CN108187229A - A kind of controllable wireless heart pacemaker system of multi-electrode pace-making - Google Patents

A kind of controllable wireless heart pacemaker system of multi-electrode pace-making Download PDF

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Publication number
CN108187229A
CN108187229A CN201810069294.1A CN201810069294A CN108187229A CN 108187229 A CN108187229 A CN 108187229A CN 201810069294 A CN201810069294 A CN 201810069294A CN 108187229 A CN108187229 A CN 108187229A
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CN
China
Prior art keywords
electrode
pace
making
pacemaker system
pacemaker
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Pending
Application number
CN201810069294.1A
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Chinese (zh)
Inventor
张海军
侯文博
王燕
李建文
周文秀
房艺
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Individual
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Individual
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Priority to CN201810069294.1A priority Critical patent/CN108187229A/en
Publication of CN108187229A publication Critical patent/CN108187229A/en
Priority to CN201821430877.4U priority patent/CN209108422U/en
Priority to CN201811018379.3A priority patent/CN110064131A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/3621Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3622Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators

Abstract

The invention discloses a kind of controllable wireless heart pacemaker systems of multi-electrode pace-making, belong to electro photoluminescence medical instruments field.There are four pacemaker systems that this is wireless or multiple stay hooks, pacing electrode are located on the stay hook of implanted device, as long as one of stay hook is punctured can play the role of pace-making in cardiac muscle.The pacemaker system has electrode " compensatory " function, when single electrode is ineffective, another electrode of exchange can be controlled to be used to pace in vitro without carrying out second of operation.In addition, the pacemaker system uses chip(Such as 74LS148 etc.), can realize that four electrodes stimulate either wherein three electrode stimulatings either two of which electrode stimulating or any of which electrode stimulating, and stimulus intensity is adjustable simultaneously according to the usage quantity of the actual clinical situation remote control and regulation electrode of patient.Present system increases the probability of electrode target point contact cardiac muscle, reduce the risk perforated during Pacemaker implantation, reduce the number that myocardial necrosis patient is implanted into again, extend the service life of implanted device, stimulus intensity also can be different due to patient, all has great reference and application value to active implanted device.

