WO2024055511A1 - 一种心脏起搏器系统、控制心脏起搏的方法及电子设备 - Google Patents

一种心脏起搏器系统、控制心脏起搏的方法及电子设备 Download PDF

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Publication number
WO2024055511A1
WO2024055511A1 PCT/CN2023/077208 CN2023077208W WO2024055511A1 WO 2024055511 A1 WO2024055511 A1 WO 2024055511A1 CN 2023077208 W CN2023077208 W CN 2023077208W WO 2024055511 A1 WO2024055511 A1 WO 2024055511A1
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WIPO (PCT)
Prior art keywords
pacemaker
authentication
processor
controller
cloud server
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PCT/CN2023/077208
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English (en)
French (fr)
Inventor
侯晓彤
贾在申
杜中涛
王粮山
李呈龙
Original Assignee
首都医科大学附属北京安贞医院
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Publication of WO2024055511A1 publication Critical patent/WO2024055511A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36507—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by gradient or slope of the heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37512—Pacemakers
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/44—Program or device authentication
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/45—Structures or tools for the administration of authentication
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the present invention relates to the technical field of medical electronic devices, and in particular to a pacemaker system, a method for controlling cardiac pacing and electronic equipment.
  • Pacemakers are divided into temporary pacemakers and permanent pacemakers.
  • permanent pacemakers they need to rely on internal battery power to work.
  • permanent pacemakers can generally work for 5 to 10 years. After the battery energy is exhausted, it needs to be replaced by a second surgery. There are Greater risk of infection.
  • the myocardial pacing lead often needs to be removed after use. The removal of the myocardial pacing lead may cause epicardial tear or even myocardial perforation.
  • Miniature pacemakers can be minimally invasively implanted through arteries, but they are only single-chamber pacemakers, which can only treat bradyarrhythmias and can easily cause pacemaker syndrome and aggravate heart failure;
  • the working parameters such as pulse interval time, pulse frequency and pulse intensity must be set before installation.
  • the parameter settings can only be changed through Surgery to remove the artificial pacemaker and reset it will not only cause secondary physical harm to the patient, but is also not very safe.
  • the present invention provides a pacemaker system, a method for controlling cardiac pacing, and an electronic device to solve some or all of the above technical problems in the prior art.
  • the present invention provides a cardiac pacemaker system, including an external controller and an internal pacemaker, wherein a first authentication unit is provided in the internal pacemaker, and a first authentication unit is provided in the external controller. There is a second authentication unit, and the first authentication unit and the second authentication unit are communicatively connected;
  • the internal pacemaker is used to obtain electrocardiographic information of the heart
  • the external controller is communicatively connected with the internal pacemaker, receives the ECG information sent by the internal pacemaker, and sends the received control instructions to the internal pacemaker.
  • system further includes a processor, wherein the processor includes an authentication unit, and the authentication unit is communicatively connected to the second authentication unit;
  • the processor is communicatively connected with the extracorporeal controller, receives the ECG information sent by the extracorporeal controller, and sends control instructions to the extracorporeal controller.
  • the processor is a cloud server or a smart terminal.
  • the processor includes a cloud server and a smart terminal
  • the authentication unit includes a third authentication unit and a fourth authentication unit
  • the third authentication unit is built into the cloud server.
  • the fourth authentication unit is built into the smart terminal, and the third authentication unit is communicatively connected to the fourth authentication unit;
  • the cloud server is communicatively connected with the external controller and the intelligent terminal, and receives the heartbeat sent by the external controller. electrical information and send cardiac risk information to the smart terminal;
  • the intelligent terminal is communicatively connected with the extracorporeal controller, receives the cardiac risk information, and sends control instructions to the extracorporeal controller.
  • the internal pacemaker includes a first antenna
  • the external controller includes a second antenna
  • the extracorporeal controller uses the second antenna to provide electrical energy to the first antenna through electromagnetic induction coupling, and the first antenna is used to power the internal pacemaker.
  • the first antenna is made of magnesium-calcium alloy.
  • a replaceable first bioprotective film is provided outside the first antenna, and the first bioprotective film can be replaced according to the service life of the pacemaker.
  • the first bioprotective film is made of polylactic acid glycolic acid, ethylene terephthalate, polyester fiber or polyether ether ketone.
  • the internal pacemaker further includes an electrode, which is connected to the endocardium or myocardial surface to stimulate the myocardium through electric current to complete pacing.
  • the internal pacemaker further includes a pacing lead, a pacing lead connector and a control chip;
  • the pacing lead is connected to the electrode and is used to receive the ECG information
  • the control chip is connected to the pacing lead connector through the pacing lead and is used to receive the ECG information.
  • a replaceable second bioprotective film is provided outside the pacing lead, and the second bioprotective film can be replaced according to the service life of the pacemaker.
  • the second bioprotective film is made of polylactic acid glycolic acid, ethylene terephthalate, polyester fiber or polyether ether ketone.
  • pacing lead connectors there are 4 pacing lead connectors in total.
  • the electrode is made of magnesium-calcium alloy material or titanium alloy material.
  • the present invention provides a method for controlling cardiac pacing, which method includes the following steps:
  • the internal pacemaker obtains the heart's electrical information
  • the external controller receives the ECG information sent by the internal pacemaker, and sends the received control instructions to the internal pacemaker to control cardiac pacing.
  • an authentication process is performed between the internal pacemaker and the external controller, including:
  • the in-body controller creates a device and sends a key and password of the device to the in-body pacemaker;
  • the internal pacemaker is preconfigured according to the received key and password, and returns the preconfigured login information to the external controller;
  • the external controller performs authentication based on the returned login information.
  • the method further includes:
  • Authentication is performed between the processor and the external controller
  • the processor receives the ECG information sent by the extracorporeal controller and sends control instructions to the extracorporeal controller.
  • the processor is a cloud server or a smart terminal.
  • a TLS handshake is performed between the processor and the external controller through an X509 certificate for authentication.
  • the method further includes: the processor includes a cloud server and an intelligent terminal, and authentication is performed between the processor and the external controller. After the authentication is passed, the processor receives the The ECG information sent by the extracorporeal controller and sending control instructions to the extracorporeal controller include:
  • the cloud server performs authentication and authentication with the external controller and the intelligent terminal respectively;
  • the cloud server receives the ECG information sent by the extracorporeal controller and sends cardiac risk information to the smart terminal;
  • the intelligent terminal After the authentication is passed, the intelligent terminal receives the cardiac risk information and sends control instructions to the external controller.
  • an authentication process is performed between the smart terminal and the cloud server, including:
  • the smart terminal sends the account number and password to the cloud server;
  • the cloud server compares the SHA256 value of the password with the passwd field value in the database to see whether it is consistent;
  • the cloud server creates a session object and transmits the session_id to the browser using setCookie;
  • the smart terminal sends an http request carrying Cookie s_id to the cloud server;
  • the cloud server receives the http request and confirms it. If the confirmation is passed, the intelligent terminal information is obtained.
