sheet 12 in this embodiment in an overlapping state.
  • Both the adhesive sheet 12 and the protective sheet 22 have electrical insulation properties, are made of soft synthetic resin such as polyurethane, and can be flexibly deformed along the skin surface of the human body A.
  • the adhesive sheet 12 is preferably colorless and transparent or colored and transparent, for example, in order to make it easier to grasp the position of each measurement electrode 14.
  • the adhesive sheet 12 may be skin-colored.
  • the protective sheet 22 harder, thicker, or colored than the adhesive sheet 12, the position of the measurement electrode 14 located at the center of the protective sheet 22 can be visually checked from the outer surface of the adhesive sheet 12. It is also possible to make the confirmation easier by touching or contacting the measuring electrode 14, or a mark such as a color indicating the position of the measuring electrode 14 may be provided on the front surface of the protective sheet 22.
  • the method of fixing the adhesive sheet 12 and the protective sheet 22 is not limited, but may be fixed by, for example, adhesion or welding.
  • the rear surface of the adhesive sheet 12 is an adhesive surface 26 that is applied to the skin a via an adhesive layer 24 made of an adhesive.
  • the area colored gray in FIG. 1 is the adhesive layer 24 on the adhesive surface 26 to which the adhesive is applied.
  • a release liner 28 is releasably attached to the adhesive surface 26 of the adhesive sheet 12 via the adhesive layer 24.
  • the adhesive layer 24 may also be provided on the back surface of the protective sheet 22.
  • a measuring electrode 14 is arranged approximately at the center.
  • the front surface of the measurement electrode 14 is covered with an adhesive sheet 12, and the rear surface of the measurement electrode 14 is exposed toward the rear, so that the electrocardiograph 10 can be attached to the skin surface of the human body A by attaching the protective sheet 22 to the skin surface of the human body A.
  • each measurement electrode 14 is superimposed on the skin a of the human body A and is electrically conductive.
  • Each measurement electrode 14 may be superimposed on the skin a of the human body A via a conductive gel (not shown).
  • each measurement electrode 14 is provided.
  • As each of the measurement electrodes 14a to 14c conventionally known electrocardiogram measurement electrodes may be employed.
  • each measurement electrode 14 is connected to a lead wire 32 (first to third lead wires 32a to 32c).
  • the lead wires 32a to 32c are wired independently from each other, and each extends from each measurement electrode 14 toward the base member 16.
  • Each lead wire 32 has its front surface covered with the adhesive sheet 12 and its rear surface covered with the protective sheet 22, and is insulated from the outside.
  • Each lead wire 32 is gathered at the end opposite to the measurement electrode 14 so as to be located approximately at the bottom center of the base member 16, and is provided on the adhesive sheet 12 as shown in FIG. The surface facing the base member 16 (front surface) is exposed through the current-carrying window 33 .
  • current-carrying wires 34a, 34b, and 34c are electrically connected to mutually independent lead wires 32a, 32b, and 32c, respectively. These current-carrying wires 34a to 34c are laminated on a flexible insulating sheet to constitute one FFC (flexible flat cable) 36 as a whole. In the FFC 36, current-carrying wires 34a to 34c connected to each measurement electrode 14 are drawn out from the front surface of the adhesive sheet 12.
  • a base member 16 is provided on the outer surface (front surface) of the adhesive sheet 12, and covers the current-carrying window 33 of the adhesive sheet 12 from the front. As shown in FIG. 3, the base member 16 has a substantially rectangular shape with rounded corners when viewed from above.
  • the base member 16 is an elastic member made of, for example, elastically deformable soft synthetic resin.
  • the base member 16 includes a bottom wall 38 having a substantially rounded rectangular shape, and a fitting peripheral wall 40 protrudes forward from the outer peripheral edge of the bottom wall 38 .
  • the fitting circumferential wall 40 is provided continuously over the entire circumference in the circumferential direction, and an engaging claw 42 that protrudes inward is provided at the protruding end (front end) of the fitting circumferential wall 40. There is.
  • the fitting peripheral wall 40 is formed to be relatively thin with respect to the bottom wall 38, and can be elastically deformed in a direction (for example, an up-down direction or a left-right direction) orthogonal to the protruding direction (front-back direction). Note that it is desirable that the engaging claws 42 are provided continuously over the entire circumference.
  • a substantially slit-shaped insertion hole 44 that penetrates the bottom wall 38 in the thickness direction (front-back direction) is provided in the substantially central portion of the bottom wall 38, and a substantially slit-shaped insertion hole 44 is provided in the left portion of the bottom wall 38.
  • Two screw holes 46, 46 are provided which are spaced apart from each other in the vertical direction.
  • the contact support portion is constituted by a substantially rectangular reinforcing plate 48.
  • the reinforcing plate 48 is a hard member made of metal, synthetic resin, or the like, and in this embodiment is made of polyethylene terephthalate (PET).
  • PET polyethylene terephthalate
  • two screw holes 49, 49 are provided at the left end portion of the reinforcing plate 48, which are spaced apart from each other in the vertical direction. These screw holes 49, 49 are formed at positions corresponding to the screw holes 46, 46 in the bottom wall 38.
  • the reinforcing plate 48 is attached to the inner surface of the bottom wall 38 with a waterproof double-sided tape 50.
  • This waterproof double-sided tape 50 and the waterproof double-sided tape 78 described later have a structure in which, for example, adhesive layers or adhesive layers are laminated on both sides of a base material, and are sufficiently thin and flexible.
  • the waterproof double-sided tapes 50 and 78 are elastic members that have elasticity in the thickness direction (back and forth direction) due to the adhesive layer or adhesive layer.
  • the base member 16 of this embodiment is provided with a shallow recess 52 that opens on the inner surface of the bottom wall 38, and the reinforcing plate 48 is attached to the bottom surface of the recess 52 (inner surface of the bottom wall 38).
  • the reinforcing plate 48 is housed in the recess 52. That is, the bottom wall 38 in the portion where the recess 52 is formed, which is thinned by the recess 52, is reinforced by the reinforcing plate 48.
  • a reinforcing plate 48 is not essential, and for example, a contact support portion (reinforcing plate 48) may be formed on the inner surface of the bottom wall 38 by integral molding or the like to provide reinforcement.
  • the recess 52 itself is not essential as long as it can stably support a contact portion in the FFC 36, which will be described later.
  • the insertion hole 44 provided in the substantially central portion of the bottom wall 38 opens at a position substantially in the center of the bottom surface of the recess 52 and slightly outside the reinforcing plate 48 .
  • the insertion hole 44 is located above the current-carrying window 33 of the adhesive sheet 12, and the FFC 36 drawn out of the adhesive sheet 12 through the current-carrying window 33 is inserted into the base member 16 through the insertion hole 44. It is being As shown in FIG. 3, the FFC 36 having the current-carrying wires 34a to 34c has its folded and extended end side superimposed on the reinforcing plate 48 on the bottom surface of the base member 16.
  • bottom wall 38 of the base member 16 is superposed and fixed to the front surface of the adhesive sheet 12.
  • the method of fixing the adhesive sheet 12 and the bottom wall 38 is not limited, and may be achieved by, for example, adhesion or welding.
  • the base member 16 (and the device body 18 attached to the base member 16) is attached to the attachment site (as shown in FIG. A region that overlaps the base member 16 and the device main body 18 in a plan view is provided.
  • two of the three measurement electrodes 14 are positioned so that their respective centers are diagonally upward on the left and right sides. Further, the center of the remaining one of the three measurement electrodes 14 (third measurement electrode 14c) is positioned upward from the center of the attachment site of the base member 16 (device main body 18).
  • the first measurement electrode 14a on the left side is used as a negative electrode
  • the second measurement electrode 14b on the right side is used as a positive electrode
  • the third measurement electrode 14c in the middle is an indifferent electrode.
  • the radius of curvature of the lower peripheral edge portion of the adhesive sheet 12 is smaller than that of the upper peripheral edge. Since the radius of curvature is larger than the radius of curvature of the base member 16 (apparatus main body 18), the shortest position from the center C of the installation site of the base member 16 (apparatus main body 18) to the outer edge of the adhesive sheet 12 is set below the base member 16 (apparatus main body 18). has been done.
  • the center C of the attachment part of the base member 16 (apparatus main body 18) is located at the position where the horizontal width dimension of the adhesive sheet 12 is the maximum (in this embodiment, the first measurement electrode 14a in FIG.
  • the second measurement electrode 14b is set so as to be offset downward from a position approximately equal to a straight line connecting the centers of the second measurement electrodes 14b and extending left and right.
  • the device main body 18, which is removably attachable to the base member 16, is a hollow casing consisting of a bottom member 54 and a lid member 56 that are overlapped and fixed to each other. It has a body 58.
  • the bottom member 54 and the lid member 56 are made of, for example, hard synthetic resin, and the internal space of the casing 58 formed between these overlapping surfaces contains an operation control device and a storage device for the electrocardiograph 10.
  • It is a housing space 64 in which an electric circuit board 60 and a power supply battery are assembled in a housed state.
  • the battery is constituted by a button battery 62.
  • Electronic components such as a CPU and a memory are mounted on the electric circuit board 60, and electrocardiogram information based on the detected potentials detected by each of the measurement electrodes 14a to 14c can be recorded.
  • an LED lamp (not shown) may be used, and depending on the state of the electrocardiograph 10, for example, when the power is turned on, when wireless communication is connected, when an electrode is disconnected, etc. Therefore, LED lamps of different colors may be lit (including constant lighting or blinking).
  • two LED lamps are provided at the right side of the electrocardiograph 10 at a distance from each other in the vertical direction.
  • each LED lamp includes a first lighting area 65a and a second lighting area 65b.
  • the lighting of the LED lamps in the first and second lighting areas 65a and 65b can be visually recognized from the outside by, for example, making at least a portion of the casing 58 of the device main body 18 transparent (including colorless or colored).
  • a soft member 96 which will be described later, provided on the lid member 56 may be transparent.
  • any of the measurement electrodes 14 may be peeled off from the skin a of the human body A.
  • any of the lead wires 32 first to third lead wires 32a to 32c
  • the energized wires 34a to 34c are disconnected, only the LED lamp in the first lighting area 65a is lit. It has become.
  • a lead-off detection mechanism 67a is provided to detect the occurrence of an abnormality.
  • a notification means 67b for notifying the patient to whom the electrocardiograph 10 is attached of the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism 67a is an LED lamp (not shown) mounted on the electric circuit board 60. It is composed of:
  • the lighting mode of the LED lamp according to the state of the electrocardiograph 10 is not limited, and when the lead-off detection mechanism 67 detects the occurrence of an abnormality in electrical continuity, the lighting mode shown in FIG. As shown in FIG. 5(b), both the LED lamps in the first and second lighting areas 65a and 65b may be lit, or as shown in FIG. 5(b), the LED lamps in the second lighting area 65b may be lit. It may be arranged so that only one of the two lights is lit.
  • the occurrence of an abnormality in electrical conductivity is detected, for example, when the value of the potential detected by each of the measurement electrodes 14a to 14c deviates from a predetermined value set based on the normally assumed action potential. It may be as follows.
  • the electronic components mounted on the electric circuit board 60 may include, for example, a wireless communication device such as BLE (Bluetooth Low Energy (registered trademark)) communication or Wi-Fi communication, or a computer equipped with a wireless receiver or the like.
  • the electrocardiogram information recorded by the electrocardiograph 10 may be transmitted to a smartphone or the like, or a wired communication device such as a USB may be provided.
  • the bottom member 54 is a generally flat member as a whole, and includes a flat plate portion 66 that extends in a direction orthogonal to the front-rear direction.
  • the bottom member 54 (flat plate part 66) has a rounded rectangular shape that is approximately the same shape as the base member 16 in plan view, and has an outer circumference that is slightly smaller than the base member 16 and is connected to the fitting peripheral wall 40 of the base member 16. It is said that it can be fitted.
  • the outer peripheral edge of the flat plate part 66 has a larger thickness dimension (front-rear direction dimension), and the outer peripheral surface of the part where the thickness dimension has been increased has an annular engagement that extends continuously in the circumferential direction over the entire circumference.
  • a matching groove 68 is provided.
  • an appropriate number of screw holes 70 are formed in the flat plate portion 66 so as to pass through the flat plate portion 66 in the thickness direction.
  • a substantially rectangular insertion hole 72 is formed through the bottom member 54 in the thickness direction, and a conductive rubber 74 as an elastic member having conductivity is inserted into the insertion hole 72. It is desirable that the conductive rubber 74 be inserted into the insertion hole 72 while maintaining sealing properties. Specifically, the conductive rubber 74 is inserted into the insertion hole 72 in a fitted state by, for example, pressing a seal protrusion protruding from the inner peripheral surface of the insertion hole 72 against the outer peripheral surface of the conductive rubber 74. . One end surface of the conductive rubber 74 in the thickness direction (the direction of insertion into the insertion hole 72) is connected to the electrical signal input portion of the electrical circuit board 60, thereby allowing signal input to the electrical circuit board 60. A terminal is constituted by the conductive rubber 74.
  • the longitudinal dimension of the conductive rubber 74 is larger than the longitudinal dimension of the insertion hole 72, and the other end surface of the conductive rubber 74 in the thickness direction protrudes outward from the outer surface (rear surface) of the bottom member 54. ing. Then, when the bottom member 54 is fitted into the base member 16 and the device main body 18 is attached, the other end surface of the conductive rubber 74 is placed on the FFC 36 superimposed on the reinforcing plate 48 of the base member 16. It is pressed against the formed conductive wires 34a to 34c to be electrically connected.
  • the conductive rubber 74 is configured to electrically connect the three current-carrying wires 34a to 34c to the three input portions on the electric circuit board 60, respectively. Further, screw holes 76, 76 are provided at positions close to the insertion hole 72, and the conductive rubber 74 is stably held by tightening screws 77, 77. In addition, in order to avoid the tightening screws 77, 77 from contacting or interfering with other members, screw holes 46, 49, 82 are formed in the base member 16, the reinforcing plate 48, and the waterproof double-sided tape 78 to be described later. Alternatively, the base member 16 and the bottom member 54 may be tightened with the tightening screws 77, 77 through the screw holes 46, 49, 82 to improve the stability of the electrical connection on both end surfaces of the conductive rubber 74. It is also possible to
  • a waterproof double-sided tape 78 is provided on the rear surface of the bottom member 54 (the rear surface of the flat plate portion 66).
  • This waterproof double-sided tape 78 is, for example, as large as or slightly larger than the reinforcing plate 48, and the end surface of the conductive rubber 74 is directed outward, where the FFC 36 is arranged, through an insertion window 80 provided at approximately the center. It stands out.
  • a waterproof double-sided tape 78 that tightly adheres to the surface of the reinforcing plate 48 when assembled to the base member 16 of the device main body 18, which will be described later, is applied around the exposed portions of the current-carrying wires 34a to 34c at the ends of the FFC 36. It is also tightly attached and fixed. Thereby, the waterproofness of the contact portions between the conductive rubber 74 and the current-carrying wires 34a to 34c can also be ensured.
  • the lid member 56 includes an upper bottom wall 86 that extends in a direction orthogonal to the front-rear direction, and a peripheral wall portion 88 that protrudes rearward from the outer peripheral edge of the upper bottom wall 86.
  • the upper bottom wall 86 has a generally rectangular shape with rounded corners in a plan view, and the peripheral wall portion 88 extends while being curved so as to gradually expand toward the rear.
  • the outer shape and size of the lid member 56 are substantially the same as those of the base member 16 in plan view.
  • substantially cylindrical screw hole forming portions 90 that protrude rearward are provided at the four corners of the upper bottom wall 86. These screw hole forming portions 90 are formed at positions corresponding to the screw holes 70 in the bottom member 54. Furthermore, a substantially cylindrical battery holder portion 92 that protrudes rearward from the upper bottom wall 86 and positions the button battery 62 is integrally provided on the left portion of the inner surface of the lid member 56 . Note that a notch is provided in a part of the circumference of the battery holder portion 92, and when the button battery 62 is housed in the device main body 18, the conductive member that elastically protrudes from the electric circuit board 60 is cut out.
  • the positive electrode of the button battery 62 can be brought into contact with the outer circumferential surface of the button battery 62 through the electrode, and the electric circuit board 60 and the positive electrode of the button battery 62 can be electrically connected to each other.
  • a conductive member that elastically contacts the negative pole of the button battery 62 is provided on the surface of the electric circuit board 60.
  • the button battery 62 is housed in the battery holder part 92 in a non-fixed state (preferably with some play), and when the button battery 62 is removed as described later, the button battery 62 can be quickly removed. It can be easily removed.
  • a button 94 as an operation switch is provided on the upper bottom wall 86 of the lid member 56 to the right of the battery holder portion 92. That is, the button 94 is constituted by a part of the upper base wall 86 and is provided on the right side of the upper base wall 86.
  • the button 94 has a generally rectangular or trapezoidal shape in plan view, and is integrally and continuously connected to the left portion of the upper bottom wall 86 on the left side of the button 94 . This continuous portion is formed to be relatively thin, and a soft member 96 made of soft synthetic resin or the like is arranged around the button 94. Pushing is possible.
  • the button 94 can be pushed in without creating a gap around the button 94, and water can be prevented from entering the inside of the device main body through the gap around the button.
  • the button 94 is used not only as a power button for turning on the power of the device main body 18, as will be described later, but also as a button for setting the time by pressing the button 94 when, for example, the patient feels something strange about his or her heart. It may have a function as an event button that can be recorded in a memory or the like mounted on the electric circuit board 60.
  • an opening 98 is provided on the right side of the peripheral wall 88 and penetrates through the peripheral wall 88 in the thickness direction, and a USB terminal 100 to which a USB can be connected is fitted into the opening 98.
  • This USB terminal section 100 is electrically connected to electronic components mounted on the electric circuit board 60, and by connecting a USB to the USB terminal section 100, electrocardiogram information recorded on the electric circuit board 60 can be transferred to the USB terminal section 100. It is said that it can be imported into Note that when the USB is not in use, for example, by covering the USB terminal section 100 with a waterproof seal lid made of a separate component (not shown), water can be prevented from entering the inside of the device main body 18 through the USB terminal section 100.
