CN1713933A - 改进的电刺激治疗病态性肥胖症的方法 - Google Patents
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Abstract
本发明提供一种改进的应用电刺激治疗肥胖症尤其是病态性肥胖症的方法。所述方法在小肠上或沿着小肠,优选在十二指肠(30)和/或空肠(40)上或沿着十二指肠(30)和/或空肠(30)提供电刺激,以提供改善的肥胖控制。在一个实施例中,该方法在胃小弯(34)提供刺激,刺激速率约2-30脉冲/分,每次脉冲持续约0.1-4秒,这样,脉冲之间有大约3-30秒的间歇。更优选地,脉冲速率约为12-14次/分,每次脉冲持续大约0.1-0.5秒,脉冲间歇约为4.5-5秒。优选地,脉冲振幅约为0.5-12毫安。更优选地,每次脉冲由一个频率约为5-100Hz的微猝发串组成。
Description
相关申请
本申请基于2002年7月26日提交的序号号为60/398,886的美国临时申请,并要求该申请的优先权,在此将其全文并入以供参考。
发明领域
本发明涉及一种改进的应用电刺激治疗肥胖症尤其病态性肥胖症及其它胃动力失调相关症状的方法。本发明所述的改进的方法在小肠上或毗邻小肠提供电刺激以改善肥胖和其它胃动力失调相关症状的控制。优选十二指肠电刺激。
发明背景
现代外科学对于肥胖的治疗通常需要减少胃顺应性以限制患者消化食物的能力,或通过缩短或绕过部分消化道以减少食物的吸收面积;某些手术同时寻求这两种目的。直到最近,在超出了接近或大于约40BMI(体重(公斤)与身高(米)的平方的比值)的肥胖值的患者中外科手术仍为保证确切效果的唯一治疗方法。
目前应用的所有主要外科方法(例如,切除或阻断胃的一部分)都存在一些即刻的或迟发的危险。因此,外科手术通常被认为是所有侵入性小的方法均失败时的极端措施。而且,即使外科治疗在某些病例也会失败因而需要外科医生重建初始的解剖状态。
最近,一种将电刺激装置植入胃壁的方法被成功使用。例如,美国专利5,423,872(1995年6月13日)提供了一种使用附着于胃窦部或胃大弯的电刺激器或起搏器治疗肥胖症和相关失调的方法。美国专利5,690,691(1997年11月25日)提供了一个可携带或可植入的胃部起搏器,包含位于胃肠道内器官内或外表面的多个单独程控的电极以传送位相性电刺激,使胃肠道组织产生蠕动的运动。虽然这些方法一般来说是成功的,但仍需为这种治疗提供改进的方法。本发明提供了一种这样的改进方法。
发明概述
本发明通过提供至少一个附着于或毗邻小肠或低位肠的电刺激或起搏装置提供一种治疗肥胖症和/或相关动力失调的方法。尤其优选十二指肠电刺激。所述电刺激可以包含相对长的脉冲或脉冲串(即微猝发串)。优选地,本发明的方法采用对十二指肠和/或空肠的刺激。优选地,单独的脉冲速率约为2-30次/分、持续约0.1-4秒,这样脉冲之间有大约3-30秒的间歇。更优选地,脉冲速率约为12-14次/分、每次脉冲持续0.1-0.5秒、脉冲间歇为4.5-5秒。优选地,脉冲振幅约为4.5-15毫安。更优选地,电刺激采用频率约10-100Hz的微猝发串的形式,更优选大约40Hz。
本发明的方法涉及肥胖和其它与患者的胃动力失调相关的症状的治疗。该方法包括使用序列电脉冲为预先设定的时间间期人工激起患者自然的胃运动以阻止或减慢胃排空,从而减慢食物经消化系统的运输。虽然不希望被理论所局限,低位小肠的刺激似乎导致胃的扩张并且由于饱胀感而减少食物的摄入。不希望被理论所局限,小肠的刺激似乎导致(和/或增加)可能抑制胃肠运动并引起饱胀感的胃肠肽的分泌。此外,不希望被理论所局限,小肠刺激似乎还加速小肠的运送并因此减少小肠内的吸收时间。
本发明提供了一种治疗患者胃动力失调的方法,所述方法包含植入至少一个电刺激装置,该装置包含一根或多根电刺激导线和一个连接至脉冲发生器的电连接器,以使所述一根或多根电刺激导线附着于或毗邻小肠,由此电刺激可通过所述一根或多根电刺激导线提供至小肠;并通过所述一根或多根电刺激导线为小肠提供电刺激。
附图简述
