WO2018153188A1 - 心律监测装置 - Google Patents

心律监测装置 Download PDF

Info

Publication number
WO2018153188A1
WO2018153188A1 PCT/CN2018/073373 CN2018073373W WO2018153188A1 WO 2018153188 A1 WO2018153188 A1 WO 2018153188A1 CN 2018073373 W CN2018073373 W CN 2018073373W WO 2018153188 A1 WO2018153188 A1 WO 2018153188A1
Authority
WO
WIPO (PCT)
Prior art keywords
waterproof
layer
adhesive layer
heart rate
monitoring device
Prior art date
Application number
PCT/CN2018/073373
Other languages
English (en)
French (fr)
Inventor
洪铭为
吴智良
邱奕元
Original Assignee
吴智良
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 吴智良 filed Critical 吴智良
Priority to EP18758419.8A priority Critical patent/EP3586732A4/en
Priority to AU2018223850A priority patent/AU2018223850B2/en
Priority to US16/486,092 priority patent/US20200054226A1/en
Publication of WO2018153188A1 publication Critical patent/WO2018153188A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02438—Detecting, measuring or recording pulse rate or heart rate with portable devices, e.g. worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/68335—Means for maintaining contact with the body using adhesives including release sheets or liners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0431—Portable apparatus, e.g. comprising a handle or case
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215—Silver or silver chloride containing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0217—Electrolyte containing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip

