TWI586324B - Blood pressure management device and method - Google Patents

Description

Blood pressure management device and method

The present invention relates to a blood pressure management device and method, and more particularly to a blood pressure management device that simultaneously provides adjustment and measurement of blood pressure functions, and a method of managing blood pressure through the device.

Cardiovascular disease is a disease that affects the heart, blood vessels, or both, and one of the most common causes of cardiovascular disease is high blood pressure. Hypertension is not only a risk factor for coronary heart disease, but also an important cause of stroke. Therefore, the World Health Organization has listed hypertension as one of the major causes of early worldwide death.

It is known that the Autonomic Nervous System (ANS) is the majority of control systems that operate under unconscious conditions, primarily to control visceral functions such as heart rate, digestion, sweating, and respiration, and ANS includes the sympathetic nervous system. (SNS) and the parasympathetic nervous system (PNS), where SNS is usually responsible for attack or flight, while PNS is usually responsible for rest and digest. In many cases, PNS and SNS have The opposite effect, one of which activates a physiological response while the other inhibits it.

In the vascular system, sympathetic activation causes the arteries to contract, which in turn increases vascular resistance and reduces blood flow to the distal end. When this occurs in the human body, increased vascular resistance increases arterial pressure and, in addition, sympathetic Nerve-induced venous contraction reduces venous compliance and blood volume, which in turn increases venous blood pressure, so sympathetic activation The overall effect is to increase cardiac output, systemic vascular resistance (arteries and veins), and arterial blood pressure.

There is considerable evidence that some of the control effects of autonomic nerves are altered through physiological feedback training. Physiological feedback training is a learning procedure in which the human system uses consciousness to control the physiological processes controlled by the autonomic nervous system. During training, biological signals that change with the autonomic nervous system in the human body, for example, heart rate or skin The temperature is monitored and immediately returned to the subject, so the subject can use this to enhance the desired response. Therefore, for people with high blood pressure, physiological feedback training is a viable effect on blood pressure. method.

In addition, studies have shown that controlling breathing can affect the balance of the sympathetic and parasympathetic nerves. In general, sympathetic activity can be achieved by reducing the respiration rate, changing the tidal volume, and/or increasing exhalation. The ratio of the period/inhalation period is lowered, and therefore, by changing the breathing rate, blood pressure can be lowered non-invasively and simply by reducing the sympathetic nerve activity.

Therefore, for users who wish to influence blood pressure by means of physiological feedback, there is a need for a blood pressure management device that provides a function of measuring blood pressure in addition to a way for the user to observe and influence autonomic nerve activity. Allowing the user to naturally and easily view the previously stored blood pressure record each time the device is used for physiological feedback training, and learn the effectiveness of the physiological feedback training to positively motivate the user to continue training in the invisible manner. It is also reasonable to allow users to take blood pressure measurements before and/or after training to instantly understand the effects of physiological feedback training, and to stimulate the idea of performing physiological feedback training when measuring blood pressure. The two complement each other and let blood pressure The purpose of management is more effectively achieved.

Furthermore, when physiological signals need to be obtained during physiological feedback training, the way in which physiological signals are acquired is also an important factor affecting the effect and willingness to use. Well known, physiological feedback training The training takes a long time. Therefore, when selecting a physiological sensor for obtaining physiological signals, there are several points to be considered. For example, if the sensor can maintain stable contact with the skin for a long time, It can avoid unstable physiological feedback information during physiological feedback; in addition, if the attention of the user in order to maintain the contact between the physiological sensor and the skin can be minimized, the user can be prevented from being unable to concentrate. Or the situation that the physiological feedback cannot be relaxed, and the sensor design that is easy to install and has low operation difficulty also helps the user to perform physiological feedback training in a more relaxed state of mind and body; The reusable physiological sensor allows the user to use it for a long time at a low cost, so that the physiological feedback training requires long-term cumulative effects. Accordingly, the present invention is based on the consideration of the blood pressure management device.

Accordingly, it is an object of the present invention to provide a blood pressure management device that simultaneously provides a function of adjusting and measuring blood pressure.

Another object of the present invention is to provide a blood pressure management device that provides a means for a user to adjust blood pressure by autonomic neurophysiological feedback training.

Another object of the present invention is to provide a blood pressure management device that uses a wearable physiological signal sensing unit to allow a physiological sensing component to be placed on a user's body for a long time and stably, thereby facilitating acquisition during feedback training. High quality physiological signals.

It is still another object of the present invention to provide a blood pressure management device which facilitates blood pressure adjustment by providing feedback of information about the autonomic nervous system of the user during physiological feedback training.

It is still another object of the present invention to provide a blood pressure management device that can be used During the physiological feedback through breathing training, a breathing guide is provided to further assist in the adjustment of blood pressure.

It is still another object of the present invention to provide a blood pressure management device that achieves a physiological feedback effect by providing information about a user's breathing during a physiological feedback by a user through breathing training, thereby facilitating blood pressure adjustment. .

Still another object of the present invention is to provide a blood pressure management device that obtains a blood pressure value by inflating a cuff tape before feedback training, and obtains a relative relationship between a blood pressure value and a physiological signal obtained by the physiological sensing element. In turn, information about trends in blood pressure changes can be provided during physiological feedback training.

Another object of the present invention is to provide a blood pressure management method having an operation flow for allowing a user to naturally record the blood pressure values before and after the feedback training period, which is helpful for understanding the effectiveness of the physiological feedback training.

Another object of the present invention is to provide a blood pressure management method for prompting a user to perform a physiological feedback training when detecting that the blood pressure value is higher than a preset value.

Another object of the present invention is to provide a blood pressure management method, which can also obtain a physiological signal capable of performing HRV analysis during blood pressure measurement, so as to simultaneously display blood pressure values and HRV analysis results, thereby allowing the user to understand blood pressure values and autonomic nerve activities. Relationship between.

Another object of the present invention is to provide a blood pressure management method, which can prompt a user to perform an HRV measurement when detecting that the blood pressure value is higher than a preset value, so that the user can understand the blood pressure value by using the HRV analysis result. The relationship between autonomic nervous activity.

Another object of the present invention is to provide a blood pressure management method capable of recording the measured blood pressure value and the process of feedback training as a user to observe blood pressure changes and physiological returns. The basis for the relationship between the training.

10‧‧‧shell

11‧‧‧Finger-type light sensor

12‧‧‧ Ear-worn light sensor

13‧‧‧Light sensor

14‧‧‧Curve belt

15‧‧‧ Devil Felt

111‧‧‧ surface

112‧‧‧bearing structure

113‧‧‧Electrode

114‧‧‧ openings

1 is a block diagram showing a blood pressure management device according to the present invention; FIGS. 2-3 are diagrams showing an exemplary embodiment using a light sensor according to the blood pressure management device of the present invention; and FIGS. 4A-4C are views showing a blood pressure management device according to the present invention; An exemplary example of a photosensor combined with a cuff; a 4D-4E diagram showing an exemplary embodiment of a blood sensor management device in accordance with the present invention, a photosensor combined with a housing; and a fifth diagram showing blood pressure management in accordance with the present invention An exemplary embodiment of a device, a photosensor in combination with a cuff, and a sixth example showing an exemplary embodiment of an electrocardiographic electrode according to the blood pressure management device of the present invention; and FIGS. 7A-7C show an electrode according to the blood pressure management device of the present invention Illustrative example in combination with a cuff; Figures 8A-8C show an exemplary embodiment of the blood pressure management device according to the present invention using the electrode arrangement shown in Figs. 7A-7C; and Figs. 9A-9C show the electrode of the blood pressure management device of the present invention. An exemplary embodiment in combination with a housing; FIG. 10 is a schematic view showing another embodiment of the blood pressure management device of the present invention; and FIG. 11 is a view showing the blood pressure management device of the present invention, which is implemented to detect skin electrical activity A paradigm example; FIG. 12 shows an exemplary blood pressure management device of the present invention, which is implemented to detect the temperature of the limb terminal Examples; Figures 13-14 show an exemplary embodiment of a blood pressure management device of the present invention using a respiratory motion sensing strap; Figure 15 shows a blood pressure management device of the present invention, using a respiratory motion sensing strap and a finger wearing PPG sensor Exemplary Embodiments; and Figures 16-19 show operational flow diagrams of the blood pressure management device of the present invention.

