http://kadhoai.com.cn 2026-04-27 08:48:23 來源:醫藥經濟報
suizhecailiaokexuejishudebuduanfazhanhejieruzhiliaoqixiederiquxiaoxinghua,weichuangshoushuyingyunersheng,ruzaibingrendefugugoujingmaishangkaiyigehenxiaodeqiekou,kejiangyixiekeyasuoxueguanzhijiashenzhiweixingxinzangbengdengxinzangbingjieruzhiliaoqixiechanpinzhijiesongrutineizhidingbuwei。

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。suizhecailiaokexuejishudebuduanfazhanhejieruzhiliaoqixiederiquxiaoxinghua,weichuangshoushuyingyunersheng,ruzaibingrendefugugoujingmaishangkaiyigehenxiaodeqiekou,kejiangyixiekeyasuoxueguanzhijiashenzhiweixingxinzangbengdengxinzangbingjieruzhiliaoqixiechanpinzhijiesongrutineizhidingbuwei。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”laianzhuangnaxietijijiaodadejiushixinzangbingjieruzhiliaoqixie。xianjiangjinjinianlaimeiguoheouzhouchangshangxinkaifadexinzangbingjieruzhiliaoqixiechanpinzuoeyaojieshao,gongduzhecankao。
自動化體外除顫儀
房fang顫chan是shi一yi種zhong極ji其qi危wei險xian的de急ji性xing發fa作zuo心xin髒zang病bing。病bing人ren一yi旦dan在zai室shi外wai發fa生sheng房fang顫chan又you得de不bu到dao及ji時shi治zhi療liao可ke在zai短duan時shi間jian內nei猝cu死si。故gu心xin房fang除chu顫chan儀yi對dui房fang顫chan患huan者zhe來lai說shuo是shi一yi種zhong救jiu命ming醫yi療liao器qi械xie產chan品pin。美mei國guo一yi公gong司si去qu年nian推tui出chu一yi種zhong可ke隨sui身shen攜xie帶dai的de自zi動dong化hua袖xiu珍zhen體ti外wai除chu顫chan儀yi(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
病bing人ren長chang期qi血xue脂zhi過guo高gao且qie不bu加jia控kong製zhi就jiu會hui導dao致zhi心xin髒zang二er尖jian瓣ban受shou損sun,關guan閉bi不bu嚴yan,從cong而er造zao成cheng心xin髒zang泵beng出chu血xue液ye部bu分fen回hui流liu到dao心xin室shi裏li,久jiu而er久jiu之zhi其qi心xin室shi就jiu會hui慢man慢man擴kuo大da(心室擴張)最(zui)終(zhong)引(yin)起(qi)心(xin)力(li)衰(shuai)竭(jie)。這(zhe)種(zhong)現(xian)象(xiang)在(zai)高(gao)血(xue)脂(zhi)病(bing)人(ren)中(zhong)十(shi)分(fen)常(chang)見(jian)。所(suo)以(yi)國(guo)際(ji)醫(yi)學(xue)界(jie)認(ren)為(wei),二(er)尖(jian)瓣(ban)損(sun)傷(shang)嚴(yan)重(zhong)的(de)病(bing)人(ren)必(bi)須(xu)及(ji)時(shi)更(geng)換(huan)新(xin)的(de)心(xin)髒(zang)瓣(ban)膜(mo),否(fou)則(ze)會(hui)引(yin)發(fa)意(yi)外(wai)猝(cu)死(si)事(shi)件(jian)。人(ren)工(gong)心(xin)髒(zang)瓣(ban)膜(mo)的(de)開(kai)發(fa)研(yan)究(jiu)工(gong)作(zuo)在(zai)西(xi)方(fang)發(fa)達(da)國(guo)家(jia)開(kai)展(zhan)較(jiao)早(zao)。過(guo)去(qu)西(xi)方(fang)臨(lin)床(chuang)醫(yi)生(sheng)大(da)多(duo)采(cai)用(yong)動(dong)物(wu)的(de)心(xin)髒(zang)瓣(ban)膜(mo)為(wei)二(er)尖(jian)瓣(ban)受(shou)損(sun)者(zhe)進(jin)行(xing)移(yi)植(zhi),後(hou)因(yin)機(ji)體(ti)排(pai)斥(chi)反(fan)應(ying)問(wen)題(ti)無(wu)法(fa)解(jie)決(jue)而(er)改(gai)用(yong)車(che)禍(huo)而(er)死(si)亡(wang)病(bing)人(ren)捐(juan)贈(zeng)的(de)心(xin)髒(zang)瓣(ban)膜(mo)進(jin)行(xing)移(yi)植(zhi),效(xiao)果(guo)較(jiao)好(hao)。