CN106310411A - Ascending aorta type ventricular assisting device - Google Patents
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- 230000002861 ventricular Effects 0.000 title claims abstract description 27
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
- A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/562—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/89—Valves
- A61M60/892—Active valves, i.e. actuated by an external force
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
- A61M2210/127—Aorta
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Abstract
本发明公开了一种升主动脉型心室辅助装置,其包括内、外两层,外层两端连接人工血管,该装置顶部由人工瓣膜封闭或术中连接人工瓣膜;且所述内、外两层间通过管道与气泵连接,借由该气泵及与气泵相连的起搏导线可对该两层间的部分进行与心脏同步的充气或吸气;其中,该外层为硬质硅胶材料,内层为软质囊性材料。借由本发明的升主动脉型心室辅助装置能够增加冠脉血供、提高终末期心脏病患者的心脏功能、延长此类患者的生存时间、改善此类患者的生活质量。
The invention discloses an ascending aorta type ventricular assist device, which comprises inner and outer layers, both ends of the outer layer are connected with artificial blood vessels, and the top of the device is closed by an artificial valve or connected with an artificial valve during operation; and the inner and outer layers The two layers are connected to an air pump through a pipeline, and the part between the two layers can be inflated or inhaled synchronously with the heart by means of the air pump and the pacing wire connected to the air pump; wherein, the outer layer is made of hard silicone material, The inner layer is soft cystic material. The ascending aorta type ventricular assist device of the present invention can increase coronary blood supply, improve heart function of patients with end-stage heart disease, prolong the survival time of such patients, and improve the quality of life of such patients.
Description
技术领域technical field
本发明涉及心室辅助装置,特别是涉及一种升主动脉型心室辅助装置。The invention relates to a ventricular assist device, in particular to an ascending aorta type ventricular assist device.
背景技术Background technique
目前临床上公认有效的治疗终末期心脏病的手段之一是心脏移植,但是由于心脏供体严重稀缺,很难满足临床需要,同时移植术后患者自身的免疫排斥反应等诸多问题难以解决,心脏移植治疗始终无法成为最常用的治疗手段。近年来,随着关于人工心脏的技术日渐成熟,加上其无伦理问题、无免疫排斥及抗排斥药带来的各种问题等多种优势,人工心脏已成为心脏移植的重要替代方法。人工心脏按用途可分为全人工心脏和心室辅助装置两种,其中全人工心脏由于体积大、植入技术复杂、术后并发症如感染、栓塞、溶血及多脏器衰竭的发生率高,耐久性差等缺陷,限制了其在临床的推广和应用,而现在应用的心室辅助装置也同样存在着植入时破坏心脏原有心肌组织,装置工作时无搏动性血流、血细胞破坏、左心房和左心室始终处于充盈状态以及内置泵故障后无法及时更换等缺点。另一种临床上较常用于改善心脏功能的手段是应用主动脉内球囊反搏(IABP),但是由于其球囊容量有限,出血事件发生率较高,需要股动脉内置管,限制活动,还可能引起动脉穿孔、夹层以及周围动脉血栓使其只能成为短期、临时的治疗方法,而无法长期使用。最近,由美国Sunshineheart公司生产的一款名为C-Pulse的心室辅助装置,其原理是由主动脉周围充气气囊规律性的压迫升主动脉产生搏动性血流进而提高心输出量,尽管该装置较好地解决了之前心室辅助装置可能出现的各种问题,但因升主动脉周围结构较为紧密,植入手术时可操作空间小,固定较困难;并且由于该装置工作时隔着主动脉血管壁使其搏出量大打折扣,同时如果患者的主动脉壁存在钙化等固有损伤,C-Pulse工作时难免会对其造成进一步损伤。At present, one of the clinically recognized and effective means of treating end-stage heart disease is heart transplantation. However, due to the severe scarcity of heart donors, it is difficult to meet clinical needs. At the same time, many problems such as immune rejection of patients after transplantation are difficult to solve. Transplantation has never been the most commonly used treatment. In recent years, as the technology of artificial heart has matured day by day, coupled with its various advantages such as no ethical issues, no immune rejection and various problems caused by anti-rejection drugs, artificial heart has become an important alternative to heart transplantation. Artificial hearts can be divided into total artificial hearts and ventricular assist devices according to their uses. Among them, total artificial hearts are due to their large size, complicated implantation techniques, and high incidence of postoperative complications such as infection, embolism, hemolysis, and multiple organ failure. Defects such as poor durability limit its clinical promotion and application, and the current ventricular assist device also has the same problem of