WO2008101409A1 - Non-electrode-lead ultra-thin micro multifunctional heart rate adjusting device - Google Patents

Non-electrode-lead ultra-thin micro multifunctional heart rate adjusting device Download PDF

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Publication number
WO2008101409A1
WO2008101409A1 PCT/CN2008/000350 CN2008000350W WO2008101409A1 WO 2008101409 A1 WO2008101409 A1 WO 2008101409A1 CN 2008000350 W CN2008000350 W CN 2008000350W WO 2008101409 A1 WO2008101409 A1 WO 2008101409A1
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WO
WIPO (PCT)
Prior art keywords
circuit
ultra
control
electrode
pacemaker
Prior art date
Application number
PCT/CN2008/000350
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English (en)
French (fr)
Inventor
Luyi Sen
Original Assignee
Sun Medical-Scientific (Shanghai) Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39709630&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2008101409(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sun Medical-Scientific (Shanghai) Co., Ltd. filed Critical Sun Medical-Scientific (Shanghai) Co., Ltd.
Priority to US12/527,424 priority Critical patent/US20100094367A1/en
Priority to AU2008217463A priority patent/AU2008217463B2/en
Priority to CA002678288A priority patent/CA2678288A1/en
Priority to EP08706525A priority patent/EP2111890A4/en
Publication of WO2008101409A1 publication Critical patent/WO2008101409A1/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
    • A61N1/372—Arrangements in connection with the implantation of 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a device for heart rhythm regulation. Background technique
  • Cardiac pacemakers have been in use for more than half a century, and the in vitro pacing approach has evolved to the current in vivo pacemaker approach.
  • the external pacemaker is bulky. Although it can change the battery and adjust the pacing frequency at any time, it is inconvenient to carry. It is easy to cause infection at the entrance of the electrode line of the human body. Therefore, it is currently used for temporary pacing in clinical practice.
  • An internal pacemaker is to bury the pacemaker under the skin, but requires surgery. Although it is easy to carry and is not susceptible to infection, it can be used for permanent pacing, but when the internal battery is exhausted, surgery is required to replace the entire pacemaker.
  • any type of pacemaker requires one or more electrode wires to connect the germination electrodes implanted in the heart muscle to the pulsating pulse generator. ' , because the smallest pacemakers so far have to be 6x33x33mm large, 12.8 grams. It is not possible to be implanted directly into the heart.
  • the small electrode can only be implanted into the endocardium or epicardium, and then the electrode is connected to the pacemaker by an electrode wire.
  • This electrode wire is more than a dozen centimeters long and needs to be introduced into the heart through the blood vessels, often causing thrombosis in the heart and blood vessels. If the pacing is in the ventricle, the electrode wire will also pass through the tricuspid valve, which will cause tricuspid regurgitation.
  • permanent pacemakers buried under the skin often cause induced contraction and vibration of the surrounding muscles, making the patient feel extremely uncomfortable.
  • the electrode wire is to be connected to a pacemaker connected to the outside of the body.
  • the wound is often infected.
  • the epithelial pacing electrode wire passes through other organs and often causes adhesions.
  • Wireless Pacemaker such as the publication number CN1657003A, published on August 24, 2005.
  • the Chinese patent application "Digital Remote Wireless ECG Monitoring System” includes portable ECG signal acquisition, display and transmission terminals, and a remote monitoring center, two parts. The terminal volume does not exceed the size of the palm.
  • the digital cellular mobile communication network is used to establish a real-time connection with the Internet, and the collected user's ECG data is sent to the remote monitoring center through the Internet and controlled by the monitoring center.
  • the telemonitoring center stores data, receives, analyzes, and displays data from a computer connected to the Internet.
  • the technical problem to be solved by the present invention is to provide an integrated pacemaker and a pacing electrode. Without an electrode connection line, the endocardium can be directly disposed by intervention and/or minimally invasive manner.
  • an electrodeless line ultra-thin micro-multifunction rhythm control device capable of detecting the corresponding biosignal and having various functions such as pacing, defibrillation and cardiac rhythm resynchronization.
  • the technical solution of the present invention is: Providing an electrodeless ultra-thin micro-multi-function rhythm control device, comprising a heart rhythm control controller, a power source located in a human body, a pacemaker and an electrode, wherein: the power source, the The device and the electrode are integrated structures, which are combined with a super-book micro-battery, an ultra-low-power power supply circuit, a wireless receiving circuit and an application circuit, and constitute a super-computer-controlled rhythm control system with heart rhythm control and defibrillation function.
  • a thin micro-electrodeless line pacemaker wherein the ultra-thin micro-electrodeless pacemaker has a foldable deployment structure, and one side/end is provided with a needle electrode, and integrally forms a small electrode body, which can be intervened And/or minimally invasively implanted directly into the human heart or the outer surface of the heart; each part of the human heart that needs to be inserted into the electrode of the pacing device, respectively corresponding to the provision of one of the ultra-thin micro-electrodeless lines with needle electrodes Beater
  • the heart rhythm control controller is composed of a multi-function microcomputer rhythm control remote controller, which is portable or implantable, and corresponds to at least one or more of the ultra-thin micro-electroless line pacemakers, and sends a control signal and Receiving the signal it returns;
  • the ultra-thin micro-electrodeless line pacemaker and/or multi-function microcomputer rhythm control remote controller is connected to the control base station via a wireless network to control the plug station and the towering machine.
  • the ultra-thin micro-electrodeless line pacemaker further includes a non-contact type charging receiving circuit;
  • the multi-function microcomputer rhythm control remote controller further includes a non-contact type charging receiving and I or transmitting circuit;
  • the non-contact type charging receiving circuit of the ultra-thin micro-electrodeless line pacemaker is used for receiving an external non-contact type charging device for charging;
  • the non-contact type charging receiving circuit of the multi-function computer rhythm control remote control controller It is used for receiving an external non-contact type charger to charge it;
  • the non-contact type charging and transmitting circuit of the multi-function microcomputer rhythm control remote control controller is used for charging the ultra-thin micro-electrodeless line pacemaker;
  • the multi-function microcomputer rhythm control remote controller when the multi-function microcomputer rhythm control remote controller is implanted in the human body, it can be used as an intermediate charger, which can accept the external non-contact type charger to charge it, and can also be ultra-thin micro-electrodeless.
  • the line pacemaker is charged to further extend the operation/life of the battery inside the ultra-thin micro-electrodeless pacemaker.
  • the needle electrode includes at least a pacing electrode and a biosensor electrode disposed coaxially, multi-core or multi-layer, and an insulating layer is disposed between the pacing electrode and the bio-sensing electrode and the outer periphery of the bio-sensing electrode.
  • the overall length of the pacing electrode is greater than the overall length of the biosensor electrode; the end of the pacing electrode and the biosensor electrode form a biosensing/pulse output electrode interface, and the interface corresponds to an application circuit disposed on the flexible circuit strip/board connection.
  • the above-mentioned ultra-book micro-battery, ultra-low-power type power supply circuit, wireless receiving and transmitting circuit, non-contact type charging receiving circuit and application circuit are connected by flexible circuit strip/board, and can be folded and unfolded;
  • An anastomosis piece is disposed around the line pacemaker, and a fixing pin hole is arranged on the anastomosis piece to facilitate suturing and/or preventing falling off.
  • the above-mentioned super-book micro battery is a rechargeable battery or a permanent battery.
  • the application circuit includes at least a signal isolation and matching circuit, a physiological sensor receiver, a micro data processing data programming circuit, an oscillating circuit and a time control circuit, a first switching circuit, a converter circuit, state and data recording and control a circuit, a second switching circuit, a pulse generator circuit, and a bioelectrical monitoring system circuit;
  • the input of the signal isolation and the Ffi circuit is connected to the electrode/antenna
  • the physiological sensor is connected with the signal isolation and matching circuit and the physiological sensor receiver
  • the first circuit of the first switching circuit Transmective via physiological sensor receiver with oscillating circuit and time control circuit and micro
  • the data processing data programming circuit is connected, the second output end of the first switching circuit is connected to the state and the data recording and control circuit via the converter circuit, and the output end of the data recording and control circuit is connected to the wireless receiving/transmitting circuit, the second switching
  • the first output end of the circuit is connected to the wireless receiving/transmitting circuit via the pulse generating I circuit, and the second output end of the second switching circuit is connected to the wireless receiving/transmitting circuit via the bioelectric monitoring system circuit.
