CN105997315B - 用于治疗肥胖症的装置、系统和方法 - Google Patents

用于治疗肥胖症的装置、系统和方法 Download PDF

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CN105997315B
CN105997315B CN201610087175.XA CN201610087175A CN105997315B CN 105997315 B CN105997315 B CN 105997315B CN 201610087175 A CN201610087175 A CN 201610087175A CN 105997315 B CN105997315 B CN 105997315B
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stomach
stomach wall
stretching
stretching device
energy
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CN105997315A (zh
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彼得·福塞尔
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IMPLANTICA PATENTS CO., LTD.
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Milutinovic Alex Holdings Ltd
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Abstract

提供一种肥胖症治疗装置,该装置包括:至少一个可操作的拉伸装置,其能植入在肥胖病人体中并适于拉伸病人胃壁的一部分;以及操作装置,用于在所述拉伸装置被植入时操作该拉伸装置,以拉伸所述胃壁部分从而引起饱胀感。

Description

用于治疗肥胖症的装置、系统和方法
本申请是申请日为2009年1月29日、申请号为200980111663.8、发明名称为“用于治疗肥胖症的装置、系统和方法”的申请的分案申请。
技术领域
本发明涉及一种用于治疗肥胖症的装置、系统和方法。
背景技术
过去,肥胖病人通过胃减小手术来治疗,以限制病人的食物摄入。目前,用于治疗肥胖症的两种胃间隔术过程,即:可调节胃束带手术(AGB)和胃垂直束带造形术(VBG),最经常执行。
在AGB中,束带被完全放置在肥胖病人的手术未损的胃周围接近其上端、在胃和食管的接合处的正下面,以限制病人的食物摄入。由于带束缚胃,因此一小胃囊被形成在带和胃中永久减小的气孔上面。少量食物填充小囊的想法导致病人感觉饱了,即,饱胀感。AGB的示例公开在美国专利4,592,339和欧洲专利0611561中。
在VBG中,典型地,胃被竖直地分为四行线性订合线,其将胃分隔为与食管相邻的细长的近侧较小隔间以及远侧较大隔间,使得较小隔间的容积为胃的容积的约10%。一圆形孔被穿出在胃中在线性订合线行的下端,且若干圆形的订合线行被放置在胃上围绕所述圆形孔。带被放置为通过圆形孔且被紧固在胃周围,由此带限定从胃的较小隔间到较大隔间的狭窄出口。一旦被紧固,则带防止胃在出口处拉伸,这引起出口经久保持其初始的小直径。病人摄入的食物被保存在较小隔间中,从而导致饱腹感。然后,食物缓慢通过出口流入较大隔间,消化在该较大隔间正常进行。VBG的示例公开在美国专利5,345,949和5,549,621中。
存在很多与AGB和VBG相关联的并发症。然而,重要的是,病人在吞食食物之前非常仔细地完全咀嚼食物,从而聚集在胃的较小隔间中的食物碎渣能够穿过较小隔间的狭窄出口。如果食物碎渣堵在出口,则其可能使病人呕吐和感觉不舒服。在这种情况下,病人应该看医生或护士。与AGB和VBG相关联的另一并发症是:病人可能在晚上受胃酸返流的困扰。
还使用胃壁的电刺激来使病人感觉饱胀。
发明内容
本发明的目的在于解决与存在的用于治疗肥胖症的胃减小手术(即AGB和VBG)相关联的并发症。
本发明的另一目的在于提供一种新的用于治疗肥胖症的装置。
这些和其他目的通过所附权利要求中描述的装置来实现。因此,通过提供一种如下装置而获得用于治疗肥胖症的装置,即该装置包括:至少一个可操作的拉伸装置,其能植入在肥胖病人体中并适于拉伸病人胃壁的一部分;以及操作装置,用于在所述拉伸装置被植入时操作该拉伸装置,以拉伸所述胃壁部分从而引起饱胀感。本发明基于以下认识:通过引起胃壁的拉伸效果而引起饱胀感。因此,不需要如AGB和VBG所需那样在胃中提供减小的永久气孔。因此,与这种减小的气孔相关联的并发症通过本发明的新装置而消除,该新装置是更简单、安全和长期工作的装置。
在拉伸装置能够拉伸胃壁的位置,拉伸装置可通过胃至胃的缝合线或订合线而保持与胃壁接触。具体而言,拉伸装置可借助于胃至胃的缝合线或订合线而被胃套叠。
拉伸装置可适于放置在胃腔中。为此,拉伸装置可适于经由胃镜或入腔器械插入胃腔,并适于通过手术附接到胃壁。可替换地,拉伸装置可适于放置在胃的外侧。
在本发明的实施例中,拉伸装置包括第一接合构件和第二接合构件,所述第一接合构件适于接合胃壁的第一部分,所述第二接合构件适于接合胃壁的与第一胃部分接近但分隔开的第二部分。操作装置适于操作第一和第二接合构件背离彼此移动,以拉伸胃的第一和第二部分之间的胃壁部分,从而引起饱胀感。第一和第二接合构件中的至少一个可适于通过胃至胃的缝合线或订合线至少部分地被胃壁套叠,从而将接合构件保持在适当位置。另外,第一和第二接合构件中的至少一个可适于通过接合构件与胃壁之间的缝合线或订合线而保持在适当位置。适当地,第一和第二接合构件中的至少一个包括组织生长促进结构,优选为网状结构,适于与胃壁接触以保证拉伸装置长期附接到胃壁。
在本发明的另一实施例中,拉伸装置包括适于被病人胃壁的一部分套叠的至少一个可膨胀主体,且操作装置包括流体贮存器,其与所述主体的室流体连通。操作装置可为非侵入性操作的,以将流体从流体贮存器分配到主体的室,从而使主体膨胀,使得当主体被套叠时,胃壁部分受到拉伸。流体贮存器可通过手动按压其来操作。操作装置可包括回动伺服机构,其中流体贮存器中的小容积流体被较大的力压缩,且主体的室在每单位容积较小的力下引起较大总容积的运动。流体贮存器可被放置在皮下或腹腔中,并可通过例如利用马达移动贮存器的壁来调整。可替换地,泵可被提供为将流体或空气从贮存器泵浦到主体的室。
术语“回动伺服机构”包含如下含义:用较大的力和小冲程进行控制的装置,即,例如少量流体在较大的力下的运动控制由非常小的力移动的较大量的流体,但可替换地或另外地包含如下含义:将作用在具有短冲程的移动元件上的很大的力转变为作用在具有长冲程的另一移动元件上的很小的力的机构。当可以通过完整皮肤手动控制装置时,优选使用回动伺服机构。
在本发明的另一实施例中,该装置包括与一个或多个较小的室接触的大室。所述室适于与分配在所述室之间的流体或空气连通。用于在所述室之间分配流体的回动伺服机构可被提供,其中大室中的小容积流体被较大的力压缩,且较小的室在每单位容积较小的力下引起较大总容积的运动。大室可适于被套叠在病人的基底胃壁中,从而也通过限制贲门切口朝向病人的隔膜肌的运动来治疗返流疾病,而小室用作拉伸装置以治疗肥胖症。大室可将流体或空气分配到小室以使它们膨胀并拉伸胃基底壁。
在本发明的另一实施例中,拉伸装置包括机械拉伸装置,其中可提供用于机械调整拉伸装置的马达。机械调节的拉伸装置可适于接合胃壁的第一部分和胃的第二部分,其中该机械调节的拉伸装置包括适于被操作装置移动的关节机构。可替换地,拉伸装置可包括适于接合胃壁的第一部分的第一接合构件和适于接合胃壁的与第一胃部分接近但分隔开的第二部分的第二接合构件,其中机械拉伸装置调节胃壁的第一和第二部分之间的距离。
作为可替代方案,以上描述的液压机构可用于通过液压分配流体或空气来调整这种机械拉伸装置。
拉伸装置可为术后非侵入性调节的。
用于操作拉伸装置的操作装置可在其最简单的形式中包括适于通过手动按压开关以操作拉伸装置进行非侵入性操作的皮下开关。
适于拉伸胃壁的至少两个不同部分的至少两个可操作拉伸装置可被提供,其中该装置适于被术后和非侵入性调整。具体而言,该装置可时常地调整,使得在第一时间,拉伸装置中的一个拉伸胃壁的一个部分,在第二时间,拉伸装置中的另一个拉伸胃壁的另一部分。
在本发明的另一实施例中,拉伸装置包括主体,其适于填充由胃的壁部分限定的容积。适当地,主体具有圆滑轮廓,而没有可能损坏病人胃壁的太尖的边缘。在主体待被套叠的地方,其可具有变化的周界,以更好地保持在被病人的胃壁部分套叠的位置。主体可被成形为类似于蛋或类似于肾。
一般而言,可使用任何种类的机械结构。可使用任何机械或液压驱动的机械机构或任何气动结构。在被提供动力时任何马达或任何泵或改变形式的移动材料可被用于实现如下简单目标:通过使胃壁的至少两个部分背离彼此移动来拉伸胃壁的一部分。
可使用任何种类的液压操作。可以意识到,可使用气动操作来代替液压操作,其中代替液压流体的空气在贮存器与由拉伸装置形成的室之间移动。优选地,贮存器具有锁定位置,从而如果该贮存器由病人处理,则将其保持在希望的位置。为了压缩贮存器,其优选保持压缩并在再次按压之后释放。
任何种类的液压方案可用于拉伸装置。液压方案可通过机械和由任何马达或泵提供动力以及通过手动来驱动。
当然,仅仅使胃的套叠部分膨胀也拉离胃壁,这也可机械、液压、气动以及由马达或泵提供动力或手动力地实现。
根据一个实施例,提供一种用于治疗病人的肥胖症的装置,该装置包括至少一个可操作的拉伸装置,其能植入在病人体中并适于拉伸病人胃壁的一部分。该装置进一步包括可植入控制单元,该可植入控制单元用于在控制单元和拉伸装置被植入时自动控制可操作拉伸装置,从而拉伸与病人吃饭关联的胃壁部分,从而引起饱胀感。
根据另一实施例,该装置进一步包括至少两个拉伸装置,第一拉伸装置和第二拉伸装置,或三个或更多拉伸装置。根据又一实施例,该装置进一步包括用于操作拉伸装置的操作装置,其中当控制单元和拉伸装置被植入时,控制单元控制操作装置拉伸胃壁部分。
根据又一实施例,该装置进一步包括传感装置,其包括用于传感病人的物理参数或拉伸装置的功能参数的传感器,其中传感装置将与所述参数相关的信息发送到控制单元,且控制单元基于该信息控制拉伸装置。该装置可适于控制拉伸装置,以在控制单元和拉伸装置被植入时间歇地拉伸胃壁。
根据一个实施例,可植入控制单元适于根据一个实施例通过随时间的变化、胃壁的拉伸量和/或在预定时间周期内对胃进行拉伸,控制由胃壁上的拉伸装置执行的拉伸量。
根据一个实施例,可植入控制单元适于基于病人的食物摄入来控制拉伸装置,可植入控制单元可被编程为包括任意如下:拉伸装置被控制以拉伸胃壁的预定时间周期以及施加在胃壁上的拉伸量。操作装置可为机械操作装置、液压操作装置、液压操作的机械操作装置或机械操作的液压操作装置。
根据一个实施例,传感装置的传感器直接或间接地传感病人的食物摄入,且可植入控制单元响应来自传感器的信号来控制操作装置以拉伸胃壁。
根据又一实施例,可植入控制单元适于控制操作装置以利用多于一个的拉伸装置来拉伸胃壁。这可通过可植入控制单元实现,该可植入控制单元适于在第一时间周期内控制第一拉伸装置以拉伸胃壁的第一部分,在第二时间周期内控制第二拉伸装置以拉伸胃壁的不同于该胃壁的第一部分的第二部分,从而允许胃壁在拉伸周期之间的较长放松。
根据一个实施例,传感装置的传感器适于传感与病人的食物摄入相关的参数,例如食管运动、食管弯曲、食管蠕动、食管拉伸、食管压力、穿过食管的食物、胃中的食物、神经活动、交感神经活动、肌肉活动、荷尔蒙活动、胃蠕动、胃拉伸、胃压力、胃弯曲、胃填充和/或胃中的酸度。传感装置也可适于传感蠕动、拉伸、弯曲、压力、运动、荷尔蒙、神经活动、PH值、酸度、容积、电容、电阻、电压、安培、光吸收或视觉、超声反射或吸收、弯曲金属、双金属和PH。
根据一个实施例,该装置进一步包括可植入贮存器,其中操作装置受贮存器液压控制。拉伸装置可适于利用病人控制而从病人身体外部得到控制,所述病人控制根据一个实施例可适于取代可植入单元的控制。可植入控制单元可适于由病人从病人身体外部来控制。
根据一个实施例,该装置进一步包括外部控制单元,其例如借助于可由病人操作的可植入开关来从病人身体外部控制可植入控制单元。
根据一个实施例,该装置包括无线远程控制器,用于从病人身体外部控制和/或编程可植入控制单元。控制单元可包括力控制器,且机械操作装置可由该力控制器控制。
根据一个实施例,可植入控制单元包括压力控制器,且液压操作装置由该压力控制器控制。
拉伸装置
根据任意实施例的装置的拉伸装置可包括第一和第二接合部分,第一部分可适于接合到胃壁的第一区域,第二部分可适于接合到胃壁的第二区域。拉伸装置由此适于拉伸胃壁的在第一区域与第二区域之间的部分。拉伸装置可包括马达,例如可植入电动马达,其相应地可操作至少一个关节,以移动该关节从而拉伸胃壁部分。
根据另一实施例,该装置可包括具有可变容积的室,所述室可适于接纳流体。该装置可进一步包括贮存器,其适于保持流体并与所述室流体连接。拉伸装置可进一步包括泵浦装置,其可适于将流体从贮存器移动到室,并由此拉伸胃壁的一部分。根据另一实施例,该装置进一步包括第二流体连接部,其适于在预定时间周期内允许流体从室流回贮存器。
液压
根据一个实施例,拉伸装置包括适于具有可变容积的室。所述室可包括至少一个可移动壁部,其可为弹性壁部。所述室可具有大致圆形且可适于接纳流体。
根据另一实施例,拉伸装置进一步包括适于保持流体并与室流体连接的贮存器,拉伸装置可进一步包括泵浦装置,其可适于经由将贮存器和室互连的第一流体连接部将流体从贮存器移动到室,由此拉伸胃壁的一部分。可以设想到,拉伸装置进一步包括第二流体连接部,其将室和贮存器互连并适于在预定时间周期内允许流体从室流回贮存器。
根据任意实施例的贮存器可适于被放置在皮下或腹部中,且贮存器可通过移动贮存器的壁来控制,这可利用合适的马达来实现。室也可包括适于膨胀室的容积的电动马达。
该装置可进一步包括回动伺服机构,其中贮存器中的小容积被较大的力压缩,且室利用每单位面积较小的力而引起较大总面积的运动。
传感器
根据任意实施例的植入在病人体中的传感器可为功能参数传感器,其传感装置的功能参数,例如用于充填内部能量源的能量的传输。在其他实施例中,传感器为物理参数传感器,其传感病人的物理参数,例如病人的食物摄入。根据任意实施例的传感器可为如下中的至少一个:体温传感器、压力传感器、血压传感器、血流量传感器、心跳传感器、呼吸传感器、电导率传感器、PH传感器、光敏传感器、气体探测传感器以及传感机械应变的传感器,例如适于传感贲门的任意收缩和放松的传感器。
根据一个实施例,该装置进一步包括反馈装置,用于将信息从病人身体内部发送到其外部,以给出与功能参数相关的反馈信息。
控制单元
根据一个实施例,该装置由适于控制拉伸装置的控制单元控制。控制单元可适于响应来自传感器的信号来控制拉伸装置或两个或更多个拉伸装置。
