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前言導(dǎo)讀

血管鈣化（vascular calcification）是動(dòng)脈粥樣硬化、高血壓、糖尿病血管病變、血管損傷、慢性腎病和衰老等普遍存在的共同的病理表現(xiàn)。

主要表現(xiàn)為血管壁僵硬性增加，順應(yīng)性降低，易導(dǎo)致心肌缺血、左心室肥大和心力衰竭，引發(fā)血栓形成、斑塊破裂，是心腦血管疾病高發(fā)病率和高死亡率的重要因素之一；亦是動(dòng)脈粥樣硬化心血管事件、腦卒中和外周血管病發(fā)生的重要標(biāo)志分子。

血管鈣化是指鈣質(zhì)物沉積在血管壁的一種病變，會(huì)導(dǎo)致血管壁變硬，順應(yīng)性降低。根據(jù)《冠狀動(dòng)脈鈣化病變?cè)\治中國(guó)專(zhuān)家共識(shí)（2021版）》，冠狀動(dòng)脈鈣化隨年齡增加而增加。此外，外周動(dòng)脈的鈣化也是常見(jiàn)問(wèn)題。無(wú)論是冠狀動(dòng)脈還是外周動(dòng)脈的鈣化，都是介入治療中非常棘手的病變。

Shockwave 概覽

近日，國(guó)家藥品監(jiān)督管理局對(duì)外發(fā)布醫(yī)療器械批準(zhǔn)證明文件（進(jìn)口）信息，健適醫(yī)療的Shockwave血管內(nèi)沖擊波“系列產(chǎn)品獲批上市，健適醫(yī)療的獲證產(chǎn)品包括設(shè)備主機(jī)、及用于治療冠狀動(dòng)脈和外周動(dòng)脈鈣化病變的多種型號(hào)導(dǎo)管。

去年3月，健適醫(yī)療與美國(guó)上市公司Shockwave Medical成立由健適控股的合資公司，引進(jìn)全球頂尖的醫(yī)療新科技 --"血管內(nèi)沖擊波"鈣化處理技術(shù)，由此加速?lài)?guó)產(chǎn)化的進(jìn)程。

筆者注意到，5月9日ShockWave Medical(股票代碼：SWAV)公布財(cái)報(bào)，公告顯示公司2022財(cái)年第一財(cái)季歸屬于母公司普通股股東凈利潤(rùn)為1452.10萬(wàn)美元，同比增長(zhǎng)161.53%；營(yíng)業(yè)收入為9363.10萬(wàn)美元，同比上漲193.51%。

ShockWave Medical, Inc.成立于2009年6月17日,是一家專(zhuān)注于開(kāi)發(fā)和商業(yè)化產(chǎn)品的醫(yī)療器械公司，旨在改變鈣化心血管疾病的治療方式。他們的目標(biāo)是通過(guò)其用于治療鈣化斑塊的聲壓力波的差異化和專(zhuān)有的局部遞送來(lái)建立醫(yī)療器械治療動(dòng)脈粥樣硬化性心血管疾病的新標(biāo)準(zhǔn)，它們稱(chēng)為血管內(nèi)碎石術(shù)（“IVL”）。

專(zhuān)利分析

筆者針對(duì)ShockWave所涉及的專(zhuān)利情況，進(jìn)行了檢索，其結(jié)果進(jìn)行如下展示：

技術(shù)解讀

Shockwave血管內(nèi)沖擊波技術(shù)的靈感來(lái)源于腎結(jié)石體外沖擊波治療，通過(guò)球囊導(dǎo)管把脈沖聲壓波輸送至鈣化部位，把鈣化的斑塊“震松”，使血管恢復(fù)彈性及血流，重塑病變血管的同時(shí)，避免了對(duì)血管內(nèi)膜的損傷。

產(chǎn)品由球囊、導(dǎo)管軸、導(dǎo)管座、充盈端口、導(dǎo)絲出口、連接器和脈沖發(fā)射器組成。

產(chǎn)品基于體外碎石沖擊波原理改進(jìn)而來(lái)，將聚焦式高強(qiáng)度 能量改為發(fā)散式低強(qiáng)度能量，通過(guò)血管內(nèi)導(dǎo)管方式導(dǎo)入外周血管對(duì)鈣化病變部位進(jìn)行松解，以緩解血管狹窄程度或便于后續(xù)治療。