  • the multi-function microcomputer rhythm control remote controller includes a microcomputer circuit module and an input/output circuit module connected via a digital communication bus; and the microcomputer module includes at least a microprocessor, a system clock, a RAM, and a ROM. And a RAM/ROM control unit; the input/output circuit module thereof includes at least a memory, a programming I time control I digital control unit, an AID converter I detector unit, a sensing/filtering/amplifier circuit, an electrode configuration switching circuit, a telemetry circuit/ Receiver I RF conversion unit, battery power charging I processing system, voltage I current reference generator, monitoring I measurement system multiplexer ADC and wireless receiving and transmitting circuit;
  • the programming I time control I digital control unit is respectively connected with the memory and the telemetry circuit/receiver I RF conversion unit, and is connected to the electrode configuration switching circuit via the AID converter I detector unit and the sensing I filter/amplifier circuit; Electrode configuration switching circuit is connected with wireless receiving/transmitting circuit, bidirectional signal exchange; battery power charging I processing system through voltage I current reference generator and programming I time control I digital control unit, monitoring I measurement system multiplexer ADC and wireless Receive I send circuit connection.
  • control base station includes a wake-up circuit/RF switching circuit BSM module, and wireless receiving
  • the ultra-thin micro-electrodeless line pacemaker receives the control signal of the multi-function microcomputer rhythm control remote control controller or the control base station, and feeds back the physiological electrical signal of the local part; the multi-function microcomputer rhythm control remote control controller or the control base station Responsible for controlling the operation of each ultra-thin micro-electrodeless pacemaker, controlling its pacing, defibrillation and heart rhythm resynchronization.
  • the multi-function microcomputer rhythm control remote controller communicates with the control base station via the wireless network, receives control commands, feeds back various physiological parameters and indicators of the monitored object, and can control each ultra-thin micro-electrode according to preset data.
  • the working state of the line pacemaker is the same.
  • the entire pacemaker is small, flexible, foldable, and can be implanted with a single collapsible super-miniature micro-electrodeless pacemaker via an interventional catheter, or via thoracoscopic or minimally invasive thoracotomy Into a single collapsible ultra-thin micro-electrodeless line pacemaker, reducing the workload and the patient's surgical pain, also Greatly reduce the cost associated with pacemaker implantation;
  • the non-contact charging method can greatly extend the working life of the device implanted in the human body, reduce the probability of failure, and avoid the pain and economic burden of the patient;
  • the multi-function microcomputer rhythm control remote control controller acts as a relay/transfer station for wireless signals. 'It also has the same or similar control functions as the control base station and computer, so the required transmitter for implantation in the body.
  • the receiving power and power consumption are greatly reduced, which helps to extend the working time and life of the power supply, and can greatly expand the range of the patient's activities and reduce the impact of wireless signals on their health;
  • the entire rhythm control device can achieve more functions, including pacing, defibrillation and re-synchronization of heart rhythm, to meet higher medical / therapeutic requirements, more reliable and practical;
  • FIG. 1 is a schematic view showing the outer dimensions and structure of a prior art pacemaker
  • FIG. 2 is a schematic view showing the outer dimensions and placement parts of the ultra-thin micro-electrodeless line pacemaker of the present invention
  • FIG. 3 is a schematic view showing the placement of an electrodeless 'line pacemaker in the corresponding part of the endocardium;
  • Figure 4 is a schematic view showing the placement of an electrodeless line pacemaker at a corresponding portion of the epicardium
  • Figure 5 is a side view showing the structure of the electrodeless line pacemaker
  • Figure 6 is a schematic top plan view of an electrodeless line pacemaker
  • FIG. 7 is a partial enlarged structural diagram of a physiological sensor/pulse output needle electrode of a pacemaker;
  • FIG. 8 is a block diagram showing the circuit configuration of the entire system of the present invention.
  • Figure 9 is an electrical schematic block diagram of an implantable electrodeless line pacemaker
  • Figure 10 is a schematic diagram of the low energy sensor circuit
  • Figure 11 is a schematic block diagram of a multi-function microcomputer rhythm control remote controller
  • Figure 12 is a schematic block diagram of an ultra low power physiological electrical signal microprocessing circuit
  • Figure 13 is a schematic block diagram showing the circuit configuration of the electrode configuration switching circuit
  • Figure 14 is a block diagram showing the circuit principle of a low-energy battery charging processing system
  • 15 to 20 are several common data and control signal flows and control methods of the entire device of the present invention. ' detailed description
  • the existing pacemaker whether in vivo or in vitro, requires one or more electrode wires 2, a pacing electrode 3 implanted on the heart muscle and a pacing pulse generator. 1 connected.
  • the technical solution of the present invention integrates a power source, a pacemaker and an electrode into an integrated structure, and combines a super-book micro battery, an ultra-low power supply circuit, a wireless receiving/transmitting circuit and an application circuit to form a microcomputer.
  • Fig. 3 the left side shows a schematic diagram of implanting a single ultra-thin micro-electrodeless line pacemaker, and the right side view is a schematic diagram of implanting a plurality of ultra-thin micro-electrodeless line pacemakers.
  • an ultra-thin micro-electrodeless line pacemaker with a needle electrode can be provided correspondingly in each part of the human heart where the cockpit electrode needs to be inserted.
  • an ultra-thin micro-electrodeless pacemaker is implanted in the desired part of the endocardium.
  • the left side shows a schematic diagram of a single ultra-thin micro-electrodeless line pacemaker implanted on the right, and the right side shows a schematic diagram of implanting multiple ultra-thin micro-electrodeless line pacemakers.
  • an ultra-thin micro-electrodeless pacemaker is implanted in the desired area on the epicardium.
  • the rest is the same as Figure 3.
  • the invention integrates the power source, the pacemaker and the electrode into an integrated structure, and has a foldable/expandable structure, which is composed of a super-book micro battery (indicated by a lithium battery 2014), an ultra-low power supply circuit,
  • the wireless receiving/transmitting circuit, the non-contact charging receiving circuit and the application circuit are combined to form an ultra-thin micro-electrodeless line pacemaker with a needle electrode at one side/end
  • its ultra-book micro-battery, ultra-low-power power supply circuit, wireless receiving/transmitting circuit, non-contact charging receiving circuit and application circuit are connected by flexible circuit strip/board, which can be folded, unfolded or curled.
  • the magnet 2018 in the figure and the coil 2011 wound around the Ti circle (coil bobbin) 2012 constitute a wireless transmitting/receiving antenna.
  • All detection and control circuits (such as the aforementioned ultra-low-power power supply circuit, wireless receiving/transmitting circuit, non- The contact type charging receiving circuit and the application circuit and the like are disposed on the flexible wiring board 2016.
  • the ceramic sheet 2013 constitutes a shielding layer to prevent the working signal from interfering with the detection and output signals of the needle electrode 2015.
  • ultra-book micro battery is a rechargeable battery or a permanent battery.
  • the ultra-thin micro-electroless line pacemaker in the middle of the ultra-thin micro-electroless line pacemaker, two pieces (which may be four or six pieces, etc., the key is even blocks) are used.
  • the middle-symmetric structure of the lithium battery the entire flexible line There are 2 or 4 folding lines 2017 on the board 2016.
  • the flexible circuit board larger than the transverse cross-sectional area of the battery can also act as an anastomosis sheet in addition to the supporting and connecting related circuits.
  • fixed pinholes are arranged at the four corners. 201, to facilitate suturing and/or preventing shedding. Due to the above structure, the entire ultra-thin micro-electroless wire pacemaker has a foldable I-expanding structure that can be smoothly placed in a catheter or thoracoscope in a folded or crimped manner.
  • an electrodeless line pacemaker for different occasions and applications such as 1) endocardial pacing; 2) epicardial permanent pacing; and 3) epicardial temporary pacing.
  • the key to the overall volume reduction of the above pacemaker is to reduce the volume of the battery.
  • the smallest rechargeable battery has been 100 times smaller than the AA battery, but it is a round bar type.
  • the smallest flat battery is 1.7mm thick and 17mm in diameter.
  • the inventors have also designed another battery that uses a non-rechargeable form, which is slightly larger in size, so that it can last for more than 10 years.
  • This ultra-thin micro-electrodeless line pacemaker includes three key technological revolutions: 1) ultra-miniature, book-type, permanent or rechargeable batteries; 2) ultra-micro pulse generators; 3) ultra-micro computer pulse governors; The combination of the three forms a small pacemaker that can be implanted directly into the heart or attached to the outer membrane of the heart.
  • a needle electrode is disposed at one side/end of the ultra-thin micro-electroless sputum and the line pacemaker, and the needle electrode includes at least a pacing electrode 2021 and a biotransmission disposed coaxially, multi-core or multi-layer.
  • the sensing electrode 2020, the first insulating layer 2023 and the second insulating layer 2022 are disposed between the pacing electrode and the bio-sensing electrode and the outer periphery of the bio-sensing electrode; the overall length of the pacing electrode is greater than that of the bio-sensing electrode The overall length; the end of the pacing electrode and the biosensor electrode penetrates the lithium battery 2014 to form a biosensing/pulse output electrode interface 2019, which is connected to an application circuit disposed on the flexible circuit board.
