用于转移被排到患者肠道中的胆胰液的设备和方法技术领域 本发明整体涉及如下装置和方法，所述装置和方法用于以外科手术方式影响患者的消化，其旨在治疗代谢紊乱，例如病态肥胖症以及相关的并存病（例如，糖尿病）、心脏病、中风、肺疾病和偶发病症。 Is discharged for transferring apparatus and methods Technical Field pancreatic bile in the intestinal tract of a patient  The present invention generally relates to apparatus and method, the apparatus and method for surgically affect digestion of a patient, which is intended to treat metabolic disorders, such as morbid obesity and related comorbidities (eg, diabetes), heart disease, stroke, lung disease and sporadic disorders. 背景技术 已经尝试许多用于病态肥胖症的非手术疗法，但事实上均没有获得持久性的成功。  Many attempts have been made non-surgical therapy for morbid obesity, but in fact did not get persistent success.  治疗病态肥胖症的外科手术方法，例如针对持久性食物吸收不良的开放式、腹腔镜式和腔内胃旁路手术，已得到日益广泛的应用并且获得了较大成功。  The surgical method of treatment of morbid obesity, such as an open, laparoscopic and endoluminal gastric bypass surgery for persistent malabsorption of food, has been increasingly widely used and gained great success. 然而，目前用于执行胃旁路术的方法涉及耗时的且高灵敏度依赖性的外科手术技术以及对患者的胃肠解剖结构的显著且通常不利的修改。 However, a method for performing gastric bypass surgery involves time-consuming and highly sensitive dependence of surgical techniques, and is generally significant and adverse changes in the anatomy of the patient parenterally.  为了避免胃旁路手术的缺点并且以更具体且有针对性的方式来影响患者的消化， 本发明着重研究用于主要影响和调整肠-肝胆汁循环而非消化道的方法和装置。 The method and apparatus of the digestive tract rather than the hepatic circulation of bile -  To avoid the disadvantages of gastric bypass surgery and more specific and targeted way to digest the patient's influence, the present invention focuses on the main effect for intestinal adjustment and . 为此，应当设想到作用于肠-肝胆汁循环的下述可能方法和机制：-调整肠-肝胆汁循环频率，尤其是胆汁循环加速度；-调整由胆汁与肠内的食物的接触和相互作用以及由胆汁与肠壁的接触而触发的生理信号；-通过调整胆汁与食物或食糜在肠内的接触空间和接触时间以及通过使胆汁与食物有针对性地分离来调整食物的可吸收性。 For this purpose, it is contemplated that in the intestinal - hepatic circulation of bile following methods and mechanisms may be:  - adjusting the intestine - liver bile cycle frequency, in particular, bile acceleration cycle;  - adjusting the intestine and bile and the contact of the food and the interaction of the physiological signal generated by the contact with the intestinal wall of the bile triggered;  - or by adjusting the bile with food and chyme contact time in the contact space through the intestine and bile and food targeted adjusting the separation of the food absorbability.  用于将消化液例如胆汁和胰液朝远侧转移到小肠内的已知装置和方法已在US 2009/0062717和US 7，314，489中有所论述。  for example, bile and pancreatic juice digestive distally to the known apparatus and method for transferring small intestine has been discussed in US 2009/0062717 and in US 7,314,489. 公开于US 7，314，489中的装置包括支架，所述支架具有远端和接合乏特氏壶腹区域中的十二指肠的近端、以及位于近端和远端之间以产生可收集胆汁的环带体积的减小直径部分。 Disclosed in US 7,314,489 between the apparatus comprises a stent, the stent having a proximal end and a distal end engaging ampulla of Vater region duodenum, proximal and distal ends and positioned to produce a reduced diameter portion of the annulus volume collected bile. 公开于US 2009/0062717中的装置包括支承架和导管，所述支承架具有侧面开口，所述导管在连接到侧面开口的近端与远侧开口端之间延伸，其中所述导管的近端可形成贮存器。 Apparatus is disclosed in US 2009/0062717 comprises a support frame and a catheter, said support frame having a lateral opening, said conduit extending between a proximal end connected to the side opening of the distal end opening, wherein the proximal end of the catheter may form a reservoir.  用于转移消化液的这些已知装置和方法收集胆汁， 但它们并不具体地影响或改变胆汁和食物与肠壁接触和相互作用的时间和空间。 These known devices and methods  for transferring the collected bile digestive juices, but they do not affect or alter the particular time and space bile and food contact and an interaction with the intestinal wall.  因此本发明的目的为改变胆汁和食物与肠壁接触和相互作用的自然时间和空间， 以引起重量减轻和/或允许以尤其微创的方式来控制糖尿病。  Therefore object of the present invention to vary with the intestinal bile and food contact and an interaction space and natural time, to cause the reduction and / or to allow a minimally invasive way to control, especially diabetes, by weight.  通过用于转移被排到患者肠道中的胆胰液的设备来实现此目的，所述设备包括： A)柔性的管状构件，所述管状构件具有：-内部食物隔离空间和-近侧密封部分，所述近侧密封部分能够接合肠壁以防止食物在管状构件和肠壁之间流动，-近侧开口端，所述近侧开口端能够接纳食物流并且将食物流引导至食物隔离空间中，-远侧开口端，所述远侧开口端能够从食物隔离空间释放食物流，-侧向开放式胆汁隔离腔，所述侧向开放式胆汁隔离腔由管状构件的外表面形成并且能够与肠壁的相邻部分一起限定胆汁隔离空间， B)食物套管部分，所述食物套管部分从柔性的管状构件的远侧开口端朝远侧延伸并具有开放式远侧食物套管端，所述食物套管部分在内部限定食物输送空间， C)胆汁转移导管，所述胆汁转移导管从胆汁隔离  The patient is discharged to the intestinal bile pancreatic juice through the apparatus for transferring this purpose, the apparatus comprising:  A) a flexible tubular member, said tubular member having:  - Internal Food insulation space and  - sealing a proximal portion, the proximal portion can engage the sealing wall in order to prevent the food from flowing between the tubular member and the wall,  - a proximal open end, said open proximal end capable of receiving food and the food stream flow to the food in the insulating space,  - a distal open end, said open distal end capable of releasing a flow of food from food insulation space,  - bile isolation chamber open side said lateral open chamber isolated bile formed by the outer surface of the tubular member and bile can define together with the adjacent portion of the insulation space of the wall,  B) food sleeve portion, the sleeve portion from the flexible food open distal end of the tubular member extending distally and having an open distal sleeve end food, the food inside the sleeve portion defining a food conveying space,  C) transferring the bile duct, the bile duct transfer isolated from the bile 朝远侧延伸并具有开放式远侧胆汁导管端，所述胆汁转移导管在内部限定与所述食物输送空间隔离的胆汁输送空间。 