A respiratory intervention device and intervention method

Abstract

The application provides a respiratory intervention device and an intervention method. The device comprises a flexible electrocardio sensor, a signal processing unit, a control unit and a body position adjusting device. The flexible electrocardio sensor comprises an electrode composite layer, a first insulating layer, an electromagnetic shielding layer and a second insulating layer arranged in sequence. The electrode composite layer comprises a first electrode, a second electrode and a polarity layer arranged between the first electrode and the second electrode. The first electrode is used for electrical connection with the signal processing unit, and the surface of the first electrode is gold-plated. The second electrode is suspended. The polarity layer comprises barium titanate and / or calcium titanate. The application realizes real-time detection of the patient's respiration through non-contact detection of the electrocardio signal, and the experience is better and the safety is higher. When electrocardio detection is performed, the polarity material with high dielectric constant is added, the coupling capacitance is increased, the electrocardio signal attenuation is reduced, the respiratory wave is accurately separated, and the occurrence of misjudgment and other operations is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and more specifically, to a respiratory intervention device and intervention method. Background Technology

[0002] Sleep is crucial for human health, serving as a vital link in the body's recovery, integration, and memory consolidation. Sleep disorders are abnormalities in the quantity and quality of sleep, or the occurrence of certain clinical symptoms during sleep. Among these, loud snoring during sleep, often accompanied by breath-holding episodes, followed by a period of time before resuming snoring with a loud snoring, and then breath-holding again, is medically termed sleep apnea syndrome. It is a common condition often accompanied by repeated complete or partial collapse of the upper airway during nighttime sleep, leading to apnea or hypoventilation.

[0003] Currently, anti-snoring technologies used during sleep mainly include: physical devices that expand the nasal or oral cavity, electrical stimulation therapy, and medication to expand the airway. Various anti-snoring products are available on the market, such as anti-snoring nasal strips, anti-snoring mouth strips, anti-snoring nasal clips, anti-snoring belts, and anti-snoring mouthguards. However, these methods are all wearable and require external products to be applied to the body, resulting in poor user comfort and experience. They also do not conform to conventional sleep lifestyles, and may cause damage to other parts of the body due to movement or dislodgement during sleep, posing certain safety risks. Summary of the Invention

[0004] The problem to be solved by the present invention is to provide a respiratory intervention device that can monitor the patient's breathing in real time, and when a breathing problem is detected, correct the patient's sleeping posture to avoid the risk of suffocation.

[0005] To address the aforementioned problems, this invention provides a respiratory intervention device, comprising: a flexible electrocardiogram (ECG) sensor, a signal processing unit, a control unit, and a body position adjustment device. The flexible ECG sensor is used to collect raw ECG data, the signal processing unit is used to obtain respiratory rate based on the raw ECG data, and the control unit is used to control the body position adjustment device to operate based on the respiratory rate. The flexible ECG sensor includes, in sequence, an electrode composite layer, a first insulating layer, an electromagnetic shielding layer, and a second insulating layer. The electrode composite layer includes a first electrode, a second electrode, and a polar layer disposed between the first electrode and the second electrode. The first electrode is electrically connected to the signal processing unit, and its surface is gold-plated. The second electrode is suspended. The polar layer includes barium titanate and / or calcium titanate.

[0006] Preferably, the electrode composite layer is obtained by coating the upper and lower surfaces of the substrate with a polar solvent and covering them with copper foil, followed by curing. The copper foil on the upper and lower surfaces of the substrate is the first electrode and the second electrode, respectively. The polar solvent comprises the following components by weight percentage: 50%-74% liquid PDMS resin material, 25%-45% polar material, 1%-5% curing agent, and 1%-2% catalyst. The polar material includes barium titanate and / or calcium titanate. The curing agent includes a hydrosiloxane. The catalyst includes a platinum catalyst.

[0007] Preferably, the first electrode includes a first region and a second region that are insulated from each other. Both the first region and the second region include a plurality of electrode pads. The electrode pads are used to connect to the electrocardiogram acquisition circuit. The region outside the electrode pads in the first region is used for grounding. The region outside the electrode pads in the second region is used to connect to the right leg drive circuit. The second electrode has a plurality of electrode pads disposed in the region corresponding to the first region. The electrode pads on the second electrode are suspended.

[0008] Preferably, the electrode sheet is a closed conductive region obtained by etching the copper foil off the electrode composite layer in a frame shape.

[0009] Preferably, the first region includes a back region corresponding to the back of the human body and other regions besides the back region, the electrode pads are arrayed in the back region, and the distribution density of the electrode pads in the back region is greater than the distribution density in the other regions.

[0010] Preferably, the body position adjustment device includes a bed frame, a bed board, and a drive unit. The drive unit is electrically connected to the control unit. The bed board has a segmented structure, including a first bed board, a second bed board, and a third bed board. The two sides of the third bed board are connected to the bed frame through support structures. The first bed board and the second bed board are independently controlled by their respective drive units and are adapted to rise and fall under the drive of their respective drive units.

