Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B17/115—Staplers for performing anastomosis in a single operation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
  • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00818—Treatment of the gastro-intestinal system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00982—General structural features
  • A61B2017/00986—Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
  • A61B2017/22054—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with two balloons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
  • A61B2017/22065—Functions of balloons
  • A61B2017/22069—Immobilising; Stabilising
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/041—Bile ducts

Definitions

• the present invention relates, in general, to devices and methods for surgically influencing the digestion of a patient with the aim to treat metabolic disorders, such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.
• metabolic disorders such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.
• a known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 .
• the known system comprises a conduit having a first end which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract and a second end attached to the ampulla of Vater.
• the known conduit catheters extend inside the intestine and tend to bundle up and to be displaced by the peristalsis of the intestinal tract so that the distal end of the catheter is frequently relocated far away from the target position intended by the surgeon.
• the known endoluminal conduit in order to follow the winding path of the intestine, the known endoluminal conduit must have a significant length which undesirably increases the flow resistance and decreases the flow rate of the bile to the distal target location in the Gl tract. Accordingly, the known conduit is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity.
• an aim of the invention is to provide a minimally invasive device and method of diverting bile from the biliary tree including the gallbladder into a section of the intestine distally to the papilla of Vater, which obviate undesired relocations of the bile conduit from the target location.
• a further aim of the invention is to increase the flow rate of the diverted bile towards the target location in the small intestine.
• At least part of the above identified aims are achieved by a method for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of:
• the extension of a transluminal catheter from the biliary fluid flow path to the target location in the intestine at least part of the duodenum can be bypassed and the bypass length can be minimized.
• the catheter by extending the catheter through an otomy at the target portion of the intestine, the distal catheter end portion cannot bundle up and cannot be dislocated away from the intended target location.
• the target portion of the intestine may be a portion of the small intestine, e.g. a distal portion of duodenum, a portion of jejunum or ileum or a portion of the large intestine, such as for example the transverse or sigmoid colon.
• the method comprises the steps of:
• entero-entero anastomosis creates a lumen continuity which obviates the risk of leakage of bowel contents in the abdominal space through the interstices between the catheter and the otomies.
• the method comprises the steps of:
• the method comprises the step of creating the first otomy at a first portion of a common bile duct.
• a device for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater comprising:
• a catheter having a proximal end portion and a distal end portion and a conduit section extending between the proximal end portion and the distal end portion,
• anastomosis device connected to the catheter, the anastomosis device having an expandable first compression portion and an expandable second compression portion, wherein the first and second compression portions are adapted to clamp a first portion of a hollow organ and a target portion of intestine to each other to cause anastomosis of the first portion and the target portion and to immobilize the catheter with respect to the anastomosis.
• the catheter comprises an external tubular wall and the anastomosis device comprises a first inflatable ring shaped balloon formed in the external wall and a second inflatable ring shaped balloon formed in the external wall at a distance from the first balloon.
• the distance between the first and second balloon is adjustable.
• FIG. 1 illustrates a device and method for a translumenal diversion of bile in accordance with an embodiment of the invention
• FIG. 1 illustrates an enlarged detail of figure 1 ;
• FIG. 3 illustrates a method for a translumenal diversion of bile in accordance with a further embodiment of the invention
• FIG. 5 illustrates a method and device for a translumenal diversion of bile in accordance with a further embodiment of the invention
• FIG. 6 to 9 illustrate method steps, a device and instrumentation for a translumenal diversion of bile in accordance with an embodiment of the invention
• FIG. 10 illustrates an anastomosis device applier used in the method in figures 6 to 9;
• FIG. 1 1 illustrate an anastomosis device after deployment and withdrawal of the applier in figure 10;
• FIG. 12 illustrates a device for a translumenal diversion of bile in accordance with a fu rther em bod i ment of the invention , wherei n the device is in a fi rst collapsed configuration;
• FIG. 13 illustrates the device of figure 12 in a second expanded configuration
• FIG. 14 illustrates a method for a translumenal diversion of bile using the device of figures 12 and 13;
• FIG. 15 illustrates a device for a translumenal diversion of bile in accordance with a further embodiment of the invention, wherein the device is shown in a first collapsed configuration (continuous line) and in a second expanded configuration (broken line);
• FIG. 16 illustrates a device for a translumenal diversion of bile in accordance with a yet further embodiment of the invention , wherein the device is shown in a first collapsed configuration (continuous line) and in a second expanded configuration (broken line);
• FIG. 17 illustrates a method and devices for a translumenal diversion of bile in accordance with a further embodiment of the invention.
