WO2015158220A1 - 颈戴式心电检测装置 - Google Patents

颈戴式心电检测装置 Download PDF

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Publication number
WO2015158220A1
WO2015158220A1 PCT/CN2015/076330 CN2015076330W WO2015158220A1 WO 2015158220 A1 WO2015158220 A1 WO 2015158220A1 CN 2015076330 W CN2015076330 W CN 2015076330W WO 2015158220 A1 WO2015158220 A1 WO 2015158220A1
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Prior art keywords
electrode
user
housing
ecg signal
neck
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PCT/CN2015/076330
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English (en)
French (fr)
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周常安
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周常安
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Publication of WO2015158220A1 publication Critical patent/WO2015158220A1/zh

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    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332—Portable devices specially adapted therefor
    • 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

Definitions

  • the present invention relates to a neck-worn electrocardiographic device, and more particularly to a neck-worn electrocardiograph device having a stable electrode contact pattern and capable of obtaining a clear and stable ECG signal.
  • an electrocardiographic detecting device is a main route for examining various heart diseases, for example, whether there is arrhythmia, cardiac hypertrophy caused by hypertension or heart valve disease, myocardial infarction, or a disorder of the heart.
  • ECG detection devices When people feel the heart discomfort and go to the hospital for examination, they often use traditional ECG detection devices. For example, 12-lead ECG detection can detect various heart problems in more detail, but if the heart is not suitable. It is an occasional symptom. For example, if the heart rhythm is not complete, it is very likely that the heart condition at the time of onset cannot be measured during the test. Therefore, in response to this sporadic symptom, the Holter electrocardiograph is used for the long time. The method of time detection, for example, wearing 24 hours to several days, it is desirable to record the electrocardiogram at the time of the symptom in this way, and the ECG event recorder is similar to the Hult electrocardiograph.
  • Hult-type electrocardiographs are often used to monitor heart conditions after cardiac surgery or medications to confirm treatment outcomes.
  • Hotter ECG machine or an ECG event recorder
  • it must be placed on the body to apply a plurality of electrodes for obtaining an electrocardiogram, and connected to a device through a connecting wire. Therefore, the user must It is quite inconvenient to stick the electrode and wear the device on the body, and it is easy to cause skin discomfort due to sticking to the electrode for a long time. These are the reasons for the user to deter, and sometimes, even after long After the time wear test, no record was recorded because there was no disease. An electrocardiogram for the analysis of sporadic symptoms. Moreover, such testing must be done with the assistance of a professional medical staff member.
  • the electrode paste must be set up in the hospital, and usually after the long-term measurement is completed, the doctor can download and record it.
  • Analysis of the ECG requires at least a few days to know what is wrong with the heart, so it is not only complicated but also lacks real-time.
  • a further improvement is a hand-held ECG detecting device which solves the problem that the device must be worn on the body for a long time by using a dry electrode that does not need to be adhered to the body, and simplifies the process.
  • the complexity of the test As disclosed in US Pat. No. 7,417,571 and US Pat. No. 7,197,351, the handheld ECG detecting device is provided with a dry electrode on the surface of the device, and can perform ECG detection by contacting the hand and/or the body surface at any time when necessary, and therefore no longer Limited by the time of wearing on the body and the electrode sticking, it can be used to monitor the heart for a longer time.
  • Such an ECG detecting device is usually also equipped with an analysis program and a display screen, which allows the user to The measurement results are known at the moment, and there is no need to wait until the hospital is returned to the hospital. Therefore, it is quite suitable for home use, and it also provides an easy way for users who are highly concerned about their heart health to regularly understand the heart condition.
  • the biggest problem faced by the above-mentioned hand-held ECG detecting device that can be carried around is also caused by the operation by hand.
  • the first problem is that the signal is weak. Because the distance between the hands and the heart is far, and the ECG signal is originally small, it is very weak and is very susceptible to environmental noise. The effect is difficult to make the analysis, and the other problem is that the operation stability is low.
  • the measurement by the two hands is easy to cause unstable phenomena such as hand shaking during the measurement, thus causing the measured electrocardiogram to appear.
  • Baseline drift, waveform distortion, etc. affect the analysis of the situation, and when the user wants the hand to maintain stability and muscle tension, or deliberately force to ensure contact with the electrode, it is also easy to exert force to affect the signal analysis of the myoelectric signal.
  • the handheld ECG detecting device since the handheld ECG detecting device has to be operated by hand, in accordance with the ergonomic requirements, coupled with the need to display the results, the size cannot be too small, and the carrying is still a certain burden; It is not always set on the body. Therefore, when testing is required, more steps are required. For example, after the device is removed and then turned on, the detection can be started, and thus the timing of detection may be missed.
  • heart rate monitoring device that is worn on the body by a neck-mounted method, for example, as disclosed in US Pat. No. 6,686,643, US Pat.
  • a neck-mounted method for example, as disclosed in US Pat. No. 6,686,643, US Pat.
  • the electrode naturally touches the body, and has a fixed force compared with the above-mentioned adhesive electrode or the operation of the surface of the electrode on the electrode, so the electrode and the electrode
  • the contact between the skin is very unstable, so it is impossible to obtain a clear and stable ECG, so it is not suitable for judging whether the heart is abnormal, for example, whether there are symptoms such as arrhythmia and myocardial infarction, plus the electrode is placed on
  • the special configuration of the neck also leads to many restrictions on the use.
  • Another object of the present invention is to provide a neck-mounted electrocardiographic detecting device that can simultaneously provide a simple one-hand operation and stable electrode contact.
  • a further object of the present invention is to provide a neck-worn electrocardiographic detecting device which can measure under the circumstance of not opening clothes and obtain a powerful electrocardiographic signal, so that it can be carried out at any time without being restricted by the occasion. ECG measurement.
  • Another object of the present invention is to provide a neck-worn electrocardiographic detecting device, which has a compact size and is convenient for long-time wear, and can provide a user with the need for measurement at any time, and then cooperate with the connection network. It can transmit data and/or information to a remote monitoring center in real time when there is a problem with the measurement results and/or when the user needs it, so it is quite suitable for long-term care at home.
  • Another object of the present invention is to provide a neck-worn electrocardiographic detecting device that can be worn on a body without affecting the user's activity, and thus is suitable for performing electrocardiogram at specific times and/or before and after a specific event, for example, before and after exercise. Signal extraction.
  • Another object of the present invention is to provide a neck-worn electrocardiographic detecting device that can be hidden in a garment for detection and display the ECG detection related information on an external device, for example, a mobile phone, in order to conform to the user. usage habit.
  • Another object of the present invention is to provide a neck-worn electrocardiographic detecting device which realizes both neck-wearing and hand-held operation modes through special electrode position design, so as to further provide a more versatile device for the user.
  • a neck-mounted ECG detecting device includes a housing having a first surface and a second surface, a first electrode and a second electrode. On the surface, an attachment component is coupled to the housing for attachment to a user's neck, and an ECG signal extraction circuit for performing an ECG signal extraction in conjunction with the first and second electrodes, wherein
  • the housing When the user wears the device through the attachment assembly, the housing is disposed in front of the user's torso, and when the user's hand applies force to the housing in a direction toward the torso, the housing It is fixed between the hand and the body, and generates a stable contact between the first and second electrodes and the skin in front of the trunk, thereby allowing the device to enter an extractable ECG signal state.
  • the stable contact achieves a switching switch to cause the device to enter the extractable ECG signal state or, alternatively, the stable contact causes a physical change of the first and second electrodes to conform to a preset a range, wherein the device enters the extractable ECG signal state, and the physical change is detected by a physical state detecting unit, wherein the physical state detecting unit can be implemented as a pressure sensing module, an impedance sensing A circuit, a capacitive sensing circuit, or a switch.
  • the ECG signal extraction will automatically initiate after a certain time.
  • the neck-mounted electrocardiographic detecting device can also provide a common mode of operation for performing ECG signal extraction together with an external device via wired or wireless means, wherein the external device can receive in real time. And displaying an electrocardiographic signal and related information from the electrocardiographic detecting device, and the user initiates recording of the electrocardiographic signal for a specific period by the external device, or, alternatively,
  • the device according to the present invention may also initiate an ECG signal extraction after being controlled by the external device after entering the extractable ECG signal state, and the external device may also include a calculation formula to provide related arrhythmia
  • the external device can be connected to a remote monitoring center through a network, and when the ECG signal meets a default condition, the external device can automatically transmit a notification signal to the remote monitoring center. .
  • the neck-mounted electrocardiographic detecting apparatus may include an information providing module for providing information related to the user's electrocardiographic detection, wherein the manner of providing the information includes screen display, sound change, vibration change, and vision. Variations, and, preferably, information related to arrhythmia may also be provided by loading an appropriate algorithm.
  • the neck-mounted electrocardiographic detecting device according to the present invention may further include a motion sensor for detecting a movement of the user's body.
  • the neck-mounted ECG detecting device may further include a third electrode positioned on a third surface adjacent to the first surface, and a fourth electrode. And a fourth surface adjacent to the first surface and opposite to the third surface for performing a handheld ECG signal extraction, wherein the first electrode and the third electrode are implemented as parallel connections And the second electrode and the fourth electrode may be implemented to be connected in parallel, or alternatively, the first electrode and the third electrode may be implemented as one piece, and the second electrode and the fourth electrode may be implemented as One piece.
  • a neck-mounted ECG detecting device includes a housing having a first surface and a second surface, a first electrode and a second electrode, respectively located in the housing On the first surface and the second surface of the housing, an attachment component is coupled to the housing for attachment to a neck of a user, and an ECG signal extraction circuit to cooperate with the first and second An electrocardiographic electrode performs an ECG signal extraction, and a physical state detecting unit is configured to sense a physical change generated by the at least one electrode contacting the skin surface of the user, wherein the user wears through the attachment component
  • the housing is disposed in front of the user's torso, and when the user's hand applies a force to the second electrode on the second surface in a direction toward the torso, the housing is fixed to the hand And a relationship between the body and the first electrode on the first surface and the skin in front of the torso, and when the stable contact causes the physical change to conform to a default range, the device enters a E
  • the physical state detecting unit is implemented as a pressure sensing module, an impedance sensing circuit, a capacitance sensing circuit, or a switch.
  • the first and second electrodes The first one is implemented as a capacitive electrode, an inductive electrode, or an electromagnetic electrode.
  • the neck-mounted electrocardiographic detecting device may further comprise a light volume change (PPG) sensor for acquiring blood physiological information, such as pulse wave information and blood oxygen concentration changes, Moreover, the acquired pulse wave information can also be calculated together with the electrocardiographic signal to obtain a pulse wave transit time (PTT) to further obtain a correlation value of the blood pressure value and/or the blood pressure change.
