WO2023160505A1

WO2023160505A1 - Shock-wave balloon catheter device and medical apparatus

Info

Publication number: WO2023160505A1
Application number: PCT/CN2023/077276
Authority: WO
Inventors: 徐鹏飞; 阙志文; 王成
Original assignee: 上海蓝帆博元医疗科技有限公司
Priority date: 2022-02-24
Filing date: 2023-02-21
Publication date: 2023-08-31
Also published as: CN114533198A

Abstract

A shock-wave balloon catheter device (100) and a medical apparatus, which comprises the shock-wave balloon catheter device (100). The shock-wave balloon catheter device (100) comprises a balloon (120), an inner tube (110) and an outer tube (130). The balloon (120) comprises an inner layer (122) and an outer layer (124), the hardness of the inner layer (122) being different from that of the outer layer (124). The balloon (120) surrounds the inner tube (110), and a distal end of the inner tube (110) is connected to a distal end of the balloon (120). The outer tube (130) is sleeved outside the inner tube (110) and is connected to a proximal end of the balloon (120). The shock-wave balloon catheter device (100) can emit high-strength shock waves to break calcified plaques, and can also provide a high dilatation pressure to fully complete the dilatation of a lesion and thus open up a blood vessel.

Description

一种冲击波球囊导管装置以及医疗设备A shock wave balloon catheter device and medical equipment

出于所有目的，本申请要求于2022年2月24日递交的中国专利申请第202210172787.4号的优先权，在此全文引用上述中国专利申请公开的内容以作为本申请的一部分。For all purposes, this application claims the priority of Chinese Patent Application No. 202210172787.4 filed on February 24, 2022, and the content disclosed in the above Chinese Patent Application is hereby cited in its entirety as a part of this application.

技术领域technical field

本公开涉及一种冲击波球囊导管装置，尤其涉及一种包含双层结构球囊的冲击波导管装置和医疗设备。The present disclosure relates to a shock wave balloon catheter device, in particular to a shock wave catheter device including a double-layer structure balloon and medical equipment.

背景技术Background technique

动脉粥样硬化是由斑块积聚引起的动脉狭窄和硬化疾病。该斑块由纤维组织、脂肪，以及钙组成。积聚的钙化斑块阻碍了血液的正常流动，减少了向身体氧气和营养的供应。从而造成供应给身体关键部位(包括大脑、心脏和四肢)血液的动脉的相关疾病。近年来，将液电效应的方法用于破坏病变血管壁上附着的钙化病灶结构，即血管内冲击波碎石术是一种有效的破坏高度钙化病灶的手段。Atherosclerosis is a narrowing and hardening of the arteries caused by plaque buildup. The plaque is composed of fibrous tissue, fat, and calcium. Accumulated calcified plaque blocks the normal flow of blood, reducing the supply of oxygen and nutrients to the body. This results in disease related to the arteries that supply blood to key parts of the body, including the brain, heart and extremities. In recent years, the method of electrohydraulic effect has been used to destroy the structure of calcified lesions attached to the wall of diseased blood vessels, that is, intravascular shock wave lithotripsy is an effective means of destroying highly calcified lesions.

发明内容Contents of the invention

本公开提供了一种冲击波球囊导管装置。该装置能发射高强度的冲击波，使钙化斑块破裂。该装置还能提供高扩张压力，充分完成病变的扩张，从而打通血管。The present disclosure provides a shock wave balloon catheter device. The device emits high-intensity shock waves that rupture calcified plaque. The device can also provide high dilation pressure to fully complete the dilation of the lesion, thereby opening up the blood vessel.

一种冲击波球囊导管装置，其包括球囊、内管、至少一冲击波电极组件和外管。球囊包括内层和外层，内层的硬度不同于外层的硬度。内管贯穿球囊，内管的远端与球囊的远端连接。冲击波电极组件设置在内管外。外管套设在内管的外部，并与球囊的近端连接。A shock wave balloon catheter device includes a balloon, an inner tube, at least one shock wave electrode assembly and an outer tube. The balloon includes an inner layer and an outer layer, the hardness of the inner layer being different from that of the outer layer. The inner tube runs through the balloon, and the distal end of the inner tube is connected with the distal end of the balloon. The shock wave electrode assembly is arranged outside the inner tube. The outer tube is sheathed on the outside of the inner tube and connected with the proximal end of the balloon.

在一个实施例中，外层的硬度大于内层的硬度。In one embodiment, the hardness of the outer layer is greater than the hardness of the inner layer.

在一个实施例中，外层由尼龙、聚对苯二甲酸乙二醇脂和聚乙烯中的一种或多种的组合制成；内层由聚醚嵌段聚酰胺共聚物、聚氯乙烯、聚氨酯和硅橡胶中的一种或多种的组合制成。In one embodiment, the outer layer is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene; the inner layer is made of polyether block polyamide copolymer, polyvinyl chloride , Polyurethane and silicone rubber in one or more combinations.

在一个实施例中，外层的硬度为71D～90D，内层的硬度为35D～70D。 In one embodiment, the hardness of the outer layer is 71D-90D, and the hardness of the inner layer is 35D-70D.

在一个实施例中，外层与内层的质量比的范围为1:3～3:1。In one embodiment, the mass ratio of the outer layer to the inner layer ranges from 1:3 to 3:1.

在一个实施例中，外层由尼龙12制成，内层由聚醚嵌段聚酰胺共聚物制成，且尼龙12与聚醚嵌段聚酰胺共聚物的质量比为1:1。In one embodiment, the outer layer is made of nylon 12, the inner layer is made of polyether block polyamide copolymer, and the mass ratio of nylon 12 to polyether block polyamide copolymer is 1:1.

在一个实施例中，冲击波电极组件包括内电极和外电极，且配置为在高压电源下在内电极和外电极之间产生高压脉冲，从而在球囊中产生机械冲击波；冲击波球囊导管装置还包括连接导线，连接导线包括沿其轴向延伸的第一电极导线和第二电极导线，内电极与第一电极导线连接，外电极与第二电极导线连接，且第一电极导线和第二电极导线配置为分别连接高压电源的两极。In one embodiment, the shock wave electrode assembly includes an inner electrode and an outer electrode, and is configured to generate a high voltage pulse between the inner electrode and the outer electrode under a high voltage power source, thereby generating a mechanical shock wave in the balloon; the shock wave balloon catheter device also It includes a connecting wire, the connecting wire includes a first electrode wire and a second electrode wire extending along its axial direction, the inner electrode is connected to the first electrode wire, the outer electrode is connected to the second electrode wire, and the first electrode wire and the second electrode wire The wires are configured to be respectively connected to two poles of the high voltage power supply.

在一个实施例中，冲击波电极组件还包括位于内电极和外电极之间的绝缘层，内电极的表面上设置有凸起引脚，绝缘层上设置有第一孔，外电极上设置有第二孔，第二孔的直径大于第一孔的直径，凸起引脚、第一孔和第二孔配置为使得凸起引脚延伸穿过第一孔并延伸至第二孔中，从而在外电极和内电极之间形成环状的放电通道。In one embodiment, the shock wave electrode assembly further includes an insulating layer located between the inner electrode and the outer electrode, protruding pins are arranged on the surface of the inner electrode, a first hole is arranged on the insulating layer, and a second hole is arranged on the outer electrode. Two holes, the diameter of the second hole is greater than the diameter of the first hole, the protruding pin, the first hole and the second hole are configured so that the protruding pin extends through the first hole and extends into the second hole, thereby externally A ring-shaped discharge channel is formed between the electrodes and the inner electrodes.

在一个实施例中，冲击波球囊导管装置包括沿内管的轴向间隔布置的多个冲击波电极组件。In one embodiment, the shock wave balloon catheter device includes a plurality of shock wave electrode assemblies arranged at intervals along the axial direction of the inner tube.

在一个实施例中，多个冲击波电极组件串联布置。In one embodiment, multiple shockwave electrode assemblies are arranged in series.

在一个实施例中，多个冲击波电极组件在内管的同一周向上排列，或周向呈角度排列。In one embodiment, multiple shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or arranged at an angle in the circumferential direction.

本公开还提出了一种医疗设备，其包括上述实施例的冲击波球囊导管装置、高压发生器，冲击波球囊导管装置还包括连接导线，连接导线的远端与冲击波电极组件连接，连接导线的近端与高压发生器连接；高压发生器的脉冲电压为500V～10kV，脉冲电压宽度为200ns～20μs，高压发生器的脉冲电流为50A～400A，脉冲电流宽度为10ns～2μs。The present disclosure also proposes a medical device, which includes the shock wave balloon catheter device and the high voltage generator of the above embodiment, the shock wave balloon catheter device also includes a connecting wire, the distal end of the connecting wire is connected to the shock wave electrode assembly, the connecting wire The proximal end is connected to a high-voltage generator; the pulse voltage of the high-voltage generator is 500V-10kV, the pulse voltage width is 200ns-20μs, the pulse current of the high-voltage generator is 50A-400A, and the pulse current width is 10ns-2μs.