  • the electrical circuit board 60 accommodated in the accommodation space 64 between the bottom member 54 and the lid member 56 is, for example, a synthetic resin board that extends in a direction orthogonal to the front-rear direction, and has a predetermined electrical element mounted on the surface thereof. It is constructed by printing and forming an electric circuit. As shown in FIG. 6, this electric circuit board 60 has a substantially rectangular shape with rounded corners in a plan view, and has cutouts at the four surrounding corners to avoid interference with the screw hole forming portion 90 of the lid member 56. A recess 102 is formed.
  • the size of the electric circuit board 60 is smaller than the lid member 56, and by overlapping the electric circuit board 60 from the opening side (rear side) of the lid member 56, the inside of the lid member 56 can be In the space, the screw hole forming portion 90 and the recess 102 also enable alignment of the electric circuit board 60 and the lid member 56.
  • the electric circuit board 60 is accommodated in the lid member 56 in a non-fixed state (preferably with some play), and when the electric circuit board 60 is removed as described later, the electric circuit board 60 can be quickly and easily removed.
  • the button battery 62 is housed in the battery holder part 92 of the lid member 56, and the electric circuit board 60 is placed on top of the button battery 62 from behind.
  • the device main body 18 shown in FIGS. 2 and 4 is constructed by overlapping the bottom member 54 on the lid member 56 and fixing it with screws 104 at four locations around the periphery.
  • the rear opening of the lid member 56 is covered by the bottom member 54, and the button battery 62 and the electric circuit board 60 are accommodated in the internal accommodation space 64.
  • each conductive member on the electric circuit board 60 is held in contact with both poles of the button battery 62, and power is supplied from the button battery 62 to the electric circuit board 60.
  • the button battery 62 and the electric circuit board 60 can be housed in the accommodation space 64 without wobbling, but the lid member 56 is simply fixed.
  • the button battery 62 and the electric circuit board 60 are placed on the cover member 56 (before the bottom member 54 is attached), the button battery 62 and the electric circuit board 60 are placed in the overlapping direction with respect to the lid member 56. So, it is accommodated freely to some extent. Further, the front end of the conductive rubber 74 protruding forward from the bottom member 54 contacts the electric circuit provided on the rear surface of the electric circuit board 60, and the conductive rubber 74 and the electric circuit board 60 are electrically connected. Ru.
  • the base member 16 and the device main body 18 as described above are assembled to each other. That is, by making the base member 16 and the device main body 18 face each other and pushing the device main body 18 into the base member 16, the outer circumferential end of the flat plate portion 66 in the bottom member 54 can close the fitting peripheral wall 40 in the base member 16.
  • the engaging claw 42 is pressed toward the outer circumferential side and is elastically deformed. Then, by further pushing the device main body 18 into the base member 16, the fitting circumferential wall 40 and the engaging claw 42 are elastically deformed, so that the engaging claw 42 of the base member 16 moves into the engaging groove of the bottom member 54. 68 in a substantially tight state.
  • the base member 16 and the device main body 18 are urged toward each other by utilizing the elasticity of the fitting circumferential wall 40 including the engaging claws 42. Even if an external force is applied that causes the base member 16 to move away from the base member 16, the assembled state of the base member 16 and the device main body 18 is maintained due to the elastic restoring force of the engaging claws 42 and the fitting peripheral wall 40. Based on the fitting effect of the fitting peripheral wall 40 on the outer peripheral portion of the device main body 18, the device main body 18 and the base member 16 are held in an overlapping state, and the base member 16 and the device main body 18 (bottom member 54) This will also improve the waterproofness between the two.
  • the screw holes 46 and 49 on the base member 16 side that communicate with each other are connected to the device main body.
  • the base member 16 and the device main body 18 may be screwed together by inserting the tightening screws 77, 77 into the screw holes 76 and 82 on the 18 side.
  • these tightening screws 77, 77 may be able to be fastened to the device main body 18 with the adhesive sheet 12 fixed to the base member 16, or the tightening screws 77, 77 may The adhesive sheet 12 may be fixed to the base member 16 after it is fastened to the device main body 18.
  • the bottom wall 38 of the base member 16 and the bottom member 54 of the device main body 18 are connected to each other via the reinforcing plate 48 and the waterproof double-sided tapes 50 and 78 located on both the front and back sides of the reinforcing plate 48. are superimposed and fixed.
  • the waterproof double-sided tape 78 is pasted on the reinforcing plate 48, and in addition to locking the engaging claw 42 in the engaging groove 68, the waterproof double-sided tape 78 is attached (and the tightening screw 77 is attached as necessary). , 77), the base member 16 and the device main body 18 are also fixed.
  • each of the conductive wires 34a to 34c exposed on the reinforcing plate 48 in the base member 16 and the conductive rubber 74 exposed rearward in the base member 16 come into contact with each other and are electrically connected.
  • the conductive rubber 74 connects the electric circuit board 60 and each of the conductive wires 34a to 34c (and the hard reinforcing plate 48 located behind them). ), and its elastic restoring force maintains stable contact between the conductive rubber 74 and the electric circuit board 60 and between the conductive rubber 74 and each of the conductive wires 34a to 34c. It looks like this.
  • each of the conductive wires 34a to 34c on the base member 16 side and the conductive rubber 74 on the device main body 18 side come into contact in the overlapping direction (front-back direction).
  • a connector portion 108 is formed by the contact points between each of the current-carrying wires 34a to 34c and the conductive rubber 74.
  • each measurement electrode 14a to 14c is energized to an electric circuit provided on an electric circuit board 60 on the apparatus main body 18 side through the connector part 108, that is, through each energizing wire 34a to 34c and the conductive rubber 74. It has become.
  • the biasing member includes a conductive rubber 74 and a base member 16 including an engaging claw 42 and a fitting peripheral wall 40 that bias the base member 16 and the device body 18 in a direction toward each other.
  • a waterproof double-sided tape 50 having elasticity in the thickness direction may be included as a biasing member, located behind each of the current-carrying wires 34a to 34c.
  • the conductive rubber 74, the base member 16, and the waterproof double-sided tape 50 overlap the contacts on the base member 16 side (each of the current-carrying wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74). It is biased in the direction. Then, the contacts on the base member 16 side (each of the current-carrying wires 34a to 34c) and the contacts on the device main body 18 side ( The overlapping state with the rear end portion of the conductive rubber 74 in a biased state is maintained more stably.
  • the electrocardiograph 10 as described above is used by being attached to the skin a of the human body A, as shown in FIG. That is, the release liner 28 is peeled off from the initial state before use shown in FIG. 1 to expose the adhesive layer 24 on the adhesive sheet 12. Then, this electrocardiograph 10 is attached to the skin a of the human body A, and each of the measurement electrodes 14a to 14c is placed at a predetermined position on the human body A.
  • the manner in which the electrocardiograph 10 is attached can be selected as appropriate depending on the waveform to be measured depending on the disease of the patient and the like.
  • the button 94 is pressed to turn on the power, and the action potentials at each of the measurement electrodes 14a to 14c are detected by a CPU provided on the electric circuit board 60, for example, according to a predetermined program.
  • the electrocardiogram information obtained based on this detected potential is recorded, for example, in a memory on the electric circuit board 60, and can be sent at any timing, for example, after the end of measurement, after the onset of symptoms, or in real time, for example, via BLE communication. or via USB to a computer or smartphone.
  • the electrocardiogram information is transmitted to a storage medium such as an external computer, it may be deleted from the on-board memory, or when the electrocardiogram information is transmitted in real time to an external storage medium and stored.
  • the bottom member 54 and the lid member 56 can be separated by removing the screws 104 that screw the bottom member 54 and the lid member 56 together.
  • the button battery 62 and the electric circuit board 60 can be taken out from the housing 58 by opening it.
  • the contacts on the base member 16 side (the current carrying wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74) overlap. Since they are in biased contact in the mating direction, the conductive state between both contacts is maintained stably even when the patient moves significantly during measurements over several days or weeks, for example.
  • the biasing members that bring these two contacts into contact in a biased state are the conductive rubber 74, the fitting peripheral wall 40 (base member 16) having the engagement claws 42, and the waterproof double-sided tape 50.
  • the connector portion 108 by employing the conductive rubber 74, which is an elastic member, as the biasing member and arranging the conductive rubber 74 in a compressed state between the electric circuit board 60 and each of the conductive wires 34a to 34c, While electrically connecting the electric circuit board 60 and each of the conductive wires 34a to 34c, elastic restoring force brings the conductive rubber 74 into contact with the electric circuit board 60, and the conductive rubber 74 and each of the conductive wires 34a to 34c. can maintain stable contact. Furthermore, by employing the conductive rubber 74 in the connector portion 108, the assembly structure of the device main body 18 and the base member 16 can be made lighter and smaller than, for example, when a mechanical conductive connector is employed. This is achieved, and the feeling of wearing the electrocardiograph 10 is reduced.
  • the conductive rubber 74 which is an elastic member
  • a reinforcing plate 48 as a contact support part is provided on the inner surface of the bottom wall 38 of the base member 16. This not only makes it possible to support and reinforce each of the energizing wires 34a to 34c arranged exposed on the front surface of the reinforcing plate 48, but also to further reduce the distance between each of the energizing wires 34a to 34c and the electric circuit board 60. It can be made smaller and the conductive rubber 74 can be placed in a more compressed state. As a result, a larger biasing force is obtained as an elastic restoring force, so that the conduction state between the electric circuit board 60, the conductive rubber 74, and each of the current-carrying wires 34a to 34c can be maintained more stably.
  • the button battery 62 and the electric circuit board 60 are housed in the housing space 64 of the housing 58 in the device main body 18, and the battery holder section 92 that positions the button battery 62 holds the housing 58. It is integrally formed with the constituting lid member 56. Thereby, for example, the battery holder portion 92 for positioning the button battery 62 can be provided more easily without providing a structure for positioning the button battery on the electric circuit board.
  • the housing 58 is composed of a bottom member 54 and a lid member 56, and the button battery 62 and the electric circuit board 60 can be removed by opening the bottom member 54 and the lid member 56, the button battery 62 and the electric circuit board 60 can be removed. 62 and the electric circuit board 60 can be easily replaced. Since the button battery 62 and the electric circuit board 60 are arranged freely to some extent with respect to the lid member 56, the lid member 56 can be opened by simply turning the lid member 56 upside down with the screws 104 removed and the bottom member 54 removed. The button battery 62 and the electric circuit board 60 can be taken out quickly and easily.
  • each of the centers of each measurement electrode 14a to 14c is connected to the base member 16 and the device main body.
  • the position is set above the center C of the attachment site No. 18.
  • the electrocardiograph 10 is attached to the human body A with the vertical direction in FIG. can be placed.
  • the center of gravity of the electrocardiograph 10 is shifted downward, and the adhesion to the human body A that is supported in a suspended state is more difficult than when, for example, the base member or the main body of the device is provided in the upper part of the adhesive sheet. It becomes easy to ensure a large area of the area, and it is possible to prevent the problem of the adhesive sheet peeling off due to the weight of the base member or the main body of the device.
  • the adhesive sheet 12 has a curved shape in which the upper peripheral edge portion has a smaller radius of curvature than the lower peripheral edge portion, and the center C of the mounting portion of the base member 16 and the device main body 18 is By setting the adhesive sheet 12 to be biased downward from the position where the width dimension in the left and right direction is the maximum, the adhesive sheet 12 is set so that the width dimension in the left and right directions is A large area can be secured. As a result, each of the measurement electrodes 14a to 14c can be arranged by making good use of this area, and a sufficient adhesion area can be ensured, which is effective in preventing the measurement electrodes 14a to 14c from shifting from their predetermined positions. is prevented.
  • the electrocardiograph 10 of this embodiment includes a lead-off detection mechanism 67a in the device main body 18 that detects the occurrence of abnormality in electrical conductivity when measuring action potentials at each of the measurement electrodes 14a to 14c. . Moreover, the occurrence of an abnormality detected in the lead-off detection mechanism 67a is notified to the patient by the notification means 67b. As a result, even if any of the measurement electrodes 14a to 14c is peeled off from the skin a of the human body A, or if any of the lead wires 32a to 32c and the current carrying wires 34a to 34c are disconnected, such an abnormality can be detected. The patient can quickly grasp the occurrence of abnormalities and take action to eliminate the abnormality.
  • the electrocardiograph 10 since the electrocardiograph 10 according to the present invention acquires electrocardiogram information over a relatively long period of time, by eliminating abnormalities early, the time during which measurements are impossible can be shortened and measurements can be made. It is possible to avoid a delay in diagnosis due to correction and reduce the burden on the patient due to re-measurement.
  • the contacts on the base member 16 side (each of the energizing wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74) are attached in the overlapping direction (front-back direction).
  • the biasing member to be biased was composed of the conductive rubber 74, the base member 16 having the engaging claws 42 and the fitting peripheral wall 40, and the waterproof double-sided tape 50, for example, the biasing member may be any one of the above.
  • the fixing structure between the base member and the main body of the device is implemented as described above.
  • the embodiment is not limited to the illustrated embodiment, and the base member does not necessarily have an elastic engagement claw or a fitting peripheral wall.
  • the engaging pawl 42 will be locked in the engaging groove 68 that opens on the outer circumferential surface of the device main body 18 as in the above embodiment.
  • an engagement groove is provided on the inner circumferential surface of the circumferential wall that protrudes rearward from the outer circumferential end of the device main body, and a fitting circumferential wall that has an engagement claw that protrudes toward the outer circumferential side of the base member is provided.
  • the engagement claw of the base member may be engaged with the engagement groove of the device main body from the inner peripheral side.
  • the conductive rubber 74 is provided to electrically connect the electric circuit board 60 and each of the current-carrying wires 34a to 34c, and connect the contacts on the base member 16 side and the contacts on the device main body 18 side.
  • a member that electrically conducts the electric circuit board and each current-carrying wire there is a member that electrically conducts the electric circuit board and each current-carrying wire, and a member that brings the contacts on the base member side and the contacts on the device body into contact in a biased state.
  • a separate member may be employed.
  • a conductive member that electrically connects the electric circuit board and each current-carrying wire a coil spring or plate is used as a biasing member that urges the electric circuit board and each current-carrying wire in a direction toward each other.
  • a member such as a spring may be separately employed to improve the stability of the contact between the electric circuit board and the conductive member and/or the contact between each current-carrying wire and the conductive member.
  • the waterproof double-sided tape 78 is provided on the rear surface of the device main body 18, and the adhesive effect of the waterproof double-sided tape 78 improves the fixing force between the device main body 18 and the base member 16.
  • the member may be fixed with, for example, a hook-and-loop fastener instead of the waterproof double-sided tape.
  • the base member 16 and the device main body 18 may be screwed together using the tightening screws 77, 77, but such a screwing structure is not essential, and a screwing structure is adopted.
  • a hook-and-loop fastener may be provided between the base member 16 and the device main body 18 as described above. Thereby, the device main body 18 may be removed from the base member 16 by simply separating the device main body 18 from the base member 16 and releasing the locking of the engagement claw 42 from the engagement groove 68. .
  • the fixing structure between the bottom member and the lid member constituting the device main body is not limited to screwing, and conventionally known fixing structures such as locking by unevenness or press-fitting can be adopted.
  • the reinforcing plate 48 which is a separate member from the bottom wall 38 is provided as a contact support part and is later fixed with waterproof double-sided tape 50, but the contact support part is formed integrally with the bottom wall.
  • the portions of the bottom wall that support the contacts may be formed thick.
  • the electrocardiograph according to the present invention not only acquires electrocardiogram information using each measurement electrode, but also acquires time by using, for example, each measurement electrode or a measuring device other than the measurement electrode, in addition to electrocardiogram waveform information.
  • Various numerical values such as the patient's heart rate, respiratory rate, internal sounds, acceleration, body temperature, blood pressure, and blood oxygen concentration may be measured and recorded, or may be transmitted to the outside of the device.
  • the device main body 18 was able to record electrocardiogram information in the memory inside the device or transmit it to the outside of the device, but the electrocardiograph according to the present invention It may be sufficient to have at least one of a recording function to the device and a transmitting function to the outside of the device.
  • the notification means for notifying the patient of the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism is not limited to the mode in which the patient is notified by lighting an LED lamp as in the above embodiment, but can be used for specific purposes. It may be configured to generate a sound or voice, or it may be configured to send a notification of the occurrence of an abnormality to the patient's smartphone or the like by, for example, wireless communication.
  • Electrocardiograph 12 Adhesive sheet 14 Measuring electrode 14a First measuring electrode 14b Second measuring electrode 14c Third measuring electrode 16 Base member (biasing member, elastic member) 18 Device body 22 Protective sheet 24 Adhesive layer 26 Adhesive surface 28 Release liner 30 Through hole 32 Lead wire 32a First lead wire 32b Second lead wire 32c Third lead wire 33 Current-carrying windows 34a, 34b, 34c Current-carrying wire 36 FFC (Flexible flat cable) 38 Bottom wall 40 Fitting peripheral wall 42 Engagement claw 44 Insertion hole 46 Screw hole 48 Reinforcement plate (contact support part) 49 Screw hole 50 Waterproof double-sided tape (biasing member, elastic member) 52 Recessed portion 54 Bottom member 56 Lid member 58 Housing 60 Electric circuit board 62 Button cell (battery) 64 Accommodation space 65a First lighting area 65b Second lighting area 66 Flat plate part 67a Lead-off detection mechanism 67b Notification means 68 Engagement groove 70 Screw hole 72 Insertion hole 74 Conductive rubber (biasing member, elastic member)

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Abstract

Provided is a novel electrocardiograph with which it is possible to reduce or eliminate at least one problem presented by electrocardiographs having a conventional structure, and to improve properties. The present invention provides an electrocardiograph (10) including an affixation sheet (12), a measurement electrode (14), a base member (16), and a device body (18). The base member (16) is provided with a bottom wall (38), and a fitting peripheral wall (40) for holding the device body (18) in a state of being overlapped with the base member (16) on the basis of an action of fitting to the device body (18). A connector part (108) comprising a contact at which electrical connection is established by the base member (16) and the device body (18) coming into contact with each other is provided between the base member (16) and the device body (18). The measurement electrode (14) is electrically connected to a device body (18)-side electric circuit through the connector part (108). There are provided biasing members (16, 50, 74) for bringing the base member (16)-side contact and the device body (18)-side contact into contact with each other in a state of being biased in the overlap direction in the connector part (108).

Description

心電計Electrocardiograph
 本発明は、人体に装着されて心電図情報を送信及び/又は記録する心電計に関するものである。 The present invention relates to an electrocardiograph that is attached to a human body and transmits and/or records electrocardiogram information.