[0011] The advantages of the respiratory intervention device of the present invention compared with the prior art are as follows:

[0012] The respiratory intervention device of this invention incorporates a flexible electrocardiogram (ECG) sensor to collect human ECG signals, separates respiratory waves from these signals, and obtains the respiratory rate. Based on the respiratory rate, it determines whether a postural adjustment device needs to be activated to change the patient's supine position in bed, thereby improving the patient's respiratory status and preventing suffocation caused by persistent respiratory problems. On one hand, by detecting ECG signals non-contactly, real-time monitoring of the patient's breathing is achieved. Compared to existing detection devices and methods that are inconsistent with conventional sleep lifestyles, this invention does not require the user to wear any products that affect comfort, resulting in a better user experience. Furthermore, the method of adjusting the patient's posture to improve breathing through the postural adjustment device is a physical intervention method, offering higher safety. On the other hand, when performing electrocardiogram (ECG) signal detection, this invention incorporates a polar material with a high dielectric constant into the flexible ECG sensor and forms a capacitor-type polar composite layer with the electrodes to increase the coupling capacitance, reduce ECG signal attenuation, and detect higher quality ECG signals. This facilitates the further separation of respiratory waves from the ECG signal, and allows for the judgment of respiratory status based on the respiratory waves, enabling timely operation of the body position adjustment device. This reduces the impact of poor detection signal quality caused by large ECG signal attenuation on the accuracy of respiratory wave separation, thereby reducing the occurrence of misjudgments and other operations.

[0013] The present invention also provides a respiratory intervention method, based on the respiratory intervention device described above, comprising:

[0014] Acquiring human electrocardiogram (ECG) signals using a flexible ECG sensor;

[0015] The human electrocardiogram (ECG) signal is filtered, amplified, and processed using an ECG acquisition circuit to obtain raw ECG data. The raw ECG data is then processed to obtain valid ECG data.

[0016] The effective ECG data is filtered out by removing baseline drift data caused by respiratory waves to obtain filtered ECG data.

[0017] Respiratory wave data are obtained based on the filtered ECG data and the valid ECG data;

[0018] The respiratory rate is obtained based on the respiratory wave data;

[0019] The body position adjustment device is controlled to operate based on the initial body position, the breathing rate, and the set frequency.

[0020] Preferably, obtaining respiratory wave data based on the filtered ECG data and the valid ECG data includes: subtracting the filtered ECG data from the valid ECG data to obtain the respiratory wave data.

[0021] Preferably, the initial body position includes a supine position and a side-lying position, the set frequency includes a first set frequency and a second set frequency, and controlling the body position adjustment device to operate according to the initial body position, the breathing rate, and the set frequency includes:

[0022] When the initial body position is the supine state, if the respiratory rate is detected to be lower than the first set frequency, the second section of the bed board of the body position adjustment device is controlled to rise and the first section of the bed board is controlled to fall. If the respiratory rate is lower than the second set frequency, the second section of the bed board of the body position adjustment device is controlled to rise and the first section of the bed board returns to the horizontal position, and the drive unit used to drive the second section of the bed board reciprocates.

[0023] When the initial body position is the side-lying position, if the respiratory rate is detected to be lower than the first set frequency, the second section of the bed board of the body position adjustment device is controlled to descend and the first section of the bed board is controlled to rise. If the respiratory rate is lower than the second set frequency, the second section of the bed board and the first section of the bed board of the body position adjustment device are controlled to return to the horizontal position, and the drive unit for driving the second section of the bed board is used to reciprocate.

[0024] The advantages of the respiratory intervention method of the present invention compared with the prior art are the same as the advantages of the respiratory intervention device compared with the prior art, and will not be repeated here. Attached Figure Description

[0025] Figure 1 This is an exploded view of the respiratory intervention device in an embodiment of the present invention;

[0026] Figure 2 This is a schematic diagram of the electrode composite layer in an embodiment of the present invention;

[0027] Figure 3 This is a schematic diagram of the structure of the first electrode in an embodiment of the present invention;

[0028] Figure 4 This is a schematic diagram of the polar layer structure in an embodiment of the present invention;

[0029] Figure 5 This is a schematic diagram of the structure of the second electrode in an embodiment of the present invention;

[0030] Figure 6 This is a comparison diagram of the flexible electrocardiogram sensor and the human body in an embodiment of the present invention;

[0031] Figure 7 This is a bottom view of the respiratory intervention device in an embodiment of the present invention;

[0032] Figure 8 This is a schematic diagram of the respiratory intervention device in a supine position in an embodiment of the present invention;

[0033] Figure 9 This is a schematic diagram of the respiratory intervention device in a lateral lying position in an embodiment of the present invention;

[0034] Figure 10 This is an initial electrocardiogram waveform diagram in an embodiment of the present invention;

[0035] Figure 11 This is a filtered electrocardiogram in an embodiment of the present invention;

[0036] Figure 12 This is a diagram of the respiratory waveform in an embodiment of the present invention.

