WO2013004264A1

WO2013004264A1 - A method and device for creating an alternative bile flow path

Info

Publication number: WO2013004264A1
Application number: PCT/EP2011/061107
Authority: WO
Inventors: Alessandro Pastorelli; Christopher J. Hess; Mark Steven Ortiz
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-07-01
Filing date: 2011-07-01
Publication date: 2013-01-10

Abstract

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, related co-morbidities such as diabetes, heart disease, stroke, pulmonary disease, neoplastic diseases and accidents. In particular, the invention comprises a method for diverting biliary fluid from a biliary fluid flow path by putting into flow communication a selected location of the biliary tree to a selected location of the intestine distal to a duodenal papilla of Vater, the method comprising the steps of: - accessing endoluminally a portion of the gastrointestinal tract of a patient with an endoscope device; - gaining visual access of the abdominal cavity of the patient; - accessing transluminal the abdominal cavity; - creating a connection between a selected location of the biliary tree and a selected location of the intestine; - putting into flow communication the selected location of the biliary tree with the selected location of the intestine. The method provides for the use of a catheter device for putting into flow communication two target organs or of an anchoring and approximating device for approximating two target organs that must be anastomosed, as described in the application.

Description

DESCRIPTION

"A METHOD AND DEVICE FOR CREATING AN ALTERNATIVE BILE FLOW PATH"

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, related co-morbidities such as diabetes, heart disease, stroke, pulmonary disease, neoplastic diseases and accidents.

Numerous non-operative therapies for morbid obesity have been tried in the past with virtually no permanent success.

Surgical methods of treating morbid obesity, such as open, laparoscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food, have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally highly invasive modifications of the patients gastrointestinal anatomy. These procedures are reserved only for the severely obese patients because they have a number of significant complications, including the risk of death. In order to avoid the drawbacks of gastric bypass surgery and to influence the digestion of a patient in a more specific and aimed way, the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract itself. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:

- modification of the entero-hepatic bile cycling frequency, particularly bile cycle acceleration;

- modification of the physiological signaling triggered by the contact and interaction of the bile with the food in the intestine and by the contact of the bile with the intestinal wall;

- modification of the food absorbability by modifying the contact space and time between the bile and the food or chime in the intestine as well as by an aimed separation of the bile from the food.

The creation of a cholecystojejunostomy has also been recommended as one option in the palliation of biliary obstruction due to pancreatic carcinoma. In these patients, an anastomosis is created between the gallbladder and jejunum, providing an alternative route for bile drainage when the distal common bile duct is occluded secondary to carcinoma in the head of the pancreas.

A known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 . The known system comprises a conduit which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract. The known conduit catheters extend inside the intestine and tend to bundle up and to be displaced by the peristalsis of the intestinal tract so that the distal end of the catheter is frequently relocated far away from the target position intended by the surgeon. Moreover, in order to follow the winding path of the intestine, the known endoluminal conduit must have a significant length which undesirably increases the flow resistance and decreases the flow rate of the bile to the distal target location in the Gl tract. Accordingly, the known conduit is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity.

In view of the drawbacks of the known art, an aim of the invention is to provide a method of and a device for diverting bile from the biliary tree including the gallbladder into a section of the intestine significantly distal to the papilla of Vater, which are minimally invasive and which increase the flow rate of the diverted bile towards the target location in the intestine with respect to the physiological entero-hepatic bile cycling.

A further aim of the invention is to obviate undesired relocations of the position of the bile diversion with respect to the target location intended by the doctor.

At least part of the above identified aims are achieved by a method for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine, the method comprising the steps of:

- accessing endoluminally a portion of the gastrointestinal tract of a patient with an endoscope device;

- gaining visual access of the abdominal cavity of the patient;

- accessing transluminal^ the abdominal cavity;

- creating a connection between a selected location of the biliary tree and a selected location of the intestine;

- putting into flow communication the selected location of the biliary tree with the selected location of the intestine.

Thanks to the cholecysto-enterostomy, the bile flows directly from the gallbladder to the selected location of intestine and bypasses at least part of the duodenum, while minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy and cannot be accidentally dislocated. The selected location of the intestine may be a portion of the small intestine, e.g. a distal portion of duodenum, a portion of jejunum or ileum or a portion of the large intestine, such as for example the transverse or sigmoid colon. According to an embodiment, the portion of the gastro-intestinal tract accessed by the endoscope device is the selected location of the intestine or, in a different embodiment, a portion of the stomach.

In an embodiment, the selected location of the intestine is a portion of the jejunum.

In an embodiment, the selected location of the biliary tract is the gallbladder.

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

- accessing endoluminally a selected location 10 of the gastrointestinal tract 2, 2' of a patient with an endoscope device 7;

- gaining visual access of the abdominal cavity of the patient;

- extending the endoscope device 7 transluminally;

- extending a catheter device 8 associated to the endoscope device 7 to a selected location 1 1 of the biliary tree 3;

- piercing a wall of the selected location 1 1 of the biliary tree 3 and anchoring a distal end of the catheter device 8 thereto;

- anchoring a proximal end of the catheter device 8 to the selected location of the gastrointestinal tract 2, 2'.