在一个实施例中，每个冲击波电极组件产生冲击波的声压强度为2Mpa～20Mpa，放电频率为0.1Hz～10Hz。In one embodiment, each shock wave electrode assembly generates a shock wave with a sound pressure intensity of 2Mpa-20Mpa, and a discharge frequency of 0.1Hz-10Hz.

在本公开实施例的冲击波球囊导管装置中，冲击波作用能够有效粉碎钙化斑块，同时球囊采用内层和外层硬度不同的双层结构设计，在有效增大球囊的***压的同时，使得球囊具有较好的顺应性和贴壁性；且先通过冲击波作用粉碎钙化斑块，再使用更高的充盈压力使球囊进一步进行扩张，通过冲击波和球囊高压扩张多次循环操作，能够有效地打通血管，避免了重新置入高压球囊进行扩张，从而缩短手术时间，降低手术成本，减少相关并发症出现的风险；并且球囊扩张压力的增加在一定程度上使得冲击波的衰减减弱，这对冲击波传递产生促进作用，球囊的高扩张压力和冲击波协同作用，使冲击波球囊导管装置还能产生更高的声压强度，能够更有效地粉碎钙化斑块。In the shock wave balloon catheter device of the embodiment of the present disclosure, the shock wave action can effectively crush the calcified plaque, and the balloon adopts a double-layer structure design with different hardness of the inner layer and the outer layer, which can effectively increase the burst pressure of the balloon at the same time , so that the balloon has better compliance and adherence; firstly, the calcified plaque is crushed by the shock wave, and then the balloon is further expanded by using a higher filling pressure. , can effectively open blood vessels, avoid re-inserting high-pressure balloons for expansion, thereby shortening operation time, reducing operation costs, and reducing the risk of related complications; Moreover, the increase of the balloon inflation pressure weakens the attenuation of the shock wave to a certain extent, which promotes the transmission of the shock wave. The high inflation pressure of the balloon and the shock wave work together to make the shock wave balloon catheter device generate a higher sound pressure. strength to more effectively crush calcified plaque.

附图说明Description of drawings

为了更清楚地说明本公开实施例的技术方案，下面将对实施例的附图作简单地介绍，显而易见地，下面描述中的附图仅仅涉及本公开的一些实施例，而非对本公开的限制。In order to illustrate the technical solutions of the embodiments of the present disclosure more clearly, the accompanying drawings of the embodiments will be briefly introduced below. Obviously, the accompanying drawings in the following description only relate to some embodiments of the present disclosure, rather than limiting the present disclosure .

图1为根据本公开的一个实施例的冲击波球囊导管装置的结构示意图。Fig. 1 is a schematic structural diagram of a shock wave balloon catheter device according to an embodiment of the present disclosure.

图2为根据本公开的一个实施例的球囊的结构示意图。Fig. 2 is a schematic structural diagram of a balloon according to an embodiment of the present disclosure.

图3为图2的球囊的剖面图。FIG. 3 is a cross-sectional view of the balloon of FIG. 2 .

图4为根据本公开的一个实施例的冲击波电极组件的截面示意图。4 is a schematic cross-sectional view of a shock wave electrode assembly according to one embodiment of the present disclosure.

图5为根据本公开的一个实施例的冲击波电极组件与普通冲击波电极组件在不同脉冲电压下的声压强度曲线图。FIG. 5 is a graph of sound pressure intensity curves of a shock wave electrode assembly and a common shock wave electrode assembly under different pulse voltages according to an embodiment of the present disclosure.

图6为设置有冲击波两电极组件的冲击波球囊导管装置的截面示意图。Fig. 6 is a schematic cross-sectional view of a shock wave balloon catheter device provided with a shock wave two-electrode assembly.

图7示出了具有两个冲击波两电极组件的冲击波球囊导管装置的示意图。Figure 7 shows a schematic diagram of a shockwave balloon catheter device with two shockwave two-electrode assemblies.

图8A为图7中的一个冲击波两电极组件的截面示意图，示出了其第一孔朝向布置。FIG. 8A is a schematic cross-sectional view of a shock wave two-electrode assembly in FIG. 7 , showing the orientation of the first hole.

图8B为图7中的另一个冲击波两电极组件的截面示意图，示出了其第一孔朝向布置。FIG. 8B is a schematic cross-sectional view of another shock wave two-electrode assembly in FIG. 7 , showing the arrangement of its first hole orientation.

图9为根据本公开的一个实施例的冲击波电极组件在不同充盈压力下的声压强度曲线图。FIG. 9 is a graph of sound pressure intensity of a shock wave electrode assembly under different filling pressures according to an embodiment of the present disclosure.

图10为不同冲击波球囊导管装置的扩张效果。Figure 10 shows the dilation effect of different shock wave balloon catheter devices.

图11为本公开的一个实施例的医疗设备的结构示意图。Fig. 11 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.

具体实施方式Detailed ways

下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本公开一部分实施例，而不是全部的实施例。基于本公开中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present disclosure with reference to the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only some of the embodiments of the present disclosure, not all of them. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present disclosure.

除非另有定义，本公开实施例使用的所有术语(包括技术和科学术语)具有与本公开所属领域的普通技术人员共同理解的相同含义。还应当理解，诸如在通常字典里定义的那些术语应当被解释为具有与它们在相关技术的上下文中的含义相一致的含义，而不应用理想化或极度形式化的意义来解释，除非本公开实施例明确地这样定义。Unless otherwise defined, all terms (including technical and scientific terms) used in the examples of the present disclosure have the same meaning have the same meaning as commonly understood by those of ordinary skill in the art to which the present disclosure belongs. It should also be understood that terms such as those defined in common dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in idealized or extremely formalized meanings, unless the disclosure Embodiments are expressly defined as such.

本公开实施例中使用的“第一”、“第二”以及类似的词语并不表示任何顺序、数量或者重要性，而只是用来区分不同的组成部分。“一个”、“一”或者“该”等类似词语也不表示数量限制，而是表示存在至少一个。同样，“包括”或者“包含”等类似的词语意指出现该词前面的元件或者物件涵盖出现在该词后面列举的元件或者物件及其等同，而不排除其他元件或者物件。在以下描述中，可能使用“上”、“下”、“前”、“后”、“顶”、“底”、“垂直”和“水平”等空间和方位术语来描述本实用新型的实施例，但应当理解的是，这些术语仅是为了便于描述图中所示的实施例，而不要求实际的装置以特定的取向构造或操作。在以下描述中，诸如“连接”、“联接”、“固定”和“附接”等术语的使用，可以指两个元件或结构之间没有其他元件或结构而直接地连接，也可以指两个元件或结构通过中间元件或结构间接地连接，除非本文另中有明确地说明。"First", "second" and similar words used in the embodiments of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "a", "an" or "the" also do not denote a limitation of quantity, but mean that there is at least one. Likewise, "comprising" or "comprises" and similar words mean that the elements or items appearing before the word include the elements or items listed after the word and their equivalents, and do not exclude other elements or items. In the following description, spatial and directional terms such as "upper", "lower", "front", "rear", "top", "bottom", "vertical" and "horizontal" may be used to describe the implementation of the present invention. For example, it should be understood that these terms are used merely for convenience in describing the embodiments shown in the figures and do not require that the actual device be constructed or operate in a particular orientation. In the following description, the use of terms such as "connected", "coupled", "fixed" and "attached" may mean that two elements or structures are directly connected with no other elements or structures in between, or that two The individual elements or structures are indirectly connected through intervening elements or structures, unless expressly stated otherwise herein.

采用传统的球囊血管成形术治疗血管钙化病变时，因钙化病变的血管段较为坚硬，顺应性较差，导致球囊难以充分扩张，甚至会发生球囊破裂等严重情况，因而，需要较高的压力通过球囊扩张钙化病变段，但发生血管夹层、穿孔、破裂、无复流等并发症的概率明显增加。When traditional balloon angioplasty is used to treat vascular calcified lesions, because the vascular segment of calcified lesions is relatively hard and has poor compliance, it is difficult to fully expand the balloon, and even serious situations such as balloon rupture may occur. The pressure of the balloon expands the calcified lesion, but the probability of complications such as vascular dissection, perforation, rupture, and no-reflow increases significantly.

