（一）技术领域(1) Technical field
本发明属于医疗器械技术领域，特别涉及一种双心室全人工心脏装置。The invention belongs to the technical field of medical devices, and particularly relates to a biventricular total artificial heart device.
（二）背景技术(2) Background technology
随着全球人口老龄化程度不断加剧，心血管疾病的发病率正处于上升阶段，而心血管疾病的终末病程就是心衰，全称为心力衰竭，是指在适量静脉回流的情况下，由于心肌细胞舒张和（或）收缩功能障碍，心排血量不足以维持各器官组织代谢需要而引起的以循环功能障碍为主的综合征，临床上以心排血量降低，器官组织血液灌流减少以及肺循环和（或）体循环静脉淤血为特征。根据《2023中国心衰行业白皮书》数据显示，2000年到2015年间，我国心衰患者的患病率增加了44%，每年约有50万左右的新增心衰患者，其中约有5%的患者会进展为难治性终末期心衰。而现有市场上针对难治性终末期心衰患者，心脏移植被认为是最佳的有效的治疗方案。据《中国心血管健康与疾病报告2020》，我国心血管疾病患病人数约为3.3亿，其中心力衰竭患者约890万人。根据我国心脏移植注册系统数据，截至2022年，我国共有72所医疗机构具备心脏移植资质，但由于供体的极度短缺，使每年心脏移植手术的数量与难治性心衰患者数量之间还存在着巨大的差距，仅很少的一部分心衰患者有望接受心脏移植手术。As the global population continues to age, the incidence of cardiovascular disease is on the rise, and the terminal course of cardiovascular disease is heart failure, which is called heart failure. A syndrome mainly caused by circulatory dysfunction caused by cell relaxation and/or systolic dysfunction and insufficient cardiac output to maintain the metabolic needs of various organs and tissues. Clinically, it is characterized by reduced cardiac output, reduced blood perfusion of organs and tissues, and It is characterized by venous congestion in the pulmonary circulation and/or systemic circulation. According to data from the "2023 China Heart Failure Industry White Paper", the prevalence of heart failure patients in my country increased by 44% from 2000 to 2015. There are about 500,000 new heart failure patients every year, of which about 5% Patients will progress to refractory end-stage heart failure. On the current market, heart transplantation is considered the best and most effective treatment option for patients with refractory end-stage heart failure. According to the "China Cardiovascular Health and Disease Report 2020", the number of people suffering from cardiovascular diseases in my country is about 330 million, of which about 8.9 million are patients with heart failure. According to data from my country's heart transplant registration system, as of 2022, a total of 72 medical institutions in my country are qualified for heart transplantation. However, due to the extreme shortage of donors, there is still a gap between the number of heart transplant surgeries each year and the number of patients with refractory heart failure. There is a huge gap, and only a small proportion of heart failure patients are expected to receive a heart transplant.
在心脏供体极度缺乏的情况下，机械循环支持装置是可以替代心脏部分功能的装置，能够为心力衰竭末期患者提供有效的帮助，给终末期心衰患者带来新的生存希望。其基本原理就是辅助或替代衰竭的心脏，完成人体的血液循环，使之能够满足人体血流动力学。When there is an extreme shortage of heart donors, mechanical circulatory support devices are devices that can replace part of the heart's functions. They can provide effective help to patients with end-stage heart failure and bring new hope for survival to patients with end-stage heart failure. Its basic principle is to assist or replace the failing heart to complete the human body's blood circulation so that it can meet the human body's hemodynamics.
机械循环支持装置包括全人工心脏和心室辅助系统。目前，在国内尚未有全人工心脏用于临床，国内医疗机构治疗心衰的临床应用多采用心脏辅助装置，也称心室辅助装置。但由于心脏左右心室的不同结构，当前心室辅助装置多只能用于左心室辅助。对用于右心室辅助应用是否会对患者产生其他的不良影响，还需要进一步临床研究和验证。Mechanical circulatory support devices include total artificial hearts and ventricular assist systems. At present, there is no total artificial heart for clinical use in China. Domestic medical institutions mostly use cardiac assist devices, also known as ventricular assist devices, for clinical applications in the treatment of heart failure. However, due to the different structures of the left and right ventricles of the heart, current ventricular assist devices can only be used for left ventricular assist. Whether its use in right ventricular assist applications will have other adverse effects on patients requires further clinical research and verification.
