WO2012007052A1 - A device for an endoluminal cholecysto - enterostomy - Google Patents

A device for an endoluminal cholecysto - enterostomy Download PDF

Info

Publication number
WO2012007052A1
WO2012007052A1 PCT/EP2010/060291 EP2010060291W WO2012007052A1 WO 2012007052 A1 WO2012007052 A1 WO 2012007052A1 EP 2010060291 W EP2010060291 W EP 2010060291W WO 2012007052 A1 WO2012007052 A1 WO 2012007052A1
Authority
WO
WIPO (PCT)
Prior art keywords
gallbladder
intestine
target portion
ring
guide wire
Prior art date
Application number
PCT/EP2010/060291
Other languages
French (fr)
Inventor
Manoel Galvao Neto
Mark S. Zeiner
James W. Voegele
Thomas Edward Albrecht
Alessandro Pastorelli
Mark Steven Ortiz
Michele D'arcangelo
Original Assignee
Ethicon Endo-Surgery, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Priority to PCT/EP2010/060291 priority Critical patent/WO2012007052A1/en
Publication of WO2012007052A1 publication Critical patent/WO2012007052A1/en

Links

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
    • 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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic
    • 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

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 which diverts bile and pancreatic secretions from the ampulla of Vater to a location d own strea m i n th e gastrointestinal tract.
  • 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 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 are minimally invasive and which increase the flow rate of the diverted bile towards the target location in the small intestine with respect to the physiological entero-hepatic bile cycling.
  • a further aim of the invention is to obviate undesired relocations of the position of the bile diversion with respect to the target location intended by the doctor.
  • 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 bile flows directly from the gallbladder in the target portion of intestine and bypasses at least part of the duodenum, while minimizing the length of the bile flow path.
  • the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy and cannot be accidentally dislocated.
  • 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:
  • the method comprises the steps of:
  • the method comprises the steps of:
  • the method comprises the steps of:
  • an inflatable balloon is provided at a distal end of the grasping instrument and the method comprises the steps of:
  • the method comprises the steps of:
  • anastomosis device having a first portion and a second portion
  • the method comprises the step of approximating and coupling the first and second portions of the anastomosis device by pulling the guide.
  • the method comprises the steps of:
  • an anastomosis device having a first portion and a second portion
  • the method comprises the step of attaching an unidirectional valve to the cholecysto-enterostomy to prevent a backflow of chime from the target portion of intestine into the gallbladder.
  • the method comprises the step of anastomosing a first segment of the intestine to a second segment of the intestine, wherein the first segment is proximal to the target portion of intestine and the second segment is distal to the target portion of intestine, thereby creating an "Omega" loop.
  • 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:
  • first ring comprising a plurality of linear segments linked together at their ends and movable to one another so that the ring can assume an elongate collapsed shape and an expanded annular shape
  • the first ring is magnetically biased into its expanded annular configuration by means of the same magnetic material which causes the magnetic attraction between the first and second rings.
  • FIG. 1 illustrates devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention
  • FIG. 2 illustrates an ultrasound endoscope used in the procedure of figure 1 ;
  • FIG. 3 to 5 illustrate further devices and steps of the procedure in figure 1 ;
  • FIGS. 6 and 7 are side views of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention
  • FIG. 8 is a front view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention
  • FIG. 9 to 12 illustrate devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention
  • FIG. 13 is a perspective view of an endoluminal anastomosis ring applier for a cholecysto- enterostomy in accordance with an embodiment of the invention
  • FIG. 14 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention
  • FIG. 15 to 18 illustrate devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention
  • FIG. 19 illustrates devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention
  • FIG. 20 illustrates devices and steps for creating an "Omega"-loop of intestine in a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a yet further embodiment of the invention
  • FIG. 23 illustrates an anastomosis device applier used in the method in figures 21 and 22;
  • FIG. 24 illustrate an anastomosis device after deployment and withdrawal of the applier in figure 23;
  • FIGS. 25A and 25B illustrate an anastomosis device in a collapsed configuration and in an expanded configuration
  • FIG. 26 to 28 illustrate steps of a procedure for the diversion of bile through a cholecysto- enterostomy using the anastomosis device in figure 25;
  • 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 for endoluminally creating a cholecysto-enterostomy for diverting biliary fluid from the gallbladder 8 to a target location in the intestine distal of the papilla of Vater 10.
  • the method comprises the steps of:
  • a guide particularly a guide wire 1 1 , from the portion of the intestinal tract through a gallbladder wall and through an intestinal wall at a target portion 12 of the intestine significantly distal to the papilla of Vater 10;
  • the bile flows directly from the gallbladder 8 in the target portion of intestine and bypasses at least part of the duodenum 2, while minimizing the length of the bile flow path.
  • the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy 13 and cannot be accidentally dislocated.
  • the creation of the cholecysto-enterostomy 13 results significantly less invasive than the known bypass procedures.
  • the target portion 12 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.
  • a portion of the duodenum 2 near the papilla of Vater 10 is accessed transorally and the guide wire 1 1 is extended from the duodenum 2 through the papilla of Vater 10 and biliary tree 7 into the gallbladder 8. Then, a tip of the guide wire 1 1 is pushed from inside the gallbladder 8 against the gallbladder wall to perforate the gallbladder wall so that the tip of the guide wire 1 1 emerges from the gallbladder 8 into the abdominal space.
  • the tip of the guide wire 1 1 is then moved out of the gallbladder 8 towards the target portion 12 of the intestine and pushed from outside the intestine against the intestinal wall of the target portion 12 to perforate the intestinal wall.
  • the tip of the guide wire 1 1 penetrates through the intestinal wall and is advanced into the target portion 12 of intestine. In this way, an open guide wire loop is created which defines the positions for the cholecysto- enterostomy 13 between the target portion 12 of the intestine and the gallbladder 8.
  • the insertion of the guide wire 1 1 through the biliary tree 7 into the gallbladder 8 can be accomplished using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique.
  • the ERCP procedure involves passing a flexible endoscope 14 through the mouth, esophagus, and stomach into the duodenum 2 near the papilla of Vater 10. The doctor then passes the guide wire 1 1 through a channel in the endoscope 14 and out into view in the duodenum 2 and inserts it into the papilla of Vater 10.
  • the transluminal perforations of the gallbladder 8 and of the intestine are preferably guided and monitored by ultrasound imaging.
  • an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14.
  • the commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose.
  • an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
  • the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13.
  • an anastomosis device having a first portion 16 and a second portion 17.
  • the anastomosis device 16, 17 is connected to the guide wire 1 1 and, by means of the guide wire 1 1 , the first portion 16 is delivered into the gallbladder 8 and the second portion 17 is delivered into the target portion 12 of the intestine.
  • Both, the first and second portions 16, 17 of the anastomosis device are configured to shape interfere with the gallbladder and with the target portion of intestine, respectively, so that the gallbladder 8 and the target portion of intestine 12 can be dragged and compressed together by means of the anastomosis device.
  • the first and second portions 16, 17 of the anastomosis device can be approximated to each other, thereby approximating the gallbladder 8 wall and the intestinal wall of target portion 12.
  • the first and second portions 16, 17 of the anastomosis device can be coupled to each other, thereby clamping the gallbladder wall against the target portion 12 wall to cause them to anastomose.
  • the first and second portions 16, 17 of the anastomosis device may comprise inflatable ring shaped dilating balloons adapted to compress the gallbladder wall and the wall of the target portion 12 of the intestine to create fistula and, hence, anastomosis therebetween.