现有技术的血管内冲击波技术是解决血管钙化的较为有效的手段，具体通过将电极与高压发生器一起作用，来破坏动脉壁中的钙化病灶。在这种类型的手术中，为了提高冲击波发生效果，使冲击波穿过球囊壁到达堵塞区域，通常使用由例如聚醚嵌段聚酰胺共聚物等硬度较低的材料制成的高柔软度球囊，其扩张压力通常在16个标准大气压以下。使用时在高柔软度球囊中充盈低压强介质使得球囊附着于血管壁，通过高压发生器向球囊内的电极施加一系列的高压脉冲，从而在导电流体中产生冲击波，冲击波穿过球囊壁到达堵塞区域，使钙化斑块破裂。然而，本公开的发明人发现，由于电极产生的冲击波强度波动较大，钙化病变可能不能完全碎裂。电极可能产生不可预计的电火花以及冲击波也会对高柔软度球囊产生潜在损害。这会增加球囊泄露风险，并致使损伤的球囊的扩张压力通常只在10个标准大气压内，从而达不到完全扩张病变的要求。此外，因高柔软度球囊扩张压力有限，临床结果表明存在约20％比例病人的钙化病变无法完成有效扩张。在这种情况下，为了进一步打通血管，需要撤出冲击波球囊导管，再重新置入高压球囊，并在高压力下充盈球囊来完成病变的有效扩张。整个治疗过程中球囊的扩充时间可至数分钟，手术时间长达数小时。这种情况不仅增加手术步骤和手术时间，还可能引发严重的心肌缺血、血流动力学紊乱等心脏不良事件，以及增加其他手术并发症的风险。The intravascular shock wave technology in the prior art is a more effective means to solve vascular calcification, specifically through the action of electrodes and high voltage generators together to destroy calcified lesions in the arterial wall. In this type of procedure, in order to improve the shock wave generation, so that the shock wave passes through the balloon wall to the blockage area, a high-flexibility ball made of a less rigid material such as polyether block polyamide copolymer is usually used bladder, its inflation pressure is usually below 16 atmospheres. When in use, the high-flexibility balloon is filled with a low-pressure medium to make the balloon adhere to the blood vessel wall, and a series of high-voltage pulses are applied to the electrodes in the balloon through a high-voltage generator, thereby generating shock waves in the conductive fluid, and the shock waves pass through the ball The cyst wall reaches the blocked area, rupturing the calcified plaque. However, the inventors of the present disclosure have found that calcified lesions may not be completely fragmented due to large fluctuations in the intensity of shock waves generated by the electrodes. Electrodes may generate unpredictable electrical sparks and shock waves with potential damage to high-flexibility balloons. This increases the risk of balloon leakage, and the inflation pressure of the damaged balloon is usually only within 10 atmospheres, thus failing to fully dilate the lesion. In addition, due to the limited inflation pressure of high-flexibility balloons, clinical results show that there are about 20% Calcified lesions in a proportion of patients could not complete effective expansion. In this case, in order to further open up the blood vessel, it is necessary to withdraw the shock wave balloon catheter, re-insert the high-pressure balloon, and inflate the balloon under high pressure to complete the effective dilation of the lesion. The inflation time of the balloon during the whole treatment process can be up to several minutes, and the operation time can be as long as several hours. This situation not only increases the operation steps and operation time, but also may cause severe myocardial ischemia, hemodynamic disorders and other cardiac adverse events, as well as increase the risk of other surgical complications.

为解决上述问题，一些现有技术方案中，通过增加高柔软度球囊壁厚来提高球囊的***压，从而提供了足够的扩张压力。但较大的壁厚会增加冲击波在传播过程中的损耗，减少作用于病变的能量，同时也降低了球囊的贴壁性和通过性。因此，目前技术很难同时兼顾球囊对高扩张压力和高冲击波声压强度的要求。In order to solve the above problems, in some prior art solutions, the burst pressure of the balloon is increased by increasing the wall thickness of the high-flexibility balloon, thereby providing sufficient expansion pressure. However, a larger wall thickness will increase the loss of the shock wave during propagation, reduce the energy acting on the lesion, and also reduce the adherence and passability of the balloon. Therefore, the current technology is difficult to simultaneously meet the requirements of the balloon for high inflation pressure and high shock wave sound pressure intensity.

本公开的实施例提供的冲击波球囊导管装置解决了上述一些技术问题，下面结合附图对本公开的实施例及其示例进行详细说明。The shock wave balloon catheter device provided by the embodiments of the present disclosure solves some of the above-mentioned technical problems. The embodiments of the present disclosure and examples thereof will be described in detail below with reference to the accompanying drawings.

图1为根据本公开的一个实施例的冲击波球囊导管装置的示意图。图2为根据本公开的一个实施例的球囊的结构示意图。图3为图2的球囊的剖面图。如图所示，冲击波球囊导管装置100包括内管110、球囊120、外管130以及冲击波电极组件200。冲击波电极组件200设置于内管110上，其具体内容将在后面详细说明。在一个实施例中，根据实际需要，冲击波电极组件的数量为多个。内管110贯穿球囊120，并且内管110的远端与球囊120的远端连接。在一个实施例中，球囊120的远端焊接在内管110上。外管130套设在内管110的外部并与球囊120的近端连接。在一个实施例中，球囊120近端部分焊接在外管130上。内管110和外管130之间的间隙形成用于接收导电流体的通道。球囊120内部为充盈腔140。FIG. 1 is a schematic diagram of a shock wave balloon catheter device according to one embodiment of the present disclosure. Fig. 2 is a schematic structural diagram of a balloon according to an embodiment of the present disclosure. FIG. 3 is a cross-sectional view of the balloon of FIG. 2 . As shown in the figure, the shock wave balloon catheter device 100 includes an inner tube 110 , a balloon 120 , an outer tube 130 and a shock wave electrode assembly 200 . The shock wave electrode assembly 200 is disposed on the inner tube 110, and its specific content will be described in detail later. In one embodiment, according to actual needs, there are multiple shock wave electrode assemblies. The inner tube 110 runs through the balloon 120 , and the distal end of the inner tube 110 is connected with the distal end of the balloon 120 . In one embodiment, the distal end of the balloon 120 is welded to the inner tube 110 . The outer tube 130 is sleeved on the outside of the inner tube 110 and connected to the proximal end of the balloon 120 . In one embodiment, the proximal portion of the balloon 120 is welded to the outer tube 130 . The gap between the inner tube 110 and the outer tube 130 forms a channel for receiving the conductive fluid. Inside the balloon 120 is a filling cavity 140 .

球囊120具有内层122和外层124的双层结构。内层122和外层124分别采用不同硬度的材料，例如采用邵氏硬度作为硬度的依据。这里，将硬度较高的材料称为“硬材料”，将硬度较低的材料称为“软材料”。硬材料包括尼龙、聚对苯二甲酸乙二醇脂和聚乙烯中的一种或多种的组合。软材料包括聚醚嵌段聚酰胺共聚物、聚氯乙烯、聚氨酯和硅橡胶中的一种或多种的组合。根据本公开实施例的球囊120，其外层可以由软材料制成(即，内层由硬材料制成，此时双层结构是内硬外软)，也可以由硬材料制成(即，内层由软材料制成，此时双层结构是内软外硬)。具体而言，内软外硬的双层结构球囊能承受更高的压力。而内硬外软的双层结构球囊具有更高的顺应性，对血管损伤小。在一个实施例中，内层122由软材料制成，外层124由硬材料制成，即内层122的硬度小于外层124的硬度。此时，软材料使得球囊120具有一定的柔顺性，有利于球囊120通过迂曲病变。同时还使得球囊120具有一定的贴壁性。而硬材料增加了球囊120的抗***能力，使得球囊120能够提供高扩张压力，从而充分完成病变的扩张并打通血管。对于传统高柔软度球囊，通常需要增加球囊壁厚来提高球囊的***压，从而提供足够的扩张压力，但较大的壁厚会增加冲击波在传播过程中的损耗，减少作用于病变的能量，同时也降低球囊的贴壁性和通过性。The balloon 120 has a double layer structure of an inner layer 122 and an outer layer 124 . The inner layer 122 and the outer layer 124 are made of materials with different hardness, for example, Shore hardness is used as the basis for hardness. Here, a material with high hardness is called "hard material", and a material with low hardness is called "soft material". The hard material includes one or more combinations of nylon, polyethylene terephthalate and polyethylene. The soft material includes one or more combinations of polyether block polyamide copolymer, polyvinyl chloride, polyurethane and silicone rubber. According to the balloon 120 of the embodiment of the present disclosure, its outer layer can be made of soft material (that is, the inner layer is made of hard material, at this time, the double-layer structure is hard on the inside and soft on the outside), or it can be made of hard material ( That is, the inner layer is made of soft material, at this time the double-layer structure is soft inside and hard outside). Specifically, the double-layer structure balloon with soft inside and hard outside can withstand higher pressure. The double-layer structure balloon with hard inside and soft outside has higher compliance and less damage to blood vessels. In a In one embodiment, the inner layer 122 is made of soft material, and the outer layer 124 is made of hard material, that is, the hardness of the inner layer 122 is smaller than that of the outer layer 124 . At this time, the soft material makes the balloon 120 have a certain flexibility, which is beneficial for the balloon 120 to pass through the tortuous lesion. Simultaneously, the balloon 120 has a certain degree of adherence to the wall. The hard material increases the anti-burst capability of the balloon 120, so that the balloon 120 can provide high expansion pressure, thereby fully completing the expansion of the lesion and opening the blood vessel. For traditional high-softness balloons, it is usually necessary to increase the wall thickness of the balloon to increase the burst pressure of the balloon to provide sufficient expansion pressure, but a larger wall thickness will increase the loss of the shock wave during propagation and reduce the impact on the lesion. The energy, but also reduce the adherence and passability of the balloon.

