CN211157660U - A device for assisting left ventricular function in refractory heart failure - Google Patents
A device for assisting left ventricular function in refractory heart failure Download PDFInfo
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Abstract
本实用新型公开了一种难治性心力衰竭左心室功能辅助装置,吸头内部设计多条吸管与囊腔隧道,外部吸孔开口于吸头的下壁及外侧,向内通向近心端锥形囊腔,其管道内与囊腔相通处设计单向阀,经单向阀与气囊内腔相通,吸管跨瓣膜内为单通道与水滴形吸头相连接,远心端与气囊室相通,梯形侧面外壁设有单向阀,单向阀通过通道与气囊室内腔相通;囊体外侧设有4个单向阀,上端为圆锥形通过气管与气腔隧道相连接;分支气管向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经动脉与体外相通,导丝下端与水滴型吸头相通。本实用新型的有益效果是在左心室功能丧失的情况下,亦可连续工作,为临床抢救,或者心脏移植争取时间。
The utility model discloses a left ventricular function auxiliary device for refractory heart failure. A suction head is designed with a plurality of suction tubes and capsule cavity tunnels. Conical cavity, a one-way valve is designed at the place where the pipeline communicates with the cavity, which communicates with the cavity of the balloon through the one-way valve. The pipette is connected to the drop-shaped suction tip through a single channel across the valve, and the distal end communicates with the balloon chamber. The outer wall of the trapezoidal side is provided with a one-way valve, which is communicated with the airbag chamber through the channel; there are 4 one-way valves on the outside of the airbag, and the upper end is conical and connected with the air cavity tunnel through the trachea; the branch bronchus passes downward through The air bag chamber is opened on the inner side of the air bag wall, and merges upward to form the main trachea, which is communicated with the body through the artery, and the lower end of the guide wire is communicated with the drop-shaped suction head. The beneficial effect of the utility model is that under the condition of loss of left ventricular function, it can also work continuously, so as to gain time for clinical rescue or heart transplantation.
Description
技术领域technical field
本实用新型属于医疗器械技术领域,涉及一种难治性心力衰竭左心室功能辅助装置。The utility model belongs to the technical field of medical devices, and relates to a left ventricular function auxiliary device for refractory heart failure.
背景技术Background technique
急性心力衰竭:主要表现为左心功能下降,即左心室泵血功能降低,心脏泵功能不全,做功减少,左心室淤血,从而导致患者出现肺部淤血,呼吸困难。该装置可以辅助左心室做功,使肺部淤血减轻,从而减少左心室做功,使左心室泵功能恢复,减轻急性左心功能不全导致肺部淤血,肺水肿,缓解患者呼吸困难,喘憋等症状,帮助患者顺利度过急性心肌梗死,急性左心功能不全以及其他原因导致的高度危险期,顺利实现康复。目前世界各国已经在临床开始应用的心衰辅助装置主要有:1、TandemHear装置,TandemHeart经由皮肤跨隔膜心室辅助 (PTVA),PTVA系统是一种左心室辅助设备LVAD,设计作为短期循环支持系统,不需要彻底的心肺通路手术。该系统由三个部分组成:TandemHeart泵,提供循环动力将氧合血液从左心房中抽吸出来,推进至全身动脉循环系统;TandemHeart 套管组件,将泵通过2条经皮肤通路腹股沟穿刺点连接起来;TandemHeart控制器,为泵提供动力,为泵提供润滑剂。2、Impella系统,为一种恒速运转系统,需要切开动脉植入,虽然操作便捷,可用于左或右心室辅助循环;但同样需要左心室功能有保留,因此患者耐受性较差,且该装置无法模拟人体血流节奏型搏动,故会导致主动脉等血管持续扩张,引起患者血压升高致头痛等不适。3、A-Med®Systems pLVAD,泵在体外,需要开胸植入,将泵管经皮肤与装置链接,可根据需要更换不同功率和心排量的泵,而不需重新置换导管系统;但明显增加患者耐受手术风险,增加感染几率。4、体外膜氧合器Extracorporeal membrane oxygenation,ECMO即体外“膜肺”,将静脉系统血液送至体外膜氧合器充分氧合后再输送至动脉系统,又称为全心肺支持Fullcardiopulmonary support。特点是氧合作用很好,但不能真正直接做到心脏“无负荷”工作,且因在外周血管建立了静脉-ECMO-动脉通路而增加了心脏后负荷。适合于伴有严重低氧血症的ACS。5、主动脉球囊反搏”装置(IBAP),经股动脉微创植入降主动脉,心电门控控制充放气,通过气囊充放气实现与心脏同步跳动,模拟心脏泵功能,辅助血液流动,实现向全身各脏器供血功能。