CN116058889A - Conveying device for transventricular wall implantation instrument - Google Patents

Abstract

The invention discloses a conveying device for a transventricular wall implantation instrument, which comprises a hollow outer catheter, a heart puncher and a conveying component; the two ends of the outer catheter are opened, and a heart apex attaching piece is arranged at one end; the heart puncher comprises a straight rod part, a tip part arranged at one end of the straight rod part and a handle arranged at the other end of the straight rod part; when the heart puncher is used for punching the ventricle wall, the heart puncher is inserted from the other end of the outer catheter, and the tip part is exposed from one end of the outer catheter; the conveying assembly comprises a conveying inner guide pipe and a pushing rod, wherein the conveying inner guide pipe is provided with an inner hollow pipe and a sealing disc arranged on the inner hollow pipe; the pushing rod is provided with a pushing rod, a pushing disc arranged at one end of the pushing rod and a pushing handle arranged at the other end of the pushing rod; the pushing rod is inserted into the inner hollow tube, and the pushing disc is contacted with the instrument to be implanted which is loaded in the inner hollow tube; when the instrument is implanted, the inner conveying guide pipe of the conveying assembly is inserted into the outer guide pipe from the other end of the outer guide pipe, and the sealing disc seals a gap between the outer guide pipe and the inner conveying guide pipe.

Description

Translated fromChinese

一种用于经心室壁植入器械的输送装置A delivery device for implanting a device through the ventricular wall

技术领域technical field

本发明涉及医疗器械技术领域，具体涉及一种带有打孔功能的用于经心室壁植入器械的输送装置，适用于需要经心室壁打孔植入到心室或心房内的用于治疗心脏类疾病的器械的输送。The present invention relates to the technical field of medical devices, in particular to a delivery device with a perforating function for implanting instruments through the ventricular wall, which is suitable for treating heart diseases that need to be perforated through the ventricular wall and implanted into the ventricle or atrium. Delivery of devices for diseases.

背景技术Background technique

心血管疾病是全球唯一患病率呈现增长趋势的非传染性疾病，而心脏疾病器械是医疗器械的第二大领域。对于数以千万计的全球心脏病患者，尤其是危重症心脏病患者来说，通过有效的器械干预、降低心脏病发病率与死亡率，已经成为相关心脏病治疗的一个有效手段。Cardiovascular disease is the only non-communicable disease with an increasing prevalence in the world, and heart disease devices are the second largest field of medical devices. For tens of millions of heart disease patients around the world, especially critical heart disease patients, it has become an effective means of heart disease treatment to reduce the incidence and mortality of heart disease through effective device intervention.

在心脏疾病治疗过程中，有一类器械需要经心室壁打孔放置于心室(或心房)内，此类器械包括无法以跨瓣膜方式植入心室内、需要在心室内进行缝合固定等情况的器械，例如安装于心室内用于治疗舒张性心衰的心室辅助装置。目前没有可经心尖(包括心室壁)将治疗心脏病的相关器械输送至心室(或者心房)内的装置，而发明一种具有心室壁打孔功能的、可将此类器械安装于心脏内的输送系统，不仅可以辅助器械的植入，还可以简化手术流程，降低手术对患者带来的损伤。During the treatment of heart disease, there is a type of device that needs to be placed in the ventricle (or atrium) through the ventricular wall. This type of device includes devices that cannot be implanted into the ventricle in a transvalvular manner, and need to be sutured and fixed in the ventricle. An example is a ventricular assist device installed in the ventricle to treat diastolic heart failure. At present, there is no device that can deliver related devices for treating heart disease to the ventricle (or atrium) through the apex of the heart (including the ventricular wall), but a device that has the function of perforating the ventricular wall and can be installed in the heart The delivery system can not only assist in the implantation of devices, but also simplify the operation process and reduce the damage caused by the operation to the patient.

发明内容Contents of the invention

本发明是基于以上现有技术而完成的，其目的在于提供一种用于经心室壁植入器械的输送装置，该输送装置具有心室壁打孔功能，能够将相关器械经心室壁输送到心脏内(心室或心房)并释放。The present invention is completed based on the above prior art, and its purpose is to provide a delivery device for implanting instruments through the ventricular wall, the delivery device has the function of perforating the ventricular wall, and can deliver related instruments to the heart through the ventricular wall Inner (ventricular or atrium) and released.