[0037] Explanation of reference numerals in the attached figures:

[0038] 1. Flexible ECG sensor; 11. Electrode composite layer; 111. First electrode; 112. Second electrode; 113. Polar layer; 114. Electrode sheet; 115. First region; 116. Second region; 117. Vent hole; 12. First insulating layer; 13. Electromagnetic shielding layer; 14. Second insulating layer; 2. Bed frame; 3. Bed board; 31. First bed board section; 32. Second bed board section; 33. Third bed board section; 4. Mattress; 5. Pillow; M1. First motor; M2. Second motor; 100. Human skin; 200. Clothing and / or bed sheet. Detailed Implementation

[0039] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0040] like Figure 1 , Figure 2 As shown, a respiratory intervention device according to an embodiment of the present invention includes: a flexible electrocardiogram sensor 1, a signal processing unit, a control unit, and a body position adjustment device. The flexible electrocardiogram sensor 1 is used to collect raw electrocardiogram data. The signal processing unit is used to obtain respiratory rate based on the raw electrocardiogram data. The control unit is used to control the body position adjustment device to operate based on the respiratory rate. The flexible electrocardiogram sensor 1 includes an electrode composite layer 11, a first insulating layer 12, an electromagnetic shielding layer 13, and a second insulating layer 14 arranged sequentially. The electrode composite layer 11 includes a first electrode 111, a second electrode 112, and a polar layer 113 disposed between the first electrode 111 and the second electrode 112. The first electrode 111 is used to be electrically connected to the signal processing unit, and the surface of the first electrode 111 is gold-plated. The second electrode 112 is suspended. The polar layer 113 includes barium titanate and / or calcium titanate.

[0041] The respiratory intervention device in this embodiment incorporates a flexible electrocardiogram sensor 1 to collect human electrocardiogram signals, separate respiratory waves from the human electrocardiogram signals, and obtain respiratory frequency based on the respiratory frequency. It then determines whether to activate the body position adjustment device to change the patient's supine position in bed, thereby improving the patient's respiratory status and preventing suffocation caused by persistent respiratory problems.

[0042] The flexible ECG sensor 1 in this embodiment achieves non-contact ECG detection based on the principle of capacitive coupling. During operation, human body charge travels from the dermis to the epidermis. However, due to the obstruction of charge movement by materials such as clothing and sheets, the charge cannot be transferred to the sensor through direct contact, causing charge accumulation on the skin and polarization. Based on the property that like charges repel and unlike charges attract, opposite charges accumulate on the sensor's electrode surface. When the charge on the skin surface opposite the electrode changes, the charge on the electrode also changes accordingly, thereby enabling non-contact detection of ECG signals. The flexible ECG sensor 1 used in this embodiment has an electrode composite layer 11 with a multi-layer structure. Compared with conventionally used single-layer electrodes, the electrode composite layer 11 in this embodiment includes a first electrode 111, a polar layer 113, and a second electrode 112 arranged sequentially. The surface of the first electrode 111 is gold-plated to increase the lifespan of the sensor. The polar layer 113 contains barium titanate and / or calcium titanate, polar materials with high dielectric constants. The first electrode 111 is closer to the human body. Therefore, the electrode composite layer 11 in this embodiment is equivalent to a capacitor. Compared with a single-layer electrode sheet, this embodiment... The increased coupling capacitance between the human skin and the electrode composite layer 11 may be due to two factors. Firstly, the polar layer 113 acts as a dielectric layer between the first electrode 111 and the second electrode 112. Because of its high dielectric constant, it effectively increases the coupling capacitance between the human skin and the electrode composite layer 11. This increased capacitance reduces the capacitive reactance, thereby lowering the total impedance and reducing the attenuation of the ECG signal during coupling. Secondly, the first electrode 111 is closer to the human skin and connected to an external signal processing unit, thus increasing the capacitance of the human body's charge on the skin. After surface polarization, opposite charges attracted to the electrical signals of human skin are coupled onto the first electrode 111. When this charge passes through the polarization layer 113, the dielectric constant of the polarization layer 113 increases significantly. Under the charge conduction effect of the polarization layer 113, the charge on the second electrode 112 is enhanced. Since the second electrode 112 is suspended, meaning its pins are not connected to any signal (neither high nor low level), the charge on the second electrode 112, in turn, also affects the charge on the first electrode 111 under the conduction effect of the polarization layer 113. The enhanced effect of the polar layer 113 allows for the acquisition of an enhanced electrocardiogram (ECG) signal on the first electrode 111, thereby improving the detection quality of the ECG signal. Furthermore, during non-contact ECG signal detection, the structure formed by human skin, insulating clothing, and capacitive coupling electrodes functions as a first-order high-pass filter. Therefore, the increased coupling capacitance between human skin and the electrode composite layer 11 lowers the cutoff frequency of the high-pass filter. Since the high-pass filter has the characteristic of passing high frequencies and blocking low frequencies, the reduced cutoff frequency allows for more effective detection of the ECG signal.It is understandable that electrocardiogram (ECG) signals are inherently weak signals, and their attenuation is significant under external interference. If the detected ECG signal is of poor quality and contains many impurities, the accuracy of the respiratory wave obtained from subsequent processing is reduced, making it difficult to accurately determine whether the patient is experiencing sleep apnea or other problems, or whether the patient's posture needs to be adjusted using a positioning device. This can easily lead to misjudgments. This embodiment addresses this by incorporating a high-dielectric-constant polar material into the flexible ECG sensor 1 and forming it with the electrodes into a capacitor-type polar composite layer. This increases the coupling capacitance, reduces ECG signal attenuation, and detects a higher-quality ECG signal. This facilitates the further separation of the respiratory wave from the ECG signal, allowing for the assessment of the respiratory status and timely adjustments to the positioning device.

