WO2012007043A1 - A method and devices for creating a closed loop bile recycling circuit isolated from food - Google Patents

A method and devices for creating a closed loop bile recycling circuit isolated from food Download PDF

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Publication number
WO2012007043A1
WO2012007043A1 PCT/EP2010/060267 EP2010060267W WO2012007043A1 WO 2012007043 A1 WO2012007043 A1 WO 2012007043A1 EP 2010060267 W EP2010060267 W EP 2010060267W WO 2012007043 A1 WO2012007043 A1 WO 2012007043A1
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WO
WIPO (PCT)
Prior art keywords
bile
absorbing portion
chyme
intestinal
flow
Prior art date
Application number
PCT/EP2010/060267
Other languages
French (fr)
Inventor
Mark S. Zeiner
Thomas Edward Albrecht
Mark Steven Ortiz
Michele D'arcangelo
Alessandro Pastorelli
Federico Bilotti
Almino Cardoso Ramos
Jose M. Berger
Michael J. Stokes
Original Assignee
Ethicon Endo-Surgery, Inc.
University Of Cincinnati
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., University Of Cincinnati filed Critical Ethicon Endo-Surgery, Inc.
Priority to PCT/EP2010/060267 priority Critical patent/WO2012007043A1/en
Publication of WO2012007043A1 publication Critical patent/WO2012007043A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0076Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12036Type of occlusion partial occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/1204Type of occlusion temporary occlusion
    • A61B17/12045Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00818Treatment of the gastro-intestinal system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections

Definitions

  • the present invention relates, in general, to devices and methods for surgically modifying organs and vessels to alter 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.
  • the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:
  • a particular aim of the present invention is to provide methods and devices for accelerating the entero-hepatic bile cycling of a patient, which are less invasive and involve fewer anatomical modifications than known gastrointestinal bypass surgery.
  • a portion of the intestine which has physiological bile absorbing characteristics such as a segment of ileum, is selected and removed from the gastrointestinal tract, while it remains attached to its lymphatic fluid and blood supplies, and the adjacent segments of the remaining intestine are connected to each other to re-establish the continuity of the intestine, and the selected and isolated bile absorbing portion connected in fluid communication with the biliary fluid from the biliary tree.
  • the previously selected and isolated bile absorbing portion of intestine is directly anastomosed to the gall bladder.
  • the isolation of the bile absorbing portion of the intestine from chyme is performed by isolating the chyme flow from an intestinal wall portion within the bile absorbing portion of the intestine, for instance by diverting the chyme flow through a dedicated chyme channel implant, and fluid connect the biliary tree with the isolated intestinal wall portion.
  • a further aim of the invention is to provide a surgical device for diverting biliary fluid, comprising:
  • - isolation means adapted to engage a bile absorbing portion of the intestine of a patient and isolate said bile absorbing portion from a flow of chyme
  • a bile flow communication duct having a proximal end adapted to couple with the biliary tree and a distal end adapted to connect to the isolated intestinal bile absorbing portion such as to create a fluid communication bypass therebetween.
  • the fluid communication between the biliary tree and the bile absorbing portion of intestine is established by extending a catheter or a natural vessel, such as a vein, from the bile absorbing portion of intestine to the biliary flow in the biliary tree.
  • the natural bile flow in the biliary tree is artificially obstructed downstream or distally from the fluid communication with the isolated bile absorbing intestinal tract, for instance by means of an external clip or an internal plug device, such that the entire bile flow produced by the liver is diverted to be reabsorbed by the isolated bile absorbing intestinal tract.
  • FIG. 1 illustrates a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a first embodiment of the invention
  • FIG. 2 illustrates a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a second embodiment of the invention
  • FIG. 3 illustrates a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a third embodiment of the invention
  • FIG. 4 and 5 illustrate alternative methods for accelerating the entero-hepatic bile cycling of a patient in accordance with a fourth and fifth embodiment of the invention
  • FIG. 6 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a sixth embodiment of the invention
  • FIG. 7 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a seventh embodiment of the invention
  • FIG. 7A is a schematic view in longitudinal cross section of a chyme channel implant for implementing the method in figure 7;
  • FIG. 8 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with an eighth embodiment of the invention
  • FIG. 8A is a schematic view in longitudinal cross section of a chyme channel implant for implementing the method in figure 8;
  • FIG. 8B illustrates an alternative anchoring method and device for anchoring a chyme channel implant to resist peristaltic forces
  • FIGS. 9 and 10 illustrate method steps and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a nineth embodiment of the invention
  • figure 1 is a partial view of the abdominal cavity of a patient, depicting the gastrointestinal tract with the esophagus 1 , stomach 2, duodenum 3, jejunum 4, ileum 5, colon 6 and mesentery with lymphatic fluid and blood supply vascularization 7, as well as the hepatic-biliary system with the liver, the biliary tree 8 with gall bladder 9, the pancreatic duct 10 and the mayor duodenal papilla of Vater 1 1 through which the bile and pancreatic fluid normally enter the duodenum 3, as well as method steps to surgically alter the digestion and particularly accelerate the entero- hepatic bile cycling of a patient.
  • the method comprises the steps of selecting a bile absorbing portion 12 of the intestine 3, 4, 5 and isolating it from a flow of chyme in the gastrointestinal tract, while preserving the lymphatic fluid and blood supply vascularization 7 of the bile absorbing portion 12 and, subsequently, creating a bile flow communication 13 or path 14 between the biliary tree 8 and the isolated intestinal bile absorbing portion 12, wherein said bile flow communication 13 or path 14 is also isolated from chyme.
