WO2024075820A1 - Défibrillateur automatisé externe - Google Patents

Défibrillateur automatisé externe Download PDF

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Publication number
WO2024075820A1
WO2024075820A1 PCT/JP2023/036430 JP2023036430W WO2024075820A1 WO 2024075820 A1 WO2024075820 A1 WO 2024075820A1 JP 2023036430 W JP2023036430 W JP 2023036430W WO 2024075820 A1 WO2024075820 A1 WO 2024075820A1
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WIPO (PCT)
Prior art keywords
electrodes
electrode
needle
external defibrillator
aed
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PCT/JP2023/036430
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English (en)
Japanese (ja)
Inventor
敏雄 千葉
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株式会社オンラインマスター
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Publication of WO2024075820A1 publication Critical patent/WO2024075820A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators

Definitions

  • the present invention relates to an automated external defibrillator.
  • AEDs automated external defibrillators
  • An AED delivers an electric shock (high-voltage pulse) to the patient's heart from outside the body via a pad-type electrode (patient electrode). This can sometimes return the patient's heart to a normal state where it beats at a regular rhythm.
  • the present invention was made in consideration of these circumstances, and aims to provide an automatic external defibrillator equipped with electrodes that can be easily and quickly attached to a patient.
  • one aspect of the present invention is an automated external defibrillator that includes a pair of electrodes that are attached to the recipient to deliver an electric shock, and the electrodes have attachment parts that are attached to the recipient's wet skin.
  • the attachment part may have, for example, a needle-shaped body that pierces the skin of the rescuee.
  • the electrode has, for example, a rod-shaped body, and the needle-shaped body is disposed at the end of the rod-shaped body.
  • the electrode has, for example, a base, and at least one of the needle-shaped bodies is disposed on the base.
  • the electrode has a gripping portion that is grasped by the rescuer of the rescuee, and a gripping portion that grasps the skin of the rescuee, and when the gripping portion is grasped by the rescuer, the gripping portions open, and the skin of the rescuee is inserted and pinched between the gripping portions, and when the gripping portion is released, the skin is grasped by the gripping portions, and the attachment portion is composed of at least the gripping portions.
  • a needle-shaped object that pierces the skin of the rescuee is disposed on the attachment part, and the attachment part includes at least the grip part and the needle-shaped object.
  • the electrode includes a plate-shaped portion and a layer of conductive adhesive containing a filler that is laminated on the plate-shaped portion, and the attachment portion is composed of the layer of conductive adhesive.
  • the attachment section for example, has a portion that reaches the subcutaneous tissue of the rescuee.
  • the needle-shaped body is made of, for example, a conductive porous material.
  • the needle-shaped body for example, has multiple conductive fibers arranged on its surface.
  • the needle-shaped body for example, has an auxiliary electrode inside, which protrudes outside the needle-shaped body and increases the surface area of the electrode.
  • the device may include an impedance measuring means for measuring the impedance between the pair of electrodes attached to the recipient, and a means for adjusting the voltage pulse applied to the recipient via the pair of electrodes according to the impedance measured by the impedance measuring means.
  • the automated external defibrillator may have a rectangular parallelepiped housing, one of the pair of electrodes may be a pad-shaped electrode and disposed on one side of the housing, and the other of the pair of electrodes may be formed in a stick shape with a needle-shaped body at one end and may be removably held on the side of the housing.
  • the electrodes have attachment parts, the electrodes of an automated external defibrillator can be quickly and easily attached to the recipient (patient) even if the recipient's (patient's) skin is wet.
  • FIG. 1 is a diagram showing the external configuration of an automated external defibrillator (AED) according to an embodiment of the present invention
  • 2 is a block diagram showing an example of an internal configuration of the AED shown in FIG. 1.
  • 4A to 4C are diagrams showing examples of positions at which electrodes of an AED according to the first embodiment are attached to a patient.
  • 3(B) is a schematic diagram showing the relationship between the electrodes of an AED and the heart when the electrodes are attached in the positions shown in FIG. 3(A), where (A) is an example of a pad-type electrode, and (B) is an example of the needle-shaped electrode shown in FIG. 6A to 6C are diagrams showing other examples of electrodes of the AED according to the first embodiment.
  • 13A to 13D are diagrams showing other examples of electrodes of the AED according to the first embodiment.
  • 5A and 5B are diagrams showing other examples of electrodes of the AED according to the first embodiment.
  • 5A and 5B are diagrams showing other examples of electrodes of the AED according to the first embodiment.
  • 5A and 5B are diagrams showing other configuration examples of the electrodes of the AED according to the first embodiment.
  • 5A and 5B are diagrams showing other configuration examples of the electrodes of the AED according to the first embodiment.
  • 6A and 6B are diagrams illustrating other configuration examples of the electrodes of the AED according to the first embodiment.
  • 13 is a diagram showing an example of a waveform of a high-voltage pulse applied by an AED according to a second embodiment.
  • FIG. 10 is a flowchart for explaining a high-voltage pulse application process of the AED according to the second embodiment.
  • FIG. 13 is a diagram showing a configuration example of an AED according to a third embodiment.
  • FIG. 15 is a block diagram showing a configuration example of the AED shown in FIG. 14.
  • FIG. 13 is a diagram showing another configuration example of the AED according to the third embodiment.
  • FIG. 13 is a diagram showing yet another configuration example of the AED according to the third embodiment.
  • AED automated external defibrillator
  • the AED 1 according to the first embodiment includes a main body 10, electrodes 30A and 30B, and cables 40A and 40B.
  • the cable 40A electrically connects the main body 10 to the electrode 30A.
  • the cable 40B electrically connects the main body 10 to the electrode 30B.