 従来から、不整脈や狭心症等の状態を確認するために、心電図測定が行われる。特に、このような心電図測定が患者の自由行動下において長時間にわたって行われる場合には、長時間にわたって心電図情報を測定し、例えば心電図情報を装置外部へ送信したり装置内部へ記録することのできる小型の心電計が人体に装着されて用いられる。このような心電計として、例えば特開2018-19958号公報(特許文献1)には、心電図情報を記録することのできる心電図記録装置が提案されている。 Conventionally, electrocardiogram measurements have been performed to check conditions such as arrhythmia and angina pectoris. In particular, when such electrocardiogram measurement is performed over a long period of time while the patient is free to move, it is possible to measure electrocardiogram information over a long period of time and, for example, to transmit the electrocardiogram information to the outside of the device or record it inside the device. A small electrocardiograph is used by being attached to the human body. As such an electrocardiograph, for example, Japanese Patent Application Publication No. 2018-19958 (Patent Document 1) proposes an electrocardiogram recording device that can record electrocardiogram information.
特開2018-19958号公報Japanese Patent Application Publication No. 2018-19958
 ところで、このような心電計は、心電図情報を測定するための測定電極や、装置を制御するための電気回路、内部に収容された電池等のバッテリ、これらを電気的に接続するリード線等を備えている。そして、従来の心電計では、例えば電気的接続部分における導通の安定性の向上や、水や汗などに対する防水性能の向上、小型軽量化による着用感の低減、バッテリ(電池)の交換の作業性の向上、体皮表面への貼着性能の向上による人体からの意図しない剥がれの防止、などといった特性の改善が要求されていた。 By the way, such an electrocardiograph includes measurement electrodes for measuring electrocardiogram information, an electric circuit for controlling the device, a battery such as a battery housed inside, and lead wires for electrically connecting these. It is equipped with Conventional electrocardiographs require, for example, improvements in the stability of conduction at electrical connections, improvements in waterproof performance against water and sweat, reduction in the feeling of wearing by making them smaller and lighter, and the need to replace batteries. There was a need for improvements in properties such as improved elasticity and improved adhesion to the surface of the human body to prevent unintentional peeling from the human body.
 本発明の解決課題とするところは、従来構造の心電計が有する問題点の少なくとも1つを軽減乃至は解消して、特性の改善を図ることのできる、新規な心電計を提供することにある。 The problem to be solved by the present invention is to provide a novel electrocardiograph that can reduce or eliminate at least one of the problems of electrocardiographs of conventional structure and improve its characteristics. It is in.
 以下、本発明を把握するための好ましい態様について記載するが、以下に記載の各態様は、例示的に記載したものであって、適宜に互いに組み合わせて採用され得るだけでなく、各態様に記載の複数の構成要素についても、可能な限り独立して認識及び採用することができ、適宜に別の態様に記載の何れかの構成要素と組み合わせて採用することもできる。それによって、本発明では、以下に記載の態様に限定されることなく、種々の別態様が実現され得る。 Hereinafter, preferred embodiments for understanding the present invention will be described. However, each of the embodiments described below is described by way of example, and may not only be adopted in combination with each other as appropriate, but also be described in each embodiment. The plurality of components can be recognized and employed as independently as possible, and can also be appropriately employed in combination with any of the components described in other embodiments. Accordingly, the present invention is not limited to the embodiments described below, and various other embodiments can be realized.
 第1の態様は、人体に装着されて心電図情報を送信及び/又は記録する心電計であって、人体の皮膚に貼着される貼着シートと、該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、該貼着シートの外面に設けられたベース部材と、該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、前記ベース部材には、前記貼着シートに固着された底壁と、前記装置本体への嵌合作用に基づいて該装置本体を該ベース部材に対して重ね合わせ状態で保持せしめる嵌合周壁とが、設けられている一方、該ベース部材と該装置本体との間には相互の重ね合わせ方向での当接によって導通される接点からなるコネクタ部が設けられており、該コネクタ部を通じて前記複数の測定電極が該装置本体側の電気回路に導通されるようになっていると共に、該コネクタ部において該ベース部材側の接点と該装置本体側の接点とを重ね合わせ方向に付勢状態で当接させる付勢部材を備えているものである。 The first aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, the base member having a bottom wall fixed to the adhesive sheet, and the device main body attached to the base member based on a fitting action to the device main body. A fitting peripheral wall is provided to hold the base member in an overlapping state, and a connector portion is provided between the base member and the main body of the device, and the connector portion is comprised of contacts that are electrically connected by contact in the mutual overlapping direction. The plurality of measurement electrodes are electrically connected to the electric circuit on the device main body side through the connector portion, and the contacts on the base member side and the contacts on the device main body side are connected in the connector portion. The device is equipped with a biasing member that urges the two to contact each other in the stacking direction.
 本態様によれば、ベース部材に対して装置本体が着脱可能とされており、且つ、付勢部材により、ベース部材側の接点と装置本体側の接点とが重ね合わせ方向において付勢された状態で当接する。これにより、ベース部材側の接点と装置本体側の接点との導通状態の維持と安定化が図られ得る。また、ベース部材と装置本体との嵌合周壁による組付構造によって、電気的接点が配されるベース部材と装置本体との間における防水性能の向上を図ることも容易となる。 According to this aspect, the device main body is removable from the base member, and the contact point on the base member side and the contact point on the device main body side are urged in the overlapping direction by the biasing member. contact with. Thereby, it is possible to maintain and stabilize the conduction state between the contact point on the base member side and the contact point on the device main body side. Moreover, the assembly structure of the base member and the device main body using the fitting peripheral wall makes it easy to improve the waterproof performance between the base member where electrical contacts are arranged and the device main body.
 第2の態様は、前記第1の態様に係る心電計において、前記付勢部材が、前記コネクタ部の前記ベース部材側と前記装置本体側との少なくとも一方に設けられて、前記ベース部材側の接点と前記装置本体側の接点とを重ね合わせ方向で付勢する弾性部材によって構成されているものである。 In a second aspect of the electrocardiograph according to the first aspect, the biasing member is provided on at least one of the base member side and the device main body side of the connector portion, and the biasing member is provided on the base member side of the connector portion. It is constituted by an elastic member that biases the contact point on the device main body side and the contact point on the device main body side in the overlapping direction.
 本態様によれば、弾性部材により付勢部材が構成されており、弾性部材における弾性的な復元力を、ベース側部材側の接点と装置本体側の接点とを重ね合わせた状態で付勢する付勢力として利用することができる。特に、コネクタ部において弾性部材として導電ゴムを採用することで、例えば機械的な通電用コネクタを採用する場合に比べて、ベース部材と装置本体との組付構造体における軽量化や小型化が達成されて、着用感の低減が図られる。 According to this aspect, the biasing member is constituted by the elastic member, and the elastic restoring force in the elastic member is biased in a state where the contact point on the base side member side and the contact point on the device main body side are overlapped. It can be used as a biasing force. In particular, by using conductive rubber as an elastic member in the connector part, the assembly structure between the base member and the device main body can be made lighter and smaller than, for example, when using a mechanical electrical connector. This reduces the feeling of wearing.
 第3の態様は、前記第1又は第2の態様に係る心電計において、前記ベース部材の前記底壁の内面において、該底壁の内面から前記コネクタ部に向けて突出する接点支持部が設けられているものである。 In a third aspect, in the electrocardiograph according to the first or second aspect, a contact support portion protruding from the inner surface of the bottom wall toward the connector portion is provided on the inner surface of the bottom wall of the base member. It is provided.
 本態様によれば、ベース部材の底壁の内面に接点支持部が設けられることから、接点支持部の分だけベース部材と装置本体とを接近させることができて、ベース部材側の接点と装置本体側の接点とをより大きな付勢力をもって当接させることもできる。例えば、前記第2の態様と組み合わせることで、弾性部材における復元力を、接点間の付勢力として一層効率的に利用することも可能になる。 According to this aspect, since the contact support portion is provided on the inner surface of the bottom wall of the base member, the base member and the device main body can be brought closer to each other by the amount of the contact support portion, and the contact point on the base member side and the device body can be brought closer to each other by the contact support portion. It is also possible to make contact with the contact point on the main body side with a larger urging force. For example, in combination with the second aspect, the restoring force in the elastic member can be used more efficiently as an urging force between the contacts.
 第4の態様は、人体に装着されて心電図情報を送信及び/又は記録する心電計であって、人体の皮膚に貼着される貼着シートと、該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、該貼着シートの外面に設けられたベース部材と、該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、該装置本体には、電気回路基板と給電用のバッテリとが収容状態で組み付けられており、且つ、該バッテリを位置決めするバッテリホルダ部が、該電気回路基板が重ね合わされる該装置本体の筐体の内面に設けられているものである。 A fourth aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, in which an electric circuit board and a power supply battery are housed and assembled in the device main body, and a battery holder portion for positioning the battery is attached to the electric circuit. It is provided on the inner surface of the casing of the main body of the device on which the substrates are stacked.
 本態様によれば、バッテリを位置決めするバッテリホルダ部が装置本体の筐体の内面に設けられることから、例えばバッテリホルダ部を電気回路基板に設ける場合に比べて、バッテリホルダ部を容易に形成することができて、構造の簡略化やバッテリの着脱の容易化を図ることができる。 According to this aspect, since the battery holder portion for positioning the battery is provided on the inner surface of the casing of the device main body, the battery holder portion can be formed more easily than, for example, when the battery holder portion is provided on the electric circuit board. As a result, the structure can be simplified and the battery can be easily attached and detached.
 第5の態様は、前記第4の態様に係る心電計において、前記バッテリがボタン電池により構成されていると共に、前記装置本体の前記筐体は、底部材と蓋部材とが重ね合わされて相互に固定されることにより、前記電気回路基板と前記ボタン電池の収容スペースが重ね合わせ面間に形成されるようになっており、該底部材と該蓋部材の一方の内面に前記バッテリホルダ部が設けられて、該バッテリホルダ部に配された前記ボタン電池に対して前記電気回路基板が重ね合わされ、該底部材と該蓋部材とが相互に固定されることにより該電気回路基板に設けられた両極の接点が該ボタン電池への当接状態にそれぞれ保持されるようになっていると共に、該底部材と該蓋部材とを開くことで該電気回路基板と該ボタン電池が該筐体から取出可能とされているものである。 In a fifth aspect, in the electrocardiograph according to the fourth aspect, the battery is constituted by a button battery, and the casing of the device main body has a bottom member and a lid member overlapped with each other. By being fixed to the button battery, a housing space for the electric circuit board and the button battery is formed between the overlapping surfaces, and the battery holder portion is provided on the inner surface of one of the bottom member and the lid member. and the electric circuit board is superimposed on the button battery arranged in the battery holder part, and the bottom member and the lid member are fixed to each other, so that the electric circuit board is provided on the electric circuit board. The contacts of both poles are held in contact with the button battery, and the electric circuit board and the button battery are removed from the housing by opening the bottom member and the lid member. It is considered possible.
 本態様によれば、装置本体の筐体が底部材と蓋部材とを含んで構成されており、これら底部材と蓋部材との間に電気回路基板とボタン電池が収容されると共に、底部材と蓋部材とを開くことで電気回路基板とボタン電池が取出可能とされている。それ故、ベース部材から装置本体を取り外して底部材と蓋部材とを開くことで、電気回路基板やボタン電池の交換を容易に行うことができる。 According to this aspect, the casing of the device main body is configured to include a bottom member and a lid member, and the electric circuit board and the button battery are housed between the bottom member and the lid member, and the bottom member The electric circuit board and button battery can be taken out by opening the lid member. Therefore, by removing the device body from the base member and opening the bottom member and lid member, the electric circuit board and button battery can be easily replaced.
 第6の態様は、人体に装着されて心電図情報を送信及び/又は記録する心電計であって、人体の皮膚に貼着される貼着シートと、該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、該貼着シートの外面に設けられたベース部材と、該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、前記貼着シートには前記測定電極が3つ設けられており、該貼着シートの左右方向略中央で上下方向下部に偏倚して設定された該装置本体の装着部位の中心から、左右の第一及び第二の測定電極の各中心が左右のそれぞれ斜め上方となるように位置設定されていると共に、第三の測定電極が該装置本体の装着部位から上方に位置設定されているものである。 A sixth aspect is an electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information, and includes an adhesive sheet that is attached to the skin of the human body, and a A plurality of measurement electrodes overlapped on the skin, a base member provided on the outer surface of the adhesive sheet, and a base member that is removably attached to the base member to transmit and transmit electrocardiogram information based on the potential detected by the measurement electrodes. and/or a recording device main body, wherein the adhesive sheet is provided with three of the measurement electrodes, and the device is set to be offset toward the bottom in the vertical direction at approximately the center in the left-right direction of the adhesive sheet. The respective centers of the first and second measurement electrodes on the left and right are positioned diagonally upward from the center of the attachment site of the main body, and the third measurement electrode is positioned diagonally upward from the center of the attachment site of the device body. The position is set above from .
 本態様によれば、貼着シートには3つの測定電極が設けられており、装置本体の中心がそれぞれの測定電極の中心よりも下方に設けられている。それ故、心電計の重心を、3つの測定電極をそれぞれ中心として全体的に広がる貼着シートの貼着面において下方に偏倚させることができて、例えば心電計の重心がより上方に位置する場合に比べて、心電計の装着状態の安定化を図り得て、意図しない人体の皮膚からの貼着シートの剥がれを抑えることができる。 According to this aspect, the adhesive sheet is provided with three measurement electrodes, and the center of the device body is provided below the center of each measurement electrode. Therefore, the center of gravity of the electrocardiograph can be biased downward on the adhesive surface of the adhesive sheet that spreads over the entire area around the three measurement electrodes, for example, the center of gravity of the electrocardiograph can be positioned higher. Compared to the case where the electrocardiograph is attached, the state in which the electrocardiograph is attached can be stabilized, and unintended peeling of the adhesive sheet from the skin of the human body can be suppressed.
 第7の態様は、前記第6の態様に係る心電計において、前記貼着シートが、下側の周縁部分に比して、上側の周縁部分が曲率半径の小さい湾曲形状とされていると共に、前記装置本体の装着部位の中心から該貼着シートの外縁までの最短位置が該装置本体の下方に設定されており、且つ、該貼着シートの左右方向の幅寸法が最大とされた位置よりも下方に偏倚して該装置本体の装着部位の中心が設定されているものである。 A seventh aspect of the electrocardiograph according to the sixth aspect is that the adhesive sheet has a curved shape in which an upper peripheral edge portion has a smaller radius of curvature than a lower peripheral edge portion. , the shortest position from the center of the attachment part of the device main body to the outer edge of the adhesive sheet is set below the device main body, and the position where the horizontal width dimension of the adhesive sheet is maximum The center of the attachment site of the device body is set to be biased downward.
 本態様によれば、例えば貼着シートの上下方向が人体の正立位で略鉛直上下方向となる装着状態を想定すると、貼着シートの貼着面が、装置本体の上方に位置することで装置本体を吊り下げるように広がる形態をもって設けられることとなり、貼着シートによる装置本体の安定した貼着状態の更なる向上が図られ得る。 According to this aspect, for example, assuming that the adhesive sheet is worn in a state where the vertical direction is approximately vertical when the human body is standing upright, the adhesive surface of the adhesive sheet is positioned above the main body of the device. Since the device body is provided in a form that spreads out so as to hang the device body, it is possible to further improve the stable adhesion state of the device body by the adhesive sheet.
 第8の態様は、患者の人体に装着されて心電図情報を送信及び/又は記録する心電計であって、人体の皮膚に貼着される貼着シートと、該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、該貼着シートの外面に設けられたベース部材と、該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、該装置本体には、該装置本体と該測定電極との間及び/又は該測定電極と該人体の皮膚との間の電気的導通性の異常の発生を検出するリードオフ検出機構が設けられており、該リードオフ検出機構により検出される電気的導通性の異常の発生を前記患者へ報知する報知手段を備えているものである。 An eighth aspect is an electrocardiograph that is attached to a patient's body to transmit and/or record electrocardiogram information, which includes an adhesive sheet that is attached to the skin of the human body, and an adhesive sheet provided on the adhesive sheet. A plurality of measurement electrodes are superimposed on the skin of a human body, a base member is provided on the outer surface of the adhesive sheet, and the adhesive sheet is removably attached to the base member, and electrocardiogram information based on the detected potential by the measurement electrodes is provided. a transmitting and/or recording device main body; A lead-off detection mechanism is provided to detect the occurrence of abnormality in electrical conductivity detected by the lead-off detection mechanism.
 本態様によれば、測定電極により活動電位を検出するに際して電気的導通性に異常が発生した場合、例えば測定電極が皮膚から剥がれたり、装置本体と測定電極とを接続するリード線等が切断した場合には、その電気的導通性の異常の発生がリードオフ検出機構により検出されるようになっている。特に、リードオフ検出機構により検出された電気的導通性の異常の発生が、報知手段により心電計を装着する患者自身に報知されることから、患者が異常の発生を確認した時点で皮膚に測定電極を貼り直したり、医療機関に赴く等して異常を解消することができる。即ち、本態様に係る心電計は、例えば数日から数週間の長期間にわたって装着されて測定が行われることから、患者自身が異常の発生を確認することで、より速やかに異常を解消することも可能であり、測定不能とされる期間を短縮して、測定し直しによる診断の遅れを回避したり、より長期間にわたる心電計の装着に伴う患者の負担等を軽減することができる。 According to this aspect, if an abnormality occurs in electrical conductivity when detecting an action potential with the measurement electrode, for example, the measurement electrode may be peeled off from the skin, or the lead wire connecting the device body and the measurement electrode may be severed. In this case, the occurrence of an abnormality in electrical continuity is detected by a lead-off detection mechanism. In particular, since the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism is notified to the patient wearing the electrocardiograph by the notification means, the moment the patient confirms that an abnormality has occurred, The abnormality can be corrected by reattaching the measurement electrode or going to a medical institution. That is, since the electrocardiograph according to this embodiment is worn for a long period of time, for example, several days to several weeks, and measurements are taken, the abnormality can be resolved more quickly by allowing the patient to confirm the occurrence of the abnormality. It is also possible to shorten the period during which measurements are not possible, avoid delays in diagnosis due to re-measurement, and reduce the burden on patients associated with wearing an electrocardiograph for a longer period of time. .