Description

A kind of controllable wireless heart pacemaker system of multi-electrode pace-making
Technical field
The invention belongs to a kind of can regulating and controlling in vitro for the multi-electrode pace-making in medical instruments field more particularly to implantable Wireless heart pacemaker system.
Background technology
Pacemaker is a kind of by impulse generator granting electric pulse, is conducted by lead electrode, stimulation cardiac muscle makes Heart excitement and contraction are implanted in the electronic instrument of patient's body, are mainly used to treat the diseases such as arrhythmia cordis.Annual China has Nearly 250,000 pacemaker is implanted, and 700,000 pacemakers are implanted in the world.It is continuous with moulding process Research and development, pacemaker develop into wireless heart pacemaker from wired, are 9.7cm from volume3To 0.8cm3Miniaturization.
There are conducting wire pacemaker related complication caused by conducting wire such as electrode cable dislocation, infection, perforation, electrode to lead Thread breakage etc. frequently occurs.And it due to there is the volume of conducting wire pacemaker larger, is imbedded in hypodermic layer and forms pouch, pouch goes out Blood phenomenon is unavoidable.Though the wireless pacemaker of micromation is small, only there are one pacing electrode, when implantation position cardiac muscle is bad When can not extremely pace, need to carry out secondary change place implantation to patient, increase the probability of operating time and myocardial perforation.
The wireless heart pacemaker system of invention, there is multiple pacing electrodes, has both avoided because conducting wire and volume are big The various complication brought can also exchange another electrode pace-making in vitro, greatly when myocardial necrosis occurs in a certain electrode implantation position The success rate being once implanted into is improved greatly, reduces the probability of myocardial perforation.
Bulletin etc., which is announced, herein by retrieval Google, Pub med, Chinese patent finds several pertinent literatures and patent, Contrast difference is as follows:2012/0172690 A1 of patent of Medtronic publication in 2012, discloses a kind of novel radio cardiac pacing Device, it is small.Be different from the present invention be it only there are one pacing electrode, can not realize exchange function;CN 202490331 U A kind of multi-electrode wireless heart pacemaker, the patent are utility model, disclose a kind of the mostly electric of simultaneous pacing atrium and ventricle Pole cardiac pacemaker system.What is be different from the present invention is that multiple electrodes are only implanted to wall of the heart or outer wall by it, is not risen Device fight in itself.
Invention content
The present invention provides a kind of wireless heart pacemaker systems that can regulate and control in vitro of the multi-electrode pace-making in implantable System, pacemaker system that this is wireless mainly include battery, circuit, multiple stay hooks, multiple electrodes, wrap up shell of battery circuit etc. Part, electrode are located on stay hook, and the two quantity is equal.In addition, the pacemaker system can also be actually needed according to patient, it is real Existing multi-electrode stimulation, and stimulus intensity is adjustable.
The stay hook, quantity are 3 or 4, are made of the material with shape memory characteristic, can be Nitinol
The electrode is located at the minimum end position of hook circular arc, and stay hook, which is opened, in transmission process keeps maximum flexibility, bullet Property completely after release stay hook be pierced into fixed in cardiac muscular tissue, electrode is in inside cardiac muscular tissue.Pacing electrode is in spherical It is applied on stay hook, spherical electrode surface can reach the effect uniformly stimulated.The stay hook table being connected with electrode Face can cover coating material see-through under one layer of insulating coating, such as the high molecular materials, such as X-ray such as PEEK.
The circuit chip of the regulation and control electrode works as heart using two chips and logic gates (such as 74LS148) During a certain electrode implantation position myocardial necrosis of pacemaker, it can remotely be transposed to the electrode in active position and normally pace, thus The pacemaker system has " electrode conversion " function, can reduce the probability of myocardial perforation;In addition, this circuit can realize any electrode Either any two electrode stimulating either arbitrary three electrode stimulatings or any number of electrodes or stimulates simultaneously for stimulation, Preferably adapt to the clinical demand of different patients.Advantages of the present invention:Multiple electrodes are paced without conducting wire, have both solved wired pace-making Device because caused by conducting wire fatigue, dislocation, infection, fracture the problems such as, and for unitary electrode wirelessly pace-making reduce myocardial perforation Risk.
Description of the drawings
Fig. 1 is the position view of the potential heart of implanted device.
Fig. 2 is the controllable wireless heart pacemaker appearance diagram of multi-electrode.
Fig. 3 is the side view of wireless heart pacemaker stay hook.
Fig. 4 stay hook schematic cross-sections.
Fig. 5 is the status diagram that the stay hook with electrode is pierced into after cardiac intima.
Fig. 6 is the circuit connection diagram and truth table for regulating and controlling multi-electrode pace-making.
Specific embodiment
The technology that the present invention describes can be applied to the medical instrument of any electrode stimulating, such as gastric stimulator, defibrillator, Brain pacemaker, deep brain stimulator, subcutaneous nerve stimulation device and other forms stimulator.It is illustrated below according to diagram Embodiment:
Refer to Fig. 1, it is illustrated that be the position view of the potential heart of implanted device.Wireless heart pacemaker 10 passes through special biography Transfer device passes through tricuspid valve to be implanted in the cardiac muscle location that right ventricle 11 illustrates (a) by atrium dextrum 13, and electrode is against in the internal membrane of heart Send out cardiac stimulating pulse pace-making.If clinical setting occurs:Implanted device implantation position patient is with myocardial necrosis, cardiac muscle knot Scab situation such as Fig. 1 (b) dotted lines round frame, 2,3, No. 4 electrodes cannot work, but do not need to be implanted into again at this time, and No. 1 electrode can be sent out Wave pace-making effect.
The multi-electrode wireless heart pacemaker schematic diagram of invention refers to Fig. 2.Implantation type wireless pacemaker 10 include battery 15, circuit 16, hook-shaped fixed component 17, the electrode 18 on fixed component, the quantity of electrode 18 It is consistent with the quantity of fixed component 17.The mechanical means such as laser welding can be used in electrode 18 and the connection mode of fixed component 17. The material of fixed component 17, which can be used, has the function of shape memory and elastomeric Nitinol, can on the surface of fixed component 17 Anti-inflammation drugs are coated with, prevents from rubbing for a long time and causes myocardial inflammation.The painting of TiN matrixes added Oxides can be used in the material of electrode 18 Layer, the shape of electrode 18 are hung on as mushroom head on implanted device fixation, and smooth surface can be both played in cardioprotection Film acts on, and can accomplish uniform electro photoluminescence.
The specific implementation details of electrode 18 and fixed component 17 are referring to Fig. 3, the side of wireless heart pacemaker fixed component Figure, the development length 21 of bending angle 20 and hook including hook, can be smoothly inserted into cardiac muscle for guarantee hook can be hook Arcuation is made in the end of son, reduces forced area increase and inserts power.The design of the curved shape of fixed component can be multi-standard, The cardiac muscular tissue of patient is had to penetrate through during elasticity is discharged, length 21 needs sufficiently large to overcome the bullet of cardiac muscular tissue thus Property, while bending angle 20 will also ensure that hook reaches certain elasticity and ensures that hook is pierced into after cardiac muscular tissue wearing successfully Go out.Bending angle 20 may be provided at 160To 180Between, bending radius is arranged between 1.7mm to 2.0mm, and length 21 is set Between 3.7mm to 4.0mm.
Stay hook 17 needs to be arranged to certain radian according to power, is designed to ellipse in nearly one end section of pacemaker, has The circular hole 25 of two same sizes, such as the schematic cross-section of Fig. 4 stay hooks.Purpose is that lead is drawn through from circuit in stay hook Circular hole 25 be connected with electrode 16.Two circular holes draw two leads, reduce the risk of electrode failure.
Electrode 18 is mounted on the bottom most position that about stay hook 17 is bent, and discharges flexible fastening completely in the heart in stay hook After flesh, electrode 18 is placed exactly in inside cardiac muscular tissue 19, and the stay hook with electrode 18 is pierced into the state signal after cardiac intima Fig. 5.
The realization of 74LS148 encoders can be used in the remote control and regulation of multi-electrode 18, can also be realized by other stored program control systems.Its core The circuit diagram and truth table of piece are shown in Fig. 6 (a), 6 (b).The pin D of two chips0~D7Respectively as input terminal I0~I15, finally under Four output terminals at end are respectively A, B, C, D, control four electrodes of wireless heart pacemaker, and low level represents effective.Such as When Enable Pin is effective, low level or high level are inputted, four electrodes can send out electro photoluminescence effect;Such as work as Enable Pin During for high level, I14Input low level, I15, it can be achieved that tri- electrodes of A, B, C play stimulation during input high level, and it is another An outer electrode does not play a role;Such as when Enable Pin be high level, input terminal I8For low level, I9~I15It, can when being high level Realize that mono- electrode of A plays stimulation, other three electrodes are in state undetermined;Such as I10For low level, I11~I15It is , it can be achieved that two electrodes play effect of stimulation, etc. during high level.Electrode can be regulated and controled according to the actual clinical situation of patient with this Quantity, also can when uncontrollable failure occurs for electrode without carry out second perform the operation in the case of be adjusted to another in time One electrode reduces the pain of patient, shortens operating time, extends the service life of implanted device.