  • f device mainly comprises an ultra-thin micro-electrodeless line pacemaker, a heart rate control remote controller and a control base station connected to the PC. . ,
  • the ultra-thin micro-electrodeless line pacemaker circuit is composed of an ultra-low power supply circuit, a wireless receiving/transmitting circuit and an application circuit;
  • the rhythm control controller is composed of a multi-function microcomputer rhythm control remote controller, which is mainly used by the wake-up circuit / RF switching circuit / A module and data interface I application microcontroller
  • I microprocessor I ADP module portable or implantable
  • the control base station is composed of a wake-up circuit / RF switching circuit / BSM module, a wireless signal receiving I transmitting circuit module and a data interface I application microcontroller I microprocessor I ADP module.
  • the ultra-thin micro-electrodeless pacemaker and/or multi-function microcomputer rhythm control remote controller is connected to the control base station via a wireless network, and the connection between the base station and the computer can be wired or wirelessly connected, data exchanged, and commanded.
  • the multifunctional microcomputer rhythm control remote control controller corresponds to at least one (or more) of the aforementioned ultra-thin micro-electrodeless line pacemakers, sends a control signal and receives the returned signal, and comprehensively controls and re-synchronizes the heart rhythm;
  • the multi-function microcomputer rhythm control remote control controller and the ultra-thin micro-electrodeless line pacemaker use a wireless communication connection.
  • the ultra-thin micro-electrodeless pacemaker can also be equipped with a non-contact charging receiving circuit; the multi-function microcomputer rhythm control remote controller can also be set with non-contact charging receiving and / Or the transmitting circuit.
  • the non-contact type charging receiving circuit of the ultra-thin micro-electrodeless line pacemaker is used for receiving an external non-contact type charger to charge it;
  • the non-contact type charging receiving circuit of the multi-function microcomputer rhythm control remote controller is used for receiving an external non-contact type charger to charge it;
  • the non-contact charging and transmitting circuit of its multi-function microcomputer rhythm control remote controller is used to charge the ultra-thin micro-electrodeless pacemaker.
  • the purpose of "using the above design” is to facilitate the user, that is, the user can charge the ultra-thin micro-electrodeless line pacemaker and the multi-function microcomputer rhythm control remote controller with an external non-contact type charging transmitting circuit.
  • the multi-function microcomputer rhythm control remote controller can be charged first, and then the ultra-thin micro-electroless line pacemaker can be charged to meet the needs of different users or different occasions.
  • the multi-function microcomputer rhythm control remote controller when the multi-function microcomputer rhythm control remote controller is implanted in the human body, Used as an intermediate charger, it can accept the external non-contact charger to charge it, and can charge the ultra-thin micro-electroless line pacemaker to further extend the ultra-thin micro-electrodeless line pacemaker. Built-in battery work / service life. '
  • the external non-contact charging transmission circuit can be set separately or together with the control base station.
  • the above-mentioned multi-function microcomputer rhythm control remote control controller can be portable (such as a mobile phone type, a watch type, etc.), or can be implanted in the body.
  • the multi-function microcomputer rhythm-regulated remote control for cardiac resynchronization is usually multi-channel because cardiac resynchronization requires the implantation of multiple ultra-thin micro-electrodeless pacemakers on the heart.
  • Multi-channel (also known as multi-channel) data transmission and control techniques are prior art and will not be described herein.
  • the composition of an application circuit for an ultra-thin micro-electrodeless line pacemaker is further described, which includes at least a signal isolation and matching circuit, a physiological sensor receiver, a micro data processing data programming circuit, an oscillating circuit, and time.
  • a control circuit a first switching circuit, a converter circuit, a state and data recording and control circuit, a second switching circuit, a pulse generator circuit, and a bioelectricity monitoring system circuit;
  • the input end of the signal isolation and matching circuit is connected to the electrode/antenna, the first switching circuit and the second switching circuit, and the sensor is connected to the signal isolation and matching circuit and the physiological sensor receiver, and the first output of the first switching circuit
  • the physiological sensor receiver is connected to the oscillating circuit and the time control circuit and the micro data processing data programming circuit, and the second output end of the first switching circuit is connected to the state and the data recording and control circuit via the converter circuit, and the data is recorded and controlled.
  • the output end of the circuit is connected to the wireless receiving/transmitting circuit, the first output end of the second switching circuit is connected to the wireless receiving/transmitting circuit via the pulse generator circuit, and the second output end of the second switching circuit is subjected to the bioelectricity monitoring system.
  • the circuit is connected to the wireless receiving circuit.
  • bioelectrical monitoring system circuit set in this figure is mainly used during defibrillation. Play a role.
  • each switch in the circuit is based on different operating states (or timings) of the sensor. Turning on or off in order, the power consumption of the entire sensor circuit is greatly reduced, the operating current is generated only during the detection and/or transmission of the biological signal, and the power is consumed, and almost no power is generated in other time periods or timings. Consumption. '
  • a multi-function microcomputer rhythm control remote controller which comprises a microcomputer circuit module and an input/output circuit module connected via a digital communication bus; and the microcomputer circuit module includes at least a microprocessor , system clock, RAM, ROM and RAM I ROM control unit; its input I output circuit module includes at least memory, programming I time control I digital control unit, A / D converter / detector unit, sensing / filtering / amplifier circuit , electrode configuration switching circuit, telemetry circuit / receiver / RF conversion unit, battery power charging / processing system, voltage I current reference generator, monitoring I measurement system multiplexer ADC and wireless receiving circuit;
  • the RF conversion unit is correspondingly connected, and is connected to the electrode configuration switching circuit through the AID converter/detector unit and the sensing I filter I amplifier circuit; the electrode configuration switching circuit is connected with the wireless receiving/transmitting circuit, and the signal exchange is performed in both directions;
  • the I processing system is connected to the programmable I time control I digital control unit, the monitoring I measurement system multiplexer ADC, and the wireless transceiver circuit via a voltage/current reference generator.
  • the voltage/current reference generator in this figure is important, and it plays an important role in both signal reception and external charging. '
  • Fig. 12 a schematic block diagram of the ultra-low-power physiological signal micro-processing circuit is specifically given, which is a further refinement of the physiological sensor receiver module in Fig. 9.
  • a schematic block diagram of the circuit configuration of the electrode configuration switching circuit is specifically provided, which is a further refinement of the electrode configuration switching circuit module in Fig. 10.
  • the whole device is composed of an electrodeless line pacemaker 201, a cardiac rhythm control remote controller 501 and a control base station 601, and the electrodeless line pacemaker receives the control signal of the heart rate control remote controller, and The physiological electrical signal of the feedback part, the data exchange and the control signal transmission between the cardiac control remote control controller and the control base station are also performed, and the cardiac rhythm control remote control controller receives the control command of the control base station, and feeds back various physiological parameters of the monitored object and Indicators, and can control the pacing, defibrillation and heart rhythm resynchronization according to the preset parameters of the electrodeless pacemaker.
  • the data transmission and the control signal transmission between the electrodeless line pacemaker and the heart rate control remote controller, and the heart rate control remote control controller and the control base station are all performed by wireless communication.
  • the whole device is composed of four electrodeless line pacemakers 201a to 201d, one heart rhythm control remote controller 501 and one control base station 601, and each electrodeless line pacemaker receives heart rhythm control Controlling the controller's control signal, and controlling the physiological electrical signal of the part where the feedback is located, the cardiac rhythm control remote controller is responsible for controlling the operation of each electrodeless line pacemaker, and also performs data exchange and control signal transmission between the control base station and the control base station.
  • the cardiac rhythm control remote controller is responsible for controlling the operation of each electrodeless line pacemaker, and also performs data exchange and control signal transmission between the control base station and the control base station.
  • the rest is the same as Figure 15.
  • the whole device is composed of an electrodeless line pacemaker 201 and a control base station 601.
  • the electrodeless line pacemaker directly receives the control signal of the control base station and feeds back the physiological electrical signal of the site.
  • the base station is directly responsible for controlling the operation of the electrodeless line pacemaker, and controls the working state of the electrodeless line pacemaker according to the data set in advance, and controls the pacing, defibrillation and heart rhythm resynchronization.
  • the whole device is composed of four electrodeless line pacemakers 201a to 201d and one control base station 601.
  • Each electrodeless line pacemaker directly receives the control signal corresponding to the control base station, and respectively feeds back the physiological power of the site.
  • the control base station is directly responsible for controlling the operation of each electrodeless line pacemaker, the rest is the same as Figure 17.