根据一个实施例,控制单元时常地控制拉伸装置,使得拉伸装置中的一个在第一时间拉伸胃壁的第一部分,拉伸装置中的另一个在第二时间拉伸胃壁的第二部分。控制单元可适于从病人身体外部例如通过无线远程控制器来控制,所述无线远程控制器相应地可包括至少一个外部信号发射器,其可适于发射包括频率调制信号、幅度调制信号或相位调制信号或其组合的无线控制信号。根据一个实施例,所述至少一个发射器适于发射包括模拟或数字信号或者模拟和数字控制信号的组合的无线控制信号,或者发射包括电场或磁场或者组合的电场和磁场的无线控制信号。
根据任意实施例的控制单元可适于植入病人皮下,且可适于控制液压系统。
该装置可进一步包括用于为控制单元提供动力的传输构件,该传输构件可包括流体传输构件和/或电引线。
根据另一实施例,该装置进一步包括外部数据通信器以及与该外部数据通信器通信的可植入内部数据通信器。内部通信器可适于将与该用于治疗肥胖症的装置相关的数据反馈回外部数据通信器,或者外部数据通信器将数据供给到内部数据通信器。
提供能量
为了对该装置提供能量,该装置可进一步包括通过诸如波信号等至少一个无线能量信号发射能量的无线能量发射器,所述波信号例如为声波信号、超声波信号、电磁波信号、红外光信号、可见光信号、超紫外光信号、激光信号、微波信号、无线电波信号、x射线信号和伽马射线信号。无线能量信号可进一步包括电场或磁场或组合的电场和磁场。
根据又一实施例,该装置包括适于为该装置提供动力的能量源,其可包括内部能量源,该内部能量源相应地可适于接收来自以无线模式发射能量的外部能量源的能量。内部能量源可进一步包括蓄能器、至少一个电压值防护罩和/或至少一个恒流防护罩。
该装置可进一步包括适于将能量从第一形式转换为第二形式的能量转换装置。
固定
根据任意实施例的装置可包括固定构件,其可适于将拉伸装置固定到病人的胃壁。固定构件可适于与缝合线或订合线接触,以将拉伸装置固定到病人的胃壁。固定构件可包括网状结构,其可适于促进长期固定到胃壁的人体组织的生长。
系统
本发明还提供一种肥胖症治疗系统,包括如上所述的用于治疗肥胖症的装置。该系统可包括皮下电子开关,其适于手动且非侵入性地控制该用于治疗肥胖症的装置的功能。
该系统可包括具有液压贮存器的液压装置,其中该用于治疗肥胖症的装置适于通过手动按压液压贮存器而被非侵入性地调整。
该系统可包括用于控制该装置的功能的无线远程控制器。无线远程控制器包括至少一个外部信号发射器,且内部信号接收器可被提供为植入在病人体中。无线远程控制器适于发射用于控制该装置的至少一个无线控制信号。无线控制信号可包括频率、幅度或相位调制信号或其组合,以及模拟或数字信号或模拟和数字信号的组合。可替换地,无线控制信号包括电场或磁场或者组合的电场和磁场。远程控制器可发射用于承载无线控制信号的载波信号。载波信号可包括数字、模拟或数字和模拟信号的组合。远程控制器可发射用于承载数字或模拟控制信号的电磁载波信号。
该系统可包括用于非侵入性地用无线能量对该装置提供能量的无线能量发射器。能量发射器通过至少一个无线能量信号发射能量。无线能量信号可包括选自如下的波信号:声波信号、超声波信号、电磁波信号、红外光信号、可见光信号、超紫外光信号、激光信号、微波信号、无线电波信号、x射线信号和伽马射线信号。可替换地,无线能量信号包括电场或磁场或者组合的电场和磁场。无线能量发射器可发射用于承载无线能量信号的载波信号。载波信号可包括数字、模拟或数字和模拟信号的组合。
该系统可包括用于将无线能量从第一形式转换为第二形式的能量转换装置。能量转换装置可在能量传输期间用第二形式能量直接操作该装置。第二形式的能量可包括直流或脉冲直流或者直流和脉冲直流的组合。第二形式的能量可包括交流或直流和交流的组合。蓄能器可被提供,其中第二形式的能量至少部分地用于对该蓄能器充电。第一或第二形式的能量可包括磁能、动能、声能、化学能、辐射能、电磁能、光电能、核能或热能。第一形式的能量和第二形式的能量中的一个可为非磁、非动态、非化学、非声学、非核或非热的。
该系统可包括适于为该装置提供动力的能量源。该能量源可包括内部能量源,其适于接收来自以无线模式发射能量的外部能量源的能量。内部能量源通过无线模式的能量充填。
该系统可包括反馈装置,用于将信息从病人身体内部发送到其外部,以给出与功能参数相关的反馈信息。
该系统可包括传感诸如系统的功能参数等参数的传感器,其与用于充填内部能量源的能量的传输相互关联。内部控制单元可被提供用于响应传感功能参数的传感器来控制该装置的操作装置。可替换地,传感器传感病人的物理参数。物理参数可为体温、血压、血流量、心跳和呼吸中的一个。物理参数传感器可为压力或蠕动传感器,或者传感测量、弯曲、拉伸或食物摄入的传感器。内部控制单元可响应传感物理参数的传感器来控制操作装置。内部控制单元可被提供为接收来自传感器的信息。
该装置的操作装置可包括马达或泵。具体而言,操作装置可包括电动马达。操作装置可为电动力的,可为液压操作装置,或者可为气动操作装置。发射的能量可直接以其无线形式影响操作装置,以致使动能在能量传输期间操作该装置的拉伸装置。
该系统可包括反馈装置,用于将信息从病人身体内部发送到其外部,以给出与功能参数相关的反馈信息。
该系统可包括外部数据通信器和与该外部数据通信器通信的可植入内部数据通信器,其中内部数据通信器适于将与用于治疗肥胖症的装置或病人相关的数据反馈回外部数据通信器,或者外部数据通信器将数据反馈到内部数据通信器。
该系统可包括可植入电子部件,其包括至少一个电压值防护罩和/或至少一个恒流防护罩。
方法
本发明还提供如下列出的方法:
(a)一种用于通过手术治疗肥胖病人的方法,该方法包括步骤:
在病人的腹壁中切割开口;
切除胃周围的一区域;
放置如上所述的用于治疗肥胖症的装置,接合病人的胃壁,并缝合胃壁。
该方法可进一步包括另外的步骤:术后调整拉伸装置,以拉伸胃壁的一部分,从而影响病人的胃口,其中调整拉伸装置的步骤从病人身体外部控制。
该方法可进一步包括另外的步骤:放置如上所述的另外的用于治疗肥胖症的装置,接合病人的胃壁,借助于所述用于治疗肥胖症的装置拉伸胃壁的第一部分,并借助于所述另外的用于治疗肥胖症的装置拉伸胃壁的第二部分。
(b)一种用于经由腹腔镜腹进路将用于治疗肥胖症的装置通过手术放置在病人体中的方法,该方法包括步骤:
将针或管状器械插入病人身体的腹部;
利用该针或管状器械用气体填充病人的腹部,由此使病人的腹腔膨胀;
在病人身体中放置至少两个腹腔镜套针;
将照相机通过腹腔镜套针之一插入病人腹部;
将至少一个切除工具通过至少两个腹腔镜套针之一插入并切除病人的意欲放置区域;以及
放置如上所述的用于治疗肥胖症的装置,接合胃壁。
(c)一种利用如上所述的用于治疗肥胖症的系统的方法,包括步骤:术后调整拉伸装置,以拉伸胃壁的一部分,从而影响病人的胃口,其中调整拉伸装置的步骤被非侵入性地执行。拉伸装置包括机械或液压拉伸装置。液压拉伸装置可包括贮存器,用于将凝胶或气体或流体移动到或移动离开拉伸装置。贮存器可被放置在使病人的手够到的皮下,以手动将流体移动到或移动离开拉伸装置。拉伸装置可由内部能量源提供动力,以拉伸或释放拉伸装置,其中借助于控制装置控制来自内部控制单元或病人身体外部的动力。用于无线传输能量的无线能量发射器为操作装置提供动力,以使得拉伸装置直接在能量传输期间致使拉伸装置拉伸胃壁。用于无线传输能量的无线能量发射器对内部能量源进行充电。回动伺服机构可被提供,其中在闭合式液压系统中移动少量流体,在第二较大闭合式液压系统中实现较大的流体运动,其中所述少量流体与大容积相比被每单位面积较大的力移动。在病人的基底胃壁中套叠的拉伸装置适于可调节,其中被放置为套叠在胃基底壁中的拉伸装置适于被调节并拉伸胃基底壁由此引起饱胀感。
该方法可进一步包括将反馈信息从身体内部发送到其外部,以给出与该装置的功能参数相关的反馈。可替换地,该方法可进一步包括将反馈信息从身体内部发送到其外部,以给出与病人的物理参数相关的反馈。装置的功能参数可与用于对内部能量源充电的能量传输相互关联。该装置可从病人身体外部编程。
该方法可进一步包括步骤:
传感病人的物理参数或装置的功能参数;以及
将传感的信息发送到适于调整拉伸装置的控制单元。
该方法可进一步包括步骤:
传感病人的物理参数或装置的功能参数;以及
将传感的信息发送到适于调整内部能量源的充填的控制单元。
该方法可进一步包括皮下放置的回动伺服机构,其具有小控制贮存器并用每单位面积较大的力从该控制贮存器移动小容积,从而用每单位面积较小的力引起拉伸装置的较大运动。
该方法可进一步包括通过手动按压皮下开关执行非侵入性调整。
该方法可进一步包括通过无线远程控制器执行非侵入性调整。
该方法可进一步包括通过无线能量发射器执行非侵入性调整。
该方法可进一步包括通过内部能量源为该用于治疗肥胖症的装置提供动力。
该方法可进一步包括通过发射无线能量的外部能量源为该用于治疗肥胖症的装置提供动力,其中所述能量源包括发射无线能量的外部能量源。
该方法可进一步包括从外部能量源发射无线能量,以对可再充内部能量源充电。
(d)一种利用如上所述的装置的方法,其中拉伸装置包括主体,其包括与适于拉伸胃壁的一个或多个较小贮存器/室接触的大室,其中所述室适于与在所述室之间运动的流体或空气连通。
(e)一种利用如上所述的装置的方法,其中大室的主容积适于成为拉伸装置最重要的容积,且其中小室用作拉伸胃壁的拉伸装置以治疗肥胖症,其中主室利用流体或凝胶与小室连通,从而在胃基底壁中引起拉伸效果,由此治疗肥胖症。
(f)一种利用如上所述的装置的方法,包括通过将大室的主容积套叠在基底胃壁中由此限制胃切口朝向病人的隔膜肌的运动来治疗返流疾病,并利用小室拉伸胃基底壁,利用流体或空气将大室与小室连通以在胃基底壁中引起拉伸效果由此治疗肥胖症。
提供一种利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的胃镜方法。该方法包括步骤:将所述装置通过食管插入病人的胃中,将所述装置放置为与胃壁接触,将所述装置固定到胃壁使得该装置能够拉伸胃壁的一部分。
根据一个实施例,固定所述装置的步骤包括步骤:将所述装置的第一部分固定到胃壁的第一部分,以及将所述装置的第二部分固定到胃壁的第二部分。固定所述装置的第一和第二部分的步骤包括步骤:利用胃至胃的缝合线或订合线来套叠第一和第二部分。
根据一个实施例,该方法包括另外的步骤:将适于拉伸胃壁的一部分的第二装置放置为与胃接触,将该第二装置固定到胃壁,利用第一装置拉伸胃壁的第一部分,并利用第二装置拉伸胃壁的第二部分。
根据一个实施例,第二部分的拉伸包括步骤:利用预定延时,延时拉伸第二部分。
根据任意实施例的方法可进一步包括步骤:将胃镜插入病人的胃中,推动胃壁的一部分以在胃的外部制备囊,将所述装置插入该囊,放置在胃壁的内部,在将所述装置插入所述囊之前或之后缝合或订合以将该装置封闭在囊中。
根据一个实施例,该方法进一步包括步骤:将胃镜插入病人的胃中,拉动胃壁的一部分以在胃的内部制备囊,在胃壁中形成到达所述囊的孔,将所述装置通过胃壁中的所述孔插入所述囊,在将所述装置通过所述孔插入之前或之后缝合或订合所述囊。
该方法可进一步包括步骤:将传输构件从所述装置放置到控制单元,所述传输构件可为流体传输构件和/或适于传输电动力的构件。
该方法可进一步包括步骤:放置控制单元,该控制单元可被放置在病人皮下。
根据一个实施例,将传输构件从所述装置放置到控制单元的步骤包括步骤:在病人的腹部切割开口,将所述传输构件连接到所述控制单元,将所述控制单元插入病人皮肤中的开口,以及将所述控制单元固定在皮下。
根据一个实施例,该方法进一步包括将传输构件从所述装置放置到控制单元的步骤包括步骤:在病人的腹部切割开口,将所述传输构件连接到所述控制单元,将所述控制单元插入病人皮肤中的开口,以被放置在腹腔中。放置控制单元的步骤包括步骤:将所述控制单元固定到腹壁。
拉伸
根据任意实施例的方法的一个实施例,该方法包括另外的步骤:术后且非侵入性地调整装置以拉伸胃壁的一部分,从而影响病人的胃口。
术后且非侵入性地调整装置以拉伸胃壁的一部分的步骤包括步骤:增大胃壁的第一部分与胃壁的第二部分之间的距离。
根据一个实施例,调整装置的步骤从病人身体外部执行,而根据其他实施例,该方法的调整装置的步骤包括通过可植入控制单元从病人内部调整装置。
根据一个实施例,调整装置的步骤包括时常地调整不同装置,以在第一时间拉伸胃壁的第一部分,在第二时间拉伸胃壁的第二部分。
根据一个实施例,该方法包括将两个或更多个装置放置为与胃接触,并时常地调整不同装置以拉伸胃壁的一部分。
手动
将装置放置为与胃接触的步骤可包括:将适于具有可变容积的装置放置为与胃接触,所述容积可通过至少一个可移动壁部分呢变化,所述至少一个可移动壁部分相应地可为至少一个弹性壁部分。
根据任意实施例的装置可具有大致圆形或者蛋形。
该装置可进一步包括皮下开关,且该方法可进一步包括按压所述开关并以便手动且非侵入性地调整该装置。
根据一个实施例,调整装置的步骤包括将流体从贮存器移动到装置的步骤。
根据一个实施例,该装置可包括泵,且该方法可包括步骤:将流体从贮存器泵浦到该装置以拉伸胃壁。
将流体从贮存器移动到该装置的步骤包括移动贮存器的壁部分的步骤。
调整装置的步骤可包括步骤:手动按压贮存器,其可被放置在皮下或腹部中。
机械
根据一个实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离包括将流体移动到具有可变容积的室中的步骤。
自动化
根据一个实施例,将装置放置为与胃接触的步骤包括将适于具有可变容积的装置放置为与胃接触。
该可适于具有可变容积的装置包括至少一个可移动壁部分,其可包括至少一个弹性壁部。
该装置可具有大致圆形或大致蛋形形状。
该装置可进一步包括皮下开关,且该方法可进一步包括按压所述开关以非侵入性地调整该装置。
调整装置的步骤可包括将流体从贮存器移动到该装置的步骤,这相应地可包括步骤:操作泵浦装置,该泵浦装置将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
该方法可进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据一个实施例,该方法可包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。
根据另一实施例,控制所述装置的步骤包括步骤:操作泵浦装置,以将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
根据一个实施例,该方法包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
传感变量的步骤可包括步骤:传感与病人的食物摄入相关的变量,该步骤可包括步骤:传感与病人的食物摄入相关的变量造成胃部的拉伸增加,并由此使病人的饱胀感增加。
机械
根据一个实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离的步骤包括将流体移动到具有可变容积的室中的步骤。
该方法可进一步包括步骤:将流体从贮存器移动到具有可变容积的室。将流体从贮存器移动到所述装置的步骤可包括步骤:操作泵浦装置,该泵浦装置将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
