新型升主動脈瘤腔內(nèi)移植物系統(tǒng)的研制與體外實驗研究
發(fā)布時間：2018-09-05 15:40
【摘要】：研究背景自1994年Dake首次報道應(yīng)用腔內(nèi)移植物(endovascular stent-graft)治療胸降主動脈動脈瘤以來,胸主動脈腔內(nèi)修復(fù)術(shù)(Thoracic endovascular aortic repair,TEVAR)由于其手術(shù)創(chuàng)傷小、臨床結(jié)果良好的特點逐漸成為胸降主動脈多種病變的主要治療方式,如Stanford B型夾層、胸降主動脈瘤、假性動脈瘤、透壁性主動脈潰瘍等。升主動脈瘤(ascending aortic aneurysm)是升主動脈管壁局部異常擴(kuò)張至正常直徑1.5倍以上的病變,占所有胸主動脈瘤的45%,可導(dǎo)致主動脈夾層甚至瘤體破裂,若不行手術(shù)治療,90%患者在5年內(nèi)死亡。目前手術(shù)治療仍以開放手術(shù)為主,采用管狀移植物置換升主動脈伴有或者不伴主動脈瓣置換,盡管手術(shù)器材和技術(shù)不斷改良,術(shù)后死亡率及并發(fā)癥率仍較高,在高齡及有并存病患者中尤甚。因此學(xué)者開始探索腔內(nèi)治療在升主動脈的應(yīng)用,已有報道采用傳統(tǒng)直管型腔內(nèi)移植物治療升主動脈瘤,但僅為少數(shù)解剖條件達(dá)到腔內(nèi)治療要求的病例。由于受升主動脈本身的解剖學(xué)特點和傳統(tǒng)的腔內(nèi)隔絕移植物本身的限制,升主動脈瘤的微創(chuàng)腔內(nèi)治療在大多數(shù)患者中仍無法適用。升主動脈瘤腔內(nèi)治療的進(jìn)一步發(fā)展需要在了解升主動脈病變形態(tài)特征的基礎(chǔ)上提高腔內(nèi)技術(shù)和改進(jìn)腔內(nèi)器具。因此,本研究旨在通過測量分析升主動脈瘤患者的解剖特征,進(jìn)而在“瘤腔錨定”(Sac-anchoring)概念的基礎(chǔ)上研制新型移植物系統(tǒng),包括特殊結(jié)構(gòu)的新型移植物、填充劑、輸送系統(tǒng)等,既可解決升主動脈的固定區(qū)不足,又可避免移植物遮蔽分支血管,進(jìn)而通過體外模擬實驗評估其可行性。研究目的(1)測量并分析升主動脈瘤樣擴(kuò)張后的病變形態(tài)特征,根據(jù)其長度、直徑、彎曲度及瘤體體積等參數(shù),設(shè)計并采用合適材料制作出可用于升主動脈腔內(nèi)治療的球囊支架;(2)測試并篩選具有液固相變性質(zhì)的高分子材料,改進(jìn)其性能獲得可用于填充球囊的填充劑;(3)設(shè)計并制作輸送系統(tǒng),與新型球囊支架組裝為完整的移植物系統(tǒng),在體外模型上完成模擬實驗,證實其可行性。研究方法(1)從2012年1月-2014年12月在醫(yī)院影像科行主動脈增強(qiáng)CT(Computed Tomography)檢查的患者中,根據(jù)入排標(biāo)準(zhǔn)篩選70例升主動脈瘤患者的影像資料,測量并分析其長度、直徑、彎曲度及瘤體體積等形態(tài)參數(shù),根據(jù)各指標(biāo)的集中、分布以及隨性別年齡變化情況,為球囊支架的設(shè)計和制作提供參考數(shù)據(jù);(2)與此同時,在目前臨床使用的具有液固相變化特點的4種高分子材料中篩選1種可作為填充劑,通過與公司合作改進(jìn)其配方以使其理化性能達(dá)到臨床使用要求,并通過力學(xué)測試驗證;(3)根據(jù)形態(tài)學(xué)研究所得結(jié)果及完成體外模擬實驗的目的,設(shè)計并制作球囊支架及配套輸送系統(tǒng),壓縮安裝移植物并連接對應(yīng)管道,組裝成完整的移植物系統(tǒng);(4)制作升主動脈瘤模型,在透視條件下完成移植物系統(tǒng)的導(dǎo)入、釋放、填充、和回撤,記錄實驗過程,證實新型移植物系統(tǒng)的可行性。結(jié)果1.形態(tài)學(xué)測量所得關(guān)鍵指標(biāo)如下:D1竇管結(jié)合部水平主動脈直徑為37.0±6.0mm,D2升主動脈瘤體最大直徑為52.6±6.0mm;L4升主動脈長度為92.56±14.79mm;L5瘤體的長度為81.52±21.01mm;T升主動脈即升主動脈彎曲度為0.23±0.10,T瘤體瘤體彎曲度為0.20±0.10;升主動脈瘤瘤體體積為171.87±58.26ml;2.篩選雙組份加成型液體硅橡膠(additional liquid silicone rubber,ALSR)作為填充劑,改進(jìn)其配方后獲得硅橡膠產(chǎn)品型號(MED4420),黏度為20000cp,固化時間5min,固化后軸向拉伸應(yīng)變?yōu)?57.48%,拉伸應(yīng)力為0.41MPa,周向拉伸應(yīng)變?yōu)?9.15%,拉伸應(yīng)力為0.52MPa,力學(xué)性能滿足要求;3.成功制作球囊支架初步樣品,球囊材料選用乳膠,直徑為70mm,容積為200ml,支架內(nèi)徑32mm,長度為75mm。成功制作集成多個功能組件(包括控制導(dǎo)絲組件、填充通道等)的輸送系統(tǒng)。成功將移植物安裝于輸送系統(tǒng),組裝為完整移植物系統(tǒng);4.成功制作瘤體長度為60mm,瘤體直徑為63mm的升主動脈瘤體外模型,在透視條件下成功導(dǎo)入移植物至升主動脈,移植物釋放后位置良好,展開順利,填充過程順利,填充壓力為5atm,注射時間為1min,填充容積約為110ml。造影提示球囊填充后貼壁好,支架通暢。結(jié)論1.本研究所得加成型液體硅橡膠可作為填充劑,達(dá)到新型移植物的要求;2.本研究研制的新型移植物系統(tǒng)可制作組裝,在體外模型上初步證實其可行性。