  • the present invention provides an electronic device, including a processor, a communication interface, a memory, and a communication bus, wherein the processor, the communication interface, and the memory complete communication with each other through the communication bus;
  • Memory used to store computer programs
  • the processor is configured to implement the method according to any embodiment of the second aspect when executing a program stored in the memory.
  • the present invention provides a computer-readable storage medium on which a computer program is stored.
  • the computer program is executed by a processor, the method according to any embodiment of the second aspect is implemented.
  • a cardiac pacemaker system provided by an embodiment of the present invention includes an external controller and an internal pacemaker, wherein a first authentication unit is provided in the internal pacemaker, and a third authentication unit is provided in the external controller. Two authentication units, the first authentication unit and the second authentication unit are communicatively connected; the internal pacemaker is used to obtain the ECG information of the heart; the external controller is connected to the internal pacemaker. The pacemaker is connected through communication, receives the electrocardiogram information sent by the internal pacemaker, and sends the received control instructions to the internal pacemaker.
  • the system provided by the present invention has the capabilities of two-way authentication and real-time ECG monitoring, and also has the functions of cloud connection and remote monitoring and diagnosis and treatment.
  • Figure 1 is one of the structural schematic diagrams of a pacemaker system provided by an embodiment of the present invention
  • FIG. 2 is a second structural schematic diagram of a pacemaker system provided by an embodiment of the present invention.
  • FIG. 3 is the third structural schematic diagram of the pacemaker system provided by the embodiment of the present invention.
  • Figure 4 is a schematic top structural view of an internal pacemaker provided by an embodiment of the present invention.
  • Figure 5 is a schematic side structural view of an internal pacemaker provided by an embodiment of the present invention.
  • Figure 6 is one of the schematic flow diagrams of a method for controlling cardiac pacing provided by an embodiment of the present invention.
  • Figure 7 is a schematic diagram of the authentication process between the external controller and the internal pacemaker
  • Figure 8 is a second schematic flowchart of a method for controlling cardiac pacing provided by an embodiment of the present invention.
  • Figure 9 is a schematic diagram of the authentication process between the external controller and the processor.
  • Figure 10 is a third schematic flowchart of a method for controlling cardiac pacing provided by an embodiment of the present invention.
  • Figure 11 is a schematic diagram of the authentication process between the smart terminal and the cloud server
  • Figure 12 is a schematic structural diagram of an electronic device according to an embodiment of the present invention.
  • FIG. 1 is one of the structural schematic diagrams of a pacemaker system provided by the present invention.
  • the pacemaker system includes: an internal pacemaker 11 and an external controller 12, wherein a first authentication unit 111 is provided in the internal pacemaker, and a second authentication unit 111 is provided in the external controller.
  • the authorization unit 121, the first authentication unit 111 and the second authentication unit 121 are communicatively connected;
  • the internal pacemaker 11 is used to obtain electrocardiographic information of the heart
  • the external controller 12 is communicatively connected with the internal pacemaker 11 , receives the ECG information sent by the internal pacemaker 11 , and sends the received control instructions to the internal pacemaker 11 .
  • Figure 2 is a second structural schematic diagram of a pacemaker system provided by the present invention.
  • the system also includes a processor 13, and the processor 13 includes Authentication unit 131, the authentication unit 131 is communicatively connected with the second authentication unit 121;
  • the processor 13 is communicatively connected with the extracorporeal controller 12 , receives the ECG information sent by the extracorporeal controller 12 , and sends control instructions to the extracorporeal controller 12 .
  • the processor 13 is a cloud server or a smart terminal. It should be noted that when the processor is an intelligent terminal, it may include one intelligent terminal, or a first intelligent terminal and a second intelligent terminal. If both the first intelligent terminal and the second intelligent terminal are included, one of them may be a medical device. For use by persons, one is for use by pacemaker wearers. No matter how many smart terminals there are, they are all equipped with authentication units to communicate with other structures.
  • FIG. 3 is the third structural schematic diagram of a pacemaker system provided by the present invention.
  • the processor 13 includes a cloud server 14 and an intelligent terminal 15.
  • the authentication unit 131 includes a third authentication unit 141 and a fourth authentication unit 151.
  • the third authentication unit 141 is built into the cloud server 14.
  • the fourth authentication unit 151 is built into the smart phone.
  • the third authentication unit 141 is communicatively connected with the fourth authentication unit 151;
  • the cloud server 14 is communicatively connected with the extracorporeal controller 12 and the smart terminal 15, receives the ECG information sent by the extracorporeal controller 12, and sends cardiac risk information to the smart terminal 15;
  • the smart terminal 15 is communicatively connected with the extracorporeal controller 12 , receives the cardiac risk information, and sends control instructions to the extracorporeal controller 12 .
  • the extracorporeal controller 12 has the function of periodically sending the heart's ECG information to the cloud server 14 and the smart terminal 15, that is, the function of sending ECG monitoring information, and also has the function of receiving ECG information from the cloud server 14 and the smart terminal.
  • control instructions such as heart pacing instructions and configuration parameters.
  • the cloud server 14 can receive the ECG information sent by the external controller 12, carry out online real-time risk warning, and identify The received cardiac risk information is actively pushed to the external controller 12 and the smart terminal 15, including the information system of the hospital/doctor bound by the user.
  • the intelligent terminal 15 can actively/passively acquire the real-time ECG monitoring and historical monitoring information of the target patient, and can actively implement cardiac pacing or set a cardiac pacing strategy based on the ECG monitoring information.
  • the pacemaker system provided by the present invention has the capabilities of two-way authentication and real-time ECG monitoring, and also has the functions of cloud connection and remote monitoring and diagnosis and treatment.
  • the present invention also provides a schematic structural diagram of an internal pacemaker, as shown in Figures 4 and 5 for details.
  • Figure 4 is a top structural schematic diagram of an internal pacemaker provided by an embodiment of the present invention.
  • Figure 5 is a schematic side structural view of an internal pacemaker provided by an embodiment of the present invention.
  • the internal pacemaker includes a first antenna 1, and the external controller includes a second antenna (not labeled).
  • the external controller 12 uses the second antenna to provide electric energy to the first antenna 1 through electromagnetic induction coupling.
  • the first antenna 1 is used to supply power to the pacemaker 11 in the body.
  • the present invention uses passive wireless power supply to make the heart start.
  • the life of the pacemaker is no longer limited by the battery.
  • the permanent pacemaker has a service life of more than 20 years. And due to the battery-free design, the weight of the whole machine is significantly reduced, which makes the patient feel better.
  • the external controller 12 has the ability to wirelessly supply power to and communicate with the internal pacemaker 11.
  • its radio frequency range should be 2 MHz to 50 MHz.
  • the radio frequency power range should be 50mW ⁇ 1000mW.
  • the shape of the first antenna 1 can be circular, square, or a three-dimensional structure, and the equivalent cross-sectional area is estimated using the following engineering formula: S ⁇ H 2 /(25*P)
  • S is the equivalent cross-sectional area of the first antenna 1 (unit is mm 2 )
  • H is the distance between the first antenna 1 and the body surface (unit is mm)
  • P is the radio frequency power of the external controller 13 (unit is W) .