根据一个实施例,操作泵浦装置的步骤包括利用无线远程控制器操作泵浦装置的步骤。
根据一个实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据一个实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离包括步骤:操作马达,该马达适于增大胃壁的第一部分与胃壁的第二部分之间的距离,由此拉伸胃壁的一部分。操作马达可包括利用无线远程控制器操作马达的步骤。
根据一个实施例,该方法进一步包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。
根据一个实施例,该方法包括步骤:操作泵浦装置,该泵浦装置将流体从贮存器移动到室,且所述室被流体填充以增大胃壁的第一部分与胃壁的第二部分之间的距离,由此拉伸胃壁的一部分。
根据一个实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据一个实施例,传感变量的步骤包括传感与病人的食物摄入相关的变量的步骤。
根据一个实施例,该方法进一步包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。传感变量的步骤可包括传感与病人的食物摄入相关的变量的步骤。
增大胃壁的第一部分与胃壁的第二部分之间的距离可包括步骤:操作机械装置,该机械装置适于增大胃壁的第一部分与胃壁的第二部分之间的距离,由此拉伸胃壁的一部分。
根据一个实施例,该装置包括机械构件,其适于移动以拉伸位于胃壁的第一与第二部分之间的胃壁的部分。该机械构件可利用马达移动以拉伸胃壁的一部分。
根据一个实施例,拉伸胃壁的一部分的步骤包括步骤:操作至少一个机械装置以拉伸胃壁的一部分。
根据一个实施例,该方法包括步骤:利用胃至胃的缝合线将机械装置套叠在胃壁中。
根据一个实施例,该方法包括步骤:使套叠的胃壁中的机械装置膨胀以拉伸胃壁。
根据一个实施例,该方法包括使胃壁膨胀的马达,根据另一实施例,该方法包括使胃壁膨胀的记忆金属。
根据另一实施例,该方法包括使胃壁膨胀的液压控制的机械装置。
放置
根据一个实施例,放置装置的步骤包括将装置放置为在胃壁的外部与胃壁相连,这可包括将所述装置放置在病人的胃基底壁中的步骤。
放置装置的步骤可包括将装置放置为在胃壁的内部与胃壁相连,这可包括将所述装置放置在病人的胃基底壁中的步骤。
固定
固定至少一个装置的步骤包括将所述至少一个装置缝合或订合到胃壁。
固定至少一个装置的步骤可包括利用胃至胃的缝合线或订合线套叠在胃壁中,在其他实施例中,固定至少一个装置的步骤包括借助于纤维组织放置适于被固定到胃壁的网。
该网可另外地由缝合线或订合线支撑,并可包括适于促进人体组织生长的结构,例如网状结构。
提供一种另外的方法,该方法包括步骤:在胃壁中形成孔;借助于器械将拉伸装置引入胃;移动所述装置通过所述孔并将其放置在胃壁的外部;在胃腔的内部形成胃壁的一部分的囊,其中所述装置被放置为抵靠胃壁的外部;将所述装置套叠在胃壁的囊中;以及优选利用缝合线或订合线密封所述孔。
提供一种另外的方法,该方法包括步骤:在胃壁中形成孔;借助于器械在胃腔的内部形成胃壁的一部分的囊;借助于所述器械将所述装置引入胃;移动所述装置通过所述孔并将其放置在胃壁的外部;借助于所述器械将所述装置引入所述囊;将所述装置套叠到胃壁;以及优选利用缝合线或订合线密封所述孔。
根据一个实施例,该方法进一步包括提供用于从病人身体外部调整拉伸装置的装置;以及操作所述装置来调整所述装置。
根据另一实施例,该方法进一步包括步骤:切割病人的皮肤,将管插入病人的腹腔,将所述管连接到容积填充装置,用通过所述管注入的流体填充所述装置。
根据另一实施例,该方法进一步包括步骤:皮下放置注入端口,并将所述管连接到所述注入端口。
根据另一实施例,该方法进一步包括步骤:提供通过所述孔连接到拉伸装置并进一步到达腹壁或穿过腹壁的管。
根据另一实施例,该方法进一步包括步骤:切割病人的皮肤,从病人的连接到拉伸装置的腹腔接纳所述管,以及用通过所述管注入的流体填充所述装置。
根据另一实施例,该方法进一步包括步骤:皮下放置注入端口,并将所述管连接到所述注入端口。
器械
进一步提供一种用于将适于拉伸病人的胃壁的一部分的装置放置为与胃壁相连的器械。该器械包括:适于可释放地保持所述装置的保持构件、适于将所述装置插入通过胃壁的插入构件以及适于帮助将所述装置固定到胃壁外部的固定构件。
所述器械可进一步包括用于在胃壁中切割孔的切割构件、用于观察胃的区域的光学构件。固定装置可适于将所述装置缝合到胃壁在其内部,或者用于将所述装置订合到胃壁在其内部,或者用于利用胃至胃的缝合线将所述装置的至少一部分套叠在胃壁中在其内部,或者用于利用胃至胃的订合线将所述装置的至少一部分套叠在胃壁中在其内部,然而,器械可适于从其外部执行所述方法。
器械可进一步包括专门的保持装置,其可包括适于利用真空或利用机械保持构件保持胃的专门的保持装置。
提供一种利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术或腹腔镜方法。该方法包括步骤:在病人的腹壁中切割孔,切除围绕所述胃的一区域,将所述装置放置为与所述胃接触,以及直接或间接通过所述胃壁的套叠将所述装置固定到所述胃壁,使得所述装置能够拉伸所述胃壁的一部分。
根据一个实施例,固定所述装置的步骤包括步骤:将所述装置的第一部分固定到所述胃壁的第一部分,以及将所述装置的第二部分固定到所述胃壁的第二部分,其中所述装置的第一和第二部分被固定,使得所述装置适于拉伸所述胃壁的在该胃壁的第一和第二部分之间的一部分。
根据另一实施例,所述装置为第一装置,所述方法包括另外的步骤:通过所述胃壁的套叠直接或间接地固定与所述胃接触的适于拉伸所述胃壁的一部分的第二装置,将所述第二装置固定到所述胃壁,利用所述第一装置拉伸所述胃壁的第一部分,以及利用所述第二装置拉伸所述胃壁的第二部分。
根据另一实施例,该方法包括另外的步骤:术后且非侵入性地调整装置,以拉伸胃壁的一部分,从而影响病人的胃口。
提供一种利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术或腹腔镜方法。
该方法包括步骤:将针或管状器械插入病人身体的腹部,利用所述针或管状器械向病人的身体填充气体,将至少两个腹腔镜套针放置在病人身体中,将照相机通过所述腹腔镜套针之一插入病人身体,将至少一个切除工具通过所述至少两个腹腔镜套针之一插入,切除所述胃的一区域,将装置引入腹腔,将所述装置放置在所述胃壁的外部,接合所述胃壁。
根据另一实施例,该方法包括:术后且非侵入性地调整装置以拉伸胃壁的一部分的步骤包括增大胃壁的第一部分与胃壁的第二部分之间的距离的步骤。
根据另一实施例,调整装置的步骤从病人的身体外部执行。
根据另一实施例,调整装置的步骤包括时常地调整不同装置,以在第一时间拉伸胃壁的第一部分,在第二时间拉伸胃壁的第二部分。
根据另一实施例,该方法包括将两个或更多个装置放置为与胃接触,并时常地调整不同装置以拉伸胃壁的一部分。固定所述装置的第一和第二部分的步骤可进一步包括利用胃至胃的缝合线或订合线来套叠第一和第二部分的步骤。
根据另一实施例,该装置进一步包括可植入控制单元,其中调整装置的方法步骤包括通过所述可植入控制单元从身体内部调整装置。
根据另一实施例,第二部分的拉伸包括步骤:利用预定延时,延时拉伸第二部分。
手动
根据另一实施例,将装置放置为与胃接触的步骤包括:将适于具有可变容积的装置放置为与胃接触,其可利用至少一个可移动壁部分调整,至少一个可移动壁部分相应地可为弹性壁部分。该装置可具有大致圆形或蛋形形状。
根据另一实施例,该装置可进一步包括皮下开关,且该方法可进一步包括按压所述开关以便手动并非侵入性地调整该装置。调整装置可包括将流体从贮存器移动到所述装置的步骤。
根据另一实施例,该装置可包括泵,且该方法可进一步包括将流体从贮存器泵浦到该装置以拉伸胃壁的步骤。
根据另一实施例,将流体从贮存器移动到该装置的步骤包括移动贮存器的壁部分的步骤,这可通过手动按压贮存器的步骤完成。
根据任意实施例,贮存器可被放置在皮下或腹部。
机械
根据另一实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离的步骤包括将流体移动到具有可变容积的室中的步骤。
自动化
根据另一实施例,将装置放置为与胃接触的步骤包括将适于具有可变容积的装置放置为与胃接触。
该适于具有可变容积的装置可包括至少一个可移动壁部分,其相应地可为弹性壁部分。
根据任意实施例的装置可包括皮下开关,该方法可进一步包括按压所述开关以非侵入性地调整所述装置。
根据另一实施例,调整装置的步骤包括将流体从贮存器移动到装置的步骤。将流体从贮存器移动到所述装置的步骤可包括步骤:操作泵浦装置,以将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
根据另一实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据另一实施例,该方法进一步包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。
根据另一实施例,控制所述装置的步骤包括步骤:操作泵浦装置,以将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
根据另一实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
传感变量的步骤可包括传感与病人的食物摄入相关的变量的步骤,这可导致增加胃部的拉伸,并由此增加病人的饱胀感。
机械
根据另一实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离的步骤可包括将流体移动到具有可变容积的室中的步骤。
根据另一实施例,将流体移动到室中的步骤包括将流体从贮存器移动到具有可变容积的室中的步骤。
根据另一实施例,将流体从贮存器移动到所述装置的步骤包括步骤:操作泵浦装置,该泵浦装置将流体从贮存器移动到所述装置,且所述装置容积膨胀并由此拉伸胃壁的一部分。
根据另一实施例,操作泵浦装置的步骤包括利用无线远程控制器操作泵浦装置的步骤。
根据另一实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据另一实施例,增大胃壁的第一部分与胃壁的第二部分之间的距离的步骤包括步骤:操作适于增大胃壁的第一部分与胃壁的第二部分之间的距离的马达,由此拉伸胃壁的一部分。
操作马达的步骤可包括利用无线远程控制器操作马达的步骤。
根据另一实施例,该方法可进一步包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。
根据另一实施例,控制所述装置的步骤可包括步骤:操作泵浦装置,以将流体从贮存器移动到室,且所述室被流体填充以增大胃壁的第一部分与胃壁的第二部分之间的距离,由此拉伸胃壁的一部分。
根据另一实施例,该方法进一步包括步骤:流体从所述装置流回贮存器,由此释放胃壁的拉伸。
根据另一实施例,传感变量的步骤包括传感与病人的食物摄入相关的变量的步骤。
根据另一实施例,该方法进一步包括步骤:利用可植入传感器传感变量,解译该传感到的变量,并利用该解译的变量控制所述装置。传感变量的步骤可包括传感与病人的食物摄入相关的变量的步骤。增大胃壁的第一部分与胃壁的第二部分之间的距离可包括步骤:操作机械装置,该机械装置适于增大胃壁的第一部分与胃壁的第二部分之间的距离,由此拉伸胃壁的一部分。装置的第一和第二部分可包括机械构件,其适于移动以拉伸胃壁的在胃壁的第一和第二部分之间的部分。
根据另一实施例,该方法包括马达,其中所述机械构件利用马达移动以拉伸胃壁的一部分。
根据另一实施例,拉伸胃壁的一部分的步骤包括步骤:操作至少一个机械装置以拉伸胃壁的一部分。
根据另一实施例,将机械装置套叠在胃壁中的步骤包括利用胃至胃的缝合线套叠。
根据另一实施例,该方法进一步包括步骤:使套叠的胃壁中的机械装置膨胀以拉伸胃壁。
根据另一实施例,套叠的机械装置包括使该套叠的机械装置膨胀的马达。
该装置可进一步包括使胃壁膨胀的记忆金属或液压控制的机械装置。
放置
根据另一实施例,放置装置的步骤包括将装置放置为在胃壁的外部或在胃基底壁中与胃壁相连,或者放置为在胃壁的内部与胃壁相连。
根据另一实施例,将装置放置为在胃壁的内部与胃壁相连可包括步骤:在胃壁中切割孔,以及通过该胃壁中的孔插入所述装置。
根据另一实施例,放置装置的步骤包括将装置放置在病人的胃基底壁中。
固定
根据另一实施例,固定至少一个装置的步骤包括:例如通过胃至胃的缝合线或订合线,将至少一个装置缝合或订合到胃壁。
固定至少一个装置的步骤可包括:利用纤维组织放置适于被固定到胃壁的网。该网可另外地由缝合线或订合线支撑,并适于促进人体组织生长,例如网状结构。
控制单元
根据另一实施例,该方法可包括将传输构件从所述装置放置到控制单元的步骤。传输构件可包括流体传输构件,或者适于传输电力的传输构件。
根据另一实施例,该方法进一步包括步骤:放置控制单元,该控制单元可被放置在病人皮下。
根据另一实施例,将控制单元放置在皮下的步骤进一步包括步骤:将控制单元插入病人腹部中的孔,以及固定控制单元。
还提供一种另外的方法,该方法包括步骤:在胃壁中形成孔;将拉伸装置引入腹部;移动所述装置通过所述孔并将其放置在胃壁的内部;在胃腔的外部形成胃壁的一部分的囊,其中所述装置被放置为抵靠胃壁的内部;将所述装置套叠在胃壁的囊中;以及优选利用缝合线或订合线密封所述孔。
根据另一实施例,根据任意实施例的方法可包括步骤:在胃壁中形成孔;移动所述装置通过所述孔并将其放置在胃壁的内部;利用器械将所述装置引入所述囊;以及优选利用缝合线或订合线密封所述孔。
根据另一实施例,该方法进一步包括提供用于从病人身体外部调整拉伸装置的装置;以及操作所述装置来调整所述装置。
根据另一实施例,该装置包括可植入控制单元,该方法进一步包括步骤:提供用于从病人身体内部调整拉伸装置的可植入控制单元;以及操作所述装置来调整所述装置。
该方法可进一步包括步骤:皮下放置注入端口,以及将与所述装置相连的管连接到该注入端口。
根据另一实施例,该方法进一步包括步骤:提供通过所述孔连接到拉伸装置并进一步到达腹壁或穿过腹壁的管。
根据另一实施例,该方法进一步包括步骤:从病人的连接到拉伸装置的腹腔接收所述管,以及用通过所述管注入的流体填充所述装置。
根据另一实施例,该方法可进一步包括步骤:皮下放置注入端口,并将所述管连接到所述注入端口。
该方法可进一步包括另外的步骤:术后且非侵入性地调整装置,以拉伸胃壁的一部分,从而影响病人的胃口。
根据另一实施例,该方法包括另外的用流体填充所述装置的步骤。
根据另一实施例,该方法可包括另外的将内部控制单元放置在病人身体内的步骤。
根据一个实施例,该方法进一步包括另外的步骤:将内部控制单元连接到所述装置,这通过液压或利用电线来完成。
