Temporary cardiac pacing system and method

Abstract

This application relates to the field of implantable medical device technology, and discloses a temporary cardiac pacing system and method. The temporary cardiac pacing system includes: an external control device and a temporary cardiac pacing device; the temporary cardiac pacing device includes an energy supply unit and a magnetic control unit; the energy supply unit and the magnetic control unit are connected via a connector; the external control device is used to generate pulsed magnetic field signals; the magnetic control unit is used to use the pulsed magnetic field signals to pulse-conduct the circuitry of the temporary cardiac pacing device, thereby controlling the energy supply unit to pulse-discharge, thereby stimulating the myocardium to induce contraction and achieve cardiac pacing. Because magnetic fields have the unique physical advantage of penetrating biological tissue almost without damage, using magnetic field signals to penetrate biological tissue can avoid damage to the biological tissue, thereby reducing the safety risks of the temporary cardiac pacing device.

Description

Technical Field

[0001] This application relates to the field of implantable medical device technology, and more particularly to a temporary cardiac pacing system and method. Background Technology

[0002] Implantable medical devices, such as temporary cardiac pacing devices, occupy an important position in the field of clinical medicine today, greatly improving patients' symptoms and quality of life, and possessing significant social and economic value. Temporary cardiac pacing devices, after being implanted in the human body, can maintain or restore a normal heart rhythm through electrical stimulation, thus being used to treat transient bradycardia after surgery, myocardial infarction, or drug overdose.

[0003] In related technologies, temporary cardiac pacing devices use optical control or radio frequency power supply schemes to achieve wireless pacing, thereby avoiding the risks of infection, myocardial perforation, displacement, and restriction of patient activity associated with wired pacing.

[0004] One approach, optical control, utilizes light signals (typically near-infrared light) to wirelessly trigger and regulate the electrical pulse output of a temporary cardiac pacing device, thereby controlling the heartbeat. However, light signals undergo multiple scatterings when penetrating biological tissue, preventing straight-line propagation and reducing the light intensity reaching the target area. This necessitates higher light intensity to ensure sufficient signal reach. High light intensity, however, carries the risk of burning biological tissue. Therefore, safety risks remain when using optical control to manage the heartbeat in a temporary cardiac pacing device.

[0005] Radio frequency (RF) power supply schemes wirelessly transmit energy via RF signals (such as electromagnetic waves ranging from a few MHz to several hundred MHz), which is then received by a temporary cardiac pacing device and converted into electrical energy to control the heartbeat. However, when RF signals are transmitted through biological tissue, they generate a thermal effect, leading to an increase in local temperature and causing tissue damage. Therefore, there are safety risks associated with using RF power supply schemes to control the heartbeat in temporary cardiac pacing devices. Summary of the Invention

[0006] This application provides a temporary cardiac pacing system and method to address the safety risks associated with wireless pacing in temporary cardiac pacing devices using optical control or radio frequency power supply schemes. The specific implementation scheme is as follows: In a first aspect, this application provides a temporary cardiac pacing system, the system comprising: an external control device and a temporary cardiac pacing device; wherein, the temporary cardiac pacing device includes an energy supply unit and a magnetic control unit; the energy supply unit and the magnetic control unit are connected via a connector; The external control device is used to generate pulsed magnetic field signals; The magnetic control unit is used to pulse-conduct the circuit of the temporary cardiac pacing device using the pulsed magnetic field signal, so as to control the energy supply unit to pulse-discharge.

[0007] Through the above-described embodiments, after the external control device generates a pulsed magnetic field signal, the magnetic control unit in the temporary cardiac pacing device uses this pulsed magnetic field signal to pulse-conduct the circuit of the temporary cardiac pacing device, thereby causing the energy supply unit to pulse-discharge to stimulate the myocardium and induce contraction, thus achieving cardiac pacing. Because magnetic fields have the unique physical advantage of penetrating biological tissue almost without damage, using magnetic field signals (i.e., pulsed magnetic field signals) to penetrate biological tissue can avoid causing damage to the biological tissue, thereby solving the safety risks caused by using optical control schemes or radio frequency power supply schemes, and significantly improving the safety of the temporary cardiac pacing device.

[0008] In one possible implementation, the positive and negative electrodes of the energy supply unit are in contact with biological tissue.

[0009] Through the above-described embodiments, the positive and negative electrodes of the energy supply unit are in direct contact with biological tissue (such as myocardial tissue). Thus, when the energy supply unit performs pulsed discharge, it can more directly stimulate the biological tissue to excite it, thereby causing the biological tissue to contract and thus controlling cardiac pacing.

[0010] In one possible implementation, the energy supply unit is a primary battery that is biocompatible or bioabsorbable.

[0011] By employing a biocompatible or bioabsorbable primary battery as the energy supply unit through the above-described embodiments, the damage to biological tissues caused by temporary cardiac pacing devices is further reduced, thereby further reducing the safety risks of temporary cardiac pacing devices.

[0012] In one possible implementation, the magnetic control unit is a miniature reed switch, a magnetostrictive switch based on soft magnetic materials, or a magnetically controlled variable resistor.

[0013] Through the above-described embodiments, since miniature reed switches, magnetostrictive switches based on soft magnetic materials, and magnetically controlled variable resistors can all utilize pulsed magnetic field signals to pulse-type conduct the circuit, miniature reed switches or magnetostrictive switches based on soft magnetic materials or magnetically controlled variable resistors can be used as magnetic control units. This allows the magnetic control unit to pulse-type conduct the circuit of the temporary cardiac pacing device using pulsed magnetic field signals generated by the external control device, thereby achieving pulsed discharge control of the energy supply unit, making temporary cardiac pacing more intelligent and more controllable.

[0014] In one possible implementation, the temporary cardiac pacing device further includes a substrate, and the connector includes a first connection layer and a second connection layer; the first connection layer is located on the upper surface of the substrate, and the second connection layer is located on the lower surface of the substrate. The energy supply unit is located above the first connection layer, and the magnetic control unit is located above the second connection layer; or The energy supply unit is located above the second connection layer, and the magnetic control unit is located above the first connection layer.

[0015] Through the above-described embodiments, a temporary cardiac pacing device is integrated into an ultra-thin integrated device.

