基于电刺激的无线家用电子尿失禁治疗仪的研究
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摘要
尿失禁是公认的影响人类健康的五大疾病之一。目前,在我国女性尿失禁发病率占总人口的40%以上。但由于尿失禁牵扯到个人隐私,很多患者不愿去医院就医,而国内现有医疗资源很难为患者提供安全、隐蔽的治疗条件,国外公司生产的便携式尿失禁治疗产品,价格昂贵且都为有线式设计,构造方面的原因使得患者在治疗过程中存在暴露问题。因此,研制一种既方便安全,又能保护患者隐私的尿失禁治疗仪显得愈发紧迫。
本课题基于尿失禁的发病机理,在分析总结国内外类似装置的基础上,自主研发了一种新型的无线便携式尿失禁治疗仪(以下简称:治疗仪)。该治疗仪包括电刺激探头和控制调节器。电刺激探头插入妇女骨盆内特定位置后,发出电脉冲对相应肌肉组织进行刺激,以达到应有的治疗效果,使之恢复正常机能。控制调节器用来控制电脉冲的幅度、频率和波形,使治疗最为有效。
本设计的创新点有:首先,将无线射频技术结合单片机技术应用于肌电刺激,实现了控制器与探头之间的无线通信,避免了使用导联带来的种种不便。其次,对传统电刺激波形进行了优化,并将其应用于该治疗仪,提升了治疗仪的治疗效果。再次,高集成度的探头设计,使治疗仪成为真正意义上的便携式仪器。此外,采用了智能处理措施,设计出独特的探头电源管理和充电方案,简化了治疗仪的操作,并保证其长期可靠的工作。
本文将从尿失禁及尿失禁治疗仪的背景及发展情况出发,介绍女性尿失禁的发病机理、分类及各种现有的治疗方法,分析、对比各种治疗方法及现有仪器的优劣后,并着重讨论治疗仪的设计思路方案,包括以下主要工作:系统的总体方案及各功能模块进行设计;探头与控制器之间无线通讯与控制系统的设计及开发;探头内+5V~+60V升压模块设计与开发;刺激波形的优化设计与实现;控制器内充电方案及友好人机界面的设计;探头刺激工作电路与充电电路之间切换电路的设计与实现。
Urinary Incontinence (UI) is one of the five most acknowledged diseases that influence human health. Currently, the incidence of UI is more than 40% of the total female population in china. But this kind of therapy is related to some individual privacy, most of the patients are reluctant to be hospitalized in the hospital. However, the existing medical resource can not supply self-help therapeutic in a safe and private environment. And the portable UI therapeutic apparatus fabricated by oversea companies are too expensive, also they use cabled technique and there exist exposure problems to use these apparatus during the therapy. So there is a great necessity to develop new UI therapeutic equipment that can easily be applicable and solve the problems of the safety and privacy.
This thesis discusses the pathogenesis of UI, analyzes and summarizes the similar equipment domestically and abroad. Then we developed a novel type of Wireless Electrical Stimulation Therapeutic Apparatus for UI (hereinafter called as WESTAUI) allodium. This WESTAUI is made up by two parts: a controller and an electrode probe. When insert the electrode probe into the specific position in the female pelvis, the controller will control the probe to emit electrical impulse via wireless radio frequency communication. The electrical impulse will activate the muscle and apply the akinetic muscle some type of treatments to help the muscle to recover its normal function. The controller also control the swing, the frequency and the shape of the pulse emitted from the electrode, to make the therapy much more efficient.
Our design has following the innovations: firstly, the radio-frequency technique and single chip processor technique are brought up to the neuromuscular electrical stimulation. The WESTAU realized the communication between the controller and the electrical stimulation probe by adopting radio-frequency technique and also avoided kinds of discommodity from the cabled technique. Secondly, it reinforced the curative effect by using the optimized electric stimulative wave in the WESTAUI. Furthermore, we adopts a series of intelligent measures, e.g., the design of the unique scheme of power management, and the battery recharging in the electrode probe, and it simplified the operation of the apparatus and ensure it to work dependably in a long turn.
