WO2012007047A1

WO2012007047A1 - A device and method for directing bile from the gallbladder in the intestine

Info

Publication number: WO2012007047A1
Application number: PCT/EP2010/060275
Authority: WO
Inventors: Michael J. Stokes; Michele D'arcangelo; Alessandro Pastorelli; Christopher J. Hess; Mark S. Zeiner; Mark Steven Ortiz; Manoel Galvao Neto
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2010-07-16
Filing date: 2010-07-16
Publication date: 2012-01-19
Also published as: CN103118607B; CN103118607A

Abstract

A device (11) for diverting bile from a gall bladder (8) to a portion of an intestine (3,4,5) comprises a first portion (12) adapted to be attached to a first lumen (13) of the biliary tree and gallbladder (7, 8), a second portion (14) adapted to be attached to second lumen (15) of a portion of intestine (3,4,5), a bile conduit portion (16) connected with at least one of the first (12) and second portion (14) and adapted to define a flow path between the first lumen (13) and the second lumen (15), a unidirectional valve (17) arranged in the flow path of the bile conduit portion (16) and adapted to prevent a flow from the second lumen (15) to the first lumen (13).

Description

"A DEVICE AND METHOD FOR DIRECTING BILE FROM THE GALLBLADDER IN THE

INTESTINE"

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 and pulmonary disease. 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:

- mod ification 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.

An aim of the present invention is therefore to provide a minimally invasive device and method to alter the entero-hepatic bile cycling by one-directional directing bile from the gallbladder in a section of the small intestine, preferably significantly distally from the papilla of Vater.

This aim is achieved by a method of diverting bile from a gallbladder to a portion of an intestine, the method comprising the steps of:

- creating a bile fluid communication path between the gall bladder and a selected portion of small intestine, the bile fluid communication path bypassing the papilla of Vater;

- equipping the bile fluid communication path with a one-way valve to prevent flow from the intestine to the gall bladder.

This allows to bypass bile directly to a desired portion of intestine which may be distal to the papilla of Vater, e.g. a distal duodenum portion, a jejunum portion or an ileum portion, while obviating the risk of chime backflow in the gallbladder.

In accordance with an aspect of the invention, the method comprises the steps of:

- gaining visualization of the intestine and the gallbladder;

- approximating the gallbladder to a portion of the small intestine;

- equipping an application device with an anastomosis device and advancing the application device from the small intestine to the gallbladder; and

- deploying the anastomosis device to attach the portion of small intestine to the gallbladder, thereby creating direct lumen continuity between the gallbladder and the portion of intestine;

- attaching a one-way valve to the anastomosis device.

In accordance with a further aspect of the invention, the method comprises the steps of:

- gaining visualization of the intestine and of a portion of the biliary tree;

- advancing a tubular bile conduit to the portion of the biliary tree;

- attaching a proximal end of the bile cond u it to the portion of biliary tree in fluid communication with the bile flow;

- placing a distal end of the bile conduit in fluid communication with a selected portion of small intestine;

- equipping the bile conduit with a one-way valve.

Compared with a direct anastomosis, extending a bile conduit between the selected portion of intestine and the biliary tree obviates significant displacements of these anatomical structures.

In accordance with aspects of the invention, the portion of biliary tree can be the gallbladder or a section of the bile duct.

The aim of the invention is further achieved by a device for diverting bile from a gallbladder to a portion of an intestine, the device having:

- a proximal portion adapted to be attached to a first lumen of the biliary tree,

- a distal portion adapted to be attached to second lumen of a portion of intestine,

- a bile conduit portion connected with at least one of the proximal and distal portions and adapted to define a flow path between the first and second lumen, - a one-way valve arranged in the flow path of the bile conduit portion and adapted to prevent a flow from the second lumen to the first lumen.

In accordance with an aspect of the invention, the device comprises an anastomosis device adapted to directly attach a gallbladder to a portion of small intestine, wherein the anastomosis device defines a flow path between the gall bladder and the portion of small intestine and a one-way valve is arranged in the flow path and adapted to prevent flow from the intestine in the gall bladder.

By creating a one-way flow of the diverted bile, the risk of lumen clogging and infection due to backflow of ch ime, particu larly infections of the biliary tree and pancreatitis, is significantly reduced.