Claims (5)

1. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making, it is characterised in that:Pacemaker system that this is wireless has Have " electrode conversion " function including battery, circuit, multiple stay hooks, multiple electrodes, wraps up the casing part of battery circuit, Middle implanted device internal cell is connected with internal circuit, and external pacing electrode is located on the stay hook of implanted device;Wherein control The circuit of multi-electrode conversion processed uses 74LS148 and logic gates.
2. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: Multiple stay hooks, as long as one of stay hook is punctured can play the role of pace-making in effective cardiac muscle, pacing electrode quantity with Stay hook quantity is equal.
3. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: There are two through-holes, circuit inner lead inside stay hook to be connect by through-hole with electrode, so as to which electrode be made to receive pulse, reaches Laser welding technology can be used in the effect of stimulation pacing, connection mode.
4. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: The quantity and intensity of pacing electrode can be adjusted according to patient's actual clinical demand, any one pace-making or arbitrary two can be used A electrode pace-making or arbitrary three electrodes pace-making can even accomplish while four electrode pace-makings.
5. a kind of controllable wireless heart pacemaker system of multi-electrode pace-making as claimed in claim 1, it is characterised in that: It can in vitro be exchanged into the case where not removing implanted device when some electrode implantation position of implanted device has myocardial necrosis The electrode of another active position normally paces.
CN201810069294.1A 2018-01-24 2018-01-24 A kind of controllable wireless heart pacemaker system of multi-electrode pace-making Pending CN108187229A (en)