The organization of this thesis is as follows: I start it with the evolution background of the UI, then I introduce the pathogenesis, the sorts and the existing therapy measures of the female UI. After contrast the quality of different apparatus and therapy measures, the emphasis is put on the discussion on the design scheme of the instrument: including the general system scenario, the design of each functional parts, the wireless communication and control system in the WESTAUI, the optimization of the +5V to +60V boost circuit in the electrode probe, optimization of the design of the stimulation current impulses, the design of the recharging scheme and the friendly interface between the controller and the probe, the design and realization of switching circuit between the stimulation circuit and the recharging circuit.
本课题基于尿失禁的发病机理,在分析总结国内外类似装置的基础上,自主研发了一种新型的无线便携式尿失禁治疗仪(以下简称:治疗仪)。该治疗仪包括电刺激探头和控制调节器。电刺激探头插入妇女骨盆内特定位置后,发出电脉冲对相应肌肉组织进行刺激,以达到应有的治疗效果,使之恢复正常机能。控制调节器用来控制电脉冲的幅度、频率和波形,使治疗最为有效。
本设计的创新点有:首先,将无线射频技术结合单片机技术应用于肌电刺激,实现了控制器与探头之间的无线通信,避免了使用导联带来的种种不便。其次,对传统电刺激波形进行了优化,并将其应用于该治疗仪,提升了治疗仪的治疗效果。再次,高集成度的探头设计,使治疗仪成为真正意义上的便携式仪器。此外,采用了智能处理措施,设计出独特的探头电源管理和充电方案,简化了治疗仪的操作,并保证其长期可靠的工作。
本文将从尿失禁及尿失禁治疗仪的背景及发展情况出发,介绍女性尿失禁的发病机理、分类及各种现有的治疗方法,分析、对比各种治疗方法及现有仪器的优劣后,并着重讨论治疗仪的设计思路方案,包括以下主要工作:系统的总体方案及各功能模块进行设计;探头与控制器之间无线通讯与控制系统的设计及开发;探头内+5V~+60V升压模块设计与开发;刺激波形的优化设计与实现;控制器内充电方案及友好人机界面的设计;探头刺激工作电路与充电电路之间切换电路的设计与实现。
Urinary Incontinence (UI) is one of the five most acknowledged diseases that influence human health. Currently, the incidence of UI is more than 40% of the total female population in china. But this kind of therapy is related to some individual privacy, most of the patients are reluctant to be hospitalized in the hospital. However, the existing medical resource can not supply self-help therapeutic in a safe and private environment. And the portable UI therapeutic apparatus fabricated by oversea companies are too expensive, also they use cabled technique and there exist exposure problems to use these apparatus during the therapy. So there is a great necessity to develop new UI therapeutic equipment that can easily be applicable and solve the problems of the safety and privacy.
This thesis discusses the pathogenesis of UI, analyzes and summarizes the similar equipment domestically and abroad. Then we developed a novel type of Wireless Electrical Stimulation Therapeutic Apparatus for UI (hereinafter called as WESTAUI) allodium. This WESTAUI is made up by two parts: a controller and an electrode probe. When insert the electrode probe into the specific position in the female pelvis, the controller will control the probe to emit electrical impulse via wireless radio frequency communication. The electrical impulse will activate the muscle and apply the akinetic muscle some type of treatments to help the muscle to recover its normal function. The controller also control the swing, the frequency and the shape of the pulse emitted from the electrode, to make the therapy much more efficient.
Our design has following the innovations: firstly, the radio-frequency technique and single chip processor technique are brought up to the neuromuscular electrical stimulation. The WESTAU realized the communication between the controller and the electrical stimulation probe by adopting radio-frequency technique and also avoided kinds of discommodity from the cabled technique. Secondly, it reinforced the curative effect by using the optimized electric stimulative wave in the WESTAUI. Furthermore, we adopts a series of intelligent measures, e.g., the design of the unique scheme of power management, and the battery recharging in the electrode probe, and it simplified the operation of the apparatus and ensure it to work dependably in a long turn.
The organization of this thesis is as follows: I start it with the evolution background of the UI, then I introduce the pathogenesis, the sorts and the existing therapy measures of the female UI. After contrast the quality of different apparatus and therapy measures, the emphasis is put on the discussion on the design scheme of the instrument: including the general system scenario, the design of each functional parts, the wireless communication and control system in the WESTAUI, the optimization of the +5V to +60V boost circuit in the electrode probe, optimization of the design of the stimulation current impulses, the design of the recharging scheme and the friendly interface between the controller and the probe, the design and realization of switching circuit between the stimulation circuit and the recharging circuit.