[Abstract]:Background Since Dake first reported the use of endovascular stent-graft in the treatment of thoracic descending aortic aneurysms in 1994, thoracic endovascular aortic repair (TEVAR) has gradually become the main treatment for many diseases of the thoracic descending aorta due to its small surgical trauma and good clinical results. Ascending aortic aneurysm (ASA) is an abnormal dilatation of the ascending aortic wall to more than 1.5 times the normal diameter, accounting for 45% of all thoracic aortic aneurysms, which can lead to aortic dissection or even rupture of the aneurysm, if not handled. 90% of the patients died within 5 years after operation. At present, open surgery is still the main treatment, and tubular graft replacement of ascending aorta with or without aortic valve replacement. Despite the continuous improvement of surgical equipment and techniques, the mortality and complication rate are still high, especially in the elderly and coexisting patients. Endovascular treatment of ascending aortic aneurysms has been reported using conventional straight-tube endovascular grafts, but only a small number of cases with anatomical conditions meet the requirements of endovascular treatment. Further development of endovascular treatment of ascending aortic aneurysms requires the improvement of endovascular techniques and instruments based on the understanding of the morphological characteristics of ascending aortic lesions. A new graft system was developed on the basis of the concept, including a new type of special structure graft, filler, delivery system, etc. It can not only solve the insufficiency of ascending aorta fixation area, but also avoid graft occlusion of branch blood vessels, and then evaluate its feasibility through in vitro simulation experiments. Objective (1) Measure and analyze the feasibility of ascending aortic aneurysm dilatation. According to the parameters of length, diameter, curvature and tumor volume, the balloon stent for ascending aorta was designed and fabricated with suitable materials; (2) Polymer materials with liquid-solid phase denaturation were tested and screened to improve their properties and obtain fillers for balloon filling; (3) Design and fabrication of balloon fillers. Methods (1) Seventy patients with ascending aortic aneurysm were screened according to the admission and exclusion criteria from January 2012 to December 2014 in the hospital imaging department for aortic contrast-enhanced CT (Computed Tomography). Imaging data were measured and analyzed for the