Acute heart failure: Mainly manifested as decreased left ventricular function, that is, decreased left ventricular pumping function, insufficiency of cardiac pumping, decreased work work, and left ventricular congestion, resulting in pulmonary congestion and difficulty breathing. The device can assist the work of the left ventricle, reduce pulmonary congestion, thereby reduce the work of the left ventricle, restore the pump function of the left ventricle, relieve the pulmonary congestion and pulmonary edema caused by acute left ventricular insufficiency, and relieve the symptoms of dyspnea and wheezing of patients. , to help patients successfully pass through acute myocardial infarction, acute left ventricular insufficiency and other high-risk periods caused by other reasons, and successfully achieve recovery. At present, the heart failure assist devices that have been used clinically in various countries in the world mainly include: 1. TandemHear device, TandemHeart percutaneous transseptal ventricular assist (PTVA), PTVA system is a left ventricular assist device LVAD, designed as a short-term circulatory support system, Complete cardiopulmonary access surgery is not required. The system consists of three parts: the TandemHeart pump, which provides the circulatory power to draw oxygenated blood from the left atrium and advance it to the systemic arterial circulation; the TandemHeart cannula assembly, which connects the pump through 2 transcutaneous access points in the groin Get up; the TandemHeart controller, which powers the pump and supplies the pump with lubricant. 2. The Impella system, a constant-speed operation system, requires arterial incision and implantation. Although the operation is convenient, it can be used for left or right ventricular auxiliary circulation; but it also requires the preservation of left ventricular function, so the patient's tolerance is poor. In addition, the device cannot simulate the rhythmic pulsation of human blood flow, so it will cause the blood vessels such as the aorta to continue to expand, causing the patient's blood pressure to rise and cause headaches and other discomforts. 3. A-Med® Systems pLVAD, the pump is outside the body and needs to be implanted in the chest. The pump tube is connected to the device through the skin, and the pump with different power and cardiac output can be replaced as needed without replacing the catheter system; but Significantly increase the patient's risk of tolerance to surgery and increase the risk of infection. 4. Extracorporeal membrane oxygenation, ECMO is the extracorporeal "membrane lung", which sends the blood from the venous system to the extracorporeal membrane oxygenator for sufficient oxygenation and then transports it to the arterial system, also known as Fullcardiopulmonary support. The characteristic is that the oxygenation is very good, but it cannot really directly achieve the "unloaded" work of the heart, and the cardiac afterload is increased due to the establishment of venous-ECMO-arterial access in the peripheral blood vessels. Suitable for ACS with severe hypoxemia. 5. The aortic balloon counterpulsation device (IBAP) is minimally invasively implanted into the descending aorta through the femoral artery, and the ECG gate controls the inflation and deflation. Assists blood flow and realizes the function of supplying blood to various organs of the body.
