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心臟瓣膜技術(shù)解析

嘉峪檢測網(wǎng) 2022-05-26 14:01

前言導讀

結(jié)構(gòu)性心臟病是近年心血管疾病領(lǐng)域提出的一個新概念，2005年由德國法蘭克福的Horst Sievert醫(yī)生首先提出，泛指一大類先天性或獲得性的以心臟和大血管結(jié)構(gòu)異常為主要表現(xiàn)的心血管疾病，如傳統(tǒng)定義的先天性心臟病、心臟瓣膜疾病和心肌病等。

廣義的結(jié)構(gòu)性心臟病是指除原發(fā)心電疾患（因某些電生理異常而發(fā)生的VT/VF）和循環(huán)疾?。ú糠指哐獕骸⒎€(wěn)定性心絞痛、ACS）以外，任何心臟結(jié)構(gòu)的異常，任何與心臟和大血管結(jié)構(gòu)有關(guān)的疾病。而狹義的結(jié)構(gòu)性心臟病是指解剖異常引起的心臟結(jié)構(gòu)改變所造成的心臟的病理生理變化。包括：（1）先天性心臟?。菏议g隔缺損（VSD）、房間隔缺損（ASD）、動脈導管未閉（PDA）等；（2）瓣膜病：二尖瓣、三尖瓣、主動脈瓣、肺動脈瓣等；（3）心肌?。悍屎裥孕募〔?、擴張型心肌病、致心律失常型右室心肌病等；（4）心肌梗塞后室間隔穿孔、室壁瘤、疤痕心肌等。

在過去十年中，結(jié)構(gòu)性心臟病的診斷及治療取得了飛速發(fā)展，成為了當今心血管疾病領(lǐng)域的一大亮點，其未來發(fā)展引人矚目。

根據(jù)弗若斯特沙利文的資料顯示，被廣泛視為針對瓣膜性心臟病高度有效療法的介入式瓣膜手術(shù)在中國仍然供不應(yīng)求，用于該等手術(shù)的經(jīng)導管心臟瓣膜器械亦然。此問題影響了大量未能得到妥善治療的病患，也為合格并致力于改變現(xiàn)狀的醫(yī)療器械從業(yè)者帶來了可觀的商業(yè)機遇。

心臟瓣膜介入器械市場概覽

瓣膜性心臟病的特點為四個心臟瓣膜（即主動脈瓣、二尖瓣、三尖瓣及肺動脈瓣）中一個或多個瓣膜出現(xiàn)損傷或缺陷。在這幾個瓣膜中，主動脈瓣控制心臟和主動脈之間的血液流動，從而控制通往身體其他部位的血管；二尖瓣和三尖瓣控制心房和心室之間的血液流動；而肺動脈瓣控制從心臟到肺的血液流動。正常運作的瓣膜可確保適當?shù)难毫鲃?，但瓣膜性心臟病會導致瓣膜變得太窄及硬化（狹窄）而無法完全開啟，或無法完全閉合（反流）。下圖顯示了不同類型的瓣膜性心臟病。

心臟瓣膜技術(shù)解析

在治療方案選擇方面，對于輕度和中度患者，一般疾病早期通過藥物治療延緩疾病的進展。對于重度患者則需要通過手術(shù)干預(yù)，因為瓣膜性心臟病是一個機械性病癥，相當于心臟這個“泵”的“閥門”壞了，僅通過藥物治療效果有限。

主動脈瓣

主動脈瓣疾病是相對嚴重的瓣膜病之一，如果患者出現(xiàn)癥狀后不及時干預(yù)，中期生存期較短。經(jīng)導管主動脈瓣膜置換術(shù)（Transcatheter aortic valve replacement ，TAVR）是針對主動脈瓣疾?。ㄓ绕涫侵鲃用}瓣狹窄）的主要治療方法。TAVR手術(shù)作為一種介入治療技術(shù)，不需要開胸，主要是經(jīng)過股動脈穿刺，然后通過導管將特制的人工瓣膜送到原有心臟瓣膜的位置，通過球囊擴張釋放后，即刻發(fā)揮作用。使用TAVR介入手術(shù)植入瓣膜的最大優(yōu)勢是患者身體接受度高，不需要開胸，從而降低了對病人的整體傷害。其次，介入手術(shù)可以在不影響心臟跳動的情況下操作，將人工瓣膜從病人的股動脈血管植入到病變的位置。