  • PPG light volume change
  • PTT pulse wave transit time
  • Figure 1 shows an operation of a known hand-held ECG detecting device
  • Figure 2 shows another mode of operation of the known hand-held ECG detecting device
  • FIG. 3 is a schematic view showing a neck-mounted ECG detecting device according to a preferred embodiment of the present invention.
  • FIG. 4 is a schematic view showing the use of a neck-mounted electrocardiographic detecting device according to a preferred embodiment of the present invention.
  • 5A-5B illustrate two types of use of a neck-mounted ECG detecting device in accordance with a preferred embodiment of the present invention
  • Figure 6 is a circuit block diagram showing a neck-mounted electrocardiographic detecting device according to the present invention.
  • Figure 7 is a cross-sectional view showing the electrode arrangement of the neck-mounted electrocardiographic detecting device of the present invention, in accordance with a preferred embodiment
  • Figure 8 is a cross-sectional view showing the housing of the neck-mounted electrocardiographic detecting device of the present invention, in accordance with a preferred embodiment
  • Figure 9 is a block diagram showing another circuit of a neck-mounted electrocardiographic detecting device according to the present invention.
  • Figure 10 is a schematic view showing the use of the neck-mounted electrocardiographic detecting device of the present invention in conjunction with an external device, in accordance with a preferred embodiment
  • Figure 11 is a schematic view showing the built-in connector of the neck-mounted electrocardiographic detecting device of the present invention, according to a preferred embodiment
  • FIGS. 12A-12B illustrate two electrode configurations of a neck-mounted electrocardiographic device according to another preferred embodiment of the present invention.
  • FIGS. 12A-12B show two handheld operating modes of the neck-mounted ECG detecting device of FIGS. 12A-12B;
  • FIG. 14 shows an electrode arrangement manner of a neck-mounted electrocardiographic detecting device according to still another preferred embodiment of the present invention.
  • Fig. 15 is a view showing the use of the neck-mounted electrocardiographic detecting device of Fig. 14.
  • the device of the present invention is implemented in a wearable form, and in many ways in which the electrocardiographic detecting device can be placed on the body, the present invention selects a neck wear, as shown in FIG.
  • the main reasons for wearing the method are as follows.
  • the device can naturally be placed in front of the torso, such as under the collarbone, in front of the chest, in front of the abdomen, etc., as the torso is the region with the strongest ECG signal, as is known to those skilled in the art. Therefore, such a setting first ensures that the obtained signal has sufficient strength.
  • the neck wear form is applied to the user in comparison to the chest strap form in which the device can also be placed on the chest.
  • the resulting sense of restraint is much smaller, thus providing a more comfortable experience.
  • the neck-wearing form also allows the device to be naturally positioned between the garment and the torso.
  • the action of the electrode touching the torso can be achieved without opening the clothes, eliminating the limitation of the use occasion, so that the user no longer has to deter due to having to wear clothes. , or bend to the weak signal of the two hands to take the signal measurement method.
  • the present invention uses a dry electrode, which allows the user to use it at any time without worrying about the problem of electrode setting, eliminating the need to use the conductive paste and eliminating the possibility of causing skin discomfort to the user.
  • the user can wear the device on the neck in daily life, and when necessary, for example, when the heart feels uncomfortable, the ECG signal detection is started in real time, or the electrocardiogram detection is performed regularly every day, effectively grasping Your own heart changes.
  • the neck-mounted electrocardiographic detecting device is also quite suitable for use during exercise.
  • the user can wear the device according to the present invention during exercise without feeling burden and rest in the middle of exercise.
  • the time is measured directly to know the impact of exercise on the heart, for example, whether sufficient exercise intensity is achieved (whether the heartbeat reaches the expected goal), or whether the heart is abnormal, especially when exercise is a good time for arrhythmia Therefore, the electrocardiogram when arrhythmia occurs can be recorded in real time through the device of the present invention.
  • FIG. 3 shows a schematic overall configuration of a neck-mounted ECG detecting device according to the present invention.
  • the neck-mounted ECG detecting device 10 according to the present invention can be seen from the appearance of having a housing 12, an attachment assembly 14, and at least two electrodes 16, wherein the attachment assembly 14 is implemented as
  • the housing 12 is coupled and attached to the neck of the user such that the housing 12 is located in front of the user's torso, for example, under the collarbone, in front of the chest, in front of the abdomen, etc., as shown in Figure 4, and the electrodes 16 is located on the surface of the housing 12.
  • the electrode according to the present invention is embodied on the same surface of the housing, such as the first surface 122 of FIG. 3, that is, when the housing is disposed through the attachment assembly.
  • the front of the torso is facing the surface of the torso, as shown in Figure 4, even if covered in the clothes, the two electrodes Contact with the skin can also be easily achieved, so it can be tested without clothing.
  • the basis of such an embodiment is that, in the form of a neck wear, the housing of the device according to the invention is placed at a position around the heart, and the position of the ECG signal is sufficient, and the limitation when the electrode position is set is small. For example, the distance can be very short.
  • the electrodes are disposed on the casing instead of the belt as in the prior art, except that the stable contact of the electrodes on the belt is not easily achieved, the main reasons are:
  • the heart near the body, is the clearest sampling position of the heart signal. Moreover, since the two electrodes are close to each other, the circuit loop is short, and various types of noise can be avoided to interfere with the ECG measurement, especially for Common mode noise, such as 50Hz/60Hz, can be easily eliminated.
  • the user can easily move the position of the electrodes through the moving housing, thereby changing the relative positions of the electrodes and the heart, and obtaining electrocardiograms of various angles.
  • an electrocardiogram of one angle can be obtained for each two electrodes, that is, the position of the electrode determines the projection angle of the electrical activity of the heart reflected by the electrocardiogram, and the heart is stereoscopic and produces a diseased heart.
  • the site may be located at any heart position. For example, the examination of myocardial infarction needs to see if there is ST drift in the ECG waveform due to myocardial necrosis, but it may not be noticeable at certain angles due to its positional relationship. At this time, it is necessary to check through the electrocardiograms of different angles. Therefore, obtaining ECGs at different angles is very helpful for judging heart disease.
  • the position of the electrodes can be easily moved through the moving housing, and the housing is located in front of the body, which is close to the heart, and can be angled even after a short distance of movement.
  • Different ECGs for differences.
  • FIGS. 5A-5B show a rectangular shell.
  • the body is rotated by 90 degrees, or other shapes of the casing may have the same effect, for example, a circular shape or an irregular shape, and the like, there is no limitation, so that even at the same body skin setting position, Get an ECG from different angles. Therefore, with such a setting, even a very simple neck-mounted electrocardiographic detecting device can also provide a multi-angle electrocardiogram for the user and provide more information about the state of the heart.
  • the electrode is disposed on the casing to overcome the Knowing the shortcomings of the neck-mounted ECG detection device, and providing the user with the most convenient and unburdened use experience without losing the signal strength.
  • the electrode is disposed through a housing having a certain hardness, and the contact stability between the electrode and the skin is improved. Further, the two electrodes are positioned on the same housing plane, and the relative positions between the two are fixed. Therefore, even if a body motion such as breathing occurs during the measurement, good contact stability can be effectively maintained.
  • the neck-mounted electrocardiographic detecting device employs a dry electrode, and therefore, the material of the electrode can be made of stainless steel as is generally known and fixed to the surface of the casing; and as an alternative
  • the electrode can also be implemented, for example, as a partial conductive coating on the surface of the casing, or the casing itself is a conductive material, and the electrode position is constructed by coating the insulating material, so that there are various possibilities. no limit.
  • a non-conductive electrode for example, an electrode form such as a capacitive type, an inductive type, or an electromagnetic type can be used to further increase the use convenience.
  • the electrocardiographic signal of the hand can be obtained even through the clothes, and the arrangement limit of the electrodes is reduced, so that there are more changes in accordance with the operating habits.
  • a housing of a non-conductive material can also be used as an electrode, for example, a part of a capacitive electrode.
  • the most easily implemented form of the attachment component is a belt body surrounding the neck, for example, a necklace or a collar, etc., but is not limited, as long as the casing is provided through the neck, the present invention is
  • the range of the materials to be used, and the materials used therein may also be changed according to actual needs.
  • it may be a belt made of various materials such as fabric, metal, rubber, and the like, without limitation.
  • the housing can be further oriented through the attachment assembly. As shown in FIGS. 5A-5B, by designing the combination of the additional component and the housing, the surface of the housing having the electrode can be further improved. Naturally facing the torso, ensuring proper contact between the electrodes and the skin.
  • an electrocardiographic signal extraction circuit of a neck-mounted ECG detecting apparatus includes an analog signal processing unit 22, a processing unit 24, a transmission module 26, and a battery 28.
  • the analog signal processing unit 22 is configured to receive the ECG signal extracted by the electrode 16, and the processing unit 24 serves as a control center of the entire ECG detecting device, and processes the extracted ECG signal, and the transmission is performed.
  • Module 26 is used for external transmission, and battery 28 is used to provide the power required to operate the ECG detection device.
  • the ECG signal extraction circuit may be implemented to be housed in the housing 12, or may be implemented to be dispersed in the housing 12 and the attachment assembly 14, or separately disposed in the attachment assembly 14, without limitation. It may be changed according to the actual implementation situation.
  • the attachment component may be implemented to have a carrying function in addition to the function of supporting the housing.
  • the attachment component may be implemented in a tubular form to accommodate the circuit.
  • the attachment component can also be implemented to communicate with the housing in a space for accommodating the circuit; or the number of the housing can be implemented as more than one to accommodate more circuits
  • Each of the housing surfaces may have electrodes, or only some of the housings may have electrodes. For example, only a start switch may be provided on the housing, etc., and thus, there is no limitation.
  • the attachment assembly 14 is simply fixed to the neck, and the device can be naturally placed in front of the trunk, such as under the collarbone, the chest, the front of the abdomen, etc. After that, it is only necessary to determine that the surface having the electrode faces the torso, so that when it is necessary to perform the detection, the handle can be easily applied by the hand and the surface of the housing having the electrode is brought into contact with the skin. And start a specific time, for example, 30 seconds, 1 minute, ECG signal detection, or determine the length of time to be detected according to their own needs.
  • the handheld ECG detection device will default to a measurement time, for example, 30 seconds or 1 minute, and automatically stops after the time has elapsed, except that the state of the heart burst is considered. In addition to time, it is also to prevent the user from maintaining the measurement posture for too long to avoid a more unstable situation in the hand operation.
  • the device of the present invention is in the form of a neck wear and has unstable the hand. Minimized, therefore, allows the user to determine the length of time to be measured each time according to actual needs. For example, when the device gives an audible reminder at the end of the predetermined 30-second measurement time, the user can still press the electrode continuously. Let the measurement continue without letting go, so that all kinds of heart conditions can be completely recorded.
  • the force applied to the housing is not limited to which part of the hand, for example, it may be a finger, a palm (hand or back), a wrist, an arm, etc., as long as the user feels convenient.
