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WO2013026474A1 - Dispositifs et procédés d'ancrage d'un manchon endoluminal dans le tractus gastro-intestinal - Google Patents

Dispositifs et procédés d'ancrage d'un manchon endoluminal dans le tractus gastro-intestinal Download PDF

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Publication number
WO2013026474A1
WO2013026474A1 PCT/EP2011/064461 EP2011064461W WO2013026474A1 WO 2013026474 A1 WO2013026474 A1 WO 2013026474A1 EP 2011064461 W EP2011064461 W EP 2011064461W WO 2013026474 A1 WO2013026474 A1 WO 2013026474A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
ring
arms
tissue
rim
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2011/064461
Other languages
English (en)
Inventor
Michael A. Murray
Mark S. Zeiner
Federico Bilotti
Michele D'arcangelo
Mark Steven Ortiz
Jason Harris
Alessandro Pastorelli
James W. Voegele
Michael J. Stokes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery Inc
Original Assignee
Ethicon Endo Surgery Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to PCT/EP2011/064461 priority Critical patent/WO2013026474A1/fr
Publication of WO2013026474A1 publication Critical patent/WO2013026474A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • 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
    • A61F5/003—Implantable devices or invasive measures inflatable

Definitions

  • the present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.
  • VBG vertical banded gastroplasty
  • Roux-En-Y gastric bypass a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
  • endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine.
  • endoluminal sleeves in certain regions of the stomach and the duodenum contributed to improve glycemic control and to reduce or eliminate other co-morbidities of obesity.
  • the lining of parts of the Gl-tract by means of endosleeves provides an alternative or an additional therapy to traditional therapies of type II diabetes and obesity.
  • Endosleeves may be placed in a brief and less invasive procedure and address the patient's fear of surgery. Contrary to traditional gastric bypass surgery, the result of endoluminal sleeve surgery is reversible and the sleeve can be removed after achievement of the clinical result, but also in case of the occurrence of undesired side effects or clinical complications.
  • a typical duodenal sleeve device is described in U.S. Pat. No. 7,267,694 where the proximal end of a flexible, floppy sleeve of impermeable material defining a sleeve lumen is endoscopically deployed and anchored with the help of a barbed stent in the pylorus or in the superior section of the duodenum, the stent also ensuring that the proximal lumen opening of the sleeve remains open. Chyme from the stomach enters the proximal lumen opening of the sleeve and passes through the sleeve lumen to the distal lumen opening.
  • Digestive enzymes secreted in the duodenum pass through the duodenum on the outside of the sleeve.
  • the enzymes and the chyme do not mix until the chyme exits from the distal lumen opening of the liner tube. In such a way, the efficiency of the process of digestion of the chyme is diminished, reducing the ability of the gastrointestinal tract to absorb calories from the food.
  • Endobarrier(R) device that is substantially a duodenal sleeve device configured so that the proximal end of the device is anchored inside the duodenal bulb with the help of a barbed anchoring stent that also keeps the proximal lumen opening open.
  • a duodenal sleeve device attached to a funnel, the funnel configured for anchored to the gastric walls inside the gastric cavity in proximity to the lower esophageal sphincter. Food passing the lower esophageal sphincter is directed by the funnel into the proximal lumen opening of the duodenal sleeve device.
  • endoluminal sleeves A further important issue with endoluminal sleeves is the risk of failure of sealing of the lined lumen and, hence, the risk of an undesired leakage of the partially digested food flow in the interstice between the lumen wall and the sleeve.
  • known endoluminal sleeve attachment devices and methods are not yet fully satisfying with regard to permitting normal biological events, including vomiting, to occur.
  • the present invention provides for an endoluminal, particularly duodenal, sleeve device and method for the transoral, or endoscopic, positioning and anchoring of an endoluminal sleeve device within a gastrointestinal tract, including, but not limited to, the pylorus, the esophagus, stomach, duodenum as well as other portions of or the entire length of the intestinal tract, etc., unless specified otherwise.
  • the surgeon or endoscopist may insert devices as described below through the patient's mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient's stomach or other intestinal tract, and does not necessarily require any external incision. Alternatively, the surgeon may insert devices as described below laparoscopically into the stomach or intestine as appropriate.
  • a duodenal sleeve device comprising:
  • a sleeve configured for deployment inside a duodenum of a human subject, the sleeve having walls of a flexible material defining a sleeve lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, - an anchoring structure comprising:
  • the anchoring structure In the collapsed closed position the anchoring structure allows the sleeve device to be endoluminally introduced in the Gl tract, particularly in the stomach and, after expanding the anchoring structure in the open position, the latter interferes with the shape and dimensions of the pyloric sphincter and prevents the sleeve device from migrating distally due to peristaltic forces.