 本発明によれば、従来構造の心電計に対して少なくとも1つの改善点を提供し得る、新規な心電計が実現可能になる。 According to the present invention, it is possible to realize a novel electrocardiograph that can provide at least one improvement over electrocardiographs of conventional structure.
本発明の1実施形態としての心電計を示す正面図A front view showing an electrocardiograph as an embodiment of the present invention 図1におけるII-II断面を拡大して示す縦断面図A vertical cross-sectional view showing an enlarged view of the II-II cross section in FIG. 図1に示された心電計において装置本体を取り外した状態を示す平面図A plan view showing the electrocardiograph shown in Figure 1 with the main body of the device removed. 図1に示された心電計の要部を分解して示す分解斜視図An exploded perspective view showing the main parts of the electrocardiograph shown in Figure 1 図1に示された心電計においてリードオフ検出機構を構成するLEDランプの点灯状態を説明するための説明図であって、(a)が第一点灯領域と第二点灯領域の両方が点灯している状態を示す図であり、(b)が第二点灯領域のみが点灯している状態を示す図FIG. 2 is an explanatory diagram for explaining the lighting state of the LED lamps constituting the lead-off detection mechanism in the electrocardiograph shown in FIG. 1, in which (a) both the first lighting area and the second lighting area are lit; (b) is a diagram showing a state in which only the second lighting area is lit; 図1に示された心電計を構成する装置本体の内部構造を示す分解斜視図An exploded perspective view showing the internal structure of the device main body that constitutes the electrocardiograph shown in Figure 1. 図1に示された心電計を人体に装着した状態の一例を示す正面図A front view showing an example of the state in which the electrocardiograph shown in Figure 1 is attached to a human body.
 以下、本発明の実施形態について、図面を参照しつつ説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
 図1,2には、本発明の1実施形態としての心電計10が示されている。この心電計10は、後述する図7に示されるように患者の人体Aに装着されて、例えば数日や数週間の長期間にわたって心電図情報を装置外部へ送信したり装置内部へ記録するものである。なお、心電計10において人体Aに装着される向きは限定されるものではないが、以下の説明において、上下方向とは図1中の上下方向、左右方向とは図1中の左右方向、前後方向とは図2中の上下方向(シート厚さ方向)をいう。 1 and 2 show an electrocardiograph 10 as one embodiment of the present invention. This electrocardiograph 10 is attached to a patient's body A as shown in FIG. 7, which will be described later, and transmits electrocardiogram information to the outside of the device or records it inside the device over a long period of time, for example, several days or weeks. It is. Note that the direction in which the electrocardiograph 10 is attached to the human body A is not limited, but in the following description, the up-down direction refers to the up-down direction in FIG. 1, and the left-right direction refers to the left-right direction in FIG. The front-rear direction refers to the up-down direction (sheet thickness direction) in FIG.
 より詳細には、心電計10は、人体Aの皮膚a(図7参照)に貼着される貼着シート12と、貼着シート12の後面(裏面)に設けられて人体Aの皮膚aに導通される複数の測定電極14と、貼着シート12の前面(表面となる外面)に設けられたベース部材16と、ベース部材16に対して着脱可能とされる装置本体18とを、含んでいる。 More specifically, the electrocardiograph 10 includes an adhesive sheet 12 that is adhered to the skin a of the human body A (see FIG. 7), and an adhesive sheet 12 that is provided on the rear surface (back side) of the adhesive sheet 12 and that is attached to the skin a of the human body A (see FIG. 7). The device includes a plurality of measurement electrodes 14 that are electrically connected to each other, a base member 16 provided on the front surface (outer surface serving as the front surface) of the adhesive sheet 12, and a device main body 18 that is removably attached to the base member 16. I'm here.
 貼着シート12の形状は限定されるものではないが、本実施形態では、図1等に示される平面視(正面図)において、全体として上下方向寸法より左右方向寸法の方が大きくされた略楕円状であり、特に本実施形態では、下側の周縁部分に比して上側の周縁部分が曲率半径の小さい湾曲形状とされて略おむすび形状(角丸の丸みを帯びた三角状)となっている。また、本実施形態の貼着シート12の後面には、各測定電極14の周りを囲むように広がる薄肉環状の保護シート22が重ね合わせ状態で固着されている。 Although the shape of the adhesive sheet 12 is not limited, in this embodiment, the shape is generally larger in the horizontal direction than in the vertical direction in a plan view (front view) shown in FIG. It has an elliptical shape, and in particular in this embodiment, the upper peripheral edge portion is curved with a smaller radius of curvature than the lower peripheral edge portion, resulting in an approximately rice ball shape (triangular shape with rounded corners). ing. Furthermore, a thin annular protection sheet 22 that extends around each measurement electrode 14 is adhered to the rear surface of the adhesive sheet 12 in this embodiment in an overlapping state.
 貼着シート12と保護シート22は、何れも電気絶縁性を有しており、例えばポリウレタン等の軟質の合成樹脂により形成されて、人体Aの皮膚表面に沿って柔軟に変形可能とされている。なお、貼着シート12は、例えば各測定電極14の位置を把握し易くするために、無色透明又は有色透明とされることが好ましい。或いは、心電計10の装着状態を他者に気付かれにくくするために、貼着シート12を肌色としてもよい。また、保護シート22を、貼着シート12に比して硬質や厚肉にしたり着色等することで、貼着シート12の外面から保護シート22の中心に位置する測定電極14の位置を、目視や接触で確認容易にすることもできるし、保護シート22の前面に測定電極14の位置を示す着色等の目印を設けてもよい。 Both the adhesive sheet 12 and the protective sheet 22 have electrical insulation properties, are made of soft synthetic resin such as polyurethane, and can be flexibly deformed along the skin surface of the human body A. . Note that the adhesive sheet 12 is preferably colorless and transparent or colored and transparent, for example, in order to make it easier to grasp the position of each measurement electrode 14. Alternatively, in order to make it difficult for others to notice that the electrocardiograph 10 is being worn, the adhesive sheet 12 may be skin-colored. In addition, by making the protective sheet 22 harder, thicker, or colored than the adhesive sheet 12, the position of the measurement electrode 14 located at the center of the protective sheet 22 can be visually checked from the outer surface of the adhesive sheet 12. It is also possible to make the confirmation easier by touching or contacting the measuring electrode 14, or a mark such as a color indicating the position of the measuring electrode 14 may be provided on the front surface of the protective sheet 22.
 なお、図2に示される心電計10では、分かり易さのために、いくつかの部材の厚さ寸法を誇張して示している。貼着シート12と保護シート22の固着方法は限定されるものではないが、例えば接着や溶着等により固着され得る。後述するように、貼着シート12の後面は、粘着剤からなる粘着層24を介して皮膚aへ貼り付けられる貼着面26とされている。図1において灰色で着色した領域が、貼着面26において粘着剤が塗布された粘着層24である。また、図1等に示されるように、使用前の初期状態では、貼着シート12の貼着面26に、粘着層24を介して剥離ライナー28が剥離可能に貼り付けられている。なお、保護シート22の裏面にも粘着層24が設けられてもよい。 Note that in the electrocardiograph 10 shown in FIG. 2, the thickness dimensions of some members are exaggerated for ease of understanding. The method of fixing the adhesive sheet 12 and the protective sheet 22 is not limited, but may be fixed by, for example, adhesion or welding. As will be described later, the rear surface of the adhesive sheet 12 is an adhesive surface 26 that is applied to the skin a via an adhesive layer 24 made of an adhesive. The area colored gray in FIG. 1 is the adhesive layer 24 on the adhesive surface 26 to which the adhesive is applied. Further, as shown in FIG. 1 and the like, in the initial state before use, a release liner 28 is releasably attached to the adhesive surface 26 of the adhesive sheet 12 via the adhesive layer 24. Note that the adhesive layer 24 may also be provided on the back surface of the protective sheet 22.
 そして、各保護シート22の中央に設けられた円形の貫通孔30には、略中心に位置して測定電極14が配されている。測定電極14の前面は貼着シート12で覆われており、測定電極14の後面が後方に向けて露出されていることにより、保護シート22を人体Aの皮膚表面に貼り付けて心電計10を人体Aに装着した際には、各測定電極14が、人体Aの皮膚aに重ね合わされて導通されるようになっている。各測定電極14は、図示しない導電性ゲルを介して人体Aの皮膚aに重ね合わされてもよい。 In a circular through hole 30 provided in the center of each protective sheet 22, a measuring electrode 14 is arranged approximately at the center. The front surface of the measurement electrode 14 is covered with an adhesive sheet 12, and the rear surface of the measurement electrode 14 is exposed toward the rear, so that the electrocardiograph 10 can be attached to the skin surface of the human body A by attaching the protective sheet 22 to the skin surface of the human body A. When attached to the human body A, each measurement electrode 14 is superimposed on the skin a of the human body A and is electrically conductive. Each measurement electrode 14 may be superimposed on the skin a of the human body A via a conductive gel (not shown).
 本実施形態では、3つの測定電極14(第一~第三の測定電極14a~14c)が設けられている。各測定電極14a~14cとしては、従来公知の心電図測定用の電極が採用され得る。また、各測定電極14にはリード線32(第一~第三のリード線32a~32c)が接続されている。各リード線32a~32cは相互に独立して配線されており、それぞれ各測定電極14からベース部材16に向かって延びている。 In this embodiment, three measurement electrodes 14 (first to third measurement electrodes 14a to 14c) are provided. As each of the measurement electrodes 14a to 14c, conventionally known electrocardiogram measurement electrodes may be employed. Further, each measurement electrode 14 is connected to a lead wire 32 (first to third lead wires 32a to 32c). The lead wires 32a to 32c are wired independently from each other, and each extends from each measurement electrode 14 toward the base member 16.
 各リード線32は、前面が貼着シート12で覆われていると共に、後面が保護シート22で覆われており、外部に対して絶縁被覆されている。各リード線32は、測定電極14と反対側の端部において、ベース部材16の底部略中央に位置するように集められ、図2に示されているように、貼着シート12に設けられた通電窓33を通じて、ベース部材16との対向面(前面)において露出されている。 Each lead wire 32 has its front surface covered with the adhesive sheet 12 and its rear surface covered with the protective sheet 22, and is insulated from the outside. Each lead wire 32 is gathered at the end opposite to the measurement electrode 14 so as to be located approximately at the bottom center of the base member 16, and is provided on the adhesive sheet 12 as shown in FIG. The surface facing the base member 16 (front surface) is exposed through the current-carrying window 33 .
 かかる通電窓33内では、互いに独立したリード線32a,32b,32cに対して、それぞれ通電線34a,34b,34cが導通されて接続されている。これらの通電線34a~34cは、柔軟な絶縁シートに積層されて、全体として1つのFFC(フレキシブルフラットケーブル)36を構成している。そして、かかるFFC36は、各測定電極14に導通された通電線34a~34cが、貼着シート12の前面から外部に引き出されている。 Within the current-carrying window 33, current-carrying wires 34a, 34b, and 34c are electrically connected to mutually independent lead wires 32a, 32b, and 32c, respectively. These current-carrying wires 34a to 34c are laminated on a flexible insulating sheet to constitute one FFC (flexible flat cable) 36 as a whole. In the FFC 36, current-carrying wires 34a to 34c connected to each measurement electrode 14 are drawn out from the front surface of the adhesive sheet 12.
 貼着シート12の表面である外面(前面)には、ベース部材16が設けられており、貼着シート12の通電窓33を前方から覆っている。図3にも示されるように、平面視においてベース部材16は略角丸の矩形状とされている。ベース部材16は、例えば弾性変形可能な軟質の合成樹脂により形成される弾性部材である。ベース部材16は、略角丸矩形状の底壁38を備えていると共に、底壁38の外周縁部からは前方に向かって嵌合周壁40が突出している。嵌合周壁40は、周方向の全周にわたって連続して設けられていると共に、嵌合周壁40の突出端部(前端部)には、内周側に突出する係合爪42が設けられている。嵌合周壁40は、底壁38に対して比較的薄肉に形成されており、突出方向(前後方向)と直交する方向(例えば上下方向や左右方向)で弾性変形可能とされている。なお、係合爪42は全周にわたって連続して設けられていることが望ましい。 A base member 16 is provided on the outer surface (front surface) of the adhesive sheet 12, and covers the current-carrying window 33 of the adhesive sheet 12 from the front. As shown in FIG. 3, the base member 16 has a substantially rectangular shape with rounded corners when viewed from above. The base member 16 is an elastic member made of, for example, elastically deformable soft synthetic resin. The base member 16 includes a bottom wall 38 having a substantially rounded rectangular shape, and a fitting peripheral wall 40 protrudes forward from the outer peripheral edge of the bottom wall 38 . The fitting circumferential wall 40 is provided continuously over the entire circumference in the circumferential direction, and an engaging claw 42 that protrudes inward is provided at the protruding end (front end) of the fitting circumferential wall 40. There is. The fitting peripheral wall 40 is formed to be relatively thin with respect to the bottom wall 38, and can be elastically deformed in a direction (for example, an up-down direction or a left-right direction) orthogonal to the protruding direction (front-back direction). Note that it is desirable that the engaging claws 42 are provided continuously over the entire circumference.
 また、底壁38の略中央部分には、底壁38を厚さ方向(前後方向)で貫通する略スリット状の挿通孔44が設けられていると共に、底壁38の左方部分には、上下方向で相互に離隔する2つのねじ孔46,46が設けられている。 Further, a substantially slit-shaped insertion hole 44 that penetrates the bottom wall 38 in the thickness direction (front-back direction) is provided in the substantially central portion of the bottom wall 38, and a substantially slit-shaped insertion hole 44 is provided in the left portion of the bottom wall 38. Two screw holes 46, 46 are provided which are spaced apart from each other in the vertical direction.
 さらに、底壁38の内面(前面)には、後述するコネクタ部108に向けて前方に突出する接点支持部が設けられている。本実施形態では、図4等にも示されるように、接点支持部が略矩形板状の補強板48により構成されている。補強板48は、金属や合成樹脂等からなる硬質の部材であり、本実施形態では、ポリエチレンテレフタレート(PET)により形成されている。また、補強板48における左端部分には、上下方向で相互に離隔する2つのねじ孔49,49が設けられている。これらねじ孔49,49は、底壁38におけるねじ孔46,46と対応する位置に形成されている。また、本実施形態では、補強板48が、防水両面テープ50により底壁38の内面に貼り付けられている。この防水両面テープ50及び後述する防水両面テープ78は、例えば基材の両面に粘着層又は接着層が重ね合わされた構造とされており、十分薄く柔軟である。そして、防水両面テープ50,78は、粘着層又は接着層により厚さ方向(前後方向)での弾性を有する弾性部材である。 Further, on the inner surface (front surface) of the bottom wall 38, a contact support portion is provided that protrudes forward toward a connector portion 108, which will be described later. In this embodiment, as shown in FIG. 4 and the like, the contact support portion is constituted by a substantially rectangular reinforcing plate 48. The reinforcing plate 48 is a hard member made of metal, synthetic resin, or the like, and in this embodiment is made of polyethylene terephthalate (PET). Furthermore, two screw holes 49, 49 are provided at the left end portion of the reinforcing plate 48, which are spaced apart from each other in the vertical direction. These screw holes 49, 49 are formed at positions corresponding to the screw holes 46, 46 in the bottom wall 38. Further, in this embodiment, the reinforcing plate 48 is attached to the inner surface of the bottom wall 38 with a waterproof double-sided tape 50. This waterproof double-sided tape 50 and the waterproof double-sided tape 78 described later have a structure in which, for example, adhesive layers or adhesive layers are laminated on both sides of a base material, and are sufficiently thin and flexible. The waterproof double- sided tapes 50 and 78 are elastic members that have elasticity in the thickness direction (back and forth direction) due to the adhesive layer or adhesive layer.
 なお、本実施形態のベース部材16には、底壁38の内面に開口する浅底の凹部52が設けられており、当該凹部52の底面(底壁38の内面)に補強板48が貼り付けられて、補強板48が凹部52内に収容配置されている。即ち、凹部52によって薄肉化された、凹部52の形成部分における底壁38が、かかる補強板48によって補強されている。尤も、かかる補強板48は必須でなく、例えば底壁38の内面に接点支持部(補強板48)を一体成形等によって形成して補強等してもよい。また、凹部52自体も必須ではなく、後述するFFC36における接点部分を安定支持し得るものであればよい。 The base member 16 of this embodiment is provided with a shallow recess 52 that opens on the inner surface of the bottom wall 38, and the reinforcing plate 48 is attached to the bottom surface of the recess 52 (inner surface of the bottom wall 38). The reinforcing plate 48 is housed in the recess 52. That is, the bottom wall 38 in the portion where the recess 52 is formed, which is thinned by the recess 52, is reinforced by the reinforcing plate 48. However, such a reinforcing plate 48 is not essential, and for example, a contact support portion (reinforcing plate 48) may be formed on the inner surface of the bottom wall 38 by integral molding or the like to provide reinforcement. Furthermore, the recess 52 itself is not essential as long as it can stably support a contact portion in the FFC 36, which will be described later.
 また、本実施形態では、底壁38の略中央部分に設けられている挿通孔44が、凹部52の底面の略中央で且つ補強板48を僅かに外れた位置に開口している。かかる挿通孔44は、貼着シート12の通電窓33上に位置しており、通電窓33を通じて貼着シート12の外部に引き出されたFFC36が、挿通孔44を通じて、ベース部材16の内部へ差し入れられている。そして、図3にも示されるように、通電線34a~34cを有するFFC36は、折り返されるようにして延び出した先端側が、ベース部材16の底面上において補強板48の上に重ね合わされている。 Further, in this embodiment, the insertion hole 44 provided in the substantially central portion of the bottom wall 38 opens at a position substantially in the center of the bottom surface of the recess 52 and slightly outside the reinforcing plate 48 . The insertion hole 44 is located above the current-carrying window 33 of the adhesive sheet 12, and the FFC 36 drawn out of the adhesive sheet 12 through the current-carrying window 33 is inserted into the base member 16 through the insertion hole 44. It is being As shown in FIG. 3, the FFC 36 having the current-carrying wires 34a to 34c has its folded and extended end side superimposed on the reinforcing plate 48 on the bottom surface of the base member 16.
