WO2012007042A1 - An anastomosis device for a cholecysto-enterostomy - Google Patents

An anastomosis device for a cholecysto-enterostomy Download PDF

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Publication number
WO2012007042A1
WO2012007042A1 PCT/EP2010/060266 EP2010060266W WO2012007042A1 WO 2012007042 A1 WO2012007042 A1 WO 2012007042A1 EP 2010060266 W EP2010060266 W EP 2010060266W WO 2012007042 A1 WO2012007042 A1 WO 2012007042A1
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WO
WIPO (PCT)
Prior art keywords
ring portion
anastomosis device
ring
gallbladder
wall
Prior art date
Application number
PCT/EP2010/060266
Other languages
French (fr)
Inventor
Mark Steven Ortiz
Alessandro Pastorelli
Almino Cardoso Ramos
David A. Dalessandro
Michele D'arcangelo
Original Assignee
Ethicon Endo-Surgery, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Priority to PCT/EP2010/060266 priority Critical patent/WO2012007042A1/en
Publication of WO2012007042A1 publication Critical patent/WO2012007042A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets 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, e.g. tourniquets
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/111—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis with means for removing a constriction after performing anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/346—Details of tips with wings

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 a conduit which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract.
  • 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 in order to follow the winding path of the intestine, 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 is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity.
  • an aim of the invention is to provide a device and method of diverting bile from the biliary tree including the gallbladder into a section of the intestine distally to the papilla of Vater, which are minimally invasive and which increase the flow rate of the diverted bile towards the target location in the small intestine with respect to the physiological entero-hepatic bile cycling.
  • a further aim of the invention is to obviate undesired relocations of the position of the bile diversion with respect to the target location intended by the doctor.
  • anastomosis device for a cholecystoenterostomy comprising:
  • - ring activating means which connect the first ring portion and the second ring portion and bias the first and second ring portion to hold a wall of the gallbladder and a wall of the target portion of intestine attached to each other to create anastomosis therebetween, wherein the anastomosis device is shaped to determine a passage hole in the gallbladder wall and intestinal wall at the cholecystoenterostomy, wherein the first ring portion is time- dependently shape changeable such that the bulk of individual pieces of the first ring portion becomes smaller than the passage hole.
  • the device allows to create a cholecystoenterostomy at the target portion of intestine significantly distal to the papilla of Vater, in which, after a programmed time, the first ring portion is automatically expelled from the gallbladder, through the anastomotic passage hole, into the intestine.
  • cholecystoenterostomy allows the bile to flow directly from the gallbladder in the target portion of intestine and to bypass at least part of the duodenum, while minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy and cannot be accidentally dislocated.
  • the target portion of the intestine 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.
  • At least the first ring portion is configured to gradually dissolve and, after a preset time, to crumble into individual fragments.
  • the first ring portion comprises at least one predetermined breaking region containing a gradually dissolvable material and indissoluble regions adjacent the predetermined breaking region.
  • the ring activating means comprise a magnet which magnetically attracts the first ring portion and the second ring portion to one another.
  • the ring activating means comprise a snap connector which snap connects the first ring portion and the second ring portion to one another.
  • the ring activating means comprise an elastically preloaded connecting portion which biases the first and second ring portions permanently in a rivet shaped tissue clamping configuration.
  • the ring activating means comprise a connecting portion in shape memory material which, upon exposure to the body heat, deforms the first and second ring portions in a tissue clamping shape.
  • FIG. 1 illustrates a device and a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention
  • FIG. 2 to 4 illustrate a device and a procedure for the creation of a cholecysto- enterostomy in accordance with an embodiment of the invention
  • FIG. 5 to 8 illustrate a device and a procedure for the creation of a cholecysto- enterostomy in accordance with a further embodiment of the invention
  • FIG. 10 is a side view of a device for the creation of a cholecysto-enterostomy in accordance with a further embodiment of the invention
  • FIG. 1 is a top view of the device in figure 10.
  • FIG. 12 to 14 illustrate devices for the creation of a cholecysto-enterostomy in accordance with further embodiments of the invention
  • FIG. 17 is a front view of the anastomosis device in figure 16;
  • FIG. 18 to 21 illustrate devices and procedural steps of the creation of a cholecysto- enterostomy in accordance with an embodiment of the invention
  • FIG. 22 is a perspective view of an anastomosis ring applier for a cholecysto- enterostomy in accordance with an embodiment of the invention
  • FIG. 23 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention.
  • FIG. 24 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with a further embodiment of the invention.
  • FIG. 25 and 26 illustrate a device for the creation of a cholecysto-enterostomy in accordance with further embodiments of the invention
  • FIGS. 27 and 28 illustrate an instrumentation and procedural steps of the creation of a cholecysto-enterostomy in accordance with an embodiment of the invention.
  • figure 1 is a partial view of the abdominal cavity of a patient, depicting the stomach 1 , duodenum 2, jejunum 3, ileum 4 and colon 5, as well as 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 2.
  • Figure 1 shows further a method and a device for creating a cholecysto- enterostomy 13 for diverting biliary fluid from the gallbladder 8 to a target portion 12 in the intestine distal of the papilla of Vater 10.
  • the method comprises the steps of:
  • the anastomosis device 1 1 comprises a first ring portion 14 intended to be placed inside the gallbladder 8, a second ring portion 15 intended to be placed inside the target portion 12 of the intestine 2, 3, 4, 5, as well as ring activating means which connect the first ring portion 14 to the second ring portion 15 and biases the first and second ring portions 14, 15 to hold the wall of the gallbladder 8 and the wall of the target portion 12 of intestine attached to each other to create anastomosis.
  • the anastomosis device 1 1 is shaped to determine a passage hole 16 in the gallbladder wall and the intestinal wall at the cholecystoenterostomy 1 3 and the first ring portion 14 is time-dependently shape changeable such that the bulk of individual pieces of the first ring portion 14 becomes smaller than the passage hole 16.
  • the first ring portion 14 is automatically expelled from inside the gallbladder 8, through the anastomotic passage hole 16, into the intestine.
  • At least the first ring portion 14 is configured to gradually dissolve and, after a preset time, to crumble into individual fragments 17 ( Figure 4).
  • the second ring portion 15 is configured to gradually dissolve and, after a preset time, crumble into individual fragments.
  • at least the first ring portion 14 comprises one or more predetermined breaking regions 18 containing a gradually dissolvable material and indissoluble regions 19 adjacent the predetermined breaking regions 18.
  • the ring activating means comprise a magnet 20 which magnetically attracts the first ring portion 14 to the second ring portion 15.
  • the first ring portion 14 may comprise a porous at least partially bio- absorbable ring body which is impregnated with a substance containing ferromagnetic particles.
  • the anastomosis device 1 1 comprises a tissue clamping coil 21 formed from a shape memory alloy wire annealed in a coil shape and subsequently longitudinally straightened in a stressed shape, the clamping coil 21 having a proximal pointed tip 22 adapted to pierce through a lumen wall and the clamping coil 21 is configured to regain its original tightly coiled shape upon exposure to the body temperature, thereby clamping the gallbladder wall and the intestinal wall between adjacent spires which form the above described first and second ring portions 14, 15.