图1A是胃的截面图。图1B是胃肠道的截面图,它显示了本发明的装置在小肠的位置。
图2是一个优选的提供给小肠的微猝发脉冲串的示意图(不按比例)。
优选实施方案详述
本发明提供了一种通过提供一个附着于或毗邻小肠的电刺激或起搏装置以使小肠可以被电刺激以治疗肥胖症和/或相关动力失调的方法。通常地,优选电刺激十二指肠和/或空肠尤其优选电刺激十二指肠。在一个特别优选的实施例中,优选电刺激十二指肠和空肠。
优选地,本发明的方法使用低位小肠刺激,刺激速率大约2-30脉冲/分,每次脉冲持续大约0.1-4秒,这样脉冲之间的间歇约为3-30秒。更优选地,脉冲速率约为12-14次/分,每次脉冲持续0.1-0.5秒,脉冲间歇为4.5-5秒。优选地,脉冲振幅约为0.5-15毫安。更优选地,每次脉冲由一个频率约5-100Hz的微猝发串组成。
本发明的方法涉及肥胖和其它与患者胃动力失调相关的症状的治疗。该方法包含在预先设定的时间间期使用序列电脉冲直接对小肠人工发送信号,从而减少食物摄入。电刺激小肠还可以阻止或减慢胃排空,从而减慢食物食物经消化系统的运送并有利于患者产生饱胀感。虽然不希望被理论所局限,这种改善被认为至少部分归因于小肠和胃之间的抑制性生物反馈机制。
本发明的方法提供对小肠的电刺激;优选地电刺激实施于小肠上至少两个部位。电刺激可由单一脉冲或脉冲串组成。通常,优选单一脉冲具有相对较长的持续时间(即约10ms-600ms)。优选地,刺激的频率类似于小肠慢波频率(在人的十二指肠约为12次/分(cpm)、回肠约为8-9cpm)。刺激也可以采取固有频率大约10-100Hz的脉冲串或微猝发串的形式。
为了进一步阐明用于治疗肥胖症和患者胃动力失调相关症状的所述的方法和装置,依据本发明,简短描述胃肠的动力生理学。图1A和1B分别图解了胃和整个胃肠道。如图1A所示,胃10由食道12供给并具有胃底16、贲门18、体部或胃体22、胃窦28、幽门32、十二指肠30(即小肠的起始部分)、和粘膜襞或皱褶26。小弯34和大弯24也被显示。胃10根据其运动性通常分为两部分:胃底16,呈紧张性胃壁运动,和中心部分或胃体22,其特征在于位相性活动。推进性胃运动起始于大弯24近侧的一点,该点在解剖上未明确表示,称为“胃起搏点”20。胃起搏点20以大约3次/分的频率发送电脉冲(除极电位),该电脉冲以波的形式以顺行方向沿着整个胃传播。
胃的胃窦28具有持续的位相性活动,目的是混合进入胃内的食物。食物排入十二指肠是胃窦28、幽门32和十二指肠30协作运动的结果。胃起搏点20自发和自然地产生沿着整个胃传播的正弦波;这些波使胃窦28与幽门32和十二指肠30协作,使食物排入消化道随后的部分(即小肠40和其后的图1B中的大肠38)。
如图1B所示,小肠40通常由十二指肠30、空肠40和回肠42组成;酶促消化和实质上全部的吸收发生在小肠内。回肠42通过回盲瓣54排空食物至大肠38。大肠38的主要特征包括盲肠56、阑尾52、升结肠44、横结肠46、降结肠48、乙状结肠50、肛管58、和最后的肛门60。为了完整也图示了横膈62、脾66、胰腺64、胆囊68和肝脏70。
既然已明确了哺乳动物例如人的胃运动生理,依据本发明的方法在于通过序列电脉冲和在预先设定时间间期电刺激小肠或低位肠,人工发信号引起患者的自然胃运动。更特殊地,序列电脉冲由一个通过腹腔镜放置于小肠的一部分或毗邻小肠的电刺激器产生。优选的电刺激部位包括沿着十二指肠30和空肠40。当然,小肠的其它部分36能使用本发明的方法进行电刺激。
刺激器既能被程控为持续刺激也能被程控为“按需”刺激(即当一个能被刺激器自身通过电导管(如果经过改良以监测电活动)感知的特定电活动发生时或在患者或医疗人员的控制下)。
电刺激器优选地具有预先设定的可以根据所需胃运动的变化和/或根据患者的病理状况而显著改变的工作频率和时间间期。通常,电刺激器具有大约2-30脉冲/分的工作频率。优选地,本发明的方法使用速率为2-30脉冲/分、每次脉冲持续约0.1-4秒从而脉冲之间具有约3-30秒间歇的小肠刺激。电压-控制性刺激每次脉冲的放电可约为1-15伏的范围变化,持续电流刺激每次脉冲的放电可在2-15毫安的范围变化。更优选地,脉冲速率约为12-14次/分、每次脉冲持续大约0.1-0.5秒、脉冲间歇约4.5-5秒。优选地,脉冲振幅约为0.5-15毫安。更优选地,每次脉冲由一个频率约为5-100Hz的微猝发串组成。图2概括地图解了一个优选的提供给低位小肠的微猝发串。
