人工双叶机械瓣设计与制造
摘要
本论文的内容是关于一种新型的双叶人工心脏瓣膜的设计与制造，可划分为三个主要部分：人工心瓣的结构设计，制造及装配工艺。
本文的研究工作是对国内外诸多瓣膜产品进行深入分析研究的基础上开展的，为了克服人工心脏瓣膜存在的各种弊端，本文提出了三种结构形式的双叶瓣，并就各种结构形式的特点进行分析比较。如圆孔型心瓣，几何结构简单，加工工艺性较优越，但在枢轴部分有血液冲刷死区，易产生血栓的隐患，而轴突式瓣环枢轴结构可减少血栓形成机率，但制造难度比圆孔型心瓣大大增加。最后，择优选出几种较理想的结构投料试制。
考虑到时间进程和经费因素，初步选定进行8字型凹槽枢轴结构平面瓣型及圆柱孔枢轴圆孔型心瓣进行试制加工，本论文工作的重点是人工心脏瓣膜的结构设计，工艺和工艺装备设计，以及人工心脏瓣膜试制。因此，详细地介绍了瓣架、瓣叶的结构设计；瓣架、瓣叶的制造工艺和工艺装备设计。完成的心脏瓣膜产品图纸、工艺和工艺装备，经试制过程考核验证，是正确的和可行的，达到了论文工作的预期目标，所作的探索，为人工心瓣的系列化设计，批量生产以及进一步研究奠定了良好的基础。
The thesis is about the design and manufacture of a new type of artificial heart valve. It can be divided into three main parts: construction of the artificial heart valve design, manufacture and assembly process.
This study is based on the analyses of a series of different types of artificial heart valve in home and abroad. To overcome the shortcoming of existed artificial heart valve, several forms of bileaflet mechanical heart valve are developed. After a thorough comparison and analysis of the characters of these forms, some ideal structures are selected to be manufactured.
In consideration of time and budget factor, the first step is to manufacture 8-type (groove axle structure) and circle bore type mechanical heart valve. Here, the concentration is on the structure design, process and process equipment design, and manufacture of valve on a trial basis. So the structure design of stent and leaflet, manufacture process and the process equipment design is introduced in detail.
The product drawings and processes are tested . The good of the Thesis is reached. The thesis form an excellent base of the series design, production and research of the artificial heart valve.
本文的研究工作是对国内外诸多瓣膜产品进行深入分析研究的基础上开展的，为了克服人工心脏瓣膜存在的各种弊端，本文提出了三种结构形式的双叶瓣，并就各种结构形式的特点进行分析比较。如圆孔型心瓣，几何结构简单，加工工艺性较优越，但在枢轴部分有血液冲刷死区，易产生血栓的隐患，而轴突式瓣环枢轴结构可减少血栓形成机率，但制造难度比圆孔型心瓣大大增加。最后，择优选出几种较理想的结构投料试制。
考虑到时间进程和经费因素，初步选定进行8字型凹槽枢轴结构平面瓣型及圆柱孔枢轴圆孔型心瓣进行试制加工，本论文工作的重点是人工心脏瓣膜的结构设计，工艺和工艺装备设计，以及人工心脏瓣膜试制。因此，详细地介绍了瓣架、瓣叶的结构设计；瓣架、瓣叶的制造工艺和工艺装备设计。完成的心脏瓣膜产品图纸、工艺和工艺装备，经试制过程考核验证，是正确的和可行的，达到了论文工作的预期目标，所作的探索，为人工心瓣的系列化设计，批量生产以及进一步研究奠定了良好的基础。
The thesis is about the design and manufacture of a new type of artificial heart valve. It can be divided into three main parts: construction of the artificial heart valve design, manufacture and assembly process.
This study is based on the analyses of a series of different types of artificial heart valve in home and abroad. To overcome the shortcoming of existed artificial heart valve, several forms of bileaflet mechanical heart valve are developed. After a thorough comparison and analysis of the characters of these forms, some ideal structures are selected to be manufactured.
In consideration of time and budget factor, the first step is to manufacture 8-type (groove axle structure) and circle bore type mechanical heart valve. Here, the concentration is on the structure design, process and process equipment design, and manufacture of valve on a trial basis. So the structure design of stent and leaflet, manufacture process and the process equipment design is introduced in detail.
The product drawings and processes are tested . The good of the Thesis is reached. The thesis form an excellent base of the series design, production and research of the artificial heart valve.
