WO2013004262A1

WO2013004262A1 - A catheter, particularly for directing biliopancreatic secretions

Info

Publication number: WO2013004262A1
Application number: PCT/EP2011/061103
Authority: WO
Inventors: Michele D'arcangelo
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-07-01
Filing date: 2011-07-01
Publication date: 2013-01-10

Abstract

A catheter (11) for directing biliopancreatic secretions comprises an elongate tubular wall (16) with an internal surface (17) which defines a fluid passage channel (18), and a plurality of agitation members (19) captively arranged inside the fluid passage channel (18) and adapted to move with respect to the tubular wall (16) in response to a flow of a liquid through the fluid passage channel (18).

Description

DESCRIPTION

"A CATHETER, PARTICULARLY 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 A1. The known system comprises a conduit having a first end which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract and a second end attached to the ampulla of Vater.

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 bil iopancreatic j uices wou ld lead to complications, such as jau nd ice 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 im mu ne system and also from the mechanical shearing effect of the bile flow through the catheter. I n addition, commonly found microorganisms in the sludge, such as Escherichia coli, can produce β-glucoronidase, 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 flu id 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, and a plurality of agitation members captively arranged inside the fluid passage channel and configured to move with respect to the tubular wall in response to a flow of a liquid through the fluid passage channel.

During the passage of a bodily fluid, for example bile, through the catheter the agitation members (or in other words the "unrest" members) are at least partially exposed to the flow and induced to move (dragged by the flow) with respect to the tubular wall, thereby impeding the deposition of sediment and harboring of bacteria inside the fluid passage channel. Moreover, the flow induced movements of the agitation members can create local turbulence which also impedes depositions and incrustations inside the catheter. As a resu lt, the catheter patency can be significantly improved and the duration of the catheter is increased.

Within the present description, the expression "captively arranged inside the fluid passage channel" means that the agitation members cannot leave the catheter or be carried away by the flow of bodily fluid through the fluid passage channel.

In accordance with an aspect of the invention, the agitation members are fixed inside the fluid passage channel in a manner that they cannot translate in a catheter longitudinal direction.

In accordance with a further aspect of the invention, the agitation members are supported and configured to rotate in response to the flow of liquid through the fluid passage channel.

In accordance with an aspect of the invention, the agitation members comprise a plurality of roller-elements, particularly balls, supported by a generally tubular cage arranged concentrically inside the tubular wall such that it holds the roller elements adjacent the internal surface of the tubular wall.

The flow induced rotation of the roller elements act as a self cleaning mechanism that will continuously scrap away deposits and sludge from the roller-element surface and break growing encrustations from the small interstices between two adjacent roller-elements.

I n accordance with a further aspect of the invention, the agitation members comprise a plurality of blade wheels, particularly impellers, rotatable about a longitudinal axis which is substantially coaxial with the tubular wall.

The flow of bodily fluid inside the fluid passage channel drives the blade wheels to rotate about the longitudinal axis, thereby creating turbulence and local flow accelerations adjacent to the internal surface of the tubular wall that impede stagnation, harboring of bacteria and sediment and subsequent clogging 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 Gl tract of a patient;

- Figure 2 illustrates a detail of the catheter in accordance with an embodiment;

- Figure 3 is a longitudinal cross-section of a portion of a catheter for directing biliopancreatic juices in accordance with an embodiment;

- Figure 4 is a perspective view of a component of the catheter in figure 3;

- Figure 5 is a schematic illustration of a working principle of the catheter in figure 3;

- F i g u re 6 i s a perspective view of a portion of a catheter for directing biliopancreatic juices (part of a tu bu lar wal l of the catheter is removed) i n accordance with a further embodiment;

- Figure 7 is a schematic illustration of a working principle of the catheter in figure 6;

- Figure 8 is a perspective transparent view of a portion of an alternative catheter concept for directing biliopancreatic juices.

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 gastrointesti nal 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 1 1 for modifying the location at which biliopancreatic secretions interact with nutrients and with the intestinal wall in a gastrointestinal tract.

The catheter 1 1 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 1 1 .

The catheter distal end portion 13 forms one or more bile outlet openings 15 through which the biliopancreatic juices are released into the intestine.

I n accordance with an aspect of the invention, the catheter 1 1 comprises an elongate tubular wall 16 extending between the proximal end portion 12 and the distal end portion 1 3 and having an internal surface 1 7 which defines a fluid passage channel 18 of the catheter 1 1 . A plurality of agitation members 19 is captively arranged inside the fluid passage channel 18 and configured to move with respect to the tubular wall 16 in response to a flow of a liquid through the fluid passage channel 18.