上述装置各有优缺点,缺点主要在于完全替代左心室,或者均要求左心室收缩泵功能保留,即要么完全置换左心室,不能实现生理学泵血,要么要求左心室功能保留且只能极小部分辅助左心室进行工作,而无法较大程度代替左心室的功能,而大部分急性左心功能衰竭,尤其冠脉前降支急性闭塞导致的急性心肌梗塞均为左心室泵功能丧失,故其临床应用适应症较为局限,效果较差。而且以上1, 2装置需要开胸行心脏置换,或心脏部分置换,创伤大,效果差,尤其远期效果差,并发症多。大部分目前临床使用的左心室辅助装置均为非心电门控类型,不能与心室收缩同步,故不能很好地模拟人体血流动力学,对脏器的血流灌注效果较差。本实用新型装置应用于早期,是针对突发,阶段性心功能不全而应用的临时心功能辅助技术,也针对晚期心功能丧失,行异体心脏置换,或人工心脏置换过渡时期替代左室辅助装置。The above devices have their own advantages and disadvantages. The main disadvantage is that they completely replace the left ventricle, or they all require the left ventricular systolic pump function to be preserved, that is, either the left ventricle is completely replaced and cannot achieve physiological pumping, or the left ventricular function is required to be preserved and only a very small part is required. It assists the left ventricle to work, but cannot replace the function of the left ventricle to a large extent. Most of the acute left ventricular failure, especially the acute myocardial infarction caused by the acute occlusion of the anterior descending coronary artery, is caused by the loss of the left ventricular pump function. The application indications are more limited and the effect is poor. Moreover, the above devices 1 and 2 require open-heart cardiac replacement, or partial cardiac replacement, which is traumatic and has poor effects, especially in the long-term, with many complications. Most of the left ventricular assist devices currently in clinical use are non-ECG-gated types, which cannot be synchronized with ventricular contraction, so they cannot simulate human hemodynamics well, and have poor blood perfusion effects on organs. The device of the utility model is applied in the early stage, and is a temporary cardiac function assistance technology applied for sudden and staged cardiac insufficiency, and also for the late cardiac function loss, allogeneic heart replacement, or artificial heart replacement in the transition period to replace the left ventricular auxiliary device .
实用新型内容Utility model content
本实用新型的目的在于提供一种难治性心力衰竭左心室功能辅助装置,本实用新型的有益效果是装置工作不需要依赖左心室功能保留,即在左心室功能丧失的情况下,亦可连续工作,为临床抢救,或者心脏移植争取时间,可以有效的降低因左心功能下降,泵功能衰竭导致的死亡率。The purpose of the present utility model is to provide a left ventricular function auxiliary device for refractory heart failure. Working to buy time for clinical rescue or heart transplantation can effectively reduce the mortality rate due to left ventricular function decline and pump failure.
本实用新型所采用的技术方案是包括螺旋形吸管和水滴型吸头,吸头内部设计多条吸管与囊腔隧道,外部吸孔开口于吸头的下壁及外侧,向内通向近心端锥形囊腔,其管道内与囊腔相通处设计单向阀,经单向阀与气囊内腔相通,吸管跨瓣膜内为单通道与水滴形吸头相连接,远心端与气囊室相通,梯形侧面外壁设有单向阀,阀门向外开放,单向阀通过通道与气囊室内腔相通;囊体为圆筒形结构,由形状记忆合金构成,体外为收缩状态,到达体内后释放即形成圆柱体,下端与心室相通,外侧设有4个单向阀,阀门向外开放,上端为圆锥形通过气管与气腔隧道相连接;分支气管向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经动脉与体外相通,导丝下端与水滴型吸头相通。The technical scheme adopted by the utility model includes a spiral-shaped suction pipe and a water drop-shaped suction head. The suction head is designed with a plurality of suction pipes and capsule cavity tunnels. The end cone-shaped cavity is designed with a one-way valve in the pipe that communicates with the cavity, which communicates with the cavity of the airbag through the one-way valve. The pipette is connected to the drop-shaped suction head through a single channel across the valve, and the distal end is connected to the airbag chamber. The outer wall of the trapezoidal side is provided with a one-way valve, the valve opens outward, and the one-way valve communicates with the airbag chamber through the channel; the airbag is a cylindrical structure and is composed of shape memory alloy, which is in a contracted state outside the body, and is released after reaching the body. That is to form a cylinder, the lower end communicates with the ventricle, the outer side is provided with 4 one-way valves, the valves are open to the outside, the upper end is conical and connected to the air cavity tunnel through the trachea; , which converges upward into the main trachea, communicates with the body through the artery, and communicates with the drop-shaped tip at the lower end of the guide wire.
