WO2012007053A1 - A length adjustable catheter for directing biliopancreatic secretions - Google Patents

A length adjustable catheter for directing biliopancreatic secretions Download PDF

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Publication number
WO2012007053A1
WO2012007053A1 PCT/EP2010/060294 EP2010060294W WO2012007053A1 WO 2012007053 A1 WO2012007053 A1 WO 2012007053A1 EP 2010060294 W EP2010060294 W EP 2010060294W WO 2012007053 A1 WO2012007053 A1 WO 2012007053A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
flexible tube
wall
longitudinal axis
tube
Prior art date
Application number
PCT/EP2010/060294
Other languages
French (fr)
Inventor
Mark S. Zeiner
Thomas Edward Albrecht
Mark Steven Ortiz
Michele D'arcangelo
Alessandro Pastorelli
Michael J. Stokes
Christopher J. Hess
Original Assignee
Ethicon Endo-Surgery, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Priority to PCT/EP2010/060294 priority Critical patent/WO2012007053A1/en
Publication of WO2012007053A1 publication Critical patent/WO2012007053A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another

Definitions

  • 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.
  • metabolic disorders such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.
  • 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, wherein the length of the conduit at the first end is adjustable and can be shortened by trimming the conduit prior to insertion into a patients body or by pulling a filamentous member applied to the conduit so that the latter will shorten in an accordion style.
  • known conduit catheter can be shortened, it cannot be easily stretched or extended and, when shortened, the conduit doesn't maintain a desired shape and internal flow section.
  • known bile conveying catheters cannot adjust the length of the conduit tract along which biliopancreatic fluids are discharged in the intestine.
  • the known bile conveying catheters cannot be used for a differentiated variation of the discharge position of bile and pancreatic fluids.
  • An aim of the present invention is therefore to provide a catheter for diverting biliopancreatic secretions, wherein the catheter has adjustable discharge zones and obviates at least some of the problems and drawbacks discussed in connection with the prior art.
  • a catheter for directing biliopancreatic secretions comprising:
  • first flexible tube having a first longitudinal axis, the first flexible tube having a wall and first outlet holes formed in the wall;
  • one of the first and second flexible tube is slidingly translatable within the other one of the first and second flexible tube.
  • the relative translation of the first and second tube may telescope the catheter, thereby varying the position of the outlet holes.
  • a relative translation of the first and second tube can selectively cover one or more outlet holes, thereby adjusting the position of the bile discharge which takes place only through the open outlet holes.
  • At least one second outlet hole or slot may be formed in the wall of the second flexible tube, so that relative translation of the first and second tube can selectively overlap the second hole or slot with at least one of the first outlet holes.
  • one of the first and second flexible tube is rotatable about the longitudinal axis with respect to the other one of the first and second flexible tube, so that relative rotation of the first and second tube can selectively overlap the second hole or slot with at least one of the first outlet holes.
  • the catheter comprises at least one additional flexible tube telescopically engaging one of the first and second tube to adjust the length of the catheter.
  • a catheter for directing biliopancreatic secretions comprising:
  • first flexible tube having a first longitudinal axis, the first flexible tube having a wall and outlet holes formed in the wall;
  • first tubular adjustable section having a longitudinal axis substantially parallel to the first longitudinal axis, the first tubular adjustable section having a wall and first adjusting holes formed in the wall;
  • a second tubular adjustable section having a longitudinal axis substantially parallel to the first longitudinal axis, the second tubular adjustable section having a wall and second adjusting holes formed in the wall,
  • first and second adjustable sections are independently slidingly within the first flexible tube to selectively align the first and second adjusting holes with the outlet holes of the first flexible tube, thereby selectively adjusting two independent groups of outlet zones for biliopancretic fluid.
  • the first adjustable section may carry bile and the second adjustable section may carry pancreatic secretions.
  • a catheter for directing biliopancreatic secretions comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, the wall comprising stiffening frame segments forming stiffening lines and flexible membrane segments formed between the stiffening lines, wherein the flexible tube can be longitudinally extended and contracted and the stiffening frame segments and flexible membrane segments are configured to elastically resist against kinking and closure of the internal passage.
  • a catheter for directing biliopancreatic secretions comprising:
  • a proximal end portion adapted to be fluid connected to the common bile duct to collect biliopancreatic secretions, - a distal open end adapted to be placed in a location downstream in the gastrointestinal tract,
  • the catheter comprises adjustment activation means connected between a first point and a second point of the catheter and adapted to approximate the first point towards the second point and to move the second point away from the first point.
  • the adjustment activation means can operate a displacement of adjusting sections, telescoping lumens as well as a contracting deformation or extension deformation of a single tube.
  • the adjustment activation means can comprise a linear micromotor, such as a piezoelectric motor, connected to a push-pull rod or a series of a linear micromotors connected to push-pull rods or a linear micromotor engaging longitudinal guide means extending along the catheter longitudinal direction.
  • a linear micromotor such as a piezoelectric motor
  • the adjustment activation means may be remote controlled.
  • a catheter for directing biliopancreatic secretions comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall is folded back on itself to define a coaxial internal and external tubular portion and an annular folding line forming a distal open catheter end, said annular folding line being displaceable by translating the external tubular portion relative to the internal tubular portion.
  • a catheter for directing biliopancreatic secretions comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein a distal end section of the wall is rolled up and can be more or less unrolled to adjust the overall catheter length and the position of its distal open end in the intestinal tract.
  • a catheter for directing biliopancreatic secretions comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall comprises a plurality of modular reversibly connectable tubular segments which can be selectively assembled and disassembled to adjust and obtain the desired catheter length.
  • a catheter for directing biliopancreatic secretions comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall comprises a plurality of tubular segments which are exposure time dependent absorbable and adapted to operate a time dependent catheter length variation.