• figure 1 is a partial view of the abdominal cavity of a patient, depicting the stomach 1 , duodenum 2, jejunum 3, ileum 4 and colon 5, as well as the biliary tree 7 with gall bladder 8, the pancreatic duct 9 and the mayor duodenal papilla of Vater 10 through which the bile and pancreatic fluid normally enter the duodenum 2.
• Figure 1 shows further a method and a device 6 for diverting biliary fluid translumenally from a biliary fluid flow path, defined by the bi liary tree 7 and the gallbladder 8, to a target location in the intestine distal of the papilla of Vater 10.
• the method comprises the steps of:
• a distal end portion 15 of the catheter 13 in the target location in the intestine. Thanks to the extension of a transluminal catheter 13 from the biliary fluid flow path to the target location in the intestine, at least part of the duodenum can be bypassed and the bypass length can be minimized. Moreover, by extending the catheter 13 through an otomy at the target portion 18 of the intestine, the distal catheter end portion 15 cannot bundle up and cannot be dislocated away from the intended target location.
• the target portion 18 of the intestine may be a portion of the small intestine, e.g. a distal portion of duodenum 2, a portion of jejunum 3 or ileum 4 or a portion of the large intestine 5, such as for example the transverse or sigmoid colon.
• the proximal end portion 14 of the catheter 13 can be anchored inside the biliary tree 7, e.g. inside the common bile duct, by means of a metallic stent 16 or alternative anchoring means connected to the proximal end portion 14.
• the first otomy 1 1 is created at a first portion 17 of the intestine, particularly at the duodenum 2 near the papilla of Vater 10, and the first portion 17 of the intestine is anastomosed to the target portion 18 of the intestine.
• Such an entero-entero anastomosis creates a lumen continuity which obviates the risk of leakage of bowel contents in the abdominal space through the interstices between the catheter 13 and the otomies 1 1 , 12.
• the catheter 13 can be extended from the biliary tree 7 through the papilla of Vater 10 and the first otomy 1 1 out of the duodenum 2 and directly into the target portion 18 of intestine, thereby creating a very short bypass path (Figure 2).
• an endoscope is inserted in the intestine to visualize the duodenum 2 near the sphincter of Oddi and to identify the first portion 17 of intestine for the first otomy 1 1 .
• the same endoscope may be used to identify the target portion 18 of intestine for the second otomy 12 distal to the papilla of Vater 10 and distal to the first otomy 1 1 .
• the first portion 17 of intestine and the target portion 18 of intestine are approximated to each other and an enteroenterostomy is formed therebetween.
• the enteroenterostomy includes a patent lumen formed by the first and second otomies 1 1 , 12 which might be performed before or after approximation and connection of the first portion 17 and the target portion 18 of the intestine.
• the creation of the enteroenterostomy may involve a laparoscopic deployment of an anastomotic ring device using an applier and a anastomosis device described in the commonly owned US 7,452,363 whose entire content is herein enclosed by reference.
• the proximal end portion 14 of the catheter 13 with the stent 16 is introduced through the papilla of Vater 10 in the common bile duct, using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique.
• the E RCP procedure involves passing a flexible endoscope through the mouth , esophagus, and stomach into the duodenum 2 near the papilla of Vater 10. The doctor then passes the catheter 13 through an instrument channel in the endoscope and out into view in the duodenum 2 and inserts it into the papilla of Vater 10.
• the stent 16 or other anchoring means is activated to connect to the bile duct and to anchor the catheter 13 thereto.
• the endoscope is withdrawn to an extend that the distal end portion 15 of the catheter 13 emerges from the instrument channel or the distal end portion 15 of the catheter 13 is expelled from the instrument channel so that it can be grasped by means of an endoscopic grasper and introduced through the enteroenterostomy in the target portion 18 of the intestine.