提供一种利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术或腹腔镜方法。该方法包括步骤:将针或管状器械插入病人身体的腹部,利用所述针或管状器械向病人的身体填充气体,将至少两个腹腔镜套针放置在病人身体中,将照相机通过所述腹腔镜套针之一插入病人身体,将至少一个切除工具通过所述至少两个腹腔镜套针之一插入,切除所述胃的一区域,将装置引入腹腔,利用胃至胃的缝合线或订合线将所述装置套叠在所述胃壁的外部,以及通过操作装置术后拉伸套叠的胃壁部分。
根据另一实施例,该方法包括另外的步骤:将第二或更多个装置引入腹腔,利用胃至胃的缝合线或订合线将所述第二或更多个装置套叠在所述胃壁的外部,以及通过操作所述第二或更多个装置术后拉伸套叠的胃壁部分。
根据另一实施例,该方法包括另外的步骤:在所述装置的彼此独立的第一或第二或更多个部分处术后拉伸套叠的胃壁部分。
提供一种另外的利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术或腹腔镜方法。该方法包括步骤:将针或管状器械插入病人身体的腹部,利用所述针或管状器械向病人的身体填充气体,将至少两个腹腔镜套针放置在病人身体中,将照相机通过所述腹腔镜套针之一插入病人身体,将至少一个切除工具通过所述至少两个腹腔镜套针之一插入,切除所述胃的一区域,将装置引入腹腔,利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述拉伸装置的第一部分套叠,以及利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述拉伸装置的与第一部分分离的第二部分套叠,以及通过操作所述装置术后拉伸所述第一和第二部分之间的胃壁部分。
根据另一实施例,该方法包括另外的步骤:将第二或更多个装置引入腹腔,利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述第二或更多个拉伸装置的第一部分套叠,以及利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述第二或更多个拉伸装置的与第一部分分离的第二部分套叠,以及通过操作所述第二或更多个装置术后拉伸所述第一和第二部分之间的胃壁部分。
根据另一实施例,该方法包括另外的步骤:利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述拉伸装置的与第一或第二部分分离的第三或更多个部分套叠,以及通过操作所述装置术后拉伸所述第一和第二部分的任意组合与第三或更多个部分之间的胃壁部分。
提供一种利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术方法,该方法包括步骤:切割人类病人的皮肤,切除胃的一区域,将装置引入腹腔,利用胃至胃的缝合线或订合线将所述胃壁外部的所述装置套叠,以及通过操作所述装置术后拉伸所述套叠的胃壁部分。
该方法可进一步包括另外的步骤:将第二或更多个装置引入腹腔,利用胃至胃的缝合线或订合线将所述胃壁外部的所述第二或更多个装置套叠,以及通过操作所述第二或更多个装置术后拉伸套叠的胃壁部分。
根据另一实施例,该方法包括另外的步骤:在所述装置的彼此独立的第一或第二或更多个部分处术后拉伸套叠的胃壁部分。
提供一种另外的利用适于拉伸病人胃壁的一部分的装置来治疗病人的肥胖症的手术方法。该方法包括步骤:切割人类病人的皮肤,切除胃的一区域,将装置引入腹腔,利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述装置的第一部分套叠,利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述装置的与第一部分分离的第二部分套叠,以及通过操作所述装置术后拉伸所述第一和第二部分之间的胃壁部分。
根据另一实施例,该方法包括另外的步骤:将第二或更多个装置引入腹腔,利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述第二或更多个拉伸装置的第一部分套叠,以及利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述第二或更多个拉伸装置的与第一部分分离的第二部分套叠,以及通过操作所述第二或更多个装置术后拉伸所述第一和第二部分之间的胃壁部分。
根据另一实施例,该方法进一步包括步骤:利用胃至胃的缝合线或订合线将放置在所述胃壁外部的所述拉伸装置的与第一或第二部分分离的第三或更多个部分套叠,以及通过操作所述装置术后拉伸所述第一和第二部分的任意组合与第三或更多个部分之间的胃壁部分。
根据另一实施例,该方法包括另外的步骤:术后且非侵入性地调整装置,以拉伸胃壁的一部分,从而影响病人的胃口。
根据任意实施例的方法可进一步包括用流体填充所述装置的步骤。
根据另一实施例,该方法包括另外的步骤:将内部控制单元放置在病人的身体内,以及将所述内部控制单元连接到所述装置,这可液压或利用电线来完成。
器械
进一步提供一种用于将适于拉伸病人的胃壁的一部分的装置放置为与胃壁相连的器械。该器械包括:适于可释放地保持所述装置的保持构件,以及适于帮助将所述装置固定到胃壁在其外部的固定构件。
器械可进一步包括用于观察胃的区域的光学构件。
器械可包括适于将所述装置缝合到胃壁在其外部的固定构件。
根据另一实施例,固定构件适于将装置订合到胃壁在其外部,在其他实施例中,固定构件适于利用胃至胃的缝合线将装置的至少一部分套叠在胃壁中在其外部。
根据另一实施例,固定构件可适于利用胃至胃的订合线将装置的至少一部分套叠在胃壁中在其外部。
进一步提供一种用于将适于拉伸病人的胃壁的一部分的装置放置为与胃壁相连的器械。该器械包括:适于可释放地保持所述装置的保持构件、适于将所述装置插入通过胃壁的插入构件以及适于帮助将所述装置固定到胃壁内部的固定构件。
所述器械可进一步包括用于在胃壁中切割孔的切割构件、用于观察胃的区域的光学构件。固定构件可适于将所述装置缝合到胃壁在其内部,或者用于将所述装置订合到胃壁在其内部,或者用于利用胃至胃的缝合线将所述装置的至少一部分套叠在胃壁中在其内部,或者用于利用胃至胃的订合线将所述装置的至少一部分套叠在胃壁中在其内部。
器械可进一步包括专门的保持装置,其可包括适于利用真空或利用机械保持构件保持胃的专门的保持装置。
拉伸装置,适于术后可被调节且包括至少一个可膨胀部分,其中所述拉伸装置适于在第一塌缩状态与第二膨胀状态之间可调节。在第一塌缩状态,可膨胀部分塌缩,在第二膨胀状态,可膨胀部分膨胀。所述可膨胀部分的外表面至少部分地包括表面结构,其具有交替的降低区域和升高区域。在所述第一塌缩和第二膨胀状态中的至少一个中,可膨胀部分适于具有在相邻升高区域之间的第一距离,其充分延伸以在一定程度上防止纤维组织的生长直接互连相邻的升高区域从而削弱所述拉伸装置的第一塌缩和第二膨胀状态之间的可调节性。所述可膨胀部分进一步包括在相邻的升高和降低区域之间的连接区域,在所述第一塌缩和第二膨胀状态中的至少一个中,进一步适于具有在相邻连接区域之间的第二距离,其充分延伸以在一定程度上防止纤维组织的生长直接互连相邻的连接区域从而削弱所述拉伸装置的第一塌缩和第二膨胀状态之间的可调节性。
根据一个实施例,可膨胀部分为中空的或包括中空主体。
根据另一实施例,拉伸装置基本上完全中空,或包括沿所述拉伸装置的大致整个长度和/或整个容积延伸的中空主体。
纤维组织可经常具有约0.5mm至约1.5mm的延伸长度或厚度,因此表面结构的元件的相关表面之间的距离适当地大于约3mm,因而大于约2×1.5mm。但是根据情况,大于约1.0mm至约3mm的距离也可能是足够的。在纤维组织可预期具有大于约1.5mm的延伸长度或厚度的情况下,表面结构的元件的相关表面之间的距离以适当的方式适应。
表面结构可包括升高和降低区域,可能合适的是,升高和降低区域的不同平面之间的距离也大于特定阈值,以利于拉伸装置的可塌缩和/或可膨胀的功能性。如果所述距离太小,则拉伸装置的可塌缩和/或可膨胀功能可受到限制。所述距离的适当间隔为约0.5至10mm,更适当为约2至8mm,最适当为约3至7mm。表面结构可包括不同的几何元件或形状以及这些元件或形状的组合,只要能够符合以上所述的该距离的条件即可。表面结构可例如包括不同形状的脊和槽。脊和槽可分别具有截面,其为例如楔形、四边形、正方形、金字塔形、截断金字塔形。进一步可能的是,脊和槽具有不同形状的截面。表面结构也可大体上包括手风琴形结构,其中相同或其中不同种类的几何物体放置在表面上。几何物体可被在实践中随机或根据一些方案放置在表面上。
其中该类型的表面结构可以是合适的一种类型的拉伸装置为其中拉伸装置应该具有本质上改变形状和/或尺寸的拉伸装置。因此,这就是纤维组织的存在本质上可妨害或阻碍拉伸装置的功能的情况。但表面结构可被任何拉伸装置使用,其中表面结构的特征对于拉伸装置而言是有利的。
附图说明
现在将通过非限制性示例并参照附图更为详细地描述本发明,在附图中:
图1示出植入在病人的胃基底壁中在胃基底壁内部的拉伸装置。
图2a示出植入在病人的胃基底壁中在胃基底壁外部的拉伸装置。
图2b示出植入在病人的胃基底壁中在胃基底壁外部的处于第二状态的拉伸装置。
图3a示出根据第一实施例的实施例,其中拉伸装置包括两个拉伸装置。
图3b示出根据第二实施例的实施例,其中拉伸装置包括两个拉伸装置。
图4a至4i示出根据不同实施例的拉伸装置。
图5a为拉伸装置10的表面结构700的截面图。
图5b为类似于图5a的截面图但带有稍微不同的表面结构700的截面图。
图5c至5e为示出本文所述的表面结构700的示例的截面的附图。
图5f示意性示出具有表面结构700的拉伸装置10的实施例。
图5g和5h示出假体的不同截面的示例。
图5i至5k为示出不同表面结构的示例的附图。
图6a至6c示出套叠在胃壁中的拉伸装置。
图7示出根据第一实施例的实施例,其中拉伸装置为机械拉伸装置。
图8示出根据第二实施例的实施例,其中拉伸装置为机械拉伸装置。
图9a示出根据第三实施例的实施例,其中拉伸装置为机械拉伸装置。
图9b示出适于帮助固定拉伸装置的网。
图9c示出根据第四实施例的实施例,其中拉伸装置为机械拉伸装置。
图10a示出根据第五实施例的实施例,其中拉伸装置为机械拉伸装置。
图10b更为详细地示出根据第五实施例的处于第一状态下的实施例,其中拉伸装置为机械拉伸装置。
图10c更为详细地示出根据第五实施例的在第二状态下的实施例,其中拉伸装置为机械拉伸装置。
图11a示出根据第一实施例的实施例,其中拉伸装置与用于治疗返流疾病的装置组合。
图11b示出根据第二实施例的实施例,其中拉伸装置与用于治疗返流疾病的装置组合。
图12a示出一实施例,其中拉伸装置与容积填充装置组合。
图12b示出手动类型的拉伸装置的又一实施例。
图12c示出自动类型的拉伸装置的又一实施例。
图13至36示出描述拉伸装置的不同功能的示意图。
图37a示出胃镜器械的控制单元。
图37b示出放置在胃中的胃镜器械。
图37c示出刺穿胃壁时的胃镜器械。
图37d更为详细地示出刺穿胃壁时的胃镜器械。
图37e示出根据一个实施例的胃镜或腹腔镜器械。
图37f示出处于第二状态的根据一个实施例的胃镜或腹腔镜器械。
图37g示出处于第三状态的根据一个实施例的胃镜或腹腔镜器械。
图37h示出处于第四状态的根据一个实施例的胃镜或腹腔镜器械。
图37i示出处于第五状态的根据一个实施例的胃镜或腹腔镜器械。
图38a至38d更为详细地示出胃镜或腹腔镜器械。
图39a至39j示出胃镜或腹腔镜器械,其在胃壁中形成腔或袋,并插入拉伸装置。
图40a至40f示出胃镜或腹腔镜器械,其在胃壁中形成腔或袋,并插入拉伸装置。
图41a、41b示出插入导线的胃镜或腹腔镜器械。
图42示出胃镜方法的流程图。
图43示出腹腔镜或手术方法的流程图。
具体实施方式
套叠在胃壁中可以被理解为物体被放置在由胃壁材料形成的腔的内侧。套叠(invagination)允许胃至胃的缝合或订合,该缝合或订合允许物体利用人体组织自愈来封闭。
在下文中,将给出各实施例的详细描述。在附图中,相同的附图标记在所有不同附图中表示相同或对应的元件。可以意识到,这些附图仅用于例示,并不以任何方式来限制范围。因此,任何涉及到的方向,例如“上”或“下”,仅指附图中所示的方向。此外,附图中所示的任何尺寸等均出于例示的目的。
图1示出肥胖症治疗装置的第一实施例。该装置包括植入在人类病人体中的拉伸装置10。在图1中,拉伸装置10套叠在病人的胃12的壁12中,拉伸装置10的主体成形为静靠胃12的壁12,并进一步具有适于静靠该壁12的外表面。这意味着拉伸装置10优选具有大致圆形形状,以不损坏胃壁。然而,胃壁12很强固,因此可以使用许多不同的形状和形式。
拉伸装置10可以多种不同方式固定到胃12的壁12a。在图1所示的实施例中,拉伸装置10套叠在胃壁12a中。在套叠之后,施加多个胃至胃的缝合线或订合线14,以保持短期套叠。这允许人体组织的生长,从而保持长期套叠。
通过扩大拉伸装置的尺寸,环绕拉伸装置10的胃壁12由于拉伸装置10的周界增大而被拉伸。通过该拉伸,胃壁中的受体指示胃被充满,由此引起病人的饱胀感。因此,当拉伸装置10收缩时,受体指示胃未被充满,由此恢复饥饿感。
拉伸装置10的膨胀和收缩可在病人的直接控制下执行。可替换地,膨胀和收缩可根据预编程的安排执行。
返回图1,该附图还示出流体操作装置,即,适于操作拉伸装置的液压或气动操作装置,其将在下文中详细描述。
拉伸装置10形成流体室,流体被允许在该流体室中流动。拉伸装置10因此形成可改变其在胃壁中所占据之容积的可膨胀室,由此形成液压或气动调整的拉伸装置10。
用于流体的调整贮存器16利用采用管的形式的管路18连接到拉伸装置10。拉伸装置10由此适于通过使液体或空气从调整贮存器16移动到由拉伸装置形成的室而被优选非侵入性地调整。
调整贮存器16可以多种方式调整。在图1所示的实施例中,调整贮存器16通过手动按压调整贮存器16来调整。换言之,调整贮存器16通过移动贮存器的壁来调整。因而优选的是,调整贮存器16被放置在皮下,由此实现非侵入性的调整。
当调整贮存器16被按压时,其容积减小,液压流体经由管路18从贮存器移动到由拉伸装置10形成的室,从而扩大或膨胀拉伸装置10。为了填充和计算装置的流体水平,进一步提供注入端口1001。注入端口优选包括自密封隔膜,例如硅隔膜。
可以意识到,可使用气动操作来代替液压操作,其中代替液压流体的空气在贮存器16与由拉伸装置10形成的室之间移动。优选地,贮存器具有锁定位置,以将其保持在希望的位置。如果病人压缩贮存器16,其优选保持压缩并在再次按压之后释放。
任何种类的液压方案可用于拉伸装置。液压方案可通过机械或电力的任何马达或泵以及通过手动来驱动。
图1进一步示出回动伺服系统,其包括调整贮存器16和伺服贮存器90。伺服贮存器90通过管路18液压地控制拉伸装置10。回动伺服功能在图33至36中更为详细的描述。图2a示出根据另一实施例的装置,在该装置中马达40适于移动调整贮存器16的壁。因而电力调整贮存器16优选被放置在病人的腹部中。在该实施例中,可被提供无线外部远程控制单元34b、c和外部能量发射装置34a以通过能量转换装置30执行马达的非侵入性调整,能量转换装置30适于向能量消耗操作装置(在本示例中的马达40)供应能量。