length, diameter, curvature and tumor volume. According to the concentration, distribution of each index and the change with sex and age, reference data were provided for the design and manufacture of balloon stent. (2) At the same time, screening was used in four kinds of polymer materials with the characteristics of liquid-solid phase change. One of them can be used as filler to improve its physical and chemical properties to meet the clinical requirements through cooperation with the company and mechanical testing verification; (3) According to the results of morphological research and the purpose of completing in vitro simulation experiment, balloon stent and matching delivery system are designed and manufactured to compress and install the graft and connect the corresponding tube. (4) A model of ascending aortic aneurysm was made and the implant system was introduced, released, filled, and withdrawn under fluoroscopy. The experimental procedure was recorded to confirm the feasibility of the new graft system. The maximum diameter of D2 ascending aortic aneurysm was 52.6 (+ 6.0 mm); the length of L4 ascending aorta was 92.56 (+ 14.79 mm); the length of L5 ascending aorta was 81.52 (+ 21.01 mm); the curvature of T ascending aorta was 0.23 (+ 0.10); the curvature of T ascending aorta was 0.20 (+ 0.10); the volume of ascending aortic aneurysm was 171.87 (+ 58.26 ml); and 2. The silicone rubber product model (MED4420) was obtained by modifying the formulation with dditional liquid silicone rubber (ALSR) as filler. The viscosity was 20 000 cp, the curing time was 5 minutes, the axial tensile strain after curing was 157.48%, the tensile stress was 0.41 MPa, the circumferential tensile strain was 99.15%, the tensile stress was 0.52 MPa, and the mechanical properties met the requirements. For the preliminary sample of the stent, the balloon material was latex with a diameter of 70 mm, a volume of 200 ml, a stent inner diameter of 32 mm and a length of 75 mm. In vitro model of ascending aortic aneurysm with a diameter of 60 mm and 63 mm, the graft was successfully implanted into the ascending aorta under fluoroscopy. The graft was well positioned after release. The filling process was smooth. The filling pressure was 5 atm, the injection time was 1 min and the filling volume was about 110 ml. Additional liquid silicone rubber can be used as filler to meet the requirements of new grafts. 2. The new graft system developed in this study can be fabricated and assembled, and its feasibility has been preliminarily confirmed in vitro model.