[0016] In one possible implementation, the connector is biocompatible or bioabsorbable.

[0017] Through the above-described embodiments, since the connector is compatible or bioabsorbable, even if the connector comes into contact with biological tissue, it will not cause significant damage to the biological tissue, thereby further improving the safety of the temporary cardiac pacing device.

[0018] In one possible implementation, the temporary cardiac pacing device further includes a control layer; wherein the control layer is constructed of a two-dimensional nanochannel material; the control layer is located between the positive and negative electrodes of the energy supply unit and the biological fluid environment.

[0019] Through the above-mentioned application embodiments, a control layer constructed of two-dimensional nanochannel material is introduced between the positive and negative electrodes of the energy supply unit and the biological fluid environment. This allows for precise control of the contact between biological fluid ions and electrode materials by utilizing the ion sieving properties of the two-dimensional nanochannel material. Consequently, the activation and degradation sequence of the battery can be programmed, further improving the reliability and intelligence level of the temporary cardiac pacing device. This also extends the lifespan of the energy supply unit, thereby further extending the lifespan of the temporary cardiac pacing device.

[0020] In one possible implementation, the external control device, when generating the pulsed magnetic field signal, is specifically used to automatically generate the pulsed magnetic field signal when the real-time heart rate of the user corresponding to the temporary cardiac pacing device is lower than the heart rate threshold. The external control device is further configured to stop generating the pulse magnetic field signal when it is determined that the user's real-time heart rate has not fallen below the heart rate threshold for a set duration, so as to restore the magnetic control unit to its initial state; wherein the initial state is an off state or a high resistance state.

[0021] Through the above-described embodiments, the external control device only generates a pulsed magnetic field signal when the user's real-time heart rate is below a heart rate threshold, making the generation of the pulsed magnetic field signal more intelligent. When the external control device determines that the user's real-time heart rate has not fallen below the heart rate threshold for a set duration, it can determine that the user's heartbeat has returned to normal, and thus determine that it is no longer necessary to use a temporary cardiac pacing device to achieve cardiac pacing. At this time, the external control device can stop generating pulsed magnetic field signals, causing the magnetic control unit to return to its initial state. This initial state is an open state or a high-resistance state. In this state, the circuit of the temporary cardiac pacing device is disconnected, causing the pacing caused by the temporary cardiac pacing device to stop.

[0022] In one possible implementation, the external control device includes an electrocardiogram monitoring module, a processing and control module, and a magnetic field generating module; The electrocardiogram monitoring module is used to collect the electrocardiogram (ECG) data of the user corresponding to the temporary cardiac pacing device in real time through skin electrodes; The processing and control module is used to determine, based on the ECG data, that the user's real-time heart rate is lower than the heart rate threshold, and to issue a magnetic field generation command. The magnetic field generating module is used to generate a pulsed magnetic field with a set frequency and pulse width according to the magnetic field generation instruction, so as to generate the pulsed magnetic field signal.

[0023] Through the above-described embodiments, since the skin electrode does not require puncture or surgery, but only needs to be attached to the body surface to collect ECG data, the ECG monitoring module collects the user's ECG data through the skin electrode, avoiding the risk of infection and further reducing the safety risks of temporary cardiac pacing devices, thus increasing user acceptance. Subsequently, the processing and control module determines that when the user's real-time heart rate is lower than the heart rate threshold based on the ECG data, it immediately issues a magnetic field generation command. This causes the magnetic field generating module to generate a pulsed magnetic field with a set frequency and pulse width according to the command, thereby generating a pulsed magnetic field signal. This allows the temporary cardiac pacing device to immediately use the pulsed magnetic field signal to pulse-conduct the circuit, thereby pulse-discharging to stimulate the myocardium to induce contraction and achieve cardiac pacing. In this way, the user's real-time dynamic monitoring and the rapid response of the pulsed magnetic field signal generation are seamlessly integrated with temporary cardiac pacing, avoiding medical risks caused by delays and further improving the safety of temporary cardiac pacing devices.

[0024] Secondly, this application also provides a temporary cardiac pacing method, the method comprising: A pulsed magnetic field signal is generated through an external control device; The circuit of the temporary cardiac pacing device is pulsedly activated by the magnetic control unit in the temporary cardiac pacing device and the pulsed magnetic field signal, so as to control the energy supply unit in the temporary cardiac pacing device to discharge pulsedly; wherein, the energy supply unit and the magnetic control unit are connected by a connector.

[0025] In the above-described embodiments, an external control device first generates a pulsed magnetic field signal. Then, the magnetic control unit in the temporary cardiac pacing device uses this pulsed magnetic field signal to pulse-conduct the circuitry of the temporary cardiac pacing device, thereby controlling the energy supply unit to pulse-discharge and stimulate the myocardium to induce contraction, thus achieving temporary cardiac pacing. Because magnetic fields have the unique physical advantage of penetrating biological tissue almost without damage, using magnetic field signals (i.e., pulsed magnetic field signals) to penetrate biological tissue avoids causing damage to the biological tissue, thereby solving the safety risks associated with optical control or radio frequency power supply schemes and significantly improving the safety of the temporary cardiac pacing device. Attached Figure Description

[0026] Figure 1 A schematic diagram of a temporary cardiac pacing system provided in an embodiment of this application; Figure 2a A schematic diagram of a temporary cardiac pacing device provided in an embodiment of this application. Figure 1 ; Figure 2b Schematic diagram 2 of a temporary cardiac pacing device provided for an embodiment of this application; Figure 3 A schematic diagram of an external control device provided in an embodiment of this application; Figure 4 A schematic flowchart of a temporary cardiac pacing method provided in this application embodiment. Figure 1 ; Figure 5 This is a schematic diagram of a temporary cardiac pacing method provided in an embodiment of this application.

[0027] Figure label: 1-Temporary cardiac pacing system; 11-Temporary cardiac pacing device; 111-Energy supply unit; 112-Magnetic control unit; 113-Connector; 12-External control device; 121-ECG monitoring module; 122-Processing and control module; 123-Magnetic field generation module. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. The specific operational methods in the method embodiments can also be applied to the device embodiments or system embodiments. It should be noted that in the description of this application, "multiple" is understood as "at least two". "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. A connected to B can represent: A and B directly connected, and A and B connected through C. Furthermore, in the description of this application, terms such as "first" and "second" are used only for distinguishing the purpose of description and should not be construed as indicating or implying relative importance or order.