  • the anastomosis device may comprise a woven tube 18 of wire constructed from a shape memory alloy, e.g. a TiNi alloy, having outer loops or ends adapted to thermally deform and evert when inserted into the walls of adjacent gallbladder 8 and target portion 12 of intestine at the anastomotic site.
  • a shape memory alloy e.g. a TiNi alloy
  • the ends of the tube 18 form petals in a manner which clamps the gallbladder 8 wall and target portion 12 wall in apposition.
  • the woven tube 18 can be endoluminally or laparoscopically deployed by means of an elongate applicator (not illustrated) which comprises a canula with a distal end designed to allow the woven tube 18 to be slipped over the canula and pulled longitudinally causing the woven tube 18 to become longer and smaller in diameter.
  • the applicator further comprises an outer sleeve adapted to be pushed over the woven tube 18 to provide a smooth surface for inserting the applicator through the walls of the approximated gallbladder 8 and target portion 12 of intestine, and to be retracted from the woven tube 18 to expose the latter, so that heat from the body causes the tube 18 to contract longitudinally and evert to clamp the lumen walls and produce the anastomosis.
  • the anastomosis between the gallbladder 8 and the target portion 12 of intestine 2,3,4,5 may be accomplished by mounting the woven tube 18 on the applicator, covering the woven tube 18 by a retractable sheath, inserting the applicator intraluminally, e.g. transorally, into the intestine to the anastomotic site, approximating the gallbladder 8 into close apposition to the intestine at the anastomotic site, piercing a wall of the target portion 18 of the intestine and a wall of the gallbladder 8, retracting the sheath and deploying the woven tube 18.
  • the anastomosis device comprises two compression rings which form the above said first 16 and second portion 17 and which are connectable to each other in a clamping relationship, for example by snap fit, press fit, magnetic attraction or screw connection, and adapted to connect the gallbladder lumen and the target portion 12 of the intestine in anastomosis.
  • an open guide wire loop with two guide wires 1 1 , 1 1 ' is created wherein the two guide wires 1 1 , 1 1 ' extend side by side through the gallbladder 8 wall and through the wall of the target portion 12 of the intestine.
  • a specifically adapted anastomosis device 44 ( Figure 14) may be used which includes a proximal ring 45 having two guide wire seats 47 each of which is adapted to slidably receive one of the two guide wires 1 1 , 1 1 ', respectively, and a distal ring 46 having two guide wire seats 48 each of which is adapted to slidably receive one of the two guide wires 1 1 , 1 1 ', respectively, and in which the proximal ring 45 and the distal ring 46 are snap-connectable to each other.
  • the proximal ring 45 may comprise two snap connecting portions 49 spaced apart at a distance which is substantially equal to a distance between two corresponding counter snap connecting portions 50 provided at the distal ring 46.
  • the guide wire seats 47 of the proximal ring 45 are defined inside the snap connecting portions 49 and the guide wire seats 48 of the distal ring 46 are defined inside the counter snap connecting portions 50 so that the axes of the ring positioning and ring guidance are aligned with the axes of the ring snap connection.
  • a deployment probe 51 ( Figure 13) may be provided which is adapted to endoluminally push the distal ring 46 along the guide wires 1 1 , 1 1 ' to a tissue portion (e.g. to the intestinal wall) of the anastomotic site.
  • the deployment probe 51 includes an elongate shaft 52 as well as a distal connector 53 with a proximal coupling portion 54 adapted to detachably connect with the distal end of the elongate shaft 52 and a distal push surface 55 which is at least partially complementary with the corresponding surface of the distal ring 46 in a way that the distal ring 46 can be captively received by the push surface 55.
  • the connector 53 of the deployment probe 51 delimits cavities 56 configured to receive with interference the distally protruding counter-snap connecting portions 50 of the distal ring 46.
  • the connector 53 comprises sliding seats 57 adapted to slidably receive the guide wires 1 1 , 1 1 ' and preferably axially aligned with the guide wire seats 48 of the distal ring 46 when the latter is received by the connector 53.
  • Such an anastomosis device and deployment device are described in EP 1915956 A1 whose content is enclosed herein by reference in its entirety.
  • the cholecysto-enterostomy 13 can be performed by fixing the proximal ring 45 of the anastomotic device 44 to a proximal end of the guide wires 1 1 , 1 1 ' inside the gallbladder 8 and delivering the proximal ring 45 to the gallbladder 8 wall by pulling a distal end of the guide wires 1 1 , 1 1 ' in a distal direction. Then, the distal ring 46 is slidably connected to a distal end of the guide wires 1 1 , 1 1 ' and pushed proximally along the guide wires 1 1 , 1 1 ' until it reaches the intestinal wall inside the target portion 12.
  • the distal end of the guide wires 1 1 , 1 1 ' are pulled distally and the distal ring 46 is contemporaneously pushed proximally to approximate the proximal and distal rings and tear the tissue portions situated upon the guide wires 1 1 , 1 1 ' between the distal and proximal rings 45, 46 in contact to another.
  • the distal ring 46 and the proximal ring 45 are snap-connected so that the tissue portions of the gallbladder and of the target portion of intestine are clamped together and allowed to anastomose.
  • the tissue internally overhanging the anastomotic ring device can now be cut to open the anastomotic lumen and the guide wires 1 1 , 1 1 ' can be withdrawn and removed from the body.
  • the introduction of the guide wires 1 1 , 1 1 ' and/or the placement of the proximal ring 45 may be assisted by laparoscopic and/or transluminal manipulation of the gallbladder 8.
  • an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
  • the unidirectional valve 19 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection.
  • the unidirectional valve 19 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
  • the unidirectional valve 19 may comprise a duckbill valve shutter 20, as illustrated in figures 6 and 7.
  • the duckbill valve shutter 20 can be manufactured from a synthetic elastomer and is shaped like the beak of a duck with a flattened end which elastically retains its flattened shape.
  • the flattened end opens to permit the bile to pass through the valve 19 in the target portion 12 of the intestine.
  • the flattened end returns to its flattened shape, thereby preventing backflow from the intestine into the gallbladder.
  • the target portion 12 of the intestine for instance the jejunum 3 is accessed transorally and a tip of the guide wire 1 1 is pushed from inside the target portion 12 against the intestinal wall to perforate the intestinal wall so that the tip of the guide wire 1 1 emerges from the target portion 12 of the intestine into the abdominal space.
  • the tip of the guide wire 1 1 is then moved out of the target portion 12 towards the gallbladder 8 and pushed from outside the gallbladder 8 against the gallbladder wall to perforate the latter.
  • the tip of the guide wire 1 1 penetrates through the gallbladder wall and is advanced inside the gallbladder 8.
  • the transluminal perforations of the intestine and of the gallbladder 8 are preferably guided and monitored by ultrasound imaging.
  • an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14.
  • the commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose.
  • an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
  • the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13.
  • the cholecysto-enterostomy 13 can be now created using the same devices and methods previously described under Point B with reference to figures 4 to 8 and figures 13 and 14 whose description is not repeated here for the sake of conciseness.
  • an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
  • the unidirectional valve 1 9 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection.
  • the unidirectional valve 19 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
  • the target portion 12 of the intestine for instance the jejunum 3 is accessed transanally and a tip of the guide wire 1 1 is pushed from inside the target portion 12 against the intestinal wall to perforate the intestinal wall so that the tip of the guide wire 1 1 emerges from the target portion 12 of the intestine into the abdominal space.
  • the tip of the guide wire 1 1 is then moved out of the target portion 12 towards the gallbladder 8 and pushed from outside the gallbladder 8 against the gallbladder wall to perforate the latter.
  • the tip of the guide wire 1 1 penetrates through the gallbladder wall and is advanced into the gallbladder 8.
  • the transluminal perforations of the intestine and of the gallbladder 8 are preferably guided and monitored by ultrasound imaging.
  • an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14.
  • the commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose.
  • an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
  • the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13.