The present invention relates to a blood pressure management device having both a blood pressure adjusting function and a blood pressure measuring function, and in the present invention, the blood pressure adjusting function is achieved by executing a physiological feedback program related to an Autonomic Nervous System (ANS). .

First, please refer to Fig. 1, which shows a block diagram of a blood pressure management device according to the present invention. The blood pressure management device includes a control circuit, an inflatable cuff, a pump, and an information providing unit, wherein the control circuit controls the operation of the blood pressure management device, and the cuff is used to surround the user A limb, which can be inflated and deflated by the pump, generates a pressure change, thereby detecting the user's blood pressure, and the information providing unit is for providing information to the user.

Furthermore, in order to achieve the purpose of adjusting blood pressure by performing physiological feedback, the blood pressure management device according to the present invention further includes a physiological signal sensing unit for measuring a physiological signal that changes due to physiological feedback during the physiological feedback, and The physiological signal sensing unit includes a wearing structure and a physiological sensing component combined with the wearing structure. Therefore, the physiological sensing component is disposed through the wearing structure during the capturing of the physiological signal. On the user.

Here, in particular, the physiological signal sensing unit according to the present invention is implemented in a wearable form because it is known that physiological feedback is performed for a predetermined period of time, for example, 15 minutes or more. For a long time, therefore, in order to allow the user to perform physiological feedback without worrying about the setting of the physiological sensing element, the present invention utilizes the manner in which the wearing structure carries the physiological sensing element, so that the physiological sensing element can be used for a long time and Stablely placed on the user, this not only helps to obtain a stable physiological signal, but also allows the user to perform the physiological feedback program more concentrically.

Therefore, the procedure for performing the physiological feedback training using the blood pressure management device of the present invention is: first, the user sets the physiological signal sensing unit to the body through the wearing structure to continuously obtain the physiological signal during the training, and then starts After the physiological feedback training, the control circuit performs a pre-loaded calculation formula to analyze the obtained physiological signal, and/or compare the analysis result with a preset target, and then obtain the physiological signal, correlation analysis The results of the information and/or the information related to the comparison results are immediately provided to the user through the information providing unit. After receiving the information, the user adjusts his or her physical and mental condition by stabilizing the emotions and relaxing the body and mind. In turn, it affects the autonomic nervous system and responds to changes in the measured physiological signals and the information provided. Therefore, the user can constantly adjust the physical and mental condition by gradually knowing the change of information, and gradually toward the physiological state of the target. This is the so-called physiological feedback loop.

Therefore, in the present invention, the information provided by the information providing unit may include, but is not limited to, information obtained by blood pressure measurement using a cuff, for example, blood pressure value, and average heart rate, and physiological feedback training. The information needed, for example, information that represents an immediate physiological condition, and information that directs the user toward the target's physiological condition.

The information provided by the information providing unit includes, but is not limited to, visual and listening. For example, the information providing unit may be implemented as a display element and/or a light-emitting element to provide information by means of text display, graphic change, and/or light change; or the information The providing unit can also be implemented as a sounding module to provide information through a change in sound frequency or volume, or in a voice manner; or the information providing unit can also be implemented as a vibration module and utilize the strength and length of vibration, such as Provide information by changing the way.

Further, the information providing unit can be further configured to output the information to an external device via a wired transmission module or a wireless transmission module to provide the information to the user through the external device, wherein The external device may be, but not limited to, a personal computer, a smart phone, a tablet computer, or a smart watch, etc., and only needs to be able to provide the information to the user, and thus, there is no limitation.

In addition, the implementation of the information providing unit also has many options. For example, in a preferred embodiment, it is implemented in combination with components worn on the user, for example, a cuff and a physiological signal. The measuring unit; alternatively, in another preferred embodiment, it is implemented in combination with an operating interface of the device, for example, a display screen, an indicator light, etc., and thus, a suitable form can be selected according to actual implementation requirements.

In the present invention, since the main purpose is to achieve the effect of adjusting blood pressure by performing a physiological feedback program affecting the autonomic nervous system, the physiological signal sensed by the physiological signal sensing unit is capable of reflecting the activity of the autonomic nerve. Physiological signal.

In general, the activity of the autonomic nervous system can be known by HRV (Heart Rate Variability) analysis. Therefore, one of the choices of the physiological sensing component is a sensor that can detect the user's heart rate sequence. For example, a photo sensor is used to detect a pulse, where the photo sensor refers to a light emitting element and a light receiving element, and utilizes PPG. (photoplethysmography) principle to obtain the optical signal sensor, for example, using the penetration method or reflection method for measuring, or using the electrocardiogram electrode to measure the electrocardiogram, the heart rate sequence for HRV analysis can be obtained; The heart rate sequence can be obtained with a pressure sensor, for example, using a cuff, or simply placing the pressure sensor directly onto the artery, such as the radial artery, and the heart rate sequence can also be derived by taking a continuous pulse.

Here, the above description of obtaining a heart rate sequence (whether by detecting a pulse wave or an electrocardiogram) by using a physiological sensing element means that a physiological sensing element is used to obtain a time series of a user's heartbeat interval, and HRV analysis is performed. This time series is analyzed. Therefore, in the following content, the two narrative modes are used alternately depending on the situation, and the two represent the same meaning.

In addition to performing HRV analysis, the activity of the autonomic nervous system can also be known by observing changes in physiological signals affected by the autonomic nervous system, such as heart rate, electrodermal activity (EDA), limb terminal temperature, etc. Among them, the heart rate is regulated by both the sympathetic nerve and the parasympathetic nerve. When the sympathetic nerve activity increases, the heart rate becomes faster. When the parasympathetic nerve activity increases, the heart rate becomes slower. Therefore, the heart rate can be observed by observing the heart rate. In addition, since the secretion of sweat glands is only affected by sympathetic nerves, and when the activity of sympathetic nerves increases, the activity of sweat glands increases. Therefore, the activity of sympathetic nerves can be known by measuring the electrical activity of EDA (Electrodermal Activity). Furthermore, because the blood vessels that are transmitted to the skin at the end of the limb are only affected by the sympathetic nerves, when the sympathetic nerve activity is reduced, the vasoconstriction is reduced, the diameter of the blood vessels is increased, the blood flow is increased, and the surface temperature of the skin is increased, so that the limbs can also be measured. The skin temperature is estimated to increase or decrease the activity of the sympathetic nerve relative to the parasympathetic nerve.

Here, it should be noted that in the present invention, whether by performing HRV Analyze, or observe the activity of the autonomic nervous system by observing changes in the physiological signals affected by the autonomic nervous system. During the execution of the physiological feedback program, relevant information can be immediately provided to the user through the information providing unit. As a basis for the user to adjust the body and mind, for example, the results of the HRV analysis, the heart rate, the skin electrical activity, and/or the temperature change of the limbs can be provided immediately, and the information provided is not limited to only one type. There are various options.

Taking real-time HRV analysis as an example, since the HRV analysis analyzes the heart rate sequence over a period of time, the real-time HRV analysis can be performed by moving the concept of the Moving Window, that is, determining the calculation time first. The segment, for example, 1 minute, or 2 minutes, after which the HRV analysis result is continuously obtained by continuously continually shifting the time segment backward, for example, every 5 seconds, for example, one every 5 seconds. The results of HRV analysis, thus achieving the purpose of providing immediate HRV analysis results, in addition, the concept of weighting can also be used to moderately increase the proportion of physiological signals closer to the analysis time, so that the analysis results are closer to immediate physiology. situation.