  • the parts can be tested and the left or right hand is not restricted. The user can freely test according to personal habits.
  • the surface of the housing that contacts the skin is implemented as a structure having improved electrode contact stability, for example, when the attachment assembly is placed on the chest, the surface can be implemented to have a curved surface to conform to the chest. Curve; or, if the attachment assembly places the housing in front of the abdomen, the surface can be implemented as a flat surface; or, if the attachment assembly places the housing under the collarbone, the surface can be implemented as a curved surface or a flat surface .
  • the housing portion in which the electrodes are disposed may be implemented to be higher than the surrounding housing surface, as shown in FIG. 7, to allow the force to be more concentrated in the electrode contact, not only to allow contact It is easier to achieve and can increase stability. Therefore, there is no limit.
  • the size of the casing should not be too large to avoid excessive burden on the neck of the user, and there is no specific limitation in terms of shape, for example, it may be a rectangle, a square, or a circle. Or irregular shapes, depending on actual needs.
  • the material of the housing is also an important factor affecting the electrode contact. It needs to be able to transmit the force of the hand to the electrode and ensure stable contact between the electrode and the skin. Therefore, the material used for the housing can have a certain degree. Hardness, to ensure the correct transmission of power, for example, plastic, in addition, can also be implemented as a flexible material, such as rubber, to increase the degree of conformity with the skin, therefore, the material can also have different options, Change in actual demand.
  • the housing may also be constructed of two materials, as shown in FIG. 8, that is, the first portion of the housing 32 facing the skin for carrying the electrodes is made of a flexible material. In order to make the surface contact with the skin, it naturally deforms with the undulation of the contact with the skin area, making the two more conformable, and making the contact between the electrode and the skin more stable, except for the surface.
  • the second part of the housing 34 can be made of a harder material to effectively convey the pressing force, so that the contact between the electrode and the skin can be unaffected regardless of the position at which the housing is placed.
  • the neck-mounted electrocardiographic detecting device may also have a function of providing information related to the user during the detection period.
  • the device according to the present invention may include an information providing module to provide information about the user's use case and/or the extracted signal, wherein the manner of providing the information includes, but is not limited to, screen display, sound. Changes, vibration changes, and visual changes, such as the color of the light-emitting components, changes in brightness, and the like.
  • the content of the provided data may also have various possibilities.
  • the device may use the sound to notify the user that the detection has started, and at the end of the predetermined detection time. Notifying the user to end the pressing action; or, when starting the detection, reminding the user that the current electrode contact condition is poor or the signal quality is not good, etc., allowing the user to adjust the force applied or the position of the housing; or Reminding or notifying the user what happened during the test,
  • sound can be used to express heartbeat changes, such as using the same sound as the heartbeat frequency, or using sound to notify the heart state, such as long tones and short to indicate different states.
  • the user result can be provided after the detection is completed. Therefore, the manner and content of the information provided are not limited, as long as the user can be accurately informed.
  • the neck-mounted electrocardiographic detecting device is disposed in front of the user's torso and adopts an operation mode for applying force to the casing. Therefore, in conjunction with such an operational behavior, the device and/or detection is activated in addition to the general operation.
  • various options are also available. For example, a switch can be provided on the housing that can be triggered by the force applied to the housing to allow the device to enter an ECG signal.
  • the extracted state is followed by activation of the device and/or detection; or, alternatively, the electrode can be coupled to a physical state detection unit 40, as shown in Figure 9, to detect a physical change in the electrode as it contacts the skin, And through the physical change, it is known whether the contact between the electrode and the skin is sufficiently stable, and thus it is known whether the device can perform ECG signal extraction.
  • the physical changes include, but are not limited to, pressure changes and impedance changes.
  • the physical state detecting unit 40 may include a pressure sensing module to know the pressure change, and determine whether the electrode is subjected to sufficient pressing.
  • the physical state detecting unit can also be implemented as a switch, and the pressure of the electrode can be also known.
  • the physical state detecting unit can also include an impedance sensing circuit or a capacitive sensing circuit. Knowing the impedance and capacitance of the electrode, and determining whether the ECG detection can be performed.
  • the physical state detecting unit is implemented as a pressure sensing module, an impedance sensing circuit, a capacitance sensing circuit, or a switch, or at least The combination of the two is not limited, and the physical state detecting component can be implemented to be connected to one of the electrodes, or all of the electrodes, depending on the actual implementation, and there is no limitation.
  • the device when the judgment is made, if the switch is not completely switched, and/or the physical change does not meet a predetermined range, indicating that the contact state between the electrode and the skin is insufficient for ECG signal extraction, the device is in ECG signal extraction.
  • whether the electrode can be used can be controlled by whether the switch is completely switched, or whether the physical change conforms to the preset range, for example, whether the electrode is turned on or not, that is, the electrode is in an unusable state. Until the switch is completely switched, or the physical change meets the preset range, the electrode is converted to a usable state, for example, turned on, and thus, it can be further confirmed.
  • the clarity of the ECG signal obtained by Baobao is more conducive to the accuracy of the analysis results.
  • the device according to the present invention can be designed as The device will automatically start detecting the ECG signal after a certain time, for example, 3 seconds; or in another preferred embodiment, the device will be converted to a certain time after, for example, 3 seconds later.
  • the state of the ECG signal extraction is performed, and thereafter, if the extractable state continues, the ECG signal detection is started. Therefore, there are various possibilities, but the actual demand changes, and there is no limitation.
  • the device according to the present invention can also be implemented in a state of signal extraction, but recording is performed only when the characteristics of the electrocardiographic signal are detected, or the sampling frequency or signal magnification is adjusted. To more complete record of all possible ECG signal changes.
  • the operation of the neck-mounted ECG detecting device according to the present invention in addition to the above-described single mode of operation, can also communicate with an external device 50 through its own transmission module, and The two work together to complete the ECG signal detection, as shown in Figure 10.
  • the transmission module may be implemented for wired or wireless transmission, for example, a USB wired connection, or a wireless connection manner such as Bluetooth, 3G, wifi, and NFC, and the external device includes, but is not limited to, Personal computers, smart phones, tablet computers, smart watches and other devices.
  • the device of the present invention is naturally hidden in the clothes, and therefore, by connecting with an external device, for example, a smart phone for daily use, it is possible to provide a more convenient operation for the user.
  • the measurement can be viewed in real time through a corresponding application executed on the mobile phone. a situation, for example, a heart rate change or an electrocardiogram waveform, etc., and in another preferred embodiment, the obtained ECG signal can be directly stored on the mobile phone in addition to the display, and in particular,
  • the user can observe the waveform through the mobile phone before selecting the ECG signal interval to be stored. For example, as described above, the user can adjust the housing angle and/or the shell before storing.
  • the position of the body and the torso is taken to obtain an electrocardiogram of different phases, and the waveform is observed in real time through the mobile phone, and then the electrocardiogram to be recorded is determined; or, alternatively, in a preferred embodiment, the mobile phone can directly pass through the application.
  • the program controls the operation of the neck-mounted ECG detecting device, for example, the user can start/stop the device and/or ECG signal extraction, or perform device setting. Therefore, no Restrictions, there may be different divisions between the two depending on actual usage requirements.
  • the device according to the invention may also be implemented to be selectable for individual operation or for cooperation with an external device.
  • the user can confirm whether there is an external device by first tapping the housing. If no external device is found, the ECG signal is separately extracted as described above.
  • An external device for example, an application on the mobile phone is turned on and allowed to be connected. At this time, the device enters a mode of connection with the external device, and then, in one case, the user continues to press the housing again to achieve electrode contact and activate the heart.
  • the electrical signal is extracted, and during the extraction, the ECG signal is displayed through the mobile phone in real time, or in another case, after the user presses the housing again to reach the electrode contact, the device enters a state in which the ECG signal can be extracted.
  • the user can initiate the extraction of the ECG signal through the interface on the mobile phone.
  • the applicable range of the neck-mounted electrocardiographic detecting device according to the present invention becomes wider, for example, through the display interface and storage of the external device.
  • the signal can be transmitted to a remote medical staff or monitoring center, or uploaded to the cloud for storage for medical personnel to access. This transmission can be implemented by the user and set for a fixed period of time, such as one week.
  • the device will automatically notify the remote monitoring of the result in real time regardless of the setting.
  • a default condition such as a low heart rate
  • the device will automatically notify the remote monitoring of the result in real time regardless of the setting.
  • the neck-mounted ECG detecting device provides several options for processing/analysing the ECG signal, for example, by the processing unit through the preloaded calculation formula.
  • the analysis of the electrocardiographic signal is transmitted to the external device for display; or the processing unit is implemented to perform only partial processing or analysis, and after being transmitted to the external device, the external device is further used.
  • the analysis may be performed; or, the ECG signal may be stored in the neck-worn device, and then processed and analyzed by the external device after being transmitted to the external device.
  • the way of processing and the results of the analysis depend on the difference in the calculus. For example, it can provide analysis of average heart rate, irregular heart rate, frequency pulse, slow pulse, etc., and can provide more detailed analysis.
  • the types and patterns of arrhythmia such as VEB, SVEB, AF, etc.
  • the basis of these analyses is a clear and stable ECG signal. Since this case is different from the well-known technology, even a simple neck-hanging form can have stable electrode contact to obtain a clear ECG signal. Therefore, these analysis results can be provided without any hindrance.
  • the neck-mounted ECG detecting device can be implemented as a direct built-in transmission connector 60, for example, a USB connector, to achieve transmission between external devices, thereby eliminating the necessity of using a connecting wire. Trouble.
  • the USB connector 60 can be covered by a movable housing portion 121 of the housing, for example, a cover. When the measurement is made, the USB connector is hidden under the cover. When the measurement is completed for wired transmission, simply moving the cover to expose the USB connector can be directly used to connect an external device, for example, a USB port of a personal computer, which is quite convenient to use.
  • the action of removing the connector based on the removal of the cover is performed when the connector is removed, and the device according to the present invention can be further implemented as an electrode and an internal circuit on the surface of the case when the cover is removed. The connection between them will also be disconnected at the same time to ensure the safety of use.
  • the device according to the present invention must have a protection mechanism for the user not to contact the electrode because the surface of the casing has electrodes.
  • the switch of the circuit switch for controlling the electrode connection is achieved when the upper and lower sides are removed, so that the electrical insulation can be naturally completed by removing the cover body, which is convenient to use. Security is also guaranteed.
  • the electrocardiographic detecting device may further comprise a motion sensing component, such as a motion sensor or an accelerometer, etc., to detect a body movement during the detection, to It is used as a reference for processing and analyzing ECG signals. For example, when an ECG signal is found to be abnormal, the situation of the body movement can be compared first, for example, whether it is in a state of strenuous exercise, or before an abnormality occurs.