[0043] Therefore, the respiratory intervention device provided in this embodiment achieves real-time monitoring of the patient's breathing through non-contact detection of electrocardiogram signals. When problems such as breathing pauses are detected, posture correction can be performed in a timely manner to avoid the risk of suffocation. Furthermore, adjusting the patient's posture through a body position adjustment device to improve breathing is a physical intervention method with higher safety.

[0044] In some embodiments, the electrode composite layer 11 is obtained by coating the upper and lower surfaces of the substrate with a polar solvent and covering them with copper foil, followed by curing. The copper foil on the upper and lower surfaces of the substrate is the first electrode 111 and the second electrode 112, respectively. The polar solvent comprises the following components by weight percentage: 50%-74% liquid PDMS resin material, 25%-45% polar material, 1%-5% curing agent, and 1%-2% catalyst. The polar material includes barium titanate and / or calcium titanate, the curing agent includes hydrosiloxane, and the catalyst includes platinum catalyst.

[0045] The liquid PDMS (polydimethylsiloxane) resin material is used to adjust the flexibility of the finished product, which determines its extensibility. This allows the sensor prepared in this embodiment to be breathable, facilitating the expulsion of moisture when used to detect human electrocardiogram signals. The curing agent content can be adjusted according to temperature and humidity. Preferably, the curing agent accounts for 2% of the total weight, and the catalyst accounts for 1.5% of the total weight, used to accelerate the curing speed.

[0046] In this embodiment, the polar solvent forms a cured layer on the substrate surface during the curing process, and together with the substrate, constitutes the polar layer 113. Since the polar solvent contains high dielectric constant polar materials such as barium titanate and calcium titanate, and the preparation process of the electrode composite layer 11 adopts a mixing and curing treatment method, which is a physical change, the original material properties can be maintained. Therefore, the resulting mixed polar solvent also has a high dielectric constant, that is, the polar layer 113 after curing also has a high dielectric constant. In this embodiment, a multi-layered electrode composite layer 11 is obtained by coating a polar solvent onto a substrate and covering it with copper foil, thus forming a capacitor. According to the capacitance calculation formula, increasing the dielectric constant of the medium between the electrodes can effectively improve the capacitance value. In this embodiment, the electrode composite layer 11 is prepared by coating the upper and lower surfaces of the substrate with a polar solvent and then covering them with copper foil. The overall structure of the two copper foil layers sandwiching the polar layer is then sent into a press or similar equipment for curing and shaping, followed by etching to obtain a multi-layered composite layer including a first electrode 111 and a second electrode 112. The small distance between the two electrodes also helps to improve the capacitance value.

[0047] In some of these implementations, such as Figures 3-5 As shown, the first electrode 111 of the electrode composite layer 11 includes a first region 115 and a second region 116 that are insulated from each other. Both the first region 115 and the second region 116 include multiple electrode pads 114, which are connected to an electrocardiogram (ECG) acquisition circuit. The electrode pads 114 in the back region of the first electrode (as shown in the middle section of Table 1, row 6, column 10) are used to detect ECG signals. The remaining electrode pads 114 are used to detect changes in the user's body position, such as supine, lateral, getting out of bed, and getting into bed. The area within the first region 115 and outside the electrode pads 114 is used for grounding, and the area within the second region 116 and outside the electrode pads 114 is used to connect to the right leg drive circuit.

[0048] No partitioned area is provided on the second electrode 112 of the electrode composite layer 11. Multiple electrode pieces 114 are also provided on the second electrode 112 in the area corresponding to the first area 115. The electrode pieces 114 on the second electrode 112 are suspended, that is, not connected to any circuit.

[0049] The electrode sheet 114 is a closed conductive region obtained by etching away copper foil in a frame shape on the electrode composite layer 11. It is understood that the frame shape after removing the copper foil is non-conductive; therefore, the circuits inside and outside the frame shape are not conductive. The closed region within the frame shape constitutes the electrode sheet 114, and the conductive lines of each electrode sheet 114 converge and connect to the ECG acquisition circuit. The shape of the electrode sheet 114 is related to the shape of the frame. For example, if the frame shape is square, the resulting electrode sheet 114 is square, including square, rectangular, or strip-shaped electrode sheets; if the frame shape is circular, the resulting electrode sheet 114 is circular. The first region 115 and the second region 116 are also two regions obtained by etching away linear copper foil on the first electrode 111 of the electrode composite layer 11. It is understood that the linear shape after etching the copper foil is non-conductive. Therefore, by etching the copper foil on the first electrode 111, the first electrode 111 can be divided into two non-conductive regions: the first region 115 and the second region 116. The electrode pads 114 in the first region 115 and the second region 116 are connected to the ECG acquisition circuit. The electrode pads in the first region 115 are used to acquire ECG signals, and the electrode pads in the second region 116 are used to detect changes in body position, such as lying supine or getting out of bed. The area outside the electrode pads 114 in the first region 115 is grounded, and the area outside the electrode pads 114 in the second region 116 is connected to the right leg drive circuit. The ECG signal is acquired through the combination of the ECG acquisition circuit and the right foot drive circuit.

