WO2012007046A1

WO2012007046A1 - A system regulating the dispensing of a body fluid

Info

Publication number: WO2012007046A1
Application number: PCT/EP2010/060273
Authority: WO
Inventors: Martin Fried; Federico Bilotti; Manoel Galvao Neto; Mark Steven Ortiz; Alessandro Pastorelli; Thomas Edward Albrecht; Christopher J. Hess; Michael J. Stokes; Mark S. Zeiner
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2010-07-16
Filing date: 2010-07-16
Publication date: 2012-01-19
Also published as: CN103002839B; CN103002839A

Abstract

A system (11) for regulating the dispensing of body fluid comprises a regulating valve (12) adapted to be placed in the flow path of a body fluid and a physiological characteristic- sensing device (13) in signal communication with the regulating valve (12) and configured to generate a control signal (14) in dependency from the physiological characteristic, wherein the regulating valve (12) is adapted to change a rate of flow of the body fluid in response to the control signal (14).

Description

A SYSTEM REGULATING THE DISPENSING OF A BODY FLUID

DESCRIPTION

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

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

Surgical methods of treating morbid obesity, such as open, laparoscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food , have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally undesirable modifications of the patient's gastrointestinal anatomy.

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. 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 particular aim of the present invention is to provide methods and devices for regulating the dispensing of a body fluid, specifically of biliopancreatic fluid, such as to aimedly influence and regulate the digestion in a particularly mini-invasive way.

Clinical experimentation has shown that the timing of the introduction of food into the jejunum and the timing of the introduction of biliopancreatic juices into the jejunum, as well as the tim ing of their mixture and interaction, may cause weight loss and or allow control of diabetes. Hence, there is a need to delay the mixing of bile and chime to a lower point in the Gl tract or to prevent the bile from interacting with the Gl tract until a more distal location is reached to discharge the bile and allow mixing. A known device and method for diverting digestive secretions, such as bile and pancreatic secretions, distally into the small intestine has been discussed in US 2009/0062717 and US 7,314,489. The device disclosed in US 7,314,489 comprises a stent having a distal end and a proximal end engaging the duodenum in the region of the ampulla of Vater, and a reduced diameter portion between the proximal and distal ends to create an annulus volume which can collect bile. The device disclosed in US 2009/0062717 comprises a support frame with a side opening and a tube extending between a proximal end connected with the side opening and a distal open end, wherein the proximal end of the tube can form a reservoir.

The known devices and methods for diverting digestive secretions collect bile, but they do not actively adjust the timing of the dispensing of bile in response to a specific physiological characteristic.

Thus, a further aim of the present invention is to modify the timing of the introduction of biliopancreatic juices into the gastrointestinal tract in dependency of a physiological characteristic of the patient's organism related with food intake and food passage through the gastrointestinal tract.

These aims are achieved by a system for regulating the dispensing of body fluid, the system comprising a regulating valve adapted to be placed in the flow path of a body fluid and a physiological characteristic - sensing device in signal communication with the regulating valve, wherein a signal from the physiological characteristic sensing device can cause the valve to change a rate of flow in the body fluid. The body fluid can be bile or pancreatic fluids and the physiological characteristic can be a pH value or a pH value variation of a fluid in a part of the body, for instance the stomach contents.

The above aims are also achieved by a method for regulating the dispensing of a body fluid, the method comprising the steps of:

- placing a regulating valve at a first location in the flow path of a body fluid in a patient's body;

- placing a sensing device at a second location in the body; and

- sensing a physiological characteristic in the second location; and generating a control signal in dependency of the sensed physiological characteristic; and

- providing the control signal to the valve to regulate the flow of the body fluid.

In accordance with an aspect of the invention, a method is provided for regulating the flow of biliopancreatic fluid, the method comprising the steps of:

- placing an actively regulated valve in a flow path of biliopancreatic fluid; and

- placing a pH sensor in the stomach; and - sensing the pH of the stomach contents; and

- generating a control signal in dependency of the sensed pH; and

- sending the control signal to the valve and regulating the flow of the biliopancreatic fluid using the information from the control signal.

This makes it possible to influence the metabolic mechanism of action without invasive surgery or significant modifications of the patient's anatomical structures.

In accordance with a further aspect of the invention, a surgical method is provided for altering the digestion of a patient, the method comprising the steps of:

- placing transorally a stent in fluid communication with the actively regulated valve at the first location on the flow path of biliopancreatic fluid;

- attaching a pH sensor at a location inside the stomach; and

- anchoring the stent inside a portion of the gastrointestinal tract, thereby increasing the resistance of the stent to the peristaltic forces acting on it.