[0029] In related technologies, when using optical control or radio frequency power supply schemes to achieve wireless pacing in temporary cardiac pacing devices, the high light intensity required for the optical signal to penetrate biological tissue can burn the tissue, and the thermal effect generated when the radio frequency signal penetrates biological tissue can cause tissue damage. Therefore, both optical control and radio frequency power supply schemes pose safety risks when implementing wireless pacing in temporary cardiac pacing devices.

[0030] Due to the unique physical advantage of magnetic fields in penetrating biological tissues with near-non-destructive force, this application proposes a temporary cardiac pacing system. After an external control device generates a pulsed magnetic field signal, the magnetic control unit in the temporary cardiac pacing device uses this pulsed magnetic field signal to pulse-conduct the circuitry (such as a stimulation current loop) of the implanted temporary cardiac pacing device. This controls the energy supply unit connected to the temporary cardiac pacing device via a connector to pulse-discharge, stimulating the myocardium to induce contraction and achieve cardiac pacing. Utilizing a magnetic field signal (i.e., a pulsed magnetic field signal) to penetrate biological tissue avoids damage caused by signal penetration.

[0031] To better understand the above technical solutions, the technical solutions of this application will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the embodiments of this application and the specific features in the embodiments are detailed descriptions of the technical solutions of this application, rather than limitations on the technical solutions of this application. In the absence of conflict, the embodiments of this application and the technical features in the embodiments can be combined with each other.

[0032] Please refer to Figure 1This application provides a temporary cardiac pacing system 1, which includes a temporary cardiac pacing device 11 and an external control device 12. The temporary cardiac pacing device 11 can be implanted in a biological body, and the external control device 12 can be located outside the biological body. When the external control device 12 generates a pulsed magnetic field signal, the pulsed magnetic field signal penetrates the biological tissue and reaches the implanted temporary cardiac pacing device 11. Subsequently, the temporary cardiac pacing device 11 uses the pulsed magnetic field signal to perform pulsed discharge, thereby stimulating the myocardium to induce contraction and achieve cardiac pacing, in order to treat transient bradycardia after surgery, myocardial infarction, or drug overdose.

[0033] The temporary cardiac pacing device 11 may include an energy supply unit 111 and a magnetic control unit 112, as well as a connector 113 for connecting the energy supply unit 111 and the magnetic control unit 112. The connector 113 may be made of a biocompatible or bioabsorbable conductive material. For example, the connector 113 may be made of candelilla wax and tungsten powder. Since tungsten powder is biocompatible and has stable conductivity, when the connector 113 contains tungsten powder, it has better conductivity stability and biocompatibility, reducing damage to biological tissues and making the temporary cardiac pacing device 11 more stable. However, besides using candelilla wax and tungsten powder to make the connector 113, the tungsten powder may be replaced with other biocompatible (or bioabsorbable) and conductive materials, such as Mg powder or Zn powder. Candelilla wax may also be replaced with other natural waxes as a binder to bond the tungsten powder (or other biocompatible or bioabsorbable conductive materials) and the magnetic control unit 112 to the energy supply unit 111, but this is not the only option.

[0034] The energy supply unit 111 can be a primary battery, but is not limited to a traditional primary battery structure. For example, the energy supply unit 111 can be a biocompatible or bioabsorbable primary battery. In the temporary cardiac pacing device 11, in addition to using a biocompatible or bioabsorbable primary battery as the energy supply unit 111, a supercapacitor can also be used as the energy supply unit 111; the energy supply unit 111 can also be configured as a bipolar stacked battery to increase the voltage; the electrodes of the energy supply unit 111 can also be fabricated as porous electrodes to increase the surface area of ​​the electrodes, thereby increasing the output current and improving degradation uniformity; any combination of two, three, or four of the following can be used as the energy supply unit 111, but it is not limited to these. The specific structure of the energy supply unit 111 can be adaptively adjusted according to the specific application scenario. Among them, the biocompatible or bioabsorbable primary battery, supercapacitor, bipolar stacked battery, and porous electrode can be realized by printing (such as printed electronics technology) or microfabrication technology.

[0035] Taking the energy supply unit 111 as an example of a biocompatible or bioabsorbable galvanic cell, the negative electrode of the energy supply unit 111 can be zinc (Zn) or magnesium (Mg), and the positive electrode can be molybdenum trioxide (MoO3), but it is not limited to these. In other words, a biocompatible or bioabsorbable galvanic cell can be magnesium-molybdenum trioxide (Mg-MoO3) or zinc-molybdenum trioxide (Zn-MoO3), but it is not limited to these. Therefore, when the circuit of the temporary cardiac pacing device 11 is pulsedly turned on, the energy supply unit 111 can pulsely discharge through the positive and negative electrodes, thereby stimulating the myocardium to induce contraction and realize cardiac pacing.

[0036] Since biocompatible or bioabsorbable galvanic cells do not cause adverse reactions in living organisms and thus cause minimal damage to biological tissues, biocompatible or bioabsorbable galvanic cells are used as the energy supply unit 111 in the temporary cardiac pacing device 11, which further reduces the safety risks of the temporary cardiac pacing device and also enables self-powering.

[0037] Therefore, when a biocompatible or bioabsorbable primary battery is used as the energy supply unit 111, even if the positive and negative electrodes of the energy supply unit 111 are in direct contact with biological tissue, it will not cause significant damage to the biological tissue. Furthermore, in this embodiment, the positive and negative electrodes of the energy supply unit 111 can be in direct contact with biological tissue (such as myocardial tissue). However, it should be noted that even if the energy supply unit 111 is not composed of a biocompatible or bioabsorbable primary battery, its positive and negative electrodes can still be in contact with biological tissue (such as myocardial tissue).