  • supplementary anchoring means may be provided to anchor the catheter in a location in the Gl tract proximal to the papilla of Vater. This creates a redundant fixation of the catheter to better resist against peristalsis forces.
  • FIG. 1 illustrates a catheter for directing biliopancreatic juices implanted in the Gl tract of a patient
  • Figu re 2 illustrates a detail of a catheter for directing biliopancreatic juices in accordance with an embodiment of the invention
  • FIG. 2A illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention
  • - Figure 3 il lustrates a detai l of a catheter for d irecting biliopancreatic juices in accordance with a further embodiment of the invention
  • - Figure 4A illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention
  • FIG. 4B is a schematic side view of a portion of the catheter in figure 4A in an extended configuration
  • FIG. 4C is a schematic side view of a portion of the catheter in figure 4A in a retracted configuration
  • FIG. 5 illustrates a detail of a catheter for di recting bi liopancreatic juices in accordance with a further embodiment of the invention
  • FIG. 6A illustrates a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention
  • FIG. 6B shows a detail of the catheter in figure 6A
  • FIG. 6C illustrates a detail of the catheter in figure 6A and an adjustment tool in accordance with an embodiment of the invention
  • Figu re 7 is a longitudinal sectional view of a detail of a catheter for d irecting biliopancreatic juices in accordance with a further embodiment of the invention.
  • Figu re 8 illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention
  • FIG. 9 illustrates a detail of a catheter for d i recti ng biliopancreatic juices in accordance with a further embodiment of the invention.
  • FIG. 1 0 illustrates a catheter for directing biliopancreatic juices and supplementary anchoring means in accordance with a further embodiment of the invention
  • FIG. 1 1 illustrates supplementary anchoring means in accordance with a further embodiment of the invention.
  • 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 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 22 adapted to be fluid connected to the common bile duct 7 to collect biliopancreatic secretions and a distal end portion 17 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 22 may have only one proximal open end 15 which can be arranged and anchored (e.g.
  • the proximal end portion 22 may be bifurcated or Y-shaped and define a proximal open bile end 15 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 1 5' intended and adapted to be inserted in the pancreatic duct 7.
  • a Y-shaped proximal end portion 22 allows 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 17 forms one or more bile outlet openings 13 and the catheter 1 1 is adapted to adjust the position in which the biliopancreatic juices are released through the outlet openings 13 into the intestine 3, 4, 5.
  • the catheter 1 1 comprises a first outer flexible tube 12 having a first longitudinal axis and first outlet holes 13 formed in the flexible tube wall and a second inner flexible tube 14 having a second longitudinal axis substantially parallel to the first longitudinal axis, wherein the second flexible tube 14 is slidingly translatable within the outer flexible tube 12 or vice versa so that a relative translation of the first 12 and second tube 14 may telescope the catheter 1 1 , thereby adjusting the position of the outlet holes 13.
  • a relative translation of the first 12 and second tube 14 can selectively cover (and obstruct) one or more outlet holes 13, thereby adjusting the position of the bile discharge which takes place only through the free outlet holes 13.
  • At least one second outlet hole or slot 18 may be formed in the wall of the second flexible tube 14, so that relative translation of the first 12 and second tube 14 can selectively overlap the second hole or slot 18 with at least one of the first outlet holes 13.
  • one of the first 12 and second flexible tube 14 (particularly the inner tube 14) may be rotatable about the longitudinal axis with respect to the other one of the first 12 and second flexible tube 14 for selectively overlapping the second hole or slot 18 with at least one of the first outlet holes 13. This allows a high number of combinations of free and obstructed outlet holes 13 and, accordingly, a versatile adaptability and variation of the bile discharge position and length in the intestine 3, 4, 5.
  • the catheter 1 1 may comprise at least one additional flexible tube 19 which is telescopically attached to one of the first 12 and second tube 14 for an additional variation of the length of the catheter 1 1.
  • the relative translation of the additional telescoping tube 19 is adapted to effect a coarse length adjustment of catheter 1 1
  • the relative movement between the outer tube 12 and inner tube 14 is adapted to effect a fine adjustment of the bile discharge position and discharge space extension.
  • the catheter 1 1 comprises a first outer flexible tube 12 having a first longitudinal axis and first outlet holes 13 formed in the flexible tube wall.
  • a first 20 and second tubular adjustable section 21 having both longitudinal axes substantially parallel to the first longitudinal axis of outer tube 12 are received inside the proximal end portion 17 of the outer tube 12 and the first and second adjustable sections 20, 21 are independently slidingly within the outer flexible tube 12 to selectively open and obstruct at least two different groups of the bile outlet holes 13.
  • the first tubular adjustable section 20 forms first adjusting holes in a wall adjacent the wall of outer tube 12 and the second tubular adjustable section 21 forms second adjusting holes in a wall adjacent the wall of outer tube 12, so that a translation of the first and second adjustable sections 20, 21 within the outer flexible tube 12 selectively overlaps the first and second adjusting holes with the bile outlet holes 13 of the outer tube 12, thereby selectively setting two independent groups of outlet zones for biliopancretic secretions.
  • the first adjustable section 20 may be fluid connected with a bile collecting end 15 of the proximal end portion 22 of the catheter 1 1 and, thus, carry bile
  • the second adjustable section 21 may be fluid connected with a pancreatic secretions collecting end 15' of the proximal end portion 22 of the catheter 1 1 and, thus, carry pancreatic secretions. I n this way, it is possible to collect bile and pancreatic fluids isolated from one another and to dispense them independently in adjustable positions and spaces inside the intestine 3, 4, 5.
  • Figures 4A to 4C illustrate an embodiment, in which the catheter 1 1 comprise a flexible tube 23 having a longitudinal axis and a wall 24 defining an internal passage 25.
  • the wall 24 comprises stiffening frame segments 26 which form stiffening lines and flexible membrane segments 27 formed between the stiffening lines.