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 a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with an embodiment of the invention;

- Figure 2 illustrates a detail of a device for diverting bile from a gallbladder to a portion of an intestine in accordance with an embodiment of the invention;

- Figures 3A and 3B illustrate a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with a further embodiment;

- Figures 4A and 4B illustrate components of a device for diverting bile from a gallbladder to a portion of an intestine in accordance with a further embodiment;

- Figures 4C to 4F show single method steps for diverting bile from a gallbladder to a portion of an intestine, using the device in figure 4A and 4B;

- Figures 5A and 5B are two side views of a unidirectional valve in accordance with an embodiment of the invention;

- Figure 6 is a perspective view of an anastomosis device with a unidirectional valve in accordance with an embodiment of the invention;

- Figures 7A and 7B are longitudinal cross-sectional views of an anastomosis device with an unidirectional valve in an open and closed configu ration in accordance with an embodiment of the invention;

- Figure 9A is a perspective view of an anastomosis device with an integrated unidirectional valve in accordance with a further embodiment of the invention; - Figure 9B is a radial cross-sectional view of the anastomosis device in figure 9A;

- Figure 10 illustrates a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with a further embodiment involving a one-way valve arranged at a distal end of a bile conduit catheter inside the intestine;

- Figure 1 1 illustrates a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with a further embodiment involving a one-way valve arranged in an intermediate tract of a bile conduit catheter outside the gallbladder and outside the intestine;

- Figure 12 illustrates a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with a further embodiment;

- Figures 13A and 13B illustrate a method and device for diverting bile from a gallbladder to a portion of an intestine in accordance with a yet further embodiment.

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, as well as the hepatic-biliary system with the liver, the bile duct 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 3. Figure 1 shows further a device 1 1 for directing bile from the gallbladder in the intestine, bypassing the papilla of Vater 10.

In accordance with a general inventive idea, the device 1 1 comprises a first portion 12 adapted to be attached to a first lumen 13 of the biliary tree 7 and a second portion 14 adapted to be attached to a second lumen 15 of a portion of intestine 3, 4, 5, in which the expression "biliary tree" is intended to include the bile duct 7 and also the gallbladder 8. The device 1 1 comprises further a bile conduit portion 16 connected with at least one of the first 12 and second portion 14 and adapted to define a flow path between the first lumen 13 and the second lumen 15, as well as a unidirectional valve 17 arranged in the flow path of the bile conduit portion 16 and adapted to prevent a flow from the second lumen 15 to the first lumen 13 or, in other words, to prevent a back flow of small bowel contents in the gallbladder 8.

I n accordance with an embodiment of th e invention, the device 1 1 comprises an anastomosis device adapted to directly attach the gallbladder 8 to a portion of small intestine 3, 4 , 5, wherein the anastomosis device defines the flow path between the gall bladder 8 and the portion of small intestine and the one-way valve 17 is connected to the anastomosis device and adapted to prevent flow from the intestine 3, 4, 5 into the gall bladder 8. By creating a one-way flow of the diverted bile, the risk of lumen clogging and infection due to backflow of chime, particularly infections of the biliary tree and pancreatitis, is significantly reduced.

In accordance with an embodiment (Figures 4A to 4F), the anastomosis device comprises a tissue clamping coil 18 formed from a shape memory alloy wire annealed in a coil shape and subsequently longitudinally straightened in a stressed shape, the clamping coil 18 having a proximal pointed tip 19 adapted to pierce through a lumen wall and the clamping coil 18 being configured to regain its original tightly coiled shape upon exposure to the body temperature, thereby clamping the first 13 and second tissue portion 15 between adjacent spires. The clamping coil 18 may be annealed in a flattened coil shape, in a tapered coil shape or in a cylindrical coil shape and subsequently forcedly straightened, e.g. rectilinear shape or in an elongated coiled shape having a distance between adjacent spires.

The shape memory alloy of the clamping coil 18 may comprise a NiTi alloy, such as for example Nitinol.

I n accordance with an embodiment, the clamping coil 1 8 may be deployed using an endoluminal or laparoscopic anastomosis instrument 20 comprising an elongate member 21 with a distally open recess 22 configured to receive the clamping coil 18 in its stressed shape, as well as a proximally (doctor's side) actuatable dispensing member slidingly received in the elongate member 21 and coupled to the recess 22 to distally dispense the clamping coil 18. The instrument 20 may further comprise a grasper 23 with two opposing grasping jaws. The grasper 23 is movable distally from the elongate member 21 distal end and can be actuated by a grasper control mechanism (not illustrated) coupled to the grasping jaws through the elongate member 21 to effect opening and closing thereof. Such an anastomosis clamping coil and instrument has been described in US 7,618,427 to Ortiz and Nobis. The entire content of US 7,618,427 is incorporated herein by reference.