Definitions

  • the present invention relates to a heart rate monitoring device, and more particularly to a heart rate monitoring device having a waterproof structure, which does not have to be removed even when showering or swimming, and has a simple structure of a patch shape, which can greatly improve the convenience in use, and It can extend the operation time and obtain long-term effective heart rhythm information for subsequent diagnosis.
  • Arrhythmia an abnormal heart rhythm, usually leads to many types of symptoms, such as loss of consciousness, palpitations, dizziness, and even death, and is often a hallmark of important underlying heart disease in the circulatory system.
  • implanted rhythm regulators are generally used, but the related symptoms are often caused by other less serious causes.
  • arrhythmia usually occurs briefly when not expected. Therefore, how to correctly diagnose arrhythmia has always been the goal of the medical community.
  • the electrodes are usually applied to the chest for a short period of time, such as within one day, and the electrodes are connected to a recording device worn on the waist belt or between the waist for monitoring the heart rhythm.
  • the disadvantage is that the electrodes need to be replaced daily, and the connected wires are annoying and uncomfortable.
  • the main object of the present invention is to provide a heart rate monitoring device for attaching to the surface of an animal body to provide a heart rate monitoring function, mainly comprising a waterproof case, a waterproof patch, at least two electrodes, a battery, and an electrical circuit system.
  • the waterproof case has a first opening and a second opening, wherein the first opening is for receiving a waterproof Universal Serial Bus (USB) slot, and is protected by a dust cover in a removable manner, and is waterproof
  • USB slot is used to connect an external USB device.
  • the second opening is for accommodating a power start button.
  • the waterproof patch is located under the waterproof case, and the horizontal size of the waterproof patch is larger than the lateral size of the waterproof case.
  • the waterproof case and the waterproof patch are mutually clamped to form a waterproof receiving space, and are attached to the surface of the animal body by the waterproof patch, wherein the battery and the circuit system are housed in the waterproof receiving space.
  • the circuit system is located within the waterproof containment space and includes a circuit board for carrying a plurality of circuit components.
  • the battery is located within the waterproof containment space and is powered by a power enable button to provide power to the circuit components of the circuitry.
  • each electrode is located below the waterproof case and each electrode extends outwardly from the waterproof containment space to form a corresponding sensing end.
  • the sensing end penetrates the waterproof patch and contacts the surface of the animal for sensing the electrical signal of the animal's body surface, and the electrical signal is processed by the circuit system to obtain and store the corresponding heart rhythm information for a long time. Achieve heart rate monitoring.
  • the waterproof case has a first opening and a second opening, which can be located at the side or the top of the waterproof case, wherein the first opening can accommodate the waterproof USB slot for connecting the external USB device, and the second opening can accommodate the power activation A button that turns on the battery to provide power.
  • the first opening is covered with a dust cover to prevent dust from clogging or affecting electrical performance.
  • the middle frame can be additionally arranged in the waterproof case for presenting the annular structure in the middle hollow, and the lower part of the middle frame can form a hook for covering and externally embedding in the circuit system, and the upper part of the middle frame can be used for The battery is carried and further fixed to provide a protection mechanism for the battery and the circuit system.
  • the hooks in the lower part of the middle frame and the card slots of the circuit boards in the circuit system are arranged to coincide with each other.
  • the circuit board of the circuit system can be clamped up and down by using the first buffer pad layer and the second buffer pad layer to provide shockproof or shock absorbing effects and protect the circuit components of the circuit board.
  • the battery can be disposed on the waterproof foam layer, and the waterproof foam layer is further disposed on the circuit board.
  • the battery, waterproof foam layer is hollowed out in the annular structure in the middle of the middle frame.
  • the waterproof patch comprises an upper release layer, a waterproof film, a reinforcement layer, a lower cover, at least two isolation layers, a conductive gel, a first adhesive layer, a second adhesive layer, and a lower release layer, wherein the waterproof film, the reinforcement layer, a lower cover, an isolating layer, a conductive gel, a first adhesive layer, a second adhesive layer, and a lower release layer, wherein the waterproof film, the reinforcing layer, the lower cover, the at least two isolation layers, the conductive gel, the first adhesive layer, and The second adhesive layer is sandwiched between the upper release layer and the lower release layer, and the upper release layer and the lower release layer are removed during use.
  • the upper release layer has an intermediate opening for enclosing the waterproof case.
  • the waterproof membrane is located below the upper release layer.
  • the reinforcing layer is located below the waterproof film and has at least two receiving spaces.
  • Each of the isolating layers is annular in shape and is adapted to fit into a corresponding receiving space of the reinforcing layer.
  • the sensing end of the electrode is located in the ring of the isolation layer.
  • the lower cover is under the reinforcing layer and is located in the middle of the reinforcing layer and is combined with the waterproof casing so that the waterproof receiving space of the waterproof casing has watertight characteristics to provide insulation protection.
  • the conductive gel is disposed under the sensing end portion, and therefore, the sensing end portion senses an electrical signal of the animal's body surface via the conductive gel, thereby preventing the surface material of the animal's body surface from affecting the sensing end portion. Sensitivity.
  • the first adhesive layer is located under the lower cover, and the first adhesive layer is sized to be equal to or close to the size of the lower cover, and the second adhesive layer is designed to be annular for accommodating the conductive gel. Also.
  • the lower release layer is used to carry the first adhesive layer, the second adhesive layer, the conductive gel, and a portion of the waterproof film.
  • the invention can improve the convenience of use, and when the waterproof patch is adhered to the skin to form a closed system, the external moisture can be prevented from entering between the waterproof patch and the skin, thereby prolonging the attachment period and the use time.
  • the present invention can facilitate sweat absorption and reduce perspiration resistance by means of the depletion zone formed by the first and second adhesive layers, which greatly contributes to the comfort of the device of the present invention when worn. And it is more stable on the user, which can prolong the wearing time and not fall off easily.
  • FIG. 1 shows an overall schematic view of a heart rate monitoring device in accordance with an embodiment of the present invention.
  • FIG. 2 is an exploded perspective view showing a waterproof case in a heart rate monitoring device according to an embodiment of the present invention.
  • FIG 3 is an exploded perspective view of a waterproof patch in a heart rate monitoring device in accordance with an embodiment of the present invention.
  • Heart rate monitoring device 1, waterproof case 10, first opening 11, second opening 12, waterproof USB slot 13, dust cover 14, external USB device 15, power start button 16, first cushion layer 17, second Buffer pad 18, anti-slip sheet 19, waterproof patch 20, upper release layer 21, waterproof film 22, reinforcing layer 23, lower cover 24, spacer layer 25, conductive gel 26, first adhesive layer 27, second The adhesive layer 28, the lower release layer 29, the electrode 30, the sensing end portion 31, the battery 40, the circuit system 50, the circuit board 51, the circuit component 52, the waterproof foam layer FL, and the middle frame MF.
  • FIG. 1 is a cross-sectional view of a heart rhythm monitoring device according to an embodiment of the present invention
  • FIG. 2 is an exploded perspective view of the waterproof case of FIG. 1
  • the heart rate monitoring device 1 of the present invention mainly includes a waterproof case 10, a waterproof patch 20, at least two electrodes 30, a battery 40, and a circuit system 50.
  • the heart rate monitoring device 1 can be attached to an animal body or a human body surface for providing a heart rate monitoring function.
  • the waterproof case 10 is placed on the waterproof patch 20 and sandwiched to each other to form a waterproof accommodation space.
  • the waterproof patch 20 extends outward from the inside of the waterproof casing 10 to the periphery of the waterproof casing. It can also be said that the waterproof patch 20 extends outward from the bottom of the waterproof casing 10 to the periphery of the waterproof casing, and the waterproof patch The periphery of 20 forms a continuous and closed shape.
