WO2023134639A1 - Blood circulation assisting device and control system - Google Patents

Abstract

A blood circulation assisting device and control system, the blood circulation assisting device comprising: a sheath tube (500), the sheath tube (500) having a proximal end and a distal end; a first balloon (300), which is sleeved over the sheath tube (500); a pump body (100), which is disposed at the distal end of the sheath tube (500) and is provided with a blood flow channel as well as a blood inlet (110) and a blood outlet (120) that are in communication with the blood flow channel; and a controller (400), which is disposed at the proximal end of the sheath tube (500) and which is configured to control the operation of the pump body (100) and is configured to intermittently drive the inflation and deflation of the first balloon (300).

Description

Translated fromChinese

血液循环辅助装置及控制系统Blood circulation assist device and control system

相关申请的交叉引用Cross References to Related Applications

本申请要求享有于2022年1月11日提交的名称为“血液循环辅助装置及控制系统”的中国专利申请CN202210028954.8的优先权，该申请的全部内容通过引用并入本文中。This application claims the priority of Chinese patent application CN202210028954.8 filed on January 11, 2022, entitled "Blood Circulation Assist Device and Control System", the entire content of which is incorporated herein by reference.

技术领域technical field

本申请实施例属于心脏辅助循环技术领域，尤其涉及一种血液循环辅助装置及控制系统。The embodiments of the present application belong to the technical field of cardiac assisted circulation, and in particular relate to a blood circulation assisting device and a control system.

背景技术Background technique

心血管疾病为心脏和血管失调疾病的统称，包括冠心病、脑血管病、风湿性心脏病和先天性心脏病等。冠心病和中风通常为急性病，主要病因为血管堵塞使血液无法流向心肌或大脑，导致器官组织缺氧坏死。血管堵塞可能由多种原因造成，其中最常见病因为由血管内壁脂肪堆积导致的血管狭窄。Cardiovascular disease is a general term for heart and vascular disorders, including coronary heart disease, cerebrovascular disease, rheumatic heart disease and congenital heart disease. Coronary heart disease and stroke are usually acute diseases. The main cause is that blood vessels cannot flow to the heart muscle or the brain due to blockage of blood vessels, resulting in hypoxia and necrosis of organs and tissues. Clogged blood vessels can be caused by a variety of reasons, the most common of which is narrowing of blood vessels caused by the accumulation of fat in the lining of blood vessels.

现有对多种心血管疾病的治疗最常用的是左心辅助装置，左心辅助装置的血泵组件可通过PCI手术引入心脏，血泵组件的血泵运转即可将血液从心脏的左心室泵入主动脉，或者将血液从下腔静脉泵入肺动脉，血泵可由位于患者体外的电机或位于患者体内的电机供电驱动。左心辅助装置可在高危PCI手术中向患者提供更稳定的血液循环支持，改善冠脉和远端器官灌注的同时减轻左心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。但是，现有的左心辅助装置为患者提供的是连续性血液循环支持，会增加胃肠道动静脉畸形以及引起获得性血管性血友病因子缺陷等潜在并发症风险。The most commonly used treatment for various cardiovascular diseases is the left ventricular assist device. The blood pump component of the left ventricular assist device can be introduced into the heart through PCI operation. The blood pump of the blood pump component can move blood from the left ventricle of the heart Pumping into the aorta, or pumping blood from the inferior vena cava into the pulmonary artery, the blood pump can be powered by a motor outside the patient's body or powered by a motor inside the patient's body. The left ventricular assist device can provide patients with more stable blood circulation support during high-risk PCI operations, improve coronary artery and distal organ perfusion while reducing the burden on the left ventricle, which is conducive to the stability of patients' signs during the operation and postoperative recovery, and promotes the heart rate of patients. recover. However, the existing left ventricular assist devices provide patients with continuous blood circulation support, which will increase the risk of potential complications such as gastrointestinal arteriovenous malformation and acquired von Willebrand factor deficiency.

发明内容Contents of the invention

本申请旨在至少解决现有技术中存在的技术问题之一。为此，本申请实施例提供了一种血液循环辅助装置及控制系统，结构巧妙，在应用时能 够产生搏动性血流，为患者心脏提供有效、可靠的血液循环支持，消除了传统心室辅助装置产生的连续性血流而带来的不利影响。This application aims to solve at least one of the technical problems existing in the prior art. For this reason, the embodiment of the present application provides a blood circulation assisting device and control system, which has an ingenious structure and can generate pulsatile blood flow during application, providing effective and reliable blood circulation support for the patient's heart, eliminating the need for traditional ventricular assist devices. Adverse effects of the continuous blood flow produced.

本申请第一方面的实施例提供了一种血液循环辅助装置，包括：The embodiment of the first aspect of the present application provides a blood circulation assisting device, comprising:

鞘管，用于安装于血管内，鞘管具有近端和远端；The sheath tube is used to be installed in the blood vessel, and the sheath tube has a proximal end and a distal end;

第一球囊，套设于鞘管并处于血管内；The first balloon is sheathed in the sheath and placed in the blood vessel;

泵体，设于鞘管的远端，具有血流通道以及与血流通道连通的血液入口和血液出口；The pump body is arranged at the far end of the sheath tube, has a blood flow channel, and a blood inlet and a blood outlet connected to the blood flow channel;

控制器，设于鞘管的近端，其被配置为控制泵体的运行，以及被配置为间歇地驱动第一球囊充气和放气。A controller, located at the proximal end of the sheath, is configured to control the operation of the pump body and to drive the inflation and deflation of the first balloon intermittently.

根据本申请第一方面实施例的血液循环辅助装置，至少具有如下有益效果：The blood circulation assistance device according to the embodiment of the first aspect of the present application has at least the following beneficial effects:

本申请的血液循环辅助装置在应用时，鞘管以及套设于鞘管的第一球囊、泵体可同步的通过经皮手术介入患者体内，使得鞘管以及设于鞘管的第一球囊介入患者血管内，泵体至少部分介入人体中为上述血管供血的心室内，并使泵体的血液入口与心室连通，血液出口与血管连通，进而使泵体实现将心室内的血液泵送至上述血管内的功能。本申请的血液循环辅助装置运行时，控制器控制泵体运行工作，泵体将心室内的血液依次沿泵体的血液入口、血液通道和血液出口流入血管内，以此将心室内的血液泵送至血管内。血液在泵体的动力作用从心室流入血管的过程中，控制器间歇地驱动第一球囊充气和放气，使得第一球囊的充气和放气呈周期性进行，进而使得第一球囊周期性地封堵和导通血管，使得血液在血管的流动过程中被周期性地堵塞和导通，从而产生与心脏周期性地舒张和收缩特性相适配的搏动性血流，消除了连续性血流而带来的不利影响，同时，也改善了患者冠脉和远端器官的血液灌注量，减轻了心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。When the blood circulation assisting device of the present application is applied, the sheath tube, the first balloon sleeved on the sheath tube, and the pump body can be inserted into the patient's body synchronously through percutaneous surgery, so that the sheath tube and the first balloon set on the sheath tube The capsule is inserted into the patient's blood vessel, and the pump body is at least partially inserted into the ventricle of the human body that supplies blood to the above-mentioned blood vessel, and the blood inlet of the pump body is connected with the ventricle, and the blood outlet is connected with the blood vessel, so that the pump body can pump the blood in the ventricle to the aforementioned intravascular functions. When the blood circulation assisting device of the present application is in operation, the controller controls the operation of the pump body, and the pump body flows the blood in the ventricle into the blood vessel along the blood inlet, blood channel and blood outlet of the pump body in sequence, thereby pumping the blood in the ventricle into the blood vessel. sent into the blood vessel. During the process of blood flowing from the ventricle into the blood vessel under the power of the pump body, the controller drives the first balloon to inflate and deflate intermittently, so that the inflation and deflation of the first balloon are performed periodically, and the first balloon Periodically block and open the blood vessels, so that the blood is periodically blocked and opened during the flow of the blood vessels, thereby generating a pulsating blood flow that matches the periodic relaxation and contraction characteristics of the heart, eliminating the continuous At the same time, it also improves the blood perfusion of the patient's coronary arteries and remote organs, reduces the burden on the ventricles, is conducive to the stability of the patient's signs during the operation and postoperative recovery, and promotes the recovery of the patient's heart.

根据本申请的一些实施例，第一球囊密封套设于鞘管的外壁，第一球囊通过充放气管路与体外的充气泵连接，控制器控制充气泵的充放气频率。According to some embodiments of the present application, the first balloon is sealed and sleeved on the outer wall of the sheath tube, the first balloon is connected to an inflator outside the body through an inflation and deflation pipeline, and the controller controls the inflation and deflation frequency of the inflator.

根据本申请的一些实施例，还包括具有弹性的第二球囊，第二球囊套设在部分泵体以及鞘管靠近泵体的部位上，第二球囊的腔体形成与血液出 口连通的血液流通腔，第二球囊开设有至少一个开窗。According to some embodiments of the present application, a second balloon with elasticity is also included, the second balloon is sheathed on part of the pump body and the part of the sheath close to the pump body, and the cavity of the second balloon is formed to communicate with the blood outlet The blood circulation cavity, the second balloon is opened with at least one window.

根据本申请的一些实施例，还包括保护套，泵体为具有压缩状态和扩张状态的弹性结构体，泵体可弹性收纳于保护套内并与保护套的内壁相抵，以保持压缩状态，当泵体脱离保护套时，泵体沿自身径向向外膨胀，以保持扩张状态。According to some embodiments of the present application, a protective cover is also included. The pump body is an elastic structure with a compressed state and an expanded state. The pump body can be elastically accommodated in the protective cover and against the inner wall of the protective cover to maintain the compressed state. When the pump body breaks away from the protective cover, the pump body expands radially outwards to maintain the expanded state.

根据本申请的一些实施例，泵体包括壳体以及设于壳体内的旋转叶轮，血流通道、血液入口和血液出口均设于壳体，旋转叶轮为具有展开状态和收纳状态的弹性结构体，当泵体保持压缩状态时，旋转叶轮弹性收纳于壳体内，当泵体切换为扩张状态时，旋转叶轮随壳体同步向外展开，以保持展开状态。According to some embodiments of the present application, the pump body includes a casing and a rotating impeller disposed in the casing, the blood flow channel, the blood inlet and the blood outlet are all arranged in the casing, and the rotating impeller is an elastic structure having a deployed state and a stored state , when the pump body maintains a compressed state, the rotating impeller is elastically accommodated in the housing, and when the pump body is switched to an expanded state, the rotating impeller expands outward synchronously with the housing to maintain the expanded state.

根据本申请的一些实施例，保护套还用于套设鞘管、第一球囊以及第二球囊。According to some embodiments of the present application, the protective sheath is also used to cover the sheath, the first balloon and the second balloon.

根据本申请的一些实施例，保护套呈两端开口的管状。According to some embodiments of the present application, the protective sheath is in the shape of a tube with two ends open.

