WO2013004266A1

WO2013004266A1 - Device for time delayed dispensing of bile

Info

Publication number: WO2013004266A1
Application number: PCT/EP2011/061113
Authority: WO
Inventors: Manoel Galvao Neto; Martin Fried; Alessandro Pastorelli; Darrel POWELL McKINLEY; David A. Dalessandro
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-07-01
Filing date: 2011-07-01
Publication date: 2013-01-10

Abstract

A device (9) for changing the timing of a biliary flow within the gastrointestinal tract has a stent (10) adapted to anchor within a biliary tree (4), a catheter (11) having a proximal end portion (12) connected to the stent (10) and forming an opening adapted to capture the biliary flow, and a distal portion (13) intended to be located in the intestine and forming a discharge opening (14) for releasing the captured biliary flow, a reservoir (15) adapted to accumulate the captured biliary flow and flow control means (16) which time-delay a release of accumulated biliary flow from the reservoir (15).

Description

DEVICE FOR TIME DELAYED DISPENSING OF BILE

The present invention relates, in general, to devices and methods for surgically manipulating 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 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 timing of their mixture and interaction, may cause weight loss and or allow control of diabetes. Hence, there is a need to delaying the dispensing of biliary fluid in the Gl tract with respect to the natural bile dispensing in response to the intake of food.

In WO2007/103773 to Laufer, a device is disclosed that routes biliary fluid from a point in the gastrointestinal tract adjacent to the ampulla of Vater to a more distal portion of the Gl tract. This device uses a stent located inside the gastrointestinal tract and forming a reservoir intended to accumulate fluid in case of an obstructed catheter. The reservoir in WO2007/103773 is not adapted to control the flow of fluid through the catheter.

What is needed, therefore, is a catheter for diverting bile that can be reliably located within the body and has a reservoir that is controllable so that the above said beneficial metabolic effects of a time delayed release of bile may be achieved by the patient.

At least some of these aims are achieved by a device for changing the timing of a biliary flow within a gastrointestinal tract, the device comprising a stent adapted to anchor within a biliary tree, a catheter having a proximal end portion connected to the stent and adapted to capture the biliary flow and a distal portion intended to be located in the gastrointestinal tract and forming a discharge opening for releasing the captured biliary flow, a reservoir formed in the catheter distally to the stent and adapted to accumulate the captured biliary flow, a flow control means arranged in the catheter and adapted to time delay a release of accumulated biliary flow from the reservoir with respect to an accumulation of the biliary flow within the reservoir. In accordance with an aspect of the invention, the flow control means comprise a tortuous, particularly a spiral shaped or helix shaped, mandatory flow channel of the reservoir, the mandatory flow channel defining a flow path length greater than its dimension in a longitudinal direction of the catheter. The captured biliary fluid is accumulated in the reservoir and is constrained to travel along the entire tortuous flow channel before reaching the discharge opening of the catheter. The flow path length of the mandatory flow channel can be purposefully selected to achieve a desired time-delay of the bile delivery in the Gl tract with respect to the capturing and accumulation of the bile flow triggered by the food intake.

I n accordance with a further aspect of the invention , the flow control means comprise a control valve arranged in the catheter distally to the reservoir and adapted to release previously accumulated biliary fluid from the reservoir only when a predetermined pressure is reached inside the reservoir.

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 device for a time delayed delivery of biliary fluid in a Gl tract of a patient in accordance with an embodiment of the invention;

- Figure 2 illustrates a method and device for a time delayed delivery of biliary fluid in a Gl tract of a patient in accordance with a further embodiment of the invention;

- Figure 3 is a schematic illustration of a device in accordance with an embodiment of the invention;

- Figure 3 A is a schematic illustration of a device in accordance with an alternative embodiment of the invention;

- Figure 4 illustrates a method for surgically placing a device for a time delayed delivery of biliary fluid in a Gl tract of a patient;

- Figures 5 and 6 illustrate details of implanted devices in accordance with embodiments of the invention;

- Figures 7 through 9 illustrate details of a biliary fluid reservoir and a control valve of the device in accordance with the invention.

Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, figures 1 , 2 and 4 are partial views of the abdominal cavity of a patient, depicting part of the gastrointestinal tract with the esophagus 1 , stomach 2, small intestine 3, as well as the hepatic-biliary system with the biliary tree 4 with gall bladder 5, the pancreatic duct 6 and the mayor duodenal papilla of Vater 7 through which the bile and pancreatic fluid normally enter the duodenum 8, as well as a device 9 for changing the timing of a biliary flow within the gastrointestinal tract.

The device 9 comprises an expandable stent 10 adapted to anchor within the biliary tree 4 and an elongate tubular catheter 1 1 . The catheter 1 1 forms a proximal end portion 12 connected to the stent 10 and having at least an opening adapted to capture the biliary flow and a distal portion 13 which is intended to be located in the intestine and which forms a discharge opening 14 for releasing the captured biliary flow. A reservoir 15 adapted to accumulate the captured biliary flow is formed in the catheter 1 1 distally to the stent 10 and flow control means 16 are arranged in the catheter 1 1 and co-operate with the reservoir 15 to time-delay a release of accumulated biliary flow from the reservoir 15 with respect to an accumulation of the biliary flow within the reservoir 15. This makes it possible to aimedly delay the contact between a flow of bile and the intestinal wall, as well as the mixing of bile with food within the intestine with respect to the natural bile cycle of a patient.

In accordance with an embodiment (Figure 3), the flow control means 16 comprise a winding, particularly a coiled spiral or helix shaped, mandatory flow channel 17 of the reservoir 15. The mandatory flow channel 17 defines a flow path length which is significantly greater, preferably at least 5 times greater, even more preferably at least 10 times greater than its dimension in a longitudinal direction of the catheter 1 1 . The captured biliary fluid is accumulated in the reservoir 15 and is constrained to travel along the entire winding mandatory flow channel 17 before reaching the discharge opening 14 of the catheter 1 1. Advantageously, the mandatory flow channel 1 7 comprises at least 5, preferably at least 1 0 full 360° windings or (approximately S-shaped) waves. The individual windings of the mandatory flow channel 17 may be formed by a bent or wound flexible tubular section packed together by an external housing 33 (Figu re 3) or, alternatively, the individual windings are defined by opposite surfaces of internal separation walls 21 of a single-path (unicursal) labyrinth 20 (Figure 3A).

The flow path length and the curvatures of the mandatory flow channel 17 can be purposefully selected to achieve a desired time-delay of the bile delivery in the intestine with respect to the capturing and accumulation of the bile flow triggered by the food intake.

In accordance with a further embodiment, emptying means may be provided to clear the biliary fluid out of the mandatory flow channel 17 in order to avoid that the entire catheter 1 1 will eventually fill up and a bile flow into the proximal end portion 13 of the catheter will contemporaneously force bile out of the distal discharge opening 14. The emptying means may comprise contracting means 18 acting on the reservoir 15 and adapted to compress the mandatory flow channel 17, e.g. at predetermined time intervals, or with a predetermined time delay after reaching one of a predetermined pressure value and a predetermined filling level inside the reservoir 15, to squeeze the biliary fluid out and empty the channel.

Alternatively, the contracting means 18 may be adapted to apply an elastic preload on the mandatory flow channel 17 or the mandatory flow channel 17 may have an elastically stretchable (e.g. elastomeric material) channel wall adapted to expand during filling with fluid and, subsequently, gradually retract to a rest shape in which a part of fluid is squeezed out of the mandatory flow channel 17.

In accordance with a further embodiment The mandatory flow channel 17 may have an externally exposed flexible wall portion adapted to be collapsed through the pressure exerted by peristalsis or intestinal contents, such that a part of fluid is squeezed out of the mandatory flow channel 17. Thanks to the windings and increased length of the mandatory flow channel 17, although the bile may be squeezed by peristalsis, it advances along the intestine much slower than the food and is eventually released with a time delay compared to the natural condition. Generally, the emptying means may be configured, e.g. by means of valves, to empty the mandatory flow channel 17 only distally through the discharge opening 14 or only proximally into a portion of the reservoir 15 upstream the mandatory flow channel 17 or in both directions.