Next, please refer to FIG. 2, which shows a schematic diagram of an embodiment of a blood pressure management device according to the present invention. In this example, the physiological signal sensing unit is implemented as a finger-type light sensor 11 to detect a user. Continuous pulse wave, so in this case, the heart rate sequence of the user can be known through the measured continuous pulse wave, and the HRV analysis can be performed after the heart rate sequence is obtained, thereby learning the activity of the autonomic nervous system. Alternatively, the activity of the sympathetic nerve and the parasympathetic nerve may be inferred by observing the heart rate. Here, although the figure shows a finger clip type photosensor provided on the fingertip, it may be implemented in other forms. It is disposed on the hand, for example, in the form of a ring, a belt around the phalanx, or a form of a proximal knuckle sandwiched between the fingers, and the like, and is not limited to the one in which the photo sensor is placed on the finger. Part.

In addition, as shown in FIG. 3, the photo sensor can also be implemented as an ear-worn photosensor 12, and the user's heart rate sequence can be known through the measured continuous pulse wave, and after the heart rate sequence is obtained. The HRV analysis further knows the activity of the autonomic nervous system, or it can also predict the activity of the sympathetic and parasympathetic nerves by observing the heart rate. Here, although the figure shows an ear clip type photo sensor sandwiched on the earlobe, it can also be implemented in other forms on the ear or an area adjacent thereto, for example, sandwiched between the pinna. Up, earplugs, or hanging on the ear, and the position of contact is not limited, for example, contact with the earlobe, the inner or back of the auricle, near the junction of the auricle and the head shell, such as the tragus In the vicinity of (tragus), in the ear canal or in the ear canal, and/or near the mastoid of the ear, etc., there is no limitation.

Here, it should be noted that although the blood pressure management device shown in FIGS. 2-3 is a form in which the housing 10 is separated from the cuff 14 , it is not limited, and the housing 10 may be pressed. The form in which the cuff 14 is carried, for example, the position of the upper arm, the forearm, or the wrist, etc., is an implementable manner.

Furthermore, as shown in FIG. 4-5, the photo sensor 13 can also be disposed on the upper limb, for example, the wrist, the upper arm, or the forearm, through the cuff 14 , and the advantage of this manner is that When the action of the venous band around the limb is completed, the setting of the photo sensor is also completed at the same time, which is more convenient.

4A-4B illustrates a possible situation in which the photosensor 13 is attached to the cuff when the housing 10 of the blood pressure management device is carried by the cuff 14. In FIG. 4A, the photo sensor 13 is disposed in the cuff 14, so in this case, the cuff has a permeable portion at a position relative to the photo sensor. In order to pass light emitted by the photo sensor, where the photo sensor can use light of various wavelengths, for example, visible light or invisible light, For example, red light and infrared (IR) are all wavelength bands that can be used. Therefore, the permeable portion refers to a portion formed by a material that can pass visible light and/or invisible light, or a hollow portion, and is not limited.

In actual implementation, the photo sensor 13 of FIG. 4A may be implemented as a circuit bonded to the surface of the casing 10 or electrically separated from the casing 10 and electrically connected to the casing 10 through a connecting wire. The relationship between the photo sensor and the cuff can also have different setting options. For example, the photo sensor can be embedded on the inner surface of the cuff and the upper limb, or can be disposed on The inside of the cuff, that is, in the cuff, or between the housing and the cuff, can be changed according to actual needs.

In addition, the photo sensor 13 can also be disposed on the cuff 14 through an attachment structure. For example, FIG. 4B shows the case of using the devil's felt 15; or, it is implemented to be placed in the cuff by means of clamping. The belt is as shown in Fig. 4C; or, the magnetic sensor can be attached to the cuff by magnetic attraction, for example, two components magnetically attracted to each other via the cuff can be used. One of the components is disposed on the housing or inside the cuff to attract another component carrying the photosensor through the magnetic force, and the two components can be implemented to have both magnetic properties, or one component has a magnetic force. The other component can be attracted by the magnetic force, and there is no limitation. Here, the magnetic force can be obtained by disposing a magnetic substance inside the component or directly forming the component from the magnetic substance, and similarly, the substance attracted by the magnetic force can also be It is placed inside the part or used to form the part.

Further, the photo sensor as shown in FIG. 4B-4C can also be implemented to be separable from the housing, and can be connected only when necessary, and in addition to extending from the housing by using the connecting wire. In addition to the situation, it can also be implemented as a wireless connection, so that the light sensor Setting the position will be more free.

Furthermore, the 4D figure shows that the photo sensor 13 and the housing 10 are integrally formed, and the light sensor 13 can be placed on the pressure when the cuff is wrapped around the limb. Between the pulse band and the limb for signal extraction, and alternatively, the light sensor can also be embodied integrally with the housing and protruding beyond the cuff, as shown in FIG. 4E. As a result, the photosensor is only attached to the limb by the action of the cuff around the limb, but is not sandwiched between the cuff and the limb. Therefore, there are various possible embodiments.

Further, the photo sensor 13 and the housing 10 shown in FIG. 4D-4E can also be implemented in a detachable form, for example, through an electrical connector or through a mechanical coupling structure, so that it is not required to be used. In this case, the light sensor can be separated from the housing, and in particular, the light sensor can be implemented only mechanically coupled with the housing, and the obtained signal is transmitted wirelessly. Therefore, there are various possibilities and no restrictions.

Therefore, when the housing is carried by the cuff, the photo sensor 13 can be implemented in combination with the cuff and/or the housing, without limitation, only need to surround the limb in the cuff. At the same time, you can complete the settings required to capture the physiological signal.

On the other hand, when the housing 10 is embodied as being separated from the cuff 14, the photo sensor 13 will only be placed on the cuff, for example, as shown in Figures 4A-4C. Depending on the form, it is placed directly on the cuff, or attached to the inside of the cuff by a devil's felt, clip or magnetic force. Figure 5 shows the photosensor attached to the edge of the cuff, and Likewise, it can be implemented as a wired or wireless connection, and when a wired connection is employed, by way of example, the electrical connection can also be hidden in the inflation tube of the cuff. Therefore, it can be implemented in various forms as needed, without limitation.

Moreover, in particular, the light sensor 13 can also be configured to be detachable from the cuff or the housing and disposed at other positions of the body, such as fingers, ears, etc., through the design of the structure. In this way, the position can be changed according to the actual use, which is more convenient.

Here, it should be noted that when the photo sensor is configured to obtain a physiological signal at a position such as a wrist, a forearm, or an upper arm, it is preferably measured by reflection in comparison with the penetration mode. Signal.

In addition, in addition to detecting pulse changes and acquiring heart rate, the photo sensor can also obtain many other physiological information about the cardiovascular system, such as blood oxygen concentration, blood volume change, etc., for example, by Different blood physiology information can be obtained by adjusting the number of illuminating sources. For example, when there are two illuminating elements, information on blood oxygen concentration can be obtained, and thus more information can be provided to the user.

Furthermore, the electrocardiogram can also be used to measure the electrocardiogram, thereby obtaining a heart rate sequence. In the present invention, in particular, the electrode is also implemented in a wearable form because, in the present invention, the main purpose of measuring the electrocardiogram is to obtain a heart rate sequence during physiological feedback, and therefore, must be during the entire physiological feedback period. Maintaining the contact between the electrode and the skin, and when the contact is actively applied by the user, in addition to the user's inconvenience caused by prolonged operation, the problem of myoelectric signal interference usually occurs, so In the case of the present invention, the present invention proposes to use the wearable structure to carry the electrode and maintain the contact between the electrode and the skin through the wearing structure, so that the user can maintain the contact between the electrode and the skin without applying force, so Focusing on relaxation, and minimizing the interference of myoelectric signals, it is more conducive to obtaining high-quality ECG signals and more accurate analysis results.