  • the flexible tube 23 can be longitudinally extended and contracted and the stiffening frame segments 26 and flexible membrane segments 27 are configured to elastically resist against kinking and closure of the internal passage 25.
  • the stiffening frame segments may comprise preformed folding lines in the tube wall 24, a helical wound stiffening wire, e.g. made of stainless steel, NiTi alloy, polyurethane, or a helical interwoven stiffening filament, such as a cylindrical, helically wound biaxial braid, also known as "Chinese finger trap" structure.
  • a helical wound stiffening wire e.g. made of stainless steel, NiTi alloy, polyurethane
  • a helical interwoven stiffening filament such as a cylindrical, helically wound biaxial braid, also known as "Chinese finger trap" structure.
  • the catheter 1 1 comprises a group of concentrically telescopically assembled tube sections 28, 28', 28" connected between the proximal end portion 22 and a distal end 16 and translatable to each other to adjust the overall length of the catheter 1 1 .
  • the adjustment of the catheter length and or the adjustment of the opening and closure of a plurality of bile outlet holes 13 can be accomplished at the time of insertion of the catheter 1 1 based on the patients anatomy or, alternatively or additionally, the bile discharge position in the intestine may be adjusted post surgically as a step of a therapy optimization or therapy adaption.
  • the catheter 1 1 comprises adjustment activation means connected between a first point 29 and a second point 30 of the catheter 1 1 and adapted to approximate the first point 29 towards the second point 30 and/or to move the second point 30 away from the first point 29.
  • adjustment activation means are only schematically illustrated in figure 5, they can be analogously integrated in all other illustrated and described exemplary embodiments and my accomplish a relative displacement of adjusting sections, telescoping lumens as well as a contracting deformation or extension deformation of a single tube of catheter 1 1.
  • the adjustment activation means can comprise a linear micromotor 31 , such as a piezoelectric motor, connected to a push-pull rod 32 or a series of a linear micromotors 31 connected to push-pull rods 32 or a linear micromotor engaging and adapted to travel along a longitudinal guide rail extended in the catheter 1 1 longitudinal direction.
  • 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 push-pull rod 32 which is then moved in a linear direction.
  • An exemplary, non limiting example of such a piezoelectric motor is the P-652- series PILine® ultrasonic motor linear slides.
  • the adjustment activation means may be remote controlled, e.g. by means of wireless RF signal communication between an extracorporeal control unit 33 and a local controller 34 associated with the adjustment actuating means.
  • the catheter 1 1 comprises a flexible tube 39 having a longitudinal axis and a wall defining an internal passage 40, wherein a distal end portion 17 of the wall is rolled up and can be more or less unrolled to adjust the overall catheter length and the position of its distal open end 16 (which is formed by the roll).
  • the length adjustment of tube 39 can be accomplished extracorporeal ⁇ before deployment of the catheter 1 1 or endoluminally by means of an endoscope and a grasper or pusher 42 which can be inserted through an instrument channel 43 and comprises a embracement portion adapted to hold and move the rolled portion allowing it to slide inside the embracement portion.
  • the flexible tube 39 may be configured to be elastically biased in a rolled, i.e. shortened, configuration and comprises locking means, such as one or more clips, adapted prevent the tube 39 from rolling back, thereby holding it in a partially o completely rolled out configuration.
  • Figure 7 shows an embodiment, in which the catheter 1 1 comprises a flexible tube 44 having a longitudinal axis and a wall defining an internal passage 45, wherein the wall comprises a plurality of modular reversibly connectable tubular segments 46 which can be selectively assembled (e.g. by shape coupling, interference coupling, snap fit) and disassembled to adjust and obtain the desired catheter length.
  • the individual modular segments 46 may be made of different materials for different requirements, such as absorbable materials, radio opaque materials, materials with radio opaque coating or additives (e.g. barium sulfate) or ultrasound opaque coating so that the catheter or selected portions of the catheter can be localized by ultrasound or radiography.
  • Figure 8 illustrates an embodiment in which the catheter 1 1 , particularly the distal end portion 17 comprises a plurality of tubular segments 47 which have different exposure time dependent absorbability characteristics, ada pted to operate a preset time dependent catheter length variation.
  • Figure 9 illustrate an embodiment, in which the catheter 1 1 comprises a flexible tube 35 having a longitudinal axis and a wall defining an internal passage 36, wherein the wall is folded back on itself to define a coaxial internal 37 and external tubular portion 38 and an annular folding line forming a distal open catheter end 16, said annular folding line being displaceable by translating the external tubular portion 38 relative to the internal tubular portion 37.
  • the catheter 1 1 may have a series outlet openings spaced in the longitudinal direction and individually activatable micro valves associated to each outlet opening and adapted to selectively open and close the outlet openings, thereby adjusting the bile discharge position and space in the intestine.
  • Various means such as bile collecting stents or catheter anchoring stents can be provided for connecting the proximal end 15 of the catheter 1 1 in fluid communication with the bile duct 7.
  • supplementary anchoring means may be provided to anchor the catheter 1 1 in a location in the Gl tract proximal to the papilla of Vater 10. This creates a redundant fixation of the catheter 1 1 to better resist against peristalsis forces.
  • Figure 10 shows a gastric coil 48 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to an arched or circular configuration adapted to shape connect with the stomach 2 such as to provide an anchor for a pull resistant anchoring wire 49 which is connected to the catheter 1 1.
  • the anchoring wire 49 can be connected, e.g. by means of T-tags, to a previously created plication 50 in the stomach wall.
  • the catheter 1 1 may be made of any material that may be absorbable by the body such as polyglycolated resins, polygalactic acid materials, and other similar materials or nonabsorbable materials such as silicone, polyethylene, polypropylene, butylated rubber, latex, and the like.