I n accordance with a further embodiment, the flow control means comprise a control valve 19 arranged in the catheter 1 1 distally to the reservoir 15 and adapted to release previously accumulated biliary fluid from the reservoir 15 with a time delay with respect to the capturing and accumulation of the bile flow triggered by the food intake.

In accordance with embodiments, the control valve 19 may be adapted to close and open the passage of fluid in dependency of a filling level of the reservoir 15 and/or of the pressure in the reservoir 15 and may be further automatically opened and/or closed after a predetermined opening time delay interval and after a predetermined closing time delay interval counted from a point in time when the predetermined filling level and/or pressure level has been reached in the reservoir 15.

The control valve 19 may comprise a spring preloaded ball valve or a duckbill valve adapted to restrict the flow until a pressure differential at the shutter section remains below threshold value and to open when the pressure differential grows above the threshold value.

Alternatively, the control valve 19 may comprise an electromechanical or electromagnetic valve actuator 22 controlled by an onboard valve controller 23, a fluid passage 24 and a shutter member 25 acting on the fluid passage 24 from inside (fig. 8) or outside (fig.9) and movable by the valve actuator 22 between an opening position in which the shutter member 25 releases the fluid passage 24 so that biliary fluid can freely flow through passage 24, and a closing position in which the shutter member 25 engages the fluid passage 24, thereby closing it.

In the exemplary embodiment of figure 8, the control valve 19 is a ball valve with an internal shutter member 25 adapted to clear and plug the fluid passage 24, respectively. Figure 9 illustrates an alternative embodiment, in which the control valve 1 9 comprises a resilient fluid passage tube 24 and an external shutter member 25 adapted to release and compress the resilient portion of the fluid passage 24, respectively.

Both illustrated embodiments of the control valve 19 allow, in their open configuration, a substantially resistance-free flow of the body fl u id wh ich is necessary for a controlled discharge of bile and pancreatic juices, since their natural secretion occurs without substantial pressure.

The pressure or filling level in the reservoir may be also detected by a sensor which transmits a pressure and/or filing level signal 14 directly to the onboard controller 23 of the control valve 19 or, alternatively, to a remote control unit (not illustrated in the figures).

In this way, biliary fluid is accumulated within the reservoir and is released with an opportune time delay to gain the desired metabolic effect on the patient. Such a metabolic effect may be e.g. a better control of diabetes, weight loss and a leaner body composition with a reduced fat mass percentage.

In accordance with a further exemplary embodiment (figure 7), the reservoir 15 may comprise a flexible or stretchable pouch 26, such as an expandable balloon. In this way, bile can drain into the pouch 26 and expand it for storage until needed. The pouch 26 itself may be fabricated from PET. In accordance with a yet further embodiment, the pouch 26 may be received in a rigid outer casing 27 acting as a protection for a flexible expandable inner wall defining the bile storage space.

The reservoir may be arranged near a distal end of the catheter 1 1 and provide a dragging surface for the peristalsis to act on in order to pull the distal catheter end distally.

In some case a partial diversion of bile may be desired which allows at least part of the biliary flow to follow its natural path. In this case the catheter must be anchored inside the biliary tree without completely obstructing the common bile duct. For this purpose a self expandable metal stent is fastened at the proximal end portion of the catheter 1 1 by means of radial spacers 28 which create a flow passage between the stent 10 and an external surface of the proximal end portion 12 of the catheter 1 1 . In this case, the external diameter of the proximal catheter end portion 12 is smaller than an internal diameter of the stent 10. After anchoring the catheter in the biliary tree, a first portion of bile is captured by the proximal catheter end, while a second portion of bile can still flow outside the catheter from the bile duct into the duodenum (figure 5).

Figu re 6 illustrates a fu rther exemplary embodiment in which at least one secondary drain channel 29 is formed in a wall of the catheter and connects a series of proximal drain holes 30 and distal drain holes 31 in order to help a portion of bile to flow separately from the captured bile through the obstructed zone of the sphincter of ODDI and then be released in the duodenum.

