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WO2012007048A1 - An apparatus and method for diverting biliopancreatic juices discharged into a patient's intestinal tract - Google Patents

An apparatus and method for diverting biliopancreatic juices discharged into a patient's intestinal tract Download PDF

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Publication number
WO2012007048A1
WO2012007048A1 PCT/EP2010/060278 EP2010060278W WO2012007048A1 WO 2012007048 A1 WO2012007048 A1 WO 2012007048A1 EP 2010060278 W EP2010060278 W EP 2010060278W WO 2012007048 A1 WO2012007048 A1 WO 2012007048A1
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WO
WIPO (PCT)
Prior art keywords
bile
food
distal
isolating
space
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/EP2010/060278
Other languages
French (fr)
Inventor
Alessandro Pastorelli
Mark S. Zeiner
Thomas Edward Albrecht
Douglas Ned Ladd
Mark Steven Ortiz
Michael J. Stokes
Christopher J. Hess
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/EP2010/060278 priority Critical patent/WO2012007048A1/en
Priority to CN201080068086.1A priority patent/CN103002840B/en
Publication of WO2012007048A1 publication Critical patent/WO2012007048A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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

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 present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:
  • a known device and method for diverting digestive secretions, such as bile and pancreatic secretions, distally into the small intestine has been discussed in US 2009/0062717 and US 7,314,489.
  • the device disclosed in US 7,314,489 comprises a stent having a distal end and a proximal end engaging the duodenum in the region of the ampulla of Vater, and a reduced diameter portion between the proximal and distal ends to create an annulus volume which can collect bile.
  • the device disclosed in US 2009/0062717 comprises a support frame with a side opening and a tube extending between a proximal end connected with the side opening and a distal open end, wherein the proximal end of the tube can form a reservoir.
  • An aim of the present invention is therefore to alter the natural time and space of contact and interaction between bile and food and the intestinal wall to cause weight loss and or allow control of diabetes in a particularly mini-invasive way.
  • an apparatus for diverting biliopancreatic juices discharged into a patient's intestinal tract comprising:
  • proximal sealing portion adapted to engage an intestinal wall to prevent food from flowing between the tubular member and the intestinal wall
  • proximal open end adapted to receive and direct the food flow into the food isolating space
  • a laterally open bile isolating cavity formed by an external surface of the tubular member and configured to define together with an adjacent portion of intestinal wall a bile isolating space
  • a bile diversion conduit extending from the bile isolating cavity distally and having an open distal bile conduit end, said bile diversion conduit defining internally a bile conveying space isolated from said food conveying space.
  • This apparatus allows to separate food or chime from the intestinal wall in a region distal of the tubular member, while diverting bile from the bile isolating cavity and without entering the sphincter of Oddi, to a point (open bile conduit end) independent from the region isolated from chime.
  • the distal open end of the bile diversion conduit is positioned at a point distal to the distal open sleeve end.
  • the food-bile-bowel contact spaces and times are significantly altered with respect to the natural situation, thereby influencing both the food absorbtion and the entero-hepatic bile cycling to obtain weight loss and or control of diabetes.
  • the bile diversion conduit comprises an external sleeve defining an annular bile conveying space around the food sleeve portion.
  • the bile conveying space is defined by an external surface of the food sleeve portion and a surrounding intestinal wall section such that the bile flows in a tract distally from the tubular member isolated from the food flow but in contact with the intestinal wall.
  • the bile diversion conduit comprises a catheter arranged outside the food sleeve portion, allowing the isolated bile to flow in exclusion from both the intestinal wall and the chime.
  • the food sleeve portion extends directly from the proximal sealing portion, forming a duodenal sleeve.
  • the distal open end of the bile conduit opens into the food sleeve portion at a point proximal of the distal open sleeve end, thereby allowing:
  • the apparatus comprises a bile draining catheter extending between a proximal end with a stent for connection of the bile draining catheter in the biliary tree and a distal end connected with the tubular member in fluid communication with the bile isolating cavity. This allows to selectively catch the bile and or the pancreatic fluid within the biliary tree and direct it in the bile isolating cavity.
  • the step of diverting the isolated bile comprises the step of extending endoluminally a bile diverting conduit from the bile isolating space in a distal direction to the point distal to the region in which the food flow is separated from the intestinal wall.
  • the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an entero-entero anastomosis or through an entero-endogenous tissue tube-entero anastomosis.
  • FIG. 1 illustrates a method and apparatus for diverting biliopancreatic juices discharged into a patient's intestinal tract in accordance with a first embodiment of the invention
  • FIG. 2 illustrates a detail of the apparatus in figure 1 ;
  • FIG. 2A illustrates a detail of the apparatus in accordance with a second embodiment of the invention
  • FIG. 3 illustrates a detail of the apparatus in accordance with a third embodiment of the invention
  • FIG. 4 illustrates a detail of the apparatus in accordance with a fourth embodiment of the invention
  • FIG. 5 illustrates a detail of the apparatus in accordance with a fifth embodiment of the invention
  • FIG. 6 - 12 illustrate a devices and methods for anchoring the apparatus in the Gl tract in accordance with embodiments of the invention
  • FIG. 13 illustrates a detail of the apparatus in accordance with a sixth embodiment of the invention.
  • FIG. 14 illustrates a detail of the apparatus in accordance with a seventh embodiment of the invention
  • FIG. 15A and 15B illustrate details of the apparatus in accordance with an eighth embodiment of the invention
  • FIG. 16 illustrates a detail of the apparatus in accordance with a further embodiment of the invention.
  • FIG. 17 illustrates a method and apparatus 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, as well as an apparatus 1 1 for diverting biliopancreatic juices discharged into a patient's intestinal tract.
  • the apparatus 1 1 comprises a preferably flexible tubular member 12 having an internal food isolating space 13 and at least a proximal sealing portion 14 adapted to engage an intestinal wall to prevent food from flowing between the tubular member 12 and the intestinal wall.
  • the tubular member 12 further forms a proximal open end 16 adapted to receive and direct the food flow into the food isolating space 13 and a distal open end 17 adapted to release the food flow from the food isolating space 13.
  • An external surface 18 of the tubular member 12 is shaped in a manner to form a laterally open bile isolating cavity 19 which is configured to define together with an adjacent portion of intestinal wall a bile isolating space 19.
  • the apparatus 1 1 further comprises a food sleeve portion 21 extending distally from the distal open end 17 of the flexible tubular member 12 and having an open distal food sleeve end 22.
  • the food sleeve portion 21 defines internally a food conveying space 23.