  • a motion sensing component such as a motion sensor or an accelerometer, etc.
  • the arrangement of the electrodes on the housing may also be extended, as shown in Figures 12A-12B, the two electrodes originally located on the first surface 122 of the housing,
  • the third and fourth surfaces 126, 128 may be respectively extended adjacent to and opposite to each other, that is, each electrode has two portions, one portion on the first surface facing the skin and the other portion Then extending opposite to each other, and the two portions can be implemented as the same electrode 162, 164, as shown in FIG. 12A, or as two electrodes but connected in parallel with each other 166a, 166b, 168a, 168b, as shown in FIG. 12B Show.
  • the device according to the present invention can be implemented to be measured by hand-held form, as shown in FIGS. 13A-13B, except that it can be placed in front of the torso for detection through the attachment assembly.
  • the user can touch one of the electrodes by holding one end of the housing, and then the other end of the electrode is contacted with the other hand or the torso, just like a general hand-held ECG detection.
  • the use of the device, and the ECG detection, in this way, can achieve a multi-purpose effect.
  • the different electrode portions may be implemented to be activated or not depending on the mode of operation, for example, by setting a switch, or may be implemented by the connection between the attached component and the housing. Deciding, for example, when the attachment assembly is coupled to the housing, indicating that the housing is in a state in front of the torso, so that the electrode portion located on the same surface is activated, and when the attachment assembly is separated from the housing , indicating that the housing has been removed from the neck, in a state in which handheld electrocardiographic detection can be performed, at which time the electrode portion located on the opposite surface is activated.
  • the electrodes on the housing may also be implemented to be located on opposite sides, as shown in FIG. 14, that is, one of the electrodes is located when the housing is disposed in front of the trunk. Facing the first surface 122 of the torso, and the other electrode is located on the second surface 124 opposite the first surface, so that when operating, the user can The second surface is biased and simultaneously contacts the electrode thereon, as shown in FIG. 15, to simultaneously contact the electrode on the first surface with the skin in front of the trunk.
  • This arrangement can also be conveniently carried out only through The ECG signal is obtained after a force application.
  • the electrode on the housing may be implemented as a non-conductive electrode as described above, for example, a capacitive type, an inductive type, or an electromagnetic type, in addition to the dry electrode form.
  • a non-conductive electrode for example, a capacitive type, an inductive type, or an electromagnetic type, in addition to the dry electrode form.
  • the electrode on the second surface can be implemented without directly contacting the skin, so that the contact of the force-applying hand can also obtain the ECG signal even through the cloth, such as clothing.
  • it can be tested, or, further, all electrodes can be implemented without direct contact with the skin, so that there is no directional restriction on the side, no matter which side The ECG signal can be extracted toward the torso, which effectively improves the user's convenience.
  • the neck-mounted ECG signal detecting device When implemented as a non-conductive electrode, the application of the neck-mounted ECG signal detecting device according to the present invention will be more extensive.
  • the device can be fixed to the front of the torso by means of a double-sided adhesive attachment assembly, so that the contact between the electrodes and the skin and the arrangement of the housing can be completed simultaneously.
  • the two electrodes may be implemented to be on the first surface or on the first and second surfaces, respectively, without limitation.
  • the number of electrodes is also not limited.
  • a reference electrode may be added to eliminate noise, and when the number of electrodes is increased, in addition to the electrode being disposed on the attachment component or extending by the connection line, The number of housings is increased to set the electrodes so that the user can easily detect the force applied to the housing.
  • the device according to the present invention may further have a light volume change (PPG) sensor disposed at a position where the force applied finger or the dry skin is contacted, so that the ECG signal can be obtained while the ECG signal is being obtained.
  • PPG light volume change
  • Information about blood physiology is also obtained, which in turn provides users with more information.
  • the light emitting component emits light into the blood vessel under the skin, and then the light detector receives light that penetrates the blood vessel or is reflected by the blood, and after obtaining a change in the light absorption value, a specific relationship is obtained.
  • the time required for the pulse wave to pass from the heart to the sensing position of the PPG sensor that is, the pulse transit time (Pulse Transit Time) can also be obtained.