 なお、ベース部材16の底壁38は、貼着シート12の前面に重ね合わされて固着されている。貼着シート12と底壁38との固着の方法は限定されるものではなく、例えば接着や溶着等によってなされ得る。 Note that the bottom wall 38 of the base member 16 is superposed and fixed to the front surface of the adhesive sheet 12. The method of fixing the adhesive sheet 12 and the bottom wall 38 is not limited, and may be achieved by, for example, adhesion or welding.
 本実施形態では、貼着シート12において、左右方向の略中央、且つ上下方向で下部に偏倚した位置にベース部材16(及びベース部材16に取り付けられる装置本体18)の装着部位(図1に示される平面視においてベース部材16及び装置本体18に重なる領域)が設けられている。そして、貼着シート12において、ベース部材16(装置本体18)の装着部位の中心(図1中の点C)から、3つの測定電極14のうちの2つ(第一及び第二の測定電極14a,14b)の各中心が、左右のそれぞれ斜め上方となるように位置設定されている。また、ベース部材16(装置本体18)の装着部位の中心から、3つの測定電極14の残りの1つ(第三の測定電極14c)の中心が、上方となるように位置設定されている。なお、限定されるものではないが、例えば左側の第一の測定電極14aが-極の関電極とされて、右側の第二の測定電極14bが+極の関電極とされる。また、真ん中の第三の測定電極14cが不関電極とされる。 In the present embodiment, in the adhesive sheet 12, the base member 16 (and the device body 18 attached to the base member 16) is attached to the attachment site (as shown in FIG. A region that overlaps the base member 16 and the device main body 18 in a plan view is provided. Then, on the adhesive sheet 12, two of the three measurement electrodes 14 (the first and second measurement electrodes 14a, 14b) are positioned so that their respective centers are diagonally upward on the left and right sides. Further, the center of the remaining one of the three measurement electrodes 14 (third measurement electrode 14c) is positioned upward from the center of the attachment site of the base member 16 (device main body 18). Note that, although not limited to this, for example, the first measurement electrode 14a on the left side is used as a negative electrode, and the second measurement electrode 14b on the right side is used as a positive electrode. Further, the third measurement electrode 14c in the middle is an indifferent electrode.
 特に、本実施形態では、ベース部材16(装置本体18)の装着部位が上下方向で下方に偏倚していることに加えて、貼着シート12において下側の周縁部分の曲率半径が上側の周縁部分の曲率半径より大きくされていることから、ベース部材16(装置本体18)の装着部位の中心Cから貼着シート12の外縁までの最短位置がベース部材16(装置本体18)の下方に設定されている。そして、ベース部材16(装置本体18)の装着部位の中心Cが、貼着シート12の左右方向の幅寸法が最大とされた位置(本実施形態では、図1において第一の測定電極14aと第二の測定電極14bの各中心をつないで左右に延びる直線と略等しい位置)よりも下方に偏倚して設定されている。 Particularly, in this embodiment, in addition to the fact that the mounting portion of the base member 16 (apparatus main body 18) is biased downward in the vertical direction, the radius of curvature of the lower peripheral edge portion of the adhesive sheet 12 is smaller than that of the upper peripheral edge. Since the radius of curvature is larger than the radius of curvature of the base member 16 (apparatus main body 18), the shortest position from the center C of the installation site of the base member 16 (apparatus main body 18) to the outer edge of the adhesive sheet 12 is set below the base member 16 (apparatus main body 18). has been done. Then, the center C of the attachment part of the base member 16 (apparatus main body 18) is located at the position where the horizontal width dimension of the adhesive sheet 12 is the maximum (in this embodiment, the first measurement electrode 14a in FIG. The second measurement electrode 14b is set so as to be offset downward from a position approximately equal to a straight line connecting the centers of the second measurement electrodes 14b and extending left and right.
 ベース部材16に対して着脱可能とされる装置本体18は、図2や図4に示されるように、底部材54と蓋部材56とが重ね合わされて相互に固定されることからなる中空の筐体58を備えている。底部材54及び蓋部材56は、例えば硬質の合成樹脂により形成されて、これらの重ね合わせ面間に形成される筐体58の内部空間は、心電計10の作動制御装置と記憶装置を含む電気回路基板60と、給電用のバッテリが収容状態で組み付けられる収容スペース64とされている。本実施形態では、バッテリが、ボタン電池62により構成されている。電気回路基板60には、CPUやメモリ等の電子部品が実装されており、各測定電極14a~14cにより検出された検出電位に基づく心電図情報を記録することができるようになっている。 As shown in FIGS. 2 and 4, the device main body 18, which is removably attachable to the base member 16, is a hollow casing consisting of a bottom member 54 and a lid member 56 that are overlapped and fixed to each other. It has a body 58. The bottom member 54 and the lid member 56 are made of, for example, hard synthetic resin, and the internal space of the casing 58 formed between these overlapping surfaces contains an operation control device and a storage device for the electrocardiograph 10. It is a housing space 64 in which an electric circuit board 60 and a power supply battery are assembled in a housed state. In this embodiment, the battery is constituted by a button battery 62. Electronic components such as a CPU and a memory are mounted on the electric circuit board 60, and electrocardiogram information based on the detected potentials detected by each of the measurement electrodes 14a to 14c can be recorded.
 また、電気回路基板60に実装される電子部品として、図示しないLEDランプを採用してもよく、例えば電源ON時や無線通信接続時、電極が外れた時など、心電計10の状態に応じて、異なる色のLEDランプが点灯(常時点灯や点滅を含む)するようになっていてもよい。本実施形態では、心電計10の右方部分において上下方向で相互に離隔して2つのLEDランプが設けられており、即ち、心電計10は、図5(a)に二点鎖線で示されるように、各LEDランプが点灯する第一点灯領域65aと第二点灯領域65bとを備えている。これら第一及び第二点灯領域65a,65bにおけるLEDランプの点灯は、例えば装置本体18の筐体58の少なくとも一部を透明(無色又は有色を含む)とすることで外部から視認することが可能であり、例えば蓋部材56に設けられる後述する軟質部材96が透明とされてもよい。 Further, as an electronic component mounted on the electric circuit board 60, an LED lamp (not shown) may be used, and depending on the state of the electrocardiograph 10, for example, when the power is turned on, when wireless communication is connected, when an electrode is disconnected, etc. Therefore, LED lamps of different colors may be lit (including constant lighting or blinking). In this embodiment, two LED lamps are provided at the right side of the electrocardiograph 10 at a distance from each other in the vertical direction. As shown, each LED lamp includes a first lighting area 65a and a second lighting area 65b. The lighting of the LED lamps in the first and second lighting areas 65a and 65b can be visually recognized from the outside by, for example, making at least a portion of the casing 58 of the device main body 18 transparent (including colorless or colored). For example, a soft member 96, which will be described later, provided on the lid member 56 may be transparent.
 なお、本実施形態では、心電計10における電源ON時において図5(a)に示されるように、第一及び第二点灯領域65a,65bにおける両方のLEDランプが点灯すると共に、心電計10における無線通信接続時において図5(b)に示されるように、第二点灯領域65bにおけるLEDランプのみが点灯するようになっている。また、各測定電極14a~14cによる活動電位の測定に異常が発生した場合、例えば人体Aの皮膚aから各測定電極14(第一~第三の測定電極14a~14c)の何れかが剥がれたり、各リード線32(第一~第三のリード線32a~32c)及び各通電線34a~34cの何れかが断線する等した場合には、第一点灯領域65aにおけるLEDランプのみが点灯するようになっている。これにより、本実施形態では、装置本体18において、装置本体18と各測定電極14a~14cとの間及び/又は各測定電極14a~14cと人体Aの皮膚aとの間の電気的導通性の異常の発生を検出するリードオフ検出機構67aが設けられている。そして、かかるリードオフ検出機構67aにより検出される電気的導通性の異常の発生を心電計10が装着される患者に報知する報知手段67bが、電気回路基板60に実装される図示しないLEDランプを含んで構成されている。 In this embodiment, when the electrocardiograph 10 is powered on, as shown in FIG. At the time of wireless communication connection in 10, only the LED lamp in the second lighting area 65b is lit, as shown in FIG. 5(b). Further, if an abnormality occurs in the measurement of action potentials by each of the measurement electrodes 14a to 14c, for example, any of the measurement electrodes 14 (first to third measurement electrodes 14a to 14c) may be peeled off from the skin a of the human body A. , if any of the lead wires 32 (first to third lead wires 32a to 32c) and the energized wires 34a to 34c are disconnected, only the LED lamp in the first lighting area 65a is lit. It has become. As a result, in this embodiment, in the device main body 18, electrical continuity between the device main body 18 and each of the measurement electrodes 14a to 14c and/or between each of the measurement electrodes 14a to 14c and the skin a of the human body A is improved. A lead-off detection mechanism 67a is provided to detect the occurrence of an abnormality. A notification means 67b for notifying the patient to whom the electrocardiograph 10 is attached of the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism 67a is an LED lamp (not shown) mounted on the electric circuit board 60. It is composed of:
 また、心電計10の状態に応じたLEDランプの点灯態様は限定されるものではなく、リードオフ検出機構67により電気的導通性の異常の発生が検出された際に、図5(a)に示されるように第一及び第二点灯領域65a,65bにおける両方のLEDランプが点灯するようになっていてもよいし、図5(b)に示されるように第二点灯領域65bにおけるLEDランプのみが点灯するようになっていてもよい。なお、電気的導通性の異常の発生は、例えば各測定電極14a~14cにより検出される電位の値が、通常想定される活動電位に基づいて設定される所定値から外れること等によって検出されるようになっていてもよい。 Further, the lighting mode of the LED lamp according to the state of the electrocardiograph 10 is not limited, and when the lead-off detection mechanism 67 detects the occurrence of an abnormality in electrical continuity, the lighting mode shown in FIG. As shown in FIG. 5(b), both the LED lamps in the first and second lighting areas 65a and 65b may be lit, or as shown in FIG. 5(b), the LED lamps in the second lighting area 65b may be lit. It may be arranged so that only one of the two lights is lit. Incidentally, the occurrence of an abnormality in electrical conductivity is detected, for example, when the value of the potential detected by each of the measurement electrodes 14a to 14c deviates from a predetermined value set based on the normally assumed action potential. It may be as follows.
 さらに、電気回路基板60に実装される電子部品として、例えばBLE(Bluetooth Low Energy(登録商標))通信やWi‐Fi通信などの無線通信装置を備えていてもよく、無線受信器を備えるコンピュータやスマートフォン等に心電計10によって記録された心電図情報が送信可能となっていてもよいし、USBなどの有線通信装置を備えていてもよい。 Further, the electronic components mounted on the electric circuit board 60 may include, for example, a wireless communication device such as BLE (Bluetooth Low Energy (registered trademark)) communication or Wi-Fi communication, or a computer equipped with a wireless receiver or the like. The electrocardiogram information recorded by the electrocardiograph 10 may be transmitted to a smartphone or the like, or a wired communication device such as a USB may be provided.
 底部材54は、全体として略平板状の部材であり、前後方向と直交する方向に広がる平板部66を備えている。底部材54(平板部66)は平面視において、ベース部材16と略同形状の角丸矩形状であり、外周囲がベース部材16よりも一回り小さくされてベース部材16の嵌合周壁40へ嵌め入れ可能とされている。平板部66の外周縁部は厚さ寸法(前後方向寸法)が大きくされており、当該厚さ寸法が大きくされた部分の外周面には、周方向に連続して全周にわたって延びる環状の係合溝68が設けられている。また、平板部66には、厚さ方向で貫通するねじ孔70が適数個形成されている。 The bottom member 54 is a generally flat member as a whole, and includes a flat plate portion 66 that extends in a direction orthogonal to the front-rear direction. The bottom member 54 (flat plate part 66) has a rounded rectangular shape that is approximately the same shape as the base member 16 in plan view, and has an outer circumference that is slightly smaller than the base member 16 and is connected to the fitting peripheral wall 40 of the base member 16. It is said that it can be fitted. The outer peripheral edge of the flat plate part 66 has a larger thickness dimension (front-rear direction dimension), and the outer peripheral surface of the part where the thickness dimension has been increased has an annular engagement that extends continuously in the circumferential direction over the entire circumference. A matching groove 68 is provided. In addition, an appropriate number of screw holes 70 are formed in the flat plate portion 66 so as to pass through the flat plate portion 66 in the thickness direction.
 さらに、底部材54には、略矩形の挿通孔72が厚さ方向で貫通して形成されており、この挿通孔72には、導電性を有する弾性部材として導電ゴム74が挿通されている。この導電ゴム74は挿通孔72に対して、シール性を保持した状態で挿通されていることが望ましい。具体的には、例えば挿通孔72の内周面に突設したシール突条を導電ゴム74の外周面に押し付けることなどにより、導電ゴム74が挿通孔72に対して嵌合状態で挿通される。かかる導電ゴム74の厚さ方向(挿通孔72への挿通方向)の一方の端面は、電気回路基板60における電気信号の入力部分に接続されており、それによって、電気回路基板60への信号入力端子が当該導電ゴム74によって構成されている。 Further, a substantially rectangular insertion hole 72 is formed through the bottom member 54 in the thickness direction, and a conductive rubber 74 as an elastic member having conductivity is inserted into the insertion hole 72. It is desirable that the conductive rubber 74 be inserted into the insertion hole 72 while maintaining sealing properties. Specifically, the conductive rubber 74 is inserted into the insertion hole 72 in a fitted state by, for example, pressing a seal protrusion protruding from the inner peripheral surface of the insertion hole 72 against the outer peripheral surface of the conductive rubber 74. . One end surface of the conductive rubber 74 in the thickness direction (the direction of insertion into the insertion hole 72) is connected to the electrical signal input portion of the electrical circuit board 60, thereby allowing signal input to the electrical circuit board 60. A terminal is constituted by the conductive rubber 74.
 導電ゴム74の前後方向寸法は、挿通孔72の前後方向寸法より大きくされており、導電ゴム74の厚さ方向の他方の端面は、底部材54の外面(後面)から外方に向かって突出している。そして、ベース部材16に対して底部材54が嵌め込まれて、装置本体18が装着された状態下で、かかる導電ゴム74の他方の端面が、ベース部材16の補強板48に重ね合わされたFFC36に形成された通電線34a~34cに対して押し付けられて導通されるようになっている。 The longitudinal dimension of the conductive rubber 74 is larger than the longitudinal dimension of the insertion hole 72, and the other end surface of the conductive rubber 74 in the thickness direction protrudes outward from the outer surface (rear surface) of the bottom member 54. ing. Then, when the bottom member 54 is fitted into the base member 16 and the device main body 18 is attached, the other end surface of the conductive rubber 74 is placed on the FFC 36 superimposed on the reinforcing plate 48 of the base member 16. It is pressed against the formed conductive wires 34a to 34c to be electrically connected.
 なお、導電ゴム74は、3つの通電線34a~34cを、電気回路基板60上の3つの入力部分に対して、それぞれ電気的に独立して接続するようになっている。また、挿通孔72に近接した位置にねじ穴76,76が設けられており、締付ねじ77,77によって導電ゴム74の安定保持が図られている。なお、かかる締付ねじ77,77の他部材への当接や干渉を回避する目的で、ベース部材16や補強板48及び後述する防水両面テープ78にねじ孔46,49,82を形成してもよいし、それらのねじ孔46,49,82を通じて、締付ねじ77,77によってベース部材16と底部材54とを締め付けて、導電ゴム74の両端面における電気接続状態の安定性向上等を図ることも可能である。 Note that the conductive rubber 74 is configured to electrically connect the three current-carrying wires 34a to 34c to the three input portions on the electric circuit board 60, respectively. Further, screw holes 76, 76 are provided at positions close to the insertion hole 72, and the conductive rubber 74 is stably held by tightening screws 77, 77. In addition, in order to avoid the tightening screws 77, 77 from contacting or interfering with other members, screw holes 46, 49, 82 are formed in the base member 16, the reinforcing plate 48, and the waterproof double-sided tape 78 to be described later. Alternatively, the base member 16 and the bottom member 54 may be tightened with the tightening screws 77, 77 through the screw holes 46, 49, 82 to improve the stability of the electrical connection on both end surfaces of the conductive rubber 74. It is also possible to
 ここで、底部材54における後面(平板部66の後面)には、防水両面テープ78が設けられている。この防水両面テープ78は、例えば補強板48と同程度か僅かに大きい大きさとされて、略中央部分に設けられた挿通窓80を通じて、導電ゴム74の端面がFFC36が配される外方に向けて突出されている。なお、後述する装置本体18におけるベース部材16への組付時において補強板48の表面に密着して固着する防水両面テープ78は、FFC36の端部における通電線34a~34cの露出部分の周囲にも密着して固着される。これにより、導電ゴム74と通電線34a~34cとの接点部分の防水性も確保され得る。 Here, a waterproof double-sided tape 78 is provided on the rear surface of the bottom member 54 (the rear surface of the flat plate portion 66). This waterproof double-sided tape 78 is, for example, as large as or slightly larger than the reinforcing plate 48, and the end surface of the conductive rubber 74 is directed outward, where the FFC 36 is arranged, through an insertion window 80 provided at approximately the center. It stands out. Note that a waterproof double-sided tape 78 that tightly adheres to the surface of the reinforcing plate 48 when assembled to the base member 16 of the device main body 18, which will be described later, is applied around the exposed portions of the current-carrying wires 34a to 34c at the ends of the FFC 36. It is also tightly attached and fixed. Thereby, the waterproofness of the contact portions between the conductive rubber 74 and the current-carrying wires 34a to 34c can also be ensured.
 蓋部材56は、図6にも示されるように、前後方向と直交する方向に広がる上底壁86と、上底壁86の外周縁部から後方に突出する周壁部88とを備えている。上底壁86は、平面視において略角丸の矩形状とされていると共に、周壁部88は、後方に向かって次第に拡開するように湾曲しながら延びている。これにより、平面視において、蓋部材56(装置本体18)の外形状及び大きさが、ベース部材16と略同じとされている。ベース部材16に対して装置本体18を組み付けた際には、ベース部材16の外周面と装置本体18(蓋部材56)の外周面とが、略段差なく滑らかに連続するようになっている。 As shown in FIG. 6, the lid member 56 includes an upper bottom wall 86 that extends in a direction orthogonal to the front-rear direction, and a peripheral wall portion 88 that protrudes rearward from the outer peripheral edge of the upper bottom wall 86. The upper bottom wall 86 has a generally rectangular shape with rounded corners in a plan view, and the peripheral wall portion 88 extends while being curved so as to gradually expand toward the rear. Thereby, the outer shape and size of the lid member 56 (apparatus main body 18) are substantially the same as those of the base member 16 in plan view. When the device main body 18 is assembled to the base member 16, the outer circumferential surface of the base member 16 and the outer circumferential surface of the device main body 18 (lid member 56) are smoothly continuous with substantially no difference in level.