  • all arms of the anchoring structure are linked together such that, during their movement from the closed position to the open position, they move all together and cannot move independently from one another. This enables a uniform expansion of the anchoring structure independently from the position of activation or manipulation of the sleeve device.
  • the anchoring structure comprises means for a shape adjustment thereof in the open position of the arms. Such adjustable shape contributes to a better adaption of the sleeve device to the anatomy of the patient.
  • the activating component comprises an inflatable ring connected to the arms at a distance from the distal arm ends and adapted to be inflated from a retracted ring shape with a reduced circumference (corresponding to the closed position of the arms) to an expanded ring shape with an increased circumference (corresponding to the open position of the arms).
  • the anchoring structure comprises an activating ring connected with the support ring by foldable hinged segments.
  • the hinged segments are connected with the arms and form a generally straightened shape when unactuated and an outwardly folded shape when actuated by approximating the activating ring towards the support ring.
  • the anchoring structure comprises further at least one snap connector which snap connects or snap ratchet connects the activating ring and the support ring to one another.
  • the membrane constitutes an end portion of a sleeve wall and is formed as a single piece and without discontinuities with a portion of the sleeve wall distal to the anchoring structure.
  • FIG. 1 illustrates a duodenal sleeve device in accordance with an embodiment, the device being in a closed configuration
  • FIG. 2 illustrates a duodenal sleeve device in accordance with a further embodiment, the device being in an open configuration
  • FIG. 3 illustrates an anchoring structure of a duodenal sleeve device in accordance with an embodiment
  • FIG. 4 illustrates an anchoring structure of a duodenal sleeve device in accordance with a further embodiment
  • FIG. 5 shows a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with an embodiment, in which the dotted lines indicate the closed position of expandable arms;
  • FIG. 6 shows a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with a further embodiment, in which the dotted lines indicate the closed position of expandable arms and a retaining sheath inserted over the anchoring structure;
  • FIG. 7 and 8 illustrate a method for endoscopically inserting and anchoring an endoluminal sleeve device in accordance with an embodiment
  • FIG. 9 and 10 show a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with a further embodiment, in a closed configuration and in an open configuration;
  • FIG. 11 illustrates an applier for anchoring an endoluminal sleeve in a Gl tract by applying fastening members to the sleeve and the surrounding tissue in accordance with an aspect of the invention
  • FIG. 12 illustrates a method step of applying fastening members to the sleeve and the surrounding tissue by means of the applier in Figure 11 ;
  • FIG. 13 illustrates an endoluminal sleeve anchored in a duodenum by means of the devices and methods illustrated in figures 1 1 and 12;
  • FIG. 14 and 15 show sleeve fastening members in accordance with embodiments of the invention.
  • FIG. 16 illustrates an applier and method for anchoring an endoluminal sleeve in a Gl tract by applying fastening members to the sleeve and the surrounding tissue in accordance with a further embodiment
  • FIG. 17 and 18 illustrate an applier, a clip and a method for anchoring an endoluminal sleeve in a Gl tract by applying the clip to the sleeve and to the surrounding tissue in accordance with a yet further embodiment
  • FIG. 19 to 21 illustrate an applier, a double T-tag fastener and a method for anchoring an endoluminal sleeve in a Gl tract by applying the double T-tag fastener to the sleeve and to the surrounding tissue in accordance with a yet further embodiment of the invention
  • FIG. 22 illustrates a method for anchoring an endoluminal sleeve in a Gl tract by applying T-tag fasteners to the sleeve and to the surrounding tissue and purse string tightening the T-tag fasteners in accordance with a yet further embodiment of the invention
  • FIG. 23 through 26 illustrate a method and devices for holding a distal portion of an endoluminal sleeve within a Gl tract in accordance with a further aspect of the invention.
  • an endoluminal sleeve device 1 for internally lining a section of the Gl tract, particularly a section of duodenum distally from the pylorus comprises a sleeve 2 configured for deployment inside a duodenum of a human subject, the sleeve 2 having walls of a flexible material defining a sleeve lumen 3, a proximal end 4 defining a proximal lumen opening 5, and a distal end 6 defining a distal lumen opening 7.