These and other objects 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 devices for regulating the flow of biliopancreatic fluid in a patient in accordance with a first embodiment of the invention;

- Figure 2 is a schematic cross-sectional view of a bile collecting device used in the method of figure 1 ;

- Figure 3 illustrates a method and devices for regulating the flow of biliopancreatic fluid in a patient in accordance with a second embodiment of the invention;

- Figure 4 illustrates a device and method for anchoring a bile collecting device in the Gl tract in accordance with a third embodiment of the invention;

- Figure 5 illustrates a device and method for anchoring a bile collecting device in the Gl tract in accordance with a fourth embodiment of the invention;

- Figure 6 illustrates a device and method for anchoring a bile collecting device in the Gl tract in accordance with a fifth embodiment of the invention;

- Figure 7 illustrates a device and method for anchoring a bile collecting device in the Gl tract in accordance with a sixth embodiment of the invention;

- Figures 8 and 8A illustrate a device and method for anchoring a bile collecting device in the Gl tract in accordance with a seventh embodiment of the invention; - Figure 9, 9A to 9C illustrate devices and method steps for anchoring a bile collecting device in the Gl tract in accordance with a eighth embodiment of the invention;

- Figures 10 illustrates a body fluid storage pouch with an actively controlled valve in accordance with an embodiment of the invention;

- Figures 1 1 and 12 are schematic representations of the control system of the regulation system in accordance with embodiments of the inventions;

- Figures 1 3 and 14 are schematic cross-sectional views of regulating valve devices according to embodiments of the invention;

Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, figure 1 is a partial view of the abdominal cavity of a patient, depicting the gastrointestinal tract with the esophagus 1 , stomach 2, duodenum 3, jejunum 4, ileum 5, colon 6, as well as the hepatic-biliary system with the liver, the biliary tree 7 with gall bladder 8, the pancreatic duct 9 and the mayor duodenal papilla of Vater 10 through which the bile and pancreatic fluid normally enter the duodenum 3, as well as a system 1 1 for regulating the dispensing of body fluid.

In accordance with an embodiment, the system 1 1 comprises a flow regulating valve 12 adapted to be placed in the flow path of a body fluid and a physiological characteristic - sensing device 13 in signal communication with the regulating valve 12 and configured to generate a control signal 14 in dependency from the physiological characteristic, wherein the regulating valve 12 changes a rate of flow of the body fluid in response to the control signal 14.

In accordance with an aspect of the invention, the body fluid can be bile and or pancreatic fluids and the physiological characteristic can be a pH value or a pH variation value and or a temperature value or a temperature variation value of a fluid in a part of the body, for instance the stomach contents.

Detailed description of embodiments of the physiological characteristic sensing device

In an exemplary embodiment, the physiological characteristic sensing device 13 may comprise a pH sensor 18 adapted to be placed and anchored in the body, particularly in the stomach 2, of a patient and adapted to generate a pH control signal 14 in dependency from the pH value or the pH variation value of the stomach contents, and transmit the pH control signal 14 directly to an onboard controller 15 of the regulation valve 12 or, alternatively, to a remote control unit 16.

The physiological characteristic sensing device 13 may further comprise a temperature sensor 19 (which may be mechanically separate from or connected with the pH sensor 18 and) adapted to be placed and anchored in the body, particularly in the stomach 2, of a patient and configured to generate a temperature control signal in dependency from a temperature or a temperature variation of the stomach contents, and transmit the temperature control signal 14 directly to the onboard controller 15 of the regulation valve 12 or, alternatively, to the remote control unit 16.

A radio signal transmitter 20 can be provided onboard the physiological characteristic - sensing device 13 for wireless transmission of the control signals 14.

In accordance with an embodiment, the physiological characteristic - sensing device 13 comprises a rechargeable onboard battery 21 for energizing the sensing function and the control signal generation and transmission, as well as a wireless onboard battery recharger 22, for instance an ultrasound or induction recharger which transforms ultrasound waves or magnetic pulses in electrical energy to recharge the battery 21 .

As a non limiting example, the physiological characteristic - sensing device 13 may comprise a Bravo® Wireless pH capsule sensor, available by Medtronic Functional Diagnostics, Minneapolis, Minnesota, USA.

The physiological characteristic - sensing device 13 is preferably incorporated in a single transorally or transnasally insertable capsule that attaches to the distal esophagus or stomach wall and transmits pH data via radio-telemetry to the remote control unit 16 or directly to the onboard controller 15 of regulating valve 12.

The sensing device 13 capsule can be attached at the end of a delivery catheter and passed through the mouth or nose until it reaches the desired position, e.g. at about 6 cm above the endoscopically measured Z-line. After positioning, the sensing device 13 is permanently or temporarily attached to the esophagus or stomach wall. The delivery catheter is then removed. Oral placement can be performed either while the patient is sedated during an endoscopy, or while the patient is awake following an esophageal manometry.