  • a bile diversion conduit 24 may extend from the bile isolating cavity 19 in a distal direction and have an open distal bile conduit end 25.
  • the bile diversion conduit defines internally a bile conveying space 26 isolated from the food conveying space 23.
  • This apparatus can be e.g. transorally inserted and deployed in the duodenum in the region of the papilla of Vater 10, so that the bile isolating cavity 19 covers the papilla of Vater 10 to receive the biliopancreatic juices.
  • the apparatus 1 1 allows to separate food or chime from the intestinal wall in a region distal of the tubular member 12, while diverting bile from the bile isolating cavity 19 to a point independent from the region isolated from chime, without any need to enter the sphincter of Oddi.
  • the tubular member 12 is configured as a stent adapted to be anchored in the small intestine, particularly in the duodenum 3 at the papilla of Vater 10, where the biliopancreatic juices normally enter the intestine, and to catch the biliopancreatic juices and direct it in the bile diverting conduit 24.
  • the bile isolating cavity 19 comprises a radially external annular cavity formed around the bile isolating space 20 and axially delimited by the radially protruding proximal lumen sealing portion 14 and a radially protruding distal lumen sealing portion 15.
  • the lumen sealing portions 14, 15 may be expandable from an initially collapsed radially smaller configuration which allows endoluminal, e.g. transoral introduction and transport of the apparatus 1 1 to the selected duodenal portion at the papilla of Vater 10, to an expanded radially larger configuration which allows the lumen sealing portions 14, 15 to tightly engage the lumen wall and anchor the tubular member 12 thereto.
  • the lumen sealing portions 14, 15 may comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid, such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
  • an expansion fluid such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
  • the distal lumen sealing portion 15 can further define one or more bile passage holes 27 which extend from the bile isolating cavity 19 to the bile diverting conduit 24 and put them in fluid communication.
  • the distal open end 25 of the bile diversion conduit 24 is positioned at a point distal to the distal open sleeve end 22. This allows to dispense food at a first position distal from the flexible tubular member 12 for the food to contact the intestinal wall, and to dispense the bile or biliopancreatic juices at a second position in the intestine which is further distally of the first position, so that the bile gets in contact with the intestinal wall (e.g. distal jejunum or ileum wall) and with the partially digested food or chime flow, after the latter has travelled along and in contact with an intestinal tract isolated from bile.
  • the intestinal wall e.g. distal jejunum or ileum wall
  • the bile diversion conduit 24 may comprise an external sleeve 28 which is substantially coaxial with the food sleeve portion 21 and defines an annular bile conveying space 26 around the food sleeve portion 21 .
  • the position of the distal bile conduit end 25 is determined by the length of the external sleeve 28 and may be in a point proximal of the distal food sleeve end 22, so that:
  • the position of the distal bile conduit end 25 may be in a point proximal of the distal food sleeve end 22, so that:
  • the bile conveying space 26 is defined by an external surface 35 of the food sleeve portion 21 and a surrounding intestinal wall section such that the bile flows in a tract 36 distally from the tubular member 12 isolated from the food flow but in contact with the intestinal wall.
  • the bile diversion conduit 24 comprises a catheter arranged outside the food sleeve portion 21 , thereby allowing the isolated bile to flow in exclusion from both the intestinal wall and the chime or food.
  • the position of the distal bile conduit end 25 is determined by the length of the external catheter and may be in a point distal to the distal food sleeve end 22, so that:
  • the food flow is in contact with the intestinal wall, while the bile remains isolated from the food and from the intestinal wall and
  • the position of the distal bile conduit end 25 may be in a point proximal to the distal food sleeve end 22, so that:
  • the bile in contact with the intestinal wall, while the food flow remains isolated from the bile and from the intestinal wall and
  • the food is mixed with the residual not yet absorbed bile and in contact with the intestinal wall.
  • the food sleeve portion extends proximally to the proximal lumen sealing portion 14 which may be configured as described in connection with the embodiments of figures 1 and 2, thereby forming a duodenal sleeve device which can be transorally inserted in the Gl tract and anchored thereto at a position in which the proximal lumen sealing portion is positioned e.g. a few centimeters proximal (upstream) to the papailla of Vater 10.
  • the distal open end 25 of the bile diverting conduit 24 may open into the food sleeve portion 21 at a point proximal of the distal open sleeve end 22, such that (when the apparatus is deployed in the Gl tract of a patient):
  • the biliopancreatic juices and the food flow are isolated from each other and from the lumen wall and;
  • the biliopancreatic juices mix with the food flow but remain still isolated from the lumen wall and;
  • the mixture of food and biliopancreatic juices get in contact with the intestinal wall.
  • the apparatus 1 1 comprises a bile drain catheter 40 extending between a proximal end 41 with a stent 42 for connection of the bile drain catheter 40 in the biliary tree 7 and a distal end 43 connected in fluid communication with the bile isolating cavity 19 of the tubular member 12. This allows to selectively catch the bile and or the pancreatic fluid within the biliary tree 7 and direct it in the bile isolating cavity 19.
  • the apparatus 1 1 may comprise an outer sleeve 44 partially extended over the tubular member 12 and connected thereto in a manner to define an annulus bile isolating space 45 between the outer sleeve 44 and the tubular member 12, so that the bile isolating space is separate from the intestinal wall.
  • the outer sleeve 44 has a lateral branch which opens into the bile isolating space 45 and forms the above described bile drain catheter 40.
  • the proximal end 41 of the bile drain catheter 40 can be positioned and anchored in the common bile duct downstream the junction point with the pancreatic duct 9 so that both bile and pancreatic juices are drained together into the bile isolating space 45.
  • the proximal end 41 of the bile drain catheter 40 can be positioned and anchored in the common bile duct upstream of the junction point with the pancreatic duct 9 so that only the bile is drained into the bile isolating space 45, while the pancreatic juices can be naturally discharged into the duodenum 3 and flow in the intestine in the interstice between the lumen wall and an external surface of the outer sleeve 44.
  • Figure 14 illustrates a yet further exemplary embodiment, in which the outer sleeve 44 may define the bile isolating space 20 and a separate pancreatic fluid isolating space 46 isolated from the bile isolating space and having a pancreatic fluid exit opening 47 at a distance from the distal bile conduit end 25.
  • the proximal section of the bile drain catheter 40 can be bifurcated defining a bile drain end 41 which can be positioned and anchored in the common bile duct upstream of the junction point with the pancreatic duct 9, and a pancreatic fluid drain end 48 which can be positioned in the pancreatic duct 9.