  • the isolated intestinal bile absorbing portion 12 is preferably a segment of ileum 5 or, alternatively, a segment of duodenum 3 distal (downstream with respect to the chyme flow direction) from the papilla of Vater 1 1 , or a portion of jejunum 4.
  • the intestinal bile absorbing portion 12 itself is totally removed from the intestine, e.g. by proximal and distal resection thereof using an endocutter stapler or surgical clamps and scissors and manual suturing.
  • this phase of the procedure which can be both open or laparoscopic, it is important to preserve the mesentery and blood supply vascularization 7 of the resected intestinal portion 12 in order to maintain its capability to reabsorb bile and recycle it back in the patient's blood stream.
  • the adjacent distal and proximal bowel stumps 13, 14 of the remaining intestine are connected to each other by means of an entero-entero- anastomosis 15 to re-establish the small bowel continuity.
  • an entero-entero- anastomosis 15 to re-establish the small bowel continuity.
  • Such a re-anastomosis of the intestine can be performed with a ci rcu lar stapler or by means of hand sutu red anastomosis.
  • the isolated intestinal bile absorbing portion 12 is then approximated to the gall bladder 9 and connected thereto through a bile diversion anastomosis 16, thereby creating lumen continuity with fluid communication with the biliary fluid from the biliary tree 8.
  • the bile diversion anastomosis 1 6 between the gall bladder 9 and the isolated intestinal bile absorbing portion 12 can be performed using a stapler, e.g. a circular stapler inserted from a first resection end of portion 12 to anastomose a second resection end thereof with the gall bladder 9, or by manual lumen aperture and suturing or by means of the application of an anastomostic pressure ring device.
  • the isolated intestinal bile absorbing portion 12 can be anastomosed to the gall bladder 9 by means of a side-to-end anastomosis forming a T- shaped lumen structure, as shown in figure 4A, or the initially tubular intestinal bile absorbing portion 12 can be longitudinally cut open to become a patch shaped wall portion which is sutured onto a previously created window opening in the gall bladder 9 to achieve a full body incorporation of the isolated intestinal bile absorbing portion 12 wall in the gall bladder 9 wall, compare figure 4B.
  • portion 12 is completely closed in order to avoid leakage of bile in the abdominal space.
  • the gall bladder 9 provides sufficient lumen wall and space for easily accessing the anastomotic site with a circular stapler and executing the bile diversion anastomosis 16.
  • the method contemplates the step of maintaining the bile tree open and unobstructed, such that a first partial bile flow in the gall bladder 9 is diverted towards the isolated bile absorbing portion of intestine 12 and a residual second partial bile flow enters the duodenum through the biliary tree 8.
  • the invention it is contemplated by the invention to divert a predominant part or the entire bile produced by the organism to the isolated intestinal bile absorbing portion 12, e.g. by plugging the biliary tree 8 from inside and/or by strangling it externally so that the bile doesn't flow preferentially or cannot flow at all down the bile duct and into the duodenum.
  • Biliary tree closure can be accomplished by endoluminally deploying a plug device 18 in the biliary tree 8, preferably proximal (upstream) of the junction point with the pancreatic d u ct 1 0 , for instance using a specifically modified ERCP (Endoscopic retrograde cholangiopancreatography) tech nique, in which the plug device 1 8 is detachably supported and deployed by a stent and comprises a circumferential sealing edge adapted to provide a flow preventing engagement of the plug device 18 with the bile duct wall, as well as one or more anchoring portions which interact with the bile duct wall to prevent displacement of the plug device 18 after withdrawal of the stent.
  • ERCP Endoscopic retrograde cholangiopancreatography
  • FIG. 2 illustrates a further embodiment of the invention, according to which the isolated intestinal bile absorbing portion 12, instead of being anastomosed with the gall bladder 9, is anastomosed to a proximal resection stump of the previously resected biliary tree 8 (preferably proximal of the junction with the pancreatic duct 10, in order to preserve the natural pancreatic fluid discharge in the duodenum) , or to a previously resected portion 19 of duodenum wall containing the hepatopancreatic ampulla and papilla of Vater 1 1 (thereby discharging both bile and pancreatic fluids in the isolated intestinal portion 12).
  • This method allows the entire flow of bile to be collected and reabsorbed in the isolated intestinal bile absorbing portion 12, thus enabling a total bile diversion, isolation from chyme and cycle acceleration.
  • the distal resection stump must be closed, e.g. by means of suture or stapling and , analogously, after resection of portion 1 9 of duodenum wall containing the hepatopancreatic ampulla and papilla of Vater 1 1 , the thus created aperture in the duodenum 3 must be equally closed, e.g. by means of suture or stapling, to prevent leakage of body fluids in the abdominal space.
  • the method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 are the same described with reference to figure 1 .
  • Figure 3 illustrates a further embodiment in which the isolated intestinal bile absorbing portion 12 is surgically anastomosed to the biliary tree 8 (preferably proximal of the junction with the pancreatic duct 10, in order to preserve the natural pancreatic fluid discharge in the duodenum), while the biliary tree 8 in fluid communication with portion 12 remains also in fluid communication with the duodenum at the sphincter of Oddi.
  • the lumen wall of the biliary tree 8 is cut longitudinally and anastomosed with the intestinal bile absorbing portion 12, resulting in a partial bile diversion and cycle acceleration.
  • a complete bile diversion would be obtainable by closing the bile tree 8 distally from the bile diversion anastomosis 16, e.g. using the plug device 18 and methods described in connection with the embodiment of figure 1 .
  • the method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 can be the same as previously described with reference to figure 1 .
  • Figure 6 illustrates a further embodiment which obviates possible problems or difficulties to move the selected and resected bile absorbing portion 12 towards the gall bladder 9.