为实现上述目的，本发明采用以下技术方案：To achieve the above object, the present invention adopts the following technical solutions:

一种用于经心室壁植入器械的输送装置，该输送装置包括中空外导管、心脏打孔器和输送组件，其中，外导管与心脏打孔器组合用于在心室壁上打孔，外导管与输送组件组合用于将器械输送到心室或心房内；A delivery device for implanting a device through the wall of the ventricle, the delivery device includes a hollow outer catheter, a heart punch and a delivery assembly, wherein the outer catheter and the heart punch are used in combination to punch a hole in the wall of the ventricle, and the outer a combination catheter and delivery assembly for delivering the device into the ventricle or atrium;

所述外导管两端开口，在其中一端设有心尖贴合片；Both ends of the outer catheter are open, and one end is provided with an apex bonding piece;

所述心脏打孔器包括直杆部分、设置在直杆部分一端的尖端部分和设置在直杆部分另一端的手柄；用于心室壁打孔时，所述心脏打孔器从所述外导管的另一端插入，尖端部分从外导管的一端露出；The heart puncher includes a straight rod part, a tip part arranged at one end of the straight rod part and a handle arranged at the other end of the straight rod part; The other end of the catheter is inserted, and the tip part is exposed from one end of the outer catheter;

所述输送组件包括输送内导管和推进杆，所述输送内导管具有内中空管和设置在内中空管上的密封盘；所述推进杆具有推杆、设置在推杆一端的推进盘和设置在推杆另一端的推柄；所述推进杆插入内中空管，推进盘与装载在内中空管内的待植入的器械接触；The delivery assembly includes a delivery inner catheter and a push rod, the delivery inner catheter has an inner hollow tube and a sealing disc arranged on the inner hollow tube; the push rod has a push rod, a push disc arranged at one end of the push rod and a push handle arranged at the other end of the push rod; the push rod is inserted into the inner hollow tube, and the push disc is in contact with the device to be implanted in the inner hollow tube;

在所述器械植入时，所述输送组件的输送内导管从所述外导管的另一端插入外导管，所述密封盘密封外导管与输送内导管之间的缝隙。When the device is implanted, the delivery inner catheter of the delivery assembly is inserted into the outer catheter from the other end of the outer catheter, and the sealing disc seals the gap between the outer catheter and the inner delivery catheter.

进一步地，所述外导管上设有止血阀门，通过该阀门控制外导管的打开和封闭。该止血阀门优选为球阀。Further, the outer catheter is provided with a hemostatic valve, through which the opening and closing of the outer catheter is controlled. The hemostatic valve is preferably a ball valve.

本发明的有益效果：Beneficial effects of the present invention:

本发明的输送装置可经由心尖处的心室壁(或其他位置的心室壁)将治疗心血管相关疾病的器械植入心脏(心室或心房)，具备心脏打孔功能且不用将打孔位置的心室壁肌肉切下来。在中空外导管设置的球阀或者其他形式阀门具有防止血液喷溅的功能，心室壁打孔后可经由输送组件将需要器械送入心脏内并将器械顶出该输送装置，从而植入心脏内。本发明的输送装置不仅可以辅助器械的植入，还可以简化手术流程，降低手术对患者带来的损伤。The delivery device of the present invention can implant the device for treating cardiovascular-related diseases into the heart (ventricle or atrium) through the ventricular wall at the apex (or the ventricular wall at other positions), and has the function of heart punching without placing the ventricle at the punching position. The wall muscle is cut off. The ball valve or other forms of valves installed in the hollow outer catheter have the function of preventing blood splashing. After the ventricle wall is perforated, the required device can be sent into the heart through the delivery component and pushed out of the delivery device, so as to be implanted in the heart. The delivery device of the present invention can not only assist the implantation of instruments, but also simplify the operation process and reduce the damage caused by the operation to the patient.

附图说明Description of drawings

图1为本发明的输送装置的中空外导管的结构示意图。Fig. 1 is a schematic structural view of the hollow outer catheter of the delivery device of the present invention.

图2为本发明的输送装置中打孔器的结构示意图。Fig. 2 is a structural schematic diagram of the puncher in the conveying device of the present invention.

图3为本发明的输送装置连接到心室壁打孔时的结构示意图。Fig. 3 is a schematic diagram of the structure of the delivery device of the present invention when it is connected to the ventricle wall to punch a hole.