  • PTT Pulse Transit Time
  • blood pressure and/or blood vessel related values can be calculated through a specific relationship between PTT and blood pressure values.
  • the setting position of the PPG sensor it can be changed according to actual needs.
  • the PPG sensor may be disposed on the same surface as the electrode to obtain blood physiological information while the electrode contacts the torso; or may be disposed on the hand to the housing.
  • blood physiological information is obtained from the hand; in addition, when the two electrodes are disposed on opposite sides of the housing to respectively contact the trunk and the skin of the hand, the setting of the PPG sensor may be located on both surfaces.
  • blood physiological information is obtained from the trunk or from the hand during the measurement of the electrocardiogram. Therefore, a suitable position can be selected according to different embodiments without limitation.
  • the electrocardiographic detecting device can also be implemented to have a label button for the user to suddenly appear when he or she feels necessary, for example, during a routine routine ECG test. The heart is uncomfortable. At this time, the time point and the like can be marked by pressing the button, so that the doctor can pay special attention to the signal change before and after the time point when viewing the recorded signal.
  • the ECG detecting device may also be provided with an alert button for the user to press when an emergency occurs in the body, triggering the processing unit to issue a warning signal, for example, issuing a warning. Acoustic, causing attention of the surrounding people, or transmitting to the care center by telephone or network, starting an emergency ambulance system, etc.
  • the electrocardiographic detecting device can also be implemented as a function of GPS positioning, In the first place, the caregiver can confirm the user's location when necessary to provide the necessary assistance.
  • the neck-mounted electrocardiographic detecting device of the present invention by adopting a neck wearing form different from the known technology, the device can be set to be large and stable in signal strength without burdening the user.
  • the front of the trunk minimizes the limitation of the placement of the electrodes on the surface of the device housing, and also reduces the use restrictions during operation, and simply applies a force to the housing with one hand, and contacts the electrodes on the surface of the housing to the skin. With the action, it is easy to complete stable electrode contact and get a clear electrocardiogram for professional interpretation of whether there is a cardiac abnormality, such as arrhythmia or myocardial infarction, thus providing a more convenient and effective heart than the known technology. Electrical detection device.

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Abstract

一种颈戴式心电检测装置（10），包括一壳体（12），具有相对的一第一表面（122）以及一第二表面（124），一第一电极以及一第二电极，位在该第一表面（122）上，一依附组件（14），与该壳体（12）相结合，用以依附至一使用者的颈部，以及一心电信号提取电路，以配合该第一及第二电极而进行一心电信号提取，其中，当该使用者透过该依附组件（14）而穿戴该装置（10）时，该壳体（12）被设置于使用者躯干的前方，以及当使用者的手部以朝向躯干的方向对该壳体（12）施力时，该壳体（12）被固定于手部及躯体之间，并在该第一及第二电极与躯干前方皮肤间产生一稳定接触，进而使该装置（10）进入一可提取心电信号状态。本装置（10）可轻松完成稳定的电极接触并得到清晰的心电图。

Description

颈戴式心电检测装置 技术领域
本发明涉及一种颈戴式心电检测装置，更进一步地是，本发明亦涉及一种具有稳定电极接触方式、并可取得清晰且稳定的心电信号的颈戴式心电检测装置。
背景技术
已知，心电检测装置是用于检查各种心脏疾病的主要途径，例如，是否有心律不整、因高血压或心脏瓣膜疾病所引起的心肌肥厚、心肌梗塞、或是狭心症等病症。
当人们感受到心脏不适而至医院进行检查时，多采用的是传统的心电检测装置，例如，十二导联心电图检测，可较详尽的检测出各种心脏问题，但若心脏不适的来源是偶发性的症状，例如，心律不整，则很可能无法在检测期间测得发病时的心脏情况，因此，因应此种偶发性症状，多会采用配戴霍特式(Holter)心电图机进行长时间检测的方式，例如，配戴24小时至数天的时间，希望以这种方式记录下出现症状时的心电图，而与霍特式心电图机类似的，心电事件记录器(ECG event recorder)也是采用长期配戴的方式，但不同地是，其让使用者自行决定记录的时间，例如，心脏觉得不舒服的时候，并透过按钮启动的方式而记录下心电图，例如，装置平常不进行记录，而是在使用者按下按钮时才记录下按压时间前后各30秒的心电图。而除了用来记录偶发性症状外，霍特式心电图机也常用于监控心脏手术或服用治疗药物后的心脏情形，以确认治疗效果。
无论是霍特式心电图机或心电事件记录器，其设置方式都必须在身上黏贴多个用以取得心电图的电极，并透过连接线连接至一装置，因此，使用者在测量期间必须一直黏贴着电极且将装置配戴于身上，相当不便，也容易因长时间黏贴电极而产生皮肤不适，这些都是让使用者却步的原因，再加上，有时也会出现即使经过长时间配戴检测后，却因没有发病而未记录下任何可 供分析偶发性症状的心电图。而且，这样的检测，必须透过专业医护人员的协助才能完成设置，例如，电极的黏贴必须在医院内设置完成，并且，通常是在完成长时间的测量后，再由医生下载记录下来的心电图进行分析，需要至少数天后才能知道心脏出了什么问题，所以，不但复杂度高，亦缺乏实时性。
因此，针对上述的这些缺点，进一步提出的改进是手持式心电检测装置，其透过采用不需黏贴于身上的干式电极而解决必须将装置长期配戴于身上的困扰，以及简化进行检测时的复杂度。如US7149571以及US7197351所揭示，手持式心电检测装置在装置的表面设置有干式电极，可随时在有需求时透过接触手及/或体表的方式而进行心电检测，因此，不再受限于配戴于身上的时间以及电极黏贴，故可更长时间地用来监控心脏的情形，而且，这样的心电检测装置通常亦配置有分析程序及显示屏幕，可让使用者在测量的当下即得知检测结果，无须等到至医院回诊，因此，相当适合居家使用，并且，也提供了对自身心脏健康有高度关心的使用者平时可自行定时了解心脏情形的简易途径。
之后，随着随身携带的电子装置，例如，智能型手机的普及，近年来出现的是与手机相结合的心电检测装置，如US8615290所揭示，其与手持式心电检测装置类似，同样是采用干式电极，差别只在于是透过手机的操作接口进行装置的操控，这样的方式让有监控心脏需求的使用者可减少随身携带的装置的数量。
不过，上述可随身携带的手持式心电检测装置面临的最大问题，却也是因为利用手进行操作所造成。当采用接触双手形式时，如图1所示，首先面临的问题就是信号较弱，由于双手与心脏距离较远，再加上心电信号原本就小，更加微弱后，非常容易受到环境噪声的影响，而让分析的进行变困难，另一个问题则是操作稳定度低，以双手进行测量的方式很容易在测量时发生如手部晃动等不稳定的现象，因而造成所测得的心电图出现基线飘移、波形变形等影响分析的状况，而且，当使用者希望手部维持稳定而肌肉紧张、或是特意用力以确保与电极间接触时，也很容易因用力而产生影响信号分析的肌电信号。
当采用一手握持装置另一边接触胸膛的方式时，如图2所示，相较于双 手操作，可较为稳定，所取得的信号也较强，只是，这样的操作方式有一个最大顾忌，就是必须掀开衣服来接触胸膛才能进行测量，自然限制了可以使用的场合，另外，胸腔因呼吸所产生的起伏，依然会造成接触胸膛的电极与接触手的电极间产生相对移动，同样会影响所测得的心电图。
此外，手持式心电检测装置由于必须由手握持而操作，在符合人体工学的需求下，再加上需要显示结果，尺寸上无法过小，携带上仍是一定的负担；而且，由于电极并未一直设置于身上，因此，欲进行检测时，需要较多的步骤，例如，先取出装置后再开机，才能开始进行检测，故亦有可能因此而错失检测的时机。
再者，有另一种利用颈挂方式穿戴于身上的心率监测装置，例如，US8668643，US20130345578，US20080287768，以及US20070106145所揭示者。此类装置虽然携带方便，但由于采用的是电极自然触碰身体的方式，相较于前述黏贴式电极、或是手部对电极表面施力等操作方式，缺乏固定的力量，因此电极与皮肤间的接触非常不稳定，也因此无法取得清晰且稳定的心电图，故并不适合用来判断心脏是否出现异常，例如，是否有心律不整、心肌梗塞等症状，再加上其将电极设置于颈部的特殊配置方式，亦导致使用上有诸多限制。
因此，确实需要一种能够解决上述缺点的心电检测装置，让使用者可更方便地使用的同时，亦可将操作时的各种不确定因素的影响降至最低。