  • the catheter 1 1 can be installed endoluminally, e.g. transorally, in the intestine and the proximal end 15 of of the catheter 1 1 may be inserted in the papilla of Vater using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique.
  • the ERCP procedure involves passing a flexible endoscope through the mouth, esophagus, and stomach into the duodenum 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 and inserts it into the papilla of Vater.
  • the present invention further contemplates the possibility of placing the catheter 1 1 in the intestine and introducing the catheter proximal end 15 in the papilla of Vater 10 by laparoscopically accessing the abdominal space, translu menally accessing the duodenum near the papilla of Vater and placing the catheter 1 1 through the duodenum i n th e desi red position with i n th e i ntesti ne an d , from i n sid e th e d uod en u m , laparoscopically introducing the conduit proximal end 15 into the papilla of Vater.
  • the system and methods of the described invention can achieve a selective variation of the location and space at which enzymatic fluids interact with the intestinal wall and with nutrients from food fluids in the Gl tract.
  • less nutrients from the food fluids will be absorbed by the body, the effectiveness of enzyme and emulsifying reagent reacting with the food fluids will be decreased, and more of the food fluids will be excreted resulting in a weight loss.
  • the altered contact space and time between the biliopancreatic juices and the intestinal wall acts on the physiological signaling mechanism of the patient, thereby influencing d iabetes and other comorbidities of obesity.

Abstract

A catheter (11) for directing biliopancreatic secretions comprises a first flexible tube (12) having a first longitudinal axis, the first flexible tube (12) having a wall and first outlet holes (13) formed in the wall, and a second flexible tube (14) having a second longitudinal axis substantially parallel to the first longitudinal axis, wherein one of the first and second flexible tube is slidingly translatable within the other one of the first and second flexible tube.

Description

"A LENGTH ADJUSTABLE CATHETER FOR DIRECTING BILIOPANCREATIC
SECRETIONS"
DESCRIPTION
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.
Su rgica l methods of treating morbid obesity, such as open , la paroscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food, have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally highly invasive modifications of the patients gastrointestinal anatomy. These procedures are reserved only for the severely obese patients because they have a number of significant complications, including the risk of death. In order to avoid the drawbacks of gastric bypass surgery and to influence the digestion of a patient in a more specific and aimed way, the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract itself. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:
- modification of the entero-hepatic bile cycling frequency, particularly bile cycle acceleration;
- modification of the physiological signaling triggered by the contact and interaction of the bile with the food in the intestine and by the contact of the bile with the intestinal wall;
- modification of the food absorbability by modifying the contact space and time between the bile and the food or chime in the intestine as well as by an aimed separation of the bile from the food.
A known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 . The known system comprises a conduit having a first end which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract and a second end attached to the ampulla of Vater, wherein the length of the conduit at the first end is adjustable and can be shortened by trimming the conduit prior to insertion into a patients body or by pulling a filamentous member applied to the conduit so that the latter will shorten in an accordion style.
While the known conduit catheter can be shortened, it cannot be easily stretched or extended and, when shortened, the conduit doesn't maintain a desired shape and internal flow section. Moreover, known bile conveying catheters cannot adjust the length of the conduit tract along which biliopancreatic fluids are discharged in the intestine. Also, the known bile conveying catheters cannot be used for a differentiated variation of the discharge position of bile and pancreatic fluids.
An aim of the present invention is therefore to provide a catheter for diverting biliopancreatic secretions, wherein the catheter has adjustable discharge zones and obviates at least some of the problems and drawbacks discussed in connection with the prior art.
This aim is achieved by a catheter for directing biliopancreatic secretions, the catheter comprising:
- a first flexible tube having a first longitudinal axis, the first flexible tube having a wall and first outlet holes formed in the wall; and
- a second flexible tube having a second longitudinal axis substantially parallel to the first longitudinal axis,
wherein one of the first and second flexible tube is slidingly translatable within the other one of the first and second flexible tube.
The relative translation of the first and second tube may telescope the catheter, thereby varying the position of the outlet holes.
Moreover, a relative translation of the first and second tube can selectively cover one or more outlet holes, thereby adjusting the position of the bile discharge which takes place only through the open outlet holes.
In accordance with an aspect of the invention, at least one second outlet hole or slot may be formed in the wall of the second flexible tube, so that relative translation of the first and second tube can selectively overlap the second hole or slot with at least one of the first outlet holes.
In accordance with a further aspect of the invention, one of the first and second flexible tube is rotatable about the longitudinal axis with respect to the other one of the first and second flexible tube, so that relative rotation of the first and second tube can selectively overlap the second hole or slot with at least one of the first outlet holes.
In accordance with a further aspect of the invention, the catheter comprises at least one additional flexible tube telescopically engaging one of the first and second tube to adjust the length of the catheter.
This aim of the invention is also achieved by a catheter for directing biliopancreatic secretions, the catheter comprising:
- a first flexible tube having a first longitudinal axis, the first flexible tube having a wall and outlet holes formed in the wall; and
- a first tubular adjustable section having a longitudinal axis substantially parallel to the first longitudinal axis, the first tubular adjustable section having a wall and first adjusting holes formed in the wall; and
- a second tubular adjustable section having a longitudinal axis substantially parallel to the first longitudinal axis, the second tubular adjustable section having a wall and second adjusting holes formed in the wall,
wherein the first and second adjustable sections are independently slidingly within the first flexible tube to selectively align the first and second adjusting holes with the outlet holes of the first flexible tube, thereby selectively adjusting two independent groups of outlet zones for biliopancretic fluid.
In accordance with an aspect of the invention, the first adjustable section may carry bile and the second adjustable section may carry pancreatic secretions.
