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WO2013004263A1 - Dispositif de raccordement pour anastomose entre un organe creux et un conduit - Google Patents

Dispositif de raccordement pour anastomose entre un organe creux et un conduit Download PDF

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Publication number
WO2013004263A1
WO2013004263A1 PCT/EP2011/061105 EP2011061105W WO2013004263A1 WO 2013004263 A1 WO2013004263 A1 WO 2013004263A1 EP 2011061105 W EP2011061105 W EP 2011061105W WO 2013004263 A1 WO2013004263 A1 WO 2013004263A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
target location
ring
proximal
conduit
Prior art date
Application number
PCT/EP2011/061105
Other languages
English (en)
Inventor
Alberto Arezzo
Martin Fried
José M. BERGER
Alessandro Pastorelli
Michele D'arcangelo
Federico Bilotti
Mark Steven Ortiz
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/EP2011/061105 priority Critical patent/WO2013004263A1/fr
Publication of WO2013004263A1 publication Critical patent/WO2013004263A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00278—Transorgan operations, e.g. transgastric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections

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 discussed in US 2005085787 A1 .
  • the known system comprises an artificial 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.
  • the known conduit catheters extend inside the intestine and tend to bundle up and to be displaced by the peristalsis of the intestinal tract so that the distal end of the catheter is frequently relocated far away from the target position intended by the surgeon.
  • the known endoluminal conduit must have a significant length which undesirably increases the flow resistance and decreases the flow rate of the bile to the distal target location in the Gl tract. Accordingly, the known conduit and method is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity. Moreover, the known methods and devices bear an inherent risk of conduit obstruction and related harboring of bacteria which may lead to severe infections and require frequent substitutions of the artificial conduits.
  • an aim of the invention is to provide a method and device for diverting bile from the biliary tree including the gallbladder into a section of the intestine distally to the papilla of Vater, which addresses at least part of the problems described in relation with the prior art.
  • An aim of the invention is to provide devices and methods which obviate the risk of undesired relocations of the bile discharge point from the target location.
  • a further aim of the invention is to increase the flow rate of the diverted bile towards the target location in the small intestine.
  • a yet further aim of the invention is to obviate the risk of obstruction and harboring of bacteria inside a bile diverting conduit.
  • a yet further aim of the invention is to provide devices and methods for improving the connection of a bile conduit to a target section of small intestine.
  • At least part of the above identified aims are achieved by a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of:
  • At least part of the natural biliary flow path e.g. part of the duodenum, can be bypassed without artificial conduits, thereby reducing the risk of obstruction and infection, as well as the risk of undesired dislocation away from the intended distal target location.
  • At least part of the above identified aims are also achieved by a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of: a) detaching a proximal portion of the common bile duct at a proximal target location from the duodenum, thereby creating a proximal lumen stump in flow communication with the common hepatic duct and a distal lumen stump in flow communication with the duodenum,
  • At least part of the above identified aims are also achieved by a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the method comprising the steps of: a) performing a cholecystectomy by transecting the cystic duct at a proximal target location, thereby creating a proximal lumen stump in flow communication with the common hepatic duct,
  • the end of the conduit is anastomosed to one of the first and second otomies by means of a connecting device having a ring connector and a tube connector initially separate from the ring connector and connectable with the ring connector by snap fit, the method comprising the phases of:
  • an anastomosis connecting device comprising:
  • a ring connector forming a passage opening and first and second ring walls defining therebetween an annular connecting seat adapted to receive and hold an edge of a tissue wall of a hollow organ, the second ring wall forming a first sealing surface facing away from the annular connecting seat,
  • a tube connector having a tubular wall with a free end insertable into a conduit and a ring flange forming a second sealing surface complementary with the first sealing surface and facing away from the free end
  • - snap coupling means adapted to snap connect the tube connector to the ring connector such that the first and second sealing surfaces are pressed together and the free end is put in flow communication with the passage opening.
  • FIG. 1 illustrates a connecting device for anastomosing a natural or artificial conduit to a hollow organ in accordance with an embodiment of the invention
  • FIG. 2 illustrates an anastomosis between a natural conduit and a hollow organ by means of the connecting device of figure 1 ;
  • FIG. 3 illustrates a connecting device for anastomosing a natural or artificial conduit to a hollow organ in accordance with a further embodiment of the invention
  • FIG. 4 illustrates an anastomosis between a natural conduit and a hollow organ by means of the connecting device of figure 3;