远程控制器可包括无线能量发射器34a,其也可用作用于非侵入性地调整拉伸装置的调整装置。当通过远程控制器34执行调整时,提供用于为调整装置提供动力的内部电源70。内部能量源70可例如为可再充电植入电池或电容器或者用于接收从病人身体外部发射的无线能量的电容器或装置。以下将参照图13至29描述调整拉伸装置10的不同方式。
如图2a所示的装置进一步包括传感器201,其传感优选与病人的食物摄入相关的病人或装置的参数。传感器利用传感器信号传输构件202连接到控制组件42。传感器可用于以全自动方式调整所述装置,即,该装置响应与病人的食物摄入相关的传感器信号,由此影响控制组件来操作拉伸装置10拉伸胃壁12,并由此引起病人的饱胀感。传感器可适于通过温度、血压、血流量、心跳、呼吸和压力中的任一个来测量病人的食物摄入,并可被放置在胃12、食管203中或与贲门204相连。根据一个实施例,所述传感器为测量贲门204的收缩和/或放松的应变仪。
如图2a所示的装置进一步包括用于液压流体的回流的第二管路222。回流适于形成希望的持续预定时间的饱胀感,之后,液压流体流回足够的量,以使拉伸装置不再拉伸胃壁,并由此使饥饿感返回给病人。该过程的适当时间为1到6小时之间。根据其他实施例,利用连接到所述管路18的阀系统在主管路18中发生回流。
为了填充和计算装置的流体水平,进一步提供注入端口1001。注入端口1001优选包括自密封隔膜,例如硅隔膜。
图2b示出处于第二状态下的根据图2a的实施例的装置,其中拉伸装置10膨胀并由此拉伸胃壁12。
图3a示出一实施例,其中两个拉伸装置10”被提供。两个拉伸装置10”均根据以上参照图1所述的原理工作。它们可适于术后且非侵入性地被调整,并适于时常地调整不同的拉伸装置,以在第一时间拉伸胃壁的第一部分并在第二时间拉伸胃壁的第二部分。
这种拉伸装置10可用于保持电子元件和/或能量源和/或液压流体。来自该装置的液压流体可被分配到若干较小的拉伸装置区域,以时常地改变拉伸区域,从而避免胃壁的任何可能的更为持久的拉伸效果。甚至机械的若干拉伸区域可被使用。根据图3a的实施例进一步包括液压阀移位装置54,其被植入在病人体中,用于在操作第一和第二拉伸装置10”之间移位。该交替形成更具可持续性的装置,这是因为胃壁中的受体受到刺激在拉伸之间获得更长的恢复时间。
在图3a中,系统为如以上参照图1所述的由病人控制的手动系统,在图3b中,系统如上文参照图2a所述利用无线能量来获得能量。
图4a至4e示出适于植入病人的拉伸装置10的不同实施例。拉伸装置10包括:当装置套叠在胃壁中时适于与胃壁12接触的表面。图4b示出拉伸装置的实施例,其中拉伸装置包括固定构件206,用于将拉伸装置缝合或订合到胃壁。固定构件206可包括用于接收所述缝合线或订合线14的孔,或者固定装置206可被刺穿,使得缝合线或订合线可刺穿胃壁和固定装置206。图4c示出根据一实施例的拉伸装置10,其中拉伸装置10包括用于向所述装置填充流体的入口构件207。所述入口构件优选连接到适于套叠在胃壁12中的液压管路18。图4d示出根据一实施例的拉伸装置10,其中拉伸装置10包括保持构件208,当所述拉伸装置10插入胃壁12的套叠囊时,保持构件208适于连接到插入装置。图4e示出根据一实施例的拉伸装置10,其中拉伸装置具有稍微卵形或蛋形的形状。图4e进一步示出附接到所述拉伸装置10的液压管路18。图4f示出根据一实施例的拉伸装置10,其中拉伸装置可被通过管路18传送的流体充胀。根据图4f所示的一个实施例,管路包括两个部分18a、18b,其中第一部分18a用于将拉伸装置10拉到适当位置并用合适的流体填充装置10,第二部分18b用于操作所述装置10。图4g示出处于紧缩状态的根据图4f的实施例的拉伸装置10。拉伸装置10以其紧缩状态被插入通过胃壁12中的孔,之后装置10被合适的流体填充以进行操作。图4h示出根据一实施例的拉伸装置10,其中拉伸装置10包括两个可移动壁部223a、223b,其可利用由柔性材料制成的手风琴结构209移动。图4i示出根据一实施例的拉伸装置,其中拉伸装置可利用四个可膨胀部分210膨胀,四个可膨胀部分210沿拉伸装置的表面对称地放置在四个位置,如图4i的截面图所示。可膨胀部分210由柔性材料制成,从而当所述拉伸装置10被液压流体填充时,允许所述部分210膨胀。
见图5a,两个升高区域701之间的第一距离708a长到足以防止直接连接两个相邻升高区域707的纤维组织的生长。也就是,可以使纤维组织在升高和降低区域701、702以及连接区域704的表面上生长。然而,由于第一距离708a的延伸长度,纤维组织被防止从一个升高区域701直接生长到另一相邻的升高区域701。
关于表述“从一个升高区域701直接生长到另一相邻的升高区域701”,其例如意味着纤维组织从一个升高区域701生长到另一个,但没有生产在连接区域704或者仅在连接区域704上生长很小程度。如图5i的704a所示,第一距离708a可从升高区域701的水平在间隔704a内测量。表述“从一个升高区域701直接生长到另一相邻的升高区域701”还包括如下情况:纤维组织生长在相邻的区域上,例如,两个相邻的连接区域704,该生长的厚度使得来自每个相邻区域的纤维组织交汇并桥接在两个升高区域701之间的距离或空间。在这种情况下,两个升高区域701之间的空间可被纤维组织部分地或完全地填充。
可能优选的是,对应于降低区域702的延伸长度的第二距离708b也延伸得足够大,以防止纤维组织从一个连接区域704直接生长到另一连接区域704。关于表述“从一个连接区域704直接生长到另一连接区域704”,其意味着纤维组织从一个连接区域704生长到另一个,但没有在降低区域702上生长或者仅在降低区域702上生长很小程度。
在图5中,包括升高和降低区域的表面结构被示出,但是除了升高和降低区域以外,也可使用许多其他几何结构,只要可以实现以上提及的防止纤维组织的生长。特别是,以上提及的防止在升高区域之间和连接区域之间生长纤维组织。
一些这种其他几何结构的示例示于图5i至5k中。在包括脊和槽的表面结构中,脊和槽也可具有不同部分,一些示例适于图5a至5e中。
现在将主要参照图5a和5b阐释一些表述和方面。在该应用中,使用了相邻升高区域701、710之间的第一距离708a、718a的概念。关于该第一距离708a、718a,其意味着大致从升高区域701、710的边缘706、714到相邻升高区域701、710的边缘706、714测量的距离。大致从边缘测量意味着:测量可从升高区域701、710的水平在第一间隔704a内完成,第一间隔704a从升高区域701、710的水平朝向相邻的降低区域702、712的水平延伸。
在该应用中,还使用了相邻连接区域704、716之间的第二距离708b、718b的概念。关于该第二距离708b、718b,其意味着大致从在连接区域704、716与降低区域702、712之间的连接点到涉及相邻连接区域704、716的另一连接点所测量的距离。大致从连接点测量意味着:测量可从降低区域702、712的水平在第二间隔704b内完成,第二间隔704b从降低区域702的水平朝向相邻升高区域701、710的水平延伸。
关于升高和降低区域,其意味着位于不同平面703、705、720、722中的区域,其中所述平面分隔开距离707、724、728。所述平面可平行或大致平行,但也可不平行。如果平面平行,则限定它们之间的距离不重要。如果平面不平行(如图5b),平面之间的距离可通过平面720、722之一的法线724、728限定,其中法线延伸到另一平面722、726中的区域上的一点,且平面之间的距离等于法线724、728的延伸长度。由图5b可见,法线724、728从平面720、722延伸到距区域的边缘近似相等距离的点。存在限定平面之间的法线或距离的两种可能方式。以法线728为例,可将法线限定为728a或728b。可适于将两个平面之间的距离限定为最长法线的延伸长度,因此平面720和722之间的距离可等于法线728a的延伸长度。该限定将在下文中使用。
升高和降低区域可具有不同形状,它们可为平面或大致平面,但它们也可具有某一种类的曲面形状。
升高区域701、710利用连接区域704、716连接到相邻的降低区域702、712。在升高/降低区域与连接区域704、716之间的连接可包括不同尺寸的半径,较大或较小的半径。当半径非常小时,将大致存在对区域进行连接的边缘706、714。
表述“可膨胀部分”暗指所述部分也是可塌缩的。
适当地,拉伸装置10至少部分地包括具有高度生物兼容性的材料,这种材料可被称为生理惰性、生物惰性或生物兼容的。
具体参照图5a和5b,在表面结构700中,在相邻升高区域701、710之间可优选地存在特定第一距离708a、718a。相邻升高区域701、710之间的距离被选定为纤维组织无法跨越相邻升高区域701、710之间的第一距离708a、718a。因此,相邻升高区域701、710之间的第一距离708a、718a优选足够大,以防止形成跨过相邻的升高区域701、710的纤维组织。
如上所述,在相邻连接区域704、716之间可优选地存在特定第二距离708b、718b。相邻连接区域704、716之间的第二距离708b、718b被选定为纤维组织无法跨过相邻连接区域704、716之间的第二距离708b、718b。因此,相邻连接区域704、716之间的第二距离708b、718b优选足够大,以防止形成跨过相邻的连接区域704、716的纤维组织。
还可优选的是,升高和降低区域的不同平面703、705、720、722、726之间的第三距离707、724、728a比特定阈值大,以便于拉伸装置发挥可塌缩和/或可膨胀功能。如果第三距离707、724、728a太小,则拉伸装置的可塌缩和/或可膨胀功能会受到限制。第三距离707、724、728a的合适间隔为0.5至10mm,更合适的为2-8mm,最合适的为3-7mm。为使纤维组织不应阻碍拉伸装置的可塌缩/可膨胀功能,优选的是,距离707、724、728a不太小,但如前所述的间隔是合适的。
表面结构700可包括不同几何形状的物体或元件,例如不同形状的脊、不同形状的凸起以及能够允许本文所述的表面结构的其他形状。升高区域701、710的面积可以非常小,但仍然形成具有希望功能的表面结构。升高区域701、710的面积可甚至几乎为零,如图5e中的例示。图5a和5b至5e示出表面结构700的示例的横截面,图5i至5k示出不同表面结构700的示例的立体图。表面结构700中的物体或元件可成行放置,以一些其他方式编排,或者可以或多或少随意分配在拉伸装置的表面上。不同类型的物体也可一同使用在表面结构700中,例如金字塔形和圆柱形物体与一些形状的脊的组合。
在图5f至5h中,拉伸装置10的实施例被示出,其中使用了表面结构700,未完全示出拉伸装置10。图3示出拉伸装置10的纵向截面,其中740表示拉伸装置10的上侧的表面结构,742表示拉伸装置10的下侧的表面结构。如图5f所示,下侧的表面结构742具有的延伸长度可比阴茎假体的上侧的表面结构740的延伸长度大。当拉伸装置10膨胀时,这为拉伸装置10赋予弯曲位置。表面结构140和142为弯曲部分的一个示例。图5g示出拉伸装置10的横截面,其中拉伸装置10包括腰部744,其中腰部包括腰表面结构746和748。带有腰表面结构746和748的腰部使拉伸装置10也可沿径向膨胀。拉伸装置10也可具有如图10所示的横截面,其包括具有四个腰表面结构750、752、754、756的腰部744,从而进一步便于使拉伸装置10也能够沿径向膨胀。图5g中的横截面沿图5f的线A1-A2截取。
图6a例示出设置有入口18b的拉伸装置10。拉伸装置10套叠在胃壁12中,入口18b可以从病人的腹区域连接到管或类似形式。管或管路18可优选地连接到控制单元42或注入端口1001。
图6b例示出套叠的拉伸装置10,其中管路18或电引线代替入口延伸到病人的腹区域。
图6c示出拉伸装置10的一部分和拉伸装置被套叠所在的胃的部分。管路18或电引线利用胃至胃的缝合线或订合线14套叠在胃壁12中,缝合线或订合线14形成放置拉伸装置10的胃壁组织的整个密封囊。管路18或电引线由此在入口18b与填充装置10的容积之间掘进于胃壁12中。
已经示出拉伸装置10的形状可采取许多不同形式。可以意识到,拉伸装置10的材料也可改变。优选的是,拉伸装置10设置有涂层,例如聚对二甲苯、聚四氟乙烯(PTFE)或聚氨酯涂层,或者这些涂层的组合,即,多层涂层。该涂层或多层涂层改善拉伸装置的性质,例如其抗磨损性。
在图7所示的另一实施例中,拉伸装置10根据与以上参照图1至6所述的原理不同的原理工作。拉伸装置10在此包括第一固定部分110a和第二固定部分110b,第一固定部分110a适于在胃壁12上的第一位置具有第一固定,第二固定部分110b适于在胃壁12上的第二位置具有第二固定。优选具有大致圆形形状并优选适于套叠在胃壁12中的这些固定部分110a、110b附接到各自腿部211的远端,腿部211接着在其各自的近端附接到操作装置,例如马达40。根据图7所示的实施例,马达为液压马达,包括液压活塞,其连接到先前参照图1所述的手动操作装置。液压活塞通过其与放置在腿部的极限处的关节212的连接影响腿部。拉伸装置110被封闭在壳体214中,以保护装置而避免纤维组织的生长,纤维组织可能损坏所述装置10的功能。然而,同样可以设想到,马达为另一液压马达、气动马达或电动马达。
拉伸装置10适于增大胃壁12上的第一位置与第二位置之间的距离,由此拉伸胃壁12。第一和/或第二固定部分110a、110b适于利用胃至胃的缝合线或订合线14至少部分地套叠在胃壁12中,从而将固定部分110a、110b关于胃壁12悬浮地保持在适当位置。
当然,第一和第二位置可以多种可能的方式被缝合或固定到胃壁,本发明覆盖所有可能性,以通过使胃壁的两个部分背离彼此移动并由此首先将装置固定到胃壁上的至少两个位置来扩张胃壁。然而,优选软悬浮连接到胃壁12,其中纤维胃至胃的组织帮助给定长期稳定的位置。
当然,仅仅使胃的套叠部分膨胀也拉离胃壁12,这也可机械、液压、气动以及由马达或泵提供动力或手动力地实现。
任何种类的机械结构可被使用,公开的机械实施例为一个示例。可使用通过机械或液压或任何气动结构驱动的任何机械。任何马达或任何泵或在被供应电力时改变形式的移动材料可被用于实现如下简单目标:通过使胃壁的至少两个部分背离彼此移动来拉伸胃壁的一部分。
图8示出根据一实施例的拉伸装置110,其中拉伸装置由可植入控制组件42控制,如前所述,传感器输入被其接收。拉伸装置因而利用泵44通过管路18调整,泵44连接到至少一个流体贮存器16、46并由连接到无线能量的接收器205、放置在皮肤36下面的能量转换构件30或者可植入能量源70(例如,可再充电电池)提供动力。
在图9a所示的变型中,第一和/或第二固定部分210a、210b分别展现出适于与胃壁12接触的结构,以促进人体组织的生长,从而确保附接到胃壁12的保拉伸装置10的长期放置。该结构优选包括网状结构213。固定部分210a、210b可适于通过固定部分与胃壁12之间的缝合线或订合线来将拉伸装置10保持在适当位置,以确保拉伸装置10的短期放置。除机械操作之外,根据图9a所示的实施例的拉伸装置10根据参照图7所述的装置发挥作用。图9b示出固定装置213,其包括适于传播纤维组织的生长以将两个固定部分固定到胃壁12的网状结构。
