醫(yī)療設(shè)備巨頭西門子醫(yī)療5月10日意外宣布,將終止其心臟介入手術(shù)機(jī)器人的業(yè)務(wù)。該決定是在公司公布了大幅下降的第二季度利潤后宣布的。
西門子醫(yī)療表示:“我們始終相信介入手術(shù)機(jī)器人技術(shù)將在未來血管治療中發(fā)揮重要作用。然而, 機(jī)器人在心臟介入領(lǐng)域的應(yīng)用落后于我們最初的預(yù)期。經(jīng)過過去幾個季度的分析決策后,西門子醫(yī)療決定停止CorPath GRX途靈(Corindus)介入手術(shù)機(jī)器人在心臟冠脈領(lǐng)域的業(yè)務(wù)?!?/span>
該公司還稱:“西門子醫(yī)療仍將繼續(xù)進(jìn)行神經(jīng)介入手術(shù)機(jī)器人的研發(fā),已經(jīng)開始著手開發(fā)新一代的機(jī)器人平臺,希望得以在關(guān)鍵的卒中發(fā)病早期,為患者帶來有效的治療?!?/span>
此消息一出,一石激起千層浪,迅速引起行業(yè)內(nèi)人士關(guān)注,血管介入機(jī)器人行業(yè)掀起大論戰(zhàn)!
對于血管介入手術(shù)機(jī)器人,筆者也在前幾日發(fā)表的文章(《關(guān)于手術(shù)機(jī)器人賽道的幾點思考》可點擊查看)中提到了自己的思考。
血管介入手術(shù)機(jī)器人是否會成為下一個內(nèi)卷主戰(zhàn)場?對于血管介入機(jī)器人,醫(yī)療器械行業(yè)人士是存在不同認(rèn)識的,有的專業(yè)人士認(rèn)為血管介入機(jī)器人是“脫衣戰(zhàn)士”,能夠降低手術(shù)操作醫(yī)生的射線暴露,提高手術(shù)效率,不過又有專業(yè)人士發(fā)出不同的聲音,認(rèn)為目前血管介入手術(shù)機(jī)器人實際上并不適合我國實情,醫(yī)生群體對于血管介入機(jī)器人的需求并不像宣傳里所提及的那么大,而且血管介入類的耗材器械種類繁多,血管介入機(jī)器人只能對數(shù)量較少的器械進(jìn)行輸送,運用范圍有限。但是不管怎么樣,不論是切實解放醫(yī)生群體的好產(chǎn)品也好,還是能夠撬動資本講故事的好產(chǎn)品也罷,血管介入手術(shù)機(jī)器人就是這樣來了。
筆者認(rèn)為,對于西門子Corindus途靈血管介入手術(shù)機(jī)器人,我們應(yīng)當(dāng)心存感謝。
是西門子這樣的大廠率先挖掘了血管介入手術(shù)機(jī)器人的市場潛力,在醫(yī)療器械領(lǐng)域公認(rèn)的“帶頭大哥”的引領(lǐng)下,我們自信的聚焦于從事于血管介入手術(shù)機(jī)器人,大部分研發(fā)初始的產(chǎn)品競標(biāo)和對照就是西門子Corindus途靈手術(shù)機(jī)器人,在國內(nèi)激烈的內(nèi)卷行情的洗禮下,各大血管介入手術(shù)機(jī)器人八仙過海,各顯神通,不斷的產(chǎn)品迭代,挖掘臨床痛點,已有產(chǎn)品實現(xiàn)了“青出于藍(lán)而勝于藍(lán)”,在我們血管介入機(jī)器的人技術(shù)發(fā)展路徑上,我們真的應(yīng)當(dāng)對西門子Corindus途靈手術(shù)機(jī)器人道一聲感謝。
現(xiàn)在,西門子Corindus途靈手術(shù)機(jī)器人主動退出市場競爭,一石激起千層浪,把當(dāng)下血管介入手術(shù)機(jī)器人的現(xiàn)狀照進(jìn)現(xiàn)實,撕開了當(dāng)下血管介入機(jī)器人臨床痛點解決不利的面紗。不管輿論再怎么看再怎么說,筆者認(rèn)為國內(nèi)當(dāng)下血管介入手術(shù)機(jī)器人各大廠家一定還會繼續(xù)將血管介入機(jī)器人做下去,雖有微調(diào)但目標(biāo)一定不會變,保持這份定力和決心的一定是自信于自家產(chǎn)品和技術(shù)的先進(jìn)性,這種先進(jìn)性的實現(xiàn)一定會加快,這正是臨床痛點被放大之后的反饋。與其遮遮掩掩,不如痛痛快快的去面對,去克服這個挑戰(zhàn),從這一點上我們也應(yīng)當(dāng)對西門子Corindus途靈手術(shù)機(jī)器人說一聲謝謝。
而且,西門子家大業(yè)大,放棄某一管線實際上對其影響是可控的甚至是不大的,但是對于我們的血管介入機(jī)器人廠家來講是做不到的,既然當(dāng)下的大環(huán)境不允許我們廠家去任性,那么在血管介入手術(shù)機(jī)器人帶頭大哥的退出之下,是不是少了一個大競爭對手,有了更好的逐鹿中原的機(jī)會,筆者認(rèn)為切實做好產(chǎn)品和技術(shù)的先進(jìn)性機(jī)會還是很大的。
其實,西門子并未放棄Corindus途靈手術(shù)機(jī)器人,而是退出了PCI領(lǐng)域,人家也明確說了,會繼續(xù)做研發(fā),聚焦于神經(jīng)外科介入手術(shù)機(jī)器人,做產(chǎn)品的顛覆,可見人家還是保留了重回賽道的基礎(chǔ)的,這個基礎(chǔ)就是產(chǎn)品和技術(shù)的先進(jìn)性,說不定哪一天來個王者歸來都不好說。而且筆者可以肯定的說,西門子Corindus途靈手術(shù)機(jī)器人的專利布局一定不會停止,在這個賽道上國內(nèi)各大血管介入手術(shù)機(jī)器人廠家依然會感受到“帶頭大哥”的威懾力,國內(nèi)各大血管介入機(jī)器人廠家不能被帶亂了節(jié)奏,要時刻保持警惕,保持一顆敬畏產(chǎn)品和技術(shù)的心。
最后我們還應(yīng)當(dāng)感謝西門子一點的是,西門子又挖掘了一個新賽道,神經(jīng)外科介入手術(shù)機(jī)器人,我覺著這頗像熱門作品的“未完待續(xù)”或者下一季的“彩蛋”,對于吃瓜群眾的我來講,真的是欲罷不能,對于NVI領(lǐng)域的血管介入手術(shù)機(jī)器人,我們是不是可以關(guān)注起來了,雖然西門子說"那將是幾年以后的事情",但是未雨綢繆起來總沒有錯。不過,西門子押寶神經(jīng)領(lǐng)域手術(shù)機(jī)器人就一定是正確的道路么,我們拭目以待。