As shown in Fig. 6, it is shown that the two electrocardiographic electrodes are respectively implemented through the ear-wearing structure. Contact with the skin near the ear or ear, and contact with the finger skin through the finger-wearing structure provides a configuration that allows the user to easily and naturally perform physiological feedback training; alternatively, both ECG electrodes can also be implemented as The form is placed on the finger through the finger-wearing structure; or the electrode can be selectively implemented as a wrist-worn form, which can also achieve the effect of actively applying force to the user and reducing the interference of the myoelectric signal.

Here, it should be noted that although the ear-wearing structure shown in the figure is in the form of an ear hook, it is not limited thereto, and may be implemented as an earplug, an ear clip sandwiched between the earlobe, or clipped to the auricle. Ear clips and other forms, and their contact position is not limited, can contact the earlobe, the inner or back of the auricle, the vicinity of the junction of the auricle and the head shell, such as near the tragus, ear canal or ear In the tract, and/or near the mastoid of the ear, etc.; or alternatively, it may be attached to the ear by means of a magnetic force, for example, two magnetically attracted each other across the ear. a component, and the electrode is disposed on two or one of the components, wherein the two components may be implemented to have magnetic properties, for example, by having a magnetic substance inside, or being a magnetic substance itself, or It is implemented by being made of a magnetically attractable material. For example, one component may be implemented to have a magnetic force, and the other component may be magnetically attracted, or both components may be implemented to have a magnetic force, and may have Various implementation possibilities no limit.

Similarly, the finger-wearing structure may have different implementation forms, for example, it may be implemented as a pinch on the fingertip, at the proximal knuckle of the finger, or fixed by a belt around the finger. Moreover, it is not limited to the part that touches the finger, and therefore, it can be changed according to actual needs, and there is no limitation.

In addition, it should be noted that in such a configuration, the ear-worn electrode is selectively worn on the left or right ear, and there is no limitation. However, after the experiment, the setting position of the other electrode is known. The setting has a considerable influence on the signal quality. When the other electrode is placed on the left upper limb, the quality of the obtained ECG signal is much better than that obtained by the right upper limb. Therefore, it is performed in contact with the ear. In the measurement of the electrocardiogram signal, it is preferable to contact the other electrode with the skin of the left upper limb, such as the upper arm, the lower arm, the wrist, the palm, the finger, etc., to avoid the poor signal quality caused by the electrode being placed on the right upper limb. Lead to misjudgment in the analysis.

Furthermore, in addition to the above-described form of the electrode bonded to the wearable structure, the electrocardiographic electrode according to the present invention can also be implemented in combination with the housing of the device itself or the venous band to surround the cuff. The action achieves electrode contact, and the user does not need to apply force.

When the electrode is implemented in combination with a cuff, in accordance with a preferred embodiment of the present invention, the electrode can be coupled to the cuff via an attachment structure , similar to the photosensor described above, for example, As shown in FIG. 7A, the attachment mechanism can be implemented as a corresponding pair of adhesive elements, for example, a devil's felt, respectively, on the electrodes and the cuffs to achieve a mutual coupling therebetween; or, as shown in FIG. 7B As shown, the attachment mechanism can also be implemented as a clamp that is coupled to the electrode to provide the electrode on the cuff by means of a clamp; or, as shown in FIG. 7C, a pair of metal clips In order to achieve electrical connection at the same time.

Further, the attachment structure can also be implemented to have a housing for accommodating the circuit. For example, in order to prevent the obtained ECG signal from sensing environmental noise through the connection line, the signal can be obtained near the electrode when the signal is acquired. Processing first, such as amplification, buffering, filtering, digitization, etc., to ensure the clarity of the signal. At this point, the circuit can be placed in the housing, and the hardness of the housing increases the electrode and skin. According to this, the housing can be further embodied to have an ergonomic structure conforming to the contacted portion, for example, to conform to the curvature of the arm, etc., and thus, there is no limitation.

However, due to the use of the attachment mechanism, when the user does not need to use the electrocardiographic electrode, or needs to clean the cuff, or needs to replace the electrode, for example, replacing the electrode with a different material, it is convenient to The electrode is removed from the vascular band and/or replaced.

Here, the electrode combined with the cuff can be connected to the housing through an external connecting wire, adhered to the inside of the cuff by a devil's felt as shown in FIG. 7A, and the transmissive clip shown in FIG. 7B. The method is set at the edge of the cuff, or when the housing is carried by the cuff, as shown in Fig. 7C, the electrical connection between the electrode and the electrode is hidden inside the cuff and is fastened. The way is set inside the cuff, so there is no limit.

Therefore, in actual implementation, if the housing of the device is carried by the cuff, it can be as shown in Figure 8A (using the connection method of Figure 7A) and Figure 8B (using the connection method of Figure 7C). The electrode arrangement is the same as that required to measure the electrocardiogram by contacting the electrode attached to the cuff with the skin of the limb surrounded by the compressed venous band, and then contacting the other electrode with the upper ear wearing structure to contact the skin near the ear or the ear. Alternatively, if the housing is not carried by the cuff, as shown in FIG. 8C (using the connection method of FIG. 7B), the finger-wearing structure may be used to make the other electrode contact the finger of the other limb. ,no limit.

In addition, when the housing of the device is carried by the cuff, if the electrode can be placed in contact with the skin when the cuff is wrapped around the limb, it can be surrounded by the cuff. The action provides an active force that allows the electrodes to contact the skin of the arm, which also reduces the interference of the EMG signal.

In this case, the structure of the housing according to the present invention, as shown in Figures 9A-9C, is embodied as having an electrode carrying structure 112 on the surface associated with the cuff to surround the limb in the cuff Touching the skin of the upper arm or forearm when it is up, so when the electrode is placed on the electrode When the structure is carried, the contact of the electrodes with the skin can also be accomplished in the action of installing the cuff.

For example, as shown in FIG. 9A, the electrode carrying structure 112 can be implemented to be located near the edge of the cuff, and the cuff is implemented to have an opening 114 at a position corresponding to the supporting structure. The contact of the electrode 113 between the skin can be simultaneously achieved by the action of the cuff around the upper arm or the forearm, or as shown in FIG. 9B, it can also be implemented to have an opening 114 in the cuff, and the electrode carries The structure 112 is located at a position corresponding thereto. Further, as shown in FIG. 9C, the electrode carrying structure 112 is implemented on the outer edges of both sides of the cuff, so that the cuff can be changed without changing. In the case of the structure, contact with the skin is achieved. Here, although both sides of the outer edge are provided with the load-bearing structure, it is not limited, and may be provided only on one side of the outer edge.

Furthermore, the electrode carrying structure can also be implemented to be contractible, for example, by using a retractable mechanism, or by using an elastic material to adapt to changes that may occur during inflation, and also to ensure The stability of the contact between the electrode and the skin.

Moreover, it should be noted that although the electrode carrying structure can be implemented as a convex form as shown, it is not limited thereto, and the combination between the visible housing and the cuff is changed. For example, it may be a bearing structure having the same height as the surface of the casing, and the contact between the electrode and the skin can be achieved only when the cuff is wrapped around the arm, and there is no limitation.

Therefore, as shown in Fig. 10, when an electrode is placed on the surface of the casing and is in contact with the skin of the surrounding limb by the surrounding venous belt (such as the casing structure shown in Fig. 9C), it is only necessary to match the upper ear. Wearing a structure that touches the electrode to the skin near the ear or ear completes the electrode configuration required to measure the ECG. Of course, it is also possible to match the finger-wearing structure so that the other electrode contacts the finger of the other limb, and therefore, there is no limitation.

Furthermore, the blood pressure management device according to the present invention can also know the change of the autonomic nerve activity during the physiological feedback by measuring the electrical activity of the skin. For example, FIG. 11 shows that two electrodes are disposed on the hand to detect the electrical activity of the skin. In the case of change, or by measuring changes in the temperature at the extremity of the limb, the change in autonomic nerve activity during physiological feedback can be obtained, as shown in Fig. 12.