根据本申请的一些实施例，还包括设于体内或体外的驱动件，驱动件的输出端直接或间接地与泵体连接，以驱动泵体运行，控制器与驱动件电连接，以控制驱动件的驱动速率。According to some embodiments of the present application, it also includes a drive member located inside or outside the body, the output end of the drive member is directly or indirectly connected to the pump body to drive the pump body to run, and the controller is electrically connected to the drive member to control the drive. drive speed of the device.

本申请第二方面的实施例提供了一种控制系统，包括：The embodiment of the second aspect of the present application provides a control system, including:

上述的血液循环辅助装置；the above-mentioned circulatory assistance device;

信号电极，耦合至泵体伸入心室的部位，以获取心室的心电图信号；The signal electrode is coupled to the part where the pump body extends into the ventricle, so as to obtain the electrocardiogram signal of the ventricle;

控制器包括第一处理器和第二处理器，第一处理器与信号电极连接，以接收心电图信号，并基于心电图信号来控制第一球囊的充气频率和放气频率，第二处理器与泵体电连接，以控制泵体的运行速率。The controller includes a first processor and a second processor, the first processor is connected with the signal electrode to receive the electrocardiogram signal, and controls the inflation frequency and deflation frequency of the first balloon based on the electrocardiogram signal, the second processor and the The pump body is electrically connected to control the operating rate of the pump body.

根据本申请第二方面实施例的控制系统，至少具有如下有益效果：The control system according to the embodiment of the second aspect of the present application has at least the following beneficial effects:

本申请的控制系统，由于具备上述的血液循环辅助装置，因此也具备该血液循环辅助装置同样的技术效果。此外，本申请的控制系统，通过在泵体伸入心室的部位上耦合信号电极，使得泵体介入患者的心室后能够获取到心室的心电图信号，第一处理器即可根据该心电图信号的来调节第一球囊的充气频率和放气频率，以使得第一球囊周期性地封堵和导通降主动脉，从而产生与患者心脏或心室搏动频率同步的博动性循环血流，为患者 心脏提供了更为有效和可靠的血液循环支持，进一步促进了患者心脏及其他组织器官功能的恢复。Since the control system of the present application includes the above-mentioned blood circulation assisting device, it also has the same technical effect as the blood circulation assisting device. In addition, the control system of the present application couples the signal electrode on the part where the pump body extends into the ventricle, so that the pump body can obtain the electrocardiogram signal of the ventricle after the pump body intervenes in the patient's ventricle, and the first processor can obtain the electrocardiogram signal according to the source of the electrocardiogram signal. Adjusting the inflation frequency and deflation frequency of the first balloon, so that the first balloon periodically occludes and conducts the descending aorta, thereby generating a pulsating circulating blood flow synchronized with the patient's heart or ventricular beat frequency, as The patient's heart provides more effective and reliable blood circulation support, which further promotes the recovery of the patient's heart and other tissues and organs.

根据本申请的一些实施例，第一球囊内设有第一压力传感器，第一压力传感器用于监测第一球囊内的压力，第一处理器与第一压力传感器连接，并基于第一压力传感器的压力信号来控制第一球囊的充气量。According to some embodiments of the present application, a first pressure sensor is provided in the first balloon, and the first pressure sensor is used to monitor the pressure in the first balloon, and the first processor is connected to the first pressure sensor, and based on the first The pressure signal of the pressure sensor is used to control the inflation volume of the first balloon.

附图说明Description of drawings

为了更清楚地说明本申请实施例的技术方案，下面将对本申请实施例中所需要使用的附图作简单地介绍，显而易见地，下面所描述的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the embodiments of the present application. Obviously, the accompanying drawings described below are only some embodiments of the present application. Those of ordinary skill in the art can also obtain other drawings based on these drawings without making creative efforts.

图1是本申请一些实施例的血液循环辅助装置的结构示意图一；Fig. 1 is a schematic structural diagram of a blood circulation assisting device according to some embodiments of the present application;

图2是本申请一些实施例的血液循环辅助装置的部分结构示意图一；Fig. 2 is a partial structural schematic diagram of a blood circulation assisting device according to some embodiments of the present application;

图3是本申请一些实施例的血液循环辅助装置的部分结构示意图二；Fig. 3 is a partial structural schematic diagram II of a blood circulation assisting device according to some embodiments of the present application;

图4是本申请一些实施例的血液循环辅助装置的结构示意图二；Fig. 4 is a second structural schematic diagram of a blood circulation assisting device according to some embodiments of the present application;

图5是本申请一些实施例的血液循环辅助装置与心脏的配合示意图一；Fig. 5 is a first schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图6是本申请一些实施例的血液循环辅助装置与心脏的配合示意图二；Fig. 6 is a second schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图7是本申请一些实施例的鞘管与第一球囊的配合结构示意图；Fig. 7 is a schematic diagram of the cooperative structure of the sheath and the first balloon in some embodiments of the present application;

图8是本申请一些实施例的控制系统的结构示意图一；FIG. 8 is a first structural diagram of a control system in some embodiments of the present application;

图9是本申请一些实施例的血液循环辅助装置的结构示意图三；Fig. 9 is a schematic structural diagram III of a blood circulation assisting device according to some embodiments of the present application;

图10是本申请一些实施例的血液循环辅助装置与心脏的配合示意图三；Fig. 10 is a third schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图11是本申请一些实施例的血液循环辅助装置与心脏的配合示意图四；Fig. 11 is a fourth schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图12是本申请一些实施例的血液循环辅助装置与心脏的配合示意图五；Figure 12 is a fifth schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图13是本申请一些实施例的血液循环辅助装置的结构示意图四；Fig. 13 is a fourth structural schematic diagram of a blood circulation assisting device according to some embodiments of the present application;

图14是本申请一些实施例的血液循环辅助装置的结构示意图五；Fig. 14 is a schematic diagram of the fifth structure of a blood circulation assisting device according to some embodiments of the present application;

图15是本申请一些实施例的血液循环辅助装置与心脏的配合示意图六；Fig. 15 is a sixth schematic diagram of cooperation between the blood circulation assisting device and the heart in some embodiments of the present application;

图16是本申请一些实施例的控制系统的结构示意图二。Fig. 16 is a second schematic structural diagram of a control system in some embodiments of the present application.

附图中：泵体100；血液入口110；血液出口120；壳体130；信号电极200；第一球囊300；控制器400；第一处理器410；第二处理器420；鞘管500；充放气管路510；充气泵600；第二球囊700；血液流通腔710；开窗720；保护套800；左心室10；主动脉瓣20；主动脉30；降主动脉40。In the drawings: pumpbody 100;blood inlet 110;blood outlet 120;housing 130;signal electrode 200;first balloon 300;controller 400;first processor 410;second processor 420;sheath 500; Inflation anddeflation pipeline 510 ;inflator pump 600 ;second balloon 700 ;blood circulation chamber 710 ;fenestration 720 ;protective cover 800 ;left ventricle 10 ;aortic valve 20 ;

具体实施方式Detailed ways

下面将详细描述本申请的各个方面的特征和示例性实施例。在下面的详细描述中，提出了许多具体细节，以便提供对本申请的全面理解。但是，对于本领域技术人员来说很明显的是，本申请实施例可以在不需要这些具体细节中的一些细节的情况下实施。下面对实施例的描述仅仅是为了通过示出本申请的示例来提供对本申请的更好的理解。Features and exemplary embodiments of various aspects of the present application will be described in detail below. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the application. It will be apparent, however, to one skilled in the art that embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

在本申请的描述中，需要理解的是，涉及到方位描述，例如上、下、前、后、左、右等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请实施例和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请实施例的限制。In the description of the present application, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc. indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only For the convenience of describing the embodiment of the present application and simplifying the description, it does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the embodiment of the present application.

在本申请实施例的描述中，若干的含义是一个或者多个，多个的含义是两个及两个以上，大于、小于、超过等理解为不包括本数，以上、以下、以内等理解为包括本数。如果有描述到第一、第二只是用于区分技术特征为目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量或者隐含指明所指示的技术特征的先后关系。In the description of the embodiments of the present application, several means one or more, and multiple means two or more. Greater than, less than, exceeding, etc. are understood as not including the original number, and above, below, within, etc. are understood as Include this number. If the description of the first and second is only for the purpose of distinguishing the technical features, it cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features relation.

本申请实施例的描述中，除非另有明确的限定，设置、安装、连接等词语应做广义理解，所属技术领域技术人员可以结合技术方案的具体内容合理确定上述词语在本申请中的具体含义。In the description of the embodiments of the present application, unless otherwise clearly defined, words such as setting, installation, and connection should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above words in this application in combination with the specific content of the technical solution .

需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将结合附图对实施例进行详细描述。It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The embodiments will be described in detail below in conjunction with the accompanying drawings.

另外，需要说明的是，在本申请实施例的描述中，除非另有明确的限 定，“体内”表示患者的组织器官内，“体外”表示患者的组织器官外。In addition, it should be noted that, in the description of the embodiments of the present application, unless otherwise clearly defined, "in vivo" means inside the tissues and organs of the patient, and "in vitro" means outside the tissues and organs of the patient.

应该说明的是，正常人体的心脏在一个搏动周期里，心脏收缩时，位于左心室和主动脉之间的主动脉瓣打开，左心室内的血液在收缩压力下流入主动脉内，以使主动脉向人体的组织器官内输血；同时，右心室与肺动脉之间的肺动脉瓣打开，右心室内的血液流入肺动脉内，以使肺动脉向人体的肺静脉以及分支器官输血。当心脏舒张时，主动脉瓣关闭，防止主动脉内的的血液回流至左心室；同时，肺动脉瓣关闭，防止肺动脉内的血液回流至右心室。人体的主动脉沿血液流动方向依次分为升主动脉、主动脉弓和降主动脉，升主动脉、主动脉弓和降主动脉依次连通。It should be noted that in a normal human heart, during a beating cycle, when the heart contracts, the aortic valve located between the left ventricle and the aorta opens, and the blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta The arteries transfuse blood into the tissues and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery opens, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery can transfuse blood to the pulmonary vein and branch organs of the human body. When the heart relaxes, the aortic valve closes to prevent blood from flowing back from the aorta to the left ventricle; at the same time, the pulmonary valve closes to prevent blood from flowing from the pulmonary artery back to the right ventricle. The aorta of the human body is divided into ascending aorta, aortic arch and descending aorta sequentially along the direction of blood flow, and the ascending aorta, aortic arch and descending aorta are connected in turn.