[0038] Furthermore, to further extend the lifespan of the energy supply unit 111, this embodiment can introduce a two-dimensional nanochannel material (such as graphene oxide film or MXene) as a control layer between the positive and negative electrodes of the energy supply unit 111 and the biological fluid environment (e.g., between the positive and negative electrodes of the energy supply unit 111 and biological tissue). This allows the ion-sieving properties of the two-dimensional nanochannel material to be utilized, enabling the control layer to selectively prevent macromolecular contaminants from contacting the electrodes and stabilize the electrochemical interface during the initial implantation of the temporary cardiac pacing device 11. Subsequently, the two-dimensional nanochannel material can be programmed to degrade or alter its hydrophilicity / hydrophobicity in the body fluid, gradually allowing ions to pass through, thereby delaying the battery activation time or controlling its degradation rate to match clinical needs. Therefore, by utilizing the ion-sieving properties of the two-dimensional nanochannel material, the control layer can precisely regulate the contact between the body fluid and the battery material, controlling the activation and degradation sequence of the galvanic cell, thereby extending the lifespan of the galvanic cell and thus extending the lifespan of the temporary cardiac pacing device 11.

[0039] In addition to two-dimensional nanochannel materials, the aforementioned control layer can also be other nanomaterials, such as nanowires and nanoparticles, thereby constructing porous electrodes through nanowires and nanoparticles to increase the reaction area and improve the output power and efficiency of the battery.

[0040] Next, the energy supply unit 111, connected to the magnetic control unit 112 via the connector 113, can use the pulsed magnetic field signal generated by the external control device 12 in the temporary cardiac pacing system 1 to pulse-conduct the circuit of the temporary cardiac pacing device 11, thereby controlling the energy supply unit 111 to pulse-discharge, so as to better stimulate the myocardium to induce contraction and achieve cardiac pacing, making the temporary cardiac pacing system 1 more controllable.

[0041] As a passive component, the magnetic control unit 112 does not require complex integrated circuits and an internal power supply, which facilitates device miniaturization, low power consumption, and low cost. Therefore, the magnetic control unit 112 can be constructed from a simple miniature reed switch to control the circuit of the temporary cardiac pacing device 11 to be turned on or off, thereby controlling the discharge or power-off of the energy supply unit 111.

[0042] For example, such as Figure 2a As shown, the magnetic control unit 112 is composed of a miniature reed switch. In the temporary cardiac pacing device 11 composed of miniature reed switches, the temporary cardiac pacing device 11 is cylindrical to facilitate implantation into the biological body and reduce damage to biological tissues. It should be noted that the cylindrical shape of the temporary cardiac pacing device 11 is only one example and is not limited to it; for example, it can also be a cuboid shape, etc. In addition, the dimensions of the temporary cardiac pacing device 11 can be: a cylinder diameter of 1.8 mm and a cylinder length of 5 mm; or a cylinder diameter of 1.5 mm and a cylinder length of 4.5 mm. The specific dimensions are not limited and can be adjusted according to the specific application scenario.

[0043] exist Figure 2a In this example, the energy supply unit 111 used to generate electrical energy in biological fluids (such as biological tissue fluid) is Mg-MoO3, where Mg is the negative electrode and MoO3 is the positive electrode. These positive and negative electrodes, also called stimulation electrodes, are in direct contact with myocardial tissue. The Mg-MoO3 is connected in series with a miniature reed switch (i.e., a magnetic control unit 112) via connector 113. Figure 2a In the example shown, the connector 113 is made of candelilla wax and tungsten powder to connect a miniature reed switch to a Mg-MoO3 positive and negative current collector.

[0044] when Figure 2a After the temporary cardiac pacing device 11 shown is implanted into the body, the reed in the miniature reed switch will pulse and engage according to the pulse magnetic field signal generated by the external control device 12, so that the circuit of the temporary cardiac pacing device 11 will pulse and conduct. At this time, Mg-MoO3 will pulse and discharge, thereby stimulating the myocardium to induce contraction and realize cardiac pacing.

[0045] Specifically, after receiving a pulsed magnetic field signal, the reed inside the miniature reed switch engages or disengages according to the frequency corresponding to the pulsed magnetic field signal (e.g., 80 Hz). When the reed is engaged, the circuit of the temporary cardiac pacing device 11 is turned on, and Mg-MoO3 can generate current and discharge. When the reed is disengaged, the circuit of the temporary cardiac pacing device 11 is turned off, and Mg-MoO3 is de-energized. Therefore, when the reed inside the miniature reed switch engages and disengages according to the frequency corresponding to the pulsed magnetic field signal, Mg-MoO3 also discharges and de-energizes according to the frequency corresponding to the pulsed magnetic field signal. This causes the myocardium to contract according to the frequency corresponding to the pulsed magnetic field signal under the stimulation of Mg-MoO3 discharging and de-energizing according to the frequency corresponding to the pulsed magnetic field signal, thereby achieving cardiac pacing and enabling the heart to pace at the frequency corresponding to the pulsed magnetic field signal.

[0046] For example, such as Figure 2b As shown, it can also be Figure 2a In the temporary cardiac pacing device 11 shown, the energy supply unit 111 is replaced with Zn-MoO3, with Zn as the negative electrode and MoO3 as the positive electrode. When Zn-MoO3 is used as the energy supply unit 111, the working process and structure of the temporary cardiac pacing device 11 are the same as those described above when Mg-MoO3 is used as the energy supply unit 111, and will not be repeated here.

[0047] Therefore, by using a miniature reed switch as the magnetic control unit 112, the circuit of the temporary cardiac pacing device 11 can be pulsedly turned on according to the pulsed magnetic field signal generated by the external control device 12. This allows for safer and more reasonable control of the temporary cardiac pacing device 11 to induce cardiac pacing, thereby further improving the safety of the temporary cardiac pacing device 11. In addition, because miniature reed switches have high sensitivity, fast response speed, low power consumption, small size, low cost, and good compatibility, using a miniature reed switch as the magnetic control unit 112 also gives the magnetic control unit 112 the characteristics of high sensitivity, fast response speed, low power consumption, small size, low cost, and good compatibility. This makes the temporary cardiac pacing device 11 constructed with this magnetic control unit 112 perform better and cost less.

