局部覆有放射膜的管腔支架研制

The Development of the Lumen stents Covered with Radiation Membrane

人体管腔支架为近年来用于治疗管腔肿瘤造成的狭窄或梗阻的最广泛、有效的治疗手段,临床应用结果表明管腔支架可以有效恢复患者的管腔生理功能,例:恢复患者因食管狭窄而引起的进食问题,恢复患者因胆管梗阻而引起的全身黄疸等。此种方法是一种较为经济有效的晚期姑息治疗手段。但传统的管腔支架对肿瘤本身的发展无任何影响,仅能短期内解决患者的管腔梗阻问题,没有任何治疗作用。针对此种情况,临床需求一种近距离放射治疗的新型管腔支架,该种支架要求:方便采用介入方式植入人体、进入人体后在短时间内能够自我恢复到相应的形状、支架带放射膜的位置准确地贴敷在管腔肿瘤表面上。为了达到上述三个基本要求,我们采用自膨式管腔支架为载体,在覆普通高分子膜工序时留下需要覆放射膜的空位,待普通高分子膜经过烘干、清洗、干燥后实施放射膜的覆膜工序。需要说明的是,与当前使用的放射性粒子三维立体定向放射治疗计划系统(TPS系统)一样,定制的放射膜面积及形状除了与临床影像诊断结果和数据相符外,还需要根据放疗支架TPS系统计算患者的临床处方剂量,经过换算后得出支架出厂时的活度。为了将定制后的放疗支架精确的植入病变管腔还需要结合中国专利200620158384.0带定位中心的介入手术用输送装置合并进行临床应用。临床应用表明放射支架同目前国内研究使用较多的普通支架捆绑"放射性粒子"相比具有下述特点:放射支架表面为放射膜,表面平整光滑,置入管腔后患者感觉舒畅;普通支架捆绑"放射性粒子"因支架表面有存放放射性粒子的"兜"置入管腔后患者会有局部异物或疼痛感;放射支架置入后"回收"非常方便,捆绑粒子的支架回收非常困难;放射性同位素在内放射支架表面的聚胺酯膜内分布均匀,置入管腔后同组织紧密接触,以"表面放射"的形态作用于肿瘤组织而非捆绑粒子的放射支架以点的方式作用于肿瘤组织,避免了腔内照射"盲点"的存在;与捆绑粒子的支架相比较,放射支架"粒子"脱落的风险为零。

Human lumen stents for in recent years is used in the treatment of luminal stenosis or obstruction of tumor causing the most extensive,effective treatment,clinical application result indicates that lumen stents can effectively restore patients lumen physiological function,for example： restore patients because of esophageal stenosis caused by eating problem,restore patients because of bile duct obstruction caused by the systemic jaundice,etc.This method is a very economical and effective palliative means.Late But the traditional lumen stents for tumor development of itself without any effect,can only short-term solution to patients of lumen obstruction problem,without any treatment function.In this paper,the clinical needs a close radiotherapy of new lumen stent,the stents requirements： convenient adopts intervention way after implantation in the human body,enter human body in a short time can self recover to corresponding shape,stents with radiation membrane position accurately stick deposited in the lumen tumor surface.In order to achieve the above three basic requirements,we adopt the turgor type lumen bracket as the carrier,in flip ordinary polymer film processes need to repeat when leaving the open,radiation membrane to ordinary polymer film after drying,clean,dry after applying radiation film laminating process.Need explanation is,with the current use of radioactive particles 3d stereotactic radiotherapy plans system（TPS system）,as customization of radiation membrane area and shape except with clinical imaging diagnostic results and data consistent outside,still need according to radiotherapy TPS system calculation stent in patients with clinical prescribed dose,after conversion reached after stent factory of activity.In order to will customize postoperative radiotherapy stent implantation of lesions accurately lumen to still need to combine the Chinese patent 200620158384.0 take position center＇s intervention operation with conveyer combination on the clinical application.Clinical application shows that the radiation stents with the current domestic research used more ordinary stents bound ＂radioactive particles＂ compared with the following features： luminal surface radiation for radiation membrane,surface smooth,placement of the lumen after patients feel repose.Ordinary stents bound ＂radioactive particles,＂ because of the surface has stored radioactive particles stent placement of ＂pocket＂ lumen after patients have local foreign bodies or pain,Radiation stent implantation after ＂recovery＂ is very convenient,and bind particle stent recycling very difficult;A radioactive isotope,radiation luminal surface of polyurethane ester membrane distributed homogeneously placement within the lumen with organization after close contact,with ＂surface radiation＂ patterns in the role of tumor tissue rather than bound particle radiation stents to point the way in the role of tumor tissue,to avoid the lumen illuminate the existence;＂blind spots＂ With the stents compared to bind particles,radiation stents ＂particle＂ loss of risk is zero.