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

- gaining visual access of the abdominal cavity of the patient;

- extending transluminally and advancing a catheter device 8 to a selected location 1 1 of the biliary tree 3;

- anchoring a proximal end of the catheter device 8 to the selected location 10 of the gastrointestinal tract 2, 2'.

- accessing endoluminally a portion 100 of the stomach 1 of a patient with an endoscope device 7;

- gaining visual access of the abdominal cavity of the patient;

- extending transgastrically the endoscope device 7 into the abdominal cavity of the patient;

- advancing a first guide-wire 30 to a selected location 10 of the intestine;

- anchoring the first guide-wire 30 to the selected location 10 of the intestine;

- advancing a second guide-wire 31 to a selected location 1 1 of the biliary tree 3; - anchoring the second guide-wire 31 to the selected location 1 1 of the biliary tree 3;

- approximating the selected location 10 of the intestine to the selected location 1 1 of the biliary tree 3;

- anastomosing the selected location 10 of the intestine to the selected location 1 1 of the biliary tree 3.

At least part of the above identified aims are further achieved by a catheter device 8 for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the device comprising:

- a catheter portion 12;

- a distal end 13 and a proximal end 14 that comprise apertures 21 and holes for putting into flow communication the exterior with the catheter portion 12 and for allowing needle means 16 to pass therethrough,

wherein the distal end 13 and the proximal end 14 comprise anchoring means 17, 18 apt to anchor the catheter device 8 to the body tissue from inside the organs that have been punctured.

The invention further relates to an anchoring and approximating device 32 for putting and maintaining two target organs into contact, the device comprising:

- a first guide-wire 30 having a distal end 30', to which first anchoring means 33, 35 are associated,

- a second guide-wire 31 having a distal end 31 ', to which second anchoring means 33',

35' are associated;

- approximating means 34 comprising a tubular structure 36 wherein the first and second guide-wires 30, 31 pass through and that is apt to keep the first and second guide- wires 30, 31 in a close condition.

These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

- Figure 1 illustrates devices and steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention;

- Figure 2A, 2B, 2C, 2D, 2E, 2F illustrate various steps of a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with a different embodiment of the invention;

- Figure 3 illustrates a device for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention;

- Figure 4 is a side view of a particular of a variant of the device of figure 3;

- Figures 5A, 5B are a side view of a particular of another variant of the device of figure 3, in two different operative conditions;

- Figures 6A, 6B are a side view of a particular of another variant of the device of figure 3, in two different operative conditions;

- Figure 7 is a side view of a different particular of a variant of the device of figure 3;

- Figure 8 is a side view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention;

- Figures 9A, B, C are a perspective view of a particular of the device of figure 8, according to various operative conditions;

- Figure 10 illustrates the device of figure 8 in an operative condition;

- Figure 1 1 illustrates an operative step according to an embodiment of the method of the invention;

- Figures 12 and 1 3 illustrate a device and method for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention, in two different operative conditions;

- Figure 14A illustrates a catheter device directing biliary fluid from a biliary fluid flow path, such as a gallbladder, to a target portion in the intestine;

- Figure 14B is an enlarged view of anchoring portions of the a catheter device in figure 13A;

- Figure 14C illustrates the device of figure 13A after deployment in a body of a patient.

Referring to the drawings where like n umerals denote like anatomical structures and components throughout the several views, figure 1 is a partial view of the abdominal cavity of a patient, depicting the stomach 1 , jejunum 2, as well as the biliary tree 3 with the gall bladder 4, the pancreatic duct 5 and the mayor duodenal papilla of Vater 6 through which the bile and pancreatic fluid normally enter the duodenum 2'. Figure 1 shows further an operative step of a method and a device for endoluminally creating a cholecysto-enterostomy for diverting biliary fluid from the gallbladder 4 to a target location in the intestine distal to the papilla of Vater 6. In a general aspect, the invention relates to a method that comprises:

- gaining visual access of the abdominal cavity of the patient;

- accessing transluminal^ the abdominal cavity;

According to an embodiment, the portion of the gastro-intestinal tract accessed by the endoscope device is the selected location of the intestine or, in a different embodiment, a portion of the stomach.

A1 ) Transluminal extension of a catheter device from the intestine to the gallbladder

In accordance with an inventive embodiment, the method comprises the steps of:

- gaining visual access of the abdominal cavity of the patient;

- extending the endoscope device 7 transluminal^ into the abdominal cavity;

- advancing a catheter device 8 associated to the endoscope device 7 to a selected location 1 1 of the biliary tree 3;

- anchoring a proximal end of the catheter device 8 to the selected location 10 of the gastro- intestinal tract 2, 2'.

Thanks to the cholecysto-enterostomy 9, the bile flows directly from the gallbladder 4 in the selected location 10 of the intestine and bypasses at least part of the duodenum 2, thus minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy 9 and cannot be accidentally dislocated.