  • a display unit 11 and an operation unit 12 are provided on one surface of the main body unit 10 .
  • the display unit 11 is configured with, for example, a liquid crystal display device, and displays various information.
  • the operation unit 12 includes various operators such as a volume 12a and a button 12b for allowing the user to input various pieces of information.
  • the AED 1 has a memory unit 13, a control unit 14, a communication unit 15, a high-voltage generation unit 16, a biosignal acquisition unit 17, a status detection unit 18, a power supply unit 19, and an audio output unit 20.
  • the memory unit 13, the control unit 14, the communication unit 15, the high-voltage generation unit 16, the biosignal acquisition unit 17, the status detection unit 18, the power supply unit 19, and the audio output unit 20 are built into the main body unit 10.
  • the power supply unit 19 includes a number of batteries connected so that the output voltage is, for example, about 120V to 200V.
  • the batteries may be primary or secondary batteries. They may also be capacitors, etc.
  • the power supply unit 19 may include a charger that charges the secondary batteries with AC power supplied from a commercial power source. They may also be capacitors, etc. instead of secondary batteries.
  • the power supply unit 19 may also be equipped with a boost circuit.
  • the power supply unit 19 is also connected to each of the display unit 11, operation unit 12, memory unit 13, control unit 14, communication unit 15, biosignal acquisition unit 17, status detection unit 18, and audio output unit 20, and supplies power for operation.
  • the control unit 14 includes a processor, such as a central processing unit (CPU) or a graphics processing unit (GPU), i.e., a computer.
  • the control unit 14 may include a single computer or may include multiple computers.
  • the control unit 14 may also include a gate array, an A/D converter, etc.
  • the control unit 14 is connected to each of the display unit 11, the operation unit 12, the memory unit 13, the communication unit 15, the high voltage generation unit 16, the biosignal acquisition unit 17, the state detection unit 18, and the audio output unit 20.
  • the control unit 14 functions as the control center of the AED 1 by operating according to the program stored in the memory unit 13.
  • the control unit 14 controls the display unit 11, operation unit 12, memory unit 13, communication unit 15, high voltage generation unit 16, biosignal acquisition unit 17, status detection unit 18, and audio output unit 20 according to the program, thereby measuring bioimpedance, performing real-time analysis of bioinformation such as electrocardiogram analysis, and controlling the output of electric shocks.
  • the storage unit 13 is composed of a non-volatile memory such as a ROM (Read Only Memory) and a volatile memory such as a RAM (Random Access Memory).
  • the non-volatile memory stores programs.
  • the volatile memory is used by the control unit 14 as a work area when executing the programs.
  • the volatile memory also temporarily stores various types of biometric information such as electrocardiogram signals.
  • the audio output unit 20 is composed of a speaker and the like, and outputs various sounds such as audio guidance and warnings under the control of the control unit 14.
  • Electrode 30A is connected to high voltage generating unit 16, biosignal acquiring unit 17, and status detecting unit 18 via cable 40A.
  • electrode 30B is connected to high voltage generating unit 16, biosignal acquiring unit 17, and status detecting unit 18 via cable 40B.
  • the electrodes 30A and 30B are each composed of a rod-shaped or stick-shaped body, and are equipped with a holding part to be held by the rescuer, and a conductive needle-shaped body arranged at one end of the holding part.
  • the needle-shaped body has a sharp tip and functions to pierce the rescuee and attach the electrodes 30A and 30B. This makes it possible to quickly and easily attach the electrodes 30A and 30B to the skin of the rescuee even if the rescuee's skin is wet.
  • a flange-shaped or other entry prevention portion 30Aa, 30Ba may be formed at a position 5 mm to 10 mm from the tip of the needle-shaped body.
  • the position, shape, number, etc. of the entry prevention portion 30Aa, 30Ba are arbitrary as long as the tip of the electrode 30A, 30B can be prevented from reaching the subcutaneous tissue and penetrating too deeply into the body.
  • the holding portion is an example of a base
  • the portion including the needle-shaped body is an example of an attachment portion that is attached to the skin of the rescue recipient.
  • the biosignal acquisition unit 17 shown in FIG. 1 acquires various biosignals such as electrocardiogram signals from electrodes 30A and 30B, as well as body temperature, heart rate, respiratory rate, blood oxygen saturation, and relative blood pressure.
  • the biosignal acquisition unit 17 filters noise from the acquired biosignals, amplifies them, and transmits them to the control unit 14.
  • the control unit 14 performs analysis of the electrocardiogram and bioinformation based on the biosignals.
  • the state detection unit 18 detects the attachment state of the electrodes 30A and 30B to the patient, for example, by measuring the impedance (biological impedance) between the electrodes 30A and 30B.
  • the state detection unit 18 outputs a signal indicating the attachment state of the electrodes 30A and 30B to the patient (a signal representing the bioimpedance) to the control unit 14 as an attachment state signal.
  • the control unit 14, the high voltage generation unit 16, and the state detection unit 18 function as a bioimpedance measuring means that measures the impedance (biological impedance) between the electrodes 30A and 30B.
  • the control unit 14 determines the attachment state of the electrodes 30A and 30B to the patient based on the attachment state signal, and causes the determined attachment state to be displayed as an image on the display unit 11 or output as sound from the audio output unit 20.
  • the high voltage generating unit 16 Based on a control signal from the control unit 14, the high voltage generating unit 16 generates a high voltage pulse (more specifically, the potential difference between electrodes 30A and 30B) equivalent to the electric shock to be given to the patient from electrodes 30A and 30B.
  • the high voltage generating unit 16 is not particularly limited in its method as long as it can give the patient an electric shock necessary to return the heart and heartbeat of a patient in cardiac arrest to a normal state.