  • the cholecysto-enterostomy 13 can be now created using the same devices and methods previously described under Point B with reference to figures 4 to 8 and figures 13 and 14 whose description is not repeated here for the sake of conciseness.
  • an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
  • the unidirectional valve 1 9 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection.
  • the unidirectional valve 1 9 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
  • a laparoscopic grasping instrument 21 having an elongate shaft and a distal tissue manipulation portion may be percutaneously introduced in the abdominal space and the gallbladder 8 may be seized and moved towards the target portion 12 of the intestine by means of the grasping instrument 21 .
  • an inflatable balloon 22 may be provided at a distal end 23 of the grasping instrument 21 and introduced in the gallbladder 8.
  • the balloon 22 inside the gallbladder 8 By inflating the balloon 22 inside the gallbladder 8, the latter is reliably held at the distal end 23 of the grasping instrument 21 and can be easily manipulated and moved to the planned position.
  • the target portion 12 of intestine may be manipulated and pushed towards the gallbladder 8 by means of the endoscope 14, e.g. a transanally inserted colonoscope.
  • the endoscope 14 e.g. a transanally inserted colonoscope.
  • at least one of the first and second portions 16, 17 of the anastomosis device may be inserted percutaneously into the gallbladder 8.
  • another one of the first and second portions 16, 17 of the anastomosis device may be inserted percutaneously into the target portion 12 of intestine.
  • the first and second portions 16, 17 of the anastomosis device may be magnetically attracted to each other so that they facilitate the mutual approximation and connection of the target portion 12 of intestine and the gallbladder 8.
  • the first portion 16 of the anastomosis device is inserted percutaneously into the gallbladder and the second portion 17 of the anastomosis device is inserted endoluminally, e.g. by means of a colonoscope, into the target portion 12 of intestine, then the target portion 12 and the gallbladder 8 are approximated and their wall sections are clamped between the magnetically attracted first and second portions 16, 17.
  • a first segment 24 of the intestine proximal to the target portion 12 and a second segment 25 of the intestine distal to the target portion 12 can be joined in an enteroenterostomy 27, thereby creating an "Omega" loop 26 of the intestine around the target portion 12.
  • the enteroenterostomy 27 can be created using an anastomosis ring device 28 having proximal 29, center 30, and distal rings 31 connected respectively by proximal and distal hinged arms, the ring device 28 having a generally cylindrical shape when unactuated and a rivet shape when actuated.
  • Figure 23 illustrates an exemplary applier 32 for the anastomosis ring device 28.
  • the applier 32 comprises an elongate implement portion 33, a handle 34 connected to the implement portion 33, an actuating member internally engaged to a selected one of the rings of the anastomosis device 28, an arresting member internally engaged to a selected second of the rings of the anastomosis device 28 and a control coupled to the handle 34 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 28.
  • Such an anastomosis device and applier have been described in US 7,452,363 whose entire content is herein incorporated by reference.
  • the applier 32 together with the ring device 28 is introduced endoluminally (continuous line in Figures 21 and 22) or laparoscopically (dashed line in Figures 21 and 22) in a selected one of the first and second segments 24, 25 of intestine and placed through a first and second otomy 35, 36 which are intended to be anastomosed.
  • the applier 32 can have a distal pointed tip 37 adapted to create the otomies when being forced through the wall of the intestine.
  • the first and second otomies 35, 36 may be created with a standard endoscopic or laparoscopic cutting instrument.
  • the applier 32 may be inserted laparoscopically through a third otomy 38 in a portion of the intestine distal to the second segment 25 and subsequently advanced to the anastomosis site. Then the distal ring 31 of the anastomosis device 28 is inserted through the previously created second otomy 36, while the proximal hinged arms of the anastomosis device 28 are actuated to expand radially so that the device 28 cannot completely slip through the second otomy 36. By pushing the applier 32 towards the first segment 24 of intestine, the second segment 25 of the intestine is approximated to the first segment 24.
  • the distal ring 31 of the anastomosis device 28 is inserted through the previously created first otomy 35 into the first segment 24 of the intestine and the distal hinged arms are activated to expand radially, thereby clamping the first segment 24 of the intestine against the second segment 25 of the intestine to allow anastomosis therebetween ( Figure 22). Then, the applier 32 can be withdrawn endoluminally or through the third otomy 38.
  • FIGs 25A and 25B illustrate a an embodiment of an anastomosis device for the endoluminal creation of the cholecystoenterostomy 13.
  • the anastomosis device comprises a first ring 39 having a plurality of (preferably an equal number of e.g. four) linear segments 40 (having preferably equal lengths) linked together at their ends and movable to one another so that the first ring 39 can assume a folded or flattened elongate collapsed shape (Figure 25A) and an expanded annular shape (Figure 25B), as well as a second ring 41 adapted to be detachably fixated to a ring seat 42 of an endoscopic ring applier 43 and magnetically attracted to the first ring 39.
  • a first ring 39 having a plurality of (preferably an equal number of e.g. four) linear segments 40 (having preferably equal lengths) linked together at their ends and movable to one another so that the first ring 39 can assume a folded or flatt
  • the first ring 39 when held in its collapsed shape and connected to the guide wire 1 1 (e.g . by a releasable clip or sheath 58), is adapted to be transportable endoluminally, through the biliary duct 7, into the gallbladder 8.
  • the first ring 39 is permanently elastically biased to its expanded configuration, e.g. by means of a spring wire which connects the individual linear segments 40 to each other.
  • the first ring 39 is configured to recover the expanded shape upon exposure to the body heat, e.g. by means of a shape memory alloy wire, e.g. a TiNi alloy wire, which connects the individual linear segments 40 to each other.
  • a shape memory alloy wire e.g. a TiNi alloy wire
  • the first ring 39 is permanently magnetically biased in its expanded configuration, preferably by means of the same magnetic material which causes the magnetic attraction between the first and second rings 39, 41.
  • a portion of the duodenum 2 near the papilla of Vater 10 is accessed transorally and the guide wire 1 1 is extended from the duodenum 2 through the papilla of Vater 10 and biliary tree 7 into the gallbladder 8. Then, a tip of the guide wire 1 1 is pushed from inside the gallbladder 8 against the gallbladder wall to perforate the gallbladder wall so that the tip of the guide wire 1 1 emerges from the gallbladder 8 into the abdominal space.
  • the tip of the guide wire 1 1 is then moved out of the gallbladder 8 towards the target portion 12 of the intestine and pushed from outside the intestine against the intestinal wall of the target portion 12 to perforate the intestinal wall.
  • the tip of the guide wire 1 1 penetrates through the intestinal wall and is advanced into the target portion 12 of intestine. In this way, an open guide wire loop is created which defines the positions for the cholecysto- enterostomy 13 between the target portion 12 of the intestine and the gallbladder 8.
  • the first ring 39 is brought in its collapsed configuration and connected to the guide wire 1 1 by means of a restraining means, such as a releasable clip or sheath 58 connected to the guide 1 1 and adapted to embrace at least partially the first ring 39, thereby keeping it in the collapsed shape. Then, the guide wire 1 1 is pulled distally so that the first ring 39 is pulled from inside the duodenum 2 through the bile duct 7 into the gallbladder 8. Then the first ring 39 is released to recover its expanded configuration.
  • a restraining means such as a releasable clip or sheath 58 connected to the guide 1 1 and adapted to embrace at least partially the first ring 39, thereby keeping it in the collapsed shape.
  • the guide wire 1 1 is pulled distally so that the first ring 39 is pulled from inside the duodenum 2 through the bile duct 7 into the gallbladder 8. Then the first ring 39 is released to recover its expanded configuration.
  • an endoscope holding the second ring 41 is moved into the target portion 12 of the intestine and the gallbladder 8 and the target portion 12 of the intestine are approximated and then clamped together between the first ring 39 and second ring 41 by means of their magnetic attraction. Subsequently, the cholecystoenterostomy 13 can be created by using the first ring 39 and second ring 41 as anastomotic compression rings and by opening a patent hole in the clamped tissue portions or by means of an additional anastomotic device, for example an anastomotic clamping coil 59 ( Figure 28).