图4为本发明的输送装置中输送内导管的结构示意图。Fig. 4 is a schematic structural view of the delivery inner catheter in the delivery device of the present invention.

图5为本发明的输送装置中推进杆的结构示意图。Fig. 5 is a structural schematic diagram of the push rod in the delivery device of the present invention.

图6为显示推进杆即将组装到输送内导管的状态的结构示意图。Fig. 6 is a schematic structural view showing a state in which the push rod is about to be assembled into the delivery inner catheter.

图7为中空外导管与输送组件组装后的结构示意图。Fig. 7 is a structural schematic diagram of the assembled hollow outer catheter and the delivery component.

图8为本发明的输送装置连接到心室壁向心室内输送器械时的结构示意图。Fig. 8 is a schematic diagram of the structure of the delivery device of the present invention when it is connected to the wall of the ventricle to deliver the instrument into the ventricle.

具体实施方式Detailed ways

以下结合附图对本发明的具体实施方式作进一步详细说明。The specific implementation manners of the present invention will be described in further detail below in conjunction with the accompanying drawings.

本发明借鉴心尖打孔器结合心血管介入手术中的经导管植入技术特点，提供一种用于经心室壁植入器械的输送装置，该输送装置带有心室壁打孔空能和器械输送功能，能在心室壁上穿孔(或打孔)，经心室壁将器械输送至心室内并能撤除。The present invention provides a delivery device for implanting instruments through the ventricular wall by referring to the apical puncher combined with the technical characteristics of transcatheter implantation in cardiovascular interventional operations. Function, can perforate (or perforate) in the ventricular wall, deliver the device into the ventricle through the ventricular wall and remove it.

具体地，如图1至图8所示，本发明的输送装置包括外导管1、心脏打孔器2和输送组件3，其中，外导管1与心脏打孔器2组合用于在心室壁上打孔，外导管1与输送组件3组合用于将器械输送到心室或心房内。Specifically, as shown in FIGS. 1 to 8 , the delivery device of the present invention includes anouter catheter 1 , aheart punch 2 and adelivery assembly 3 , wherein theouter catheter 1 and theheart punch 2 are used in combination on the ventricular wall Perforation, theouter catheter 1 is combined with thedelivery assembly 3 for delivering the device into the ventricle or atrium.

如图1、3所示，外导管1两端开口，在靠近外导管1头部11的一端设有心尖贴合片12，该心尖贴合片12的设置用于将本发明的输送装置连接到心室壁上，与心尖处的心室壁贴合。外导管1的中间段为中空直杆部分13，在外导管1的另一端设有球阀等阀门14，用于控制该端的外导管1的封闭和打开。As shown in Figures 1 and 3, both ends of theouter catheter 1 are open, and an end close to thehead 11 of theouter catheter 1 is provided with anapex bonding sheet 12, and the setting of theapex bonding sheet 12 is used to connect the delivery device of the present invention. to the ventricular wall, and fits the ventricular wall at the apex. The middle section of theouter conduit 1 is a hollowstraight part 13, and the other end of theouter conduit 1 is provided with avalve 14 such as a ball valve, which is used to control the closing and opening of theouter conduit 1 at this end.

如图2所示，心脏打孔器2包括直杆部分22、设置在直杆部分22一端的尖端部分21和设置在直杆部分22另一端的手柄23。手柄23的形状没有特殊限制，只要便于心脏打孔器2的操作即可，例如可以是如图2所示的柱形手柄，也可以是如图3所示的T形杆状手柄。如图3所示，用于心室壁打孔时，心脏打孔器2从外导管1的另一端(即靠近阀门14的一端)插入外导管1内，尖端部分21从外导管的一端露出；As shown in FIG. 2 , theheart punch 2 includes a straight rod portion 22 , atip portion 21 disposed at one end of the straight rod portion 22 , and ahandle 23 disposed at the other end of the straight rod portion 22 . The shape of thehandle 23 is not particularly limited, as long as it is convenient for the operation of theheart punch 2, for example, it can be a cylindrical handle as shown in FIG. 2 , or a T-shaped rod handle as shown in FIG. 3 . As shown in Figure 3, when being used for ventricle wall punching, theheart puncher 2 is inserted in theouter catheter 1 from the other end of the outer catheter 1 (that is, the end near the valve 14), and thetip portion 21 is exposed from one end of the outer catheter;