D u ri n g i m pl antation of th e d evice 1 1 , th e a n astomos is i n stru m ent 20 ca n be laparoscopically inserted through a trocar proximal (with respect to the surgeon) to the second lumen 15 of the intestine. For instance, an enter ostomy may be formed in the jejunum 4 distal to the desired target location for the anastomosis with the gallbladder 8 and the instrument 20 is inserted through the ostomy in the jejunum 4 and advanced retrograde up the jejunum. At the selected target location for the anastomosis, the grasper 23 jaws are closed to form a piercing tip and the grasper 23 is distally advanced through the tissue wall of the second lumen 15 (jejunal wall). Then the grasper 23 jaws are opened to grasp the tissue wall of the first lumen 13 of the gall bladder 8. The grasper 23 is then drawn proximally to approximate and juxtapose the lumen walls 13, 15 and the clamping coil 18 is distally dispensed through the walls of the approximated lumens. Then the clamping coil 18 relaxes into its coiled shape with at least one spire (first portion 12) on the distal side of the first lumen 13 and another spire (second portion 14) on the proximal side of the second lumen 80. The fully relaxed clamping coil 18 then forms the anastomosis attachment, so that healing will occur between the two lumen walls. The lumen walls are then cut through in the center opening of the annular clamping coil 18 to create patency. Subsequently, the unidirectional valve 17 is inserted laparoscopically or endolumenally to the anastomosis site and attached to the clamping coil 18, e.g. inserted in the center opening of the coil 18 and connected thereto by snap fit, press-fit or shape connection.

In accordance with a further exemplary embodiment (Figures 5A and 5B), the anastomosis device may comprise a woven tube 24 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 first 13 and second lumen 15 at the anastomotic site. By thermally deforming and everting, the ends of the tube 24 form petals in a manner which clamps the first 13 and second lumen 15 in apposition.

The woven tube 24 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 24 to be slipped over the canula and pulled longitudinally causing the woven tube 24 to become longer and smaller in diameter. The applicator further comprises an outer sleeve adapted to be pushed over the woven tube 24 to provide a smooth surface for inserting the applicator through the walls of the approximated second (intestinal) lumen 15 and first (gallbladder) lumen 13, and to be retracted from the woven tube 24 to expose the latter, so that heat from the body causes the tube 24 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 to Park, whose content is enclosed herein by reference in its entirety.

The anastomosis between the gallbladder 8 and the selected portion of intestine 3,4,5 may be accomplished by mounting the woven tube 24 on the applicator, covering the woven tube 24 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 intestinal lumen 15 and a wall of the gallbladder lumen 13, retracting the sheath and deploying the woven tube 24. Subsequently, the unidirectional valve 17 is inserted laparoscopically or endolumenally to the anastomosis site and attached to the reverted tube 24, e.g. by snap fit, press-fit or shape connection.

In accordance with an exemplary embodiment shown in figures 3A and 3B, the anastomosis device comprises two pressure rings 40, 41 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 first 13 and second lumen 15 in anastomosis.

The unidirectional valve 17 is formed on or connected with at least one of the first 40 and second pressure ring 41 .

In accordance with further embodiments (Figures 10 to 13), the bile conduit portion 16 comprises an elongate flexible tube, such as a catheter, extending between the first portion 12 and the second portion 14 and having a length which is sufficient to fluid connect the first portion 12 and the second portion 14 without significantly approximating the second (intestinal) lumen 15 to the first (gallbladder) lumen 13. This arrangement obviates the need to anastomose the selected portion of intestine directly to the gallbladder and allows both anatomical structures to remain in their natural anatomical position.

In the exemplary embodiment of figure 10, a single path catheter 25 is extended from inside the gallbladder 8 translumenally into the small intestine, e.g. the jejunum 4 or ileum 5, and the unidirectional valve 17 is attached to a distal end 26 of catheter 25 to prevent backflow of chime from the intestine towards the gallbladder 8.

Alternatively, as illustrated in figure 1 1 , the unidirectional valve 17 may be arranged in an intermediate tract 27 of the catheter 25, so that the valve 17 can be positioned outside the gallbladder 8 and outside the intestine 3, 4, 5. This makes it possible to use a unidirectional valve having greater dimensions without risking obstruction of the intestine or excessive reduction of the bile flow section inside the valve 25.