  • the clamping coil 21 may be annealed in a flattened coil shape, in a tapered coil shape or in a cylindrical coil shape and subsequently forcedly straightened, e.g. rectilinear shape or in an elongated coiled shape having a distance between adjacent spires.
  • the shape memory alloy of the clamping coil 21 may comprise a NiTi alloy, such as for example Nitinol.
  • the clamping coil 21 may be deployed using an endoluminal or laparoscopic anastomosis instrument 23 comprising an elongate member 24 with a distally open recess 25 configured to receive the clamping coil 21 in its stressed shape, as well as a distally (doctor's side) actuatable dispensing member slidingly received in the elongate member 24 and coupled to the recess 25 to proximally dispense the clamping coil 21 .
  • the instrument 20 may further comprise a grasper 26 with two opposing grasping jaws.
  • the grasper 26 is movable proximally from the elongate member 24 proximal end and can be actuated by a grasper control mechanism (not illustrated) coupled to the grasping jaws through the elongate member 24 to effect opening and closing thereof.
  • a grasper control mechanism (not illustrated) coupled to the grasping jaws through the elongate member 24 to effect opening and closing thereof.
  • the anastomosis instrument 23 is laparoscopically or endoluminally inserted in the target portion 12 of the intestine, the grasper 26 jaws are closed to form a piercing tip and the grasper 26 is advanced through the intestinal wall into the abdominal space. Then the grasper 26 jaws are opened to grasp the wall of the gall bladder 8. The grasper 26 is then drawn distally to approximate and juxtapose the gallbladder wall and the intestinal wall at the target portion 12, and the clamping coil 21 is proximally dispensed through the walls of the approximated lumens.
  • the clamping coil 21 relaxes into its coiled shape with at least one spire (first ring portion 14) inside the gallbladder 8 and another spire (second ring portion 15) inside the target portion 12 of the intestine.
  • the fully relaxed clamping coil 21 then forms the anastomosis attachment, so that healing will occur between the two lumen walls.
  • the lumen walls are then cut through in the center opening of the annular clamping coil 21 to create the passage hole 16.
  • at least the first ring portion 14 of the clamping coil 21 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body.
  • the predetermined breaking regions 18 may be provided between indissoluble spire segments 19 having a circumferential extension of less than 300°, preferably less than 270°, even more preferably less than or equal to 180°, so that the fragmented spires can easily go through the anastomosis passage hole 16.
  • the angular pitch between the predetermined breaking regions 18 of the clamping coil 21 may be selected in a manner that the individual predetermined breaking regions 18 are axially misaligned.
  • the predetermined breaking regions 18 are arranged such that a predetermined breaking region 18 of a spire of the clamping coil 21 is always overlapped by an indissoluble spire segment 19 of an adjacent spire.
  • the anastomosis device 1 1 may comprise a woven tube 27 of wire constructed from a shape memory alloy, e.g. a TiNi alloy, such as Nitinol, having outer loops or ends adapted to thermally deform and evert when inserted into the walls of adjacent gallbladder 8 and the target portion 12.
  • a shape memory alloy e.g. a TiNi alloy, such as Nitinol
  • the ends of the tube 27 form petals in a manner which clamps the gallbladder 8 wall and the intestinal wall in apposition.
  • the woven tube 27 can be endoluminally or laparoscopically deployed by means of an elongate applicator (not illustrated) which comprises a canula with a distal end designed to allow the woven tube 27 to be slipped over the canula and pulled longitudinally causing the woven tube 27 to become longer and smaller in diameter.
  • the applicator further comprises an outer sleeve 28 adapted to be pushed over the woven tube 27 to provide a smooth surface for inserting the applicator through the walls of the approximated gallbladder 8 and target portion 12 of the intestine, and to be retracted from the woven tube 27 to expose the latter, so that heat from the body causes the tube 27 to contract longitudinally and evert to clamp the tissue walls and produce the anastomosis.
  • woven tube anastomosis device and applicators for its deployment have been described e.g. in US 2003032967 A1 , US20050070939A1 , US 20050070934 A1 , US 20050070926A1 and US20050070921 A1 , whose content is enclosed herein by reference in its entirety.
  • the woven tube 27 is additionally provided with the previously described time dependent shape changing features.
  • the anastomosis between the gallbladder 8 and the target portion 12 of the intestine may be accomplished by mounting the woven tube 27 on the applicator, covering the woven tube 27 by the retractable sleeve 28, inserting the applicator into the intestine to the anastomotic site, approximating the gallbladder 8 into close apposition to the intestine at the anastomotic site, piercing the wall of the intestine and the wall of the gallbladder 8, retracting the sleeve 28 and deploying the woven tube 27, thereby positioning its first ring portion 14 inside the gallbladder and its second ring portion 15 inside the target portion of intestine.
  • the ring activating means comprise an elastically preloaded connecting portion which biases the first and second ring portions 14, 15 permanently in a rivet shaped tissue clamping configuration.
  • the anastomosis device is advantageously held in a radially retracted elastically deformed shape, for instance by an applicator with a ring seat adapted to receive the anastomosis ring device and a retractable sleeve adapted to cover the anastomosis device during insertion and to release the anastomosis device after positioning, so that the latter can elastically revert to its rivet shape and clamp the wall of the gallbladder 8 against the wall of the target portion 12 of the intestine.
  • the first and second ring portions 14, 15 of the anastomosis device 1 1 may comprise inflatable ring shaped dilating balloons or ring sector shaped dilating balloon chambers 29 adapted to compress the gallbladder 8 wall and the wall of the target portion 12 of the intestine to create fistula and, hence, anastomosis therebetween.
  • the predetermined breaking regions 18 are formed between two adjacent inflatable balloon chambers 29 to allow controlled fragmentation and expulsion of the ring portions 14, 15.
  • the predetermined brea ki ng regi on s 1 8 may be provided at a con sta nt an gu lar pitch arou n d th e circumference of the ring portion 14, 15.
  • the cholecystoenterostomy 13 can be created using an anastomosis device having proximal 42, center 43, and distal rings 44 connected respectively by proximal and distal hinged arms forming the above said first and second ring portions 14, 15.
  • the ring device has a generally cylindrical shape when unactuated and a rivet shape when actuated.
  • FIG 20 illustrates an exemplary applier 45 for the anastomosis ring device.
  • the applier 45 comprises an elongate implement portion 46, a handle 47 connected to the implement portion 46, an actuating member internally engaged to a selected one of the rings of the anastomosis device, an arresting member internally engaged to a selected second of the rings of the anastomosis device and a control coupled to the handle 47 and configured to cause movement of the actuating member, and thus the engaged ring, toward the arresting member, and thus the selected second ring, causing actuating the interposed hinged arms of the ring device.
  • the general structure of such an anastomosis device and applier have been described in US 7,452,363 whose entire content is herein incorporated by reference.
  • the applier 45 together with the ring device is introduced endoluminally (not illustrated) or laparoscopically ( Figures 18 and 19) in the target portion 12 of the intestine and placed through a first otomy 48 created in the target portion 12 and a second otomy 49 created in the gallbladder 8 wall.