It extends and has an open distal end of the catheter distally bile, the bile transfer conduit defining the inside of the food conveying space conveying space isolated from bile.  此设备将食物或食糜与肠壁在管状构件远侧的区域中隔离，同时将胆汁从胆汁隔离腔且不进入奥狄括约肌而转移到独立于与食糜隔离的区域的位置（开放式胆汁导管端)O发明内容 根据本发明的一个方面，胆汁转移导管的远侧开口端定位在远侧开放式套管端的远侧的位置处。  This device will chyme food or with the intestinal wall in the region of the tubular member distal isolation while the bile from the bile into the isolation chamber and not be transferred to the sphincter of Oddi independent and isolated regions chyme position ( the open end of the bile duct) O SUMMARY oF tHE iNVENTION  according to an aspect of the present invention, at the transfer position bile duct open distal end positioned distal to the distal open end of the sleeve.  这允许在柔性的管状构件远侧的第一位置分配食物以使食物接触肠壁，并且允许在第一位置更远侧的肠内第二位置分配胆汁或胆胰液，以使得胆汁与肠壁接触（例如，远侧空肠或回肠壁）并且在食糜流已沿肠道移行且接触与胆汁隔离的肠道之后，与部分消化的食物和食糜流接触。  This allows the distribution of food in the first position of the flexible tubular member such that the distal wall food contact, in the first position and allow a more distal intestine in bile or bile second dispensing position pancreatic juice, bile and such contacting the intestinal wall (e.g., distal jejunum wall or back) and after migration along the intestinal chyme has flow and in contact with the intestinal bile isolated, partially digested in contact with food and chyme stream. 因此，相对于自然状态而言，食物-胆汁-肠的接触空间和时间得到显著改变，从而影响食物吸收和肠肝胆汁循环以获得体重减轻和/或糖尿病的控制。 Thus, with respect to the natural state, the food - bile - intestinal contact time and spatial change significantly, thereby affecting food absorption and enterohepatic circulation of bile to obtain the control weight loss and / or diabetes.  根据本发明的另一个方面，胆汁转移导管包括外部套，所述外部套限定围绕食物套管部分的环形胆汁输送空间。  According to another aspect of the invention, transfer conduit comprises an outer sleeve bile, the bile outer sleeve defining an annular space surrounding the food conveying section of the sleeve.  根据本发明的另一个方面，胆汁输送空间由食物套管部分的外表面和周围肠壁部分限定，以使得胆汁以与食物流隔离但与肠壁接触的方式从管状构件朝远侧流入肠道内。  According to another aspect of the invention, the bile transport space by the outer surface of the sleeve portion and a peripheral wall portion defining a food, such as to the bile in contact with the intestinal wall but isolated from the flow of food and distally from the tubular member flow into the intestine.  根据本发明的另一个方面，胆汁转移导管包括布置在食物套管部分外部的导管， 以允许隔离的胆汁独立于肠壁和食糜流动。  According to another aspect of the invention, the bile transfer conduit comprises a portion of the outer sleeve is disposed in a food conduit, to permit independent isolated bile and intestinal digesta flow.  根据本发明的另一个方面，食物套管部分直接从近侧密封部分延伸，从而形成十二指肠套管。  According to another aspect of the invention, the food sleeve portion extends directly from the proximal sealing portion, thereby forming a duodenal cannula.  根据本发明的另一个方面，胆汁导管的远侧开口端在远端开口套管端近侧的位置处通入食物套管部分，由此允许：-胆胰液和食物流入第一部分，其中这两者彼此隔离并且与管腔壁隔离；-胆胰液与食物流在位于第一部分远侧且仍与管腔壁隔离的第二部分中混合；-食物和胆胰液在第二部分远侧的位置处与肠壁接触。  According to another aspect of the invention, the bile duct at a location distal opening at the distal end of the cannula into the proximal open end of the sleeve portion of food, thereby allowing:  - bile and pancreatic juice flowing into food a first portion, wherein both isolated from each other and isolated from the lumen wall;  - bile and pancreatic juice in the food stream mixing a second portion located distal of the first portion and is still isolated from the lumen wall;  - food bile and pancreatic juice in contact with the second portion at a distal position with the intestinal wall.  根据本发明的另一个方面，所述设备包括在近端和远端之间延伸的胆汁引流导管，所述近端具有支架以连接胆管树中的胆汁引流导管，所述远端连接与胆汁隔离腔流体连通的管状构件。  According to another aspect of the invention, the device comprises a biliary drainage catheter between the proximal and distal ends, said stent having a proximal end connected to biliary drainage catheters biliary tree, the distal connector bile tubular member in fluid communication with the isolation chamber. 这允许选择性地捕集胆管树内的胆汁和/或胰液并将其引导至胆汁隔离腔中。 This allows to selectively trap bile and / or pancreatic juice in the biliary tree and is guided to the bile isolation chamber.  本发明的上述目的还通过用于转移被排到患者肠道中的胆胰液的方法实现，所述方法包括： A)在乏特氏壶腹区域处形成位于装置和肠壁之间的胆汁隔离空间； B)将食物流与肠壁在胆汁隔离空间远端的区域中分离； C)将隔离的胆汁从胆汁隔离空间转移到其中食物流与肠壁分离的区域的远侧的位置。  