WO2013004262A1 - Cathéter, particulièrement destiné à diriger des sécrétions biliopancréatiques - Google Patents

Cathéter, particulièrement destiné à diriger des sécrétions biliopancréatiques Download PDF

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Publication number
WO2013004262A1
WO2013004262A1 PCT/EP2011/061103 EP2011061103W WO2013004262A1 WO 2013004262 A1 WO2013004262 A1 WO 2013004262A1 EP 2011061103 W EP2011061103 W EP 2011061103W WO 2013004262 A1 WO2013004262 A1 WO 2013004262A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
tubular wall
passage channel
fluid passage
flow
Prior art date
Application number
PCT/EP2011/061103
Other languages
English (en)
Inventor
Michele D'arcangelo
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/EP2011/061103 priority Critical patent/WO2013004262A1/fr
Publication of WO2013004262A1 publication Critical patent/WO2013004262A1/fr

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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
    • 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

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 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.
  • Clinical catheter occlusion has been observed to occur in 28% - 58% of patients after a time interval of 131 days to 324 days.
  • 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, 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.
  • 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.
  • the flow induced movements of the agitation members can create local turbulence which also impedes depositions and incrustations inside the catheter.
  • the catheter patency can be significantly improved and the duration of the catheter is increased.
  • 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.
  • the agitation members are fixed inside the fluid passage channel in a manner that they cannot translate in a catheter longitudinal direction.
  • the agitation members are supported and configured to rotate in response to the flow of liquid through the fluid passage channel.
  • 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.
  • the agitation members comprise a plurality of blade wheels, particularly impellers, rotatable about a longitudinal axis which is substantially coaxial with the tubular wall.
  • FIG. 1 illustrates a catheter for directing biliopancreatic juices implanted in the Gl tract of a patient
  • FIG. 2 illustrates a detail of the catheter in accordance with an embodiment
  • FIG. 3 is a longitudinal cross-section of a portion of a catheter for directing biliopancreatic juices in accordance with an embodiment
  • FIG. 4 is a perspective view of a component of the catheter in figure 3;
  • FIG. 5 is a schematic illustration of a working principle of the catheter in figure 3;
  • FIG. 7 is a schematic illustration of a working principle of the catheter in figure 6;
  • FIG. 8 is a perspective transparent view of a portion of an alternative catheter concept for directing biliopancreatic juices.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • actuation means 32 may be manually operable to forcedly move the agitation members 19.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (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

L'invention concerne un cathéter (11) pour diriger des sécrétions biliopancréatiques, lequel cathéter comprend une paroi tubulaire allongée (16) comportant une surface interne (17) qui définit un canal (18) de passage de fluide, et une pluralité d'éléments d'agitation (19) agencés de manière captive à l'intérieur du canal (18) de passage de fluide et conçus pour se déplacer par rapport à la paroi tubulaire (16) en réponse à un écoulement d'un liquide à travers le canal (18) de passage de fluide.
PCT/EP2011/061103 2011-07-01 2011-07-01 Cathéter, particulièrement destiné à diriger des sécrétions biliopancréatiques WO2013004262A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/061103 WO2013004262A1 (fr) 2011-07-01 2011-07-01 Cathéter, particulièrement destiné à diriger des sécrétions biliopancréatiques

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/061103 WO2013004262A1 (fr) 2011-07-01 2011-07-01 Cathéter, particulièrement destiné à diriger des sécrétions biliopancréatiques

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WO2013004262A1 true WO2013004262A1 (fr) 2013-01-10

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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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995020986A1 (fr) * 1994-02-02 1995-08-10 The Johns-Hopkins University Drain tuteur a ailettes pour canal biliaire
EP1508312A1 (fr) * 2003-08-20 2005-02-23 Ethicon Endo-Surgery, Inc. Dispositif facilitant la malabsorption nutritionnelle
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2007139920A2 (fr) * 2006-05-26 2007-12-06 Endosphere, Inc. Perfectionnements apportés à des procédés et des dispositifs destinés à refréner l'appétit et/ou réduire l'ingestion alimentaire
WO2009091965A1 (fr) * 2008-01-18 2009-07-23 Med Institute, Inc. Système de fixation d'un dispositif intravasculaire ayant un corps extensible tubulaire

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995020986A1 (fr) * 1994-02-02 1995-08-10 The Johns-Hopkins University Drain tuteur a ailettes pour canal biliaire
EP1508312A1 (fr) * 2003-08-20 2005-02-23 Ethicon Endo-Surgery, Inc. Dispositif facilitant la malabsorption nutritionnelle
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
WO2007139920A2 (fr) * 2006-05-26 2007-12-06 Endosphere, Inc. Perfectionnements apportés à des procédés et des dispositifs destinés à refréner l'appétit et/ou réduire l'ingestion alimentaire
WO2009091965A1 (fr) * 2008-01-18 2009-07-23 Med Institute, Inc. Système de fixation d'un dispositif intravasculaire ayant un corps extensible tubulaire

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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