[0048] However, it should be noted that in this embodiment, the magnetic control unit 112 can be, in addition to the aforementioned miniature reed switch, a magnetostrictive switch based on soft magnetic materials or a magnetically controlled variable resistor, but it is not limited to these. For example, the magnetic control unit 112 can also be made of a fully bioabsorbable soft magnetic composite material to achieve complete bioabsorbability and customized magnetic properties of the magnetic control unit 112, further improving the safety of the temporary cardiac pacing device 11, but it is not limited to these.

[0049] In addition, in this embodiment, a printing process (such as printed electronics technology) can be used to manufacture the temporary cardiac pacing device 11 as an ultra-thin integrated device. This printed electronics technology can employ screen printing, inkjet printing, aerosol jet printing, or other techniques, and the specific printed electronics technology can be flexibly selected according to the specific application scenario.

[0050] Specifically, interconnecting layers are printed on the upper and lower surfaces of a temporary or biodegradable substrate using printed electronics technology. The interconnecting layer printed on the upper surface of the substrate can be designated as the first interconnecting layer, and the interconnecting layer printed on the lower surface can be designated as the second interconnecting layer. These first and second interconnecting layers constitute connector 113. In this case, the first and second interconnecting layers can also possess biocompatibility or bioabsorbability to reduce damage to biological tissues, while also being conductive. For example, the first and second interconnecting layers can be composed of candelilla wax and tungsten powder, or other biocompatibility (or bioabsorbability) and conductive materials (such as Mg powder, Zn powder, etc.) combined with natural wax (such as candelilla wax), thus possessing both conductivity and biocompatibility (or bioabsorbability).

[0051] Then, on the first connecting layer, electrodes for the galvanic cell (i.e., energy supply unit 111 also serving as stimulation electrode) and conductive lines are printed using printed electronics technology, thereby constructing the energy supply unit 111 on the first connecting layer to achieve high system integration and thinness of the energy supply unit 111. On the second connecting layer, a magnetron unit 112 is printed using a mounting method or printed electronics technology. Alternatively, on the second connecting layer, electrodes for the galvanic cell (i.e., energy supply unit 111 also serving as stimulation electrode) and conductive lines are printed using printed electronics technology, thereby constructing the energy supply unit 111 on the second connecting layer to achieve high system integration and thinness of the energy supply unit 111. On the first connecting layer, a magnetron unit 112 is printed using a mounting method or printed electronics technology. A layer of biocompatible or bioabsorbable material, such as a biocompatible encapsulation layer, can be further encapsulated on top of the magnetron unit 112. Alternatively, the magnetron unit 112 can be directly contacted with biological tissue; the specific application is not limited. In this way, the temporary cardiac pacing device 11 is integrated into an ultra-thin integrated device.

[0052] In this manner, the structure of the temporary cardiac pacing device 11, which is an ultra-thin integrated device, can be as follows: the first connecting layer is located on the upper surface of the substrate, and the second connecting layer is located on the lower surface of the substrate; the energy supply unit 111 is located on the first connecting layer, and the magnetic control unit 112 is located on the second connecting layer, or the energy supply unit 111 is located on the second connecting layer, and the magnetic control unit 112 is located on the first connecting layer.

[0053] Similarly, to better extend the lifespan of the energy supply unit 111 in the temporary cardiac pacing device 11, during the process of manufacturing the temporary cardiac pacing device 11 into an ultra-thin integrated device using a printing process, a layer of two-dimensional nanochannel material (such as graphene oxide film, MXene) can be introduced between the electrode of the galvanic cell and the biological fluid environment as a control layer. This utilizes the ion sieving properties of the two-dimensional nanochannel material to precisely control the contact between the fluid sample and the battery material, controlling the activation and degradation sequence of the galvanic cell, thereby extending its lifespan. Alternatively, another nanomaterial, such as nanowires or nanoparticles, can be introduced between the electrode of the galvanic cell and the biological fluid environment as a control layer to construct a porous electrode, thereby increasing the reaction area and improving the battery's output power and efficiency.

[0054] Furthermore, after the aforementioned temporary cardiac pacing device 11 is implanted into the body, when the external control device 12 generates a pulsed magnetic field signal, the pulsed magnetic field signal can penetrate biological tissue without damage and reach the magnetic control unit 112. When the magnetic control unit 112 receives the pulsed magnetic field signal, it pulses and conducts the circuit of the temporary cardiac pacing device 11, thereby controlling the energy supply unit 111 to pulse and discharge to stimulate the myocardium to induce contraction and realize cardiac pacing.

[0055] In the embodiments of this application, the above-mentioned external control device 12 can be a wearable device to provide more convenient services to users (such as patients), but it is not limited to this.

[0056] Furthermore, to more intelligently control the generation of the pulsed magnetic field signal, the aforementioned external control device 12 can also generate the pulsed magnetic field signal according to set conditions. For example, the set condition can be that the user's (e.g., a patient's) real-time heart rate is lower than a heart rate threshold, and the external control device 12 generates a pulsed magnetic field signal when it determines that the user's real-time heart rate is lower than the heart rate threshold; alternatively, it can be that the user's (e.g., a patient's) real-time heart rate is lower than the heart rate threshold for a set duration, and the external control device 12 generates a pulsed magnetic field signal when it determines that the user's real-time heart rate is lower than the heart rate threshold for a set duration. This pulsed magnetic field signal can be a pulsed magnetic field signal with a set frequency and pulse width, and the frequency of this pulsed magnetic field signal can be a set frequency that can be adjusted according to specific application scenarios to suit different users. The heart rate threshold can also be adjusted according to specific application scenarios to suit different users.

[0057] In this embodiment of the application, the value of the heart rate threshold can be the same as the value of the set frequency, for example, both can be 80Hz, but it can also be different, and can be adjusted according to the specific application scenario.

[0058] Optionally, after generating a pulsed magnetic field signal so that the magnetic control unit 112 can use the pulsed magnetic field signal to control the energy supply unit 111 to perform pulsed discharge, the external control device 12 can continue to detect the real-time heart rate of the corresponding user. If it is determined that the real-time heart rate of the user is still lower than the heart rate threshold, the pulsed magnetic field signal can continue to be generated so that the magnetic control unit 112 can continue to use the pulsed magnetic field signal to control the energy supply unit 111 to perform pulsed discharge in order to achieve cardiac pacing.