• the catheter 13 may be additionally fixated to the anastomosis device or to the entero-entero anastomosis, thereby immobilizing the catheter 13 with respect to the target portion 18 of the intestine. Then the endoscope can be withdrawn from the body of the patient. The resulting situation is illustrated in figures 1 and 2.
• the catheter 13 may comprise an antimicrobial coating 19 containing e.g. silver.
• the first otomy 1 1 is created at a first portion 17 of the gallbladder 8 and the first portion 17 of the gallbladder 8 is anastomosed to th e ta rget portion 18 of the intestine 2, 3, 4, 5.
• a cholecystoenterostomy is created instead of an enteroenterostomy and the proximal end portion 14 of the catheter 13 is extended through the gallbladder wall, thereby avoiding an insertion of the catheter 13 through the papilla of Vater in the very delicate common bile duct.
• the gallbladder 8 can be approximated to the target portion 18 of the intestine through a percutaneous introduction of a grasping instrument into the abdominal space and grasping the gallbladder 8 by means of the grasping instrument and pulling the gallbladder 8 towards and against the target portion 18 of the intestine.
• the grasping instrument may comprise opposing jaws connected to a rigid shaft or, alternatively, the grasping instrument may comprise an inflatable balloon connected to a distal end of a rigid shaft and having an inflated shape adapted to engage the gallbladder 8 and push it towards and against the target portion 18 of the intestine.
• a distal tip of the grasping instrument together with the inflatable balloon may be percutaneously introduced into the gallbladder 8 and the balloon is inflated inside the gallbladder to engage the latter.
• the cholecystoenterostomy is created by laparoscopic deployment of an anastomotic ring device using an applier and an anastomosis device described in the commonly owned US 7,452,363 whose entire content is herein enclosed by reference.
• the anastomosis device may be completely bioabsorbable or biofragmentable or only a proximal (gallbladder side) compression portion of the anastomosis device may be bioabsorbable or biofragmentable so that the anastomosis device can be expelled together with the stool.
• the proximal end portion 14 of the catheter 13 with the stent 16 is introduced through the cholecystoenterostomy (i.e. through the second and first otomy) in the gallbladder 8 and, possibly, run up into the cystic duct.
• ERCP Endoscopic Retrograde Cholangio Pancreatography
• ERCP Endoscopic Retrograde Cholangio Pancreatography
• This can be advantageously accomplished by a modified ERCP (Endoscopic Retrograde Cholangio Pancreatography) like procedure which involves passing a flexible side viewing scope through the rectum and colon into the target portion 18 of the intestine 2, 3, 4, 5 or, alternatively, passing the flexible side viewing scope transorally into the target portion 18 of the intestine and, then passing the catheter 13 through an instrument channel in the endoscope and out into view in the target portion 18 of the intestine and inserting the proximal catheter end portion 14 through the cholecystoenterostomy in the gallbladder 8 and, possibly, guiding it up into the cystic duct.
• ERCP Endoscopic Retrograde Cholangio Pancreatography
• the stent 16 or other anchoring means is activated to anchor the catheter 13 in the gallbladder 8 or in the cystic duct.
• the side view scope is withdrawn to an extend that the distal end portion 15 of the catheter 13 emerges from the instrument channel or the distal end portion 1 5 of the catheter 1 3 is expelled from the instrument channel in the target portion 1 8 of the intestine.
• a plug 20 may be deployed in the common bile duct distal of the proximal catheter end ( Figure 9).
• the catheter 1 3 may be additionally fixated to the anastomosis device or to the cholecystoentero-anastomosis, thereby immobilizing the catheter 13 with respect to the target portion 18 of the intestine. Then the endoscope can be withdrawn from the body of the patient. The resulting situation is illustrated in figure 9.
• both the cholecystoenterostomy and the placement of the translumenal catheter 13 can also be accomplished using a laparoscopic approach, as illustrated in figures 6 to 1 1 .
• Figure 1 1 shows an exemplary anastomosis ring device 22 having proximal 23, center 24, and distal rings 25 connected respectively by proximal and distal hinged arms, the ring device 22 having a generally cylindrical shape when unactuated and a rivet shape when actuated.
• Figure 10 illustrates an exemplary applier 21 for the anastomosis ring device 22.