Abstract

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 visualization of a gallbladder (8) and of a portion of the intestinal tract (2, 3, 4, 5), accessing endoluminally the portion of the intestinal tract (2, 3, 4, 5), extending a guide (11) from the portion of the intestinal tract through a gallbladder wall and through an intestinal wall at a target portion (12) of the intestine significantly distal to the papilla of Vater (10), approximating the gallbladder (8) and the target portion (12) of intestine to each other along the guide (11) and anastomosing the gallbladder (8) to the target portion (12) of intestine to create a cholecysto-enterostomy (13).

Description

A DEVICE FOR AN ENDOLUMINAL CHOLECYSTO - ENTEROSTOMY
DESCRIPTION
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.
Numerous non-operative therapies for morbid obesity have been tried in the past with virtually no permanent success.
Surgical methods of treating morbid obesity, such as open, laparoscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food, have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally highly invasive modifications of the patients gastrointestinal anatomy. These procedures are reserved only for the severely obese patients because they have a number of significant complications, including the risk of death. In order to avoid the drawbacks of gastric bypass surgery and to influence the digestion of a patient in a more specific and aimed way, the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract itself. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:
- modification of the entero-hepatic bile cycling frequency, particularly bile cycle acceleration;
- modification of the physiological signaling triggered by the contact and interaction of the bile with the food in the intestine and by the contact of the bile with the intestinal wall;
- modification of the food absorbability by modifying the contact space and time between the bile and the food or chime in the intestine as well as by an aimed separation of the bile from the food.
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 which diverts bile and pancreatic secretions from the ampulla of Vater to a location d own strea m i n th e gastrointestinal tract. 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. Moreover, 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.
In view of the drawbacks of the known art, an aim of the invention is to provide a 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 are minimally invasive and which increase the flow rate of the diverted bile towards the target location in the small intestine with respect to the physiological entero-hepatic bile cycling.
A further aim of the invention is to obviate undesired relocations of the position of the bile diversion with respect to the target location intended by the doctor.
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:
- gaining visualization of a gallbladder and of a portion of the intestinal tract;
- accessing endoluminally a portion of the gastrointestinal tract;
- extending a guide from the portion of the intestinal tract through a gallbladder wall and through an intestinal wall at a target portion of the intestine significantly distal to the papilla of Vater;
- approximating the gallbladder and the target portion of intestine to each other along the guide;
- anastomosing the gallbladder to the target portion of intestine to create a cholecysto- enterostomy.
Thanks to the cholecysto-enterostomy at the target portion of the intestine, the bile flows directly from the gallbladder in the target portion of intestine and bypasses at least part of the duodenum, while minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy and cannot be accidentally dislocated.
Moreover, thanks to the endoluminal access to the intestine and to the mixed endoluminal- transluminal extension of the guide from the portion of the intestinal tract th rough the gallbladder wall and through the intestinal wall, the creation of the cholecysto-enterostomy results significantly less invasive than the known bypass procedures.
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.
In accordance with an aspect of the invention, the method comprises the steps of:
- accessing transorally a portion of the duodenum near the papilla of Vater;
- extending the guide from the duodenum through the papilla of Vater and biliary tree into the gallbladder;
- pushing a tip of the guide from inside the gallbladder against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide out of the gallbladder towards the target portion of the intestine
- pushing a tip of the guide from outside the intestine against the intestinal wall of the target portion to perforate the intestinal wall;
- advancing the guide into the target portion of intestine.
In accordance with a further aspect of the invention, the method comprises the steps of:
- introducing an ultrasound endoscope transorally in the target portion of the intestine;
- pushing a tip of the guide from inside the target portion of the intestine against the intestinal wall to perforate the intestinal wall;
- advancing the guide out of the target portion of intestine towards the gallbladder;
- pushing a tip of the guide from outside the gallbladder against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide into the gallbladder.
In accordance with a further aspect of the invention, the method comprises the steps of:
- introducing an ultrasound endoscope transanally in the target portion of the intestine;
- pushing a tip of the guide from inside the target portion of the intestine against the intestinal wall to perforate the intestinal wall;
- advancing the guide out of the target portion of intestine towards the gallbladder;
- pushing a tip of the guide from outside the gallbladder against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide into the gallbladder.
In accordance with an aspect of the invention, the method comprises the steps of:
- percutaneous introduction of a grasping instrument in the abdominal space;
- engaging the gallbladder and approximating the gallbladder towards the target portion of the intestine by means of the grasping instrument.
In accordance with an aspect of the invention, an inflatable balloon is provided at a distal end of the grasping instrument and the method comprises the steps of:
- introducing the distal end of the grasping instrument and the inflatable balloon in the gallbladder;
- engaging the gallbladder by inflating the inflatable balloon inside the gallbladder.
In accordance with a further aspect of the invention, the method comprises the steps of:
- providing an anastomosis device having a first portion and a second portion;
- connecting the anastomosis device to the guide and delivering, by means of the guide, the first portion into the gallbladder and, possibly, the second portion into the target portion of intestine.
In accordance with a yet further aspect of the invention, the method comprises the step of approximating and coupling the first and second portions of the anastomosis device by pulling the guide.
In accordance with a yet further aspect of the invention, the method comprises the steps of:
- providing an anastomosis device having a first portion and a second portion; and
- inserting at least the first portion of the anastomosis device percutaneously into the gallbladder.
In accordance with an aspect of the invention, the method comprises the step of attaching an unidirectional valve to the cholecysto-enterostomy to prevent a backflow of chime from the target portion of intestine into the gallbladder.
In accordance with a yet further aspect of the invention, the method comprises the step of anastomosing a first segment of the intestine to a second segment of the intestine, wherein the first segment is proximal to the target portion of intestine and the second segment is distal to the target portion of intestine, thereby creating an "Omega" loop.
This makes it possible to create a preferential path for the intestinal contents remote from the cholecysto-enterostomy, thereby obviating the risk of bacterial contamination and infection as well as the need of a unidirectional valve at the cholecysto-enterostomy.
At least part of the above identified aims are further achieved by 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, the device comprising:
- a first ring comprising a plurality of linear segments linked together at their ends and movable to one another so that the ring can assume an elongate collapsed shape and an expanded annular shape;
- a second ring magnetically attracted to the first ring,
- a guide adapted to transport the first ring endoluminally through a biliary duct into a gallbladder,
- restraining means for holding the first ring in its collapsed shape and connecting it to the guide.
Thanks to the endoluminal placement of the first ring in the gallbladder and to the magnetic attraction of the first and second rings, the approximation of the target portion of intestine to the gallbladder, their mutual compression and anastomosis is greatly facilitated.
In accordance with an aspect of the invention, the first ring is magnetically biased into its expanded annular configuration by means of the same magnetic material which causes the magnetic attraction between the first and second rings.
These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
- Figure 1 illustrates devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figure 2 illustrates an ultrasound endoscope used in the procedure of figure 1 ;
- Figures 3 to 5 illustrate further devices and steps of the procedure in figure 1 ;
- Figures 6 and 7 are side views of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figure 8 is a front view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figures 9 to 12 illustrate devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention;
- Figure 13 is a perspective view of an endoluminal anastomosis ring applier for a cholecysto- enterostomy in accordance with an embodiment of the invention;
- Figure 14 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figures 15 to 18 illustrate devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention;
- Figure 19 illustrates devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a further embodiment of the invention;
- Figure 20 illustrates devices and steps for creating an "Omega"-loop of intestine in a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a yet further embodiment of the invention;
- Figures 21 and 22 illustrate devices and steps of the procedure in figure 20 in accordance with an embodiment of the invention;
- Figure 23 illustrates an anastomosis device applier used in the method in figures 21 and 22;
- Figure 24 illustrate an anastomosis device after deployment and withdrawal of the applier in figure 23;
- Figures 25A and 25B illustrate an anastomosis device in a collapsed configuration and in an expanded configuration;
- Figures 26 to 28 illustrate steps of a procedure for the diversion of bile through a cholecysto- enterostomy using the anastomosis device in figure 25;
Referring to the drawings where like n umerals denote like anatomical structures and components throughout the several views, 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 for endoluminally creating a cholecysto-enterostomy for diverting biliary fluid from the gallbladder 8 to a target location in the intestine distal of the papilla of Vater 10.
In accordance with a general inventive idea, the method comprises the steps of:
- gaining visualization of the gallbladder 8 and of a portion of the intestinal tract 2, 3, 4, 5;
- accessing endoluminally a portion of the gastrointestinal tract 2, 3, 4, 5;
