http://www.kadhoai.com.cn 2026-04-14 22:09:23 來源:醫藥經濟報
隨sui著zhe材cai料liao科ke學xue技ji術shu的de不bu斷duan發fa展zhan和he介jie入ru治zhi療liao器qi械xie的de日ri趨qu小xiao型xing化hua,微wei創chuang手shou術shu應ying運yun而er生sheng,如ru在zai病bing人ren的de腹fu股gu溝gou靜jing脈mai上shang開kai一yi個ge很hen小xiao的de切qie口kou,可ke將jiang一yi些xie可ke壓ya縮suo血xue管guan支zhi架jia甚shen至zhi微wei型xing心xin髒zang泵beng等deng心xin髒zang病bing介jie入ru治zhi療liao器qi械xie產chan品pin直zhi接jie送song入ru體ti內nei指zhi定ding部bu位wei。

心髒病無論是在發達國家抑或發展中國家均為常見病種。據美國衛生部公布的統計資料,目前該國成年人中大約有15%~20%的人存在心髒問題,其中包括最常見的冠心病、心室擴張、心力衰竭、早搏和其它心髒疾病。而上述心髒病很難用常規藥物治療。自上世紀80年代以來,美國和歐洲醫療器械廠商陸續開發出一些專門用於心髒病治療的“介入治療器械”,其中最常見的幾類介入治療器械產品包括心髒起搏器、心房除顫儀和血管支架等三大類產品。上述產品在國際市場上的年銷售額合計已逾30億美元。隨sui著zhe材cai料liao科ke學xue技ji術shu的de不bu斷duan發fa展zhan和he介jie入ru治zhi療liao器qi械xie的de日ri趨qu小xiao型xing化hua,微wei創chuang手shou術shu應ying運yun而er生sheng,如ru在zai病bing人ren的de腹fu股gu溝gou靜jing脈mai上shang開kai一yi個ge很hen小xiao的de切qie口kou,可ke將jiang一yi些xie可ke壓ya縮suo血xue管guan支zhi架jia甚shen至zhi微wei型xing心xin髒zang泵beng等deng心xin髒zang病bing介jie入ru治zhi療liao器qi械xie產chan品pin直zhi接jie送song入ru體ti內nei指zhi定ding部bu位wei。醫生們再也不必做手術風險巨大、難度極高的“心髒直視手術”來lai安an裝zhuang那na些xie體ti積ji較jiao大da的de舊jiu式shi心xin髒zang病bing介jie入ru治zhi療liao器qi械xie。現xian將jiang近jin幾ji年nian來lai美mei國guo和he歐ou洲zhou廠chang商shang新xin開kai發fa的de心xin髒zang病bing介jie入ru治zhi療liao器qi械xie產chan品pin作zuo扼e要yao介jie紹shao,供gong讀du者zhe參can考kao。
自動化體外除顫儀
fangchanshiyizhongjiqiweixiandejixingfazuoxinzangbing。bingrenyidanzaishiwaifashengfangchanyoudebudaojishizhiliaokezaiduanshijianneicusi。guxinfangchuchanyiduifangchanhuanzhelaishuoshiyizhongjiumingyiliaoqixiechanpin。meiguoyigongsiquniantuichuyizhongkesuishenxiedaidezidonghuaxiuzhentiwaichuchanyi(AED),其(qi)體(ti)積(ji)僅(jin)有(you)普(pu)通(tong)香(xiang)煙(yan)盒(he)大(da)小(xiao),可(ke)放(fang)進(jin)上(shang)衣(yi)口(kou)袋(dai)裏(li)。病(bing)人(ren)一(yi)旦(dan)突(tu)發(fa)房(fang)顫(chan),該(gai)儀(yi)器(qi)能(neng)自(zi)動(dong)偵(zhen)知(zhi)到(dao)心(xin)率(lv)異(yi)常(chang)並(bing)立(li)即(ji)發(fa)出(chu)電(dian)脈(mai)衝(chong)信(xin)號(hao),使(shi)病(bing)人(ren)心(xin)髒(zang)重(zhong)新(xin)恢(hui)複(fu)正(zheng)常(chang)跳(tiao)動(dong)。自(zi)動(dong)袖(xiu)珍(zhen)式(shi)體(ti)外(wai)除(chu)顫(chan)儀(yi)的(de)發(fa)明(ming)使(shi)無(wu)數(shu)房(fang)顫(chan)病(bing)人(ren)可(ke)順(shun)利(li)外(wai)出(chu)旅(lv)遊(you)或(huo)參(can)加(jia)各(ge)種(zhong)社(she)交(jiao)活(huo)動(dong)。
心髒瓣膜