  • the first antenna 4 is made of magnesium-calcium alloy, and the complete degradation time is adjusted by controlling the ratio of magnesium-calcium elements in the alloy.
  • the complete degradability time of the first antenna 1 is controlled at about 3 months, and the impedance of the first antenna 1 is controlled within the range of 50 ⁇ 0.1 ⁇ .
  • a first biological protective film 2 is provided outside the first antenna 1.
  • the first biological protective film 2 is made of polylactic acid glycolic acid or ethylene terephthalate. Made of alcohol ester, polyester fiber or polyether ether ketone, it is non-toxic and harmless to organisms before and after degradation, has good flexibility and feels comfortable to the human body.
  • polylactic acid glycolic acid materials are generally used, and the degradation time is controlled by controlling parameters such as the thickness of the protective film.
  • the general thickness range is 10um ⁇ 1mm, and the complete degradation time is generally 1 week. ⁇ 3 months.
  • ethylene terephthalate or polyester fiber or polyether ether ketone materials are generally used.
  • the pacemaker provided by the present invention is easy to use because the first bioprotective film set outside the first antenna is replaceable and can be replaced according to the service life of the pacemaker. For example, when a permanent heart is required, When using a pacemaker, you can choose the first bioprotective film made of ethylene terephthalate or polyester fiber or polyether ether ketone material. When a temporary pacemaker is needed, it will be directly made of terephthalate.
  • the first bioprotective film made of ethylene glycol diformate or polyester fiber or polyether ether ketone material is replaced with the first bioprotective film made of polylactic acid glycolic acid material, in other words, the first bioprotective film
  • the membrane can be replaced at any time.
  • the first bioprotective membrane made of the corresponding material is directly selected and placed outside the first antenna.
  • the internal pacemaker 11 includes a base 3 that supports the circuit and has certain strength and flexibility.
  • the substrate 3 is made of hydrophilic polyurethane with a thickness between 20um and 100um, and the required integrated circuit is realized on the substrate through a semiconductor sputtering process.
  • the internal pacemaker 11 also includes an electrode 4, which is connected to the endocardium or myocardial surface, forms an electrical circuit with the heart, and stimulates the myocardium through electric current to complete pacing.
  • electrode 4 is connected to the endocardium or myocardial surface, forms an electrical circuit with the heart, and stimulates the myocardium through electric current to complete pacing.
  • the material selection of electrode 4 is different.
  • electrodes 4 are made of degradable magnesium-calcium alloy materials.
  • non-degradable materials are chosen. Made of titanium alloy.
  • the internal pacemaker further includes a pacing lead 5 , a pacing lead connector 6 and a control chip 7 , the pacing lead 5 It is connected with the electrode 4 for receiving ECG information; the control chip 7 is connected with the pacing lead connector 6 through the pacing lead 4 and is used for receiving ECG information.
  • control chip 7 can generally be made by thin film integrated circuit technology on the substrate, with a thickness of less than 50um, and has the capabilities of rectification, authentication, communication control, pulse control and ECG monitoring. Only authenticated triggering of cardiac pacing pulses is allowed.
  • a second bioprotective film 8 is provided outside the pacing lead 5.
  • the second bioprotective film 8 is made of polylactic acid glycolic acid, ethylene terephthalate, polyester fiber or polyether ether. Made from ketones. It should be noted that the second bioprotective film 8 is made of the same material as the first bioprotective film 2 .
  • the second bioprotective film is also replaceable and can be replaced according to the service life of the pacemaker, for example, when permanent cardiac pacing is required.
  • a second bioprotective film made of ethylene terephthalate or polyester fiber or polyether ether ketone material When a temporary pacemaker is needed, it will be directly made of terephthalate.
  • the second bioprotective film made of glycol ester, polyester fiber or polyether ether ketone material is replaced with a second bioprotective film made of polylactic acid glycolic acid material.
  • the second bioprotective film can be replaced at any time.
  • the second bioprotective film made of the corresponding material can be directly selected and placed on the pacing lead. outside.
  • the pacing lead 5 connects the electrode 4 and the main body of the internal pacemaker 11 to transmit pacing current and ECG monitoring signals.
  • the selection of the material of the pacing lead 5 needs to match the selection of the material of the electrode 4.
  • the pacing lead material should be made of magnesium calcium alloy material.
  • the pacing lead material should be made of magnesium calcium alloy.
  • the wire material should be made of titanium alloy. Therefore, as a temporary pacemaker, patients can be discharged from the hospital without waiting to remove the pacing wire after surgery, and they can still receive health monitoring for a certain period of time after discharge.
  • the alloy ratio of the pacing lead 4 is the same as that of the first antenna 1, but it should be composed of multiple strands of thinner alloy wires, with the number of strands being no less than 10 strands, and the total diameter not being greater than 1 mm.
  • each component of the internal pacemaker in the present invention uses degradable materials. Therefore, the present invention has the ability to switch between a temporary pacemaker and a permanent pacemaker by replacing the bioprotective film, pacing wires and electrodes. Pacemaker capabilities.
  • pacing lead connectors 6 are provided, so that the internal pacemaker has the ability of dual-chamber pacing, which can solve the problem of atrioventricular block and achieve synchronous pacing of the left and right atria and ventricles.
  • the doctor can independently choose to connect two or four pacing wire connectors 6 according to the needs of single-chamber pacing or dual-chamber pacing. When performing single-chamber pacing, he can choose to connect two pacing wires. Wire connector 6, the remaining 2 can be closed.
  • Embodiments of the present invention provide a pacemaker system, including an external controller and an internal pacemaker, wherein a first authentication unit is provided in the internal pacemaker, and a second authentication unit is provided in the external controller. unit, the first authentication unit and the second authentication unit are communicatively connected; the internal pacemaker is used to obtain the ECG information of the heart; the external controller communicates with the internal pacemaker Connect, receive the electrocardiogram information sent by the internal pacemaker, and send the received control instructions to the internal pacemaker.
  • the system provided by the present invention has the ability to monitor and analyze the patient's health status in real time through the cloud server, which will greatly improve the patient's post-healing health management and improve the patient's life and health level.
  • FIG. 6 is a schematic flow chart of a method of controlling cardiac pacing provided by an embodiment of the present invention.
  • the method of controlling cardiac pacing is applied to the pacemaker system in the above embodiment. As shown in Figure 6, the method includes the following step:
  • Step 110 The internal pacemaker obtains the ECG information of the heart.
  • Step 120 Authentication is performed between the internal pacemaker and the external controller.
  • Step 130 After the authentication is passed, the external controller receives the ECG information sent by the internal pacemaker, and sends the received control instructions to the internal pacemaker to control cardiac pacing.
  • the authentication and authentication process between the external controller and the internal pacemaker is: External controller creates device , and sends the key and password to the internal pacemaker.
  • the internal pacemaker is preconfigured based on the received key and password, and then returns a triplet of login information to the external control
  • the external controller verifies based on the login information. If the verification is passed, the internal pacemaker sends its relevant data to the external controller.
  • the external controller sends relevant instructions to the internal pacemaker for execution based on the received relevant data. .
