内嵌式支架重建犬主动脉弓的实验研究
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摘要
目的：设计制作适合完全腔内技术重建犬主动脉弓的内嵌式支架型血管，并研究其植入方案、可行性和有效性；为临床提供适合于人体主动脉弓应用的支架型血管设计方案，完成新产品开发的初步动物实验研究。
方法：
1.犬主动脉弓数据测量：选取体重25~30kg的雄性杂种犬6只，通过血管造影和尸体解剖，了解其升主动脉、主动脉弓、分支动脉、降主动脉等部位的解剖特点，并测量各血管的长度及直径。
2.内嵌式支架的设计与制作：根据采集的数据设计并制作适合于重建犬主动脉弓的内嵌式分支支架及输送器。该系统由带内嵌式分支的主体及侧支组成，以聚酯膜通过不可吸收的缝合线与多个自扩张的镍钛合金支架段缝合而成。支架型血管由上海微创医疗器械有限公司按照临床标准制作完成。
3.可行性及疗效观察：①单分支实验研究：雄性杂种犬2只，经腹主动脉释放主体支架，自右侧腋动脉选择性进入主体分支，然后释放侧支支架；②双分支实验研究：雄性杂种犬5只，经腹主动脉释放主体支架，经双侧腋动脉分别选择性进入主体分支，然后释放侧支支架；③对术中支架的定位和释放情况进行总结，观察内漏、支架形态，测量支架释放后升主动脉与降主动脉的压差。
结果：
手术情况：单分支支架技术成功率为100％，平均失血量60ml。双分支支架技术成功率为60%（3/5），平均失血量(130.3±8.7) ml，技术未成功的两例的原因分别是左锁骨下动脉重建失败和支架覆盖双侧颈动脉。
治疗效果：1例因主体支架直径过小，存在近端I型内漏；5例手术成功术后DSA检查显示各移植物位置及形态良好，分支血管通畅。
压力测量：单分支植入后升、降主动脉平均压差为5mmHg，双分支为12mmHg。
结论：内嵌式支架型血管系统结构设计合理，制备工艺成熟，操作切实可行；单分支支架技术成功率更高，但对于人体需要结合颈部血管旁路术；双分支支架操作难度较大，但可以实现完全腔内技术重建主动脉弓；其对临床应用具有十分重要的指导意义；产品设计和生产工艺需要进一步完善，远期结果有待观察。
Objective: To design and manufacture the embedded branched stent-grafts toreconstruct aortic arch in canine by completely endovascular repair. To researchthe interventional method, feasibility and effectiveness. To provid the stent-graftsdesign proposal for the reconstruction of human aortic arch and finish thepreliminary empirical study for the new product development.
Methods:
1. Measurement of canine aortic arch: Six25~30kg male hybird canines werechosed. By the angiography and anatomy, we measured the length and diameter ofascending aorta, aortic arch, branch vessel of aortic arch and descending aortarespectively.
2. Designment and Manufacture: According to the assembled data, the shape ofthe embeded branched stent-grafts and delivery system were formulated. Thisstent-graft system includes main body with embeded branched stent-graft and sidebranch stent-grafts. They were suctured with Ni-Ti thread and PET graft. Thesystem was manufactured in MicroPort Scientific Corporation (Shanghai).
3. Feasibility and observation of therapeutic effect:①Simple branched system:2male dogs, right axillary artery and abdominal aorta were exposed by openoperation. Directed by X-ray, the main body was inserted from AA. Then the wirewas selected into the embeded stent-graft. The side branch stent-graft was insertedand released to reconduct the innominate artery.②Double branched system:5male dogs, bilateral axillary artery and abdominal aorta were exposed by openoperation. The main body was inserted from AA. Then the wires were selectedinto the embeded stent-grafts. The side branch stent-grafts were inserted andreleased to reconduct the innominate artery and LSA.③Endoleak, morphology,migration, and pressure difference between ascending aorta and descending aorta were observed after the reconstruction.
Results:The technical success of single branched system was100%, the mean bleedingvolume was60ml. The technical success of double branched system was60%(3/5), the mean bleeding volume was (130.3±8.7) ml. The reasons of failed caseswere LSA can not be reconstructed and CCA were covered.One case existed typeⅠendoleak for the stent-graft was smaller. The successful5cases got nice result. The morphology, position and radiography were satisfied.The difference of pressure between ascending aorta and descending aorta were5mmHg (single branch) and12mmHg (double branch).
Conclusions: The design of embeded branched stent-graft is reasonable, itsmanufacture technology is mature and manipulation is practicable. The singlebranched system is simpler, but in human the RCCA-LCCA-LSA bypass isnecessary. The double branched system is more difficult, but in human it cancompletely endovascular reconstruct the aortic arch. This study has importantguiding significance for clinical applications. The design and manufacturetechnology need to be improved in the future. Long term result research isnecessary.