During the passage of a bodily fluid, for example bile and or pancreatic secretions, through the catheter 1 1 the agitation members 19 are at least partially exposed to the flow and induced to move (dragged by the flow) with respect to the tubular wall 16, thereby impeding the deposition of sediment and harboring of bacteria inside the fluid passage channel 18. Moreover, the flow induced movements of the agitation members 19 can create local turbulences which also impede depositions and incrustations inside the catheter. As a result, the catheter patency can be significantly improved and the duration of the catheter is increased.

Within the present description, the expression "captively arranged inside the fluid passage channel" means that the agitation members 19 cannot leave the catheter or be carried away by the flow of bodily fluid through the fluid passage channel 18. In accordance with an embodiment, the agitation members 19 are fixed inside the fluid passage channel 18 in a manner that they cannot translate in a catheter 1 1 longitudinal direction. The agitation members 19 may be supported and configured to rotate in response to the flow of liquid through the fluid passage channel 18. In accordance with an exemplary embodiment (Figures 3 - 5), the agitation members 19 comprise a plurality of roller-elements, particularly balls 20, supported by a generally tubular cage 21 arranged concentrically inside the tubular wall 16 such that it holds the roller elements adjacent the internal surface 17 of the tubular wall 16. The roller elements may be arranged in a manner that radially internal sides 23 of the roller elements face inside the fluid passage channel 18 and are exposed to the flow of bodily fluid (arrow 22 in Figure 5), while radially external sides 24 of the roller elements are less exposed to the flow 22 of bodily fluid or partially or completely shielded from the flow 22, such that the unilateral thrust of the flow on the roller elements impel a spinning movement to the latter.

The cage 21 may be formed by a thin walled tubular profile of plastic material with a (preferably regular) pattern of radial substantially circular holes 25 wherein the smallest distance between two adjacent holes 25 is smaller than the diameter of at least one of the two holes 25. Preferably, the roller-elements, particularly the balls 20, are held between the cage 21 and the tubular wall 16 and the radial holes 25 in the cage 21 have a diameter which is smaller than the largest diameter of the ball 20 received therein, such that the ball 20 cannot escape through the hole 25.

The internal surface 17 of the tubular wall 16 may comprise impressions 26 which partially receive the roller-elements and which have a complementary shape to the shape of the roller-elements, e.g. spherical cap-shaped impressions 26 in the case of spheres 20.

In accordance with a further exemplary embodiment (Figures 6, 7), the agitation members 19 may comprise a plurality of blade wheels 27, such as e.g. impellers, which are arranged to rotate about a longitudinal axis L substantially coaxial with the tubular wall 16.

The individual blade wheels 27 may comprise an annular or tubular hub portion 28 rotatably supported by an axle 30 and a plurality of blades 29 protruding outward from the hub portion 28 and towards the tubular wall 16. The blades 29 are inclined with respect to the axle 30 and, hence, with respect to the direction of flow through the catheter 1 1 in a manner that the thrust of the flow through the catheter 1 1 is transformed in a rotational movement of the blade wheels 27. The axle 30 may be supported and positioned with respect to the tubular wall 16 by two or more support frames 31 , e.g. cross frames connected to the tubular wall 16 and forming a seat 32, e.g. a ring shaped swivel seat, which receives a free end or an intermediate section of the axle 30. The blade wheels 27 may be inserted over the axle 30 and tubular spacers 32 (also inserted over the axle 30) may be provided between respectively two consecutive blade wheels 27 to position them at a desired pitch.

The flow 22 of bodily fluid inside the fluid passage channel 18 drives the blade wheels 27 to rotate about the longitudinal axis L, thereby creating turbulence and local flow accelerations adjacent to the internal surface 17 of the tubular wall 16 that impede stagnation, harboring of bacteria and clogging of the catheter 1 1 .

Even though the agitation members 19 are moved by the flow 22 of bodily fluids th rough th e fl u id passage ch an n el 1 8 , i n accorda nce with a yet fu rth er embodiment, actuation means 32 may be provided which are adapted to move the agitation members 19 with respect to the tubular wall 16 independently from a flow through the flow passage channel 18. This makes it possible to actively clean the fluid passage channel of the catheter.

In accordance with an embodiment, the actuating means 32

may comprise e.g. electromagnetic motor means or piezoelectric motor means and 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 32. Alternatively, the actuation means 32 may be manually operable to forcedly move the agitation members 19. To this end, a manual actuation portion connected with at least some of the agitation members 19 may protrude outside the catheter 1 1 such that it can be engaged and moved by means of a surgical instrument, e.g. an endoluminal grasper or laparoscopic grasper.

