"A DEVICE AND METHOD FOR CONVEYING BILE TOWARDS A TARGET

LOCATION IN THE INTESTINE"

The present invention relates, in general, to devices and methods for surgically influencing the digestion of a patient with the aim to treat metabolic disorders, such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.

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

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

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

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

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

A known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 . The known system comprises a conduit having a first end which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract and a second end attached to the ampulla of Vater.

The known conduit can divert only the amount of bile which has been released through the sphincter of ODDI and the flow rate of bile through the known conduit might not be sufficient 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, there is a need to provide a minimally invasive device and method of diverting bile from the biliary tree including the gallbladder into a section of the small intestine distally to the papilla of Vater, which increase the flow rate of the diverted bile towards the target location in the small intestine.

These and other aims are achieved by a method for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of:

- extending a catheter translumenally from the biliary fluid flow path through the intraperitoneal space to said target location in the intestine distal to the duodenal papilla of Vater,

- connecting a pump to the catheter and operating the pump to accelerate a bile flow through the catheter,

- arranging the pump within the intraperitoneal space.

Arranging the pump inside the intraperitoneal space allows to extend the catheter along a shortest possible direct path from the biliary tree, including the gall bladder, to a distal section of the small intestine and to approximate the target section of the intestine to the biliary tree inside the abdominal space, in order to keep the entire catheter length short. The short catheter length together with the pumping action reduces the time it takes for the diverted bile to flow from the biliary tree through the catheter to the target location in the intestine.

The drawbacks of the prior art are also obviated by a method for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of:

- extending a catheter translumenally from the biliary fluid flow path through the intraperitoneal space to said target location in the intestine distal to the duodenal papilla of Vater,

- connecting a pump to the catheter and operating the pump to accelerate a bile flow through the catheter,

- arranging the pump within the gallbladder.

Arranging the pump inside the gallbladder allows to extend the catheter along a shortest possible direct path from the biliary tree to a distal section of the small intestine and to approximate the target section of the intestine to the biliary tree or even in direct contact to each other, in order to keep the entire catheter length short. The short catheter length together with the pumping action reduces the time it takes for the diverted bile to flow from the biliary tree through the catheter to the target location in the intestine.

In accordance with a further aspect of the invention, a method is proposed for diverting biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of:

- arranging a catheter isolated from the intraperitoneal space and intraluminally from inside the biliary tree through the papilla of Vater to the target location in the intestine distal to the papilla of Vater,

- connecting a pump to the catheter and operating the pump to accelerate a bile flow through the catheter,

- arranging the pump within the small intestine.

Extending the catheter strictly intraluminally and arranging the pump inside the small intestine allows to place the entire device with an endoluminal procedure in an ambulatory surgery center, thereby greatly reducing the cost.

In accordance with a further aspect of the invention, the method comprises the step of feeding a diluting liquid into the biliary tree and pumping the biliary fluid mixed with the diluting liquid through the catheter. The dilution of the biliary fluid facilitates the transport into the pump and through the catheter and reduces the risk of stone formation and clogging both in the catheter and in the biliary tree.

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

- connecting the pump to the catheter by connecting the pump to a closed pushing conduit containing a pushing fluid and connecting a portion of the pushing conduit with a flexible wall of the catheter,

- operating the pump to pulsatingly displace the pushing fluid inside the closed pushing conduit, thereby pulsatingly deforming the flexible wall of the catheter. This generates a kneading or peristaltic deformation of the catheter which conveys the biliary fluid distally and removes possible sediment from the internal catheter surface, thereby reducing the risk of obstruction. Moreover, by interposing a pushing conduit between the catheter and the pump, the catheter can be routed along a shortest possible direct path from the biliary tree to a distal section of the small intestine, in order to keep the entire catheter length short, while the pump can be arranged in a more appropriate location remote from the catheter. Also in this case, the short catheter length together with the pumping action reduces the time it takes for the diverted bile to flow from the biliary tree through the catheter to the target location in the intestine.

A further aim of the invention is to provide a device for conveying bodily fluid, particularly 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 having a proximal end portion and a distal end portion and a duct portion extending between the proximal end portion and the distal end portion, said duct portion having a flexible wall which delimits an internal channel of the catheter,

- a closed pushing conduit containing a pushing fluid, the pushing conduit being connected with the duct portion of the catheter such that the flexible wall separates the internal channel from the pushing fluid,

- a pump connected to the pushing conduit and operable to pulsatingly displace the pushing fluid inside the pushing conduit, thereby pulsatingly deforming the flexible wall of the catheter.