  • the bile drain catheter 40 may further comprise an internal septum 51 extending from the bifurcation point to the bile isolation space 45 and pancreatic juices isolation space 46 so that the bile is drained into the bile isolating space 45, while the pancreatic juices are drained into the pancreatic juices isolation space 46.
  • the pancreatic fluid exit opening 47 is arranged directly on the food isolating space 13 so that the pancreatic juices are mixed with the food flow approximately in their natural position of contact, but isolated from the intestinal wall (figure 14).
  • the apparatus 1 1 may comprise a proximal sleeve 49 (illustrated e.g. in figure 1 and 2A) extending between a funnel shaped proximal open end 50 adapted to be anchored within the stomach 2, e.g. by shape coupling with the pylorus, and a distal open end 52 connected to the proximal aperture 16 of the tubular member 12.
  • the proximal sleeve 49 can anchor the apparatus 1 1 to better resist against peristaltic forces and may collect food contained in the stomach 2 and direct it into the food isolating space 13, without contact with the intestinal wall.
  • the latter in order to resist the peristaltic forces acting on the apparatus 1 1 , the latter can be anchored in the gastrointestinal tract, e.g. by means of a gastric coil 53 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape connect with the stomach 2 such as to provide an anchor for an anchoring wire 54 which is connected to a proximal end of the tubular member 12 (figure 1 1 ).
  • a gastric coil 53 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape connect with the stomach 2 such as to provide an anchor for an anchoring wire 54 which is connected to a proximal end of the tubular member 12 (figure 1 1 ).
  • the anchoring wire 54 can be connected, e.g. by means of T-tags, to a previously created plication 55 in the stomach wall.
  • the apparatus 1 1 can be anchored to the intestinal wall by means of a submucosal band 56 inserted in the lumen wall and extending all around it such as to form an anchoring ring which creates a bottleneck portion in the intestinal wall, adapted to engage a corresponding annular anchoring groove 57 formed e.g. in one of the lumen sealing portions 14, 15 of the tubular member 12.
  • Figure 7 illustrates a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of a gastric stent 58 and an attached elastically expandable (possibly shape memory) arch 59 adapted to create a shape connection with the stomach 2.
  • a gastric stent 58 and an attached elastically expandable (possibly shape memory) arch 59 adapted to create a shape connection with the stomach 2.
  • Figure 8 illustrates a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of T-tags 60 fired from the inside of the intestine in the intestinal wall, thereby forming fixation points, and connected with a proximal end of the tubular member 12.
  • FIGS 9 and 9A illustrate a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of an annular anchoring portion 61 having a plurality of anchoring barbs 62, said barbs 62 being movable, e.g. rotatable, from a rest position in which the barbs 62 are contained within the encumbrance of the anchoring portion 61 to enable unobstructed endoluminal transport of the apparatus 1 1 , to a working position in which the barbs 62 protrude radially outward, thereby piercing the lumen wall and, hence, anchoring the apparatus 1 1 thereto.
  • an annular anchoring portion 61 having a plurality of anchoring barbs 62, said barbs 62 being movable, e.g. rotatable, from a rest position in which the barbs 62 are contained within the encumbrance of the anchoring portion 61 to enable unobstructed endoluminal transport of the apparatus 1 1 , to
  • the apparatus 1 1 can be anchored in the Gl tract by means of a tubular anchoring portion 63 having one or more anchoring holes 64 intended to face intestinal wall portions and adapted to allow these intestinal wall portion to be pulled into the holes 64 and fixed thereto.
  • An endoluminal suction device 55 may be provided for sucking the lumen wall portion from inside the tubular anchoring portion 63 and pulling them in the anchoring holes 64, as well as means and methods for creating a permanent (mushroom head type) swelling of the lumen wall portion, preventing it from withdrawal from the anchoring holes 64.
  • Such means and methods for creating a permanent swelling of the lumen wall portion may comprise the submucosal injection of a swelling agent or sclerosant agent or insertion of a plastic bead, e.g. Poly(methyl methacrylate) PMMA, in the tissue portions which have been previously pulled through the anchoring holes 64.
  • a swelling agent or sclerosant agent or insertion of a plastic bead, e.g. Poly(methyl methacrylate) PMMA
  • an outer sleeve 65 may be provided with a lateral hole 66 adapted to be placed over the sphincter of Oddi to define a space for isolating the bile discharged in the duodenum.
  • a reinforcing mesh 68 may be bonded to the sleeve to provide reinforcement of a suture area.
  • a stripe of surgical felt 69 may be applied to the outside of the outer sleeve 65 in the region of the reinforcing mesh 68 and suture area.
  • proximal end edge 67 and the edge of the lateral hole 66 can be sutured to the duodenal wall so that the lateral hole 66 is placed around the sphincter of Oddi, thereby providing leak free connections with the lumen wall, suitable to define food flow and bile isolating spaces as previously described.
  • a continuous or discrete external pledget 70 made of surgical felt may be arranged in the suture area on the outside of the duodenal wall to prevent sutures from cutting the serosa and pulling through the lumen wall.
  • a duckbill exit valve (not illustrated in detail) may be arranged in the distal end region of the food sleeve portion 21 and or the bile diversion conduit 24, to prevent chime back flow and infection risk.
  • Figure 16 illustrates a further exemplary embodiment of an apparatus for isolating food, bile, gastric secretions and duodenal secretions, in which the apparatus comprises three sleeves 72, 73, 74, coaxially inserted in one another and having different proximal inlet openings at different positions and different distal outlet openings at different positions to isolate and mix secretions at specified locations.
  • the present invention concerns further a method for diverting biliopancreatic juices discharged into a patient's intestinal tract, the method comprising:
  • the step of diverting the isolated bile comprises the step of extending endoluminally a bile diverting conduit from the bile isolating space in a distal direction to the point distal to the region in which the food flow is separated from the intestinal wall.
  • the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an entero- entero anastomosis or through an endogenous lumen bypass 71 having a proximal end anastomosed to the intestinal wall in the bile isolating space and a distal end anastomosed to a distal target location of the intestine, so that the bile is isolated and diverted through the bypass 71 , while the food flow is isolated and conveyed by the food sleeve portion 21.

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Abstract

An apparatus (11) for diverting biliopancreatic juices discharged into a patient's intestinal tract, comprising a tubular member (12) having an internal food isolating space (13) and a proximal sealing portion (14), a laterally open bile isolating cavity (19) configured to define together with an adjacent portion of intestinal wall a bile isolating space (19), a food sleeve portion (21 ) extending distally from the flexible tubular member (12), a bile diversion conduit (24) extending from the bile isolating cavity (19) in a distal direction and having a distal open bile conduit end (25).