本发明通常使用常规的腹腔镜或微创外科技术将所需一根或多根电刺激装置放置于小肠36上或毗邻小肠36,从而能够实现对小肠36的电刺激。常规的电刺激装置可被用于本发明的实践中。这样的装置包括,例如,那些在以下专利申请中所描述的:美国专利5,423,872(1995年6月3日)(一种可植入于胃窦区的胃的电刺激器,产生序列电脉冲以刺激整个胃,从而人工激起自然的胃运动以阻止排空或减慢食物经胃的运送);美国专利5,690,691(1997年11月25日)(一种可携带或可植入的胃的起搏器,使用多个沿胃大弯分布的电极在不同部位输送位相性电刺激以加速或减弱胃肠道的蠕动运动);美国专利5,836,994(1998年11月7日)(一种可植入的胃的刺激器,并可通过一根或多根预设频率带宽的传感器直接感知胃的内在电活动的功能,以基于被感知的电活动的数量应用或终止刺激);美国专利5,861,014(1999年1月19日)(一种可植入的胃的刺激器,用于感知胃肠道的异常电活动以便为预先设定的时间间期或为异常电活动的时间间期提供电刺激以治疗胃节律异常);PCT申请序列号PCT/US98/10402(1998年5月21日申请)和美国专利申请序列号09/424,324(2000年1月26日申请)(带有尖齿以协助将其固定于适当位置的植入装置);美国专利6,041,258(2000年3月21日)(用于腹腔镜外科带有改进的柄的电刺激装置);美国专利申请序列号09/640,201(2000年8月16日申请)(可附着于肠组织或腹腔内部组织或内脏具抗分离能力的电刺激装置);基于美国临时申请序列号60/129,198和60/129,199(均于1999年4月14日提交)题为“胃刺激器设备及安装方法”的PCT申请序列号PCT/US00/09910(2000年4月14日提交;代理记录号3581/006PCT);基于美国临时申请序列号60,129,209(1999年4月14日提交)和60/466,387(1999年12月17日提交)题为“胃刺激器设备和使用方法”的PCT申请序列号PCT/US00/10154(2000年4月14日提交;代理记录号3581/004PCT);和题为“通过与胃的内在电活动相关的触发的胃的电刺激有目的影响胃的运动和/或效率的方法和设备”的美国临时专利申请序列号60/235,660(2000年9月26日提交)。所以这些专利、专利申请、临时专利申请、和/或出版物在此通过参考被结合。
优选的电刺激装置包含多个具有伸长的体部的电导管,所述伸长的体部具有一配有一根或多根固定或附着于胃的小弯区域的电刺激导线的远端和一用于附着脉冲发生器的近端。所述一根或多根电刺激导线通过或使用脉冲发生器连于电源。这种优选的电刺激装置已被描述于,例如,PCT申请序列号PCT/US98/10402(1998年5月21日提交)、美国专利申请序列号09/424,324(2000年1月26日提交)、和美国专利申请序列号09/640,201(2000年8月16日提交)。当然,放置或附着电刺激装置时应十分小心以避免小肠的机械性绞窄。
本方法也可与电刺激胃肠道的其它部分同时应用。例如,电刺激可被应用于小肠和胃肠道内一或多个部位。电刺激部位可与另一个同步或不同步。
下面的实例用于描述本发明但并不局限于此。
实施例1。该实施例阐述了作用于急性食物摄入的十二指肠电刺激(DES)。8只健康的狗,每一只均配有一个胃套管以测量胃紧张性和一对位于十二指肠浆膜的双极电极。实施无DES的过程(对照)和有DES的过程(发明方法)。所述DES过程使用10次/分的重复单一脉冲;所述脉冲脉宽334ms、振幅为6毫安。28小时禁食后,受试狗在DES或无DES的情况下非限制性供给固体食物和水1小时。该试验在四只迷走神经(干)切断术后的狗上重复进行。在类似的研究中,在基础状态下30分钟、DES时30分钟和DES后30分钟分别使用计算机处理的衡压器装置测量固定压力下的胃容积。