In accordance with an aspect of the invention, one way valves are provided in the internal channel of the catheter to convert the pulsating deformation of the flexible wall in an unidirectional flow of a fluid through the internal channel.

In accordance with a further aspect of the invention the pushing conduit comprises a closed loop conduit and the pump is adapted to pulsatingly circulate the pushing fluid, particularly a saline solution, in a d irection wh ich , at the flexible wall, corresponds to an unidirectional flow direction in the internal channel.

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.

- Figures 1 through 5 illustrate methods for translumenally pumping bile towards a target location in the intestine in accordance with embodiments of the invention;

- Figure 6 illustrates a further method and a device for pumping bile towards a target location in the intestine in accordance with an embodiment of the invention;

- Figure 7 illustrates a device for conveying a bodily fluid in accordance with an embodiment of the invention;

- Figures 8 to 10 illustrate cross-sectional views in plane X-X in figure 7 in accordance with embodiments of the invention.

- Figure 1 1 illustrates a method for intraluminally pumping bile towards a target location in the intestine in accordance with an 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 stomach 1 , duodenum 2, jejunum 3, ileum 4, colon 5, as well as the biliary tree 6 with gall bladder 7, the pancreatic duct 8 and the mayor duodenal papilla of Vater 9 through which the bile and pancreatic fluid normally enter the duodenum 2. Figure 1 shows further a method and a device 10 for diverting and conveying biliary fluid from the biliary fluid flow path to a target location 12 in the intestine 3, 4 distal of the papilla of Vater 9.

In accordance with a general inventive idea, the method comprises the steps of extending a catheter 1 1 translumenally from the biliary fluid flow path through the abdominal cavity (particularly the intraperitoneal space) to the target location 12 in the intestine 3, 4 distal to the duodenal papilla of Vater 9, connecting a pump 13 to the catheter 1 1 and operating the pump 13 to accelerate a bile flow through the catheter 1 1 , and arranging the pump 13 within the intraperitoneal space inside the abdominal cavity.

By arranging the pump 13 in the intraperitoneal space inside the abdominal cavity the catheter 1 1 can be extended along a shortest possible direct path from the biliary tree 6, e.g. the gall bladder 7 or the common bile duct, to a distal section of the small intestine 3, 4 and to approximate the target location 12 of the intestine to the biliary tree 6 inside the abdominal space, in order to keep the entire catheter length short. The short catheter length together with the pumping action reduces the time it takes for the diverted bile to flow from the biliary tree 6 through the catheter 1 1 to the target location 12 in the intestine.

In accordance with an embodiment, a proximal end portion 15 of the catheter 1 1 forms an inlet opening 20 and is arranged within the gallbladder 7 by inserting it through a previously created cholecystomy 16 which may be purse stringed around the catheter 1 1 . A distal end portion 17 of the catheter 1 1 forms an outlet opening 19 and is arranged within the intestine by inserting it through a previously created enterotomy 18 which may be purse stringed around the catheter 1 1. In this manner, it becomes possible to capture the biliary fluid directly from inside the gallbladder 7 where it is naturally stored, and to pump the bile through the catheter 1 1 in the target location 12, independently from a contraction of the gallbladder 7. In accordance with an embodiment, the pump 13 may be operated in response to a contraction of the gall bladder 7, e.g. by means of a pressure sensor 21 connected to the catheter 1 1 and adapted to sense a pressure inside the catheter proximal (upstream) of the pump 13 and a pump control adapted to operate the pump 13 when the pressure sensed by the pressure sensor 21 exceeds a predetermined threshold value. I n this embodiment, the natural bile flow will be redirected, accelerated and pressurized following an initial physiological signal , i .e. a contraction of the gall bladder.

In accordance with a further embodiment, at one or both of the cholecystomy 16 and enterotomy 18 the catheter 1 1 may be provided with a mesh shaped flange 22 protruding radially outward from a tubular catheter wall and adapted to form a serosal ingrowth media to assure a reliable tissue adherence and seal.