The selected location 10 of the intestine may be a portion of the small intestine, e.g. a distal portion of duodenum 2', a portion of jejunum 2 or ileum or a portion of the large intestine, such as for example the transverse or sigmoid colon. According to an embodiment of the invention, a cholecysto-jejunostomy is created.

A2) Detailed description of a transoral cholecvsto-ieiunostomy with transluminal extension of an endoscope device and further extension of a catheter device from the intestine to the gallbladder

A catheter device 8 associated to an endoscope device 7 is provided.

The catheter device 8, as depicted in figure 3, comprises a catheter portion 12 of a length selected on the basis of the flow path that has to be established between the selected locations of the biliary tree and of the intestine.

The catheter device 8 has a distal end 13 and a proximal end 14.

The distal end 13 has an ogival head 15 which terminates at its tip with a hole wherein needle means 16 apt to puncture a body tissue of a starting organ and of a target organ, i.e. an intestine wall and a gallbladder wall, are inserted. The needle means 1 6 are typically connected to an operating wire (not shown) that allows them to be pulled out once the perforation of the body tissues has been accomplished. Further apertures 21 may be provided in order to create a flow communication between the punctured organ and the catheter portion 12.

The distal end 13 comprises anchoring means 17 apt to grasp the body tissue from inside the target organ that has been punctured.

The proximal end 14 of the catheter device 8 is flared and is provided with anchoring means 18 (see also figure 7) that are apt to grasp the body tissue from inside the starting organ that has been punctured. The proximal end 14 is open to allow an operating wire carrying the needle means 16 to be inserted in the catheter portion 12 and to put in flow communication the two selected locations of the biliary tree and of the intestine, respectively.

The anchoring means 17, 18 may be for example barbs, hooks, teeth or the like.

In the embodiment shown in figure 4, the anchoring means 17 are associated to the ogival head 15 of the distal end 13 and are constituted by a plurality of barbs extending downwards from an attachment point 19 on the surface of the head 15. The anchoring means 17 are apt to take an extended position (as shown in figure 4) - wherein they grasp the body tissue and anchor the distal end 13 of the catheter device 8 to the target organ from the inside - and a retracted position (not shown), wherein they are kept to adhere on the surface of the head 13. Typically, the anchoring means 17 are made of a flexible material, such as a shape memory alloy material like nitinol, so that they can automatically assume the extended position as soon as they are free. According to an embodiment, the anchoring means 1 7 are kept in the retracted position by a sleeve (not shown) that can slide along the catheter portion 12 to free the barbs. Alternatively, the anchoring means 17 are already in the extended position when the head 15 punctures the body tissue and are compressed to the retracted position upon passing through the hole in the organ wall, so that, as soon as they pass the organ wall, they are able to return automatically to their extended position.

The distal end 13 of the catheter device 8 comprises an annular groove 20 between the ogival head 15 and the catheter portion 12, which serves as a seat to accommodate the lips of the pierced organ wall and cooperates with the anchoring means 17 to avoid or at least to limit an undesired displacement of the device.

In a different embodiment, shown in figures 5A and 5B, the ogival head 15 of the catheter device 8 is connected to the catheter portion 12 by a stem portion 22 that accommodates the anchoring means 17. The stem portion 22 has a diameter which is less than the diameter of both the head 15 and the catheter portion 12, so that undercuts 23, 23' are formed.

A sleeve 24 is slidably inserted over the catheter portion 12 and can be moved between a closure position (figure 5A) - wherein it abuts against the undercut 23 of the ogival head 15 - and an open position (figure 5B).

As in the previous embodiment, the anchoring means 17 are constituted by a plurality of barbs, that however extend upwards from an attachment point 25 on the surface of the stem portion 22. The anchoring means 17 are apt to take an extended position (as shown in figure 5B) - wherein they grasp the body tissue and anchor the distal end 13 of the catheter device 8 to the target organ from the inside - and a retracted position (shown in figure 5A), wherein they are kept inside the gap between the stem portion 22 and the sleeve 24. Typically, the anchoring means 17 are made of a flexible material, such as a shape memory alloy material like nitinol, so that they can automatically assume the extended position when the sleeve 24 is open.

The embodiment shown in figures 6A and 6B differs from the previous embodiment uniquely in that the anchoring means 17 are linked to the undercut 23 of the head 13 instead of on the stem portion 22 and in that they extend downwards from their attachment points 25.

According to a still different embodiment, shown in figures 8, 9 and 10, the catheter device 8 comprises a catheter portion 12, a distal end 13 and a proximal end 14, wherein the distal end 13 and the proximal end 14 have the same conformation and comprise a tip hole, wherein needle means 16 are inserted so that they emerge from the distal end 13. The needle means 16 may be a rotary needle connected to an operating cable that emerges from the proximal end 14 of the device and can be operated by the doctor from the exterior.