Corindus途靈介入手術(shù)機(jī)器人技術(shù)起源于以色列,以色列海法醫(yī)院成功研制出用于心血管介入的手術(shù)機(jī)器人Remote navigation system(RNS),該系統(tǒng)采用多組摩擦輪分別遞送導(dǎo)引導(dǎo)絲和球囊支架導(dǎo)管,并首次開展了臨床實驗。2012年美國醫(yī)療機(jī)器人公司Corindus Vascular?Robotics使用RNS技術(shù)開發(fā)的初代產(chǎn)品Corpath200獲得了FDA批準(zhǔn)上市用于PCI,又于2016年第四季度Corindus的二代產(chǎn)品CorPath?獲得了FDA批準(zhǔn)上市用于PCI。
值得注意的是,2019年8月8日,西門子醫(yī)療宣布以11億美元收購Corindus Vascular Robotics,Corindus途靈介入手術(shù)機(jī)器人至此納入西門子醫(yī)療旗下。
特別指出的是,西門子醫(yī)療的Corindus途靈最新一代CorPath?GRX介入手術(shù)機(jī)器人還通過國家藥監(jiān)局器審中心的創(chuàng)新醫(yī)療器械特別審查申請,獲準(zhǔn)進(jìn)入特別審查程序。
下圖給出了Corindus途靈手術(shù)機(jī)器人(CorPath?GRX)的產(chǎn)品實物示意。

CorPath?GRX產(chǎn)品實物示意
CorPath系統(tǒng)是第一個獲得 FDA 批準(zhǔn)并獲得CE標(biāo)志的機(jī)器人平臺,專為介入醫(yī)生設(shè)計。在 CorPath 機(jī)器人輔助干預(yù)期間,該產(chǎn)品是由硬件設(shè)備及耗材組合使用的系統(tǒng),通過醫(yī)生坐在遠(yuǎn)程工作區(qū)使用操作桿或控制臺上的觸摸屏,實現(xiàn)介入設(shè)備的遠(yuǎn)程傳輸和操作。
Corindus途靈血管介入機(jī)器人整體系統(tǒng)圖如下所示:

Corindus途靈血管介入機(jī)器人整體系統(tǒng)圖
機(jī)器人裝置是Corindus途靈手術(shù)機(jī)器人的核心部件之一,其主要包括及其支撐臂及其一次性Cassette。如下附圖所示:

Corindus途靈血管介入機(jī)器人支撐臂系統(tǒng)圖

Corindus途靈血管介入機(jī)器人一次性Cassette系統(tǒng)圖
筆者通過視頻的形式,給各位讀者展示Corindus途靈血管介入機(jī)器人的技術(shù)組成和使用方法。(溫馨提示:視頻有背景音樂)
西門子Corindus途靈手術(shù)機(jī)器人做了全方位的系統(tǒng)專利保護(hù)。筆者從Corindus途靈血管介入機(jī)器人涉及的相關(guān)專利中擇機(jī)選擇了3組專利進(jìn)行了解析,相關(guān)結(jié)果如下:
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Remote control catheterization
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Catheterization procedures are very commonly performed for diagnosis and treatment of diseases of the heart and vascular system. The catheterization procedure is generally initiated by inserting a guide wire into a blood vessel in the patient's body. The guide wire is then guided to the desired location, most commonly in one of the heart vessels or elsewhere in the vascular system. At this point the catheter is slid over the guide wire into the blood vessel and/or heart. Once the catheter is in the desired position, the guide wire can then be removed, leaving the catheter in location. Alternatively, in some procedures, the catheter is inserted without using a guide wire. The catheter may be used to pass ancillary devices into the body, such as an angioplasty balloon, or to perform other diagnostic or therapeutic procedures.
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A remote control catheterization system (20) includes a propelling device (28), which controllably inserts a flexible, elongate probe (26) into the body of a patient (22). A control console (34), in communication with the propelling device, includes user controls (38, 40) which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device.
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Transmission for a remote catheterization system