图9c示出根据图9a的实施例的处于第二状态的拉伸装置,其中两个固定部分已经彼此分离,且胃12已被拉伸。
图10a示出根据一实施例的拉伸装置,其中拉伸装置为通过电源线32’连接到控制组件42的电机械拉伸装置。电源线32连接到动力转换装置30,与无线能量的接收器205(例如线圈)接触,接收器205从无线能量的发射器34a接收能量。控制组件可进一步包括电池70,用于存储从无线能量发射装置34a接收的能量。控制组件接收来自传感器201的输入,传感器201根据本实施例为测量贲门204的收缩和/或放松的应变仪。
图10b进一步详细示出拉伸装置10。拉伸装置10包括壳体,其具有由柔性材料制成的手风琴结构209,以使壁部分能够移动。电源线32连接到电动马达的定子217,所述马达进一步包括设有螺纹的转子218,转子218与包括对应螺纹的可移位构件219相互作用。移位构件可旋转地固定到壳体接触构件220,其推靠壳体以影响拉伸装置的容积并由此拉伸胃12。
图10c示出处于第二状态下的根据图10b的拉伸装置,其中拉伸装置10膨胀并由此拉伸胃壁12。
图11a示出一实施例,其中适于治疗返流疾病的装置与根据以上任意实施例的拉伸装置组合。在装置410套叠在基底416中之后,由多个胃至胃的缝合线或订合线422a组成的固定被施加,以保持套叠短期不受损。由多个胃至胃的缝合线或订合线422b组成的第二固定被设置为将装置410保持在贲门414上方的位置。缝合线或订合线422b被施加在基底416的壁与食管424的壁之间。另外,采用缝合线或订合线422c形式的第三固定可被提供在基底416的壁与隔膜418的壁之间,也用于将装置410保持在贲门414上方的位置。
在图11a所示的第四实施例中,返流疾病治疗装置410的尺寸在被植入时可被调整。返流疾病治疗装置410与通过引线452b连接到返流疾病治疗装置410的皮下液压贮存器452关联,其中非侵入性调整可通过手动按压贮存器452执行。按压贮存器452将液压流体经由引线452b从贮存器452移位到较小的室410b。返流疾病治疗装置410接着连接到一个或多个较小的室410b。采用该方式,病人可以适于治疗的方式来调节流疾病治疗装置410的尺寸。
而且,以上实施例可替换地也用于治疗肥胖症。在该实施例中,通过利用返流疾病主体的容积来包含流体,并进一步利用连接到该装置主体的一个或多个较小的室40b被泵填充流体来膨胀并由此拉伸基底壁来制造饱胀感,该装置可适于治疗肥胖症。小室410b也适于被套叠在基底胃壁中,且当被填充流体时,发生胃的膨胀,这导致人体传感器反馈,从而造成饱胀感。皮下液压贮存器/泵使病人能够方便地泵浦液压流体以填充小室410b,从而造成他或她希望的饱胀感。
可替换实施例示于图11b中。该实施例基本类似于图11a所示的实施例,不同之处在于如何控制返流治疗装置410和室410b。这里,室410b不由皮下的泵控制,而是由动力式内部控制单元456控制。内部控制单元456包括如下机构,该机构用于使病人控制应该如何使用装置410来进行关于返流和/或肥胖症的治疗。其也可包括将动力供应到所述装置的机构。
内部控制单元456可包括电池470、电开关472、马达/泵444、贮存器452、注入端口1001。带有远程控制器的能量发射装置34适于控制装置并为该装置提供动力。例如,如果装置是电、液压、气动或机械操作的,则项目根据环境选择。
装置10可用于保持电子元件和/或能量源和/或液压流体。
图12a示出可调节容积填充装置810,其被套叠在病人的胃12的胃壁中。容积填充装置810适于占据胃中的空间,并由此减小可放置食物的容积。另外,根据任意实施例的可调节拉伸装置10被套叠在病人的胃基底壁中。优选的是,容积填充装置810显著大于拉伸装置10。
容积填充装置810和拉伸装置10经由其中设置有泵54的第一流体管52彼此流体连通。泵54由能量转换装置30控制,能量转换装置30适于经由能量供应管线56向泵54供应能量。能量转换装置30还连接到设置在病人食管中的传感器201,使得食物摄入可被检测。
容积填充装置810和拉伸装置10还经由第二流体管58彼此流体连通,第二流体管58优选具有比第一流体管52小的截面面积。
该设置结构的操作如下。容积填充装置810用在上述实施例中,即,其减小病人的胃12的食物腔的尺寸。另外,当通过利用泵54将流体从容积填充装置810泵浦到拉伸装置10而扩大拉伸装置10时,胃基底壁得到拉伸,从而造成病人的饱胀感。因此,例如当食物摄入被传感器201检测到时,流体自动泵浦到拉伸装置10,以增加饱胀感并由此限制食物摄入。
当流体已被注入拉伸装置10时,其中的内部压力高于容积填充装置810中的内部压力。该压力差将引起第二、优选较窄的管58中的流体从拉伸装置10流动到容积填充装置810。流动率将首要通过压力差和第二管58的截面面积以及其他可能方法来确定。优选的是,第二管的尺寸适于使得容积填充装置810和拉伸装置10中的压力将在流体已被注入拉伸装置10以引起饱胀感之后的3个小时之后恢复平衡。
在该实施例中,第二管58的功能是允许流体从拉伸装置10返回容积填充装置810。可以意识到,该功能还可通过第一管52中的泵54执行,且因而第二管58可被省略。
现在将参照图12b描述用于治疗肥胖症的装置的又一可替换实施例,其示出被治疗肥胖症的病人的胃12。该装置包括采用可充胀装置10形式的容积填充装置810,其被套叠在病人的胃12的壁12a中。然而,在该情况下,套叠在基底(即,胃的上部,在该处胃壁中的受体的数量较大)执行,且可充胀装置用作针对胃基底壁一部分的拉伸装置。
用于流体的调整贮存器利用采用管的形式的管路18连接到可充胀装置。可充胀装置810由此适于通过使液体或空气从调整贮存器移动到由可充胀装置810形成的室而被优选非侵入性地调整。可充胀装置810的调整优选包括回动伺服机构,即,小容积例如通过病人的手指启动,且该小容积与较大容积(即,调整贮存器)相连。
因此,可充胀装置810被放置在胃壁外部,并适于拉伸胃基底壁的一部分,由此影响病人的胃口。通过扩大拉伸装置的尺寸,由于可充胀拉伸装置810的周界增大,因此环绕可充胀拉伸装置810的胃基底壁被拉伸。通过该拉伸,胃壁中的受体指示胃被充满,由此引起病人的饱胀感。因此,当拉伸装置810收缩时,受体指示胃没有满,由此恢复饥饿感。可以意识到,该实施例组合了减小胃食物腔的容积以及拉伸胃壁12的部分的效果,由此增加治疗效果。
拉伸装置810的膨胀和收缩可在病人的直接控制下执行。可替换地,膨胀和收缩可根据预编程安排执行。
在图12c所示的优选实施例,传感器201被设置在合适的位置,例如食管处。采用可充胀拉伸装置形式的容积填充装置810类似于图12b所示的容积填充装置810。通过提供一个或多个传感器,用于治疗肥胖症的装置可被自动化,这是因为采用可充胀拉伸装置形式的容积填充装置810的尺寸根据进入胃的食物腔的食物量来调节。流体由此移动在可充胀容积填充装置810与流体贮存器之间。
系统
现在将参照图13至29描述大体上由附图标记28表示且包括如上所述的拉伸装置的肥胖症治疗系统。
图8的系统包括放置在病人腹部中的拉伸装置10。采用植入的能量转换装置30形式的内部能量源适于经由动力供应管线32向肥胖症治疗系统的能量消耗部件供应能量。外部能量发射装置34包括发射由能量接收器接收的无线信号的无线远程控制器,能量接收器可并入植入的能量转换装置30或与其分立。植入的能量转换装置30将能量从信号转换为经由动力供应管线32供应的电能。
图8的系统以更概括的框图形式示于图15中,其中大体上由竖直线示出的病人的皮肤36将线右侧的病人的内部与线左侧的外部分离。
图13示出简化框图,其示出拉伸装置10、经由动力供应管线32为拉伸装置提供动力的能量转换装置30、以及外部能发射装置34。
图14示出等同于图17的实施例的本发明的实施例,不同之处在于可由极化能操作的采用电开关38形式的回动装置也植入在病人体中,以使拉伸装置10回动。外部能量发射装置34的无线远程控制器发射承载极化能的无线信号,植入的能量转换装置30将无线极化能转换为极化电流,以操作电开关38。当电流的极性被植入的能量转换装置30移位时,电开关38使通过拉伸装置10执行的功能回动。
图15示出等同于图13的实施例的本发明的实施例,不同之处在于植入在病人体中用于调整拉伸装置10的操作装置40被设置在植入的能量转换装置30与拉伸装置10之间。该操作装置可采用马达40的形式,例如电动伺服马达。当外部能量发射装置34的远程控制器将无线信号发射到植入的量转换装置30的接收器时,马达40由植入的能量转换装置30的能量提供动力。
图16示出等同于图17的实施例的本发明的实施例,不同之处在于其也包括操作装置,该操作装置采用包括马达/泵单元78的组件42的形式且流体贮存器46植入在病人体中。在该情况下,拉伸装置10被液压操作,即液压流体通过马达/泵单元44从流体贮存器46通过管路48泵浦到拉伸装置10以操作该拉伸装置,液压流体通过马达/泵单元44从拉伸装置10泵浦回流体贮存器46,以使拉伸装置恢复起始位置。植入的能量转换装置30将无线能量转换为电流,例如极化电流,以经由电源供应管线50为马达/泵单元44提供动力。
还可以设想到,拉伸装置包括气动操作装置,以代替液压操作的拉伸装置10。在该情况下,加压空气可用于调整,流体贮存器由空气室代替,流体由空气代替。
在所有这些实施例中,能量转换装置30可包括可再充蓄能器(例如电池或电容器)以被无线能量充电,并将功能供应给装置的任何能量消耗部分。
外部能量发射装置34优选是无线的,且可包括远程控制的控制装置,用于从人体外部控制装置。
这种控制装置可包括无线远程控制器以及最可能间接地与病人的手接触的任何植入部分的手动控制器,例如放置在皮肤下面的用于按压的按钮。
图17示出本发明的实施例,其包括带有无线远程控制器的外部能量发射装置34、在该情况下液压操作的拉伸装置10、以及植入能量转换装置30,并进一步包括液压流体贮存器52、马达/泵单元44和采用液压阀移位装置54形式的回动装置,所有均植入在病人体内。当然,液压操作可易于通过仅仅改变泵浦方向执行,液压阀因此可被省略。远程控制器可为与外部能量发射分离或包括在其内的装置。马达/泵单元44的马达为电动马达。响应来自外部能量发射装置34的无线远程控制器的控制信号,植入的能量转换装置30利用由控制信号承载的能量为马达/泵单元44提供能量,其中马达/泵单元44将液压流体分配在液压流体贮存器52与拉伸装置10之间。外部能量发射装置34的远程控制器控制液压阀移位装置54,以使液压流体流动方向在一个方向与另一相反方向之间改变,在所述一个方向上,流体由马达/泵单元44从液压流体贮存器52泵浦到拉伸装置10以操作拉伸装置,在所述另一相反方向上,流体由马达/泵单元44从拉伸装置10泵浦到液压流体贮存器52以将拉伸装置恢复到起始位置。
图18示出等同于图17的实施例的本发明的实施例,不同之处在于由外部能量发射装置34的无线远程控制器控制的内部控制单元56、蓄能器58和电容器60也被植入在病人体中。内部控制单元56将从植入的能量转换装置30接收的电能的存储布置在蓄能器58中,蓄能器58将能量供应到拉伸装置10。响应来自外部能量发射装置34的无线远程控制器的控制信号,内部控制单元56或者释放来自蓄能器58的电能并将释放的电能经由动力线62和64转换,或者直接将来自植入的能量转换装置30的电能经由动力线66、稳定电流的电容60、动力线68和动力线64转换,用于操作拉伸装置10。
内部控制单元优选可从病人身体外部编程。在优选实施例中,内部控制单元被编程为调整拉伸装置10,以根据预编程的时间或来自任意传感器的输入来安排拉伸胃,所述任意传感器传感病人的任何可能的物理参数或装置的任何功能参数。
根据可替换方案,图18的实施例中的电容器60可被省略,根据另一可替换方案,该实施例中的蓄能器58可被省略。
图19示出等同于图13的实施例的本发明的实施例,不同之处在于用于供应能量以操作拉伸装置10的电池70和用于切换拉伸装置10的操作的电开关72也被植入在病人体中。电开关72通过由植入的能量转换装置30供应的能量操作,以从电池70未被使用的截止模式切换到电池70供应能量以操作拉伸装置10的导通模式。
图20示出等同于图19的实施例的本发明的实施例,不同之处在于可由外部能量发射装置34的无线远程控制器控制的内部控制单元56也被植入在病人体中。在该情况下,电开关72通过由植入的能量转换装置30供应的能量操作,以从防止无线远程控制器控制内部控制单元56且电池未被使用的截止模式切换到允许无线远程控制器控制内部控制单元56以从电池70释放电能从而操作拉伸装置10的待命模式。
图21示出等同于图20的实施例的本发明的实施例,不同之处在于蓄能器58代替电池70,且植入的部件被不同地互连。在该情况下,蓄能器58存储来自植入的能量转换装置30的能量。响应来自外部能量发射装置34的无线远程控制器的控制信号,内部控制单元56控制电开关72,以从蓄能器58未被使用的截止模式切换到蓄能器58供应能量以操作拉伸装置10的导通模式。
图22示出等同于图21的实施例的本发明的实施例,不同之处在于电池70也被植入在病人体中,且植入的部件被不同地互连。响应来自外部能量发射装置34的无线远程控制器的控制信号,内部控制单元56控制蓄能器58输送能量来操作电开关72,以从电池70未被使用的截止模式切换到电池70供应能量以操作拉伸装置10的导通模式。
可替换地,电开关72可通过由蓄能器58供应的能量操作,以从防止无线远程控制器控制电池70供应电能且不被使用的截止模式切换到允许无线远程控制器控制电池70供应电能以操作拉伸装置10的待命模式。
应该理解的是,开关应该被解释在其最宽泛的实施例中。这意味着FPGA或DA转换器或任何其他电部件或电路可切换优选从身体外部或由内部控制单元控制的导通或截止。
图23示出等同于图19的实施例的本发明的实施例,不同之处在于马达40、采用齿轮箱74形式的机械回动装置、以及用于控制齿轮箱74的内部控制单元56也被植入在病人体中。内部控制单元56控制齿轮箱74回动由拉伸装置10(被机械操作)执行的功能。更简单的是电动切换马达的方向。
图24示出等同于图22的实施例的本发明的实施例,不同之处在于植入的部件被不同地互连。因此,在该情况下,当蓄能器58(适当而言,电容器)启动电开关72以切换到导通模式时,内部控制单元56由电池70提供动力。当电开关72处于其导通模式时,内部控制单元56被允许控制电池70供应或不供应用于操作拉伸装置10的能量。
图25示意性示出用于实现各种连通选择的装置的植入部件的能设想到的组合。基本上,存在拉伸装置10、内部控制单元56、马达或泵单元44、和包括外部无线远程控制器的外部能量发射装置34。如上所述,无线远程控制器发射控制信号,该控制信号由内部控制单元56接收,内部控制单元56相应地控制装置的各种植入部件。