Figures 9A, B and C show the distal end 1 3 in three different operating conditions. The description that will be reported herein below is applicable to the proximal end 14 as well. The distal end 13 has an ogival head 15 and a cylindrical body 26 comprising one or more apertures 21 that put into flow communication the target organ with the catheter portion 12. A fixed ring 27 and a first and second slidable rings 28, 28' are positioned around the cylindrical body 26, in such a way that the slidable rings 28, 28' are opposite with respect to the fixed ring 27 and can be made to slide from a rest position to an operative position towards the fixed ring 27, as shown by the arrows in figures 9B and C.

A first wire 29 has a first end connected to the first slidable ring 28 and a second end connected to the fixed ring 27. Analogously, a second wire 29' has a first end connected to the second slidable ring 28' and a second end connected to the fixed ring 27. The first and second wires 29, 29' are wound around the cylindrical body 26, so that, when the slidable rings 28, 28' are in their rest position (figure 9A), the wires 29, 29' stand on the surface of the cylindrical body 26.

The wires 29, 29' are made of a flexible material. Typically, they are made of a shape memory alloy material such as nitinol, so that, when the slidable rings 28, 28' are in their operating conditions close to the fixed ring 27, the wires 29, 29' automatically spring to their coiled condition (figure 9C).

The wires 29, 29', together with the first and second slidable rings 28, 28' and the fixed ring 27 which they are fixed to, constitute the anchoring means 17 in this embodiment.

As shown in figure 10, the correct positioning of the distal end 13 and of the proximal end 14 requires the fixed ring 27 to be positioned at the cross section of the organ wall, while the first slidable ring 28 is positioned outside and the second slidable ring 28' is inside the organ. When the slidable rings 28, 28' are moved to the operating position, the coiled wires 29, 29' sandwich the organ wall and anchor the catheter device 8 to the selected locations of the biliary tree and of the intestine, respectively.

The movement of the slidable rings 28, 28' can be actuated by the doctor from the exterior. However, in some embodiments, the driving force of the wires 29, 29' that tend to return to their coiled condition can be so high to cause the two slidable rings 28, 28' to be automatically drawn towards the fixed ring 27. In such a case, the slidable rings 28, 28' must be kept in the rest position of figure 9A by means of a sleeve (not shown) that must be removed after the device has been properly positioned as described above.

In accordance with a further embodiment (Figures 14A - C), a catheter device 8 is provided which comprises a catheter portion 12, a distal end 13 and a proximal end 14, wherein the distal end 13 and the proximal end 14 may have the same conformation and comprise a tip hole, wherein needle means 16 are insertable so that they can emerge at least from the distal end 13. The needle means 16 may comprise a rotary needle connected to an operating cable that emerges from the proximal end 14 of the device and that can be operated by the doctor from the exterior. The tip and needle means 16 can be arranged laterally to an inlet or outlet opening of the catheter device 8 or they may be received within such an opening and removable from the distal end 13 and/or from the proximal end 14 after piercing of the tissue walls and placement of the catheter device 8.

The catheter device 8 comprises near each one of the distal end 13 and the proximal end 14 an onboard anchoring device having proximal 42, center 43, and distal rings 44 connected respectively by proximal and distal hinged arms which form first and second ring portions 39, 40. The anchoring device has a generally cylindrical shape (about the catheter wall) when unactuated and a rivet shape when actuated.

In accordance with an embodiment, the proximal and distal end portions of the catheter device 8 are introduced endoluminally or laparoscopically through a first otomy 41 in the intestine and through a second otomy 45 in the gallbladder 8 wall, wherein the otomies can be created by means of the piercing needle 16 when being forced through the wall of the intestine and of the gallbladder. Alternatively, the first and second otomies 41 , 45 may be created with a standard endoscopic or laparoscopic cutting instrument.

Then the proximal ring 42 and the distal ring 44 are shifted towards each other to deform the anchoring device in the rivet shape and clamp the wall of the gallbladder and of the intestine, respectively, thereby reliably anchoring the catheter device 8.

The approximation movement of the proximal and distal rings 42, 44 can be activated locally or extracorporeal^ by means of pulling strings or ring pushing devices and at least one snap connector may be provided which snap connects or snap ratchet connects the first ring portion 14 and the second ring portion 15 (or in other words: the proximal ring 42 and the distal ring 44) to one another.

In the following, embodiments of methods will be described which use devices illustrated in figures 1 through 13, in which method steps performed by means of the devices in figures 8 to 10, may be performed mutatis mutantis by means of catheter device illustrated in figures 14A to 14C.

I n accordance with an embodiment (Figure 1 ), a portion of the jejunum 2 is accessed transorally by means of an endoscope device 7 until a selected location 10 is reached. The endoscope device 7 carries a catheter device 8. A catheter device 8 as the ones described previously can conveniently be used. An operating wire or cable ending with a needle means 16 is inserted in the catheter device 8 and emerges from its distal end 13. Then, the tip of the needle means 16 is pushed from inside the selected location 10 of the jejunum 2 against the intestine wall to perforate the intestine wall so that the needle means 16 emerges from the jejunum 2 into the abdominal space. The endoscope device 7 is then advanced through the intestine wall to gain direct visual access of the abdominal cavity.