destroying the original myocardial tissue of the heart when it is implanted, and there is no pulsating blood flow, blood cell destruction, and left atrium when the device is working. And the left ventricle is always in a filling state and the built-in pump cannot be replaced in time after failure. Another clinical method that is more commonly used to improve cardiac function is the application of intra-aortic balloon pump (IABP). However, due to the limited capacity of the balloon, the incidence of bleeding events is high, and femoral artery catheters are required to restrict activities. It may also cause arterial perforation, dissection, and peripheral arterial thrombosis so that it can only be used as a short-term and temporary treatment, but cannot be used for a long time. Recently, a ventricular assist device called C-Pulse produced by Sunshineheart Company of the United States is based on the principle that the inflated balloon around the aorta regularly compresses the ascending aorta to generate pulsating blood flow and thereby increase cardiac output. It has better solved various problems that may have occurred in the previous ventricular assist device, but because the structure around the ascending aorta is relatively tight, the operable space is small during implantation surgery, and it is difficult to fix; and because the device works through the aortic vessel At the same time, if the patient's aortic wall has inherent damage such as calcification, C-Pulse will inevitably cause further damage to it when working.
由此,亟需一种新型的治疗装置或者方法在不降低治疗效果情况下治疗终末期心脏病,同时能够降低使用中的不良事件发生率、减轻或者避免各种可能出现的问题,进而提高终末期心脏病患者的治疗效果,并能够一定程度上延长心脏辅助装置的使用时间。Therefore, there is an urgent need for a new type of treatment device or method to treat end-stage heart disease without reducing the treatment effect, and at the same time reduce the incidence of adverse events in use, alleviate or avoid various possible problems, and then improve the end-stage disease. The treatment effect of patients with end-stage heart disease can prolong the use time of cardiac assist devices to a certain extent.
发明内容Contents of the invention
鉴于上述的各种问题,本发明要解决的技术问题是提供一种新型结构的心脏辅助装置从而提高终末期心脏病患者的治疗效果。In view of the various problems above, the technical problem to be solved by the present invention is to provide a heart assist device with a new structure so as to improve the treatment effect of end-stage heart disease patients.
为达上述目的,本发明提供了一种升主动脉型心室辅助装置,包括内、外两层,外层两端连接人工血管,以便与病人的大血管连接,该装置顶部由人工瓣膜封闭或术中连接人工瓣膜;且所述内、外两层间通过管道与气泵连接,借由该气泵及与气泵相连的起搏导线可对该两层间的部分进行与心脏同步的充气或吸气;其中,该外层为硬质硅胶材料,内层为软质囊性材料。In order to achieve the above-mentioned purpose, the present invention provides a kind of ascending aorta type ventricular assist device, comprises inner and outer two layers, and artificial blood vessel is connected at both ends of outer layer, so that be connected with patient's great blood vessel, and the top of this device is closed by artificial valve or The artificial valve is connected during the operation; and the inner and outer layers are connected to an air pump through a pipeline, and the part between the two layers can be inflated or inhaled synchronously with the heart by means of the air pump and the pacing wire connected to the air pump ; Wherein, the outer layer is made of hard silica gel material, and the inner layer is made of soft cystic material.
其中,使用时,所述气泵设于体外;该装置设置人工瓣膜封闭或术中连接人工瓣膜的一端配置为与升主动脉的远心端吻合;该装置未设置人工瓣膜的一端配置为与升主动脉的近心端吻合。Wherein, when in use, the air pump is set outside the body; the device is configured to close the artificial valve or the end connected to the artificial valve is configured to coincide with the distal end of the ascending aorta; the end of the device not provided with the artificial valve is configured to coincide with the The proximal end of the aorta is anastomosed.