Description

"AN APPARATUS AND METHOD FOR DIVERTING BILIOPANCREATIC JUICES DISCHARGED INTO A PATIENT'S INTESTINAL TRACT"
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 with virtually no permanent success.
Surgical methods of treating morbid obesity, such as open, laparoscopic and endoluminal gastric bypass surgery aiming to permanent malabsorption of the food , have been increasingly used with greater success. However, current methods for performing a gastric bypass involve time-consuming and highly dexterity dependent surgical techniques as well as significant and generally undesirable modifications of the patient's gastrointestinal anatomy.
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. 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 device and method for diverting digestive secretions, such as bile and pancreatic secretions, distally into the small intestine has been discussed in US 2009/0062717 and US 7,314,489. The device disclosed in US 7,314,489 comprises a stent having a distal end and a proximal end engaging the duodenum in the region of the ampulla of Vater, and a reduced diameter portion between the proximal and distal ends to create an annulus volume which can collect bile. The device disclosed in US 2009/0062717 comprises a support frame with a side opening and a tube extending between a proximal end connected with the side opening and a distal open end, wherein the proximal end of the tube can form a reservoir. These known devices and methods for diverting digestive secretions collect bile, but they do not specifically influence or alter the time and space of contact and interaction between bile and food and the intestinal wall.
An aim of the present invention is therefore to alter the natural time and space of contact and interaction between bile and food and the intestinal wall to cause weight loss and or allow control of diabetes in a particularly mini-invasive way.
This aim is achieved by an apparatus for diverting biliopancreatic juices discharged into a patient's intestinal tract, said apparatus comprising:
A) a flexible tubular member having:
- an internal food isolating space and
- a proximal sealing portion adapted to engage an intestinal wall to prevent food from flowing between the tubular member and the intestinal wall,
- a proximal open end adapted to receive and direct the food flow into the food isolating space,
- a distal open end adapted to release the food flow from the food isolating space,
- a laterally open bile isolating cavity formed by an external surface of the tubular member and configured to define together with an adjacent portion of intestinal wall a bile isolating space,
B) a food sleeve portion extending distally from the distal open end of the flexible tubular member and having an open distal food sleeve end, said food sleeve portion defining internally a food conveying space,
C) a bile diversion conduit extending from the bile isolating cavity distally and having an open distal bile conduit end, said bile diversion conduit defining internally a bile conveying space isolated from said food conveying space.
This apparatus allows to separate food or chime from the intestinal wall in a region distal of the tubular member, while diverting bile from the bile isolating cavity and without entering the sphincter of Oddi, to a point (open bile conduit end) independent from the region isolated from chime.
I n accordance with an aspect of the invention, the distal open end of the bile diversion conduit is positioned at a point distal to the distal open sleeve end.
This allows to dispense food at a first position distal from the flexible tubular member for the food to contact the intestinal wall, and to dispense the bile or biliopancreatic juices at a second position in the intestine which is further distally of the first position, so that the bile gets in contact with the intestinal wall (e.g. distal jejunum or ileum wall) and with the partially digested food or chime flow, after the latter has travelled along and in contact with an intestinal tract isolated from bile. Thus, the food-bile-bowel contact spaces and times are significantly altered with respect to the natural situation, thereby influencing both the food absorbtion and the entero-hepatic bile cycling to obtain weight loss and or control of diabetes.
In accordance with a further aspect of the invention, the bile diversion conduit comprises an external sleeve defining an annular bile conveying space around the food sleeve portion. In accordance with a yet further aspect of the invention, the bile conveying space is defined by an external surface of the food sleeve portion and a surrounding intestinal wall section such that the bile flows in a tract distally from the tubular member isolated from the food flow but in contact with the intestinal wall.
In accordance with a further aspect of the invention, the bile diversion conduit comprises a catheter arranged outside the food sleeve portion, allowing the isolated bile to flow in exclusion from both the intestinal wall and the chime.
In accordance with a yet further aspect of the invention, the food sleeve portion extends directly from the proximal sealing portion, forming a duodenal sleeve.
In accordance with a yet further aspect of the invention, the distal open end of the bile conduit opens into the food sleeve portion at a point proximal of the distal open sleeve end, thereby allowing:
- the biliopancreatic juices and the food to flow in a first section, in which both are isolated from each other and from the lumen wall and;
- the biliopancreatic juices to mix with the food flow in a second section distal of the first section and still isolated from the lumen wall and;
- the mixture of food and biliopancreatic juices to get in touch with the intestinal wall at a point distal of the second section.
In accordance with a yet further aspect of the invention, the apparatus comprises a bile draining catheter extending between a proximal end with a stent for connection of the bile draining catheter in the biliary tree and a distal end connected with the tubular member in fluid communication with the bile isolating cavity. This allows to selectively catch the bile and or the pancreatic fluid within the biliary tree and direct it in the bile isolating cavity.
This previously discussed aim of the invention is also achieved by a method for diverting biliopancreatic juices discharged into a patient's intestinal tract, the method comprising:
A) forming a bile isolating space between a device and the intestinal wall at the region of the ampulla of vater; B) separating the food flow from the intestinal wall in a region distal from the bile isolating space;
C) diverting the isolated bile from the bile isolating space to a point distal to the region in which the food flow is separated from the intestinal wall.
I n accordance with an aspect of the invention , the step of diverting the isolated bile comprises the step of extending endoluminally a bile diverting conduit from the bile isolating space in a distal direction to the point distal to the region in which the food flow is separated from the intestinal wall.
In accordance with a further aspect of the invention, the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an entero-entero anastomosis or through an entero-endogenous tissue tube-entero anastomosis.
