Single-cavity anti-heart-failure pacing system and method based on single-left-ventricle pacing dynamic fusion self-excitation
阅读说明：本技术 基于单左室起搏动态融合自身激动的单腔抗心衰起搏系统及方法 (Single-cavity anti-heart-failure pacing system and method based on single-left-ventricle pacing dynamic fusion self-excitation ) 是由 蒲里津 金华 马雪娟 陈小龙 赵玲 华宝桐 王静 赵璐露 于 2021-09-23 设计创作，主要内容包括：本发明提供了基于单左室起搏动态融合自身激动的单腔抗心衰起搏系统,包括单腔起搏脉冲发生器,和植入左室侧或侧后静脉的左室起搏电极,其特征在于：左室电极于冠状窦近端识别A波、V波并同时满足固定稳定,左室电极在冠状窦近端呈预塑大S型,在S型的顶及底部设置4个兼有感知及起搏功能的位点,在左室电极头端为起搏位点仅具备起搏功能,当钢丝退出后恢复预塑S型,可检测满足感知及起搏功能要求的任一个位点进行程控实现识别A波、V波及起搏心房,左室电极头端仅设置起搏功能。本发明能代替目前进口三腔抗心衰起搏系统,可将治疗费用降低70％,对减少患者及医保的经济负担,节约有限的医疗资源用于救治更多患者。(The invention provides a single-chamber anti-heart failure pacing system based on single-left chamber pacing dynamic fusion self-excitation, which comprises a single-chamber pacing pulse generator and a left chamber pacing electrode implanted in the left chamber side or the lateral posterior vein, and is characterized in that: the left ventricular electrode identifies A waves and V waves at the proximal end of the coronary sinus and simultaneously meets the requirements of fixation and stability, the left ventricular electrode is in a pre-molded large S shape at the proximal end of the coronary sinus, 4 sites with sensing and pacing functions are arranged at the top and the bottom of the S shape, the pacing site only has the pacing function at the head end of the left ventricular electrode, the pre-molded S shape is recovered after the steel wire is withdrawn, any site meeting the requirements of the sensing and pacing functions can be detected and programmed to realize the identification of the A waves and the V waves and the pacing atrium, and the head end of the left ventricular electrode is only provided with the pacing function. The invention can replace the imported three-cavity anti-heart failure pacing system at present, can reduce the treatment cost by 70 percent, reduce the economic burden of patients and medical insurance, and save limited medical resources for curing more patients.)
1. Based on single left ventricle pace-making dynamic fusion self excited single chamber anti heart failure pace-making system, including single chamber pace-making pulse generator with implant left ventricle side or the left ventricle pace-making electrode of side back vein, its characterized in that: the left ventricular electrode identifies A waves and V waves at the proximal end of the coronary sinus and simultaneously meets the requirements of fixation and stability, the left ventricular electrode is in a pre-molded large S shape at the proximal end of the coronary sinus, 4 sites with sensing and pacing functions are arranged at the top and the bottom of the S shape, the pacing site only has the pacing function at the head end of the left ventricular electrode, the pre-molded S shape is recovered after the steel wire is withdrawn, any site meeting the requirements of the sensing and pacing functions can be detected and programmed to realize the identification of the A waves and the V waves and the pacing atrium, and the head end of the left ventricular electrode is only provided with the pacing function.
2. The method for dynamically fusing self-excited single-cavity anti-heart-failure pacing system based on single left ventricular pacing is characterized by comprising the following specific steps of:
the lower limit frequency interval is 1000ms, the sensitivity is divided into two levels of 4.5mv and 1.5mv, the default initial sensitivity of the system is 4.5mv, and the two levels of sensitivity alternately operate to identify A waves and V waves after an initialization program is operated, and the definition is as follows: based on the sensitivity SA defaults to 4.5mv, the wave A can be identified through program control, and then based on the sensitivity SV, the wave V can be identified through program control and defaults to 1.5 mv.