  • the device 1 has further an anchoring structure 8 comprising:
  • the anchoring structure 8 In the collapsed closed position ( Figure 1) the anchoring structure 8 allows the sleeve device 1 to be endoluminally introduced in the Gl tract, particularly in the stomach 10 and, after expanding the anchoring structure 8 in the open position ( Figure 2), the latter interferes with the shape and dimensions of the pyloric sphincter 16 and prevents the sleeve device 1 from migrating distally due to peristaltic forces.
  • all arms 11 of the anchoring structure 8 are linked together such that, during their movement from the closed position to the open position, they move all together and cannot move independently from one another. This enables a uniform expansion of the anchoring structure 8 independently from the position of activation or manipulation of the sleeve device 1.
  • the sleeve device 1 may comprise an activating component 17 which is connected to all arms 1 1 and guided to move with respect to the support ring 9 such that the relative movement of the activating component 17 with respect to the support ring 9 moves the arms 1 1 from the closed position to the open position and vice versa.
  • the activating component 17, e.g. an activating ring or bushing is rotatably supported by the support ring 9 and forms cam portions which engage the arms 1 1 in a manner to generate the movement of the arms 1 1 from the closed position to the open position and vice versa.
  • the activating component 17, e.g. an activating ring or bushing, is slidably supported by the support ring 9 and coupled with the arms 11 in a manner that a relative translation between the activating component 17 and the support ring 9 in a sleeve longitudinal (proximal-distal) direction generates the movement of the arms 11 from the closed position to the open position and vice versa (compare Figure 5).
  • a plurality of latching seats 18 may be provided for a snap engagement of the latching tooth 19 in multiple relative positions of the activating component 17 with respect to the support ring 9, thereby allowing a shape adjustment of the anchoring structure in the open position of the arms 1 1.
  • Such adjustable shape contributes to a better adaption of the sleeve device 1 to the anatomy of the patient.
  • the activating component 17 and the support ring 9 may form auxiliary latching seats and auxiliary latching teeth (not shown) adapted to snap engage each other and to hold the arms 11 in the closed position.
  • the arms 1 1 may be permanently elastically biased in the closed position, thereby increasing the resistance against an undesired accidental expansion of the anchoring structure 8 or completely obviating the need of auxiliary latching means.
  • the activating component comprises an inflatable ring 20 connected to the arms 1 1 at a distance from the distal arm ends 13 and adapted to be inflated from a retracted ring shape with a reduced circumference (corresponding to the closed position of the arms 11) to an expanded ring shape with an increased circumference (corresponding to the open position of the arms 1 1).
  • the inflation of the inflatable ring can be accomplished by an endoscopic inflation syringe or by a detachable inflation line 21 extending from the inflatable ring 20 and connectable to an extracorporeal insufflating pump (not illustrated).
  • a solidifying agent may be arranged inside the inflatable ring 20, which solidifying agent is adapted to solidify after reaction with an insufflating fluid, thereby locking the inflatable ring 20 in the expanded shape.
  • a solidifying agent may be mixed with an insufflating fluid before injection thereof into the inflatable ring 20.
  • the inflatable ring 20 is arranged at the proximal arm ends 14, while in the embodiment in Figure 4 the inflatable ring 20 is arranged near a middle region of the arms 1 1.
  • the activating component 17 comprises an activating ring 23 connected with the support ring 9 by foldable hinged segments 24.
  • the hinged segments 24 are connected with the arms 11 and form a generally straightened shape when unactuated and an outwardly folded shape when actuated by approximating the activating ring 23 towards the support ring 9.
  • the activating component 17 comprises at least one snap connector 25, 26 which snap connects or snap ratchet connects the activating ring 23 and the support ring 9 to one another.
  • a distal hinged segment 27 of the hinged segments 24 may be formed by a distal end portion of the arms 1 1 to simplify the anchoring structure 8.
  • the arms 1 1 may be permanently elastically biased in the open position and temporarily held in the closed position by a tubular sheath 29 inserted over the anchoring structure 8.
  • a tubular sheath 29 inserted over the anchoring structure 8.
  • the arms 1 1 are released to move from the closed position to the open position where the arms 11 are locked either by the elastic preload only or by means of additional mechanical latching means, e.g. by snap latching means.
  • the anchoring structure 8 may comprise barbs 28 which are exposed and protrude outward when the arms 1 1 are in the open position to pierce surrounding tissue and further improve anchoring of the sleeve device 1 , and which barbs 28 may be covered by the anchoring structure 8 when the arms 1 1 are in the closed position to protect the mouth and esophagus and to avoid trauma during endoluminal introduction of the sleeve device in the Gl tract.