- extending a guide, particularly a guide wire 1 1 , from the portion of the intestinal tract through a gallbladder wall and through an intestinal wall at a target portion 12 of the intestine significantly distal to the papilla of Vater 10;
- approximating the gallbladder 8 and the target portion 12 of intestine to each other along the guide 1 1 ;
- anastomosing the gallbladder 8 to the target portion 12 of intestine to create a cholecysto- enterostomy 13.
Thanks to the cholecysto-enterostomy 13 at the target portion 12 of the intestine, the bile flows directly from the gallbladder 8 in the target portion of intestine and bypasses at least part of the duodenum 2, while minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy 13 and cannot be accidentally dislocated.
Moreover, thanks to the endoluminal access to the intestine and to the mixed endoluminal- transluminal extension of the guide wire 1 1 from the portion of the intestinal tract through the gallbladder 8 wall and through the intestinal wall, the creation of the cholecysto-enterostomy 13 results significantly less invasive than the known bypass procedures.
The target portion 12 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.
A) Detailed description of a transoral cholecysto-enterostomy with transluminal extension of a guide from the gallbladder to the intestine
In accordance with an embodiment (Figures 1 to 5), a portion of the duodenum 2 near the papilla of Vater 10 is accessed transorally and the guide wire 1 1 is extended from the duodenum 2 through the papilla of Vater 10 and biliary tree 7 into the gallbladder 8. Then, a tip of the guide wire 1 1 is pushed from inside the gallbladder 8 against the gallbladder wall to perforate the gallbladder wall so that the tip of the guide wire 1 1 emerges from the gallbladder 8 into the abdominal space. The tip of the guide wire 1 1 is then moved out of the gallbladder 8 towards the target portion 12 of the intestine and pushed from outside the intestine against the intestinal wall of the target portion 12 to perforate the intestinal wall. The tip of the guide wire 1 1 penetrates through the intestinal wall and is advanced into the target portion 12 of intestine. In this way, an open guide wire loop is created which defines the positions for the cholecysto- enterostomy 13 between the target portion 12 of the intestine and the gallbladder 8.
In accordance with an embodiment, the insertion of the guide wire 1 1 through the biliary tree 7 into the gallbladder 8 can be accomplished using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique. The ERCP procedure involves passing a flexible endoscope 14 through the mouth, esophagus, and stomach into the duodenum 2 near the papilla of Vater 10. The doctor then passes the guide wire 1 1 through a channel in the endoscope 14 and out into view in the duodenum 2 and inserts it into the papilla of Vater 10. The transluminal perforations of the gallbladder 8 and of the intestine are preferably guided and monitored by ultrasound imaging. For this purpose, an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14. The commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose. Additionally, an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
After placement of the guide wire 1 1 , the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13.
B) Detailed description of methods and devices for creating the cholecysto-enterostomy
13 In accordance with an embodiment, an anastomosis device is provided having a first portion 16 and a second portion 17. The anastomosis device 16, 17 is connected to the guide wire 1 1 and, by means of the guide wire 1 1 , the first portion 16 is delivered into the gallbladder 8 and the second portion 17 is delivered into the target portion 12 of the intestine. Both, the first and second portions 16, 17 of the anastomosis device are configured to shape interfere with the gallbladder and with the target portion of intestine, respectively, so that the gallbladder 8 and the target portion of intestine 12 can be dragged and compressed together by means of the anastomosis device.
By securing one of the first and second portions 16, 17 to the guide wire 1 1 so that it cannot slide with respect to the latter, and sliding the other one of the first and second portions 16, 17 along the guide wire 1 1 in a direction opposed to a pulling direction of the guide wire 1 1 , the first and second portions 16, 17 of the anastomosis device can be approximated to each other, thereby approximating the gallbladder 8 wall and the intestinal wall of target portion 12.
Analogously, by pulling the guide wire 1 1 and pushing a portion of the anastomosis device in a direction opposed to the pulling direction of the guide wire, the first and second portions 16, 17 of the anastomosis device can be coupled to each other, thereby clamping the gallbladder wall against the target portion 12 wall to cause them to anastomose.
In accordance with an alternative embodiment, the first and second portions 16, 17 of the anastomosis device may comprise inflatable ring shaped dilating balloons adapted to compress the gallbladder wall and the wall of the target portion 12 of the intestine to create fistula and, hence, anastomosis therebetween.
In accordance with a yet further exemplary embodiment (Figures 6 to 8), the anastomosis device may comprise a woven tube 18 of wire constructed from a shape memory alloy, e.g. a TiNi alloy, having outer loops or ends adapted to thermally deform and evert when inserted into the walls of adjacent gallbladder 8 and target portion 12 of intestine at the anastomotic site. By thermally deforming and everting, the ends of the tube 18 form petals in a manner which clamps the gallbladder 8 wall and target portion 12 wall in apposition.
The woven tube 18 can be endoluminally or laparoscopically deployed by means of an elongate applicator (not illustrated) which comprises a canula with a distal end designed to allow the woven tube 18 to be slipped over the canula and pulled longitudinally causing the woven tube 18 to become longer and smaller in diameter. The applicator further comprises an outer sleeve adapted to be pushed over the woven tube 18 to provide a smooth surface for inserting the applicator through the walls of the approximated gallbladder 8 and target portion 12 of intestine, and to be retracted from the woven tube 18 to expose the latter, so that heat from the body causes the tube 18 to contract longitudinally and evert to clamp the lumen walls and produce the anastomosis.
Such a woven tube anastomosis device and applicator have been described in US 2003032967 A1 and US7, 1 15,136 to Park, whose content is enclosed herein by reference in its entirety. A similar anastomosis device and applicator have been described in US 7,608,086 to Tanaka et al, whose content is enclosed herein by reference in its entirety.
The anastomosis between the gallbladder 8 and the target portion 12 of intestine 2,3,4,5 may be accomplished by mounting the woven tube 18 on the applicator, covering the woven tube 18 by a retractable sheath, inserting the applicator intraluminally, e.g. transorally, into the intestine to the anastomotic site, approximating the gallbladder 8 into close apposition to the intestine at the anastomotic site, piercing a wall of the target portion 18 of the intestine and a wall of the gallbladder 8, retracting the sheath and deploying the woven tube 18.
In accordance with a yet further exemplary embodiment, the anastomosis device comprises two compression rings which form the above said first 16 and second portion 17 and which are connectable to each other in a clamping relationship, for example by snap fit, press fit, magnetic attraction or screw connection, and adapted to connect the gallbladder lumen and the target portion 12 of the intestine in anastomosis.
In accordance with a further exemplary embodiment (Figures 13 and 14), an open guide wire loop with two guide wires 1 1 , 1 1 ' is created wherein the two guide wires 1 1 , 1 1 ' extend side by side through the gallbladder 8 wall and through the wall of the target portion 12 of the intestine. In this case a specifically adapted anastomosis device 44 (Figure 14) may be used which includes a proximal ring 45 having two guide wire seats 47 each of which is adapted to slidably receive one of the two guide wires 1 1 , 1 1 ', respectively, and a distal ring 46 having two guide wire seats 48 each of which is adapted to slidably receive one of the two guide wires 1 1 , 1 1 ', respectively, and in which the proximal ring 45 and the distal ring 46 are snap-connectable to each other. For this purpose the proximal ring 45 may comprise two snap connecting portions 49 spaced apart at a distance which is substantially equal to a distance between two corresponding counter snap connecting portions 50 provided at the distal ring 46.
Advantageously, the guide wire seats 47 of the proximal ring 45 are defined inside the snap connecting portions 49 and the guide wire seats 48 of the distal ring 46 are defined inside the counter snap connecting portions 50 so that the axes of the ring positioning and ring guidance are aligned with the axes of the ring snap connection.
For the transportation and deployment of the anastomosis device 44, a deployment probe 51 (Figure 13) may be provided which is adapted to endoluminally push the distal ring 46 along the guide wires 1 1 , 1 1 ' to a tissue portion (e.g. to the intestinal wall) of the anastomotic site. In accordance with an embodiment, the deployment probe 51 includes an elongate shaft 52 as well as a distal connector 53 with a proximal coupling portion 54 adapted to detachably connect with the distal end of the elongate shaft 52 and a distal push surface 55 which is at least partially complementary with the corresponding surface of the distal ring 46 in a way that the distal ring 46 can be captively received by the push surface 55. For instance, the connector 53 of the deployment probe 51 delimits cavities 56 configured to receive with interference the distally protruding counter-snap connecting portions 50 of the distal ring 46. Moreover, the connector 53 comprises sliding seats 57 adapted to slidably receive the guide wires 1 1 , 1 1 ' and preferably axially aligned with the guide wire seats 48 of the distal ring 46 when the latter is received by the connector 53. Such an anastomosis device and deployment device are described in EP 1915956 A1 whose content is enclosed herein by reference in its entirety.
In this embodiment, the cholecysto-enterostomy 13 can be performed by fixing the proximal ring 45 of the anastomotic device 44 to a proximal end of the guide wires 1 1 , 1 1 ' inside the gallbladder 8 and delivering the proximal ring 45 to the gallbladder 8 wall by pulling a distal end of the guide wires 1 1 , 1 1 ' in a distal direction. Then, the distal ring 46 is slidably connected to a distal end of the guide wires 1 1 , 1 1 ' and pushed proximally along the guide wires 1 1 , 1 1 ' until it reaches the intestinal wall inside the target portion 12. Then, the distal end of the guide wires 1 1 , 1 1 ' are pulled distally and the distal ring 46 is contemporaneously pushed proximally to approximate the proximal and distal rings and tear the tissue portions situated upon the guide wires 1 1 , 1 1 ' between the distal and proximal rings 45, 46 in contact to another. Then, the distal ring 46 and the proximal ring 45 are snap-connected so that the tissue portions of the gallbladder and of the target portion of intestine are clamped together and allowed to anastomose. The tissue internally overhanging the anastomotic ring device can now be cut to open the anastomotic lumen and the guide wires 1 1 , 1 1 ' can be withdrawn and removed from the body.