In case of temporarily fixation of the sensing device 13, e.g. by suction similar to the fixation of the above cited BRAVO pH probe, the latter doesn't need an onboard battery charger and will fall off within a period ranging from about 7 to 14 days and is passed in the stool. The sensing device 13 might or might not be recovered and reused.

Moreover the physiological characteristic sensing device 13 may be incorporated in a capsu le wh ich can be swal lowed li ke a pil l and wh ich has a docki ng interface for automatically dock to a previously implanted capsule catching device. Possible embodiments of the docking interface and the capsule catching device are disclosed for example in US patent applications US 2010/0063486, US 2010/0056874, US 2010/0049120, US 2010/0049012, US 2009/0306632 which relate to a diagnostic pill catching system and whose entire content is incorporated herein by reference.

In case of permanent fixation of the sensing device 13, the onboard battery should be rechargeable wireless.

In an embodiment, the physiological characteristic sensing device 13 may be configured as a tooth implant and adapted to sense pH values or pH variation values in the mouth of a patient. This embodiment provides simple implantation, maintenance and replacement of the sensing device, without any need for surgery or endoscopic procedures.

Detailed description of embodiments of the regulating valve

The regulating valve 12 may comprise an electromechanical or electromagnetic valve actuator 26 controlled by an onboard valve controller 15, a fluid passage 27 and a shutter member 28 acting on the fluid passage 27 from inside (fig. 1 3) or outside (fig.14) and movable by the valve actuator 26 between an opening position in which the shutter member 28 releases the fluid passage 27 so that a body fluid can freely flow through passage 27, and a closing position in which the shutter member 28 engages the fluid passage 27, thereby closing it.

I n the exemplary embodiment of figure 13, the regulating valve 12 is a ball valve with an internal shutter member 28 adapted to release and plug the fluid passage 27, respectively. Figure 14 illustrates an alternative embodiment, in which the regulating valve 12 comprises a resilient fluid passage tube 27 and an external shutter member 29 adapted to release and compress the resilient portion of the fluid passage 27, respectively.

Both illustrated embodiments of the regulating valve 12 allow, in their open configuration, a substantially resistance-free flow of the body fluid which is necessary for a controlled discharge of bile and pancreatic ju ices, since their natural secretion occurs without substantial pressure.

Detailed description of embodiments of the system controller

In accordance with an embodiment, the remote control unit 16 has a sensor control signal receiver 23, a programmable signal elaboration unit 24, e.g. a microprocessor, and a valve control signal transmitter 25 and is adapted to receive the control signal 14 from the pH sensor 13 and to generate a valve control signal 17 as a function of the received control signal 14 and a valve control program loaded in a memory of the signal elaboration unit 24 and to transmit the valve control signal 14 to the onboard controller 15 of the regulation valve 12.

The remote control unit 16 may be adapted to cooperate with the battery recharger 22, particularly to generate ultrasound waves or magnetic pulses which can be transformed by the battery recharger 22 in electrical energy to recharge the battery 21 .

In case of direct transmission of the control signal 14 from the sensing device 13 to the regulating valve 12, the onboard controller 15 of valve 12 may have a control signal receiver 30 and a programmable signal elaboration unit 31 , e.g. a microprocessor, and is adapted to receive the control signal 14 from the pH sensor 13 and to activate the valve actuator 26 in dependency from the received control signal 14 and a valve control program loaded in a memory of the signal elaboration unit 31 .

In general, the onboard valve controller 15 or the remote control unit 16 can be adapted to receive a control signal 14 from the sensing device 13 which represents the physiological characteristic, e.g. pH and or temperature of the contents of the stomach 2 of the patient, and operate the valve actuator 26 to adjust the fluid passage 27 flow section.

In one exemplary embodiment, the signal elaboration units of the onboard valve controller 15 or the remote control unit 16 are configured and programmed for comparing measured physiological characteristic values to predetermined target values. For example, where the sensor device comprises a pH sensor or a temperature sensor, the signal elaboration units 24, 31 can be adapted to compare the pH or temperature detected by the sensor device 13 to a predetermined target pH or temperature.

To facilitate the comparison, the signal elaboration units of the onboard valve controller 15 or the remote control unit 16 can be configured to receive input signals representative of target values. I n addition to comparing values, the signal elaboration units of the onboard valve controller 15 or the remote control unit 16 can be programmed to calculate a change of the physiological characteristic on the basis of a series of subsequently received control signals

14 and a timing information.

The signal elaboration units of the onboard valve controller 15 or of the remote control unit

16 can be further programmed to calculate a desired fluid passage 27 flow section for the regulating valve 12 to achieve a target flow rate of body fluid.