本发明与现有技术不同之处在于本发明取得了如下技术效果:本发明的升主动脉型心室辅助装置具有植入过程中无心肌手术损伤,装置工作时血流为搏动性、无需抗凝,血细胞无破坏、左心房和左心室间歇性空置状态,外置泵可备用,故障后易于及时更换,可长期安置,局部解剖空间基本满足装置植入,不用游离正常的周围组织,对主动脉壁血管条件无苛刻要求的优点。同时,如果是全心衰的病人,还可进行肺动脉主干的新型升主动脉型心室辅助装置的安置手术来改善右心功能。最终,通过新型升主动脉型心室辅助装置的应用能够增加冠脉血供、提高终末期心脏病患者的心脏功能、延长此类患者的生存时间、改善此类患者的生活质量。如果病人经过一段时间的治疗,心功能恢复正常,可随时停用该装置,恢复正常循环。The difference between the present invention and the prior art is that the present invention has achieved the following technical effects: the ascending aortic ventricular assist device of the present invention has no myocardial surgical injury during implantation, and the blood flow is pulsating when the device is working, and no anticoagulation is required. , blood cells are not destroyed, the left atrium and left ventricle are intermittently empty, the external pump can be used as a backup, it is easy to replace in time after failure, and can be placed for a long time. The local anatomical space basically meets the device implantation. The advantage of no stringent requirements for mural vascular conditions. At the same time, if it is a patient with total heart failure, a new type of ascending aortic ventricular assist device in the main pulmonary artery can be placed to improve the right heart function. Ultimately, the application of the new ascending aortic ventricular assist device can increase the coronary blood supply, improve the cardiac function of patients with end-stage heart disease, prolong the survival time of such patients, and improve the quality of life of such patients. If the patient's heart function returns to normal after a period of treatment, the device can be stopped at any time to restore normal circulation.
下面结合附图对本发明的升主动脉型心室辅助装置作进一步说明。The ascending aortic ventricular assist device of the present invention will be further described below in conjunction with the accompanying drawings.
附图说明Description of drawings
图1为本发明升主动脉型心室辅助装置的剖视结构示意图;Fig. 1 is a schematic cross-sectional structure diagram of an ascending aortic ventricular assist device of the present invention;
图2为使用本发明升主动脉型心室辅助装置时的放气状态示意图;Fig. 2 is a schematic diagram of the deflated state when using the ascending aortic ventricular assist device of the present invention;
图3为使用本发明升主动脉型心室辅助装置时的充气状态示意图。Fig. 3 is a schematic diagram of the inflation state when using the ascending aortic ventricular assist device of the present invention.
附图标记说明:100‐升主动脉型心室辅助装置;102‐外层;104‐内层;103‐内、外层间部分;105‐人工瓣膜;106‐人工血管;107‐管道;108‐气泵;200‐升主动脉;300‐主动脉瓣;400‐头臂干;600‐左颈总动脉;800‐左锁骨下动脉。Explanation of reference signs: 100-Ascending aortic ventricular assist device; 102-Outer layer; 104-Inner layer; 103-Part between inner and outer layers; 105-Artificial valve; 106-Artificial blood vessel; Air pump; 200‐ascending aorta; 300‐aortic valve; 400‐brachiocephalic trunk; 600‐left common carotid artery; 800‐left subclavian artery.
具体实施方式detailed description
以下结合实施例,对本发明上述的和另外的技术特征和优点作更详细的说明。The above-mentioned and other technical features and advantages of the present invention will be described in more detail below in conjunction with the embodiments.