  • the "electric shock necessary to return the heart and heartbeat of a patient in cardiac arrest to a normal state" is, for example, an electric shock with a voltage value of 1000-3000V, a current value of 15-30A, a pulse width of 2ms-20ms, and energy of 150-360J.
  • the high voltage generating unit 16 it is preferable to adopt the high voltage pulse generating circuit disclosed in JP 2022-182010 A and JP 2022-182010 A, and the high voltage generating unit described in the specification and drawings first attached to the application of International Patent Application PCT/JP2023/30715.
  • the high voltage generating unit it is possible to provide an AED 1 that is small, lightweight, and ready for use in a short time.
  • electrodes 30A and 30B are attached to the patient near the right front chest and the left side of the chest or flank, respectively, as shown in FIG. 3(A). That is, the needle-shaped conductor parts at the tips of electrodes 30A and 30B are inserted into the patient near the right front chest and the left side of the chest or flank, respectively.
  • the attachment positions of the electrodes 30A and 30B are not limited to the example shown in FIG. 3(A).
  • the attachment positions of the electrodes 30A and 30B are arbitrary as long as they are paired with each other on the heart, that is, as long as they are capable of delivering an electric shock to the heart.
  • the electrodes 30A and 30B are attached at positions that can generate a path for a current generated by a high-voltage pulse to pass from one of the electrodes 30A and 30B through the heart to the other.
  • the electrode 30A may be attached to the right shoulder or upper right arm
  • the electrode 30B may be attached to the left shoulder or upper left arm.
  • FIG. 4(A) shows the positional relationship between the electrodes 31A, 31B and the heart H when conventional pad-type electrodes 31A, 31B are attached to a patient.
  • the pad-type electrodes 31A and 31B are attached to the patient's skin K at a position where an electric shock can be administered to the heart H.
  • AED1 is used in situations where it is necessary to quickly and accurately measure the electrocardiogram to determine whether or not an electric shock is necessary, and if it is determined to be necessary, to administer an electric shock as quickly as possible.
  • electrodes 31A and 31B must be attached appropriately to the appropriate positions on the patient as quickly as possible.
  • pad-type electrodes 31A and 31B it is often difficult to attach pad-type electrodes 31A and 31B to the appropriate positions on the skin K. For example, this may occur when the surface of the skin K is wet with bodily fluids or rainwater, or when exposing the chest is hesitant.
  • Electrodes 30A and 30B have a needle-like shape, and at least the tip is made of a conductor such as metal. Therefore, as shown in Fig. 4(B), the user (rescuer) can quickly and easily attach electrodes 30A and 30B to the patient (rescuee) by simply piercing the tip of electrodes 30A and 30B into the skin K or subcutaneous tissue at a predetermined position of the patient (rescuee). Therefore, electrodes 30A and 30B can be quickly and easily attached to the rescuee whose skin K is covered with liquid such as body fluids or rainwater. In addition, electrodes 30A and 30B can be pierced into the patient through clothing, so that electrodes 30A and 30B can be quickly attached even if the patient is a woman.
  • the conductive portions of the pad-shaped electrodes 31A and 31B are present outside the patient's skin K.
  • at least a portion of the conductive portions of the electrodes 30A and 30B of the present embodiment are located in the subcutaneous tissue beyond the patient's skin K. Therefore, the bioimpedance between the electrodes 30A and 30B can be reduced compared to the conventional embodiment.
  • a person's bioimpedance is divided into skin impedance and subcutaneous tissue impedance.
  • Pad-shaped electrodes 31A and 31B shown in FIG. 4(A) are attached to the surface of the skin K.
  • Skin impedance is 30 to 100 k ⁇ per cm2 due to the stratum corneum on the surface, which is one of the causes of high bioimpedance.
  • the impedance between the electrodes 31A, 31B and the skin K also becomes high.
  • the tips of electrodes 30A and 30B are present in the subcutaneous tissue. This allows current to flow inside the patient's body without being affected by the resistance of the stratum corneum or the condition of the skin K. As a result, bioimpedance can be reduced.
  • the needle-shaped electrodes 30A and 30B shown in FIG. 4(B) can achieve the following first and second effects compared to the conventional pad-type electrodes 31A and 31B shown in FIG. 4(A).
  • Electrodes 30A and 30B when there is no need to distinguish between electrodes 30A and 30B, and between electrodes 31A and 31B, they will be collectively referred to as “electrodes 30" and “electrodes 31.” Additionally, cables 40A and 40B will be collectively referred to as “cable 40.”
  • the first effect is that the electrode 30 has an attachment part that has a needle-shaped body. Therefore, the electrode 30 can be quickly and easily attached to the patient by simply inserting the needle-shaped body (attachment part) into an appropriate position of the patient's skin K. This effect is hereinafter referred to as the "easy attachment effect.”
  • the easy attachment effect is particularly noticeable for patients whose skin K surface is wet with bodily fluids or rainwater.
  • the electrode 30 can be quickly and easily attached even when the patient is fully clothed.
  • the second effect is that by attaching the needle-shaped body of the electrode 30 to the patient so that it reaches the subcutaneous tissue, it is possible to reduce bioimpedance without being affected by skin impedance.
  • this effect will be referred to as the "impedance reduction effect.”
  • the electrode 30 of the embodiment does not need to achieve both the first effect and the second effect. It is sufficient for the electrode 30 to achieve the first effect, and it is more preferable for the electrode 30 to achieve the second effect.
  • the electrode 32 shown in FIG. 5 can be used as the electrode of the AED 1.
  • the electrode 32 has a grip portion 321, a holding portion 322, and a coil spring (biasing member) (not shown), similar to a clothespin.