  • the whole device is composed of four electrodeless line pacemakers 201a to 201d, one heart rate control remote controller 501 and one control base station 601, and the electrodeless line pacemaker 201a first receives the heart rate control remote controller.
  • the control signal is respectively transmitted to the electrodeless line pacemakers 201b to 201d, and the electrodeless line pacemaker 201a also receives the feedback physiological electric signals of the electrodeless line pacemakers 201b to 201d, and is uniformly transmitted to the heart rhythm.
  • the remote control controller is regulated and transmitted to the control base station, and the cardiac rhythm control remote controller exchanges and controls the remaining electrodeless line pacemaker through the electrodeless line pacemaker 201a; the electrodeless line pacemaker 201a at this time It functions as a relay and forwarding station.
  • the whole device is composed of four electrodeless line pacemakers 201a to 201d and one control base station 601.
  • the electrodeless line pacemaker 201a directly receives the control signal for controlling the base station, and then transmits the control signals to the electrodes without electrodes.
  • the line pacemakers 201b to 201d, the electrodeless line pacemaker 201a also receives the feedback physiological electric signals of the electrodeless line pacemakers 201b to 201d, and uniformly transmit them to the control base station, and the control base station passes the electrodeless line pacemaker.
  • 201a performs data exchange and control on the remaining electrodeless line pacemakers; likewise, the electrodeless line pacemaker 201a at this time functions as a relay and repeater station.
  • each of the electrodeless line pacemakers receives the control signal of the heart rhythm control remote controller or the control base station, and feeds back the physiological electrical signals of the local part; and the heart rate control remote control controller or the control base station is responsible for controlling each of the ultra-thin micro-electrodeless lines.
  • the beater operates to control its pacing, defibrillation, and heart rhythm resynchronization.
  • this invention includes four creative breakthroughs:
  • Ultra-thin micro-electrodeless line pacemaker It is a combination of a collector, an electrode line and a pacemaker. These include three key technological revolutions: 1) ultra-miniature, book-type, rechargeable or permanent batteries; 2) ultra-micro pulse generators; 3) ultra-micro computer pulse regulators; these three combine to form a small electrode body , it It can be bent or folded and can be directly implanted into the human heart or outside the heart by intervention and I or minimally invasive means.
  • ultra-miniature wireless pulse generator for various purposes: suitable for 1) endocardial pacing; 2) epicardial permanent pacing; and 3) epicardial temporary pacing.
  • Multi-channel wireless micro-computer rhythm control controller There are at least three main functions: 1,) pacing; 2) defibrillation; 3) heart rhythm resynchronization.
  • ultra-thin micro-electrodeless pacemakers pacing/defibrillation/cardiac resynchronization
  • maintaining normal heart rhythm and enhancing systolic function are: maintaining normal heart rhythm and enhancing systolic function.
  • the invention is widely applicable to the field of treatment of various patients with arrhythmia and systolic dysfunction.
  • the above embodiments are only used to explain and explain the present invention, and are not intended to limit the scope of the invention, and the scope of the invention may be made without departing from the scope and scope of the invention. Various changes or modifications of the invention are possible.
  • the invention combines the existing pacemaker and the pacing electrode into one, has no electrode connection line, and the pacemaker has small volume and foldable, and can be directly disposed in the heart or the heart through intervention and/or minimally invasive manner.
  • the corresponding bioelectric signal can be detected on the corresponding part of the outer membrane, and has various functions such as pacing, defibrillation and heart rhythm resynchronization. It can be charged by non-contact charging method, which greatly prolongs the working life of the device implanted in the human body and reduces the probability of its failure.
  • the multi-function microcomputer '1 law regulates the remote controller to act as a relay for wireless signals.
  • the entire rhythm control device can achieve more functions and can meet the requirements.
  • Higher medical/treatment requirements more reliable and practical, can be widely used in the treatment of patients with arrhythmia and systolic dysfunction.

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Description

无电极线超薄微型多功能心律调控装置 相关申请
本申请要求于 2007年 2月 16日提交的申请号为 200710037687.6的中国发明 专利申请的优先权。 技术领域
本发明属于医疗器械领域， 尤其涉及一种用于心律调控的装置。 背景技术
心脏起搏器的应用已经有半个多世纪了， 从开始的体外起搏方式， 已经发展 到了现在的体内起搏方式。
体外起搏器体积大， 虽然能随时更换电池及调整起搏频率， 但携带不方便， 旦在人体的电极线入口处容易发生感染， 故目前临床上多用于临时性起搏。
体内起搏器是将起搏器埋在皮下， 但是需要动手术。 其虽然携带方便， 不容 易感染， 可用于永久性起搏， 但是在其内装电池耗尽时， 需要动手术来更换整个 起搏器。
不管是体内还是体外起搏器， 任何一种起博器都需要有一根或一根以上的电 极线， 将植入在心脏肌肉上的起博电极与起博脈冲发生器联接起来。 ' , 因为到目前为止心脏起搏器最小的也要有 6x33x33mm大， 12.8克重。 它不 可能被直接植入到心脏上。
由于心脏在跳动， 这么大体积的起博器会限制心脏的收缩与舒张。 而且， 因 起搏器体积大， 无法被固定在搏动的心脏上。 如果强行将它缝在心脏上的话， 会 造成心脏肌肉撕裂。 因此只能将小电极植入心内膜或心外膜上， 然后用电极线将 电极与起搏器连接起来。 此电极线长十几厘米， 需要穿过血管引入心脏， 在心脏 与血管内常引起血栓形成。 如在心室内起搏的话， 电极线还要通过三尖瓣， 会造 成三尖瓣关闭不全。 此外， 埋在皮下的永久起搏器常常造成周围的肌肉的感应收 缩和震动， 使患者感到极为不适。
- 1 - 确认本 作为临时起搏器， 电极线要引出皮外与体外的起搏器连接。 在人体的电极线; 出口处， 伤口常感染。 心外膜起搏的电极线要穿过其它脏器， 亦经常引起粘连 < 最近， 有所谓的无线心脏起搏器 （Wireless Pacemaker ) , 如公开号为 CN1657003A, 公开日期为 2005年 8月 24日的中国专利申请"数字式远程无线心 电监护系统"， 其包括便携式心电信号采集、 显示和发送终端， 和远程监护中心 、两部分。 终端体积不超过手掌大小， 利用数字式蜂窝移动通信网络建立与英特网 的实时连接， 将采集到的使用者的心电数据通过英特网发送到远程监护中心， 并 接受监护中心的控制。远程监护中心由连接到英特网的计算机将数据接收、分析、 显示存储起来。
但是上述技术方案只是指控制台计算机对皮下起搏器的无线控制与信息传 递，、而不是真正的没有电极线的起搏器， 故而依然无法解决由于起搏器与起搏电 极之间的电极连接线的存在所带来的诸多缺陷。 发明内容
本发明所要解决的技术问题是提供一种将现有的起搏器与起搏电极合二为 一的， 没有电极连接线的， 可通过介入和 /或微创的方式直接设置在心内膜或心 外膜相应部位上， 能进行相应生物信号的检测， 且具有起搏、 除颤和心律再同步 等多种功能的无电极线超薄微型多功能心律调控装置。
本发明的技术方案是： 提供一种无电极 超薄微型多功能心律调控装置， 包括心律调控控制器、 位于人体体内的电源、 起博器和电极， 其特征是： 其所述 的电源、 起博器和电极为一体化结构， 由超簿微型电池、 超低耗式电源电路、 无 线收 I发电路和应甩电路结合， 构成一带有微电脑心律调控系统、 具有心律调控 和除颤功能的超薄微型无电极线起搏器， 所述的超薄微型无电极线起搏器呈可折 叠展开结构， 其一侧 /端设置有针状电极， 并整体构成一个小电极体， 它可以通 过介入和 /或微创的方式直接植入人体心脏内或心脏外表面； 人体心脏各个需 要插入起博器电极的部位， 分别对应设置一个所述的带有针状电极的超薄微型无 电极线起搏器；
其心律调控控制器由多功能微电脑心律调控遥控控制器构成， 为便携式或可 植入式， 其与至少一个或多个所述的超薄微型无电极线起搏器所对应， 发出控制 信号并接收其返回的信号；
其多功能微电脑心律调控遥控控制器与各超薄微型无电极线起搏器之间无 线通讯连接， 综合调控， 使心律再同步；
其超薄微型无电极线起搏器和 /或多功能微电脑心律调控遥控控制器经过 无线网络与控制基站连接， 控制塞站与计耸机连揍。
其超薄微型无电极线起搏器还包括非接触型充电接收电路； 所述的多功能微 电脑心律调控遥控控制器还包括非接触型充电接收和 I或发射电路; .