The system 1 1 for regulating the dispensing and flow of bodily fluid can further include an external programming device 32 that is in communication with the signal elaboration unit 24, 31 of the onboard valve controller 15 or of the remote control unit 16 and which might be integrated in the extracorporeal remote control unit 16.

In general, the programming device 32 can include a user interface that allows an operator to input one or more instructions to be communicated to the signal elaboration unit 24, 31 of the onboard valve controller 15 or of the remote control unit 1 6. For example, the external programming device 32 can be adapted to transmit a signal to the signal elaboration unit 24, 31 that is representative of a predetermined target value for the pH change or temperature of the stomach contents of a patient, as well as a signal that is representative of a desired bile release time lag or bile release time lead with respect to the food flow through the Gl tract. The external programming device 32 can include a display element for communicating information to a user, such as parameters of a set body fluid dispensing regulation scheme, measured physiological characteristics, low battery alerts.

As already mentioned , in accordance with an exemplary embodiment, the implantable physiological characteristic sensing device 13, valve controller 15, remote control unit 16 (if provided) and external programming device 32 can be configured to communicate via radiofrequency (RF) communication. To this purpose, the sensing device 13, the valve controller 15, the remote control unit 16 (if provided) and the external programming device 32 can include signal transmitters and receivers or antennas that can be configured to send and/or receive signals from one another. Such communication allows non-invasive control of the regulating valve actuator 26. The antennas can have a variety of configurations as well as be disposed at various locations in the system 1 1. For example, in one exemplary embodiment, both the controller 15 and antenna associated therewith can be disposed on the implantable regulating valve 12. I n another embodiment, the controller 15 can be contained within the implantable regulating valve 12 but the antenna can be arranged on a separate implant. In yet another exemplary embodiment, both the external control unit 16 and antenna associated therewith can be arranged separate from the regulating valve 12. In an embodiment, the valve controller 15 or remote control unit 16 are configured and programmed to operate the valve actuator 26 for closing the regulating valve 12 in response to (a pH variation control signal 14 indicative of) the introduction of food into the stomach 2, thereby accumulating bile and/or pancreatic juices in the flow path without flowing into the digestive tract (at the time when the food passes distally into the small intestine).

In a further embodiment, the valve controller 15 or remote control unit 16 may be configured and programmed to operate the valve actuator 26 for opening the regulating valve 12 in response to (a pH variation control signal 14 indicating) that the food has already left the stomach 2 and is transported further distally in the digestive tract, thereby dispensing bile and/or pancreatic juices into the digestive tract after a certain time delay with respect to the passage of food from the stomach in the small bowel.

In a further exemplary embodiment, the valve controller 15 or remote control unit 16 may be configured and programmed to compare the pH and/or temperature control signal 14 or signal 14 sequence with memorized reference values to identify the point in time when food has entered the stomach 2 as well as the point in time when the food has passed from the stomach 2 into the intestine.

Moreover, the valve controller 15 or remote control unit 16 may be configured and programmed to extrapolate the position of a food or chime flow in the Gl tract in dependency of the point of time the food entered the stomach and the point of time the food entered the intestine and a memorized time reference curve or value.

The onboard valve controller 15 or remote control unit 16 may be programmed to activate the opening and/or closure and/or to adjust the flow section of the regulating valve 12 in dependency of the food position in the Gl tract and preset lead time intervals and/or lag time intervals between the food transport in the e.g. jejunum and the dispensing of biliopancreatic juices.

The described flow adjusting method and devices can be calibrated according to the individual physiological conditions of a patient and obtain advantageous benefits of weight loss and control of diabetes.

In accordance with an embodiment, the system 1 1 may comprise a bile collecting device 33 or stent adapted to be anchored in the small intestine, particularly in the duodenum 3 at the papilla of Vater 10, where the biliopancreatic juices normally enter the intestine, and to catch the biliopancreatic juices and direct it in the fluid passage 27 of the regulating valve 12.

Detailed description of embodiments of the bile collecting device

In an exemplary embodiment, the bile collecting device 33 comprises a tubular food passage channel 34 having a preferably funnel shaped proximal open end 35 adapted to receive the food flow conveyed by the intestinal peristalsis and a preferably funnel shaped distal open end 36 adapted to release the food from channel 34 distally into the intestine, as well as a laterally open bile collecting cavity 37 isolated from the food passage channel 34 and configured to define together with an adjacent portion of intestinal wall a substantially sealed bile collecting chamber 38.

In accordance with the exemplary, non limiting embodiment illustrated in figures 1 and 2, the bile collecting cavity 37 comprises a radially external ring cavity formed around the food passage channel 34 and axially delimited by radially protruding proximal 39 and distal 40 lumen sealing portions.