  • the waterproof patch 20 is attached to the surface of the animal body to form a closed system between the waterproof patch 20 and the surface of the animal body to prevent external moisture from entering, and the battery 40 and the circuit system 50 are housed in the waterproof receiving space.
  • the waterproof case 10 can be made of a material such as plastic, metal, silicone, rubber or carbon fiber. It is to be noted that the lateral dimension of the waterproof patch 20 is specifically designed to be larger than the lateral dimension of the waterproof case 10.
  • each of the electrodes 30 is electrically connected to the circuitry 50 and is configured to be positioned below the waterproof case 10.
  • the circuit system 50 has at least two conductive elements, and at least one exposed area of the upper portion of each of the electrodes 30 under the waterproof case 10 is in contact with the corresponding at least two conductive elements to form an electrical connection.
  • the battery 40 is located in the waterproof accommodation space.
  • the circuit system 50 is located within the waterproof containment space and includes a circuit board 51 for carrying a plurality of circuit components 52, and the circuit components 52 are operated by the battery 40 to provide power.
  • Battery 40 can be a disposable battery or a rechargeable secondary battery, such as a button cell or a lithium polymer battery.
  • each electrode 30 is electrically connected to the circuit board 51.
  • the electrode 30 extends outwardly from the waterproof containment space to form a corresponding sensing end 31 for contacting the surface of the animal body.
  • the sensing end portion 31 penetrates the waterproof patch 20 to contact the body surface of the animal for sensing an electrical signal of the animal's body surface, wherein the electrical signal is processed by the circuit system 50 to obtain and store the long-term phase.
  • Corresponding heart rhythm information to achieve heart rate monitoring.
  • the portions of the adjacent two electrode sensing ends that are in contact with the body surface have a shortest relative distance of at least 5 cm.
  • the shapes of the adjacent two electrodes are asymmetrical to each other.
  • the waterproof case 10 has a first opening 11 and a second opening 12, wherein the first opening 11 can be used to accommodate a waterproof Universal Serial Bus (USB) slot 13, and the first opening 11 can be protected.
  • the dust cover 14 is protected in a removable manner to prevent dust from clogging and affecting the quality of electrical operation.
  • the waterproof USB slot 13 can be used to connect the external USB device 15.
  • the second opening 12 is for receiving the power start button 16. Battery 40 is turned on by power enable button 16 to provide power to circuit component 52.
  • the waterproof USB slot 13 is waterproof and electrically connected to the circuitry 50.
  • the waterproof USB slot 13 is covered with a layer of soft silicone rubber or rubber material to interfere with the first opening 11 of the waterproof case 10 to form a watertight structure to achieve a waterproof function, thereby preventing moisture from entering the waterproof case 10.
  • the waterproof USB slot 13 may be disposed such that the slot surface protrudes from the first opening 11 , is parallel to the first opening 11 or lower than the first opening 11 .
  • an external USB device 15 such as a computer or mobile phone, can be connected to the waterproof USB slot 13 via a USB cable such that the external USB device 15 can access the internal data of the circuitry 50.
  • the external USB device 15 is further electrically connected to circuit elements 52 in the circuitry 50, such as memory components, within the waterproof containment space, thereby enabling access to memory data.
  • the dust cover 14 covers the waterproof USB slot 13 and is adhered to the outside of the waterproof case 10 by an adhesive layer around the bottom of the waterproof case 10 to prevent dust from entering the waterproof USB slot 13 and affecting data capture or avoiding users.
  • the USB is not operated as directed.
  • the data prevents the user from accidentally or deliberately removing the dust cover 14 during the wearing of the device.
  • the dust cover 14 can be made of a material such as plastic, metal, silicone, rubber or carbon fiber.
  • the present invention may further include a first buffer pad layer 17 and a second buffer pad 18, which can clamp the circuit board 51 up and down. The circuit component 52 is thus protected.
  • the first buffer pad layer 17 and the second buffer pad 18 may be made of materials of different hardness such as plastic, silicone, rubber, foam, and the like.
  • the outer shape of the first buffer pad layer 17 is also combined with the circuit component 52 of the circuit system 50 to form an irregular shape.
  • the outer shape of the second cushioning gasket 18 may be at least equal to or greater than the surface of the circuit component 52 to ensure that its various portions are protected.
  • the waterproof case 10 can also be provided with a slip preventing sheet 19 on the outer side of the waterproof case 10 for preventing the user from inadvertently slipping when holding the heart rate monitoring device 1 of the present invention.
  • the heart rate monitoring device 1 of the present invention may further include a middle frame MF disposed in the waterproof case 10 to present an annular structure with an intermediate hollow.
  • the lower portion of the middle frame MF can form a hook for cladding and externally embedded in the circuit system 50, and the middle frame MF can further secure the battery 40 and the circuit system 50 to provide additional protection.
  • the heart rate monitoring device 1 of the present invention may further be provided with a waterproof foam layer FL.
  • the waterproof foam layer FL is disposed on the circuit board 51, the battery 40 is disposed on the waterproof foam layer FL, and the battery 40 and the waterproof foam layer FL are in the annular structure of the middle frame MF.
  • the outer shape of the waterproof foam layer FL can be designed to be equal to or smaller than the battery 40. Therefore, when the user is in a normal active environment and the heart rhythm monitoring device 1 of the present invention is dynamically used, the waterproof foam layer FL can provide a buffering effect, greatly reducing the force when subjected to vibration or external impact, and avoiding abnormal operation of the battery 40. .
  • the waterproof patch 20 includes an upper release layer 21, a waterproof film 22, a reinforcement layer 23, a lower cover 24, at least two isolation layers 25, a conductive gel 26, a first adhesive layer 27, and a second adhesive layer 28. And a lower release layer 29.
  • the waterproof film 22, the reinforcing layer 23, the lower cover 24, the at least two isolation layers 25, the conductive gel 26, the first adhesive layer 27, and the second adhesive layer 28 are sandwiched between the upper release layer 21 and the lower release layer. Between 29, and the upper release layer 21 and the lower release layer 29 are removed during use.
  • the upper release layer 21 is attached to the waterproof film 22, and in addition to having a protective effect, it can also provide the stiffness of the patch itself during the attaching operation, preventing the waterproof film from collapsing and being difficult to attach, and after the attaching operation is completed.
  • the upper release layer 21 can be removed.
  • the upper release layer 21 and the lower release layer 29 may be composed of a plastic or paper material.
  • the waterproof foam layer FL may be composed of an inner closed cell or an open cell polymer foamed material. Further, the periphery of the waterproof foam layer FL and the periphery of the lower edge of the waterproof case 10 are aligned with each other, and are bonded to the waterproof case 10 and the waterproof film 22 by an adhesive layer around the waterproof foam layer FL to provide the waterproof case 10 The waterproof effect of the interior space.
  • the upper release layer 21 has an intermediate opening for enclosing the waterproof casing 10, that is, the waterproof casing 10 can be fitted into the intermediate opening.
  • the waterproof film 22 is located below the upper release layer 21 and the waterproof foam layer FL, and extends outward from the inside of the waterproof case 10 toward the periphery of the waterproof case 10.
  • the waterproof membrane 22 is viscous and becomes a closed system when attached to the skin, so that external moisture cannot enter between the adhesive layer and the skin to prolong the attachment cycle.
  • the waterproof film 22 may have a thickness of less than 0.1 mm and is malleable.
  • the waterproof film 22 is made of a water-repellent substrate coated with a surface layer of a glue, for example, an acrylic adhesive is applied to a PU (polyurethane) substrate.
  • the waterproof film 22 is located above the first adhesive layer 27 and the second adhesive layer 28, and covers a range that covers and surrounds the first adhesive layer 27 and the second adhesive layer 28.
  • At least two electrodes 30 are located below the waterproof membrane 22 and are electrically connected to the circuitry 50 within the housing 10 .
  • the electrode 30 is distributed and configured to be integrated into the waterproof patch 20 and extend outward to the outside of the waterproof case 10, and the skin 30 can be directly or indirectly contacted by the electrode 30 outside the waterproof case 10, and the heart rhythm can be measured and transmitted to the internal circuit system. 50.