In accordance with a further embodiment, the conduit portion 16 can comprise a multi lumen tube (not illustrated) or a multiple path catheter 28 forming a closed loop (Figure 12) with a first perforated tract 29 adapted to be placed inside the gallbladder 8 and a second perforated tract 30 adapted to be placed inside the intestine 3, 4, 5, and a first 31 and second bile flow tract 32 extending between the perforated tracts, so that bile can enter the catheter 28 through the first perforated tract 29 and flow either direction towards the second perforated tract 30 through which it can flow in the intestine. In this embodiment, a first unidirectional valves 1 7 can be arranged in the first bile flow tract 31 and a second unidirectional valve 17' can be arranged in the second bile flow tract 32. The two parallel bile flow tracts 31 , 32 provide a fluid communication redundancy which assures the desired bile diversion also in case of clogging of one flow tract.

Figure 13A illustrates an exemplary embodiment in which the proximal catheter end is placed in the bile duct 7 rather than directly in the gallbladder 8. The catheter 25 tip may be deployed translumenally by means of a needle introducer, as schematically shown in Figure 13B.

In accordance with an embodiment (Figure 2), the unidirectional valve 17 may comprise a one-way check valve 34 comprising a valve housing 35 defining a flow section and a shutter 36, e.g. a ball shutter, biased by a spring element 37 in a closed position in which the flow section is sh ut and a flow prevented . The shutter 36 is displaceable by a predetermined bile pressure on the gallbladder side of the valve 34 to an opening position in which the flow section is at least partially free to allow a flow through the valve. A possible pressure increase on the intestinal side of valve 34 would push the shutter 36 even more in its closed position, preventing a backflow of chime from the intestine towards the gallbladder or biliary tree.

The valve housing, shutter and spring element are fabricated of a biologically compatible material, such as titanium , stainless steel or polycarbide material , e.g. Poly(methyl methacrylate).

The valve 34 can be formed on or connectable to the previously described anastomosis devices or incorporated in or attached to the previously described flexible elongated catheters.

In accordance with a further embodiment, the unidirectional valve 17 may comprise a flexible tube 38 which defines internally a flow section and has a proximal open end 42 intended to be connected in fluid communication with the gallbladder 8 and a flattened distal open end 39 intended to be arranged in fluid communication with the intestine 3, 4, 5. The flattened distal end 39 is elastically biased in a rolled up or folded configuration in which the flow section is shut and adapted to roll out or unfold, thereby opening the flow section, in response to a given fluid pressure acting on the proximal open end 42. An increase of the pressure on the distal end 39 will cause the latter to flatten or fold even more, thereby holding the internal flow section shut and preventing a backflow of chime from the intestine 3, 4, 5 in the gallbladder 8.

The flexible tube 38 may comprise an elastic spring member incorporated in the tube wall or acting on the tube wall to bias the distal end 39 in the rolled up or folded configuration. The flexi ble tu be 38 can be formed on or con nectable to the previously described anastomosis devices or incorporated in or attached to the previously described flexible elongated catheters.

In accordance with a further embodiment (Figure 4B), the unidirectional valve 17 may comprise a tubular body 43 with an external surface 44. The external surface 44 forms a peripheral annular cavity 45 adapted to receive an anastomosis device or a rim of an anastomotic lumen to connect the unidirectional valve 17 to the anastomosis between the gallbladder 8 and the intestine 3, 4, 5 or to the anastomosis ring device.

The tubular body 43 may be elastically deformable to allow radial deformation thereof during insertion into the anastomotic lumen and or into the anastomosis ring device and subsequent elastic radial expansion to accomplish a shape fit or interference fit between both components.

In accordance with a non limiting exemplary embodiment, the unidirectional valve 17 may comprise a duckbill valve shutter 46, as illustrated in figures 4B, 5A and 5B. The duckbill valve shutter 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 17 in the intestine. When pressure is removed, however, the flattened end returns to its flattened shape, thereby preventing backflow from the intestine into the gallbladder.

The duckbill valve shutter 46 can be formed on or connectable to the previously described anastomosis devices or incorporated in or attached to the previously described flexible elongated catheters.

I n accordance with a further embodiment (Figure 6), the unidirectional valve 1 7 may comprise a valve body 47 defining a flow section and a flap 48 elastically biased in a closing position in which the flap 48 shuts the flow section and prevents a flow. The flap 48 is displaceable by a predetermined bile pressure on the gallbladder side of the valve body 47 to an opening position in which the flow section is at least partially free to allow a flow through the valve. A possible pressure increase on the intestinal side of valve body 47 would push the flap 48 even more in its closed position, preventing a backflow of chime from the intestine towards the gallbladder or biliary tree.