本公开实施例的球囊120采用双层结构特征，一方面表现出更好的贴壁性，即当球囊120充盈低压强介质时，球囊120能更好地紧贴附着于血管壁。另一方面，在使球囊具有相同***压的前提下，与聚醚嵌段聚酰胺共聚物制成的球囊相比，使用双层结构的球囊壁厚更小，从而减少了冲击波能量在传递过程中的损耗。这使更多的能量能够传递至病变，从而更好地击碎钙化斑块。The balloon 120 of the embodiment of the present disclosure adopts a double-layer structure feature, on the one hand, it exhibits better adhesion to the wall, that is, when the balloon 120 is filled with a low-pressure medium, the balloon 120 can better adhere to the blood vessel wall. On the other hand, under the premise of making the balloon have the same burst pressure, compared with the balloon made of polyether block polyamide copolymer, the wall thickness of the balloon using the double layer structure is smaller, thereby reducing the shock wave energy losses during transmission. This allows more energy to be delivered to the lesion to better break down calcified plaque.

本公开实施例的球囊120是由软材料和硬材料制成，球囊***压、顺应性和贴壁性与材料本身硬度以及软材料和硬材料的质量比相关联。软材料的硬度为35D～70D，硬材料的硬度为71D～90D；其中软材料的硬度优选为69D，硬材料的硬度优选为81D。其中，软材料的质量占球囊120总质量的比例范围为25％-75％，硬材料的质量占球囊120总质量的比例范围为25％-75％。即，本公开实施例的球囊120中的软材料与硬材料的质量比范围为1:3至3:1。通过对该质量比进行调节，球囊120的***压、顺应性和贴壁性会发生明显的变化。The balloon 120 of the embodiment of the present disclosure is made of soft material and hard material, and the burst pressure, compliance and wall adhesion of the balloon are related to the hardness of the material itself and the mass ratio of the soft material to the hard material. The hardness of the soft material is 35D-70D, and the hardness of the hard material is 71D-90D; the hardness of the soft material is preferably 69D, and the hardness of the hard material is preferably 81D. Wherein, the mass of the soft material accounts for 25%-75% of the total mass of the balloon 120, and the mass of the hard material accounts for 25%-75% of the total mass of the balloon 120. That is, the mass ratio of the soft material to the hard material in the balloon 120 of the embodiment of the present disclosure ranges from 1:3 to 3:1. By adjusting the mass ratio, the burst pressure, compliance and wall-adherence of the balloon 120 will be significantly changed.

现有血管内冲击波碎石技术为保证冲击波声压强度和能量传输通常采用由聚醚嵌段聚酰胺共聚物制成的高柔软度球囊，例如当球囊120完全由一种软材料制成，即球囊120为软材料球囊时，测试结果显示相同壁厚的该球囊的顺应性为5.0％-8％，球囊120具有半顺应性和良好的贴壁性，球囊120的***压为10atm～16atm，但该***压无法满足对钙化病变的有效扩张的需求；而为提高球囊扩张压力，将现有技术中的聚醚嵌段聚酰胺共聚物材料替换为硬度较高的材料时，例如当球囊120完全由一种硬材料制成，即球囊120为硬材料球囊时，测试结果显示相同壁厚的该球囊的顺应性为0％-0.5％，球囊120的***压为24atm～30atm，但球囊120为非顺应性球囊且贴壁性较差，且采用硬材料制成的球囊会影响冲击波声压强度和能量传输效果；而为了提高球囊扩张压力，通过增加高柔软度球囊壁厚来提高球囊的***压时，较大的壁厚会增加冲击波在传播过程中的损耗，减少作用于病变的能量，同时也会降低球囊的贴壁性和通过性。因此，本申请的发明人发现目前的技术很难同时兼顾球囊的顺应性、贴壁性、以及对高扩张压力和高冲击波声压强度的要求。The existing intravascular shock wave lithotripsy technology usually uses a highly flexible balloon made of polyether block polyamide copolymer to ensure the shock wave sound pressure intensity and energy transmission. For example, when the balloon 120 is completely made of a soft material , that is, when the balloon 120 is a soft material balloon, the test results show that the compliance of the balloon with the same wall thickness is 5.0%-8%, the balloon 120 has semi-compliance and good adherence, and the balloon 120 Burst pressure is 10atm ~ 16atm, but the burst pressure can not meet the demand for effective expansion of calcified lesions; and in order to improve the inflation pressure of the balloon, the polyether block polyamide copolymer material in the prior art is replaced with a higher hardness For example, when the balloon 120 is completely made of a hard material, that is, when the balloon 120 is a hard material balloon, the test results show that the compliance of the balloon with the same wall thickness is 0%-0.5%. The burst pressure of the balloon 120 is 24atm to 30atm, but the balloon 120 is a non-compliant balloon and has poor wall adhesion, and the balloon made of hard material will affect the shock wave sound pressure intensity and energy transmission effect; High balloon inflation pressure, when the burst pressure of the balloon is increased by increasing the wall thickness of the high-flexibility balloon, the larger wall thickness will increase the loss of the shock wave during propagation, reduce the energy acting on the lesion, and also reduce the Adherence and passability of the balloon. Therefore, the inventors of the present application found that the current technology is difficult to simultaneously satisfy the requirements of balloon compliance, wall adhesion, high dilation pressure and high shock wave sound pressure intensity.

本公开实施例的球囊120采用内层和外层硬度不同的双层结构设计，能够在保证球囊顺应性和贴壁性的同时满足对球囊高***压和高冲击波声压强度的需求。例如，在球囊120的顺应性为0.5％-3.0％的情况下，球囊120具有半顺应性。因此，通过调节硬材料与软材料的质量比，使得双层结构球囊一方面具有软材料球囊的较好的顺应性和贴壁性，另一方面还具有硬材料球囊的较高的***压，球囊120的***压为30atm。The balloon 120 of the embodiment of the present disclosure adopts a double-layer structure design with different hardness of the inner layer and the outer layer, which can meet the requirements of high burst pressure and high shock wave sound pressure intensity of the balloon while ensuring the compliance and wall adhesion of the balloon . For example, where the compliance of the balloon 120 is 0.5%-3.0%, the balloon 120 is semi-compliant. Therefore, by adjusting the mass ratio of the hard material to the soft material, the double-layer structure balloon has better compliance and wall-adherence of the soft material balloon on the one hand, and has a higher flexibility of the hard material balloon on the other hand. The burst pressure of the balloon 120 is 30 atm.

在一个实施例中，内层122由软材料聚醚嵌段聚酰胺共聚物(Pebax)制成，外层124由硬材料尼龙12制成，两层囊体之间紧密结合，如图2和图3所示。内层122的Pebax材料可赋予球囊120一定的柔顺性，有利于通过迂曲病变，外层124的尼龙12可增加球囊120的抗***能力，使得球囊120能够提供高扩张压力。但考虑到过高的扩张压力会对血管壁产生创伤，导致血管反弹、夹层、形成血栓。在优选的实施例中，Pebax与尼龙12的质量比为1:1，Pebax的硬度为69D，尼龙12的硬度为81D，此时球囊120的***压为20atm，顺应性为1.5％。在另一实施例中，Pebax与尼龙12的质量比为1:1，Pebax的硬度为63D，尼龙12的硬度为81D。In one embodiment, the inner layer 122 is made of soft material polyether block polyamide copolymer (Pebax), and the outer layer 124 is made of hard material nylon 12, tightly bonded between the two layers of capsules, as shown in Figure 2 and Figure 3 shows. The Pebax material of the inner layer 122 can endow the balloon 120 with a certain degree of flexibility, which is conducive to passing tortuous lesions, and the nylon 12 of the outer layer 124 can increase the anti-burst ability of the balloon 120, so that the balloon 120 can provide high inflation pressure. However, it is considered that excessive expansion pressure will cause trauma to the vessel wall, resulting in vessel rebound, dissection, and thrombus formation. In a preferred embodiment, the mass ratio of Pebax to Nylon 12 is 1:1, the hardness of Pebax is 69D, and the hardness of Nylon 12 is 81D. At this time, the burst pressure of the balloon 120 is 20 atm, and the compliance is 1.5%. In another embodiment, the mass ratio of Pebax to nylon 12 is 1:1, the hardness of Pebax is 63D, and the hardness of nylon 12 is 81D.