[0059] Optionally, after generating a pulsed magnetic field signal to enable the magnetic control unit 112 to control the energy supply unit 111 to pulse-discharge, the external control device 12 continues to monitor the real-time heart rate of the corresponding user. Alternatively, if the external control device 12 determines that the user's real-time heart rate is not lower than the heart rate threshold while monitoring the user's real-time heart rate, it indicates that the user's heartbeat has returned to normal and the heart can beat autonomously. At this time, the external control device 12 can stop generating the pulsed magnetic field signal to allow the magnetic control unit 112 to return to its initial state. This initial state is either an open state or a high-resistance state. The high-resistance state is a state where the resistance is higher than the resistance threshold. When the magnetic control unit 112 is in an open state or a high-resistance state, it indicates that the magnetic control unit 112 has not connected the circuit of the temporary cardiac pacing device 11, and the energy supply unit 111 cannot discharge. Therefore, after the magnetic control unit 112 returns to its initial state, the pacing caused by the temporary cardiac pacing device 11 will stop. At this time, the temporary cardiac pacing system 1 can stop working.

[0060] To improve the accuracy of determining when a user's heart rate has returned to normal, the external control device 12 generates a pulsed magnetic field signal so that the magnetic control unit 112 can use this signal to control the energy supply unit 111 to pulse-discharge. Alternatively, when monitoring the user's real-time heart rate, the external control device 12 may stop generating the pulsed magnetic field signal only after confirming that the user's real-time heart rate has not fallen below a heart rate threshold for a set duration. This avoids misjudgments of a user's heart rate returning to normal due to unexpected occurrences of the heart rate not falling below the threshold. The set duration can be flexibly adjusted according to specific application scenarios.

[0061] Because the temporary cardiac pacing device 11 in the temporary cardiac pacing system 1 is biocompatible or bioabsorbable and causes little damage to biological tissues, even if the temporary cardiac pacing device 11 has completed its cardiac pacing task, it can be removed without surgery, thereby avoiding damage to biological tissues caused by surgery. Thus, the use of this temporary cardiac pacing system 1 further reduces the safety risks of the temporary cardiac pacing device 11.

[0062] Optionally, after generating a pulsed magnetic field signal to enable the magnetic control unit 112 to control the energy supply unit 111 to perform pulsed discharge, the external control device 12 continues to monitor the real-time heart rate of the corresponding user. Alternatively, when monitoring the real-time heart rate of the corresponding user, if the external control device 12 determines that the user's real-time heart rate is not lower than the heart rate threshold, it can continue to monitor the user's real-time heart rate to perform corresponding operations until it is determined that the user's real-time heart rate is not lower than the heart rate threshold for a set duration. Alternatively, if it is determined that the user's real-time heart rate is neither lower than the heart rate threshold nor not lower than the heart rate threshold for a set duration (e.g., the set duration includes a first moment and a second moment, where the real-time heart rate is lower than the heart rate threshold at the first moment and not lower than the heart rate threshold at the second moment), the external control device 12 continues to monitor the user's real-time heart rate to perform corresponding operations until it is determined that the user's real-time heart rate is not lower than the heart rate threshold for a set duration.

[0063] In this embodiment, the external control device 12 may include an electrocardiogram monitoring module 121, a processing and control module 122, and a magnetic field generating module 123, thereby generating pulsed magnetic field signals through the electrocardiogram monitoring module 121, the processing and control module 122, and the magnetic field generating module 123.

[0064] For example, such as Figure 3 As shown, when the ECG monitoring module 121 in the external control device 12 collects the electrocardiogram (ECG) data of the patient corresponding to the temporary cardiac pacing device 11 in real time through the skin electrode, the processing and control module 122 analyzes the ECG data to obtain the analysis results. For example, the processing and control module 122 uses signal filtering and data analysis to analyze the ECG data to obtain the real-time heart rate.

[0065] Subsequently, the processing and control module 122 determines, based on the analysis results (such as real-time heart rate), whether the user's (e.g., the patient's) real-time heart rate is lower than a heart rate threshold (i.e., a pacing threshold). If it determines that the user's real-time heart rate is lower than the heart rate threshold, it issues a magnetic field generation command. This magnetic field generation command instructs the magnetic field generation module 123 in the external control device 12 to generate a pulsed magnetic field with a set frequency and pulse width.

[0066] Furthermore, after receiving the magnetic field generation command from the processing and control module 122, the magnetic field generation module 123 can generate a pulsed magnetic field with a set frequency and pulse width according to the magnetic field generation command, thereby generating a pulsed magnetic field signal with a set frequency. This allows the magnetic control unit 112 to use the pulsed magnetic field signal to pulse-conduct the circuit of the temporary cardiac pacing device 11, thereby controlling the energy supply unit 111 to pulse-discharge, thereby stimulating the myocardium to induce contraction and realize cardiac pacing.

[0067] Optionally, if the processing and control module 122 determines that the user's real-time heart rate is not lower than the heart rate threshold, then the ECG monitoring module 121 can continue to collect the corresponding patient's ECG data in real time through skin electrodes. This allows the processing and control module 122 to continue to determine, based on the ECG data, whether the patient's real-time heart rate is lower than the heart rate threshold (and / or whether the patient's real-time heart rate is consistently lower than the heart rate threshold within a set time period, and / or whether the patient's real-time heart rate is consistently within the set time period, and / or whether the patient's real-time heart rate is neither consistently below nor consistently below the heart rate threshold within a set time period), and to perform corresponding operations until it is determined that the patient's real-time heart rate is consistently within the set time period.

[0068] Therefore, the external control device 12, through the electrocardiogram monitoring module 121, the processing and control module 122, and the magnetic field generation module 123, can more intelligently control the generation of pulse magnetic field signals, making the temporary cardiac pacing system 1 more intelligent and controllable.

[0069] In the embodiments of this application, the temporary cardiac pacing system 1 may include only one temporary cardiac pacing device 11 or multiple temporary cardiac pacing devices 11, so that multiple temporary cardiac pacing devices 11 can work together.