  • the membrane 15 may be stretchable or foldable and extends all around the anchoring structure 8. In the open position of the anchoring structure 8, the membrane 15 creates a funnel shaped proximal opening 5 of the sleeve 2 and provides a sealing contact between the proximal sleeve end 4 and the surrounding tissue, e.g. a gastric wall 12.
  • the membrane 15 may be grafted from an elastomeric material or from a silicone rubber film, e.g. from a Silastic® silicone mold commercialized by DOW CORNING®.
  • the membrane 15 constitutes an end portion of a sleeve wall 22 and is formed monolithically, i.e. as a single piece and without discontinuities, with a portion of the sleeve wall 22 distal to the anchoring structure 8.
  • the support ring 9 may be embodied as a short cylindrical tube section made of semi-rigid plastic material and connected to the sleeve 2 by means of an adhesive or by molding.
  • the distal ends 13 of the arms 1 1 may be rotatably connected to the support ring 9 by means of hinges or, alternatively, distal ends 13 of the arms 11 may be rigidly connected to the support ring 9 and form a flexible hinge region, e.g. a film hinge, near the support ring 9, so that the arms 1 1 can rotate with respect to the support ring 9 by flexure of the flexible hinge region.
  • a flexible hinge region e.g. a film hinge
  • the arms 11 may be connected to the support ring 9 by injection molding as a monolithic unit or, alternatively, by gluing or welding or overmolding.
  • the arms 1 1 may have a curved shape such as to define an olive shaped or ellipsoid shaped or conical framework with a rounded or truncated tip in the closed position of the arms 1 1 and a dome or cap shaped framework in their open position.
  • the anchoring structure 8 may be configured to receive the sleeve 2 in a compacted, e.g. folded or rolled, configuration inside a receiving space defined by the membrane 15 and arms 1 1 and the closed position. This facilitates the introduction of the device 1 to the target site in the Gl tract and protects the sleeve 2 from unfolding or tangling as long as the anchoring structure 8 remains closed.
  • the sleeve device 1 is endoluminally introduced in the stomach 10, the anchoring structure is then expanded to seat inside the distal antrum and bear against the pylorus 16, and the sleeve is distally extended inside the duodenum.
  • FIG. 11 to 22 In accordance with a further aspect of the invention ( Figures 11 to 22) methods and devices are provided for anchoring an endoluminal sleeve 2 within a gastrointestinal tract by applying fastening members 30, 31 , 32, 33 to both a proximal rim or flange 34 of the sleeve 2 and to the surrounding tissue 35 at a target anchoring location in the Gl tract.
  • the sleeve 2 used for the anchoring method may have a wall of a flexible material defining a sleeve lumen 3, a proximal end 4 defining a proximal lumen opening 5, and a distal end 6 defining a distal lumen opening 7 and the proximal rim or flange 34 formed at the proximal sleeve end 4.
  • the sleeve is endoluminally inserted in the Gl tract, e.g. in the duodenum 36, and the proximal sleeve rim 34 is positioned in the target anchoring location, e.g. in the antrum or in the proximal duodenum immediately distally of the pylorus 16. Then, a plurality of portions of the sleeve rim 34 are approximated to adjacent portions of surrounding tissue 35 of the Gl wall. The approximated sleeve rim 34 portions and tissue 35 portions are then connected to each other by attaching each one of a plurality of fastening members 30, 31 , 32, 33 to respectively a pair of approximated tissue 35 and sleeve rim 34 portions. In this manner, the sleeve rim 34 can be anchored to the surrounding tissue 35 in a plurality of anchoring points around its circumference.
  • the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed by applying suction to both the sleeve rim 34 and the tissue 35.
  • the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed simultaneously in different positions at the sleeve rim 34.
  • the step of applying the fastening members may comprise applying a plurality of the fastening members sequentially one after the other in different positions at the sleeve rim 34 and, analogously, also the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed sequentially in different positions at the sleeve rim 34.
  • an applier 37 having a flexible hollow shaft 38 which is insertable over an endoscope 39 and a distal applier head 40 which forms a plurality of (e.g. four) acquisition cavities 41 at different circumferential positions.
  • Each acquisition cavity 41 comprises at least one suction aperture 42 connected by a suction duct to an extracorporeal suction pump (not shown) and adapted to acquire, by suction, adjacent tissue and sleeve portions into the acquisition cavity 41.
  • a fastener applier 43 is provided which is adapted to apply the fastening member to the acquired tissue 35 and sleeve rim 34 portions.