而患有心血管疾病的病因主要体现血液无法及时流向心肌或大脑，导致器官组织缺氧坏死。现有对多种心血管疾病的治疗最常用的是左心辅助装置，左心辅助装置的血泵组件可通过PCI手术引入心脏，血泵组件的血泵运转即可将血液从心脏的左心室泵入主动脉，或者将血液从下腔静脉泵入肺动脉，血泵可由位于患者体外的电机或位于患者体内的电机供电驱动。左心辅助装置可在高危PCI手术中向患者提供更稳定的血液循环支持，改善冠脉和远端器官灌注的同时减轻左心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。The etiology of cardiovascular disease mainly reflects that blood cannot flow to the heart muscle or brain in time, resulting in hypoxia and necrosis of organs and tissues. The most commonly used treatment for various cardiovascular diseases is the left ventricular assist device. The blood pump component of the left ventricular assist device can be introduced into the heart through PCI operation. The blood pump of the blood pump component can move blood from the left ventricle of the heart Pumping into the aorta, or pumping blood from the inferior vena cava into the pulmonary artery, the blood pump can be powered by a motor outside the patient's body or powered by a motor inside the patient's body. The left ventricular assist device can provide patients with more stable blood circulation support during high-risk PCI operations, improve coronary artery and distal organ perfusion while reducing the burden on the left ventricle, which is conducive to the stability of patients' signs during the operation and postoperative recovery, and promotes the heart rate of patients. recover.

为了满足微创化和大流量的需求，现有的左心辅助装置的血泵需要同时满足小型化和较高泵血流量的要求。电机需要提供高达五万转每分的高转速驱动血泵进行泵血，而为了模拟与心脏跳动频率同步的搏动性血流输送，需要依靠动力电机频繁的转动与制动使得血泵反复的转动与停转，使血泵产生搏动性血流输送，这在技术上很难实现。另外，左心辅助装置在运行时，由于左心室和主动脉之间形成了泵血通道，血泵反复的转动与停转会带来血流从主动脉回流至左心室的风险，这不利于患者心脏功能的恢复。In order to meet the requirements of minimal invasiveness and high flow rate, the blood pump of the existing left ventricular assist device needs to meet the requirements of miniaturization and high pump blood flow rate at the same time. The motor needs to provide a high speed of up to 50,000 rpm to drive the blood pump to pump blood. In order to simulate the pulsating blood flow that is synchronized with the heart beat frequency, it is necessary to rely on the frequent rotation and braking of the power motor to make the blood pump rotate repeatedly. And stop, so that the blood pump produces pulsatile blood delivery, which is technically difficult to achieve. In addition, when the left ventricular assist device is in operation, due to the blood pumping channel formed between the left ventricle and the aorta, the repeated rotation and stop of the blood pump will bring the risk of blood flow back from the aorta to the left ventricle, which is not conducive to recovery of cardiac function in patients.

经本申请发明人研究发现，由于现有的左心辅助装置为患者提供的是连续性血液循环支持，而不是与心脏跳动频率同步的搏动性或脉动性血液循环，这会增加胃肠道动静脉畸形以及引起获得性血管性血友病因子缺陷等潜在并发症风险。The inventors of the present application found that because the existing left ventricular assist device provides patients with continuous blood circulation support instead of pulsating or pulsating blood circulation synchronous with the beating frequency of the heart, which will increase the gastrointestinal motility. Venous malformations and the risk of potential complications such as acquired von Willebrand factor deficiency.

本申请的血液循环辅助装置即可为患者的心脏提供稳定的搏动性血液循环支持，改善患者的心血管疾病，促进患者心脏的恢复。The blood circulation assisting device of the present application can provide stable pulsating blood circulation support for the patient's heart, improve the cardiovascular disease of the patient, and promote the recovery of the patient's heart.

请参见图1、图2、图3、图4，本申请公开了一种血液循环辅助装置，包括：鞘管500、第一球囊300、泵体100以及控制器400。Referring to FIG. 1 , FIG. 2 , FIG. 3 , and FIG. 4 , the present application discloses a blood circulation assisting device, including: asheath tube 500 , afirst balloon 300 , apump body 100 and acontroller 400 .

其中，鞘管500用于安装于血管内，鞘管500具有近端和远端，需要说明的是，鞘管500的“远端”是指远离医生的方向，鞘管500的“近端”指靠近医生的方向。第一球囊300套设于鞘管500并处于血管内。泵体100设于鞘管500的远端，泵体100具有血流通道以及与血流通道连通的血液入口110和血液出口120，泵体100用于将心室内的血液泵送至血管内，控制器400设于鞘管500的近端，控制器400被配置为控制泵体100的运行，以及被配置为间歇地驱动第一球囊300充气和放气，以使第一球囊300至少部分地封堵血管，以配合泵体100产生搏动性血流。Wherein, thesheath tube 500 is used to be installed in a blood vessel, and thesheath tube 500 has a proximal end and a distal end. Point toward the doctor. Thefirst balloon 300 is sleeved on thesheath tube 500 and is inside the blood vessel. Thepump body 100 is arranged at the distal end of thesheath tube 500. Thepump body 100 has a blood flow channel and ablood inlet 110 and ablood outlet 120 communicating with the blood flow channel. Thepump body 100 is used to pump the blood in the ventricle into the blood vessel. Thecontroller 400 is arranged at the proximal end of thesheath tube 500, and thecontroller 400 is configured to control the operation of thepump body 100, and is configured to intermittently drive thefirst balloon 300 to inflate and deflate, so that thefirst balloon 300 is at least Partially block blood vessels to cooperate with thepump body 100 to generate pulsatile blood flow.

需要说明的是，在本申请中，鞘管500均为柔性可弯曲结构体，泵体100、鞘管500以及设于鞘管500的第一球囊300通过经皮手术介入患者相应的血管或输血器官时，不会对相应的血管或输血器官造成结构损伤，并能够很好地适配相应血液管路的弯曲或盘旋形状。It should be noted that, in this application, thesheath tube 500 is a flexible and bendable structure, and thepump body 100, thesheath tube 500 and thefirst balloon 300 provided on thesheath tube 500 are inserted into the corresponding blood vessels or blood vessels of the patient through percutaneous surgery. When a blood organ is transfused, no structural damage will be caused to the corresponding blood vessel or blood transfusion organ, and it can well adapt to the curved or coiled shape of the corresponding blood pipeline.

在本申请中，泵体100可选为微型的叶轮泵，叶轮泵中的旋转叶轮的持续旋转即可将心室内的血液输送至血管内。当然，泵体100也可为其他的轴流离心泵，其能够具备输送血流的作用即可，具体结构不作限制。泵体100的启停以及运转速度可由控制器400操控。In this application, thepump body 100 may be a miniature impeller pump, and the continuous rotation of the rotating impeller in the impeller pump can deliver the blood in the ventricle to the blood vessel. Of course, thepump body 100 can also be other axial flow centrifugal pumps, which only need to have the function of transporting blood flow, and the specific structure is not limited. The start-stop and running speed of thepump body 100 can be controlled by thecontroller 400 .

在本申请中，第一球囊300的形状不作限制，其可为柱状、球体或椭圆体状。可选的，第一球囊300为可充气扩张和放气收缩的椭球体囊。控制器400可通过设置于第一球囊300的电子气阀或设置于鞘管500上的气动管路来驱动第一球囊300充气和放气。In the present application, the shape of thefirst balloon 300 is not limited, and it may be columnar, spherical or ellipsoidal. Optionally, thefirst balloon 300 is an ellipsoidal balloon that can be inflated and deflated. Thecontroller 400 can drive thefirst balloon 300 to inflate and deflate through an electronic air valve provided on thefirst balloon 300 or a pneumatic circuit provided on thesheath tube 500 .

本申请的血液循环辅助装置在应用时，鞘管500以及设于鞘管500的第一球囊300、泵体100可同步的通过经皮手术介入患者体内，使得鞘管500以及设于鞘管500的第一球囊300介入患者血管内，泵体100至少部分介入人体中为上述血管供血的心室内，并使泵体100的血液入口110与心室连通，血液出口120与血管连通，进而使泵体100实现将心室内的血 液泵送至上述血管内的功能。When the blood circulation assisting device of the present application is applied, thesheath tube 500 and thefirst balloon 300 disposed on thesheath tube 500 and thepump body 100 can be synchronously inserted into the patient's body through a percutaneous operation, so that thesheath tube 500 and thefirst balloon 300 disposed on the sheath tube Thefirst balloon 300 of 500 is inserted into the patient's blood vessel, and thepump body 100 is at least partly inserted into the ventricle of the human body that supplies blood to the above-mentioned blood vessel, and theblood inlet 110 of thepump body 100 is communicated with the ventricle, and theblood outlet 120 is communicated with the blood vessel, thereby making theThe pump body 100 realizes the function of pumping the blood in the ventricle into the above-mentioned blood vessel.

本申请的血液循环辅助装置运行时，控制器400控制泵体100运行工作，泵体100将心室内的血液依次沿泵体100的血液入口110、血液通道和血液出口120流入血管内，以此将心室内的血液泵送至血管内。When the blood circulation assisting device of the present application is running, thecontroller 400 controls the operation of thepump body 100, and thepump body 100 flows the blood in the ventricle into the blood vessel sequentially along theblood inlet 110, the blood channel and theblood outlet 120 of thepump body 100, thereby Pumps blood from the ventricles into the blood vessels.

血液在泵体100的动力作用从心室流入血管的过程中，控制器400间歇地驱动第一球囊300充气和放气，使得第一球囊300的充气和放气呈周期性进行，进而使得第一球囊300周期性地封堵和导通血管，使得血液在血管的流动过程中被周期性地堵塞和导通，从而产生与心脏周期性地舒张和收缩特性相适配的搏动性血流，消除了连续性血流而带来的不利影响，同时，也改善了患者冠脉和远端器官的血液灌注量，减轻了心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。During the process of blood flowing from the ventricle into the blood vessel under the power of thepump body 100, thecontroller 400 drives thefirst balloon 300 to inflate and deflate intermittently, so that the inflation and deflation of thefirst balloon 300 are performed periodically, thereby making the Thefirst balloon 300 blocks and opens the blood vessels periodically, so that the blood is periodically blocked and opened during the flow of the blood vessels, thereby generating pulsating blood that matches the periodic relaxation and contraction characteristics of the heart. It eliminates the adverse effects caused by continuous blood flow, and at the same time, it also improves the blood perfusion volume of the patient's coronary artery and remote organs, reduces the burden on the ventricle, and is conducive to the stability of the patient's signs during the operation and postoperative recovery, and promotes The patient's heart recovers.

参见图5和图6，本申请的血液循环辅助装置以患者左心室10以及与左心室10连通的主动脉30为应用场景为例(即在本实施例中，心室具体为左心室10，血管具体为主动脉30)说明本血液循环辅助装置的具体应用、工作原理以及带来的效果。Referring to Fig. 5 and Fig. 6, the blood circulation assisting device of the present application takes the patient'sleft ventricle 10 and theaorta 30 communicating with theleft ventricle 10 as an example (that is, in this embodiment, the ventricle is specifically theleft ventricle 10, and the blood vessel Specifically, the aorta 30) illustrates the specific application, working principle and effects of the blood circulation assisting device.