After having identified a selected location 1 1 of the gallbladder 4, the catheter device together with the needle means 16 are advanced to the said selected location and the needle means 16 is pushed from outside against the wall of the selected location 1 1 to perforate the gallbladder wall.

The catheter device 8 is then anchored to the selected locations 10, 1 1 of the jejunum 2 and the gallbladder 4, as explained above in relation to the various embodiments of the device. This intervention can be performed according to the NOTES (Natural Orifice Transluminal Endoscopic Surgery) technique.

The transluminal perforations of the gallbladder 4 and of the intestine are preferably guided and monitored by ultrasound imaging. For this purpose, an ultrasound transducer may be installed on the distal tip of the endoscope device 7. The commercially available endoscope GF-UC160P-O L5 with E U-C60 ultrasound processor by Olympus may be used for this purpose.

Additionally, an external ultrasound transducer can be used for monitoring and guidance of the position of the operating wire carrying the needle means 16 and of the catheter device 8.

A3) Transoral cholecvsto-jeiunostomy with transluminal extension of a catheter device from the intestine to the gallbladder

In a different embodiment, the method comprises the steps of:

- gaining visual access of the abdominal cavity of the patient;

- extending transluminal^ and advancing a catheter device 8 to a selected location 1 1 of the biliary tree 3;

This method provides for the use of the same catheter devices 8 as descried above.

A portion of the jejunum 2 is accessed transorally by means of an endoscope device 7 until a selected location 10 is reached. The endoscope device 7 carries a catheter device 8. An operating wire or cable ending with a needle means 16 is inserted in the catheter device 8 and emerges from its distal end 13. Then, the tip of the needle means 16 is pushed from inside the selected location 10 of the jejunum 2 against the intestine wall to perforate the intestine wall so that the needle means 16 emerges from the jejunum 2 into the abdominal space. The catheter device 8 is then advanced through the intestine wall. After having identified a selected location 1 1 of the gallbladder 4, the catheter device together with the needle means 16 is advanced to the said selected location and the needle means 16 is pushed from outside against the wall of the selected location 1 1 to perforate the gallbladder wall.

The catheter device 8 is then anchored to the selected locations 10, 1 1 of the jejunum 2 and of the gallbladder 4 as explained above in relation to the various embodiments of the device. This intervention can be performed according to the NOTES (Natural Orifice Transluminal Endoscopic Surgery) technique.

B1 ) Transoral cholecvsto-ieiunostomy with transluminal extension from the stomach of an endoscope device and anastomosis of gallbladder with jejunum

According to an inventive embodiment, the method comprises:

- gaining visual access of the abdominal cavity of the patient;

- advancing a first guide-wire 30 to a selected location 10 of the intestine;

- advancing a second guide-wire 31 to a selected location 1 1 of the biliary tree 3;

- anchoring the second guide-wire 31 to the selected location 1 1 of the biliary tree 3;

This embodiment of the method can conveniently be performed when the selected location 10 of the intestine can not be easily reached endoluminally by either a transoral or a transanal technique.

In an embodiment, the selected location 1 1 of the biliary tree 3 is the gallbladder 4. B2) Detailed description of a transoral cholecvsto-ieiunostomy with transgastrical extension of an endoscope device and anastomosis of the intestine to the gallbladder

To perform this method, an anchoring and approximating device 32 is used. The device 32 comprises a first guide-wire 30, a second guide-wire 31 and approximating means 34.

The first and second guide-wires 30, 31 have a respective proximal end (not shown), apt to be operated by a doctor, and a distal end 30', 31 ' , to which anchoring means 33, 33' are associated.

The anchoring means 33, 33' may be a T-tag (as shown in figures 2A-2F) or, in a different embodiment, a magnetic ring 35, 35' (see figure 1 1 ). In this latter case, the magnetic ring 35 of the first guide-wire 30 and the magnetic ring 35' of the second guide-wire 31 must be of opposite polarity, in order to be attracted each other and to provide for a junction of the two selected locations 10, 1 1 . In another embodiment, one of the two magnetic rings 35, 35' is a magnet and the other one is made of a ferromagnetic material that can be attracted by the magnet.

In an embodiment, the magnetic rings 35, 35' can be made in a collapsible structure, so that the ring can be collapsed to an elongated shape that facilitates the introduction of the ring through the organ wall at the selected location 1 0, 1 1 . Once the ring 35, 35' has been introduced into the target organ , it can assume its open configuration that allows the corresponding guide-wire 30, 31 to be anchored to the intestine and the gallbladder, respectively.

In an embodiment, the approximating means 34 are constituted by a tubular structure 36 having a first and a second open end 36a, 36b and a longitudinal lumen 37 extending between such ends, wherein the first and second guide-wires 30, 31 can be inserted. When the guide- wires 30,31 , after having been anchored to the respective selected locations 10, 1 1 , are pulled from outside, they are kept in an approached condition by the approximating means 34, so that finally their respective distal ends 30', 31 ' are also approached together with the selected locations 10, 1 1 of the target organs which they are anchored to.