[0050] In some embodiments, the first region 115 includes a back region corresponding to the back of the human body and other regions besides the back region. Electrode pads 114 are arrayed within the back region, and the distribution density of the electrode pads 114 in the back region is greater than the distribution density in the other regions. The back region corresponds to the back of the human body and is used to detect electrocardiogram signals. The other regions roughly correspond to the waist and hip positions of the human body, and the second region 116 corresponds to the lower leg position. The electrode pads 114 in the other regions of the first region 115 and the second region 116 are used to detect changes in body position, such as supine, lateral, getting out of bed, and getting into bed. Therefore, the distribution density of the electrode pads 114 in the back region is greater than the distribution density in the other regions. Figure 6 As shown, square electrode sheets 114 are arranged in an array on the electrode composite layer 11. This arrangement is also called a regular arrangement, such as... Figure 6 As shown in (a). When the electrode sheet 114 is elongated and arranged laterally on the electrode composite layer 11, this arrangement is also called a horizontal arrangement, as shown in... Figure 6 As shown in (b). From left to right in the figure are a schematic diagram of the human body, a diagram with electrodes arranged vertically, and a diagram with electrodes arranged horizontally. Additionally, through... Figure 6It can also be seen that the sensor in this embodiment is proportional to the human body. The overall size of the sensor is similar to that of the human body. The sensor is laid under the sheet, and when the human body lies on it, the electrode plate 114 is located on the back of the human body.

[0051] To facilitate a deeper understanding of the structure of the flexible ECG sensor, this embodiment describes its fabrication steps through specific examples. Exemplarily, a substrate is prepared, which can be a carbon fiber board or a glass fiber substrate. A polar solvent is prepared, comprising: PDMS: 50%–74%; barium titanate and / or calcium titanate: 25%–45%; curing agent: 1%–5%; catalyst: 1%–2%. The prepared polar solvent is applied to the upper and lower surfaces of the carbon fiber board, and then a flat thin copper sheet is applied to both surfaces. The entire structure is fed into a press machine and held at 120–180°C under high pressure for 2 hours to cure and form the electrode composite layer 11. Electrode patterns are etched onto the upper and lower surfaces of the electrode composite layer 11 to complete the via circuit. A first insulating layer 12, an electromagnetic shielding layer 13, and a second insulating layer 14 are then applied to the electrode composite layer 11 to obtain the sensor. Preferably, ventilation holes 117 are provided at the same position on each layer of the sensor, penetrating the electrode composite layer 11, the first insulating layer 12, the electromagnetic shielding layer 13, and the second insulating layer 14, so as to facilitate the timely discharge of human body moisture and improve user comfort.

[0052] In some embodiments, the body position adjustment device includes a bed frame 2, a bed board 3, and a drive unit. The drive unit is electrically connected to the control unit. The bed board 3 has a segmented structure, including a first bed board 31, a second bed board 32, and a third bed board 33. The two sides of the third bed board 33 are connected to the bed frame 2 through support structures. The first bed board 31 and the second bed board 32 are independently controlled by their respective drive units and are adapted to rise and fall under the drive of their respective drive units.

[0053] In this embodiment, the bed board is laid on the bed frame 2. The bed board has a multi-segment structure, consisting of three segments from head to toe. For example... Figure 1 As shown, the third bed board 33 is mainly used to support the lower limbs and can also be called the lower limb bed board. The second bed board 32 is mainly used to support the torso and can also be called the torso bed board. The first bed board 31 is mainly used to support the head and neck and can also be called the headrest bed board. The lower limb bed board is connected to the bed frame 2, and the bed frame 2 is used to support the lower limb bed board. The headrest bed board and the torso bed board are raised and lowered by their respective drive units.

[0054] Preferably, both the headrest section and the torso section of the bed board are driven by a motor for lifting and lowering, such as... Figure 7As shown, the drive unit for the headrest section bed board is a second motor M2. The stator of the second motor M2 is fixed to the bottom of the torso section bed board, and the rotor of the second motor M2 is fixed to the bottom of the headrest section bed board. The rotation of the rotor causes the headrest section bed board to rotate relative to the torso section bed board, thereby achieving the raising and lowering of the headrest section bed board. The drive unit for the torso section bed board is a first motor M1. The stator of the first motor M1 is fixed to the bottom of the lower limb section bed board, and the rotor of the first motor M1 is fixed to the bottom of the torso section bed board. The rotation of the rotor causes the torso section bed board to rotate relative to the lower limb section bed board, thereby achieving the raising and lowering of the torso section bed board. It can be understood that an electric motor, as a device that converts electrical energy into power, can achieve rotational motion by utilizing the force generated by the interaction of magnetic fields and current. It includes a stator and a rotor. The stator mainly consists of an iron core, stator coils, and a frame, and can generate a rotary magnetic field. The rotor mainly consists of an iron core, rotor coils, and a shaft. The magnetic forces generated by the stator coil and the rotor coil interact, causing the rotor to rotate and output torque outward, thereby driving the connected components to rotate. In this embodiment, the second motor M2 is located at the bottom of the first bed plate 31 and the second bed plate 32, and also serves to connect the first bed plate 31 and the second bed plate 32. The second motor M2 is fixed to the bottom of the second bed plate 32 by steel plates, threaded connectors, etc., and the first motor M1 is fixed to the bottom of the third bed plate 33 by steel plates, threaded connectors, etc.