其超薄微型无电极线起搏器的非接触型充电接收电路用于接收外置的非接 触型充电器对其进行的充电； 其多功能 电脑心律调控遥控控制器的非接触型充 电接收电路用于接收外置的非接触型充电器对其进行的充电； 其多功能微电脑心 律调控遥控控制器的非接触型充电发射电路用于对超薄微型无电极线起搏器进 行充电； .
其中， 当多功能微电脑心律调控遥控控制器植入人体内时， 能用作中间充电 器， 其既可以接受外置的非接触型充电器对其进行的充电， 又可对超薄微型无电 极线起搏器进行充电， 以进一步延长超薄微型无电极线起搏器内置电池的工作 /使用寿命。
具体的， 上述针状电极至少包括同轴、 多芯或多层设置的起搏电极和生物传 感电极，在起搏电极与生物传感电极之间以及生物传感电极的外周，设置绝缘层； 起搏电极的整体长度大于生物传感电极的整体长度； 起搏电极和生物传感电极的 末端构成生物传感 /脉冲输出电极接口， 接口与设置在柔性线路带 /板上的应用 电路对应连接。
上述的超簿微型电池、 超低耗式电源电路、 无线收 I发电路、，非接触型充电 接收电路和应用电路之间用柔性线路带 /板连接， 可折叠展开； 在超薄微型无电 极线起搏器的周围设置有吻合片， 吻合片上设置固定针孔， 以便于缝合固定和 / 或防止脱落。 、
上述的超簿微型电池为可充电电池或永久电池。
进一步的， 所述的应用电路至少包括信号隔离和匹配电路、 生理传感器接收 器、 微数据处理数据编程电路、 振荡电路和时间控制电路、 第一切换电路、 转换 器电路、 状态与数据记录及控制电路、 第二切换电路、 脉冲发生器电路和生物电 监测系统电路；
其中， 信号隔离和匹 ffi电路的输入端与电极 /天线、 第一切换电路和第二切 换电路连接， 生理传感器与信号隔离和匹配电路和生理传感器接收器连接， 第一 切换电路的第一路输 ώ端经生理传感器接收器与振荡电路和时间控制电路和微 数据处理数据编程电路连接， 第一切换电路的第二路输出端经转换器电路与状态 与数据记录及控制电路连接， 数据记录及控制电路的输出端与无线收 /发电路连 接， 第二切换电路的第一路输出端经脉冲发生 I 电路与无线收 /发电路连接， 第 二切换电路的第二路输出端经生物电监测系统电路与无线收 /发电路连接。
进一步的， 所述的多功能微电脑心律调控遥控控制器包括经过数字通信总线 连接的微型计算机电路模块和输入 /输出电路模块； 其微型计算机 ^路模块至少 包括微处理器、 系统时钟、 RAM、 ROM和 RAM / ROM控制单元； 其输入 /输 出电路模块至少包括存储器、 编程 I时间控制 I数字控制单元、 A I D转换器 I 探测器单元、 传感 /过滤 /放大器电路、 电极配置交换电路、 遥测电路 /接受器 I RF 转换单元、 电池电源充电 I处理系统、 电压 I电流参考发生器、 监测 I测 量系统多工器 ADC和无线收 I发电路；
其中， 编程 I时间控制 I数字控制单元分别与存储器和遥测电路 /接受器 I RF 转换单元对应连接， 并经过 A I D转换器 I探测器单元和传感 I过滤 /放大 器电路与电极配置交换电路连接； 电极配置交换电路与无线收 /发电路连接， 双 向进行信号交换； 电池电源充电 I处理系统经过电压 I电流参考发生器与编程 I 时间控制 I数字控制单元、监测 I测量系统多工器 ADC和无线收 I发电路连接。
进一步的， 所述的控制基站包括唤醒电路 / RF转接电路 BSM模块、 无线收
I发电路模块和数据接口 I应用微控制器 I微处理器 ADP模块； 控制基站与所 述计算机之间采用有线或无线方式进行连接、 数据交换和指令传递。 '
上述的超薄微型无电极线起搏器接收多功能微电脑心律调控遥控控制器或 控制基站的控制信号， 并反馈所在部位的生理电信号； 所述的多功能微电脑心律 调控遥控控制器或控制基站负责控制各个超薄微型无电极线起搏器的运行， 控制 其起搏、 除颤和心律再同步。
上述的多功能微电脑心律调控遥控控制器通过无线网络与控制基站进行通 讯， 接收控制指令， 反馈被监测对象的各种生理参数和指标， 并可根据预先设置 好的数据调控各超薄微型无电极线起搏器的工作状态。
与现有技术比较， 本发明的优点是：
1. 起搏器与起搏电极之间无电极连接线结构， 避免了现有技术的诸多弊端；
2. 整个起搏器体积小， 柔软、 可折叠， 完全可以经介入导管植入单个的可折 叠式超寧微型无电极线起搏器， 或者， 经胸腔镜或在微创开胸手术时植入单个的 可折叠式超薄微型无电极线起搏器， 减少了手术工作量和患者的手术痛苦， 亦大 大降低了起搏器植入的相关费用；
. 3.采用非接触式充电方式， 可大大延长植入人体内的装置的工作寿命， 减少 其故障发生几率， 也避免了患者的开刀痛苦和经济负担；
4. 采用多功能微电脑心律调控遥控控制器充当无线信号的中继 /中转站，'其 自身也具有与控制基站和计算机相同或相似的控制功能， 故植入体内的起搏器所 需的发射、接收功率和电能消耗大大降低，有助于延长其电源的工作时间和寿命， 亦可大大扩展患者的活动范围， 减少无线信号对其健康的影响；
5. 整个心律调控装置可实现的功能更多， 可以实现包括起搏， 除颤和心律再 同步等诸多功能， 能满足更高的医疗 /治疗要求， 更加可靠、 实用；
5. 创造了一种无电极线的心律调控的最新概念，并可利用此概念与理论来指 导进一步发明各种微型的、 无电极线的、.单功能或多功能的心律调节与控制器。 附图概述
图 1是现有技术起搏器的外形尺寸和结构示意图；
图 2是本发明超薄微型无电极线起搏器的外形尺寸和放置部位示意图； 图 3是将无电极'线起搏器放置在心内膜相应部位的示意图； 、
图 4是将无电极线起搏器放置在心外膜相应部位的示意图；
图 5是无电极线起搏器的侧视结构示意图；
图 6是无电极线起搏器的俯视结构示意图；
图 7是起搏器生理传感 /脉冲输出针状电极的局部放大结构示意图； 图 8是本发明的整个系统电路构成方框图；
图 9是植入式无电极线起搏器的电原理方框图；
图 10是低能耗传感器电路原理图； '
图 11是多功能微电脑心律调控遥控控制器的原理方框图；
图 12是超低能耗生理电信号微处理电路的原理方框图；
图 13是电极配置交换电路的电路结构示意框图；
图 14是低能耗电池充电处理系统电路原理方框图；
图 15至图 20， 是本发明整套装置常见的几种数据和控制信号流向及其控制 方式。 ' 具体实施方式
图 1中， 现有的起搏器， 不论是体内式还是体外式， 都需要有一根或一根以 上的电极线 2，将植入在心脏肌肉上的起搏电极 3与起搏脉冲发生器 1联接起来。
因为到目前为止心脏起搏器最小的也要有 6x33 x33mm大， 12.8克重。显然， 它是不可能被直接 入到心脏上的。
图 2中， 本发明的技术方案将电源、 起博器和电极整合为一体化结构， 由超 簿微型电池、 超低耗式电源电路、 无线收 /发电路和应用电路结合， 构成一带有 微电脑心律调控系统、 具有心律调控和赊颤功能的超薄微型无电极线起搏器， 所 述的超薄微型无电极线起搏器呈可折叠展开结构， 其一侧 /端设置有针状电极， 并整体构成一个小电极体， 它可以通过介入和 /或微创的方式直接植入人体心脏 内或心脏外表面。
图 3中， 左侧图示为植入单个超薄微型无电极线起搏器的示意图， 其右侧图、 示为植入多个超薄微型无电极线起搏器的示意图。
由于其体积小， 在人体心脏各个需要插入起博器电极的部位， 可分别对应设 置一个带有针状电极的超薄微型无电极线起搏器。
从图中可见， 超薄微型无电极线起搏器植入在心内膜上需要的部位。
图 4中， 当超薄微型无电极线起搏器植入需要心外膜上的相应部位时， 可借 助胸腔镜或在开胸手术时植入心脏外膜。
其左侧图示为植入单个超薄微型无电极线起搏器的示意图， 其右侧图示为植 入多个超薄微型无电极线起搏器的示意图。
从图中同样可见， 超薄微型无电极线起搏器植入在心外膜上需要的部位。 其余同图 3 。
图 5中， 本发明将电源、 起博器和电极整合为一体化结构， 呈可折叠 /展幵 结构， 由超簿微型电池 （图中以锂电池 2014表示）、 超低耗式电源电路、 无线收 /发电路、非接触型充电接收电路和应用电路（图中将这几部分统称为模块 2017 ) 结合， 构成超薄微型无电极线起搏器， 其一侧 /端设置有针状电极 2015， 其超簿 微型电池、 超低耗式电源电路、 无线收 /发电路、 非接触型充电接收电路和应用 电路之间用柔性线路带 /板连接， 可折叠、 展开或卷曲。