The object of the present invention is also a method bile pancreatic juice is discharged to the intestinal achieved by the patient for transferring, said method comprising:  A) forming means and positioned at a wall region of the ampulla of Vater lack insulating space between the bile;  B) separating the food stream with the intestinal wall in the region of the distal end of the insulating space bile;  C) isolating the bile from the bile transferred to the insulation space wherein the food stream with the intestinal wall a location distal of separate regions.  根据本发明的一个方面，转移隔离的胆汁的步骤包括如下步骤：将胆汁转移导管在腔内从胆汁隔离空间沿远侧方向延伸到其中食物流与肠壁分离的区域的远侧的位置。  In accordance with one aspect of the present invention, the step of transferring the isolated bile comprising the steps of: transferring the bile from the bile duct lumen extending in the distal direction insulation space wherein the food stream to the distal region of the separation wall position.  根据本发明的另一个方面，转移隔离的胆汁的步骤包括如下步骤：通过肠-肠吻合或通过肠-内源组织管-肠吻合在胆汁隔离空间中的肠壁与肠的远侧靶位置之间形成直接管腔连通。  According to another aspect of the present invention, the step of transferring the isolated bile comprising the steps of: through the gut - intestinal anastomosis or by - endogenous tissue tube - anastomosis isolated space in the bile and gut distal wall a lumen in direct communication between the target position. ·附图说明 通过附图及其说明，本发明的这些和其它方面和优点将变得明显，所述附图及其说明示出了本发明的实施例，并连同上面给出的本发明的整体描述以及下文给出的实施例的具体实施方式用于解释本发明的原理。 · BRIEF DESCRIPTION  description and the accompanying drawings These and other aspects and advantages of the invention will become apparent from the description and illustrate embodiments of the present invention, the accompanying drawings, given in conjunction with the above DETAILED dESCRIPTION Example embodiments given below and the overall description of the present invention serve to explain the principles of the invention. -图1示出了根据本发明的第一实施例的用于转移被排到患者肠道中的胆胰液的方法和设备；-图2示出了图1中的设备的细节；-图2A示出了根据本发明的第二实施例的设备的细节；-图3示出了根据本发明的第三实施例的设备的细节；-图4示出了根据本发明的第四实施例的设备的细节；-图5示出了根据本发明的第五实施例的设备的细节；-图6-12示出了根据本发明的实施例的用于将设备锚定到胃肠道中的装置和方法;-图13示出了根据本发明的第六实施例的设备的细节；-图14示出了根据本发明的第七实施例的设备的细节；-图15A和15B示出了根据本发明的第八实施例的设备的细节；-图16示出了根据本发明的另一个实施例的设备的细节；-图17示出了根据本发明的另一个实施例的方法和设备。  - Figure 1 shows a first embodiment for transferring embodiment of the present invention is a method and apparatus is discharged to the intestinal bile pancreatic patient;  - Figure 2 shows the apparatus 1 in FIG. details;  - Figure 2A shows a detail of a second embodiment of the apparatus of the present invention;  - Figure 3 shows a detail of the device according to the third embodiment of the present invention;  - Figure 4 shows a detail of the apparatus according to the fourth embodiment of the present invention;  - Figure 5 shows a detail of the device according to the fifth embodiment of the present invention;  - 6-12 shown in FIG. according to an embodiment of the device of the present invention will be anchored to the apparatus and method of the gastrointestinal tract;  - Figure 13 shows a detail of the device according to a sixth embodiment of the present invention;  - FIG. 14 shows a detail of the device according to a seventh embodiment of the present invention;  - Figures 15A and 15B illustrate details of the apparatus according to the eighth embodiment of the present invention;  - Figure 16 shows the details of the device according to another embodiment of the present invention;  - Figure 17 illustrates a method and apparatus according to another embodiment of the present invention. 具体实施方式 参见附图，其中在多个视图中类似的数字代表类似的解剖结构和部件，图1为患者的腹腔的局部视图，其中示出了具有食道1、胃2、十二指肠3、空肠4、回肠5、结肠6的胃肠道，以及具有肝脏、包含胆囊8的胆管树7、胰管9、以及乏特氏壶腹的十二指肠大乳头10 (胆汁和胰液穿过其正常地进入十二指肠3)的肝胆系统，以及用于转移被排到患者肠道中的胆胰液的设备11。 DETAILED DESCRIPTION  Referring to the drawings, in the several views wherein like numerals denote like anatomical structures and components, FIG. 1 is a partial view of a patient's abdominal cavity, is shown having an esophagus, stomach 2, twelve duodenum 3, 4 jejunum, ileum 5, 6 of the colon of the gastrointestinal tract, as well as having a liver, gall bladder biliary tree comprising 8 7 9 duct, ampulla of Vater and the duodenal papilla 10 (bile and normal pancreatic juice into the duodenum through 3) of the hepatobiliary system, and a transfer device 11 is discharged to the intestinal bile pancreatic juice patient.  根据实施例，设备11包括优选柔性的管状构件12，所述管状构件12具有内部食物隔离空间13和至少近侧密封部分14，所述近侧密封部分14能够接合肠壁以防止肠壁在管状构件12和肠壁之间流动。  According to an embodiment, the device 11 preferably comprises a flexible tubular member 12, the tubular member 12 has an inner space 13 and the food isolation seal at least a proximal portion 14, the proximal portion 14 can engage the sealing wall in order to prevent intestinal walls of the flow between the tubular member 12 and the intestinal wall. 管状构件12还形成近侧开口端16和远侧开口端17，所述近侧开口端16能够接纳食物流并将其引导至食物隔离空间13中，所述远侧开口端17能够从食物隔离空间13释放食物流。 The tubular member 12 is also formed in the proximal open end 16 and a distal open end 17, a proximal open end 16 is capable of receiving a flow of food and the food is guided to the isolation space 13, the distal end opening 17 can be isolated from the food space 13 to release the food stream. 