bingrenchangqixuezhiguogaoqiebujiakongzhijiuhuidaozhixinzangerjianbanshousun,guanbibuyan,congerzaochengxinzangbengchuxueyebufenhuiliudaoxinshili,jiuerjiuzhiqixinshijiuhuimanmankuoda(心室擴張)zuizhongyinqixinlishuaijie。zhezhongxianxiangzaigaoxuezhibingrenzhongshifenchangjian。suoyiguojiyixuejierenwei,erjianbansunshangyanzhongdebingrenbixujishigenghuanxindexinzangbanmo,fouzehuiyinfayiwaicusishijian。rengongxinzangbanmodekaifayanjiugongzuozaixifangfadaguojiakaizhanjiaozao。guoquxifanglinchuangyishengdaduocaiyongdongwudexinzangbanmoweierjianbanshousunzhejinxingyizhi,houyinjitipaichifanyingwentiwufajiejueergaiyongchehuoersiwangbingrenjuanzengdexinzangbanmojinxingyizhi,xiaoguojiaohao。jinnianlaimeiguodengfadaguojiachangshangyikaifachuduozhongliyongduoxinggaofenzicailiaozhizuoderengongbanmo,tamenkegongzhirurentihouyongjiushiyong,yebuhuiyinqijitipaichifanying。baokuomeiguoheoumengguojiadengduogeguojiajunyipizhungairengongbanmoshangshi。
血管成型介入器械
因(yin)嚴(yan)重(zhong)動(dong)脈(mai)粥(zhou)樣(yang)硬(ying)化(hua)而(er)引(yin)起(qi)心(xin)血(xue)管(guan)狹(xia)窄(zhai)和(he)心(xin)肌(ji)梗(geng)死(si)是(shi)目(mu)前(qian)世(shi)界(jie)各(ge)國(guo)最(zui)為(wei)常(chang)見(jian)的(de)一(yi)種(zhong)心(xin)髒(zang)病(bing)。而(er)普(pu)通(tong)藥(yao)物(wu)難(nan)以(yi)達(da)到(dao)消(xiao)除(chu)動(dong)脈(mai)內(nei)壁(bi)積(ji)累(lei)的(de)大(da)量(liang)脂(zhi)類(lei)斑(ban)塊(kuai)和(he)恢(hui)複(fu)血(xue)管(guan)暢(chang)通(tong)的(de)效(xiao)果(guo)。近(jin)幾(ji)年(nian)來(lai)美(mei)國(guo)和(he)歐(ou)洲(zhou)廠(chang)商(shang)陸(lu)續(xu)開(kai)發(fa)上(shang)市(shi)一(yi)種(zhong)名(ming)為(wei)心(xin)血(xue)管(guan)成(cheng)型(xing)器(qi)械(xie)的(de)創(chuang)新(xin)型(xing)醫(yi)療(liao)器(qi)械(xie)產(chan)品(pin)。這(zhe)類(lei)產(chan)品(pin)的(de)特(te)點(dian)是(shi):外觀為細長型柔性管子,多用特殊金屬材料製成,經壓縮後體積纖小,可經由微小身體切口在CT監jian視shi下xia送song入ru冠guan狀zhuang動dong脈mai阻zu塞sai處chu,最zui終zhong自zi動dong舒shu展zhan開kai來lai,並bing將jiang已yi狹xia窄zhai的de動dong脈mai血xue管guan重zhong新xin撐cheng開kai,從cong而er達da到dao使shi血xue流liu保bao持chi通tong暢chang和he恢hui複fu心xin肌ji供gong血xue的de效xiao果guo。血xue管guan成cheng型xing器qi械xie的de問wen世shi被bei國guo際ji醫yi學xue界jie視shi為wei21世紀介入治療器械產品的一大新進展。
心髒主持器械新產品
所suo謂wei心xin髒zang主zhu持chi器qi械xie,其qi實shi就jiu是shi輔fu助zhu心xin髒zang工gong作zuo的de一yi種zhong新xin型xing介jie入ru治zhi療liao器qi械xie產chan品pin。對dui某mou些xie嚴yan重zhong心xin衰shuai病bing人ren,其qi心xin髒zang已yi無wu法fa泵beng出chu足zu量liang的de血xue液ye供gong應ying全quan身shen各ge髒zang器qi和he組zu織zhi,對dui他ta們men來lai說shuo,唯wei一yi的de辦ban法fa就jiu是shi植zhi入ru一yi顆ke新xin的de健jian康kang心xin髒zang,但dan要yao找zhao到dao合he適shi的de供gong體ti心xin髒zang談tan何he容rong易yi。長chang期qi以yi來lai,這zhe些xie因yin嚴yan重zhong心xin衰shuai而er隻zhi能neng躺tang在zai病bing床chuang上shang的de病bing人ren無wu疑yi在zai聽ting天tian由you命ming。