【學(xué)位授予單位】：第二軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R654.3
本文編號：2224714
[Abstract]:Background Since Dake first reported the use of endovascular stent-graft in the treatment of thoracic descending aortic aneurysms in 1994, thoracic endovascular aortic repair (TEVAR) has gradually become the main treatment for many diseases of the thoracic descending aorta due to its small surgical trauma and good clinical results. Ascending aortic aneurysm (ASA) is an abnormal dilatation of the ascending aortic wall to more than 1.5 times the normal diameter, accounting for 45% of all thoracic aortic aneurysms, which can lead to aortic dissection or even rupture of the aneurysm, if not handled. 90% of the patients died within 5 years after operation. At present, open surgery is still the main treatment, and tubular graft replacement of ascending aorta with or without aortic valve replacement. Despite the continuous improvement of surgical equipment and techniques, the mortality and complication rate are still high, especially in the elderly and coexisting patients. Endovascular treatment of ascending aortic aneurysms has been reported using conventional straight-tube endovascular grafts, but only a small number of cases with anatomical conditions meet the requirements of endovascular treatment. Further development of endovascular treatment of ascending aortic aneurysms requires the improvement of endovascular techniques and instruments based on the understanding of the morphological characteristics of ascending aortic lesions. A new graft system was developed on the basis of the concept, including a new type of special structure graft, filler, delivery system, etc. It can not only solve the insufficiency of ascending aorta fixation area, but also avoid graft occlusion of branch blood vessels, and then evaluate its feasibility through in vitro simulation experiments. Objective (1) Measure and analyze the feasibility of ascending aortic aneurysm dilatation. According to the parameters of length, diameter, curvature and tumor volume, the balloon stent for ascending aorta was designed and fabricated with suitable materials; (2) Polymer materials with liquid-solid phase denaturation were tested and screened to improve their properties and obtain fillers for balloon filling; (3) Design and fabrication of balloon fillers. Methods (1) Seventy patients with ascending aortic aneurysm were screened according to the admission and exclusion criteria from January 2012 to December 2014 in the hospital imaging department for aortic contrast-enhanced CT (Computed Tomography). Imaging data were measured and analyzed for the length, diameter, curvature and tumor volume. According to the concentration, distribution of each index and the change with sex and age, reference data were provided for the design and manufacture of balloon stent. (2) At the same time, screening was used in four kinds of polymer materials with the characteristics of liquid-solid phase change. One of them can be used as filler to improve its physical and chemical properties to meet the clinical requirements through cooperation with the company and mechanical testing verification; (3) According to the results of morphological research and the purpose of completing in vitro simulation experiment, balloon stent and matching delivery system are designed and manufactured to compress and install the graft and connect the corresponding tube. (4) A model of ascending aortic aneurysm was made and the implant system was introduced, released, filled, and withdrawn under fluoroscopy. The experimental procedure was recorded to confirm the feasibility of the new graft system. The maximum diameter of D2 ascending aortic aneurysm was 52.6 (+ 6.0 mm); the length of L4 ascending aorta was 92.56 (+ 14.79 mm); the length of L5 ascending aorta was 81.52 (+ 21.01 mm); the curvature of T ascending aorta was 0.23 (+ 0.10); the curvature of T ascending aorta was 0.20 (+ 0.10); the volume of ascending aortic aneurysm was 171.87 (+ 58.26 ml); and 2. The silicone rubber product model (MED4420) was obtained by modifying the formulation with dditional liquid silicone rubber (ALSR) as filler. The viscosity was 20 000 cp, the curing time was 5 minutes, the axial tensile strain after curing was 157.48%, the tensile stress was 0.41 MPa, the circumferential tensile strain was 99.15%, the tensile stress was 0.52 MPa, and the mechanical properties met the requirements. For the preliminary sample of the stent, the balloon material was latex with a diameter of 70 mm, a volume of 200 ml, a stent inner diameter of 32 mm and a length of 75 mm. In vitro model of ascending aortic aneurysm with a diameter of 60 mm and 63 mm, the graft was successfully implanted into the ascending aorta under fluoroscopy. The graft was well positioned after release. The filling process was smooth. The filling pressure was 5 atm, the injection time was 1 min and the filling volume was about 110 ml. Additional liquid silicone rubber can be used as filler to meet the requirements of new grafts. 2. The new graft system developed in this study can be fabricated and assembled, and its feasibility has been preliminarily confirmed in vitro model.
【學(xué)位授予單位】：第二軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R654.3
【參考文獻(xiàn)】
相關(guān)期刊論文 前1條
1 常光其;李曉曦;李松奇;胡作軍;呂偉明;王深明;;腔內(nèi)修復(fù)聯(lián)合旁路手術(shù)治療DeBakeyⅠ型升主動脈夾層[J];中國實用外科雜志;2005年12期
，本文編號：2224714
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