 蓋部材56における周壁部88の内側の空間において上底壁86の四隅には、後方に突出する略筒状のねじ穴形成部90が設けられている。これらのねじ穴形成部90は、底部材54におけるねじ孔70と対応する位置に形成されている。また、蓋部材56における内面の左方部分には、上底壁86から後方に突出して、ボタン電池62を位置決めする略筒状のバッテリホルダ部92が一体的に設けられている。なお、バッテリホルダ部92の周上の一部には切欠きが設けられており、ボタン電池62を装置本体18に収容した際に、電気回路基板60から弾性的に突出する導通部材が切欠きを通じてボタン電池62の+極である外周面に接触することができて、電気回路基板60とボタン電池62の+極とを電気的に導通することができる。ボタン電池62の-極へ弾性的に接触する導通部材は、電気回路基板60の面上に設けられている。本実施形態では、ボタン電池62が、非固定状態で(好適には、ある程度の遊びをもって)バッテリホルダ部92に収容配置されており、後述するボタン電池62の取り外し時において、ボタン電池62が迅速簡便に取り外せるようになっている。 In the space inside the peripheral wall portion 88 of the lid member 56, substantially cylindrical screw hole forming portions 90 that protrude rearward are provided at the four corners of the upper bottom wall 86. These screw hole forming portions 90 are formed at positions corresponding to the screw holes 70 in the bottom member 54. Furthermore, a substantially cylindrical battery holder portion 92 that protrudes rearward from the upper bottom wall 86 and positions the button battery 62 is integrally provided on the left portion of the inner surface of the lid member 56 . Note that a notch is provided in a part of the circumference of the battery holder portion 92, and when the button battery 62 is housed in the device main body 18, the conductive member that elastically protrudes from the electric circuit board 60 is cut out. The positive electrode of the button battery 62 can be brought into contact with the outer circumferential surface of the button battery 62 through the electrode, and the electric circuit board 60 and the positive electrode of the button battery 62 can be electrically connected to each other. A conductive member that elastically contacts the negative pole of the button battery 62 is provided on the surface of the electric circuit board 60. In this embodiment, the button battery 62 is housed in the battery holder part 92 in a non-fixed state (preferably with some play), and when the button battery 62 is removed as described later, the button battery 62 can be quickly removed. It can be easily removed.
 また、蓋部材56の上底壁86においてバッテリホルダ部92よりも右方には、操作スイッチとしてのボタン94が設けられている。即ち、ボタン94は、上底壁86の一部により構成されており、上底壁86の右方部分に設けられている。ボタン94は、平面視において略矩形状乃至は略台形状であり、ボタン94の左側において上底壁86の左方部分と一体的に連続してつながっている。この連続部分は比較的薄肉に形成されていると共に、ボタン94の周囲には、軟質の合成樹脂等からなる軟質部材96が配されており、軟質部材96の弾性変形を伴いつつ、ボタン94の押込みが可能とされている。これにより、ボタン94の周囲に隙間を設けることなくボタン94の押込みが可能とされて、ボタンの周囲の隙間を通じて装置本体の内部に水が浸入することが防止され得る。なお、ボタン94は、後述するように装置本体18の電源をONにするための電源用のボタンとしてだけでなく、例えば患者が心臓に違和感を感じた際にボタン94を押すことでその時刻を電気回路基板60に実装されるメモリ等に記録することができる、イベントボタンとしての機能を有していてもよい。 Further, a button 94 as an operation switch is provided on the upper bottom wall 86 of the lid member 56 to the right of the battery holder portion 92. That is, the button 94 is constituted by a part of the upper base wall 86 and is provided on the right side of the upper base wall 86. The button 94 has a generally rectangular or trapezoidal shape in plan view, and is integrally and continuously connected to the left portion of the upper bottom wall 86 on the left side of the button 94 . This continuous portion is formed to be relatively thin, and a soft member 96 made of soft synthetic resin or the like is arranged around the button 94. Pushing is possible. Thereby, the button 94 can be pushed in without creating a gap around the button 94, and water can be prevented from entering the inside of the device main body through the gap around the button. Note that the button 94 is used not only as a power button for turning on the power of the device main body 18, as will be described later, but also as a button for setting the time by pressing the button 94 when, for example, the patient feels something strange about his or her heart. It may have a function as an event button that can be recorded in a memory or the like mounted on the electric circuit board 60.
 さらに、周壁部88における右方には、周壁部88を厚さ方向で貫通する開口部98が設けられており、この開口部98にはUSBを接続することのできるUSB端子部100が嵌め込まれている。このUSB端子部100は、電気回路基板60に実装される電子部品と電気的に接続しており、USB端子部100にUSBを接続することで、電気回路基板60に記録された心電図情報がUSBに取込可能とされている。なお、USBの非使用時には、例えばUSB端子部100を図示しない別部品からなる防水シール蓋などで覆うことで、USB端子部100を通じての装置本体18の内部への水の浸入が防止され得る。 Furthermore, an opening 98 is provided on the right side of the peripheral wall 88 and penetrates through the peripheral wall 88 in the thickness direction, and a USB terminal 100 to which a USB can be connected is fitted into the opening 98. ing. This USB terminal section 100 is electrically connected to electronic components mounted on the electric circuit board 60, and by connecting a USB to the USB terminal section 100, electrocardiogram information recorded on the electric circuit board 60 can be transferred to the USB terminal section 100. It is said that it can be imported into Note that when the USB is not in use, for example, by covering the USB terminal section 100 with a waterproof seal lid made of a separate component (not shown), water can be prevented from entering the inside of the device main body 18 through the USB terminal section 100.
 これら底部材54と蓋部材56との間の収容スペース64に収容される電気回路基板60は、例えば前後方向と直交する方向に広がる合成樹脂製の基板の表面に所定の電気素子が実装されたり電気回路が印刷形成等されることで構成されている。図6に示されるように、この電気回路基板60は平面視において略角丸の矩形状であり、周囲の四隅には蓋部材56におけるねじ穴形成部90との干渉を回避するための切欠状の凹部102が形成されている。平面視において、電気回路基板60の大きさは蓋部材56よりも小さくされており、電気回路基板60を蓋部材56の開口部側(後側)から重ね合わせることで、蓋部材56の内部の空間において、ねじ穴形成部90と凹部102とにより電気回路基板60と蓋部材56との位置合わせも可能となる。本実施形態では、電気回路基板60が、非固定状態で(好適には、ある程度の遊びをもって)蓋部材56に収容配置されており、後述する電気回路基板60の取り外し時において、電気回路基板60が迅速簡便に取り外せるようになっている。 The electrical circuit board 60 accommodated in the accommodation space 64 between the bottom member 54 and the lid member 56 is, for example, a synthetic resin board that extends in a direction orthogonal to the front-rear direction, and has a predetermined electrical element mounted on the surface thereof. It is constructed by printing and forming an electric circuit. As shown in FIG. 6, this electric circuit board 60 has a substantially rectangular shape with rounded corners in a plan view, and has cutouts at the four surrounding corners to avoid interference with the screw hole forming portion 90 of the lid member 56. A recess 102 is formed. In plan view, the size of the electric circuit board 60 is smaller than the lid member 56, and by overlapping the electric circuit board 60 from the opening side (rear side) of the lid member 56, the inside of the lid member 56 can be In the space, the screw hole forming portion 90 and the recess 102 also enable alignment of the electric circuit board 60 and the lid member 56. In this embodiment, the electric circuit board 60 is accommodated in the lid member 56 in a non-fixed state (preferably with some play), and when the electric circuit board 60 is removed as described later, the electric circuit board 60 can be quickly and easily removed.
 そして、図4,6に示されるように、蓋部材56におけるバッテリホルダ部92にボタン電池62を収容して、更にボタン電池62の後方から電気回路基板60を重ね合わせて載置した状態で、蓋部材56に対して底部材54を重ね合わせて、周囲の4箇所においてねじ104で固定することにより、図2や図4に示される装置本体18が構成される。これにより、蓋部材56の後方開口部が底部材54により覆蓋されると共に、内部の収容スペース64にボタン電池62と電気回路基板60が収容される。この結果、前述のように電気回路基板60上の各導通部材がボタン電池62の両極にそれぞれ当接状態に保持されて、ボタン電池62から電気回路基板60へ給電される。即ち、底部材54と蓋部材56とが相互に固定されることにより電気回路基板60に設けられた両極の接点が、ボタン電池62の各極への当接状態にそれぞれ保持されるようになっている。なお、底部材54と蓋部材56とをねじ104で固定することにより、収容スペース64内においてボタン電池62及び電気回路基板60が略がたつくことなく収容配置されることとなるが、単に蓋部材56にボタン電池62及び電気回路基板60を載置した状態(底部材54の取付前の状態)では、前述のように、ボタン電池62及び電気回路基板60は、蓋部材56に対して重ね合わせ方向で、ある程度フリーに収容されている。また、底部材54から前方に突出する導電ゴム74の前端部が、電気回路基板60の後面に設けられた電気回路に接触して、導電ゴム74と電気回路基板60とが電気的に接続される。 As shown in FIGS. 4 and 6, the button battery 62 is housed in the battery holder part 92 of the lid member 56, and the electric circuit board 60 is placed on top of the button battery 62 from behind. The device main body 18 shown in FIGS. 2 and 4 is constructed by overlapping the bottom member 54 on the lid member 56 and fixing it with screws 104 at four locations around the periphery. As a result, the rear opening of the lid member 56 is covered by the bottom member 54, and the button battery 62 and the electric circuit board 60 are accommodated in the internal accommodation space 64. As a result, as described above, each conductive member on the electric circuit board 60 is held in contact with both poles of the button battery 62, and power is supplied from the button battery 62 to the electric circuit board 60. That is, by fixing the bottom member 54 and the lid member 56 to each other, the contacts of both poles provided on the electric circuit board 60 are held in contact with each pole of the button battery 62. ing. Note that by fixing the bottom member 54 and the lid member 56 with the screws 104, the button battery 62 and the electric circuit board 60 can be housed in the accommodation space 64 without wobbling, but the lid member 56 is simply fixed. As described above, when the button battery 62 and the electric circuit board 60 are placed on the cover member 56 (before the bottom member 54 is attached), the button battery 62 and the electric circuit board 60 are placed in the overlapping direction with respect to the lid member 56. So, it is accommodated freely to some extent. Further, the front end of the conductive rubber 74 protruding forward from the bottom member 54 contacts the electric circuit provided on the rear surface of the electric circuit board 60, and the conductive rubber 74 and the electric circuit board 60 are electrically connected. Ru.
 上記の如きベース部材16と装置本体18とが相互に組み付けられる。即ち、ベース部材16と装置本体18とを対向させて、ベース部材16に対して装置本体18を押し込むことで、底部材54における平板部66の外周端部により、ベース部材16における嵌合周壁40及び係合爪42が外周側へ押圧されて弾性変形する。そして、ベース部材16に対して装置本体18を更に押し込むことで、嵌合周壁40及び係合爪42の弾性的な復元変形により、ベース部材16の係合爪42が底部材54の係合溝68に略密着状態で係止される。要するに、係合爪42を含む嵌合周壁40の弾性を利用して、ベース部材16と装置本体18(底部材54)とが相互に接近方向に付勢されており、仮に装置本体18に対してベース部材16から離隔するような外力が及ぼされたとしても、係合爪42及び嵌合周壁40の弾性的な復元力によりベース部材16と装置本体18との組付状態が維持される。この嵌合周壁40による装置本体18の外周部分への嵌合作用に基づいて、装置本体18とベース部材16とが重ね合わせ状態で保持されて、ベース部材16と装置本体18(底部材54)との間の防水性の向上も図られる。 The base member 16 and the device main body 18 as described above are assembled to each other. That is, by making the base member 16 and the device main body 18 face each other and pushing the device main body 18 into the base member 16, the outer circumferential end of the flat plate portion 66 in the bottom member 54 can close the fitting peripheral wall 40 in the base member 16. The engaging claw 42 is pressed toward the outer circumferential side and is elastically deformed. Then, by further pushing the device main body 18 into the base member 16, the fitting circumferential wall 40 and the engaging claw 42 are elastically deformed, so that the engaging claw 42 of the base member 16 moves into the engaging groove of the bottom member 54. 68 in a substantially tight state. In short, the base member 16 and the device main body 18 (bottom member 54) are urged toward each other by utilizing the elasticity of the fitting circumferential wall 40 including the engaging claws 42. Even if an external force is applied that causes the base member 16 to move away from the base member 16, the assembled state of the base member 16 and the device main body 18 is maintained due to the elastic restoring force of the engaging claws 42 and the fitting peripheral wall 40. Based on the fitting effect of the fitting peripheral wall 40 on the outer peripheral portion of the device main body 18, the device main body 18 and the base member 16 are held in an overlapping state, and the base member 16 and the device main body 18 (bottom member 54) This will also improve the waterproofness between the two.
 また、係合爪42が係合溝68に係止されてベース部材16と装置本体18とが位置合わせされた状態で、相互に連通されるベース部材16側のねじ孔46,49と装置本体18側のねじ穴76及びねじ孔82とに対して、締付ねじ77,77が挿通されて、ベース部材16と装置本体18とがねじ止めされてもよい。なお、この場合、これらの締付ねじ77,77は、ベース部材16に対して貼着シート12が固着された状態で装置本体18に締結可能とされてもよいし、締付ねじ77,77を装置本体18に締結した後に、ベース部材16に対して貼着シート12が固着されてもよい。 In addition, when the engagement claw 42 is engaged with the engagement groove 68 and the base member 16 and the device main body 18 are aligned, the screw holes 46 and 49 on the base member 16 side that communicate with each other are connected to the device main body. The base member 16 and the device main body 18 may be screwed together by inserting the tightening screws 77, 77 into the screw holes 76 and 82 on the 18 side. In this case, these tightening screws 77, 77 may be able to be fastened to the device main body 18 with the adhesive sheet 12 fixed to the base member 16, or the tightening screws 77, 77 may The adhesive sheet 12 may be fixed to the base member 16 after it is fastened to the device main body 18.
 すなわち、図4にも示されるように、ベース部材16の底壁38と装置本体18の底部材54とが、補強板48及び補強板48の前後両側に位置する防水両面テープ50,78を介して重ね合わされて固定される。これにより、防水両面テープ78が補強板48に貼り付けられて、係合爪42の係合溝68への係止に加えて、防水両面テープ78による接着(及び必要に応じて締付ねじ77,77によるねじ止め)によってもベース部材16と装置本体18とが固定されるようになっている。この結果、ベース部材16において補強板48上に露出する各通電線34a~34cとベース部材16において後方に露出する導電ゴム74とが相互に接触して、電気的に接続される。特に、本実施形態では、ベース部材16と装置本体18とが固定された状態において、導電ゴム74が、電気回路基板60と各通電線34a~34c(及びその後方に位置する硬質の補強板48)との間で圧縮されており、その弾性的な復元力により、導電ゴム74と電気回路基板60との接触及び導電ゴム74と各通電線34a~34cとの接触が安定して維持されるようになっている。 That is, as shown in FIG. 4, the bottom wall 38 of the base member 16 and the bottom member 54 of the device main body 18 are connected to each other via the reinforcing plate 48 and the waterproof double- sided tapes 50 and 78 located on both the front and back sides of the reinforcing plate 48. are superimposed and fixed. As a result, the waterproof double-sided tape 78 is pasted on the reinforcing plate 48, and in addition to locking the engaging claw 42 in the engaging groove 68, the waterproof double-sided tape 78 is attached (and the tightening screw 77 is attached as necessary). , 77), the base member 16 and the device main body 18 are also fixed. As a result, each of the conductive wires 34a to 34c exposed on the reinforcing plate 48 in the base member 16 and the conductive rubber 74 exposed rearward in the base member 16 come into contact with each other and are electrically connected. In particular, in this embodiment, when the base member 16 and the device main body 18 are fixed, the conductive rubber 74 connects the electric circuit board 60 and each of the conductive wires 34a to 34c (and the hard reinforcing plate 48 located behind them). ), and its elastic restoring force maintains stable contact between the conductive rubber 74 and the electric circuit board 60 and between the conductive rubber 74 and each of the conductive wires 34a to 34c. It looks like this.
 従って、本実施形態では、ベース部材16と装置本体18との間において、ベース部材16側の各通電線34a~34cと装置本体18側の導電ゴム74が重ね合わせ方向(前後方向)で当接することによって導通されており、各通電線34a~34cと導電ゴム74との接点によりコネクタ部108が形成されている。そして、各測定電極14a~14cが、コネクタ部108を通じて、即ち各通電線34a~34c及び導電ゴム74を介して、装置本体18側の電気回路基板60に設けられた電気回路に通電されるようになっている。 Therefore, in this embodiment, between the base member 16 and the device main body 18, each of the conductive wires 34a to 34c on the base member 16 side and the conductive rubber 74 on the device main body 18 side come into contact in the overlapping direction (front-back direction). A connector portion 108 is formed by the contact points between each of the current-carrying wires 34a to 34c and the conductive rubber 74. Then, each measurement electrode 14a to 14c is energized to an electric circuit provided on an electric circuit board 60 on the apparatus main body 18 side through the connector part 108, that is, through each energizing wire 34a to 34c and the conductive rubber 74. It has become.