对未手术的狗和迷走神经切除术后的狗DES均显著减少食物摄入,未手术的狗(DES治疗组344±38g而对照组487±34g(p=0.001));迷走神经切除术后的狗(DES治疗组137±109g而对照组448±72g(p=0.02))。水的摄入在所有受试动物基本相同。
胃容积测量表明DES显著松弛胃。基础胃容积为321±37ml,DES期间增加至439±29ml(p=0.04),DES后恢复至358±48ml。
这样,DES显著减少食物的摄入并因此对肥胖的治疗有效。虽然不希望被理论局限,这种抑制似乎不是迷走神经调节而可能是由于对胃的松弛作用。
实施例2。这个试验在麻醉的SD大鼠上实施。每组10只共四组大鼠进行下述试验:组1:对照组一未进行电刺激;组2:使用长脉冲(200ms、4mA,28次/分)进行小肠电刺激;组3:使用脉冲串(刺激2秒、终止3秒;频率40Hz、脉宽2ms、振幅4mA)进行小肠电刺激;组4:使用脉冲串(脉冲/刺激参数同组3)进行小肠电刺激加利多卡因(0.5mg溶于10ml盐水在电刺激期间滴至小肠浆膜)。
在45分钟的试验间期内,每组均通过插入近端空肠的导管灌注脂肪溶液(甘油三酸酯),然后用另一个插入远端空肠的导管收集。通过总的脂肪灌注量和在远端空肠总的回收量的差别估计脂肪的吸收。一对浆膜电极植入近端空肠在脂肪溶液灌注期间被激活以进行电刺激(2-4组)。45分钟试验间期内四组的平均脂肪吸收总量如下:组1-约37%;组2-约21%(与对照组1相比p<0.05);组3-约6%(与对照组1或长脉冲组2相比p<0.001);组4-24%(与对照组1相比p<0.05;与脉冲串组3相比)。因此,可观察到电刺激导致的脂肪吸收的实质性和显著性减少。利多卡因对脉冲串刺激效果的部分阻断(组4与组3相比)提示了肠神经在脉冲串电刺激中的作用。
在本发明中使用的方法和电刺激器易进行多种改进和变化,所有改进和变化都在本发明宗旨的范围内。此外,所有细节可被技术上相当的元件代替。特殊的电刺激器所应用的材料、形状和尺寸可以根据需要改变。
Claims (19)
1.一种在患者体内治疗肥胖症的方法,所述方法包括
植入一个电刺激装置,该装置包含一根或多根电刺激导线和一个连接至脉冲发生器的电连接器,以使所述一根或多根电刺激导线附着于或毗邻患者的小肠,由此电刺激可通过所述一根或多根电刺激导线提供至小肠;和
通过所述一根或多根电刺激导线为小肠提供电刺激。
2.如权利要求1所述的方法,其中,所述一根或多根电刺激导线在沿着十二指肠和空肠的位置附着于或毗邻小肠。
3.如权利要求1所述的方法,其中,提供给小肠的电刺激具有约2-30脉冲/分的工作频率。
4.如权利要求2所述的方法,其中,提供给小肠的电刺激速率约为2-30脉冲/分。
5.如权利要求3所述的方法,其中,提供给小肠的电刺激速率约为2-15脉冲/分,每次脉冲持续约0.1-4秒,这样脉冲之间有约3-30秒的间歇。
6.如权利要求4所述的方法,其中,提供给小肠的电刺激速率约为2-15脉冲/分,每次脉冲持续约0.1-4秒,这样脉冲之间有约3-30秒的间歇。
7.如权利要求3所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
8.如权利要求4所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
9.如权利要求5所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
10.如权利要求6所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
11.一种在患者体内治疗肥胖症的方法,所述方法包括
植入至少两个电刺激装置,其中每个电刺激装置包含一根或多根电刺激导线和一个连接至脉冲发生器的电连接器,以使所述一根或多根电刺激导线附着于或毗邻患者的小肠,由此电刺激可通过所述一根或多根电刺激导线在沿着小肠的两个或多个不同的部位提供至小肠;和