Further, in the wearing structure in which the electrocardiographic electrode is disposed, a photo sensor may be further added, for example, in the finger-wearing structure or the ear-wearing structure, so that the measured electrocardiogram signal and the pulse wave are transmitted through It can be obtained the time required for the pulse wave to pass from the heart to the sensing position of the light sensor, which is called Pulse Transit Time (PTT), and because PTT is related to the arterial hardness that affects the blood pressure. Therefore, the reference blood pressure value can be calculated through a specific relationship between the PTT and the blood pressure value, so that the user can immediately provide a blood pressure change trend during the physiological feedback; in addition, similarly, The light sensor is placed at different positions, such as the ear and the finger, and the same information is obtained by calculating the time difference between the two pulse waves.

As is well known in the art, if a corresponding blood pressure value is to be calculated by PTT, it is indispensable to perform calibration using a standard blood pressure measuring device, and since the device according to the present invention has a permeable pulse. With the function of blood pressure measurement, this calibration action can be conveniently performed directly by the same device, and the user can achieve the preparation action of obtaining the instantaneous blood pressure value during the physiological feedback in the natural operation.

In addition, in particular, since the present invention has a function of performing blood pressure measurement through a cuff, the blood pressure management device according to the present invention can be combined with a physiological sensing element that can obtain a physiological signal affected by autonomic nerves. Information about the trend of blood pressure changes by the user is provided immediately during the physiological feedback training.

Just measure blood pressure and get physical information before the start of physiological feedback training The steps of obtaining the initial blood pressure value and the physiological signal respectively, and performing a calibration procedure between the measured physiological signal and the initial blood pressure value, so that the physiological signal measured at this time can be regarded as In order to be a reference value relative to the initial blood pressure value, then, after starting the physiological feedback procedure, it is only necessary to compare the continuously obtained physiological signal with the reference value to know the trend of the blood pressure value. Here, the physiological signal may be, but is not limited to, skin electrical activity, limb terminal temperature, heart rate, and the like.

For example, if the detected physiological signal is galvanic activity, the blood pressure value and the EDA detection (for example, expressed as a resistance value or a conductance value) are respectively taken before the start of the physiological feedback program, and the value is regarded as A reference value, after which the resistance value decreases due to an increase in sympathetic activity, and an increase in sympathetic activity represents an increase in vasoconstriction and an increase in blood pressure, so that the resistance value can be measured instantaneously during physiological feedback. A rise or fall that provides information about the trend of changes in blood pressure associated with the user.

In addition, in addition to directly inferring the trend of blood pressure changes in the physiological signals obtained, as described above, the instant HRV analysis can also be used as a basis for providing similar information, or the aforementioned PTT can also be used for inference. There is no limit to the trend of blood pressure.

Moreover, since the physiological condition of the human body changes at any time, the recalibration can be naturally completed by the blood pressure measurement before each physiological feedback training, and the relationship between the physiological signal and the blood pressure value in accordance with the current physiological condition can be obtained.

In the case of performing physiological feedback training using the various sensing elements described above, the implementation of the information providing unit may have various possibilities, for example, may be implemented as components such as an ear wearing structure, a finger wearing structure, a housing, or a cuff. In combination, there is no limitation. In addition, the information providing unit can also output information to an external device through a wired or wireless transmission module. Therefore, there may be There are no restrictions on various implementation options. In addition, the manner in which information is provided is not limited, and may be presented by means of hearing, visual, tactile, etc., for example, as a sounding module, a vibration module, and/or a display module and/or a light-emitting element.

In a preferred embodiment, when combined with the ear-worn structure, due to proximity to the ear, it is preferably implemented as a sounding module that allows sound to enter the ear directly, providing better privacy, or, Since the ear-wearing structure contacts the skin, it can also be implemented as a vibration module, or can be implemented as a display module and/or a light-emitting element extending to the front of the eye. Therefore, a suitable form can be selected according to actual needs.

In addition, the content of the information provided by the information providing unit is also not limited. For example, it may be a change in blood pressure value, or a trend related to blood pressure; it may be a measured physiological signal, for example, heart rate, skin resistance value, end limb temperature, etc.; may be an analysis result of a physiological signal, for example, HRV analysis result; may be the result of comparison with the target value, for example, the difference between the skin resistance value, the end limb temperature and the target value, and the difference between the HRV analysis result and the target value; or may be the user's autonomic nervous information For example, sympathetic activity is inhibited and/or parasympathetic activity is increased. Therefore, the content of the information may vary depending on the measured physiological signal, the user's needs, and the like, without limitation.

In addition, there are various options for the information providing unit to provide information during the physiological feedback training. For example, when the information is provided by using the visual method, it can be implemented to display the instantaneous change of the physiological signal by using the text, and the physiological signal is instantaneous. The results of the analysis, the immediate comparison with the target value, and/or the user's autonomic nervous information, in such a way that the user can adjust the physical and mental condition by understanding their immediate physiological changes to gradually achieve the target physiology Condition; or, alternatively, can also be implemented to utilize graphics, illuminance, and light flicker frequency The difference between the target and the target value is provided to the user. Since the target value usually represents a physiological state in which the body and mind are more relaxed and stable, when the target value is closer to the target value, the pattern change is slowed down and the brightness of the light is changed. Small, or the blinking frequency is slower, etc., and when the difference from the target value is larger, it means that the higher the user's physical and mental tension, the stronger the pattern change, the higher the brightness, or the blinking frequency. Express in a quick way.

When information is provided by means of hearing, the above information can also be provided. For example, the user can be informed of the instantaneous change of the physiological signal, the immediate analysis result of the physiological signal, and/or the target value by means of a voice reminder. Instant comparison results, etc.; or, the difference between the performance and the target value can be expressed by the frequency and/or volume of the sound. For example, the louder the volume and the higher the frequency, the more nervous the user's physical and mental condition is, and the difference from the target value. The larger, the smaller the volume and the lower the frequency, the more relaxed the user is and the closer to the target value.

When the information is provided by the haptic method, it may be implemented to use vibration to remind whether the target range is reached, or may be represented by the time interval of generating the vibration signal and/or the strength of the vibration, etc., and whether the target range is reached, and/or the target The difference between the values, for example, may cause the user to relax when the target range is exceeded, or may be, by the stronger the vibration and the shorter the vibration interval, the more the user's physical and mental condition is tight, and the target value The larger the difference, the weaker the vibration and the longer the vibration interval, the more relaxed the user is, the closer to the target value.

Here, it should be noted that the information providing manner of the information providing unit is not limited regardless of the sensing element used and regardless of the physiological signal detected.

In the concept of another aspect of the present invention, physiological feedback can also be performed by means of breathing guidance to achieve an effect that affects autonomic nerve activity. This is because, in addition to being controlled by the autonomic nervous system, breathing can also be directly controlled by autonomic consciousness, in which breathing is on the autonomic nervous system. The effect of the system is to increase parasympathetic activity during exhalation and increase sympathetic activity during inhalation. Therefore, many studies have indicated that the balance between sympathetic and parasympathetic nerves can be changed by controlling respiration.

According to the research content, respiratory rate, tidal volume, and ratio during exhalation/inhalation are factors affecting sympathetic and parasympathetic activity. Among them, slower rate can reduce the activity of sympathetic nerves, while faster rate will make sympathetic Increased neurological activity. For example, the respiratory rate of a typical adult falls within the range of 10-18 times per minute. When the rate of respiration can be reduced to 5-8 times per minute, it can help increase parasympathetic nerves. The activity, in addition, when the ratio during the exhalation/inhalation period is increased, that is, when there is a longer exhalation period relative to the inspiratory period, the activity of the parasympathetic nerve can also be improved. Therefore, under the premise that the human body can control the breathing with consciousness, it is indeed possible to change the activity balance of the sympathetic nerve and the parasympathetic nerve by autonomously controlling the respiratory activity, thereby improving the blood pressure caused by the autonomic nervous imbalance or the sympathetic nerve activity. Under normal circumstances, and achieve the purpose of regulating blood pressure.