 また、コネクタ部108においてベース部材16側の接点(各通電線34a~34c)と装置本体18側の接点(導電ゴム74の後端部)とを重ね合わせ方向に付勢状態で当接させる付勢部材が、導電ゴム74及び、ベース部材16と装置本体18とを相互に接近する方向に付勢する係合爪42及び嵌合周壁40を含むベース部材16とを含んでいる。更に、付勢部材として、各通電線34a~34cの後方に位置して厚さ方向で弾性を有する防水両面テープ50を含んでいてもよい。即ち、導電ゴム74、ベース部材16及び防水両面テープ50は、ベース部材16側の接点(各通電線34a~34c)と装置本体18側の接点(導電ゴム74の後端部)とを重ね合わせ方向で付勢している。そして、防水両面テープ78による接着や、必要に応じて採用される締付ねじ77,77によるねじ止めにより、ベース部材16側の接点(各通電線34a~34c)と装置本体18側の接点(導電ゴム74の後端部)との付勢状態での重ね合わせが、一層安定して維持される。 Further, in the connector portion 108, the contacts on the base member 16 side (each of the current-carrying wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74) are brought into contact with each other in a biased state in the stacking direction. The biasing member includes a conductive rubber 74 and a base member 16 including an engaging claw 42 and a fitting peripheral wall 40 that bias the base member 16 and the device body 18 in a direction toward each other. Furthermore, a waterproof double-sided tape 50 having elasticity in the thickness direction may be included as a biasing member, located behind each of the current-carrying wires 34a to 34c. That is, the conductive rubber 74, the base member 16, and the waterproof double-sided tape 50 overlap the contacts on the base member 16 side (each of the current-carrying wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74). It is biased in the direction. Then, the contacts on the base member 16 side (each of the current-carrying wires 34a to 34c) and the contacts on the device main body 18 side ( The overlapping state with the rear end portion of the conductive rubber 74 in a biased state is maintained more stably.
 上記の如き心電計10は、図7に示されるように、人体Aの皮膚aに貼り付けられて使用される。即ち、図1に示される使用前の初期状態から、剥離ライナー28を剥がして、貼着シート12における粘着層24を露出させる。そして、この心電計10を人体Aの皮膚aに貼り付けて、各測定電極14a~14cを人体Aの所定の位置に配置する。なお、心電計10の貼り付け方(各測定電極14a~14cの位置)は、患者の疾患等に応じて主に測定したい波形等によって適宜選択され得る。 The electrocardiograph 10 as described above is used by being attached to the skin a of the human body A, as shown in FIG. That is, the release liner 28 is peeled off from the initial state before use shown in FIG. 1 to expose the adhesive layer 24 on the adhesive sheet 12. Then, this electrocardiograph 10 is attached to the skin a of the human body A, and each of the measurement electrodes 14a to 14c is placed at a predetermined position on the human body A. The manner in which the electrocardiograph 10 is attached (the positions of the measurement electrodes 14a to 14c) can be selected as appropriate depending on the waveform to be measured depending on the disease of the patient and the like.
 その後、ボタン94を押して電源をONにして、例えば電気回路基板60上に設けられたCPUにより所定のプログラムに従って、各測定電極14a~14cにおける活動電位を検出する。この検出電位に基づいて得られた心電図情報は、例えば電気回路基板60上のメモリに記録されて、例えば測定終了後や症状の発症後、又はリアルタイムなど、任意のタイミングで、例えばBLE通信を介して、又はUSBを介して、コンピュータやスマートフォンに取り込まれる。なお、心電図情報は、送信によって外部のコンピュータ等の記憶媒体に取り込まれた後は、基盤上メモリから消去されても良いし、リアルタイムで心電図情報を外部の記憶媒体に送信して記憶させる場合には基盤上メモリに記憶させなくても良い。このような各測定電極14a~14cによる心電図情報の取得は、例えば数日や数週間にわたって行われる。所定の測定期間が満了すると、各測定電極14a~14cによる活動電位の検出及び心電図情報のメモリへの記録は終了し、電気回路基板60に実装されたLEDランプが所定の態様で点灯する。その後、心電計10が人体Aの皮膚aから取り外される。 Thereafter, the button 94 is pressed to turn on the power, and the action potentials at each of the measurement electrodes 14a to 14c are detected by a CPU provided on the electric circuit board 60, for example, according to a predetermined program. The electrocardiogram information obtained based on this detected potential is recorded, for example, in a memory on the electric circuit board 60, and can be sent at any timing, for example, after the end of measurement, after the onset of symptoms, or in real time, for example, via BLE communication. or via USB to a computer or smartphone. In addition, after the electrocardiogram information is transmitted to a storage medium such as an external computer, it may be deleted from the on-board memory, or when the electrocardiogram information is transmitted in real time to an external storage medium and stored. does not need to be stored in the memory on the base. Acquisition of electrocardiogram information by each of the measurement electrodes 14a to 14c is performed over several days or weeks, for example. When the predetermined measurement period expires, the detection of action potentials by each of the measurement electrodes 14a to 14c and the recording of electrocardiogram information in the memory are completed, and the LED lamps mounted on the electric circuit board 60 are turned on in a predetermined manner. Thereafter, the electrocardiograph 10 is removed from the skin a of the human body A.
 なお、装置本体18内のボタン電池62や電気回路基板60を交換する際には、底部材54と蓋部材56とをねじ止めしているねじ104を取り外すことで底部材54と蓋部材56とを開くことができて、筐体58からボタン電池62及び電気回路基板60を取り出すことができる。 Note that when replacing the button battery 62 and electric circuit board 60 inside the device main body 18, the bottom member 54 and the lid member 56 can be separated by removing the screws 104 that screw the bottom member 54 and the lid member 56 together. The button battery 62 and the electric circuit board 60 can be taken out from the housing 58 by opening it.
 本実施形態の心電計10によれば、コネクタ部108においてベース部材16側の接点(各通電線34a~34c)と装置本体18側の接点(導電ゴム74の後端部)とが、重ね合わせ方向で付勢状態で当接していることから、例えば数日や数週間にわたる測定において患者が大きく動く場合にも、両接点間の導通状態が安定して維持される。これら両接点を付勢状態で当接させる付勢部材は、導電ゴム74や、係合爪42を有する嵌合周壁40(ベース部材16)及び防水両面テープ50である。 According to the electrocardiograph 10 of the present embodiment, in the connector portion 108, the contacts on the base member 16 side (the current carrying wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74) overlap. Since they are in biased contact in the mating direction, the conductive state between both contacts is maintained stably even when the patient moves significantly during measurements over several days or weeks, for example. The biasing members that bring these two contacts into contact in a biased state are the conductive rubber 74, the fitting peripheral wall 40 (base member 16) having the engagement claws 42, and the waterproof double-sided tape 50.
 特に、コネクタ部108において、付勢部材として弾性部材である導電ゴム74を採用して、導電ゴム74を電気回路基板60と各通電線34a~34cとの間で圧縮状態で配置することにより、電気回路基板60と各通電線34a~34cとを電気的に接続しつつ、弾性的な復元力により導電ゴム74と電気回路基板60との接触、及び導電ゴム74と各通電線34a~34cとの接触を安定して維持することができる。更に、コネクタ部108において導電ゴム74を採用することで、例えば機械的な通電用コネクタを採用する場合に比べて、装置本体18とベース部材16との組付構造体における軽量化及び小型化が達成されて、心電計10の着用感の低減が図られる。 In particular, in the connector portion 108, by employing the conductive rubber 74, which is an elastic member, as the biasing member and arranging the conductive rubber 74 in a compressed state between the electric circuit board 60 and each of the conductive wires 34a to 34c, While electrically connecting the electric circuit board 60 and each of the conductive wires 34a to 34c, elastic restoring force brings the conductive rubber 74 into contact with the electric circuit board 60, and the conductive rubber 74 and each of the conductive wires 34a to 34c. can maintain stable contact. Furthermore, by employing the conductive rubber 74 in the connector portion 108, the assembly structure of the device main body 18 and the base member 16 can be made lighter and smaller than, for example, when a mechanical conductive connector is employed. This is achieved, and the feeling of wearing the electrocardiograph 10 is reduced.
 また、ベース部材16における底壁38の内面には、接点支持部としての補強板48が設けられている。これにより、補強板48の前面に露出して配される各通電線34a~34cを支持して補強することができるだけでなく、各通電線34a~34cと電気回路基板60との離隔距離をより小さくすることができて、導電ゴム74をより圧縮された状態で配置することができる。この結果、弾性的な復元力として、より大きな付勢力が得られることから、電気回路基板60と導電ゴム74と各通電線34a~34cとの導通状態を更に安定して維持することができる。 Furthermore, a reinforcing plate 48 as a contact support part is provided on the inner surface of the bottom wall 38 of the base member 16. This not only makes it possible to support and reinforce each of the energizing wires 34a to 34c arranged exposed on the front surface of the reinforcing plate 48, but also to further reduce the distance between each of the energizing wires 34a to 34c and the electric circuit board 60. It can be made smaller and the conductive rubber 74 can be placed in a more compressed state. As a result, a larger biasing force is obtained as an elastic restoring force, so that the conduction state between the electric circuit board 60, the conductive rubber 74, and each of the current-carrying wires 34a to 34c can be maintained more stably.
 さらに、本実施形態では、ボタン電池62及び電気回路基板60が、装置本体18における筐体58の収容スペース64に収容されており、ボタン電池62を位置決めするバッテリホルダ部92は、筐体58を構成する蓋部材56に一体形成されている。これにより、例えば電気回路基板にボタン電池を位置決めする構造等を設けることがなく、より容易にボタン電池62を位置決めするバッテリホルダ部92を設けることができる。 Furthermore, in this embodiment, the button battery 62 and the electric circuit board 60 are housed in the housing space 64 of the housing 58 in the device main body 18, and the battery holder section 92 that positions the button battery 62 holds the housing 58. It is integrally formed with the constituting lid member 56. Thereby, for example, the battery holder portion 92 for positioning the button battery 62 can be provided more easily without providing a structure for positioning the button battery on the electric circuit board.
 特に、筐体58が底部材54と蓋部材56とによって構成されており、これら底部材54と蓋部材56を開くことによってボタン電池62及び電気回路基板60が取出可能であることから、ボタン電池62や電気回路基板60の交換を容易に実現することができる。これらボタン電池62及び電気回路基板60は、蓋部材56に対してある程度フリーに配置されていることから、ねじ104を外し底部材54を取り除いた状態で、蓋部材56をひっくり返すだけで蓋部材56からボタン電池62及び電気回路基板60を迅速簡便に取り出すことができる。 In particular, since the housing 58 is composed of a bottom member 54 and a lid member 56, and the button battery 62 and the electric circuit board 60 can be removed by opening the bottom member 54 and the lid member 56, the button battery 62 and the electric circuit board 60 can be removed. 62 and the electric circuit board 60 can be easily replaced. Since the button battery 62 and the electric circuit board 60 are arranged freely to some extent with respect to the lid member 56, the lid member 56 can be opened by simply turning the lid member 56 upside down with the screws 104 removed and the bottom member 54 removed. The button battery 62 and the electric circuit board 60 can be taken out quickly and easily.
 更にまた、本実施形態では、3つの測定電極(第一~第三の測定電極14a~14c)が設けられており、各測定電極14a~14cの中心の何れもが、ベース部材16及び装置本体18の装着部位の中心Cよりも上方に位置設定されている。これにより、図7中の上下方向を鉛直方向として心電計10が人体Aに装着される場合には、各測定電極14a~14cよりも重量のあるベース部材16や装置本体18を鉛直下方に配置することができる。この結果、心電計10における重心位置が下方に偏倚することとなり、例えばベース部材や装置本体が貼着シートにおける上方部分に設けられる場合に比べて、吊り下げ状態で支持する人体Aへの接着領域の面積を大きく確保することが容易となって、ベース部材や装置本体の重量により貼着シートが剥がれるという不具合を防止することができる。 Furthermore, in this embodiment, three measurement electrodes (first to third measurement electrodes 14a to 14c) are provided, and each of the centers of each measurement electrode 14a to 14c is connected to the base member 16 and the device main body. The position is set above the center C of the attachment site No. 18. As a result, when the electrocardiograph 10 is attached to the human body A with the vertical direction in FIG. can be placed. As a result, the center of gravity of the electrocardiograph 10 is shifted downward, and the adhesion to the human body A that is supported in a suspended state is more difficult than when, for example, the base member or the main body of the device is provided in the upper part of the adhesive sheet. It becomes easy to ensure a large area of the area, and it is possible to prevent the problem of the adhesive sheet peeling off due to the weight of the base member or the main body of the device.
 また、貼着シート12が、下側の周縁部分に比して、上側の周縁部分が曲率半径の小さい湾曲形状とされていると共に、ベース部材16及び装置本体18の装着部位の中心Cが、貼着シート12において左右方向の幅寸法が最大とされた位置よりも下方に偏倚して設定されていることで、貼着シート12においてベース部材16及び装置本体18に対して上方及び左右両側の面積を広く確保することができる。これにより、この領域を巧く利用して各測定電極14a~14cを配置できると共に、貼着面積を十分に確保することができて、各測定電極14a~14cが、所定位置からずれることが効果的に防止される。 Further, the adhesive sheet 12 has a curved shape in which the upper peripheral edge portion has a smaller radius of curvature than the lower peripheral edge portion, and the center C of the mounting portion of the base member 16 and the device main body 18 is By setting the adhesive sheet 12 to be biased downward from the position where the width dimension in the left and right direction is the maximum, the adhesive sheet 12 is set so that the width dimension in the left and right directions is A large area can be secured. As a result, each of the measurement electrodes 14a to 14c can be arranged by making good use of this area, and a sufficient adhesion area can be ensured, which is effective in preventing the measurement electrodes 14a to 14c from shifting from their predetermined positions. is prevented.
 さらに、本実施形態の心電計10は、装置本体18において、各測定電極14a~14cにおける活動電位の測定に際して、電気的導通性の異常の発生を検出するリードオフ検出機構67aを備えている。また、リードオフ検出機構67aにおいて検出された異常の発生は、報知手段67bにより患者に報知されるようになっている。これにより、例えば各測定電極14a~14cの何れかが人体Aの皮膚aから剥がれた場合や、各リード線32a~32c及び各通電線34a~34cの何れかが断線等した場合も、かかる異常の発生を患者が速やかに把握することができて、異常を解消するための行動をとることができる。特に、本発明に係る心電計10は、比較的長期間にわたって心電図情報を取得するものであることから、早期に異常を解消することで、測定不能とされる時間を短くし、測定をし直すことによる診断の遅れを回避したり、再度測定することによる患者の負担を軽減することができる。 Furthermore, the electrocardiograph 10 of this embodiment includes a lead-off detection mechanism 67a in the device main body 18 that detects the occurrence of abnormality in electrical conductivity when measuring action potentials at each of the measurement electrodes 14a to 14c. . Moreover, the occurrence of an abnormality detected in the lead-off detection mechanism 67a is notified to the patient by the notification means 67b. As a result, even if any of the measurement electrodes 14a to 14c is peeled off from the skin a of the human body A, or if any of the lead wires 32a to 32c and the current carrying wires 34a to 34c are disconnected, such an abnormality can be detected. The patient can quickly grasp the occurrence of abnormalities and take action to eliminate the abnormality. In particular, since the electrocardiograph 10 according to the present invention acquires electrocardiogram information over a relatively long period of time, by eliminating abnormalities early, the time during which measurements are impossible can be shortened and measurements can be made. It is possible to avoid a delay in diagnosis due to correction and reduce the burden on the patient due to re-measurement.
 以上、本発明の実施形態について詳述してきたが、本発明はその具体的な記載によって限定されない。 Although the embodiments of the present invention have been described in detail above, the present invention is not limited by the specific description.
 前記実施形態では、コネクタ部108においてベース部材16側の接点(各通電線34a~34c)と装置本体18側の接点(導電ゴム74の後端部)とを重ね合わせ方向(前後方向)に付勢させる付勢部材が、導電ゴム74、係合爪42及び嵌合周壁40を有するベース部材16、防水両面テープ50によって構成されていたが、例えば付勢部材は上記のうちの何れか1つによって構成されていればよい。例えば、導電ゴムが電気回路基板と各通電線との間で圧縮されて、導電ゴムと各通電線とが付勢状態で当接していれば、ベース部材と装置本体との固定構造は前記実施形態に例示の態様に限定されるものではなく、ベース部材において、弾性的な係合爪や嵌合周壁は必須なものではない。尤も、ベース部材において係合爪や嵌合周壁が設けられる場合であっても、前記実施形態のように係合爪42が装置本体18の外周面に開口する係合溝68に係止される態様に限定されるものではなく、装置本体の外周端から後方に突出する周壁の内周面に係合溝が設けられると共に、ベース部材において外周側に突出する係合爪を有する嵌合周壁が設けられることで、ベース部材の係合爪が内周側から装置本体の係合溝に対して係止されるようになっていてもよい。 In the embodiment described above, in the connector portion 108, the contacts on the base member 16 side (each of the energizing wires 34a to 34c) and the contacts on the device main body 18 side (the rear end of the conductive rubber 74) are attached in the overlapping direction (front-back direction). Although the biasing member to be biased was composed of the conductive rubber 74, the base member 16 having the engaging claws 42 and the fitting peripheral wall 40, and the waterproof double-sided tape 50, for example, the biasing member may be any one of the above. It suffices if it is configured by For example, if the conductive rubber is compressed between the electric circuit board and each current-carrying wire, and the conductive rubber and each current-carrying wire are in contact with each other in an energized state, the fixing structure between the base member and the main body of the device is implemented as described above. The embodiment is not limited to the illustrated embodiment, and the base member does not necessarily have an elastic engagement claw or a fitting peripheral wall. Of course, even if the base member is provided with an engaging pawl or a fitting circumferential wall, the engaging pawl 42 will be locked in the engaging groove 68 that opens on the outer circumferential surface of the device main body 18 as in the above embodiment. Although not limited to the embodiment, an engagement groove is provided on the inner circumferential surface of the circumferential wall that protrudes rearward from the outer circumferential end of the device main body, and a fitting circumferential wall that has an engagement claw that protrudes toward the outer circumferential side of the base member is provided. By being provided, the engagement claw of the base member may be engaged with the engagement groove of the device main body from the inner peripheral side.
 また、前記実施形態では導電ゴム74が設けられて、電気回路基板60と各通電線34a~34cとを電気的に導通しつつ、ベース部材16側の接点と装置本体18側の接点とを付勢状態で当接させていたが、例えば電気回路基板と各通電線とを電気的に導通する部材と、ベース部材側の接点と装置本体側の接点とを付勢状態で当接させる部材とは、別個の部材が採用されてもよい。例えば、電気回路基板と各通電線とを電気的に導通する導通部材を採用しつつ、電気回路基板と各通電線とを相互に接近する方向に付勢する付勢部材としてのコイルスプリングや板ばね等の部材を別途採用して、電気回路基板と導通部材との接触及び/又は各通電線と導通部材との接触の安定性の向上を図るようにしてもよい。 Further, in the embodiment described above, the conductive rubber 74 is provided to electrically connect the electric circuit board 60 and each of the current-carrying wires 34a to 34c, and connect the contacts on the base member 16 side and the contacts on the device main body 18 side. For example, there is a member that electrically conducts the electric circuit board and each current-carrying wire, and a member that brings the contacts on the base member side and the contacts on the device body into contact in a biased state. A separate member may be employed. For example, while employing a conductive member that electrically connects the electric circuit board and each current-carrying wire, a coil spring or plate is used as a biasing member that urges the electric circuit board and each current-carrying wire in a direction toward each other. A member such as a spring may be separately employed to improve the stability of the contact between the electric circuit board and the conductive member and/or the contact between each current-carrying wire and the conductive member.
