CN111632217A - A ventricular circulatory aid device with an intermediate impeller - Google Patents
A ventricular circulatory aid device with an intermediate impeller Download PDFInfo
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- CN111632217A CN111632217A CN202010413170.8A CN202010413170A CN111632217A CN 111632217 A CN111632217 A CN 111632217A CN 202010413170 A CN202010413170 A CN 202010413170A CN 111632217 A CN111632217 A CN 111632217A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
- A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
- A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
- A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
- A61M60/414—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
- A61M60/81—Pump housings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
- A61M60/867—Devices for guiding or inserting pumps or pumping devices into the patient's body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
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- Heart & Thoracic Surgery (AREA)
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Abstract
本发明涉及医疗器械领域,具体地说是一种加速式体外驱动心室循环辅助装置,包括驱动装置、导管轴套、泵血管、头端叶轮和中间叶轮,其中泵血管内部中空且两端开口,导管轴套前端与所述泵血管后端连接且连接处设有头端叶轮,所述导管轴套上设有中间叶轮,且所述头端叶轮和中间叶轮通过驱动装置驱动转动。本发明利用头端叶轮将血液由心室泵入主动脉中,利用中间叶轮加速血液在血管内的流速,提高泵血效率,或者逆流泵血以减慢远端血流维持血压,保证重要脏器的供血。
The invention relates to the field of medical devices, in particular to an accelerated external drive ventricular circulation auxiliary device, comprising a drive device, a catheter bush, a pump blood vessel, a head-end impeller and an intermediate impeller, wherein the pump blood vessel is hollow inside and open at both ends, The front end of the catheter shaft sleeve is connected with the rear end of the pump blood vessel, and the connection is provided with a head end impeller, the catheter shaft sleeve is provided with an intermediate impeller, and the head end impeller and the intermediate impeller are driven to rotate by a driving device. The invention utilizes the head-end impeller to pump blood from the ventricle into the aorta, utilizes the intermediate impeller to accelerate the blood flow rate in the blood vessel, improves the blood pumping efficiency, or pumps the blood in reverse flow to slow down the distal blood flow to maintain blood pressure, and ensure important organs blood supply.
Description
技术领域technical field
本发明涉及医疗器械领域,具体地说是一种设有中间叶轮的心室循环辅助装置。The invention relates to the field of medical instruments, in particular to a ventricular circulation auxiliary device provided with an intermediate impeller.
背景技术Background technique
在医学临床中,当患者的心脏功能严重受损时,比如急性心肌梗死并发心力衰竭和心源性休克时,在患者常规治疗或需进行介入治疗,或者外科手术前后以及术后出现并发症等情况时,都需要对心脏进行循环支持,使患者度过危险期。In clinical medicine, when the patient's cardiac function is severely damaged, such as acute myocardial infarction complicated with heart failure and cardiogenic shock, the patient is routinely treated or needs interventional therapy, or complications occur before and after surgery and after surgery, etc. In all cases, circulatory support to the heart is required to enable the patient to pass through the dangerous period.
为了满足上述治疗需要,一些心室辅助循环装置应运而生,其通常包括泵血管、导管轴套、叶轮、驱动装置等结构,其中驱动装置用于驱动叶轮转动实现泵血,所述驱动装置可采用设于人体内的方式直接驱动叶轮,也可以采用体外驱动方式通过导管轴套内的转轴传动驱动叶轮。但现有技术中的心室辅助循环装置通常只在导管远端设有叶轮,泵血效率有其极限,只能通过增加叶轮直径或提高叶轮转速实现提高泵血效率目的,但叶轮直径受植入导管限制,不能设计过大,叶轮转速过高则可导致血细胞的破裂,出现血小板减少或溶血,威胁患者生命。In order to meet the above-mentioned treatment needs, some ventricular assisted circulation devices have emerged, which usually include structures such as pump blood vessels, catheter bushings, impellers, and driving devices, wherein the driving device is used to drive the impeller to rotate to realize blood pumping. The impeller can be directly driven by the method of being installed in the human body, or the impeller can be driven by external driving through the rotating shaft in the catheter bushing. However, the ventricular assisted circulation device in the prior art is usually only provided with an impeller at the distal end of the catheter, and the blood pumping efficiency has its limit. The catheter is limited and cannot be designed to be too large. If the impeller rotates too high, it can cause the rupture of blood cells, thrombocytopenia or hemolysis, which threatens the life of the patient.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种设有中间叶轮的心室循环辅助装置,利用头端叶轮将血液由心室泵入主动脉中,利用中间叶轮加速血液在血管内的流速,提高泵血效率,或者更为严重情况下,血压无法维持时,中间叶轮采用与常规相反结构逆流泵血,以减慢远端血流维持血压,保证重要脏器的供血。The purpose of the present invention is to provide a ventricular circulation auxiliary device provided with an intermediate impeller, which utilizes the head-end impeller to pump blood from the ventricle into the aorta, utilizes the intermediate impeller to accelerate the flow rate of blood in the blood vessel, improves the pumping efficiency, or In severe cases, when blood pressure cannot be maintained, the middle impeller adopts the opposite structure to pump blood in reverse flow to slow down the distal blood flow to maintain blood pressure and ensure the blood supply to important organs.