In a different embodiment, shown in figure 12, the approximating means 34 are constituted by a tubular structure 36 having a first and a second open end 36a, 36b and a longitudinal lumen 37 extending between such ends, wherein the wall of the tubular structure 36 comprises a hole 38, which is preferably positioned at a median distance from the open ends 36a, 36b. The guide-wires 30, 31 are made to pass through the hole 38 and to extend their respective distal ends 30', 31 ' out of the opposite open ends 36a, 36b of the tubular structure 36. The operation of the device according to this embodiment is analogous to the one described just above. In another embodiment, shown in figure 13, the approximating means 34, analogously with respect to the embodiment of figure 12, are constituted by a tubular structure 36 having a first and a second open end 36a, 36b and a longitudinal lumen 37 extending between such ends, wherein the wall of the tubular structure 36 comprises a hole 38, which is preferably positioned at a median distance from the open ends 36a, 36b. The difference consists in the fact that the tubular structure 36 or the first and second open ends 36a, 36b thereof are made of, or comprise barbs or the like made of a shape memory alloy material such as nitinol, that, in the rest position, are bent as indicated by the dotted lines in figure 13. In such a way, as shown in figure 13, once the target organs have been brought to a close position and a portion thereof has been inserted into the tubular structure 36, the ends 36a, 36b (or the barbs or the like associated thereto) are allowed to assume their rest, bent condition, thus grasping from outside the surface of the target organs around the selected locations 10, 1 1 .

With reference to the sequence of operations shown in figures 2A-2F, the inventive method will now be described.

As depicted in figure 2A, a portion of the stomach 1 is accessed transorally by means of an endoscope device 7. The endoscope device 7 carries puncturing means (not shown) to perforate the organ walls and an anchoring and approximating device 32, such as the ones described herein above. By means of the puncturing means, the stomach 1 wall is perforated, in order to access transgastrically the abdominal space with the endoscope device 7. The endoscope device 7 is then advanced through the stomach wall to gain direct visual access of the abdominal cavity.

After having identified a selected location 10 of the intestine 2, 2', the endoscope device 7 is advanced to the said selected location and the puncturing means are pushed from outside against the wall of the selected location 10 to perforate the intestine wall, to allow the anchoring means 33, 33' associated to the first guide-wire 30 to pass through the intestine wall. When the anchoring means 33, 33' are constituted by T-tags, an endoluminal T-tag applicator will normally be used in place of said puncturing means.

As the first guide-wire 30 has been anchored to the selected location 10 of the intestine 2, 2', the endoscope device 7 is then advanced in the abdominal cavity to identify a selected location 1 1 of the biliary tree 3, i.e. the gallbladder 4 (figure 2B)., and the above operation is repeated.

Once also the second guide-wire 31 has been anchored to the gallbladder 4 (figure 2C), the two guide-wires 30, 31 are pulled from the outside by the operator, while at the same time they are kept close each other by means of the approximating means 34. The effect is that the two selected locations 10, 1 1 of the intestine and of the gallbladder, respectively, are put into contact (figure 2D). Typically, the interested portion of the target organs is at least partially brought inside the approximating means 34 (figures 2F or 13). At this point, the doctor can suitably operate an anastomosis of the two organs. Finally, the guide-wires 30, 31 are cut or torn in order to be retracted and the endoscope device 7 is also retracted from the patient's body.

When the anchoring means 33, 33' are constituted by the magnetic rings 35, 35' described above, the attractive pressure to which the selected locations 10, 1 1 of the target organs are subjected may cause a necrosis of the tissue over time, so that the anastomosis can naturally be established without the direct intervention of the surgeon.

It can be appreciated that the above described order of operations can be inverted, as the first guide-wire 30 can be anchored to the biliary tree 3 location 1 1 , while the second guide-wire 31 will be anchored to the intestine 2, 2' location 10.

This intervention can be performed according to the NOTES (Natural Orifice Transluminal Endoscopic Surgery) technique.

The transluminal perforations of the gallbladder 4 and of the intestine are preferably guided and monitored by ultrasound imaging. For this purpose, an ultrasound transducer may be installed on the distal tip of the endoscope device 7. The commercially available endoscope GF-UC160P-OL5 with E U-C60 ultrasound processor by Olympus may be used for this purpose.

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 catheter device (8) for diverting biliary fluid from a biliary fluid flow path by putting into flow communication a selected location (1 1 ) of the biliary tree (3) with a selected location (10) in the intestine (2, 2') distal to a duodenal papilla of Vater, the device comprising:

- a catheter portion (12);

- a distal end (13) and a proximal end (14) that comprise apertures (21 ) and holes for putting into flow communication the exterior with the catheter portion (12) and for allowing needle means (16) to pass therethrough,

wherein the distal end (13) and the proximal end (14) comprise anchoring means (17, 18) apt to anchor the catheter device (8) to a body tissue from inside of the selected locations (10, 1 1 ) of the intestine (2, 2') and of the biliary tree (3).