发明内容
本发明的目的在于提供一种颈戴式心电检测装置，以透过颈部作为设置于使用者身上的媒介而自然地被设置在心电信号稳定且容易操作的位置。
本发明另一目的在于提供一种颈戴式心电检测装置，其可同时提供简易的单手操作方式以及稳定的电极接触。
本发明再一目的在于提供一种颈戴式心电检测装置，其可在不掀开衣服的情刑下进行测量，并取得强大的心电信号，因而可不再受限于所在场合，随时进行心电测量。
本发明又一目的在于提供一种颈戴式心电检测装置，其具有小巧的体积，且方便长时间穿戴，可提供使用者随时进行测量的需求，再配合连接网络， 就可在测量结果出现问题及/或使用者有需要时，传送数据及/或信息至远程的监控中心，实时反应，故相当适合居家长期照护所需。
本发明又一目的在于提供一种颈戴式心电检测装置，其可穿戴于身上而不影响使用者的活动，因此适合在特定时间及/或特定活动前后，例如，运动前后，进行心电信号的提取。
本发明的又一目的在于提供一种颈戴式心电检测装置，其可隐藏于衣服内进行检测，并实时将心电检测相关信息显示于外部装置，例如，手机上，以符合使用者的使用习惯。
本发明又一目的在于提供一种颈戴式心电检测装置，其通过特殊电极位置设计而实现颈戴及手持两种操作方式，以进一步提供使用者更具选择性的一机多用装置。
根据本发明一方面的构想，一种颈戴式心电检测装置包括一壳体，具有相对的一第一表面以及一第二表面，一第一电极以及一第二电极，位在该第一表面上，一依附组件，与该壳体相结合，用以依附至一使用者的颈部，以及一心电信号提取电路，以配合该第一及第二电极而进行一心电信号提取，其中，当该使用者透过该依附组件而穿戴该装置时，该壳体被设置于使用者躯干的前方，以及当使用者的手部以朝向躯干的方向对该壳体施力时，该壳体被固定于手部及躯体之间，并在该第一及第二电极与躯干前方皮肤间产生一稳定接触，进而使该装置进入一可提取心电信号状态。
较佳地是，该稳定接触达成一开关切换，而使该装置进入该可提取心电信号状态，或者，替代地，该稳定接触使该第一及第二电极的一物理变化符合一预设范围，而使该装置进入该可提取心电信号状态，且该物理变化是通过一物理状态检测单元而进行检测，其中，该物理状态检测单元可实施为一压力感测模块，一阻抗感测电路，一电容感测电路，或一开关。另外，在一较佳实施例中，当根据本发明的装置进入该可提取心电信号状态后，心电信号提取会在一特定时间后自动起始。
再者，根据本发明的颈戴式心电检测装置亦可提供一共同运作模式，以透过有线或无线方式而与一外部装置共同进行心电信号提取，在此，该外部装置可实时接收并显示来自该心电检测装置的心电信号以及相关信息，并由使用者通过该外部装置而起始一特定期间的心电信号记录，或者，替代地， 根据本发明的该装置亦可在进入该可提取心电信号状态后，受到该外部装置的控制而起始心电信号提取，并且，该外部装置亦可包括一演算式，以提供相关心律不整的信息，此外，进一步地，该外部装置可透过一网络而连接至一远程监控中心，且当该心电信号符合一默认条件时，该外部装置可自动传送一通知信号至该远程监控中心。
另外，根据本发明的颈戴式心电检测装置可包括一信息提供模块，以提供使用者相关心电检测的信息，其中，提供信息的方式包括，屏幕显示，声音变化，振动变化，以及视觉变化，并且，较佳地，透过加载适当的演算式，亦可提供相关心律不整的信息。此外，根据本发明的颈戴式心电检测装置尚可包括一动作传感器，以检测使用者的身体移动情形。
在一较佳实施例中，根据本发明的颈戴式心电检测装置可进一步包括一第三电极，位在与该第一表面相邻的一第三表面上，以及一第四电极，位在与该第一表面相邻且与该第三表面相对的一第四表面上，以用于进行一手持式心电信号提取，其中，该第一电极以及该第三电极可实施为并联连接，以及该第二电极以及该第四电极可实施为并联连接，或者，替代地，该第一电极以及该第三电极可实施为一体成型，以及该第二电极以及该第四电极可实施为一体成型。
根据本发明另一方面的构想，一种颈戴式心电检测装置包括一壳体，具有相对的一第一表面以及一第二表面，一第一电极以及一第二电极，分别位在该壳体的该第一表面以及该第二表面上，一依附组件，与该壳体相结合，用以依附至一使用者的颈部，一心电信号提取电路，以配合该第一及第二心电电极而进行一心电信号提取，以及一物理状态检测单元，用以感知至少一电极在接触使用者皮肤表面时所产生的一物理变化，其中，当该使用者透过该依附组件而穿戴该装置时，该壳体被设置于使用者躯干的前方，当使用者的手部以朝向躯干的方向对该第二表面上的该第二电极施力时，该壳体被固定于手部及躯体之间，并在位于该第一表面上的该第一电极与躯干前方皮肤间产生一稳定接触，以及当该稳定接触使该物理变化符合一默认范围时，该装置进入一可提取心电信号状态。
较佳地是，该物理状态检测单元实施为一压力感测模块，一阻抗感测电路，一电容感测电路，或一开关。亦较佳地是，该第一及第二电极的至少其 中一实施为电容式电极，感应式电极，或电磁式电极。
此外，在一较佳实施例中，根据本发明的颈戴式心电检测装置可进一步包括一光容积变化(PPG)传感器，以取得血液生理信息，例如，脈波信息以及血氧濃度變化，並且，所取得的脉波信息還可与心电信号一起计算得出脉波传递时间(PTT)，以进一步获得血压值及/或血压变化的相关数值。
附图说明
图1显示公知手持式心电检测装置的一种操作方式；
图2显示公知手持式心电检测装置的另一种操作方式；
图3显示根据本发明一较佳实施例的颈戴式心电检测装置的示意图；
图4显示根据本发明一较佳实施例的颈戴式心电检测装置的使用示意图；
图5A-图5B显示根据本发明一较佳实施例的颈戴式心电检测装置的二种使用型态；
图6显示根据本发明的颈戴式心电检测装置的电路方框图；
图7显示根据一较佳实施例，本发明颈戴式心电检测装置的电极设置的剖面示意图；
图8显示根据一较佳实施例，本发明颈戴式心电检测装置的壳体的剖面示意图；
图9显示根据本发明的颈戴式心电检测装置的另一电路方框图；
图10显示根据一较佳实施例，本发明颈戴式心电检测装置与一外部装置共同使用时的示意图；
图11显示根据一较佳实施例，本发明颈戴式心电检测装置内建连接器的示意图；
图12A-图12B显示根据本发明另一较佳实施例的颈戴式心电检测装置的二种电极配置方式；
图13A-图13B显示如图12A-图12B的颈戴式心电检测装置的二种手持操作方式；
图14显示根据本发明再一较佳实施例的颈戴式心电检测装置的电极配置方式；以及
图15显示如图14的颈戴式心电检测装置的使用示意图。
其中，附图标记说明如下；
10   颈戴式心电检测装置
12   壳体
121  可移动壳体部分
122  第一表面
124  第二表面
126  第三表面
128  第四表面
14   依附组件
16，162，164，166a，166b，168a，168b  电极
22   模拟信号处理单元
24   处理单元
26   传输模块
28   电池
32   第一部分壳体
34   第二部分壳体
40   物理状态检测单元
50   外部装置
60   连接器
具体实施方式
有鉴于让使用者可实时记录下心电图的目的，本发明的装置实施为穿戴形式，而在许多可将心电检测装置设置于身上的方式中，本发明选择了颈戴，如图4所示的穿戴方式，主要的理由如下。
首先，透过颈挂的形式，装置可自然地被置于躯干前方，如锁骨下方、胸前、腹部前方等位置，因为正如本领域的技术人员所知，躯干是心电信号最强的区域，因此，这样的设置首先确保了所取得的信号有足够的强度。
再者，相较于同样可将装置设置于胸前的胸带形式，颈戴形式对使用者 所带来的束缚感小上许多，因而可提供较舒适的使用经验。
另外，颈戴形式也让装置可自然的位在衣服与躯干之间，电极接触躯干的动作不需掀开衣服就可达成，消除使用场合的限制，让使用者不再因必须掀衣而却步，或屈就于信号较弱的双手取信号测量方式。
此外，本发明采用干式电极，让使用者可随时使用，无须担心电极设置的问题，省去必须使用导电膏的麻烦以及消除可能造成使用者出现皮肤不适现象的疑虑。
因此，透过采用颈戴方式，根据本发明的克服了前述公知技术的各种缺点，例如，需要黏贴电极、可能引起皮肤不适、信号强度不够、缺乏实时性、需掀衣进行测量等问题。
而也由于采用颈戴的形式让使用者可无负担地长期穿戴于身上，再加上可自然、容易地随时取得强度足够的心电信号，因此，相当适合应用于居家看护领域，举例而言，使用者可在日常生活中将装置戴于颈部，而在随时有需要时，例如，觉得心脏不舒服时，实时地启动心电信号检测，或是每天定期地进行心电图检测，有效地掌握自身的心脏变化。
另外，根据本发明的颈戴式心电检测装置亦相当适介在运动时使用，举例而言，使用者可在运动过程中戴着根据本发明的装置而不会感到负担，并在运动中间休息的时间直接进行测量而得知运动对心脏所造成的影响，例如，是否达到了足够的运动强度(心跳是否达到预期目标)，或是心脏是否出现异常等，尤其运动是心律不整的好发时间，因此，透过本发明的装置就可很实时的纪录下发生心律不整时的心电图。
请参阅图3，其显示根据本发明的颈戴式心电检测装置的整体配置示意图。如图所示，根据本发明的颈戴式心电检测装置10从外观上可看出具有一壳体12，一依附组件14，以及至少二电极16，其中，该依附组件14实施为与该壳体12相结合，并可依附至使用者的颈部，以使该壳体12位于使用者躯干的前方，例如，锁骨下方、胸前、腹部前方等位置，如图4所示，而电极16则是位于壳体12的表面。
在一较佳实施例中，根据本发明的电极实施为位在该壳体的同一个表面上，如图3的第一表面122上，亦即，当壳体透过该依附组件而设置于躯干前方时，朝向躯干的该表面上，如图4所示，即使覆盖于衣服中，两个电极 与皮肤间的接触亦可轻易达成，因此不需掀衣亦可进行检测。而如此的实施方式的基础就在于，透过颈戴的形式，根据本发明的装置的壳体被设置在心脏周围的位置，心电信号强度够的位置，在设置电极位置时的限制小，例如，距离可以很短。
在本发明中，电极被设置于壳体上，而非如公知技术的带体上，除了带体上电极的稳定接触不易达成外，主要的原因是：
首先，如前所述，心脏附近，也就是躯体，是心脏信号最清晰的取样位置，而且，由于二个电极彼此很接近，电路回路短，可避免各类噪声干扰心电测量，特别是对于共模噪声，如50Hz/60Hz可轻易加以排除。
再者，当电极皆位于壳体上时，使用者可以很轻易地透过移动壳体就移动电极位置，进而改变电极与心脏的相对位置，就可得到各种不同角度的心电图。
在进行心电图测量时，每两电极就可得出一个角度的心电图，也就是，电极的设置位置决定了心电图所反应的心脏电气活动的投影角度，而由于心脏是立体的，且产生病变的心脏部位可能位在任何心脏位置，例如，心肌梗塞的检查需要察看心电波形中是否出现因心肌坏死而出现的ST飘移，但往往可能因为其发生位置的关系而在某些角度下无法被察觉，此时，就需要透过不同角度的心电图才有可能检查得出来，因此，取得不同角度的心电图对于判断心脏疾病有很大的帮助。
所以，当电极皆位于壳体上时，电极位置可以很简单地透过移动壳体而移动，再加上壳体位在躯体前方，与心脏距离很近，即使短距离的移动亦可获得具角度差别的不同心电图。
除了上述移动壳体的方式外，具优势地是，本发明的装置亦可提供另一种选择，利用转动壳体的方式而取得不同角度的心电图，例如，图5A-图5B显示了长方形壳体旋转90度的情形，或者，其他形状的壳体也可有同样的效果，例如，圆形或不规则形状等，没有限制，如此一来，即使在同一个身體皮膚的设置位置处亦可取得不同角度的心电图。因此，透过这样的设置，即使是很简单的一个颈戴式心电检测装置，同样可以为使用者提供多角度的心电图，并提供更多有关心脏状态的信息。
所以，对本发明的装置而言，就是由于电极设置于壳体上，才能克服公 知颈戴式心电检测装置的缺点，进而在不损失信号强度的情形下，同时提供使用者最方便且无负担的使用经验。
另外，透过具有一定硬度的壳体来设置电极，也让电极与皮肤间的接触稳定性获得提升，再加上，两个电极位在同一壳体平面上，两者间的相对位置被固定，因此，即使于测量期间出现如呼吸等身体动作，仍可有效地维持良好的接触稳定度。
如上所述，根据本发明的颈戴式心电检测装置采用的是干式电极，因此，电极的材质可以如一般所熟知的采用不锈钢材质，并固定至壳体表面上；而作为另外的选择，电极也可实施为，举例而言，壳体表面的局部导电涂层，或是壳体本身即为导电材质，利用涂覆绝缘材质而建构出电极位置，因此，可以有各种可能性，没有限制。
此外，由于本发明采用颈戴形式，且装置被隐藏于衣服内，因此，亦可考虑使用非导电电极，例如，可采用电容式、感应式、电磁式等的电极形式，以进一步增加使用方便性，例如，藉此即使透过衣物亦可取得手部的心电信号，也让电极的配置限制减少，以因应操作习惯而有更多的变化。而当采用此种非导电电极时，还可利用非导电材质的壳体作为电极，例如，电容式电极的一部分。