  • the pair of grip portions 322 are in contact with each other and in a closed state due to the action of the coil spring (biasing member).
  • the user rescueer grasps the pair of grip portions 321 to open the pair of grip portions 322, inserts and clamps the skin K between the pair of grip portions 322, and releases the grip of the grip portions 321.
  • the grip portions 322 are clamped to hold the skin K due to the action of the coil spring. As a result, the grip portions 322 come into contact with the skin K and are electrically connected to the skin K.
  • the pair of grip portions 321 are an example of a base, and the pair of grip portions 322 are an example of an attachment portion.
  • the user can quickly attach the electrode 32 to the patient's skin K with a simple operation.
  • the electrode 32 has an easy-to-attach effect.
  • the gripping portion 322 of the electrode 32 may have multiple needle-shaped bodies 323.
  • the length of each needle-shaped body 323 is such that its tip reaches the subcutaneous tissue when the gripping portion 322 is in contact with the skin K, for example, about 5 mm to 10 mm. Therefore, when the skin K is gripped by the gripping portion 322, the tip of the needle-shaped body 323 is located within the subcutaneous tissue. This allows the electrode 32 to achieve an impedance reduction effect.
  • the needle-shaped body 323 may be of such a length that its tip reaches the subcutaneous tissue even through clothing, for example, about 10 mm to 15 mm.
  • the needle-shaped body 323 forms part of the attachment portion.
  • the pad-shaped electrode 33 shown in FIG. 6(A) comprises a plate-shaped portion 331 and a number of needle-shaped bodies 332 formed on one surface of the plate-shaped portion 331.
  • the length of each needle-shaped body 332 is a length that allows the plate-shaped portion 331 to reach the subcutaneous tissue when in contact with the skin K, for example, about 5 mm to 10 mm.
  • the length of the needle-shaped body 332 may be a length that allows the tip to reach the subcutaneous tissue even through clothing, for example, about 10 mm to 20 mm.
  • the plate-shaped portion 331 is an example of a base, and the multiple needle-shaped bodies 332 are each an example of an attachment portion.
  • the planar shape of the plate-like portion 331 may be substantially rectangular as shown in FIG. 6(B) or stick-like as shown in FIG. 6(C). Also, as shown in FIG. 6(D), a cover 333 may be provided to protect the needle-like body 332. When in use, the cover 333 is removed before attaching the electrode 33 to the patient.
  • the pad-type electrode (pad-shaped electrode) 34 shown in FIG. 7A is composed of a plate-shaped portion 341 and a conductive adhesive layer 342 arranged on one surface of the plate-shaped portion 341.
  • the adhesive layer 342 is composed of, for example, a conductive adhesive or a conductive gel.
  • the adhesive layer 342 preferably includes, for example, a conductive filler (filler) 343.
  • the conductive adhesive layer 342 may also be composed of a silicone coating gel containing adhesive.
  • the filler 343 is for improving the conductivity of the conductive adhesive, and is preferably a carbon filler or a metal (preferably silver, which has high conductivity).
  • conductive adhesive or conductive gel please refer to "Conductive Adhesive Technology" in "Journal of the Japan Society for Precision Engineering, Vol. 79, No. 8, 2013, pp. 730-734".
  • the user can quickly and easily attach the electrode 34 to the patient by pressing the adhesive layer 342 against the patient's skin K, even if the surface of the skin K is wet.
  • the plate-shaped portion 341 is an example of a base
  • the conductive adhesive layer 342 is an example of an attachment portion.
  • release paper 344 On the adhesive layer 342. When in use, peel off the release paper 344 from the adhesive layer 342 and then attach the electrode 34 to the patient.
  • an adhesive layer 342 may be disposed on the electrode 33 shown in FIG. 6(A). Similarly, an adhesive layer 342 may be disposed on the electrode 32 shown in FIG. 5, etc.
  • the AED 1 When using the AED 1, it is desirable to have a small bioimpedance. In order to reduce the bioimpedance, it is desirable to increase the surface area of the electrode, or more precisely, the contact area with the patient's tissue. However, simply increasing the surface area results in a larger electrode size. Below, we will use electrode 30 as an example to explain a method for increasing the effective surface area without increasing the size of the electrode itself.
  • the needle-shaped body 35 that comes into contact with the subcutaneous tissue of the patient, from a conductive porous material.
  • the conductive porous material is composed of, for example, porous metal, porous carbon, etc. It is also desirable for the porous material to be highly hydrophilic. The surface of the electrode may be hydrophilized. The porous material has many pores 351 and a large specific surface area. Therefore, even if the shape and size are the same, the needle-shaped body 35 formed from a porous material has a larger surface area than an electrode formed from a non-porous material.
  • the needle-shaped body 35 formed from a porous material is an example of an attachment part.
  • the needle-shaped body 35 When the electrode 30 is attached to a patient, the needle-shaped body 35 is hydrophilic, so bodily fluids spread over the surface of the porous electrode 30 of the needle-shaped body 35 and come into contact with it. Therefore, the contact area between the electrode 30 and the patient is large. This makes it possible to reduce bioimpedance.
  • conductive and flexible fibers (conductive fibers) 352 may be arranged on the needle-shaped body 35. Because the fibers 352 are flexible, when the needle-shaped body 35 is inserted into the patient, the fibers 352 are pressed against the surface of the needle-shaped body 35 and do not provide significant resistance. On the other hand, the portion of the fibers 352 that has entered the subcutaneous tissue of the needle-shaped body 35 spreads out and becomes a current path, increasing the effective surface area of the electrode 30. This makes it possible to reduce bioimpedance.
  • the electrode 30 may increase in size after it is attached to the patient.