引文
[1]张宝仁，朱家麟．人造心脏瓣膜置换术(第二版)．北京：人民卫生出版社，1993
[2]杨子彬．人工心脏瓣膜研究进展．现代临床医学工程杂志，1995，1
[3]杨子彬．生物医学工程学．黑龙江科学技术出版社，2000
[4]MICHAEL SZYCHER.PH.D AND STEVEN J.LEE,J.D.MBA:Cardiovascular Devices for the 1990s JOURNAL OF BLOMATERIALS APPLICATIONS VOLUME8-July, 1993
[5]YOSR A.M. HAGGAG, B.Sc.(Eng), M .Eng., Ph.D., P.E. An Overview of Materials Considerations for Prosthetic Cardiac Valves. Journal of Clinical Engineering Vol. 14, No.3, May-June, 1989
[6]R.O. Ritchie P. Lubock Fatigue Life Estimation Procedures, for the Endurance of a Cardiac Valve Prosthesis: Stress/Life and Damage-Tolerant Analyses Journal of Biomechanical Engineering MAY 1986,Vol. 108/153
[7]Cooley, D.A., (1977), The quest for the perfect prosthetic heart valve, J. Assoc. Adv. Med. Instrum., 11(2):82-84
[8]Richord GJ, Beavan AL, Strzepa P: Cavitation threshold ranking and erosion characteristics of heart valve prostheses, The 4th international clinical symposium, Barcelona 1993
[9]Erickson RL, Thulin LI, Richard GJ: Mechanical heart valve sound Louolneess-An in vitro study. J Heart Valve Dis 1994
[10]Carrier M, Martineau JP, Bonan R. clinical and hemodynamic assessment of the omniscience Prosthetic heart valve, J Thor Cardiovasc Surg, 1987
[11]Czer LS, Chaux A, Matlofl JM, et al: Ten-year experience with St. Jude Medical valve for primary valve replacement. J thorac Cardiovasc Surg 1990
[12]John H, Fielder Ethical Issues in Biomedical Engineering: The Bjork-Shiley Heart Valve IEEE ENGINEERING IN MEDICINE AND BIOLOGY March 1991
[13]R. Heiliger, J.Geks, Ch. Mittermayer Preliminary Results of a Comparative Test of Mechanical Bileaflet Valves and Tilting Disc Valves Biomediznische Thechnik Band31 Heft 7-8/1986
[14]Birol Yamak, Erol Sener, Ugursay Kiziltepes, Kamil Gol, Onurcan Tartan, Binali Mavitas, Oguz Tasdemir, Kemal Bayazit Low Dose Anticoagulation after St. Jude Medical Prosthesis Implantation in Patients Under 18 Years of Age. J Heart Valve Dis Vol.4.No.3 May 1995
[15]Wells SA: Aortic Valve replacement. Curr Probl Surg. XXX(7),1993
[16]R. Heiliger, J. Geks and C. Mittermayer, RESUTS OF A COMPARATIVE IN VITRO STUDY OF DUROMEDICS AND BJORK-SHILEY MONOSTRUT MITRAL HEART VALVE PROSTHESES. J. Biomed. Eng. 1987, Vol. 9, April
[17]T. GRAF, H. FISCHER, H. REUL, G. RAU, Cavitation potential of mechanical heart valve prostheses, The International Journal of Artificial Organs/Vol. 14/no. 3, 1991
[18]Helmut Reul, Ulrich Steinseifer, Martin Knoch, Gunter Ran, Development,Manufacturing and Validation of a Single-Leaflet Mechanical Heart Valve Prosthesis. J Heart Valve Dis Vol. 4. No. 5 September 1995