 前記実施形態では、装置本体18の後面に防水両面テープ78が設けられて、防水両面テープ78の接着効果により装置本体18とベース部材16との固定力が向上されていたが、装置本体とベース部材とは防水両面テープに代えて、例えば面ファスナーによって固定されてもよい。これにより、装置本体を共通として、ベース部材及び貼着シートを交換することで異なる複数の患者に本発明に係る心電計を利用することができて、装置本体を複数回使用することができる。 In the embodiment described above, the waterproof double-sided tape 78 is provided on the rear surface of the device main body 18, and the adhesive effect of the waterproof double-sided tape 78 improves the fixing force between the device main body 18 and the base member 16. The member may be fixed with, for example, a hook-and-loop fastener instead of the waterproof double-sided tape. As a result, the electrocardiograph according to the present invention can be used for multiple different patients by using a common device body and replacing the base member and adhesive sheet, and the device body can be used multiple times. .
 なお、前述のように、ベース部材16と装置本体18とは締付ねじ77,77によってねじ止めされてもよいが、このようなねじ止めの構造は必須ではなく、ねじ止めの構造を採用することなく、且つ上記のようにベース部材16と装置本体18との間に防水両面テープ78に代えて、例えば面ファスナーを設けてもよい。これにより、単に装置本体18をベース部材16から離隔させて係合溝68への係合爪42の係止を解除することで、ベース部材16から装置本体18が取り外せるようになっていてもよい。 Note that, as described above, the base member 16 and the device main body 18 may be screwed together using the tightening screws 77, 77, but such a screwing structure is not essential, and a screwing structure is adopted. Alternatively, instead of the waterproof double-sided tape 78, for example, a hook-and-loop fastener may be provided between the base member 16 and the device main body 18 as described above. Thereby, the device main body 18 may be removed from the base member 16 by simply separating the device main body 18 from the base member 16 and releasing the locking of the engagement claw 42 from the engagement groove 68. .
 また、装置本体を構成する底部材と蓋部材との固定構造もねじ止めに限定されるものではなく、凹凸による係止や圧入等、従来公知の固定構造が採用され得る。 Further, the fixing structure between the bottom member and the lid member constituting the device main body is not limited to screwing, and conventionally known fixing structures such as locking by unevenness or press-fitting can be adopted.
 前記実施形態では、接点支持部として底壁38と別部材とされた補強板48が設けられて防水両面テープ50により後固着されていたが、接点支持部は底壁に対して一体形成されてもよく、例えば底壁において接点(各通電線34a~34c)を支持する部分を厚肉に形成する等してもよい。 In the embodiment described above, the reinforcing plate 48 which is a separate member from the bottom wall 38 is provided as a contact support part and is later fixed with waterproof double-sided tape 50, but the contact support part is formed integrally with the bottom wall. For example, the portions of the bottom wall that support the contacts (each of the current-carrying wires 34a to 34c) may be formed thick.
 なお、本発明に係る心電計は、各測定電極により心電図情報を取得するだけでなく、心電図の波形情報に加えて、例えば各測定電極又は測定電極以外の測定機器を用いる等して、時刻や患者の心拍数、呼吸数、体内音、加速度、体温、血圧、血中酸素濃度等の各種数値が測定及び記録されたり、装置外部へ送信されるようになっていてもよい。また、前記実施形態では、心電計10において装置本体18が心電図情報を装置内部のメモリに記録したり装置外部へ送信できるようになっていたが、本発明に係る心電計は、装置内部への記録機能と、装置外部へ送信する機能との少なくとも一方を有しているだけでもよい。 The electrocardiograph according to the present invention not only acquires electrocardiogram information using each measurement electrode, but also acquires time by using, for example, each measurement electrode or a measuring device other than the measurement electrode, in addition to electrocardiogram waveform information. Various numerical values such as the patient's heart rate, respiratory rate, internal sounds, acceleration, body temperature, blood pressure, and blood oxygen concentration may be measured and recorded, or may be transmitted to the outside of the device. Furthermore, in the embodiment described above, in the electrocardiograph 10, the device main body 18 was able to record electrocardiogram information in the memory inside the device or transmit it to the outside of the device, but the electrocardiograph according to the present invention It may be sufficient to have at least one of a recording function to the device and a transmitting function to the outside of the device.
 リードオフ検出機構により検出された電気的導通性の異常の発生を患者に報知する報知手段は、前記実施形態のようにLEDランプの点灯によって患者に報知する態様に限定されるものではなく、特定の音や音声を発生するようになっていてもよいし、例えば無線通信等によって患者のスマートフォン等に異常発生の通知を送信するようになっていてもよい。 The notification means for notifying the patient of the occurrence of an electrical conductivity abnormality detected by the lead-off detection mechanism is not limited to the mode in which the patient is notified by lighting an LED lamp as in the above embodiment, but can be used for specific purposes. It may be configured to generate a sound or voice, or it may be configured to send a notification of the occurrence of an abnormality to the patient's smartphone or the like by, for example, wireless communication.
10 心電計
12 貼着シート
14 測定電極
14a 第一の測定電極
14b 第二の測定電極
14c 第三の測定電極
16 ベース部材(付勢部材、弾性部材)
18 装置本体
22 保護シート
24 粘着層
26 貼着面
28 剥離ライナー
30 貫通孔
32 リード線
32a 第一のリード線
32b 第二のリード線
32c 第三のリード線
33 通電窓
34a,34b,34c 通電線
36 FFC(フレキシブルフラットケーブル)
38 底壁
40 嵌合周壁
42 係合爪
44 挿通孔
46 ねじ孔
48 補強板(接点支持部)
49 ねじ孔
50 防水両面テープ(付勢部材、弾性部材)
52 凹部
54 底部材
56 蓋部材
58 筐体
60 電気回路基板
62 ボタン電池(バッテリ)
64 収容スペース
65a 第一点灯領域
65b 第二点灯領域
66 平板部
67a リードオフ検出機構
67b 報知手段
68 係合溝
70 ねじ孔
72 挿通孔
74 導電ゴム(付勢部材、弾性部材)
76 ねじ穴
77 締付ねじ
78 防水両面テープ
80 挿通窓
82 ねじ孔
86 上底壁
88 周壁部
90 ねじ穴形成部
92 バッテリホルダ部
94 ボタン
96 軟質部材
98 開口部
100 USB端子部
102 凹部
104 ねじ
108 コネクタ部
A 人体
a 皮膚
C 装置本体の装着部位の中心
10 Electrocardiograph 12 Adhesive sheet 14 Measuring electrode 14a First measuring electrode 14b Second measuring electrode 14c Third measuring electrode 16 Base member (biasing member, elastic member)
18 Device body 22 Protective sheet 24 Adhesive layer 26 Adhesive surface 28 Release liner 30 Through hole 32 Lead wire 32a First lead wire 32b Second lead wire 32c Third lead wire 33 Current-carrying windows 34a, 34b, 34c Current-carrying wire 36 FFC (Flexible flat cable)
38 Bottom wall 40 Fitting peripheral wall 42 Engagement claw 44 Insertion hole 46 Screw hole 48 Reinforcement plate (contact support part)
49 Screw hole 50 Waterproof double-sided tape (biasing member, elastic member)
52 Recessed portion 54 Bottom member 56 Lid member 58 Housing 60 Electric circuit board 62 Button cell (battery)
64 Accommodation space 65a First lighting area 65b Second lighting area 66 Flat plate part 67a Lead-off detection mechanism 67b Notification means 68 Engagement groove 70 Screw hole 72 Insertion hole 74 Conductive rubber (biasing member, elastic member)
76 Screw hole 77 Tightening screw 78 Waterproof double-sided tape 80 Insertion window 82 Screw hole 86 Upper bottom wall 88 Peripheral wall 90 Screw hole forming portion 92 Battery holder portion 94 Button 96 Soft member 98 Opening 100 USB terminal portion 102 Recess 104 Screw 108 Connector part A Human body a Skin C Center of attachment site on device body

Claims (8)

  1.  人体に装着されて心電図情報を送信及び/又は記録する心電計であって、
     人体の皮膚に貼着される貼着シートと、
     該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、
     該貼着シートの外面に設けられたベース部材と、
     該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、
     前記ベース部材には、前記貼着シートに固着された底壁と、前記装置本体への嵌合作用に基づいて該装置本体を該ベース部材に対して重ね合わせ状態で保持せしめる嵌合周壁とが、設けられている一方、
     該ベース部材と該装置本体との間には相互の重ね合わせ方向での当接によって導通される接点からなるコネクタ部が設けられており、該コネクタ部を通じて前記複数の測定電極が該装置本体側の電気回路に導通されるようになっていると共に、
     該コネクタ部において該ベース部材側の接点と該装置本体側の接点とを重ね合わせ方向に付勢状態で当接させる付勢部材を備えている心電計。
    An electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information,
    An adhesive sheet that is attached to the skin of the human body,
    a plurality of measurement electrodes provided on the adhesive sheet and superimposed on the skin of the human body;
    a base member provided on the outer surface of the adhesive sheet;
    a device main body that is removably attachable to the base member and that transmits and/or records electrocardiogram information based on the potential detected by the measurement electrode;
    The base member includes a bottom wall fixed to the adhesive sheet, and a fitting peripheral wall that holds the device main body in an overlapping state with respect to the base member based on a fitting action to the device main body. , while
    A connector portion is provided between the base member and the device main body, and the connector portion includes contacts that are electrically connected by contacting each other in the overlapping direction, and the plurality of measurement electrodes are connected to the device main body side through the connector portion. It is designed to be electrically connected to the electric circuit of
    An electrocardiograph comprising a biasing member that biases a contact point on the base member side and a contact point on the device main body side in the overlapping direction into contact with each other in the connector portion.
  2.  前記付勢部材が、前記コネクタ部の前記ベース部材側と前記装置本体側との少なくとも一方に設けられて、前記ベース部材側の接点と前記装置本体側の接点とを重ね合わせ方向で付勢する弾性部材によって構成されている請求項1に記載の心電計。 The biasing member is provided on at least one of the base member side and the device main body side of the connector portion, and biases the contact point on the base member side and the contact point on the device main body side in an overlapping direction. The electrocardiograph according to claim 1, wherein the electrocardiograph is made of an elastic member.
  3.  前記ベース部材の前記底壁の内面において、該底壁の内面から前記コネクタ部に向けて突出する接点支持部が設けられている請求項1又は2に記載の心電計。 The electrocardiograph according to claim 1 or 2, wherein a contact support portion is provided on the inner surface of the bottom wall of the base member and protrudes from the inner surface of the bottom wall toward the connector portion.
  4.  人体に装着されて心電図情報を送信及び/又は記録する心電計であって、
     人体の皮膚に貼着される貼着シートと、
     該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、
     該貼着シートの外面に設けられたベース部材と、
     該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、
     該装置本体には、電気回路基板と給電用のバッテリとが収容状態で組み付けられており、且つ、
     該バッテリを位置決めするバッテリホルダ部が、該電気回路基板が重ね合わされる該装置本体の筐体の内面に設けられている心電計。
    An electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information,
    An adhesive sheet that is attached to the skin of the human body,
    a plurality of measurement electrodes provided on the adhesive sheet and superimposed on the skin of the human body;
    a base member provided on the outer surface of the adhesive sheet;
    a device main body that is removably attachable to the base member and that transmits and/or records electrocardiogram information based on the potential detected by the measurement electrode;
    An electric circuit board and a battery for power supply are housed and assembled in the main body of the device, and
    An electrocardiograph in which a battery holder portion for positioning the battery is provided on the inner surface of a casing of the device main body on which the electric circuit board is superimposed.
  5.  前記バッテリがボタン電池により構成されていると共に、
     前記装置本体の前記筐体は、底部材と蓋部材とが重ね合わされて相互に固定されることにより、前記電気回路基板と前記ボタン電池の収容スペースが重ね合わせ面間に形成されるようになっており、
     該底部材と該蓋部材の一方の内面に前記バッテリホルダ部が設けられて、該バッテリホルダ部に配された前記ボタン電池に対して前記電気回路基板が重ね合わされ、該底部材と該蓋部材とが相互に固定されることにより該電気回路基板に設けられた両極の接点が該ボタン電池への当接状態にそれぞれ保持されるようになっていると共に、該底部材と該蓋部材とを開くことで該電気回路基板と該ボタン電池が該筐体から取出可能とされている請求項4に記載の心電計。
    The battery is constituted by a button battery, and
    In the casing of the apparatus main body, the bottom member and the lid member are overlapped and fixed to each other, so that a space for accommodating the electric circuit board and the button battery is formed between the overlapping surfaces. and
    The battery holder portion is provided on the inner surface of one of the bottom member and the lid member, the electric circuit board is overlapped with the button battery arranged in the battery holder portion, and the bottom member and the lid member are provided with the battery holder portion. By fixing them to each other, the contacts of both poles provided on the electric circuit board are held in contact with the button battery, and the bottom member and the lid member are fixed to each other. The electrocardiograph according to claim 4, wherein the electrical circuit board and the button battery can be removed from the housing by opening the housing.
  6.  人体に装着されて心電図情報を送信及び/又は記録する心電計であって、
     人体の皮膚に貼着される貼着シートと、
     該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、
     該貼着シートの外面に設けられたベース部材と、
     該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、
     前記貼着シートには前記測定電極が3つ設けられており、
     該貼着シートの左右方向略中央で上下方向下部に偏倚して設定された該装置本体の装着部位の中心から、左右の第一及び第二の測定電極の各中心が左右のそれぞれ斜め上方となるように位置設定されていると共に、第三の測定電極の中心が該装置本体の装着部位の中心から上方に位置設定されている心電計。
    An electrocardiograph that is attached to a human body to transmit and/or record electrocardiogram information,
    An adhesive sheet that is attached to the skin of the human body,
    a plurality of measurement electrodes provided on the adhesive sheet and superimposed on the skin of the human body;
    a base member provided on the outer surface of the adhesive sheet;
    a device main body that is removably attachable to the base member and that transmits and/or records electrocardiogram information based on the potential detected by the measurement electrode;
    The adhesive sheet is provided with three measurement electrodes,
    The center of each of the first and second measurement electrodes on the left and right is diagonally upward from the center of the attachment site of the device main body, which is set at approximately the center in the left-right direction of the adhesive sheet and offset downward in the vertical direction. An electrocardiograph, in which the center of the third measurement electrode is set above the center of the attachment site of the device main body.
  7.  前記貼着シートが、下側の周縁部分に比して、上側の周縁部分が曲率半径の小さい湾曲形状とされていると共に、
     前記装置本体の装着部位の中心から該貼着シートの外縁までの最短位置が該装置本体の下方に設定されており、且つ、
     該貼着シートの左右方向の幅寸法が最大とされた位置よりも下方に偏倚して該装置本体の装着部位の中心が設定されている請求項6に記載の心電計。
    The adhesive sheet has a curved shape in which an upper peripheral edge portion has a smaller radius of curvature than a lower peripheral edge portion, and
    The shortest position from the center of the attachment site of the device main body to the outer edge of the adhesive sheet is set below the device main body, and
    7. The electrocardiograph according to claim 6, wherein the center of the attachment site of the device body is set to be offset downward from a position where the width dimension in the left-right direction of the adhesive sheet is maximum.
  8.  患者の人体に装着されて心電図情報を送信及び/又は記録する心電計であって、
     人体の皮膚に貼着される貼着シートと、
     該貼着シートに設けられて人体の皮膚に重ね合わされる複数の測定電極と、
     該貼着シートの外面に設けられたベース部材と、
     該ベース部材に対して着脱可能とされて、前記測定電極による検出電位に基づく心電図情報を送信及び/又は記録する装置本体とを、含み、
     該装置本体には、該装置本体と該測定電極との間及び/又は該測定電極と該人体の皮膚との間の電気的導通性の異常の発生を検出するリードオフ検出機構が設けられており、該リードオフ検出機構により検出される電気的導通性の異常の発生を前記患者へ報知する報知手段を備えている心電計。
    An electrocardiograph that is attached to a patient's body to transmit and/or record electrocardiogram information,
    An adhesive sheet that is attached to the skin of the human body,
    a plurality of measurement electrodes provided on the adhesive sheet and superimposed on the skin of the human body;
    a base member provided on the outer surface of the adhesive sheet;
    a device main body that is removably attachable to the base member and that transmits and/or records electrocardiogram information based on the potential detected by the measurement electrode;
    The device main body is provided with a lead-off detection mechanism that detects occurrence of abnormality in electrical continuity between the device main body and the measurement electrode and/or between the measurement electrode and the skin of the human body. and an electrocardiograph comprising a notification means for notifying the patient of the occurrence of an abnormality in electrical conductivity detected by the lead-off detection mechanism.
PCT/JP2023/006967 2022-03-07 2023-02-27 Electrocardiograph WO2023171441A1 (en)

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Citations (4)

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US4904213A (en) * 1989-04-06 1990-02-27 Motorola, Inc. Low impedance electric connector
JP2016054890A (en) * 2014-09-09 2016-04-21 Cyberdyne株式会社 Contact type sensor
US20160120433A1 (en) * 2014-10-31 2016-05-05 Irhythm Technologies, Inc. Wearable monitor
US20160302684A1 (en) * 2015-04-14 2016-10-20 LifeWatch Technologies, Ltd. Electrode housing and a monitoring device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4904213A (en) * 1989-04-06 1990-02-27 Motorola, Inc. Low impedance electric connector
JP2016054890A (en) * 2014-09-09 2016-04-21 Cyberdyne株式会社 Contact type sensor
US20160120433A1 (en) * 2014-10-31 2016-05-05 Irhythm Technologies, Inc. Wearable monitor
US20160302684A1 (en) * 2015-04-14 2016-10-20 LifeWatch Technologies, Ltd. Electrode housing and a monitoring device

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