  • the isolated intestinal bile absorbing portion 12 is put in bile fluid communication with the biliary tree 8 by means of extending an additional bile conveying duct 20, for instance a catheter or a natural lumen such as a vein of the patient, from the gall bladder 9 or biliary tree 8 to the isolated intestinal bile absorbing portion 12 in order to discharge the thus diverted bile flow over a certain distance in the intestinal bile absorbing portion 12, without any necessity to displace portion 12 towards the gall bladder 9.
  • an additional bile conveying duct 20 for instance a catheter or a natural lumen such as a vein of the patient
  • a complete bile diversion would be obtainable by closing the bile tree 8, e.g. using the plug device 18 and methods described in connection with the embodiment of figure 1 .
  • the method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 can be those previously described with reference to the embodiment of figure 1 .
  • Figures 7 and 8 illustrate embodiments, in which the isolation of the intestinal bile absorbing portion 12 from the flow of chyme is performed by isolating the chyme flow itself from an intestinal wall portion 21 within the selected bile absorbing portion 12 of the intestine by means of a dedicated chyme channel implant 22.
  • the chyme channel implant 22 is configured and dimensioned to be deployable inside the intestine and comprises a tubular chyme passage channel 23 having a preferably funnel shaped proximal open end 24 adapted to receive the chyme flow conveyed by the intestinal peristalsis and a preferably funnel shaped distal open end 25 adapted to release the chyme from channel 23 distally into the intestine, as well as a laterally open bile collecting cavity 26 isolated from the chyme passage channel 23 and configured to define together with an adjacent portion of intestinal wall a substantially sealed bile collecting and absorbing chamber 27.
  • the bile collecting cavity 26 comprises a radially external ring cavity formed around the chyme passage channel 23 and axially delimited by radially protruding proximal 28 and distal 29 lumen sealing portions.
  • the lumen sealing portions 28, 29 are preferably expandable from an initially collapsed radially smaller configuration in order to allow endoluminal transport of the chyme channel implant 22 to the selected intestinal bile absorbing portion 12 and subsequent deployment thereof by expanding the lumen sealing portions 28, 29.
  • the lumen sealing portions 28, 29 may comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid, such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
  • an expansion fluid such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
  • At least one of the lumen sealing portions 28, 29, preferably the proximal lumen sealing portions 28 can further define a bile passage hole 30 which opens into the bile collecting cavity 26 and to which a bile conveying tube 31 , such as a catheter or a natural endogenous structure, can be coupled from inside the intestine for creating the bile fluid path to the inside of the bile collecting and absorbing chamber 27, as illustrated in figures 8 and 8A.
  • a bile conveying tube 31 such as a catheter or a natural endogenous structure
  • the chyme channel implant 22 it is possible to obtain an accelerated bile reabsorbtion without chyme contact, while leaving the selected bile absorbing portion of intestine 12 in its natural anatomical environment.
  • the bile collecting and absorbing chamber 27 is created by delivering the chyme channel implant 22 (which is still in its initial collapsed configuration) with the help of an enteroscope transanally to the previously selected intestinal bile absorbing portion 12, e.g. a distal segment of the ileum 5 and deploying the chyme channel implant 22 by expanding its lumen sealing portions 28, 29.
  • a catheter is laparoscopically extended and fluid connected between the biliary tree 8 and the selected intestinal bile absorbing portion 12 inside the bile collecting and absorbing chamber 27, thereby creating a shunt between the biliary tree 8 and the intestinal bile absorbing portion 12 that totally diverts bile separate from the chyme flow and accelerates the bile cycling.
  • a prosthetic shunting structure for provid i ng the bi le conveyi ng tu be 31 wou ld be to u se an endogenous structure, such as a segment of bile duct or of the saphenous vein of the patient.
  • a further alternative solution to the implantation of a prosthetic shunting structure contemplates to transect the biliary tree 8 and anastomose its distal stump with the intestinal bile absorbing portion 12, with the result to divert the bile directly and totally.
  • the following two favorite positions for transecting the biliary tree 8 are identified:
  • Figure 8 illustrates an embodiment of an alternative endoscopic approach and devices to divert the bile flow to the bile collecting and absorbing chamber 27, in which a catheter is extended endolumenally from the biliary tree 8 inside the intestine down to the chyme channel implant 22 and coupled to its bile passage hole 30 to create the bile conveying tube 31 .
  • the latter can be additionally anchored in the gastrointestinal tract, e.g. by means of a gastric coil 32 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape interfere with the stomach such as to provide an anchor for an anchoring wire 33 which is connected to the intraluminal bile conveying tube 31 or directly with the chyme channel implant 22.
  • a gastric coil 32 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape interfere with the stomach such as to provide an anchor for an anchoring wire 33 which is connected to the intraluminal bile conveying tube 31 or directly with the chyme channel implant 22.
  • the anchoring wire 33 can be connected to a previously created plication 34 in the stomach wall, as schematically shown in figure 8B.
  • the method step of isolating the intestinal bile absorbing portion 12 from a flow of chyme comprises the step of resecting the intestine at a proximal end B of the selected portion 12, e.g.
  • a distal end region C of the bile absorbing portion 12 has not been resected from and remains attached to the gastrointestinal tract.
  • the remaining proximal resection stump A of the intestine (which was initially proximally adjacent to the portion 12, as shown in figure 9) is connected in anastomosis at or distally from the distal region C of the bile absorbing portion 12, thereby creating an anatomical Y - structure without chyme flow in the branched bile absorbing portion 12.