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 method and apparatus for diverting biliopancreatic juices discharged into a patient's intestinal tract in accordance with a first embodiment of the invention;
- Figure 2 illustrates a detail of the apparatus in figure 1 ;
- Figure 2A illustrates a detail of the apparatus in accordance with a second embodiment of the invention;
- Figure 3 illustrates a detail of the apparatus in accordance with a third embodiment of the invention;
- Figure 4 illustrates a detail of the apparatus in accordance with a fourth embodiment of the invention;
- Figure 5 illustrates a detail of the apparatus in accordance with a fifth embodiment of the invention;
- Figures 6 - 12 illustrate a devices and methods for anchoring the apparatus in the Gl tract in accordance with embodiments of the invention;
- Figure 13 illustrates a detail of the apparatus in accordance with a sixth embodiment of the invention;
- Figure 14 illustrates a detail of the apparatus in accordance with a seventh embodiment of the invention; - Figures 15A and 15B illustrate details of the apparatus in accordance with an eighth embodiment of the invention;
- Figure 16 illustrates a detail of the apparatus in accordance with a further embodiment of the invention;
- Figure 17 illustrates a method and apparatus 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, as well as an apparatus 1 1 for diverting biliopancreatic juices discharged into a patient's intestinal tract. In accordance with an embodiment, the apparatus 1 1 comprises a preferably flexible tubular member 12 having an internal food isolating space 13 and at least a proximal sealing portion 14 adapted to engage an intestinal wall to prevent food from flowing between the tubular member 12 and the intestinal wall. The tubular member 12 further forms a proximal open end 16 adapted to receive and direct the food flow into the food isolating space 13 and a distal open end 17 adapted to release the food flow from the food isolating space 13. An external surface 18 of the tubular member 12 is shaped in a manner to form a laterally open bile isolating cavity 19 which is configured to define together with an adjacent portion of intestinal wall a bile isolating space 19.
The apparatus 1 1 further comprises a food sleeve portion 21 extending distally from the distal open end 17 of the flexible tubular member 12 and having an open distal food sleeve end 22. The food sleeve portion 21 defines internally a food conveying space 23.
Moreover, a bile diversion conduit 24 may extend from the bile isolating cavity 19 in a distal direction and have an open distal bile conduit end 25. The bile diversion conduit defines internally a bile conveying space 26 isolated from the food conveying space 23.
This apparatus can be e.g. transorally inserted and deployed in the duodenum in the region of the papilla of Vater 10, so that the bile isolating cavity 19 covers the papilla of Vater 10 to receive the biliopancreatic juices. In this position, the apparatus 1 1 allows to separate food or chime from the intestinal wall in a region distal of the tubular member 12, while diverting bile from the bile isolating cavity 19 to a point independent from the region isolated from chime, without any need to enter the sphincter of Oddi. In accordance with an embodiment, the tubular member 12 is configured as a stent adapted to be anchored in the small intestine, particularly in the duodenum 3 at the papilla of Vater 10, where the biliopancreatic juices normally enter the intestine, and to catch the biliopancreatic juices and direct it in the bile diverting conduit 24.
In an exemplary embodiment, the bile isolating cavity 19 comprises a radially external annular cavity formed around the bile isolating space 20 and axially delimited by the radially protruding proximal lumen sealing portion 14 and a radially protruding distal lumen sealing portion 15.
The lumen sealing portions 14, 15 may be expandable from an initially collapsed radially smaller configuration which allows endoluminal, e.g. transoral introduction and transport of the apparatus 1 1 to the selected duodenal portion at the papilla of Vater 10, to an expanded radially larger configuration which allows the lumen sealing portions 14, 15 to tightly engage the lumen wall and anchor the tubular member 12 thereto.
To this end, the lumen sealing portions 14, 15 may comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid, such as a saline solution, or a solidifying expansion agent, such as a hardening polymer foam or paste.
In accordance with an embodiment, the distal lumen sealing portion 15 can further define one or more bile passage holes 27 which extend from the bile isolating cavity 19 to the bile diverting conduit 24 and put them in fluid communication.
In accordance with an embodiment, the distal open end 25 of the bile diversion conduit 24 is positioned at a point distal to the distal open sleeve end 22. This allows to dispense food at a first position distal from the flexible tubular member 12 for the food to contact the intestinal wall, and to dispense the bile or biliopancreatic juices at a second position in the intestine which is further distally of the first position, so that the bile gets in contact with the intestinal wall (e.g. distal jejunum or ileum wall) and with the partially digested food or chime flow, after the latter has travelled along and in contact with an intestinal tract isolated from bile.
In accordance with a further embodiment (figures 2, 3), the bile diversion conduit 24 may comprise an external sleeve 28 which is substantially coaxial with the food sleeve portion 21 and defines an annular bile conveying space 26 around the food sleeve portion 21 . In this embodiment, the position of the distal bile conduit end 25 is determined by the length of the external sleeve 28 and may be in a point proximal of the distal food sleeve end 22, so that:
- in a first tract 29 distal to the tubular member 12 the food flow and the bile flow are isolated from one another and from the intestinal wall,
- in a second tract 30 distal to the first tract 29 and extending distally from the distal bile conduit end 25, the bile is in contact with the intestinal wall, while the food flow remains isolated from the bile and from the intestinal wall and
- in a third tract 31 distal to the second tract 30 and extending distally from the distal food sleeve end 22, the food flow is mixed with the residual not yet absorbed bile and in contact with the intestinal wall (figure 3).
In an alternative exemplary embodiment (figure 2A), the position of the distal bile conduit end 25 may be in a point proximal of the distal food sleeve end 22, so that:
- in a first tract 32 distal to the tubular member 12 the food flow and the bile flow are isolated from one another and from the intestinal wall,
- in a second tract 33 distal to the first tract 32 and extending distally from the distal food sleeve end 22, the food flow mixes with the bile, while both the food flow and the bile remain isolated from the intestinal wall and
- in a third tract 34 distal to the second tract 33 and extending distally from the distal bile conduit end 25, the food and bile get in contact with the intestinal wall.
In an alternative embodiment (figure 4), the bile conveying space 26 is defined by an external surface 35 of the food sleeve portion 21 and a surrounding intestinal wall section such that the bile flows in a tract 36 distally from the tubular member 12 isolated from the food flow but in contact with the intestinal wall.
I n accordance with an exemplary embodiment (figure 5), the bile diversion conduit 24 comprises a catheter arranged outside the food sleeve portion 21 , thereby allowing the isolated bile to flow in exclusion from both the intestinal wall and the chime or food.
In this embodiment, the position of the distal bile conduit end 25 is determined by the length of the external catheter and may be in a point distal to the distal food sleeve end 22, so that:
- in a first tract 37 distal to the tubular member 12 the food flow and the bile flow are isolated from one another and from the intestinal wall,
- in a second tract 38 distal to the first tract 37 and extending distally from the distal food sleeve end 22, the food flow is in contact with the intestinal wall, while the bile remains isolated from the food and from the intestinal wall and
- in a third tract 39 distal to the second tract 38 and extending distally from the distal bile conduit end 25, the bile is mixed with the residual not yet absorbed food and in contact with the intestinal wall (figure 5).