  • the applier 45 can have a proximal pointed tip 50 adapted to create the otomies 48, 49 when being forced through the wall of the intestine and of the gallbladder.
  • the first and second otomies 48, 49 may be created with a standard endoscopic or laparoscopic cutting instrument.
  • the applier 45 may be inserted laparoscopically through a third otomy 51 in a portion of the intestine near the target portion 12 and subsequently advanced to the anastomosis site. Then the proximal ring 42 of the anastomosis device is inserted through the previously created first otomy 48, while the distal hinged arms of the anastomosis device are actuated to expand radially so that the anastomosis device cannot completely slip through the first otomy 48. By pushing the applier 45 towards the gallbladder 8, the target portion 12 of the intestine is approximated to the gallbladder 8.
  • the proximal ring 42 of the anastomosis device is inserted through the previously created second otomy 49 into the gallbladder 8 and the proximal hinged arms (first ring portion 14) are activated to expand radially, thereby clamping the target portion 12 of the intestine against the gallbladder wall to allow anastomosis therebetween ( Figures 19 and 21 ). Then, the applier 45 can be withdrawn endoluminally or through the third otomy 51 .
  • At least the ring portion located inside the gallbladder 8 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body.
  • the ring activating means comprise at least one snap connector which snap connects or snap ratchet connects the first ring portion 14 and the second ring portion 15 to one another.
  • an open guide wire loop with two guide wires 30, 30' is created wherein the two guide wires 30, 30' extend side by side through the gallbladder 8 wall and through the wall of the target portion 12 of the intestine.
  • a specifically adapted anastomosis device (Figure 23) may be used which includes a first ring portion
  • first ring portion 14 having two first guide wire seats 31 each of which is adapted to slidably receive one of the two guide wires 30, 30', respectively, and a second ring portion 15 having two second guide wire seats 32 each of which is adapted to slidably receive one of the two guide wires 30, 30', respectively, and in which the first ring portion 14 and the second ring portion 15 are snap-connectable to each other.
  • the first ring portion 14 may comprise two snap connecting portions 33 spaced apart at a distance which is substantially equal to a distance between two corresponding counter snap connecting portions 34 provided at the second ring portion 15.
  • first guide wire seats 31 of the first ring portion 14 are defined inside the snap connecting portions 33 and the second guide wire seats 32 of the second ring portion 15 are defined inside the counter snap connecting portions 34 so that the axes of the ring position ing and ring gu idance are aligned with the axes of the ring snap connection.
  • a deployment probe 35 ( Figure 22) may be provided which is adapted to endoluminally push the second ring portion 15 along the guide wires 30, 30' to a tissue portion (e.g. to the intestinal wall) of the anastomotic site.
  • the deployment probe 35 includes an elongate shaft 36 as well as a proximal connector 37 with a distal coupling portion 38 adapted to detachably connect with the proximal end of the elongate shaft 36 and a proximal push surface 39 which is at least partially complementary with the corresponding surface of the second ring portion 15 in a way that the second ring portion
  • the connector 37 of the deployment probe 35 delimits cavities 40 configured to receive with interference the distally (towards the doctor) protruding counter-snap connecting portions 34 of the second ring portion 15.
  • the connector 37 comprises sliding seats 41 adapted to slidably receive the guide wires 30, 30' and preferably axially aligned with the distal guide wire seats 32 of the second ring portion 15 when the latter is received by the connector 37.
  • the general structure of such an anastomosis device and deployment device is described in EP 1915956 A1 whose content is enclosed herein by reference in its entirety.
  • Figure 24 illustrates a further exemplary embodiment, in which the first and second ring portions 14, 15 have corresponding first and second tissue contact surfaces 52, 53 intended to face each other and having an u ndu lated shape relative to a plane perpendicular to an axis X of the ring portions 14, 15.
  • the ring activating means may comprise at least one snap connector which snap connects or snap ratchet connects the first ring portion 14 and the second ring portion 15 to one another.
  • the general structure of such an an astomosis d evice h ave been descri bed i n WO2007/101526A1 whose content is herein enclosed by reference in its entirety.
  • the ring portion located inside the gallbladder 8 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body.
  • the predetermined breaking regions 18 may be provided between indissoluble ring segments 19 having a circumferential extension of less than or equal to 180°, preferably about 90°, so that the fragmented segments can easily go through the anastomosis passage hole 16.
  • the ring activating means of the anastomosis device comprises a locking device 54 adapted to connect the first 14 and second ring portion 15 to lock the anastomosis device in its actuated configuration.
  • the locking device 54 may be distinct from the first 14 and second ring portion 15.
  • the locking device 54 comprises a distal shoulder 57 which engages a distal end surface 58 of the second ring portion 15 and a longitudinal portion 55 distally projecting from the proximal shoulder 57 and insertable in the passage openings of both the first and second ring portions 14, 15.
  • the longitudinal portion 55 forms a bushing portion 56 adapted to cover an inside surface of the tissue portions 8, 12 when they are clamped between the first and second ring portions 14, 15, and one or more connectors 59 adapted to engage the first ring portion 14, e.g. elastically supported snapper teeth adapted to snap engage the first ring portion 14.
  • the bushing portion 56 comprises a substantially tubular wall (having preferably a circumferentially continuous, uninterrupted cross-section) suitable to cover a prevalent portion of the inside surface of the clamped tissue portions 8, 1 2. Also i n th is em bodiment, the anastomosis device is time dependency shape changeable and may comprise one or more predetermined breaking regions 18 containing a gradually dissolvable material and indissoluble regions 19 adjacent the predetermined breaking regions 18.
  • the anastomosis device comprises a tubular member 60 having a longitudinal axis L, a first radially protruding flange 61 (forming the first ring portion 14) intended to be placed inside the gallbladder 8, a second radially protruding flange 62 (forming the second ring portion 15) intended to be placed inside the target portion 12 of the intestine, as well as an annular cavity 63 defined between the first and second flanges 61 , 62 and adapted to receive an intestinal wall and a gallbladder wall in apposition.
  • the tubular member 60 is made of a biocompatible material and can be deployed laparoscopically or endoluminally by means of an applier 64 having a cylindrical seat 65 adapted to receive the tubular member 60 and an insertion tip 66 comprising a plurality of flaps or petals 67 which extend from the seat 65 proximally (towards the patient) and which are permanently biased in a closure position in which the petals 67 form a proximally tapered tip and close the cylindrical seat 65.
  • the applier 64 comprises further a pusher 68 arranged inside the cylindrical seat 65 distal (doctor's side) to the tubular member 60 and operable to push the tubular member 60 in a proximal direction out of the cylindrical seat 65.
  • the cylindrical seat 65 and the insertion tip 66 are configured that, upon proximal expulsion of the tubular member 60, the latter urges the flaps or petals 67 radially apart, thereby opening the tip 66 and allowing the open flaps 67 to be withdrawn distally (towards the doctor) from the tubular member 60.