  • the electrode 30 includes a case electrode 353 and a conductive pin group 354 housed in the case electrode 353.
  • the pin group 354 corresponds to an auxiliary electrode with respect to the case electrode 353, which corresponds to the electrode body.
  • At least the tip 353a of the case electrode 353 has a sharp outer shape, and the case electrode 353 is formed in a needle shape as a whole.
  • the inside of the case electrode 353 is hollow.
  • a slider 355 is disposed in the hollow part of the case electrode 353.
  • a stopper button 356 is disposed near the base of the case electrode 353.
  • the tip 353a of the case electrode 353 is formed so that it can be opened and closed.
  • the case electrode 353 has a sharp tip and can be inserted into the patient's body.
  • the tip 353a is open, the tip of the internal space of the case electrode 353 is open, allowing the pin group 354 to enter and exit.
  • the slider 355 is engaged with the base of the case electrode 353. With the slider 355 engaged with the base of the case electrode 353, it is biased toward the tip by a biasing member 357.
  • a group of pins 354 is fixed to the slider 355.
  • the case electrode 353 and the group of pins 354 are electrically connected to the cable 40.
  • the stopper button 356 is linked to the tip 353a and the slider 355. When the stopper button 356 is operated, it has the function of releasing the engagement between the tip 353a and the engagement between the slider 355 and the case electrode 353.
  • the pin group 354 is housed in the case electrode 353, and the tip portion 353a is closed.
  • the user inserts the tip 353a of the electrode 30 in this state into the patient's body to attach it.
  • the tip 353a reaches the subcutaneous tissue
  • the user releases the stopper button 256.
  • the stopper button 356 By releasing the stopper button 356, the mutual engagement of the tip parts 353a is released, the tip parts 353a open, and the engagement of the slider 355 with the base end of the case electrode 353 is released.
  • the slider 355 is pushed out by the bias of the biasing member 357, and the pin group 354 is pushed out of the case electrode 353 as shown in FIG. 9B.
  • the pin group 354 extends beyond the case electrode 353 in the subcutaneous tissue of the patient and further spreads. Therefore, the effective surface area of the electrode 30 as a whole is increased. This makes it possible to reduce the bioimpedance.
  • the pin group 354 protrudes from the opening at the tip of the case electrode 353, but the target and the position from which it protrudes can be any as long as the auxiliary electrode can increase the effective surface area of the electrode 30.
  • the means for moving the auxiliary electrode can also be any.
  • the pin group 354 may protrude from the side of the case electrode 353.
  • the shape of the protruding pins may also be arbitrary.
  • the pin group 354 may be replaced with cotton-like conductive fibers 358.
  • the needle-shaped body is conical, but the shape of the needle-shaped body is not limited to a cone, and may be any shape, such as a pyramidal or sawtooth shape, as long as it can be easily inserted into the skin and reach the subcutaneous tissue.
  • a method of biasing the slider 355 with a coil spring to move it has been disclosed, but the biasing means is arbitrary and may be a leaf spring or the like, or may be a body other than a spring such as rubber. It may also be manually pushed out.
  • an AED 1 can be provided that is equipped with electrodes that can be quickly and easily attached to a patient.
  • an AED 1 with low bioimpedance can be provided.
  • the number of high voltage pulses applied is not limited to one.
  • multiple sets of positive and negative pulses may be applied.
  • an AED that can apply a high-voltage pulse of almost constant energy any number of times, regardless of fluctuations in bioimpedance.
  • the electrodes are assumed to be needle-shaped electrodes 30A and 30B.
  • the voltage pulse to be applied when the bioimpedance is at the reference value Rr is preset and stored in the memory unit 13.
  • an instruction to display an electrocardiogram is given by operating the operation unit 12.
  • the control unit 14 acquires the voltage between the electrodes 30A and 30B via the biosignal acquisition unit 17, and displays it on the display unit 11.
  • the rescuer checks the electrocardiogram and determines whether or not an electric shock is necessary. If it is determined that an electric shock is necessary, the rescuer operates the operation unit 12 to set the number of pulses to be applied, and then issues an instruction to apply a high-voltage pulse.
  • control unit 14 When the control unit 14 starts processing, it controls the high voltage generation unit 16 to apply a preset reference voltage between electrodes 30A and 30B.
  • the state detection unit 18 measures the current flowing through electrodes 30A and 30B and notifies the control unit 14 of the measured value.
  • the control unit 14 measures the impedance between electrodes 30A and 30B from the reference voltage applied by the high voltage generation unit 16 and the current detected by the state detection unit 18 (step S11).
  • the control unit 14 obtains a ratio RH of the measured impedance Rb to a preset reference value Rr of the impedance (step S12).
  • the control unit 14 adjusts the waveform of the generated voltage pulse according to the calculated ratio. For example, when adjusting the voltage of the high-voltage pulse, the voltage of the reference waveform is multiplied by ⁇ RH.
  • the pulse width (application time) of the reference waveform is multiplied by RH (step S13).
  • the application number i is set to 1 (step S14).
  • the control unit 14 then controls the high voltage generating unit 16 to output a pulse of the voltage waveform adjusted in step S13 for the set pulse width (step S15).
  • the control unit 14 determines whether the number of applied pulse sets, i, has reached a set value (step S16), and if not (step S16: No), increments i by 1 (step S17), waits for a fixed period of time, for example, 2 to 4 seconds, and then returns to step S15 to apply the next pulse set.
  • control unit 14 determines in step S16 that the set number i of applied pulses has reached the set value (step S16: Yes), it ends the high-voltage pulse application process. After that, it may automatically proceed to the process of displaying the electrocardiogram.