  • the material of the electrode 30 may be composed of silver chloride (AgCl) or silver-silver chloride (Ag/AgCl) or composed of various conductive materials, and then coated, plated or printed with a layer of silver chloride (AgCl).
  • a silver-silver chloride (Ag/AgCl) layer or a material with tensile strength, such as rubber, silica gel, PU (Polyurethane) or TPU (Thermoplastic Polyurethane), then coated, plated or printed with a layer of chlorine
  • a layer of silver (AgCl) or a layer of silver-silver chloride (Ag/AgCl) is used as a signal transmission medium between the skin and the conductive material.
  • the reinforcing layer 23 is located under the waterproof film 22 and below the electrode 30, and the upper and lower portions of the reinforcing layer 23 each have an adhesive layer for attaching the electrode 30 and the waterproof film 22 upward, and simultaneously bonding the second paste downward. Layer 28.
  • the main function of the reinforcing layer 23 is to strengthen the tensile strength of the electrode 30.
  • the reinforcing layer 23 has a corresponding number of holes with at least two electrodes 30, such as at least two receiving spaces, outside the waterproof casing 10, and an area where the sensing end 31 of each electrode 30 overlaps the reinforcing layer 23 for accommodating A number of isolation layers 25 and conductive gel 26. Further, the area of the reinforcing layer 23 is smaller than the area of the waterproof film 22.
  • the reinforcing layer 23 can be made of materials such as plastic, silicone, rubber, and the like.
  • the spacer layer 25 is adhered to the underside of the corresponding at least two electrodes 30 and is located in the receiving space of the corresponding reinforcing layer 23.
  • the barrier layer 25 also has a partially hollowed out area to accommodate the corresponding conductive gel 26.
  • the function of the isolation layer 25 is to isolate the conductive gel 26 and the second adhesive layer 28 from contact between the two to cause internal moisture or substance exchange, which affects the conductive effect of the conductive gel 26.
  • the barrier layer 25 may be made of a material that does not absorb water or a small amount of water, such as plastic, silicone, rubber or foam.
  • each of the isolation layers 25 is annular in shape, for accommodating the corresponding accommodation space of the reinforcement layer 23, and the sensing end portion 31 of each electrode 30 Located in the ring of the corresponding isolation layer 25.
  • the conductive gel 26 has electrical conductivity and viscosity, one side adheres to the underside of the corresponding at least two electrodes 30, and the other side contacts the skin, and serves as a conduction medium for the heart rate measurement signal between the skin and the electrode 30.
  • the conductive gel 26 contains a small amount of water, a resin and an electrolyte.
  • the lower cover 24 is below the reinforcing layer 23, and is located in the middle of the reinforcing layer 23, and is aligned with the waterproof case 10 for bonding with each other to make the waterproof receiving space have watertight characteristics. Furthermore, the upper surface of the lower cover 25 may have a hook that is compatible with the slot of the waterproof case 10, so that the entire patch and the waterproof case 10 can be tightly coupled to have a waterproof function.
  • the material of the lower cover 24 may be plastic, metal or carbon fiber, etc., and is a tough material. Therefore, it can carry the internal circuit system 50 and has a protective effect.
  • the front surface of the first adhesive layer 27 is an adhesive layer having adhesiveness, and the back surface of the first adhesive layer 27 has an adhesive layer which can be combined with the lower surface of the lower cover 24. Since the surface of the adhesive layer of the first adhesive layer 27 is attached to the skin, the lower cover 24 can be prevented from being displaced and shaken. Therefore, the heart rate monitoring device of the present invention is relatively stable on the user, and the wearing time can be extended without being easily detached.
  • the adhesive layer of the first adhesive layer 27 may further have a plurality of depletion regions, and the first adhesive layer 27 is divided into a plurality of discrete segments.
  • the adhesive layer of the first adhesive layer 27 may be composed of a hydrating gel (Hydrocolloid), a polyurethane (PU) glue, a silica gel, a rubber, a hot melt adhesive or an acrylic adhesive, either alone or in combination.
  • a substrate such as a water-absorbing substrate such as non-woven fabric, hydrogel or polymerizable group containing a hydrophilic group such as a carboxyl group (-COOH) or a hydroxyl group (-OH).
  • a non-absorbent substrate such as a PU (Polyurethane) waterproof gas permeable membrane or the like.
  • the surface of the second adhesive layer 28 further includes an adhesive layer having adhesiveness, and the back surface of the second adhesive layer 28 is bonded to the adhesive layer of the lower portion of the reinforcing layer 23.
  • the adhesive layer of the second adhesive layer 28 has holes corresponding to the reinforcing layer 23 for accommodating the corresponding isolation layer 25 and the conductive gel 26. Therefore, when the surface of the adhesive layer of the second adhesive layer 28 is attached to the skin, the void can assist the conductive gel 26 to be firmly adhered to the skin without being easily displaced.
  • the adhesive layer of the second adhesive layer 28 may further have a plurality of depletion regions and divide the second adhesive layer 28 into a plurality of discrete segments.
  • the adhesive layer of the second adhesive layer 28 may be composed of a material such as a hydrocolloid, a PU glue, a silica gel, a rubber, a hot melt adhesive or an acrylic adhesive, either alone or in a composite manner, or may be composed of the above materials and
  • a substrate is attached on the back side, such as a water-absorbent substrate such as a non-woven fabric, a hydrogel, or a high molecular polymer containing a hydrophilic group such as a carboxyl group (-COOH) or a hydroxyl group (-OH), or a non-absorbent substrate.
  • PU Polyurethane
  • the lower release layer 29 is attached to the bottommost layer of the overall waterproof patch 20 for covering and protecting the adhesive material contacting the skin in the waterproof patch 20 to avoid contamination.
  • the lower release layer 29 may be provided with a waterproof layer and a release agent or a release layer on the surface of the paper substrate, or a release layer or a release layer may be attached to the surface of the plastic substrate for the purpose of The release layer reduces the adhesion when removed from the patch, and avoids peeling off the adhesive material on the patch.
  • the lower release layer 29 can be further configured to separate the two lobes and attach a dust protection sticker to the gap between the two detachment layers, which allows the user to go from inside to outside via the handle on the two-lobed release layer.
  • the lower release layer 29 is removed, so that the peeling of the adhesive material on the waterproof patch 20 can also be avoided.
  • the first adhesive layer 27 is located under the lower cover 24, and the size of the first adhesive layer 27 is equal to or close to the size of the lower cover 24, and the second adhesive layer 28 is configured to have a ring shape for accommodating Conductive gel 26. Further, the lower release layer 29 is configured to carry the conductive gel 26, the first adhesive layer 27, and the second adhesive layer 28.
  • the lower edge of the waterproof case 10 can be closely combined with the lower cover 24 and the waterproof foam layer FL to form a watertight structure, and the inner wall of the waterproof case 10 has a card slot, and can be tightly coupled with the hook around the lower cover 24.
  • the above-described circuit system 50 is placed between the waterproof case 10 and the waterproof patch 20, and the circuit component 52 includes an appropriately configured analog, digital electrical component and data storage memory.
  • the circuit system 50 is responsible for performing power supply management, filtering of heart rate measurement signals, analog to digital signal conversion, and data storage.
  • the circuit system 50 may further have a wireless transmission unit, such as a Bluetooth, WiFi or optical communication transmission unit, which can transmit the measured or accessed heart rate information to an external system device, such as a computer or a mobile phone, and is performed by an external device. Reprocessing and analysis of data.
  • the present invention is characterized in that it has a simple structure and can be in the form of a patch, which can improve the convenience of use, and does not need to be taken off even when showering or swimming, in particular, the waterproof patch is attached to the skin to form.
  • the present invention can facilitate sweat absorption and reduce perspiration resistance by means of the depletion zone formed by the first and second adhesive layers, which greatly contributes to the comfort of the device of the present invention when worn. And it is more stable on the user, which can prolong the wearing time and not fall off easily.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Signal Processing (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