對于手術(shù)數(shù)量和滲透率，根據(jù)著名分析機構(gòu)的相關(guān)分析，我國TAVR手術(shù)的數(shù)量從2017年的200臺增加至2020年的3,600臺，復(fù)合年增長率為173.9%，且預(yù)計將從2020年的3,600臺增加至2025年的42,000臺及2030年的109,400臺，2020年至2025年的復(fù)合年增長率為63.3%且2025年至2030年的復(fù)合年增長率為21.1%。我國TAVR手術(shù)的滲透率由2017年的0.0%增長至2020年的0.5%，并預(yù)計將進一步增長至2025年的4.5%及2030年的10.2%。下表顯示我國TAVR手術(shù)的數(shù)量及滲透率。

心臟瓣膜技術(shù)解析

對于產(chǎn)品市場，根據(jù)著名分析機構(gòu)的相關(guān)分析，我國TAVR市場于2020年達到人民幣555.8百萬元，2017年至2020年的復(fù)合年增長率為138.0%，TAVR市場預(yù)計將于2025年增至人民幣5,055.7百萬元，于2030年增至人民幣11,490.5百萬元，2020年至2025年的復(fù)合年增長率為55.5%，而2025年至2030年的復(fù)合年增長率為17.8%。下表顯示我國的過往及預(yù)測TAVR產(chǎn)品市場：

心臟瓣膜技術(shù)解析

TAVR 具備巨大的臨床價值創(chuàng)造、商業(yè)價值實現(xiàn)以及高技術(shù)壁壘和長期不可替代性，同時，仍在不斷優(yōu)化迭代技術(shù)水平，不斷優(yōu)化其對于主動脈瓣狹窄和反流的治療效果?？梢哉f，TAVR 是名副其實的長坡厚雪賽道。

二尖瓣

筆者通過查閱，在全球范圍內(nèi)，已有多種已上市的經(jīng)導管二尖瓣設(shè)備獲得FDA/CE批準，其中目前只有雅培的MitraClip在中國獲得了緣對緣TMVr的批準。

二尖瓣位于左心房和左心室之間的交接處。二尖瓣開放可使來自左心房的血液充盈左心室，左心室收縮時二尖瓣關(guān)閉，以使泵出的血液只能流入主動脈，而不會回流至左心房。當二尖瓣未完全閉合時，部份血液會漏回左心房，稱為MR。二尖瓣反流是最為常見的結(jié)構(gòu)性心臟病，如果不進行醫(yī)治，可能導致嚴重的并發(fā)癥。

中國的中度至重度二尖瓣反流患病數(shù)由2016年的9.8百萬人增至2020年的10.8百萬人，2016年至2020年的復(fù)合年增長率為2.5%。此數(shù)字預(yù)計將于2025年達到12.1百萬人，并于2030年達到13.2百萬人，2020年至2025年的復(fù)合年增長率為2.3%，2025年至2030年的復(fù)合年增長率為1.8%。下表顯示中國的過往及預(yù)測中度至重度二尖瓣反流患病數(shù)：

心臟瓣膜技術(shù)解析

針對二尖瓣反流的手術(shù)治療包括傳統(tǒng)開胸（開胸手術(shù)）及介入治療，而介入治療進一步劃分為二尖瓣修復(fù)術(shù)及二尖瓣置換術(shù)。

經(jīng)導管二尖瓣(TMV)治療是一種基于導管的技術(shù)，通過不涉及開胸手術(shù)的介入手術(shù)修復(fù)或置換二尖瓣。經(jīng)導管二尖瓣治療采用與手術(shù)治療相同的原理，適用于無法耐受傳統(tǒng)手術(shù)的中重度二尖瓣反流患者，經(jīng)導管二尖瓣（TMV）治療的主要入路途徑包括經(jīng)心尖及經(jīng)股入路，兩者皆適用于經(jīng)導管二尖瓣置換術(shù)（TMVR）及經(jīng)導管二尖瓣修復(fù)術(shù)（TMVr）。