• the applier 21 comprises an elongate implement portion 26, a handle 27 connected to the implement portion 26, an actuating member internally engaged to a selected one of the rings of the anastomosis device 22, an arresting member internally engaged to a selected second of the rings of the anastomosis device 22 and a control coupled to the handle 27 and configured to cause movement of the actuating member, and thus the engaged ring, toward the arresting member, and thus the selected second ring, causing actuating the interposed hinged arms of the ring device 22.
• Such an anastomosis device and applier have been described in the above mentioned US 7,452,363.
• the applier 21 together with the ring device 22 is introduced in the abdominal space through a laparoscopic access port and placed through the first and second otomies 1 1 , 12 which are intended to be anastomosed.
• the applier 21 can have a distal pointed tip 28 adapted to create the otomies when being forced through the wall of the intestine and or gallbladder.
• the first and second otomies 1 1 , 12 may be created with a standard laparoscopic cutting instrument.
• the applier 21 may be inserted through a third otomy 29 in a portion of the intestine distal to the target portion 18 and subsequently advanced proximally to the target portion 18. Then the distal ring 25 of the anastomosis device 22 is inserted through the previously created second otomy 1 2 , wh ile the proximal hinged arms of the anastomosis device 22 are actuated to expand radially so that the device 22 cannot completely slip through the second otomy 12. By pushing the applier 21 towards the gallbladder 8, the target portion 18 of the intestine is approximated to the first portion 17 of the gallbladder 8.
• the distal ring 25 of the anastomosis device 22 is inserted through the previously created first otomy 1 1 inside the gallbladder 8 and the distal hinged arms are activated to expand radially, thereby clamping the first portion 17 of the gallbladder 8 against the target portion 18 of the intestine to allow anastomosis therebetween (Figure 7).
• the applier 21 can be withdrawn through the third otomy 29 and the catheter 13 can be inserted through the third otomy 29 and the second and first otomies 12, 1 1 at the cholecystoenterostomy into the gallbladder 8 and, possibly, into the cystic duct ( Figure 8).
• the stent 16 or other anchoring means may be activated to anchor the catheter 13 in the gallbladder 8 or in the cystic duct ( Figure 9). Additionally, the catheter 13 can be fixated to the anastomosis device 22 to immobilize the catheter distal end portion 15 with respect to the target portion 18 of the intestine.
• the resulting bypass allows to divert the bile originating from the liver to the target location in the intestine.
• the first otomy 1 1 is created at a first portion 18 of the common bile duct. This allows to place the proximal catheter end portion 14 in the biliary fluid flow path without entering the papilla of Vater 10 and without manipulating the gallbladder 8.
• the bile is caused to bypass part of the small intestine 2, 3 by placing the catheter 13 so that the proximal catheter end portion 14 is positioned in the common bile duct and the distal catheter end portion 15 is positioned in the jejunum 3 or ileum 5.
• the bile is caused to completely bypass the small intestine 2, 3, 4 by placing the catheter 13 in a transcolonic approach, so that the proximal catheter end portion 14 is positioned in the common bile duct and the distal catheter end portion 15 is positioned in the large bowel 5, for example in the transverse bowel.
• a laparoscopic access port is created and a laparoscopic cutting instrument is inserted through the access port in the abdominal space to perform the first otomy 1 1 at the bile duct 7 and the second otomy 12 at the colon 5. Then the cutting instrument is withdrawn and the catheter 13 is inserted through the access port in the abdominal space. The proximal end portion 14 of the catheter 13 is inserted through the first otomy 1 1 in the bile duct 7 in retrograde direction (against the direction of the natural flow of the bile) and the stent 16 or other anchoring means is deployed to anchor the proximal catheter end portion 14 in the bile duct 7. Then a purse string suture is applied to the first otomy 1 1 around the catheter 13 to seal the first otomy 1 1 .
• the distal end portion 15 of the catheter 13 is inserted through the second otomy 12 in the colon 5 and a purse string suture is applied to the second otomy 12 around the catheter 13 to seal the second otomy 12. Then the instrumentation is withdrawn from the patient's body and the access ports are removed and the apertures in the abdominal wall are sutured.
• Undesired backflow of stool or chime from the intestine can be prevented by arranging an unidirectional valve 30 (illustrated in Figure 17), such as a collapsible low pressure flapper valve at the distal end of the catheter 13.