In an alternative exemplary embodiment (not illustrated), the position of the distal bile conduit end 25 may be in a point proximal to the distal food sleeve end 22, so that:
- in a first tract distal to the tubular member 12 the food flow and the bile flow are isolated from one another and from the intestinal wall,
- in a second tract distal to the first tract and extending distally from the distal bile conduit end 25, the bile is in contact with the intestinal wall, while the food flow remains isolated from the bile and from the intestinal wall and
- in a third tract distal to the second tract and extending distally from the distal food sleeve end 22, the food is mixed with the residual not yet absorbed bile and in contact with the intestinal wall.
In accordance with a further embodiment, the food sleeve portion extends proximally to the proximal lumen sealing portion 14 which may be configured as described in connection with the embodiments of figures 1 and 2, thereby forming a duodenal sleeve device which can be transorally inserted in the Gl tract and anchored thereto at a position in which the proximal lumen sealing portion is positioned e.g. a few centimeters proximal (upstream) to the papailla of Vater 10.
In accordance with an exemplary embodiment, the distal open end 25 of the bile diverting conduit 24 may open into the food sleeve portion 21 at a point proximal of the distal open sleeve end 22, such that (when the apparatus is deployed in the Gl tract of a patient):
- in a first tract distal to the tubular member 12, the biliopancreatic juices and the food flow are isolated from each other and from the lumen wall and;
- in a second tract distal to the first tract, the biliopancreatic juices mix with the food flow but remain still isolated from the lumen wall and;
- in a third tract of intestine distal to the second tract, the mixture of food and biliopancreatic juices get in contact with the intestinal wall.
In accordance with a further exemplary embodiment (figure 13), the apparatus 1 1 comprises a bile drain catheter 40 extending between a proximal end 41 with a stent 42 for connection of the bile drain catheter 40 in the biliary tree 7 and a distal end 43 connected in fluid communication with the bile isolating cavity 19 of the tubular member 12. This allows to selectively catch the bile and or the pancreatic fluid within the biliary tree 7 and direct it in the bile isolating cavity 19.
The apparatus 1 1 may comprise an outer sleeve 44 partially extended over the tubular member 12 and connected thereto in a manner to define an annulus bile isolating space 45 between the outer sleeve 44 and the tubular member 12, so that the bile isolating space is separate from the intestinal wall. The outer sleeve 44 has a lateral branch which opens into the bile isolating space 45 and forms the above described bile drain catheter 40. In accordance with an embodiment, the proximal end 41 of the bile drain catheter 40 can be positioned and anchored in the common bile duct downstream the junction point with the pancreatic duct 9 so that both bile and pancreatic juices are drained together into the bile isolating space 45. Alternatively, the proximal end 41 of the bile drain catheter 40 can be positioned and anchored in the common bile duct upstream of the junction point with the pancreatic duct 9 so that only the bile is drained into the bile isolating space 45, while the pancreatic juices can be naturally discharged into the duodenum 3 and flow in the intestine in the interstice between the lumen wall and an external surface of the outer sleeve 44.
Figure 14 illustrates a yet further exemplary embodiment, in which the outer sleeve 44 may define the bile isolating space 20 and a separate pancreatic fluid isolating space 46 isolated from the bile isolating space and having a pancreatic fluid exit opening 47 at a distance from the distal bile conduit end 25. The proximal section of the bile drain catheter 40 can be bifurcated defining a bile drain end 41 which can be positioned and anchored in the common bile duct upstream of the junction point with the pancreatic duct 9, and a pancreatic fluid drain end 48 which can be positioned in the pancreatic duct 9. The bile drain catheter 40 may further comprise an internal septum 51 extending from the bifurcation point to the bile isolation space 45 and pancreatic juices isolation space 46 so that the bile is drained into the bile isolating space 45, while the pancreatic juices are drained into the pancreatic juices isolation space 46.
In accordance with an embodiment, the pancreatic fluid exit opening 47 is arranged directly on the food isolating space 13 so that the pancreatic juices are mixed with the food flow approximately in their natural position of contact, but isolated from the intestinal wall (figure 14).
In accordance with a further aspect of the invention , the apparatus 1 1 may comprise a proximal sleeve 49 (illustrated e.g. in figure 1 and 2A) extending between a funnel shaped proximal open end 50 adapted to be anchored within the stomach 2, e.g. by shape coupling with the pylorus, and a distal open end 52 connected to the proximal aperture 16 of the tubular member 12. The proximal sleeve 49 can anchor the apparatus 1 1 to better resist against peristaltic forces and may collect food contained in the stomach 2 and direct it into the food isolating space 13, without contact with the intestinal wall.
Alternatively or additionally, in order to resist the peristaltic forces acting on the apparatus 1 1 , the latter can be anchored in the gastrointestinal tract, e.g. by means of a gastric coil 53 which can elastically deform from an extended configuration adapted for transoral or transnasal transportation thereof into the stomach 2, to a wound arched or circular configuration adapted to shape connect with the stomach 2 such as to provide an anchor for an anchoring wire 54 which is connected to a proximal end of the tubular member 12 (figure 1 1 ).
In a further exemplary embodiment, illustrated in figure 12, the anchoring wire 54 can be connected, e.g. by means of T-tags, to a previously created plication 55 in the stomach wall. In a yet further exemplary embodiment, illustrated in figure 6, the apparatus 1 1 can be anchored to the intestinal wall by means of a submucosal band 56 inserted in the lumen wall and extending all around it such as to form an anchoring ring which creates a bottleneck portion in the intestinal wall, adapted to engage a corresponding annular anchoring groove 57 formed e.g. in one of the lumen sealing portions 14, 15 of the tubular member 12.
Figure 7 illustrates a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of a gastric stent 58 and an attached elastically expandable (possibly shape memory) arch 59 adapted to create a shape connection with the stomach 2.
Figure 8 illustrates a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of T-tags 60 fired from the inside of the intestine in the intestinal wall, thereby forming fixation points, and connected with a proximal end of the tubular member 12.
Figures 9 and 9A illustrate a yet further exemplary embodiment, in which the apparatus 1 1 can be anchored in the Gl tract by means of an annular anchoring portion 61 having a plurality of anchoring barbs 62, said barbs 62 being movable, e.g. rotatable, from a rest position in which the barbs 62 are contained within the encumbrance of the anchoring portion 61 to enable unobstructed endoluminal transport of the apparatus 1 1 , to a working position in which the barbs 62 protrude radially outward, thereby piercing the lumen wall and, hence, anchoring the apparatus 1 1 thereto.