  • Figure 8 is a schematic flowchart 2 of a method for controlling cardiac pacing provided by an embodiment of the present invention. As shown in Figure 8 , the method for controlling cardiac pacing further includes:
  • Step 210 Authentication is performed between the processor and the external controller.
  • Step 220 After the authentication is passed, the processor receives the ECG information sent by the extracorporeal controller and sends control instructions to the extracorporeal controller.
  • the processor is a cloud server or a smart terminal.
  • the following is a brief introduction to the authentication and authentication process between the external controller and the processor.
  • the authentication and authentication process between the external controller and the processor is: the processor and the external controller use the X509 certificate. TLS handshake for mutual authentication, the processor authenticates the IoT HuB, and the external controller authenticates the device, the processor transmits data to the external controller, and the external controller transmits configuration signals or control signals to the processor.
  • the processor includes a cloud server and a smart terminal.
  • Figure 10 is the third schematic flow chart of a method for controlling cardiac pacing provided by an embodiment of the present invention. As shown in Figure 10, authentication is performed between the processor and the external controller. After the authentication is passed, the processor receives The ECG information sent by the extracorporeal controller and control instructions are sent to the extracorporeal controller, including:
  • Step 310 The cloud server performs authentication and authentication with the external controller and the smart terminal respectively;
  • Step 320 After all authentication and authentication are passed, the cloud server receives the ECG information sent by the extracorporeal controller and sends the cardiac risk information to the smart terminal;
  • Step 330 Perform authentication and authentication between the external controller and the smart terminal
  • Step 340 After the authentication is passed, the smart terminal receives the cardiac risk information and sends a control instruction to the external controller.
  • the authentication process between the smart terminal and the cloud server When the user accesses the external controller for the first time through the smart terminal, the smart terminal The terminal transmits the user's account and password to the cloud server. The cloud server detects whether the account exists in the database. If the account exists, the SHA256 value of the password of the account is compared with the passwd field value in the database. If they are consistent, then After the verification is passed, the cloud server creates a session object and transmits the session_id to the browser using setCookie. The browser confirms whether the setCookie field exists. If it exists, the smart terminal logs in successfully and sends an http request to the cloud server, carrying the cookie.
  • the cloud server receives the request and confirms it. If the confirmation is passed, it obtains the user's smart terminal information, and transmits the user's corresponding internal pacemaker list and internal pacemaker related information to the smart terminal.
  • the user account and password in Figure 11 are only examples and are not limited here.
  • An embodiment of the present invention provides a method for controlling cardiac pacing.
  • the internal pacemaker obtains the ECG information of the heart; authentication is performed between the internal pacemaker and the external controller; after the authentication is passed, the external control