The lumen sealing portions 39, 40 are preferably expandable from an initially collapsed radially smaller configuration in order to allow endoluminal, e.g. transoral introduction and transport of the bile collecting device 33 to the selected duodenal portion at the papilla of Vater 10 and subsequent deployment thereof by expanding the lumen sealing portions 39, 40.

To this end, the lumen sealing portions 39, 40 may comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid, such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.

In accordance with an embodiment, the proximal lumen sealing portion 39 can further define a bile passage hole 41 which opens into the bile collecting cavity 37 and to which a bile conduit 42, such as a catheter, can be coupled for creating a bile flow path isolated from food and chime and also isolated from the intestinal wall.

I n an exemplary embodiment, the bile conduit 42 comprises a flexible tube extended between a proximal open end and a distal open end, wherein the proximal open end is fluid connected with the inside of the bile collecting cavity 37 and the distal open end can be positioned in the intestine further distally of the bile collecting device 33, as illustrated in figures 1 and 2.

The regulating valve 12 can be fluid connected with the bile collecting device 33 or with the bile conduit 42 to control the bile flow rate therethrough.

In an exemplary embodiment, the regulating valve 12 may be placed near the distal open end of the bile conduit 42, thereby providing an additional bile accumulation space inside the bile conduit 42. In alternative exemplary embodiments, the regulating valve 12 may be placed near the proximal open end of the bile conduit 42 or in a central region thereof.

Thanks to the above described features of the bile collecting device 33 it is possible to collect biliopancreatic juices without chime contact and without accessing the very delicate biliary tree 7 with a catheter.

With reference to the embodiments of figures 1 and 2, the bile collecting chamber 38 is created by delivering the bile collecting device 33 (which is still in its initial collapsed configuration) and the attached bile conduit 42 (if provided) with the help of an endoscope transorally to the position of the ampulla of Vater 10 and subsequently deploying the bile collecting device 33 by expanding its lumen sealing portions 39, 40.

In a further exemplary embodiment the bile collecting device may comprise a stent of the type described in US patent application 2009/0062717 to Laufer, whose content is herein enclosed by reference.

I n accordance with an alternative embodiment, illustrated in figure 1 0, the system for regulating the dispensing of body fluid 1 1 may comprise a storage pouch 59 for accumulating and holding biliopancreatic juices, a bile draining catheter 60 which can be needle introduced in the common bile duct 7 and which extends between a proximal open end adapted to be fixated in the biliary tree 7 and a distal open end connected with a proximal inlet aperture of the storage pouch 59 so that bile is directly drained from the biliary tree into the storage pouch 59, as well as a bile dispensing catheter 61 connecting a distal outlet aperture of the storage pouch 59 with the regulating valve 12 and, if provided with a body fluid pump system. In accordance with an exemplary embodiment, the storage pouch 59 may comprise an expandable balloon, such that bile can drain into it and expand it for storage until needed (namely, until dispensed by the pH controlled valve actuation). The balloon itself may be fabricated from PET.

In accordance with a yet further embodiment, the storage pouch 59 may comprise a rigid outer wall 62 acting as a protection for a flexible expandable inner wall 63 defining the bile storage space.

In accordance with a further embodiment, a body fluid discharge overflow valve or discharge overflow pump may be provided and, possibly, integrated in the regulating valve 12, that is configured to allow part of the accumulated body fluid to drain into the intestine, when a maximum body fluid storage capacity is reached.

Detailed description of embodiments of anchoring devices for the bile collecting device and regulating valve

In accordance with a further aspect of the invention, the system 1 1 may comprise a first sleeve 43 (illustrated in figure 1 ) extending between a funnel shaped proximal open end 44 adapted to be anchored within the stomach 2, e.g. by shape coupling with the pylorus, and a distal open end 45 connected to the proximal aperture 35 of the bile collecting device 33. The first sleeve 43 can anchor the bile collecting device 33 to better resist against peristaltic forces and may collect food contained in the stomach 2 and direct it into the food passage channel 34, without contact with the intestinal wall.

In an exemplary non-limiting embodiment, a second sleeve 64 may extend from the distal open end 36 of the bile collecting device 33 distally to separate chime or partially digested food from the intestinal wall, while at the same time the bile conduit 42 catheter may separate biliopancreatic fluid from both the intestinal wall and the chime (compare figure 2). Alternatively or additionally, in order to resist the peristaltic forces acting on the devices 33, 42, 12, the latter can be anchored in the gastrointestinal tract, e.g. by means of a gastric coil 46 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2 , to a wou nd arched or circular configuration adapted to shape interfere with the stomach 2 such as to provide an anchor for an anchoring wire 47 which is connected to a proximal end of the bile collecting device 33 (figure 3).