經(jīng)導管二尖瓣治療技術(shù)匯總?cè)缦聢D所示：

心臟瓣膜技術(shù)解析

我國TMV介入治療市場預(yù)計將從2021年的人民幣52.5百萬元增加至2025年的人民幣1,861.2百萬元，2021年至2025年的復(fù)合年增長率為144.0%，而2030年的TMV介入治療市場預(yù)計將達到人民幣7,578.8百萬元，2025年至2030年的復(fù)合年增長率為32.4%。下表顯示我國的過往及預(yù)測TMV介入治療市場規(guī)模：

心臟瓣膜技術(shù)解析

專利分析

在眾多的TAVR產(chǎn)品中，作為心臟瓣膜領(lǐng)域的鼻祖和絕對巨頭-愛德華的SAPIEN 3備受矚目，國外醫(yī)療巨頭產(chǎn)品在中國的上市，也將國內(nèi)TAVR帶入“戰(zhàn)國時代"；對于二尖瓣而言，筆者通過查閱，在全球范圍內(nèi)，已有多種已上市的經(jīng)導管二尖瓣設(shè)備獲得FDA/CE批準，其中只有雅培的MitraClip在中國獲得了緣對緣TMVr的批準。因此，本文對愛德華的Sapien 3和雅培的MitraClip進行聚焦，以饗讀者。如若獲取完整心臟瓣膜醫(yī)療器械專利清單與專利分析可以與筆者取得聯(lián)系，共同交流學習。

愛德華-Sapien 3

從全球TAVR市場范圍來看上，比較公認的市場格局為：愛德華占比約60%，美敦力占比約30%，雅培、波士頓科學等占剩余10%份額。目前，愛德華陸續(xù)已上市的TAVR產(chǎn)品共有兩種——SAPIEN 3、以及SAPIEN 3 Ultra，為標桿級別的器械。2020年6月，愛德華SAPIEN 3在中國獲得NMPA批準，成為首款獲得中國監(jiān)管機構(gòu)批準的國外瓣膜產(chǎn)品。

技術(shù)脈絡(luò)

對于SAPIEN 3技術(shù)脈絡(luò)，筆者通過如下圖片向各位讀者進行展示：

心臟瓣膜技術(shù)解析

SAPIEN 3技術(shù)脈絡(luò)示意圖

技術(shù)理解

對于SAPIEN 3技術(shù)要點，其主要包括四個主要方面部分，筆者通過如下圖片向各位讀者進行展示：

心臟瓣膜技術(shù)解析

SAPIEN 3技術(shù)要點示意圖

另外，對于SAPIEN 3技術(shù)拆解，其裝配關(guān)系如下四幅圖所示：

心臟瓣膜技術(shù)解析

SAPIEN 3技術(shù)裝配示意圖

重點專利

根據(jù)SAPIEN 3相關(guān)重點專利，愛德華對其進行了細致性的專利布局，筆者從涉及的相關(guān)專利中分別擇機選擇了3組專利進行了解析，相關(guān)結(jié)果如下：需要特別說明的是，如若獲取完整專利清單與專利分析情況可以與筆者取得聯(lián)系，共同交流學習：

公開/公告號	US5411552B	申請日	1994-06-14
發(fā)明名稱	Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
解決的技術(shù)問題	The valve prosthesis according to the invention does not require an actual operation but merely a small intervention to optionally expose the body channel, e.g., a vein, through which the insertion takes place. Thus, patients for whom an operation would be associated with high risk can be offered implantation of, for instance, cardiac valves. After the implantation has taken place, the after-treatment will advantageously be shorter than normally, which means fewer hospital days for the patient. Moreover, it is assumed that it will be possible to implantate the valve prosthesis under local anaesthetic.
技術(shù)方案	A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) are secured to the projecting apices (4). The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion. The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.
相關(guān)附圖