2. The catheter device (8) of claim 1 , wherein the proximal end (14) of the catheter device (8) is flared.

3. The catheter device (8) of claim 1 or 2, wherein the anchoring means (17, 18) are selected from barbs, hooks and teeth.

4. The catheter device (8) according to any one of claims 1 to 3, wherein the anchoring means (17) that are associated to the distal end (13) are constituted by a plurality of barbs extending downwards from an attachment point (19) and are apt to take an extended position, wherein they grasp the body tissue and anchor the distal end (13) of the catheter device (8) thereto, and a retracted position.

5. The catheter device (8) according to claim 4, wherein the barbs are made of a shape memory alloy material, so that they can automatically assume the extended position as soon as they are free and wherein the barbs are kept in the retracted position by a sleeve.

6. The catheter device (8) according to any one of claims 1 to 5, wherein the distal end (13) of the catheter device (8) comprises an ogival head (15) and an annular groove (20) between the ogival head (15) and the catheter portion (12).

7. The catheter device (8) according to any one of claims 1 to 3, wherein the distal end (13) has an ogival head (15), the ogival head (15) being connected to the catheter portion (12) by a stem portion (22) that accommodates the anchoring means (17), wherein the stem portion (22) has a diameter which is less than the diameter of both the ogival head (15) and the catheter portion (12), so that undercuts (23, 23') are formed.

8. The catheter device (8) according to claim 7, wherein a sleeve (24) is slidably inserted over the catheter portion (12) and can be moved between a closure position, wherein it abuts against the undercut (23) of the ogival head (15), and an open position, and wherein the anchoring means (17) are constituted by a plurality of barbs, that extend upwards from an attachment point (25) on the surface of the stem portion (22).

9. The catheter device (8) according to claim 7, wherein a sleeve (24) is slidably inserted over the catheter portion (12) and can be moved between a closure position, wherein it abuts against the undercut (23) of the ogival head (15), and an open position, and wherein the anchoring means (17) are constituted by a plurality of barbs, that extend downwards from an attachment point (25) on the undercut (23).

10. The catheter device (8) according to claim 8 or 9, wherein the barbs are apt to take an extended position, wherein they grasp the body tissue, and a retracted position, wherein they are kept inside the gap between the stem portion (22) and the sleeve (24) and wherein the anchoring means (17) are made of a shape memory alloy material , so that they can automatically assume the extended position when the sleeve (24) is open.

1 1 . The catheter device (8) according to claim 1 , wherein the distal end (13) and the proximal end (14) have the same conformation and comprise a cylindrical body (26), a fixed ring (27) and a first and second slidable rings (28, 28') being positioned around the cylindrical body

(26) , in such a way that the slidable rings (28, 28') are opposite with respect to the fixed ring

(27) and can be made to slide from a rest position to an operative position towards the fixed ring (27); a first wire (29) has a first end connected to the first slidable ring (28) and a second end connected to the fixed ring (27) and a second wire (29') has a first end connected to the second slidable ring (28') and a second end connected to the fixed ring (27), wherein the first and second wires (29, 29') are wound around the cylindrical body (26), so that, when the slidable rings (28, 28') are in the rest position, the wires (29, 29') stand on the surface of the cylindrical body (26).

12. The catheter device (8) of claim 1 1 , wherein the wires (29, 29') are made of shape memory alloy material, so that, when the slidable rings (28, 28') are in the operative position close to the fixed ring (27), the wires (29, 29') automatically spring to a coiled condition.

13. The catheter device (8) according to claim 1 , wherein said anchoring means (17, 18) comprise proximal (42), center (43), and distal rings (44) connected respectively by proximal and distal hinged arms forming a first (39) and second ring portion (40), wherein said anchoring means (1 7, 18) have a generally cylindrical shape when unactuated and a rivet shape when actuated.

14. A method for diverting biliary fluid from a biliary fluid flow path by putting into flow communication a selected location of the biliary tree to a selected location of the intestine distal to a duodenal papilla of Vater, the method comprising the steps of: - accessing endoluminally a portion of the gastrointestinal tract of a patient with an endoscope device;

- gaining visual access of the abdominal cavity of the patient;

- accessing transluminal^ the abdominal cavity;

15. The method of claim 14, comprising the steps of:

- accessing endoluminally a selected location (10) of the gastrointestinal tract (2, 2') of a patient with an endoscope device (7);

- gaining visual access of the abdominal cavity of the patient;

- extending the endoscope device (7) transluminal^;

- extending a catheter device (8) associated to the endoscope device (7) to a selected location (1 1 ) of the biliary tree (3);

- piercing a wall of the selected location (1 1 ) of the biliary tree (3) and anchoring a distal end of the catheter device (8) thereto;

- anchoring a proximal end of the catheter device (8) to the selected location of the gastrointestinal tract (2, 2').