The device 1 can be applied to a patients d igestive system by passing an endoscope transorally through the esophagus and the stomach into the duodenum near the papilla of Vater, then extending the stent 10 with the proximal end portion 12 of the catheter 1 1 through an instrument channel of the endoscope 32 into the biliary tree 4. Then the stent is expanded to anchor the proximal catheter end portion 12 in the bile duct and the distal portion of the catheter 1 1 with the reservoir 15 and, possibly, the control valve 19 are pushed to slide out of the endoscope 32 and into the duodenum.

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. Device (9) for changing the timing of a biliary flow within the gastrointestinal tract, the device (9) comprising:

- a stent (10) adapted to anchor within a biliary tree (4),

- a catheter (1 1 ) having a proximal end portion (12) connected to the stent (10) and forming an opening adapted to capture the biliary flow, and a distal portion (13) intended to be located in the intestine and forming a discharge opening (14) for releasing the captured biliary flow,

- a reservoir (15) formed in the catheter (1 1 ) distally to the stent (10) and adapted to accumulate the captured biliary flow,

- flow control means (16) adapted to time-delay a release of accumulated biliary flow from the reservoir (15) with respect to an accumulation of the biliary flow within the reservoir (15).

2. Device (9) according to claim 1 , wherein the flow control means (16) comprise a winding mandatory flow channel (17) of the reservoir (15), the mandatory flow channel (17) defining a flow path length which is significantly greater than its dimension in a longitudinal direction of the catheter (1 1 ).

3. Device (9) according to claim 2, wherein the mandatory flow channel (17) has a coiled shape.

4. Device (9) according to claim 2, wherein the flow path length of the mandatory flow channel (17) is at least 5 times greater, preferably at least 10 times greater than its dimension in the longitudinal direction of the catheter (1 1 ).

5. Device (9) according to claim 2, in which individual windings of the mandatory flow channel (17) are formed by a wound flexible tubular section packed together by an external housing (33).

6. Device (9) according to claim 2, in which individual windings of the mandatory flow channel (17) are formed by opposite surfaces of internal separation walls (21 ) of a single-path labyrinth (20).

7. Device (9) according to any one of claims 2 to 6, comprising emptying means adapted to clear fluid out of the mandatory flow channel (17).

8. Device (9) according to claim 7, in which said emptying means comprises contracting means (18) acting on the reservoir (15) and adapted to compress the mandatory flow channel (17).

9. Device (9) according to claim 8, in which said contracting means (18) are adapted to compress the mandatory flow channel (17) at predetermined time intervals.

10. Device (9) according to claim 8, in which said contracting means (18) are adapted to compress the mandatory flow channel (17) with a predetermined time delay after reaching one of a predetermined pressure value and a predetermined filling level inside the reservoir (15).

11. Device (9) according to claim 8, in which the mandatory flow channel (17) has an elastically stretchable channel wall adapted to expand during filling with fluid and, subsequently, gradually retract to a rest shape such that at least part of fluid is squeezed out of the mandatory flow channel (17).

12. Device (9) according to claim 7, in which the mandatory flow channel (17) has an externally exposed flexible wall portion adapted to be collapsed through the pressure exerted by intestinal peristalsis.

13. Device (9) according to any one of the preceding claims, in which said flow control means comprise a control valve (19) arranged in the catheter (1 1 ) distally to the reservoir (15).

14. Device (9) according to claim 13, in which the control valve (19) is adapted to close and open a passage of fluid in dependency of one of a filling level and a pressure in the reservoir (15).

15. Device (9) according to claim 13 o r 14, in which the control valve (19) automatically opens after a predetermined opening time delay interval and closes after a predetermined closing time delay interval counted from a point in time when one of a predetermined filling level and a predetermined pressure level has been reached in the reservoir (15).

16. Device (9) according to any one of the preceding claims, in which the stent (10) comprises an expandable metal stent fastened at the proximal end portion (12) of the catheter (1 1 ) by means of radial spacers (28) which create a flow passage between the stent (10) and an external surface of the proximal end portion (12).