图中的磁铁 2018和绕在 Ti圈（线圈骨架） 2012上的线圈 2011， 构成无线发 射 /接收天线。
所有的检测、 控制电路 （如前述的超低耗式电源电路、 无线收 /发电路、 非 接触型充电接收电路和应用电路等）设置在柔性线路板 2016上 陶瓷片 2013构 成屏蔽层， 以免工作信号干扰针状电极 2015的检测和输出信号。 「
其超簿微型电池为可充电电池或永久电池。
图 6中， 在超薄微型无电极线起搏器的中部， 采用了设置两块 （亦可为四块 或六块等， 关键在于为偶数块） 锂电池的中分对称结构， 整个柔性线路板 2016 上设置有 2条或 4条折叠线 2017，大于电池横向截面积的柔性线路板除了承载和 连接相关电路之外， 还可充当吻合片， 图中在其四个角设置了固定针孔 201， 以 便于缝合固定和 /或防止脱落。 ' 由于采用了上述结构， 整个超薄微型无电极线起搏器呈可折叠 I展开结构， 使之能顺利地用折叠或卷曲的方式放入介入导管或胸腔镜中。
这将： 1 ) 便介入性植入；
2) 有足够的柔软性和可伸缩性来适应心脏的收缩和舒张。 根据不同用途， 我们设计了适用于 1 )心内膜起搏； 2)心外膜永久起搏； 和 3 ) 心外膜临时起搏等不同场合和用途的无电极线起搏器。
上述起搏器整体体积缩小的关键在于减小电池的体积， 目前， 最小的可充电 电池的体积.已经比 AA电池小 100倍， 但是是圆棒型的。 最小的扁型电池是厚 1.7mm, 直径 17mm。 我们在此基楚上将可充电 池的体积进一步縮小到： 厚 1.2mm, 直径 8mm以下。
同时， 发明人也设计了另一种采用非充电形式的电池， 其体积稍增大， 这样 也能达到可连续使用 10年以上的使用寿命。
本超薄微型无电极线起搏器包括三项关键性技术革命： 1 ) 超微型， 簿型， 永久或可充电电池； 2)超微型脉冲发生器； 3 ) 超微型电脑脉冲调控器； 这三者 结合构成一个小起搏器， 它可以直接植入心脏内或紧贴在心脏外膜上。
图 7中， 在超薄微型无电 Ϊ及线起搏器的一侧 /端设置有针状电极， 其针状电 极至少包括同轴、 多芯或多层设置的起搏电极 2021和生物传感电极 2020， 在起 搏电极与生物传感电极之间以及生物传感电极的外周， 设置了第一绝缘层 2023 和第二绝缘层 2022;'起搏电极的整体长度大于生物传感电极的整体长度；起搏电 极和生物传感电极的末端贯穿锂电池 2014后形成生物传感 /脉冲输出电极接口 2019, 该接口与设置在柔性线路板上的应用电路对应连接。
实际使用时， 针状电极插入心肌， 加上吻合片和固定针孔的 E合， 可防止超 薄微型无电极线起搏器的脱落， 亦可防止假信号的产生和不必要的电击。 图 8中， 提供了一种本发明的示范性电路构成方框图， 可见: f装置主要有超 薄微型无电极线起搏器、 心律调控遥控控制器和与 PC机连接的控制基站三大部 分构成。 ，
其超薄微型无电极线起搏器电路由超低耗式电源电路、 无线收 /发电路和应 用电路构成； ,
其心律调控控制器由多功能微电脑心律调控遥控控制器构成， 该遥控控制器 在电路上主要由唤醒电路 / RF转接电路 / A 模块和数据接口 I应用微控制器
I微处理器 I ADP模块构成， 为便携式或可植入式；
其控制基站由唤醒电路 / RF转接电路 / BSM模块、 无线信号接收 I发射电 路模块和数据接口 I应用微控制器 I微处理器 I ADP模块构成。
超薄微型无电极线起搏器和 /或多功 微电脑心律调控遥控控制器经过无 线网络与控制基站连接， 控制基站与计算机之间可采用有线或无线方式进行连 接、 数据交换和指令传递。
其多功能微电脑心律调控遥控控制器与至少一个（或多个）前述的超薄微型 无电极线起搏器所对应， 发出控制信号并接收其返回的信号， 综合调控， 使心律 再同步； 其多功能微电脑心律调控遥控控制器与各超薄微型无电极线起搏器之间 采用无线通讯连接。
出于对电源电池使用寿命和体积的考虑， 超薄微型无电极线起搏器还可设置 非接触型充电接收电路； 多功能微电脑心律调控遥控控制器也还可设置非接触型 充电接收和 /或发射电路。
其超薄微型无电极线起搏器的非接触型充电接收电路用于接收外置的非接 触型充电器对其进行的充电；
其多功能微电脑心律调控遥控控制器的非接触型充电接收电路用于接收外 置的非接触型充电器对其进行的充电；
其多功能微电脑心律调控遥控控制器的非接触型充电发射电路用于对超薄 微型无电极线起搏器进行充电。
" 采用如上设计的'目的， 是为了方便使用者， 即使用者可以用外置式非接触型 充电发射电路对超薄微型无电极线起搏器和多功能微电脑心律调控遥控控制器 进行充电， 也可先对多功能微电脑心律调控遥控控制器进行充电， 再由其对超薄 微型无电极线起搏器进行充电， 以满足不同使用者或不同场合的使用需求。
作为一种应用示范， 当多功能微电脑心律调控遥控控制器植入人体内时， 能 用作中间充电器， 其既可以接受外置的非接触型充电器对其进行的充电， 又可对 超薄微型无电极线起搏器进行充电， 进一步延长超薄微型无电极线起搏器内 置电池的工作 /使用寿命。 '
外置式非接触型充电发射电路可以是单独设置的， 也可与控 基站设置在一 起。
由于采用模块化的设计结构， 上述功能是易于实现的。
关于非接触型充电装置的技术和具体线路或工作原理， 可参考公告号为
CN2891444A的中国发明专利"一种非接触式充电器 "或公告号为 CN2682716Y的 中国实用新型专利"一种用于人体内医用装置的非接触式充电器"中的相关内容， 在此不再详述。
上述的多功能微电脑心律调控遥控控制器是可以便携式的 （如手机型， 手表 型等等）， 也可是体内植入式的。
它将具有三种主要功能： 1 )起搏； 2) 除颤； 3 ) 心脏再同步； 但是也可以
- 只有单功能和双功能的， 其选择的标准除了体积大小方面的考虑之外， 还要考虑 患者的实际治疗需求， 同样需要考虑的还包括制造成本方面的原因， 针对不同的 用户， 可以通过选择不同的功能模块来实现比较经济的购置和使用成本。
用作心脏再同步的多功能微电脑心律调控遥控控制器通常是多通道的， 因为 心脏再同步需要在心脏上植入多个超薄微型无电极线起搏器。
多通道（也被称为多信道）数据传送和控制技术为已有技术，在此不再叙述。 在图 9中， 进一步的描述了超薄微型无电极线起搏器.的应用电路的组成， 其 至少包括信号隔离和匹配电路、 生理传感器接收器、 微数据处理数据编程电路、 振荡电路和时间控制电路、 第一切换电路、 转换器电路、 状态与数据记录及控制 电路、 第二切换电路、 脉冲发生器电路和生物电监测系统电路；
其中， 信号隔离和匹配电路的输入端与电极 /天线、 第一切换电路和第二切 换电路连接， 生 ¾传感器与信号隔离和匹配电路和生理传感器接收器连接， 第一 切换电路的第 路输出端经生理传感器接收器与振荡电路和时间控制 路和微 数据处理数据编程电路连接， 第一切换电路的第二路输出端经转换器电路与状态 与数据记录及控制电路连接， 数据记录及控制电路的输出端与无线收 /发电路连 接， 第二切换电路的第一路输出端经脉冲发生器电路与无线收 /发电路连接， 第 二切换电路的第二路输出端经生物电监测系统电路与无线收 I发电路连接。
, 值得注意的是本图中所设置的生物电监测系统电路， 其主要在除颤过程中发 挥作用。
图 10中， 进一步的描述了超薄微型无电极线起搏器的低能耗传感器电路结 构， 在比较电路的控制下， 根据传感器所处 的不同工作状态 （或时序）， 该电 路中的各个开关依次有序地接通或断开， 使得整个传感器电路耗电量大大下降， 仅仅在需要检测和 /或传送生物信号期间才产生工作电流， 消耗电能， 而在其他 时段或时序中几乎不产生电能消耗。 '
为了有助于理解此技术， 可以参考奥地利人理査德佛塞斯 （Richard M Forsyth) 的文章 "Mixed-signal Integrated Circuits for Low Power, Battery Driven Applications" ( http://www.techonline.eom/learning/techpaper/l 97002893 或 http：〃 www.austriamicrosystems.com/02news/data/Austrochip2004_Villach— RForsyth.pd f)， 其中对低功耗的混合信号电路设计、优化实施各种电路模块以及具体实施电 路和整体集成的解决方案等均有详细的论述， 在此不再叙述。
