WO2012163415A1

WO2012163415A1 - Catheter for directing biliopancreatic secretions

Info

Publication number: WO2012163415A1
Application number: PCT/EP2011/058983
Authority: WO
Inventors: Alessandro Pastorelli; Michele D'arcangelo
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-05-31
Filing date: 2011-05-31
Publication date: 2012-12-06

Abstract

A catheter (11) for directing biliopancreatic secretions comprises an elongate tubular wall (16) extending between a proximal end portion (12) and a distal end portion (13) and having an internal surface (17) which defines a fluid passage channel (18), a sweeping grid (19) arranged inside the fluid passage channel (18) and adapted to be moved with respect to the tubular wall (16) thereby sweeping the internal surface (17), actuating means (20) which move the sweeping grid (19) with respect to the tubular wall (16).

Description

DESCRIPTION

CATHETER FOR DIRECTING BILIOPANCREATIC SECRETIONS

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 e.g. discussed in US 2005085787 Al . 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.

One of the major problems with plastic catheters is their tendency to clog over time. Bile catheter obstructions and the subsequent failure of drainage of the biliopancreatic juices would lead to complications, such as jaundice and cholangitis, and must therefore be obviated by exchanging the entire catheter. Clinical catheter occlusion has been observed to occur in 28% - 58% of patients after a time interval of 131 days to 324 days. Even though the mechanism of catheter occlusion is not yet completely understood, it has been postulated that shortly after the implantation of a plastic stent or catheter, proteins contained in the biliary fluid, such as fibronectin, collagen, fibrin and immunoglobulin A, coat the internal catheter surface and promote harboring of bacteria. Subsequent glycocalix formation by the adhered bacteria forms a gel-like biofilm that protects the bacteria from antibiotics, from the action of the immune system and also from the mechanical shearing effect of the bile flow through the catheter. In addition, commonly found microorganisms in the sludge, such as Escherichia coli, can produce β- g 1 u c o r o n i d a s e , which can deconjugate bilirubin glucoronide and precipitate calcium bilirubinate which adds to the depositions inside the catheter. Research over the past two decades has concentrated on improving the patency of implanted catheters and stents focusing on appropriate materials, catheter- and stent position, catheter shape and dimensions, as well as on the administration of antibiotics and drugs affecting the constituents of the biliary fluid and the depositions and sediments inside the catheter. However, to date, catheter diameter dimensioning is the only factor that has proven to effectively influence catheter patency and clogging time.

An aim of the present invention is therefore to provide a catheter for directing biliopancreatic secretions, wherein the catheter obviates premature obstruction and assures a sufficient patency for the planned catheter life time.

This and other aims are achieved by a catheter for directing biliopancreatic secretions, the catheter comprising an elongate tubular wall extending between a first end portion and a second end portion and having an internal surface which defines a fluid passage channel of the catheter, a sweeping grid arranged inside the fluid passage channel and adapted to be moved with respect to the tubular wall and to sweep said internal surface during said movement, and actuating means for moving the sweeping grid with respect to the tubular wall .

The rubbing action of the sweeping grid on the tubular wall tears and removes adhering biological film, bacteria and sediment deposits from the internal surface, thereby significantly improving the patency and increasing the duration of the catheter.

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

- Figure 1 illustrates a catheter for directing biliopancreatic juices implanted in the GI tract of a patient ;

- Figure 2 is a cross-sectional view of the catheter in accordance with an embodiment;

- Figure 3 is a transparent perspective view of a portion of a catheter for directing biliopancreatic juices in accordance with an embodiment;

Figure 4 is a transparent perspective view of a portion of a catheter for directing biliopancreatic juices in accordance with a further embodiment; - Figure 5 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in working conditions;

- Figure 6 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices, illustrating rotational activating means for moving a sweeping grid;

- Figure 7 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a further embodiment;

- Figure 8 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a yet further embodiment;

- Figure 9 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a yet further embodiment.

Referring to the drawings in which 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. Figure 1 shows further a catheter 11 for modifying the location at which biliopancreatic secretions interact with nutrients and with the intestinal wall in a gastrointestinal tract.