一种心律监测装置（1），用于贴附至动物体表面而提供心律监测功能，包括防水壳（10）；防水贴片（20），位于防水壳（10）的下面，防水壳（10）与防水贴片（20）相互包夹而形成防水容纳空间，并由防水贴片（20）贴附于动物体表面上；电路***（50），位于防水容纳空间内；电池（40），位于防水容纳空间内；以及至少二个电极（30），连接至电路***（50），每个电极（30）从防水容纳空间向外延伸以形成相对应的感测端部（31），感测端部（31）穿透防水贴片（20）而接触到动物体表，用于感测动物体表的电气信号。心律监测装置具防水功能，且具有贴片状的简单结构，能改善使用便利性，还可延长操作时间，获得长时间心律信息，实现心律监测功能。

Description

心律监测装置
相关申请的交叉引用
本申请主张2017年2月22日在中国提交的中国专利申请号No.201710095407.0的优先权，其全部内容通过引用包含于此。
技术领域
本发明涉及一种心律监测装置，尤其是涉及具有防水特性，即使在淋浴、游泳时也不必取下，而且具有贴片状的简单结构的心律监测装置，能大幅改善使用上的便利性，还可延长操作时间，并获得长时间的有效心律信息以供后续诊断。
背景技术
心律不整，即心脏律动异常，一般会导致多种类型的症状，如意识丧失、心悸、头晕、甚至死亡，而且通常是循环***中重要潜在心脏疾病的标志。为防止发生心律不整，远离死亡的威胁，一般是利用植入心律调节器，但是相关的症状往往由于其他不太严重的原因所引起。尤其，心律不整通常是在不预期时短暂发生。因此，如何能正确诊断出心律不整一直以来都是医疗界的努力目标。
在现有技术中，通常利用电极短期贴于胸前，比如一天以内，且电极连接至配戴在腰带上或在腰际间的记录装置，用于监控心律。不过，其缺点是需要每日更换电极，而且连接的电线很恼人，造成不适感。
此外，上述现有技术的有效记录时间也相当有限，无法长时间操作、记录心律信息。常常在进行某些运动或活动时，比如洗澡，必须取下电极、记录装置，造成使用上很不方便。
因此，很需要一种新式非侵入性的心律监测装置，具有贴片状的简单结构，能改善使用上的便利性，还可延长整体操作时间，尤其是需要具有防水特性，即使在淋浴、游泳时也不必取下的心律监测装置，进而解决上述现有技术的问题。
发明内容
本发明的主要目的在于提供一种心律监测装置，用于贴附至动物体表面而提供心律监测功能，主要包括防水壳、防水贴片、至少二个电极、电池以及电路***。防水壳具有第一开口及第二开口，其中第一开口用于容纳防水通用串行总线(Universal Serial Bus，USB)插槽，且由防尘盖以可移除的方式覆盖而保护，而防水USB插槽用于连接外部USB装置。此外，第二开口用于容纳电源启动按键。
防水贴片位于防水壳的下面，且防水贴片的横向尺寸大于防水壳的横向尺寸。防水壳及防水贴片相互包夹而形成防水容纳空间，并由防水贴片贴附于动物体表面上，其中电池和电路***容纳于防水容纳空间内。
电路***位于防水容纳空间内，并包括电路板，用于承载多个电路元件。电池位于防水容纳空间内，并由电源启动按键打开而提供电源给电路***的所述电路元件。
所有电极电气连接至电路***，且每个电极位于防水壳的下面而每个电极从防水容纳空间向外延伸以形成相对应的感测端部。此外，感测端部穿透防水贴片而接触到动物体表，用于感测动物体表的电气信号，电气信号经电路***处理，从而获得、储存长时间的相对应的心律信息，以实现心律监测功能。
进一步而言，防水壳具有第一开口及第二开口，可位于防水壳的侧面或顶部，其中第一开口可容纳防水USB插槽，用于连接外部USB装置，而第二开口可容纳电源启动按键，用于打开电池而提供电源。此外，第一开口用防尘盖覆盖，以防灰尘阻塞或影响电气性能。再者，可额外配置中框于防水壳内，用于呈现中间镂空的环形结构，且中框的下部可形成卡勾，用于包覆并外嵌于电路***，而中框的上部可用于承载电池，且进一步固定而提供电池、电路***的保护机构。尤其，中框下部的卡勾及电路***中电路板的卡槽配置成相互吻合。
电路***的电路板可利用第一缓冲垫片层、第二缓冲垫片层而上下包夹住，提供防震或减震功效，保护电路板的电路元件。电池可配置在防水泡棉层上，且防水泡棉层进一步安置在电路板上。尤其，电池、防水泡棉层在中 框的中间镂空环形结构中。
防水贴片包括上离型层、防水膜、强化层、下盖、至少二个隔离层、导电凝胶、第一粘贴层、第二粘贴层、下离型层，其中防水膜、强化层、下盖、隔离层、导电凝胶、第一粘贴层、第二粘贴层以及下离型层，其中防水膜、强化层、下盖、至少二个隔离层、导电凝胶、第一粘贴层及第二粘贴层包夹在上离型层与下离型层之间，且上离型层和下离型层在使用时被移除。
上离型层具有中间开口，用于围住防水壳。防水膜位于上离型层的下面。强化层位于该防水膜的下面，并具有至少二个容纳空间。每个隔离层的形状是环形，用于套入强化层的相对应容纳空间。尤其，电极的感测端部位于隔离层的环形中。下盖在强化层的下面，且位于强化层的中间，并与防水壳对齐而结合，使得防水壳的防水容纳空间具水密特性，以提供隔绝保护作用。此外，导电凝胶设置于感测端部的下面，因此，感测端部经由导电凝胶以感测动物体表的电气信号，可防止动物体表的表面物质影响感测端部的感测灵敏度。
第一粘贴层位于下盖的下面，且第一粘贴层的大小设计成等于或接近于下盖的大小，而第二粘贴层设计成环形，用于容纳导电凝胶。此外。下离型层用于承载第一粘贴层、第二粘贴层、导电凝胶以及部分的防水膜。
本发明可改善使用的便利性，并利用防水贴片粘贴到皮肤上而形成封闭***时，可使得外部水气无法进入防水贴片与皮肤之间，因而延长贴附周期及使用时间。此外，当使用者出汗时，本发明可借助第一、第二粘贴层所形成的空乏区而有利汗液吸收以及减少排汗阻力，非常有助于本发明装置在配戴时的舒适性，且在使用者身上较为稳固，可延长配戴时间而不易脱落。
附图说明
图1显示了依据本发明的实施例的心律监测装置的整体示意图。
图2显示了依据本发明的实施例的心律监测装置中的防水壳的分解立体示意图。
图3显示了依据本发明的实施例的心律监测装置中的防水贴片的分解立体示意图。
附图标记说明：
心律监测装置1、防水壳10、第一开口11、第二开口12、防水USB插槽13、防尘盖14、外部USB装置15、电源启动按键16、第一缓冲垫片层17、第二缓冲垫片18、止滑片19、防水贴片20、上离型层21、防水膜22、强化层23、下盖24、隔离层25、导电凝胶26、第一粘贴层27、第二粘贴层28、下离型层29、电极30、感测端部31、电池40、电路***50、电路板51、电路元件52、防水泡棉层FL、中框MF。
具体实施方式
以下结合附图及附图标记对本发明的实施方式做更详细的说明，使熟悉本领域的技术人员在研读本说明书后能予以实施。
请同时参阅图1、图2及图3，其中图1为本发明的实施例的心律监测装置的剖示图，图2为图1中的防水壳的分解立体示意图，而图3为图1中的防水贴片的分解立体示意图。
如图1、图2及图3所示，本发明的心律监测装置1主要包括防水壳10、防水贴片20、至少二个电极30、电池40及电路***50。心律监测装置1可贴附至动物体或人体表面，用于提供心律监测功能。
具体而言，防水壳10位于防水贴片20上，并相互包夹而形成防水容纳空间。另一方面，防水贴片20从防水壳10的内部向防水壳的周围向外延伸，亦可称防水贴片20是从防水壳10的底部向防水壳的周围向外延伸，则防水贴片20的***形成连续且封闭的外形。由防水贴片20贴附于动物体表面，可使得防水贴片20及动物体表面之间形成封闭***，避免外部水气进入，而电池40、电路***50容纳于防水容纳空间内。防水壳10可由塑胶、金属、硅胶、橡胶或碳纤维等材料制成。要注意的是，防水贴片20的横向尺寸特别设计成大于防水壳10的横向尺寸。
此外，每个电极30电气连接至电路***50，且配置成位于防水壳10的下面。进一步说明，电路***50具有至少二个导电元件，位于防水壳10下面的每个电极30的上部至少有一个外露区域与相对应的至少二个导电元件接触，从而形成电气连接。
电池40位于防水容纳空间内。电路***50位于防水容纳空间内，并包括电路板51，用于承载多个电路元件52，且所述电路元件52由电池40提供电源而运行。电池40可为一次性电池或可重复充电的二次性电池，例如钮扣型电池或锂聚合物电池。
进一步而言，每个电极30电气连接至电路板51。尤其，电极30从防水容纳空间向外延伸以形成相对应的感测端部31，用于接触动物体表面。再者，感测端部31穿透防水贴片20而接触到动物体表，用于感测动物体表的电气信号，其中电气信号经电路***50处理，从而获得，并储存长时间的相对应的心律信息，以实现心律监测功能。此外，相邻的二个电极感测端部各自与体表接触的部位，其最短的相对距离至少为5厘米。另一方面，相邻的二个电极的外形彼此是不对称的。
更加具体而言，防水壳10具有第一开口11及第二开口12，其中第一开口11可用于容纳防水通用串行总线(Universal Serial Bus，USB)插槽13，且第一开口11可由防尘盖14以可移除的方式覆盖而保护，防止灰尘阻塞而影响电气操作品质。再者，防水USB插槽13可用于连接外部USB装置15。第二开口12用于容纳电源启动按键16。电池40由电源启动按键16打开而提供电源给所述电路元件52。
进一步，防水USB插槽13具有防水性，并与电路***50电气连接。防水USB插槽13的周围包覆一层软性硅胶或橡胶材料，可与防水壳10的第一开口11相互干涉而形成水密结构，以达到防水功能，可避免水气进入防水壳10内。另外，防水USB插槽13可设置为插槽面突出于第一开口11、平行于第一开口11或低于第一开口11。再者，外部USB装置15，例如电脑或手机，可通过USB电缆线与防水USB插槽13连接，使得外部USB装置15可存取电路***50的内部资料。外部USB装置15还进一步在防水容纳空间内与电路***50中的电路元件52电气连接，比如记忆体元件，因而可进行记忆体资料的存取。