  • FIG. 5 illustrates a connecting device for anastomosing a natural or artificial conduit to a hollow organ in accordance with a yet further embodiment of the invention
  • FIG. 6 illustrates an anastomosis between a natural conduit and a hollow organ by means of the connecting device of figure 5;
  • FIG. 7 illustrates a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine in accordance with an embodiment of the invention
  • FIG. 8 illustrates a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine in accordance with a fu rther embodiment of the invention
  • FIG. 9 illustrates a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine in accordance with a yet further embodiment of the invention
  • FIG. 10 and 1 1 illustrate a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine in accordance with a further embodiment of the invention
  • FIG. 12 and 13 illustrate a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine in accordance with a further embodiment of the invention
  • FIG. 14 illustrate a method for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine i n accordance with a fu rther embodiment of the invention
  • FIG. 15 illustrate a method for diverting biliary fluid from a natural biliary fluid flow path to a target location i n the i ntesti ne i n accordan ce with another embodiment of the invention.
  • figures 7 through 14 illustrate methods for diverting biliary fluid from a natural biliary fluid flow path 1 to a target location in the intestine 2 distal to a duodenal papilla of Vater 3.
  • the method comprises the steps of: a) creating a first otomy 4 in a proximal target location 5 in the natural biliary fluid flow path 1 ,
  • At least part of the natural biliary flow path e.g. part of the duodenum, can be bypassed without artificial conduits, thereby reducing the risk of obstruction and infection, as well as the risk of undesired dislocation away from the intended distal target location.
  • the conduit 8 may be e.g. grafted from vein material, sections of small bowel (e.g. a piece of jejunum), sections of cystic duct or of common bile duct.
  • the distal target location 7 of the intestine 2 may be a portion of the small intestine, e.g. a distal portion of duodenum, a portion of jejunum or ileum or a portion of the large intestine, such as for example the transverse or sigmoid colon.
  • the distal end 10 of the conduit 8 is anastomosed to a distal target location 7 e.g. in the jejunum or in the ileum, thereby creating an ileum biliary drain branch which directs biliary fluid rapidly towards the terminal ileum where it is re-absorbed. I n this way it is possible to achieve a considerable acceleration of the enterohepatic circulation (EHC).
  • EHC enterohepatic circulation
  • the method comprises performing an incision into the gallbladder 1 1 to create a cholecystomy and anastomosing the proximal end 9 of the conduit 8 to the cholecystomy, in order for biliary fluid to be diverted from the natural biliary flow path 1 at the gallbladder.
  • the method comprises creating the first otomy 4 in the duodenal wall adjacent the sphincter of ODDI 3, in order for biliary fluid to be diverted from the natural biliary flow path 1 immediately downstream the sphincter of ODDI.
  • the method comprises performing an incision into the gallbladder 1 1 to create a cholecystomy, transecting the jejunum, thereby creating a distal jejunal stump 12 and a proximal jejunal stump 13 ( Figure 10), then anastomosing the distal jejunal stump 12 to the cholecystomy and anastomosing the proximal jejunal stump 1 3 to a second enterotomy 6 created in a section of intestine distal from the distal jejunal stump 12 ( Figure 1 1 ).
  • a Y-shaped bifurcation of the intestine 2 is thus created which diverts a flow of bile directly from the gallbladder 1 1 into the distal jejunal stump 12.
  • the method may be implemented by a laparoscopic procedure with endoluminal assistance. After having mobilized the interested target area, the distal jejunum or ileum is transected laparoscopically to create the above said distal and proximal stumps 1 2, 1 3. Then, the distal stump 12 is laparoscopically pulled to the gallbladder 1 1 and a side-to-side cholecystenterostomy 14 ( Figure 13) or a front-to- side cholecystenterostomy 15 ( Figure 1 1 ) is performed therebetween to create lumen continuity between the gallbladder 1 1 and the distal stump 12.
  • a flexible endoscope (not illustrated in the figures) with an instrument channel is introduced transanally and guided with laparoscopic assistance through the colon 16 and through the ileal cecal valve 17 into the small intestine (ileum or jejunum) to the distal target location 7.
  • the intestinal wall at the distal target location 7 can now be perforated by a piercing instrument guided through the instrument channel of the endoscope.
  • the thus created second otomy 6 can be dilated by means of a balloon dilator guided along the piercing instrument through the instrument channel of the endoscope.
  • the proximal stump 13 can now be grasped and approximated to the second otomy 6 either laparoscopically and/or by an endoscopic grasper extended through the second otomy 6 into the abdominal space. Then , the proximal stump 13 and the second otomy 6 are anastomosed to re-establish intestinal lumen continuity.
  • an anatomical configuration is created which allows a first part of bile to flow from the gallbladder 1 1 directly in the ileum or distal jejunum and a second part of bile to flow along its natural path 1 to the duodenum. This shortens the time it takes for the bile to contact the terminal ileum and, at the same time, provides bile inside the duodenum to trigger physiological signaling mechanisms related with the early phases of digestion.