需要说明的是，本文中的“顺应性”是指在工作压力区间范围内，随着充盈压力的增加引起的球囊120直径的变化率。换句话说，球囊120在名义压力下具有名义直径，其顺应性的大小等于充盈压力每增加一个大气压时球囊120直径的增加量除以名义直径。目前，顺应性的范围界定并没有严格统一的划分，仅仅是在少部分团体中用经验值来界定。通常情况下，当增加充盈压力时，球囊120直径基本不变，则可认为球囊具有非顺应性。“贴壁性”是指球囊120在充盈一定压强介质后附着于血管壁时的贴合紧密程度，其主要与球囊120的形变量有关。换句话说，容易发生形变的球囊120会更容易与病变贴合。此外，贴壁性与顺应性相关联，具体来说，具有顺应性的球囊120的贴壁性最好，具有非顺应性的球囊120的贴壁性最差。“***压”是指球囊120在扩张过程中达到的最大扩张压力。It should be noted that the "compliance" herein refers to the change rate of the diameter of the balloon 120 caused by the increase of the filling pressure within the working pressure range. In other words, balloon 120 has a nominal diameter at nominal pressure, and its compliance is equal to the increase in diameter of balloon 120 divided by the nominal diameter for each one atmosphere increase in inflation pressure. At present, there is no strict and uniform division of the scope of compliance, and it is only defined by experience in a small number of groups. Generally, when the inflation pressure is increased, the diameter of the balloon 120 remains substantially unchanged, and the balloon can be considered to be non-compliant. “Adherence” refers to the tightness of the balloon 120 when it is filled with a certain pressure medium and adheres to the blood vessel wall, which is mainly related to the deformation of the balloon 120 . In other words, a balloon 120 that is prone to deformation will fit the lesion more easily. In addition, the adherence is related to the compliance, specifically, the adherence of the compliant balloon 120 is the best, and the adherence of the non-compliant balloon 120 is the worst. "Burst pressure" refers to the maximum inflation pressure reached by the balloon 120 during expansion.

钙化斑块作为一种非均质且各向异性的物质，其内部随机分布有各种尺度级别的孔隙和裂隙。对于严重的钙化病变，单纯靠球囊扩张，打通作用有限。因此，当前采用血管内冲击波碎石术对高度钙化病灶进行破坏。然而，由于现有电极结构产生的冲击波强度波动较大，钙化病变可能不能完全碎裂。因此本公开采用了冲击波电极组件200，其截面示意图如图4所示。冲击波电极组件200包括内电极210、外电极230以及位于内电极210和外电极230之间的绝缘层220。内电极210的表面上设置有凸起引脚212，绝缘层220上设置有第一孔222。外电极230上设置有第二孔232，并且第二孔232的直径大于第一孔222的直径。凸起引脚212延伸穿过第一孔222并延伸至第二孔232中，使得外电极230与凸起引脚212之间形成了环状间隙，该间隙使得外电极230与内电极210之间构成了放电回路。具体来讲，冲击波球囊导管装置100还包括连接导线(参见图11的连接导线320)，连接导线包括沿其轴向延伸的第一电极导线和第二电极导线(未示出)，内电极与第一电极导线连接，外电极与第二电极导线连接，且第一电极导线和第二电极导线配置为分别连接高压电源的两极。在该高压电源下，内电极210和外电极230之间产生高压脉冲，从而在球囊120中产生机械冲击波。当将冲击波电极组件200放入液体中，给予其适当的脉冲电压，该电极组件可击穿充盈液体。在凸起引脚212于外电极230间发出位置稳定的电火花，产生冲击波。将冲击波电极组件设置在所述内管外，该冲击波通过球囊120内部的液体的传播，冲击球囊壁和钙化区域。反复的脉冲可以破坏钙化灶的结构，扩张狭窄血管，而不损伤周围的软组织。稳定的电火花也能减少对球囊损伤的潜在可能性，从而确保具有提高球囊耐压的可行性。本公开发明人实验研究了未设置有凸起引脚的普通冲击波电极组件和本公开的冲击波电极组件200在施加不同脉冲电压下的声压强度，如图5所示。在相同脉冲电压下，相比于普通冲击波电极组件，根据本公开的冲击波电极组件200能够更高效地产生高强度的声压，即表现出更高的声压强度。这更有利于有效的破坏钙化病变，提高冲击波球囊导管装置100的治疗效果。Calcified plaque is a heterogeneous and anisotropic substance with randomly distributed particles of various sizes inside. Degree-level pores and cracks. For severe calcified lesions, relying solely on balloon dilation has limited effect on opening up. Therefore, endovascular shock wave lithotripsy is currently used to destroy highly calcified lesions. However, calcified lesions may not be completely fragmented due to large fluctuations in the intensity of the shock wave generated by the existing electrode structure. Therefore, the present disclosure adopts a shock wave electrode assembly 200 , the cross-sectional schematic diagram of which is shown in FIG. 4 . The shock wave electrode assembly 200 includes an inner electrode 210 , an outer electrode 230 and an insulating layer 220 between the inner electrode 210 and the outer electrode 230 . Protruding pins 212 are disposed on the surface of the internal electrode 210 , and first holes 222 are disposed on the insulating layer 220 . A second hole 232 is disposed on the external electrode 230 , and the diameter of the second hole 232 is larger than that of the first hole 222 . The protruding pin 212 extends through the first hole 222 and extends into the second hole 232, so that an annular gap is formed between the external electrode 230 and the protruding pin 212, and the gap makes the gap between the external electrode 230 and the internal electrode 210 constitutes a discharge circuit. Specifically, the shock wave balloon catheter device 100 also includes connecting wires (see connecting wire 320 in FIG. 11 ), the connecting wires include a first electrode wire and a second electrode wire (not shown) extending along its axial direction, and the inner electrode The outer electrode is connected to the first electrode lead, and the outer electrode is connected to the second electrode lead, and the first electrode lead and the second electrode lead are configured to be respectively connected to two poles of the high-voltage power supply. Under the high-voltage power supply, a high-voltage pulse is generated between the inner electrode 210 and the outer electrode 230 , thereby generating a mechanical shock wave in the balloon 120 . When the shock wave electrode assembly 200 is put into the liquid and given an appropriate pulse voltage, the electrode assembly can break down the filled liquid. A stable electric spark is emitted between the protruding pin 212 and the external electrode 230 to generate a shock wave. The shock wave electrode assembly is arranged outside the inner tube, and the shock wave propagates through the liquid inside the balloon 120 to impact the balloon wall and the calcification area. Repeated pulses can destroy the structure of calcified foci and dilate narrow blood vessels without damaging the surrounding soft tissue. A stable electric spark can also reduce the potential for damage to the balloon, thereby ensuring the feasibility of improving the pressure resistance of the balloon. The inventors of the present disclosure experimentally studied the sound pressure intensity of a common shock wave electrode assembly without protruding pins and the shock wave electrode assembly 200 of the present disclosure under different pulse voltages, as shown in FIG. 5 . Under the same pulse voltage, compared with common shock wave electrode assemblies, the shock wave electrode assembly 200 according to the present disclosure can generate high-intensity sound pressure more efficiently, that is, exhibit higher sound pressure intensity. This is more conducive to effectively destroying calcified lesions and improving the therapeutic effect of the shock wave balloon catheter device 100 .

在一个实施例中，内电极210是片状结构。绝缘层220和外电极230是环状结构。一个冲击波电极组件200中包括多个内电极210，绝缘层220包括多个第一孔222，外电极230包括多个第二孔232。其中，内电极210、第一孔222以及第二孔232的数量相等。实际手术过程中，可能存在多处钙化病灶需要处理，因此可以采用具有多个内电极210的冲击波电极组件200，从而在冲击波球囊导管装置100上构建多个放电区域。一方面提高了冲击波球囊导管装置100同时处理多处钙化病灶的能力，另一方面，可能提高冲击波在内管110周向空间上分布的均匀性，从而有利于钙化病变的处理。以下将这种具有多个内电极210结构的冲击波电极组件200称为“冲击波多电极组件”。换句话说，冲击波多电极组件是根据本公开的冲击波电极组件200的一个示例。图6示出了设置有冲击波两电极组件的冲击波球囊导管装置100的截面示意图。如图所示，冲击波两电极组件的两个内电极210-1和210-2设置在内管外，两个内电极210-1和210-2的朝向呈180度。此外，可根据待处理钙化病灶的实际位置分布情况，对冲击波多电极组件的多个内电极210在内管110周向上的分布进行相应调整，本公开对此不作限制。In one embodiment, the internal electrode 210 is a sheet-like structure. The insulating layer 220 and the external electrode 230 are ring structures. A shock wave electrode assembly 200 includes a plurality of inner electrodes 210 , the insulating layer 220 includes a plurality of first holes 222 , and the outer electrode 230 includes a plurality of second holes 232 . Wherein, the numbers of the internal electrodes 210 , the first holes 222 and the second holes 232 are equal. In the actual operation process, there may be multiple calcified lesions that need to be treated, so the shock wave electrode assembly 200 with multiple internal electrodes 210 can be used, thereby Multiple discharge regions are constructed on the shock wave balloon catheter device 100 . On the one hand, it improves the ability of the shock wave balloon catheter device 100 to treat multiple calcified lesions at the same time; on the other hand, it may improve the uniformity of shock wave distribution in the circumferential space of the inner tube 110, thereby facilitating the treatment of calcified lesions. Hereinafter, the shock wave electrode assembly 200 having a structure of multiple inner electrodes 210 is referred to as a "shock wave multi-electrode assembly". In other words, a shockwave multi-electrode assembly is one example of a shockwave electrode assembly 200 according to the present disclosure. FIG. 6 shows a schematic cross-sectional view of a shock wave balloon catheter device 100 provided with a shock wave two-electrode assembly. As shown in the figure, the two inner electrodes 210-1 and 210-2 of the shock wave two-electrode assembly are arranged outside the inner tube, and the orientation of the two inner electrodes 210-1 and 210-2 is 180 degrees. In addition, the distribution of the multiple internal electrodes 210 of the shock wave multi-electrode assembly in the circumferential direction of the inner tube 110 can be adjusted accordingly according to the actual distribution of calcified lesions to be treated, which is not limited in the present disclosure.