  • the applier 64 equipped with the tubular member 60 is pushed with the closed tip 66 through the wall of the target portion 12 of the intestine and through the gallbladder wall, and positioned so that the ring shaped cavity 63 of the tubular member 60 is aligned with the apposed gallbladder wall and intestinal wall. Then the pusher 68 is operated to drive the tubular member 60 proximally out of the seat 65 and, at the same time, the applier 64 is withdrawn distally (towards the doctor) from the tubular member 60 and from the apposed tissue walls, thereby exposing the annular cavity 63 which receives the tissue to be anastomosed.
  • the predetermined breaking regions 18 may be provided between indissoluble ring segments 19 having a circumferential extension of less than or equal to 180°, preferably about 90°, so that the fragmented segments can easily go through the anastomosis passage hole 16.

Abstract

An anastomosis device (11) for a cholecystoenterostomy comprises a first ring portion (14) intended to be placed inside a gallbladder (8), a second ring portion (15) intended to be placed inside a target portion (12) of an intestine, wherein the anastomosis device (11) is shaped to determine a passage hole (16) in the gallbladder wall and intestinal wall at the cholecystoenterostomy (13) and at least the first ring portion (14) is time-dependently shape changeable such that the bulk of individual pieces of the first ring portion (14) becomes smaller than the passage hole (16).

Description

DESCRIPTION
"AN ANASTOMOSIS DEVICE FOR A CHOLECYSTO-ENTEROSTOMY"
The present invention relates, in general, to devices and methods for surgically influencing the digestion of a patient with the aim to treat metabolic disorders, such as morbid obesity and related co-morbidities, such as diabetes, heart disease, stroke, pulmonary disease, and accidents.
Numerous non-operative therapies for morbid obesity have been tried in the past with virtually no permanent success.
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 highly invasive modifications of the patients gastrointestinal anatomy. These procedures are reserved only for the severely obese patients because they have a number of significant complications, including the risk of death. In order to avoid the drawbacks of gastric bypass surgery and to influence the digestion of a patient in a more specific and aimed way, the present invention focuses on methods and devices for primarily influencing and modifying the entero-hepatic bile cycling rather than the digestive tract itself. To this end, the following possible approaches and mechanisms of action on the entero-hepatic bile cycling are contemplated:
- modification of the entero-hepatic bile cycling frequency, particularly bile cycle acceleration;
- modification of the physiological signaling triggered by the contact and interaction of the bile with the food in the intestine and by the contact of the bile with the intestinal wall; - modification of the food absorbability by modifying the contact space and time between the bile and the food or chime in the intestine as well as by an aimed separation of the bile from the food.
A known minimally invasive bypass system and method for modifying the location at which bile and pancreatic secretions interact with nutrients in a gastrointestinal tract has been discussed in US 2005085787 A1 . The known system comprises a conduit which diverts bile and pancreatic secretions from the ampulla of Vater to a location downstream in the gastrointestinal tract. 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.
Moreover, in order to follow the winding path of the intestine, 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 is not suitable to obtain a significant acceleration of the bile cycling compared to the natural entero-hepatic bile cycling velocity.
In view of the drawbacks of the known art, an aim of the invention is to provide a device and method of diverting bile from the biliary tree including the gallbladder into a section of the intestine distally to the papilla of Vater, which are minimally invasive and which increase the flow rate of the diverted bile towards the target location in the small intestine with respect to the physiological entero-hepatic bile cycling.
A further aim of the invention is to obviate undesired relocations of the position of the bile diversion with respect to the target location intended by the doctor.
At least part of the above identified aims are achieved by an anastomosis device for a cholecystoenterostomy, the device comprising:
- a first ring portion intended to be placed inside a gallbladder,
- a second ring portion intended to be placed inside a target portion of the intestine,
- ring activating means which connect the first ring portion and the second ring portion and bias the first and second ring portion to hold a wall of the gallbladder and a wall of the target portion of intestine attached to each other to create anastomosis therebetween, wherein the anastomosis device is shaped to determine a passage hole in the gallbladder wall and intestinal wall at the cholecystoenterostomy, wherein the first ring portion is time- dependently shape changeable such that the bulk of individual pieces of the first ring portion becomes smaller than the passage hole.
The device allows to create a cholecystoenterostomy at the target portion of intestine significantly distal to the papilla of Vater, in which, after a programmed time, the first ring portion is automatically expelled from the gallbladder, through the anastomotic passage hole, into the intestine.
The thus obtained cholecystoenterostomy allows the bile to flow directly from the gallbladder in the target portion of intestine and to bypass at least part of the duodenum, while minimizing the length of the bile flow path. Moreover, the position at which the diverted bile is dispensed into the intestine is defined by the cholecysto-enterostomy and cannot be accidentally dislocated.
The target portion of the intestine 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.
In accordance with an aspect of the invention, at least the first ring portion is configured to gradually dissolve and, after a preset time, to crumble into individual fragments.
In accordance with a further aspect of the invention, the first ring portion comprises at least one predetermined breaking region containing a gradually dissolvable material and indissoluble regions adjacent the predetermined breaking region.
This makes it possible to reconcile the contrasting needs of high mechanical strength and constant shape of the ring portions while they hold and compress the anastomosed tissue portions and a controlled degradation and fragmentation of the first ring portion to allow its removal from the gallbladder.
In accordance with a further aspect of the invention, the ring activating means comprise a magnet which magnetically attracts the first ring portion and the second ring portion to one another.
In accordance with a further aspect of the invention, the ring activating means comprise a snap connector which snap connects the first ring portion and the second ring portion to one another.
In accordance with a further aspect of the invention, the ring activating means comprise an elastically preloaded connecting portion which biases the first and second ring portions permanently in a rivet shaped tissue clamping configuration.
In accordance with a further aspect of the invention, the ring activating means comprise a connecting portion in shape memory material which, upon exposure to the body heat, deforms the first and second ring portions in a tissue clamping shape.
These and other aspects and advantages of the present invention shall be made apparent from the accom pa nyi n g d rawi ngs a nd the descri ption thereof, wh ich ill ustrate 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 device and a procedure for the diversion of bile through a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figures 2 to 4 illustrate a device and a procedure for the creation of a cholecysto- enterostomy in accordance with an embodiment of the invention;
- Figures 5 to 8 illustrate a device and a procedure for the creation of a cholecysto- enterostomy in accordance with a further embodiment of the invention; - Figure 10 is a side view of a device for the creation of a cholecysto-enterostomy in accordance with a further embodiment of the invention;
- Figure 1 1 is a top view of the device in figure 10.