The aim of the invention is also achieved by a catheter for directing biliopancreatic secretions, the catheter comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, the wall comprising stiffening frame segments forming stiffening lines and flexible membrane segments formed between the stiffening lines, wherein the flexible tube can be longitudinally extended and contracted and the stiffening frame segments and flexible membrane segments are configured to elastically resist against kinking and closure of the internal passage.
This allows to stretch or contract a single flexible tube, for instance in an accordion or bellows like manner, and obviate the risk of kinking and closure of the internal lumen due to overlapping bending of the tube wall.
The aim of the invention is also achieved by a catheter for directing biliopancreatic secretions, the catheter comprising:
- a proximal end portion adapted to be fluid connected to the common bile duct to collect biliopancreatic secretions, - a distal open end adapted to be placed in a location downstream in the gastrointestinal tract,
- a group of concentrically telescopically assembled tube sections connected between the proximal end portion and the distal open end and translatable to each other to adjust the overall length of the catheter.
I n accordance with an aspect of the invention, the catheter comprises adjustment activation means connected between a first point and a second point of the catheter and adapted to approximate the first point towards the second point and to move the second point away from the first point.
The adjustment activation means can operate a displacement of adjusting sections, telescoping lumens as well as a contracting deformation or extension deformation of a single tube.
In accordance with an aspect of the invention, the adjustment activation means can comprise a linear micromotor, such as a piezoelectric motor, connected to a push-pull rod or a series of a linear micromotors connected to push-pull rods or a linear micromotor engaging longitudinal guide means extending along the catheter longitudinal direction.
In accordance with a further embodiment, the adjustment activation means may be remote controlled.
The aim of the invention is also achieved by a catheter for directing biliopancreatic secretions, the catheter comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall is folded back on itself to define a coaxial internal and external tubular portion and an annular folding line forming a distal open catheter end, said annular folding line being displaceable by translating the external tubular portion relative to the internal tubular portion.
The aim of the invention is further achieved by a catheter for directing biliopancreatic secretions, the catheter comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein a distal end section of the wall is rolled up and can be more or less unrolled to adjust the overall catheter length and the position of its distal open end in the intestinal tract.
The aim of the invention is further achieved by a catheter for directing biliopancreatic secretions, the catheter comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall comprises a plurality of modular reversibly connectable tubular segments which can be selectively assembled and disassembled to adjust and obtain the desired catheter length.
The aim of the invention is further achieved by a catheter for directing biliopancreatic secretions, the catheter comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, wherein the wall comprises a plurality of tubular segments which are exposure time dependent absorbable and adapted to operate a time dependent catheter length variation.
By selectively setting the location at which enzymatic fluids interact with nutrients from food fluids in the Gl tract, less nutrients from the food fluids will be absorbed by the body, the effectiveness of enzyme and emulsifying reagent reacting with the food fluids will be decreased, and more of the food fluids will be excreted resulting in a weight loss. Thus, the proportion of absorbed food fluids to excreted food fluids is changed which results in the weight loss. Additionally, the adjustable contact space between biliopancreatic juices and the intestinal wall will influence the physiological signaling mechanism and the bile cycling time of the patient which can have beneficial effects on the control of diabetes. Various means, such as bile collecting stents or catheter anchoring stents can be provided for connecting a proximal open end of the catheter in fluid communication with the bile duct.
In accordance with a further aspect of the invention, supplementary anchoring means may be provided to anchor the catheter in a location in the Gl tract proximal to the papilla of Vater. This creates a redundant fixation of the catheter to better resist against peristalsis forces.
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;
- Figu re 2 illustrates a detail of a catheter for directing biliopancreatic juices in accordance with an embodiment of the invention;
- Figure 2A illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention;
- Figure 3 il lustrates a detai l of a catheter for d irecting biliopancreatic juices in accordance with a further embodiment of the invention; - Figure 4A illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention;
- Figure 4B is a schematic side view of a portion of the catheter in figure 4A in an extended configuration;
- Figure 4C is a schematic side view of a portion of the catheter in figure 4A in a retracted configuration;
- Figure 5 illustrates a detail of a catheter for di recting bi liopancreatic juices in accordance with a further embodiment of the invention;
- Figure 6A illustrates a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention;
- Figure 6B shows a detail of the catheter in figure 6A;
- Figure 6C illustrates a detail of the catheter in figure 6A and an adjustment tool in accordance with an embodiment of the invention;
- Figu re 7 is a longitudinal sectional view of a detail of a catheter for d irecting biliopancreatic juices in accordance with a further embodiment of the invention;
- Figu re 8 illustrates a detail of a catheter for directing biliopancreatic juices in accordance with a further embodiment of the invention;
- Figure 9 illustrates a detail of a catheter for d i recti ng biliopancreatic juices in accordance with a further embodiment of the invention;
- Figure 1 0 illustrates a catheter for directing biliopancreatic juices and supplementary anchoring means in accordance with a further embodiment of the invention;
- Figure 1 1 illustrates supplementary anchoring means in accordance with a further embodiment of the invention.
Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, figure 1 is a partial view of the abdominal cavity of a patient, depicting the 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 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 22 adapted to be fluid connected to the common bile duct 7 to collect biliopancreatic secretions and a distal end portion 17 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 22 may have only one proximal open end 15 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 22 may be bifurcated or Y-shaped and define a proximal open bile end 15 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 1 5' intended and adapted to be inserted in the pancreatic duct 7. Such a Y-shaped proximal end portion 22 allows 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 17 forms one or more bile outlet openings 13 and the catheter 1 1 is adapted to adjust the position in which the biliopancreatic juices are released through the outlet openings 13 into the intestine 3, 4, 5.
In accordance with an embodiment (Figure 2), the catheter 1 1 comprises a first outer flexible tube 12 having a first longitudinal axis and first outlet holes 13 formed in the flexible tube wall and a second inner flexible tube 14 having a second longitudinal axis substantially parallel to the first longitudinal axis, wherein the second flexible tube 14 is slidingly translatable within the outer flexible tube 12 or vice versa so that a relative translation of the first 12 and second tube 14 may telescope the catheter 1 1 , thereby adjusting the position of the outlet holes 13.