上述的防尘盖14覆盖防水USB插槽13，且其底部周围通过粘贴层而粘附于防水壳10的外部，可避免落尘进入防水USB插槽13中而影响资料撷取，或避免使用者未依指示任意操作USB。此外，在防尘盖14的侧面还具有针状 孔洞，此设计在进行资料撷取前，需利用特殊工具***孔洞而将防尘盖移除，如此防水USB插槽13外露，方可撷取资料，另一方面又可避免使用者于配戴装置期间，不小心、或蓄意将防尘盖14移除。较佳地，防尘盖14可由塑胶、金属、硅胶、橡胶或碳纤维等材料制成。
为加强电路板51的稳固性以避免电路元件52因震动而影响正常操作，本发明可进一步包括第一缓冲垫片层17及第二缓冲垫片18，可上下相互包夹住电路板51，从而保护所述电路元件52。
第一缓冲垫片层17及第二缓冲垫片18可由不同硬度的塑胶、硅胶、橡胶、泡棉等材料制成。第一缓冲垫片层17的外形还与电路***50的电路元件52结合，形成不规则状。第二缓冲垫片18的外形的涵盖范围可至少等同或大于电路元件52的表面，以确保其各部位受到保护。
防水壳10还可在防水壳10的外侧配置止滑片19，用于避免使用者在手持本发明的心律监测装置1时因疏忽而滑脱。
本发明的心律监测装置1可进一步包括中框MF，配置于防水壳10内而呈现中间镂空的环形结构。尤其，中框MF的下部可形成卡勾，用于包覆并外嵌于电路***50，且中框MF能进一步固定电池40及电路***50而提供额外的保护。
本发明的心律监测装置1还可进一步配置有防水泡棉层FL。防水泡棉层FL安置在电路板51上，电池40配置在防水泡棉层FL上，且电池40及防水泡棉层FL在中框MF的环形结构中。防水泡棉层FL的外形面积可设计成等于或小于电池40。因此，当使用者处于正常活动环境下而动态使用本发明的心律监测装置1时，防水泡棉层FL能提供缓冲作用，大幅减轻受震动或外部冲击时的力量，避免电池40的运行发生异常。
更进一步说明，防水贴片20包括上离型层21、防水膜22、强化层23、下盖24、至少二个隔离层25、导电凝胶26、第一粘贴层27、第二粘贴层28以及下离型层29。其中，防水膜22、强化层23、下盖24、至少二个隔离层25、导电凝胶26、第一粘贴层27、第二粘贴层28包夹在上离型层21与下离型层29之间，且上离型层21和下离型层29在使用时被移除。
上离型层21贴附于防水膜22上，除了具有保护作用外，还可在贴附操 作时提供贴片本身的挺性，避免防水膜塌陷而难以贴附，而在贴附操作完成后即可将上离型层21移除。较佳地，上离型层21和下离型层29可由塑胶或纸类材料所组成。
再者，防水泡棉层FL可由内部密闭式(close cell)或开放式(open cell)的聚合物发泡材料构成。此外，防水泡棉层FL的周围与防水壳10的下缘周围相互对齐，并通过在防水泡棉层FL的周围的粘胶层而与防水壳10以及防水膜22结合，以提供防水壳10的内部空间的防水作用。
上述的上离型层21具有中间开口，用于围住防水壳10，亦即，防水壳10可套入中间开口内。
防水膜22位于上离型层21和防水泡棉层FL的下面，且从防水壳10的内部向防水壳10的周围向外延伸。防水膜22具有粘性，贴附于皮肤时成为一个封闭***，使外部水气无法进入贴附层与皮肤之间，以延长贴附周期。防水膜22的厚度可小于0.1mm，并具有延展性。较佳地，防水膜22由防水基材经表层涂布粘胶所制成，例如，将丙烯酸胶黏剂(acrylic adhesive)涂布于PU(polyurethane)基材上。进一步来说，防水膜22位于第一粘贴层27和第二粘贴层28的上方，且其涵盖范围是覆盖且围绕第一粘贴层27和第二粘贴层28的周围。
至少二个电极30位于防水膜22的下面，并在防水壳10的内部与电路***50电气连接。电极30的分布和配置为整合至防水贴片20当中，且向外延伸至防水壳10的外部，通过防水壳10外部的电极30直接或间接接触皮肤，可测量心律，再传达至内部电路***50。电极30的材料可由氯化银(AgCl)或银-氯化银(Ag/AgCl)所组成，或由各种导电材料组成，再涂布、电镀或印刷上一层氯化银(AgCl)层或银-氯化银(Ag/AgCl)层，或由具有抗张强度的材料，如橡胶、硅胶、PU(Polyurethane)或TPU(Thermoplastic Polyurethane)组成，再涂布、电镀或印刷上一层氯化银(AgCl)层或银-氯化银(Ag/AgCl)层，以作为皮肤与导电材料之间的信号传导媒介。
强化层23位于防水膜22的下面以及电极30的下方，且强化层23的上、下部各具有一个粘胶层，用于向上粘贴电极30与防水膜22，并同时向下粘合第二粘贴层28。强化层23主要的功能在于强化电极30的抗张强度。强化 层23具有与至少二个电极30相应数目的孔洞，比如至少二个容纳空间，位于防水壳10的外部、各电极30的感测端部31与强化层23重叠的区域，用于容纳相应数目的隔离层25与导电凝胶26。另外，强化层23的面积小于防水膜22的面积。强化层23可由塑胶、硅胶、橡胶等材料所制成。
隔离层25粘附于相应的至少二个电极30的下方且位于相对应的强化层23的容纳空间内。隔离层25还具有部分镂空区域以容纳相对应的导电凝胶26。隔离层25的作用为隔离导电凝胶26与第二粘贴层28，避免两者接触而造成内含水分或物质交换，影响导电凝胶26的导电效果。
隔离层25可由不吸水或少量吸水的材料所制成，例如塑胶、硅胶、橡胶或泡棉等材料。
此外，所有隔离层25均在强化层23的下面，且每个隔离层25的形状均是环形，用于套入强化层23的相对应的容纳空间，每个电极30的感测端部31位于相对应的隔离层25的环形中。
导电凝胶26具有导电性与粘性，一面粘附于相应的至少二个电极30的下面，另一面接触皮肤，可作为皮肤与电极30之间心律测量信号的传导媒介。导电凝胶26内含少量水、树脂与电解质。
下盖24在强化层23的下面，且位于强化层23的中间，并与防水壳10对齐，用于相互结合而使得防水容纳空间具有水密特性。再者，下盖25的上表面可具有卡勾，能与防水壳10的卡槽相容，使得整个贴片与防水壳10能够紧密结合而具防水功能。另一方面，下盖24的材料可为塑胶、金属或碳纤维等，属质地较坚韧的材料，因此，能够承载内部的电路***50，具有保护作用。
第一粘贴层27的正面为具有粘性的粘贴层，且第一粘贴层27的背面具有粘胶层，可与下盖24的下面相结合。第一粘贴层27的粘贴层的表面在贴于皮肤后，可避免下盖24发生位移而晃动，所以本发明的心律监测装置在使用者身上比较稳固，可延长配戴时间而不易脱落。第一粘贴层27的粘贴层可进一步具有多个空乏区，而将第一粘贴层27分为多个不连续的片段。由于使用者会出汗，通过空乏区可有利于汗液的吸收并减少排汗的阻力，非常有助于本发明配戴时的舒适性。另一方面，第一粘贴层27的粘贴层可由水合胶 (Hydrocolloid)、聚氨基甲酸酯(Polyurethane，PU)胶、硅胶、橡胶、热熔胶或丙烯酸胶黏剂等材料以单独或复合的方式组成，或可由上述材料并在背面附上一层基材，例如吸水基材如不织布、水凝胶或含有羧基(-COOH)、羟基(-OH)等亲水性基团的高分子聚合物，或者不吸水基材如PU(Polyurethane)防水透气膜等所组成。
进一步而言，第二粘贴层28的表面还包括具有粘性的粘贴层，且第二粘贴层28的背面与强化层23的下部的粘胶层相结合。第二粘贴层28的粘贴层具有与强化层23相对应的孔洞，用于容纳相对应的隔离层25与导电凝胶26。因此，当第二粘贴层28的粘贴层的表面贴于皮肤后，所述空洞可协助导电凝胶26稳固粘贴于皮肤而不易位移。再者，第二粘贴层28的粘贴层可进一步具有多个空乏区而将第二粘贴层28分为多个不连续的片段。由于使用者会出汗，可借助空乏区有利汗液吸收以及减少排汗阻力，非常有助于本发明在配戴时的舒适性。较佳地，第二粘贴层28的粘贴层可由水合胶(Hydrocolloid)、PU胶、硅胶、橡胶、热熔胶或丙烯酸胶黏剂等材料以单独或复合的方式所组成，或可由上述材料以及在背面附上一层基材，例如吸水基材如不织布、水凝胶或是含有羧基(-COOH)、羟基(-OH)等亲水性基团的高分子聚合物，或者不吸水基材如PU(Polyurethane)防水透气膜等所组成。
下离型层29附于整体防水贴片20的最底层，用于覆盖并保护防水贴片20中接触皮肤的粘贴材料，可避免污染。下离型层29可为纸类基材表面再附上一层防水层及离型剂或离型层，或塑胶类基材表面再附上一层离型剂或离型层，目的在于将该离型层从贴片移除时降低粘着力，避免带动贴片上的粘贴材料剥离。
下离型层29可进一步设置成分离两瓣，并于两瓣离型层中间缝隙上贴附一个防尘保护贴，该形式可让使用者经由两瓣离型层上的把手，从里往外移除下离型层29，如此也可避免带动防水贴片20上的粘贴材料剥离。
整体而言，第一粘贴层27位于下盖24的下面，且第一粘贴层27的大小等于或接近于下盖24的大小，而第二粘贴层28配置成具有环形的形状，可用于容纳导电凝胶26。此外，下离型层29配置成用于承载导电凝胶26、第一粘贴层27及第二粘贴层28。
另外，防水壳10的下缘周围可与下盖24及防水泡棉层FL紧密结合，形成水密结构，且防水壳10的内壁具有卡槽，可与下盖24的周围的卡勾紧密结合。
进一步而言，上述的电路***50置于防水壳10与防水贴片20之间，且电路元件52包括适当配置的类比、数位电气元件以及资料储存记忆体。其中电路***50负责执行电源供应管理、心律测量信号的滤波、类比至数位信号转换以及资料储存。此外，电路***50可进一步具有无线传输单元，例如蓝牙、WiFi或光通讯传输单元，可将所测量或存取的心律信息通过无线传输至外部***装置，例如电脑或手机，并由外部装置进行资料的再处理与分析。
综上所述，本发明的特点在于具有简单结构，可为贴片状，能改善使用的便利性，即使在淋浴、游泳时也不必取下，尤其是，防水贴片粘贴到皮肤上而形成封闭***时，可使得外部水气无法进入防水贴片与皮肤之间，因而延长贴附周期及使用时间。此外，当使用者出汗时，本发明可借助第一、第二粘贴层所形成的空乏区而有利于汗液吸收以及减少排汗阻力，非常有助于本发明装置在配戴时的舒适性，且在使用者身上较为稳固，可延长配戴时间而不易脱落。
以上所述仅用于解释本发明的较佳实施例，并非企图据以对本发明做任何形式上的限制，因此，凡有在相同的发明精神下所作有关本发明的任何修饰或变更，皆仍应包括在本发明意图保护的范畴。