左心室辅助装置有两大方向，介入式和植入式。介入式体积小，手术创伤小，但同样的输出流量也更小，适用于心衰前中期患者的治疗，但也可能引起主动脉瓣关闭不全、主动脉反流等不良反应。轴流泵和离心泵等植入式同样也有一些相似缺陷：1、都不能实现右心室辅助；2、都是通过旋转的方式提供血流，高速转动的叶轮会对血液产生破坏性，易引起血栓增加卒中风险；3、只能提供连续血流，异于正常心脏的生理性搏动，无法满足正常血流动力学，会引发脉搏异常，影响各器官血液灌注；4、无法保证泵体内部没有血液残留，增加血栓形成风险；5、长期连续的左心室血流输出，无法使左右心室达到平衡，进而增加右心衰竭风险；6、一旦发生故障停泵，血液在泵内部停滞时间过长，再次启泵时极易发生意外事故。There are two major directions for left ventricular assist devices, interventional and implantable. The interventional type has a small volume and less surgical trauma, but the same output flow is also smaller. It is suitable for the treatment of patients with early and middle stages of heart failure, but it may also cause aortic valve insufficiency, aortic regurgitation and other adverse reactions. Implantable pumps such as axial flow pumps and centrifugal pumps also have some similar shortcomings: 1. Neither can achieve right ventricular assist; 2. Both provide blood flow through rotation. The high-speed rotating impeller will be destructive to the blood and easily cause Thrombus increases the risk of stroke; 3. It can only provide continuous blood flow, which is different from the physiological pulse of the normal heart and cannot meet normal hemodynamics. It will cause abnormal pulse and affect the blood perfusion of various organs; 4. There is no guarantee that there is no blood inside the pump body. Remaining blood increases the risk of thrombosis; 5. Long-term continuous left ventricular blood flow output cannot balance the left and right ventricles, thereby increasing the risk of right heart failure; 6. Once the pump fails and stops, the blood stagnates inside the pump for too long. Accidents can easily occur when starting the pump again.
申请号为202310096170.3、名称为一种压力驱动式心脏辅助装置的发明专利公开了以下内容：当心脏收缩时，压力囊腔减压，使主动脉瓣膜和单向瓣膜之间产生一个低压区，从而降低了左心室后负荷；当心脏舒张时，增加压力囊腔内的压力， 使主动脉瓣膜和单向瓣膜之间产生一个高压区，从而产生第二个压力波，增加冠脉血流灌注和外周灌注。其根本原理是在心室的输出侧增加了一套类似二级隔膜泵的装置，来模拟类似主动脉自身扩展收缩的功能。如果隔膜泵的工作频率与心脏自身搏动周期不匹配，则无法实现预想设计的辅助射血功能，反而会因在心室和动脉之间增加了单向瓣膜，而加大了心室后负荷，进而引发更严重后果；即使通过心电和压力传感器监控心脏状态，但由于信号传输及调节都会存在滞后的现象，在现有技术条件下也无法做到与心脏的自身频率完全一致。The invention patent with application number 202310096170.3 and titled a pressure-driven cardiac assist device discloses the following: when the heart contracts, the pressure sac is decompressed, creating a low-pressure area between the aortic valve and the one-way valve, thereby Reduces left ventricular afterload; when the heart relaxes, the pressure in the pressure sac increases, creating a high-pressure area between the aortic valve and the one-way valve, thereby generating a second pressure wave, increasing coronary blood perfusion and Peripheral perfusion. The basic principle is to add a device similar to a secondary diaphragm pump on the output side of the ventricle to simulate a function similar to the expansion and contraction of the aorta itself. If the working frequency of the diaphragm pump does not match the heart's own beating cycle, the designed auxiliary ejection function cannot be achieved. Instead, a one-way valve will be added between the ventricle and the artery, which will increase ventricular afterload and cause More serious consequences; even if the heart status is monitored through ECG and pressure sensors, due to the hysteresis phenomenon in signal transmission and regulation, it cannot be completely consistent with the heart's own frequency under the current technical conditions.
（三）发明内容(3) Contents of the invention
本发明为了弥补现有技术的不足，提供了一种双心室全人工心脏装置。In order to make up for the shortcomings of the prior art, the present invention provides a biventricular total artificial heart device.