  • the device receives the ECG information sent by the internal pacemaker, and sends the received control instructions to the internal pacemaker to control cardiac pacing.
  • the embodiment of the present invention provides an electronic device, including a processor 111, a communication interface 112, a memory 113, and a communication bus 114.
  • the processor 111, the communication interface 112, and the memory 113 are completed through the communication bus 114. communication between each other.
  • Memory 113 used to store computer programs
  • the processor 111 is configured to implement the method of controlling cardiac pacing provided by the foregoing method embodiment when executing a program stored on the memory 113 .
  • Embodiments of the present invention also provide a computer-readable storage medium on which a computer program is stored.
  • the computer program is executed by a processor, the method for controlling cardiac pacing provided in the foregoing method embodiments is implemented.
  • RAM random access memory
  • ROM read-only memory
  • electrically programmable ROM electrically erasable programmable ROM
  • registers hard disks, removable disks, CD-ROMs, or anywhere in the field of technology. any other known form of storage media.

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Abstract

本发明公开了一种心脏起搏器系统、控制心脏起搏的方法及电子设备，心脏起搏系统包括体外控制器及体内起搏器，其中，所述体内起搏器内设置有第一鉴权单元，所述体外控制器内设置有第二鉴权单元，所述第一鉴权单元和所述第二鉴权单元通信连接；所述体内起搏器，用于获取心脏的心电信息；所述体外控制器，与所述体内起搏器通信连接，接收所述体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器。其次之外，本发明还提供了一种控制心脏起搏的方法。发明提供的技术方案，具备双向鉴权认证和实时心电监测的能力，同时具备云连接和远程监测和诊疗的功能。

Description

一种心脏起搏器系统、控制心脏起搏的方法及电子设备
相关申请的交叉引用
本申请要求在2022年9月15日提交中国专利局、申请号为202211123534.4、发明名称为“一种心脏起搏器系统、控制心脏起搏的方法及电子设备”的中国专利申请的优先权，其全部内容通过引用的方式并入本文中。
技术领域
本发明涉及医疗电子器械技术领域，尤其涉及一种心脏起搏器系统、控制心脏起搏的方法及电子设备。
背景技术
心脏起搏器分为临时心脏起搏器和永久心脏起搏器。对于永久型心脏起搏器，其需要依赖内部的电池供电才能够工作，根据内部电池的容量，永久型心脏起搏器一般可工作5～10年，电池能量耗竭后需二次手术更换，存在较大感染风险。对于临时心脏起搏器，在使用后，往往需要拆除心肌起搏导线，在拆除心肌起搏导线的过程中可能会导致心外膜撕裂甚至心肌穿孔。对于微型心脏起搏器，可通过动脉血管微创植入，但仅为单腔起搏器，只能治疗缓慢性心率失常，且容易引起起搏器综合症，加重心衰；
另外，心脏人工心脏起搏器工作时脉冲间隔时间、脉冲频率以及脉冲强度等工作参数，必须在安装之前设定好，但是随着病人年龄、病情等的变换需要更改参数设置，也只能通过手术的方式取出人工心脏起搏器重新进行设置，这不仅会给病人带来二次身体伤害，且安全性不高。
发明内容
本发明提供了一种心脏起搏器系统、控制心脏起搏的方法及电子设备，以解决现有技术中上述部分或全部技术问题。
为实现上述目标，本发明提供了以下技术方案：
第一方面，本发明提供了一种心脏起搏器系统，包括体外控制器及体内起搏器，其中，所述体内起搏器内设置有第一鉴权单元，所述体外控制器内设置有第二鉴权单元，所述第一鉴权单元和所述第二鉴权单元通信连接；
所述体内起搏器，用于获取心脏的心电信息；
所述体外控制器，与所述体内起搏器通信连接，接收所述体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器。
在一个可能的实现方式中，所述系统还包括处理器，其中，所述处理器包括鉴权单元，所述鉴权单元与所述第二鉴权单元通信连接；
所述处理器，与所述体外控制器通信连接，接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器。
在一个可能的实现方式中，所述处理器为云服务器或智能终端。
在一个可能的实现方式中，所述处理器包括云服务器和智能终端，所述鉴权单元包括第三鉴权单元和第四鉴权单元，所述第三鉴权单元内置于所述云服务器内，所述第四鉴权单元内置于所述智能终端内，所述第三鉴权单元与所述第四鉴权单元通信连接；
所述云服务器，与所述体外控制器和所述智能终端通信连接，接收所述体外控制器发送的心 电信息，并发送心脏风险信息给所述智能终端；
所述智能终端，与所述体外控制器通信连接，接收所述心脏风险信息，并发送控制指令给所述体外控制器。
在一个可能的实现方式中，所述体内起搏器包括第一天线，所述体外控制器包括第二天线；
所述体外控制器利用所述第二天线，通过电磁感应耦合的方式向所述第一天线提供电能，所述第一天线用于向所述体内起搏器供电。
在一个可能的实现方式中，所述第一天线为镁钙合金制成。
在一个可能的实现方式中，所述第一天线外设置有可替换的第一生物保护膜，所述第一生物保护膜根据心脏起搏器的使用年限需求进行更换。
在一个可能的实现方式中，所述第一生物保护膜采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成。
在一个可能的实现方式中，所述体内起搏器还包括电极，所述电极与心脏内膜或心肌表面连接，通过电流刺激心肌完成起搏。
在一个可能的实现方式中，所述体内起搏器还包括起搏导线、起搏导线连接器和控制芯片；
所述起搏导线与所述电极连接，用于接收所述心电信息；
所述控制芯片通过所述起搏导线与所述起搏导线连接器连接，用于接收所述心电信息。
在一个可能的实现方式中，所述起搏导线外设置有可更换的第二生物保护膜，所述第二生物保护膜根据心脏起搏器的使用年限需求进行更换。
在一个可能的实现方式中，所述第二生物保护膜采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成。
在一个可能的实现方式中，所述起搏导线连接器共4只。
在一个可能的实现方式中，所述电极为镁钙合金材料或钛合金材料制成。
第二方面，本发明提供了一种控制心脏起搏的方法，所述方法包括以下步骤：
体内起搏器获取心脏的心电信息；
体内起搏器和体外控制器之间进行鉴权认证；
待鉴权认证通过后，体外控制器接收体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器，用以控制心脏起搏。
在一个可能的实现方式中，体内起搏器和体外控制器之间进行鉴权认证过程，包括：
所述体内控制器创建设备，并将所述设备的钥匙和密码发送给所述体内起搏器；