Moreover, a relative translation of the first 12 and second tube 14 can selectively cover (and obstruct) one or more outlet holes 13, thereby adjusting the position of the bile discharge which takes place only through the free outlet holes 13.
In accordance with a further exemplary embodiment (Figure 2A), at least one second outlet hole or slot 18 may be formed in the wall of the second flexible tube 14, so that relative translation of the first 12 and second tube 14 can selectively overlap the second hole or slot 18 with at least one of the first outlet holes 13. Alternatively or additionally, one of the first 12 and second flexible tube 14 (particularly the inner tube 14) may be rotatable about the longitudinal axis with respect to the other one of the first 12 and second flexible tube 14 for selectively overlapping the second hole or slot 18 with at least one of the first outlet holes 13. This allows a high number of combinations of free and obstructed outlet holes 13 and, accordingly, a versatile adaptability and variation of the bile discharge position and length in the intestine 3, 4, 5.
In accordance with a further development of the embodiments of figure 2 and figure 2A, the catheter 1 1 may comprise at least one additional flexible tube 19 which is telescopically attached to one of the first 12 and second tube 14 for an additional variation of the length of the catheter 1 1.
In this context, it is contemplated that the relative translation of the additional telescoping tube 19 is adapted to effect a coarse length adjustment of catheter 1 1 , while the relative movement between the outer tube 12 and inner tube 14 is adapted to effect a fine adjustment of the bile discharge position and discharge space extension.
In accordance with a further embodiment (Figure 3), the catheter 1 1 comprises a first outer flexible tube 12 having a first longitudinal axis and first outlet holes 13 formed in the flexible tube wall. A first 20 and second tubular adjustable section 21 having both longitudinal axes substantially parallel to the first longitudinal axis of outer tube 12 are received inside the proximal end portion 17 of the outer tube 12 and the first and second adjustable sections 20, 21 are independently slidingly within the outer flexible tube 12 to selectively open and obstruct at least two different groups of the bile outlet holes 13. In accordance with an embodiment, the first tubular adjustable section 20 forms first adjusting holes in a wall adjacent the wall of outer tube 12 and the second tubular adjustable section 21 forms second adjusting holes in a wall adjacent the wall of outer tube 12, so that a translation of the first and second adjustable sections 20, 21 within the outer flexible tube 12 selectively overlaps the first and second adjusting holes with the bile outlet holes 13 of the outer tube 12, thereby selectively setting two independent groups of outlet zones for biliopancretic secretions.
For example, the first adjustable section 20 may be fluid connected with a bile collecting end 15 of the proximal end portion 22 of the catheter 1 1 and, thus, carry bile, and the second adjustable section 21 may be fluid connected with a pancreatic secretions collecting end 15' of the proximal end portion 22 of the catheter 1 1 and, thus, carry pancreatic secretions. I n this way, it is possible to collect bile and pancreatic fluids isolated from one another and to dispense them independently in adjustable positions and spaces inside the intestine 3, 4, 5.
Figures 4A to 4C illustrate an embodiment, in which the catheter 1 1 comprise a flexible tube 23 having a longitudinal axis and a wall 24 defining an internal passage 25. The wall 24 comprises stiffening frame segments 26 which form stiffening lines and flexible membrane segments 27 formed between the stiffening lines. The flexible tube 23 can be longitudinally extended and contracted and the stiffening frame segments 26 and flexible membrane segments 27 are configured to elastically resist against kinking and closure of the internal passage 25.
In accordance with exemplary embodiments, the stiffening frame segments may comprise preformed folding lines in the tube wall 24, a helical wound stiffening wire, e.g. made of stainless steel, NiTi alloy, polyurethane, or a helical interwoven stiffening filament, such as a cylindrical, helically wound biaxial braid, also known as "Chinese finger trap" structure.
This allows to lengthen or shorten the flexible tube 23, for instance in an accordion or bellows like manner, and obviate the risk of kinking and closure of the internal passage 25 due to overlapping bending of the tube wall 24.
I n accordance with a further embodiment, the catheter 1 1 comprises a group of concentrically telescopically assembled tube sections 28, 28', 28" connected between the proximal end portion 22 and a distal end 16 and translatable to each other to adjust the overall length of the catheter 1 1 .
The adjustment of the catheter length and or the adjustment of the opening and closure of a plurality of bile outlet holes 13 can be accomplished at the time of insertion of the catheter 1 1 based on the patients anatomy or, alternatively or additionally, the bile discharge position in the intestine may be adjusted post surgically as a step of a therapy optimization or therapy adaption.
In accordance with an embodiment, the catheter 1 1 comprises adjustment activation means connected between a first point 29 and a second point 30 of the catheter 1 1 and adapted to approximate the first point 29 towards the second point 30 and/or to move the second point 30 away from the first point 29.
Even though the adjustment activation means are only schematically illustrated in figure 5, they can be analogously integrated in all other illustrated and described exemplary embodiments and my accomplish a relative displacement of adjusting sections, telescoping lumens as well as a contracting deformation or extension deformation of a single tube of catheter 1 1.
In accordance with an embodiment, the adjustment activation means can comprise a linear micromotor 31 , such as a piezoelectric motor, connected to a push-pull rod 32 or a series of a linear micromotors 31 connected to push-pull rods 32 or a linear micromotor engaging and adapted to travel along a longitudinal guide rail extended in the catheter 1 1 longitudinal direction. 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 push-pull rod 32 which is then moved in a linear direction. 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 adjustment activation means may be remote controlled, e.g. by means of wireless RF signal communication between an extracorporeal control unit 33 and a local controller 34 associated with the adjustment actuating means.