本发明是通过如下技术方案实现的：The present invention is achieved through the following technical solutions:
一种双心室全人工心脏装置，包括人工心脏本体，其特征是：所述人工心脏本体包括心室外壳，心室外壳内设有心室内膜，心室外壳上设有心室入口和心室出口，心室入口设有入口单向瓣膜，心室出口设有出口单向瓣膜，心室内膜设有驱动出入口，驱动出入口连接脉冲气压驱动器。A biventricular total artificial heart device, including an artificial heart body, characterized in that: the artificial heart body includes a ventricular shell, the ventricular shell is provided with an endocardium, the ventricular shell is provided with a ventricular inlet and a ventricular outlet, and the ventricular inlet is provided with a ventricular inlet and a ventricular outlet. There is an inlet one-way valve, the ventricular outlet is equipped with an outlet one-way valve, and the intraventricular membrane is equipped with a driving inlet and outlet, and the driving inlet and outlet are connected to a pulse air pressure actuator.
所述驱动出入口与脉冲气压驱动器之间通过驱动管路相连接。The driving inlet and outlet are connected to the pulse air pressure driver through a driving pipeline.
所述驱动管路由连接驱动出入口的内驱动管路和连接脉冲气压驱动器的外驱动管路构成，内驱动管路与外驱动管路之间连接转换接头。The drive pipeline is composed of an internal drive pipeline connected to the drive inlet and outlet and an external drive pipeline connected to the pulse air pressure driver. A conversion joint is connected between the internal drive pipeline and the external drive pipeline.
所述脉冲气压驱动器上设有过滤网，过滤网外设有盖板。The pulse air pressure driver is provided with a filter screen, and a cover plate is provided outside the filter screen.
所述脉冲气压驱动器内安装有电池。A battery is installed in the pulse air pressure driver.
本发明的有益效果是：能够完全替代原生心脏左右两个心室的全部功能，从根本上改善了难治性心衰症状，满足人体血流动力学特性，解决了终末期心衰患者心脏移植供体不足的问题。The beneficial effects of the present invention are: it can completely replace all the functions of the left and right ventricles of the original heart, fundamentally improve the symptoms of refractory heart failure, meet the hemodynamic characteristics of the human body, and solve the problem of heart transplant supply for patients with end-stage heart failure. The problem of physical inadequacy.
（四）附图说明(4) Description of drawings
下面结合附图对本发明作进一步的说明。The present invention will be further described below in conjunction with the accompanying drawings.
附图1为本发明的爆炸结构示意图；Figure 1 is a schematic diagram of the explosion structure of the present invention;
附图2为本发明的心室舒张期结构示意图；Figure 2 is a schematic structural diagram of the ventricular diastole phase of the present invention;
附图3为本发明的心室收缩期结构示意图；Figure 3 is a schematic structural diagram of the ventricular systole of the present invention;
图中，1人工心脏本体，2心室外壳，3心室内膜，4心室入口，5心室出口，6入口单向瓣膜，7出口单向瓣膜，8驱动出入口，9脉冲气压驱动器，10驱动管路，11内驱动管路，12外驱动管路，13转换接头，14过滤网，15盖板，16电池。In the figure, 1 artificial heart body, 2 ventricular shell, 3 ventricular endothelium, 4 ventricular inlet, 5 ventricular outlet, 6 inlet one-way valve, 7 outlet one-way valve, 8 drive inlet and outlet, 9 pulse air pressure driver, 10 drive pipeline , 11 internal drive pipeline, 12 external drive pipeline, 13 adapter, 14 filter, 15 cover, 16 battery.
（五）具体实施方式(5) Specific implementation methods
附图为本发明的一种具体实施例。该实施例包括人工心脏本体1，人工心脏本体1包括心室外壳2，心室外壳2内设有心室内膜3，心室外壳2上设有心室入口4和心室出口5，心室入口4设有入口单向瓣膜6，心室出口5设有出口单向瓣膜7，心室内膜3设有驱动出入口8，驱动出入口8连接脉冲气压驱动器9。驱动出入口8与脉冲气压驱动器9之间通过驱动管路10相连接。驱动管路10由连接驱动出入口8的内驱动管路11和连接脉冲气压驱动器9的外驱动管路12构成，内驱动管路11与外驱动管路12之间连接转换接头13。脉冲气压驱动器9上设有过滤网14，过滤网14外设有盖板15。脉冲气压驱动器9内安装有电池16。The accompanying drawing shows a specific embodiment of the invention. This embodiment includes an artificial heart body 1. The artificial heart body 1 includes a ventricular shell 2. The ventricular shell 2 is provided with an intraventricular endothelium 3. The ventricular shell 2 is provided with a ventricular inlet 4 and a ventricular outlet 5. The ventricular inlet 4 is provided with an inlet unit. Toward the valve 6, the ventricular outlet 5 is provided with an outlet one-way valve 7, and the intraventricular membrane 3 is provided with a driving inlet and outlet 8, which is connected to the pulse air pressure driver 9. The driving inlet and outlet 8 and the pulse air pressure driver 9 are connected through a driving pipeline 10 . The driving pipe 10 is composed of an inner driving pipe 11 connected to the driving inlet and outlet 8 and an outer driving pipe 12 connected to the pulse air pressure driver 9. A conversion joint 13 is connected between the inner driving pipe 11 and the outer driving pipe 12. The pulse air pressure driver 9 is provided with a filter screen 14, and a cover plate 15 is provided outside the filter screen 14. A battery 16 is installed in the pulse air pressure driver 9 .
