美迪醫(yī)療網(wǎng)報道：一種導(dǎo)航系統(tǒng)可以引導(dǎo)內(nèi)窺鏡設(shè)備在肺部三維地圖上行進，包括氣管鏡不能達到的區(qū)域。該系統(tǒng)已經(jīng)獲得美國食品藥品管理局批準。

當前，在肺組織外周區(qū)域進行氣管鏡操作是幾乎盲法進行的，而外周區(qū)域是大多數(shù)病變所在區(qū)域，但是氣管鏡本身不能到達。因此，大多數(shù)氣管鏡檢查得不到目的區(qū)域的內(nèi)窺鏡檢查資料，以至于手術(shù)的成功比例相當?shù)停?jīng)常得到不可靠的檢查結(jié)果。類似困難還阻礙了對淋巴結(jié)的檢查，而淋巴結(jié)活檢對肺癌的分期相當重要。新系統(tǒng)的設(shè)計能夠克服這些差異，而無論是使用哪個廠家的標準氣管鏡、診斷或者治療氣管鏡。2003～2004年在歐洲和以色列成功進行了有關(guān)外周肺組織病變活檢的臨床試驗。

該系統(tǒng)叫做superDimension/Bronchus，包含了10項美國，被Technology Review (Massachusetts Institute of Technology,Boston, USA)評選為2004年世界上五大出類拔萃之一，而且是五項中唯一的醫(yī)療保健。

superDimension公司(Tel-Aviv, Israel)總裁兼首席執(zhí)行官David Tolkowsky說：“FDA批準的是該系列產(chǎn)品中的第一個，我們計劃來年在介入肺臟學領(lǐng)域中推廣這種產(chǎn)品。”正是該公司將該系統(tǒng)進行了商品化。

Navigation System for Pulmonary Tract
 
A navigation system guides endoscopic instruments on a three-dimensional (3D) roadmap of the lungs, including areas beyond the reach of a bronchoscope. The system has been cleared by the U.S. Food and Drug Administration (FDA).

Currently, bronchoscopy is performed rather blindly in the peripheral areas of the lungs, where most lesions are situated but where the bronchoscope itself cannot reach. Therefore, most bronchoscopies are performed without endoscopic vision of the targeted area, so that success rates of the procedure are low, and unreliable results are common. Similar difficulties hinder access to the lymph nodes, where proper biopsy is critical for the staging of lung cancer. The new system is designed to correct these deficiencies while making use of any standard bronchoscope and any standard diagnostic or therapeutic bronchoscopic tool from any vendor. Successful clinical trials on the biopsy of peripheral lung lesions were conducted in Europe and Israel in 2003-2004.

The system, called superDimension/Bronchus, is covered by 10 U.S. patents and was selected this year by Technology Review (Massachusetts Institute of Technology, Boston, USA) as one of the five most outstanding patents in the world for 2004, and was the only healthcare patent among those five.

“This FDA approval is the first in a series of products that we plan to introduce in coming years in the field of interventional pulmonology,” remarked David Tolkowsky, president and CEO of superDimension (Tel-Aviv, Israel), which is commercializing the system.