- Figures 12 to 14 illustrate devices for the creation of a cholecysto-enterostomy in accordance with further embodiments of the invention;
- Figures 15 a nd 1 6 a re cross-sectional views of an anastomosis device during deployment in accordance with an embodiment;
- Figure 17 is a front view of the anastomosis device in figure 16;
- Figures 18 to 21 illustrate devices and procedural steps of the creation of a cholecysto- enterostomy in accordance with an embodiment of the invention;
- Figure 22 is a perspective view of an anastomosis ring applier for a cholecysto- enterostomy in accordance with an embodiment of the invention;
- Figure 23 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with an embodiment of the invention;
- Figure 24 is a perspective view of an anastomosis device for a cholecysto-enterostomy in accordance with a further embodiment of the invention;
- Figures 25 and 26 illustrate a device for the creation of a cholecysto-enterostomy in accordance with further embodiments of the invention;
- Figures 27 and 28 illustrate an instrumentation and procedural steps of the creation of a cholecysto-enterostomy in accordance with an 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 stomach 1 , duodenum 2, jejunum 3, ileum 4 and colon 5, as well as 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 2. Figure 1 shows further a method and a device for creating a cholecysto- enterostomy 13 for diverting biliary fluid from the gallbladder 8 to a target portion 12 in the intestine distal of the papilla of Vater 10.
In accordance with a general inventive idea, the method comprises the steps of:
- approximating the gallbladder 8 and the target portion 12 of the intestine to each other; and
- connecting a wall of the gallbladder 8 to a wall of the target portion 12 of the intestine by means of an anastomosis device 1 1 to create a cholecysto-enterostomy 13;
- creating a passage hole 16 in the gallbladder 8 wall and intestinal wall at the cholecysto- enterostomy;
- after a predetermined time, changing the shape of the anastomosis device 1 1 and expelling it through the passage hole 16 in the intestine, particularly dissolving at least part of the anastomosis device 1 1 .
The anastomosis device 1 1 comprises a first ring portion 14 intended to be placed inside the gallbladder 8, a second ring portion 15 intended to be placed inside the target portion 12 of the intestine 2, 3, 4, 5, as well as ring activating means which connect the first ring portion 14 to the second ring portion 15 and biases the first and second ring portions 14, 15 to hold the wall of the gallbladder 8 and the wall of the target portion 12 of intestine attached to each other to create anastomosis. The anastomosis device 1 1 is shaped to determine a passage hole 16 in the gallbladder wall and the intestinal wall at the cholecystoenterostomy 1 3 and the first ring portion 14 is time-dependently shape changeable such that the bulk of individual pieces of the first ring portion 14 becomes smaller than the passage hole 16.
Than ks to the time dependent shape change of the fi rst ring portion 14, after a programmed time, the first ring portion 14 is automatically expelled from inside the gallbladder 8, through the anastomotic passage hole 16, into the intestine.
In accordance with an embodiment, at least the first ring portion 14 is configured to gradually dissolve and, after a preset time, to crumble into individual fragments 17 (Figure 4). Alternatively, also the second ring portion 15 is configured to gradually dissolve and, after a preset time, crumble into individual fragments. In accordance with a further exemplary embodiment, at least the first ring portion 14 comprises one or more predetermined breaking regions 18 containing a gradually dissolvable material and indissoluble regions 19 adjacent the predetermined breaking regions 18.
This makes it possible to reconcile the contrasting needs of high mechanical strength and constant shape of the ring portions 14, 15 while they hold and compress the anastomosed tissue portions and a controlled degradation and fragmentation of at least the first ring portion 14 to allow its removal from the gallbladder 8.
In accordance with an exemplary embodiment (Figure 4), the ring activating means comprise a magnet 20 which magnetically attracts the first ring portion 14 to the second ring portion 15. The first ring portion 14 may comprise a porous at least partially bio- absorbable ring body which is impregnated with a substance containing ferromagnetic particles.
In accordance with an embodiment (Figures 5 to 8), the anastomosis device 1 1 comprises a tissue clamping coil 21 formed from a shape memory alloy wire annealed in a coil shape and subsequently longitudinally straightened in a stressed shape, the clamping coil 21 having a proximal pointed tip 22 adapted to pierce through a lumen wall and the clamping coil 21 is configured to regain its original tightly coiled shape upon exposure to the body temperature, thereby clamping the gallbladder wall and the intestinal wall between adjacent spires which form the above described first and second ring portions 14, 15. The clamping coil 21 may be annealed in a flattened coil shape, in a tapered coil shape or in a cylindrical coil shape and subsequently forcedly straightened, e.g. rectilinear shape or in an elongated coiled shape having a distance between adjacent spires.
The shape memory alloy of the clamping coil 21 may comprise a NiTi alloy, such as for example Nitinol.
I n accordance with an embodiment, the clamping coil 21 may be deployed using an endoluminal or laparoscopic anastomosis instrument 23 comprising an elongate member 24 with a distally open recess 25 configured to receive the clamping coil 21 in its stressed shape, as well as a distally (doctor's side) actuatable dispensing member slidingly received in the elongate member 24 and coupled to the recess 25 to proximally dispense the clamping coil 21 . The instrument 20 may further comprise a grasper 26 with two opposing grasping jaws. The grasper 26 is movable proximally from the elongate member 24 proximal end and can be actuated by a grasper control mechanism (not illustrated) coupled to the grasping jaws through the elongate member 24 to effect opening and closing thereof. Such an anastomosis clamping coil and instrument has been described in US 7,618,427 to Ortiz and Nobis. The entire content of US 7,618,427 is incorporated herein by reference.
Duri ng implantation of the clamping coil 21 , the anastomosis instrument 23 is laparoscopically or endoluminally inserted in the target portion 12 of the intestine, the grasper 26 jaws are closed to form a piercing tip and the grasper 26 is advanced through the intestinal wall into the abdominal space. Then the grasper 26 jaws are opened to grasp the wall of the gall bladder 8. The grasper 26 is then drawn distally to approximate and juxtapose the gallbladder wall and the intestinal wall at the target portion 12, and the clamping coil 21 is proximally dispensed through the walls of the approximated lumens. Then the clamping coil 21 relaxes into its coiled shape with at least one spire (first ring portion 14) inside the gallbladder 8 and another spire (second ring portion 15) inside the target portion 12 of the intestine. The fully relaxed clamping coil 21 then forms the anastomosis attachment, so that healing will occur between the two lumen walls. The lumen walls are then cut through in the center opening of the annular clamping coil 21 to create the passage hole 16. After a preset time interval for the healing of the anastomosed tissue, at least the first ring portion 14 of the clamping coil 21 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body. In this embodiment, the predetermined breaking regions 18 may be provided between indissoluble spire segments 19 having a circumferential extension of less than 300°, preferably less than 270°, even more preferably less than or equal to 180°, so that the fragmented spires can easily go through the anastomosis passage hole 16. Moreover, the angular pitch between the predetermined breaking regions 18 of the clamping coil 21 may be selected in a manner that the individual predetermined breaking regions 18 are axially misaligned. Preferably, the predetermined breaking regions 18 are arranged such that a predetermined breaking region 18 of a spire of the clamping coil 21 is always overlapped by an indissoluble spire segment 19 of an adjacent spire.
In accordance with a further exemplary embodiment (Figures 10 to 14), the anastomosis device 1 1 may comprise a woven tube 27 of wire constructed from a shape memory alloy, e.g. a TiNi alloy, such as Nitinol, having outer loops or ends adapted to thermally deform and evert when inserted into the walls of adjacent gallbladder 8 and the target portion 12. By thermally deforming and everting, the ends of the tube 27 form petals in a manner which clamps the gallbladder 8 wall and the intestinal wall in apposition.