优选采用传感器76形式的反馈装置可被植入在病人体中,以传感病人的物理参数,例如食管203中的收缩波动,以告知病人正在吃饭。内部控制单元56、或者可替换地外部能量发射装置34的外部无线远程控制器可响应来自传感器76的信号控制拉伸装置10。收发器可与传感器76组合,以将关于传感到的物理参数的信息发送到外部无线远程控制器。无线远程控制器可包括信号发射器或收发器,内部控制单元56可包括信号接收器或收发器。可替换地,无线远程控制器可包括信号接收器或收发器,内部控制单元56可包括信号发射器或收发器。以上收发器、发射器和接收器可用于将关于拉伸装置10的信息或数据从病人身体内部发送到其外部。
可替换地,传感器76可被布置为传感拉伸装置10的功能参数。
在马达/泵单元44和用于为马达/泵单元44提供动力的电池70被植入时,电池70可装备有收发器,以发送关于电池70的状况的信息。更精确而言,当为电池或蓄能器进行能量充电时,与所述充电过程相关的反馈信息被发送,且能量供应相应地改变。
图26示出可替换实施例,其中拉伸装置10从病人身体外部调整。肥胖治疗系统28包括经由皮下开关80连接到电池70的拉伸装置10。因此,拉伸装置10的调整通过手动按压皮下开关非侵入性地执行,由此拉伸装置10的操作被导通和截止。可以意识到,所示实施例为简化版,其他部件(例如内部控制单元或本申请公开的任何其他部分)可被添加到该肥胖治疗系统。
图27示出可替换实施例,其中肥胖治疗系统28包括与液压流体贮存器52流体连接的拉伸装置10。非侵入性调整通过手动按压连接到拉伸装置10的液压贮存器执行。
根据本发明的系统的另外的实施例包括反馈装置,用于将信息从病人身体内部发送到其外部,以给出与拉伸装置或系统的至少一个功能参数或病人的物理参数有关的反馈信息,由此最优化系统的性能。
装置的一个优选功能参数可与用于对内部能量源充电的能量传输相互关联。
在图28中,适应性示出一设置结构,用于将准确量的能量供应到植入在病人体中的肥胖治疗系统28,病人的皮肤36由竖直线表示。拉伸装置10连接到植入的能量转换装置30,例如位于病人体内,优选在病人皮肤36紧下面。一般而言,植入的能量转换装置30可被放置在腹部、胸腔、肌肉筋膜(例如,腹壁中)、皮下、或任何其他合适的位置。植入的能量转换装置30适于接收从设置在外部能量发射装置34中的外部能量源34a发射的无限能量E,外部能量发射装置34位于病人皮肤36外部并处于植入的能量转换装置30邻近。
本领域众所周知,无线能量E可大体上利用任何合适的经皮肤能量传输(TET)装置传输,例如包括布置在外部能量源34a中的主线圈和布置在植入的能量转换装置30中的相邻的次线圈的装置。当电流通过主线圈供给时,采用电压形式的能量被引入于次线圈中,次线圈可用于操作拉伸装置,例如在将输入能量存储于能量存储装置或诸如电池或电容器等的蓄能器之后。然而,本发明大体上不限于任何特定的能量传输技术,TET装置或能量存储装置以及任何种类的无线能量可被使用。
身体内部对装置接收的能量值可与装置使用的能量相当。装置使用的术语因而被理解为也包括装置存储的能量。如上所述,传输的能量值可基于确定的能量平衡利用控制外部能量源34a的外部控制单元34b调整。为了传输正确的能量值,能量平衡和所需的能量值可利用与拉伸装置10相连的内部控制单元56确定。内部控制单元56因而可被布置为接收由合适的传感器或类似物获得的各种测量结果,所述传感器或类似物未被示出,从而测量拉伸装置10的特定特性,一定程度上反映正确操作拉伸装置10所需的能量值。而且,病人的当前状况也可利用合适的测量装置或传感器检测到,以提供反映病人状况的参数。因此,这种特性和/或参数可与拉伸装置10的当前状态相关,例如功耗、操作模式和温度,以及由例如体温、血压、心跳和呼吸反映的病人状况。
此外,能量存储装置或蓄能器58可选择性地连接到植入的能量转换装置30,以积蓄接收的能量,从而供拉伸装置10稍后使用。可替换地或可添加地,还可测量这种蓄能器的也反映所需的能量值的特性。蓄能器可由电池替代,测量的特性可与电池的当前状态相关,例如电压、温度等。为了向拉伸装置10提供充足的电压和电流,也避免过度加热,清楚理解的是,电池应最佳地通过接收来自植入的能量转换装置30的正确能量值(即不过少或过多)来充电。蓄能器也可为具有对应特性的电容器。
例如,电池特性可定期测量以确定电池的当前状态,然后该当前状态可在内部控制单元56中的合适的存储机构中被存储为状态信息。因此,无论何时进行新的测量,存储的电池状态信息可相应地更新。采用该方式,电池的状态可通过传输正确的能量值来“计算”,以保持优化条件下的电池。
因此,基于由上述传感器或者拉伸装置10或病人的测量装置或者能量存储装置(如果使用的话)或者其任意组合所得出的测量结果,内部控制单元56适于确定能量平衡和/或当前所需的能量值(每单位时间的能量或积蓄的能量)。内部控制单元56进一步连接到内部信号发射器82,其被布置为将反映确定的所需能量值的控制信号发射到与外部控制单元34b相连的外部信号接收器34c。从外部能量源34a发射的能量值因而可响应接收到的控制信号来调整。
可替换地,传感器测量结果可被直接发射到外部控制单元34b,其中能量平衡和/或当前所需的能量值可通过外部控制单元34b确定,因而将内部控制单元56的上述功能集成在外部控制单元34b中。在该情况下,内部控制单元56可被省略,且传感器测量结果被直接供应到内部信号发射器82,其将所述测量结果发送到外部信号接收器34c和外部控制单元34b。能量平衡和当前所需的能量值因而可基于这些传感器测量结果通过外部控制单元34b确定。
因此,本方案采用反馈表示所需能量的信息,这比先前的方案更有效,因为其基于与接收的能量相比的实际使用的能量,例如关于与拉伸装置使用的能量率相比而言的能量值、能量差或能量接收率。拉伸装置可利用接收的能量消耗或存储在能量存储装置或类似物中的能量。因此,以上论述的不同参数如果相关或需要则可被使用,然后用作确定实际能量平衡的工具。然而,这种参数本质上也可能对于内部采取的任何动作以特定地操作拉伸装置均是需要的。
内部信号发射器82和外部信号接收器34c可被实施为分立的单元,利用合适的信号传输机构,例如无线电、红外(IR)或超声信号。可替换地,内部信号发射器82和外部信号接收器34c可分别集成在植入的能量转换装置30和外部能量源34a中,以基本上利用相同的发射技术沿相对于能量传输相反的方向传递控制信号。控制信号可在频率、相位或幅度方面进行调制。
总之,图28中示出的能量供应设置结构可基本上以如下方式操作。能量平衡首先由内部控制单元56确定。反映所需的能量值的控制信号也由内部控制单元56形成,且控制信号从内部信号发射器82发射到外部信号接收器34c。可替换地,能量平衡可通过取代植入的外部控制单元34b确定,如上所述。在该情况下,控制信号可承载由各种传感器形成的测量结果。由外部能量源34a发射的能量值然后可例如响应接收到的控制信号基于确定的能量平衡通过外部控制单元34b来调整。该过程可在正在进行的能量传输期间以特定间隔间歇地重复,或者可在能量传输期间或多或少连续地作用。
传输的能量值可大体上通过调节外部能量源34a中的各种发射参数来调整,例如电压、电流、幅度、波动频率和脉冲特性。
因此,提供一种方法,用于控制供应到植入在病人体中的电操作拉伸装置的无线能量的发射。无线能量E从位于病人体外的外部能量源发射,并由位于病人体内的内部能量接收器接收,内部能量接收器连接到拉伸装置,以用于将接收的能量直接或间接地供应到拉伸装置。能量平衡在由内部能量接收器接收的能量与用于拉伸装置的能量之间确定。从内部能量源发射的无线能量E然后基于确定的能量平衡来控制。
还提供一种系统,用于控制供应到植入在病人体中的电操作拉伸装置的无线能量的发射。该系统适于从位于病人体外的外部能量源发射无线能量E,无线能量E由位于病人体内的植入的能量转换装置接收,植入的能量转换装置连接到拉伸装置,以用于将接收的能量直接或间接地供应到拉伸装置。该系统进一步适于确定由植入的能量转换装置接收的能量与用于拉伸装置的能量之间的能量平衡,并基于确定的能量平衡控制从外部能量源的无线能量E的发射。
该装置的功能参数与用于对内部能量源充电的能量传输相互关联。
在又一可替换实施例中,外部能量源从病人身体外部控制以释放电磁无线能量,释放的电磁无线能量用于操作拉伸装置。
在另一实施例中,外部能量源从病人身体外部控制以释放非磁无线能量,释放的非磁无线能量用于操作拉伸装置。
本领域技术人员将意识到,根据图17至29的以上各种实施例可以多种不同方式组合。例如,由极化能操作的电开关38可并入图11、18至24的任意实施例,液压阀移位装置54可并入图16的实施例,齿轮箱74可并入图15的实施例。请注意开关仅仅可以意味着任何电子电路或部件。
用于操作拉伸装置的能量的无线传输被描述为允许非侵入性操作。将意识到,拉伸装置也可用电线约束能量来操作。一个这种示例示于图29中,其中外部开关84利用动力线86和88互连在外部能量源34a与操作装置(例如调整拉伸装置10的电动马达)之间。外部控制单元34b控制外部开关的操作,以实现拉伸装置10的正确操作。
液压或气动提供动力
图30至33更为详细地示出为根据本发明的用于治疗肥胖症的装置提供液压或气动动力的四种不同方式的框图。
图30示出以上参照任意图1至6所述的用于治疗肥胖症的装置。该装置包括拉伸装置10以及另一个分立的调整贮存器16、单向泵44和供选阀54。
图31示出拉伸装置10和流体贮存器16。通过以任何其他不同方式移动调整贮存器的壁或改变调整贮存器的尺寸,拉伸装置的调节可在没有任何阀、而只是流体畅通经过的情况下在任何时间通过移动贮存器壁来执行。
图32示出拉伸装置10、双向泵44和调整贮存器16。
图33示出回动伺服系统的框图,其中第一闭合式系统控制第二闭合式系统。伺服系统包括调整贮存器16和伺服贮存器90。伺服贮存器90通过机械互连器94机械地控制拉伸装置10,拉伸装置具有可膨胀/可接触腔。该腔优选通过从与拉伸装置10流体连接的大型可调节贮存器92供应液压流体而膨胀或收缩。可替换地,腔包含可压缩气体,其可在伺服贮存器90的控制下被压缩和膨胀。
伺服贮存器90也可为拉伸装置自身的一部分。
在一个实施例中,调整贮存器被放置在皮下在病人皮肤36下面,并通过用手指推动其外表面来操作。该肥胖治疗系统例示于图34a至34c中。在图34a中,柔性皮下调整贮存器16被示出为通过管路18连接到鼓起形的伺服贮存器90。该手风琴形状的伺服贮存器90被包含在柔性拉伸装置10中。在图34a所示的状态下,伺服贮存器90包含最少的流体,大部分流体被发现于调整贮存器16中。由于伺服贮存器90与拉伸装置10之间的机械互连,拉伸装置10的外部形状收缩,即,其比其最大容积占据得更小。该最大容积在附图中用虚线示出。
图34b示出一状态,其中使用者(例如植入有拉伸装置的病人)按压调整贮存器16,以使其内包含的流体流动通过管路18并流进伺服贮存器90,其由于其手风琴形状而纵向膨胀。该膨胀相应地使拉伸装置10膨胀,使得其占据其最大容积,由此拉伸收缩的胃壁(未示出)。
调整贮存器16优选设置有用于在压缩后保持其形状的机构。因而,如图中的 16a示意性所示,这意味着当使用者释放调整贮存器时,也将拉伸装置10保持在拉伸位置。通过该方式,调整贮存器本质上用作肥胖治疗系统的导通/截止开关。
现在将参照图35和36a至36c描述液压或气动操作的可替换实施例。图35所示的框图包括控制第二闭合式系统的第一闭合式系统。第一系统包括调整贮存器16和伺服贮存器90。伺服贮存器90通过机械互连器94机械地控制大型可调节贮存器92。具有可膨胀/可收缩腔的拉伸装置10相应地通过从与拉伸装置10流体相连的大型可调节贮存器92供应液压流体而控制。
现在将参照图36a至36c描述本实施例的示例。类似于先前的实施例,调整贮存器被放置在皮下在病人皮肤下面,并通过用手指推动其外表面来操作。调整贮存器16通过管路18与手风琴形伺服贮存器90流体相连。在图34a所示的第一闭合式系统16、18、90中,伺服贮存器90包含最少流体,大部分流体在调整贮存器16中。
伺服贮存器90机械连接到大型可调节贮存器92,在该示例中也具有手风琴形状但比伺服贮存器90的直径大。大型可调节贮存器92与拉伸装置10流体相连。这意味着当使用者推动调整贮存器16由此将流体从调整贮存器16移位到伺服贮存器90时,伺服贮存器90的膨胀将使较大容积的流体从大型可调节贮存器92移位到拉伸装置10。换言之,在该回动伺服机构中,调整贮存器中的小容积被较大的力压缩,且这利用每单位面积较小的力而造成较大总面积的运动。
类似于以上参照图34a至34c所述的先前实施例,调整贮存器16优选设置有用于在压缩后保持其形状的机构。因而,如图中的 16a示意性所示,这意味着当使用者释放调整贮存器时,也将拉伸装置10保持在拉伸位置。通过该方式,调整贮存器本质上用作肥胖治疗系统的导通/截止开关。
方法
一种通过手术治疗肥胖病人的方法,该方法包括步骤:在病人的腹壁切割开口,切除胃周围的一区域,将用于治疗的装置放置到病人胃壁的一部分,以及缝合胃壁。
用于治疗肥胖症的装置优选经由腹腔镜腹肌路径放置在病人体中,包括步骤:将针或管状器械插入病人身体的腹部,利用所述针或管状器械向病人腹部填充气体,由此使病人的腹腔膨胀,将至少两个腹腔镜套针放置在病人身体中,将照相机通过所述腹腔镜套针之一插入病人腹部,将至少一个切除工具通过所述至少两个腹腔镜套针之一插入并切除病人的意欲放置区域,以及将用于治疗肥胖症的装置放置为与胃壁相连。
该方法可进一步包括术后调整至少一个拉伸装置的步骤,从而:拉伸胃壁的一部分并从病人身体外部调整拉伸装置从而影响病人的胃口。
器械
现在将参照图5a至5i描述一种将拉伸装置10套叠在胃壁12外部的入腔方法。起初,器械600(优选是胃镜器械)插入病人的嘴,见图5a。该器械包括注入装置610、602,用于将流体或装置注入病人的胃。器械600进一步包括适于控制器械的操作的控制单元606。为此,控制单元606包括一个或多个操控装置,在该附图所示的实施例中采用两个摇杆603和两个控制按钮604的形式。显示器605被提供用于显示由观察胃内部的光学装置提供的图像,所述光学装置布置在细长构件607外端例如为照相机(未示出),见图5e至5i。可包括沿细长构件延伸的连接电线的照相机可受到放置在细长构件上远端的光源(未示出)的帮助,以照射胃的内部。光学装置也可包括沿细长构件放置并从病人身体引出的光导纤维,以从外部观察胃的内部。
该器械进一步插入食管并至病人的胃中,见图37b。通过器械600,在胃12的壁中形成孔12b。为此,该器械在其远端设置有一个或多个切割器615。当然这些切割器可被设计为不同方式,例如围绕管状器械的中心轴线旋转的齿形辊式切割器。
在胃壁中切割孔之后,器械600的远端插入并通过孔2b,使得其终止在胃壁12a的外部。这示于图37c以及图37d中,图37c示出胃12的侧视图,图37d为沿图37c的线Vd-Vd截取的胃的剖视图。
器械600适于围绕胃壁12中的孔12b在胃的外部形成“腔”或“囊”。现在将描述提供囊的这种器械和方法。
图37e至37i示出用于通过在放置有拉伸装置10的胃壁12材料中形成囊将拉伸装置10套叠在胃壁12中的腹腔镜器械或胃镜器械。大体上由附图标记600表示且可包括以上参照图4a至4d描述的特征的器械包括具有近端和远端的细长构件607,细长构件607具有比病人的食管小的直径且为柔性的,以允许将柔性细长构件607以其远端先入地引导通过病人的喉咙、食管并进入胃12到胃壁12a。