近jin年nian來lai,美mei國guo和he歐ou洲zhou醫yi療liao器qi械xie廠chang商shang陸lu續xu開kai發fa上shang市shi一yi些xie新xin穎ying的de心xin髒zang主zhu持chi器qi械xie產chan品pin,對dui它ta們men的de開kai發fa上shang市shi,為wei嚴yan重zhong心xin髒zang病bing人ren帶dai來lai了le生sheng的de希xi望wang。因yin為wei利li用yong這zhe些xie被bei業ye內nei人ren士shi稱cheng為wei心xin室shi主zhu持chi器qi械xie(VADs)的新產品,可幫助心髒泵出正常容積的血液,供應全身器官。實際上,VADs的作用相當於一台袖珍機械血液泵。最早研製VADs的目的是為了讓心髒病人在漫長的等待移植期間,能順利活下去,因為手術醫生不知道要等待多長時間才能找到合適的供體心髒。
jinnianlai,suizhecailiaokexuejishutufeimengjinshidefazhan,meiguoyiliaoqixiechangshangzhongyukaifachuzhenzhengyiyishangdekezhirurengongxinzangbengchanpin,congerkeshiyanzhongxinzangbingrenwuxudengdaigongtixinzangerzhijiezhirurengongxinzangbengzhileidejieruzhiliaoqixie,erqiebingrendeshenghuozhiliangjiaohao。rujuguowaimeitizuixinbaodao,meiguopicibaodaxueyixuezhongxinbujiuqiankaifachuyizhongxinxingxinzangbeng(商品名Impella 2.5 system),其qi體ti積ji僅jin比bi市shi售shou吸xi飲yin料liao用yong塑su料liao吸xi管guan稍shao粗cu一yi點dian,利li用yong微wei創chuang手shou術shu在zai腹fu股gu溝gou血xue管guan開kai一yi小xiao口kou,插cha入ru這zhe種zhong袖xiu珍zhen心xin髒zang泵beng,將jiang其qi推tui至zhi腹fu部bu,可ke幫bang助zhu病bing人ren加jia大da心xin髒zang泵beng出chu血xue液ye的de數shu量liang,滿man足zu全quan身shen需xu要yao。2009年,美國FDA已批準第一隻緊湊型VADs上市,美國醫學界對此產品評價較高。
藥物洗脫支架
血(xue)管(guan)支(zhi)架(jia)現(xian)已(yi)成(cheng)為(wei)世(shi)界(jie)各(ge)國(guo)嚴(yan)重(zhong)冠(guan)心(xin)病(bing)患(huan)者(zhe)使(shi)用(yong)頻(pin)率(lv)最(zui)高(gao)的(de)一(yi)種(zhong)介(jie)入(ru)治(zhi)療(liao)器(qi)械(xie)產(chan)品(pin)。如(ru)據(ju)報(bao)道(dao),很(hen)多(duo)冠(guan)心(xin)病(bing)人(ren)血(xue)管(guan)內(nei)甚(shen)至(zhi)陸(lu)續(xu)安(an)裝(zhuang)了(le)幾(ji)根(gen)血(xue)管(guan)支(zhi)架(jia),但(dan)第(di)一(yi)代(dai)血(xue)管(guan)支(zhi)架(jia)存(cun)在(zai)的(de)主(zhu)要(yao)問(wen)題(ti)是(shi)很(hen)多(duo)病(bing)人(ren)在(zai)植(zhi)入(ru)血(xue)管(guan)支(zhi)架(jia)後(hou),6個月內會出現血管再狹窄現象(即血管支架內腔被脂類物質大量堵塞而造成血流不暢)。醫生隻能通過2次手術取出舊支架,再安裝一個新支架。自九十年代末以來,國外廠商陸續開發出若幹種新型藥物洗脫型支架(這類新型支架能源源不斷地釋放出藥物)。這些可防止血脂類物質附著在支架內壁上的藥物包括他克莫司和紫杉醇等。現在,歐美市場上不添加藥物的“光支架”產品已少見,絕大多數上市支架產品均為藥物洗脫型支架。就血管支架而言,早期的純金屬絲支架已讓位給柔軟性好、壓ya縮suo性xing較jiao大da的de格ge柵zha狀zhuang支zhi架jia和he可ke吸xi收shou支zhi架jia等deng新xin產chan品pin。這zhe類lei新xin穎ying血xue管guan支zhi架jia在zai國guo際ji市shi場chang上shang銷xiao量liang較jiao大da,它ta們men的de最zui大da優you點dian是shi不bu容rong易yi造zao成cheng血xue管guan再zai狹xia窄zhai。
國外市場上其它新上市的心髒病介入治療器械新產品包括:各種植入式心房除顫儀、心血管消融導管、可調節心室血流量和心率不齊的新型起搏器(心率再同步起搏器)等等。這類心髒病介入治療器械在國際醫療器械市場上無疑有著廣闊的發展空間。