通过所述一根或多根电刺激导线在沿着小肠的两个或多个不同的部位为小肠提供电刺激。
12.如权利要求11所述的方法,其中,植入两个电刺激装置以为在沿着小肠的两个不同部位提供电刺激。
13.如权利要求12所述的方法,其中,所述两个不同的部位沿着十二指肠或空肠。
14.如权利要求12所述的方法,其中,提供给小肠的电刺激具有约2-30脉冲/分的工作频率。
15.如权利要求13所述的方法,其中,提供给小肠的电刺激速率约为2-30脉冲/分。
16.如权利要求12所述的方法,其中,提供给小肠的电刺激速率约为2-15脉冲/分,每次脉冲持续约0.1-4秒,这样脉冲之间有约3-30秒的间歇。
17.如权利要求13所述的方法,其中,提供给小肠的电刺激速率约为2-15脉冲/分,每次脉冲持续约0.1-4秒这样脉冲之间有约3-30秒的间歇。
18.如权利要求12所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
19.如权利要求13所述的方法,其中,每次脉冲由一个频率约5-100Hz的微猝发串组成。
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CNA038178990A Pending CN1713933A (zh) | 2002-07-26 | 2003-07-25 | 改进的电刺激治疗病态性肥胖症的方法 |
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-
2003
- 2003-07-25 WO PCT/US2003/023374 patent/WO2004011085A1/en active Application Filing
- 2003-07-25 EP EP03771874A patent/EP1551498A1/en not_active Withdrawn
- 2003-07-25 US US10/627,908 patent/US20040088022A1/en not_active Abandoned
- 2003-07-25 CA CA002491912A patent/CA2491912A1/en not_active Abandoned
- 2003-07-25 AU AU2003263816A patent/AU2003263816A1/en not_active Abandoned
- 2003-07-25 CN CNA038178990A patent/CN1713933A/zh active Pending
- 2003-07-25 JP JP2004524851A patent/JP2005533613A/ja active Pending
-
2005
- 2005-01-26 IL IL16651605A patent/IL166516A0/xx unknown
-
2008
- 2008-01-31 US US12/023,809 patent/US20080183238A1/en not_active Abandoned
Also Published As
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EP1551498A1 (en) | 2005-07-13 |
WO2004011085A1 (en) | 2004-02-05 |
AU2003263816A1 (en) | 2004-02-16 |
JP2005533613A (ja) | 2005-11-10 |
US20040088022A1 (en) | 2004-05-06 |
IL166516A0 (en) | 2006-01-15 |
CA2491912A1 (en) | 2004-02-05 |
US20080183238A1 (en) | 2008-07-31 |
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