In accordance with a further embodiment (Figures 7A and 7B), the unidirectional valve 17 comprises a valve body 49 forming a support grate 50 for a flexible diaphragm 51 and a flow section extending through the support grate 50. The flexible diaphragm 51 is supported to rest elastically against the support grate 50 on a distal side (intestinal side) of the valve body 49 thereby shutting the flow section and preventing a flow through the valve body 49. The diaphragm 51 is liftable from the support grate 50 by a predetermined bile pressure on a proximal (gallbladder) side of the valve body 49 to an opening position in which the flow section is at least partially free to allow a flow through the valve body. A possible pressure increase on a second (intestinal) side of the valve body 49 pushes the diaphragm 51 against the support grate 50, preventing a backflow of chime from the intestine towards the gallbladder or biliary tree.

In accordance with an embodiment, the support grate 50 has a conical, pyramide or generally tapered shape with a convex tapered end 52 facing the first side of the valve body 49 and a cavity 53 facing the second side of the valve body 49 and the diaphragm 51 is fixed in the cavity 53 and elastically deflectable towards the second side of the valve body 49.

The valve body 49 can be formed on or con nectable to the previously described anastomosis devices or incorporated in or attached to the previously described flexible elongated catheters.

Figures 8A and 8B illustrate a further embodiment, wherein the unidirectional valve 17 comprises a valve body 54 having a proximal plate 55 and a distal plate 56. The proximal plate 55 forms a central shutter portion 57 and an external passage portion 58 with one or more passage openings arranged radially outside the shutter portion 57. The distal plate 56 forms a central passage opening 59 and an external pressure portion 60 with a pressure area greater than the sectional area of the passage opening 59.

The proximal 55 and distal plate 56 are arranged and shaped in a manner that the central shutter portion 57 of the proximal plate 55 elastically engages the distal plate 56 and closes the central passage opening 59 from a proximal side of the valve body 54.

Figures 9A and 9B illustrate a yet further exemplary embodiment of the unidirectional valve, configured as a double sided flapper valve based on substantially the same concept described in connection with Figure 6.

From the present description, those skilled in the art will appreciate how the disclosed device and method for directing bile from the gallbladder in a portion of intestine obtain the aims of the invention. Particularly, the described device and method make it possible to aimedly alter the entero-hepatic bile cycling and contact space between bile and food and the small bowel, while preventing the risk of backflow of chime from the intestine to the gallbladder.

Moreover, the described methods for directing bile from the gallbladder in the intestine may be performed at least partially transumbilically using a multiple port access device 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 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 device (1 1 ) for diverting bile from a gallbladder (8) to a portion of an intestine (3,4,5), the device (1 1 ) comprising:

- a first portion (12) adapted to be attached to a first lumen (13) of the biliary tree and gallbladder (7, 8),

- a second portion (14) adapted to be attached to second lumen (1 5) of a portion of intestine (3,4,5),

- a bile conduit portion (16) connected with at least one of the first (12) and second portion (14) and adapted to define a flow path between the first lumen (13) and the second lumen (15),

- a unidirectional valve (17) arranged in the flow path of the bile conduit portion (16) and adapted to prevent a flow from the second lumen (15) to the first lumen (13).

2. A device (1 1 ) according to claim 1 , comprising an anastomosis device adapted to directly attach the gallbladder (8) to the portion of intestine (3, 4, 5), said anastomosis device defining said flow path between the gall bladder (8) and the portion of intestine and the oneway valve (17) being connected to the anastomosis device.

3. A device (1 1 ) according to claim 2, wherein the anastomosis device comprises a tissue clamping coil (18) formed from a shape memory alloy wire annealed in a coil shape and having a pointed tip (19) adapted to pierce through a lumen wall, said clamping coil (18) being configured to regain its original tightly coiled shape upon exposure to the body temperature, thereby clamping the first (13) and second tissue portion (15) between adjacent spires, in which the unidirectional valve (17) is inserted in a center opening of the coil (18).

4. A device (1 1 ) according to claim 2, wherein the anastomosis device comprises a woven tube (24) of wire constructed from a shape memory alloy and having outer ends adapted to thermally deform and evert when inserted into the walls of adjacent first (13) and second lumen (15), thereby clamping the first (13) and second lumen (15) in apposition, in which the unidirectional valve (17) is connectable to the reverted tube (24).