进一步,吸管跨瓣膜段长度30-50cm,扁叶型。Further, the length of the transvalvular segment of the straw is 30-50 cm, and the shape is flat leaf.
进一步,囊体为360度附壁设计。Further, the capsule body is a 360-degree Coanda design.
进一步,气囊闭锁点为下部靠上1/3位置。Further, the airbag locking point is the upper 1/3 position of the lower part.
附图说明Description of drawings
图1是本实用新型装置结构示意图。Figure 1 is a schematic diagram of the structure of the device of the present invention.
图中,1、导丝;2、水滴形吸头;3、吸孔;4、螺旋形吸管;5、单向阀;6、近心端锥形囊腔;7、气囊室;8、囊体;9、分支气管;10、气管升段;11、气管弓段;12气管降段;13、心电门控气泵;14、心电导联线;15、吸管与囊腔隧道;16、气管与气腔隧道;17、吸管跨瓣膜段;18、囊腔。In the figure, 1. Guide wire; 2. Drop-shaped suction tip; 3. Suction hole; 4. Spiral suction tube; 5. One-way valve; 6. Proximal conical cavity; 7. Balloon chamber; Body; 9. Branched bronchi; 10. Ascending segment of trachea; 11. Arch of trachea; 12. Descending segment of trachea; 13. ECG-gated air pump; 14. ECG lead wire; 15. Straw and cystic tunnel; 16. Trachea With the air cavity tunnel; 17, the suction tube across the valve segment; 18, the cyst cavity.
具体实施方式Detailed ways
下面结合具体实施方式对本实用新型进行详细说明。The present invention will be described in detail below in conjunction with specific embodiments.
本实用新型装置如图1所示,室内段:分为螺旋形吸管4和水滴型吸头2 两部分,吸头内部设计多条吸管与囊腔隧道15,外部吸孔3开口于吸头的下壁及外侧,向内通向近心端锥形囊腔6,其管道内与囊腔18相通处设计单向阀,经单向阀5与气囊内腔相通,血液被吸入后,保证在气囊充气阶段,血液不返流,并经囊腔单向阀5将排到主动脉内。吸管跨瓣膜段17长度30-50cm,扁叶型设计,内为单通道与水滴形吸头2相连接,远心端与气囊室7相通,梯形侧面外壁设计单向阀5,数量4个,阀门向外开放,保证冠脉供血的同时,避免射血损伤冠脉开口,单向阀5通过通道与气囊室7内腔相通。囊体8为360度附壁设计,排气阶段,气囊回缩,囊腔18空间增大,呈负压,血液自吸头经螺旋形吸管吸入囊腔18,充气时呈向心性膨胀,将血液同时向主动脉窦底近心端及主动脉弓两个方向排送,保证冠状动脉及锁骨下动脉,颈动脉及外周动脉供血。The device of this utility model is shown in Figure 1. The indoor section is divided into two parts: a helical suction pipe 4 and a water-drop suction head 2. The suction head is designed with a plurality of suction pipes and a
气囊闭锁点为下部靠上1/3位置,优先下部充气,保证下壁气囊先膨胀,以保证三分之一的血液灌注冠脉,三分之二的血液向主动脉方向分流,防止较多血液灌注冠状动脉,损伤其冠脉开口。The airbag locking point is the upper 1/3 of the lower part, and the lower part is inflated first to ensure that the lower wall airbag is inflated first, so as to ensure that one-third of the blood perfuses the coronary arteries and two-thirds of the blood is shunted to the aorta, preventing more Blood perfuses the coronary arteries, damaging their coronary ostia.