本申请的血液循环辅助装置具体应用时，鞘管500以及设于鞘管500的第一球囊300、泵体100同步的通过经皮手术介入患者体内，并使得泵体100至少部分跨过患者的主动脉瓣20以伸入患者的左心室10，以使泵体100的血液入口110与左心室10连通、血液出口120直接或间接地连通主动脉30，鞘管500穿设在主动脉30内并向主动脉30延伸，设于鞘管500的第一球囊300处于降主动脉40的部位。When the blood circulation assisting device of the present application is specifically applied, thesheath tube 500, thefirst balloon 300 disposed on thesheath tube 500, and thepump body 100 are synchronously inserted into the patient's body through percutaneous surgery, and thepump body 100 is at least partially across the patient's body. Theaortic valve 20 is inserted into the patient'sleft ventricle 10, so that theblood inlet 110 of thepump body 100 communicates with theleft ventricle 10, and theblood outlet 120 directly or indirectly communicates with theaorta 30, and thesheath tube 500 is perforated in theaorta 30 Inner and extending toward theaorta 30 , thefirst balloon 300 disposed on thesheath tube 500 is at the position of the descendingaorta 40 .

再参见图5和图6，整个血液循环辅助装置运行时，控制器400控制泵体100运行工作，泵体100将心室内的血液依次沿泵体100的血液入口110、血液通道和血液出口120流入血管内，以此将心室内的血液泵送至血管内。Referring to Fig. 5 and Fig. 6 again, when the whole blood circulation assisting device is in operation, thecontroller 400 controls the operation of thepump body 100, and thepump body 100 transfers the blood in the ventricle along theblood inlet 110, the blood channel and theblood outlet 120 of thepump body 100 in sequence. Flows into the blood vessels to pump blood from the ventricles into the blood vessels.

血液在泵体100的动力作用从左心室10流入主动脉30的过程中，控制器400先驱动第一球囊300充气膨胀，当第一球囊300的外壁与降主动脉40的内壁接触时，第一球囊300完全充气，此时，第一球囊300全部封堵降主动脉40，血液被第一球囊300阻滞在降主动脉40的上游位置处， 使得升主动脉以及主动脉弓的血流量增加，升主动脉输送至左右冠状动脉升主动脉的分支动脉的血流量也相应的增加，主动脉弓输送至头臂干、左颈总动脉以及左锁骨下动脉主动脉弓的分支动脉的血流量也相应的增加，患者头部的血流量相应增加，有助于缺血性神经系统疾病的缓解和治疗。During the process of blood flowing from theleft ventricle 10 into theaorta 30 under the dynamic action of thepump body 100, thecontroller 400 first drives thefirst balloon 300 to inflate and expand. When the outer wall of thefirst balloon 300 contacts the inner wall of the descendingaorta 40 , thefirst balloon 300 is fully inflated. At this time, thefirst balloon 300 completely blocks the descendingaorta 40, and the blood is blocked at the upstream position of the descendingaorta 40 by thefirst balloon 300, so that the ascending aorta and aortic arch The blood flow of the ascending aorta to the branch arteries of the ascending aorta of the left and right coronary arteries increases accordingly, and the blood flow of the aortic arch to the branch arteries of the brachiocephalic trunk, left common carotid artery and left subclavian artery aortic arch There is also a corresponding increase, and the blood flow in the patient's head increases accordingly, which is helpful for the alleviation and treatment of ischemic nervous system diseases.

需要说明的是，第一球囊300也可具体设置在患者的腹主动脉降主动脉位于腹腔内的一段的下游位置处，同理，第一球囊300完全充气后，血液被第一球囊300阻滞在腹主动脉的上游，使得腹主动脉的上游血量增加，腹主动脉输送至肝动脉以及肾动脉腹主动脉的分支动脉的血流量相应的增加，有助于缺血性肝、肾系统疾病的缓解和治疗。It should be noted that thefirst balloon 300 can also be specifically arranged at the downstream position of the patient's abdominal aorta descending aorta in the section of the abdominal cavity. Similarly, after thefirst balloon 300 is fully inflated, the blood Thesac 300 blocks the upstream of the abdominal aorta, so that the upstream blood volume of the abdominal aorta increases, and the blood flow of the abdominal aorta to the hepatic artery and the branch arteries of the abdominal aorta of the renal artery increases accordingly, which contributes to the ischemic Relief and treatment of liver and kidney system diseases.

第一球囊300封堵降主动脉40短暂时间后，控制器400再驱动第一球囊300放气收缩，使得第一球囊300的外壁逐渐远离降主动脉40的内壁，降主动脉40的血液得到导通，血液继续沿降主动脉40流动。上述过程中即完成第一球囊300的一个充气和放气周期，产生一个周期的搏动性血流循环。After thefirst balloon 300 occludes the descendingaorta 40 for a short period of time, thecontroller 400 drives thefirst balloon 300 to deflate and contract, so that the outer wall of thefirst balloon 300 gradually moves away from the inner wall of the descendingaorta 40, and the descendingaorta 40 The blood in the tube is opened, and the blood continues to flow along the descendingaorta 40 . In the above process, one cycle of inflation and deflation of thefirst balloon 300 is completed, and a cycle of pulsatile blood flow is generated.

显然，血液在泵体100的动力作用从左心室10流入主动脉30的过程中，控制器400间歇地驱动第一球囊300充气和放气，使得第一球囊300的充气和放气呈周期性进行，进而使得第一球囊300周期性地封堵和导通降主动脉40，使得血液在降主动脉40的流动过程中被周期性地堵塞和导通，从而产生与患者心脏周期性地舒张和收缩特性相适配的搏动性血流，消除传统心室辅助装置产生的连续性血流而带来的不利影响，同时，也改善了患者冠脉和远端器官的血液灌注量，减轻了左心室10负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。Obviously, during the process of blood flowing from theleft ventricle 10 into theaorta 30 under the power of thepump body 100, thecontroller 400 drives thefirst balloon 300 to inflate and deflate intermittently, so that the inflation and deflation of thefirst balloon 300 is periodically, so that thefirst balloon 300 periodically occludes and conducts the descendingaorta 40, so that the blood is periodically blocked and communicated during the flow of the descendingaorta 40, thereby generating a cycle that is consistent with the patient's heart The pulsatile blood flow that matches the diastolic and systolic characteristics eliminates the adverse effects of continuous blood flow produced by traditional ventricular assist devices, and at the same time improves the blood perfusion of the patient's coronary arteries and distal organs. It reduces the burden on theleft ventricle 10, which is beneficial to the stability of the patient's signs during the operation and postoperative rehabilitation, and promotes the recovery of the patient's heart.

另外，需要说明的是，在本实施例中，控制器400可设置于患者体外或耦合至位于患者体内的泵体100或鞘管500上。作为一个实施例，控制器400被编程以接收指示患者的左心室10和主动脉30之间的血流动力学状态的变化或波动信号，进而根据该信号来实时调节泵体100的运转速率以及第一球囊300的充气量和放气量，以使主动脉30向其他组织和器官输送的血量满足要求，并实现第一球囊300对降主动脉40的全部封堵或部分封堵，以此产生与患者心脏搏动特性相适配的搏动性血流。In addition, it should be noted that, in this embodiment, thecontroller 400 can be disposed outside the patient's body or coupled to thepump body 100 or thesheath tube 500 inside the patient's body. As an embodiment, thecontroller 400 is programmed to receive a change or fluctuation signal indicating the hemodynamic state between theleft ventricle 10 and theaorta 30 of the patient, and then adjust the operation rate of thepump body 100 in real time according to the signal and The amount of inflation and deflation of thefirst balloon 300, so that the blood volume delivered by theaorta 30 to other tissues and organs meets the requirements, and realize the complete or partial occlusion of the descendingaorta 40 by thefirst balloon 300, This produces a pulsatile blood flow adapted to the beating characteristics of the patient's heart.

可选的，可在泵体100的相应位置耦合压力传感器、速率传感器以及信号电极，当泵体100介入患者的相应部位后，上述的压力传感器、速率传感器以及信号电极被同步的植入，使得压力传感器可实时监测并反馈患者左心室10或主动脉30的血液充盈压力血压信号、速率传感器可实时监测并反馈左心室10与主动脉30之间的血流速率信号以及信号电极可实时监测并反馈左心室10或主动脉30的心电图信号，控制器400分别与上述的压力传感器、速率传感器以及信号电极连接，控制器400被编程基于上述血液充盈压力信号和/或血流速率来实时调整第一球囊300的充气量和放气量以及泵体100的运转速率，同时，控制器400被编程基于上述的心电图信号并根据心电图信号反馈的心脏搏动周期或搏动频率来实时调整第一球囊300的充气频率、放气频率以及充气和放气的间隔周期，以此间歇地驱动第一球囊300充气和放气，从而产生与患者心脏搏动同步的搏动性血流。通过上述设置，使得本申请的血液循环辅助装置在控制器400的精确控制下为患者心脏提供高效、可靠的搏动性血液循环支持。Optionally, pressure sensors, rate sensors, and signal electrodes can be coupled to corresponding positions of thepump body 100. When thepump body 100 intervenes in the corresponding parts of the patient, the above-mentioned pressure sensors, rate sensors, and signal electrodes are implanted synchronously, so that The pressure sensor can monitor and feed back the blood filling pressure and blood pressure signal of the patient'sleft ventricle 10 oraorta 30 in real time; the rate sensor can monitor and feed back the blood flow rate signal between theleft ventricle 10 and theaorta 30 in real time; Feedback the electrocardiogram signal of theleft ventricle 10 or theaorta 30, thecontroller 400 is respectively connected with the above-mentioned pressure sensor, rate sensor and signal electrode, and thecontroller 400 is programmed to adjust the second pulse in real time based on the above-mentioned blood filling pressure signal and/or blood flow rate. The inflation and deflation volume of aballoon 300 and the operating speed of thepump body 100. At the same time, thecontroller 400 is programmed to adjust thefirst balloon 300 in real time based on the above-mentioned electrocardiogram signal and the heart beat cycle or beat frequency fed back by the electrocardiogram signal. The inflation frequency, the deflation frequency and the interval period between inflation and deflation are used to intermittently drive thefirst balloon 300 to inflate and deflate, thereby generating a pulsatile blood flow synchronized with the patient's heartbeat. Through the above settings, the blood circulation assisting device of the present application provides efficient and reliable pulsatile blood circulation support for the patient's heart under the precise control of thecontroller 400 .

参见图1、图5、图6、图7和图8，在本申请的一些实施例中，第一球囊300密封套设于鞘管500的外壁，第一球囊300通过充放气管路510与体外的充气泵600连接，控制器400控制充气泵600的充放气频率，以使充气泵600对第一球囊300间歇性地充气和放气。Referring to Fig. 1, Fig. 5, Fig. 6, Fig. 7 and Fig. 8, in some embodiments of the present application, thefirst balloon 300 is hermetically sleeved on the outer wall of thesheath tube 500, and thefirst balloon 300 passes through the inflation anddeflation pipeline 510 is connected with theair pump 600 outside the body, and thecontroller 400 controls the inflation and deflation frequency of theair pump 600 so that theair pump 600 inflates and deflates thefirst balloon 300 intermittently.