In an embodiment, the physiological characteristic sensing device 13 may be housed in or connected to the gastric coil 46, thereby enabling reliable fixation thereof in the stomach 2. In a further exemplary embodiment, illustrated in figure 4, the anchoring wire 47 can be connected, e.g. by means of T-tags, to a previously created plication 48 in the stomach wall. I n a yet further exemplary embodiment, illustrated in figure 5, the bile collecting device 33 can be anchored to the intestinal wall by means of a submucosal band 49 inserted in the lumen wall and extending all around it such as to form an anchoring ring which creates a bottleneck portion in the intestinal wall , adapted to engage a corresponding annular anchoring groove 50 formed in at least one of the lumen sealing portions 39, 40 of the bile collecting device 33.

Figure 6 illustrates a yet further exemplary embodiment, in which the bile collecting device 33 can be anchored in the Gl tract by means of a gastric stent 51 and an attached elastically expandable (possibly shape memory) arch 52 adapted to create a shape connection with the stomach 2.

Figure 7 illustrates a yet further exemplary embodiment, in which the bile collecting device 33 can be anchored in the Gl tract by means of T-tags 53 fired from the inside of the intestine in the intestinal wall, thereby forming fixation points, and connected with a proximal end of the bile collecting device 33.

Figures 8 and 8A illustrate a yet further exemplary embodiment, in which the bile collecting device 33 can be anchored in the Gl tract by means of an annular anchoring portion 54 having a plurality of anchoring barbs 55, said barbs 55 being movable, e.g. rotatable, from a rest position in which the barbs 55 are contained within the encumbrance of the anchoring portion 54 to enable unobstructed endoluminal transport of the device 33, to a working position in which the barbs 55 protrude radially outward, thereby piercing the lumen wall and, hence, anchoring the device 33 thereto.

In a further exemplary embodiment, illustrated in figures 9 - 9C, the bile collecting device 33 can be anchored in the Gl tract by means of a tubular anchoring portion 56 having one or more anchoring holes 57 intended to face intestinal wall portions and adapted to allow these intestinal wall portion to be pulled into the holes 57 and fixed thereto. An endoluminal suction device 58 may be provided for sucking the lumen wall portion from inside tubular anchoring portion 56 and pulling them in the anchoring holes 57, as well as means and methods for creating a permanent (mushroom head type) swelling of the lumen wall portion, preventing it from withdrawal from the anchoring holes 57. Such means and methods for creating a permanent swelling of the lumen wall portion may comprise the submucosal injection of a swelling agent or sclerosant agent or insertion of a plastic bead, e.g. Poly(methyl methacrylate) PMMA, in the tissue portions which have been previously pulled through the anchoring holes 57.

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 system (1 1 ) for regulating the dispensing of body fluid, the system (1 1 ) comprising a regulating valve (12) adapted to be placed in the flow path of a body fluid and a physiological characteristic-sensing device (13) in signal communication with the regulating valve (12) and configured to generate a control signal (1 4) in dependency from the physiological characteristic, wherein the regulating valve (12) is adapted to change a rate of flow of the body fluid in response to the control signal (14).

2. System (1 1 ) according to claim 1 , wherein the physiological characteristic sensing device (13) comprises a pH sensor (18) adapted to be placed and anchored in the stomach (2) of a patient and adapted to generate a pH control signal (14) in dependency from the pH value of the stomach contents and transmit the pH control signal (14) to a controller (15; 16) of the regulation valve (12).

3. System (1 1 ) according to claim 1 or 2, wherein the physiological characteristic sensing device (13) comprises a temperature sensor (19) adapted to be placed and anchored in the stomach (2) and configured to generate a temperature control signal in dependency from a temperature of the stomach contents and transmit the temperature control signal directly to a controller (15; 16) of the regulation valve (12).

4. System (1 1 ) according to any of the preceding claims, comprising a radio signal transmitter (20) can be provided onboard the physiological characteristic-sensing device (13) for wireless transmission of the control signals (14).

5. System (1 1 ) according to any of the preceding claims, in which said physiological characteristic-sensing device (13) comprises:

- a rechargeable onboard battery (21 ) for powering the sensing function and the control signal generation and transmission,

- a wireless onboard battery recharger (22).

6. System (1 1 ) according to any of the preced ing claims, in which the physiological characteristic sensing device (13) is incorporated in a single transorally insertable capsule.

7. System (1 1 ) according to claim 6, comprising a capsule catching device adapted to be anchored in the esophageal gastric lumen and having a capsule catching interface configured to selectively catch, hold and release said sensing device (13) capsule.

8. System (1 1 ) according to claim 1 , wherein the physiological characteristic sensing device (13) is configured as a tooth implant and adapted to sense pH values in the mouth of a patient.