In a further exemplary embodiment, illustrated in figures 10 - 10C, the apparatus 1 1 can be anchored in the Gl tract by means of a tubular anchoring portion 63 having one or more anchoring holes 64 intended to face intestinal wall portions and adapted to allow these intestinal wall portion to be pulled into the holes 64 and fixed thereto. An endoluminal suction device 55 may be provided for sucking the lumen wall portion from inside the tubular anchoring portion 63 and pulling them in the anchoring holes 64, as well as means and methods for creating a permanent (mushroom head type) swelling of the lumen wall portion, preventing it from withdrawal from the anchoring holes 64. Such means and methods for creating a permanent swelling of the lumen wall portion may comprise the submucosal injection of a swelling agent or sclerosant agent or insertion of a plastic bead, e.g. Poly(methyl methacrylate) PMMA, in the tissue portions which have been previously pulled through the anchoring holes 64.
With reference to figures 15A and 15B, an outer sleeve 65 may be provided with a lateral hole 66 adapted to be placed over the sphincter of Oddi to define a space for isolating the bile discharged in the duodenum. At an edge around the lateral hole 66 and at an edge around a proximal end 67 of the outer sleeve 65, a reinforcing mesh 68 may be bonded to the sleeve to provide reinforcement of a suture area. Moreover, a stripe of surgical felt 69 may be applied to the outside of the outer sleeve 65 in the region of the reinforcing mesh 68 and suture area. The proximal end edge 67 and the edge of the lateral hole 66 can be sutured to the duodenal wall so that the lateral hole 66 is placed around the sphincter of Oddi, thereby providing leak free connections with the lumen wall, suitable to define food flow and bile isolating spaces as previously described. Moreover, a continuous or discrete external pledget 70 made of surgical felt may be arranged in the suture area on the outside of the duodenal wall to prevent sutures from cutting the serosa and pulling through the lumen wall.
In accordance with a yet further exemplary embodiment of the invention, a duckbill exit valve (not illustrated in detail) may be arranged in the distal end region of the food sleeve portion 21 and or the bile diversion conduit 24, to prevent chime back flow and infection risk.
Figure 16 illustrates a further exemplary embodiment of an apparatus for isolating food, bile, gastric secretions and duodenal secretions, in which the apparatus comprises three sleeves 72, 73, 74, coaxially inserted in one another and having different proximal inlet openings at different positions and different distal outlet openings at different positions to isolate and mix secretions at specified locations.
Independently from the described apparatus embodiments, the present invention concerns further a method for diverting biliopancreatic juices discharged into a patient's intestinal tract, the method comprising:
A) forming a bile isolating space between an apparatus and the intestinal wall at the region of the ampulla of Vater;
B) separating the food flow from the intestinal wall in a region distal from the bile isolating space;
C) diverting the isolated bile from the bile isolating space to a point distal to the region in which the food flow is separated from the intestinal wall.
In accordance with an embodiment, the step of diverting the isolated bile comprises the step of extending endoluminally a bile diverting conduit from the bile isolating space in a distal direction to the point distal to the region in which the food flow is separated from the intestinal wall.
In accordance with a further exemplary embodiment (figure 17), the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an entero- entero anastomosis or through an endogenous lumen bypass 71 having a proximal end anastomosed to the intestinal wall in the bile isolating space and a distal end anastomosed to a distal target location of the intestine, so that the bile is isolated and diverted through the bypass 71 , while the food flow is isolated and conveyed by the food sleeve portion 21.
Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. An apparatus (1 1 ) for diverting biliopancreatic juices discharged into a patient's intestinal tract, comprising a tubular member (12) having:
- an internal food isolating space (13) and a proximal sealing portion (14) adapted to engage an intestinal wall to prevent food from flowing between the tubular member (12) and the intestinal wall,
- a proximal open end (16) adapted to receive and direct the food flow into the food isolating space (1 3) and a distal open end (1 7) adapted to release the food flow from the food isolating space (13),
- a laterally open bile isolating cavity (19) configured to define together with an adjacent portion of intestinal wall a bile isolating space (19),
said apparatus (1 1 ) further comprising:
- a food sleeve portion (21 ) extending distally from the distal open end (17) of the flexible tubular member (12) and having an distal open food sleeve end (22), said food sleeve portion (21 ) defining internally a food conveying space (23),
- a bile diversion conduit (24) extending from the bile isolating cavity (19) in a distal direction and having a distal open bile conduit end (25), said bile diversion conduit defining internally a bile conveying space (26) isolated from the food conveying space (23).
2. Apparatus (1 1 ) according to claim 1 , wherein the distal open end (25) of the bile diversion conduit (24) is positioned at a point distal to the distal open sleeve end (22).
3. Apparatus (1 1 ) according to claim 1 , wherein the distal open end (25) of the bile diverting conduit (24) may open into the food sleeve portion (21 ) at a point proximal of the distal open sleeve end (22).
4. Apparatus (1 1 ) according to claim 1 , wherein the distal open sleeve end (22) may open into the bile diverting conduit (24) at a point proximal of the distal open end (25) of the bile diverting conduit (24).
5. Apparatus (1 1 ) according to claim 1 , in which the tubular member (12) is a stent adapted to be anchored in the small intestine where the biliopancreatic juices normally enter the intestine, and to catch the biliopancreatic juices and direct it in the bile diverting conduit (24), wherein said bile isolating cavity (19) comprises an annular cavity formed around the bile isolating space (20) and axially delimited by a radially protruding proximal lumen sealing portion (14) and a radially protruding distal lumen sealing portion (15).
6. Apparatus (1 1 ) according to claim 2, in which said lumen sealing portions (14, 15) are expandable from an initially collapsed radially smaller configuration to an expanded radially larger configuration.
7. Apparatus (1 1 ) according to claim 6, in which the lumen sealing portions (14, 15) comprise expandable balloon segments which can be permanently expanded by injection of an expansion fluid.
8. Apparatus (1 1 ) according to claim 1 , wherein the bile diversion conduit (24) comprises an external sleeve (28) coaxial with the food sleeve portion (21 ), thereby defining an annular bile conveying space (26) around the food sleeve portion (21 ).
9. Apparatus (1 1 ) according to claim 1 , in which said bile diversion conduit (24) comprises a catheter arranged outside the food sleeve portion (21 ).
10. Apparatus (1 1 ) according to any one of the preceding claims, comprises a bile drain catheter (40) extending between a proximal end (41 ) configured to be arranged in the biliary tree (7) and a distal end (43) connected in fluid communication with the bile isolating cavity (19).
11. Apparatus (1 1 ) according to claim 10, comprising an outer sleeve (44) extended over the tubular member (12) and connected thereto in a manner to define an annulus bile isolating space (45) between the outer sleeve (44) and the tubular member (12), said outer sleeve (44) having a lateral branch which opens into the bile isolating space (45) and which forms said bile drain catheter (40).