  • the Y-structure can be advantageously created using a translumenal guide wire approach to define the Y-anatomy and transport and deploy an anastomotic ring device at the entero-entero anastomotic site at A-C, in combination with a multiple access port or single incisional laparoscopic surgery (SILS) bile diversion anastomosis 16.

Abstract

A method for diverting biliary fluid, comprising the steps of isolating a bile absorbing portion (12) of the intestine from a flow of chyme, while preserving vascularization of said bile absorbing portion, and creating a bile flow communication between the biliary tree (8, 9) and the isolated intestinal bile absorbing portion (12), wherein said bile flow communication (13, 14, 16, 20, 31) is also isolated from chyme.

Description

DESCRIPTION
"A METHOD AND DEVICES FOR CREATING A CLOSED LOOP BILE RECYCLING
CIRCUIT ISOLATED FROM FOOD"
The present invention relates, in general, to devices and methods for surgically modifying organs and vessels to alter 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 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 wel l as sign ificant and general ly u n desi rable mod ifications of the patient's gastrointestinal anatomy.
In order to avoid the drawbacks of gastric bypass surgery and to alter 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. 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 chyme in the intestine as well as by an aimed separation of the bile from the food.
A particular aim of the present invention is to provide methods and devices for accelerating the entero-hepatic bile cycling of a patient, which are less invasive and involve fewer anatomical modifications than known gastrointestinal bypass surgery.
This aims are achieved by a surgical method for altering the digestion of a patient, comprising the steps of:
- isolating a bile absorbing portion of the intestine from a flow of chyme, while preserving vascularization of said bile absorbing portion, and - creating a bile flow communication or path between the biliary tree and the isolated bile absorbing portion, wherein said bile flow communication or path is also isolated from chyme.
In this way, it is possible to create a closed loop bile recycling circuit which is isolated from the food and accelerated with respect to the normal physiological entero-hepatic bile cycling.
In accordance with an aspect of the invention , a portion of the intestine which has physiological bile absorbing characteristics, such as a segment of ileum, is selected and removed from the gastrointestinal tract, while it remains attached to its lymphatic fluid and blood supplies, and the adjacent segments of the remaining intestine are connected to each other to re-establish the continuity of the intestine, and the selected and isolated bile absorbing portion connected in fluid communication with the biliary fluid from the biliary tree.
This makes it possible to maintain the gastro-intestinal tract anatomically substantially unchanged, to divert and convey at least part of the bile which has been produced by the liver directly to the isolated bile absorbing portion of intestine, independently from the chyme flow and from the intestinal peristalsis in the gastrointestinal tract, and to reabsorb the diverted bile in the patient's bloodstream thanks to the preserved natural lymphatic fluid and blood supplies of the isolated bile absorbing portion of intestine.
In accordance with a further aspect of the invention, the previously selected and isolated bile absorbing portion of intestine is directly anastomosed to the gall bladder.
This shortens significantly the bile fluid path from the biliary tree to the bile absorbing portion of intestine with respect to the natural anatomical condition, in which the bile enters the duodenum through the hepatopancreatic ampulla (of Vater) and travels distally along the duodenum, the entire jejunum and part of the ileum until it becomes reabsorbed. Moreover, a direct anastomosis with the gall bladder obviates difficulties and risks involved with a fluid connection of the isolated bile absorbing portion of intestine with the much more delicate biliary tree, such as difficult access and visibility and risk of lesions, infections and pancreatitis.
In accordance with a yet further aspect of the invention, the isolation of the bile absorbing portion of the intestine from chyme is performed by isolating the chyme flow from an intestinal wall portion within the bile absorbing portion of the intestine, for instance by diverting the chyme flow through a dedicated chyme channel implant, and fluid connect the biliary tree with the isolated intestinal wall portion. To this end, a further aim of the invention is to provide a surgical device for diverting biliary fluid, comprising:
- isolation means adapted to engage a bile absorbing portion of the intestine of a patient and isolate said bile absorbing portion from a flow of chyme,
- a bile flow communication duct having a proximal end adapted to couple with the biliary tree and a distal end adapted to connect to the isolated intestinal bile absorbing portion such as to create a fluid communication bypass therebetween.
This makes it possible to obtain an accelerated bile reabsorbtion without chyme contact, while leaving the selected bile absorbing portion of intestine in its natural anatomical environment.
In accordance with a yet further aspect of the invention, the fluid communication between the biliary tree and the bile absorbing portion of intestine is established by extending a catheter or a natural vessel, such as a vein, from the bile absorbing portion of intestine to the biliary flow in the biliary tree.
This obviates the necessity to displace the selected bile absorbing intestinal portion towards the biliary tree and gall bladder and vice versa and isolates the thus diverted bile flow from the chyme in the gastrointestinal tract.
In accordance with a yet further aspect of the invention, the natural bile flow in the biliary tree is artificially obstructed downstream or distally from the fluid communication with the isolated bile absorbing intestinal tract, for instance by means of an external clip or an internal plug device, such that the entire bile flow produced by the liver is diverted to be reabsorbed by the isolated bile absorbing intestinal tract.