  • the fastening member may comprise a split ring fastener 30 starting as a relatively straight piece of material preferably sharpened to a very fine point at one end.
  • the fastener applier 43 has a curved forming member 44 and a driver 45.
  • the free end of the curved forming member 44 may be offset from the other or driving end attached to the applier 37 and driver 45.
  • the straight fastener 30 is driven by the driver 45 through the curved forming member 44 to the free end so that the sharpened point of the fastener 30 is immediately adjacent the sleeve rim 34 and tissue 35 to be joined.
  • the fastener 30 As the fastener 30 is curved, it is directed so the pointed end engages the sleeve rim 34 and tissue 35 to be joined. The fastener 30 is continued to be driven in a circular configuration through the sleeve rim 34 and tissue 35. As the fastener 30 is curved back on itself to form a ring or loop ( Figure 14) or multiple loop ( Figure 15), the sleeve rim 34 and tissue 35 that have been engaged are held together.
  • the fastener 30 may be permanently elastically biased in a split ring or split coiled shape 31 , as illustrated in Figures 14 and 15 and received inside the fastener applier 43 in a temporarily straightened shape, so that when the fastener 30 is driven out of the fastener applier 43 and through the approximated sleeve rim 34 and tissue 35, it elastically bends back in its original split ring or split coiled shape.
  • Each fastener applier 43 may receive a plurality of fasteners 30 and the distal applier head 40 may be rotated inside the Gl tract and sequentially apply groups of fasteners 30 in different circumferential positions of the sleeve rim 34.
  • a flexible applier comprising a fastener applier 43 as described in connection with figures 11 and 12 is routed through an instrument channel 46 of an endoscope 39 and receives a plurality of fastening members 30 which are sequentially applied to the previously approximated sleeve rim 34 and tissue 35 portions.
  • the step of applying the fastening members to the approximated sleeve rim 34 and tissue portions 35 may comprise applying a clip 33 having opposite jaws 47 adapted to permanently clamp the sleeve rim 34 portion and the tissue portion 35 together.
  • the step of approximating the sleeve rim 34 portions and the tissue portions 35 may comprise pulling, e.g. by suction, a sleeve rim 34 portion and an adjacent tissue portion 35 together between the opened jaws 47 of the clip 33.
  • the clip 33 itself may be a single piece clip in elastic or shape memory material, e.g. Nitinol.
  • the clip 33 in shape memory material may have an open position below a transition temperature and a closed position above the transition temperature, wherein the transition temperature is above room temperature but below human body temperature.
  • the clip 33 can be activated by exposing it inside the Gl tract to the body temperature. Prior to activation, the clip 33 may be actively cooled to avoid an undesired phase transition before deployment of the clip.
  • the phase transition of the clip 33 may be triggered by actively heating the clip during its application to the sleeve rim 34 and tissue 35 portions.
  • the transition temperature of the clip 33 may also be higher than the human body temperature and the clip material is configured that after cooling down to body temperature the closed shape is maintained.
  • a clip applier 48 may comprise electric, inductive or conductive heating means or a separate endoscopic heating device may be used.
  • the clip 33 may be a single piece clip or a clip with two opposite jaws 47 which are hinged together and elastically biased to the closed configuration by an elastic spring or by a shape memory material as described above.
  • the step of applying the fastening member to the approximated tissue portion 35 and sleeve rim 34 portion may comprise loading a double T-tag fastener 32 inside a hollow needle 49 and piercing the hollow needle 49 through the approximated tissue portion 35 and sleeve rim 34 portion, then expelling a first anchoring end 50 of the double T-tag fastener 32 at a first side of the approximated tissue and sleeve rim portions, then withdrawing the hollow needle 49 from the approximated tissue and sleeve rim portions and expelling a second anchoring end 51 of the double T-tag fastener 32 at an opposite second side of the approximated tissue and sleeve rim portions, thereby fastening them together.
  • the step of applying the fastening member to the approximated tissue portion 35 and sleeve rim 34 portion may comprise applying T-tag fasteners 52 to different pairs of approximated tissue 35 and sleeve rim 34 portions, the T-tag fasteners 52 having a suture 53 extending therefrom, and knotting together the sutures 53 of the applied T-tag fasteners 52 and purse string like tightening the sutures 53.
  • the T-tag fasteners can be applied by means of the hollow needle 49 ( Figures 19, 21) and the tissue end sleeve rim portions can be approximated by means of a suction cup 54 ( Figure 19) or acquisition cavity 41 (as shown in Figure 1 1).
