前言导读

血管钙化（vascular calcification）是动脉粥样硬化、高血压、糖尿病血管病变、血管损伤、慢性肾病和衰老等普遍存在的共同的病理表现。

主要表现为血管壁僵硬性增加，顺应性降低，易导致心肌缺血、左心室肥大和心力衰竭，引发血栓形成、斑块破裂，是心脑血管疾病高发病率和高死亡率的重要因素之一；亦是动脉粥样硬化心血管事件、脑卒中和外周血管病发生的重要标志分子。

血管钙化是指钙质物沉积在血管壁的一种病变，会导致血管壁变硬，顺应性降低。根据《冠状动脉钙化病变诊治中国专家共识（2021版）》，冠状动脉钙化随年龄增加而增加。此外，外周动脉的钙化也是常见问题。无论是冠状动脉还是外周动脉的钙化，都是介入治疗中非常棘手的病变。

Shockwave 概览

近日，国家药品监督管理局对外发布医疗器械批准证明文件（进口）信息，健适医疗的Shockwave血管内冲击波“系列产品获批上市，健适医疗的获证产品包括设备主机、及用于治疗冠状动脉和外周动脉钙化病变的多种型号导管。

去年3月，健适医疗与美国上市公司Shockwave Medical成立由健适控股的合资公司，引进全球顶尖的医疗新科技 --"血管内冲击波"钙化处理技术，由此加速国产化的进程。

笔者注意到，5月9日ShockWave Medical(股票代码：SWAV)公布财报，公告显示公司2022财年第一财季归属于母公司普通股股东净利润为1452.10万美元，同比增长161.53%；营业收入为9363.10万美元，同比上涨193.51%。

ShockWave Medical, Inc.成立于2009年6月17日,是一家专注于开发和商业化产品的医疗器械公司，旨在改变钙化心血管疾病的治疗方式。他们的目标是通过其用于治疗钙化斑块的声压力波的差异化和专有的局部递送来建立医疗器械治疗动脉粥样硬化性心血管疾病的新标准，它们称为血管内碎石术（“IVL”）。

专利分析

笔者针对ShockWave所涉及的专利情况，进行了检索，其结果进行如下展示：

技术解读

Shockwave血管内冲击波技术的灵感来源于肾结石体外冲击波治疗，通过球囊导管把脉冲声压波输送至钙化部位，把钙化的斑块“震松”，使血管恢复弹性及血流，重塑病变血管的同时，避免了对血管内膜的损伤。

产品由球囊、导管轴、导管座、充盈端口、导丝出口、连接器和脉冲发射器组成。

产品基于体外碎石冲击波原理改进而来，将聚焦式高强度 能量改为发散式低强度能量，通过血管内导管方式导入外周血管对钙化病变部位进行松解，以缓解血管狭窄程度或便于后续治疗。

产品导管上含有若干液电式能量波源（脉冲发射器），通过接受发生器传递的电能转化为机械能向外输出冲击波能量。能量波源外部含有球囊，与球囊加压装置配合使用可用于扩张狭窄部位血管，球囊内部可注入生理盐水/造影剂的混合液用于传递冲击波能量。

Shockwave血管内冲击波技术相关产品的结构组成和工作原理可参考如下视频：

专利概览

笔者对Shockwave的相关专利根据类别分别进行了整理和剖析，这里笔者从众多专利中选择了若干进行了解析，相关相关结果如下：Shockwave的完整专利清单和分析笔者也已开展完成，如感兴趣可以与笔者取得联系，共同交流学习：

公开/公告号	US8888788B2	申请日	2013-03-14
发明名称	Low profile electrodes for an angioplasty shock wave catheter
解决的技术问题	Currently, angioplasty balloons are used to open calcified lesions in the wall of an artery. However, as an angioplasty balloon is inflated to expand the lesion in the vascular wall, the inflation pressure stores a tremendous amount of energy in the balloon until the calcified lesion breaks or cracks. That stored energy is then released and may stress and injure the wall of the blood vessel.
技术方案	Described herein are low-profile electrodes for use with an angioplasty shockwave catheter. A low-profile electrode assembly may have an inner electrode, an insulating layer disposed over the inner electrode such that an opening in the insulating layer is aligned with the inner electrode, and an outer electrode sheath disposed over the insulating layer such that an opening in the outer electrode sheath is coaxially aligned with the opening in the insulating layer. This layered configuration allows for the generation of shockwaves that propagate outward from the side of the catheter. In some variations, the electrode assembly has a second inner electrode, and the insulating layer and outer electrode may each have a second opening that are coaxially aligned with the second inner electrode. An angioplasty shockwave catheter may have a plurality of such low-profile electrode assemblies along its length to break up calcified plaques along a length of a vessel.
相关附图

公开/公告号	US10973538B2	申请日	2018-12-17
发明名称	Shockwave catheter system with energy control
解决的技术问题	A still further important aspect of prior art attempts to use shock waves from electrical arcs for therapeutic purposes is that from the time the high voltage is first applied to the electrodes to the time in which the arc occurs there is a dwell time (Td) that is highly variable from one high voltage application to the next. To account for the dwell times that are long, prior art strategies have relied upon high voltage applications where all high voltage pulse durations or pulse widths are of the same length and of a length sufficient to extend through the longest of the anticipated dwell times plus the associated arc and steam bubble. As a result, when the dwell times are shorter than the maximum, the high voltage application durations are longer than necessary and can unnecessarily extend the arc and the steam bubble well beyond a time required to produce a shock wave of maximum intensity. The result is wasted energy, extended electrode erosion, and unnecessary heating of the adjoining tissue.
技术方案	A system that breaks calcium in a liquid includes a catheter including first and second electrodes arranged to receive there-across a high electrical voltage at an initial low current. The high electrical voltage causes an electrical arc to form across the electrodes creating a gas bubble within the liquid, a high current to flow through the electrodes, and a mechanical shock wave. A power source provides the electrodes with the high electrical voltage at the initial current and terminates the high electrical voltage in response to the high current flow through the electrodes.
相关附图

结  语

目前，对于IVL而言而言，国内已有不少厂家正在进行相关研发和临床试验，不过目前技术依然以Shockwave等国外企业为主，不过随着国内重视程度不断提高的情况下，中国公司蓄势待发，在一片被普遍看好的市场中开始暗流涌动，虽然目前为止还没有真正意义上的国产IVL成品上市，但是随着各个“卡脖子”技术不断攻克，国产IVL一定会在近几年实现重大突破和问世。

目前，国内各大IVL领域医疗厂商还会将Shockwave等重要竞品作为标杆和对照，但是随着各大国内厂商联动产学研医生多方力量，不断创新，必将推动中国IVL业更智能化、精准化、便携化的发展，也会逐步摆脱国外竞品带来的压力和技术障碍，不过，国外巨头公司和国内新兴企业在知识产权方面布局更加紧密，IVL赛道上的各个国内厂商之间的竞争也会逐渐激烈，届时相关知识产权问题也必将会成为各大IVL厂商的研究重点课题，后续相关产品的的研发和专利事务值得持续关注。