所述体内起搏器根据接收的钥匙和密码进行预配，并将预配后的登录信息返回给所述体外控制器；
所述体外控制器根据返回的所述登录信息进行认证。
在一个可能的实现方式中，所述方法还包括：
处理器与体外控制器之间进行鉴权认证；
待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器。
在一个可能的实现方式中，所述处理器为云服务器或智能终端。
在一个可能的实现方式中，所述处理器和所述体外控制器之间通过X509证书进行TLS握手，用以进行鉴权认证。在一个可能的实现方式中，所述方法还包括：所述处理器包括云服务器和智能终端，所述处理器与体外控制器间进行鉴权认证，待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器，包括：
所述云服务器分别与所述体外控制器和所述智能终端进行鉴权认证；
待鉴权认证均通过后，所述云服务器接收所述体外控制器发送的心电信息，并发送心脏风险信息给所述智能终端；
所述体外控制器与所述智能终端之间进行鉴权认证；
待鉴权认证通过后，所述智能终端接收所述心脏风险信息，并发送控制指令给所述体外控制器。
在一个可能的实现方式中，智能终端和云服务器之间进行鉴权认证过程，包括：
所述智能终端将账号和密码发送给所述云服务器；
若所述账号存在所述云服务器的数据库中，则所述云服务器将所述密码的SHA256值与数据库中的passwd字段值对比是否一致；
若一致，则所述云服务器创建一个session对象，并将session_id用setCookie传输给浏览器；
若浏览器确认setCookie字段存在，则所述智能终端向所述云服务器发送携带Cookie s_id的http请求；
所述云服务器接收所述http请求并进行确认，确认通过，则获取智能终端信息。
第三方面，本发明提供了一种电子设备，包括处理器、通信接口、存储器和通信总线，其中，处理器，通信接口，存储器通过通信总线完成相互间的通信；
存储器，用于存放计算机程序；
处理器，用于执行存储器上所存放的程序时，实现如第二方面任一项实施例的方法。
第四方面，本发明提供了一种计算机可读存储介质，其上存储有计算机程序，计算机程序被处理器执行时实现如第二方面任一项实施例的方法。
本发明实施例提供的上述技术方案与现有技术相比具有如下优点：
本发明实施例提供的一种心脏起搏器系统，包括体外控制器及体内起搏器，其中，所述体内起搏器内设置有第一鉴权单元，所述体外控制器内设置有第二鉴权单元，所述第一鉴权单元和所述第二鉴权单元通信连接；所述体内起搏器，用于获取心脏的心电信息；所述体外控制器，与所述体内起搏器通信连接，接收所述体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器。本发明提供的系统，具备双向鉴权认证和实时心电监测的能力，同时具备云连接和远程监测和诊疗的功能。
附图说明
图1为本发明实施例提供的心脏起搏器系统结构示意图之一；
图2为本发明实施例提供的心脏起搏器系统结构示意图之二；
图3为本发明实施例提供的心脏起搏器系统结构示意图之三；
图4为本发明实施例提供的体内起搏器的俯视结构示意图；
图5为本发明实施例提供的体内起搏器的侧视结构示意图；
图6为本发明实施例提供的控制心脏起搏的方法流程示意图之一；
图7为体外控制器与体内起搏器之间的鉴权认证过程示意图；
图8为本发明实施例提供的控制心脏起搏的方法流程示意图之二；
图9为外控制器与处理器之间的鉴权认证过程示意图；
图10为本发明实施例提供的控制心脏起搏的方法流程示意图之三；
图11为智能终端与云服务器之间的鉴权认证过程示意图；
图12为本发明实施例提供一种电子设备结构示意图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
为便于对本发明实施例的理解，下面将结合附图以具体实施例做进一步的解释说明，实施例并不构成对本发明实施例的限定。
需要说明的是，在本文中，诸如“第一”和“第二”等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括要素的过程、方法、物品或者设备中还存在另外的相同要素。
在本发明中，“在一个示例中”用来表示“用作例子、例证或说明”。本发明中被描述为“在一个示例中”的任何实施例不一定被解释为比其它实施例更优选或更具优势。为了使本领域任何技术人员能够实现和使用本发明，给出了以下描述。在以下描述中，为了解释的目的而列出了细节。应当明白的是，本领域普通技术人员可以认识到，在不使用这些特定细节的情况下也可以实现本发明。在其它实例中，不会对公知的结构和过程进行详细阐述，以避免不必要的细节使本发明的描述变得晦涩。因此，本发明并非旨在限于所示的实施例，而是与符合本发明所公开的原理和特征的最广范围相一致。
针对背景技术中所提及的技术问题，本发明实施例提供了一种心脏起搏器系统，具体参见图1所示，图1为本发明提供的一种心脏起搏器系统结构示意图之一，如图1所示，心脏起搏器系统包括：体内起搏器11和体外控制器12，其中，体内起搏器内设置有第一鉴权单元111，体外控制器内设置有第二鉴权单元121，第一鉴权单元111和第二鉴权单元121通信连接；
所述体内起搏器11，用于获取心脏的心电信息；
所述体外控制器12，与所述体内起搏器11通信连接，接收所述体内起搏器11发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器11。
在一个示例中，如图2所示，图2为本发明提供的一种心脏起搏器系统结构示意图之二，如图2所示，该系统还包括处理器13，所述处理器13包括鉴权单元131，所述鉴权单元131与所述第二鉴权单元121通信连接；
所述处理器13，与所述体外控制器12通信连接，接收所述体外控制器12发送的所述心电信息，并将控制指令发送给所述体外控制器12。
在一个可能的实施方式中，处理器13为云服务器或智能终端。需要指出的是，当处理器为智能终端时，可以包括一个智能终端，也可以包括第一智能终端和第二智能终端，若同时包括第一智能终端和第二智能终端，则其中一个是医护人员使用，一个是心脏起搏器的佩戴者使用。无论是几个智能终端，其内都设置有鉴权单元，与其他结构之间进行通信连接。
在另外一个示例中，如图3所示，图3为本发明提供的一种心脏起搏器系统结构示意图之三，如图3所示，处理器13包括云服务器14和智能终端15，所述鉴权单元131包括第三鉴权单元141和第四鉴权单元151，所述第三鉴权单元141内置于所述云服务器14内，所述第四鉴权单元151内置于所述智能终端15内，所述第三鉴权单元141与所述第四鉴权单元151通信连接；
所述云服务器14，与所述体外控制器12和所述智能终端15通信连接，接收所述体外控制器12发送的心电信息，并发送心脏风险信息给所述智能终端15；
所述智能终端15，与所述体外控制器12通信连接，接收所述心脏风险信息，并发送控制指令给所述体外控制器12。
通过上述的描述可知，体外控制器12具备周期性的向云服务器14和智能终端15发送心脏的心电信息的功能，即发送心电监测信息的功能，同时具备接收从云服务器14和智能终端15的控制指令，如心脏起搏指令和配置参数等能力。
另外，云服务器14可以接收体外控制器12发送的心电信息，开展在线实时风险预警，将识 别到的心脏风险信息主动推送给体外控制器12、智能终端15，包括用户绑定的医院/医生的信息系统中。
智能终端15可以主动/被动获取目标患者的心电实时监测和历史监测信息，可根据心电监测信息主动实施心脏起搏或设置心脏起搏策略。
本发明提供的心脏起搏器系统，具备双向鉴权认证和实时心电监测的能力，同时具备云连接和远程监测和诊疗的功能。
在一个示例中，本发明还提供了一种体内起搏器的结构示意图，具体详见图4和图5所示，其中，图4为本发明实施例提供的体内起搏器的俯视结构示意图，图5为本发明实施例提供的体内起搏器的侧视结构示意图。
如图4所示，体内起搏器包括第一天线1，体外控制器包括第二天线(未标注)。体外控制器12利用第二天线，通过电磁感应耦合的方式向第一天线1提供电能，第一天线1用于向体内起搏器11供电，本发明采用无源无线供电的方式，使得心脏起搏器的寿命不再受限于电池，永久心脏起搏器具有20年以上的使用寿命，且由于采用无电池设计，整机重量大幅下降，患者感受好。
具体地，体外控制器12具备向体内心脏起搏器11无线供电和与之通信的能力，考虑电磁场的衰减，其射频频率范围应为2MHz～50MHz。考虑电磁兼容性以及体内心脏起搏器11的功耗，射频功率范围应为50mW～1000mW。
另外，考虑辐射安全、抗干扰、患者舒适度等条件，第一天线1的外形可采用圆形、方形或三维立体结构，等效截面积采用如下工程公式估算：
S≈H2/(25*P)