These and other objects and advantages of the present invention shall be made apparent from th e accom pa nyi n g d rawi n gs a n d th e d escri ption thereof, wh ich i llustrate 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 a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a first embodiment of the invention;
- Figure 2 illustrates a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a second embodiment of the invention;
- Figure 3 illustrates a method for accelerating the entero-hepatic bile cycling of a patient in accordance with a third embodiment of the invention;
- Figures 4 and 5 illustrate alternative methods for accelerating the entero-hepatic bile cycling of a patient in accordance with a fourth and fifth embodiment of the invention;
- Figure 6 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a sixth embodiment of the invention;
- Figure 7 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a seventh embodiment of the invention;
- Figure 7A is a schematic view in longitudinal cross section of a chyme channel implant for implementing the method in figure 7;
- Figure 8 illustrates a method and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with an eighth embodiment of the invention;
- Figure 8A is a schematic view in longitudinal cross section of a chyme channel implant for implementing the method in figure 8;
- Figure 8B illustrates an alternative anchoring method and device for anchoring a chyme channel implant to resist peristaltic forces;
- Figures 9 and 10 illustrate method steps and devices for accelerating the entero-hepatic bile cycling of a patient in accordance with a nineth embodiment of the invention;
Referring to the drawings where like numerals 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 gastrointestinal tract with the esophagus 1 , stomach 2, duodenum 3, jejunum 4, ileum 5, colon 6 and mesentery with lymphatic fluid and blood supply vascularization 7, as well as the hepatic-biliary system with the liver, the biliary tree 8 with gall bladder 9, the pancreatic duct 10 and the mayor duodenal papilla of Vater 1 1 through which the bile and pancreatic fluid normally enter the duodenum 3, as well as method steps to surgically alter the digestion and particularly accelerate the entero- hepatic bile cycling of a patient.
In general terms, the method comprises the steps of selecting a bile absorbing portion 12 of the intestine 3, 4, 5 and isolating it from a flow of chyme in the gastrointestinal tract, while preserving the lymphatic fluid and blood supply vascularization 7 of the bile absorbing portion 12 and, subsequently, creating a bile flow communication 13 or path 14 between the biliary tree 8 and the isolated intestinal bile absorbing portion 12, wherein said bile flow communication 13 or path 14 is also isolated from chyme.
The isolated intestinal bile absorbing portion 12 is preferably a segment of ileum 5 or, alternatively, a segment of duodenum 3 distal (downstream with respect to the chyme flow direction) from the papilla of Vater 1 1 , or a portion of jejunum 4.
In order to partially or totally divert bile from the gall bladder 9 to the selected intestinal bile absorbing portion 12, while avoiding contact or passage of chyme, in accordance with an embodiment, the intestinal bile absorbing portion 12 itself is totally removed from the intestine, e.g. by proximal and distal resection thereof using an endocutter stapler or surgical clamps and scissors and manual suturing. During this phase of the procedure, which can be both open or laparoscopic, it is important to preserve the mesentery and blood supply vascularization 7 of the resected intestinal portion 12 in order to maintain its capability to reabsorb bile and recycle it back in the patient's blood stream.
After the total resection of portion 12, the adjacent distal and proximal bowel stumps 13, 14 of the remaining intestine are connected to each other by means of an entero-entero- anastomosis 15 to re-establish the small bowel continuity. Such a re-anastomosis of the intestine can be performed with a ci rcu lar stapler or by means of hand sutu red anastomosis.
The isolated intestinal bile absorbing portion 12 is then approximated to the gall bladder 9 and connected thereto through a bile diversion anastomosis 16, thereby creating lumen continuity with fluid communication with the biliary fluid from the biliary tree 8. The bile diversion anastomosis 1 6 between the gall bladder 9 and the isolated intestinal bile absorbing portion 12 can be performed using a stapler, e.g. a circular stapler inserted from a first resection end of portion 12 to anastomose a second resection end thereof with the gall bladder 9, or by manual lumen aperture and suturing or by means of the application of an anastomostic pressure ring device.
Alternatively, in order to increase the bile absorbing surface area in immediate fluid communication with the gall bladder 9, the isolated intestinal bile absorbing portion 12 can be anastomosed to the gall bladder 9 by means of a side-to-end anastomosis forming a T- shaped lumen structure, as shown in figure 4A, or the initially tubular intestinal bile absorbing portion 12 can be longitudinally cut open to become a patch shaped wall portion which is sutured onto a previously created window opening in the gall bladder 9 to achieve a full body incorporation of the isolated intestinal bile absorbing portion 12 wall in the gall bladder 9 wall, compare figure 4B.
In any case it should be assured that, apart from the anastomotic passage to the gall bladder 9, portion 12 is completely closed in order to avoid leakage of bile in the abdominal space.
Thanks to the preserved natural lymphatic fluid and blood supplies of the isolated bile absorbing portion of intestine 12 and to its bile diversion anastomosis 16 with the gall bladder 9 the thus diverted bile is rapidly reabsorbed and recycled in the patient's bloodstream. Moreover, the gall bladder 9, particularly the fundus 17 of the gall bladder provides sufficient lumen wall and space for easily accessing the anastomotic site with a circular stapler and executing the bile diversion anastomosis 16.
In accordance with an embodiment, the method contemplates the step of maintaining the bile tree open and unobstructed, such that a first partial bile flow in the gall bladder 9 is diverted towards the isolated bile absorbing portion of intestine 12 and a residual second partial bile flow enters the duodenum through the biliary tree 8.
Alternatively, it is contemplated by the invention to divert a predominant part or the entire bile produced by the organism to the isolated intestinal bile absorbing portion 12, e.g. by plugging the biliary tree 8 from inside and/or by strangling it externally so that the bile doesn't flow preferentially or cannot flow at all down the bile duct and into the duodenum. Biliary tree closure can be accomplished by endoluminally deploying a plug device 18 in the biliary tree 8, preferably proximal (upstream) of the junction point with the pancreatic d u ct 1 0 , for instance using a specifically modified ERCP (Endoscopic retrograde cholangiopancreatography) tech nique, in which the plug device 1 8 is detachably supported and deployed by a stent and comprises a circumferential sealing edge adapted to provide a flow preventing engagement of the plug device 18 with the bile duct wall, as well as one or more anchoring portions which interact with the bile duct wall to prevent displacement of the plug device 18 after withdrawal of the stent.