  • Modification 12 shows an example in which two sets of high-voltage pulses of a so-called BTE waveform (biphasic truncated exponential waveform) are applied to the patient, but the waveform of the high-voltage pulse and the number of sets are arbitrary. For example, one set of an RLB waveform (biphasic direct current waveform) or an MDS (monophasic sinusoidal waveform) may be applied, or three or more sets may be applied.
  • BTE waveform biphasic truncated exponential waveform
  • One suitable method for realizing such a system is to have the AED function as a communications device.
  • the AED function can send and receive various information with terminals of remote doctors and the medical community (ambulance teams and emergency hospitals in the case of an emergency). For example, electrocardiogram (signals) and heart rate information acquired by the AED can be provided to ambulance teams and emergency hospitals, which can then communicate to rescuers appropriate measures for the patient, such as whether or not an electric shock is required.
  • the AED 2 is integrated with a communication device.
  • the communication device is assumed to be a smartphone.
  • the communication device is not limited to a smartphone, and may be any device having a communication function, such as a tablet, a palmtop computer, an amateur radio device, or a vending machine.
  • the AED 2 includes an AED configuration (hereinafter, AED section) 21 and a smartphone configuration (hereinafter, smartphone section) 22.
  • the AED section 21 and smartphone section 22 share a battery 23 and a shared section 24.
  • the shared section 24 includes, for example, the display section 11, the operation section 12, the memory section 13, the control section 14, the communication section 15, the audio output section 20, etc.
  • the AED unit 21 has, for example, the configuration of the AED 1 illustrated in FIG. 2.
  • the smartphone unit 22 has, for example, the configuration of a known smartphone.
  • the AED unit 21, smartphone unit 22, and battery 23 are housed in a single housing.
  • all or part of the battery 23 constituting the power supply unit 19 may be disposed in an external device.
  • a case 25 may be prepared for the AED 2, and an external battery 26 may be disposed in the case 25.
  • the power plug 27 of the case 25 is connected to the power connector of the AED 2, and power is automatically supplied from the external battery 26 to the AED 2. In this way, it is possible to supply a large amount of power to the AED 2 while suppressing the size of the power supply unit 19 in the AED 2.
  • AED2 is more expensive than commercially available smartphones because it includes AED unit 21. However, because it is an integrated unit, it can share the same battery as a commercially available smartphone and can be carried around at all times.
  • smartphone refers to a device that is equipped with an OS such as iPhone (registered trademark) or Andoroid (registered trademark), can carry out various communication methods similar to those of commercially available devices, and is in an environment in which various application software can be installed and executed.
  • OS such as iPhone (registered trademark) or Andoroid (registered trademark)
  • the functional configuration of the AED in FIG. 2 is realized by hardware that is originally equipped on the smartphone, hardware that is externally attached to the smartphone, and a software program executed on the smartphone.
  • the display unit 11 can be configured by a display placed on one side of the smartphone, as shown in FIG. 14(B).
  • the operation unit 12 can be configured by hardware buttons that are originally equipped on the smartphone, and software buttons that are displayed on the display unit 11.
  • the memory unit 13, the control unit 14, and the communication unit 15 can be configured using hardware that is originally built into the smartphone.
  • the high voltage generating unit 16 can be configured by hardware that the smartphone is originally equipped with, or by hardware that is attached externally to the smartphone.
  • the biosignal acquisition unit 17 and the condition detection unit 18 can be configured as a software program executed on a smartphone.
  • the power supply unit 19 can be configured by a battery 23 attached to the smartphone.
  • the battery 23 of the smartphone can be shared as the power supply unit 19 of the AED 1.
  • the electrode 30A can be placed on the back of the housing, which is generally rectangular as a whole, as shown in FIG. 14(A). In this case, it is preferable to use the electrode 30A with the adhesive layer 342 shown in FIG. 7(A) to facilitate easy attachment.
  • the cable 40A is wired inside the main body 10 of the AED 1.
  • the electrode 30B is needle-shaped as shown in FIG. 4(B). As shown in FIG. 12(A), the electrode 30B is removably stored on the side of the housing with an attachment together with the cable 40B.
  • electrodes 30A and 30B shown in Figs. 14(A) and (B) is merely an example and can be modified.
  • electrode 30A may be needle-shaped as shown in Fig. 4(B).
  • electrode 30A may be made retractable (detachable) on the other side of the housing.
  • at least one of electrodes 30A and 30B may be clothespin-shaped as shown in Fig. 5.
  • the smartphone 50 functions as a remote controller (hereinafter, remote control) for the AED 1A.
  • the smartphone 50 is a normal commercially available smartphone that does not have an AED function.
  • AED app Special application software (hereinafter referred to as the "AED app") that enables the operation of the AED 1A is installed on the smartphone 50.
  • the user (rescuer) of the AED 1A can operate the AED 1A using the smartphone 50 via wireless communication.
  • the AED 1A shown in FIG. 16 differs from the AED 1 in FIG. 1 in that the electrode 30A is pad-type and attached to the back of the AED 1A.
  • the rest of the configuration is the same as in FIG. 1.
  • the cable 40A is wired inside the main body 10 of the AED 1.
  • electrode 30A and 30B in FIG. 16 is merely one example, and for example, electrode 30A may also be needle-shaped as shown in FIG. 4(B), or at least one of electrodes 30A and 30B may be clothespin- and pinholder-shaped as shown in FIG. 5.
  • the communication unit 15 of the AED 1A shown in FIG. 16 wirelessly communicates with the smartphone 50 via Wi-fi (registered trademark) or Bluetooth (trademark).
  • the communication unit 15 receives a control signal for operating the AED 1A (hereinafter referred to as an "operation signal") from the smartphone 50 and provides it to the control unit 14.