In a yet further exemplary embodiment, illustrated in figures 6A to 6C, the catheter 1 1 comprises a flexible tube 39 having a longitudinal axis and a wall defining an internal passage 40, wherein a distal end portion 17 of the wall is rolled up and can be more or less unrolled to adjust the overall catheter length and the position of its distal open end 16 (which is formed by the roll). The length adjustment of tube 39 can be accomplished extracorporeal^ before deployment of the catheter 1 1 or endoluminally by means of an endoscope and a grasper or pusher 42 which can be inserted through an instrument channel 43 and comprises a embracement portion adapted to hold and move the rolled portion allowing it to slide inside the embracement portion.
The flexible tube 39 may be configured to be elastically biased in a rolled, i.e. shortened, configuration and comprises locking means, such as one or more clips, adapted prevent the tube 39 from rolling back, thereby holding it in a partially o completely rolled out configuration.
Figure 7 shows an embodiment, in which the catheter 1 1 comprises a flexible tube 44 having a longitudinal axis and a wall defining an internal passage 45, wherein the wall comprises a plurality of modular reversibly connectable tubular segments 46 which can be selectively assembled (e.g. by shape coupling, interference coupling, snap fit) and disassembled to adjust and obtain the desired catheter length. The individual modular segments 46 may be made of different materials for different requirements, such as absorbable materials, radio opaque materials, materials with radio opaque coating or additives (e.g. barium sulfate) or ultrasound opaque coating so that the catheter or selected portions of the catheter can be localized by ultrasound or radiography.
Figure 8 illustrates an embodiment in which the catheter 1 1 , particularly the distal end portion 17 comprises a plurality of tubular segments 47 which have different exposure time dependent absorbability characteristics, ada pted to operate a preset time dependent catheter length variation.
Figure 9 illustrate an embodiment, in which the catheter 1 1 comprises a flexible tube 35 having a longitudinal axis and a wall defining an internal passage 36, wherein the wall is folded back on itself to define a coaxial internal 37 and external tubular portion 38 and an annular folding line forming a distal open catheter end 16, said annular folding line being displaceable by translating the external tubular portion 38 relative to the internal tubular portion 37.
In accordance with a further embodiment, the catheter 1 1 may have a series outlet openings spaced in the longitudinal direction and individually activatable micro valves associated to each outlet opening and adapted to selectively open and close the outlet openings, thereby adjusting the bile discharge position and space in the intestine.
By selectively adjusting the location at which enzymatic fluids interact with nutrients from food fluids in the Gl tract, less nutrients from the food fluids will be absorbed by the body, the effectiveness of enzyme and emulsifying reagent reacting with the food fluids will be decreased, and more of the food fluids will be excreted resulting in a weight loss. Thus, the proportion of absorbed food fluids to excreted food fluids is changed which results in the weig ht loss. Add itional ly, th e variably adjustable contact space between biliopancreatic juices and the intestinal wall will influence the physiological signaling mechanism and the bile cycling time of the patient which can have beneficial effects on the control of diabetes.
Various means, such as bile collecting stents or catheter anchoring stents can be provided for connecting the proximal end 15 of the catheter 1 1 in fluid communication with the bile duct 7.
In accordance with a further embodiment, supplementary anchoring means may be provided to anchor the catheter 1 1 in a location in the Gl tract proximal to the papilla of Vater 10. This creates a redundant fixation of the catheter 1 1 to better resist against peristalsis forces.
Figure 10 shows a gastric coil 48 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to an arched or circular configuration adapted to shape connect with the stomach 2 such as to provide an anchor for a pull resistant anchoring wire 49 which is connected to the catheter 1 1.
In a further exemplary embodiment, illustrated in figure 1 1 , the anchoring wire 49 can be connected, e.g. by means of T-tags, to a previously created plication 50 in the stomach wall.
The catheter 1 1 may be made of any material that may be absorbable by the body such as polyglycolated resins, polygalactic acid materials, and other similar materials or nonabsorbable materials such as silicone, polyethylene, polypropylene, butylated rubber, latex, and the like.
The catheter 1 1 can be installed endoluminally, e.g. transorally, in the intestine and the proximal end 15 of of the catheter 1 1 may be inserted in the papilla of Vater using e.g. an ERCP (Endoscopic Retrograde Cholangio Pancreatography) like technique. The ERCP procedure involves passing a flexible endoscope through the mouth, esophagus, and stomach into the duodenum 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 and inserts it into the papilla of Vater.
The present invention further contemplates the possibility of placing the catheter 1 1 in the intestine and introducing the catheter proximal end 15 in the papilla of Vater 10 by laparoscopically accessing the abdominal space, translu menally accessing the duodenum near the papilla of Vater and placing the catheter 1 1 through the duodenum i n th e desi red position with i n th e i ntesti ne an d , from i n sid e th e d uod en u m , laparoscopically introducing the conduit proximal end 15 into the papilla of Vater.
The system and methods of the described invention can achieve a selective variation of the location and space at which enzymatic fluids interact with the intestinal wall and with nutrients from food fluids in the Gl tract. As a consequence, less nutrients from the food fluids will be absorbed by the body, the effectiveness of enzyme and emulsifying reagent reacting with the food fluids will be decreased, and more of the food fluids will be excreted resulting in a weight loss. Moreover, the altered contact space and time between the biliopancreatic juices and the intestinal wall acts on the physiological signaling mechanism of the patient, thereby influencing d iabetes and other comorbidities of obesity.
On the basis of the preceding disclosure, those skilled in the art will appreciate the advantageous effects of the proposed devices and methods for adjusting the length and or the bile outlet position of a bile directing catheter 1 1.