本发明的目的是通过以下技术方案来实现的:The purpose of this invention is to realize through the following technical solutions:
一种设有中间叶轮的心室循环辅助装置,包括驱动装置、导管轴套、泵血管、头端叶轮和中间叶轮,其中泵血管内部中空且两端开口,导管轴套前端与所述泵血管后端连接且连接处设有头端叶轮,所述导管轴套上设有中间叶轮,且所述头端叶轮和中间叶轮通过驱动装置驱动转动。A ventricular circulation auxiliary device provided with an intermediate impeller, comprising a driving device, a catheter shaft sleeve, a pump vessel, a head-end impeller and an intermediate impeller, wherein the pump vessel is hollow inside and has open ends at both ends, and the front end of the catheter sleeve is connected to the back of the pump vessel. The ends are connected and a head-end impeller is arranged at the connection, an intermediate impeller is arranged on the conduit sleeve, and the head-end impeller and the intermediate impeller are driven to rotate by a driving device.
所述导管轴套设有中间叶轮的位置设有缩径部和过渡套,所述过渡套一端与所述缩径部相连且连接处设有输入开口,所述过渡套另一端通过中间连杆与导管轴套相连,且相邻中间连杆之间形成输出开口,所述过渡套内设有中间叶轮。The position where the conduit sleeve is provided with the intermediate impeller is provided with a diameter reducing portion and a transition sleeve, one end of the transition sleeve is connected with the diameter reducing portion and an input opening is provided at the connection, and the other end of the transition sleeve passes through the intermediate connecting rod It is connected with the catheter shaft sleeve, and an output opening is formed between adjacent intermediate connecting rods, and an intermediate impeller is arranged in the transition sleeve.
所述过渡套内壁包括过渡套弧形壁和过渡套直线壁,且所述缩径部外壁、输入开口以及过渡套弧形壁光滑衔接。The inner wall of the transition sleeve includes an arc-shaped wall of the transition sleeve and a linear wall of the transition sleeve, and the outer wall of the reduced diameter portion, the input opening and the arc-shaped wall of the transition sleeve are smoothly connected.
所述导管轴套设有中间叶轮的位置设有过渡套,且所述过渡套两端分别通过中间连杆与对应侧的导管轴套相连,并且一端相邻中间连杆之间形成所述输入开口,另一端相邻中间连杆之间形成输出开口。A transition sleeve is provided at the position where the intermediate impeller is provided on the conduit sleeve, and both ends of the transition sleeve are respectively connected with the conduit sleeve on the corresponding side through an intermediate connecting rod, and the input is formed between the adjacent intermediate connecting rods at one end. opening, and an output opening is formed between the adjacent intermediate links at the other end.
所述泵血管前端设有柔性部,且所述柔性部通过沿着圆周方向均布的第一连杆与泵血管前端相连,并且相邻两个第一连杆之间的空隙形成泵入开口,所述泵血管后端通过沿着圆周方向均布的第二连杆与导管轴套前端连接,并且相邻两个第二连杆之间的空隙形成泵出开口。The front end of the pump blood vessel is provided with a flexible part, and the flexible part is connected with the front end of the pump blood vessel through the first connecting rods evenly distributed along the circumferential direction, and the gap between the two adjacent first connecting rods forms a pumping opening The rear end of the pump blood vessel is connected with the front end of the catheter shaft sleeve through second connecting rods evenly distributed along the circumferential direction, and the gap between two adjacent second connecting rods forms a pumping opening.