图 11 中， 进一步的描述了多功能微电脑心律调控遥控控制器的电原理方框 图， 其包括经过数字通信总线连接的微型计算机电路模块和输入 /输出电路模 块； 其微型计算机电路模块至少包括微处理器、 系统时钟、 RAM、 ROM和 RAM I ROM控制单元； 其输入 I输出电路模块至少包括存储器、 编程 I时间控制 I 数字控制单元、 A / D转换器 /探测器单元、 传感 /过滤 /放大器电路、 电极配 置交换电路、 遥测电路 /接受器 / RF 转换单元、 电池电源充电 /处理系统、 电 压 I电流参考发生器、 监测 I测量系统多工器 ADC和无线收 I发电路；
其中， 编程 I时间控制 I数字控制单元分别与存储器和遥测电路 I接受器 I
RF 转换单元对应连接， 并经过 A I D转换器 /探测器单元和传感 I过滤 I放大 器电路与电极配置交换电路连接； 电极配置交换电路与无线收 /发电路连接， 双 向进行信号交换； 电池电源充电 I处理系统经过电压/电流参考发生器与编程 I 时间控制 I数字控制单元、监测 I测量系统多工器 ADC和无线收 I发电路连接。
本图中电压 /电流参考发生器比较重要， 其在信号接收和对外充电过程中均 扮演了一个重要的角色。 '
图 12 中， 具体给出了超低能耗生理电 号微处理电路的原理方框图， 其是 图 9中生理传感器接收器模块的进一步细化。
图 13中， 具体提供了电极配置交换电路的电路结构示意框图， 其是图 10中 ' 电极配置交换电路模块的进一步细化。
图 14 中， 详细提供了低能耗电池充电处理系统电路原理方框图， 其是图 8 中超低耗式电源电路的进一步细化。
由于上述附图中内容并未涉及超出本领域技术人员所能理解的范围， 故本领 域的普通技术人员完全可以理解上述附图所给出的含义和设计思路， 其具体细节 在此不再叙述。
为了更好地理解本发明的上述技术方案，可以参考公告号为 CN2569743Y的 中国实用新型专利"家用电脑的心电人工智能监护装置"、 公告号为 CN2836724Y 的中国实用新型专利 "远程实时心电保健预诊监护装置 "以及公告号 为 CN200977153Y 的中国实用新型专利 "†对高危心脏病患者的便携式远程实时 监护仪"。
更进一步的， 还可以参考国际专利申请号为 PCT/US99/24739, 国际专利申 请日为 1999年 10月 22 日， 在先申请日为 1998年 10月 22日， 在先申请号为 US 09/177,540， 发明名称为 "CIRCUIT AND METHOD FOR IMPLANTABLE DUAL SENSOR MEDICAL ELECTRICAL LEAD" 的 PCT申请， 以及国际专利申 、 请号为 PCT/US 1997/004840， 国际专利申请日为 1997年 3月 25日， 在先申请日 为 1996年 4月 23日，在先申请号为 US 08/636， 455，发明名称为 "LOW ENERGY PACING PULSE WAVEFORM FOR IMPLANTABLE PACEMAKER"的 PCT申请 中的相关内容。
需要注意的是， 上述诸文件只应看作有助于对本申请技术方案的理解， 而不 应看作是对本申请某些部分的某种限制。
图 15至图 20中， 公开了本发明整套装置比较常见的几种数据交换方式和控 制信号流向及其控制顺序。
图 15中，整套装置由 1个无电极线起搏器 201、 1个心律调控遥控控制器 501 和 1个控制基站 601构成，无电极线起搏器接收心律调控遥控控制器的控制信号， 并反馈所在部位的生理电信号， 心律调控遥控控制器与控制基站之间亦进行数据 交换和控制信号的传递， 心律调控遥控控制器接收控制基站的控制指令， 反馈被 监测对象的各种生理参数和指标， 并可根据预先设置好的 ¾据调控无电极线起搏 器的工作状态， 控制其起搏、 除颤和心律再同步。
其中， 无电极线起搏器与心律调控遥控控制器之间， 以及心律调控遥控控制 器与控制基站之间的数据传送和控制信号的传递均釆用无线通讯方式进行
图 16'中， 整套装置由 4个无电极线起搏器 201a ~ 201d 、 1个心律调控遥控 控制器 501和 1个控制基站 601构成， 各个无电极线起搏器分别接收心律调控遥 控控制器的控制信号， 并对 反馈所在部位的生理电信号， 心律调控遥控控制器 负责控制各个无电极线起搏器的运行， 其与控制基站之间亦进行数据交换和控制 信号的传递， 其余同图 15 。
图 17中， 整套装置由 1个无电极线起搏器 201和 1个控制基站 601构成， 无电极线起搏器直接接收控制基站的控制信号， 并反馈所在部位的生理电信号，. 由控制基站直接负责控制无电极线起搏器的运行， 并根据预年设置好的数据调控 无电极线起搏器的工作状态， 控制其起搏、 除颤和心律再同步。
图 i8中， 整套装置由 4个无电极线起搏器 201a〜 201d和 1个控制基站 601 构成， 各个无电极线起搏器直接接收控制基站对应的控制信号， 并分别反馈所在 部位的生理电信号， 由控制基站直接负责控制各个无电极线起搏器的运行， 其余 同图 17 。
图 19中， 整套装置由 4个无电极线起搏器 201a ~ 201d 、 1个心律调控遥控 控制器 501和 1个控制基站 601构成， 无电极线起搏器 201a首先接收心律调控 遥控控制器的控制信号，再将控制信号分别传输给无电极线起搏器 201b ~ 201d ， 无电极线起搏器 201a同时还接收无电极线起搏器 201b ~ 201d的反馈生理电信 号， 并统一传送给心律调控遥控控制器， 由其再传送给控制基站， 心律调控遥控 控制器通过无电极线起搏器 201a对其余无电极线起搏器进行数据交换和控制； 此时的无电极线起搏器 201a起到了一个中继和转发站的功能。
图 20中， 整套装置由 4个无电极线起搏器 201a ~ 201d和 1个控制基站 601 构成， 无电极线起搏器 201a直接接收控制基站的控制信号， 再将控制信号分别 传输给无电极线起搏器 201b ~ 201d ，无电极线起搏器 201a同时还接收无电极线 起搏器 201b ~ 201d的反馈生理电信号， 并统一传送给控制基站， 由控制基站通 过无电极线起搏器 201a对其余无电极线起搏器进行数据交换和控制； 同样， 此 时的无电极线起搏器 201a起到了一个中继和转发站的功能。
可见， 各个无电极线起搏器接收心律调控遥控控制器或控制基站的控制信 号， 并反馈所在部位的生理电信号； 而心律调控遥控控制器或控制基站负责控制 各个超薄微型无电极线起搏器的运行， 控制其起搏、 除颤和心律再同步。
综上， 本项发明包括了四方面的创造性突破：
1、 超薄微型无电极线起搏器： 它集电极， 电极线， 起搏器三者为一身。 其 中包括三项关键性技术革命： 1 ) 超微型， 簿型， 可充电或永久式电池； 2 ) 超微 型脉冲发生器； 3 ) 超微型电脑脉冲调控器； 这三者结合构成一个小电极体， 它 能弯曲或折叠， 可以通过介入和 I或微创的方式直接植入人体心脏内或心脏外¾ 面。
2、各种用途的超微型无线脉冲发生传递器的设计：有适用于 1 )心内膜起搏; 2) 心外膜永久起搏； 和 3 ) 心外膜临时起搏。
3、 多通道无线微型电脑心律调控控制器： 至少可以有三种主要功能： 1,)起 搏； 2) 除颤； 3 ) 心律再同步。
4、 无线微型电脑心律调控控制器的网络连接与控制： 1 ) 发射器； 2 ) 接收 器；' 3 ) 控制软件。
超薄微型无电极线起搏器 （起搏 /除颤 /心脏再同步） 的主要用途是： 维持 正常心律， 增强心脏收缩功能。
本发明可广泛用于各种有心律失常和心脏收缩功能不全的病人的治疗领域。 以上的各实施例仅仅是用来解释和说明本发明的， 而并非用作对本发明权利 要求之发明范围的限定， 本领域的普通技术人员， 完全可以在不背离本发明思路 和范围的情况下， 对本发明做出各种的变化或变形。