[0055] like Figure 8 The diagram shows the respiratory intervention device in a supine position. Since the patient's head is in a slightly elevated position for greater comfort when lying supine, the trunk and headrest sections of the bed can be appropriately raised by driving the first motor M1 and the second motor M2, with the headrest section slightly higher than the trunk section. Figure 9 The diagram shows the state of the respiratory intervention device when the patient is in a side-lying position. Since a certain amount of space needs to be reserved for the patient's shoulders when lying on their side, so that the patient can breathe smoothly, the trunk section of the bed board can be lowered appropriately by driving the first motor M1, and the headrest section of the bed board can be raised appropriately by driving the second motor M2.

[0056] Therefore, the respiratory intervention device in this embodiment adds a flexible electrocardiogram sensor 1 to the bed board, uses the sensor to detect the patient's electrocardiogram signal, extracts the patient's respiratory information through the electrocardiogram signal, and then determines whether to perform postural intervention based on the respiratory information. For example, the patient's posture can be adjusted by raising and lowering the bed board to make breathing smoother, or the patient can be awakened by the reciprocating motion of the motor to avoid the patient's breathing apnea and suffocation.

[0057] This invention also provides a respiratory intervention method, based on the above-described respiratory intervention device, comprising:

[0058] Human electrocardiogram (ECG) signals are acquired using a flexible ECG sensor 1.

[0059] The human electrocardiogram (ECG) signal is filtered, amplified, and processed using an ECG acquisition circuit to obtain raw ECG data. The raw ECG data is then processed to obtain valid ECG data.

[0060] The effective ECG data is filtered out by removing baseline drift data caused by respiratory waves to obtain filtered ECG data.

[0061] Respiratory wave data are obtained based on the filtered ECG data and the valid ECG data;

[0062] The respiratory rate is obtained based on the respiratory wave data;

[0063] The body position adjustment device is controlled to operate based on the initial body position, the breathing rate, and the set frequency.

[0064] In some embodiments, acquiring human electrocardiogram (ECG) signals using the flexible ECG sensor 1 includes:

[0065] Step S110: Obtain the first electrode 111 piece on the back region of the flexible ECG sensor 1. The first electrode 111 piece is the electrode 114 that generates ECG signals in the electrode piece 114 on the back region.

[0066] Step S120: Select any two electrodes from the first electrode 111 as the positive and negative electrodes of the electrocardiogram (ECG), input them into the ECG acquisition circuit, and obtain the quality of the ECG signal acquired by the ECG acquisition circuit.

[0067] Step S130: Select the target positive electrode and the target negative electrode according to the quality of the ECG signal; wherein, after selecting the target ECG electrode, the ECG is continuously collected by the fixed pair of positive and negative electrodes during the period when the human body remains static. However, if the human body changes its posture, the quality of the ECG obtained by the current collection pair will change. At this time, it is necessary to select a suitable positive and negative electrode detection pair again and return to step S110.

[0068] Step S140: Use the target positive electrode and the target negative electrode as inputs to the ECG acquisition circuit to acquire human ECG signals.

[0069] like Figure 1 , Figure 8 , Figure 9As shown, a mattress 4 is laid on the bed board, and a sensor and a pillow 5 are laid on the mattress 4. A person lies on the sensor. It can be understood that the person's skin 100 is separated from the sensor by clothing and / or a sheet 200. The back of the person corresponds to the back area on the sensor. Since the back area of ​​the sensor has a large number of electrode pads 114 arranged in an array, the acquisition circuit board needs to periodically scan whether these electrode pads 114 are in working condition. To reduce costs, the circuits corresponding to unused electrode pads 114 can be turned off. For example, in this embodiment, there are two signal selections. First, during the time the patient is lying on the bed, the acquisition point at the contact position will couple out a capacitor, and the circuits corresponding to the electrode pads 114 that the person is not in contact with can be turned off. Then, the electrode pads 114 covered by the person are combined in pairs to obtain the two electrode pads 114 with the best signal quality, and these are used as the target positive and target negative electrodes and input into the signal acquisition circuit. At this time, the remaining electrode pads 114 can be turned off, thus obtaining a single-lead ECG signal. Of course, if the area of ​​the electrode pads 114 is reduced to a certain range, multi-lead ECG signals can also be detected.

[0070] The method of this embodiment can be used to select electrode pads 114 that can acquire the best quality ECG signal. Specifically, as shown in Table 1, the serial numbers in Table 1 represent the serial numbers of electrode pads 114. Assuming that a total of 60 electrode pads 114 are designed in 6 rows and 10 columns on the back, when the user lies down, the electrode pads 114 located in the center in 6 rows and 4 columns (as shown by the underlined area in Table 1) are pressed down. To reduce computational resources, the remaining electrode pads 114 do not need to be processed. The electrode pads 114 that cover the human body are referred to as the first electrode pads 111 (i.e., the corresponding electrode pads 114 in Table 1). Two electrode pads are randomly selected from the first electrode pads 111 to form the positive and negative ECG electrodes, which are then input into the circuit. For example: electrode pad number 13 is selected as the positive ECG electrode, and electrode pad number 14 is selected as the negative ECG electrode. These are input into the ECG acquisition circuit to determine whether they are ECG signals and their signal quality. Similarly, electrode 13 (114) is selected as the positive electrode for ECG, and electrode 15 (114) as the negative electrode for ECG. These are then input into the ECG acquisition circuit to determine if they constitute an ECG signal and their quality. After combining these with electrode 13 (114), a combination with electrode 14 (114) as the positive electrode for ECG is selected. This process is repeated for all possible combinations, and the best combination is chosen, such as the combination of electrode 13 (positive electrode) and electrode 66 (negative electrode). It's also possible that a signal can only be measured when electrode 13 (114) is used as the negative electrode and electrode 66 (114) as the positive electrode; in this case, simply changing the polarity will suffice. Once these are designated as the target positive and negative electrodes, subsequent ECG signal input will be handled by these two electrode pads (114).