管状构件12的外表面18以形成侧向开放式胆汁隔离腔19的方式成型，所述侧向开放式胆汁隔离腔19能够与肠壁的相邻部分一起限定胆汁隔离空间19。 The outer surface 18 of the tubular member 12 to form an isolated bile manner laterally open cavities 19 forming the lateral open chamber 19 can be isolated from the bile of bile insulation space 19 is defined together with the adjacent portion of the intestinal wall.  设备11还包括食物套管部分21，所述食物套管部分21从柔性的管状构件12的远侧开口端17朝远侧延伸并具有开放式远侧食物套管端22。  The apparatus 11 further comprises a sleeve portion 21 of food, the food portion 21 from the distal sleeve of the flexible tubular member 12 extending distally open end 17 and having an open distal end 22 of cannula food. 食物套管部分21在内部限定食物输送空间23。 Food sleeve portion 21 within the space 23 defined food conveyed.  此外，胆汁转移导管24可从胆汁隔离腔19沿远侧方向延伸并具有开放式远侧胆汁导管端25。  In addition, the bile transfer conduit 24 may extend from a distal direction bile isolation chamber 19 and having an open distal end of the bile duct 25. 胆汁转移导管在内部限定与食物输送空间23隔离的胆汁输送空间26。 Bile transfer conduit defined internally with food conveying space 23 space 26 isolated from the bile transport.  可将此设备例如经口插入和调配到乏特氏乳头区域10处的十二直肠中，以使得胆汁隔离腔19覆盖乏特氏乳头10以接纳胆胰液。  This device may be, for example, oral formulations, and is inserted into the duodenum papilla of Vater 10 region, to isolate chamber 19 such that the bile cover Vater's papilla 10 to receive bile pancreatic juice. 按照这种定位，设备11允许将食物或食糜与肠壁在管状构件12远侧的区域中隔离，同时允许将胆汁从胆汁隔离腔19转移到独立于与食糜隔离的区域的位置，且无需进入奥狄括约肌。 In this position, the device 11 allows the chyme food or with the intestinal wall in the region of the isolation distal tubular member 12, while allowing the transfer of bile from the bile into the isolation chamber 19 independently of the position of chyme isolated regions, and without entering the sphincter of Oddi.  根据实施例，管状构件12能够支架，所述支架能够被锚定在小肠中，尤其是胆胰液正常进入肠的乏特氏乳头10处的十二指肠3中，并且能够捕集胆胰液并将其引导至胆汁转移导管24中。 Duodenum  According to an embodiment, the tubular member 12 can be a bracket capable of being anchored in the small intestine, especially the bile into the intestine of normal pancreatic juice Vater's papilla at 103, and is capable of trapping bile pancreatic juice and bile guided to the transfer conduit 24.  在示例性实施例中，胆汁隔离腔19包括径向外部环形腔，所述径向外部环形腔围绕胆汁隔离空间20形成并且由径向突出的近侧管腔密封部分14和径向突出的远侧管腔密封部分15轴向界定。  In an exemplary embodiment, the bile isolation chamber 19 includes a radially outer annular chamber, said radially outer annular chamber 20 is formed around the insulation space and bile proximal lumen by the sealing portion 14 and a radially projecting radially projecting distal sealing portion 15 axially defines a lumen.  管腔密封部分14，15可从初始收缩的径向较小构型膨胀至膨胀的径向较大构型， 所述初始收缩的径向较小构型允许将设备11经管腔（经口）引入和输送到乏特氏乳头10 处的所选十二指肠部分，所述膨胀的径向较大构型允许管腔密封部分14，15紧密地接合管腔壁并且将管状构件12锚定到管腔壁。  14, 15 radially collapsible from an initial configuration smaller lumen of the sealing portion is expanded to a radially expanded configuration larger, the initial shrinkage radially smaller configuration allows the device 11 administered chamber (oral) is introduced and conveyed to the selected portions of the duodenal papilla of Vater 10, the expanded radially larger lumen configuration allows the sealing portions 14, 15 tightly engages the tubular and the lumen wall anchoring member 12 to the lumen wall.  为此，管腔密封部分14，15可包括可膨胀式球囊区段，所述可膨胀式球囊区段可通过注入膨胀流体例如盐水溶液、或固化膨胀剂例如硬化聚合物泡沫或糊剂而永久性地膨胀。  To this end, the lumen of the sealing portions 14, 15 may comprise an inflatable balloon section, the inflatable balloon expandable section by injecting a fluid such as saline solution, bulking agents such as hardened or cured polymer foam or paste and permanently expanded.  根据实施例，远侧管腔密封部分15还可限定一个或多个胆汁通道孔27，所述胆汁通道孔27从胆汁隔离腔19延伸到胆汁转移导管24并将这两者放置成流体连通。  According to an embodiment, the distal lumen of the sealing portion 15 may also define one or more bile passage holes 27, the passage hole 27 extending from the bile bile isolation chamber 19 into the bile duct 24 and the transfer is placed in both the fluid communication.  根据实施例，胆汁转移导管24的远侧开口端25定位在远侧开放式套管端22远侧的位置处。  According to an embodiment, the bile duct 24 transfers the distal end 25 of the opening 22 is positioned at a location distal to the distal open end of the sleeve. 这允许在柔性的管状构件12远侧的第一位置分配食物以使食物与肠壁接触，并且允许在第一位置更远侧的肠内第二位置分配胆汁或胆胰液，以使得胆汁与肠壁（例如， 远侧空肠或回肠壁）接触，并且在食糜流已沿肠道移行且接触与胆汁隔离的肠道之后，与部分消化的食物或食糜流接触。 This allows the distribution of food 12 in the first position distal flexible tubular member into contact with the intestinal wall so that the food, in the first position and allow a more distal intestine in bile or bile second dispensing position pancreatic juice, bile and gut such walls (e.g., distal jejunum, or back wall) contact and, after intestinal digesta flow is transitional along and in contact with the intestinal bile isolated, partially digested food in contact with or chyme stream.  根据另一个实施例（图2，3)，胆汁转移导管24可包括外部套28，所述外部套28 基本上与食物套管部分21同轴并且限定围绕食物套管部分21的环形胆汁输送空间26。  