5. A device (1 1 ) according to claim 2, wherein the anastomosis device comprises two initially separate pressure rings (40 , 41 ) connectable to each other i n a clam pi ng relationship and adapted to connect the first (13) and second lumen (15) in anastomosis, in which the unidirectional valve (17) is connected with at least one of the first (40) and second pressure ring (41 ).

6. A device (1 1 ) according to claim 1 , wherein the bile conduit portion (16) comprises an elongate flexible tube extending between said first portion (12) and said second portion (14).

7. A device (1 1 ) according to claim 6, wherein the elongate flexible tube comprises a single path catheter (25) adapted to be extended from inside the gallbladder (8) translumenally into the small intestine.

8. A device (1 1 ) according to claim 7, wherein the unidirectional valve (17) is attached to a distal end (26) of the catheter (25).

9. A device (1 1 ) according to claim 7, wherein the unidirectional valve (17) is arranged in an intermediate tract (27) of the catheter (25).

10. A device (1 1 ) according to claim 6, wherein the elongate flexible tube comprises a multiple path catheter (28) forming a closed loop with a first perforated tract (29) adapted to be placed inside the gallbladder (8) and a second perforated tract (30) adapted to be placed inside a portion of the intestine (3, 4 , 5) and a first (31 ) and second bile flow tract (32) extending between the perforated tracts.

11. A device (1 1 ) according to any one of the preceding claims, wherein the unidirectional valve (17) comprises a one-way check valve (34) having a valve housing (35) defining a flow section and a ball shutter (36) biased by a spring element (37) in a closed position in which the flow section is shut, said ball shutter (36) being displaceable by a predetermined bile pressure on a gallbladder side of the valve (34) to an opening position in which the flow section is at least partially free.

12. A device (1 1 ) according to any one of claims 1 to 1 1 , wherein the unidirectional valve (17) comprises a flexible tube (38) defining internally a flow section and having a proximal open end (42) intended to be connected in fluid communication with the gallbladder (8) and a flattened distal open end (39) intended to be arranged in fluid communication with the intestine, wherein the flattened distal end (39) is elastically biased in a rolled u p configuration in which the flow section is shut and adapted to roll out, thereby opening the flow section, in response to a given fluid pressure acting on the proximal open end (42).

13. A device (1 1 ) according to claim 12, wherein the flexible tube (38) comprises an elastic spring member acting on the tu be wall to bias the d istal end (39) in the rolled up configuration.

14. A device (1 1 ) according to claim 2, wherein the unidirectional valve (17) comprises an elastically deformable tubular body (43) having an external surface (44), said external surface (44) forming a circumferential annular cavity (45) adapted to receive a ring shaped anastomosis device to connect the unidirectional valve (17) to the anastomosis device.

15. A device (1 1 ) according to any one of claims 1 to 1 1 , wherein the unidirectional valve (17) comprises a duckbill valve shutter (46).

16. A device (1 1 ) according to any one of claims 1 to 1 1 , wherein the unidirectional valve (17) comprises a valve body (47) defining a flow section and a flap (48) elastically biased in a closing position in which the flap (48) shuts the flow section and prevents a flow, said flap being displaceable by a predetermined bile pressure on a gallbladder side of the valve body (47) to an opening position in which the flow section is at least partially free to allow a flow through the valve.

17. A device (1 1 ) according to any one of claims 1 to 1 1 , wherein the unidirectional valve (17) comprises a valve body (49) forming a support grate (50) for a flexible diaphragm (51 ) and a flow section extending through the support grate (50), the flexible diaphragm (51 ) being supported to rest elastically against the support grate (50) on a distal side of the valve body (49) thereby shutting the flow section, said diaphragm (51 ) being liftable from the support grate (50) by a predetermined bile pressure on a proximal side of the valve body (49) so that the flow section is at least partially free to allow a flow through the valve body.

18. A method of diverting bile from a gallbladder to a portion of an intestine, the method comprising the steps of:

- arranging a unidirectional valve in the bile fluid communication path to prevent flow from the intestine to the gall bladder.

19. Method according to claim 18, comprising the steps of:

- gaining visualization of the intestine and the gallbladder;

- approximating the gallbladder to a portion of the small intestine;

- attaching a one-way valve to the anastomosis device.

20. Method according to claim 18, comprising the steps of:

- gaining visualization of the intestine and of a portion of the biliary tree;

- advancing a tubular bile conduit to the portion of the biliary tree;

- attaching a proximal end of the bile conduit to the portion of biliary tree in fluid communication with the bile flow;

- equipping the bile conduit with a one-way valve.

21. Method according to claim 20, wherein the portion of biliary tree is the gallbladder.