[0071] Table 1:

[0072]

[0073]

[0074] In some embodiments, obtaining respiratory wave data based on the filtered ECG data and the valid ECG data includes: subtracting the filtered ECG data from the valid ECG data to obtain the respiratory wave data.

[0075] The filter can be a Butterworth high-pass filter or an IIR filter. Taking an IIR filter as an example, obtaining the filtered ECG data includes the following steps:

[0076] First, acquire valid ECG data. Assume the ECG signal acquisition frequency is 500Hz, meaning 500 valid ECG data points are generated per second. The original valid ECG data is 16 bits, but it is sent as 8 bits (1 byte), forming an ECG signal data file named xindian.txt. cECG_Wave_LowByte represents the lower 8 bits of the ECG signal, and cECG_Wave_HighByte represents the higher 8 bits. Divide the ECG signal in the file into two categories and process them according to Formula 1 to obtain the valid ECG data cECG_Raw_Wave, as shown in Formula 1 below:

[0077] cECG_Raw_Wave=((cECG_Wave_HighByte*256+cECG_Wave_LowByte)-32768)*4.096 / 32768;

[0078] Secondly, the effective ECG data is processed using an IIR filter to obtain the data after filtering out baseline drift caused by respiratory waves, i.e., the filtered ECG data, denoted as cECG_Wave_RemoveRes.

[0079] Finally, the effective ECG data cECG_Raw_Wave is subtracted from the filtered ECG data cECG_Wave_RemoveRes to obtain the respiratory wave data, denoted as Respiratory_Wave.

[0080] like Figure 10 The image shown is a 10-second segment of a valid electrocardiogram (ECG) waveform captured using MATLAB. The horizontal axis represents time, and the vertical axis represents amplitude. Figure 10 The valid electrocardiogram shown is finally obtained after noise reduction. Figure 11 , Figure 11 This is the filtered electrocardiogram. Figure 12 The respiratory waveform is obtained by subtracting the initial valid electrocardiogram from the filtered electrocardiogram. It can be seen that there are 3 fluctuations in the waveform within 10 seconds, which means that 3 complete breaths occurred within 10 seconds, and the frequency is 18 breaths / minute.

[0081] In some embodiments, the initial body position includes a supine position and a side-lying position, the set frequency includes a first set frequency and a second set frequency, and the initial body position, based on the breathing frequency and the set frequency, controls the body position adjustment device to operate as follows:

[0082] When the initial body position is the supine state, if the respiratory rate is detected to be lower than the first set frequency, the second section of the bed board 32 of the body position adjustment device is controlled to rise and the first section of the bed board 31 is controlled to fall. If the respiratory rate is lower than the second set frequency, the second section of the bed board 32 of the body position adjustment device is controlled to rise and the first section of the bed board 31 is restored to the horizontal position, and the drive unit (i.e. the first motor M1) used to drive the second section of the bed board 32 to reciprocate.

[0083] When the initial body position is the side-lying state, if the respiratory rate is detected to be lower than the first set frequency, the second section of the bed board 32 of the body position adjustment device is controlled to descend and the first section of the bed board 31 is controlled to rise. If the respiratory rate is lower than the second set frequency, the second section of the bed board 32 and the first section of the bed board 31 of the body position adjustment device are controlled to return to the horizontal position, and the drive unit (i.e. the first motor M1) of the second section of the bed board 32 is used to drive the reciprocating motion.

[0084] A normal respiratory rate is generally 14-18 breaths per minute. Therefore, in this embodiment, the first set frequency is set to 14 breaths per minute. When the respiratory rate is detected to be below 14 breaths per minute while the patient is lying flat, the second motor M2 controls the first section of the bed board 31 to descend, and the first motor M1 controls the second section of the bed board 32 to rise, causing the patient's head to tilt back to ensure airway patency. In this embodiment, the second set frequency is 4 breaths per minute. When the respiratory rate is detected to be below 4 breaths per minute, it indicates that the patient's breathing is extremely weak and there is a risk of suffocation. Therefore, the second section of the bed board 32 is raised, and the first section of the bed board 31 returns to a horizontal position, raising the entire upper body. This can be done at 90°, or at other angles, preferably 60°. Simultaneously, the first motor is controlled to reciprocate, creating a rocking motion to wake the patient.

[0085] When the patient is lying on their side, if the respiratory rate is less than 14 breaths per minute, the airway needs to be kept clear. The first motor M1 is controlled to lower the second bed board, and the second motor M2 is controlled to raise the first bed board. When the respiratory rate is less than 4 breaths per minute, after the first, second, and third bed boards are returned to a horizontal position, the first motor M1 is controlled to rock back and forth until the patient is awakened.