The woven tube 27 can be endoluminally or laparoscopically deployed by means of an elongate applicator (not illustrated) which comprises a canula with a distal end designed to allow the woven tube 27 to be slipped over the canula and pulled longitudinally causing the woven tube 27 to become longer and smaller in diameter. The applicator further comprises an outer sleeve 28 adapted to be pushed over the woven tube 27 to provide a smooth surface for inserting the applicator through the walls of the approximated gallbladder 8 and target portion 12 of the intestine, and to be retracted from the woven tube 27 to expose the latter, so that heat from the body causes the tube 27 to contract longitudinally and evert to clamp the tissue walls and produce the anastomosis.
The general structure of such a woven tube anastomosis device and applicators for its deployment have been described e.g. in US 2003032967 A1 , US20050070939A1 , US 20050070934 A1 , US 20050070926A1 and US20050070921 A1 , whose content is enclosed herein by reference in its entirety. In accordance with the present invention the woven tube 27 is additionally provided with the previously described time dependent shape changing features.
The anastomosis between the gallbladder 8 and the target portion 12 of the intestine may be accomplished by mounting the woven tube 27 on the applicator, covering the woven tube 27 by the retractable sleeve 28, inserting the applicator into the intestine to the anastomotic site, approximating the gallbladder 8 into close apposition to the intestine at the anastomotic site, piercing the wall of the intestine and the wall of the gallbladder 8, retracting the sleeve 28 and deploying the woven tube 27, thereby positioning its first ring portion 14 inside the gallbladder and its second ring portion 15 inside the target portion of intestine.
In accordance with an alternative embodiment of the invention, the ring activating means comprise an elastically preloaded connecting portion which biases the first and second ring portions 14, 15 permanently in a rivet shaped tissue clamping configuration. In this embodiment, during transport to the anastomosis site, the anastomosis device is advantageously held in a radially retracted elastically deformed shape, for instance by an applicator with a ring seat adapted to receive the anastomosis ring device and a retractable sleeve adapted to cover the anastomosis device during insertion and to release the anastomosis device after positioning, so that the latter can elastically revert to its rivet shape and clamp the wall of the gallbladder 8 against the wall of the target portion 12 of the intestine.
In accordance with a further embodiment (Figures 15 to 17), the first and second ring portions 14, 15 of the anastomosis device 1 1 may comprise inflatable ring shaped dilating balloons or ring sector shaped dilating balloon chambers 29 adapted to compress the gallbladder 8 wall and the wall of the target portion 12 of the intestine to create fistula and, hence, anastomosis therebetween. I n this embodiment, the predetermined breaking regions 18 are formed between two adjacent inflatable balloon chambers 29 to allow controlled fragmentation and expulsion of the ring portions 14, 15. The predetermined brea ki ng regi on s 1 8 may be provided at a con sta nt an gu lar pitch arou n d th e circumference of the ring portion 14, 15.
In accordance with a further exemplary embodiment (Figures 18 to 21 ), the cholecystoenterostomy 13 can be created using an anastomosis device having proximal 42, center 43, and distal rings 44 connected respectively by proximal and distal hinged arms forming the above said first and second ring portions 14, 15. The ring device has a generally cylindrical shape when unactuated and a rivet shape when actuated.
Figure 20 illustrates an exemplary applier 45 for the anastomosis ring device. The applier 45 comprises an elongate implement portion 46, a handle 47 connected to the implement portion 46, an actuating member internally engaged to a selected one of the rings of the anastomosis device, an arresting member internally engaged to a selected second of the rings of the anastomosis device and a control coupled to the handle 47 and configured to cause movement of the actuating member, and thus the engaged ring, toward the arresting member, and thus the selected second ring, causing actuating the interposed hinged arms of the ring device. The general structure of such an anastomosis device and applier have been described in US 7,452,363 whose entire content is herein incorporated by reference.
I n accordance with an embodiment, the applier 45 together with the ring device is introduced endoluminally (not illustrated) or laparoscopically (Figures 18 and 19) in the target portion 12 of the intestine and placed through a first otomy 48 created in the target portion 12 and a second otomy 49 created in the gallbladder 8 wall. The applier 45 can have a proximal pointed tip 50 adapted to create the otomies 48, 49 when being forced through the wall of the intestine and of the gallbladder. Alternatively, the first and second otomies 48, 49 may be created with a standard endoscopic or laparoscopic cutting instrument.
As shown in figures 18 and 19, the applier 45 may be inserted laparoscopically through a third otomy 51 in a portion of the intestine near the target portion 12 and subsequently advanced to the anastomosis site. Then the proximal ring 42 of the anastomosis device is inserted through the previously created first otomy 48, while the distal hinged arms of the anastomosis device are actuated to expand radially so that the anastomosis device cannot completely slip through the first otomy 48. By pushing the applier 45 towards the gallbladder 8, the target portion 12 of the intestine is approximated to the gallbladder 8. Then the proximal ring 42 of the anastomosis device is inserted through the previously created second otomy 49 into the gallbladder 8 and the proximal hinged arms (first ring portion 14) are activated to expand radially, thereby clamping the target portion 12 of the intestine against the gallbladder wall to allow anastomosis therebetween (Figures 19 and 21 ). Then, the applier 45 can be withdrawn endoluminally or through the third otomy 51 . After completion of the cholecystoenterostomy 1 3 and a preset time interval for the healing of the anastomosed tissue, at least the ring portion located inside the gallbladder 8 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body.
In accordance with a yet further embodiment, the ring activating means comprise at least one snap connector which snap connects or snap ratchet connects the first ring portion 14 and the second ring portion 15 to one another.
For example (Figures 22 to 24), an open guide wire loop with two guide wires 30, 30' is created wherein the two guide wires 30, 30' extend side by side through the gallbladder 8 wall and through the wall of the target portion 12 of the intestine. In this case a specifically adapted anastomosis device (Figure 23) may be used which includes a first ring portion
14 having two first guide wire seats 31 each of which is adapted to slidably receive one of the two guide wires 30, 30', respectively, and a second ring portion 15 having two second guide wire seats 32 each of which is adapted to slidably receive one of the two guide wires 30, 30', respectively, and in which the first ring portion 14 and the second ring portion 15 are snap-connectable to each other. For this purpose the first ring portion 14 may comprise two snap connecting portions 33 spaced apart at a distance which is substantially equal to a distance between two corresponding counter snap connecting portions 34 provided at the second ring portion 15.
Advantageously, the first guide wire seats 31 of the first ring portion 14 are defined inside the snap connecting portions 33 and the second guide wire seats 32 of the second ring portion 15 are defined inside the counter snap connecting portions 34 so that the axes of the ring position ing and ring gu idance are aligned with the axes of the ring snap connection.