[19]田兴丽．人工心脏膜优化设计与制造道德．学士学位论文．西南交通大学机械工程学院，2000
[20]张云运．人工心脏瓣膜CAD设计与制造．硕士学位论文．西南交通大学机械工程学院，2001
[21]朱家麟、张宝仁、蔡用之等．国产侧倾碟瓣1013例临床应用经验．中华心血管病杂志1992
[22]田子朴，罗传兴，黄旭中等．双叶机械瓣的研制和临床应用初步报告．中华胸心血管外科杂志1992
[23]康振黄．心瓣流体动力学．成都：四川教育出版社，1991
[24][美]布鲁克斯，丁夫译校．有色合金的热处理组织与性能，北京：冶金工业出版社，1988
[25]张宝昌．有色金属及其热处理．西安：西北工业大学出版社，1993
[26]仇启源，庞思勤．现代金属切削技术．北京：机械工业出版社，1992
[27]董春玲，吴国梁等．电子精密机械制造工艺学．成都：电子科技大学出版社，1994
[28]邹盛铨．血流动力学与血管人工器官．成都：成都科技大学出版社，1991
[29]美国可切削性数据中心．机械加工切削数据手册．北京：机械工业出版社，1989
[30]袁哲俊．金属切削刀具．上海：上海科学技术出版社，1987
[31]黄天铭．机械制造工艺学．重庆：重庆大学出版社，1991
[32]顾崇衔．机械制造工艺(第三版)．西安：陕西科学技术出版社，1997
[33]徐发仁．机床夹具设计，重庆：重庆大学出版社，1993
[34]李庆华．材料力学．成都：西南交通大学出版社，1994
[35]虞莲莲．实用有色金属材料手册．北京：机械工业出版社．2001
[36]余承业．航天制造工程手册，特种加工公司．北京：航天工业出版社，1993
[37]赵如福．金属机械加工工艺人员手册．上海：上海科学技术出版社，1990
[38]上海市金属切削技术协会．金属切削手册．上海：上海科学技术出版社，1984
[39]王先逵．精密加工技术实用手册．北京：机械工业出版社，2001
[40]刘晋春，赵家齐．特种加工．北京：机械工业出版社，1994
[41]陈传良主编．特种加工技术．北京：科学技术出版社，1989
[42]王先逵主编．机械制造工艺学．北京：机械工业出版社，1995
[43]刘正埙．我国特种加工技术的最新进展．电加工，1999，(5)
[44]赵万生等．国外特种加工技术的最新进展．电加工，1999，(5)
[45]孟少农主编．机械加工工艺手册：第2卷·北京：机械工业出版社，1991
[46]卡兹马莱科J著．切削、磨料与腐蚀加工原理．高希正、刘德忠等译．北
京：机械工业出版社，1985
[47]李洪主编．机械加工技术手册．北京：北京出版社，1989
[48]王启平等编者．精密加工工艺学．北京：国防工业出版社，1990
[49]袁哲俊编著．精密和超精密加工技术．哈尔滨：哈尔滨工业大学出版社，1990
[50]袁哲俊，王先逵．精密和超精密加工技术．北京：机械工业出版社，1999
[51](日)微细加工技术编辑委员会．微细加工技术．朱怀义，赵巾奎译．北京：清华大学出版社，1983
[2]杨子彬．人工心脏瓣膜研究进展．现代临床医学工程杂志，1995，1
[3]杨子彬．生物医学工程学．黑龙江科学技术出版社，2000
[4]MICHAEL SZYCHER.PH.D AND STEVEN J.LEE,J.D.MBA:Cardiovascular Devices for the 1990s JOURNAL OF BLOMATERIALS APPLICATIONS VOLUME8-July, 1993
[5]YOSR A.M. HAGGAG, B.Sc.(Eng), M .Eng., Ph.D., P.E. An Overview of Materials Considerations for Prosthetic Cardiac Valves. Journal of Clinical Engineering Vol. 14, No.3, May-June, 1989
[6]R.O. Ritchie P. Lubock Fatigue Life Estimation Procedures, for the Endurance of a Cardiac Valve Prosthesis: Stress/Life and Damage-Tolerant Analyses Journal of Biomechanical Engineering MAY 1986,Vol. 108/153
[7]Cooley, D.A., (1977), The quest for the perfect prosthetic heart valve, J. Assoc. Adv. Med. Instrum., 11(2):82-84
[8]Richord GJ, Beavan AL, Strzepa P: Cavitation threshold ranking and erosion characteristics of heart valve prostheses, The 4th international clinical symposium, Barcelona 1993
[9]Erickson RL, Thulin LI, Richard GJ: Mechanical heart valve sound Louolneess-An in vitro study. J Heart Valve Dis 1994
[10]Carrier M, Martineau JP, Bonan R. clinical and hemodynamic assessment of the omniscience Prosthetic heart valve, J Thor Cardiovasc Surg, 1987
[11]Czer LS, Chaux A, Matlofl JM, et al: Ten-year experience with St. Jude Medical valve for primary valve replacement. J thorac Cardiovasc Surg 1990