其中S为第一天线1的等效截面积(单位为mm2)，H为第一天线1与体表的距离(单位为mm)，P为体外控制器13的射频功率(单位为W)。
为使得第一天线1在人体内具有可控降解的能力，第一天线4采用镁钙合金材质，通过控制合金中镁钙元素的比例调整完全降解的时间。第一天线1的完全可降解时间控制在3个月时间左右，第一天线1的阻抗控制在50Ω±0.1Ω范围内。
为保护体内起搏器11的结构和电路不受生物环境的腐蚀，第一天线1外设置有第一生物保护膜2，第一生物保护膜2采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成，降解前后应对生物体无毒无害，柔韧性好，人体感受舒适。具体地，当适用于临时心脏起搏器场景时，一般选用聚乳酸乙醇酸材料，通过控制保护膜的厚度等参数控制降解时间，一般的厚度范围为10um～1mm，完全降解时间一般在1周～3个月。当适用于永久心脏起搏器时，一般采用对苯二甲酸乙二醇酯或聚酯纤维或聚醚醚酮材料。本发明提供的心脏起搏器使用方便，这是因为其第一天线外设置的第一生物保护膜是可更换的，根据心脏起搏器的使用年限需求进行更换，比如，当需要使用永久心脏起搏器时，可选择由对苯二甲酸乙二醇酯或聚酯纤维或聚醚醚酮材料制成的第一生物保护膜，当需要使用临时心脏起搏器时，则直接将由对苯二甲酸乙二醇酯或聚酯纤维或聚醚醚酮材料制成的第一生物保护膜更换为由聚乳酸乙醇酸材料制成的的第一生物保护膜，换句话说，第一生物保护膜是可以随时更换的，在手术过程种，根据用户需要使用的心脏起搏器的年限需求，直接选择对应材料制成的第一生物保护膜设置在第一天线外。
在一个示例中，体内起搏器11包括基底3，对电路起支撑作用，具有一定的强度和柔韧性。具体地，基底3采用亲水型聚氨酯制成，厚度在20um～100um之间，基底之上通过半导体溅射工艺实现所需的集成电路。
在一个示例中，体内起搏器11还包括电极4，电极4与心脏内膜或心肌表面连接，与心脏形成电回路，通过电流刺激心肌完成起搏。在不同的心脏起搏器中，电极4的材料选择有所不同，在临时心脏起搏器中，电极4选用可降解的镁钙合金材料制作，在永久心脏起搏器中，选择不可降解的钛合金制作。
在一个示例中，体内起搏器还包括起搏导线5、起搏导线连接器6和控制芯片7，起搏导线5 与电极4连接，用于接收心电信息；控制芯片7通过起搏导线4与起搏导线连接器6连接，用于接收心电信息。
其中，控制芯片7在基底之上一般可通过薄膜集成电路工艺制成，厚度小于50um，具备整流、鉴权、通信控制、脉冲控制以及心电监测的能力。仅允许鉴权后的触发心脏起搏脉冲。
为保护起搏导线5，在起搏导线5外设置有第二生物保护膜8，第二生物保护膜8采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成。需要指出的是，第二生物保护膜8与所述第一生物保护膜2的材质一致。同时，为使得心脏起搏器使用方便，同第一生物保护膜一样，第二生物保护膜也是可更换的，根据心脏起搏器的使用年限需求进行更换，比如，当需要使用永久心脏起搏器时，可选择由对苯二甲酸乙二醇酯或聚酯纤维或聚醚醚酮材料制成的第二生物保护膜，当需要使用临时心脏起搏器时，则直接将由对苯二甲酸乙二醇酯或聚酯纤维或聚醚醚酮材料制成的第二生物保护膜更换为由聚乳酸乙醇酸材料制成的的第二生物保护膜。换句话说，第二生物保护膜是可以随时更换的，在手术过程种，根据用户需要使用的心脏起搏器的年限需要，直接选择对应材料制成的第二生物保护膜设置在起搏导线外。
起搏导线5连接电极4和体内心脏起搏器11的主体，传输起搏电流和心电监测信号。起搏导线5材料的选择需要与电极4材料的选择匹配，在临时心脏起搏器应用场景中，起搏导线材料应选择镁钙合金材料制作，在永久心脏起搏器应用场景中，起搏导线材料应选择钛合金材料制作。因此，作为临时心脏起搏器，患者术后无需等待拔除起搏导线即可出院，出院后在一定时间内仍能够得到健康监护。
起搏导线4的合金比例与第一天线1一致，但应由多股更细的合金丝合成，股数不少于10股，总直径不大于1mm。
通过上述的描述可知，本发明中的体内起搏器中的各部件采用可降解的材料，因此，本发明具备通过更换生物保护膜以及起搏导线和电极的方式切换临时心脏起搏器和永久心脏起搏器的能力。
在本发明中，优选地，具备4只起搏导线连接器6，使得体内起搏器具备双腔起搏的能力，可以解决房室传导阻滞的问题，实现左右心房心室同步起搏。在实际应用过程中，医生可根据单腔起搏或双腔起搏的需求自主的选择连接2根或4根起搏导线连接器6，在进行单腔起搏时，选择连接2根起搏导线连接器6，剩余的2根可以封闭处理。
本发明实施例提供心脏起搏器系统，包括体外控制器及体内起搏器，其中，所述体内起搏器内设置有第一鉴权单元，所述体外控制器内设置有第二鉴权单元，所述第一鉴权单元和所述第二鉴权单元通信连接；所述体内起搏器，用于获取心脏的心电信息；所述体外控制器，与所述体内起搏器通信连接，接收所述体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器。本发明提供的系统，具备通过云服务器实时监测和分析患者健康状态的能力，将大大改善患者的愈后健康管理，提高患者的生活和健康水平。
以上，为本发明所提供的心脏起搏器系统实施例，下文中则介绍说明本发明所提供的控制心脏起搏的方法实施例，具体参见如下。
图6为本发明实施例提供的一种控制心脏起搏的方法流程示意图，控制心脏起搏的方法应用于如上述实施例中的心脏起搏器系统，如图6所示，该方法包括以下步骤：
步骤110，体内起搏器获取心脏的心电信息。
步骤120，体内起搏器和体外控制器之间进行鉴权认证。
步骤130，待鉴权认证通过后，体外控制器接收体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器，用以控制心脏起搏。
下面简单介绍体外控制器与体内起搏器之间的鉴权认证过程，具体的，如图7所示，体外控制器与体内起搏器之间的鉴权认证过程为：体外控制器创建设备，并将钥匙和密码发送给体内起搏器，体内起搏器根据接收的钥匙和密码进行预配，然后返回一个三元组的登录信息给体外控制 器，体外控制器根据登录信息进行验证，若验证通过，则体内起搏器将其相关数据发送给体外控制器，体外控制器根据接收到的相关数据，发送相关指令给体内起搏器进行执行。
在一个示例中，图8为本发明实施例提供的控制心脏起搏的方法流程示意图之二，如图8所示，控制心脏起搏的方法还包括：
步骤210，处理器与体外控制器之间进行鉴权认证。
步骤220，待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器。
在一个可能的实现方式中，处理器为云服务器或智能终端。下面简单介绍体外控制器与处理器之间的鉴权认证过程，如图9所示，体外控制器与处理器之间的鉴权认证过程为：处理器和体外控制器之间通过X509证书进行TLS握手，进行相互认证，处理器验证了IoT HuB，而体外控制器验证了设备，处理器向体外控制器传输了数据，而体外控制器向处理器传输了配置信号或控制信号。
在一个示例中，处理器包括云服务器和智能终端。图10为本发明实施例提供的控制心脏起搏的方法流程示意图之三，如图10所示，所述处理器与体外控制器间进行鉴权认证，待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器，包括：
步骤310，所述云服务器分别与所述体外控制器和所述智能终端进行鉴权认证；
步骤320，待鉴权认证均通过后，所述云服务器接收所述体外控制器发送的心电信息，并发送心脏风险信息给所述智能终端；
步骤330，所述体外控制器与所述智能终端之间进行鉴权认证；
步骤340，待鉴权认证通过后，所述智能终端接收所述心脏风险信息，并发送控制指令给所述体外控制器。
下面简单介绍智能终端与云服务器之间的鉴权认证过程，如图11所示，智能终端与云服务器之间的鉴权认证过程：用户通过智能终端第一次访问时体外控制器时，智能终端将用户的账号和密码传送给云服务器，云服务器检测数据库中是否存在该账号，若存在该账号，则将该账号的密码的SHA256值与数据库中的passwd字段值进行对比，若一致，则校验通过，然后云服务器创建一个session对象，并将session_id用setCookie传输给浏览器，浏览器确认setCookie字段是否存在，若存在，则智能终端登录成功，并向云服务器发送http请求，并携带Cookie s_id，云服务器接收请求并进行确认，若确认通过，则获取用户的智能终端信息，并将用户对应的体内起搏器清单及体内起搏器的相关信息传输给智能终端。其中，图11中的用户的账号和密码仅仅是举例说明，在此不做限定。