S101: running SA to identify the n-2A wave, denoted An-2；
S102: starting a refractory period of 120 ms;
s103: running SV identification Vn-2；
S104: measurement An-2-Vn-2Interval, marked as AVDn-2；
S105: running SA to identify the (n-1) th A wave, denoted An-1；
S106: measurement An-2-An-1Interval of time;
s107: turning on AVDn-2VI (ms) refractory period;
s108: opening a 2 XVIms V wave identification window at the end of the refractory period to operate SV identification V waves and recording as Vn-1；
S109: measurement An-1-Vn-1Interval, marked as AVDn-1；
S110: opening An-2-An-1Interval-AVDn-1-AI refractory period (ms);
s111: opening a 2 multiplied by AImsA wave identification window at the end of a refractory period to operate SA identification An;
s112: AVIn ═ AVD operationn-1×ε。
3. The method of a single-chamber anti-heart-failure pacing system based on single-left-chamber pacing dynamic fusion self-activation according to claim 2, characterized in that:
after the A wave and the V wave are identified, a refractory period is started, meanwhile, in order to ensure that the expected next A wave and V wave can be correctly identified, the maximum values of the differences of the A-A interval and the AVD between two adjacent heart beats are respectively defined as AI, default 40ms and programmable, and VI is default 20ms and programmable, namely after the A wave and the V wave are identified, the sensing window (lasting 2 xAIms and 2 xVI ms respectively) of the next A wave and the V wave must be in the previous A-The A interval and AVD value are opened when AI and VI are subtracted, i.e. the refractory period is An-2-An-1Interval-AVDn-1AI or AVDn-2－VI。
4. The method of a single-chamber anti-heart-failure pacing system based on single-left-chamber pacing dynamic fusion self-activation according to claim 2, characterized in that: the pacing system AVIn ═ AVD n-1 × epsilon, and epsilon defaults to 0.65, programmable, atrial sense compensation defaults to 30 ms.
5. The method of a single-chamber anti-heart-failure pacing system based on single-left-chamber pacing dynamic fusion self-activation according to claim 3, characterized in that: the nth optimized AVI is defined as AVIn, the previously measured self AVD is defined as AVD n-1, n is heart beat series, and n is more than or equal to 3.
6. A computer storage medium, on which a computer program is stored which, when being executed by a processor, carries out the steps of the method according to claims 2-5.
Technical Field
The invention belongs to the field of biomedical signal processing, and particularly relates to a single-cavity anti-heart failure pacing system and method based on single left ventricular pacing dynamic fusion self-excitation.
Background
The key core technology of heart resynchronization therapy pacing system (CRT-P) heart failure resistance therapy is mastered in foreign companies, at present, no heart failure resistance pacing system with domestic independent intellectual property right exists, the price monopoly causes the cost of implanting the imported CRT-P system to be expensive, a large amount of medical resources are consumed, heavy economic burden is brought to national medical insurance and families of patients, and in countries and regions with underdeveloped economy, a plurality of Chronic Heart Failure (CHF) patients often have to give up heart failure resistance pacing therapy due to economic difficulty; the right ventricular electrode implantation of the imported three-cavity CRT-P system needs to pass through the tricuspid valve, so that the closure of the tricuspid valve can be influenced, the reflux is caused, and the cardiac insufficiency can be induced and aggravated; in addition, not only are the complexity and risks of ray exposure and operation increased by implanting three electrodes through subclavian veins, but also the volume of the three-cavity pacing system is larger, vascular complications and capsular bag infection risks are increased, and the trend that electrode implantation becomes the development of the pacing technology is reduced as much as possible, for example, recently, a leadless pacemaker developed abroad for treating bradycardia is applied to clinic; the software and hardware design of the three-cavity and double-cavity pacing system is more complex than that of the single-cavity system, and the cost is higher than that of the single-cavity pacing system by more than 2-3 times. The atrioventricular node and right-sided his-pump system of CHF patients undergoing anti-heart failure pacing therapy are normally conducting, and the right ventricle may be excited by itself by descent without pacing. The traditional left ventricular electrode is implanted through a coronary venous system without passing through a tricuspid valve, the