For the transportation and deployment of the anastomosis device 1 1 , a deployment probe 35 (Figure 22) may be provided which is adapted to endoluminally push the second ring portion 15 along the guide wires 30, 30' to a tissue portion (e.g. to the intestinal wall) of the anastomotic site. I n accordance with an embodiment, the deployment probe 35 includes an elongate shaft 36 as well as a proximal connector 37 with a distal coupling portion 38 adapted to detachably connect with the proximal end of the elongate shaft 36 and a proximal push surface 39 which is at least partially complementary with the corresponding surface of the second ring portion 15 in a way that the second ring portion
15 can be captively received by the push surface 39. For instance, the connector 37 of the deployment probe 35 delimits cavities 40 configured to receive with interference the distally (towards the doctor) protruding counter-snap connecting portions 34 of the second ring portion 15.
Moreover, the connector 37 comprises sliding seats 41 adapted to slidably receive the guide wires 30, 30' and preferably axially aligned with the distal guide wire seats 32 of the second ring portion 15 when the latter is received by the connector 37. The general structure of such an anastomosis device and deployment device is described in EP 1915956 A1 whose content is enclosed herein by reference in its entirety.
Figure 24 illustrates a further exemplary embodiment, in which the first and second ring portions 14, 15 have corresponding first and second tissue contact surfaces 52, 53 intended to face each other and having an u ndu lated shape relative to a plane perpendicular to an axis X of the ring portions 14, 15. Also in this embodiment, the ring activating means may comprise at least one snap connector which snap connects or snap ratchet connects the first ring portion 14 and the second ring portion 15 to one another. The general structure of such an an astomosis d evice h ave been descri bed i n WO2007/101526A1 whose content is herein enclosed by reference in its entirety.
After completion of the cholecystoenterostomy 13 and a preset time interval for the healing of the anastomosed tissue, at least the ring portion located inside the gallbladder 8 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body. In this embodiment, the predetermined breaking regions 18 may be provided between indissoluble ring segments 19 having a circumferential extension of less than or equal to 180°, preferably about 90°, so that the fragmented segments can easily go through the anastomosis passage hole 16.
I n accordance with a further exemplary embodiment (Figures 25 and 26), the ring activating means of the anastomosis device comprises a locking device 54 adapted to connect the first 14 and second ring portion 15 to lock the anastomosis device in its actuated configuration. The locking device 54 may be distinct from the first 14 and second ring portion 15.
Advantageously, the locking device 54 comprises a distal shoulder 57 which engages a distal end surface 58 of the second ring portion 15 and a longitudinal portion 55 distally projecting from the proximal shoulder 57 and insertable in the passage openings of both the first and second ring portions 14, 15. The longitudinal portion 55 forms a bushing portion 56 adapted to cover an inside surface of the tissue portions 8, 12 when they are clamped between the first and second ring portions 14, 15, and one or more connectors 59 adapted to engage the first ring portion 14, e.g. elastically supported snapper teeth adapted to snap engage the first ring portion 14.
In accordance with an embodiment, the bushing portion 56 comprises a substantially tubular wall (having preferably a circumferentially continuous, uninterrupted cross-section) suitable to cover a prevalent portion of the inside surface of the clamped tissue portions 8, 1 2. Also i n th is em bodiment, the anastomosis device is time dependency shape changeable and may comprise one or more predetermined breaking regions 18 containing a gradually dissolvable material and indissoluble regions 19 adjacent the predetermined breaking regions 18.
In accordance with an embodiment (Figures 27 to 28), the anastomosis device comprises a tubular member 60 having a longitudinal axis L, a first radially protruding flange 61 (forming the first ring portion 14) intended to be placed inside the gallbladder 8, a second radially protruding flange 62 (forming the second ring portion 15) intended to be placed inside the target portion 12 of the intestine, as well as an annular cavity 63 defined between the first and second flanges 61 , 62 and adapted to receive an intestinal wall and a gallbladder wall in apposition. The tubular member 60 is made of a biocompatible material and can be deployed laparoscopically or endoluminally by means of an applier 64 having a cylindrical seat 65 adapted to receive the tubular member 60 and an insertion tip 66 comprising a plurality of flaps or petals 67 which extend from the seat 65 proximally (towards the patient) and which are permanently biased in a closure position in which the petals 67 form a proximally tapered tip and close the cylindrical seat 65. The applier 64 comprises further a pusher 68 arranged inside the cylindrical seat 65 distal (doctor's side) to the tubular member 60 and operable to push the tubular member 60 in a proximal direction out of the cylindrical seat 65. The cylindrical seat 65 and the insertion tip 66 are configured that, upon proximal expulsion of the tubular member 60, the latter urges the flaps or petals 67 radially apart, thereby opening the tip 66 and allowing the open flaps 67 to be withdrawn distally (towards the doctor) from the tubular member 60.
As illustrated in figures 27 and 28, the applier 64 equipped with the tubular member 60 is pushed with the closed tip 66 through the wall of the target portion 12 of the intestine and through the gallbladder wall, and positioned so that the ring shaped cavity 63 of the tubular member 60 is aligned with the apposed gallbladder wall and intestinal wall. Then the pusher 68 is operated to drive the tubular member 60 proximally out of the seat 65 and, at the same time, the applier 64 is withdrawn distally (towards the doctor) from the tubular member 60 and from the apposed tissue walls, thereby exposing the annular cavity 63 which receives the tissue to be anastomosed.
Advantageously, after completion of the cholecystoenterostomy 1 3 and a preset time interval for the healing of the anastomosed tissue, at least the ring portion located inside the gallbladder 8 will dissolve as described above and its fragments are expelled through the passage hole 16 into the intestine and out of the body. I n this embodiment, the predetermined breaking regions 18 may be provided between indissoluble ring segments 19 having a circumferential extension of less than or equal to 180°, preferably about 90°, so that the fragmented segments can easily go through the anastomosis passage hole 16. Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to l im it the scope of the clai ms to such particu lar embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. An anastomosis device (1 1 ) for a cholecystoenterostomy, the anastomosis device (1 1 ) comprising:
- a first ring portion (14) intended to be placed inside a gallbladder (8),
- a second ring portion (15) intended to be placed inside a target portion (12) of an intestine,
- ring activating means which connect the first ring portion (14) and the second ring portion (15) and bias the first and second ring portion to hold a wall of the gallbladder (8) a n d a wa l l of th e ta rget porti on (12) attached to each other to create said cholecystoenterostomy (13) therebetween,
wherein said anastomosis device (1 1 ) is shaped to determine a passage hole (16) in the gallbladder wall and intestinal wall at the cholecystoenterostomy (13),
wherein at least said first ring portion (14) is time-dependently shape changeable such that the bulk of individual pieces of the first ring portion (14) becomes smaller than the passage hole (16).
2. Anastomosis device (1 1 ) according to claim 1 , wherein at least said first ring portion (14) is configured to gradually dissolve and, after a preset time, crumble into individual fragments (17).
3. Anastomosis device (1 1 ) according to claim 2, wherein the first ring portion (14) comprises:
- at least one predetermined breaking region (18) containing a gradually dissolvable material and
- indissoluble regions (19) adjacent the predetermined breaking region (18).
4. Anastomosis device (1 1 ) according to claim 3, wherein said indissoluble regions (19) comprise indissoluble ring segments (19) having a circumferential extension of less than or equal to 180°.