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To insert a catheter manually, the physician applies torque and axial push force on the proximal end of a guide wire to effect tip direction and axial advancement at the distal end. However, it is difficult to control the distal tip of the catheter from the proximal end. Although these navigation techniques are effective, they are tedious, require extraordinary skill, and result in long medical procedures that fatigue the user.
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An apparatus for imparting motion from at least one of a plurality of motion sources into linear, rotary, or combined linear and rotary motion of an elongated device, the apparatus comprising a transmission for translating the motion to linear or rotary motion of the elongated device.
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Before performing an interventional procedure with the disclosed invention, a diagnostic procedure is typically performed. An exemplary diagnostic procedure performed before performing a PCI may include a number of steps. Starting in the femoral artery, a 0.038 guide wire is run over the top of the aortic arch. A diagnostic catheter is advanced over the 0.038 guide wire after which the 0.038 guide wire is removed allowing the diagnostic catheter (DC) to return to its preformed shape enabling the DC to access either the left or the right ostium of the aorta. A contrast media is injected through the DC and the heart is x-rayed to identify the existence and location of any lesion. A y-connector may be secured to the end of the DC outside of the patient. The y-connector provides a means for introducing the contrast media or medication. The y-connector employs a one way valve both at the y-connector leg and the free open end. The 0.038 guide is then reinserted into the DC advanced over the top of the aortic arch, and the diagnostic catheter is removed. When the diagnostic is completed the 0.038 guide wire may be left in place for use in a PCI procedure.
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A robotic catheter system is provided. The catheter system includes a housing, and the housing has a sidewall and a longitudinal axis. The catheter system includes a recess formed in the sidewall of the housing and a drive mechanism supported by the housing. The drive mechanism is configured to impart movement to a catheter device. The catheter system includes a first channel configured to receive a catheter device, and the first channel has a opening located within the recess.
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筆者通過文獻(xiàn)獲知,CorPath GRX是途靈第二代機(jī)器人輔助系統(tǒng),建立在 CorPath 200 臨床成功的基礎(chǔ)上,該系統(tǒng)在全球100多個項目中擁有約10,000多個案例??偨Y(jié)而來,Corindus途靈血管介入機(jī)器人具有如下性能優(yōu)勢:
①?復(fù)雜病例的臨床成功,所有治療病變的臨床成功率為98.2%,CTO病例的臨床成功率為99.1%。
②?減少對患者的輻射,與手動PCI相比,患者的輻射劑量降低了20%。
③?減少支架使用,使用CorPath準(zhǔn)確測量冠狀動脈解剖結(jié)構(gòu)可以將不必要的額外支架的使用減少8.3%。
④?減少對醫(yī)生的輻射,主要操作員的輻射暴露減少了95%。