Figure 2 illustrates a further exemplary embodiment which differs from the embodiment of figure 1 in that the proximal end portion 15 of the catheter 1 1 is arranged within the duodenum 2 at the papilla of Vater 9 by inserting it through a previously created proximal enterotomy 23 in the duodenum 2 near the papilla of Vater 9 and by connecting the inlet opening 20 from inside the duodenum 2 to the sphincter of ODDI in a flow communication with the common bile duct 14 and, preferably, isolating the common bile duct 14 from the duodenum. Also in this embodiment, the proximal enterotomy 23 can be purse stringed around the catheter 1 1 and serosal ingrowth can be promoted by a mesh shaped flange 22. In accordance with a further embodiment (Figure 3), the proximal end portion 15 of the catheter 1 1 is arranged within a hepatic duct 24, i.e. within the right or left or common hepatic d uct, for instance by means of a laparoscopic transhepatic cholangiography. For this purpose, a thin needle is inserted laparoscopically through the liver 25 (transhepatic) into the hepatic duct 24 or further down in the bile duct 14. Then contrast media is injected, and the bile duct system is outlined, wherein imaging may be performed by fluoroscopy. Following the initial injection of contrast media (x-ray dye) into the bile duct during the transhepatic cholangiography, a small guide wire is guided through the needle, into the hepatic duct 24 and possibly into the common bile duct while watching the wire and ducts on x-ray. Over this guide wire, the proximal catheter end portion 15 is then inserted and fixated in the hepatic duct 24 to allow the bile to be drained from the liver, thereby avoiding manipulation of the very delicate and fragile common bile duct. The proximal end portion 15 of the catheter 1 1 may be fixated in the hepatic duct 24 by means of suture or an anchoring member, such as for example a metal stent, an inflatable balloon or a barbed anchoring portion.

The common bile duct 14 may be blocked by clipping or transection in order to route the entire flow of bile through the catheter 1 1.

The remaining method steps and device features are substantially identical to those previously described in connection with the embodiments of figures 1 and 2 and are here not repeated for the sake of conciseness.

In accordance with a further embodiment (Figures 4, 5), instead of arranging the pump 13 inside the intraperitoneal space, the pump is connected to the proximal end portion 15 of the catheter 1 1 and arranged within the gallbladder 7, while the catheter 1 1 can be inserted and positioned as described in relation with the embodiment of figure 1 . By arranging the pump 13 directly inside the gallbladder 7 it is possible to extend the catheter 1 1 along a short and direct path from the biliary tree to a distal section of the small intestine and to approximate the target section of the intestine to the biliary tree or even in direct contact to each other, in order to keep the entire catheter length short.

In order to keep the target location 12 close to the gall bladder 7, the latter may be attached to the target section of intestine by means of a choledochoenterostomy, wherein the catheter 1 1 is extended from inside the gallbladder 7 directly through the choledochoenterostomy into the intestine.

With regard to all described embodiments, the method may comprise an operation of the pump 13 at regular time intervals such that:

- a substantial accumulation of bile in the biliary tree 6 and gall bladder 7 is prevented, thereby obviating the need to passively preventing the bile from flowing through the sphincter of ODDI into the duodenum, e.g. by blocking the common bile duct, or - an accumulation of bile in the biliary tree 6 and gall bladder 7 is maintained within a predetermined limit, such that, in response of a contraction of the gall bladder 7 during chyme transit through the intestine, only a reduced volume of bile is released through the sphincter of ODDI into the duodenum.

In accordance with a further embodiment (Figure 1 1 ), instead of arranging the pump 13 inside the intraperitoneal space or inside the gallbladder 7, the method comprises arranging a catheter 1 1 isolated from the intraperitoneal space and intraluminally from inside the biliary tree 6 through the papilla of Vater 9 to the target location 12 in the intestine distal to the papilla of Vater 9, connecting a pump 13 to the catheter 1 1 and operating the pump 13 to accelerate a bile flow through the catheter 1 1 , in which the pump 13 is arranged within the small intestine. By extending the catheter 1 1 strictly intraluminally and arranging the pump 13 inside the small intestine, the entire device can be placed with an endoluminal procedure in an ambulatory surgery center, thereby greatly reducing the cost.

In accordance with a further embodiment (figure 5), a diluting liquid 26, e.g. saline solution or water, may be fed into the biliary tree 6, particularly in the gallbladder 7 and the biliary fluid mixed with the diluting liquid 26 is pumped through the catheter 1 1 . The dilution of the biliary fluid facilitates its transport into the pump 13 and through the catheter 1 1 and reduces the risk of stone formation and clogging both in the catheter and in the biliary tree.

For this purpose, the device 1 0 may comprise a diluting conduit 29 with a discharge opening 30, a reservoir 27 connected to the diluting conduit 29 and adapted to receive and hold a volume of the diluting liquid 26, and diluting pump means 28 connected to the diluting conduit 29 and adapted to convey the diluting liquid 26 from the reservoir 27 through the diluting conduit 29 and out of the discharge opening 30. Preferably, the diluting pump means 28 are adapted to operate in dependency of or in synchrony with the operation of the pump 13.