采用本发明的双心室全人工心脏装置，心室外壳2具有一定强度，能够保持其特殊的仿心室形状，形成一个密闭的腔体，心室内膜3柔软光滑，心室内膜3固定于心室外壳2的内壁上，将心室外壳2的腔体又分成M和N两个独立的腔室，其中心室外壳2与心室内膜3之间形成的腔室M用于心室充盈回流时血液的储存，另一侧心室内膜3内部的独立腔室N，经驱动出入口8与内驱动管路11相连，再通过转换接头13，经外驱动管路12，连接到脉冲气压驱动器9上。当脉冲气压驱动器9提供周期性脉冲气压时，心室内膜3形成的腔室N会随气压波动舒张和收缩，另一侧腔室M的容积随着一同发生变化。在舒张期阶段，腔室N内形成负压，腔室N容积变小，血液在血压的作用下，经入口单向瓣膜6流入腔室M，腔室M容积增大；在收缩期阶段，腔室N内随着驱动压力的升高，容积逐渐增大，迫使腔室M的容积减小，使腔室M内部充盈的血液，经出口单向瓣膜6流出心室。心室入口4连接到原生心房，心室出口5连接相应的主动脉或肺动脉。入口单向瓣膜6和出口单向瓣膜7可以起到原生心脏瓣膜的功能，保证血液流向，防止血液反流。腔室M的容积在50-80ml之间，可以通过调节周期性脉冲气压的频率，使腔室M处于部分填充、完全射血的最佳状态，使其既能够提供足够的心输出量，也可以自适应人体在运动或静息时，对心供血量的不同需求，从而达到理想的血流动力学特性。脉冲气压驱动器9由主泵、备用泵、电池16、控制系统、显示界面等组成，电池16可以为泵提供能源，方便患者便携式临时外出，也可以通过外部电源直接供电。泵体可以提供周期性脉冲气压，经两条驱动管路10分别传输至体内植入部分的左、右心室，使两个心室可以做到同步舒张和收缩，协调工作。Using the biventricular total artificial heart device of the present invention, the ventricular shell 2 has a certain strength and can maintain its special imitation ventricular shape to form a closed cavity. The intraventricular endothelium 3 is soft and smooth, and the ventricular endothelium 3 is fixed to the ventricular shell 2 On the inner wall of the ventricular shell 2, the cavity of the ventricular shell 2 is divided into two independent chambers M and N. The chamber M formed between the central ventricular shell 2 and the ventricular endothelium 3 is used to store blood when the ventricle is filled and reflowed. The independent chamber N inside the endocardium 3 of the other side of the ventricle is connected to the inner drive pipeline 11 through the drive inlet and outlet 8, and then connected to the pulse air pressure driver 9 through the external drive pipeline 12 through the conversion joint 13. When the pulse air pressure driver 9 provides periodic pulse air pressure, the chamber N formed by the endocardium 3 of the ventricle will relax and contract with the fluctuation of air pressure, and the volume of the chamber M on the other side will change along with it. In the diastolic phase, negative pressure is formed in the chamber N, and the volume of the chamber N becomes smaller. Under the action of blood pressure, blood flows into the chamber M through the inlet one-way valve 6, and the volume of the chamber M increases; in the systolic phase, As the driving pressure increases, the volume in chamber N gradually increases, forcing the volume of chamber M to decrease, causing the blood filled in chamber M to flow out of the ventricle through the outlet one-way valve 6 . The ventricular inlet 4 is connected to the native atrium, and the ventricular outlet 5 is connected to the corresponding aorta or pulmonary artery. The inlet one-way valve 6 and the outlet one-way valve 7 can function as native heart valves to ensure blood flow and prevent blood reflux. The volume of chamber M is between 50-80ml. By adjusting the frequency of periodic pulse air pressure, chamber M can be in the best state of partial filling and complete blood ejection, so that it can provide sufficient cardiac output and also It can adapt to the human body's different needs for cardiac blood supply during exercise or rest, thereby achieving ideal hemodynamic characteristics. The pulse air pressure driver 9 is composed of a main pump, a backup pump, a battery 16, a control system, a display interface, etc. The battery 16 can provide energy for the pump, which is convenient for the patient to carry out temporarily, and can also be directly powered by an external power supply. The pump body can provide periodic pulse air pressure, which is transmitted to the left and right ventricles of the implanted part in the body through the two drive lines 10, so that the two ventricles can relax and contract synchronously and work in a coordinated manner.
