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WO2012163415A1 - Cathéter pour diriger des sécrétions biliopancréatiques - Google Patents

Cathéter pour diriger des sécrétions biliopancréatiques Download PDF

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Publication number
WO2012163415A1
WO2012163415A1 PCT/EP2011/058983 EP2011058983W WO2012163415A1 WO 2012163415 A1 WO2012163415 A1 WO 2012163415A1 EP 2011058983 W EP2011058983 W EP 2011058983W WO 2012163415 A1 WO2012163415 A1 WO 2012163415A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
sweeping
tubular wall
grid
sweeping grid
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2011/058983
Other languages
English (en)
Inventor
Alessandro Pastorelli
Michele D'arcangelo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery Inc
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/EP2011/058983 priority Critical patent/WO2012163415A1/fr
Publication of WO2012163415A1 publication Critical patent/WO2012163415A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/041—Bile ducts
    • 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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

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.
  • 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.
  • 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.
  • 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.
  • commonly found microorganisms in the sludge such as Escherichia coli, can produce ⁇ - 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.
  • 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.
  • a catheter for directing biliopancreatic secretions 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.
  • FIG. 1 illustrates a catheter for directing biliopancreatic juices implanted in the GI tract of a patient ;
  • FIG. 2 is a cross-sectional view of the catheter in accordance with an embodiment
  • FIG. 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
  • FIG. 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;
  • FIG. 7 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a further embodiment
  • FIG. 8 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a yet further embodiment
  • FIG. 9 is a cross-sectional view of a portion of the catheter for directing biliopancreatic juices in accordance with a yet further embodiment.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the scraping bars 21 of the sweeping grid 19 may comprise a scraping surface 24 forming an obtuse angle ⁇ 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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) .
  • 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.
  • 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

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un cathéter (11) pour diriger des sécrétions biliopancréatiques qui comprend une paroi tubulaire allongée (16) s'étendant entre une partie d'extrémité proximale (12) et une partie d'extrémité distale (13) et ayant une surface interne (17) qui définit un canal de passage de fluide (18), une grille de balayage (19) agencée à l'intérieur du canal de passage de fluide (18) et adaptée pour être déplacée par rapport à la paroi tubulaire (16) de manière à balayer la surface interne (17), des moyens d'actionnement (20) qui déplacent la grille de balayage (19) par rapport à la paroi tubulaire (16).
PCT/EP2011/058983 2011-05-31 2011-05-31 Cathéter pour diriger des sécrétions biliopancréatiques Ceased WO2012163415A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/058983 WO2012163415A1 (fr) 2011-05-31 2011-05-31 Cathéter pour diriger des sécrétions biliopancréatiques

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/058983 WO2012163415A1 (fr) 2011-05-31 2011-05-31 Cathéter pour diriger des sécrétions biliopancréatiques

Publications (1)

Publication Number Publication Date
WO2012163415A1 true WO2012163415A1 (fr) 2012-12-06

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ID=44626879

Family Applications (1)

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PCT/EP2011/058983 Ceased WO2012163415A1 (fr) 2011-05-31 2011-05-31 Cathéter pour diriger des sécrétions biliopancréatiques

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2005067647A2 (fr) * 2004-01-09 2005-07-28 The Catheter Exchange, Inc. Drain comprenant une structure de retrait d'occlusion
WO2008048823A2 (fr) * 2006-10-17 2008-04-24 Wilson-Cook Medical Inc. Dispositif de nettoyage d'endoscope
US20090188531A1 (en) * 2008-01-25 2009-07-30 Boyle Jr Edward M Methods and devices to clear obstructions from medical tubes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2005067647A2 (fr) * 2004-01-09 2005-07-28 The Catheter Exchange, Inc. Drain comprenant une structure de retrait d'occlusion
WO2008048823A2 (fr) * 2006-10-17 2008-04-24 Wilson-Cook Medical Inc. Dispositif de nettoyage d'endoscope
US20090188531A1 (en) * 2008-01-25 2009-07-30 Boyle Jr Edward M Methods and devices to clear obstructions from medical tubes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter

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