The catheter 11 comprises a proximal end portion 12 adapted to be fluid connected to the common bile duct 7 to collect biliopancreatic secretions and a distal end portion 13 adapted to be placed in a location downstream in the gastrointestinal tract, that is to say in a location significantly distal to the papilla of Vater, such as in the distal section of the duodenum 3, in the jejunum 4 or ileum 5. The catheter proximal end portion 12 may have only one proximal open end 14 which can be arranged and anchored (e.g. by means of a stent) in the bile duct proximally (to collect only bile) or distally to the junction point with the pancreatic duct 9 (to collect both bile and pancreatic juices). Alternatively, the proximal end portion 12 may be bifurcated or Y- shaped and define a proximal open bile end 14 intended and adapted to be inserted in the bile duct 7 proximal to the junction point with the pancreatic duct 9, and a proximal open pancreatic end 14' intended and adapted to be inserted in the pancreatic duct 7. Such a Y-shaped proximal end portion 12 would allow to collect bile and pancreatic juices separately and to keep them isolated or mix them further distally in the catheter 11.

The catheter distal end portion 13 forms one or more bile outlet openings 15 through which the biliopancreatic juices are released into the intestine. In accordance with an aspect of the invention, the catheter 11 comprises an elongate tubular wall 16 extending between the proximal end portion 12 and the distal end portion 13 and having an internal surface 17 which defines a fluid passage channel 18 of the catheter 11. A sweeping grid 19 is arranged inside the fluid passage channel 18 and adapted to be moved with respect to the tubular wall 16 and to sweep the internal surface 17 during the movement of grid 19.

The catheter 11 comprises further actuating means 20 for moving the sweeping grid 19 with respect to the tubular wall 16.

The rubbing action of the sweeping grid 19 on the tubular wall 16 tears and removes adhering biological film, bacteria and sediment deposits from the internal surface 17. This leads to significant improvements of the patency of the catheter and, hence, to an increase of the catheter duration.

In accordance with an embodiment, the sweeping grid 19 has a generally tubular shape and is arranged immediately adjacent to and concentric with the tubular wall 16. The tubular sweeping grid 9 forms a plurality of interconnected scraping bars 21 and a plurality of window openings 22 between the scraping bars 21, wherein the window openings 22 expose portions of the internal surface 17 of the tubular wall 16 to the fluid passage channel 18 and, during the movement of the sweeping grid 19, the scraping bars 21 sweep over the exposed internal surface 17 portions and detach undesired depositions of biofilm and sediments which could otherwise lead to catheter clogging.

In accordance with an embodiment, the area of the internal surface 17 covered by all scraping bars 21 of the grid 19 is smaller, preferably significantly smaller, than the area of the internal surface 17 exposed through the window openings 22 of the grid 19. In this manner a predominant area of the entire catheter surface (i.e. of the outer wall and of the grid) defining the fluid passage channel 18 is swept and cleaned from undesired sludge depositions and only a minor surface area (i.e. the surface of the scraping bars 21 of the sweeping grid 19) is not subjected to direct cleansing action.

Moreover, the comparatively thin shape and small dimensions of the scraping bars 21 of the sweeping grid 19 provide only a very poor harboring surface for undesired depositions, which can accumulate only to a non-critical size above which they tend to break and detach due to an insufficient anchoring area.

In accordance with an embodiment, the area of all window openings 22 of the sweeping grid 19 is greater than the area of the scraping bars 21 thereof, or in other words of the structure of the sweeping grid 19 (the generally tubular curved grid 19 is considered to be developed in a plane and the areas are measured in this development plane) , preferably the ratio of the area of all window openings 22 of the sweeping grid 19 divided by the area of the scraping bars 21 or, in other words, of the structure of the sweeping grid 19 is greater than 2, even more preferably greater than 3.

In accordance with an embodiment, the sweeping grid 19 extends or moves along a predominant part of the length of the catheter 11 or along the entire length of the catheter, including the proximal end portion 12 and the distal end portion 13 thereof in order to clean also the proximal and distal open ends 14, 15.