公開/公告號	US8591575B2	申請日	2007-03-28
發(fā)明名稱	Method of dilating a stenotic aortic valve and implanting a prosthetic valve
解決的技術(shù)問題	However, this technique has been abandoned by most physicians because of the very high restenosis rate which occurs in about 80% of the patients within 10 to 12 months. Indeed, immediately after deflation of the balloon, a strong recoil phenomenon often produces a loss of half or even two thirds of the opening area obtained by the inflated balloon. For instance, inflation of a 20 mm diameter balloon in a stenosed aortic orifice of 0.5 cm2 area gives, when forcefully and fully inflated, an opening area equal to the cross sectional area of the maximally inflated balloon, i.e., about 3 cm2. However, measurements performed a few minutes after deflation and removal of the balloon have only an area around 1 cm2 to 1.2 cm2. This is due to the considerable recoil of the fibrous tissue of the diseased valve. The drawback in this procedure has also been clearly shown on fresh post mortem specimens.
技術(shù)方案	A method for treating a stenotic native aortic valve in a human heart is provided. The method comprises dilating the stenotic native aortic valve using a dilatation catheter and then deploying a prosthetic heart valve within the dilated stenotic native aortic valve. The prosthetic heart valve comprises a collapsible and expandable metallic stent and a valvular structure formed of a synthetic biocompatible material. The valvular structure is positioned substantially between the inlet and outlet ends of the stent for preventing the flow of blood in one direction. The prosthetic heart valve may further comprise an internal sleeve for creating a seal along at least a portion of the stent wall.
相關(guān)附圖

公開/公告號	US8382826B2	申請日	2010-08-12
發(fā)明名稱	Method of delivering a prosthetic heart valve
解決的技術(shù)問題	Although a variety of bendable and steerable devices have been proposed over the years, each of the existing devices has shortcomings that limit its effectiveness. Accordingly, an urgent need exists for an improved steerable delivery system to facilitate advancement of an implant and/or therapy device through a patient's vasculature to a treatment site. It is desirable that such a system overcomes the shortcomings associated with existing devices. It is also desirable that such a system be versatile, reliable and easy to use. The present invention addresses this need.
技術(shù)方案	A method of delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes the delivery sleeve assembly to bend for facilitating navigation through a patient's vasculature. A stretchable cover is preferably placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the vicinity of the native valve site, the prosthetic valve may be accurately positioned by advancing the balloon catheter relative to the delivery sleeve assembly and then deployed within the native valve site by inflating the balloon. In an alternative embodiment, the delivery sleeve assembly may be used to advance a self-expanding prosthetic heart valve through a patient's vasculature and a pusher member may be used to eject the prosthetic valve at the native valve site.
相關(guān)附圖

專利糾紛

需要特別說明的是，作為心臟瓣膜領(lǐng)域的巨頭公司，愛德華在知識產(chǎn)權(quán)方面高度重視，引領(lǐng)了醫(yī)療器械領(lǐng)域最著名的專利糾紛案件：在TAVR領(lǐng)域，美敦力、愛德華生命科學、波士頓科學就產(chǎn)品和市場展開了激烈的專利三國戰(zhàn)。愛德華生命科學向美敦力發(fā)起專利侵權(quán)訴訟，指控美敦力的CoreValve心臟瓣膜產(chǎn)品侵犯其Sapien心臟瓣膜產(chǎn)品的專利技術(shù)，經(jīng)多年訴訟，雙方最終和解，美敦力向愛德華生命科學支付超7.5億美元。波士頓科學和愛德華生命科學之間的專利糾紛也纏斗數(shù)年，圍繞愛德華生命科學的Sapien 3 及Sapien 3 Ultra心臟瓣膜升級產(chǎn)品，雙方相互指控專利侵權(quán)，最終達成和解，愛德華生命科學向波士頓科學支付1.8億美元。

不僅如此，愛德華還就心臟瓣膜相關(guān)專利對勝猶達（雅培）、戈爾、庫克、CarboMedics、Neovasc等公司展開過專利戰(zhàn)，由此可見愛德華對知識產(chǎn)權(quán)保護的決心和戰(zhàn)斗力。筆者對上述案件均進行過細致的研究汲取，感興趣的讀者可以和筆者取得聯(lián)系，一起溝通學習。

雅培-MitraClip

MitraClip 的故事始于 1990 年代后期的加利福尼亞，醫(yī)療器械公司 Evalve Inc.（MitraClip 原研公司，2009年被雅培收購）的團隊希望實現(xiàn)一些新目標——使用基于導管的方法修復(fù)跳動心臟中的二尖瓣。

技術(shù)理解

MitraClip實物如下所示：

心臟瓣膜技術(shù)解析

MitraClip工作示意如下所示：

心臟瓣膜技術(shù)解析

雅培全球領(lǐng)先的MitraClip是一種微創(chuàng)性的經(jīng)導管二尖瓣返流修補術(shù)，為手術(shù)高風險的中重度二尖瓣返流患者提供了一種可替代選擇的治療手段，讓他們能夠進行不開胸、無需體外循環(huán)支持、創(chuàng)傷小、手術(shù)時間短、安全性高的微創(chuàng)手術(shù)。