  • the common bile duct 19 may be blocked or artificially obstructed downstream the junction of the hepatic duct 18 with the cystic duct 20 such that the entire biliary fluid produced by the liver 21 is diverted through the gallbladder 1 1 to the distal target location in the intestine.
  • an alternative method ( Figures 8, 14) is proposed for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the alternative method comprising the steps of:
  • This method allows to use at least part of the common bile duct directly as bile diverting conduit and obviates the attachment of an additional piece of artificial conduit or of conduit grafted from natural tissue.
  • the total amount of bile is diverted to the distal target location 7 of the intestine 2 and the distal lumen stump 23 must be closed and sealed in order to prevent leakage of intestinal contents and/or pancreatic juices in the abdominal space.
  • the proximal portion of the common bile duct 19 is detached from the duodenum by a circumferential transection of the duodenal wall around the sphincter of ODDI 3. This can be accomplished laparoscopically by means of scissors or a hot knife and suture.
  • both the papilla of Vater and the sphincter of ODDI remain intact and within the biliary bypass path and can thus contribute to prevent backflow of chime and retrograde infection of the biliary tree or pancreatitis.
  • the proximal portion of the common bile duct 19 is detached from the duodenum by transecting the common bile duct 19.
  • an alternative method ( Figure 15) for diverting biliary fluid from a natural biliary fluid flow path to a target location in the intestine distal to a duodenal papilla of Vater, the alternative method comprising the steps of:
  • This method allows to use part of the cystic duct directly as bile diverting conduit and obviates the attachment of an additional piece of artificial conduit or of conduit grafted from natural tissue.
  • a partial flow of bile is diverted to the distal target location 7 of the intestine 2 and a residual flow of bile is discharged in the duodenum along the natural biliary flow path.
  • Total bile diversion may be obtained by additionally blocking the common bile duct.
  • an end of the conduit 8 may be anastomosed to one of the proximal and distal target locations by a connecting device having a ring connector and a tube connector initially separate from the ring connector and connectable with the ring connector by snap fit.
  • the anastomosis is performed by connecting the ring connector to one of the proximal and distal target locations 5, 7 of the natural biliary flow path 1 , connecting the tube connector to the conduit 8 and, subsequently, approximating and snap connecting the ring connector to the tube connector.
  • the connecting device 27 may comprise:
  • a ring connector 28 forming a passage opening 29 and first and second ring walls 30, 31 defining therebetween an annular connecting seat 32 adapted to receive and hold an edge 33 of a tissue wall of a hollow organ 34, the second ring wall 31 forming a first sealing surface 35 facing away from the annular connecting seat 32,
  • a tube connector 36 having a tubular wall 37 with a free end 38 insertable into a conduit 39 a n d a ri n g fl a n g e 40 forming a second sealing surface 41 complementary with the first sealing surface 35 and facing away from the free end 38,
  • first snap coupling means adapted to snap connect the tube connector 36 to the ring connector 28 such that the first and second sealing surfaces 35, 41 are pressed together and the free end 38 is put in flow communication with the passage opening 29.
  • the first snap coupling means comprise toothed pins 42 protruding from one of the first and second sealing surfaces 35, 41 and corresponding snap holes 43 formed in the other one of the first and second sealing surfaces 35, 41 and adapted to receive the pins 42 with snap fit.
  • the ring connecter 28 may comprise an internal compression ring forming the first ring wall 30 and an external compression ring forming the second ring wall 31 , as well as second snap coupling means adapted to snap connect the external ring to the internal ring to compress the tissue edge 33 therebetween.
  • the second snap coupling means may comprise toothed studs 42 protruding from one of the first and second ring walls 30, 31 and corresponding second holes 45 formed in the other one of the first and second ring walls 30, 31 and adapted to (adjustably) receive the studs 42 with snap fit.
  • the toothed studs 42 protrude from the first ring wall 30 and are insertable by snap fit in through holes 45 of the second ring wall 31 such that a toothed free end of the stud 42 protrudes from the first sealing surface 35 and forms the above said pin 42 for the snap connection with the tube connector 36.
  • the snap holes 43 may extend coaxially inside the toothed studs 42 and may be configured such that, by snap coupling the tube connector 36 with the ring connector 28, the toothed pins 42 penetrate the snap holes 43 inside the toothed studs 42 and lock the latter in the second holes 45 to prevent detachment of the compression rings.
  • the free end 38 can be inserted by interference fit in the conduit end and may have a circumferential groove 47 into which the conduit can be tightened by means of a suture loop 46.
  • connection device 27 may be made of PET or titanium alloy and may comprise a unidirectional valve which prevents undesired backflow e.g. from the ring connector 28 to the tube connector 36.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Child & Adolescent Psychology (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