Figure 2 illustrates a further embodiment of the invention, according to which the isolated intestinal bile absorbing portion 12, instead of being anastomosed with the gall bladder 9, is anastomosed to a proximal resection stump of the previously resected biliary tree 8 (preferably proximal of the junction with the pancreatic duct 10, in order to preserve the natural pancreatic fluid discharge in the duodenum) , or to a previously resected portion 19 of duodenum wall containing the hepatopancreatic ampulla and papilla of Vater 1 1 (thereby discharging both bile and pancreatic fluids in the isolated intestinal portion 12). This method allows the entire flow of bile to be collected and reabsorbed in the isolated intestinal bile absorbing portion 12, thus enabling a total bile diversion, isolation from chyme and cycle acceleration.
Of course after resection of the bile tree 8, the distal resection stump must be closed, e.g. by means of suture or stapling and , analogously, after resection of portion 1 9 of duodenum wall containing the hepatopancreatic ampulla and papilla of Vater 1 1 , the thus created aperture in the duodenum 3 must be equally closed, e.g. by means of suture or stapling, to prevent leakage of body fluids in the abdominal space. The method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 are the same described with reference to figure 1 .
Figure 3 illustrates a further embodiment in which the isolated intestinal bile absorbing portion 12 is surgically anastomosed to the biliary tree 8 (preferably proximal of the junction with the pancreatic duct 10, in order to preserve the natural pancreatic fluid discharge in the duodenum), while the biliary tree 8 in fluid communication with portion 12 remains also in fluid communication with the duodenum at the sphincter of Oddi. In this case the lumen wall of the biliary tree 8 is cut longitudinally and anastomosed with the intestinal bile absorbing portion 12, resulting in a partial bile diversion and cycle acceleration. In this case, a complete bile diversion would be obtainable by closing the bile tree 8 distally from the bile diversion anastomosis 16, e.g. using the plug device 18 and methods described in connection with the embodiment of figure 1 .
Also in this embodiment, the method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 can be the same as previously described with reference to figure 1 .
Figure 6 illustrates a further embodiment which obviates possible problems or difficulties to move the selected and resected bile absorbing portion 12 towards the gall bladder 9. In accordance with this embodiment, the isolated intestinal bile absorbing portion 12 is put in bile fluid communication with the biliary tree 8 by means of extending an additional bile conveying duct 20, for instance a catheter or a natural lumen such as a vein of the patient, from the gall bladder 9 or biliary tree 8 to the isolated intestinal bile absorbing portion 12 in order to discharge the thus diverted bile flow over a certain distance in the intestinal bile absorbing portion 12, without any necessity to displace portion 12 towards the gall bladder 9.
Also in this embodiment, a complete bile diversion would be obtainable by closing the bile tree 8, e.g. using the plug device 18 and methods described in connection with the embodiment of figure 1 .
The method steps and variants concerning the selection and isolation of the intestinal bile absorbing portion 12 can be those previously described with reference to the embodiment of figure 1 .
Figures 7 and 8 illustrate embodiments, in which the isolation of the intestinal bile absorbing portion 12 from the flow of chyme is performed by isolating the chyme flow itself from an intestinal wall portion 21 within the selected bile absorbing portion 12 of the intestine by means of a dedicated chyme channel implant 22. The chyme channel implant 22 is configured and dimensioned to be deployable inside the intestine and comprises a tubular chyme passage channel 23 having a preferably funnel shaped proximal open end 24 adapted to receive the chyme flow conveyed by the intestinal peristalsis and a preferably funnel shaped distal open end 25 adapted to release the chyme from channel 23 distally into the intestine, as well as a laterally open bile collecting cavity 26 isolated from the chyme passage channel 23 and configured to define together with an adjacent portion of intestinal wall a substantially sealed bile collecting and absorbing chamber 27.
In accordance with the exemplary, non limiting embodiment illustrated in figures 7 and 8, the bile collecting cavity 26 comprises a radially external ring cavity formed around the chyme passage channel 23 and axially delimited by radially protruding proximal 28 and distal 29 lumen sealing portions.
The lumen sealing portions 28, 29 are preferably expandable from an initially collapsed radially smaller configuration in order to allow endoluminal transport of the chyme channel implant 22 to the selected intestinal bile absorbing portion 12 and subsequent deployment thereof by expanding the lumen sealing portions 28, 29.
To this end , the lumen sealing portions 28, 29 may comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid, such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
At least one of the lumen sealing portions 28, 29, preferably the proximal lumen sealing portions 28 can further define a bile passage hole 30 which opens into the bile collecting cavity 26 and to which a bile conveying tube 31 , such as a catheter or a natural endogenous structure, can be coupled from inside the intestine for creating the bile fluid path to the inside of the bile collecting and absorbing chamber 27, as illustrated in figures 8 and 8A.
Thanks to the above described features of the chyme channel implant 22 it is possible to obtain an accelerated bile reabsorbtion without chyme contact, while leaving the selected bile absorbing portion of intestine 12 in its natural anatomical environment.
With reference to the embodiment of figure 7, the bile collecting and absorbing chamber 27 is created by delivering the chyme channel implant 22 (which is still in its initial collapsed configuration) with the help of an enteroscope transanally to the previously selected intestinal bile absorbing portion 12, e.g. a distal segment of the ileum 5 and deploying the chyme channel implant 22 by expanding its lumen sealing portions 28, 29. Once the bile collecting and absorbing chamber 27 has been created, a catheter is laparoscopically extended and fluid connected between the biliary tree 8 and the selected intestinal bile absorbing portion 12 inside the bile collecting and absorbing chamber 27, thereby creating a shunt between the biliary tree 8 and the intestinal bile absorbing portion 12 that totally diverts bile separate from the chyme flow and accelerates the bile cycling. As already mentioned above, an alternative solution to the implantation of a prosthetic shunting structure for provid i ng the bi le conveyi ng tu be 31 wou ld be to u se an endogenous structure, such as a segment of bile duct or of the saphenous vein of the patient.