具体的，再参见图2、图3、图4、图5和图6，在本实施例中，泵体100伸入左心室10或处于主动脉30的部位上耦合有与控制器400连接的信号电极200，该信号电极200即可实时监测并反馈左心室10或主动脉30的心电图信号，控制器400被编程基于上述的心电图信号并根据心电图信号反馈的心脏搏动周期和搏动频率来实时控制并调整充气泵600的充气频率、放气频率以及二者之间的间隔周期，以使充气泵600间歇地驱动第一球囊300充气和放气，从而产生与患者心脏搏动同步的搏动性血流。Specifically, referring to FIG. 2 , FIG. 3 , FIG. 4 , FIG. 5 and FIG. 6 , in this embodiment, thepump body 100 protrudes into theleft ventricle 10 or is coupled to the position of theaorta 30 connected to thecontroller 400 Thesignal electrode 200, thesignal electrode 200 can monitor and feed back the electrocardiogram signal of theleft ventricle 10 or theaorta 30 in real time, and thecontroller 400 is programmed to control in real time based on the above electrocardiogram signal and the heart beat cycle and pulse frequency fed back by the electrocardiogram signal And adjust the inflation frequency and deflation frequency of theair pump 600 and the interval period between the two, so that theair pump 600 drives thefirst balloon 300 to inflate and deflate intermittently, thereby generating pulsating blood synchronously with the patient's heartbeat. flow.

此外，在本实施例中，第一球囊300呈椭圆体状，第一球囊300的两端与鞘管500的外壁密封连接，防止气体泄露，第一球囊300的左右两侧相对鞘管500处于第一球囊300腔体内部的部位对称，以使第一球囊300均匀地封堵或导通降主动脉40，保证血液流动的流畅性和稳定性，同时， 鞘管500还起到对第一球囊300支撑和承载的作用，使得第一球囊300稳定地进行充气扩张和放气收缩，也避免了第一球囊300在充气和放气过程中移动或错位，而影响对降主动脉40的封堵或导通效果。In addition, in this embodiment, thefirst balloon 300 is in the shape of an ellipsoid, and the two ends of thefirst balloon 300 are sealed and connected with the outer wall of thesheath 500 to prevent gas leakage. The left and right sides of thefirst balloon 300 are opposite to the sheath. The part of thetube 500 inside the cavity of thefirst balloon 300 is symmetrical, so that thefirst balloon 300 can evenly block or open the descendingaorta 40 to ensure smoothness and stability of blood flow. At the same time, thesheath tube 500 also It plays the role of supporting and carrying thefirst balloon 300, so that thefirst balloon 300 can be inflated and deflated and contracted stably, and also avoids thefirst balloon 300 from moving or dislocation during the inflation and deflation process, which will affect the Occlusion or pass-through effect on the descendingaorta 40 .

此外，在本实施例中，为了提高第一球囊300充放气的精确性，鞘管500上可设置与充放气管路510连接的电子阀门，鞘管500内可开设用于安装电线的线道，电子阀门通过穿设于线道的电线与控制器400电连接，以使得控制器400控制电子阀门的开闭，控制器400、电子阀门以及充气泵600三者的配合动作，实现了对第一球囊300充气和放气的精准控制。同时，为了精确控制第一球囊300的充其量和放气量，第一球囊300内还可以设置与控制器400连接的压力传感器，该压力传感器用于实时监测第一球囊300内的压力，控制器400可基于该压力信号判断第一球囊300的充气量或放气量是否符合要求，以此控制第一球囊300对降主动脉40的封堵程度。In addition, in this embodiment, in order to improve the accuracy of inflation and deflation of thefirst balloon 300, an electronic valve connected to the inflation anddeflation pipeline 510 can be provided on thesheath tube 500, and a hole for installing wires can be opened in thesheath tube 500. The electronic valve is electrically connected to thecontroller 400 through the wires passing through the circuit, so that thecontroller 400 controls the opening and closing of the electronic valve, and the coordinated action of thecontroller 400, the electronic valve and theair pump 600 realizes Precise control over the inflation and deflation of thefirst balloon 300. At the same time, in order to accurately control the maximum and deflation volume of thefirst balloon 300, a pressure sensor connected to thecontroller 400 can also be arranged in thefirst balloon 300, and the pressure sensor is used to monitor the pressure in thefirst balloon 300 in real time. Thecontroller 400 can determine whether the inflation or deflation of thefirst balloon 300 meets requirements based on the pressure signal, so as to control the degree of occlusion of the descendingaorta 40 by thefirst balloon 300 .

参见图9，在本申请的一些实施例中，本申请的血液循环辅助装置还包括具有弹性的第二球囊700，第二球囊700套设在部分泵体100以及鞘管500靠近泵体100的部位上，第二球囊700的腔体形成与血液出口120连通的血液流通腔710，第二球囊700开设有至少一个用于连通血液流通腔710和血管的开窗720。Referring to Fig. 9, in some embodiments of the present application, the blood circulation assisting device of the present application further includes a secondelastic balloon 700, thesecond balloon 700 is sleeved on part of thepump body 100 and thesheath tube 500 is close to thepump body 100, the cavity of thesecond balloon 700 forms ablood flow cavity 710 communicating with theblood outlet 120, and thesecond balloon 700 is provided with at least onewindow 720 for communicating theblood flow cavity 710 and blood vessels.

需要说明的是，泵体100的部分段和鞘管500的部分段穿设于第二球囊700的腔体内并分别与第二球囊700的两端密封连接，以此为第二球囊700的膨胀和收缩提供支撑，防止第二球囊700沿泵体100或鞘管500移动。可以将泵体100、鞘管500、第一球囊300以及第二球囊700理解为一体件，即泵体100、鞘管500、第一球囊300以及第二球囊700可通过经皮手术同步的植入患者体内的相应的血管或输血器官内。第二球囊700可以理解为具有初始记忆状态的椭球体或软管，第二球囊700远离泵体100的外壁沿周向均匀且间隔地开设有多个用于连通血液流通腔710和血管的开窗720，以使血液流通腔710中的血液能够均匀地流入血管。It should be noted that a part of thepump body 100 and a part of thesheath tube 500 are penetrated into the cavity of thesecond balloon 700 and are respectively sealed and connected with both ends of thesecond balloon 700, so that the second balloon The expansion and deflation of 700 provides support preventing movement of thesecond balloon 700 along thepump body 100 or thesheath 500 . Thepump body 100, thesheath tube 500, thefirst balloon 300 and thesecond balloon 700 can be understood as one piece, that is, thepump body 100, thesheath tube 500, thefirst balloon 300 and thesecond balloon 700 can be passed through the skin The surgery is synchronously implanted into the corresponding blood vessels or blood transfusion organs in the patient's body. Thesecond balloon 700 can be understood as an ellipsoid or hose with an initial memory state. The outer wall of thesecond balloon 700 away from thepump body 100 is uniformly and spaced along the circumference with a plurality of holes for communicating with theblood flow cavity 710 and blood vessels. Thewindow 720 is opened, so that the blood in theblood flow cavity 710 can evenly flow into the blood vessel.

同样的，在本实施例中，本申请的血液循环辅助装置以患者左心室10以及与左心室10连通的主动脉30为应用场景为例(即在本实施例中，心 室为左心室，血管为主动脉)说明本实施例的血液循环辅助装置的具体应用、工作原理以及带来的效果：Similarly, in this embodiment, the blood circulation assisting device of the present application takes the patient'sleft ventricle 10 and theaorta 30 communicating with theleft ventricle 10 as an example (that is, in this embodiment, the ventricle is the left ventricle, and the blood vessel Aorta) to illustrate the specific application, working principle and effects of the blood circulation assisting device of this embodiment:

参见图9、图10和图11，其中，图10是患者的主动脉瓣20处于打开状态示意图，图11是患者的主动脉瓣20处于关闭状态示意图。Referring to Fig. 9, Fig. 10 and Fig. 11, Fig. 10 is a schematic diagram of the patient'saortic valve 20 in an open state, and Fig. 11 is a schematic diagram of the patient'saortic valve 20 in a closed state.

本实施例的血液循环辅助装置具体应用时，鞘管500以及设于鞘管500的第一球囊300、泵体100同步的通过经皮手术介入患者体内，并使得泵体100全部跨过患者的主动脉瓣20进而伸入患者的左心室10，以使泵体100的血液入口110与左心室10连通，同时，使得第二球囊700跨过患者的主动脉瓣20而穿设于患者的左心室10与主动脉30之间，并使患者的主动脉瓣20的三个瓣叶分别接触第二球囊700的外壁。同时，鞘管500沿主动脉30的轨迹延伸至降主动脉40，并使得设于鞘管500的第一球囊300处于降主动脉40内，此即完成对泵体100、第二球囊700、鞘管500以及第一球囊300的植入。可以理解的是，在本实施例中，泵体100的血液出口120通过第二球囊700的血液流通腔710以及开窗720间接地连通主动脉30。When the blood circulation assisting device of this embodiment is actually applied, thesheath tube 500, thefirst balloon 300 disposed on thesheath tube 500, and thepump body 100 are synchronously inserted into the patient's body through percutaneous surgery, and thepump body 100 is completely passed over the patient. Theaortic valve 20 of the patient then extends into the patient'sleft ventricle 10, so that theblood inlet 110 of thepump body 100 communicates with theleft ventricle 10, and at the same time, thesecond balloon 700 crosses the patient'saortic valve 20 and penetrates the patient between theleft ventricle 10 of the patient and theaorta 30 , and make the three leaflets of the patient'saortic valve 20 contact the outer wall of thesecond balloon 700 respectively. At the same time, thesheath tube 500 extends along the track of theaorta 30 to the descendingaorta 40, and makes thefirst balloon 300 arranged on thesheath tube 500 in the descendingaorta 40, which completes thepump body 100, thesecond balloon 700 , implantation ofsheath 500 andfirst balloon 300 . It can be understood that, in this embodiment, theblood outlet 120 of thepump body 100 indirectly communicates with theaorta 30 through theblood flow cavity 710 and thewindow 720 of thesecond balloon 700 .

整个血液循环辅助装置在工作运行时，泵体100工作，左心室10内的血液在泵体100的作用下依次沿泵体100的血液入口110、血流通道以及血液出口120后流入第二球囊700的血液流通腔710中，血液流通腔710的血液再通过开窗720流入主动脉30内。When the whole blood circulation assisting device is in operation, thepump body 100 works, and the blood in theleft ventricle 10 flows into the second ball along theblood inlet 110, blood flow channel andblood outlet 120 of thepump body 100 under the action of thepump body 100. In theblood flow cavity 710 of theballoon 700 , the blood in theblood flow cavity 710 flows into theaorta 30 through thefenestration 720 .