Claims (10)

  1. 一种心律监测装置，其特征在于，用于贴附至动物体表面而提供心律监测功能，该心律监测装置包括：防水壳；防水贴片，位于所述防水壳的下面，所述防水贴片的横向尺寸大于所述防水壳的横向尺寸，且所述防水壳与所述防水贴片相互包夹而形成防水容纳空间，并由所述防水贴片贴附于动物体表面上；电路***，位于所述防水容纳空间内，并包括电路板，用于承载多个电路元件；电池，位于所述防水容纳空间内；以及至少二个电极，该电极电气连接至所述电路***，每个电极位于所述防水壳的下面，且每个电极从所述防水容纳空间向外延伸以形成相对应的感测端部，该感测端部穿透所述防水贴片而接触到动物体表，用于感测所述动物体表的电气信号，该电气信号经所述电路***处理，从而获得、储存长时间的相对应的心律信息，以实现所述心律监测功能。
  2. 根据权利要求1所述的心律监测装置，其特征在于，所述防水壳具有第一开口，用于容纳防水通用串行总线插槽，所述防水USB插槽电气连接至所述电路***，并连接外部USB装置。
  3. 根据权利要求2所述的心律监测装置，其特征在于，所述防水USB插槽具有防水性，防水USB插槽的周围包覆一层软性材料，所述软性材料可与所述防水壳的第一开口相互干涉而形成水密结构，以达到防水功能，从而避免水气进入所述防水壳内。
  4. 根据权利要求1所述的心律监测装置，其特征在于，所述防水壳配置有止滑片，且该止滑片位于所述防水壳的外侧，用于避免使用者在手持所述心律监测装置时发生滑脱。
  5. 根据权利要求1所述的心律监测装置，其特征在于，进一步包括中框，配置于中框防水壳内而呈现中间镂空的环形结构，其中所述中框的下部形成卡勾，用于包覆并外嵌于所述电路***，且所述中框进一步固定所述电池及所述电路***而提供保护。
  6. 根据权利要求5所述的心律监测装置，其特征在于，进一步包括防水泡棉层，其中所述防水泡棉层安置在所述电路板上，电池配置在所述防水泡 棉层上，且所述电池及所述防水泡棉层在所述中框的环形结构中。
  7. 根据权利要求1所述的心律监测装置，其特征在于，所述防水壳配置有电源启动按键，电池由该电源启动按键打开而提供电源给所述电路元件，所述防水壳具有第二开口，该第二开口容纳所述电源启动按键。
  8. 根据权利要求1所述的心律监测装置，其特征在于，所述防水贴片包括：上离型层，具有中间开口，用于围住该防水壳；防水膜，位于所述上离型层的下面；强化层，位于所述防水膜的下面，并具有至少二个容纳空间；至少二个隔离层，在所述强化层的下面，且每个隔离层的形状是环形，用于套入所述强化层的相对应的容纳空间，且每个电极的感测端部位于相对应的所述隔离层的环形中；下盖，在所述强化层的下面，且位于所述强化层的中间，并与所述防水壳对齐，用于相互结合而使得所述防水容纳空间具有水密特性；导电凝胶，设置于所述感测端部的下面；第一粘贴层，位于所述下盖的下面，且该第一粘贴层的大小等于或接近于所述下盖的大小；第二粘贴层，配置成具有环形的形状，用于容纳所述导电凝胶；以及下离型层，用于承载所述第一粘贴层、所述第二粘贴层及所述导电凝胶，
    其中，防水膜、强化层、下盖、隔离层、导电凝胶、第一粘贴层及第二粘贴层包夹在上离型层与下离型层之间，且所述上离型层和所述下离型层在使用时被移除。
  9. 根据权利要求8所述的心律监测装置，其特征在于，所述第一粘贴层的正面为具有粘性的粘贴层，且所述第一粘贴层的背面具有粘胶层，该粘胶层与所述下盖的下面相结合，所述第一粘贴层的粘贴层具有多个空乏区而将所述第一粘贴层分为多个不连续的片段，所述第一粘贴层的粘贴层由水合胶、聚氨基甲酸酯胶、硅胶、橡胶、热熔胶或丙烯酸胶黏剂的材料以单独或复合的方式组成。
  10. 根据权利要求8所述的心律监测装置，其特征在于，所述第二粘贴层的正面为具有粘性的粘贴层，且所述第二粘贴层的背面具有粘胶层，该粘胶层与所述强化层的下面结合，所述第二粘贴层的粘贴层具有与所述强化层相对应的孔洞，用于容纳相对应的隔离层及导电凝胶，所述第二粘贴层具有多个空乏区，而将该第二粘贴层分为多个不连续的片段，所述第二粘贴层的 粘贴层由水合胶、聚氨基甲酸酯胶、硅胶、橡胶、热熔胶或丙烯酸胶黏剂的材料以单独或复合的方式组成。
PCT/CN2018/073373 2017-02-22 2018-01-19 心律监测装置 WO2018153188A1 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP18758419.8A EP3586732A4 (en) 2017-02-22 2018-01-19 DEVICE FOR MONITORING THE HEARTHYTHM
AU2018223850A AU2018223850B2 (en) 2017-02-22 2018-01-19 Heart rhythm monitoring apparatus
US16/486,092 US20200054226A1 (en) 2017-02-22 2018-01-19 Heart Rhythm Monitoring Apparatus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710095407.0A CN108451523A (zh) 2017-02-22 2017-02-22 心律监测装置
CN201710095407.0 2017-02-22