Preferably, the tubular wall 16 is continuous and without lateral apertures in the regions overlapped by the window openings 22 of the sweeping grid.

The sweeping grid 19 may be formed by a plastic tube provided with cut out apertures forming the window openings 22 or, alternatively, the sweeping grid 19 may be formed by a tubular mesh of metal wire or plastic wire 23, in which the wire 23 forms the above said scraping bars 21.

In accordance with a further embodiment, the scraping bars 21 of the sweeping grid 19 may comprise a scraping surface 24 forming an obtuse angle β with the internal surface 17 exposed through the adjacent window opening 22 and converging in a sharp scraping edge 24 adapted to cut through and scrape away depositions from the internal surface 17 during the t r a n s 1 a t i o n a 1 or rotational movement of the sweeping grid 19 with respect to the tubular wall 16.

In accordance with an embodiment, the actuating means 20 are configured to move the sweeping grid 19 intermittently or continuously with respect to the tubular wall 16, wherein the movement may be an alternating translational back and forth movement in a longitudinal direction of the catheter 11 or a rotational movement about a longitudinal catheter axis. The rotational movement may comprise a cyclic unidirectional rotation and/or a back and forth type alternating rotation.

In accordance with a non-limiting exemplary embodiment, the actuating means 20 may comprise an electric motor formed by stator windings 25 connected to (preferably incorporated or encapsulated in) the tubular wall 16 and rotor magnets 26 or windings connected to (preferably incorporated or encapsulated in) the sweeping grid 19. Alternati ely, the actuating means 20 may comprise one or more linear micromotors 27, such as a piezoelectric motor, connected to the tubular wall 16 and engaging with and adapted to travel along a longitudinal or circumferential guide rail 28 formed on the sweeping grid 19 to move (translate or rotate) the latter with respect to the tubular wall 16.

Such a piezoelectric motor may have a reciprocating expanding lateral piezo member pushing on two clutching piezo members mounted inside a tubular housing and electrified in sequence to grip the guide rail which is then moved. An exemplary, non limiting example of such a piezoelectric motor is the P-652-series PILine® ultrasonic motor linear slides.

In accordance with a further embodiment, the activation means 20 may be locally controlled by an onboard controller or remote controlled, e.g. by means of wireless RF signal communication between an extracorporeal control unit and a local controller associated with the actuating means. The actuation means may further comprise a battery having a charging level sufficient for the planned life time of the catheter 11 or a remotely rechargeable battery, e.g. by means of an inductive extracorporeal charger.

The actuations means are configured to automatically move the sweeping grid 19 with respect to the tubular wall 16, e.g. following an intermittent actuation scheme which performs e.g. every 24 hours a short movement period of e.g. 15 seconds - 120 seconds.

The tubular wall 16 and also the sweeping grid 19 are preferably flexible to facilitate the implantation of the catheter and to better follow the physiological structures to which the catheter 11 is applied. The tubular wall 16 may be grafted at least partially in silicone, polyethylene, polypropylene, butylated rubber, latex and the like.

In order to increase torque-, kink- and compression resistance of the catheter 11, the tubular wall 16 may be additionally reinforced with a metal or plastic wire mesh 29, e.g. with a braided wire mesh, which can be coextruded together with or incorporated and encapsulated in the tubular wall 16 base material (e.g. polyethylene) .

The catheter 11 can be installed endoluminally, e.g. transorally, in the intestine and the proximal end portion 12 of the catheter 11 may be inserted in the papilla of Vater 10 using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique. The ERCP procedure involves passing a flexible endoscope through the mouth, esophagus 1, and stomach 2 into the duodenum 3 near the papilla of Vater 10. The doctor then passes the catheter 11 through a channel in the endoscope and out into view in the duodenum 3 and inserts it into the papilla of Vater 10.