5. Anastomosis device (1 1 ) according to any one of claims 1 to 4, wherein the ring activating means comprise a magnet (20) which magnetically attracts the first ring portion (14) and the second ring portion (15) to each other.
6. Anastomosis device (1 1 ) according to claim 5, wherein said first ring portion (14) comprises a porous at least partially bio-absorbable ring body which is impregnated with a substance containing ferromagnetic particles.
7. Anastomosis device (1 1 ) according to any one of claims 1 to 4, wherein the ring activating means comprise an elastically preloaded connecting portion which biases the first ring portion (14) and second ring portion (15) permanently in a tissue clamping configuration.
8. Anastomosis device (1 1 ) according to any one of claims 1 to 4, wherein the ring activating means comprise a connecting portion in shape memory material which, upon exposure to the body heat, deforms the first ring portion (14) and the second ring portion (15) in a tissue clamping shape.
9. Anastomosis device (1 1 ) according to claim 8, comprising a tissue clamping coil (21 ) formed from a shape memory alloy wire annealed in a coil shape and having a pointed tip (22) adapted to pierce through a lumen wall, said clamping coil (21 ) being configured to regain its original tightly coiled shape upon exposure to the body temperature, thereby clamping the gallbladder wall and the intestinal wall between adjacent spires which form said first and second ring portions (14, 15).
10. Anastomosis device (1 1 ) according to claim 9, wherein said predetermined breaking regions (18) are formed between indissoluble spire segments (19), said indissoluble spire segments (19) having a circumferential extension of less than 270°, preferably less than or equal to 180°.
11. Anastomosis device (1 1 ) according to claim 10, wherein the predetermined breaking regions (18) are arranged such that each predetermined breaking region (18) of a spire of the clamping coil (21 ) is overlapped by an indissoluble spire segment (19) of an adjacent spire.
12. Anastomosis device (1 1 ) according to any one of claims 1 to 4, wherein said first ring portion (14) comprise inflatable dilating balloon chambers (29) adapted to compress the gallbladder (8) wall against the wall of the target portion (12), said predetermined breaking regions (18) being formed between adjacent inflatable balloon chambers (29).
13. Anastomosis device (1 1 ) according to any one of claims 1 to 4, comprising proximal (42), center (43), and distal rings (44) connected respectively by proximal and distal h inged arms formi ng said first (1 4) and second ri ng portion (1 5), wherei n said anastomosis device (1 1 ) has a generally cylindrical shape when unactuated and a rivet shape when actuated.
14. Anastomosis device (1 1 ) according to any one of the preceding claims, wherein the ring activating means comprise a snap connector (33, 34; 59) which snap connects the first ring portion (14) and the second ring portion (15) together.
15. An anastomosis instrument for a cholecysto-enterostomy (13), the anastomosis instrument comprising: A) a tubular member (60) having a longitudinal axis, a first radially protruding flange (61 ), a second radially protruding flange (62) and an annular cavity (63) formed between the first and second flanges (61 , 62) and adapted to receive an intestinal wall and a gallbladder wall in apposition,
B) an applier (64) having:
- a seat (65) adapted to receive the tubular member (60),
- an insertion tip (66) comprising a plurality of petals (67), said petals (67) extending from said seat (65) proximally and being permanently biased in a closure position in which the petals (67) form a proximally tapered tip and close the seat (65),
- a pusher (68) arranged inside the seat (65) distal to the tubular member (60) and operable to push the tubular member (60) in a proximal direction out of the seat (65), wherein said seat (65) and said insertion tip (66) are configured that, upon proximal expulsion of the tubular member (60), said tubular member (60) urges the petals (67) radially apart, thereby opening the tip (66) and allowing the petals (67) to be withdrawn distally from the tubular member (60).
16. A method for creating a cholecysto-enterostomy (13) for diverting biliary fluid from a gallbladder (8) to a target portion (12) in the intestine distal of the papilla of Vater (10), the method comprising the steps of:
- approximating the gallbladder (8) and the target portion (12) of the intestine to each other; and
- connecting a wall of the gallbladder (8) to a wall of the target portion (12) of the intestine by means of an anastomosis device (1 1 ) to create a cholecysto-enterostomy (13);
- creating a passage hole (16) in the gallbladder (8) wall and intestinal wall at the cholecysto-enterostomy (13);
- after a predetermined time, changing the shape of the anastomosis device (1 1 ) and expelling it through the passage hole (16) into the intestine.
17. Method according to claim 1 , comprising the step of time-dependently dissolving at least part of the anastomosis device (1 1 ).
PCT/EP2010/060266 2010-07-16 2010-07-16 An anastomosis device for a cholecysto-enterostomy WO2012007042A1 (en)

Priority Applications (1)

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EP2608723A4 (en) * 2010-08-26 2015-09-23 Pavilion Medical Innovations Helical fasteners and methods for deploying same
US9381041B2 (en) 2009-04-21 2016-07-05 Xlumena, Inc. Methods and devices for access across adjacent tissue layers
WO2018138616A1 (en) * 2017-01-30 2018-08-02 Ethicon Llc Non-magnetic fragmentable tissue compression devices
CN108577917A (en) * 2018-05-17 2018-09-28 南京微创医学科技股份有限公司 The self-service anastomosis clamp of alimentary canal and its release device
US10154844B2 (en) 2016-07-25 2018-12-18 Virender K. Sharma Magnetic anastomosis device and delivery system
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US10952732B2 (en) 2013-02-21 2021-03-23 Boston Scientific Scimed Inc. Devices and methods for forming an anastomosis
US11076856B2 (en) 2016-05-23 2021-08-03 Mor Research Applications Ltd. Anastomosis device
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9381041B2 (en) 2009-04-21 2016-07-05 Xlumena, Inc. Methods and devices for access across adjacent tissue layers
EP2608723A4 (en) * 2010-08-26 2015-09-23 Pavilion Medical Innovations Helical fasteners and methods for deploying same
US10952732B2 (en) 2013-02-21 2021-03-23 Boston Scientific Scimed Inc. Devices and methods for forming an anastomosis
US10449075B2 (en) 2015-12-15 2019-10-22 Steven Sounyoung Yu Biliary diversion catheter
US11076856B2 (en) 2016-05-23 2021-08-03 Mor Research Applications Ltd. Anastomosis device
US10154844B2 (en) 2016-07-25 2018-12-18 Virender K. Sharma Magnetic anastomosis device and delivery system
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system
CN114587469A (en) * 2016-07-25 2022-06-07 维兰德.K.沙马 Magnetic anastomosis device and delivery system
EP3970631A1 (en) * 2017-01-11 2022-03-23 Virender K. Sharma Cardiac shunt device and delivery system
US10376265B2 (en) 2017-01-30 2019-08-13 Ethicon Llc Non-magnetic fragmentable tissue compression devices
WO2018138616A1 (en) * 2017-01-30 2018-08-02 Ethicon Llc Non-magnetic fragmentable tissue compression devices
CN108577917A (en) * 2018-05-17 2018-09-28 南京微创医学科技股份有限公司 The self-service anastomosis clamp of alimentary canal and its release device

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