According to another embodiment (FIGS. 2 and 3), bile transfer conduit 24 may include an outer sleeve 28, the outer sleeve 28 is substantially coaxial with the food portion 21 and the sleeve portion 21 defines an annular sleeve surrounding the food bile transport space 26. 在此实施例中，远侧胆汁导管端25的位置取决于外部套28的长度并且可位于远侧食物套管端22的近侧的位置处，以使得：-在管状构件12远侧的第一管道29中，食物流和胆汁流彼此隔离并且与肠壁隔离，-在第一管道29远侧且从远侧胆汁导管端25朝远侧延伸的第二管道30中，胆汁与肠壁接触，而食物流仍与胆汁和肠壁隔离，并且-在第二管道30远侧且从远侧食物套管端22朝远侧延伸的第三管道31中，食物流与残余的仍未被吸收的胆汁混合并且与肠壁接触（图3)。 In this embodiment, the position of the distal end of the bile duct 25 depends on the length of the outer sleeve 28 and may be located at a position proximal to the distal 22 end of the food casing, such that:  - the tubular member 12 away a first side conduit 29, the flow of food and bile flow and isolated from each other and isolated from the intestinal wall,  - a second conduit 30 and 25 extending distally from the distal end of the catheter in the bile duct 29 distal of the first , in contact with the intestinal bile, food and bile flow and remain isolated from the intestinal wall, and  - a second conduit 30 and distally from the distal end 22 of the cannula food third conduit 31 extending distally, bile food mixed with the residual stream is absorbed yet and in contact with the intestinal wall (FIG. 3).  在可供选择的示例性实施例中（图2A)，远侧胆汁导管端25的位置可位于远侧食物套管端22的近侧的位置处，以使得：-在管状构件12远侧的第一管道32中，食物流和胆汁流彼此隔离并且与肠壁隔离，-在第一管道32远侧且从远侧食物套管端22朝远侧延伸的第二管道33中，食物流与胆汁混合，而食物流和胆汁仍与肠壁隔离，并且-在第二管道33远侧且从远侧胆汁导管端25朝远侧延伸的第三管道34中，食物和胆汁与肠壁接触。  In an alternative exemplary position exemplary embodiment (FIG. 2A), the distal end of the bile duct 25 may be located at a position proximal to the distal 22 end of the food casing, such that:  - in the tubular member 12 distal the first conduit 32, the flow of food and bile flow and isolated from each other and isolated from the intestinal wall,  - a first conduit 32 and distally from the distal end 22 distally food cannula extending second conduit 33, the food is mixed with bile flow, bile flow and food remains isolated from the intestinal wall, and  - the bile duct and extends from the distal end 25 distally in the distal third of the second conduit 33 conduit 34, the food and bile in contact with the intestinal wall.  在可供选择的实施例中（图4)，胆汁输送空间26由食物套管部分21的外表面35 和周围肠壁部分限定，以使得胆汁以与食物流隔离但与肠壁接触的方式从管状构件12朝远侧流入肠道36中。  In an alternative embodiment (FIG. 4), bile transport space 26 from the outer surface of the food portion 21 of the sleeve 35 and the peripheral wall portion defining such bile in contact with the food, but isolated from the flow with the intestinal wall way from the tubular member 12 flows into the intestinal tract 36 distally.  根据示例性实施例（图5)，胆汁转移导管24包括布置在食物套管部分21外部的导管，从而允许隔离的胆汁独立于肠壁和食糜或食物流动。  According to an exemplary embodiment (FIG. 5), bile transfer conduit 24 comprises a sleeve portion 21 disposed outside of the food conduit, thereby allowing the isolation of bile and intestinal chyme or independent of food flow.  在此实施例中，远侧胆汁导管端25的位置取决于外部导管的长度并且可位于远侧食物套管端22的远侧的位置处，以使得：-在管状构件12远侧的第一管道37中，食物流和胆汁流彼此隔离并且与肠壁隔离，-在第一管道37远侧且从远侧食物套管端22朝远侧延伸的第二管道38中，食物流接触肠壁，而胆汁仍与食物和肠壁隔离，并且-在第二管道38远侧且从远侧胆汁导管端25朝远侧延伸的第三管道39中，胆汁与残余的仍未被吸收的食物混合并且与肠壁接触（图5)。  In this embodiment, the position of the distal end of the bile duct 25 depends on the length and may be located outside of the catheter 22 at a location distal a distal end of the food casing, such that:  - the tubular member 12 a first conduit 37 distally, food and bile flow stream and isolated from each other and isolated from the intestinal wall,  - and the end of the sleeve 22 extends distally from the distal conduit 37 of the first food distal second the duct 38, the flow of food in contact with the intestinal wall, but is still isolated from the bile and intestinal food, and  - a second conduit and a third conduit 38 distal the distal end of the bile duct 25 extending distally from 39 , food residue mixed with bile are absorbed and not yet in contact with the intestinal wall (FIG. 5).  在可供选择的示例性实施例中（未示出），远侧胆汁导管端25的位置可位于远侧食物套管端22的近侧的位置处，以使得：-在管状构件12远侧的第一管道中，食物流和胆汁流彼此隔离并且与肠壁隔离， 0078]-在第一管道远侧且从远侧胆汁导管端25朝远侧延伸的第二管道中，胆汁与肠壁接触，而食物流仍与胆汁和肠壁隔离，并且-在第二管道远侧且从远侧食物套管端22朝远侧延伸的第三管道中，食物与残余的仍未被吸收的胆汁混合并且与肠壁接触。  In an exemplary embodiment alternative embodiment (not shown), the distal end of the bile duct 25 may be located at a position proximal to the position 22 of the distal end of the food casing, such that:  - in the first conduit 12 of the distal tubular member, the flow of food and bile flow and isolated from each other with the intestinal wall isolation, 0078] - a first conduit and the second conduit distal biliary catheter distal end 25 extends distally in contact with the intestinal bile, food and bile flow and remain isolated from the intestinal wall, and  - and the second conduit distal from the distal end of the cannula food third conduit 22 extends distally, the food in contact with the intestinal wall and the residue is mixed with bile not yet absorbed.  