In accordance with an embodiment, the introduction of the guide wires 1 1 , 1 1 ' and/or the placement of the proximal ring 45 may be assisted by laparoscopic and/or transluminal manipulation of the gallbladder 8.
After completion of the cholecysto-enterostomy 13, an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
The unidirectional valve 19 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection. Alternatively, the unidirectional valve 19 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
In accordance with an embodiment, the unidirectional valve 19 may comprise a duckbill valve shutter 20, as illustrated in figures 6 and 7. The duckbill valve shutter 20 can be manufactured from a synthetic elastomer and is shaped like the beak of a duck with a flattened end which elastically retains its flattened shape. When the bile pressure in the gallbladder 8 reaches a certain value, the flattened end opens to permit the bile to pass through the valve 19 in the target portion 12 of the intestine. When pressure is removed, however, the flattened end returns to its flattened shape, thereby preventing backflow from the intestine into the gallbladder.
C) Detailed description of a transoral cholecysto-enterostomy with transluminal extension of a guide from the intestine to the gallbladder
In accordance with a further embodiment (Figures 9 to 12), the target portion 12 of the intestine, for instance the jejunum 3, is accessed transorally and a tip of the guide wire 1 1 is pushed from inside the target portion 12 against the intestinal wall to perforate the intestinal wall so that the tip of the guide wire 1 1 emerges from the target portion 12 of the intestine into the abdominal space. The tip of the guide wire 1 1 is then moved out of the target portion 12 towards the gallbladder 8 and pushed from outside the gallbladder 8 against the gallbladder wall to perforate the latter. The tip of the guide wire 1 1 penetrates through the gallbladder wall and is advanced inside the gallbladder 8.
In this manner, an open guide wire loop is created (Figure 10) which defines the positions for the cholecysto-enterostomy 1 3 between the target portion 12 of the intestine and the gallbladder 8.
The transluminal perforations of the intestine and of the gallbladder 8 are preferably guided and monitored by ultrasound imaging. For this purpose, an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14. The commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose. Additionally, an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
After placement of the guide wire 1 1 , the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13. The cholecysto-enterostomy 13 can be now created using the same devices and methods previously described under Point B with reference to figures 4 to 8 and figures 13 and 14 whose description is not repeated here for the sake of conciseness.
After completion of the cholecysto-enterostomy 13, an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
The unidirectional valve 1 9 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection. Alternatively, the unidirectional valve 19 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
D) Detailed description of a transanal cholecvsto-enterostomy with transluminal extension of a guide from the intestine to the gallbladder
In accordance with a further embodiment (Figures 15 to 18), the target portion 12 of the intestine, for instance the jejunum 3, is accessed transanally and a tip of the guide wire 1 1 is pushed from inside the target portion 12 against the intestinal wall to perforate the intestinal wall so that the tip of the guide wire 1 1 emerges from the target portion 12 of the intestine into the abdominal space. The tip of the guide wire 1 1 is then moved out of the target portion 12 towards the gallbladder 8 and pushed from outside the gallbladder 8 against the gallbladder wall to perforate the latter. The tip of the guide wire 1 1 penetrates through the gallbladder wall and is advanced into the gallbladder 8.
In this way, an open guide wire loop is created (Figure 10) which defines the positions for the cholecysto-enterostomy 13 between the target portion 12 of the intestine and the gallbladder 8.
The transluminal perforations of the intestine and of the gallbladder 8 are preferably guided and monitored by ultrasound imaging. For this purpose, an ultrasound transducer 15 may be installed on the distal tip of the endoscope 14. The commercially available endoscope GF- UC160P-OL5 with EU-C60 ultrasound processor by Olympus may be used for this purpose. Additionally, an external ultrasound transducer can be used for monitoring and guidance of the position of the guide wire 1 1 .
After placement of the guide wire 1 1 , the gallbladder 8 and the target portion 12 of the intestine are approximated to each other along the guide wire 1 1 and anastomosed to create the cholecysto-enterostomy 13.
The cholecysto-enterostomy 13 can be now created using the same devices and methods previously described under Point B with reference to figures 4 to 8 and figures 13 and 14 whose description is not repeated here for the sake of conciseness.
After completion of the cholecysto-enterostomy 13, an unidirectional valve 19 may be attached to the anastomosis to prevent a backflow of chime from the target portion of intestine into the gallbladder.
The unidirectional valve 1 9 may be inserted laparoscopically or endolumenally to the anastomosis site and attached to the anastomosis device, e.g. by snap fit, press-fit or shape connection. Alternatively, the unidirectional valve 1 9 may be formed as a single piece or preassembled with at least one portion of the anastomosis device prior to the deployment of the latter.
E) Percutaneous manipulation of the gallbladder
To facilitate the mutual positioning of the gallbladder 8 and the target portion 12 of intestine (Figure 19), a laparoscopic grasping instrument 21 having an elongate shaft and a distal tissue manipulation portion may be percutaneously introduced in the abdominal space and the gallbladder 8 may be seized and moved towards the target portion 12 of the intestine by means of the grasping instrument 21 .
For this purpose, an inflatable balloon 22 may be provided at a distal end 23 of the grasping instrument 21 and introduced in the gallbladder 8. By inflating the balloon 22 inside the gallbladder 8, the latter is reliably held at the distal end 23 of the grasping instrument 21 and can be easily manipulated and moved to the planned position.
On the other hand, the target portion 12 of intestine may be manipulated and pushed towards the gallbladder 8 by means of the endoscope 14, e.g. a transanally inserted colonoscope. In accordance with a yet further embodiment, at least one of the first and second portions 16, 17 of the anastomosis device may be inserted percutaneously into the gallbladder 8. Also, another one of the first and second portions 16, 17 of the anastomosis device may be inserted percutaneously into the target portion 12 of intestine. The first and second portions 16, 17 of the anastomosis device may be magnetically attracted to each other so that they facilitate the mutual approximation and connection of the target portion 12 of intestine and the gallbladder 8.
Alternatively, the first portion 16 of the anastomosis device is inserted percutaneously into the gallbladder and the second portion 17 of the anastomosis device is inserted endoluminally, e.g. by means of a colonoscope, into the target portion 12 of intestine, then the target portion 12 and the gallbladder 8 are approximated and their wall sections are clamped between the magnetically attracted first and second portions 16, 17. F) Detailed description of an endoluminal cholecysto-enterostomy with enteroenterostomy to form an omega-loop structure
In accordance with an embodiment (Figure 20), in addition to the method steps described so far, a first segment 24 of the intestine proximal to the target portion 12 and a second segment 25 of the intestine distal to the target portion 12 can be joined in an enteroenterostomy 27, thereby creating an "Omega" loop 26 of the intestine around the target portion 12. This makes it possible to create a preferential path for the intestinal contents remote from the cholecysto- enterostomy 13 and to obviate the risk of bacterial contamination and infection as well as the need of a unidirectional valve at the cholecysto-enterostomy 13. I n accordance with an exemplary embodiment (Figures 21 to 24), the enteroenterostomy 27 can be created using an anastomosis ring device 28 having proximal 29, center 30, and distal rings 31 connected respectively by proximal and distal hinged arms, the ring device 28 having a generally cylindrical shape when unactuated and a rivet shape when actuated.
Figure 23 illustrates an exemplary applier 32 for the anastomosis ring device 28. The applier 32 comprises an elongate implement portion 33, a handle 34 connected to the implement portion 33, an actuating member internally engaged to a selected one of the rings of the anastomosis device 28, an arresting member internally engaged to a selected second of the rings of the anastomosis device 28 and a control coupled to the handle 34 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 28. Such an anastomosis device and applier have been described in US 7,452,363 whose entire content is herein incorporated by reference.
I n accordance with an embodiment, the applier 32 together with the ring device 28 is introduced endoluminally (continuous line in Figures 21 and 22) or laparoscopically (dashed line in Figures 21 and 22) in a selected one of the first and second segments 24, 25 of intestine and placed through a first and second otomy 35, 36 which are intended to be anastomosed. The applier 32 can have a distal pointed tip 37 adapted to create the otomies when being forced through the wall of the intestine. Alternatively, the first and second otomies 35, 36 may be created with a standard endoscopic or laparoscopic cutting instrument.
As shown in figure 22 (dashed line), the applier 32 may be inserted laparoscopically through a third otomy 38 in a portion of the intestine distal to the second segment 25 and subsequently advanced to the anastomosis site. Then the distal ring 31 of the anastomosis device 28 is inserted through the previously created second otomy 36, while the proximal hinged arms of the anastomosis device 28 are actuated to expand radially so that the device 28 cannot completely slip through the second otomy 36. By pushing the applier 32 towards the first segment 24 of intestine, the second segment 25 of the intestine is approximated to the first segment 24. Then the distal ring 31 of the anastomosis device 28 is inserted through the previously created first otomy 35 into the first segment 24 of the intestine and the distal hinged arms are activated to expand radially, thereby clamping the first segment 24 of the intestine against the second segment 25 of the intestine to allow anastomosis therebetween (Figure 22). Then, the applier 32 can be withdrawn endoluminally or through the third otomy 38.
G) Detailed description of a transoral cholecysto-enterostomy with transluminal extension of a guide from the gallbladder to the intestine and endoluminal deployment of a collapsible anastomotic ring