• the valve 17 closes when intestinal or colonic peristalsis tend to push chime or stool into the catheter 13 and opens when bile flows down the catheter and the internal bile pressure exceeds the external pressure at a distal catheter outlet opening.
• a transhepatic introduction of the catheter 13 through the liver into the bile duct 7 is contemplated.
• the distal catheter end portion 15 is fed through the first otomy 1 1 out of the bile duct 7 towards a transilluminated target portion 18 of the colon 5 and through the second otomy 12 into the colon 5.
• the catheter 13 is inserted transhepatically through the liver into the bile duct 7 and the distal catheter end portion 15 is fed through the papilla of Vater 10 into the duodenum 2 and through a previously created first otomy 1 1 in the duodenal wall out of the duodenum 2 towards a transilluminated target portion 18 of the colon 5 and through the second otomy 12 into the colon 5.
• Such a chronic trauma of the intestinal wall can be obviated through re-establishing the intestinal lumen continuity by means of a duodeno-colono-anastomosis between the first and second otomies 1 1 , 12 and extending the catheter 13 from inside the bile duct 7 through the papilla of Vater 10 and through the duodeno-colono-anastomosis into the target portion 18 of the colon 5 ( Figure 5).
• the devices and methods which have been described above in connection with the entero-entero-anastomoses and cholecysto-entero-anastomosis m ay be u sed .
• the d u od en o-colono- anastomosis can also be accomplished using an anastomosis device and applier as described in US 7,618,427 whose entire content is incorporated herein by reference.
• Figures 12 to 16 illustrate further embodiments of the device 6 for diverting biliary fluid from the biliary fluid flow path 7, 8 to the target location in the intestine distal to a duodenal papilla of Vater 10.
• the device 6 comprises the catheter 13 with its proximal end portion 14 and distal end portion 15 and a conduit section 31 extending between the proximal end portion 14 and the distal end portion 15, as wel l as an anastomotic coupler 32 connected connected to the catheter 13.
• the anastomotic coupler 32 comprises a first expandable compression portion 33 and a second expandable compression portion 34, wherein the first and second compression portions 33, 34 are adapted to clamp the first portion 17 of a hollow organ and the target portion 18 of the intestine to each other to cause anastomosis of the first portion 17 and the target portion 18 and to immobilize the catheter 13 with respect to the resulting anastomosis.
• the compression portions 33, 34 allow for endoscopic or laparoscopic placement of the catheter 13 through the first and second otomies 1 1 , 12.
• the catheter 13 comprises an external tubular wall 35 and the anastomotic coupler 32 comprises a first inflatable ring shaped balloon formed in the external wall 32 and a second inflatable ring shaped balloon formed in the external wall 32 at a distance from the first balloon.
• a first marker 36 which can be visualized, for instance a radio opaque region, is provided at the catheter tract between the compression portions 33, 44 and further markers 37 may be provided adjacent to the compression portions 33, 44 opposite the first marker 36.
• the markers 36, 37 help localization of the compression portions 33, 44 and facilitate a correct positioning of the catheter 13.
• Figure 14 illustrates an exemplary non limiting use of the device 6 for creati ng a cholecystoenterostomy and extending the catheter 13 through the anastomotic lumen, e.g. in one of the methods described above in connection with figure 9.
• the distance between the first and second compression portions 33, 34 is adjustable to regulate the compression force acting on the first portion 1 7 and the target portion 18 in the anastomosis site.
• a threaded adjustment coupling 38 ( Figure 15) or a ratcheting adjustment coupling 39 ( Figure 16) may be provided in the catheter 13 between the first and second compression portions 33, 34.
• the ratcheting adjustment coupling 39 may further comprise a pulling string 40 having a first end connected to a first ratcheting portion of two engaging ratcheting portions and a second end emerging from the catheter 13 on the side opposite the first ratcheting portion and adapted to be grasped and pulled to further approximate the ratcheting portions.

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• 2010
  • 2010-07-16 WO PCT/EP2010/060268 patent/WO2012007044A1/en active Application Filing
  • 2010-07-16 CN CN2010800680382A patent/CN103002815A/zh active Pending

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