16. The method of claim 14, comprising the steps of:

- gaining visual access of the abdominal cavity of the patient;

- extending transluminal^ and advancing a catheter device (8) to a selected location (1 1 ) of the biliary tree (3);

- anchoring a proximal end of the catheter device (8) to the selected location (10) of the gastro-intestinal tract (2, 2').

17. The method of claim 15 or claim 16, comprising the step of providing a catheter device (8) as defined in any claim 1 to 13.

18. The method of claim 15 or claim 16, comprising the steps of.

- providing a catheter device (8) having a distal end (13) and a proximal end (14), wherein the distal end (13) and the proximal end (14) have the same conformation and comprise a cylindrical body (26), a fixed ring (27) and a first and second slidable rings (28, 28') being positioned around the cylindrical body (26), in such a way that the slidable rings (28, 28') are opposite with respect to the fixed ring (27) and can be made to slide from a rest position to an operative position towards the fixed ring (27); a first wire (29) has a first end connected to the first slidable ring (28) and a second end connected to the fixed ring (27) and a second wire (29') has a first end connected to the second slidable ring (28') and a second end connected to the fixed ring (27), wherein the first and second wires (29, 29') are wound around the cylindrical body (26), so that, when the slidable rings (28, 28') are in the rest position, the wires (29, 29') stand on the surface of the cylindrical body (26);

- positioning the fixed ring (27) at the cross section of the wall of the selected location (10, 1 1 ) of the intestine (2, 2') and of the biliary tree (3), respectively, and positioning the first slidable ring (28) outside and the second slidable ring (28') inside the said wall.

19. An anchoring and approximating device (32) for putting and maintaining two target organs into contact, the device comprising:

- a first guide-wire (30) having a distal end (30'), to which first anchoring means (33) are associated,

- a second guide-wire (31 ) having a distal end (31 '), to which second anchoring means (33') are associated;

- approximating means (34) comprising a tubular structure (36) wherein the first and second guide-wires (30, 31 ) pass through and that is apt to keep the first and second guide-wires (30, 31 ) in a close condition.

20. The device (32) of claim 19, wherein the anchoring means (33, 33') are T-tags.

21. The device (32) of claim 19, wherein the anchoring means (33, 33') are magnetic rings (35, 35').

22. The device (32) of claim 21 , wherein the magnetic ring (35) of the first guide-wire (30) and the magnetic ring (35') of the second guide-wire (31 ) are of opposite polarity.

23. The device (32) of claim 21 , wherein one of the two magnetic rings (35, 35') is a magnet and the other one is made of a ferromagnetic material that can be attracted by the magnet.

24. The device (32) of any claim 21 to 23, wherein the magnetic rings (35, 35') are made in a collapsible structure, so that the ring can be collapsed to an elongated shape or it can assume an open configuration.

25. The device (32) of any claim 1 9 to 24 , wherein the tu bular structure (36) of the approximating means (34) has a first and a second open end (36a, 36b) and a longitudinal lumen (37) extending between such ends, wherein the first and second guide-wires (30, 31 ) can be inserted.

26. The device (32) of any claim 21 to 23, wherein the tubular structure (36) of the approximating means (34) has a first and a second open end (36a, 36b) and a longitudinal lumen (37) extending between such ends, wherein a wall of the tubular structure (36) comprises a hole (38), and wherein the first and second guide-wire (30, 31 ) are made to pass through the hole (38) and to extend their respective distal ends (30', 31 ') out of the open ends (36a, 36b) of the tubular structure (36).

27. The device (32) of any claim 21 to 23 , wherein the tu bular structure (36) of the approximating means (34) has a first and a second open end (36a, 36b) and a longitudinal lumen (37) extending between such ends, wherein a wall of the tubular structure (36) comprises a hole (38), wherein the tubular structure (36) or the first and second open ends (36a, 36b) thereof are made of, or comprise barbs or the like made of a shape memory alloy material that, in a rest position, are bent, so that, once the target organs have been brought to a close position and a portion thereof has been inserted into the tubular structure (36), the ends 36a, 36b, or the barbs or the like associated thereto, are allowed to assume the rest position.

28. The method of claim 14, comprising the steps of:

- accessing endoluminally a portion (100) of the stomach (1 ) of a patient with an endoscope device (7);

- gaining visual access of the abdominal cavity of the patient;

- extending transgastrically the endoscope device (7) into the abdominal cavity of the patient;

- advancing a first guide-wire (30) to a selected location (10) of the intestine;

- anchoring the first guide-wire (30) to the selected location (10) of the intestine;

- advancing a second guide-wire (31 ) to a selected location (1 1 ) of the biliary tree (3);

- anchoring the second guide-wire (31 ) to the selected location (1 1 ) of the biliary tree (3);

- approximating the selected location (10) of the intestine to the selected location (1 1 ) of the biliary tree (3);

- anastomosing the selected location (10) of the intestine to the selected location (1 1 ) of the biliary tree (3).

29. The method of claim 28, comprising the step of providing an anchoring and approximating device (32) as defined in any claim 19 to 27.