La présente invention concerne un dispositif de raccordement (27) permettant de réaliser une anastomose entre un organe creux et un conduit. Ce dispositif comprend un raccord annulaire (28), un raccord tubulaire (36), et organe de raccord rapide. Le raccord annulaire (27) constitue une première et une seconde paroi annulaire (30, 31) définissant un siège de raccord annulaire (32) conçu pour recevoir une paroi d'organe creux (34). Le raccord tubulaire (36) comporte, d'une part une paroi tubulaire (37) pourvue d'une extrémité libre (38) pouvant s'insérer à l'intérieur d'un conduit (39), et d'autre part une bride annulaire (40). Enfin, l'organe de raccord rapide est conçu pour brancher sur le raccord annulaire (28) la bride annulaire du raccord tubulaire (36).
PCT/EP2011/061105 2011-07-01 2011-07-01 Dispositif de raccordement pour anastomose entre un organe creux et un conduit WO2013004263A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/061105 WO2013004263A1 (fr) 2011-07-01 2011-07-01 Dispositif de raccordement pour anastomose entre un organe creux et un conduit

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/061105 WO2013004263A1 (fr) 2011-07-01 2011-07-01 Dispositif de raccordement pour anastomose entre un organe creux et un conduit

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Cited By (4)

* 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
WO2022166903A1 (fr) * 2021-02-05 2022-08-11 南微医学科技股份有限公司 Dispositif d'anastomose
EP4021313A4 (fr) * 2019-11-18 2023-08-23 Buck Surgical LLC Coupleur anastomotique
US12201298B2 (en) 2019-11-18 2025-01-21 Buck Surgical Llc Anastomotic coupler

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052474A1 (fr) * 1997-05-22 1998-11-26 Kensey Nash Corporation Systeme d'anastomose et technique d'utilisation
US20050080439A1 (en) * 2000-04-29 2005-04-14 Carson Dean F. Devices and methods for forming magnetic anastomoses and ports in vessels
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
US20070225642A1 (en) * 2001-12-20 2007-09-27 Houser Russell A Catheter Securement Device
EP1908420A1 (fr) * 2006-10-06 2008-04-09 Ethicon Endo-Surgery, Inc. Dispositif d'anneau d'anastomose avec ferrure de verrouillage
US20100069933A1 (en) * 2006-01-16 2010-03-18 D Arcangelo Michele Positioning device for deploying at least one locking portion of an anastomotic device and method for carrying out anastomosis in tracts of the digestive tube

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052474A1 (fr) * 1997-05-22 1998-11-26 Kensey Nash Corporation Systeme d'anastomose et technique d'utilisation
US20050080439A1 (en) * 2000-04-29 2005-04-14 Carson Dean F. Devices and methods for forming magnetic anastomoses and ports in vessels
US20070225642A1 (en) * 2001-12-20 2007-09-27 Houser Russell A Catheter Securement Device
US20050085787A1 (en) 2003-10-17 2005-04-21 Laufer Michael D. Minimally invasive gastrointestinal bypass
US20100069933A1 (en) * 2006-01-16 2010-03-18 D Arcangelo Michele Positioning device for deploying at least one locking portion of an anastomotic device and method for carrying out anastomosis in tracts of the digestive tube
EP1908420A1 (fr) * 2006-10-06 2008-04-09 Ethicon Endo-Surgery, Inc. Dispositif d'anneau d'anastomose avec ferrure de verrouillage

Cited By (5)

* 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
EP4021313A4 (fr) * 2019-11-18 2023-08-23 Buck Surgical LLC Coupleur anastomotique
US11998208B2 (en) 2019-11-18 2024-06-04 Buck Surgical Llc Anastomotic coupler
US12201298B2 (en) 2019-11-18 2025-01-21 Buck Surgical Llc Anastomotic coupler
WO2022166903A1 (fr) * 2021-02-05 2022-08-11 南微医学科技股份有限公司 Dispositif d'anastomose

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