在一个实施例中，在冲击波球囊导管装置100中，沿内管110的轴向间隔布置有多个冲击波多电极组件。如果要处理的钙化病灶有多个，并且间隔一定距离。若冲击波球囊导管装置100采用单个冲击波多电极组件，则需要将冲击波球囊导管装置100输送到不同钙化病灶的位置上进行逐个处理，操作不便。因此针对上述情况，可以采用具有沿内管110的轴向间隔布置的多个冲击波多电极组件200的冲击波球囊导管装置100。在一个实施例中，多个冲击波多电极组件200串联布置。图7示出了具有两个冲击波两电极组件200的冲击波球囊导管装置100的示意图。同时根据待处理钙化病灶的实际位置分布，对不同冲击波电极组件200在内管110轴向上的分布进行相应调整，本公开对此不作限制。如图7、图8A和图8B所示，第一冲击波两电极组件200A固定在内管110上，与之间隔的第二冲击波两电极组件200B相对第一冲击波两电极组件200A沿内管110周向旋转90角度，从而第一冲击波两电极组件的第一孔222A-1与第二冲击波两电极组件的第一孔222B-1的朝向呈90角度。相应地，在布置有多个冲击波两电极组件的冲击波球囊导管装置100中，根据实际需要，可以将相邻的冲击波两电极组件的第一孔222的朝向布置成任意角度，本公开对此不作限制。例如，三个冲击波两电极组件的第一孔222的朝向依次间隔60度分布，四个冲击波两电极组件的第一孔222的朝向依次间隔45度分布。此外，在布置有多个冲击波多电极组件的冲击波球囊导管装置100中，也可以进行与上述方法相似的布置，这里不再赘述。In one embodiment, in the shock wave balloon catheter device 100 , a plurality of shock wave multi-electrode assemblies are arranged at intervals along the axial direction of the inner tube 110 . If there are multiple calcified lesions to be treated, and they are separated by a certain distance. If the shock wave balloon catheter device 100 uses a single shock wave multi-electrode assembly, it is necessary to transport the shock wave balloon catheter device 100 to different calcified lesions for treatment one by one, which is inconvenient to operate. Therefore, for the above situation, the shock wave balloon catheter device 100 having a plurality of shock wave multi-electrode assemblies 200 arranged at intervals along the axial direction of the inner tube 110 may be used. In one embodiment, multiple shockwave multi-electrode assemblies 200 are arranged in series. FIG. 7 shows a schematic diagram of a shockwave balloon catheter device 100 with two shockwave two-electrode assemblies 200 . At the same time, according to the actual distribution of calcified lesions to be treated, the distribution of different shock wave electrode assemblies 200 in the axial direction of the inner tube 110 is adjusted accordingly, which is not limited in the present disclosure. As shown in FIG. 7 , FIG. 8A and FIG. 8B , the first shock wave two-electrode assembly 200A is fixed on the inner tube 110 , and the second shock wave two-electrode assembly 200B is separated from the first shock wave two-electrode assembly 200A along the circumference of the inner tube 110 . Rotate 90 degrees, so that the orientation of the first hole 222A-1 of the first shock wave two-electrode assembly and the first hole 222B-1 of the second shock wave two-electrode assembly form an angle of 90 degrees. Correspondingly, in the shock wave balloon catheter device 100 arranged with multiple shock wave two-electrode assemblies, according to actual needs, the orientations of the first holes 222 of adjacent shock wave two-electrode assemblies can be arranged at any angle. No limit. For example, the orientations of the first holes 222 of the three shock wave two-electrode assemblies are sequentially distributed at intervals of 60 degrees, and the orientations of the first holes 222 of the four shock wave two-electrode assemblies are sequentially distributed at intervals of 45 degrees. In addition, in the shock wave balloon catheter device 100 in which multiple shock wave multi-electrode assemblies are arranged, arrangements similar to the above-mentioned method can also be performed, which will not be repeated here.

根据发明人实验研究，根据本发明的实施例的双层球囊120对提高冲击波电极组件200发出冲击波的声压强度具有有益效果。 According to the inventor's experimental research, the double-layer balloon 120 according to the embodiment of the present invention has a beneficial effect on improving the sound pressure intensity of the shock wave emitted by the shock wave electrode assembly 200 .

图9显示球囊的不同充盈压力下冲击波电极组件200发出的冲击波的声压强度。在固定脉冲电压的条件下，选用水为充盈液体介质，双层球囊120内充盈压力从0atm增长到20atm，产生冲击波的声压强度呈现出先增长后降低的趋势。这主要是以下两方面的共同作用。一方面，充盈压力的持续增大，致使水介质对冲击波击穿通道形成的阻碍作用增强，导致冲击波击穿放电能量损耗增多，冲击波产生的声压强度降低。另一方面，从冲击波传递的角度来说，充盈压力的增加在一定程度上使得冲击波的衰减减弱，这对冲击波传递产生促进作用。当充盈压力较低时(0atm-6atm)，充盈压力促进冲击波传递的作用强于对冲击波击穿的抑制作用。因此，冲击波的声压强度随着充盈压力的升高而增大，当充盈压力为6atm时，冲击波声压强度最大，达到峰值。当充盈压力继续增大时(6atm-20atm)，充盈压力促进冲击波传递的作用有限，导致充盈压力对冲击波击穿的抑制作用明显高于促进冲击波传递的作用，从而表现出冲击波声压强度逐步减弱的趋势。在每一组放电参数下均对应一个最优的充盈压力值，从而使得病灶致裂效果最好。FIG. 9 shows the sound pressure intensity of the shock wave emitted by the shock wave electrode assembly 200 under different inflation pressures of the balloon. Under the condition of a fixed pulse voltage, water is selected as the filling liquid medium, and the filling pressure in the double-layer balloon 120 increases from 0 atm to 20 atm, and the sound pressure intensity of the shock wave presents a trend of first increasing and then decreasing. This is mainly due to the joint effect of the following two aspects. On the one hand, the continuous increase of the filling pressure increases the hindrance effect of the water medium on the formation of the shock wave breakdown channel, which leads to an increase in the energy loss of the shock wave breakdown discharge and a decrease in the sound pressure intensity generated by the shock wave. On the other hand, from the perspective of shock wave transmission, the increase of filling pressure weakens the shock wave attenuation to a certain extent, which promotes the shock wave transmission. When the filling pressure is low (0atm-6atm), the effect of filling pressure on promoting shock wave transmission is stronger than its inhibiting effect on shock wave breakdown. Therefore, the sound pressure intensity of the shock wave increases with the increase of the filling pressure. When the filling pressure is 6atm, the sound pressure intensity of the shock wave is the largest and reaches the peak value. When the filling pressure continues to increase (6atm-20atm), the effect of filling pressure on promoting shock wave transmission is limited, resulting in the effect of filling pressure on shock wave breakdown being significantly higher than that of promoting shock wave transmission, thus showing that the intensity of shock wave sound pressure gradually weakens the trend of. Each set of discharge parameters corresponds to an optimal filling pressure value, so that the effect of lesion fracturing is the best.

根据本发明的实施例的双层球囊120在保证冲击波能够产生最佳声压强度的同时，还具有较高的充盈压力，双层球囊120和冲击波组件200协同作用，能够有效治疗钙化病变。脉冲冲击波在高能等离子体的驱动下作用于钙化病变。由于充盈水介质良好的传能特性，在钙化裂隙处产生振动效应。这造成原有水压裂隙和初始裂隙扩展和发育，最终裂隙相互贯通，形成宏观的贯通裂缝。在短时间内重复进行高压脉冲放电。钙化病变在充盈压力和高压放电形成的多次脉冲共同协同作用下，裂缝延展长度增加。裂缝的数量增多，进而更容易碎裂。原则上，在保证声压强度的条件下，选择更高的充盈压力，能够获得更高扩张力，从而有更好的钙化病变碎裂效果。The double-layer balloon 120 according to the embodiment of the present invention ensures that the shock wave can generate the optimal sound pressure intensity, and at the same time, it also has a relatively high filling pressure. The double-layer balloon 120 and the shock wave assembly 200 work together to effectively treat calcified lesions . Pulsed shock waves act on calcified lesions driven by high-energy plasma. Due to the good energy transfer characteristics of the filled water medium, a vibration effect is generated at the calcified fracture. This causes the expansion and development of the original hydraulic fractures and the initial fractures, and finally the fractures interpenetrate with each other to form macroscopic through fractures. High-voltage pulse discharge is repeated in a short period of time. In calcified lesions, under the synergistic effect of filling pressure and multiple pulses formed by high-voltage discharge, the crack extension length increases. The number of cracks increases, which in turn makes it easier to chip. In principle, under the condition of ensuring the sound pressure intensity, choosing a higher filling pressure can obtain a higher expansion force, and thus have a better fragmentation effect of calcified lesions.