A further alternative solution to the implantation of a prosthetic shunting structure contemplates to transect the biliary tree 8 and anastomose its distal stump with the intestinal bile absorbing portion 12, with the result to divert the bile directly and totally. In this case, the following two favorite positions for transecting the biliary tree 8 are identified:
- Proximal (upstream) from the junction between the pancreatic duct 10 and the bile duct 8, so that all bile but no pancreatic fluids are diverted;
- Between the junction of the pancreatic duct 10 and the ampulla of Vater, such that both bile and pancreatic fluid are diverted.
Figure 8 illustrates an embodiment of an alternative endoscopic approach and devices to divert the bile flow to the bile collecting and absorbing chamber 27, in which a catheter is extended endolumenally from the biliary tree 8 inside the intestine down to the chyme channel implant 22 and coupled to its bile passage hole 30 to create the bile conveying tube 31 .
In order to resist the peristaltic forces acting on the devices 22, 31 , the latter can be additionally anchored in the gastrointestinal tract, e.g. by means of a gastric coil 32 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape interfere with the stomach such as to provide an anchor for an anchoring wire 33 which is connected to the intraluminal bile conveying tube 31 or directly with the chyme channel implant 22.
Alternatively, the anchoring wire 33 can be connected to a previously created plication 34 in the stomach wall, as schematically shown in figure 8B.
In accordance with a further embodiment (figures 9, 10), the method step of isolating the intestinal bile absorbing portion 12 from a flow of chyme comprises the step of resecting the intestine at a proximal end B of the selected portion 12, e.g. in the jejunum or ileum, and displacing the proximal end B of portion 12 (which corresponds to the distal resection stump B) towards the gall bladder 9 and biliary tree 8 and, subsequently, connecting the proximal end B of bile absorbing portion 12 in fluid communication with either the gall bladder 9 or the biliary tree 8 or an additional bile conveying duct 20 using the method steps and devices already described in relation with the embodiments of figures 1 ,2,3,4 and 6, with the only difference that, in the present embodiment, a distal end region C of the bile absorbing portion 12 has not been resected from and remains attached to the gastrointestinal tract.
In fact, the remaining proximal resection stump A of the intestine (which was initially proximally adjacent to the portion 12, as shown in figure 9) is connected in anastomosis at or distally from the distal region C of the bile absorbing portion 12, thereby creating an anatomical Y - structure without chyme flow in the branched bile absorbing portion 12. The Y-structure can be advantageously created using a translumenal guide wire approach to define the Y-anatomy and transport and deploy an anastomotic ring device at the entero-entero anastomotic site at A-C, in combination with a multiple access port or single incisional laparoscopic surgery (SILS) bile diversion anastomosis 16.
The described procedures can be performed at least partially transumbilically using a m u lti p l e po rt d evi ce and procedural steps described and illustrated in US2010/0081883A1 , as well as at least partially transvaginal^ using devices and procedures described and illustrated in US2010/0081864A1 . The complete content of these cited publications is herein incorporated by reference.
Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to l im it the scope of the clai ms to such particu lar embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. A method for diverting biliary fluid, comprising the steps of:
- isolating a bile absorbing portion (12) of the intestine from a flow of chyme, while preserving vascularization of said bile absorbing portion, and
- creating a bile flow communication between the biliary tree (8, 9) and the isolated intestinal bile absorbing portion (12), wherein said bile flow communication (13, 14, 16, 20, 31 ) is also isolated from chyme.
2. A method according to claim 1 , comprising the steps of:
- selecting a portion (12) of the intestine wh ich has physiological bile absorbing characteristics,
- removing the selected intestinal bile absorbing portion (12) from the gastrointestinal tract, while it remains attached to its lymphatic fluid and blood supplies (7), and
- connecting the adjacent segments of the remaining intestine to each other to re-establish the continuity of the intestine, and
- connecting the isolated intestinal bile absorbing portion (12) in fluid communication with the biliary fluid from the biliary tree (8).
3. A method according to claim 1 , wherein the step of isolating the intestinal bile absorbing portion (12) from a flow of chyme comprises the steps of:
- resecting the intestine at a proximal end (B) of the selected bile absorbing portion (12), - displacing the proximal end (B) of bile absorbing portion (12) towards the gall bladder (9) and biliary tree (8) and,
- subsequently, connecting the proximal end (B) of bile absorbing portion (12) in fluid communication with the gall bladder (9),
- anastomosing the remaining proximal resection stump (A) of the intestine at a distal region (C) of the bile absorbing portion (12), thereby creating an anatomical Y structure without chyme flow in the branched bile absorbing portion (12).
4. A method according to claim 2, comprising the step of anastomosing the isolated intestinal bile absorbing portion (12) to the gall bladder (9).
5. A method according to claim 4, comprising the step of anastomosing the isolated intestinal bile absorbing portion (12) to the gall bladder (9) by means of a side-to-end anastomosis forming a T-shaped lumen structure.
6. A method according to claim 4, comprising the steps of:
- cutting open the initially tubular intestinal bile absorbing portion (12) to form a patch shaped wall portion, and - suturing said patch shaped wall portion onto a previously created window opening in the gall bladder (9) to create a full body incorporation of the bile absorbing portion (12) in the wall of gall bladder (9).