  • FIG. 23 there is provided a method and system for holding a distal portion of sleeve 2 in place.
  • the system comprises an elastic ring 55 which has a coiled compacted shape ( Figure 26) and which can be elastically deformed in an expanded annular shape, wherein the expanded annular shape of ring 55 can be locked by a mutual (shape-) coupling of its two free ends 56, 57.
  • the system further comprises an endoluminal ring applier 58 having a flexible insertion shaft 59 and a ring fastening head 60 arranged at a distal end 61 of shaft 59.
  • the ring fastening head 60 comprises an annular ring seat 62 adapted to receive the elastic ring 55 in the compacted shape, and a ring spreading mechanism 63 comprising a central slider 64 movable by a moving mechanism with respect to the ring seat 62 and a plurality of two or more rigid spreading rods 65 having a proximal end hinged to the central slider 64 and a distal end hinged to the ring seat 62, such that a translation of the central slider 64 with respect to the ring seat 62 changes the angle between the spreading rods 65 and the slider 64, thereby radially expanding or retracting the ring seat 62.
  • the moving mechanism my comprise a push and/or pull mechanism which is activatable by an extracorporeal plunger 66 arranged at a proximal end of the applier 58 and which may be elastically biased in a position in which the ring seat 62 is radially retracted to allow endoluminal insertion of the applier 58 inside the Gl tract and inside the sleeve 2 as well as endoluminal withdrawal therefrom.
  • the plunger 66 can be activated to spread the spreading rods 65 and, hence, expand the ring seat 62.
  • the expanded ring seat 62 widens the elastic ring 55 to the expanded shape in which the ring 55 engages the sleeve 2 internally and presses the sleeve 2 against the lumen of the Gl tract to hold it firmly in position.
  • the expanded shape of the ring 55 is achieved, its free ends 56, 57 connect to one another and lock the ring 55 in the expanded shape. It is now possible to retract the ring seat 62, e.g. by releasing the plunger 66 so that the moving mechanism can elastically return to its rest position, which allows withdrawal of the applier from the sleeve 2 and from the Gl tract of the patient.
  • the distal sleeve portion can be attached to the elastic ring 55 prior to its insertion in the Gl tract and the distal sleeve portion can be inserted and positioned in its planned position by means of the applier 58 before deploying the elastic ring 55.
  • the elastic ring 55 can stabilize the position of a distal sleeve portion and hold its lumen wide open to prevent blockage.
  • Positioning of the ring fastening head 60 and deployment of the elastic ring 55 can be monitored and visualized by means of a scope (not shown) passed through an internal channel 67 formed in the applier 58 insertion shaft 59.
  • the sleeve 2 itself is sufficiently flexible to follow the curvature of the duodenum. Further, in some embodiments the walls of the sleeve are sufficiently flexible and/or collapsible to allow duodenal peristalsis to drive chyme through the lumen of the sleeve. Sufficient collapsibility of the walls of the sleeve prevents continuous intimate contact of the outer surface of the sleeve with the duodenal mucosa, avoiding damage to the duodenal mucosa and allowing digestive secretions not collected into the sleeve lumen to pass through the duodenal lumen outside the sleeve lumen.
  • At least a portion of the wall of a sleeve may be porous or semipermeable to allow entry of digestive secretions into the sleeve lumen and/or to allow the flow of fluids and digested matter out of the sleeve lumen.
  • At least a portion of the wall of a sleeve may be impermeable, analogous to the Endobarrier(R) by Gl Dynamics Inc, Watertown, Mass., USA and as described in U.S. Pat. No. 7,267,694 which is included by reference as if fully set forth herein.
  • the diameter of the sleeve lumen may be substantially constant along the entire length of the liner tube.
  • the luminal diameter may be not more than about 30 mm, not more than about 25 mm and even not more than about 20 mm.
  • the proximal end of the sleeve may be flared and may define a funnel-like structure.
  • the length of the sleeve may be any suitable length and may be selected in accordance with clinical decisions made by the treating physician.
  • a typical sleeve is between about 25 cm and about 160 cm long.
  • the sleeve is selected so that when the duodenal sleeve device is deployed, the distal lumen opening of the sleeve is located distal to the duodenal-jejunal flexure and empties out into the jejunum. In some embodiments, the sleeve may be even longer.
  • Suitable materials from which the sleeve for implementing the invention are fashioned include silicone, polyurethane, polyethylene (e.g., low density polyethylene films) and fluoropolymers (e.g., expanded polytetrafluoroethylene).