根据另一个实施例，食物套管部分可从可结合图1和2的实施例所述进行构造的近侧管腔密封部分14向近端延伸，由此形成可经口插入胃肠道并且锚定在其某个位置的十二指肠套管装置，其中近侧管腔密封部分定位在例如乏特氏乳头10近端（上游）的若干厘米处。  According to another embodiment, the food of the sleeve portion may be a proximal portion configured to seal the lumen 14 extends proximally from a connection with the embodiment of Figures 1 and 2, thereby forming insertable orally parenterally and channel means duodenal cannula at one of its anchored position, wherein the sealing portion is positioned proximal lumen at the proximal end 10, for example, several centimeters Vater's papilla (upstream).  根据示例性实施例，胆汁转移导管24的远侧开口端25可在远侧开放式套管端22 近端的某个位置处通入食物套管部分21内，以使得（当将所述设备调配到患者的胃肠道中时）：-在管状构件12远侧的第一管道中，胆胰液和食物流彼此隔离并且与管腔壁隔离；-在第一管道远端的第二管道中，胆胰液与食物流混合，但仍与管腔壁隔离；-在第二管道远端的第三管道中，食物和胆胰液与肠壁接触。  According to an exemplary embodiment, the bile transfer conduit 24 distally open end 25 can pass into the food portion of the inner sleeve 21 at a location 22 at the proximal end of the cannula distal open end, such that (when the when the device is deployed into the gastrointestinal tract of the patient):  - a first conduit 12 in the distal tubular member, pancreatic juice and bile flow of food isolated from each other and isolated from the lumen wall;  - a first conduit the distal end of the second duct, pancreatic juice and bile flow mixing food, but still isolated from the lumen wall;  - a second conduit in the distal end of the third conduit, the food in contact with the intestinal wall pancreatic juice and bile.  根据另一个示例性实施例（图13)，设备11包括在近端41和远端43之间延伸的胆汁引流导管40，所述近端41具有支架42以连接胆管树7中的胆汁引流导管40，所述远端43与管状构件12的胆汁隔离腔19以流体连通的方式连接。  According to another exemplary embodiment (FIG. 13), device 11 comprises a biliary drainage conduit 40 between the proximal 41 and distal ends 43 extending to the proximal end 41 having a bracket 42 connected to the biliary tree. 7 biliary drainage catheter 40, the distal end 4319 connected in fluid communication with a bile manner isolated cavity of the tubular member 12. 这允许选择性地捕集胆管树7内的胆汁和/或胰液并将其引导至胆汁隔离腔19中。 This allows the selective capture of bile in the biliary tree 7 and / or the guide into the bile and pancreatic juice isolation chamber 19.  设备11可包括外部套44，所述外部套44在管状构件12之上部分地延伸并以在外部套44和管状构件12限定环形胆汁隔离空间45的方式与其连接，以使得胆汁隔离空间与肠壁隔离。  Device 11 may include an outer sleeve 44, the outer sheath 44 partially extends over the tubular member 12 and outer sleeve 44 in the manner and the tubular member 12 defines an annular space 45 is isolated from the bile connected thereto, such that the bile isolate space and isolated from the intestinal wall. 外部套44具有通入胆汁隔离空间45中并且形成上述胆汁引流导管40的侧向分支。 Outer sleeve 44 having a side branch into the bile insulating space 45 is formed above and biliary drainage conduit 40. 根据实施例，胆汁引流导管40的近端41可定位并锚定在胆总管与胰管9的联接位置下游的胆总管中，以使得将胆汁和胰液一起引流到胆汁隔离空间45中。 According to an embodiment, the proximal end 40 of the biliary drainage catheter 41 may be positioned and anchored in the coupling position of the common bile duct and the pancreatic duct downstream of the common bile duct 9, so that together with the drainage of bile and pancreatic juice into the bile in the insulating space 45. 作为另外一种选择，胆汁引流导管40的近端41可定位并锚定在胆总管与胰管9的联接位置上游的胆总管中，以使得仅将胆汁引流到胆汁隔离空间45中，而胰液可自然地排到十二指肠3中并且在管腔壁和外部套44的外表面之间的间隙中流入肠。 Alternatively, the proximal end 40 of the bile drainage catheter 41 may be positioned and anchored in the common bile duct with bile duct upstream of the position of the coupling 9, so that only the isolated bile drainage space 45 into the bile, pancreatic juice and naturally discharged to the intestinal duodenum 3 and flows into the gap between the lumen wall and the outer surface of the outer jacket 44.  图14示出了另一个示例性实施例，其中外部套44可限定胆汁隔离空间20和单独的胰液隔离空间46，所述胰液隔离空间46与胆汁隔离空间隔离并且具有距远侧胆汁导管端25 —距离的胰液出口47。  FIG. 14 illustrates another exemplary embodiment, wherein the outer sleeve 44 may define a space 20 isolated from the bile and pancreatic juice separate insulation space 46, space 46 isolated from the pancreatic juice and bile from the insulation space and having a distal bile isolation end of the conduit 25 - pancreatic juice from the outlet 47. 胆汁引流导管40的近侧部分可为分叉的，以限定胆汁引流端41和胰液引流端48，所述胆汁引流端41可定位并锚定在胆总管与胰管9的联接位置上游的胆总管中，所述胰液引流端48可定位在胰管9中。 Biliary drainage catheter proximal portion 40 may be bifurcated to define pancreatic juice and bile drainage drainage end 41 end 48, the biliary drainage end 41 may be positioned and anchored in the coupling position upstream of the common bile duct and the bile duct 9 manifold, the pancreatic juice drainage end 48 may be positioned in the duct 9. 胆汁引流导管40还可包括内部隔膜51，所述内部隔膜51从分叉位置延伸到胆汁隔离空间45和胰液隔离空间46，以使得将胆汁引流到胆汁隔离空间45中，而将胰液引流到胰液隔离空间46中。 Biliary drainage catheter 40 may further include an inner diaphragm 51, the diaphragm 51 extends from the inner diverging space 45 into the bile and pancreatic juice isolation insulating space 46, such that the biliary drainage insulating space 45 into the bile, pancreatic juice and the drainage of the pancreatic juice insulating space 46.  