囊体8,此部分为圆筒形结构,由形状记忆合金构成,体外为收缩状态,到达体内后释放即形成圆柱体,下端与心室相通,在其外侧设计4个单向阀5,阀门向外开放,上端为圆锥形通过气管与气腔隧道16相连接。Capsule 8, this part is a cylindrical structure and is made of shape memory alloy. It is in a contracted state outside the body. After reaching the body, it is released to form a cylinder. The lower end communicates with the ventricle. It is open to the outside, and the upper end is conical and connected to the air cavity tunnel 16 through the trachea.
分支气管9为2-4根,向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经股动脉与体外相通。导丝1下端与水滴型吸头相通,先将导丝1送至左心室,沿交换轨道导入水滴吸头2,经体外段气管与体外相通,便于交换。气管升段10、气管弓段11、气管降段12与体外相接。心电门控气泵13需要进行心电门控,靠心电图上升支R波触发,即R波上升期心室收缩早期开始排气-也就是抽吸,T波开始时心室舒张早期,此时主动脉瓣关闭开始充气,此时主动脉瓣关闭 -排血至主动脉内,此装置为氮气驱动装置,氮气为外部持续冷却后进行充放气工作。本装置亦可同时在急性心梗时辅助冠脉介入治疗。The branch bronchioles 9 are 2-4, which pass downward through the balloon chamber and open on the inner side of the balloon wall, merge upward into the main trachea, and communicate with the body through the femoral artery. The lower end of the guide wire 1 is communicated with the drop-shaped suction head. First, the guide wire 1 is sent to the left ventricle, and the water drop suction head 2 is introduced along the exchange track. The ascending
本实用新型装置外接气泵驱动,心电门控,通过心电导联线14与患者链接,通过气管外管连接体内气囊,通过气囊充气,放气,模拟并同步左心室收缩过程,辅助左心室搏血,减轻左心室前负荷。The device of the utility model is driven by an external air pump, controlled by an electrocardiogram, connected with the patient through an
本实用新型装置工作过程:1气囊于心室舒张末期放气,此时气囊回缩,囊腔空间扩大,并呈负压状态,从左心室抽血15-20ml,从而减少左心室血容量,降低左室收缩前负荷,降低左心室做功,降低心肌耗氧量,改善心功能。2于收缩末期即舒张极早期开始充气,此时气囊膨胀,囊腔空间被压缩,并呈正压状态,从左心室抽血15-20ml,分别经本装置的近心端及远心端排血孔,排出血液至主动脉,此时可以主动辅助主动脉瓣膜关闭,从而改善冠脉及外周供血。The working process of the device of the utility model: 1. The air bag is deflated at the end of ventricular diastole. At this time, the air bag is retracted, the space of the air bag is expanded, and it is in a negative pressure state. Left ventricular systolic preload, reduce left ventricular work, reduce myocardial oxygen consumption, and improve cardiac function. 2. Inflation starts at the end of systole, that is, in the very early period of diastole. At this time, the balloon is inflated, the space of the sac is compressed, and it is in a positive pressure state. 15-20ml of blood is drawn from the left ventricle, and it is discharged through the proximal and distal ends of the device. The blood hole discharges blood to the aorta, which can actively assist the closure of the aortic valve, thereby improving coronary and peripheral blood supply.
本实用新型装置优点还在于可缓解晚期左心功能不全,延长患者寿命,改善急性心梗导致急性左心衰患者预后,PCI术中无复流,TIMI血流0-1级。可代替目前临床使用的IBAP。The device of the utility model also has the advantages of relieving late left heart insufficiency, prolonging the life of patients, improving the prognosis of patients with acute left heart failure caused by acute myocardial infarction, no reflow during PCI operation, and TIMI blood flow level 0-1. It can replace the current clinical use of IBAP.
以上所述仅是对本实用新型的较佳实施方式而已,并非对本实用新型作任何形式上的限制,凡是依据本实用新型的技术实质对以上实施方式所做的任何简单修改,等同变化与修饰,均属于本实用新型技术方案的范围内。The above is only a preferred embodiment of the present invention, and does not limit the present invention in any form. Any simple modifications made to the above embodiments according to the technical essence of the present invention, equivalent changes and modifications, All belong to the scope of the technical solution of the present invention.
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