coronary vein is positioned in the left atrioventricular groove, an electrode which enters a certain distance from a coronary sinus ostium into the far end of the left ventricular electrode can simultaneously record atrial (A) wave, ventricular (V) wave and self atrioventricular conduction time (AVD), so that the research and development of a left ventricular electrode with a sensing function at the near end of the coronary sinus can sense the self AVD, and then the optimal atrioventricular interval (AVI) for single left ventricular pacing and self-descending activation fusion can be calculated based on the AVD to realize pacing anti-heart failure treatment. The single-cavity CRT system based on the fusion of the AVI of the automatic optimization pacing system and the self excitation normally downloaded from the right Hippon system can reserve the physiological AVD function of the atrioventricular node and restore the physiological excitation sequence of the right ventricle, and is more physiological; because the implantation of the right ventricle and the right atrium electrode is not needed, the risks of tricuspid valve regurgitation and atrial fibrillation and heart failure induction caused by the implantation of the right ventricle electrode are completely avoided, and the method has important significance for improving the response rate of CRT and improving the cardiac function, life quality and prognosis of CHF patients. The invention creatively establishes a solution for realizing the CRT by replacing an imported three-cavity CRT-P system with a domestic single cavity, can reduce the cost of the CRT by 70 percent, reduces the average 8 ten thousand of the imported three-cavity CRT-P system to 2 thousand, can greatly reduce the economic burden of patients and national medical insurance, saves limited medical resources for treating more CHF patients, and particularly has important popularization value and wide application prospect in developing countries and regions with underdeveloped economy. The system solves the dilemma of a domestic CRT-P system without independent intellectual property, accords with the national level, strengthens original innovation and leadability, is a key technology, points to the guidance of the current urgent need for solving and having long-distance requirements, can solve the situation that the current domestic anti-heart-failure pacing therapy completely depends on import, and has important significance for improving the domestic research and development capability and the influence at home and abroad in the field.
Disclosure of Invention
The invention aims to provide a single-cavity heart failure resisting pacing system and a single-cavity heart failure resisting pacing method based on pacing and self-excitation fusion so as to achieve the purpose of realizing the resynchronization therapy of heart failure by the excitation fusion of pacing and self-downloading.
The technical scheme of the invention is as follows:
the invention provides a single-chamber anti-heart failure pacing system based on single left chamber pacing dynamic fusion self-excitation, which comprises a single-chamber pacing pulse generator and a left chamber pacing electrode implanted into the left chamber side or the lateral posterior vein, wherein the left chamber electrode identifies A waves and V waves at the proximal end of coronary sinus and simultaneously satisfies fixation and stability, the left chamber electrode is in a pre-plastic large S shape at the proximal end of the coronary sinus, 4 sites with sensing and pacing functions are arranged at the top and the bottom of the S shape, the pacing site at the head end of the left chamber electrode only has the pacing function, when the steel wire is withdrawn and the pre-plastic S shape is restored, any site meeting the requirements of the sensing and pacing functions can be detected for program control to realize identification of the A waves and the V waves and the atrium, and the head end of the left chamber electrode only has the pacing function.
In a second aspect, the invention provides a method for a single-chamber anti-heart failure pacing system based on single-left-chamber pacing dynamic fusion self-excitation, which comprises the following specific steps:
the lower limit frequency interval is 1000ms, the sensitivity is divided into two levels of 4.5mv and 1.5mv, the default initial sensitivity of the system is 4.5mv, and the two levels of sensitivity alternately operate to identify A waves and V waves after an initialization program is operated, and the definition is as follows: an a-wave is identified based on the sensitivity SA (4.5 mv by default, programmable), followed by a V-wave is identified based on the sensitivity SV (1.5 mv by default, programmable).