本发明采用人工心室替代原生心室，通过周期性的脉动气压，驱动植入部分人工心室进行舒张和收缩，从而完成人工心脏的泵血功能。本发明采用气动方式作为驱动源，但驱动流体不限于气体，也可以是液体或其他介质。人工心室的容量大小，可根据实际需求量进行优化，在50-80ml范围内调整选择。本发明的植入部分所用材料均为生物相容性材料。脉冲气压驱动器9采用了柱塞泵方式，但不限于其他各种能够提供周期性的驱动方式。The invention uses an artificial ventricle to replace the native ventricle, and drives the implanted part of the artificial ventricle to relax and contract through periodic pulsating air pressure, thereby completing the blood pumping function of the artificial heart. The present invention uses pneumatic mode as the driving source, but the driving fluid is not limited to gas, and can also be liquid or other media. The capacity of the artificial ventricle can be optimized according to actual demand and adjusted within the range of 50-80ml. The materials used in the implanted part of the present invention are all biocompatible materials. The pulse air pressure driver 9 adopts a plunger pump method, but is not limited to other various driving methods that can provide periodic driving methods.
本发明完全替代了原生心脏衰竭的心室部分，使用人工心室进行替代，可以理解为半心脏移植状态，能够满足心衰末期、左右心室同时心力衰竭患者的临床治疗需求。替代后的人工心室，可以完全实现原生心室舒张、收缩的射血功能，提供满足人体血流动力学的血液输出，提供稳定心输出量。无旋转运动部件，原理简单，植入部分无磨损，不会对血液造成破坏形成血栓。模仿原生心脏的搏动，提供脉动性输出，适合于各器官的血液灌注。左右心室能够协同工作，最接近原生心脏的工作状态，不再借助原生心脏的自身搏动，不存在与原心脏搏动不协调或无法同步的情况。对于患者适应症的范围广，不限于心力衰竭晚期患者，同样可以适用于心脏瓣膜异常、先天性心脏病、心脏发育异常等患者。The present invention completely replaces the ventricular part of native heart failure with an artificial ventricle, which can be understood as a semi-heart transplant state and can meet the clinical treatment needs of patients with end-stage heart failure and simultaneous left and right ventricular heart failure. The replaced artificial ventricle can fully realize the ejection function of the native ventricle to relax and contract, provide blood output that meets human hemodynamics, and provide stable cardiac output. There are no rotating moving parts, the principle is simple, there is no wear on the implanted part, and it will not cause damage to the blood and form thrombosis. Mimics the pulsation of the native heart and provides pulsatile output, suitable for blood perfusion of various organs. The left and right ventricles can work together, which is closest to the working state of the native heart. It no longer relies on the native heart's own pulsation, and there is no incoordination or failure to synchronize with the original heart's pulsation. It has a wide range of patient indications, not limited to patients with advanced heart failure, but can also be applied to patients with heart valve abnormalities, congenital heart disease, cardiac developmental abnormalities, etc.
| Application Number | Priority Date | Filing Date | Title |
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| CN202311296116.XACN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311296116.XACN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
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| CN117298445Atrue CN117298445A (en) | 2023-12-29 |
| Application Number | Title | Priority Date | Filing Date |
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| CN202311296116.XAPendingCN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN119215323A (en)* | 2024-09-18 | 2024-12-31 | 新心医疗器械(北京)有限公司 | An adaptive driving method for a total artificial heart |
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| CN119215323A (en)* | 2024-09-18 | 2024-12-31 | 新心医疗器械(北京)有限公司 | An adaptive driving method for a total artificial heart |
| Publication | Publication Date | Title |
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