根据实施例，胰液出口47直接布置在食物隔离空间13上，以使得胰液与食物流大致在它们接触的自然位置混合，但与肠壁隔离（图14)。  According to an embodiment, secretin outlet 47 arranged directly on the food insulation space 13, so that the flow of pancreatic juice and food are mixed in a substantially natural position they are in contact, but the isolation wall (FIG. 14).  根据本发明的另一个方面，设备11可包括在漏斗形近侧开口端50和远侧开口端52之间延伸的近侧套管49 (示于例如图1和2A中），所述漏斗形近侧开口端50能够例如通过与幽门适形连接而锚定在胃2内，所述远侧开口端52连接到管状构件12的近侧孔16。  According to another aspect of the invention, apparatus 11 may include a funnel-shaped proximal opening in the proximal end of the sleeve 49 extending between end 50 and a distal opening 52 (shown in FIGS. 1 and 2A for example), the end of said funnel-shaped proximal opening 50 can be formed for example by suitable connecting pyloric anchored in the stomach 2, the open distal end of the tubular member 52 is connected to the proximal aperture 12 of 16. 近侧套管49可锚定设备11以较好地对抗蠕动力，并且可收集容纳在胃2中的食物并将其在不接触肠壁的情况下引导至食物隔离空间13中。 Food proximal sleeve 49 may be anchored to device 11 against the better creep strength, and may be housed in the collection of gastric 2 and guided to the isolation space 13 in food without contacting the intestinal wall.  作为另外一种选择或除此之外，为了抵抗作用在设备11上的蠕动力，可例如通过胃线圈53将所述设备11锚定在胃肠道中，所述胃线圈53可从延展构型（能够将其经口或经鼻输送到胃2内）弹性变形为旋拧弓形或圆形构型（能够适形地接合胃2以便对连接到管状构件12的近端的锚定线54提供锚定）（图11)。  Alternatively or in addition, in order to resist peristaltic forces acting on the device 11, coil 53 may be, for example, through the stomach 11 to anchor the device in the gastrointestinal tract, from the stomach coil 53 extended configuration (which can be conveyed orally or nasally into the stomach 2) screwed to the elastically deformable arcuate or circular configuration (being able to conform to the stomach 2 to engage the proximal end of the tubular member 12 is connected to the anchor providing an anchor line 54) (FIG. 11).  在图12所示的另一个示例性实施例中，可例如通过T形箍将锚定线54连接到先前在胃壁中形成的折襞55。  In another exemplary embodiment illustrated in FIG. 12, may be connected, for example via a T-shaped collar to the anchor line 54 previously formed in the stomach wall 55 of the plication.  在图6所示的另一个示例性实施例中，可通过粘膜下带56将设备11锚定到肠壁， 所述粘膜下带56插入管腔壁中并且完全围绕其延伸，由此形成锚定环以在肠壁中产生瓶颈部分，所述瓶颈部分能够接合形成于例如管状构件12的管腔密封部分14，15中的一者内的相应环形锚定凹槽57。  In another exemplary embodiment illustrated in FIG. 6, by the device 56 with submucosal anchored to wall 11, with the mucous membrane 56 is inserted into the lumen wall extends around and completely, by the this formed the anchor ring in the intestinal wall to produce a neck portion, the neck portion is formed, for example, can engage the respective annular sealing portions 14, 15 in the lumen of the tubular member 12 of one anchoring groove 57.  图7示出了另一个示例性实施例，其中可通过胃支架58和附接的可弹性膨胀式(可能地形状记忆）弓形件59将设备11锚定在胃肠道中，所述弓形件59能够与胃2形成适形连接。  FIG. 7 shows another exemplary embodiment, wherein the (possibly shape memory) 59 bracket 11 anchor the device in the GI tract through the stomach and the attachment bracket 58 may be elastically expandable type, the can be formed arcuate member 59 connected to the conformal 2 stomach.  图8示出了另一个示例性实施例，其中可通过T形箍60将设备11锚定在胃肠道中，所述T形箍60从肠的内部击送到肠壁中由此形成固定位置并且与管状构件12的近端连接。  FIG. 8 shows another exemplary embodiment wherein the cuff 60 through a T-shaped anchor device 11 in the gastrointestinal tract, the T-shaped ferrule 60 from the inside of the intestine to the intestinal wall thereby strike forming a fixed position and is connected to the proximal end of the tubular member 12.  图9和9A示出了另一个示例性实施例，其中可通过具有多个锚定倒钩62的环形锚定部分61将设备11锚定在胃肠道中，所述倒钩62可从静止位置移动（例如，旋转）到工作位置，在所述静止位置中倒钩62容纳在锚定部分61的圆周内以允许设备11的无阻挡腔内输送，在所述工作位置中倒钩62径向向外突出，由此刺穿管腔壁并因而将设备11锚定到管腔壁。  FIGS. 9 and 9A illustrate another exemplary embodiment, wherein the anchoring by having a plurality of annular barbs 62 of the anchor portion 61 anchors the device 11 in the gastrointestinal tract, the barbs 62 may rest position (e.g., rotation) from the operative position to the barbs received in the rest position 62 to allow an unobstructed cavity delivery device 11, the barbs in the working position in the inner circumferential portion 61 of the anchor 62 radially outwardly, thereby piercing the lumen wall and thus anchoring the device 11 to the lumen wall.
 在图10-10C所示的另一个示例性实施例中，可通过具有一个或多个锚定孔64的管状锚定部分63将设备11锚定在胃肠道中，所述锚定孔64设计为面向肠壁部分并且能够允许将这些肠壁部分牵拉到孔64内并与其固定。  In another exemplary embodiment illustrated in FIG 10-10C, by having one or more anchor holes 64 of the tubular portion 63 of the anchoring device 11 is anchored in the gastrointestinal tract, the anchor holes 64 designed to face the wall portion and can allow these wall portions pulled into the bore 64 and secured thereto. 可提供用于从管状锚定部分63内部抽吸管腔壁部分并将其牵拉到锚定孔64内的腔内抽吸装置55、以及用于产生管腔壁部分的永久性（蘑菇头型）溶胀以防止其从锚定孔64缩回的装置和方法。 May be provided for anchoring the tubular portion 63 from the interior portion of the chamber wall and the suction tube is pulled into the cavity of the anchoring holes 64 of the suction means 55, and for generating a permanent part of the lumen wall (mushroom head type) swollen method and apparatus to prevent it from the anchor hole 64 is retracted. 