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 particu lar 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:
- a first flexible tube (12) having a first longitudinal axis, the first flexible tube (12) having a wall and first outlet holes (13) formed in the wall; and
- a second flexible tube (14) having a second longitudinal axis substantially parallel to the first longitudinal axis,
wherein one of the first and second flexible tube is slidingly translatable within the other one of the first and second flexible tube.
2. A catheter (1 1 ) according to claim 1 , wherein at least one second outlet hole (18) is formed in the wall of the second flexible tube (14), so that relative translation of the first and second tube can selectively overlap the second hole (18) with at least one of the first outlet holes (13).
3. A catheter (1 1 ) according to claim 1 or 2, wherein one of the first (12) and second flexible tube (14) is rotatable about the longitudinal axis with respect to the other one of the first and second flexible tube, so that relative rotation of the first and second tube can selectively overlap the second hole (18) with at least one of the first outlet holes (13).
4. A catheter (1 1 ) according to any one of the preceding claims, comprising at least one additional flexible tube (19) telescopically engaging one of the first (12) and second tube (14) and adapted for a coarse length adjustment of the catheter (1 1 ).
5. A catheter (1 1 ) according to claim 1 , comprising:
- a first tubular adjustable section (20) having a longitudinal axis substantially parallel to the first longitudinal axis, the first tubular adjustable section (20) having a wall and first adjusting holes formed in the wall; and
- a second tubular adjustable section (21 ) having a longitudinal axis substantially parallel to the first longitudinal axis, the second tubular adjustable section (21 ) having a wall and second adjusting holes formed in the wall,
wherein the first (20) and second adjustable section (21 ) are independently slidingly within the first flexible tube (12) to selectively align the first and second adjusting holes with the outlet holes (13) of the first flexible tube (12), thereby selectively adjusting two independent groups of outlet zones for biliopancretic fluid.
6. A catheter (1 1 ) according to claim 5, wherein the first adjustable section (20) is fluid connected with a bile collecting end (15) of a proximal end portion (22) of the catheter (1 1 ) and the second adjustable section (21 ) is fluid connected with a pancreatic secretions collecting end (15') of the proximal end portion (22) of the catheter (1 1 ).
7. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising a flexible tube (23) having a longitudinal axis and a wall (24) defining an internal passage (25), the wall (24) comprising stiffening frame segments (26) forming stiffening lines and flexible membrane segments (27) formed between the stiffening lines, wherein the flexible tube (23) can be longitudinally extended and contracted and the stiffening frame segments (26) and flexible membrane segments (27) are configured to elastically resist against kinking and closure of the internal passage (25).
8. A catheter (1 1 ) according to claim 7, wherein the stiffening frame segments (26) comprise preformed folding lines in the tube wall (24).
9. A catheter (1 1 ) according to claim 7, wherein the stiffening frame segments (26) comprise a helical wound stiffening wire.
10. A catheter (1 1 ) according to claim 7, wherein the stiffening frame segments (26) comprise a cylindrical, helically wound biaxial braid.
11. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising a flexible tube (35) having a longitudinal axis and a wall defining an internal passage (36), the wall being folded back on itself to define a coaxial internal (37) and external tubular portion (38) and an annular folding line forming a distal open catheter end (16), said annular folding line being displaceable by translating the external tubular portion (38) relative to the internal tubular portion (37).
12. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising:
- a flexible tube (39) having a longitudinal axis and a wall defining an internal passage (40), wherein a distal end section of the wall is elastically biased in a rolled configuration and can be unrolled to adjust the overall catheter (1 1 ) length,
- locking means adapted prevent the tube (39) from rolling back, thereby holding it in a partially o completely rolled out configuration.
13. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising a flexible tube (44) having a longitudinal axis and a wall defining an internal passage (45), the tube (44) comprising a plurality of modular reversibly connectable tubular segments (46) which can be selectively assembled and disassembled to adjust the catheter (1 1 ) length.
14. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, the tube comprising a plurality of tubular segments (47) which are exposure time dependent absorbable and adapted to operate a time dependent catheter (1 1 ) length variation.
15. A catheter (1 1 ) according to any one of the preceding claims, comprising:
- a proximal end portion (22) adapted to be fluid connected to the common bile duct (7) to collect biliopancreatic secretions,
- a distal end portion (17) adapted to be placed in a location downstream in the gastrointestinal tract,
- a group of concentrically telescopically assembled tube sections (28, 28' , 28") connected between the proximal end portion (22) and the distal end portion (17) and translatable to each other to adjust the overall length of the catheter (1 1 ).
16. A catheter (1 1 ) according to any one of the preceding claims, comprising adjustment activation means (31 , 32) connected between a first point (29) and a second point (30) of the catheter (1 1 ) and adapted to displace the first point (29) relative to the second point (30).
17. A catheter (1 1 ) according to claim 16, wherein the adjustment activation means (31 , 32) comprise a linear micromotor (31 ) connected to a transmission rod (32).
18. A catheter (1 1 ) according to claim 12, wherein the adjustment activation means (31 , 32) comprise a linear micromotor adapted to engage and travel along a longitudinal guide rail extended in the catheter (1 1 ) longitudinal direction.
19. A catheter (1 1 ) according to claim 16, in which the adjustment activation means (31 ,
32) are remote controlled.
20. A catheter (1 1 ) for directing biliopancreatic secretions, the catheter (1 1 ) comprising a flexible tube having a longitudinal axis and a wall defining an internal passage, the catheter (1 1 ) further comprising a series outlet openings spaced in the longitudinal direction and individually activatable micro valves associated to each outlet opening and adapted to selectively open and close the outlet openings.
21. A catheter (1 1 ) accord ing to any one of the precedi ng claims, comprising supplementary anchoring means adapted to anchor the catheter (1 1 ) in the Gl tract.
PCT/EP2010/060294 2010-07-16 2010-07-16 A length adjustable catheter for directing biliopancreatic secretions WO2012007053A1 (en)

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