技術(shù)脈絡(luò)

MitraClip系統(tǒng)相關(guān)產(chǎn)品主要組成部分如下圖所示：

心臟瓣膜技術(shù)解析

對于MitraClip相關(guān)技術(shù)，其發(fā)展歷程重要節(jié)點如下圖所示：

心臟瓣膜技術(shù)解析

對于MitraClip相關(guān)技術(shù)，其經(jīng)歷了多次技術(shù)迭代，目前來看，其產(chǎn)品技術(shù)已經(jīng)更新至第四代，其技術(shù)迭代如下圖所示：

心臟瓣膜技術(shù)解析

重要專利

對于MitraClip相關(guān)專利，筆者對MitraClip進行了系統(tǒng)性梳理和全面性研究，感興趣的讀者可以與筆者取得聯(lián)系，對梳理和研究內(nèi)容一起交流學習，這里筆者將MitraClip部分相關(guān)重要專利進行羅列：

公開/公告號	US6629534B1	申請日	2000-04-07
發(fā)明名稱	Methods and apparatus for cardiac valve repair
解決的技術(shù)問題	it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves, particularly the tricuspid valve which is the other atrioventricular valve. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart. Still more preferably, the methods, devices, and systems should not require that the heart be bypassed, although the methods, devices, and systems should be useful with patients who are bypassed and/or whose heart may be temporarily stopped by drugs or other techniques.
技術(shù)方案	The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.
相關(guān)附圖

公開/公告號	US7563267B2	申請日	2003-05-19
發(fā)明名稱	Fixation device and methods for engaging tissue
解決的技術(shù)問題	it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed either endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart or by a minimally invasive approach. Further, such devices and systems should provide features which allow repositioning and optional removal of a fixation device prior to fixation to ensure optimal placement. Still more preferably, the methods, devices, and systems would be useful for repair of tissues in the body other than heart valves.
技術(shù)方案	The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.
相關(guān)附圖

公開/公告號	US7666204B2	申請日	2003-05-19
發(fā)明名稱	Multi-catheter steerable guiding system and methods of use
解決的技術(shù)問題	it would be desirable to provide an access or guiding system having an adjustable distal end which is capable of being positioned within a target body cavity in a desired orientation. The system should have a large lumen diameter to accommodate the passage of a variety of devices, should have good wall strength to avoid kinking or collapse when bent around tight curves, and should have good column, tensile, and torsional strength to avoid deformation when the devices are passed through the lumen and torqued or translated. The steering mechanisms should provide for a high degree of controlled deflection at the distal end of the system but should not take up significant lumen area to allow for passage of interventional devices. Further, the system should be positionable in a manner which allows compound curves to be formed, for example curvature within more than one plane.
技術(shù)方案	Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.
相關(guān)附圖

公開/公告號	US7608091B2	申請日	2003-07-03
發(fā)明名稱	Methods and apparatus for cardiac valve repair
解決的技術(shù)問題	it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves, particularly the tricuspid valve which is the other atrioventricular valve. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart. Still more preferably, the methods, devices, and systems should not require that the heart be bypassed, although the methods, devices, and systems should be useful with patients who are bypassed and/or whose heart may be temporarily stopped by drugs or other techniques.
技術(shù)方案	The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.
相關(guān)附圖