Therefore, in the present invention, a respiratory guidance signal having a breathing pattern for adjusting blood pressure is provided, for example, a respiratory rate of 5-8 times per minute which reduces sympathetic activity, and/or Under the premise of natural breathing, the increased exhalation period is provided to the user through the information providing unit, so that the user can adjust the breathing following the change mode, thereby achieving the effect of adjusting the blood pressure.

One of the options of the breathing guide signal is to provide a fixed guiding signal to prompt the user to adjust the breathing to be the same, and thereby achieve the effect of adjusting the blood pressure, wherein the fixed guiding signal can be, for example, Respiratory rate that helps lower blood pressure, for example, 8 times per minute, or guidance to increase the proportion during exhalation/inhalation, without limitation, and can provide a variety of fixed guidance signals, for example, 7 per minute Times, 6 times per minute, or 5 times per minute, etc. Let users choose their own pilot signals that meet their needs.

Alternatively, a gradient guide signal is provided, and the user's breathing gradually approaches an ideal breathing rate and a ratio of exhalation/inhalation periods. For example, the gradient guidance signal can be implemented to provide a gradual change. The slow breathing mode allows the user to adapt gradually to avoid discomfort due to a sudden drop in speed. For example, in a 15 minute training session, the first 5 minutes provide a rate of 10 per minute, and the middle 5 minutes provide a minute. The rate of 8 times, and the rate of 6 times per minute in the last 5 minutes, can also be implemented as a gradual increase in breathing period, for example, in a 15 minute training session, the first 5 minutes provide exhalation period / A 1:1 lead during inhalation, a 2:1 lead in the middle 5 minutes, and a 3:1 lead in the last 5 minutes.

Further, if the physiological signal sensing unit is used in combination to detect the physiological signal that can respond to the respiratory change, the user can know whether his breathing matches the breathing guide signal, and adjust his breathing immediately, and If after a certain period of time, for example, after a period of breathing instruction training for the same period of time, or after repeated breathing instruction training, it is still unable to keep up with the pilot signal, the user may choose another A pilot signal that is closer to the current physiological conditions to avoid disturbing the breathing in order to comply with the pilot signal.

Furthermore, the information about the breathing mode obtained above can also be used as a basis for adjusting the breathing guide signal, thereby providing a dynamic guidance signal that can be adjusted by the user in real time, that is, through instant use. The breathing condition of the person to know what the breathing rate is, and/or whether it falls within a rate range that is conducive to lowering blood pressure, and dynamically adjust the guiding signal so that the user can reach the breathing guide in the most relaxed and comfortable manner. The effect of training.

For example, in a preferred embodiment, when the measured breath has fallen within a preset rate that is conducive to lowering blood pressure, for example, less than 8 times per minute, the user is allowed to Breathing without guidance, only when the breathing pattern is out of range, for example, too fast, guiding; in another preferred embodiment, the pilot signal drives the user's breathing rate in a segmental manner. Slower, and if the user cannot follow the rhythm of the pilot signal within a certain time after the guidance rate is slowed down, then return to the respiratory guidance rate of the previous segment and change again after a certain time. Slow, and by repeating such a procedure, the user's breathing can be gently guided toward the target breathing mode. Therefore, it can be changed according to the current physiological state of the user or the actual needs, thereby providing various dynamic guiding methods without limitation.

Furthermore, when the respiratory guidance training is used in conjunction with the physiological signal sensing unit, it may be further implemented to detect physiological signals that change due to respiratory effects on the autonomic nerve, as described above, during respiratory guidance training. Provides information about the autonomic nervous activity and lets the user know if the breathing adjustment has the desired effect on the autonomic nervous activity, for example, whether a reduction in sympathetic activity that contributes to a decrease in blood pressure is achieved.

For example, the information providing unit can display the information about the heart rate, the electrical activity of the skin, the temperature of the extremity of the limb, and the like, and/or the relevant respiratory and heart rate obtained through spectrum calculation, while providing the respiratory guidance signal. Synchronization information, so that the user can immediately know the effect of breathing adjustment on the autonomic nerve, for example, whether the activity of the parasympathetic nerve is improved, or whether the activity of the sympathetic nerve has decreased, etc., It will make the physiological feedback program using the breathing guide signal more efficient.

When actually implemented, as described above, the information providing unit outputs a respiratory guidance signal in addition to the information of the relevant physiological signal for the user to use as a basis for adjusting his breathing.

Here, when the respiratory guidance signal is provided, the information is provided as described above. The unit may be implemented in a form combined with a component worn on the user, or may be combined with an operation interface of the device, without limitation, and there are various options for providing the guidance signal, for example, There is no limit to the way of visual, auditory, and/or tactile guidance. The choice of visual guidance includes, but is not limited to, graphic changes, text display, change in illumination brightness, and/or change in signal number, etc., all of which are suitable methods, for example, utilizing a pattern of breathing changes in the display element. The pattern guides the user to inhale and exhale; or the amount of LED light changes to represent inhalation and exhalation; or the text can be used to directly inform the user to inhale and exhale.

In addition, when the method of auditory guidance is adopted, the selection includes, but is not limited to, sound changes and voices, for example, the intensity of the sound may represent the inhalation and exhalation changes; or the different sound types represent the inhalation and exhalation. And let the user follow, for example, bird sounds, sea waves, different music tracks, etc.; or the user can be informed by voice to inhale or exhale, for example, when breathing instruction training is just started, The user's breathing mode can be guided through the "inhalation" and "exhalation" voice instructions that match the breathing pattern, and the user is informed that the user's breathing has been consistent with the desired mode of change. Maintain the current breathing rate, and stop the voice guidance of "inhalation" and "exhalation". Therefore, there are various options that can be varied depending on the actual implementation requirements, without limitation.

Furthermore, when tactile guidance is employed, it is preferred to provide a change in vibration through a combination of components that are in contact with the user's body, for example, a housing carried with a cuff, a compressed pulsed belt. Or, the components of the physiological signal sensing unit are combined, and the manner of changing the vibration is also not limited. For example, the vibration signal can be used to remind the user of proper exhalation and/or inhalation. At the beginning of the time, or only when the user's breathing mode is found to be deviated from the preset target guiding signal, the vibration guidance is generated.

Here, it is advantageous that when the hearing and/or tactile guidance is adopted, the user can pry the eyes during the breathing guide training, which is more conducive to body relaxation and breathing adjustment.

In addition, the execution time of the breathing guide training can also be changed according to the actual needs of the user. For example, it can be provided for a fixed number of time lengths, for example, 10 minutes, 15 minutes, or 20 minutes, for the user to self. Alternatively, it may be implemented to vary depending on physiological conditions during training, and there is no limitation.

In addition, in a preferred embodiment, the respiratory guidance signal (which may be a fixed, gradual, or dynamic guidance signal) may also be implemented to be output to the external device via the information providing unit and the wired/wireless transmission module. Then, for example, a smart phone, a tablet, a smart watch, etc., and the external device provides the breathing guide signal to the user for breathing training.

In particular, in another preferred embodiment, the respiratory guidance signal is implemented to be generated by the external device and provided to the user, and the external device further receives the physiological component from the information providing unit. The information about the user's breathing pattern obtained by the signal sensing unit is provided to the user while providing the breathing guide signal, or is used as a basis for adjusting the breathing guide signal, and the external device is also Information about the user's breathing patterns that are required to be received may be further stored as a reference for subsequent viewing of the records.

Here, when the physiological signal sensing unit is configured to detect breathing, the physiological sensing component can be implemented as a sensor commonly detected on the market, for example, on the chest and/or the abdomen. Respiratory motion sensing components to sense body cavity fluctuations caused by breathing, such as RIP straps (Respiratory Inductance Plethysmography (RIP), and piezo respiratory effort belts, Set on the nose The respiratory airflow tube of the respiratory tract detects changes in respiratory airflow and a thermal sensor placed between the nose and mouth to sense changes in the temperature of the respiratory airflow.