所述泵血管前端的泵入开口与一个扩张头端相连,所述扩张头端包括记忆合金制成的扩张架和套设在所述扩张架上的导流膜,所述泵血管后端通过沿着圆周方向均布的第二连杆与导管轴套前端连接,且相邻两个第二连杆之间的空隙形成泵出开口。The pumping opening at the front end of the pump blood vessel is connected with an expansion head end, and the expansion head end includes an expansion frame made of memory alloy and a diversion membrane sleeved on the expansion frame, and the back end of the pump blood vessel passes through the expansion frame. The second connecting rods evenly distributed along the circumferential direction are connected with the front end of the catheter bushing, and the gap between two adjacent second connecting rods forms a pumping opening.
所述扩张架包括多个由记忆合金制作而成的支撑梁,所述支撑梁后端连接所述泵血管,所述支撑梁前端为自由端,所述导流膜覆盖固设于所述支撑梁上。The expansion frame includes a plurality of support beams made of memory alloy, the rear end of the support beam is connected to the pump blood vessel, the front end of the support beam is a free end, and the guide film is covered and fixed on the support beam .
所述导管轴套后端与体外驱动装置连接,所述导管轴套内部设有转轴,并且所述转轴通过所述体外驱动装置驱动旋转,所述头端叶轮和中间叶轮设于所述转轴上。The rear end of the catheter shaft sleeve is connected with an extracorporeal drive device, the interior of the catheter shaft sleeve is provided with a rotating shaft, and the rotating shaft is driven to rotate by the external drive device, and the head end impeller and the intermediate impeller are arranged on the rotating shaft .
所述转轴为螺旋缠绕管。The rotating shaft is a spiral wound tube.
所述驱动装置为体内驱动装置,包括头端驱动装置和中间驱动装置,所述头端驱动装置和中间驱动装置均设于导管轴套中,且所述头端叶轮通过所述头端驱动装置驱动转动,所述中间叶轮通过中间驱动装置驱动转动。The drive device is an internal drive device, including a head end drive device and an intermediate drive device, the head end drive device and the intermediate drive device are both arranged in the catheter shaft sleeve, and the head end impeller passes through the head end drive device. Driven to rotate, the intermediate impeller is driven to rotate by an intermediate drive device.
本发明的优点与积极效果为:The advantages and positive effects of the present invention are:
1、本发明利用头端叶轮将血液由心室泵入主动脉中,利用中间叶轮加速血液在血管内的流速,提高泵血效率,或者利用中间叶轮减慢靠近心脏一端的远端血流,维持血压,其中大部分情况下所述中间叶轮可采用泵出的血流与正常血流同方向结构,以提高泵血效率,但若患者为心脏泵衰竭并伴有血压下降时,此时采用中间叶轮泵出血流与正常血流方向相反结构,通过逆流泵血减慢远端血流,维持血压,保证重要脏器的供血。1. The present invention utilizes the head-end impeller to pump blood from the ventricle into the aorta, utilizes the intermediate impeller to accelerate the flow rate of blood in the blood vessel, improves the pumping efficiency, or utilizes the intermediate impeller to slow down the distal blood flow near one end of the heart, maintaining Blood pressure, in most cases, the middle impeller can adopt the structure of pumped blood flow in the same direction as normal blood flow to improve the pumping efficiency, but if the patient has heart pump failure accompanied by blood pressure drop, the middle impeller is used at this time. The blood flow of the impeller pump is in the opposite direction to the normal blood flow. Through the countercurrent pumping blood, the distal blood flow is slowed down, the blood pressure is maintained, and the blood supply to the important organs is guaranteed.
2、本发明在泵血管和过渡套上均设有定位元件以实时监测位置,另外在泵血管和过渡套上还设有压力传感器和温度传感器,以实时监测血液压力、温度等参数。2. In the present invention, positioning elements are provided on both the pump blood vessel and the transition sleeve to monitor the position in real time, and a pressure sensor and a temperature sensor are also provided on the pump blood vessel and the transition sleeve to monitor parameters such as blood pressure and temperature in real time.