公開/公告號	US10828042B2	申請日	2003-05-19
發(fā)明名稱	Fixation devices, systems and methods for engaging tissue
解決的技術(shù)問題	it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed either endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart or by a minimally invasive approach. Further, such devices and systems should provide features which allow repositioning and optional removal of a fixation device prior to fixation to ensure optimal placement. Still more preferably, the methods, devices, and systems would be useful for repair of tissues in the body other than heart valves.
技術(shù)方案	System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween. The first gripping element and the second gripping element each includes a plurality of barbs extending therefrom, the plurality of barbs of each of the first gripping element and the second gripping element being aligned transversely in at least one row. The fixation device further includes a covering disposed on each of the first gripping element and the second gripping element, wherein the plurality of barbs of the first gripping element and the second gripping element, respectively, protrude through the covering.
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公開/公告號	CN102395331B	申請日	2009-12-15
發(fā)明名稱	用于可植入的固定設(shè)備的分離機構(gòu)
解決的技術(shù)問題	希望的是提供用于執(zhí)行二尖瓣和其他心臟瓣膜修復(fù)的替代和額外的方法、設(shè)備和系統(tǒng)。優(yōu)選地，這種方法、設(shè)備和系統(tǒng)宜不要求開放的胸部路徑，并能夠血管內(nèi)執(zhí)行或者通過微創(chuàng)方法執(zhí)行，血管內(nèi)執(zhí)行即使用從患者遠離心臟的脈管推進到心臟的設(shè)備來執(zhí)行。此外，這些設(shè)備和系統(tǒng)應(yīng)該提供允許在固定之前重新定位和隨意移除固定設(shè)備的特征，以確保最佳布置。這種設(shè)備還應(yīng)該容易輸送和部署。更優(yōu)選地，該方法、設(shè)備和系統(tǒng)將用于修復(fù)心臟瓣膜以外的身體組織。
技術(shù)方案	本發(fā)明提供用于組織接近和在治療部位進行修復(fù)的設(shè)備、系統(tǒng)和方法。本發(fā)明的設(shè)備、系統(tǒng)和方法能夠應(yīng)用在各種治療手術(shù)中，包括血管內(nèi)、微創(chuàng)和開放式外科手術(shù)，并且能夠用在各種解剖區(qū)域，包括腹部、胸腔、心血管系統(tǒng)、心臟、腸道、胃、尿道、膀胱、肺和其他器官、血管和組織。本發(fā)明在那些需要到達遠處組織位置的微創(chuàng)或者血管內(nèi)通路的手術(shù)特別有用，其中使用的器械必須通過長的、狹窄且彎曲的路徑到達治療部位。另外，本發(fā)明的很多設(shè)備和系統(tǒng)適于被倒轉(zhuǎn)并從患者的任何位置處移除，而不與內(nèi)部組織干涉或損傷內(nèi)部組織。
相關(guān)附圖

專利糾紛

愛德華（Edwards ）的二尖瓣器械PASCAL直接競標雅培（Abbott）的MitraClip，雙方在歐洲展開了一場專利大戰(zhàn)。雅培在多個歐洲市場提起的訴訟中指控 Edwards 的經(jīng)導管瓣膜修復(fù)系統(tǒng) Pascal 侵犯了其 MitraClip 的多項專利。

毫無疑問的，這是TMVr領(lǐng)域最受關(guān)注的專利侵權(quán)訴訟，目前該案已于2020年7月完結(jié)，所涉及金額高達數(shù)億美元。

目前，國內(nèi)不少在研TMVr產(chǎn)品也是競標MitraClip，隨著國產(chǎn)TMVr產(chǎn)品的上市，相關(guān)專利問題必須得到高度重視，通過愛德華和雅培之間的專利戰(zhàn)，國產(chǎn)TMVr產(chǎn)品必然可以得到較大的專利啟發(fā)，感興趣的讀者朋友可以與筆者取得聯(lián)系，一同學習交流。

結(jié) 語

誠如領(lǐng)域內(nèi)人士共同認識的那樣，結(jié)構(gòu)性心臟病醫(yī)療器械逐漸贏得市場追捧，據(jù)不完全統(tǒng)計，目前我國重點結(jié)構(gòu)性心臟病器械正在進行臨床試驗，全球以及國內(nèi)各大結(jié)構(gòu)性心臟病領(lǐng)域醫(yī)療廠商也必會將雅培、愛德華等大廠作為重要的標桿和對照，聯(lián)動產(chǎn)學研醫(yī)生多方力量，不斷創(chuàng)新，推動中國結(jié)構(gòu)性心臟病行業(yè)更智能化、精準化、微創(chuàng)化的發(fā)展，相關(guān)知識產(chǎn)權(quán)問題也必將會成為各大結(jié)構(gòu)性心臟病廠商的研究重點課題，后續(xù)相關(guān)產(chǎn)品的的研發(fā)和專利事務(wù)值得持續(xù)關(guān)注。

來源：醫(yī)械知識產(chǎn)權(quán)

心臟瓣膜技術(shù)解析

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