胃刺穿装置或切割器615被设置在细长构件607上处于其远端处,以刺穿胃壁12a,从而在胃壁12a中形成孔,以允许将细长构件607引导通过孔。胃刺穿装置615可适于能操作以在胃基底壁12a被刺穿之后收缩所述胃刺穿装置5,而不进一步损坏主体内的组织。器械进一步包括专用保持装置609,其被设置在细长构件607上在刺穿装置615的近侧。
细长构件进一步包括可膨胀构件611,其适于在细长构件刺穿胃壁12a之后膨胀,由此帮助形成适于保持容积填充装置610的腔或囊。可膨胀构件611可包括可充胀圆形气球,其被设置在柔性细长构件607的远端部分周界周围。
现在将详细描述当套叠容积填充装置时的方法步骤。在器械600被插入胃12之后,胃刺穿装置615被放置为与胃壁12接触,见图37e。胃刺穿装置或切割器615因而被引入以在胃壁中形成孔12b,之后至少可膨胀构件611被引导通过胃壁12中的孔12b。专用保持装置609在该步骤进入保持状态,其中其沿径向膨胀,以形成针对胃壁12的大致圆形的邻接表面,见图37f。采用该方式,胃刺穿装置615和可膨胀构件611经过胃壁中的孔12所进行的插入限于图37f所示的位置。
可膨胀构件611然后膨胀。在该情况下,可膨胀构件包括气球或类似物,空气或其他流体注入其中。
细长构件607的包括可膨胀构件611的部分然后沿近端方向收缩,如图37g中的箭头所示,由此将胃壁612拉到由专用保持装置609形成的篮框或杯状结构中。
缝合或订合装置608被进一步设置为与细长构件607相连的装置或分立的器械。缝合或订合构件包括缝合或订合端613,其适于利用胃至胃的缝合线或订合线14关闭腔或囊。
在图37h所示的进一步的步骤中,可充胀拉伸装置10以其充胀状态被放置在杯状结构中。拉伸装置10然后被充胀到其充胀或膨胀状态,见图37i。该拉伸装置10的充胀可通过将流体或凝胶注入充胀的拉伸装置中实现。其也可通过注入允许固化的材料由此形成固态装置10实现。因此,示于图37h和37i中的拉伸装置10可例示出气球状装置,其随后被流体或凝胶或可替换地被简单地注入由胃壁12形成的杯状结构的材料填充。
用于填充拉伸装置10的流体可为适于填充拉伸装置10的任何合适的流体,例如盐溶液。在另一实施例中,当该流体为适于转换为固体状态的流体时,该流体可为液型聚氨酯。
为了最小化或全部消除泄漏,流体为等渗的,即,其具有与人类身体流体相同的渗透压度。防止扩散的另一方式是提供包括大分子(例如碘分子)的流体。
胃至胃的缝合线或订合线14优选设置有固定部分,其呈现例如网状结构的结构,适于与胃壁12接触以促进人类组织的生长,从而确保附接到胃壁的拉伸装置的长期放置。
由此,处于充胀或膨胀状态的可充胀装置10通过病人的在胃壁12外部的胃壁部分套叠。
在一个或多个上述步骤期间,胃可优选通过胃镜器械被气体充胀。
以上参照图37a至37i描述的拉伸装置10被描述为可充胀拉伸装置。可以意识到,其也可为具有弹性的弹性拉伸装置,从而允许压缩以被插入胃镜器械,其在离开器械之后膨胀为膨胀状态。
在一个实施例中,拉伸装置10包括可膨胀为膨胀状态的可充胀拉伸装置10。在该情况下,可充胀拉伸装置10设置有流体的入口18b,并适于连接到胃镜器械。现在将参照图38a至38d详细描述该实施例。
处于非膨胀状态的可充胀拉伸装置示于图38a中。大致气球状的充胀的拉伸装置10具有入口18b。在该状态下,可充胀拉伸装置10具有最多几毫米的直径,从而允许其利用胃镜管状器械600通过病人的食管插入胃,或者利用图38b所示的管状器械600通过腹腔镜方法中的腹腔镜套针。该器械包括外套筒600a和可相对于外套筒纵向移位的内套筒600b。内套筒在其远端设置有切割器,其采用切割边缘615的形式。该切割边缘可用于在胃壁中切割孔,如以下详细所述。
当器械从其内部或外部到达胃壁(见图38c)时,内套筒从其外套筒的位置向前并与与胃壁12a接触。内套筒的切割边缘615因而在胃壁中切割孔,以允许随后容积填充装置10插入通过该孔,见图38d。为了将拉伸装置推动通过该孔,活塞602可被设置在器械中。因此,该器械进一步包括活塞602,其适于将充胀的拉伸装置10从示于图38b中的内套筒中的位置推出到示于图38d中的内套筒外部的位置。
为了保护充胀的拉伸装置10免受内套筒的切割边缘615影响,另外的保护套筒(未示出)可被设置在拉伸装置周围。
图39a至39j示出在将拉伸装置10接合到病人的胃壁12的方法中所用的器械。该器械适于被插入通过窄管形物体,例如,使用在入腔过程中的胃镜,或者使用在腹腔镜过程中的腹腔镜套针。该器械包括器械650,其适于通过包括多个环形构件的结构而为柔性的,然而,同样可以设想到,所述细长构件650适于通过由柔性或可调节材料制成的所述细长构件650而为柔性的。细长构件650被从其外部或内部插入主体并被放置为与病人的胃壁12接近。细长构件650具有专用保持装置651,其适于通过机械抓取构件或真空来保持胃。专用保持装置651包括第一关节652和第二关节653,其使专用保持装置651可相对于细长构件650操作,并由此将保持装置651的包括机械抓取构件或真空元件的部分与病人的胃壁12接触。图39b示出被放置为与人类病人的胃壁12接触时的专用保持装置651,在此之后专用保持装置651连接到胃壁12,以保持胃壁12。图39c示出当执行将推杆654从细长构件650推进的步骤时的器械。推杆654推动胃壁12以形成其腔或囊。图39d示出该器械相对于图39a至39c转动90度。该视图示出专用保持构件651a、651b,当推杆654推动以形成腔或囊时,专用保持构件651a、651b可操作地附接到细长构件650的两侧并与胃壁12接触,从而保持胃壁12。当推杆654将胃壁12推到希望的位置时,专用保持装置651a、651b朝向推杆654移动,由此关闭腔或囊。
在腔或囊被形成之后,其需要被密封。图39f示出缝合或订合装置655从细长构件650的前移。缝合或订合装置655被定位为与胃壁相连,在此之后缝合或订合装置开始进行胃壁12的缝合和订合,从而形成胃至胃的缝合线或订合线14的密封。该器械沿病人的胃壁12移动,由此腔或囊利用该装置形成和密封,如图39g和39h所示。当腔或囊或希望的尺寸已被形成和密封时,插入构件656从细长构件650前移。插入构件656适于插入可充胀的拉伸装置10,如本申请前文所述。在插入构件656已被定位在腔或囊中之后,利用加压流体或气体或者将所述可充胀装置10推入腔或囊中的机械前移构件,拉伸装置10被插入通过插入构件656并至腔或囊中。因而,插入构件用流体或气体充胀可充胀拉伸装置,并利用胃至胃的缝合线或订合线14密封囊的最后部分。所述实施例阐释了插入可充胀拉伸装置的过程,然而同样可以设想到,拉伸装置10通过由弹性材料制成的拉伸装置10而为可膨胀的。
图40a至40f示出使用在将拉伸装置10接合到病人的胃壁12的方法中的器械。该器械适于被插入通过窄管形物体,例如,使用在入腔过程中的胃镜,或者使用在腹腔镜过程中的腹腔镜套针。该器械包括细长构件660,其适于通过包括多个环形构件的结构而为柔性的,然而,同样可以设想到,所述细长构件660适于通过由柔性或可调节材料制成的所述细长构件660而为柔性的。细长构件660被从其外部或内部插入主体并被放置为与病人的胃壁12接近。细长构件660具有多个专用保持装置661,其适于通过机械抓取构件或真空来保持胃。专用保持装置661利用锁定环662被锁定在细长构件660旁边的位置。专用保持装置由柔性材料制成并预弯曲以在所述锁定环662被移除时膨胀为漏斗形装置。处于漏斗形膨胀状态的专用保持装置示于图40b中。图40b进一步示出专用保持装置661,其被放置为与人类病人的胃壁12接触,在此之后专用保持装置661连接到胃壁12,以保持胃壁12。图40c示出当执行推杆665从细长构件660前移的步骤时的器械。推杆665推动胃壁12以形成其腔或囊。当推杆664已将胃壁12推到希望的位置时,专用保持装置661朝向推杆664移动,由此关闭腔或囊。
在腔或囊已被形成之后,其需要被密封。图40d示出缝合或订合装置665从细长构件660的前移。缝合或订合装置665被定位为与胃壁12相连,在此之后缝合或订合装置665开始进行胃壁12的缝合或订合,从而形成胃至胃的缝合线或订合线14的密封。之后,插入构件668从细长构件660前移,专用保持装置661收缩。插入构件666适于插入可充胀的拉伸装置10,如本申请前文所述。在插入构件666已被定位在腔或囊中之后,利用加压流体或气体或者将所述可充胀装置10推入腔或囊中的机械前移构件,拉伸装置10被插入通过插入构件666并至腔或囊中。因而,插入构件656用流体或气体充胀可充胀拉伸装置,并利用胃至胃的缝合线或订合线14密封囊的最后部分。所述实施例阐释了插入可充胀拉伸装置10的过程,然而同样可以设想到,拉伸装置10通过由弹性材料制成的拉伸装置10而为可膨胀的。图40f示出拉伸装置10套叠在胃壁12中时在利用胃至胃的缝合线或订合线14密封的腔或囊中的拉伸装置10。
图41a示出使用在将根据本申请的任意实施例的拉伸装置接合到胃壁12的方法中的器械。该器械包括细长构件670,其适于通过包括多个环形构件的结构而为柔性的,然而同样可以设想到,所述细长构件670适于通过由柔性或可调节材料制成的所述细长构件670而为柔性的。细长构件670被从其内部插入主体并被放置为与病人的胃壁12接近。胃刺穿构件672被放置在细长构件670的远端,收缩地固定到保护套筒673,该保护套筒适于保护身体的组织在已执行切割操作之后免受尖锐刺穿构件672或切割器672的影响。
图41b示出在切割操作已被执行且胃刺穿构件或切割器672已被收缩到保护套筒673中之后的包括细长构件670的器械。导线671被推动通过细长构件670、通过胃壁12中形成的孔并通出腹部,放置在病人皮肤的内部,皮肤从外部被刺穿以使导线671能够离开腹部。导线671因而可用于引导附接到拉伸装置10的管路18或引线,从而从其内部放置在胃中。带有管路18或电引线的拉伸装置10为根据本申请的任意实施例的拉伸装置10。管路18或电引线的引导使管路18或电引线能够附接到从腹部的外部放置在病人皮下的控制单元42。
图42示出描述在插入用于拉伸胃壁的一部分的装置的入腔方法中所需的步骤的流程图,该方法包括步骤:将器械插入病人的食管203(步骤1a),利用器械将装置通过食管203插入病人的胃(步骤2a),将装置10放置为与胃壁12接触(步骤3a),将装置固定到胃壁12,使得该装置能够拉伸胃壁12的一部分。所述方法可进一步包括在完成放置装置之后非侵入性地调整装置的步骤。
图43示出描述在插入用于拉伸胃壁的一部分的装置的腹方法中所需的步骤的流程图,该方法包括步骤:在所述病人的腹壁中切割孔(步骤1b),切除胃周围的一区域(步骤2b),将所述装置放置为与胃接触(步骤3b),以及通过胃壁的套叠将装置直接或间接地固定到胃壁,使得该装置能够拉伸所述胃壁的一部分(步骤4b)。所述方法可进一步包括步骤:利用缝合线或订合线14关闭腹部中的孔,以及在完成放置装置之后非侵入性地调整该装置。

Claims (15)

1.一种肥胖症治疗装置,包括:
至少一个可操作拉伸装置(10、10”、110a、110b、410b、50、810),其能植入在病人体中并适于拉伸所述病人的胃壁(12)的一部分,以及
能植入的操作装置(90、42、54、40、217、218、452),包括流体贮存器,所述流体贮存器适于与所述拉伸装置流体连通,其中所述能植入的操作装置构造用以非侵入性地操作被植入时的所述拉伸装置,通过将来自所述流体贮存器的流体移动到所述拉伸装置以充胀所述拉伸装置,以使所述胃壁部分被拉伸,从而引起饱胀感,
其中,所述肥胖症治疗装置的特征在于:所述可操作拉伸装置适于靠着所述胃壁的外部而放置。
2.根据权利要求1所述的装置,其中所述拉伸装置包括第一接合构件(10”、110a、210a、410b)和第二接合构件(10”、110b、210b、410b),所述第一接合构件适于接合所述胃壁的第一部分,所述第二接合构件适于接合与所述胃壁的第一部分接近但分隔开的所述胃壁的第二部分,其中当所述接合构件接合所述胃壁的第一部分和所述胃壁的第二部分时,所述操作装置适于操作所述第一和第二接合构件背离彼此,以拉伸所述胃壁的第一部分和所述胃壁的第二部分之间的胃壁部分,从而引起临时的饱胀感。
3.根据权利要求2所述的装置,其中所述第一和第二接合构件中的至少一个适于通过胃至胃的缝合线或订合线至少部分地被所述胃壁套叠,从而将所述接合构件保持在适当位置。
4.根据权利要求2-3中的任意一项所述的装置,其中所述第一和第二接合构件中的至少一个包括组织生长促进结构(213),其适于与所述胃壁的外部接触以保证所述拉伸装置长期附接到所述胃壁。
5.根据权利要求1所述的装置,其中所述拉伸装置包括主体(10、10”、110a、110b、410b、50、810),其适于填充由所述胃的壁部分限定的容积。
6.根据权利要求5所述的装置,其中所述主体是适于被所述病人的胃壁的一部分套叠的可膨胀主体,其中所述流体贮存器(16、46、52、90、452)与所述可膨胀主体的室流体连通,且其中所述操作装置能非侵入性地操作以将流体从所述流体贮存器分配到所述可膨胀主体的室,以使所述主体膨胀,使得当所述可膨胀主体套叠时,所述胃壁部分被拉伸。
7.根据权利要求6所述的装置,其中在所述胃壁的外部,所述可膨胀主体适于通过胃至胃的订合线至少部分地被所述胃壁套叠。
8.根据权利要求6所述的装置,其中所述流体贮存器(452)适于通过手动按压所述流体贮存器进行操作。
9.根据权利要求6或8所述的装置,其中所述操作装置包括回动伺服机构(90),且其中所述流体贮存器中的小容积的流体被较大的力压缩,且所述主体的室在每单位容积较小的力下造成较大总容积的运动。
10.根据权利要求1-3和5中任意一项所述的装置,其中所述拉伸装置包括机械调整拉伸装置。
11.根据权利要求10所述的装置,进一步包括用于调整拉伸装置的马达(40、217、218、444、78)或泵(444、54、78)。
12.根据权利要求1-3和5-8中任意一项所述的装置,其中所述操作装置包括适于通过手动按压进行非侵入性操作以操作所述拉伸装置的皮下开关(38、72、80、472)。
13.根据权利要求1-3和5-8种任意一项所述的装置,其中所述装置包括至少两个可操作拉伸装置(410b),其适于拉伸所述胃壁的至少两个不同部分,其中所述装置适于被术后且非侵入性地调整。
14.根据权利要求13所述的装置,其中所述装置适于能够被术后且非侵入性地时常地调整为使得在第一时间所述拉伸装置中的一个拉伸所述胃壁的一个部分,在第二时间,所述拉伸装置的另一个拉伸所述胃壁的另一部分。
15.根据权利要求1-3和5-8中任意一项所述的装置,其中所述装置进一步包括以下中的至少一个:内部能量源(70、470)、非侵入性地用无线能量对所述装置提供能量的无线能量接收器(205),以及接收用于对所述内部能量源充电的无线能量的能量接收器。
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