The tubular wall 1 6 and also a hold ing structure for the agitation members, particularly the cage 21 in the figure 3 embodiment and also the axle 30 in the figure 6 embodiment, may be advantageously flexible to facilitate the implantation of the catheter 1 1 and to better follow the physiological structures to which the catheter 1 1 is applied. The tubular wall 16 may be grafted at least partially in silicone, polyethylene, polypropylene, butylated rubber, latex and the like. The tubular wall 16 or the cage 20 may comprise an inner coating which forms the internal surface 17 of PTFE or Dacron (Polyethylene terephthalate) to provide a low friction and inert biocompatible surface for the biliary fluid to flow through.

In order to increase torque-, kink- and compression resistance of the catheter 1 1 , 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 tu bular wal l 1 6 base material (e.g. polyethylene).

Figure 8 illustrates a portion of an alternative catheter 33, having an elongate tubular wall 16 with an internal surface 17 which defines a fluid passage channel 18 of the catheter 33. One or more helical flow deviation members 34 are arranged inside the fluid passage channel 18 to create a locally turbulent flow of the bodily fluid through the fluid passage channel 18. The flow deviation members 34 may be stationary or rotatable with respect to the tubular wall 16.

During the passage of a bodily fluid, for example bile and or pancreatic secretions, through the catheter 1 1 the locally turbulent flow impedes the deposition of sediment and harboring of bacteria inside the fluid passage channel 18.

The catheter 1 1 according to the invention can be installed endoluminally, e.g. transorally, in the intestine and the proximal end portion 12 of the catheter 1 1 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 1 1 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 1 1 in the intestine and introducing the catheter proximal end portion 12 in the papilla of Vater 10 by laparoscopically accessing the abdominal space, translumenally accessing the duodenum 3 near the papilla of Vater 10 and placing the catheter 1 1 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 1 1 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 (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) 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 plurality of agitation members (19) captively arranged inside the fluid passage channel (18) and adapted to move with respect to the tubular wall (16) in response to a flow of a liquid through the fluid passage channel (18).

2. A catheter (1 1 ) according to claim 1 , in which the agitation members (19) are fixed inside the fluid passage channel (18) in a manner that they cannot translate in a catheter (1 1 ) longitudinal direction.

3. A catheter (1 1 ) according to claim 1 or 2, comprising a generally tubular cage (21 ) arranged concentrically inside the tubular wall (16) and holding a plurality of rotatable roller-elements adjacent the internal surface (17), said rotatable roller- elements forming said agitation members (19).

4. A catheter (1 1 ) according to claim 3, in which the roller-elements comprise balls (20).

5. A catheter (1 1 ) according to claim 3, in which the roller elements are arranged in a manner that radially internal sides (23) of the roller elements face inside the fluid passage channel (18) and radially external sides (24) of the roller elements are at least partially or completely shielded from a flow (22) through the fluid passage channel (18).

6. A catheter (1 1 ) according to claim 4, in which the cage (21 ) is formed by a thin walled tubular profile of plastic material with a pattern of radial substantially circular holes (25), wherein the smallest distance between two adjacent holes (25) is smaller than the diameter of at least one of the two holes (25).

7. A catheter (1 1 ) according to claim 3, in which the internal surface (17) of the tubular wall (16) forms impressions (26) which partially receive the roller-elements and which have a complementary shape to the shape of the roller-elements.

8. A catheter (1 1 ) according to claim 1 or 2, in which the agitation members (19) comprise a plurality of blade wheels (27) arranged to rotate about a longitudinal axis (L) substantially coaxial with the tubular wall (16).

9. A catheter (1 1 ) according to claim 8, in which said blade wheels (27) form an hub portion (28) rotatably supported by an axle (30) and a plurality of blades (29) protruding from the hub portion (28) outward and towards the tubular wall (16), the blades (29) being inclined with respect to the axle (30).

10. A catheter (1 1 ) according to claim 9, in which the axle (30) is positioned with respect to the tubular wall (16) by at least two support frames (31 ) connected to the tubular wall (16) and forming a seat (32) which receives a section of the axle (30).

11. A catheter (1 1 ) according to claim 9, in which tubular spacers (32) are inserted over the axle (30) between consecutive blade wheels (27).

12. A catheter (1 1 ) according any one of the preceding claims, comprising actuation means (32) adapted to move the agitation members (19) with respect to the tubular wall (16) independently from a flow through the flow passage channel (18).

13. A catheter (1 1 ) according to claim 12, in which the actuating means (32) are manually operable to forcedly move the agitation members (19).

14. A catheter (1 1 ) according to any one of the preceding claims, in which the catheter (1 1 ) is flexible.

15. A method for i m provi ng the paten cy of a catheter ( 1 1 ) for d i recti ng biliopancreatic secretions, the catheter (1 1 ) 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), the method comprising the steps of:

- providing a plurality of agitation members (19) inside the fluid passage channel (18), and

- moving the agitation members (19) with respect to the tubular wall (1 6) in response to a flow of a liquid through the fluid passage channel (18).