引文
1杨荣, Raz.下尿路功能性疾患.上海学林出版社.1987:101
2谢瑶洁,何仲,吴欣娟,朱兰.尿失禁患者生活质量研究进展.中国实用护理杂志. 2006, 22(12): 48~50
3 Nemir. A, M iddleton RP.Stress incontinence in young nulliparous women, American Journal of Obstetrics and Gynecology, 68(4): 1166~1168
4 Ouslander JG.Urinary incontinence in nursing homes. Journal of the American geriatrics society.1990, 38:289~291
5吴士良,段继宏,杨勇,那彦群.不同人群的女性尿失禁调查分析,中华泌尿外科杂志. 2004,25(9): 588~58
6段继宏,杨勇,吴士良等.北京地区尿失禁发病率调查.北京医科大学学报.2000, 2:74~75
7宋岩峰,谭燕英,卢昆林,曾华,熊晓燕.沿海地区女性尿失禁流行病学调查.人民军医, 2003, 46(7): 383~385
8 Ishilo O.Hirai L, Sumi T, et al.Ogits S. Hormone replacement therapy plus pelvic floor muscle exercise for postmenopausal stress incontinence. A randomized, controlled trial. J Reprod Med.2001, 46(3):213
9 Sampselle CM, Bums PA, Dougherty MC, et al. Contience for women, evidence-based practice. J Obstet gynecol Neonatal Nurs.1999, 28(6 suppl 1):25
10骆毅,于兰馥.女性泌尿科学.人民卫生出版社. 1987, 72~79
11 Paul Abrams.尿动力学.第2版.人民卫生出版社. 1999, 238
12 Kralj B. Conservative treatment of female stress urinary incontinence with functional electrical stimulation. Eur J Obsetet Gynecol Reprod Biol. 1999, 85(1):56~56
13 Sung Ms, Hong JY, Cboi YH, et al.FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci. 2000, 15(3):303~308
14 Grill WM,Craggs MD, Foreman RD, et al. Emerging clinical applications of electrical stimulation:opportunities for restoration of function.J Rehavil Res Dev, 2001,38(6):641~653
15 Indrekvam S.Sandvik H, Hunskaar S.A Norwegian national cobort of 3198women treated with home-managed electrical stimulation for urinary incontinence-effectiveness and treatment results. Scand J UrolNephrol, 2001, 35(1):32~39
16 Jeyaseelan SM, Oldham JA.Electrical stimulation as a treatment for stress incontinence.Br J Nurs.2000, 9(15):1001~1007
17 Jeyaseelan SM, Haslam EJ, Winstanley J, et al.An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence a randomized, double–blind, controlled trial, Clin Rehabil.2000.14(6):631~640
18姚学俊,韩真.直流感应电治疗压力性尿失禁江苏医药.1998, 24(12):923
19苏静,文建国,王庆伟,张鹏,刘奎,张瑞莉.电刺激盆底肌治疗女性真性压力性尿失禁效果及尿动力学变化.郑州大学学报(医学版).2006, 41(2):204~206
20 Caputo RM, Benson JT, MeClellan E, Intravaginal maximal electrical stimulation in the treatment of urinary incontinence. J Report Med. 1993, 38(9):667~671
21 SuIlg MS, Choi YH, Back SH, Hong JY, Yon H.The effect of pevic floor muscle exercise penuine stress incontinence among Korean women–focusing on effects on the quality of life.Yonsei Med J.2000, 41(2):237~251.
22贺石林,李俊成,秦晓群.临床生理学.北京科学出版社,2001: 67~68
23张丽君,黄爱萍.女性压力性尿失禁的非手术治疗.山东医药.2006:46(24)
24 Schafer W, Abrams P, Liao LM, et a1.Good urodynamic practices: uroflowmetry, filling cystometry, and pressure.flow studies.Neurourol Urodyna.2002, 21(3):261
25 Liberson W, et al. Functional electrotherapy: stimulation of the peroneal never synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961, 42:01-105
26王晓玉,罗新.女性尿失禁盆底复健的行为治疗和物理治疗.实用妇产科杂志. 2005,21(3): 42~143.
27张军卫,靳风烁.盆底肌电刺激在女性尿失禁治疗中的应用.中华物理医学与康复杂志. 2004, 26(6):344~346
28女性尿失禁非手术治疗学术研讨会会议纪要.中国妇产科临床杂志. 2004, 5(1): 5~15.