  • the control unit 14 controls the operation of the AED 1A based on the operation signal.
  • the smartphone 50 functions as a controller for the AED 1A.
  • the communication unit 15 also transmits biosignals, such as electrocardiogram signals, acquired by the biosignal acquisition unit 17 of the AED 1A to the smartphone 50.
  • the smartphone 50 can further transmit biosignals, such as electrocardiogram signals, to a terminal of a remote doctor or medical community via the Internet or the like.
  • the smartphone 50 In order for the smartphone 50 to function as a controller for the AED 1A, it is necessary to wirelessly connect the smartphone 50 and the AED 1A. However, since commercially available smartphones 50 are designed to be wirelessly connected to an unspecified number of people, it takes a certain amount of time to wirelessly connect to the AED 1A.
  • a dedicated controller 60 may be used to enable immediate connection to the AED 1A.
  • the dedicated controller 60 shown in FIG. 17 has a program pre-installed that has the same functions as the AED app for the smartphone 50 in FIG. 16. That is, the AED 1A in FIG. 17 is connected to the dedicated controller 60.
  • the wireless communication may be radio wave communication or infrared communication. It may also be wired, etc.
  • the AED 1A and the controller are connected in a 1: ⁇ ratio of AED 1A:controller (smartphone 50).
  • the AED 1A:controller (dedicated controller 60) is 1:1.
  • the AED 1A is instantly connected to the dedicated controller 60, making it possible to operate the AED 1A quickly.
  • the AEDs 2 and 1A having a communication function have been described above with reference to FIGS.
  • records of bioinformation such as an electrocardiogram and heart rate obtained by the AED can be remotely transmitted in real time to an emergency team or an emergency hospital, and the emergency team or emergency hospital can remotely transmit appropriate measures for the patient, such as whether or not an electric shock is required, to the rescuer.
  • vital signs (biological signals, etc.) other than the electrocardiogram signal can be remotely transmitted in real time from the AED to an emergency team or an emergency hospital in this way, it will be possible to provide even more appropriate measures to the patient.
  • the sensor for acquiring such vital signs other than the electrocardiogram signal may be built into the AED 1, 1A, 2, the smartphone 50, or the dedicated controller 60, or may be external.
  • the external sensor can communicate with the AED 1, 1A, 2, the smartphone 50, or the dedicated controller 60 using any method.
  • a small earphone-type sensor 61 may be stored in a removable state in the dedicated controller 60.
  • the earphone-type sensor 61 may be placed in the AED 1, 1A, or 2.
  • This earphone-type sensor is attached to the patient's outer ear and obtains the patient's vital signs (e.g., body temperature, respiratory rate, heart rate, relative blood pressure, blood oxygen saturation, etc.) from the circulatory dynamics of the tissues and structures in the middle ear behind the eardrum, and transmits the same to the AED 1, 1A, or 2, smartphone 50, and dedicated controller 60 via a specified wireless communication method such as Bluetooth (registered trademark).
  • a specified wireless communication method such as Bluetooth (registered trademark).
  • a rescuer first attaches the electrodes 30A and 30B of the AED 1A to the anterior chest of the patient (rescued person). This makes it possible to remotely transmit records of an electrocardiogram (signal), heart rate, etc. acquired by the AED 1 to an ambulance or an emergency hospital. Furthermore, the rescuer inserts the earphone sensor 61 into the ear canal of the patient. The earphone sensor 61 then acquires vital signs of the patient from tissues and structures deep in the eardrum of the patient and transmits them to the AED 1A. The AED 1A transmits the vital signs to an ambulance or an emergency hospital in real time.
  • AEDs are ideal when combined with the functions of smartphones. There are no particular limitations on how they can be combined, and they can be integrated or separate.
  • the AEDs 1A and 2 can refine not only the bio-information (heart rate, etc.) obtained from the electrodes 30 but also the AED activation condition algorithm. Furthermore, for example, the AEDs 1A and 2 can link (communicate) with an IoT medical device using BLE to supplementarily acquire vital signs that cannot be acquired from the electrodes 30.
  • the earphone-type sensor 61 described above can acquire vital signs such as body temperature, respiratory rate, heart rate, relative blood pressure, and blood oxygen saturation. Using such vital signs can prevent erroneous activation or failure of the AED 1.
  • the AEDs 1A and 2 can notify remote doctors and the medical community (ambulance teams and emergency hospitals in case of an emergency) of the patient's condition in real time using a long-distance communication function (WAN 4G/5G (registered trademark), Internet connection function).
  • the medical community includes government agencies (nearby fire stations, ambulance teams, medical institutions, etc.).
  • the AEDs 1A and 2 can use the short-distance communication function to notify medical personnel who are near the patient (within a range of 10 to 100 m) of the occurrence of an emergency.
  • the medical personnel who receive the notification can use the AEDs 1A and 2 to take appropriate measures to rescue the patient (person to be rescued). In this way, the survival rate of patients can be improved by having medical personnel participate in rescue efforts early.
  • the AEDs 1A and 2 can further have a function of transmitting an image (which may be a still image or a video) of the patient's condition to an emergency team or emergency hospital when a rescuer is providing first aid.
  • an image which may be a still image or a video
  • the emergency team or doctor can learn in advance the state of the patient's injuries and posture (including the direction of the head, the state of the airway, the direction of the limbs, etc.), allowing them to make appropriate preparations.
  • the resolution of the patient's image may be automatically controlled up to a maximum resolution of 8K depending on the communication conditions.
  • the AED 1 (smartphone function) of the rescuer may be controlled to provide a communication band (communication bands for multiple smartphones as necessary) that enables communication between the AED 1 (smartphone function) of the rescuer and a smartphone held by another rescuer in the vicinity through short-distance communication.