在此，该依附组件最容易实施的形式是环绕颈部的带体，例如，项链或项圈等，但并不受限，只要是可透过颈部而设置壳体的方式，皆属本发明所涵盖的范围，并且，其所使用的材质亦可依实际需求而改变，例如，可以是织物、金属、橡胶等各种材质制成的带体，没有限制。
再者，更进一步地，还可透过依附组件而帮助壳体进行定向，如图5A-图5B所示，通过设计附加组件与壳体间的结合方式，可让具有电极的壳体表面更自然地朝向躯干，进而确保电极与皮肤间的正确接触。
接着，请参阅图6，其显示根据本发明的颈戴式心电检测装置的心电信号提取电路，包括一模拟信号处理单元22，一处理单元24，一传输模块26，以及一电池28，其中，该模拟信号处理单元22用以接收透过电极16所提取的心电信号，该处理单元24作为整个心电检测装置的控制中心，并会对所提取的心电信号进行处理，该传输模块26用以进行对外的传输，而该电池28则是用以提供操作心电检测装置时所需的电力。
在此，该心电信号提取电路可实施为容置于该壳体12中，或者，也可实施为分散于壳体12及依附组件14中，或是单独设置于依附组件14内，没有限制，可依实际实施情形而变化，举例而言，该依附组件除了提供支持壳体的功能外，亦可实施为具有承载功能，例如，该依附组件可实施为如管状的形式，以将电路容置于其中，在此，进一步地，该依附组件还可实施为其容置电路的空间与壳体相通；或者，该壳体的数量也可实施为多于一个，以容置更多的电路，而每一个壳体表面则可皆具有电极，或是仅部分壳体上具有电极，例如，壳体上亦可仅设置启动开关，等，因此，没有限制。
当使用者在使用根据本发明的装置时，如图4所示，只需将依附组件14固定于颈部，装置就可自然地被放置于躯干前方，如锁骨下方、胸前、腹部前方等，之后，只需确定具有电极的表面朝向躯干即可，如此一来，当有需要进行检测时，就可轻松地利用手对壳体施力，并使具有电极的壳体表面接触至皮肤，而开始一特定时间，例如，30秒、1分钟，的心电信号检测，或是依照自身需求而决定要检测的时间长度。
在此，需要注意地是，一般而言，手持式心电检测装置多会默认一测量时间，例如，30秒或1分钟，并在时间到了以后自动停止，除了是考虑心脏突发状态的持续时间外，亦在于让使用者无须维持测量姿势过久，以避免手部操作出现更不稳定的情形，不过，本发明的装置由于是采用颈戴的形式，并已将手部不稳定的因素降至最低，因此，可让使用者依照实际需求决定每次要测量的时间长度，举例而言，当装置在预定的30秒测量时间结束而发出声音提醒时，使用者仍可通过持续按压电极不放手而让测量继续，以让各种心脏情形都可完整被记录下来。
亦需要注意地是，用以对壳体施力的，并不限于是手的哪个部位，例如，可以是手指、手掌(手心或手背)、手腕、手臂等，只要是使用者觉得方便的手部部位，皆可完成检测，而且，亦不限制使用左手或右手，使用者可自由地依个人习惯进行检测。
由于电极与皮肤间的接触，仰赖的是介于施力手以及皮肤之间的壳体，因此，壳体需要能正确且适当的将施力传导至电极以及皮肤，故较佳地是，用以接触皮肤的壳体表面实施为具有增进电极接触稳定性的结构，举例而言，当依附组件将壳体设置于胸前时，该表面可实施为具有弧面，以符合胸部的 曲线；或者，若依附组件将壳体设置于腹部前方时，则该表面可实施为平面即可；又或者，若依附组件将壳体设置于锁骨下方时，则该表面可实施为曲面或平面。此外，特别地，在一较佳实施例中，设置电极的壳体部分可实施为高于周围的壳体表面，如图7所示，以让施力更集中在电极接触，不但可让接触更容易达成，亦可增加稳定度。因此，没有限制。
再者，由于采用颈挂形式，因此，壳体的尺寸不宜过大，以避免使用者颈部负担过大，而在形状方面，同样没有特定的限制，例如，可以是长方形、正方形、圆形、或不规则的形状，可视实际需求而变化。
另外，壳体的材质亦是影响电极接触的一个重要因素，其需要能够将手部施力传达至电极，并确保电极与皮肤间的稳定接触，因此，壳体所使用的材质可具有一定的硬度，以确保力量的正确传达，例如，塑料，另外，也可实施为具有挠性的材质，例如，橡胶，以增加与皮肤间的服贴度，因此，材质同样可有不同的选择，可实际需求而变化。
在一较佳实施例中，该壳体亦可实施为由两种材质所构成，如图8所示，亦即，面向皮肤、用来承载电极的第一部分壳体32采用具有挠性的材质，以让该表面在接触皮肤的时候，可自然地随着接触皮肤区域的起伏而产生形变，使两者间更为服贴，也让电极与皮肤的接触更为稳定，而除了该表面以外的第二部分壳体34，就可使用较坚硬的材质，以达到有效传达按压力量的效果，如此一来，无论壳体被设置的位置为何，电极与皮肤间的接触都可不受影响。
在检测期间。除了进行心电信号的提取外，根据本发明的颈戴式心电检测装置亦可具备提供使用者相关于检测期间的信息的功能。举例而言，根据本发明的装置可包括一信息提供模块，以提供使用者相关于使用情形及/或所提取的信号的信息，其中，信息提供的方式包括，但不限于，屏幕显示，声音变化，振动变化，以及视觉变化，例如，发光组件的颜色、亮度变化等方式。
而所提供的数据的内容亦可有各种可能，举例而言，当使用者按压壳体而欲开始进行测量时，装置可利用声音通知使用者检测已开始，并在预定的检测时间结束时通知使用者可结束按压动作；或者，可在开始检测时提醒使用者目前电极接触状况不佳或信号质量不佳等，让使用者调整施力大小、或是壳体的位置；又或者，可在检测期间提醒或通知使用者发生了什么情形， 例如，可利用声音表现心跳变化，如利用与心跳频率一样的响声，或用声音通知心脏状态，如长音与短音表示不同的状态。另外，更进一步地，可在检测完成后，提供使用者结果。因此，信息提供的方式及内容皆不受限制，只要能够确切地让使用者获得了解即可。
根据本发明的颈戴式心电检测装置由于是设置于使用者的躯干前方，并采用对壳体施力的操作方式，因此，配合这样的操作行为，装置及/或检测的启动，除了一般开启电源及/或启动检测的方式外，还可有各种选择，例如，可在壳体上设置一开关，其可受到对壳体的施力的触发，而使装置进入可进行心电信号提取的状态，以接着启动装置及/或检测；或者，作为替代，可将电极连接至一物理状态检测单元40，如图9所示，以检测电极在接触皮肤时所产生的一物理变化，并透过该物理变化而得知电极与皮肤间的接触是否足够稳定，因而可知装置是否已可进行心电信号提取。
在此，该物理变化包括，但不限于，压力变化以及阻抗变化，举例而言，该物理状态检测单元40可包括压力感测模块，以得知压力变化，而判断电极所受到的按压是否足够，或是该物理状态检测单元也可实施为一开关，同样可得知电极所承受的压力大小，又或者，该物理状态检测单元亦可包括阻抗感测电路、或电容感测电路，以得知电极的阻抗、电容变化，而判断是否可进行心电检测，因此，该物理状态检测单元实施为一压力感测模块，一阻抗感测电路，一电容感测电路，或一开关，或至少其中之二的组合，不受限制，并且，该物理状态检测组件可实施为连接至其中一个电极、或是所有的电极，可视实际实施情况而定，同样没有限制。
所以在进行判断时，若该开关未完全切换，及/或该物理变化不符合一预设范围，表示电极与皮肤间的接触状态不足以进行心电信号提取，因此，装置处于心电信号提取无法被启动的状态，若该开关已完全切换及/或该物理变化符合一预设范围时，表示电极与皮肤间达成了足以进行心电信号提取的接触，因此，装置转换为该心电信号提取可被启动的状态。
在此，特别地，还可透过开关是否切换完全、或物理变化是否符合预设范围的判断来控制电极是否可被使用，例如，导通与否，也就是，电极是处于不可使用的状态，直到开关完全被切换后、或该物理变化符合该预设范围后，电极才转换为可使用的状态，例如，被导通，如此一来，将可进一步确 保所取得的心电信号的清晰度，更有利于分析结果的准确性。
而更进一步地，在判断为可进行心电信号提取后，如何启动装置及/或检测，同样有各种选择，举例而言，在一较佳实施例中，根据本发明的装置可设计为，装置会在一定时间后，例如，3秒后，自动开始进行检测心电信号；或在一另一较佳实施例中，装置在一定时间后，例如，3秒后，才会转换为可进行心电信号提取的状态，之后，若可提取状态仍持续，则启动心电信号检测，因此，有各种可能，可是实际需求而变化，没有限制。
此外，配合上述的启动及判断方式，根据本发明的装置亦可实施为一直处于信号提取的状态，但仅在检测到心电信号特征时才进行记录，或是才调整取样频率或信号放大倍率，以更加完整的记录下所有可能的心电信号变化。
在另一方面的构想中，根据本发明的颈戴式心电检测装置的运作，除了上述的单独运作模式，亦可透过本身所具有的传输模块而与一外部装置50进行沟通，并以两者共同合作的方式完成心电信号检测，如图10所示。
在此，不受限地，该传输模块可以实施为进行有线或无线传输，例如，USB有线连接，或蓝牙、3G、wifi及NFC等无线连接方式，而该外部装置则包括，但不限于，个人计算机，智能型手机，平板计算机，智能手表等装置。
由于采用颈戴的形式，本发明的装置很自然地会隐藏于衣服中，因此，透过与外部装置的连接，例如，日常使用的智能型手机，将可提供使用者更方便的操作。
当与外部装置共同进行心电信号提取时，两者间的合作可以有各种选择，举例而言，在一较佳实施例中，可透过手机上执行的相对应应用程序而实时察看测量情形，例如，心率变化或心电图波形等，而在一另一较佳实施例中，则是可在显示之外亦将所取得的心电信号直接储存在手机上，且特别地，在一又一实施例中，使用者可透过手机先观察波形后，再选择要储存的心电信号区间，例如，如前所述，使用者在储存前，可先调整壳体角度、及/或壳体与躯干接触的位置而取得不同相位的心电图，并透过手机实时观察波形，之后再决定要记录下的心电图为何；或者，替代地，在一较佳实施例中，手机可直接透过应用程序而控制颈戴式心电检测装置的运作，例如，使用者可透过手机启动/停止装置及/或心电信号提取，或进行装置设定等。因此，没有 限制，两者间可以根据实际使用需求而有不同的分工。
更进一步地，根据本发明的装置亦可实施为可选择进行单独操作或是与外部装置合作。举例而言，当欲进行检测时，使用者可透过先轻按壳体而确认是否存在有外部装置，若未发现外部装置，就如前所述单独进行心电信号提取，若发现存在有外部装置，例如，手机上的应用程序已开启，并允许联机，此时，装置进入与外部装置连接的模式，之后，其中一情形是，使用者再次持续按压壳体而达成电极接触并启动心电信号提取，且在提取期间，心电信号实时地透过手机进行显示，或者，其中另一情形是，使用者再次按压壳体而达成电极接触后，装置进入可进行心电信号提取的状态，而让使用者可透过手机上的接口启动心电信号的提取。
而透过提供如此的可与外部装置共同合作的模式，根据本发明的颈戴式心电检测装置的可应用范围亦变得更为广泛，举例而言，可通过外部装置的显示接口及储存空间，进行个人心脏健康管理，以减少颈戴式装置的体积及成本，亦增加使用意愿；或是，透过外部装置本身具有的网络连接，例如，手机的3G网络连接，所取得的心电信号可传送至远程的医护人员或监控中心，或是上传至云端进行储存，以供医护人员进行存取，此传送可实施为由使用者执行、设定在固定的一段时间后进行，如一星期一次，或是每次测量结束皆自动地传送等，不受限制；而更进一步地，亦可实施为，当分析结果显示心脏出现异常时，例如，符合一默认条件，如心跳速度过低、或心电图出现不正常的节律、波形时，装置无论设定为何皆会实时自动地将此结果通知远程的监控中心，以让监控中心立即了解使用者的身体状况，例如，若此心脏异常伴随着生命危险时，这样的实时传送，就可让救援更为实时。
接着，在取得心电信号后，根据本发明的颈戴式心电检测装置提供有数种处理/分析心电信号的选择，举例而言，可由该处理单元透过预载的演算式而进行对心电信号的分析，并将分析结果传送至该外部装置进行显示；或者，该处理单元实施为仅进行部分的处理、或分析，而在传输至该外部装置后，再利用外部装置进行更进一步的分析；或者，也可以选择先将心电信号储存于颈戴式装置中，待传输至外部装置后再由外部装置进行处理及分析。
而处理的方式以及分析的结果，则是取决于演算式的不同。举例而言，可提供平均心率、不规则心率、频脉、缓脉等分析，也可提供更详细的分析 结果，例如，心律不整的种类与型态，如VEB、SVEB、AF等，而除了提供不同病症的分析外，亦可针对需求不同而进行如实时分析，每个心跳(beat-to-beat)分析，固定时间区间(例如，30秒)分析，以及连续分析等各种时间基础的分析方式，故没有限制。正如前述，这些分析的基础在于清晰且稳定的心电信号，电由于本案通过有别于公知技术的设置让即使是简单的颈挂形式亦可有稳定的电极接触以取得清晰的心电信号，因而可以无碍地提供这些分析结果。
在此，特别地是，根据本发明的颈挂式心电检测装置可实施为直接内建传输连接器60，例如，USB连接器，来达成外部装置之间的传输，以省却必须使用连接线的麻烦。举例而言，如图11所示，该USB连接器60可由该壳体的一可移动壳体部分121，例如，一盖体，所覆盖，在进行测量时，USB连接器隐藏于盖体下，而当测量完成欲进行有线传输时，只需移动该盖体而露出USB连接器，就可直接用来连接上外部装置，例如，个人计算机的USB端口，使用上相当方便。