9. System (1 1 ) according to claim 1 , wherein said regulating valve (12) comprises an onboard valve controller (15), a valve actuator (26) controlled by the valve controller (15), a fluid passage (27) and a shutter member (28) acting on the fluid passage (27) and movable by the valve actuator (26) between an opening position in which the shutter member (28) releases the fluid passage (27) so that a body fluid can freely flow through the fluid passage (27), and a closing position in which the shutter member (28) engages the fluid passage (27), thereby closing it.

10. System (1 1 ) according to claim 9, in which said onboard controller (15) of the regulating valve (12) comprises

- a control signal receiver (30) adapted to receive the control signal (14) from the sensing device (13),

- a programmable signal elaboration unit (31 ) with a memory and a microprocessor, adapted to activate the valve actuator (26) in dependency from the received control signal (14) and a valve control program loaded in said memory.

11. System (1 1 ) according to claim 1 , comprising a remote control unit (16) having:

- a control signal receiver (23) adapted to receive the control signal (14) from the sensing device (13),

- a programmable signal elaboration unit (24) with a memory and a microprocessor, adapted to generate a valve control signal (17) as a function of the received control signal (14) and a valve control program loaded in said memory,

- a valve control signal transmitter (25) adapted to transmit the valve control signal (14) to the onboard controller (15) of the regulation valve (12).

12. System (1 1 ) according to claim 10 or 1 1 , wherein the signal elaboration unit (15; 16) is configured and programmed for:

- comparing measured physiological characteristic values to predetermined target values; - calculating a change of the physiological characteristic on the basis of a series of subsequently received control signals (14) and a timing information.

13. System (1 1 ) according to any of the preceding claims, in which a valve controller (15; 16) is configured and programmed to:

- operate a valve actuator (26) for closing the regulating valve (12) in response to a pH variation control signal (14) indicating the introduction of food into the stomach (2).

- operate the valve actuator (26) for opening the regulating valve (12) with a set time delay in response to a pH variation control signal (14) indicating that the food has left the stomach (2) and is transported further distally in the digestive tract.

14. System (1 1 ) according to any of the preceding claims, in which a valve controller (15; 16) is configured and programmed to:

- compare a physiological characteristic control signal (14) sequence with memorized reference values to calculate a point in time when food has entered the stomach (2) as well as the point in time when the food has passed from the stomach (2) into the intestine;

- extrapolate the position of a food or chime flow in the Gl tract in dependency of the point of time the food entered the stomach (2) and the point of time the food entered the intestine and memorized time reference values;

- activate a valve actuator (26) of the regulating valve (12) for adjusting the flow section in dependency of the food position in the Gl tract and preset lead time intervals and lag time intervals between the food transport and the dispensing of biliopancreatic juices.

15. System (1 1 ) according to any of the preceding claims, comprising a bile collecting device (33) adapted to be anchored in the small intestine at the papilla of Vater (10) and to catch the biliopancreatic juices and direct it in a fluid passage (27) of the regulating valve (12).

16. System (1 1 ) according to claim 15, in which the bile collecting device (33) comprises: - a tubular food passage channel (34) having a proximal open end (35) adapted to receive the food flow and a distal open end (36) adapted to release the food from channel (34) distally into the intestine,

- a laterally open bile collecting cavity (37) isolated from the food passage channel (34) and configured to define together with an adjacent portion of intestinal wall a sealed bile collecting chamber (38),

said regulating valve (12) being fluid connected with said bile collecting cavity (37).

17. System (1 1 ) according to claim 16, in which the bile collecting device (33) comprises proximal (39) and distal (40) lumen sealing portions which are expandable from an initially collapsed radially smaller configuration, said lumen sealing portions (39, 40) comprising expandable balloon segments which can be permanently expanded by injection of an expansion fluid or solidifying expansion agent.

18. System (1 1 ) according to claim 16, comprising a bile conduit (42) having a proximal open end and a distal open end and a flexible tube extended therebetween, wherein the proximal open end is fluid connected with the inside of the bile collecting cavity (37) of the bile collecting device (33) and the distal open end can be positioned in the intestine further distally of the bile collecting device (33), said regulating valve (12) being arranged in said bile conduit (42) to control the bile flow rate therethrough.

19. System (1 1 ) according to claim 1 , comprising:

- a storage pouch (59) for accumulating and holding biliopancreatic juices, - a bile draining catheter (60) which can be needle introduced in the biliary tree (7) and which extends between a proximal open end adapted to be fixated in the biliary tree (1 1 ) and a distal open end connected with a proximal inlet aperture of the storage pouch (59),

- a bile dispensing catheter (61 ) connecting a distal outlet aperture of the storage pouch (59) with the regulating valve (12),

20. System (1 1 ) according to claim 19, in which the storage pouch (59) comprise an expandable balloon, such that bile can drain into it and expand it for storage.