7. A method according to claim 2, comprising the steps of:
- resecting the biliary tree (8),
- anastomosing the isolated intestinal bile absorbing portion (12) to a proximal resection stump of the previously resected biliary tree (8),
- closing the distal resection stump of the biliary tree.
8. A method according to claim 2, comprising the step of anastomosing the isolated intestinal bile absorbing portion (12) laterally to the biliary tree 8 proximal of the junction with the pancreatic duct (10), while the biliary tree (8) remains in fluid communication with the duodenum at the sphincter of Oddi.
9. A method according to claim 1 , wherein the step of isolating the intestinal bile absorbing portion (12) from chyme comprises isolating the chyme flow from an intestinal wall portion (21 ) within the bile absorbing portion (12), while leaving the bile absorbing portion (12) in the gastrointestinal tract.
10. A method according to claim 9, comprising the step of:
- providing a chyme channel implant (22) configured to be deployable inside the intestine and comprising:
- a tubular chyme passage channel (23) having a proximal open end (24) adapted to receive the chyme flow and a distal open end (25) adapted to release the chyme from channel (23),
- a laterally open bile collecting cavity (26) isolated from the chyme passage channel (23) and adapted to define with an adjacent portion of intestinal wall a sealed bile collecting and absorbing chamber (27),
- deploying said chyme channel implant (22) in the intestinal bile absorbing portion (12).
11. A method according to the claim 10, comprising the step of extending a bile conveying tube (31 ) endoluminally from the biliary tree (8) to the bile collecting cavity (26) of said chyme channel implant.
12. A method according to claim 10, comprising the step of anchoring the chyme channel implant (22) in the gastrointestinal tract by means of:
- fixating an anchoring device (32, 34) in the stomach (2), and
- connecting the anchoring device (32, 34) with the chyme channel implant (22).
13. A method according to claim 1 , wherein the fluid communication between the biliary tree (8, 9) and the isolated intestinal bile absorbing portion (12) is created by extending an additional bile conveying duct (20, 31 ) from the intestinal bile absorbing portion (12) to the biliary flow in the biliary tree (8,9).
14. A method according to claim 13, wherein said additional bile conveying duct (20) is selected in the group consisting of:
- a catheter,
- a natural lumen of the patient.
15. A method according to claim 1 , wherein the natural bile flow in the biliary tree (8) is artificially obstructed, such that the total bile flow is diverted and reabsorbed by the isolated intestinal bile absorbing portion (12).
16. A method according to claim 15, comprising the step of deploying a plug device (18) inside the biliary tree (8).
17. A method according to claim 15, comprising the step of obstructing the biliary tree (8) proximal of the junction point with the pancreatic duct (10).
18. A method according to claim 16, wherein the plug device (18) in the biliary tree is deployed using an endoscopic retrograde cholangiopancreatography technique, in which the plug device (18) is detachably supported and deployed by a stent and wherein said plug device (18) comprises:
- a circumferential sealing edge adapted to provide a flow preventing engagement with the bile duct wall,
- one or more anchoring portions which interact with the bile duct wall to prevent displacement of the plug device (18).
19. A method according to claim 1 , comprising the step of performing the method transumbilically using a multiple port device.
20. A method according to claim 1 , comprising the step of performing the method transvaginally.
21. A method according to claim 1 , wherein the isolated intestinal bile absorbing portion (12) is a segment of the jejunum-ileum tract.
22. A surgical device for diverting biliary fluid, comprising:
- isolation means adapted to engage a bile absorbing portion (12) of the intestine of a patient and isolate said bile absorbing portion (12) from a flow of chyme,
- a bile flow communication duct (20, 31 ) having a proximal end adapted to couple with the biliary tree (8, 9) and a distal end adapted to connect to the isolated intestinal bile absorbing portion (12) such as to create a fluid communication bypass therebetween.
23. A surgical device according to claim 22, comprising a chyme channel implant (22) configured to be deployable inside the intestine and comprising:
- a tubular chyme passage channel (23) having a proximal open end (24) adapted to receive the chyme flow and a distal open end (25) adapted to release the chyme from channel (23),
- a laterally open bile collecting cavity (26) isolated from the chyme passage channel (23) and adapted to define with an adjacent portion of intestinal wall a sealed bile collecting and absorbing chamber (27).
24. A surgical device according to claim 23, wherein said bile collecting cavity (26) comprises a radially external ring cavity formed around the chyme passage channel (23) and axially delimited by radially protruding proximal (28) and distal (29) lumen sealing portions.
25. A surgical device according to claim 24, wherein said lumen sealing portions (28, 29) are expandable from an initially collapsed configuration.
26. A surgical device according to claim 25, wherein said lumen sealing portions (28, 29) comprise permanently expandable balloon segments and means for injection of an expansion fluid.
27. A surgical device according to claim 26, wherein said expansion fluid comprises an initially fluidic solidifying expansion agent.
28. A surgical device according to claim 22, wherein said proximal lumen sealing portion (28) defines a bile passage hole (30) which opens into the bile collecting cavity (26) and to which a bile conveying tube (31 ) couples.
29. A surgical device according to claim 22, comprising further a plug device (18) having:
- a circumferential sealing edge adapted to provide a flow preventing engagement with the bile duct wall,
- one or more anchoring portions adapted to interact with the bile duct wall to prevent displacement of the plug device (18).
30. A surgical device according to claim 22, comprising further an anchoring means adapted to connect with the stomach (2) and to hold the device (22) in position against peristaltic forces.
PCT/EP2010/060267 2010-07-16 2010-07-16 A method and devices for creating a closed loop bile recycling circuit isolated from food WO2012007043A1 (en)

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