The discharge opening of the diluting conduit 29 can be arranged translumenally inside the biliary tree 6, particularly inside the gallbladder 7 (using e.g. the same surgical techniques described for the placement of the proximal catheter end portion 15 in the embodiment of Figure 1 ), while the reservoir 27 and the diluting pump means 28 can be advantageously placed subcutaneously or intramurally in the abdominal wall.

In accordance with a yet further embodiment (Figure 6) the pump 13 is connected to the catheter 1 1 by connecting the pump 13 to a closed pushing conduit 31 containing a pushing fluid and connecting a portion of the pushing conduit 31 with a flexible wall 33 of the catheter 1 1 , and operating the pump 13 to pulsatingly displace the pushing fluid inside the closed pushing conduit 31 , thereby pulsatingly deforming the flexible wall 33 of the catheter 1 1 .

This generates a kneading or peristaltic deformation of the catheter 1 1 which conveys the biliary fluid distally and removes possible sediment from the internal catheter surface, thereby reducing the risk of obstruction. Moreover, by interposing the pushing conduit 31 between the catheter 1 1 and the pump 13, the catheter 1 1 can be routed along a shortest possible direct path from the biliary tree to a distal section of the small intestine, in order to keep the entire catheter length short, while the pump 13 can be arranged in a more appropriate location remote from the catheter 1 1 .

The pump 13 and also a possible pushing liquid reservoir 38 connected with the pump 13 can be e.g. placed in the intraperitoneal space or subcutaneously or intramurally in the abdominal wall.

Figures 7 through 10 illustrate a device 10 for conveying bodily fluid, particularly for conveying biliary fluid from a biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater. The device 10 comprises a catheter 1 1 having a proximal end portion 15 and a distal end portion 17 and a duct portion 32 extending between the proximal end portion 15 and the distal end portion 17. The duct portion 32 forms a flexible wall 33 which delimits an internal channel 34 of the catheter 1 1 . A closed pushing conduit 31 contains a pushing fluid and is connected with the duct portion 32 of the catheter 1 1 such that the flexible wall 33 separates the internal channel 34 from the pushing fluid. A pump 13 is connected to the pushing conduit 31 and operable to pulsatingly displace the pushing fluid inside the pushing conduit 31 , thereby pulsatingly deforming the flexible wall 33 of the catheter 1 1. Moreover, one way valves 35 may be provided in the internal channel 34 of the catheter 1 1 to convert the pulsating deformation of the flexible wall 33 in an unidirectional flow of a fluid through the internal channel 34.

I n accordance with an embodiment (Figures 6, 7) the pushing conduit 31 comprises a closed loop conduit and the pump 13 is adapted to pulsatingly circulate the pushing fluid, particularly a saline solution, in a direction which, at the flexible wall 33, corresponds to an unidirectional flow direction in the internal channel 34 of the catheter 1 1. The generated circulating wave of pushing liquid facilitates the unidirectional transport of bodily fluid through the catheter 1 1 .

The device 10 may comprise a single piece dual lumen tube 36 forming the duct portion 32 and a portion of the pushing conduit 31 extending parallel adjacent to the duct portion 32, as well as the flexible wall 33 separating the internal channel 34 of the duct portion 32 from the portion of the pushing conduit 31.

In accordance with the exemplary embodiment of figure 8, the duct portion 32 of the catheter 1 1 and the adjacent portion of the pushing conduit 31 are arranged side by side and contained by a substantially non extensible external tubular wall 37 which delimits both lumens.

In accordance with the exemplary embodiment of figure 9, the duct portion 32 of the catheter 1 1 extends substantially coaxially inside the adjacent portion of the pushing conduit 31 which defines a substantially ring shaped space contained by the non extensible external tubular wall 37.

In accordance with the exemplary embodiment of figure 10, the portion of the pushing conduit 31 extends substantially coaxially inside the adjacent duct portion 32 of the catheter 1 1 which defines a substantially ring shaped space contained by the non extensible external tubular wall 37.

The non extensible external wall 37 assures that the expansion of the pushing conduit 31 effectively compresses the internal catheter channel 34.

In accordance with an embodiment, the pump 13 may comprise an onboard power source with an inductive rechargi ng u n it adapted to be energized by an extracorporeal charging station configured to operate a transcutaneous energy transfer (TET).

In accordance with an embodiment, the pumping operation can be automatically or manually controlled, adjusted and activated by means of an extracorporeal magnetic pump controller which may be integrated in the above mentioned charging station or distinct from the latter. The pump controller is adapted to generate and transmit to the pump 13 a control signal by magnetic induction in a near-field propagation mode and the pump 13 is adapted to pump the bile in response to and in accordance with the control signal.

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.