  • the sleeve is fashioned from fluoropolymer or polyethylene film impregnated with polyurethane or silicone to reduce permeability, as taught in U.S. Pat. No. 7,267,694.
  • the sleeve may include one or more markers (e.g., barium) designed for viewing the position of the sleeve within the intestines through fluoroscopy, such as a longitudinal rib or other markers that are spaced along the length of sleeve.
  • markers e.g., barium
  • sleeve may further include components that inhibit twisting or kinking of the sleeve itself.
  • these components include one or more stiffening elements, such as rings, coupled to either the inside or the outside of the sleeve at spaced locations along its length. These rings can, for example, be made of a slightly thicker silicone material that would resist twisting or kinking of the sleeve around the ring.
  • the stiffening elements may be in spiral shape or extending lengthwise along at least a portion of the sleeve.
  • the sleeve may be initially folded or rolled up and packed into the interior of an applier.
  • the distal end of sleeve may be initially closed, e.g. with a small polymeric or silicone seal and forms a programmed tearing line, e.g. a perforation, along which the distal end can tear open by the internal pressure of the chyme flow.
  • bypass conduits can be created in the Gl tract of a patient to achieve a malabsorptive effect in cases where such an effect may enhance weight loss, as well as the initially described effects on hormonal signaling in general.
  • the described devices and procedures obviate undesired migration of the sleeve away from its original anchoring position and addresses the need of reliable sealing of the lined lumen.
  • some embodiments of the described devices and methods are beneficial with regard to permitting normal biological events, including vomiting, to occur.

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif de manchon endoluminal (1) destiné à revêtir l'intérieur d'une section du tractus gastro-intestinal, qui comprend un manchon (2) conçu pour se déployer à l'intérieur d'un tractus gastro-intestinal, une structure d'ancrage (8) dotée d'une bague de support (9) reliée à une extrémité proximale (4) du manchon, une pluralité de bras extensibles (11) articulés sur la bague de support (9) et mobiles depuis une configuration « parapluie fermé » vers une configuration « parapluie ouvert », une membrane (15) reliée aux bras (11) et s'étendant tout autour de la structure d'ancrage (8), formant ainsi une toile entre les bras adjacents (11) et le moyen de verrouillage des bras (11) dans la configuration « parapluie ouvert ».
PCT/EP2011/064461 2011-08-23 2011-08-23 Dispositifs et procédés d'ancrage d'un manchon endoluminal dans le tractus gastro-intestinal Ceased WO2013026474A1 (fr)

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016040756A1 (fr) * 2014-09-12 2016-03-17 Baradarian Robin Manchon de barrière intestinale à section d'ancrage extensible
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
WO2017201586A1 (fr) * 2016-05-27 2017-11-30 Harry Frydenberg Implant de barrière gastro-intestinale et méthode d'utilisation associée, ancre chirurgicale et instrument de pose pour ancres chirurgicales
US9980727B2 (en) 2011-07-25 2018-05-29 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
WO2019018858A1 (fr) 2017-07-21 2019-01-24 Gi Dynamics, Inc. Systèmes de pose de dispositif gastrointestinal et méthodes d'utilisation de ceux-ci
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
CN113171538A (zh) * 2021-05-06 2021-07-27 王畅 一种肠道治疗用截流装置
US11871929B2 (en) 2017-10-19 2024-01-16 SafeHeal SAS Complex surgical device for carrying out and protecting an anastomosis
US12213673B2 (en) 2023-03-17 2025-02-04 SafeHeal SAS Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis
US12447262B2 (en) 2019-06-24 2025-10-21 SafeHeal SAS Kit for washing an intestinal anastomosis in situ

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040148034A1 (en) 2002-11-01 2004-07-29 Jonathan Kagan Apparatus and methods for treatment of morbid obesity
US7121283B2 (en) 2001-08-27 2006-10-17 Synecor, Llc Satiation devices and methods
US7267694B2 (en) 2002-12-02 2007-09-11 Gi Dynamics, Inc. Bariatric sleeve
US20090187206A1 (en) * 2006-05-26 2009-07-23 Binmoeller Kenneth F Conformationally-Stabilized Intraluminal Device for Medical Applications