3、本发明可以在泵血管远端设有扩张头端引导血液流动,以增大入血面积,减缓血液流速,避免血液流速过急影响血液溶血指数等指标,减少血细胞损伤。3. The present invention can be provided with an expansion head at the distal end of the pump vessel to guide the blood flow, so as to increase the blood entry area, slow down the blood flow rate, prevent the blood flow rate from affecting the blood hemolysis index and other indicators, and reduce blood cell damage.
附图说明Description of drawings
图1为本发明实施例1的结构示意图,1 is a schematic structural diagram of
图2为图1中的A处放大图,Fig. 2 is an enlarged view of A in Fig. 1,
图3为图2中的泵血管立体示意图,Fig. 3 is the three-dimensional schematic diagram of the pump blood vessel in Fig. 2,
图4为图1中的B处放大图,Fig. 4 is the enlarged view of B in Fig. 1,
图5为图4中过渡套的剖视图,Fig. 5 is the sectional view of the transition sleeve in Fig. 4,
图6为本发明实施例2的结构示意图,6 is a schematic structural diagram of
图7为图6中的C处放大图,Fig. 7 is the enlarged view of C in Fig. 6,
图8为图6中实施例2的工作状态示意图,Fig. 8 is the working state schematic diagram of
图9为现有技术中的心室循环辅助装置工作状态示意图,9 is a schematic diagram of the working state of the ventricular circulatory assist device in the prior art,
图10为本发明实施例3的头端驱动装置安装位置示意图,Fig. 10 is a schematic diagram of the installation position of the head end drive device according to the third embodiment of the present invention,
图11为本发明实施例3的中间驱动装置安装位置示意图。FIG. 11 is a schematic diagram of the installation position of the intermediate drive device according to
其中,1为泵血管,101为泵入开口,102为柔性部,103为泵出开口,104为第一连杆,105为第二连杆,2为头端叶轮,3为中间叶轮,301为缩径部,302为过渡套,303为过渡套弧形壁,304为中间连杆,305为输入开口,306为过渡套直线壁,307为第一中间堵块,4为导管轴套,401为转轴,402为堵块,5为体外驱动装置,6为心室,7为主动脉,8为扩张头端,801为扩张架,802为导流膜,9为头端驱动装置,10为中间驱动装置。Among them, 1 is the pump blood vessel, 101 is the pump inlet opening, 102 is the flexible part, 103 is the pump outlet opening, 104 is the first connecting rod, 105 is the second connecting rod, 2 is the head end impeller, 3 is the middle impeller, 301 302 is the transition sleeve, 303 is the arc-shaped wall of the transition sleeve, 304 is the intermediate connecting rod, 305 is the input opening, 306 is the linear wall of the transition sleeve, 307 is the first intermediate block, 4 is the catheter shaft sleeve, 401 is the rotating shaft, 402 is the block, 5 is the external drive device, 6 is the ventricle, 7 is the aorta, 8 is the expansion head, 801 is the expansion frame, 802 is the diversion membrane, 9 is the head end driving device, 10 is Intermediate drive.
具体实施方式Detailed ways
下面结合附图对本发明作进一步详述。The present invention will be described in further detail below in conjunction with the accompanying drawings.