[0086] While the disclosure is as stated above, its scope of protection is not limited thereto. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of this disclosure, and all such changes and modifications will fall within the protection scope of this invention.

Claims

1. A respiratory intervention device, characterized in that, include: The system comprises a flexible electrocardiogram (ECG) sensor (1), a signal processing unit, a control unit, and a body position adjustment device. The flexible ECG sensor (1) is used to collect raw ECG data. The signal processing unit is used to obtain respiratory rate based on the raw ECG data. The control unit is used to control the body position adjustment device based on the respiratory rate. The flexible ECG sensor (1) includes an electrode composite layer (11), a first insulating layer (12), an electromagnetic shielding layer (13), and a second insulating layer (14) arranged sequentially. The electrode composite layer (11) includes a first electrode (111), a second electrode (112), and a polar layer (113) disposed between the first electrode (111) and the second electrode (112). The first electrode (111) is used to be electrically connected to the signal processing unit, and the surface of the first electrode (111) is gold-plated. The second electrode (112) is suspended. The polar layer (113) includes barium titanate and / or calcium titanate. The first electrode (111) includes a first region (115) and a second region (116) that are insulated from each other. Both the first region (115) and the second region (116) include a plurality of electrode pieces (114). The electrode pieces (114) are used to connect to the electrocardiogram acquisition circuit. The area in the first region (115) outside the electrode pieces (114) is used for grounding. The area in the second region (116) outside the electrode pieces (114) is used to connect to the right leg drive circuit. The area on the second electrode (112) corresponding to the first region (115) is provided with a plurality of electrode pieces (114). The electrode pieces (114) on the second electrode (112) are suspended.

2. The respiratory intervention device according to claim 1, characterized in that, The electrode composite layer (11) is obtained by coating the upper and lower surfaces of the substrate with a polar solvent and covering them with copper foil, and then curing them. The copper foil on the upper and lower surfaces of the substrate is the first electrode (111) and the second electrode (112), respectively. The polar solvent comprises the following components by weight percentage: 50%-74% liquid PDMS resin material, 25%-45% polar material, 1%-5% curing agent, and 1%-2% catalyst. The polar material includes barium titanate and / or calcium titanate, the curing agent includes hydrogen-containing siloxane, and the catalyst includes platinum catalyst.

3. The respiratory intervention device according to claim 1, characterized in that, The electrode sheet (114) is a closed conductive area obtained by etching the copper foil off the electrode composite layer (11) in a frame shape.

4. The respiratory intervention device according to claim 1, characterized in that, The first region (115) includes a back region corresponding to the back of the human body and other regions besides the back region. The electrode sheets (114) are arrayed in the back region, and the distribution density of the electrode sheets (114) in the back region is greater than the distribution density in the other regions.

5. The respiratory intervention device according to any one of claims 1-4, characterized in that, The body position adjustment device includes a bed frame (2), a bed board (3) and a drive unit. The drive unit is electrically connected to the control unit. The bed board (3) has a segmented structure. The bed board (3) includes a first bed board (31), a second bed board (32) and a third bed board (33). The two sides of the third bed board (33) are connected to the bed frame (2) through a support structure. The first bed board (31) and the second bed board (32) are independently controlled by their respective drive units and are adapted to rise and fall under the drive of their respective drive units.

6. A respiratory intervention method, characterized in that, Based on the respiratory intervention device as described in any one of claims 1-5, comprising: Human electrocardiogram (ECG) signals were acquired using a flexible ECG sensor (1); The human electrocardiogram (ECG) signal is filtered, amplified, and processed using an ECG acquisition circuit to obtain raw ECG data. The raw ECG data is then processed to obtain valid ECG data. The effective ECG data is filtered out by removing baseline drift data caused by respiratory waves to obtain filtered ECG data. Respiratory wave data are obtained based on the filtered ECG data and the valid ECG data; The respiratory rate is obtained based on the respiratory wave data; The body position adjustment device is controlled to operate based on the initial body position, the breathing rate, and the set frequency.

7. The respiratory intervention method according to claim 6, characterized in that, The step of obtaining respiratory wave data based on the filtered ECG data and the valid ECG data includes: subtracting the filtered ECG data from the valid ECG data to obtain the respiratory wave data.

8. The respiratory intervention method according to claim 6, characterized in that, The initial body position includes a supine position and a side-lying position; the set frequency includes a first set frequency and a second set frequency; and controlling the body position adjustment device based on the initial body position, the breathing frequency, and the set frequency includes: When the initial body position is the supine state, if the respiratory rate is detected to be lower than the first set frequency, the second section bed board (32) of the body position adjustment device is controlled to rise and the first section bed board (31) is controlled to fall. If the respiratory rate is lower than the second set frequency, the second section bed board (32) of the body position adjustment device is controlled to rise and the first section bed board (31) is restored to the horizontal position, and the drive unit used to drive the second section bed board (32) to reciprocate. When the initial body position is the side-lying state, if the respiratory rate is detected to be lower than the first set frequency, the second section bed board (32) of the body position adjustment device is controlled to descend and the first section bed board (31) is controlled to rise. If the respiratory rate is lower than the second set frequency, the second section bed board (32) and the first section bed board (31) of the body position adjustment device are controlled to return to the horizontal position, and the drive unit used to drive the second section bed board (32) to reciprocate.

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