As shown in Fig. 13, the blood pressure management device according to the present invention is provided with a respiratory motion sensing element, such as a piezoelectric breathing band sensor or a RIP strap, to obtain a user's breathing signal during breathing guided training. During the breathing-guided training, the user sets the strap on the chest or the abdomen, relaxes and begins to breathe, and according to the breathing guidance signal on the display element (and the information related to the physiological signal that changes due to breathing) ), or the guidance of the sound to adjust your breathing, and complete the breathing guide training process after a period of time.

Here, as shown in Fig. 14, it can also be implemented as two straps, without limitation, and, as has been pointed out, the use of abdominal breathing helps to increase the activity of parasympathetic nerves. Therefore, when using two When strapping, by means of the chest and the abdomen, it is possible to distinguish whether the user is performing abdominal breathing.

Alternatively, changes in breathing can also be known by observing fluctuations in blood volume caused by breathing or by measuring heart rate. First, since exhalation and inhalation can cause fluctuations in blood volume, for example, can be observed in arteries, veins, and microvessels, by using a light sensor, the penetration or reflection can be analyzed from the subject. The blood signal of the blood obtains information about the fluctuation of the blood volume, and then the user's breathing behavior; furthermore, since the heart rate is controlled by the autonomic nerve, the breathing will cause changes in the heartbeat due to the influence on the autonomic nervous system. That is, the so-called Respiratory Sinus Arrhythmia (RSA), in general, the heartbeat is accelerated during inhalation, and the heartbeat is slowed down during breathing, so the respiratory changes can be known by observing the heart rate. Therefore, it is possible to use a sensor that can obtain a heart rate sequence as described above, for example, a photo sensor, an electrocardiographic electrode, etc., while providing breathing during respiratory guided training. Information about change.

In addition, since increasing the amplitude of the RSA helps trigger the Relaxation Response and relieves the accumulated pressure, the effect of increasing the proportion of parasympathetic/sympathetic nerve activity is achieved, so that the user's heart rate change pattern can be observed, and When the heart rate starts to accelerate, the user is informed by the guide that the inhalation can be started, and when the heart rate begins to slow down, the user is informed by the guide that the exhalation can be started, so as to increase the amplitude of the RSA and achieve the purpose of adjusting the blood pressure. In addition, due to the magnitude of the amplitude of the peaks and troughs of the RSA, that is, the difference between the maximum and minimum values of the heart rate during a breathing cycle is related to the activity of the autonomic nervous system. This information is provided to the user on the fly as a basis for the user to adjust the physiological activity.

Furthermore, as shown in FIG. 15, in addition to the respiratory motion sensing element, the heart rate sequence can be obtained by using the finger-clip photo sensor, and the heart rate can be obtained by such a sensor setting. Further confirming the effects of breathing-guided training, because of the better harmony and synchronization between breathing and heart rate, it represents a more orderly and coordinated heartbeat rhythm, that is, the human body is in a relatively relaxed and stable state. Therefore, it can also be used to judge the effectiveness of respiratory guidance training and/or as information provided to the user immediately by analyzing whether the breathing and heart rate are harmonious and synchronized. For example, the frequency range can be frequency-domaind. Analysis, when the spectrum is more concentrated, it means that the synchronization between the two is higher, or the phase difference between the two can be calculated. When the phase difference is smaller, the synchronization is higher between the two; or, instead, Ground, you can also use the ear-wearing structure and the finger-wearing structure to set the electrodes to obtain the ECG signal, and then use the strap to obtain the breathing signal, which can achieve the same effect; or, in the strap Side of the addition of ECG electrodes in contact with the skin, get the ECG signal. Therefore, it can be changed according to the actual needs and usage habits of the user, and there is no limit.

It should be noted that although the above examples specifically describe the manner of implementation, the invention is not limited to the use in a single instance, may be combined between multiple instances, or partially combined, or multiple instances. The above examples are used interchangeably, and thus the above examples are only a few of the many possible embodiments, and those skilled in the art can modify them without departing from the scope of the invention.

Furthermore, in accordance with a further aspect of the present invention, in order to allow the user to immediately know the effect of the physiological feedback performed by the user, the blood pressure management device according to the present invention also provides an operational flow for the user to physiologically reward. The training effect is evaluated immediately after the training is completed.

Figure 16 is a flow chart showing the operation of the blood pressure management device according to the present invention. When the user uses the blood pressure management device according to the present invention, the pressure pulse band is first wrapped around the arm, and if the physiological signal sensing unit is provided, the physiological signal sensing unit is set, for example, an electrocardiographic electrode or a photo sensor. After that, after pressing the start button, the blood pressure measurement starts, the pressure band is inflated and deflated to obtain the blood pressure value and displayed to the user, and then the physiological feedback program is started, and during the physiological feedback, according to the progress The program and the measured physiological signals may provide information about the measured physiological signals, information about the autonomic nervous system, trends in related blood pressure trends, and/or respiratory guidance signals for use by the user. The physiological feedback is performed accordingly, and when the training is finished, the device starts another blood pressure measurement, that is, the pressure band is again inflated and deflated to obtain the blood pressure value after the physiological feedback training, so that as long as By comparing the blood pressure values before and after training, the user can know the effectiveness of the physiological feedback training.

Therefore, through such a process, the user will naturally know immediately after the completion of the overall process whether the performed physiological feedback training achieves the intended purpose, which is quite convenient, and such a process also causes changes in blood pressure values and physiological feedback training. Process, and blood pressure values and training Relationships, etc. are all recorded, which is beneficial for long-term tracking management.

Further, the above operation flow may also be implemented in a guided manner, for example, through the information providing unit, or the external device executes a program, and provides a guiding instruction in an audible or visual manner, and the user Simply follow the instructions to complete the physiological feedback training easily and naturally and learn about the effects achieved by the training.

For example, first, when the device is activated, the user may be instructed to surround the cuff with an upper limb, and if the physiological sensing component is provided, the physiological sensing component is set, and then the cuff is transmitted through the cuff. Blood pressure measurement is performed to obtain the blood pressure value before the physiological feedback training, and then the user is guided to start the physiological feedback training, and during the physiological feedback, according to the procedure performed and the measured physiological signal, the user may be provided. Information on the measured physiological signals, information on related autonomic nerves, trends in related blood pressure trends, and/or respiratory guidance signals to guide the physiological feedback program, and when the training is over, indicate the use again. The blood pressure measurement is performed using a cuff to obtain a blood pressure value after training.

Here, the operation guiding mechanism is mainly presented by means of voice, for example, by "please attach a pressure band", "please start blood pressure measurement", "please start physiological feedback training", "please follow the screen" The user is prompted to reduce the complexity of the operation by guiding the breathing, "please start the blood pressure measurement again", and in a preferred embodiment, the permeable and ear-worn physiological signal sensing unit A combined sound module is implemented, for example, as a physiological sensing element in the form of a headset to further simplify operational complexity.

Alternatively, the display of the user's operation steps may be provided by means of a screen display, or the voice and screen display may be simultaneously used for guiding, and the external device may be further utilized as a medium for guiding the operation flow, for example, for example. , smart phone, flat Board computers, etc., therefore, there is no limit.

The basis for such a convenient execution process is that the blood pressure management device of the present invention has multiple functions, in addition to being able to detect the user's autonomic nerve activity, provide respiratory guidance, perform HRV measurement and analysis, and provide synchronization between heart rate and breathing. In addition to sexual information, there is also a blood pressure measurement function. Therefore, the user can perform training in order to adjust blood pressure, and the same device can confirm whether the purpose of blood pressure adjustment is achieved, which is quite efficient, and, in order to For physiological feedback training, the user only needs to add the action of the physiological signal sensing unit in addition to the actions required for performing the blood pressure measurement, and has no complicated operation procedure, and is simple and convenient.

Furthermore, since many hardware devices required for blood pressure measurement and physiological feedback training can be shared, for example, control circuits, information providing units, etc., it is more cost effective under the premise of multiple functions.