如图1~8所示,本发明包括驱动装置、导管轴套4、泵血管1、头端叶轮2和中间叶轮3,其中泵血管1内部中空且两端设有开口,导管轴套4前端与所述泵血管1后端连接且连接处设有头端叶轮2,所述导管轴套4上设有中间叶轮3,且所述头端叶轮2和中间叶轮3通过驱动装置驱动转动。As shown in Figures 1 to 8, the present invention includes a driving device, a
如图1~3所示,所述泵血管1前端设有泵入开口101、后端设有泵出开口103,本发明工作时,所述导管轴套4与泵血管1连接处的头端叶轮2转动使心室6内的血液由所述泵入开口101进入泵血管1,并经由所述泵出开口103流出进入主动脉7中,从而实现心脏血液循环。As shown in FIGS. 1 to 3 , the
如图2所示,在所述导管轴套4前端设有堵块402将导管轴套4内部与外部隔离实现密封,保证人体内血液不会进入导管轴套4中,同时所述叶轮2的叶轮轴通过转套或轴承等结构支撑可转动地安装于所述堵块402上。As shown in FIG. 2 , a
如图1所示,所述导管轴套4上可根据需要设置一个或多个中间叶轮3,如图4~5所示,所述导管轴套4上设有中间叶轮3的位置设有缩径部301和过渡套302,且所述缩径部301与过渡套302的连接处设有输入开口305,所述过渡套302另一端设有中间叶轮3,并且所述过渡套302设有中间叶轮3的一端通过多个中间连杆304与导管轴套4相连,并且相邻中间连杆304之间形成输出开口。根据患者病情不同,所述中间叶轮3可采用泵出的血流与正常血流同方向结构,也可采用泵出的血流与正常血流反方向结构,其中大部分情况下所述中间叶轮3使泵出的血流与正常血流同方向以提高泵血效率,但若患者为心脏泵衰竭并伴有血压下降等情况时,此时采用中间叶轮3泵出血流与正常血流方向相反结构,并通过逆流泵血减慢靠近心脏一端的远端血流,维持血压,避免血压进一步降低,保证重要脏器的供血。当所述中间叶轮3需要反方向泵血时,中间叶轮3及其相关的缩径部301、过渡套302、输入开口305、输出开口等结构均按导管轴套4纵轴的前后方向镜像改变,并且叶轮角度也根据需要相应改变。As shown in FIG. 1 , one or more
如图5所示,所述过渡套302内壁包括过渡套弧形壁303和过渡套直线壁306,其中所述缩径部301外壁与过渡套弧形壁303光滑衔接,这样血液流动时先沿着缩径部301外侧凹面自然流入到输入开口305中,并在中间叶轮3作用下沿着输入开口305以及所述过渡套弧形壁303的弧状自然流动,所述缩径部301外壁外侧、输入开口305以及过渡套弧形壁303内侧形成一个尽量和缓的弧形流道,以保证血液沿着弧形流道自然流动,所述过渡套直线壁306内设有所述中间叶轮3与所述弧形流道配合泵血,且所述中间叶轮3最大直径避免与其他部件旋转干涉。As shown in FIG. 5 , the inner wall of the
如图5所示,所述缩径部301内设有第一中间堵块307将过渡套303前侧的导管轴套4内部密封,同样所述过渡套303后侧的导管轴套4端部设有第二中间堵块实现后侧导管轴套4内部密封。As shown in FIG. 5 , the
所述过渡套302也可以采用和图3所示泵血管1类似结构,也即所述过渡套302两端分别通过中间连杆304直接与对应侧的导管轴套4相连,且一端相邻中间连杆304之间形成所述输入开口305,另一端相邻中间连杆304之间形成输出开口。The
为了监测本发明各部分的位置,所述泵血管1以及所述过渡套302上可设有定位元件,所述定位元件可采用显影环或显影涂层配合显影设备实现定位,所述显影环和显影涂层均为本领域公知技术。In order to monitor the position of each part of the present invention, the
本发明也可以在泵血管1上以及所述过渡套302上设置定位检测头,并利用现有技术中的检测场发生系统实现泵血管1两端以及所述过渡套302的精确定位。目前医学上常用的定位方式主要包括磁场定位、电场定位等方式,其中磁场定位原理是在人体躯干外部产生一个空间编码的低频低功率磁场,在人体内部形成磁场梯度,并通过安装在医用元件上的磁感应器探查该磁场并反推出磁感应器所在位置,进而确定医用元件位置,而电场定位原理通常是利用电流电极在人体内部形成正交电流场,医用元件植入人体后,通过安装在医用元件上的电感应器检测电极之间的阻抗,进而显示元件走过的路径。无论何种定位方式,一般都配有一套包括电脑和显示屏在内的定位处理系统,如果此时病人的身体是处于相对稳定的状态,那么带有感应器的医用元件在人体内游走的轨迹可通过定位处理系统换算处理并在显示屏上显示,供医生参考确认,比如对进入血管的起博电极进行定位时,在一些解剖结构特征比较明显的部位,如上下腔,三尖瓣、右室流出道等部位可以凭借医生的经验,对电极导管位置做出比较准确的判断。因此本发明中的检测场发生系统可以为磁场发生系统,此时所述定位检测头对应为磁感应器,所述检测场发生系统也可以为电场发生系统,此时所述定位检测头对应为电感应器,In the present invention, a positioning detection head can also be provided on the