近(jin)年(nian)來(lai)美(mei)國(guo)等(deng)發(fa)達(da)國(guo)家(jia)廠(chang)商(shang)已(yi)開(kai)發(fa)出(chu)多(duo)種(zhong)利(li)用(yong)惰(duo)性(xing)高(gao)分(fen)子(zi)材(cai)料(liao)製(zhi)作(zuo)的(de)人(ren)工(gong)瓣(ban)膜(mo),它(ta)們(men)可(ke)供(gong)植(zhi)入(ru)人(ren)體(ti)後(hou)永(yong)久(jiu)使(shi)用(yong),也(ye)不(bu)會(hui)引(yin)起(qi)機(ji)體(ti)排(pai)斥(chi)反(fan)應(ying)。包(bao)括(kuo)美(mei)國(guo)和(he)歐(ou)盟(meng)國(guo)家(jia)等(deng)多(duo)個(ge)國(guo)家(jia)均(jun)已(yi)批(pi)準(zhun)該(gai)人(ren)工(gong)瓣(ban)膜(mo)上(shang)市(shi)。
血管成型介入器械
yinyanzhongdongmaizhouyangyinghuaeryinqixinxueguanxiazhaihexinjigengsishimuqianshijiegeguozuiweichangjiandeyizhongxinzangbing。erputongyaowunanyidadaoxiaochudongmaineibijileidedaliangzhileibankuaihehuifuxueguanchangtongdexiaoguo。jinjinianlaimeiguoheouzhouchangshangluxukaifashangshiyizhongmingweixinxueguanchengxingqixiedechuangxinxingyiliaoqixiechanpin。zheleichanpindetedianshi: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(wei)21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
suoweixinzangzhuchiqixie,qishijiushifuzhuxinzanggongzuodeyizhongxinxingjieruzhiliaoqixiechanpin。duimouxieyanzhongxinshuaibingren,qixinzangyiwufabengchuzuliangdexueyegongyingquanshengezangqihezuzhi,duitamenlaishuo,weiyidebanfajiushizhiruyikexindejiankangxinzang,danyaozhaodaoheshidegongtixinzangtanherongyi。changqiyilai,zhexieyinyanzhongxinshuaierzhinengtangzaibingchuangshangdebingrenwuyizaitingtianyouming。jinnianlai,meiguoheouzhouyiliaoqixiechangshangluxukaifashangshiyixiexinyingdexinzangzhuchiqixiechanpin,duitamendekaifashangshi,weiyanzhongxinzangbingrendailaileshengdexiwang。yinweiliyongzhexiebeiyeneirenshichengweixinshizhuchiqixie(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。
近jin年nian來lai,隨sui著zhe材cai料liao科ke學xue技ji術shu突tu飛fei猛meng進jin式shi的de發fa展zhan,美mei國guo醫yi療liao器qi械xie廠chang商shang終zhong於yu開kai發fa出chu真zhen正zheng意yi義yi上shang的de可ke植zhi入ru人ren工gong心xin髒zang泵beng產chan品pin,從cong而er可ke使shi嚴yan重zhong心xin髒zang病bing人ren無wu需xu等deng待dai供gong體ti心xin髒zang而er直zhi接jie植zhi入ru人ren工gong心xin髒zang泵beng之zhi類lei的de介jie入ru治zhi療liao器qi械xie,而er且qie病bing人ren的de生sheng活huo質zhi量liang較jiao好hao。如ru據ju國guo外wai媒mei體ti最zui新xin報bao道dao,美mei國guo匹pi茨ci堡bao大da學xue醫yi學xue中zhong心xin不bu久jiu前qian開kai發fa出chu一yi種zhong新xin型xing心xin髒zang泵beng(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、yasuoxingjiaodadegezhazhuangzhijiahekexishouzhijiadengxinchanpin。zheleixinyingxueguanzhijiazaiguojishichangshangxiaoliangjiaoda,tamendezuidayoudianshiburongyizaochengxueguanzaixiazhai。
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。