如图4、5所示，输送组件3包括输送内导管31和推进杆32，输送内导管31具有内中空管311和设置在内中空管311上的密封盘312；推进杆32具有推杆322、设置在推杆322一端的推进盘321和设置在推杆322另一端的推柄323。如图6所示，推进杆32沿图中箭头方向从内中空管311的一端插入输送内导管31内，直至推进盘321与装载在内中空管311另一端(头部位置)内的待植入的器械4接触，通过操控推柄323能够推动器械4向内中空管311的另一端的出口方向移动并推出。As shown in Figures 4 and 5, thedelivery assembly 3 includes a deliveryinner catheter 31 and apusher rod 32, the deliveryinner catheter 31 has an innerhollow tube 311 and asealing disc 312 arranged on the innerhollow tube 311; thepusher rod 32 has a pusher Therod 322 , thepush plate 321 arranged at one end of thepush rod 322 and thepush handle 323 arranged at the other end of thepush rod 322 . As shown in Figure 6, thepush rod 32 is inserted into the deliveryinner catheter 31 from one end of the innerhollow tube 311 in the direction of the arrow in the figure until thepush plate 321 is connected to the other end (head position) of the innerhollow tube 311. When thedevice 4 to be implanted contacts, thedevice 4 can be pushed toward the outlet of the other end of the innerhollow tube 311 and pushed out by manipulating thepush handle 323 .

如图7所示，在进行器械的植入时，输送组件3的输送内导管从所述外导管的另一端(即靠近阀门14的一端)插入外导管，此时密封盘密封外导管1与输送内导管31之间形成的缝隙。As shown in Fig. 7, when the instrument is implanted, the delivery inner catheter of thedelivery assembly 3 is inserted into the outer catheter from the other end of the outer catheter (that is, the end near the valve 14), and the sealing disc seals theouter catheter 1 and theouter catheter 1 at this time. The gap formed between theinner catheters 31 is delivered.

下面具体说明使用本发明的输送装置将治疗心脏疾病的器械植入心室内操作过程。The operation process of using the delivery device of the present invention to implant the device for treating heart disease into the ventricle will be described in detail below.

将中空外导管1经患者开胸或者小切口伸入心室壁植入位置，中空外导管头部11顶到心室壁外，将中空外导管1的心尖贴合片12缝合到心室壁上；将打孔器2经由中空外导管1呈打开状态的球阀14和中空外导管的直杆部分13而从中空外导管头部11伸出，推动或者转动打孔器2的手柄23，通过直杆部分22将力传递至打孔器的尖端部分21，将心室壁打穿，取出打孔器2，关闭球阀14；将被输送的器械4装于输送内导管31的内中空管311的头部位置，然后将推进杆32安装入输送内导管31中并顶住器械4，然后将装有器械4的输送组件3经由中空外导管1的球阀14和中空外导管的直杆部分13从中空外导管头部11伸出并进入心脏5内，推动推进杆32的推柄323，通过推杆322将力传递至推进盘321，将器械4推出整个装置推进心脏5内，取出推进杆32，关闭球阀14；将中空外导管1的心尖贴合片12的缝合处拆除，并将中空外导管1取出，缝合心脏5。Extend the hollowouter catheter 1 into the implantation site of the ventricular wall through the patient's thoracotomy or a small incision, push thehead 11 of the hollow outer catheter to the outside of the ventricular wall, and sew theapex bonding piece 12 of the hollowouter catheter 1 to the ventricular wall; Thehole punch 2 protrudes from the hollowouter conduit head 11 through theball valve 14 in the open state of the hollowouter conduit 1 and thestraight rod part 13 of the hollow outer conduit, and pushes or turns thehandle 23 of thepunch 2 to pass through the straight rod part. 22 transmit the force to thetip part 21 of the puncher, puncture the wall of the ventricle, take out thepuncher 2, and close theball valve 14; install the transportedinstrument 4 on the head of the innerhollow tube 311 of the deliveryinner catheter 31 position, then install thepusher rod 32 into the deliveryinner catheter 31 and withstand thedevice 4, and then thedelivery assembly 3 with thedevice 4 is removed from the hollow outer catheter through theball valve 14 of the hollowouter catheter 1 and thestraight rod part 13 of the hollow outer catheter. The catheter head 11 protrudes and enters theheart 5, pushes thepush handle 323 of thepush rod 32, transmits the force to thepush plate 321 through thepush rod 322, pushes thedevice 4 out of the whole device and pushes it into theheart 5, takes out thepush rod 32, and closes theBall valve 14; remove the suturing part of theapex bonding sheet 12 of the hollowouter catheter 1, take out the hollowouter catheter 1, and suture theheart 5.