21. System (1 1 ) according to claim 15, comprising a first sleeve (43) extending between a funnel shaped proximal open end (44) adapted to be anchored within the stomach (2) and a distal open end (45) connected to a proximal aperture (35) of the bile collecting device (33), said first sleeve (43) being adapted to anchor the bile collecting device (33) in the Gl tract and to collect food contained in the stomach (2) and direct it into the food passage channel (34) without contact with the intestinal wall.

22. System (1 1 ) according to claim 15 or 21 , comprising a second sleeve (64) extended from a distal open end (36) of the bile collecting device (33) distally to separate partially digested food from the intestinal wall.

23. System (1 1 ) according to claim 15, comprising an anchoring device for anchoring the bile collecting device (33) in the Gl tract, said anchoring device being selected in the group consisting of:

- a gastric coil (46) which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach (2), to a wound arched configuration adapted to shape connect with the stomach (2),

- an anchoring wire (47) with T-tag connectors for fixation to a plication (48) in the stomach wall,

- a submucosal band (49) adapted to be inserted in the intestinal wall to form an anchoring ring and an annular anchoring groove (50) formed in the bile collecting device (33) and adapted to engage the anchoring ring,

- T-tag anchors (53) adapted to be fired from the inside of the intestine in the intestinal wall to form fixation points, said T-tag anchors (53) being connectable with a proximal end of the bile collecting device (33).

- an annular anchoring portion (54) having a plurality of anchoring barbs (55), said barbs (55) being movable, from a rest position in which the barbs (55) are contained within the encumbrance of the anchoring portion (54) to a working position in which the barbs (55) protrude radially outward, - a tubular anchoring portion (56) having one or more anchoring holes (57) intended to face intestinal wall portions and adapted to allow these intestinal wall portion to be pulled into the holes (57) and fixed thereto, and means for creating a permanent mushroom head type swelling of the lumen wall portion, preventing it from withdrawal from the anchoring holes (57).

24. A method for regulating the dispensing of a body fluid, the method comprising the steps of:

- placing a regulating valve (12) at a first location in the flow path of a body fluid in a patient's body; and

- placing a physiological characteristic-sensing device (13) at a second location in the body; and

- sensing a physiological characteristic in the second location; and

- generating a control signal (14) in dependency of the sensed physiological characteristic; and

- providing the control signal (14) to the regulating valve (12) to regulate the flow of the body fluid.

25. A method according to claim 1 , comprising the steps of:

- placing an actively regulated valve (12) in a flow path of biliopancreatic fluid;

- placing a pH sensor device (13) in the stomach (2) of a patient;

- sensing the pH of the stomach contents;

- generating a control signal (14) in dependency of the sensed pH;

- sending the control signal (14) to the valve (12);

- activating the valve (12) to regulate the flow of the biliopancreatic fluid in dependency of information contained in the control signal.

26. Method according to claim 25, comprising the steps of:

- placing transorally a bile collecting device (33) in fluid communication with an actively regulated valve (12) at a first location on the flow path of biliopancreatic fluid;

- attaching a pH sensing device (13) at a location inside the stomach (2); and

- anchoring the bile collecting device (33) inside a portion of the gastrointestinal tract.

27. Method according to claim 25, comprising the steps of:

- incorporating the pH sensing device (13) in a single capsule;

- attaching the pH sensing device (13) capsule at the end of a delivery catheter and passing it through the mouth or nose until it reaches the desired position in the esophageal-gastric lumen; - fixating the sensing device (13) capsule to the esophageal gastric wall;

- removing the delivery catheter.

28. Method according to claim 27, in which the step of fixating the sensing device (13) capsule to the esophageal gastric wall comprises the step of temporarily fixation by suction.

29. Method according to claim 25, comprising the steps of

- incorporating the physiological characteristic sensing device (13) in a single capsule which can be swallowed;

- implanting a capsule catching device in the stomach (2) of a patient;

- swallowing the physiological characteristic sensing device (13) capsule;

- docking the sensing device (13) capsule to said capsule catching device;

- after a selected time interval, releasing the sensing device (13) capsule from said capsule catching device.

30. Method according to claim 25, comprising the steps of creating a bile collection chamber (38) by:

- delivering a bile collecting device (33) having expandable lumen sealing portions (39, 40) with the help of an endoscope transorally in the small intestine to the position of the ampulla of Vater (10),

- subsequently deploying the bile collecting device (33) by expanding the lumen sealing portions (39, 40) against the intestinal wall.

31. Method according to claim 25, comprising the steps of:

- comparing measured physiological characteristic values to predetermined target values;

- operate a valve actuator (26) for closing the regulating valve (12) in response to a pH variation control signal (14) indicating the introduction of food into the stomach (2),