Publications (1)

Publication Number Publication Date
WO2018153188A1 true WO2018153188A1 (zh) 2018-08-30

Family

ID=63222120

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/073373 WO2018153188A1 (zh) 2017-02-22 2018-01-19 心律监测装置

Country Status (5)

Country Link
US (1) US20200054226A1 (zh)
EP (1) EP3586732A4 (zh)
CN (1) CN108451523A (zh)
AU (1) AU2018223850B2 (zh)
WO (1) WO2018153188A1 (zh)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11278243B2 (en) * 2018-05-16 2022-03-22 General Electric Company Repositionable surface electrodes
CN109330586A (zh) * 2018-11-21 2019-02-15 深圳市亮动科技开发有限公司 一种贴膜结构及心电监测装置
CN109730674B (zh) * 2019-01-31 2024-04-30 青岛光电医疗科技有限公司 一次性防水型心电电极及移动式心电监测设备
CN113057642A (zh) * 2019-12-31 2021-07-02 吴智良 生理讯号监测装置
CN111528837B (zh) * 2020-05-11 2021-04-06 清华大学 可穿戴脑电信号检测装置及其制造方法
EP4153031A1 (en) * 2020-05-22 2023-03-29 Given Imaging Ltd. Medical patch
WO2023234332A1 (ja) * 2022-06-03 2023-12-07 日東電工株式会社 生体センサ
WO2024005022A1 (ja) * 2022-06-30 2024-01-04 日東電工株式会社 生体センサ

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8428682B1 (en) * 2006-06-16 2013-04-23 Orbital Research Inc. Wet or dry electrode, other sensors, actuators, or markers with a novel adhesive collar
CN103462601A (zh) * 2013-09-24 2013-12-25 深圳先进技术研究院 医用电极贴及其制备方法
US20150313499A1 (en) * 2014-04-30 2015-11-05 Electronics And Telecommunications Research Institute Electrode patch for measuring electrical signal from body and physiological signal measurement apparatus using the same
CN105455805A (zh) * 2014-09-25 2016-04-06 准讯生医股份有限公司 长时间心电量测记录装置
TWI565446B (zh) * 2015-12-14 2017-01-11 準訊生醫股份有限公司 長時間生理訊號量測貼片

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050010155A1 (en) * 2001-05-02 2005-01-13 La Pointique International Ltd. Elastic material for compression braces and the like
EP2091424B1 (en) * 2006-12-07 2016-05-04 Koninklijke Philips N.V. Handheld, repositionable ecg detector
WO2009036313A1 (en) * 2007-09-14 2009-03-19 Corventis, Inc. Adherent device with multiple physiological sensors
JP5559425B2 (ja) * 2010-05-12 2014-07-23 イリズム・テクノロジーズ・インコーポレイテッド 長期粘着用の装置機構及び構成要素
US9439599B2 (en) * 2011-03-11 2016-09-13 Proteus Digital Health, Inc. Wearable personal body associated device with various physical configurations
US9700222B2 (en) * 2011-12-02 2017-07-11 Lumiradx Uk Ltd Health-monitor patch
US9737701B2 (en) * 2012-05-31 2017-08-22 Zoll Medical Corporation Long term wear multifunction biomedical electrode
US10244949B2 (en) * 2012-10-07 2019-04-02 Rhythm Diagnostic Systems, Inc. Health monitoring systems and methods
WO2014116825A1 (en) * 2013-01-24 2014-07-31 Irhythm Technologies, Inc. Physiological monitoring device
WO2016130545A1 (en) * 2015-02-09 2016-08-18 Vios Medical Singapore PTE LTD Patient worn sensor assembly
CN205729613U (zh) * 2016-04-26 2016-11-30 赵士伟 一种医用纱布绷带

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8428682B1 (en) * 2006-06-16 2013-04-23 Orbital Research Inc. Wet or dry electrode, other sensors, actuators, or markers with a novel adhesive collar
CN103462601A (zh) * 2013-09-24 2013-12-25 深圳先进技术研究院 医用电极贴及其制备方法
US20150313499A1 (en) * 2014-04-30 2015-11-05 Electronics And Telecommunications Research Institute Electrode patch for measuring electrical signal from body and physiological signal measurement apparatus using the same
CN105455805A (zh) * 2014-09-25 2016-04-06 准讯生医股份有限公司 长时间心电量测记录装置
TWI565446B (zh) * 2015-12-14 2017-01-11 準訊生醫股份有限公司 長時間生理訊號量測貼片

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3586732A4 *

Also Published As

Publication number Publication date
CN108451523A (zh) 2018-08-28
US20200054226A1 (en) 2020-02-20
EP3586732A1 (en) 2020-01-01
EP3586732A4 (en) 2020-12-09
AU2018223850B2 (en) 2020-01-30
AU2018223850A1 (en) 2019-10-03

Similar Documents

Publication Publication Date Title
WO2018153188A1 (zh) 心律监测装置
CN106859628B (zh) 长时间生理信号测量贴片
JP3220800U (ja) 心電図検査装置
US11464432B2 (en) Monitoring device for attachment to a surface of a subject
JP4921349B2 (ja) 生理状態のモニタリング、分析および伝達のためのウェアラブル無線装置
US20210205139A1 (en) Moisture sensing wound dressing
TWI669097B (zh) 心律監測裝置
JP6507254B2 (ja) 生体情報測定装置
CN102525450A (zh) 单次使用的生物医学传感器
US11540950B2 (en) Moisture sensing wound dressing
KR102287701B1 (ko) 생체 정보 측정 장치
WO2018154016A1 (en) Wearable sensing device and sensor unit for acquiring one or more physiological signals of a subject
EP4137050A1 (en) Bioelectrode that can be worn for a long period of time
JP6454993B2 (ja) 生体情報収集装置と生体情報収集装置用粘着部材
CN113116355B (zh) 生理监测器
JP2022533762A (ja) 生体情報検出機能付き歯ブラシ
CN212913208U (zh) 一种便于收纳的无创脑电传感器
CN208511019U (zh) 心电监测电极片
CN209966362U (zh) 一种心电信号采集设备
TWI719792B (zh) 生理監測器
CN215017621U (zh) 一种脑功能监测电极
CN214048849U (zh) 心电电极片装置和心电监护设备
CN116831587B (zh) 心电电极片和心电监护装置
KR20240030808A (ko) 생체 신호를 모니터링하기 위한 디바이스
CN113057642A (zh) 生理讯号监测装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18758419

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2018758419

Country of ref document: EP

Effective date: 20190923

ENP Entry into the national phase

Ref document number: 2018223850

Country of ref document: AU

Date of ref document: 20180119

Kind code of ref document: A