本发明实施例提供的一种控制心脏起搏的方法，体内起搏器获取心脏的心电信息；体内起搏器和体外控制器之间进行鉴权认证；待鉴权认证通过后，体外控制器接收体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器，用以控制心脏起搏。通过该方式，可以实现双向鉴权认证和实时心电监测，并可以云连接和远程监测和诊疗。
如图12所示，本发明实施例提供了一种电子设备，包括处理器111、通信接口112、存储器113和通信总线114，其中，处理器111，通信接口112，存储器113通过通信总线114完成相互间的通信。
存储器113，用于存放计算机程序；
在本发明一个实施例中，处理器111，用于执行存储器113上所存放的程序时，实现前述方法实施例提供的控制心脏起搏的方法。
本发明实施例还提供了一种计算机可读存储介质，其上存储有计算机程序，计算机程序被处理器执行时实现如前述方法实施例提供的控制心脏起搏的方法。
专业人员应该还可以进一步意识到，结合本文中所公开的实施例描述的各示例的单元及算法步骤， 能够以电子硬件、计算机软件或者二者的结合来实现，为了清楚地说明硬件和软件的可互换性，在上述说明中已经按照功能一般性地描述了各示例的组成及步骤。这些功能究竟以硬件还是软件方式来执行，取决于技术方案的特定应用和设计约束条件。专业技术人员可以对每个特定的应用来使用不同方法来实现所描述的功能，但是这种实现不应认为超出本发明的范围。
结合本文中所公开的实施例描述的方法或算法的步骤可以用硬件、处理器执行的软件模块，或者二者的结合来实施。软件模块可以置于随机存储器(RAM)、内存、只读存储器(ROM)、电可编程ROM、电可擦除可编程ROM、寄存器、硬盘、可移动磁盘、CD-ROM、或技术领域内所公知的任意其它形式的存储介质中。
以上仅是本发明的具体实施方式，使本领域技术人员能够理解或实现本发明。对这些实施例的多种修改对本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所发明的原理和新颖特点相一致的最宽的范围。

Claims (23)

  1. 一种心脏起搏器系统，其特征在于，包括体外控制器及体内起搏器，其中，所述体内起搏器内设置有第一鉴权单元，所述体外控制器内设置有第二鉴权单元，所述第一鉴权单元和所述第二鉴权单元通信连接；
    所述体内起搏器，用于获取心脏的心电信息；
    所述体外控制器，与所述体内起搏器通信连接，接收所述体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器。
  2. 根据权利要求1所述的系统，其特征在于，所述系统还包括处理器，其中，所述处理器包括鉴权单元，所述鉴权单元与所述第二鉴权单元通信连接；
    所述处理器，与所述体外控制器通信连接，接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器。
  3. 根据权利要求2所述的系统，其特征在于，所述处理器为云服务器或智能终端。
  4. 根据权利要求2所述的系统，其特征在于，所述处理器包括云服务器和智能终端，所述鉴权单元包括第三鉴权单元和第四鉴权单元，所述第三鉴权单元内置于所述云服务器内，所述第四鉴权单元内置于所述智能终端内，所述第三鉴权单元与所述第四鉴权单元通信连接；
    所述云服务器，与所述体外控制器和所述智能终端通信连接，接收所述体外控制器发送的心电信息，并发送心脏风险信息给所述智能终端；
    所述智能终端，与所述体外控制器通信连接，接收所述心脏风险信息，并发送控制指令给所述体外控制器。
  5. 根据权利要求1-4所述的系统，其特征在于，所述体内起搏器包括第一天线，所述体外控制器包括第二天线；
    所述体外控制器利用所述第二天线，通过电磁感应耦合的方式向所述第一天线提供电能，所述第一天线用于向所述体内起搏器供电。
  6. 根据权利要求5所述的系统，其特征在于，所述第一天线为镁钙合金制成。
  7. 根据权利要求5所述的系统，其特征在于，所述第一天线外设置有可替换的第一生物保护膜，所述第一生物保护膜根据心脏起搏器的使用年限需求进行更换。
  8. 根据权利要求7所述的系统，其特征在于，所述第一生物保护膜采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成。
  9. 根据权利要求1-4所述的系统，其特征在于，所述体内起搏器还包括电极，所述电极与心脏内膜或心肌表面连接，通过电流刺激心肌完成起搏。
  10. 根据权利要求9所述的系统，其特征在于，所述体内起搏器还包括起搏导线、起搏导线连接器和控制芯片；
    所述起搏导线与所述电极连接，用于接收所述心电信息；
    所述控制芯片通过所述起搏导线与所述起搏导线连接器连接，用于接收所述心电信息。
  11. 根据权利要求10所述的系统，其特征在于，所述起搏导线外设置有可更换的第二生物保护膜，所述第二生物保护膜根据心脏起搏器的使用年限需求进行更换。
  12. 根据权利要求11所述的系统，其特征在于，所述第二生物保护膜采用聚乳酸乙醇酸、对苯二甲酸乙二醇酯、聚酯纤维或聚醚醚酮制成。
  13. 根据权利要求10所述的系统，其特征在于，所述起搏导线连接器共4只。
  14. 根据权利要求9所述的系统，其特征在于，所述电极为镁钙合金材料或钛合金材料制成。
  15. 一种控制心脏起搏的方法，其特征在于，所述方法包括以下步骤：
    体内起搏器获取心脏的心电信息；
    体内起搏器和体外控制器之间进行鉴权认证；
    待鉴权认证通过后，体外控制器接收体内起搏器发送的所述心电信息，并将接收的控制指令发送给所述体内起搏器，用以控制心脏起搏。
  16. 根据权利要求15所述的方法，其特征在于，体内起搏器和体外控制器之间进行鉴权认证过程，包括：
    所述体内控制器创建设备，并将所述设备的钥匙和密码发送给所述体内起搏器；
    所述体内起搏器根据接收的钥匙和密码进行预配，并将预配后的登录信息返回给所述体外控制器；
    所述体外控制器根据返回的所述登录信息进行认证。
  17. 根据权利要求15所述的方法，其特征在于，所述方法还包括：
    处理器与体外控制器之间进行鉴权认证；
    待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器。
  18. 根据权利要求17所述的方法，其特征在于，所述处理器为云服务器或智能终端。
  19. 根据权利要求17或18所述的方法，其特征在于，所述处理器和所述体外控制器之间通过X509证书进行TLS握手，用以进行鉴权认证。
  20. 根据权利要求17所述的方法，其特征在于，所述方法还包括：所述处理器包括云服务器和智能终端，所述处理器与体外控制器间进行鉴权认证，待鉴权认证通过后，处理器接收所述体外控制器发送的所述心电信息，并将控制指令发送给所述体外控制器，包括：
    所述云服务器分别与所述体外控制器和所述智能终端进行鉴权认证；
    待鉴权认证均通过后，所述云服务器接收所述体外控制器发送的心电信息，并发送心脏风险信息给所述智能终端；
    所述体外控制器与所述智能终端之间进行鉴权认证；
    待鉴权认证通过后，所述智能终端接收所述心脏风险信息，并发送控制指令给所述体外控制器。
  21. 根据权利要求20所述的方法，其特征在于，智能终端和云服务器之间进行鉴权认证过程，包括：
    所述智能终端将账号和密码发送给所述云服务器；
    若所述账号存在所述云服务器的数据库中，则所述云服务器将所述密码的SHA256值与数据库中的passwd字段值对比是否一致；
    若一致，则所述云服务器创建一个session对象，并将session_id用setCookie传输给浏览器；
    若浏览器确认setCookie字段存在，则所述智能终端向所述云服务器发送携带Cookie s_id的http请求；
    所述云服务器接收所述http请求并进行确认，确认通过，则获取智能终端信息。
  22. 一种电子设备，其特征在于，包括处理器、通信接口、存储器和通信总线，其中，处理器，通信接口，存储器通过通信总线完成相互间的通信；
    存储器，用于存放计算机程序；
    处理器，用于执行存储器上所存放的程序时，实现如权利要求15-21任一项所述的方法。
  23. 一种计算机可读存储介质，其上存储有计算机程序，其特征在于，计算机程序被处理器执行时实现如权利要求15-21任一项所述的方法。
PCT/CN2023/077208 2022-09-15 2023-02-20 一种心脏起搏器系统、控制心脏起搏的方法及电子设备 WO2024055511A1 (zh)

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