方法：
1.犬主动脉弓数据测量：选取体重25~30kg的雄性杂种犬6只，通过血管造影和尸体解剖，了解其升主动脉、主动脉弓、分支动脉、降主动脉等部位的解剖特点，并测量各血管的长度及直径。
2.内嵌式支架的设计与制作：根据采集的数据设计并制作适合于重建犬主动脉弓的内嵌式分支支架及输送器。该系统由带内嵌式分支的主体及侧支组成，以聚酯膜通过不可吸收的缝合线与多个自扩张的镍钛合金支架段缝合而成。支架型血管由上海微创医疗器械有限公司按照临床标准制作完成。
3.可行性及疗效观察：①单分支实验研究：雄性杂种犬2只，经腹主动脉释放主体支架，自右侧腋动脉选择性进入主体分支，然后释放侧支支架；②双分支实验研究：雄性杂种犬5只，经腹主动脉释放主体支架，经双侧腋动脉分别选择性进入主体分支，然后释放侧支支架；③对术中支架的定位和释放情况进行总结，观察内漏、支架形态，测量支架释放后升主动脉与降主动脉的压差。
结果：
手术情况：单分支支架技术成功率为100％，平均失血量60ml。双分支支架技术成功率为60%（3/5），平均失血量(130.3±8.7) ml，技术未成功的两例的原因分别是左锁骨下动脉重建失败和支架覆盖双侧颈动脉。
治疗效果：1例因主体支架直径过小，存在近端I型内漏；5例手术成功术后DSA检查显示各移植物位置及形态良好，分支血管通畅。
压力测量：单分支植入后升、降主动脉平均压差为5mmHg，双分支为12mmHg。
结论：内嵌式支架型血管系统结构设计合理，制备工艺成熟，操作切实可行；单分支支架技术成功率更高，但对于人体需要结合颈部血管旁路术；双分支支架操作难度较大，但可以实现完全腔内技术重建主动脉弓；其对临床应用具有十分重要的指导意义；产品设计和生产工艺需要进一步完善，远期结果有待观察。
Objective: To design and manufacture the embedded branched stent-grafts toreconstruct aortic arch in canine by completely endovascular repair. To researchthe interventional method, feasibility and effectiveness. To provid the stent-graftsdesign proposal for the reconstruction of human aortic arch and finish thepreliminary empirical study for the new product development.
Methods:
1. Measurement of canine aortic arch: Six25~30kg male hybird canines werechosed. By the angiography and anatomy, we measured the length and diameter ofascending aorta, aortic arch, branch vessel of aortic arch and descending aortarespectively.
2. Designment and Manufacture: According to the assembled data, the shape ofthe embeded branched stent-grafts and delivery system were formulated. Thisstent-graft system includes main body with embeded branched stent-graft and sidebranch stent-grafts. They were suctured with Ni-Ti thread and PET graft. Thesystem was manufactured in MicroPort Scientific Corporation (Shanghai).
3. Feasibility and observation of therapeutic effect:①Simple branched system:2male dogs, right axillary artery and abdominal aorta were exposed by openoperation. Directed by X-ray, the main body was inserted from AA. Then the wirewas selected into the embeded stent-graft. The side branch stent-graft was insertedand released to reconduct the innominate artery.②Double branched system:5male dogs, bilateral axillary artery and abdominal aorta were exposed by openoperation. The main body was inserted from AA. Then the wires were selectedinto the embeded stent-grafts. The side branch stent-grafts were inserted andreleased to reconduct the innominate artery and LSA.③Endoleak, morphology,migration, and pressure difference between ascending aorta and descending aorta were observed after the reconstruction.
Results:The technical success of single branched system was100%, the mean bleedingvolume was60ml. The technical success of double branched system was60%(3/5), the mean bleeding volume was (130.3±8.7) ml. The reasons of failed caseswere LSA can not be reconstructed and CCA were covered.One case existed typeⅠendoleak for the stent-graft was smaller. The successful5cases got nice result. The morphology, position and radiography were satisfied.The difference of pressure between ascending aorta and descending aorta were5mmHg (single branch) and12mmHg (double branch).
Conclusions: The design of embeded branched stent-graft is reasonable, itsmanufacture technology is mature and manipulation is practicable. The singlebranched system is simpler, but in human the RCCA-LCCA-LSA bypass isnecessary. The double branched system is more difficult, but in human it cancompletely endovascular reconstruct the aortic arch. This study has importantguiding significance for clinical applications. The design and manufacturetechnology need to be improved in the future. Long term result research isnecessary.
引文
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