S101: running SA to identify the n-2A wave, denoted An-2；
S102: starting a refractory period of 120 ms;
s103: running SV identification Vn-2；
S104: measurement An-2-Vn-2Interval, marked as AVDn-2；
S105: running SA to identify the (n-1) th A wave, denoted An-1；
S106: measurement An-2-An-1Interval of time;
s107: turning on AVDn-2VI (ms) refractory period;
s108: and opening a 2 XVI ms V wave identification window at the end of the refractory period to operate an SV identification V wave, and recording as Vn-1；
S109: measurement An-1-Vn-1Interval, marked as AVDn-1；
S110: opening An-2-An-1Interval-AVDn-1-AI refractory period (ms);
s111: opening a 2 xAI msA wave identification window at the end of the refractory period to operate SA identification An;
s112: AVIn ═ AVD operationn-1×ε。
Preferably, upon recognition of a and V waves, a refractory period will be initiated, while to ensure correct recognition of the expected next a-wave and V-wave, the maximum values of the difference between a-a interval and AVD between two adjacent heart beats are defined as AI (40 ms default, programmable) and VI (20 ms default, programmable), respectively, i.e. after recognition of a-wave and V-wave, the next a-wave and V-wave sensing window must be opened when the previous a-a interval and AVD values are subtracted from AI and VI, i.e. the refractory period is an-2-An-1Interval-AVDn-1AI or AVDn-2－VI。
Preferably, the pacing system AVIn ═ AVD n-1 × epsilon, and epsilon defaults to 0.65, programmable, atrial sense compensation defaults to 30 ms.
Preferably, the nth optimized AVI is defined as AVIn, the previously measured self AVD is defined as AVD n-1, n is the heart beat series, and n ≧ 3.
In a third aspect, the invention provides a computer storage medium having a computer program stored thereon, wherein the program, when executed by a processor, performs the steps of the method of the second aspect.
Compared with the prior art, the method has the beneficial effects that
The system can replace the imported three-cavity anti-heart failure pacing system at present, can reduce the treatment cost by 70 percent, has important significance and application value for reducing the economic burden of patients and medical insurance, saving limited medical resources and treating more patients, and popularizing underdeveloped developing China.
Drawings
Fig. 1 is a flow chart of an AVI algorithm optimized by a single-chamber anti-heart failure pacing system.
Detailed Description
The following description of specific embodiments of the present invention is provided in connection with examples to facilitate a better understanding of the present invention.
Examples
Hardware preparation: the single-cavity pacing pulse generator is based on a domestic Qinming 8631 single-cavity pacing pulse generator.
As shown in fig. 1, the present embodiment provides a single-chamber anti-heart failure pacing system based on single left ventricular pacing dynamic fusion self-activation, which includes a single-chamber pacing pulse generator and a left ventricular pacing electrode implanted in the left ventricular side or the lateral posterior vein, wherein the left ventricular electrode recognizes a-wave and V-wave at the proximal end of the coronary sinus and simultaneously satisfies fixation and stabilization, the left ventricular electrode is pre-molded in a large S-shape at the proximal end of the coronary sinus, 4 sites having both sensing and pacing functions are disposed at the top and bottom of the S-shape, the pacing site at the head end of the left ventricular electrode only has a pacing function, when the steel wire is withdrawn and the pre-molded S-shape is restored, any one site satisfying the requirements of the sensing and pacing functions can be detected for program control to recognize a-wave, V-wave and atrial, and the pacing function is only disposed at the head end of the left ventricular electrode.