当心脏或左心室10收缩时，主动脉瓣20呈打开状态，第二球囊700在血液冲击下呈现完全扩张状态，左心室10的血液在泵体100作用下正常输送至主动脉30内。When the heart or theleft ventricle 10 contracts, theaortic valve 20 is in an open state, thesecond balloon 700 is in a fully expanded state under the impact of blood, and the blood in theleft ventricle 10 is normally delivered to theaorta 30 by the action of thepump body 100 .

当心脏或左心室10由收缩状态切换为舒张状态过程中，主动脉瓣20关闭，即主动脉瓣20的三个瓣叶相互靠近并对合，从而主动脉瓣20的三个瓣叶分别向内挤压与第二球囊700的接触部位，将第二球囊700沿上述的接触部位的连线压缩，以使血液流通腔710处于主动脉瓣20部位的宽度减小，当主动脉瓣20完全关闭后，血液流通腔710处于主动脉瓣20部位的宽度被压缩至最小，此时，允许血液流入血液流通腔710的口径被压缩至最窄，从而使得血液流通腔710中的血液流量以及从血液流通腔710流 向主动脉30的血液流量降至最低。When the heart or theleft ventricle 10 switches from the systolic state to the diastolic state, theaortic valve 20 is closed, that is, the three leaflets of theaortic valve 20 are close to each other and close together, so that the three leaflets of theaortic valve 20 respectively Squeeze the contact part with thesecond balloon 700, and compress thesecond balloon 700 along the line of the above contact part, so that the width of theblood flow cavity 710 at theaortic valve 20 is reduced. When theaortic valve 20 After it is completely closed, the width of theblood flow cavity 710 at theaortic valve 20 is compressed to the minimum. At this time, the caliber that allows blood to flow into theblood flow cavity 710 is compressed to the narrowest, so that the blood flow in theblood flow cavity 710 and Blood flow from theblood flow lumen 710 to theaorta 30 is minimized.

当心脏或左心室10重新收缩时，主动脉瓣20再次打开，第二球囊700与主动脉瓣20的接触部位不再被主动脉瓣20挤压或约束，第二球囊700扩张膨胀，恢复至完全扩张状态，血液流通腔710的流通口径恢复至最大，左心室10的血液在泵体作用下再次以初始的流量输送至主动脉30内。When the heart or theleft ventricle 10 re-contracts, theaortic valve 20 opens again, and the contact portion between thesecond balloon 700 and theaortic valve 20 is no longer squeezed or constrained by theaortic valve 20, and thesecond balloon 700 expands, After returning to the fully expanded state, the flow diameter of theblood flow cavity 710 is restored to the maximum, and the blood in theleft ventricle 10 is transported to theaorta 30 at the original flow rate again under the action of the pump body.

上述过程即产生一个周期的搏动性血流输出。The above process produces a cycle of pulsatile blood flow output.

显然，第二球囊700的腔体形成的血液流通腔710能够随主动脉瓣20的关闭与打开同步地被挤压与恢复，使得泵体输送至主动脉30的血液流量随主动脉瓣20的关闭与打开同步地减小与增大，以使左心室10的血液在泵体作用下输送至主动脉30内的血液流量的变化频率与患者的心脏搏动舒张与收缩频率相适配，以此产生与患者心脏搏动舒张与收缩同步的搏动性血流。Apparently, theblood circulation cavity 710 formed by the cavity of thesecond balloon 700 can be squeezed and restored synchronously with the closing and opening of theaortic valve 20, so that the blood flow delivered by the pump body to theaorta 30 follows theaortic valve 20. The closing and opening of the valves decrease and increase synchronously, so that the change frequency of the blood flow of theleft ventricle 10 transported to theaorta 30 under the action of the pump body matches the diastolic and systolic frequency of the patient's heartbeat, so as to This produces pulsatile blood flow that is synchronized with the diastole and contraction of the patient's heart beat.

本申请第二球囊700的巧妙设计，配合患者主动脉瓣20的正常开闭状态，不需要配合相应的信号电极或压力传感器获取的心电图信号，就能使整个血液循环辅助装置产生与患者心脏搏动舒张与收缩同步的搏动性血流，有效消除了传统心室辅助装置产生的连续性血流而带来的并发症风险，同时，也在一定程度上防止了主动脉瓣20在闭合状态下血液流通腔710或主动脉30内的血液回流至左心室10，也改善了患者冠脉和远端器官的血液灌注量，减轻了左心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。The ingenious design of thesecond balloon 700 of the present application, in conjunction with the normal opening and closing state of the patient'saortic valve 20, does not need to cooperate with the corresponding signal electrodes or the electrocardiogram signal obtained by the pressure sensor, so that the entire blood circulation assisting device can produce a The pulsatile blood flow synchronized with diastole and systole effectively eliminates the risk of complications caused by the continuous blood flow generated by traditional ventricular assist devices, and at the same time prevents theaortic valve 20 from closing when theaortic valve 20 is closed. The return of blood in thecirculation cavity 710 or theaorta 30 to theleft ventricle 10 also improves the blood perfusion of the patient's coronary arteries and distal organs, reduces the burden on the left ventricle, and is beneficial to the stability of the patient's signs during the operation and postoperative recovery, and promotes The patient's heart recovers.

需要说明的是，在上述过程中，处于降主动脉40位置处的第一球囊300可一直处于将降主动脉40导通的状态，即第一球囊300一直保持扁平的未充气状态，确保整条主动脉30处于导通状态，保证血液在主动脉30内的正常流动。It should be noted that, during the above process, thefirst balloon 300 at the position of the descendingaorta 40 can always be in the state of conducting the descendingaorta 40, that is, thefirst balloon 300 is always kept flat and uninflated. Ensure that theentire aorta 30 is in a conduction state to ensure normal flow of blood in theaorta 30 .

需要说明的是，当心脏或左心室10由收缩状态切换为舒张状态过程中，心脏瓣膜关闭可能无法使血液流通腔710压缩至最窄状态，仍然有血液流出至主动脉30中，此时可依靠第一球囊300的充气使降主动脉40内的压力增大，进而增大主动脉30上游的压力，借助血液对第二球囊700外壁的挤压来完全关闭血液流通腔710。It should be noted that, when the heart or theleft ventricle 10 switches from the systolic state to the diastolic state, the closure of the heart valve may not be able to compress theblood circulation cavity 710 to the narrowest state, and there is still blood flowing out into theaorta 30. The pressure in the descendingaorta 40 is increased by the inflation of thefirst balloon 300 , and then the pressure upstream of theaorta 30 is increased, and theblood circulation cavity 710 is completely closed by the extrusion of the blood on the outer wall of thesecond balloon 700 .

当然，在本实施例的上述过程中，当第二球囊700的血液流通腔710在主动脉瓣20的闭合状态下被压缩时，控制器400可驱动第一球囊300充气，以使第一球囊300部分或全部封堵降主动脉40，此时，以此提高降主动脉40上游的血液压力，有助于主动脉30内的血液克服微动脉以及毛细血管主动脉30的分支血管的阻力而汇入静脉，同时将沿途器官所产生的代谢产物排出；Of course, in the above-mentioned process of this embodiment, when theblood flow cavity 710 of thesecond balloon 700 is compressed in the closed state of theaortic valve 20, thecontroller 400 can drive thefirst balloon 300 to inflate, so that the second balloon 700 Aballoon 300 partially or completely blocks the descendingaorta 40. At this time, increasing the blood pressure upstream of the descendingaorta 40 helps the blood in theaorta 30 to overcome the arterioles and capillary branches of theaorta 30 It flows into the vein due to the resistance, and at the same time discharges the metabolites produced by the organs along the way;

当第二球囊700在主动脉瓣20的打开状态下恢复至完全扩张状态时，控制器400再驱动第一球囊300放气，以使第一球囊300导通降主动脉40，再次保证血液在主动脉30内的正常流动。When thesecond balloon 700 returns to the fully expanded state under the open state of theaortic valve 20, thecontroller 400 drives thefirst balloon 300 to deflate again, so that thefirst balloon 300 leads to the descendingaorta 40, again Ensure the normal flow of blood in theaorta 30 .

不难理解的是，再参见图12，在上述过程中，当患者的心脏短暂停跳时，通过控制器400对第一球囊300间歇地充气和放气的方式，以此达到降主动脉40间歇地被第一球囊300封堵和导通的效果。而且，控制器400控制第一球囊300充气频率和放气频率可被编程为与患者手术前心脏跳动同步的频率，如60-100次/min，实现降主动脉40在短暂的时间内被第一球囊300封堵和导通，巧妙地模拟了心脏跳动心室舒张和收缩，直至患者心脏重新跳动，通过上述方式达到及时为心脏的组织器官供给搏动性血流的功能，使得整个血液循环装置短暂代理心脏，同时也为医生采用相应的治疗措施使心脏复跳争取足够的时间，有助于患者心脏及其组织器官的功能恢复。It is not difficult to understand that, referring to Fig. 12 again, in the above process, when the patient's heart stops beating briefly, thecontroller 400 intermittently inflates and deflates thefirst balloon 300 to reach the descendingaorta 40 is intermittently blocked and opened by thefirst balloon 300. Moreover, thecontroller 400 controls the inflation frequency and deflation frequency of thefirst balloon 300, which can be programmed to a frequency synchronized with the heartbeat of the patient before the operation, such as 60-100 times/min, so that the descendingaorta 40 can be closed in a short period of time. The blockage and conduction of thefirst balloon 300 skillfully simulates the diastole and contraction of the beating heart ventricle until the patient's heart beats again. Through the above method, the function of supplying pulsatile blood flow to the tissues and organs of the heart in time is achieved, so that the whole blood circulation The device temporarily represents the heart, and at the same time buys enough time for the doctor to take corresponding treatment measures to make the heart re-beat, which is helpful for the functional recovery of the patient's heart and its tissues and organs.

参见图13、图14和图15，在本申请的一些实施例中，还包括保护套800，泵体100为具有压缩状态和扩张状态的弹性结构体，泵体100可弹性收纳于保护套800内并与保护套800的内壁相抵，以保持压缩状态，当泵体100脱离保护套800时，泵体100沿自身径向向外膨胀，以保持扩张状态。Referring to Fig. 13, Fig. 14 and Fig. 15, in some embodiments of the present application, aprotective sheath 800 is also included, thepump body 100 is an elastic structure having a compressed state and an expanded state, and thepump body 100 can be elastically accommodated in theprotective sheath 800 When thepump body 100 breaks away from theprotective sleeve 800, thepump body 100 expands radially outwards to maintain the expanded state.