请参阅图1,本发明的升主动脉型心室辅助装置100,包括硬质硅胶材料外层102、软质囊性材料内层104,外层102两端连接人工血管106,用于和自体血管进行吻合。装置100顶部由人工瓣膜105封闭或术中连接人工瓣膜;并且内、外两层间通过管道107与气泵108连接,借由气泵108及与气泵相连的起搏导线可对该两层间的部分103进行与心脏同步的充气或吸气。Please refer to Fig. 1, the ascending aorta type ventricular assist device 100 of the present invention comprises a hard silicone material outer layer 102, a soft cystic material inner layer 104, and the two ends of the outer layer 102 are connected with artificial blood vessels 106 for use with autologous blood vessels Perform an anastomosis. The top of the device 100 is closed by an artificial valve 105 or is connected to an artificial valve during operation; and the inner and outer layers are connected to the air pump 108 through a pipeline 107, and the part between the two layers can be controlled by the air pump 108 and the pacing lead connected to the air pump. 103 performs inflation or inspiration synchronously with the heart.
可通过下述方法将本发明的升主动脉型心室辅助装置植入患者体内:患者在静脉和吸入复合全身麻醉下,经胸正中切口。建立体外循环,将主动脉阻断钳尽量远的夹在升主动脉200远心端近头臂干400的位置。主动脉根部灌注心脏停跳液使心脏停跳后切除升主动脉200,使用本发明的升主动脉型心室辅助装置100将升主动脉200进行替换。本发明升主动脉型心室辅助装置近心端(即未设置人工瓣膜的一端)与升主动脉近心端吻合;远心端(即设置人工瓣膜或术中连接人工瓣膜的一端)与升主动脉远心端进行吻合,空气管道107通过患者左侧第二肋间近胸骨开口处引出体外与气泵108相连。The ascending aorta type ventricular assist device of the present invention can be implanted into the patient's body through the following method: the patient undergoes a median thoracotomy under general anesthesia combined with intravenous and inhalation. Establish extracorporeal circulation, clamp the aortic blocking forceps as far as possible at the position near the brachial trunk 400 at the distal end of the ascending aorta 200 . The aortic root is perfused with cardioplegia to stop the heart, and then the ascending aorta 200 is resected, and the ascending aorta type ventricular assist device 100 of the present invention is used to replace the ascending aorta 200 . The proximal end of the ascending aorta type ventricular assist device of the present invention (that is, the end without an artificial valve) is anastomosed with the proximal end of the ascending aorta; The distal end of the artery is anastomosed, and the air pipeline 107 is led out of the body through the patient's left second intercostal space near the opening of the sternum and connected to the air pump 108 .
请参阅图2和图3,分别为使用本发明升主动脉型心室辅助装置时的放气和充气状态示意图。当心脏收缩时,该装置通过体外的气泵108进行吸气,使主动脉内形成一定的负压,可以最大程度上降低心脏的后负荷,更好的维护心脏功能,同时由于人工瓣膜的存在,可避免因气泵吸气导致的主动脉远端血液逆流;当心脏舒张时,装该置通过体外的气泵108进行充气,主动脉瓣300关闭,人工瓣膜105处于开放状态,将内层104的囊性材料向内压缩使该装置内部的血液向前推动,给心脏在收缩期射入主动脉内的血进行加压和推进,增加主动脉远端和冠状动脉的血供。Please refer to FIG. 2 and FIG. 3 , which are respectively schematic diagrams of the deflated and inflated states when using the ascending aortic ventricular assist device of the present invention. When the heart contracts, the device inhales air through the external air pump 108 to form a certain negative pressure in the aorta, which can reduce the afterload of the heart to the greatest extent and better maintain the heart function. At the same time, due to the existence of the artificial valve, It can avoid the backflow of blood at the distal end of the aorta caused by air pump suction; when the heart relaxes, the device is inflated by the external air pump 108, the aortic valve 300 is closed, the artificial valve 105 is in an open state, and the inner layer 104 of the sac The inward compression of the elastic material pushes the blood inside the device forward, pressurizes and propels the blood injected by the heart into the aorta during systole, and increases the blood supply to the distal end of the aorta and the coronary arteries.
以上所述的实施例仅仅是对本发明的优选实施方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案作出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。The above-mentioned embodiments are only descriptions of preferred implementations of the present invention, and are not intended to limit the scope of the present invention. Variations and improvements should fall within the scope of protection defined by the claims of the present invention.
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CN110124133A (en) * | 2019-05-13 | 2019-08-16 | 青岛大学附属医院 | A kind of refractory heart failure left ventricular function auxiliary device |
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