The working method of the single-cavity anti-heart failure pacing system based on the single-left-chamber pacing dynamic fusion self-excitation comprises the following specific steps:
the lower limit frequency interval is 1000ms, the sensitivity is divided into two levels of 4.5mv and 1.5mv, the default initial sensitivity of the system is 4.5mv, and the two levels of sensitivity alternately operate to identify A waves and V waves after an initialization program is operated, and the definition is as follows: a wave identified based on the sensitivity SA (default 4.5mv, programmable) followed by a wave identified based on the sensitivity SV (default 1.5mv, programmable); after A and V waves are identified, a refractory period is started, and in order to ensure that the expected next A wave and V wave can be correctly identified, the maximum value of the difference between the A-A interval and the AVD between two adjacent heart beats is defined as AI, default 40ms and can be programmed, and VI is default 20ms and can be programmed, namely after A wave and V wave are identified, the next A wave and V wave sensing window (respectively lasting 2 xAI ms and 2 xVI ms) must be opened when the previous A-A interval and AVD value are reduced by AI and VI, namely, the refractory period is An-2-An-1Interval-AVDn-1AI or AVDn-2－VI。
S101: running SA to identify the n-2A wave, denoted An-2；
S102: starting a refractory period of 120 ms;
s103: running SV identification Vn-2；
S104: measurement An-2-Vn-2Interval, marked as AVDn-2；
S105: running SA to identify the (n-1) th A wave, denoted An-1；
S106: measurement An-2-An-1Interval of time;
s107: turning on AVDn-2VI (ms) refractory period;
s108: and opening a 2 XVI ms V wave identification window at the end of the refractory period to operate an SV identification V wave, and recording as Vn-1；
S109: measurement An-1-Vn-1Interval, marked as AVDn-1；
S110: opening An-2-An-1Interval-AVDn-1-AI refractory period (ms);
s111: opening a 2 xAI msA wave identification window at the end of the refractory period to operate SA identification An;
s112: AVIn ═ AVD operationn-1×ε。
The pacing system AVIn ═ AVDn-1X epsilon and epsilon defaults to 0.65, programmable, atrial sense compensation defaults to 30 ms.
Defining the nth optimized AVI as AVIn and defining the previously measured self AVD as AVDn-1N is heart beat series, n is not less than 3.
The working principle of the invention is as follows: the designed left ventricular electrode is in a pre-molded large S shape at the near end of the coronary sinus, 4 sites with sensing and pacing functions are arranged at the top and the bottom of the S shape, the pacing site is arranged at the head end of the left ventricular electrode, the pre-molded S shape is recovered after the steel wire is withdrawn, A waves, V waves and AVD of the left ventricular electrode can be identified in the coronary sinus, and any site meeting the sensing requirement is sensed and paced through program control detection. The degree of priority of left ventricular activation over self AVD is defined as the left ventricular priority coefficient (epsilon, default 0.65, programmable), namely the percentage of the pacing system optimized AVI to self AVD, namely epsilon is the optimized AVI/self AVD, based on the Qinming 8631 single-cavity pacing system, the sensitivity is divided into two grades of 4.5mv and 4.5mv1.5mv, load and beat by beat and discern self A wave, V wave and determine algorithm of self AVD, run initialization program back run two grade of sensitivity alternatively in order to discern A wave and V wave respectively, what discerned based on A wave sensitivity (SA, acquiesce 4.5mv, can programme-controled) is A wave, then what discerned based on V wave sensitivity (SV, acquiesces 1.5mv, can programme-controled) is V wave, can measure the time interval between two adjacent A waves and V wave automatically namely the AVD of self at the same time, the AVD of self will change with the heart room period, this system will beat by beat based on self AVD of the previous heart beat according to the algorithm, the best AVI of the pacing system, namely AVIn ═ AVDn-1And x epsilon (wherein epsilon defaults to 0.65, can be programmed and can also be obtained through titration optimization after the pacing system is implanted) so as to achieve the aim of realizing the resynchronization treatment of the heart failure by pacing and self-downloaded activation fusion.
While the foregoing is directed to the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.
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