利用定位检测头定位时,人体相应部位置于检测场发生系统中,然后开始下入导管,本发明进入人体后,泵血管1上以及所述过渡套302的定位检测头发出信号给定位处理系统,定位处理系统可将信号处理并在显示屏上显示,医生通过观察定位处理系统的显示屏即可确认泵血管1以及所述过渡套302位置。所述定位检测头、检测场发生系统、定位处理系统均为本领域公知技术且均为市购产品。When the positioning detection head is used for positioning, the corresponding part of the human body is placed in the detection field generating system, and then the catheter starts to be lowered. After the present invention enters the human body, the positioning detection head on the
另外所述泵血管1和过渡套302上也可以设置压力传感器、温度传感器等元件,以实时监测血液压力、温度等参数,所述压力传感器和温度传感器均为本领域公知技术且为市购产品。In addition, the
本发明的泵血管1前端可根据需要设计成柔性部102或扩张头端8,并且驱动装置可以根据需要选择体外驱动装置5形式或体内驱动装置形式。The front end of the
实施例1Example 1
如图1~3所示,本实施例采用体外驱动装置5形式,并且所述泵血管1前端设有柔性部102以防止对人体内部器官造成损伤,所述柔性部102为弯曲软头,所述弯曲软头可避免损伤血管壁或心室内壁。As shown in Figures 1-3, this embodiment adopts the form of an
如图1所示,导管轴套4后端延伸至人体外并与体外驱动装置5连接,所述导管轴套4内部设有转轴401,并且所述转轴401通过所述体外驱动装置5驱动旋转,所述头端叶轮2和中间叶轮3均通过所述转轴401驱动转动,其中如图2所示,所述导管轴套4前端设有密封的堵块402将导管轴套4内部与外部隔离,所述头端叶轮2的轮轴通过轴承支承安装于所述堵块402上,且所述头端叶轮2的轮轴末端与所述转轴401固连,而如图5所示,所述缩径部301内设有第一中间堵块307将过渡套303前侧的导管轴套4内部密封,所述过渡套303后侧的导管轴套4端部设有第二中间堵块实现后侧导管轴套4内部密封,所述中间叶轮3的前侧轮轴通过轴承支承安装于所述第一中间堵块307上,所述中间叶轮3的后侧轮轴通过轴承支承安装于所述第二中间堵块上,且所述中间叶轮3的前侧轮轴和后侧轮轴分别与对应侧导管轴套4内的转轴401固连。As shown in FIG. 1 , the rear end of the
本实施例中,所述转轴401可采用螺旋缠绕管,在保证驱动叶轮转动同时也具有一定柔性,并可随导管轴套4形变,所述螺旋缠绕管为本领域公知技术且为市购产品。In this embodiment, the
如图3所示,所述柔性部102尾端通过沿着圆周方向均布的多个第一连杆104与泵血管1前端相连,且相邻两个第一连杆104之间的空隙形成泵入开口101,所述泵血管1后端通过沿着圆周方向均布的多个第二连杆105与导管轴套4前端连接,且相邻两个第二连杆105之间的空隙形成泵出开口103,所述头端叶轮2旋转直径要小于所述各个第二连杆105围合的圆周直径,以避免头端叶轮2旋转干涉。As shown in FIG. 3 , the tail end of the
所述头端叶轮2、中间叶轮3、泵血管1、各个堵块及各个连杆均可采用医用合金等材料制成。The head-
本实施例的工作原理为:The working principle of this embodiment is:
如图9所示,现有技术中的心室辅助循环装置通常只在前端设有叶轮用于将心室6内的血液泵出至主动脉7中,对于一些心衰严重的患者来说,如果仅靠头端的叶轮泵血,泵血效率有其极限。As shown in FIG. 9, the ventricular assisting circulation device in the prior art is usually only provided with an impeller at the front end for pumping the blood in the
本实施例如图1所示,除了在导管轴套4前端设有头端叶轮2外,在导管轴套4上也可以根据需要设置一个或多个中间叶轮3,头端叶轮2主要用于将血液由心室6泵入主动脉7中,而根据患者病情不同,所述中间叶轮3可采用泵出的血流与正常血流同方向结构,也可采用泵出的血流与正常血流反方向结构,其中大部分情况下所述中间叶轮3使泵出的血流与正常血流同方向以提高泵血效率,但若患者为心脏泵衰竭并伴有血压下降等情况时,此时需采用中间叶轮3泵出血流与正常血流方向相反结构,以通过逆流泵血减慢远端血流,维持血压,保证重要脏器的供血。另外泵血管1前端的设有柔性部102可避免损伤血管壁或心室内壁。In this embodiment, as shown in FIG. 1 , in addition to the head-
本实施例下管植入过程与现有技术中的心室辅助循环装置下管植入过程相同。The implantation process of the lower tube in this embodiment is the same as the implantation process of the lower tube of the ventricular assisting circulation device in the prior art.