產(chǎn)品導(dǎo)管上含有若干液電式能量波源（脈沖發(fā)射器），通過(guò)接受發(fā)生器傳遞的電能轉(zhuǎn)化為機(jī)械能向外輸出沖擊波能量。能量波源外部含有球囊，與球囊加壓裝置配合使用可用于擴(kuò)張狹窄部位血管，球囊內(nèi)部可注入生理鹽水/造影劑的混合液用于傳遞沖擊波能量。

Shockwave血管內(nèi)沖擊波技術(shù)相關(guān)產(chǎn)品的結(jié)構(gòu)組成和工作原理可參考如下視頻：

專(zhuān)利概覽

筆者對(duì)Shockwave的相關(guān)專(zhuān)利根據(jù)類(lèi)別分別進(jìn)行了整理和剖析，這里筆者從眾多專(zhuān)利中選擇了若干進(jìn)行了解析，相關(guān)相關(guān)結(jié)果如下：Shockwave的完整專(zhuān)利清單和分析筆者也已開(kāi)展完成，如感興趣可以與筆者取得聯(lián)系，共同交流學(xué)習(xí)：

公開(kāi)/公告號(hào)	US8888788B2	申請(qǐng)日	2013-03-14
發(fā)明名稱(chēng)	Low profile electrodes for an angioplasty shock wave catheter
解決的技術(shù)問(wèn)題	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.
技術(shù)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.
相關(guān)附圖

公開(kāi)/公告號(hào)	US10973538B2	申請(qǐng)日	2018-12-17
發(fā)明名稱(chēng)	Shockwave catheter system with energy control
解決的技術(shù)問(wèn)題	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.
技術(shù)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.
相關(guān)附圖

結(jié)  語(yǔ)

目前，對(duì)于IVL而言而言，國(guó)內(nèi)已有不少?gòu)S家正在進(jìn)行相關(guān)研發(fā)和臨床試驗(yàn)，不過(guò)目前技術(shù)依然以Shockwave等國(guó)外企業(yè)為主，不過(guò)隨著國(guó)內(nèi)重視程度不斷提高的情況下，中國(guó)公司蓄勢(shì)待發(fā)，在一片被普遍看好的市場(chǎng)中開(kāi)始暗流涌動(dòng)，雖然目前為止還沒(méi)有真正意義上的國(guó)產(chǎn)IVL成品上市，但是隨著各個(gè)“卡脖子”技術(shù)不斷攻克，國(guó)產(chǎn)IVL一定會(huì)在近幾年實(shí)現(xiàn)重大突破和問(wèn)世。

目前，國(guó)內(nèi)各大IVL領(lǐng)域醫(yī)療廠商還會(huì)將Shockwave等重要競(jìng)品作為標(biāo)桿和對(duì)照，但是隨著各大國(guó)內(nèi)廠商聯(lián)動(dòng)產(chǎn)學(xué)研醫(yī)生多方力量，不斷創(chuàng)新，必將推動(dòng)中國(guó)IVL業(yè)更智能化、精準(zhǔn)化、便攜化的發(fā)展，也會(huì)逐步擺脫國(guó)外競(jìng)品帶來(lái)的壓力和技術(shù)障礙，不過(guò)，國(guó)外巨頭公司和國(guó)內(nèi)新興企業(yè)在知識(shí)產(chǎn)權(quán)方面布局更加緊密，IVL賽道上的各個(gè)國(guó)內(nèi)廠商之間的競(jìng)爭(zhēng)也會(huì)逐漸激烈，屆時(shí)相關(guān)知識(shí)產(chǎn)權(quán)問(wèn)題也必將會(huì)成為各大IVL廠商的研究重點(diǎn)課題，后續(xù)相關(guān)產(chǎn)品的的研發(fā)和專(zhuān)利事務(wù)值得持續(xù)關(guān)注。