WO2010074712A2 (fr) * 2008-12-27 2010-07-01 Duggirala Chandra S Dispositifs de traitement de l'obésité et méthodes d'utilisation desdits dispositifs
US20110004228A1 (en) * 2009-07-01 2011-01-06 E2 Llc Systems and Methods for Treating Obesity and Type 2 Diabetes
WO2011099940A1 (fr) * 2010-02-11 2011-08-18 National University Of Singapore Système, dispositif, et procédé permettant de modifier l'absorption de substances par une paroi gastro-intestinale

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7121283B2 (en) 2001-08-27 2006-10-17 Synecor, Llc Satiation devices and methods
US20040148034A1 (en) 2002-11-01 2004-07-29 Jonathan Kagan Apparatus and methods for treatment of morbid obesity
US7267694B2 (en) 2002-12-02 2007-09-11 Gi Dynamics, Inc. Bariatric sleeve
US20090187206A1 (en) * 2006-05-26 2009-07-23 Binmoeller Kenneth F Conformationally-Stabilized Intraluminal Device for Medical Applications
WO2010074712A2 (fr) * 2008-12-27 2010-07-01 Duggirala Chandra S Dispositifs de traitement de l'obésité et méthodes d'utilisation desdits dispositifs
US20110004228A1 (en) * 2009-07-01 2011-01-06 E2 Llc Systems and Methods for Treating Obesity and Type 2 Diabetes
WO2011099940A1 (fr) * 2010-02-11 2011-08-18 National University Of Singapore Système, dispositif, et procédé permettant de modifier l'absorption de substances par une paroi gastro-intestinale

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
US12048433B2 (en) 2011-07-25 2024-07-30 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US12137911B1 (en) 2011-07-25 2024-11-12 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US12042148B2 (en) 2011-07-25 2024-07-23 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US11857191B2 (en) 2011-07-25 2024-01-02 Charam Khosrovaninejad Method of chirurgical treatment using a surgical anchor device
US12324584B2 (en) 2011-07-25 2025-06-10 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US9980727B2 (en) 2011-07-25 2018-05-29 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US12433592B2 (en) 2011-07-25 2025-10-07 Charam Khosrovaninejad Surgical device for controlled anchoring in the intestine
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
US10307280B2 (en) 2013-08-28 2019-06-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
US20170119567A1 (en) * 2014-09-12 2017-05-04 Robin Baradarian Intestinal barrier sleeve with expandable anchor section
US10327937B2 (en) * 2014-09-12 2019-06-25 Robin Baradarian Intestinal barrier sleeve with expandable anchor section
EP3673867A1 (fr) * 2014-09-12 2020-07-01 Baradarian, Robin Manchon de barrière intestinale doté d'une section d'ancrage extensible
EP3191017A4 (fr) * 2014-09-12 2018-04-25 Baradarian, Robin Manchon de barrière intestinale à section d'ancrage extensible
WO2016040756A1 (fr) * 2014-09-12 2016-03-17 Baradarian Robin Manchon de barrière intestinale à section d'ancrage extensible
US9579228B2 (en) * 2014-09-12 2017-02-28 Robin Baradarian Intestinal barrier sleeve with expandable anchor section
US20160095732A1 (en) * 2014-09-12 2016-04-07 Robin Baradarian Intestinal barrier sleeve with expandable anchor section
WO2017201586A1 (fr) * 2016-05-27 2017-11-30 Harry Frydenberg Implant de barrière gastro-intestinale et méthode d'utilisation associée, ancre chirurgicale et instrument de pose pour ancres chirurgicales
EP3654890A4 (fr) * 2017-07-21 2021-08-04 GI Dynamics, Inc. Systèmes de pose de dispositif gastrointestinal et méthodes d'utilisation de ceux-ci
WO2019018858A1 (fr) 2017-07-21 2019-01-24 Gi Dynamics, Inc. Systèmes de pose de dispositif gastrointestinal et méthodes d'utilisation de ceux-ci
US12042150B2 (en) 2017-10-19 2024-07-23 SafeHeal SAS Systems and methods for introducing a device for protecting an anastomosis
US11871929B2 (en) 2017-10-19 2024-01-16 SafeHeal SAS Complex surgical device for carrying out and protecting an anastomosis
US12478377B2 (en) 2017-10-19 2025-11-25 SafeHeal SAS Systems and methods for introducing a device for protecting an anastomosis
US12447262B2 (en) 2019-06-24 2025-10-21 SafeHeal SAS Kit for washing an intestinal anastomosis in situ
CN113171538A (zh) * 2021-05-06 2021-07-27 王畅 一种肠道治疗用截流装置
US12213673B2 (en) 2023-03-17 2025-02-04 SafeHeal SAS Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis
US12239321B2 (en) 2023-03-17 2025-03-04 SafeHeal SAS Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis
US12245766B2 (en) 2023-03-17 2025-03-11 SafeHeal SAS Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis

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