Figures 25A and 25B illustrate a an embodiment of an anastomosis device for the endoluminal creation of the cholecystoenterostomy 13. The anastomosis device comprises a first ring 39 having a plurality of (preferably an equal number of e.g. four) linear segments 40 (having preferably equal lengths) linked together at their ends and movable to one another so that the first ring 39 can assume a folded or flattened elongate collapsed shape (Figure 25A) and an expanded annular shape (Figure 25B), as well as a second ring 41 adapted to be detachably fixated to a ring seat 42 of an endoscopic ring applier 43 and magnetically attracted to the first ring 39. Moreover, the first ring 39, when held in its collapsed shape and connected to the guide wire 1 1 (e.g . by a releasable clip or sheath 58), is adapted to be transportable endoluminally, through the biliary duct 7, into the gallbladder 8.
Thanks to the endoluminal placement of the first ring 39 in the gallbladder 8 and to the magnetic attraction of the first and second rings 39, 41 , the approximation of the target portion 12 of intestine to the gallbladder 8, as well as their mutual compression and anastomosis is greatly facilitated.
In accordance with an embodiment, the first ring 39 is permanently elastically biased to its expanded configuration, e.g. by means of a spring wire which connects the individual linear segments 40 to each other.
Alternatively, the first ring 39 is configured to recover the expanded shape upon exposure to the body heat, e.g. by means of a shape memory alloy wire, e.g. a TiNi alloy wire, which connects the individual linear segments 40 to each other.
In accordance with a yet further embodiment, the first ring 39 is permanently magnetically biased in its expanded configuration, preferably by means of the same magnetic material which causes the magnetic attraction between the first and second rings 39, 41.
In accordance with an embodiment (Figures 26 to 28), a portion of the duodenum 2 near the papilla of Vater 10 is accessed transorally and the guide wire 1 1 is extended from the duodenum 2 through the papilla of Vater 10 and biliary tree 7 into the gallbladder 8. Then, a tip of the guide wire 1 1 is pushed from inside the gallbladder 8 against the gallbladder wall to perforate the gallbladder wall so that the tip of the guide wire 1 1 emerges from the gallbladder 8 into the abdominal space. The tip of the guide wire 1 1 is then moved out of the gallbladder 8 towards the target portion 12 of the intestine and pushed from outside the intestine against the intestinal wall of the target portion 12 to perforate the intestinal wall. The tip of the guide wire 1 1 penetrates through the intestinal wall and is advanced into the target portion 12 of intestine. In this way, an open guide wire loop is created which defines the positions for the cholecysto- enterostomy 13 between the target portion 12 of the intestine and the gallbladder 8.
After placement of the guide wire 1 1 , the first ring 39 is brought in its collapsed configuration and connected to the guide wire 1 1 by means of a restraining means, such as a releasable clip or sheath 58 connected to the guide 1 1 and adapted to embrace at least partially the first ring 39, thereby keeping it in the collapsed shape. Then, the guide wire 1 1 is pulled distally so that the first ring 39 is pulled from inside the duodenum 2 through the bile duct 7 into the gallbladder 8. Then the first ring 39 is released to recover its expanded configuration. An endoscope holding the second ring 41 is moved into the target portion 12 of the intestine and the gallbladder 8 and the target portion 12 of the intestine are approximated and then clamped together between the first ring 39 and second ring 41 by means of their magnetic attraction. Subsequently, the cholecystoenterostomy 13 can be created by using the first ring 39 and second ring 41 as anastomotic compression rings and by opening a patent hole in the clamped tissue portions or by means of an additional anastomotic device, for example an anastomotic clamping coil 59 (Figure 28).
Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. 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:
- gaining visualization of a gallbladder (8) and of a portion of the intestinal tract (2, 3, 4, 5); - accessing endoluminally the portion of the intestinal tract (2, 3, 4, 5);
- extending a guide (1 1 ) from the portion of the intestinal tract through a gallbladder wall and through an intestinal wall at a target portion (12) of the intestine significantly distal to the papilla of Vater (10);
- approximating the gallbladder (8) and the target portion (12) of intestine to each other along the guide (1 1 );
- anastomosing the gallbladder (8) to the target portion (12) of intestine to create a cholecysto- enterostomy (13).
2. A method according to claim 1 , wherein the target portion (12) of the intestine is a portion of the jejunal-ileal tract.
3. A method according to claim 1 , wherein the target portion (12) of the intestine is a portion of the colon (5).
4. A method according to claim 1 , comprising the steps of:
- accessing transorally a portion of the duodenum (2) near the papilla of Vater (10);
- extending a guide wire (1 1 ) from the duodenum (2) through the papilla of Vater (10) and biliary tree (7) into the gallbladder (8);
- pushing a tip of the guide wire (1 1 ) from inside the gallbladder (8) against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide wire (1 1 ) out of the gallbladder (8) towards the target portion (12) of the intestine;
- pushing a tip of the guide wire (1 1 ) from outside the intestine against the intestinal wall of the target portion (12) to perforate the intestinal wall;
- advancing the guide wire (1 1 ) into the target portion (12) of intestine.
5. A method according to claim 4, comprising the steps of:
- passing a flexible endoscope (14) transorally into the duodenum (2) near the papilla of Vater (10);
- passing the guide wire (1 1 ) through a channel in the endoscope (14) and inserting the guide wire (1 1 ) into the papilla of Vater (10).
6. A method according to claim 1 , comprising the steps of:
- introducing an ultrasound endoscope (14) transorally in the target portion (12) of the intestine;
- pushing a tip of a guide wire (1 1 ) from inside the target portion (12) of the intestine against the intestinal wall to perforate the intestinal wall;
- advancing the guide wire (1 1 ) out of the target portion (12) of intestine towards the gallbladder (8);
- pushing a tip of the guide wire (1 1 ) from outside the gallbladder (8) against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide wire (1 1 ) into the gallbladder.
7. A method according to claim 1 , comprising the steps of:
- introducing an ultrasound endoscope (14) transanally in the target portion (12) of the intestine;
- pushing a tip of a guide wire (1 1 ) from inside the target portion (12) of the intestine against the intestinal wall to perforate the intestinal wall;
- advancing the guide wire (1 1 ) out of the target portion (12) of intestine towards the gallbladder (8);
- pushing a tip of the guide wire (1 1 ) from outside the gallbladder (8) against the gallbladder wall to perforate the gallbladder wall;
- advancing the guide wire (1 1 ) into the gallbladder.
8. A method according to any one of the preceding claims, comprising the steps of:
- percutaneous introduction of a grasping instrument (21 ) in the abdominal space;
- engaging the gallbladder (8) and approximating the gallbladder (8) towards the target portion (12) of the intestine by means of the grasping instrument (21 ).
9. A method according to claim 8, comprising the steps of:
- providing an inflatable balloon (22) at a distal end (23) of the grasping instrument (21 ); and - introducing the distal end (23) of the grasping instrument (21 ) and the inflatable balloon (22) in the gallbladder (8);
- holding the gallbladder (8) by inflating the inflatable balloon (22) inside the gallbladder (8).
10. A method according any one of the preceding claims, comprising the steps of:
- guiding the transluminal perforations of the gallbladder (8) and of the intestine by ultrasound imaging, using an ultrasound transducer (15) installed on the distal tip of an endoscope (14).
11. A method according any one of the preceding claims, comprising the step of attaching an unidirectional valve (19) to the cholecystoenterostomy (13) such that a backflow of chime from the target portion (12) of intestine into the gallbladder (8) is prevented.
12. A method according any one of the preceding claims, comprising the steps of: - providing an anastomosis device having a first portion (16) and a second portion (17);
- connecting the first portion (16) of the anastomosis device to the guide (1 1 ) and delivering, by means of the guide (1 1 ), the first portion (16) into the gallbladder.
13. A method according to claim 12, comprising the steps of approximating and coupling the first and second portions (16, 17) of the anastomosis device by pulling the guide (1 1 ).
14. A method according any one of the preceding claims, comprising the steps of:
- providing an anastomosis device having a first portion (16) and a second portion (17); and
- inserting at least the first portion (16) of the anastomosis device percutaneously into the gallbladder (8).
15. A method according any one of the preceding claims, comprising the step of:
- creating an "Omega" loop (26) of the intestine around the target portion (12) by joining a first segment (24) of the intestine proximal to the target portion (12) and a second segment (25) of the intestine distal to the target portion (12) in an enteroenterostomy (27).
16. An anastomosis device for the endoluminal creation of a cholecystoenterostomy (13), the device comprising:
- a first ring (39) having a plurality of linear segments (40) linked together at their ends and movable to one another so that the first ring (39) can assume a folded elongate collapsed shape and an expanded annular shape,
- a second ring (41 ) magnetically attracted to the first ring (39),
- a guide (1 1 ) adapted to transport the first ring (39) endoluminally through a biliary duct (7) into a gallbladder (8);
- restraining means for holding the first ring (39) in its collapsed shape and connecting it to said guide (1 1 ).
17. An anastomosis device according to claim 16, in which said second ring (41 ) is adapted to be detachably fixated to a ring seat (42) of an endoscopic ring applier (43).
18. An anastomosis device according to claim 16, in which said segments (40) have equal length.
19. An anastomosis device according to any one of claims 16 to 18, in which said segments (40) are of an equal number.
20. An anastomosis device according to any one of claims 16 to 19, in which said restraining means comprise a releasable clip or sheath (58) connected to the guide (1 1 ) and adapted to embrace at least partially said first ring (39), thereby keeping the first ring (39) in the collapsed shape.
21. An anastomosis device according to any one of claims 16 to 20, in which said first ring (39) is permanently elastically biased to its expanded configuration.
22. An anastomosis device according to any one of claims 16 to 20, in which said first ring (39) comprises a shape memory alloy wire connecting the individual segments (40) to each and adapted to recover the expanded shape of the first ring (39) upon exposure to the body heat.
23. An anastomosis device according to any one of claims 16 to 20, in which said first ring (39) is permanently magnetically biased in its expanded shape.
24. An anastomosis device according to claim 23, in which said first ring (39) is permanently magnetically biased in its expanded shape by means of the same magnetic material that causes the magnetic attraction between the first and second rings (39, 41 ).
PCT/EP2010/060291 2010-07-16 2010-07-16 A device for an endoluminal cholecysto - enterostomy WO2012007052A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/060291 WO2012007052A1 (en) 2010-07-16 2010-07-16 A device for an endoluminal cholecysto - enterostomy