本公开实施例的冲击波球囊导管装置100具有上述双层结构的球囊120以及冲击波电极组件200的组合设计，这可以既满足该装置在高充盈压力下发射冲击波的要求，还可以保证球囊的贴壁效果。The shock wave balloon catheter device 100 of the embodiment of the present disclosure has the combined design of the above-mentioned double-layer balloon 120 and the shock wave electrode assembly 200, which can not only meet the requirements of the device for emitting shock waves under high filling pressure, but also ensure that the balloon wall-attachment effect.

本公开的发明人使用石膏圈作为钙化模型，研究了以下三种情况下采用相同冲击波球囊导管装置100的扩张效果，记录不同条件下石膏圈的碎裂情况。在第一组实验中，冲击波电极组件200在0atm充盈压力下发射冲击波。在第二组实验中，冲击波球囊导管装置100只使用6atm的充盈压力。在第三组实验中，冲击波电极组件200在6atm充盈压力下发射冲击波。结果发现，第一组实验和第二组实验中的冲击波球囊导管装置100都无法使石膏圈碎裂。而在第三组实验中，在6atm充盈压力下，冲击波电极组件200发射数次冲击波即可使石膏圈碎裂。这些结果表明，球囊120扩张和冲击波的确存在协同作用。冲击波电极组件200在较高压力下发射冲击波，会更有利于钙化裂纹的产生，从而破坏钙化病变。The inventors of the present disclosure used a plaster ring as a calcification model to study the expansion effect of the same shock wave balloon catheter device 100 under the following three conditions, and recorded the fragmentation of the plaster ring under different conditions. In a first set of experiments, the shockwave electrode assembly 200 delivered shockwaves at 0 atm filling pressure. In a second set of experiments, the shock wave balloon catheter device 100 was only used with an inflation pressure of 6 atm. In a third set of experiments, the shock wave electrode assembly 200 delivered shock waves at a filling pressure of 6 atm. turn out, The shock wave balloon catheter device 100 in both the first and second experiments was unable to fracture the plaster circle. In the third group of experiments, under the filling pressure of 6 atm, the shock wave electrode assembly 200 can emit several shock waves to break the gypsum circle. These results indicate that there is indeed a synergy between balloon 120 expansion and the shock wave. The shock wave emitted by the shock wave electrode assembly 200 under higher pressure is more conducive to the generation of calcification cracks, thereby destroying calcification lesions.

此外，本公开的发明人还研究了具有不同配置的冲击波球囊导管装置100的扩张效果，如图10所示。扩张效果测试均是在相同脉冲电压和相同充盈压力条件下进行。测试结果显示，采用本公开的冲击波球囊导管装置100，相比较软质球囊，双层球囊可以在更少的放电次数下击碎钙化模型；相比较不设置有凸起引脚结构的冲击波电极组件，在相同脉冲电压条件下，本公开实施例的冲击波电极组件200可以在更少的放电次数下击碎钙化模型。双层球囊由于独特的结构特征，一方面，在有效增大球囊的***压的同时，使得球囊具有较好的顺应性和贴壁性，另一方面，在使球囊具有相同***压的前提下，与软质球囊相比，使用双层结构的球囊壁厚更小，较小的壁厚减少了冲击波能量在传递过程中的损耗，使更多的能量能够传递至病变，从而更好的击碎钙化斑块。这种布置有冲击波电极组件200以及双层结构的球囊120的冲击波球囊导管装置100能够有效的击碎钙化斑块，并且具有优异的扩张效果，可以应用于血管成形术中。In addition, the inventors of the present disclosure also studied the expansion effect of the shock wave balloon catheter device 100 with different configurations, as shown in FIG. 10 . The expansion effect test was carried out under the same pulse voltage and filling pressure. The test results show that using the shock wave balloon catheter device 100 of the present disclosure, compared with the soft balloon, the double-layer balloon can crush the calcified model with fewer discharge times; The shock wave electrode assembly, under the same pulse voltage condition, the shock wave electrode assembly 200 of the embodiment of the present disclosure can crush the calcification model with fewer discharge times. Due to the unique structural features of the double-layer balloon, on the one hand, while effectively increasing the burst pressure of the balloon, it makes the balloon have better compliance and adhesion; on the other hand, it makes the balloon have the same burst pressure Under the premise of pressure, compared with soft balloons, the wall thickness of the double-layered balloon is smaller, and the smaller wall thickness reduces the loss of shock wave energy during the transmission process, so that more energy can be transmitted to the lesion , so as to better crush the calcified plaque. The shock wave balloon catheter device 100 arranged with the shock wave electrode assembly 200 and the double-layer balloon 120 can effectively crush calcified plaques and has an excellent expansion effect, and can be applied in angioplasty.

根据本公开的冲击波球囊导管装置100因其独特的双层球囊设计具有较高的***压，可达20个标准大气压。在发射的冲击波使得病变产生裂纹后，可以直接对球囊120进行进一步扩张。较高的扩张压力避免了传统冲击波球囊导管装置扩张不足而需要再次置入高压球囊配合使用的情况。高效稳定的冲击波电极组件200为整个冲击波导管装置100提供了较高的声压强度，球囊120的双层结构提供了足够的扩张压力。两者协同作用能够充分扩张病变，打通血管。从而减少手术步骤，缩短手术时间，并减少手术并发症的风险。The shock wave balloon catheter device 100 according to the present disclosure has a high burst pressure, up to 20 standard atmospheres, due to its unique double-layer balloon design. The balloon 120 can be further expanded directly after the emitted shock wave causes cracks in the lesion. The higher expansion pressure avoids the situation that the traditional shock wave balloon catheter device is under-expanded and needs to be re-inserted with a high-pressure balloon for use. The efficient and stable shock wave electrode assembly 200 provides high sound pressure intensity for the entire shock wave guide device 100 , and the double-layer structure of the balloon 120 provides sufficient expansion pressure. The synergistic effect of the two can fully expand the lesion and open up the blood vessels. Thereby reducing surgical steps, shortening operating time, and reducing the risk of surgical complications.

此外，本发明人还提出一种医疗设备。如图11所示，该医疗设备包括上述的冲击波球囊导管装置100、高压发生器310和导管座330。上述冲击波球囊导管装置100还包括连接导线320，该连接导线320的远端通过导管座330与冲击波电极组件200连接。连接导线320的近端与高压发生器310连接。高压发生器需满足如下参数要求：高压发生器的脉冲电压为500V～10kV，脉冲电压宽度为200ns～20μs；高压发生器的脉冲电流为50A～400A，脉冲电流宽度为10ns～2μs。在一个实施例中，每个冲击波电极组件200产生冲击波的声压强度为2Mpa～20Mpa，放电频率为0.1Hz～10Hz。在一个实施例中，连接导线320包含第一电极导线和第二电极导线，第一电极导线与内电极210相连，第二电极导线与外电极230相连。In addition, the inventor also proposes a medical device. As shown in FIG. 11 , the medical device includes the above-mentioned shock wave balloon catheter device 100 , a high pressure generator 310 and a catheter adapter 330 . The above-mentioned shock wave balloon catheter device 100 further includes a connecting wire 320 , the distal end of which is connected to the shock wave electrode assembly 200 through the catheter adapter 330 . The proximal end of the connecting wire 320 is connected to the high voltage generator 310 . The high voltage generator needs to meet the following parameter requirements: the pulse voltage of the high voltage generator is 500V ~ 10kV, the pulse voltage width is 200ns ~ 20μs; the pulse current of the high voltage generator is 50A ~ 400A, the pulse The current width is 10ns ~ 2μs. In one embodiment, each shock wave electrode assembly 200 generates a shock wave with a sound pressure intensity of 2Mpa-20Mpa, and a discharge frequency of 0.1Hz-10Hz. In one embodiment, the connecting wire 320 includes a first electrode wire and a second electrode wire, the first electrode wire is connected to the inner electrode 210 , and the second electrode wire is connected to the outer electrode 230 .