12. Apparatus (1 1 ) according to claim 1 1 , in which said outer sleeve (44) defines the bile isolating space (20) and a separate pancreatic fluid isolating space (46) with a pancreatic fluid exit opening (47) at a distance from the distal bile conduit end (25),
in which a proximal section of the bile drain catheter (40) is bifurcated and forms a bile drain end (41 ) and a pancreatic fluid drain end (48) and the bile drain catheter (40) comprises an internal septum (51 ) extended from the bifurcation point to the bile isolation space (45) and pancreatic juices isolation space (46).
13. Apparatus (1 1 ) according to claim 12, in which the pancreatic fluid exit opening (47) is arranged directly on the food isolating space (13).
14. Apparatus (1 1 ) according to claim 1 , comprising a proximal sleeve (49) extending between a funnel shaped proximal open end (50) adapted to be anchored within the stomach (2) and a distal open end (52) connected to the proximal aperture (16) of the tubular member (12).
15. System (1 1 ) according to claim 1 , comprising an anchoring device for anchoring the tubular member (1 1 ) in the Gl tract, said anchoring device being selected in the group consisting of: - a gastric coil (53) which can elastically deform from an extended configuration to a wound arched configuration adapted to shape connect with the stomach (2) such as to provide an anchor for an anchoring wire (54) which is connected to a proximal end of the tubular member (12),
- an anchoring wire (54) and a plurality of T-tags adapted to connect the anchoring wire to a plication (55) in the stomach wall,
- a submucosal band (56) adapted to be inserted in the lumen wall such as to form an anchoring ring in the intestinal wall, adapted to engage a corresponding annular anchoring groove (57) formed in the tubular member (12),
- a gastric stent (58) and an attached elastically expandable arch (59) adapted to create a shape connection with the stomach (2),
- T-tags (60) applicable from the inside of the intestine in the intestinal wall and connected with a proximal end of the tubular member (12),
- an annular anchoring portion (61 ) having a plurality of anchoring barbs (62), said barbs (62) being movable from a withdrawn rest position to a working position in which the barbs (62) protrude radially outward,
- a tubular anchoring portion (63) having one or more anchoring holes (64) adapted to face intestinal wall portions and to allow these intestinal wall portion to be pulled into the holes (64) and fixed thereto, and means for creating a permanent mushroom head type swelling of the lumen wall portion, preventing it from withdrawal from the anchoring holes (64),
- an outer sleeve (65) with a proximal end and a lateral hole (66) which can be sutured to the duodenal wall so that the lateral hole (66) is placed around the sphincter of Oddi, said outer sleeve comprising a reinforcing mesh (68) bonded to an edge around the lateral hole (66) and to an edge around a proximal end (67) of the outer sleeve (65), said reinforcement mesh providing a reinforced suture area, a stripe of surgical felt (69) applied to the outside of the outer sleeve (65) in the region of the reinforcing mesh (68).
16. System (1 1 ) according to claim 1 , comprising a duckbill exit valve arranged in the distal end region of at least one of the food sleeve portion (21 ) and the bile diversion conduit (24).
17. An apparatus (1 1 ) for diverting biliopancreatic juices discharged into a patient's intestinal tract, comprising a tubular member (12) having:
- an internal food isolating space (13) and a proximal sealing portion (14) adapted to engage an intestinal wall to prevent food from flowing between the tubular member (12) and the intestinal wall,
- a proximal open end (16) adapted to receive and direct the food flow into the food isolating space (13) and a distal open end (17) adapted to release the food flow from the food isolating space (13),
- a laterally open bile isolating cavity (19) configured to define together with an adjacent portion of intestinal wall a bile isolating space (19),
said apparatus (1 1 ) further comprising:
- a food sleeve portion (21 ) extending distally from the distal open end (17) of the flexible tubular member (12) and having an distal open food sleeve end (22), said food sleeve portion (21 ) defining internally a food conveying space (23),
- a bile conveying space (26) isolated from the food conveying space (23), said bile conveying space being defined by an external surface (35) of the food sleeve portion (21 ) such that bile can flow isolated from the food flow but in contact with the intestinal wall.
18. An apparatus (1 1 ) for diverting biliopancreatic juices discharged into a patient's intestinal tract, comprising three sleeves (72, 73, 74), coaxially inserted in one another and having different proximal inlet openings at different positions and different distal outlet openings at different positions to isolate and mix secretions at specified locations.
19. Method for diverting biliopancreatic juices discharged into a patient's intestinal tract, the method comprising:
A) forming a bile isolating space between an apparatus and the intestinal wall at the region of the ampulla of Vater;
B) separating the food flow from the intestinal wall in a region distal from the bile isolating space;
C) diverting the isolated bile from the bile isolating space to a point distal to the region in which the food flow is separated from the intestinal wall.
20. Method according to claim 19, in which the step of diverting the isolated bile comprises the step of extending endoluminally a bile diverting conduit from the bile isolating space in a distal direction to the point distal to the region in which the food flow is separated from the intestinal wall.
21. Method according to claim 19, in which the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an entero-entero anastomosis.
22. Method according to claim 19, in which the step of diverting the isolated bile comprises the step of creating a direct lumen continuity between the intestinal wall in the bile isolating space and a distal target location of the intestine through an endogenous lumen bypass (71 ) having a proximal end anastomosed to the intestinal wall in the bile isolating space and a distal end anastomosed to a distal target location of the intestine.
PCT/EP2010/060278 2010-07-16 2010-07-16 An apparatus and method for diverting biliopancreatic juices discharged into a patient's intestinal tract Ceased WO2012007048A1 (en)

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ITRM20110379A1 (en) * 2011-07-19 2013-01-20 Francesco Greco IMPLANTABLE SYSTEM FOR OBESITY TREATMENT.
WO2013028841A1 (en) * 2011-08-23 2013-02-28 Ethicon Endo-Surgery, Inc. Device for anchoring an endoluminal sleeve in the gi tract
US9480590B2 (en) 2011-08-23 2016-11-01 Ethicon Endo-Surgery, Inc. Device for anchoring an endoluminal sleeve in the GI tract
US11647943B2 (en) 2017-06-07 2023-05-16 Samsung Medical Center PH measuring device and pH monitoring system including same
CN113171538A (en) * 2021-05-06 2021-07-27 王畅 A blocking device for intestinal treatment
CN113171538B (en) * 2021-05-06 2023-05-02 海安市人民医院 Cut-off equipment for intestinal tract treatment

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CN103002840A (en) 2013-03-27

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