不难理解的是，泵体100在介入患者体内之前，泵体100弹性收纳保护套800，且泵体100的外壁与保护套800的内壁相抵，使得泵体100保持压缩状态。需要说明的是，保护套800为柔性可弯曲结构体，可通过经皮手术将弹性收纳于其内的泵体100同步地介入患者的输血器官内。具体的，当泵体100部分或全部伸入至左心室10内后，操作医生即可将保护套 800抽出，以使得保护套800脱离泵体100，此时，泵体100不再被保护套800约束并在自身的弹性作用力下沿自身径向向外膨胀，完成扩张，相应的，设置于泵体100的血液入口110、血流通道以及血液出口120的内径均得到扩张增大，进而增大了泵体100将左心室10内的血液泵送至主动脉30的输送流量。It is not difficult to understand that before thepump body 100 is inserted into the patient's body, thepump body 100 elastically accommodates theprotective sheath 800 , and the outer wall of thepump body 100 is against the inner wall of theprotective sheath 800 , so that thepump body 100 remains in a compressed state. It should be noted that theprotective sheath 800 is a flexible and bendable structure, and thepump body 100 elastically accommodated therein can be inserted into the patient's blood transfusion organ synchronously through percutaneous surgery. Specifically, when thepump body 100 is partially or completely inserted into theleft ventricle 10, the operating doctor can pull out theprotective sheath 800 so that theprotective sheath 800 is separated from thepump body 100. At this time, thepump body 100 is no longer covered by the protective sheath. 800 constrains and expands outward radially under its own elastic force to complete the expansion. Correspondingly, the inner diameters of theblood inlet 110, the blood flow channel and theblood outlet 120 arranged in thepump body 100 are all expanded, and then The delivery flow of thepump body 100 to pump the blood in theleft ventricle 10 to theaorta 30 is increased.

显然，通过保护套800和泵体100可压缩和扩张的配合设计，可有效减小泵体100介入患者相应血管或输血器官而形成的手术创口面积，提高了整个泵体100在相同的手术创口面积下的泵血流量，也相应减轻了泵体100通过经皮手术介入体内而对患者造成的组织损伤，显著改善术后出血的不良反应。Obviously, through the compressible and expandable cooperative design of theprotective cover 800 and thepump body 100, the surgical wound area formed by thepump body 100 intervening in the patient's corresponding blood vessel or blood transfusion organ can be effectively reduced, and the operation of theentire pump body 100 on the same surgical wound can be improved. The pump blood flow rate under the area also correspondingly reduces the tissue damage caused by thepump body 100 percutaneously intervening in the body, and significantly improves the adverse reaction of postoperative bleeding.

再参见图13、图14和图15，在本申请的一些实施例中，泵体100包括壳体130以及设于壳体130内的旋转叶轮，血流通道、血液入口110和血液出口120均设于壳体130，旋转叶轮为具有展开状态和收纳状态的弹性结构体，当泵体100保持压缩状态时，旋转叶轮弹性收纳于壳体130内，当泵体100切换为扩张状态时，旋转叶轮随壳体130同步向外展开，以保持展开状态。此外，保护套800还用于套设鞘管500、第一球囊300以及第二球囊700。需要说明的是，为了保证整个泵体10良好的压缩和扩张状态，壳体130可选为弹性壳体。Referring again to Fig. 13, Fig. 14 and Fig. 15, in some embodiments of the present application, thepump body 100 includes ahousing 130 and a rotating impeller disposed in thehousing 130, the blood flow channel, theblood inlet 110 and theblood outlet 120 are all Set in thehousing 130, the rotating impeller is an elastic structure with an expanded state and a stored state. When thepump body 100 maintains a compressed state, the rotating impeller is elastically accommodated in thehousing 130. When thepump body 100 is switched to an expanded state, it rotates The impeller is deployed outward synchronously with thecasing 130 to maintain the deployed state. In addition, theprotective sheath 800 is also used to cover thesheath tube 500 , thefirst balloon 300 and thesecond balloon 700 . It should be noted that, in order to ensure good compression and expansion of theentire pump body 10 , thehousing 130 may be an elastic housing.

不难理解的是，整个血液循环辅助装置在介入患者体内之前，泵体100、鞘管500、第一球囊300以及第二球囊700均处于保护套800内，其中，泵体100的旋转叶轮弹性收纳于壳体130内，第二球囊700收纳于保护套800内。It is not difficult to understand that before the entire blood circulation assisting device is inserted into the patient's body, thepump body 100, thesheath tube 500, thefirst balloon 300 and thesecond balloon 700 are all in theprotective sheath 800, wherein the rotation of thepump body 100 The impeller is elastically accommodated in thecasing 130 , and thesecond balloon 700 is accommodated in theprotective sheath 800 .

整个血液循环辅助装置需要介入患者体内时，保护套800可通过经皮手术沿预定的介入轨迹将处于其内的泵体100、第二球囊700、鞘管500以及第一球囊300同步带入相应的血管或输血器官内，而后，操作医生再将保护套800从患者体内抽出，使得壳体130以及设于壳体130内的旋转叶轮在自身的弹性作用下沿径向向外扩张，从而增大了壳体130的内径和旋转叶轮的外径，相应的，设置于壳体130的血液入口110、血流通道以及血液出口120的内径均得到扩张增大，以此达到对患者产生较小的手术创 口面积的前提下，进一步提高泵体100将左心室10内的血液泵送至主动脉30的输送流量的效果。同时，确保整个泵体100能够产生足够的泵血流量的基础上，进一步使得泵体100以及整个血液循环辅助装置更加微型化，进一步减轻了血液循环辅助装置介入患者体内而造成的组织损伤。When the entire blood circulation assisting device needs to be inserted into the patient's body, theprotective sheath 800 can synchronize thepump body 100, thesecond balloon 700, thesheath tube 500 and thefirst balloon 300 within it through a percutaneous operation along a predetermined intervention trajectory. into the corresponding blood vessel or blood transfusion organ, and then the operating doctor pulls theprotective sheath 800 out of the patient's body, so that thecasing 130 and the rotating impeller inside thecasing 130 expand radially outward under the action of its own elasticity, As a result, the inner diameter of thehousing 130 and the outer diameter of the rotating impeller are increased. Correspondingly, the inner diameters of theblood inlet 110, the blood flow channel, and theblood outlet 120 arranged in thehousing 130 are all enlarged, so as to achieve the effect on the patient. On the premise of a small surgical wound area, the delivery flow effect of thepump body 100 to pump the blood in theleft ventricle 10 to theaorta 30 is further improved. At the same time, on the basis of ensuring that theentire pump body 100 can generate sufficient pump blood flow, thepump body 100 and the entire blood circulation assisting device are further miniaturized, further reducing tissue damage caused by the blood circulation assisting device being inserted into the patient's body.

此外，在本申请的一些实施例中，保护套800呈两端开口的管状，以此方便保护套800从患者体内抽出。In addition, in some embodiments of the present application, theprotective sheath 800 is in the shape of a tube with both ends open, so as to facilitate the extraction of theprotective sheath 800 from the patient's body.

在本申请的一些实施例中，还包括设于体内或体外的驱动件，驱动件的输出端直接或间接地与泵体100连接，以驱动泵体100运行，控制器400与驱动件电连接，以控制驱动件的驱动速率。In some embodiments of the present application, it also includes a driving element located inside or outside the body, the output end of the driving element is directly or indirectly connected to thepump body 100 to drive thepump body 100 to run, and thecontroller 400 is electrically connected to the driving element , to control the driving speed of the driver.

具体的，驱动件可为电机或马达。当驱动件设于患者体内时，驱动件可直接设于泵体100内并使得驱动件的输出端与泵体100的旋转叶轮直接连接；当驱动件设于体外时，驱动件的输出端通过传动绞丝与泵体100的旋转叶轮间接传动连接，传动绞丝可穿设于鞘管500内。同样的，控制器400被编程以接收指示患者的左心室10和主动脉30之间的血流动力学状态的变化或波动信号，根据该信号来实时通过驱动件驱动控制泵体100的旋转叶轮的旋转速率，进而达到实时调节泵体100的泵血流量的效果。当然，为了进一步提供泵体100的泵血流量，泵体100内的旋转叶轮可以具有多个，多个旋转叶轮沿周向分布，并将旋转叶轮设计为螺旋叶，以此增大对血液的抽吸效果。Specifically, the driving part can be a motor or a motor. When the driver is located in the body of the patient, the driver can be directly arranged in thepump body 100 and the output end of the driver is directly connected to the rotating impeller of thepump body 100; The transmission twisted wire is indirect transmission connection with the rotating impeller of thepump body 100 , and the transmission twisted wire can be passed through thesheath tube 500 . Similarly, thecontroller 400 is programmed to receive a change or fluctuation signal indicating the hemodynamic state between theleft ventricle 10 and theaorta 30 of the patient, and to drive and control the rotating impeller of thepump body 100 through the driving member in real time according to the signal. The rotation speed of thepump body 100 can be adjusted in real time to achieve the effect of real-time adjustment of the pump blood flow rate of thepump body 100. Of course, in order to further provide the pumping blood flow rate of thepump body 100, there may be multiple rotating impellers in thepump body 100, the plurality of rotating impellers are distributed along the circumferential direction, and the rotating impellers are designed as helical blades, so as to increase the blood pressure. Suction effect.

另外，参见图8和图16，本申请还提供了一种控制系统，该控制系统包括上述的血液循环辅助装置以及信号电极200。其中，信号电极200耦合至泵体100伸入心室的部位，以获取心室的心电图信号，控制器400包括第一处理器410和第二处理器420，第一处理器410与信号电极200连接，以接收心电图信号，并基于心电图信号来控制第一球囊300的充气频率和放气频率，第二处理器420与泵体100电连接，以控制泵体100的运行速率。In addition, referring to FIG. 8 and FIG. 16 , the present application also provides a control system, which includes the above-mentioned blood circulation assisting device and thesignal electrode 200 . Wherein, thesignal electrode 200 is coupled to the part of thepump body 100 extending into the ventricle to obtain the electrocardiogram signal of the ventricle. Thecontroller 400 includes afirst processor 410 and asecond processor 420, thefirst processor 410 is connected to thesignal electrode 200, Thesecond processor 420 is electrically connected with thepump body 100 to control the operating rate of thepump body 100 to receive the electrocardiogram signal and control the inflation frequency and deflation frequency of thefirst balloon 300 based on the electrocardiogram signal.

同样的，本申请的控制系统以患者左心室10以及与左心室10连通的主动脉30为应用场景为例即在本实施例中，心室具体为左心室10，血管具体为主动脉30说明本控制系统的具体应用、工作原理以及带来的效果。Similarly, the control system of the present application takes the patient'sleft ventricle 10 and theaorta 30 communicating with theleft ventricle 10 as an example application scenario, that is, in this embodiment, the ventricle is specifically theleft ventricle 10, and the blood vessel is specifically theaorta 30. The specific application, working principle and effects of the control system.