29 Kralj B.Conservative treatment of female stress urinary incontinence withfunctional electrical stimulation. Eur J Obstet Gynecol Reprod Biol. 1999, 85(1):53~56
30郭应禄,杨勇.尿失禁.山东科学技术出版社. 2003:203~210
31顾正,林家瑞,原芸,黄晓琳,华小梅.电刺激技术在运动康复中的应用研究.中国临床康复.2002, 6(l9)2827~2828
32 Dolan LM, HoskerGL, MaUettVT, et a1. Stressincontinence and pelvic floor neurophysiology 15 years after the first dehvery. Br J Obstet Gynae-col, 2003, 110:l107~1114
33林志商,项平,陈黎明.微电刺激仪在治疗妇女尿失禁之临床应用.医疗装备. 2003, 16(5):25~28
34 Nager CW, Schulz JA, Stanton SL, et a1. Correlation of Urethral closure pressure, leak-point pressure and incontinence severity measures. Int Urogynecol J Pelvic Floor Dys- funct, 2001, 12(6):395
35 Groves DA, Bowman EM, Brown VJ.Recordings from the ratlocus coeruleus during acute vagal nerve stimulation in theanaesthetised rat.Neurosci Lett 2005, 379:174~179.
36熊杰锋,刁颖敏, UC2577升压控制电路及其在膀胱功能电刺激器上的应用.电子器件应用. 2003, 5(1):53-55
37范能胜,便携式尿失禁电刺激治疗仪的研制.现代医学仪器与应用. 2007, 19(2):69-71
38 Dallas Semiconductor Data Book, DS18B20 Data Sheet.
39 DALLAS DS18B20数据手册[Z]http://www.maximic.com
40 Elias MFM, Nor KM, Rahim NA, et al. Lithium-ion battery charger for high energy application. Power Engineering Conference. 2003, 283-288
41 Texas Instruments.LM317 3-Terminal Adjustable Regulator[EB/OL] http://www.21icsearch.com/so.asp. (2001-12)[2008-03-03]
42蔡惟铮,杨春玲,集成电子技术.高等教育出版社. 2004:317~319
2谢瑶洁,何仲,吴欣娟,朱兰.尿失禁患者生活质量研究进展.中国实用护理杂志. 2006, 22(12): 48~50
3 Nemir. A, M iddleton RP.Stress incontinence in young nulliparous women, American Journal of Obstetrics and Gynecology, 68(4): 1166~1168
4 Ouslander JG.Urinary incontinence in nursing homes. Journal of the American geriatrics society.1990, 38:289~291
5吴士良,段继宏,杨勇,那彦群.不同人群的女性尿失禁调查分析,中华泌尿外科杂志. 2004,25(9): 588~58
6段继宏,杨勇,吴士良等.北京地区尿失禁发病率调查.北京医科大学学报.2000, 2:74~75
7宋岩峰,谭燕英,卢昆林,曾华,熊晓燕.沿海地区女性尿失禁流行病学调查.人民军医, 2003, 46(7): 383~385
8 Ishilo O.Hirai L, Sumi T, et al.Ogits S. Hormone replacement therapy plus pelvic floor muscle exercise for postmenopausal stress incontinence. A randomized, controlled trial. J Reprod Med.2001, 46(3):213
9 Sampselle CM, Bums PA, Dougherty MC, et al. Contience for women, evidence-based practice. J Obstet gynecol Neonatal Nurs.1999, 28(6 suppl 1):25
10骆毅,于兰馥.女性泌尿科学.人民卫生出版社. 1987, 72~79
11 Paul Abrams.尿动力学.第2版.人民卫生出版社. 1999, 238
12 Kralj B. Conservative treatment of female stress urinary incontinence with functional electrical stimulation. Eur J Obsetet Gynecol Reprod Biol. 1999, 85(1):56~56
13 Sung Ms, Hong JY, Cboi YH, et al.FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci. 2000, 15(3):303~308
14 Grill WM,Craggs MD, Foreman RD, et al. Emerging clinical applications of electrical stimulation:opportunities for restoration of function.J Rehavil Res Dev, 2001,38(6):641~653
15 Indrekvam S.Sandvik H, Hunskaar S.A Norwegian national cobort of 3198women treated with home-managed electrical stimulation for urinary incontinence-effectiveness and treatment results. Scand J UrolNephrol, 2001, 35(1):32~39
16 Jeyaseelan SM, Oldham JA.Electrical stimulation as a treatment for stress incontinence.Br J Nurs.2000, 9(15):1001~1007
17 Jeyaseelan SM, Haslam EJ, Winstanley J, et al.An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence a randomized, double–blind, controlled trial, Clin Rehabil.2000.14(6):631~640
18姚学俊,韩真.直流感应电治疗压力性尿失禁江苏医药.1998, 24(12):923
19苏静,文建国,王庆伟,张鹏,刘奎,张瑞莉.电刺激盆底肌治疗女性真性压力性尿失禁效果及尿动力学变化.郑州大学学报(医学版).2006, 41(2):204~206
20 Caputo RM, Benson JT, MeClellan E, Intravaginal maximal electrical stimulation in the treatment of urinary incontinence. J Report Med. 1993, 38(9):667~671
21 SuIlg MS, Choi YH, Back SH, Hong JY, Yon H.The effect of pevic floor muscle exercise penuine stress incontinence among Korean women–focusing on effects on the quality of life.Yonsei Med J.2000, 41(2):237~251.