虽然在上文中描述了各要素 （诸如系统、 单元、 模块、 电路或构件）在某些 组合中所起的作用， 但应明确地理解， 所要求保护的组合中的一种或多种要素， 在某些情况下可从该组合中删除， 要求保护的组合可以是针对亚组合或亚组合的 变体。
特别认为，如本领域普通技术人员， 以现有知识或后来的设计所看到的那样， ' 对要求保护的主题进行的非实质性改变， 将同等地落在本申请权利要求的范围 内。 因此， 本领域普通技术人员目前或后来知道的明显替换， 也应属于已定义要 素的范围内。 、
因此应明白， 本申请的权利要求包括所有上述图解说明和描述的内容、 所有 概念上的等同物、 所有基本上掺入了本发明基本思路的明显替代物。
本领域的普通技术人员应当认识到， 只要在本发明的实质精神范围内， 对以 上各实施例的变化或变形， 都将落在本申请之权利要求所要求的保护范围内。 工业应用性
本发明将现有的起搏器与起搏电极合二为一， 无电极连接线， 其起搏器体积 小、 可折叠， 可通过介入和 /或微创的方式直接设置在心脏内或心外膜相应部位 上， 能进行相应生物电信号的检测，且具有起搏、除颤和心律再同步等多种功能， 可采用非接触式充电方式充电， 大大延长了植入人体内的装置的工作寿命， 减少 了其故障发生几率； 采用多功能微电脑' 1 律调控遥控控制器充当无线信号的中继
/中转站， 故植入体内的起搏器所需的发射、 接收功率和电能消耗大大降低， 有 助于延长其电源的工作时间和寿命； 整个心律调控装置可实现的功能更多， 能满 足更高的医疗 /治疗要求， 更加可靠、 实用， 可广泛用于各种有心律失常和心脏 收缩功能不全的病人的治疗领域。

Claims

权利 要 求 书
1. 一种无电极线超薄微型多功能心律调控装置， 包括心律调控控制器、位于 人体体内的电源、 起博器和电极， 其特征是：
其所述的电源、 起博器和电极为一体化结构， 由超簿微型电池、 超低耗式 电源电路、 无线收 /发电路和应用电路结合， 构成一带有微电脑心律调控系统、 具有心律调控和除颤功能的超薄微型无电极线库搏器， 所述的超薄微型无电极线 起搏^呈可折叠展开结构， 其一侧 /端设置有针状电极， 并整体构成一个小电极 体， 它可以通过介入和 I或 创的方式直接植入人体心脏内或心 外表面； 在人体心脏各个需要插入起博器电极的部位， 分别对应设置一个所述的带 有针状电极的超薄微型无电极线起搏器；
其心律调控控制器由多功能微电脑心律调控遥控控制器构成， 为便携式或 可植入式， 其与至少一个或多个所述的超薄微型无电极线起搏器所对应， 发出控 制信号并接收其返回的信号； .
其多功能微电脑心律调控遥控控制器与各超薄 型无电极线起搏器之间 无线通讯连接， 综合调控， 使心律再同步；
其超薄微型无电极线起搏器和 /或多功能微电脑心律调控遥控控制器经 过无线网络与控制基站连接， 控制基站与计算机连接。
2. 按照权 要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 所述的超薄微型无电极线起搏器还包括非接触型充电接收电路； 所述的多功能微 电脑心律调控遥控控制器还包括非接触型充电接收和 /或发射电路； 其超薄微型 无电极线起搏器的非接触型充电接收电路用于接收外置的非接触型充电器对其 进行的充电； 其多功能微电脑心律调控遥控控制器的非接触型充电接收电路用于 接收外置的非接触型充电器对其进行的充电； 其多功能微电脑心律调控遥控控制 器的非接触型充电发射电路用于对超薄微型无电极线起搏器进行充电；
其中， 当多功能微电脑心律调控遥控控制器植入人体内时， 能用作中间充 电器， 其既可以接受外置的非接触型充电器对其进行的充电， 又可对超薄微型无 电极线起搏器进行充电， 以进一步延长超薄微型无电极线起搏器内置电池的工 作 /使用寿命。
3. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 所述的针状电极至少包括同轴、 多芯或多层设置的起搏电极和生物传感电极， 在 起搏电极与生物传感电极之间以及生物传感电极的外周， 设置绝缘层; 起搏电极 : 的整体长度大于生物传感电极的整体长度； 起搏电极和生物传感电极的末端构成 生物传感 I脉冲输出电极接口， 接 ϋ与设置在柔性线路带 I板上的应用电路对应 '连接。
4. 按照权利要求 1或 2所述的无电极线超薄微型多功能心律调控装置，其特 征是所述的超簿微型电池、 超低耗式电源电路、 无线收 /发电路、 非接触型充电 接收电路和应用电路之间用柔性线路带 /板连接， 可折叠展开； 在超薄微型无电 极线起搏器的周围设置有吻合片， 吻合片上设置固定针孔， 以便于缝合固定和 / 或防止脱落。
.
5. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 万述的超簿微型电池为可充电电池或永久电池。
6. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 所述的应用电路至少包括信号隔离和匹配电路、 生理传感器接收器、 微数据处理 数据编程电路、 振荡电路和时间控制电路、 第一切换电路、 转换器电路、 状态与 数据记录及控制电路、 第二切换电路、 脉冲发生器电路和生物电监测系统电路； 其中， 信号隔离和匹配电路的输入端与电极 /天线、 第一切换电路和第二 切换电路连接， 生理传感器与信号隔离和匹配电路和生理传感器接收器连接， 第 一切换电路的第一路输出端经生理传感器接收器与振荡电路和时间控制电路和 微数据处理数据编程电路连接， 第一切换电路的第二路输出端经转换器电路与状 态与数据记录及控制电路连接， 数据记录及控制电路的输出端与无线收 /发电路 连接， 第二切换电路的第一路输出端经脉冲发生器电路与无线收 /发电路连接， 第二切换电路的第二路输出端经生物电监测系统电路与无线收 /发电路连接。
7. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 所述的多功能微电脑心律调控遥控控制器包括经过数字通信总线连接的微型计 算机电路模块和输入 /输出电路模块； 其微型计算机电路模块至少包括微处理 器、 系统时钟、 RAM、 ROM和 RAM / ROM控制单元； 其输入 /输出电路模块 至少包括存储器、编程 I时间控制 I数字控制单元、 A I D转换器 I探测器单元、 传感 /过滤 /放大器电路、 电极配置交换电路、 遥测电路 /接受器 / RF 转换单 元、 电池电源充电 /处理系统、 电压 /电流参考发生器、 监测 /测量系统多工器 ADC和无线收 /发电路； 其中， 编程 I时间控制 I数字控制单元分别与存储器和遥测电路 /接受器 I RF 转换单元对应连接， 并经过 A I D转换器 I探测器单元和传感 /过滤 /放 木器电路与电极配置交换电路连接； 电极配置交换电路与无线收 I发电路连接， 双向进行信号交换； 电池电源充电 I处理系统经过电压 I电流参考发生器与编程 I时间控制 I数字控制单元、 监测 I测量系统多工器 ADC和无线收 I发电路连 接。 .
8. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 " 所述的控制基站包括唤醒电路 I RF转接电路 BSM模块、无线收 I发电路模块和 数据接口 /应用微控制器 /微处理器 ADP模块； 控制基站与所述计算机之间采 用有线或无线方式进行连接、 数据交换和指令传递。
9. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置，其特征是 所述的超薄微型无电极线起搏器接收多功能微电脑心律调控遥控控制器或控制 基站的控制信号， 并反馈所在部位的生理电信号； 所述的多功能微电脑心律调控 遥控控制器或控制基站负责控制各个超薄微型无电极线起搏器的运行， 控制其起 搏、 除颤和心律再同步。
10. 按照权利要求 1所述的无电极线超薄微型多功能心律调控装置， 其特征 是所述的多功能微电脑心律调控遥控控制器通过无线网络与控制基站进行通讯， 接收控制指令， 反馈被监测对象的各种生理参数和指标， 并可根据预先设置好的 数据调控各超薄微型无电,极线起埒器的工作状态。
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