而进一步地，基于移开盖体而露出连接器是进行传输时所必须进行的动作，根据本发明的装置，可进一步实施为，当移开盖体时，壳体表面上的电极与内部电路之间的连接亦会同时被断开，以确保使用安全性。
这是因为，当外部装置是连接至市电的装置时，例如，个人计算机，根据本发明的装置由于壳体表面具有电极，因此必须要能提供保护机制，让使用者不会因为接触电极而发生触电的情形，而由于移除盖体是进行传输连接前自然且必须的动作，因此，若能配合适当的电路设计，例如，连接电极的电路绕经该盖体，或是该盖体可透过结构而在阖上及移开时达成控制电极连接的电路开关的切换等，如此一来，就可很自然透过移除盖体的动作而一起完成这样的电绝缘，不但使用方便，安全性亦受到保障。
在一较佳实施例中，根据本发明的心电检测装置可进一步包括一移动感测组件，例如，动作传感器(motion sensor)或加速度器(accelerometer)等，检测检测期间的身体移动情形，以在处理及分析心电信号时做为参考的依据，例如，当发现心电信号出观异常时，可先比对身体移动的情形，例如，是否正处于剧烈运动的状态，或是出现异常前是否发生跌倒等，以提高判断的准确性；或者，当用于居家看护时，可用来了解使用者的身体活动情形，例如， 是否发生跌倒，睡眠是否安稳，运动时间是否足够等，不但可作为分析心电信号时做为参考，也有助于看护者了解使用者日常生活情形。
再者，根据本发明再一方面的构想，壳体上电极的配置形式亦可有延伸的变化，如图12A-图12B所示，原本位于壳体的第一表面122上的两个电极，可分别延伸至与其所在表面相邻且彼此相对的第三及第四表面126，128上，亦即，每一个电极具二个部分，一个部分在面向皮肤的第一表面上，而另一部分则延伸为彼此相对，且此两个部分可实施为同一片电极162，164，如图12A所示，或是实施为二片电极但彼此并联连接166a，166b，168a，168b，如图12B所示。
透过这样的设置，根据本发明的装置除了可透过依附组件而设置于躯干前方进行检测外，当自颈部取下时，还可实施为利用手持形式进行测量，如图13A-图13B所示，由于电极的延伸，因此，使用者可以通过握住壳体的一端而接触其中一个电极，再很方使地将另一端的电极接触另一手或是躯干，正如一般手持式心电检测装置的使用方式，而进行心电检测，如此一来，就可以达成一机多用的效果。
在此，不同的电极部分可以根据操作模式的不同而实施为启动或不启动，例如，通过设置一开关而进行切换，或者，也可实施为由该依附组件与该壳体间的连接情形来决定，例如，当依附组件与该壳体相连接时，表示壳体是可被设置于躯干前方的状态，因此，位在同一表面的电极部分被启动，而当依附组件与该壳体分离时，表示壳体已自颈部取下，处于可执行手持式心电检测的状态，此时，位在相对表面的电极部分被启动。
另外，根据本发明又一方面的构想，壳体上的电极亦可实施为位在相对面上，如图14所示，亦即，其中一个电极位在该壳体被设置于躯干前方时，朝向躯干的第一表面122上，而另一个电极则是位在与该第一表面相对的第二表面124上，如此一来，操作的时候，使用者可在欲进行测量时对壳体的该第二表面施力，并同时接触其上的电极，如图15所示，以同时使位在该第一表面上的电极接触躯干前方的皮肤，如此的配置方式同样可以很方便地仅透过一个施力动作就取得心电信号。
在此情形下，如前所述，位于壳体上的电极除了干式电极形式外，也可实施为如前所述的非导电电极，例如，电容式、感应式、或电磁式等，以增 加使用方便性，举例而言，可仅将该第二表面上的电极实施为不需直接接触皮肤，让施力手的接触即使隔着布料，如衣服，也同样可取得心电信号，因此，无论壳体的设置位置为何，都可进行检测，或者，更进一步地，亦可所有电极皆实施为不需直接接触皮肤，如此一来，将可让使用上没有方向性限制，无论哪一面朝向躯干皆可进行心电信号的提取，有效提升使用者的使用方便性。
当实施为非导电电极时，根据本发明的颈戴式心电信号检测装置的应用方式将可更为广泛。举例而言，就可透过具双面黏性的依附组件而将装置固定于躯干前方，如此一来，电极与皮肤间的接触以及壳体的设置就可同时完成。在此情形下，二个电极可实施为皆位在第一表面上，或是分别位在第一及第二表面上，没有限制。
此外，根据又一方面的构想，电极的数量亦不受限，例如，可增设参考电极以消除噪声，而当电极数量增加时，除了将电极设置于依附组件或利用连接线延伸外，也可增加壳体数量来设置电极，让使用者能以同样方便地以对壳体施力的方式进行检测。
进一步地，根据本发明的装置还可具有一光容积变化(PPG)传感器，设置于施力手指、或驱干皮肤会接触到的位置，如此一来，就可在取得心电信号的同时，亦取得相关血液生理的信息，进而提供使用者更多的信息。在使用PPG传感器时，光发射组件会发射光线进入皮肤下血管，之后，再由光检测器接收穿透血管、或经血液反射的光线，而在取得光线吸光值的改变后，经过特定关系式的计算，就可得出有关血液生理的信息，举例而言，由于心跳会造成血流体积变化，因而使光线吸光值出现变化，故可取得脉波信息，或者，血液中氧气含量也会造成光线吸光值的改变，因此也可取得血氧浓度变化，让使用者了解体内的氧气量变化。
其中，在可同时取得心电信号以及脉波信息的情形下，还可得出脉波从心脏传至PPG传感器之感测位置所需的时间，也就是所谓的脉波传递时间(Pulse Transit Time，PTT)，且由于PTT与影响血压高低之动脉血管硬度有关，因此就可透过PTT与血压值间特定的关系而计算出血压及/或血管相关数值。
至于PPG传感器的设置位置，则可根据实际需求而改变。举例而言，当 两电极皆位于与躯干接触的同一表面上时，此时，PPG传感器可与电极设置于同一表面上，以在电极接触躯干的同时取得血液生理信息；或者也可设置于手部对壳体进行施力的表面上，以自手部取得血液生理信息；另外，当两电极实施为设置于壳体的相对两表面而分别接触躯干及手部皮肤时，则PPG传感器的设置可位于两表面的其中任一上，以于进行心电测量时自躯干、或自手部取得血液生理信息。因此，可依不同的实施方式而选择适合的位置，没有限制。
在一较佳实施例中，根据本发明的心电检测装置亦可实施为具有一标示按键，以让使用者在觉得有需要时，例如，在进行每日的例行心电检测时突然出现心脏不适，此时，就可通过按压该按键的方式而标记下时间点等，让事后医生在观看所记录下的信号时，可特别注意该个时间点前后的信号变化。
在又一较佳实施例中，根据本发明的心电检测装置亦可设置有一警示按键，以供使用者在身体发生紧急情况时进行按压，触发该处理单元发出一警示信号，例如，发出警示声，引起周围人的注意，或是透过电话或网络传送至看护中心，启动紧急救护系统等；而更进一步地，根据本发明的心电检测装置亦可实施为具有GPS定位的功能，如此一来，看护者就可在有需要时，确认使用者的位置，以提供必要的协助。
综上所述，根据本发明的颈戴式心电检测装置，通过采用不同于公知技术的颈戴形式，使装置可在不对使用者产生负担的情形下，被设置在信号强度大且稳定的躯干前方，进而使得电极于装置壳体表面的设置位置限制减至最小，亦降低操作时的使用限制，并且，仅需单手简单对壳体施力、使壳体表面的电极接触至皮肤的动作，就可轻松完成稳定的电极接触并得到清晰的心电图，以供进行是否出现心脏异常，如心律不整、或心肌梗塞的专业判读，因此，确实提供了较公知技术更为方便且有效的心电检测装置。

Claims (26)

  1. 一种颈戴式心电检测装置，包括：
    一壳体，具有相对的一第一表面以及一第二表面；
    一第一电极以及一第二电极，位在该第一表面上；
    一依附组件，与该壳体相结合，用以依附至一使用者的颈部；以及
    一心电信号提取电路，以配合该第一及第二电极而进行一心电信号提取，
    其中，
    当该使用者透过该依附组件而穿戴该装置时，该壳体被设置于使用者躯干的前方；以及
    当使用者的手部以朝向躯干的方向对该壳体施力时，该壳体被固定于手部及躯体之间，并在该第一及第二电极与躯干前方皮肤间产生一稳定接触，进而使该装置进入一可提取心电信号状态。
  2. 如权利要求1所述的装置，其中，该稳定接触达成一开关切换，而使该装置进入该可提取心电信号状态。
  3. 如权利要求1所述的装置，其中，该稳定接触使该第一及第二电极的一物理变化符合一预设范围，而使该装置进入该可提取心电信号状态。
  4. 如权利要求3所述的装置，其更包括一物理状态检测单元，用以感知该第一及第二电极的至少其中之一在接触使用者皮肤表面时所产生的该物理变化。
  5. 如权利要求4所述的装置，其中，该物理状态检测单元实施为一压力感测模块，一阻抗感测电路，一电容感测电路，或一开关，或至少其中之二的组合。
  6. 如权利要求1所述的装置，其中，该装置在进入该可提取心电信号状态一特定时间后，自动起始心电信号提取。
  7. 如权利要求1所述的装置，其中，该装置被建构为具有一共同运作模式，以透过有线或无线方式而与一外部装置共同进行心电信号提取。
  8. 如权利要求7所述的装置，其中，该外部装置实时接收并显示来自该心电检测装置的心电信号以及相关信息。
  9. 如权利要求8所述的装置，其中，使用者通过该外部装置而起始一特 定期间的心电信号记录。
  10. 如权利要求7所述的装置，其中，该装置进入该可提取心电信号状态后，受到该外部装置的控制而起始心电信号提取。
  11. 如权利要求7所述的装置，其中，该外部装置透过一网络而连接至一远程监控中心。
  12. 如权利要求11所述的装置，其中，当该心电信号符合一默认条件时，该外部装置自动传送一通知信号至该远程监控中心。
  13. 如权利要求7所述的装置，其中，该外部装置更包括一演算式，以提供相关心律不整的信息。
  14. 如权利要求1所述的装置，其更包括一演算式，以提供相关心律不整的信息。
  15. 如权利要求1所述的装置，其中，该心电信号提取电路设置于该壳体及/或该依附组件中。
  16. 如权利要求1所述的装置，其更包括一信息提供模块，以提供使用者相关心电检测的信息，其中，提供信息的方式包括，屏幕显示，声音变化，振动变化，以及视觉变化。
  17. 如权利要求1所述的装置，其更包括一动作传感器，以检测使用者的身体移动情形。
  18. 如权利要求1所述的装置，其更包括一第三电极，位在与该第一表面相邻的一第三表面上，以及一第四电极，位在与该第一表面相邻且与该第三表面相对的一第四表面上，以用于进行一手持式心电信号提取。
  19. 如权利要求18所述的装置，其中，该第一电极以及该第三电极实施为并联连接，以及该第二电极以及该第四电极实施为并联连接。
  20. 如权利要求18所述的装置，其中，该第一电极以及该第三电极实施为一体成型，以及该第二电极以及该第四电极实施为一体成型。
  21. 如权利要求1所述的装置，其更包括一光容积变化传感器，以取得使用者的脉波信息，其中，该脉波信息可与心电信号一起计算得出脉波传递时间，以进一步获得血压及/或血管相关数值。
  22. 一种颈戴式心电检测装置，包括：
    一壳体，具有相对的一第一表面以及一第二表面；
    一第一电极以及一第二电极，分别位在该壳体的该第一表面以及该第二表面上；
    一依附组件，与该壳体相结合，用以依附至一使用者的颈部；
    一心电信号提取电路，以配合该第一及第二心电电极而进行一心电信号提取；以及
    一物理状态检测单元，用以感知该第一及第二电极的至少其中一在接触使用者皮肤表面时所产生的一物理变化，
    其中，
    当该使用者透过该依附组件而穿戴该装置时，该壳体被设置于使用者躯干的前方；
    当使用者的手部以朝向躯干的方向对该第二表面上的该第二电极施力时，该壳体被固定于手部及躯体之间，并在位于该第一表面上的该第一电极与躯干前方皮肤间产生一稳定接触；以及
    当该稳定接触使该物理变化符合一默认范围时，该装置进入一可提取心电信号状态。
  23. 如权利要求22所述的装置，其更包括一光容积变化传感器，以取得使用者的脉波信息，其中，该脉波信息可与心电信号一起计算得出脉波传递时间，以进一步获得血压及/或血管相关数值。
  24. 如权利要求22所述的装置，其中，该物理状态检测单元实施为一压力感测模块，一阻抗感测电路，一电容感测电路，或一开关，或至少其中之二的组合。
  25. 如权利要求22所述的装置，其中，该第一及第二电极的至少其中一实施为电容式电极，感应式电极，或电磁式电极。
  26. 如权利要求22所述的装置，其中，该装置被建构为具有一共同运作模式，以透过有线或无线方式而与一外部装置共同进行心电信号提取。
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