[0070] For example, two temporary cardiac pacing devices 11 are implanted in the anterior wall of the right ventricle and the lateral wall of the left ventricle of the user's heart, respectively. Then, different magnetic sensitivities (such as different attraction field strengths) are set for the magnetic control units 112 in the two temporary cardiac pacing devices 11. Then, pulse magnetic field signals of different intensities are emitted by the external control device 12. According to the pre-set conditions, one of the two temporary cardiac pacing devices 11 is selectively activated, or both temporary cardiac pacing devices 11 are activated at the same time, thereby realizing biventricular synchronous pacing.

[0071] For example, the magnetic sensitivity of the magnetic control unit 112 in the temporary cardiac pacing device 11 implanted in the anterior wall of the right ventricle of the user's heart is A1-A2, and the magnetic sensitivity of the magnetic control unit 112 in the temporary cardiac pacing device 11 implanted in the lateral wall of the left ventricle of the user's heart is A3-A4. When the magnetic sensitivity corresponding to the pulsed magnetic field signal emitted by the external control device 12 is in the range of A1-A2, the temporary cardiac pacing device 11 in the anterior wall of the right ventricle of the user's heart is activated to pulse and discharge to stimulate pacing of the right ventricle; when the magnetic sensitivity corresponding to the pulsed magnetic field signal emitted by the external control device 12 is in the range of A3-A4, the temporary cardiac pacing device 11 in the lateral wall of the left ventricle of the user's heart is activated to pulse and discharge to stimulate pacing of the left ventricle; when the magnetic sensitivity corresponding to the pulsed magnetic field signal emitted by the external control device 12 is in both the range of A1-A2 and A3-A4, both temporary cardiac pacing devices 11 are activated simultaneously, thereby achieving biventricular synchronous pacing.

[0072] It should be noted that even if the temporary cardiac pacing system 1 contains only one temporary cardiac pacing device 11, the magnetic sensitivity (such as the attraction field strength within a set range) of the magnetic control unit 112 can be set to a set range, so that the temporary cardiac pacing device 11 can be turned on under the set range of magnetic sensitivity conditions, thereby more intelligently controlling the energy supply unit 111 to perform pulsed discharge; it can also be set to turn on the temporary cardiac pacing device 11 after the magnetic control unit 112 receives any pulse magnetic field signal, but it is not limited to this and can be flexibly adjusted according to the specific application scenario.

[0073] In addition to implanting a temporary cardiac pacing device 11 in the temporary cardiac pacing system 1 in the anterior wall of the right ventricle and / or the lateral wall of the left ventricle of the user's heart, multiple temporary cardiac pacing devices 11 can be integrated on the transcatheter aortic valve replacement (TAVR) stent frame to facilitate the prevention and management of postoperative atrioventricular block.

[0074] In addition, the temporary cardiac pacing system 1 described in this application embodiment can also be applied to neuromodulation, orthopedics and rehabilitation and other application scenarios.

[0075] For example, in neuromodulation, an absorbable magnetically controlled vagus nerve stimulator can be prepared to treat epilepsy, or a peripheral nerve stimulator can be used to promote regeneration, through a temporary cardiac pacing device 11 in a temporary cardiac pacing system 1.

[0076] For example, in orthopedics and rehabilitation, the temporary cardiac pacing device 11 in the temporary cardiac pacing system 1 is implanted at the fracture site to promote bone healing through magnetically controlled electrical stimulation; or it is used for functional electrical stimulation rehabilitation of skeletal muscles.

[0077] In summary, the temporary cardiac pacing system 1 provided in this application embodiment utilizes the non-destructive penetration characteristic of magnetic fields to achieve absolutely reliable and safe wireless control of deep implants (i.e., temporary cardiac pacing devices 11), fundamentally solving the penetration bottlenecks of technologies such as optical control schemes and radio frequency power supply schemes. Simultaneously, this temporary cardiac pacing system 1 inherently supports programmable synchronous pacing across multiple devices and sites through magnetic field encoding, providing a completely new platform for advanced cardiac resynchronization therapy (CRT).

[0078] Furthermore, the temporary cardiac pacing system 1 provided in this application embodiment can also be implemented in conjunction with a minimally invasive implantation method, which greatly reduces the risk of infection for patients and is particularly suitable for pediatric patients, postoperative temporary support and other scenarios.

[0079] Furthermore, the temporary cardiac pacing device 11 in the temporary cardiac pacing system 1 is manufactured using printed electronics technology, thus laying the foundation for large-scale, low-cost, and flexible production, while achieving an ultra-thin structure and high integration of the device. In addition, the introduction of nanomaterials, particularly two-dimensional nanochannel materials, into the temporary cardiac pacing device 11 facilitates "programmed" and precise control of the device's operation and degradation processes, thereby improving the reliability and intelligence level of both the temporary cardiac pacing device 11 and the temporary cardiac pacing system 1.

[0080] Based on the same inventive concept, this application also provides a temporary cardiac pacing method based on the temporary cardiac pacing system provided in any of the foregoing embodiments. See also... Figure 4 As shown, the method includes: S401 generates pulsed magnetic field signals through an external control device.

[0081] S402 utilizes the magnetic control unit and pulsed magnetic field signal in the temporary cardiac pacing device to pulse-conduct the circuit of the temporary cardiac pacing device, thereby controlling the energy supply unit in the temporary cardiac pacing device to pulse-discharge.

[0082] The energy supply unit and the magnetic control unit are connected by a connector, and the external control device is outside the biological body, while the temporary cardiac pacing device is implanted inside the biological body.

[0083] In this manner, after a pulsed magnetic field signal is generated by an external control device, the magnetic control unit in the temporary cardiac pacing device uses this signal to pulse-like conduct the circuitry of the device. This, in turn, controls the energy supply unit to pulse-like discharge, stimulating the myocardium to induce contraction and achieve cardiac pacing. Because magnetic fields possess the unique physical advantage of penetrating biological tissue almost without damage, using pulsed magnetic field signals to penetrate biological tissue avoids causing damage and thus resolves the safety risks associated with optical control or radio frequency power supply schemes, thereby improving the safety of the temporary cardiac pacing device.

[0084] In one possible implementation, refer to Figure 5 As shown, the process by which a temporary cardiac pacing system achieves cardiac pacing through an external control device can be described as follows: S501 collects patients' ECG data in real time.

[0085] The patient has a temporary cardiac pacing device implanted in a temporary cardiac pacing system; the ECG data may be the raw ECG data collected.