  • a communication band communication bands for multiple smartphones as necessary
  • the AEDs 1A and 2 can have a function for communicating with an ambulance team or an emergency hospital when a rescuer rescues a patient.
  • the ambulance team or emergency hospital can appropriately give instructions on first aid measures according to the patient's condition and ask questions to further understand the situation.
  • emergency teams or hospitals can more appropriately give instructions on first aid and ask further questions based on the state of the patient's injuries and posture (including the direction of the head, the state of airway management, and the direction of the limbs, etc.).
  • the present invention is not limited to the above-mentioned embodiment, and includes modifications and improvements within the scope of achieving the object of the present invention.
  • the electrodes 30 are not limited to the form of the above-mentioned embodiment.
  • the electrodes of the AED to which the present invention is applied need only be easy to attach, and preferably also have an impedance reduction effect as needed.
  • the pair of electrodes that are attached to the skin of the rescuee (patient) to deliver an electric shock have the function (first function) of serving as an attachment part that attaches a conductive part to the skin in a wet state.
  • the function of at least a part of the electrode 30 piercing the skin is an example of the first function.
  • the gripping portion 322 opens, and the skin of the rescuee (patient) is inserted and pinched between the gripping portions 322.
  • the gripping portion 322 grasps the skin (this does not exclude the possibility that the tips of the numerous electrodes arranged in a pinholder shape may penetrate partially under the skin, causing a decrease in bioimpedance due to the epidermal tissue). This is an example of the first function.
  • the function of attaching the conductive adhesive layer 324 to the patient's skin is an example of the first function.
  • the electrode 30 in order to achieve the impedance reducing effect, it is sufficient for the electrode 30 to have the second function of being attached so that at least a part of it is present inside the skin of the rescuee (patient).
  • the function of a part of the electrode 30 piercing the skin and reaching the subcutaneous tissue is an example of the second function.
  • the function of at least a part of the needle-shaped body 323 reaching the skin tissue is an example of the second function.
  • the functional block diagram shown in FIG. 2 is merely an example and is not particularly limited. In other words, it is sufficient if the function capable of executing the above-mentioned series of processes as a whole is provided, and the type of functional block used to realize this function is not particularly limited to the example in FIG. 2.
  • the locations of the functional blocks are not limited to those shown in Fig. 2 and may be arbitrary.
  • at least a part of the functional blocks of the AED 1 may be provided in another information processing device capable of communicating with the AED 1 (for example, the smartphone 50 in Fig. 7 or the dedicated controller 60 in Fig. 8), or vice versa.
  • a single functional block may be configured as a single piece of hardware, or may be configured in combination with a single piece of software.
  • the program constituting the software is installed into a computer or the like from a network or a recording medium.
  • the computer may be a computer built into dedicated hardware, or may be a computer capable of executing various functions by installing various programs, such as a server, a general-purpose smartphone, or a personal computer.
  • Recording media containing such programs are not only configured as removable media that are distributed separately from the device body in order to provide each user with the program, but also configured as recording media etc. that are provided to each user in a state where they are already installed in the device body.
  • the steps describing the program to be recorded on the recording medium include not only processes that are performed in chronological order, but also processes that are not necessarily performed in chronological order but are executed in parallel or individually.
  • AED automated external defibrillator
  • 10 Main body 11: Display 12: Operation section 13: Memory section 14: Control section 15: Communication section 16: High voltage generation section 17: Biosignal acquisition section 18: Status detection section 19: Power supply section 20: Audio output section 30, 30A, 30B, 31 to 34: Electrodes 40, 40A, 40B: Cables 50: Smartphone 60: Dedicated controller 321: Grip section 322: Holding section 323: Needle-shaped body

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  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

Dans la présente invention, des électrodes (30A) et (30B) d'un défibrillateur externe automatisé sont placées sur la peau d'une personne en cours de sauvetage (patient) et appliquent un choc électrique. Au niveau des sections d'extrémité distale des électrodes (30A) et (30B), les électrodes (30A) et (30B) sont configurées à partir de corps en forme d'aiguille. La perforation de la peau à l'aide des électrodes (30A) et (30B) permet aux électrodes (30A) et (30B) d'être placées rapidement et facilement même sur la peau qui est humide avec un fluide corporel ou de l'eau de pluie.
PCT/JP2023/036430 2022-10-05 2023-10-05 Défibrillateur automatisé externe WO2024075820A1 (fr)

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JP2022-160854 2022-10-05

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030130427A1 (en) * 2001-05-01 2003-07-10 Cleary Gary W. Two-phase, water-absorbent bioadhesive composition
JP2009154008A (ja) * 2000-01-18 2009-07-16 Koninkl Philips Electronics Nv 電荷に基づく除細動方法及び装置
JP2015500090A (ja) * 2011-12-06 2015-01-05 カーディオスライヴ インコーポレイテッド 患者の経胸的インピーダンスを減少させる器具及び方法
US11433249B1 (en) * 2022-04-04 2022-09-06 Altrix Medical, Inc. Compact AED with one distal electrode

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009154008A (ja) * 2000-01-18 2009-07-16 Koninkl Philips Electronics Nv 電荷に基づく除細動方法及び装置
US20030130427A1 (en) * 2001-05-01 2003-07-10 Cleary Gary W. Two-phase, water-absorbent bioadhesive composition
JP2015500090A (ja) * 2011-12-06 2015-01-05 カーディオスライヴ インコーポレイテッド 患者の経胸的インピーダンスを減少させる器具及び方法
US11433249B1 (en) * 2022-04-04 2022-09-06 Altrix Medical, Inc. Compact AED with one distal electrode

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