22贺石林,李俊成,秦晓群.临床生理学.北京科学出版社,2001: 67~68
23张丽君,黄爱萍.女性压力性尿失禁的非手术治疗.山东医药.2006:46(24)
24 Schafer W, Abrams P, Liao LM, et a1.Good urodynamic practices: uroflowmetry, filling cystometry, and pressure.flow studies.Neurourol Urodyna.2002, 21(3):261
25 Liberson W, et al. Functional electrotherapy: stimulation of the peroneal never synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961, 42:01-105
26王晓玉,罗新.女性尿失禁盆底复健的行为治疗和物理治疗.实用妇产科杂志. 2005,21(3): 42~143.
27张军卫,靳风烁.盆底肌电刺激在女性尿失禁治疗中的应用.中华物理医学与康复杂志. 2004, 26(6):344~346
28女性尿失禁非手术治疗学术研讨会会议纪要.中国妇产科临床杂志. 2004, 5(1): 5~15.
29 Kralj B.Conservative treatment of female stress urinary incontinence withfunctional electrical stimulation. Eur J Obstet Gynecol Reprod Biol. 1999, 85(1):53~56
30郭应禄,杨勇.尿失禁.山东科学技术出版社. 2003:203~210
31顾正,林家瑞,原芸,黄晓琳,华小梅.电刺激技术在运动康复中的应用研究.中国临床康复.2002, 6(l9)2827~2828
32 Dolan LM, HoskerGL, MaUettVT, et a1. Stressincontinence and pelvic floor neurophysiology 15 years after the first dehvery. Br J Obstet Gynae-col, 2003, 110:l107~1114
33林志商,项平,陈黎明.微电刺激仪在治疗妇女尿失禁之临床应用.医疗装备. 2003, 16(5):25~28
34 Nager CW, Schulz JA, Stanton SL, et a1. Correlation of Urethral closure pressure, leak-point pressure and incontinence severity measures. Int Urogynecol J Pelvic Floor Dys- funct, 2001, 12(6):395
35 Groves DA, Bowman EM, Brown VJ.Recordings from the ratlocus coeruleus during acute vagal nerve stimulation in theanaesthetised rat.Neurosci Lett 2005, 379:174~179.
36熊杰锋,刁颖敏, UC2577升压控制电路及其在膀胱功能电刺激器上的应用.电子器件应用. 2003, 5(1):53-55
37范能胜,便携式尿失禁电刺激治疗仪的研制.现代医学仪器与应用. 2007, 19(2):69-71
38 Dallas Semiconductor Data Book, DS18B20 Data Sheet.
39 DALLAS DS18B20数据手册[Z]http://www.maximic.com
40 Elias MFM, Nor KM, Rahim NA, et al. Lithium-ion battery charger for high energy application. Power Engineering Conference. 2003, 283-288
41 Texas Instruments.LM317 3-Terminal Adjustable Regulator[EB/OL] http://www.21icsearch.com/so.asp. (2001-12)[2008-03-03]
42蔡惟铮,杨春玲,集成电子技术.高等教育出版社. 2004:317~319