[0086] The S502 performs signal filtering and data analysis on ECG data to obtain the real-time heart rate.

[0087] S503 determines whether the real-time heart rate is below the heart rate threshold.

[0088] This heart rate threshold is the pacing threshold. When determining whether the real-time heart rate is below the heart rate threshold, the temporary cardiac pacing system can determine whether the current real-time heart rate is below the heart rate threshold, whether the real-time heart rate is below the heart rate threshold for a set duration, whether the real-time heart rate is not below the heart rate threshold for a set duration, or whether the real-time heart rate is neither below nor not below the heart rate threshold for a set duration. Based on the corresponding determination results, the system will perform the appropriate operation.

[0089] Taking the determination of whether the current real-time heart rate is lower than the heart rate threshold as an example, when it is determined that the real-time heart rate is not lower than the heart rate threshold, step S501 is continued to be executed to collect the patient's ECG data in real time for corresponding processing until it is determined that the real-time heart rate is not lower than the heart rate threshold within the set duration. At this time, it can be determined that the user's heart has resumed spontaneous beating, so the generation of pulse magnetic field signal can be stopped, so that the magnetic control unit in the temporary cardiac pacing device can be restored to the initial state, so that the cardiac pacing caused by the temporary cardiac pacing device stops, thereby stopping the temporary cardiac pacing system from working.

[0090] When it is determined that the real-time heart rate is lower than the heart rate threshold, step S504 is executed.

[0091] The aforementioned steps S501-S503 can all be implemented using an external control device.

[0092] S504, automatic pacing.

[0093] When the patient's real-time heart rate is lower than the heart rate threshold, the temporary cardiac pacing system uses the magnetic field generating module in the external control device to generate a pulsed magnetic field with a set frequency and pulse width. This generates a pulsed magnetic field signal at a set frequency, which is then used by the magnetic control unit in the temporary cardiac pacing device to pulse-conduct the circuit of the temporary cardiac pacing device. This controls the energy supply unit in the temporary cardiac pacing device to discharge in a pulsed manner, thereby achieving automatic cardiac pacing.

[0094] After automatic pacing is controlled, step S501 can continue to be executed to continue collecting the patient's ECG data and processing it accordingly until it is determined that the real-time heart rate has not fallen below the heart rate threshold within the set duration. At this point, it can be determined that the user's heart has resumed spontaneous beating, thereby stopping the generation of the pulse magnetic field signal so that the magnetic control unit in the temporary cardiac pacing device returns to its initial state, causing the cardiac pacing caused by the temporary cardiac pacing device to stop, and thus stopping the temporary cardiac pacing system from working.

[0095] Obviously, those skilled in the art can make various modifications and variations to this application without departing from the spirit and scope of this application. Therefore, if such modifications and variations fall within the scope of the claims of this application and their equivalents, this application also intends to include such modifications and variations.

Claims

1. A temporary cardiac pacing system, characterized in that, include: An external control device and a temporary cardiac pacing device; wherein the temporary cardiac pacing device includes an energy supply unit and a magnetic control unit; the energy supply unit and the magnetic control unit are connected by a connector; The external control device is used to generate pulsed magnetic field signals; The magnetic control unit is used to pulse-conduct the circuit of the temporary cardiac pacing device using the pulsed magnetic field signal, so as to control the energy supply unit to pulse-discharge.

2. The system as described in claim 1, characterized in that, The positive and negative electrodes of the energy supply unit are in contact with biological tissue.

3. The system as described in claim 1 or 2, characterized in that, The energy supply unit is a primary battery that is biocompatible or bioabsorbable.

4. The system as described in claim 1, characterized in that, The magnetic control unit is a miniature reed switch, a magnetostrictive switch based on soft magnetic materials, or a magnetically controlled variable resistor.

5. The system as described in claim 1, characterized in that, The temporary cardiac pacing device further includes a substrate, and the connector includes a first connecting layer and a second connecting layer; the first connecting layer is located on the upper surface of the substrate, and the second connecting layer is located on the lower surface of the substrate; The energy supply unit is located above the first connection layer, and the magnetic control unit is located above the second connection layer; or The energy supply unit is located above the second connection layer, and the magnetic control unit is located above the first connection layer.

6. The system as described in claim 1 or 5, characterized in that, The connector is biocompatible or bioabsorbable.

7. The system as described in any one of claims 1-2, 4-5, characterized in that, The temporary cardiac pacing device further includes a control layer; wherein the control layer is constructed of two-dimensional nanochannel material; the control layer is located between the positive and negative electrodes of the energy supply unit and the biological fluid environment.

8. The system as described in claim 1, characterized in that, When the external control device generates a pulsed magnetic field signal, it is specifically used to automatically generate the pulsed magnetic field signal when the real-time heart rate of the user corresponding to the temporary cardiac pacing device is lower than the heart rate threshold. The external control device is further configured to stop generating the pulse magnetic field signal when it is determined that the user's real-time heart rate has not fallen below the heart rate threshold for a set duration, so as to restore the magnetic control unit to its initial state; wherein the initial state is an off state or a high resistance state.

9. The system as described in claim 1 or 8, characterized in that, The external control device includes an electrocardiogram monitoring module, a processing and control module, and a magnetic field generating module; The electrocardiogram monitoring module is used to collect the electrocardiogram (ECG) data of the user corresponding to the temporary cardiac pacing device in real time through skin electrodes; The processing and control module is used to determine, based on the ECG data, that the user's real-time heart rate is lower than the heart rate threshold, and to issue a magnetic field generation command. The magnetic field generating module is used to generate a pulsed magnetic field with a set frequency and pulse width according to the magnetic field generation instruction, so as to generate the pulsed magnetic field signal.

10. A temporary cardiac pacing method, characterized in that, The temporary cardiac pacing system as described in any one of claims 1-9 comprises: A pulsed magnetic field signal is generated through an external control device; The circuit of the temporary cardiac pacing device is pulsedly activated by the magnetic control unit in the temporary cardiac pacing device and the pulsed magnetic field signal, so as to control the energy supply unit in the temporary cardiac pacing device to discharge pulsedly; wherein, the energy supply unit and the magnetic control unit are connected by a connector.

Images