在本实施例中，第一处理器410被编程基于信号电极200获取的心电图信号反馈的心脏搏动周期或搏动频率来实时调整第一球囊300的充气频率、放气频率以及充气和放气的间隔周期，以此间歇地驱动第一球囊300充气和放气，从而产生与患者心脏搏动同步的搏动性血流。需要说明的是，第一处理器410可通过体外的心电图设备与信号电极200信号连接。In this embodiment, thefirst processor 410 is programmed to adjust the inflation frequency, deflation frequency, and inflation and deflation rate of thefirst balloon 300 in real time based on the heart beat cycle or beat frequency fed back by the electrocardiogram signal acquired by thesignal electrode 200. Thefirst balloon 300 is intermittently driven to inflate and deflate at intervals, so as to generate a pulsatile blood flow synchronized with the patient's heartbeat. It should be noted that, thefirst processor 410 may be signally connected to thesignal electrode 200 through an extracorporeal electrocardiogram device.

同理，第二处理器420可根据植入患者主动脉30的压力传感器所监测的压力信号，从而根据该压力信号转化成的血液流量信号来控制泵体100的运行速度，进而实时调整泵体100的泵血流量。通过上述设置，使得本申请的血液循环辅助装置在第一处理器410和第二处理器420的精确控制下为患者心脏提供更为有效和可靠的血液循环支持，进一步促进了患者心脏及其他组织器官功能的恢复。Similarly, thesecond processor 420 can control the operating speed of thepump body 100 according to the pressure signal monitored by the pressure sensor implanted in the patient'saorta 30, and then convert the pressure signal into a blood flow signal, and then adjust the pump body in real time. 100 pump blood flow. Through the above settings, the blood circulation assisting device of the present application provides more effective and reliable blood circulation support for the patient's heart under the precise control of thefirst processor 410 and thesecond processor 420, further promoting the improvement of the patient's heart and other tissues. Restoration of organ function.

另外，在本申请的一些实施例中，第一球囊300内设有第一压力传感器，第一压力传感器用于监测第一球囊300内的压力，第一处理器410与第一压力传感器连接，并基于第一压力传感器的压力信号来控制第一球囊300的充气量。In addition, in some embodiments of the present application, a first pressure sensor is provided inside thefirst balloon 300, and the first pressure sensor is used to monitor the pressure inside thefirst balloon 300, and thefirst processor 410 communicates with the first pressure sensor connected, and control the inflation rate of thefirst balloon 300 based on the pressure signal of the first pressure sensor.

应该理解的是，在本实施例中，第一压力传感器可实时监测第一球囊300内的压力，控制器400即基于该压力信号判断第一球囊300的充气量或放气量是否符合要求，以此控制第一球囊300对降主动脉40的封堵程度，以使主动脉30内的血液流量符合对分支动脉和组织器官的供血要求。It should be understood that, in this embodiment, the first pressure sensor can monitor the pressure inside thefirst balloon 300 in real time, and thecontroller 400 judges whether the inflation or deflation of thefirst balloon 300 meets the requirements based on the pressure signal. In this way, the degree of occlusion of the descendingaorta 40 by thefirst balloon 300 is controlled, so that the blood flow in theaorta 30 meets the blood supply requirements for branch arteries and tissues and organs.

显然，本申请的血液循环辅助装置以及控制系统，能够产生与患者心脏搏动(舒张与收缩)特性相适配的搏动性血流，有效消除了传统心室辅助装置产生的连续性血流而带来的并发症风险，减轻了心室负担，有利于术中患者体征稳定和术后康复，促进患者心脏恢复。Apparently, the blood circulation assist device and control system of the present application can generate a pulsatile blood flow that matches the characteristics of the patient's heart beat (diastole and systole), effectively eliminating the problems caused by the continuous blood flow produced by traditional ventricular assist devices. It reduces the risk of complications, reduces the burden on the ventricles, is beneficial to the stability of the patient's signs during the operation and postoperative recovery, and promotes the recovery of the patient's heart.

需要说明的是，本申请的血液循环辅助装置以及控制系统不限制于仅应用于左心室以及与左心室连通的主动脉的这一段血液流路中，还可应用于右心室以及与右心室连通的肺动脉等血流流路中，产生的效果原理与上述的说明一致，在此不再赘述。It should be noted that the blood circulation assisting device and control system of the present application are not limited to the blood flow path of the left ventricle and the aorta communicating with the left ventricle, but can also be applied to the right ventricle and the aorta communicating with the right ventricle. In the blood flow channels such as the pulmonary artery, the principle of the effect is consistent with the above description, and will not be repeated here.

以上，仅为本申请实施例的具体实施方式，但本申请实施例的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请实施例揭露的 技术范围内，可轻易想到各种等效的修改或替换，这些修改或替换都应涵盖在本申请实施例的保护范围之内。因此，本申请实施例的保护范围应以权利要求的保护范围为准。The above is only the specific implementation of the embodiment of the present application, but the protection scope of the embodiment of the present application is not limited thereto. Any person familiar with the technical field can easily think of various Equivalent modification or replacement, these modifications or replacement should be covered within the scope of protection of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application should be determined by the protection scope of the claims.

Claims (10)

Translated fromChinese

一种血液循环辅助装置，包括：A blood circulation assist device, comprising:鞘管，所述鞘管具有近端和远端；a sheath having a proximal end and a distal end;第一球囊，套设于所述鞘管；the first balloon is sleeved on the sheath;泵体，设于所述鞘管的远端，具有血流通道以及与所述血流通道连通的血液入口和血液出口；a pump body, located at the distal end of the sheath tube, having a blood flow channel and a blood inlet and a blood outlet communicating with the blood flow channel;控制器，设于所述鞘管的近端，其被配置为控制所述泵体的运行，以及被配置为间歇地驱动所述第一球囊充气和放气。A controller, located at the proximal end of the sheath, is configured to control the operation of the pump body and to drive the first balloon to inflate and deflate intermittently.根据权利要求1所述的血液循环辅助装置，其中，所述第一球囊密封套设于所述鞘管的外壁，所述第一球囊通过充放气管路与体外的充气泵连接，所述控制器控制所述充气泵的充放气频率。The blood circulation assisting device according to claim 1, wherein the first balloon is sealed and sleeved on the outer wall of the sheath, and the first balloon is connected to an extracorporeal air pump through an inflation and deflation pipeline, so The controller controls the inflation and deflation frequency of the air pump.根据权利要求1所述的血液循环辅助装置，其中，还包括具有弹性的第二球囊，所述第二球囊套设在部分所述泵体以及所述鞘管靠近所述泵体的部位上，所述第二球囊的腔体形成与所述血液出口连通的血液流通腔，所述第二球囊开设有至少一个开窗。The blood circulation assisting device according to claim 1, further comprising a second elastic balloon, the second balloon is sheathed on a part of the pump body and a part of the sheath close to the pump body Above, the cavity of the second balloon forms a blood circulation cavity communicating with the blood outlet, and the second balloon is opened with at least one window.根据权利要求3所述的血液循环辅助装置，其中，还包括保护套，所述泵体为具有压缩状态和扩张状态的弹性结构体，所述泵体可弹性收纳于所述保护套内并与所述保护套的内壁相抵，以保持所述压缩状态，当所述泵体脱离所述保护套时，所述泵体沿自身径向向外膨胀，以保持扩张状态。The blood circulation assisting device according to claim 3, further comprising a protective cover, the pump body is an elastic structure having a compressed state and an expanded state, and the pump body can be elastically accommodated in the protective cover and is in contact with the protective cover. The inner walls of the protective sheath are opposed to maintain the compressed state, and when the pump body breaks away from the protective sheath, the pump body expands radially outward along itself to maintain the expanded state.根据权利要求4所述的血液循环辅助装置，其中，所述泵体包括壳体以及设于所述壳体内的旋转叶轮，所述血流通道、所述血液入口和血液出口均设于所述壳体，所述旋转叶轮为具有展开状态和收纳状态的弹性结构体，当所述泵体保持压缩状态时，所述旋转叶轮弹性收纳于所述壳体内，当所述泵体切换为扩张状态时，所述旋转叶轮随所述壳体同步向外展开，以保持展开状态。The blood circulation assisting device according to claim 4, wherein the pump body comprises a housing and a rotating impeller arranged in the housing, and the blood flow channel, the blood inlet and the blood outlet are all arranged in the The casing, the rotating impeller is an elastic structure with an expanded state and a stored state. When the pump body maintains a compressed state, the rotating impeller is elastically accommodated in the casing, and when the pump body is switched to an expanded state , the rotating impeller is deployed outward synchronously with the casing to maintain the deployed state.根据权利要求4所述的血液循环辅助装置，其中，所述保护套还用于套设所述鞘管、所述第一球囊以及所述第二球囊。The blood circulation assisting device according to claim 4, wherein the protective sheath is also used to cover the sheath tube, the first balloon and the second balloon.根据权利要求4所述的血液循环辅助装置，其中，所述保护套呈两 端开口的管状。The blood circulation assisting device according to claim 4, wherein the protective sheath is in the shape of a tube with both ends open.根据权利要求1至7任一项所述的血液循环辅助装置，其中，还包括设于体内或体外的驱动件，所述驱动件的输出端直接或间接地与所述泵体连接，以驱动所述泵体运行，所述控制器与所述驱动件连接，以控制所述驱动件的驱动速率。The blood circulation assisting device according to any one of claims 1 to 7, further comprising a driving member arranged inside or outside the body, the output end of the driving member is directly or indirectly connected to the pump body to drive The pump body operates, and the controller is connected with the driving member to control the driving speed of the driving member.一种控制系统，包括：A control system comprising:如权利要求1至8任一项所述的血液循环辅助装置；The blood circulation assisting device according to any one of claims 1 to 8;信号电极，耦合至所述泵体伸入所述心室的部位，以获取所述心室的心电图信号；a signal electrode coupled to the part where the pump body extends into the ventricle, so as to obtain the electrocardiogram signal of the ventricle;所述控制器包括第一处理器和第二处理器，所述第一处理器与所述信号电极连接，以接收所述心电图信号，并基于所述心电图信号来控制所述第一球囊的充气频率和放气频率，所述第二处理器与所述泵体电连接，以控制所述泵体的运行速率。The controller includes a first processor and a second processor, the first processor is connected to the signal electrode to receive the electrocardiogram signal, and controls the movement of the first balloon based on the electrocardiogram signal. Inflation frequency and deflation frequency, the second processor is electrically connected with the pump body to control the operation rate of the pump body.根据权利要求9所述的控制系统，其中，所述第一球囊内设有第一压力传感器，所述第一压力传感器用于监测所述第一球囊内的压力，所述第一处理器与所述第一压力传感器连接，并基于所述第一压力传感器的压力信号来控制所述第一球囊的充气量。The control system according to claim 9, wherein a first pressure sensor is provided in the first balloon, and the first pressure sensor is used to monitor the pressure in the first balloon, and the first processing The device is connected with the first pressure sensor, and controls the inflation amount of the first balloon based on the pressure signal of the first pressure sensor.

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