[12]John H, Fielder Ethical Issues in Biomedical Engineering: The Bjork-Shiley Heart Valve IEEE ENGINEERING IN MEDICINE AND BIOLOGY March 1991
[13]R. Heiliger, J.Geks, Ch. Mittermayer Preliminary Results of a Comparative Test of Mechanical Bileaflet Valves and Tilting Disc Valves Biomediznische Thechnik Band31 Heft 7-8/1986
[14]Birol Yamak, Erol Sener, Ugursay Kiziltepes, Kamil Gol, Onurcan Tartan, Binali Mavitas, Oguz Tasdemir, Kemal Bayazit Low Dose Anticoagulation after St. Jude Medical Prosthesis Implantation in Patients Under 18 Years of Age. J Heart Valve Dis Vol.4.No.3 May 1995
[15]Wells SA: Aortic Valve replacement. Curr Probl Surg. XXX(7),1993
[16]R. Heiliger, J. Geks and C. Mittermayer, RESUTS OF A COMPARATIVE IN VITRO STUDY OF DUROMEDICS AND BJORK-SHILEY MONOSTRUT MITRAL HEART VALVE PROSTHESES. J. Biomed. Eng. 1987, Vol. 9, April
[17]T. GRAF, H. FISCHER, H. REUL, G. RAU, Cavitation potential of mechanical heart valve prostheses, The International Journal of Artificial Organs/Vol. 14/no. 3, 1991
[18]Helmut Reul, Ulrich Steinseifer, Martin Knoch, Gunter Ran, Development,Manufacturing and Validation of a Single-Leaflet Mechanical Heart Valve Prosthesis. J Heart Valve Dis Vol. 4. No. 5 September 1995
[19]田兴丽．人工心脏膜优化设计与制造道德．学士学位论文．西南交通大学机械工程学院，2000
[20]张云运．人工心脏瓣膜CAD设计与制造．硕士学位论文．西南交通大学机械工程学院，2001
[21]朱家麟、张宝仁、蔡用之等．国产侧倾碟瓣1013例临床应用经验．中华心血管病杂志1992
[22]田子朴，罗传兴，黄旭中等．双叶机械瓣的研制和临床应用初步报告．中华胸心血管外科杂志1992
[23]康振黄．心瓣流体动力学．成都：四川教育出版社，1991
[24][美]布鲁克斯，丁夫译校．有色合金的热处理组织与性能，北京：冶金工业出版社，1988
[25]张宝昌．有色金属及其热处理．西安：西北工业大学出版社，1993
[26]仇启源，庞思勤．现代金属切削技术．北京：机械工业出版社，1992
[27]董春玲，吴国梁等．电子精密机械制造工艺学．成都：电子科技大学出版社，1994
[28]邹盛铨．血流动力学与血管人工器官．成都：成都科技大学出版社，1991
[29]美国可切削性数据中心．机械加工切削数据手册．北京：机械工业出版社，1989
[30]袁哲俊．金属切削刀具．上海：上海科学技术出版社，1987
[31]黄天铭．机械制造工艺学．重庆：重庆大学出版社，1991
[32]顾崇衔．机械制造工艺(第三版)．西安：陕西科学技术出版社，1997
[33]徐发仁．机床夹具设计，重庆：重庆大学出版社，1993
[34]李庆华．材料力学．成都：西南交通大学出版社，1994
[35]虞莲莲．实用有色金属材料手册．北京：机械工业出版社．2001
[36]余承业．航天制造工程手册，特种加工公司．北京：航天工业出版社，1993
[37]赵如福．金属机械加工工艺人员手册．上海：上海科学技术出版社，1990
[38]上海市金属切削技术协会．金属切削手册．上海：上海科学技术出版社，1984
[39]王先逵．精密加工技术实用手册．北京：机械工业出版社，2001
[40]刘晋春，赵家齐．特种加工．北京：机械工业出版社，1994
[41]陈传良主编．特种加工技术．北京：科学技术出版社，1989
[42]王先逵主编．机械制造工艺学．北京：机械工业出版社，1995
[43]刘正埙．我国特种加工技术的最新进展．电加工，1999，(5)
[44]赵万生等．国外特种加工技术的最新进展．电加工，1999，(5)
[45]孟少农主编．机械加工工艺手册：第2卷·北京：机械工业出版社，1991
[46]卡兹马莱科J著．切削、磨料与腐蚀加工原理．高希正、刘德忠等译．北
京：机械工业出版社，1985
[47]李洪主编．机械加工技术手册．北京：北京出版社，1989
[48]王启平等编者．精密加工工艺学．北京：国防工业出版社，1990
[49]袁哲俊编著．精密和超精密加工技术．哈尔滨：哈尔滨工业大学出版社，1990
[50]袁哲俊，王先逵．精密和超精密加工技术．北京：机械工业出版社，1999
[51](日)微细加工技术编辑委员会．微细加工技术．朱怀义，赵巾奎译．北京：清华大学出版社，1983