Here, the final result shows that there are various ways, for example, the blood pressure value measured before and after the breathing guide training can be displayed at the same time, or the difference between the two blood pressure values can be displayed, and the display can also be displayed in conjunction. The length of training, and let the user know the relationship between the length of training and the change of blood pressure value. Therefore, there is no limit, mainly to let the user know the change of blood pressure value.

In addition, in addition to the above-described process for allowing the user to simultaneously perform blood pressure measurement and physiological feedback training and know the training effect, the blood pressure management device according to the present invention also has another reminding mechanism, as shown in FIG. 17, which can be used for blood pressure measurement. When the blood pressure value is found to be too high, for example, when the value is higher than a preset value, the user is reminded to perform physiological feedback training to perform blood pressure adjustment, so that the user can naturally perform physiological feedback training, which is quite convenient.

Here, the reminder can also have different options, such as screen display, light display, sound or voice reminder, and/or vibrating reminder. In addition, the preset value of the blood pressure is too high, and can be used by the user. There is no limit to setting or following the settings of the device itself, for example, the blood pressure standard of the WHO.

Furthermore, please refer to Fig. 18. Since the HRV analysis can provide information on the autonomic nerve, when the physiological signal sensing unit has the physiological signal obtained by the physiological sensing element, the HRV analysis can be performed according to the heart rate sequence. In this case, the blood pressure management device according to the present invention can be further implemented to perform physiological signal acquisition while measuring blood pressure, so as to provide the HRV analysis result to the user in addition to the blood pressure value after the blood pressure measurement is completed. For example, by using a physiological sensing element such as a photo sensor, an electrocardiographic electrode, and/or a pressure sensor, the time series of the user's heartbeat interval can be obtained while the blood pressure is measured, and then, An HRV analysis is performed on the time series to thereby obtain information on autonomic nervous activity.

The HRV analysis performed may be selected according to requirements. For example, a frequency domain may be performed to obtain total power (TP) that can be used to evaluate the overall heart rate variability, and the reaction may be reflected in the parasympathetic sense. High-frequency power (HF), which can reflect sympathetic nerve activity, or low-frequency power (LF) of sympathetic and parasympathetic nerves, and the balance of reactive sympathetic/parasympathetic nerves. LF/HF (low-frequency power ratio), etc. In addition, after performing frequency analysis, the degree of harmony of the operation of the autonomous nerve can be known by observing the state of the frequency distribution; or, time domain analysis can also be performed (Time Domain), which obtains an SDNN that can be used as an indicator of overall heart rate variability, can be used as an indicator of long-term overall heart rate variability, SDANN, as an indicator of short-term overall heart rate variability, and can be used to estimate high frequency in heart rate variability. mutated R-MSSD, NN50, and PNN50.

In this case, if hypertension occurs, the correlation between high blood pressure and the autonomic nervous system can be further judged by the HRV analysis result, for example, whether the sympathetic activity is too high or the autonomic nervous system is imbalanced. It is quite convenient.

Later, when the high blood pressure is found to be related to the autonomic nervous system from the results of the HRV analysis, in addition to providing the related information to the user, the user can be further reminded to perform the physiological feedback training and again after the physiological feedback training is completed. Physiological signals were measured and HRV analysis was performed to see if the balance of the autonomic nerves was improved.

In addition, since the time required for performing the HRV analysis is long, as shown in FIG. 19, it can also be implemented to remind the user to perform HRV when the blood pressure value is found to be too high, for example, above a preset value. The measurement is to determine whether the high blood pressure is related to the autonomic nerve through the HRV analysis result.

After the blood pressure measurement and the physiological feedback training are completed, the blood pressure management device according to the present invention can store the blood pressure measurement result of the user instantly and for a long time by the built-in memory, and simultaneously record the user training process. Through such chronological records, the present invention will provide cross-analysis results for users other than individual blood pressure measuring devices or physiological feedback training devices.

First, most directly, it can provide a comparison of blood pressure values before and after performing training. By the order of occurrence time during the recording period, in addition to immediately knowing the difference in blood pressure values before and after the training, the user can also trace back to the blood pressure before a certain training, and how many times after the training. Blood pressure, simply by comparing the records of the training that has been experienced, can clearly understand the impact of the length and frequency of training on blood pressure changes.

For example, the user may select a certain time point, for example, before the physiological feedback training, the measured blood pressure value is used as a reference value, and then compare with the reference value every time the training is performed, for example, setting The comparison result is automatically generated by the system, so that the user can obtain a clear quantitative value, for example, the relationship between the number of training accumulations and the change in blood pressure, which will help increase the motivation for the user to continue training. Moreover, since the effects of physiological feedback training have cumulative effects, long-term observations will be more helpful in understanding the effects of physiological feedback on blood pressure adjustment.

In addition, since the blood pressure of a person varies with time and activity, it is also possible to set reference values for different time periods, for example, morning, noon, and evening reference values, and blood pressure values measured after physiological feedback training. Compare with the reference value of the similar time period to avoid making an incorrect judgment; or, the user can freely select the reference value according to his own needs and establish a comparison benchmark to perform the analysis that is most helpful to him, so there is no limit. .

In summary, according to the present invention, a blood pressure management device capable of simultaneously providing two functions of blood pressure adjustment and blood pressure measurement provides a means for the user to adjust blood pressure by physiological feedback training, and during the execution of the physiological feedback program, The physiological sensing component for obtaining the physiological signal related to the autonomic nervous activity is placed on the user through the wearing form, and provides long-term and stable contact between the physiological sensing component and the human body to obtain high quality. The physiological signal, and because of the blood pressure measurement function at the same time, allows the user to immediately confirm the effect of physiological feedback on blood pressure adjustment; in addition, the blood pressure management device according to the present invention can also help by providing a respiratory guidance signal The user can perform the physiological feedback program, which can effectively achieve the effect of adjusting blood pressure. In addition, by chronologically recording the physiological feedback training process and the blood pressure measurement value, the user can easily monitor the change of the blood pressure value, and the physiological feedback training for the blood pressure. Change brought The effect helps to achieve the goal of adjusting blood pressure more effectively.

Claims (6)

A blood pressure management method includes the steps of: detecting a user's blood pressure through a blood pressure management device; comparing the measured blood pressure with a predetermined condition; and when the measured blood pressure does not match the preset condition Ending the measurement; or when the measured blood pressure matches the preset condition, generating a prompt message to notify the user; the user knows that the two match according to the prompt information, and selects whether to execute an HRV Measuring; when the user chooses not to perform the HRV measurement, the measurement is ended; or when the user chooses to perform the HRV measurement, the user performs the HRV measurement using a wearable physiological signal sensing unit of the blood pressure management device, Obtaining a time series of user heartbeat intervals; performing an HRV frequency domain analysis based on the time series; obtaining at least one HRV analysis result; generating sympathetic and parasympathetic activity on behalf of the user based on the HRV analysis result Information; and the sympathetic and parasympathetic activities of the representative user through an information providing unit of the blood pressure management device Information provided to the user. The method of claim 1, further comprising the steps of: generating a correlation between the HRV analysis result and the blood pressure value; and providing the information representing the connection to the information through the information providing unit By. The method of claim 1, wherein the physiological signal sensing unit comprises a wearing structure, and at least one physiological sensing component is disposed on the wearing structure, and wherein the The physiological sensing element is one or more of the following groups, including: a photo sensor, an ECG electrode, and a pressure sensor. The method of claim 1, wherein the physiological signal sensing unit is worn by a part of a user's body selected from the group consisting of: an ear, a finger, a limb, and a torso. The method of claim 1, further comprising the step of: further generating one or more of the following information according to the HRV analysis result, including: total power (TP), high frequency power ( High Frequency Power, HF), Low Frequency Power (LF), LF/HF, and frequency distribution status. The method of claim 1, wherein the preset condition is implemented as a blood pressure higher than a predetermined value.