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CN201810069294.1A CN108187229A (en) 2018-01-24 2018-01-24 A kind of controllable wireless heart pacemaker system of multi-electrode pace-making
CN201821430877.4U CN209108422U (en) 2018-01-24 2018-09-03 A kind of controllable wireless heart pacemaker of multi-electrode pace-making
CN201811018379.3A CN110064131A (en) 2018-01-24 2018-09-03 A kind of controllable wireless heart pacemaker system and production method of multi-electrode pace-making

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CN201821430877.4U Active CN209108422U (en) 2018-01-24 2018-09-03 A kind of controllable wireless heart pacemaker of multi-electrode pace-making
CN201811018379.3A Pending CN110064131A (en) 2018-01-24 2018-09-03 A kind of controllable wireless heart pacemaker system and production method of multi-electrode pace-making

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109568793A (en) * 2018-12-25 2019-04-05 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker and without conducting wire pacing system
CN109745619A (en) * 2019-01-23 2019-05-14 深圳大学 pacemaker control system and control method
CN110064131A (en) * 2018-01-24 2019-07-30 张海军 A kind of controllable wireless heart pacemaker system and production method of multi-electrode pace-making
CN110152191A (en) * 2019-05-22 2019-08-23 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker
CN110585589A (en) * 2019-09-05 2019-12-20 复旦大学附属中山医院 Multi-electrode lead for cardiac pacing and manufacturing and using methods thereof
CN111420274A (en) * 2020-04-03 2020-07-17 复旦大学附属中山医院 Fixing device and pacing electrode lead thereof
CN110585589B (en) * 2019-09-05 2024-04-19 复旦大学附属中山医院 Multi-electrode lead for cardiac pacing and manufacturing and using methods thereof

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CN117504137B (en) * 2024-01-05 2024-03-12 山东瑞安泰医疗技术有限公司 Cardiac pacemaker fixing device and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6640135B1 (en) * 2000-04-06 2003-10-28 Cardiac Pacemakers, Inc. Apparatus and method for spatially and temporally distributing cardiac electrical stimulation
CN202490331U (en) * 2012-03-21 2012-10-17 杭州凯健医疗器械有限公司 Wireless multi-electrode cardiac pacemaker
CN205287255U (en) * 2015-12-24 2016-06-08 西华大学 Interactive cardiac pacemaking system
CN108187229A (en) * 2018-01-24 2018-06-22 张海军 A kind of controllable wireless heart pacemaker system of multi-electrode pace-making

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110064131A (en) * 2018-01-24 2019-07-30 张海军 A kind of controllable wireless heart pacemaker system and production method of multi-electrode pace-making
CN109568793A (en) * 2018-12-25 2019-04-05 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker and without conducting wire pacing system
CN109568793B (en) * 2018-12-25 2023-08-04 创领心律管理医疗器械(上海)有限公司 Leadless pacemaker and leadless pacing system
CN109745619A (en) * 2019-01-23 2019-05-14 深圳大学 pacemaker control system and control method
CN110152191A (en) * 2019-05-22 2019-08-23 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker
CN110152191B (en) * 2019-05-22 2023-06-16 创领心律管理医疗器械(上海)有限公司 Leadless pacemaker
CN110585589A (en) * 2019-09-05 2019-12-20 复旦大学附属中山医院 Multi-electrode lead for cardiac pacing and manufacturing and using methods thereof
CN110585589B (en) * 2019-09-05 2024-04-19 复旦大学附属中山医院 Multi-electrode lead for cardiac pacing and manufacturing and using methods thereof
CN111420274A (en) * 2020-04-03 2020-07-17 复旦大学附属中山医院 Fixing device and pacing electrode lead thereof

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CN209108422U (en) 2019-07-16
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