用于产生管腔壁部分的永久性溶胀的这些装置和方法可包括将膨胀剂或硬化剂粘膜下注入或将塑性小球（聚（甲基丙烯酸甲酯）PMMA)引入先前已牵拉穿过锚定孔64的组织部分中。 These apparatus and methods for generating a permanent swelling of the lumen wall portion may include injection or plastic beads (poly (methyl methacrylate) of PMMA) has been pulled through the previously introduced into the mucosal swelling agents or hardener tissue portion 64 in the anchor hole.  参照图15A和15B，外部套65可设置有侧向孔66，所述侧向孔66能够被放置在奥狄括约肌之上以限定用于隔离排到十二指肠内的胆汁的空间。  Referring to FIGS. 15A and 15B, the outer sleeve 65 may be provided with a lateral hole 66, the lateral hole 66 can be placed over the spacer to define a sphincter of Oddi in the duodenum bile discharged space. 在围绕侧向孔66的边缘处以及在围绕外部套65的近端67的边缘处，可将加固网68粘合到套管以提供缝合区域的加固。 Around the lateral edge of hole 66 and at the edge of the outer sleeve 65 around the proximal end 67, the reinforcing mesh may be adhered to the sleeve 68 to provide a region of reinforcement stitching. 此外,可将外科用毡条69在加固网68和缝合面积的区域中施加到外部套65的外部。 Further, surgical outer jacket 69 is applied to the exterior in the region of 65 plus 68 and fixed with sutures in the area of felt strips. 可将近端边缘67和侧向孔66的边缘缝合到十二指肠壁，以使得侧向孔66设置在奥狄括约肌周围，从而与管腔壁形成无泄漏连接，由此适于限定出食物流和胆汁隔离空间，如此前所述。 Proximal edge 67 and side edge apertures 66 may be sewn to the duodenal wall, so that lateral apertures 66 disposed around the sphincter of Oddi, thereby forming a leak-free connection to the lumen wall, thereby defining a suitable food bile flow and spatial isolation, as previously described. 此外，可将由外科用毡制成的连续或不连续外部纱布70布置在十二指肠壁外部的缝合区域上以防止缝线切割浆膜和牵拉出管腔壁。 Further, by continuous or discontinuous external gauze 70 is arranged on the outside of the duodenal wall to prevent the surgical suture region made of felt and pulled out of the serosal suture cutting lumen wall.  根据本发明的另一个示例性实施例，可将鸭嘴形出口阀（未详细示出）布置在食物套管部分21和/或胆汁转移导管24的远端区域中，以防止食糜返流和感染风险。  According to another exemplary embodiment of the present invention, the duckbill valve outlet (not shown in detail) arranged in and / or the distal region 24 of the food transfer conduit bile sleeve portion 21 to prevent food Mi reflux and the risk of infection.  图16示出了用于隔离食物、胆汁、胃分泌液和十二直肠分泌液的设备的另一个示例性实施例，其中所述设备包括三个套管72，73，74，所述套管72，73，74同轴地插入彼此之中并且具有位于不同位置的不同近侧入口和位于不同位置的不同远侧出口以在指定位置隔离和混合分泌液。  FIG. 16 illustrates another exemplary embodiment for isolation of food, bile, gastric secretion apparatus and the secretion of the duodenum, wherein the apparatus comprises three sleeves 73, 74, the said sleeve 73, 74 is coaxially inserted into each other and have different at different positions proximal inlet and a distal outlet to isolate different location and at a specified mixing exudates at different positions.  独立于所述设备实施例，本发明还涉及用于转移被排到患者肠道中的胆胰液的方法，所述方法包括： A)在乏特氏壶腹区域处形成位于设备和肠壁之间的胆汁隔离空间； B)将食物流与肠壁在胆汁隔离空间远端的区域中分离； C)将隔离的胆汁从胆汁隔离空间转移到其中食物流与肠壁分离的区域的远侧的位置。  Example embodiments of said apparatus independent of, the present invention further relates to a method for transferring bile pancreatic juice is discharged to the intestinal tract in a patient, said method comprising:  A) is formed is located at a region of the ampulla of Vater lack bile insulating space between the device and the wall;  B) separating the food stream with the intestinal wall in the region of the distal end of the insulating space bile;  C) isolating the bile from the bile transferred to the insulation space wherein the food a location distal wall separating the stream area.  根据实施例，转移隔离的胆汁的步骤包括如下步骤：将胆汁转移导管在腔内从胆汁隔离空间沿远侧方向延伸到其中食物流与肠壁分离的区域的远侧的位置。  According to the procedure includes the following steps embodiment, the transfer of isolated bile: bile transfer conduit extends within the cavity from the bile insulation space wherein a distal direction to the distal location food stream separate regions of the intestinal wall.  根据另一个示例性实施例（图17)，转移隔离的胆汁的步骤包括如下步骤：通过肠-肠吻合或通过内源性腔内旁路71 (具有吻合到胆汁隔离空间中的肠壁的近端和吻合到肠的远侧靶位置的远端）在胆汁隔离空间中的肠壁与肠的远侧靶位置之间形成直接管腔连通，以使得通过旁路71隔离和转移胆汁，同时通过食物套管部分21隔离和输送食物流。  According to another exemplary embodiment (FIG. 17), the step of transferring the isolated bile comprising the steps of: through the gut - anastomosis or bypass cavity 71 by endogenous (to coincide with the intestinal bile insulating space direct communication with a lumen formed between the distal and proximal end wall of the intestine distal to the anastomosis target site) the target position of the distal wall of the intestine in bile isolated space, through the bypass 71 so that the isolation and transfer of bile , while the flow of food through the sleeve portion 21 and spacer transporting food.  尽管已详细描述了本发明的优选实施例，但申请人的目的并不是将权利要求的范围限于这些特定实施例，而是涵盖属于本发明的范围内的所有修改形式和替代构造。  Although described in detail preferred embodiments of the present invention, but is not the intention of the applicant to limit the scope of the claims to these specific embodiments, but encompasses all modifications and alternate constructions falling within the scope of the present invention.