在实际工作中，电流通过第一电极导线传输到内电极210，内电极210通过充盈的导电流体与外电极230构成回路。高压脉冲将导电流体击穿，在第一孔222的轴向方向上产生冲击波。然后，电流传输至外电极230，并沿第二电极导线回到高压发生器。冲击波电极组件200产生的冲击波通过球囊120内部的液体的传播，冲击球囊壁和钙化区域。反复的脉冲可以破坏钙化灶的结构，扩张狭窄血管，而不损伤周围的软组织。并且，在本公开实施例的医疗设备中，球囊采用双层结构设计，在有效增大球囊的***压的同时，使得球囊具有较好的顺应性和贴壁性。而且，冲击波球囊导管装置还能产生更高的声压强度。通过高声压强度与高充盈压力的协同作用，可更容易粉碎钙化斑块。因而本公开实施例的医疗设备能更有效地破坏病变血管壁上附着的钙化病灶结构，提高对堵塞病变的治疗效果。In actual work, the current is transmitted to the inner electrode 210 through the first electrode wire, and the inner electrode 210 forms a loop with the outer electrode 230 through the filled conductive fluid. The high-voltage pulse breaks down the conductive fluid, generating shock waves in the axial direction of the first hole 222 . Then, the current is transmitted to the outer electrode 230, and returns to the high voltage generator along the second electrode lead. The shock wave generated by the shock wave electrode assembly 200 propagates through the liquid inside the balloon 120 and impacts the balloon wall and the calcification area. Repeated pulses can destroy the structure of calcified foci and dilate narrow blood vessels without damaging the surrounding soft tissue. Moreover, in the medical device of the embodiment of the present disclosure, the balloon adopts a double-layer structure design, which makes the balloon have better compliance and wall adhesion while effectively increasing the burst pressure of the balloon. Furthermore, shockwave balloon catheter devices can also generate higher acoustic pressure intensities. Through the synergistic effect of high acoustic pressure intensity and high filling pressure, calcified plaque can be more easily comminuted. Therefore, the medical device of the embodiment of the present disclosure can more effectively destroy the calcified lesion structure attached to the wall of the diseased blood vessel, and improve the therapeutic effect on the blocked lesion.

有以下几点需要说明：The following points need to be explained:

(1)本公开实施例附图只涉及到本公开实施例涉及到的结构，其他结构可参考通常设计。(1) Embodiments of the present disclosure The drawings only relate to the structures involved in the embodiments of the present disclosure, and other structures may refer to common designs.

(2)在不冲突的情况下，本公开的实施例及实施例中的特征可以相互组合以得到新的实施例。(2) In the case of no conflict, the embodiments of the present disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

以上，仅为本公开的具体实施方式，但本公开的保护范围并不局限于此，本公开的保护范围应以权利要求的保护范围为准。 The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto, and the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

一种冲击波球囊导管装置，其特征在于，包括：A shock wave balloon catheter device, characterized in that it comprises:

球囊，所述球囊包括内层和外层，所述内层的硬度不同于所述外层的硬度；a balloon comprising an inner layer and an outer layer, the hardness of the inner layer being different than the hardness of the outer layer;

内管，所述内管贯穿所述球囊，所述内管的远端与所述球囊的远端连接；an inner tube, the inner tube runs through the balloon, and the distal end of the inner tube is connected to the distal end of the balloon;

至少一冲击波电极组件，所述冲击波电极组件设置在所述内管外；at least one shock wave electrode assembly, the shock wave electrode assembly is disposed outside the inner tube;

以及外管，所述外管套设在所述内管的外部，并与所述球囊的近端连接。and an outer tube, the outer tube is sheathed on the outside of the inner tube and connected to the proximal end of the balloon.
如权利要求1所述的冲击波球囊导管装置，其特征在于，所述外层的硬度大于所述内层的硬度。The shock wave balloon catheter device according to claim 1, wherein the hardness of the outer layer is greater than that of the inner layer.
如权利要求2所述的冲击波球囊导管装置，其特征在于，所述外层由尼龙、聚对苯二甲酸乙二醇脂和聚乙烯中的一种或多种的组合制成；The shock wave balloon catheter device according to claim 2, wherein the outer layer is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene;

所述内层由聚醚嵌段聚酰胺共聚物、聚氯乙烯、聚氨酯和硅橡胶中的一种或多种的组合制成。The inner layer is made of one or more combinations of polyether block polyamide copolymer, polyvinyl chloride, polyurethane and silicone rubber.
如权利要求2所述的冲击波球囊导管装置，其特征在于，所述外层的硬度为71D～90D，所述内层的硬度为35D～70D。The shock wave balloon catheter device according to claim 2, wherein the hardness of the outer layer is 71D-90D, and the hardness of the inner layer is 35D-70D.
如权利要求2所述的冲击波球囊导管装置，其特征在于，所述外层与所述内层的质量比的范围为1:3～3:1。The shock wave balloon catheter device according to claim 2, wherein the mass ratio of the outer layer to the inner layer ranges from 1:3 to 3:1.
如权利要求1所述的冲击波球囊导管装置，其特征在于，所述外层由尼龙12制成，所述内层由聚醚嵌段聚酰胺共聚物制成，且尼龙12与聚醚嵌段聚酰胺共聚物的质量比为1:1。The shock wave balloon catheter device according to claim 1, wherein the outer layer is made of nylon 12, the inner layer is made of polyether block polyamide copolymer, and nylon 12 is embedded with polyether The mass ratio of segmented polyamide copolymers is 1:1.
如权利要求1所述的冲击波球囊导管装置，其特征在于，The shock wave balloon catheter device according to claim 1, wherein,

所述冲击波电极组件包括内电极和外电极，且配置为在高压电源下在所述内电极和所述外电极之间产生高压脉冲，从而在所述球囊中产生机械冲击波；The shock wave electrode assembly includes an inner electrode and an outer electrode, and is configured to generate a high voltage pulse between the inner electrode and the outer electrode under a high voltage power supply, thereby generating a mechanical shock wave in the balloon;

所述冲击波球囊导管装置还包括连接导线，所述连接导线包括沿其轴向延伸的第一电极导线和第二电极导线，所述内电极与所述第一电极导线连接，所述外电极与所述第二电极导线连接，且所述第一电极导线和所述第二电极导线配置为分别连接所述高压电源的两极。The shock wave balloon catheter device also includes a connecting wire, the connecting wire includes a first electrode wire and a second electrode wire extending along its axial direction, the inner electrode is connected to the first electrode wire, and the outer electrode It is connected to the second electrode wire, and the first electrode wire and the second electrode wire are configured to be respectively connected to two poles of the high voltage power supply.
如权利要求7所述的冲击波球囊导管装置，其特征在于，所述冲击波电极组件还包括位于所述内电极和所述外电极之间的绝缘层，所述内电极的表面上设置有凸起引脚，所述绝缘层上设置有第一孔，所述外电极上设置有第二孔，所述第二孔的直径大于所述第一孔的直径，所述凸起引脚、所述第一孔和所述第二孔配置为使得所述凸起引脚延伸穿过所述第一孔并延伸至所述第二孔中，从而在所述外电极和所述内电极之间形成环状的放电通道。The shock wave balloon catheter device according to claim 7, wherein the shock wave electrode assembly further comprises an insulating layer between the inner electrode and the outer electrode, and the inner electrode Protruding pins are provided on the surface, a first hole is provided on the insulating layer, a second hole is provided on the external electrode, the diameter of the second hole is larger than the diameter of the first hole, and the protruding The protruding pin, the first hole and the second hole are configured such that the protruding pin extends through the first hole and into the second hole, so that the external electrode and the A circular discharge channel is formed between the internal electrodes.
如权利要求1所述的冲击波球囊导管装置，其特征在于，所述冲击波球囊导管装置包括沿所述内管的轴向间隔布置的多个所述冲击波电极组件。The shock wave balloon catheter device according to claim 1, characterized in that, the shock wave balloon catheter device comprises a plurality of shock wave electrode assemblies arranged at intervals along the axial direction of the inner tube.
如权利要求9的冲击波球囊导管装置，其特征在于，多个所述冲击波电极组件串联布置。The shock wave balloon catheter device of claim 9, wherein a plurality of said shock wave electrode assemblies are arranged in series.
如权利要求9的冲击波球囊导管装置，其特征在于，多个所述冲击波电极组件在所述内管的同一周向上排列，或周向呈角度排列。The shock wave balloon catheter device according to claim 9, wherein a plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or are arranged in an angular circumferential direction.
一种医疗设备，其特征在于，包括如权利要求1-11中任一项所述的冲击波球囊导管装置、高压发生器，所述冲击波球囊导管装置还包括连接导线，所述连接导线的远端与所述冲击波电极组件连接，所述连接导线的近端与所述高压发生器连接；所述高压发生器的脉冲电压为500V～10kV，脉冲电压宽度为200ns～20μs，所述高压发生器的脉冲电流为50A～400A，脉冲电流宽度为10ns～2μs。A medical device, characterized in that it includes the shock wave balloon catheter device and the high voltage generator according to any one of claims 1-11, the shock wave balloon catheter device also includes a connecting wire, and the connecting wire The far end is connected to the shock wave electrode assembly, and the proximal end of the connecting wire is connected to the high voltage generator; the pulse voltage of the high voltage generator is 500V～10kV, and the pulse voltage width is 200ns～20μs, and the high voltage generator The pulse current of the device is 50A ~ 400A, and the pulse current width is 10ns ~ 2μs.
如权利要求12所述的医疗设备，其特征在于，每个所述冲击波电极组件产生的冲击波的声压强度为2Mpa～20Mpa，放电频率为0.1Hz～10Hz。 The medical device according to claim 12, characterized in that the sound pressure intensity of the shock wave generated by each shock wave electrode assembly is 2Mpa-20Mpa, and the discharge frequency is 0.1Hz-10Hz.