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/060291 WO2012007052A1 (en) 2010-07-16 2010-07-16 A device for an endoluminal cholecysto - enterostomy

Publications (1)

Publication Number Publication Date
WO2012007052A1 true WO2012007052A1 (en) 2012-01-19

Family

ID=42555938

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/060291 WO2012007052A1 (en) 2010-07-16 2010-07-16 A device for an endoluminal cholecysto - enterostomy

Country Status (1)

Country Link
WO (1) WO2012007052A1 (en)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2485899C1 (en) * 2012-02-03 2013-06-27 Ильдар Искандарович Галимов Method of transduodenal papillosphyncterotomy with papillosphyncteroplasty and device for its realisation
US9381041B2 (en) 2009-04-21 2016-07-05 Xlumena, Inc. Methods and devices for access across adjacent tissue layers
WO2018022180A1 (en) 2016-07-25 2018-02-01 Sharma Virender K Magnetic anastomosis device delivery system
WO2018158395A1 (en) 2017-03-01 2018-09-07 Universite Libre De Bruxelles Device for shearing tissue
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US10952732B2 (en) 2013-02-21 2021-03-23 Boston Scientific Scimed Inc. Devices and methods for forming an anastomosis
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system
WO2023052962A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
WO2023052934A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
WO2023052938A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
US11957421B2 (en) 2021-09-29 2024-04-16 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030032967A1 (en) 2001-06-20 2003-02-13 Park Medical, Llc Anastomotic device
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2005065412A2 (en) * 2003-12-31 2005-07-21 Valentx, Inc. Devices and methods for treating morbid obesity
US7115136B2 (en) 2001-06-20 2006-10-03 Park Medical Llc Anastomotic device
US20070010834A1 (en) * 2000-04-29 2007-01-11 Sharkawy A A Components, systems and methods for forming anastomoses using magnetism or other coupling means
EP1894514A2 (en) * 2006-08-28 2008-03-05 Olympus Medical Systems Corp. Ultrasonic endoscope, catheter with balloon, magnet indwelling device, and magnet set
EP1915956A1 (en) 2006-09-08 2008-04-30 Ethicon Endo-Surgery, Inc. Surgical instrumentation for performing endoluminal and/or transluminal anastomosis
WO2008101077A1 (en) * 2007-02-15 2008-08-21 Ethicon Endo-Surgery, Inc Surgical devices using magnetic force to form an anastomosis
US7452363B2 (en) 2003-09-30 2008-11-18 Ethicon Endo-Surgery, Inc. Applier for fastener for single lumen access anastomosis
WO2009048954A1 (en) * 2007-10-09 2009-04-16 Wilson-Cook Medical, Inc. Magnetic anastomosis device having improved delivery
US7608086B2 (en) 2003-09-30 2009-10-27 Ethicon Endo-Surgery, Inc. Anastomosis wire ring device
EP2151199A1 (en) * 2008-08-05 2010-02-10 Tyco Healthcare Group, LP Magnetic compression anastomosis device

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070010834A1 (en) * 2000-04-29 2007-01-11 Sharkawy A A Components, systems and methods for forming anastomoses using magnetism or other coupling means
US20030032967A1 (en) 2001-06-20 2003-02-13 Park Medical, Llc Anastomotic device
US7115136B2 (en) 2001-06-20 2006-10-03 Park Medical Llc Anastomotic device
US7452363B2 (en) 2003-09-30 2008-11-18 Ethicon Endo-Surgery, Inc. Applier for fastener for single lumen access anastomosis
US7608086B2 (en) 2003-09-30 2009-10-27 Ethicon Endo-Surgery, Inc. Anastomosis wire ring device
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2005065412A2 (en) * 2003-12-31 2005-07-21 Valentx, Inc. Devices and methods for treating morbid obesity
EP1894514A2 (en) * 2006-08-28 2008-03-05 Olympus Medical Systems Corp. Ultrasonic endoscope, catheter with balloon, magnet indwelling device, and magnet set
EP1915956A1 (en) 2006-09-08 2008-04-30 Ethicon Endo-Surgery, Inc. Surgical instrumentation for performing endoluminal and/or transluminal anastomosis
WO2008101077A1 (en) * 2007-02-15 2008-08-21 Ethicon Endo-Surgery, Inc Surgical devices using magnetic force to form an anastomosis
WO2009048954A1 (en) * 2007-10-09 2009-04-16 Wilson-Cook Medical, Inc. Magnetic anastomosis device having improved delivery
EP2151199A1 (en) * 2008-08-05 2010-02-10 Tyco Healthcare Group, LP Magnetic compression anastomosis device

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9381041B2 (en) 2009-04-21 2016-07-05 Xlumena, Inc. Methods and devices for access across adjacent tissue layers
RU2485899C1 (en) * 2012-02-03 2013-06-27 Ильдар Искандарович Галимов Method of transduodenal papillosphyncterotomy with papillosphyncteroplasty and device for its realisation
US10952732B2 (en) 2013-02-21 2021-03-23 Boston Scientific Scimed Inc. Devices and methods for forming an anastomosis
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter
US10154844B2 (en) 2016-07-25 2018-12-18 Virender K. Sharma Magnetic anastomosis device and delivery system
CN109788953A (en) * 2016-07-25 2019-05-21 维兰德.K.沙马 Magnetic stapling apparatus and delivery system
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
WO2018022180A1 (en) 2016-07-25 2018-02-01 Sharma Virender K Magnetic anastomosis device delivery system
CN109788953B (en) * 2016-07-25 2022-03-08 维兰德.K.沙马 Magnetic anastomosis device and delivery system
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system
WO2018158395A1 (en) 2017-03-01 2018-09-07 Universite Libre De Bruxelles Device for shearing tissue
US11337722B2 (en) 2017-03-01 2022-05-24 Universite Libre De Bruxelles Device for shearing tissue
WO2023052962A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
WO2023052934A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
WO2023052938A1 (en) 2021-09-29 2023-04-06 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments
US11957421B2 (en) 2021-09-29 2024-04-16 Cilag Gmbh International Methods and systems for controlling cooperative surgical instruments

Similar Documents

Publication Publication Date Title
WO2012007052A1 (en) A device for an endoluminal cholecysto - enterostomy
JP4658556B2 (en) Fastener applier for single lumen access anastomosis
CN109044438B (en) Device and method for forming anastomotic stoma
JP4531514B2 (en) Single lumen placement ring for interluminal anastomosis
US7757924B2 (en) Single fold system for tissue approximation and fixation
US8679139B2 (en) Delivery system for magnetic anastomosis device
WO2013087092A1 (en) An applier and a method for anchoring a lining to a hollow organ
WO2012007042A1 (en) An anastomosis device for a cholecysto-enterostomy
WO2012007044A1 (en) A device for translumenal diversion of bile
WO2012091930A2 (en) Methods for biliary diversion
US9717494B2 (en) Applier for anchoring a lining to a hollow organ
WO2013026474A1 (en) Devices and methods for anchoring an endoluminal sleeve in the gi tract
WO2012072138A1 (en) An applier and a method for anchoring a lining to a hollow organ
WO2012007047A1 (en) A device and method for directing bile from the gallbladder in the intestine
WO2008028725A1 (en) Surgical instrumentation for performing endoluminal and/or transluminal anastomosis
WO2012007045A1 (en) A device and method for subcutaneous diversion of bile
EP1908421B1 (en) A carrier member, anastomotic device and instrumentation for performing endoluminal and/or transluminal anastomosis
WO2013004264A1 (en) A method and device for creating an alternative bile flow path
WO2008135081A1 (en) An anastomotic applier and method for performing endoluminal and/or transluminal anastomosis.
WO2012072137A1 (en) An endoluminal lining system and a method for endoluminally lining a hollow organ
WO2012072134A1 (en) An endoluminal lining and a method for endoluminally lining a hollow organ
WO2008135083A1 (en) An anastomotic applier and method for performing endolumenal and/or transluminal anastomosis
EP2139406A1 (en) An anastomotic applier and method for performing endolumenal and/or transluminal anastomosis
WO2012150578A1 (en) Device and method for forming an anastomosis
Pastorelli et al. A DEVICE FOR TRANSLUMENAL DIVERSION OF BILE

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10732717

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 10732717

Country of ref document: EP

Kind code of ref document: A1