简单来讲，本发明的输送装置采用中空外导管作为打孔和输送的通用管道，首先采用安装于可防止心室内血液喷出的中空外导管的打孔器将心脏打孔，打孔器移除而中空外导管仍安装于心脏上，然后将装有待植入器械的输送内导管安装于中空外导管中并进入心室内，器械到达心室内指定位置后通过顶出机构将器械顶出输送内导管，然后撤回输送内导管，最后撤除中空外导管。To put it simply, the delivery device of the present invention uses a hollow outer catheter as a general pipe for punching and delivery. First, the heart is punched with a puncher installed in the hollow outer catheter that can prevent blood from being ejected in the ventricle. The hollow outer catheter is still installed on the heart, and then the delivery inner catheter with the device to be implanted is installed in the hollow outer catheter and enters the ventricle. After the device reaches the designated position in the ventricle, the device is ejected out of the delivery inner catheter through the ejection mechanism. catheter, then withdraw the delivery inner catheter, and finally withdraw the hollow outer catheter.

本发明的输送装置可经由心尖处的心室壁(或其他位置的心室壁)将治疗心血管相关疾病的器械植入心脏(心室或心房)，具备心脏打孔功能且不用将打孔位置的心室壁肌肉切下来。在中空外导管设置的球阀或者其他形式阀门具有防止血液喷溅的功能，心室壁打孔后可经由输送组件将需要器械送入心脏内并将器械顶出该输送装置，从而植入心脏内。本发明的输送装置不仅可以辅助器械的植入，还可以简化手术流程，降低手术对患者带来的损伤。The delivery device of the present invention can implant the device for treating cardiovascular-related diseases into the heart (ventricle or atrium) through the ventricular wall at the apex (or the ventricular wall at other positions), and has the function of heart punching without placing the ventricle at the punching position. The wall muscle is cut off. The ball valve or other forms of valves installed in the hollow outer catheter have the function of preventing blood splashing. After the ventricle wall is perforated, the required device can be sent into the heart through the delivery component and pushed out of the delivery device, so as to be implanted in the heart. The delivery device of the present invention can not only assist the implantation of instruments, but also simplify the operation process and reduce the damage caused by the operation to the patient.

最后应当说明的是，以上所示均为本发明的较佳实施方式，并不用于限制本发明，凡在本发明的精神和原则之内所做的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。Finally, it should be noted that the above are all preferred implementation modes of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention shall be Included within the protection scope of the present invention.

Claims (3)

1. A delivery device for transventricular implantation of an instrument, the delivery device comprising a hollow outer catheter, a cardiac punch, and a delivery assembly, wherein the outer catheter in combination with the cardiac punch is used to punch a hole in a ventricular wall, and the outer catheter in combination with the delivery assembly is used to deliver the instrument into a ventricle or atrium;

the two ends of the outer catheter are open, and a heart apex attaching piece is arranged at one end of the outer catheter;

the heart puncher comprises a straight rod part, a tip part arranged at one end of the straight rod part and a handle arranged at the other end of the straight rod part; for ventricular wall perforation, the cardiac punch is inserted from the other end of the outer catheter, and the tip part is exposed from one end of the outer catheter;

the conveying assembly comprises a conveying inner guide pipe and a pushing rod, wherein the conveying inner guide pipe is provided with an inner hollow pipe and a sealing disc arranged on the inner hollow pipe; the pushing rod is provided with a pushing rod, a pushing disc arranged at one end of the pushing rod and a pushing handle arranged at the other end of the pushing rod; the pushing rod is inserted into the inner hollow tube, and the pushing disc is contacted with the instrument to be implanted, which is loaded in the inner hollow tube;

during implantation of the instrument, the inner conveying guide pipe of the conveying assembly is inserted into the outer guide pipe from the other end of the outer guide pipe, and the sealing disc seals a gap between the outer guide pipe and the inner conveying guide pipe.

2. A delivery device for a transventricular implantation apparatus as claimed in claim 1 wherein a hemostatic valve is provided on the outer catheter through which opening and closing of the outer catheter is controlled.

3. The delivery device for a transventricular implantation instrument of claim 1, wherein the hemostatic valve is a ball valve.

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