The present invention further contemplates the possibility of placing the catheter 11 in the intestine and introducing the catheter proximal end portion 12 in the papilla of Vater 10 by laparoscopically accessing the abdominal space, t r an s 1 umen a 11 y accessing the duodenum 3 near the papilla of Vater 10 and placing the catheter 11 through the duodenum 3 in the desired position within the intestine and, from inside the duodenum 3, laparoscopically introducing the catheter proximal end portion 12 into the papilla of Vater 10. The catheter 11 and methods of the described invention assure an improved patency over time and reduce the risk of catheter clogging and related clinical complications. Moreover, the described catheter obviates the need of frequent catheter replacements and, hence, the need of frequent surgical manipulation of the region of the biliary tree and pancreatic duct

Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. A catheter (11) for directing biliopancreatic secretions, the catheter (11) comprising:

an elongate tubular wall (16) extending between a proximal end portion (12) and a distal end portion (13) and having an internal surface (17) which defines a fluid passage channel (18),

- a sweeping grid (19) arranged inside the fluid passage channel (18) and adapted to be moved with respect to the tubular wall (16) thereby sweeping the internal surface (17) ,

- actuating means (20) which move the sweeping grid (19) with respect to the tubular wall (16) .

2. A catheter (11) according to claim 1, in which the sweeping grid (19) has a generally tubular shape and is arranged immediately adjacent to and concentric with the tubular wall (16) .

3. A catheter (11) according to claim 1 or 2, in which sweeping grid (9) forms a plurality of interconnected scraping bars (21) and a plurality of window openings (22) between the scraping bars (21), wherein the window openings (22) expose portions of the internal surface (17) to the fluid passage channel (18) and, during the movement of the sweeping grid (19), the scraping bars (21) sweep over the exposed internal surface (17) portions to detach undesired depositions.

4. A catheter (11) according to claim 3, in which the area of the internal surface (17) covered by all scraping bars (21) is smaller than the area of the internal surface (17) exposed through the window openings (22 ) .

5. A catheter (11) according to claim 3, in which the ratio of the area of all window openings (22) divided by the area of the structure of the sweeping grid (19) is greater than 2, preferably greater than 3.

6. A catheter (11) according to any one of the preceding claims, in which sweeping grid (19) is adapted to sweep over a predominant part of the length of the tubular wall (16) .

7. A catheter (11) according to any one of the preceding claims, in which sweeping grid (19) is adapted to sweep over the entire length of the tubular wall (16), including the proximal end portion (12) and the distal end portion (13) thereof.

8. A catheter (11) according to any one of the preceding claims, in which the tubular wall (16) is continuous and without lateral apertures in the regions overlapped by the window openings (22) of the sweeping grid (19) .

9. A catheter (11) according to any one of the preceding claims, in which the sweeping grid (19) is formed by a plastic tube provided with cut out apertures forming the window openings (22) .

10. A catheter (11) according to any one of the preceding claims, in which the sweeping grid (19) is formed by a tubular mesh of wire (23) forming scraping bars (21) .

11. A catheter (11) according to claim 3, in which the scraping bars (21) form a scraping surface (24) which forms an obtuse angle (β) with the internal surface (17) exposed through the adjacent window opening (22) and converges in a sharp scraping edge (24) .

12. A catheter (11) according to claim 1, in which the actuating means (20) are configured to move the sweeping grid (19) intermittently.

13. A catheter (11) according to claim 1, in which the actuating means (20) are configured to move the sweeping grid (19) continuously.

14. A catheter (11) according to claim 1, in which the actuating means (20) comprise an electric motor formed by stator windings (25) connected to the tubular wall (16) and rotor magnets (26) or windings connected to the sweeping grid (19) .

15. A catheter (11) according to claim 1, in which the actuating means (20) comprise a linear micromotor (27), connected to the tubular wall (16) and adapted to engage and travel along a guide rail (28) formed on the sweeping grid (19) to move the sweeping grid (19) with respect to the tubular wall (16) .

16. A method for improving the patency of a catheter (11) for directing bili opancreat ic secretions, the catheter (11) comprising an elongate tubular wall (16) extending between a proximal end portion (12) and a distal end portion (13), the tubular wall (16) having an outer layer ( 17 ) ,

the method comprising the steps of:

- providing at least one sweeping grid (19) inside the fluid passage channel (18), and

- moving said sweeping grid (19) with respect to the tubular wall (16) thereby sweeping the internal surface (17) .