实施例2Example 2
如图6~8所示,本实施例采用体外驱动装置5形式,但本实施例与实施例1的区别在于:所述泵血管1前端设有扩张头端8用于增大入血面积,使血流和缓流入,降低泵血过程中的能量消耗。As shown in Figures 6-8, this embodiment adopts the form of an
如图6~8所示,所述扩张头端8包括扩张架801和铺设在所述扩张架801上的导流膜802,所述扩张架801后端与所述泵血管1前端的泵入开口101固连,所述扩张架801前端可自动张开,且张开同时将导流膜802撑开形成近似喇叭状的入血口引导血液向一定方向流动,增大入血面积同时使血流和缓流入。本实施例中,所述扩张架801包括多个由记忆合金制作而成的支撑梁,所述支撑梁后端与泵入开口101固连,所述支撑梁前端为自由端,所述导流膜802覆盖固设于所述支撑梁上。所述记忆合金为本领域公知技术,其广泛应用于医疗领域,所述支撑梁由于记忆合金特性可压缩且可自动张开,另外本实施例中,所述导流膜802材质可采用聚合物,比如聚氨酯等,具备足够的弹性和强度,此为本领域公知技术,并且由于所述导流膜802具有弹性且将支撑梁包裹,可起到避免损伤血管壁或心室内壁的作用。As shown in FIGS. 6-8 , the
本实施例中,所述泵血管1后端通过沿着圆周方向均布的多个第二连杆105与导管轴套4前端连接,相邻两个第二连杆105之间的空隙形成泵出开口103。In this embodiment, the rear end of the
本实施例的工作原理为:The working principle of this embodiment is:
现有技术中的心室辅助循环装置泵血管前端的入血口通常较小,这限制了泵血效率,并且易导致血液流速加快,如图8所示,本实施例在泵血管1远端设有扩张头端8,下管时所述扩张头端8通过压缩记忆合金制成的支撑梁呈现出压缩状态,方便下管,进入心室6后扩张头端8由于记忆合金特性作用自动张开,并将导流膜802撑开形成入血口,增大入血面积同时也使血液和缓流入,降低泵血过程中的能量消耗,同时中间叶轮3用于加速血液在血管内的流速,或者患者为心脏泵衰竭并伴有血压下降等情况时逆流泵血。The blood inlet at the front end of the pump blood vessel of the ventricular assisting circulation device in the prior art is usually small, which limits the blood pumping efficiency and easily leads to an increase in the blood flow rate. As shown in FIG. There is an
本实施例的下管植入过程与现有技术中的心室辅助循环装置下管植入过程基本相同,区别仅在于下管时将所述扩张头端8压缩。The implantation process of the lower tube in this embodiment is basically the same as the implantation process of the lower tube of the ventricular assist circulation device in the prior art, and the difference is only that the
实施例3Example 3
如图10~11所示,本实施例采用体内驱动装置形式,省却了转轴401等结构。As shown in FIGS. 10-11 , this embodiment adopts the form of an in-body drive device, omitting structures such as the
如图10~11所示,本实施例中的驱动装置5包括头端驱动装置9和中间驱动装置10,所述头端驱动装置9和中间驱动装置10均为微型电机并固设于导管轴套4中,其中如图10所示,所述头端叶轮2的轮轴穿过堵块402后与所述头端驱动装置9驱动端固连,如图11所示,所述中间叶轮3前侧轮轴通过轴承支承安装于所述第一中间堵块307上,所述中间叶轮3后侧轮轴穿过所述第二中间堵块后与对应的中间驱动装置10驱动端固连。所述头端驱动装置9和中间驱动装置10为本领域公知技术且为市购产品,。As shown in FIGS. 10 to 11 , the driving
本实施例可根据需要在泵血管1前端设置柔性部102或扩张头端8。In this embodiment, a
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