WO2012136249A1 - Système de revêtement endoluminal et procédé de revêtement endoluminal d'un organe creux - Google Patents

Système de revêtement endoluminal et procédé de revêtement endoluminal d'un organe creux Download PDF

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Publication number
WO2012136249A1
WO2012136249A1 PCT/EP2011/055272 EP2011055272W WO2012136249A1 WO 2012136249 A1 WO2012136249 A1 WO 2012136249A1 EP 2011055272 W EP2011055272 W EP 2011055272W WO 2012136249 A1 WO2012136249 A1 WO 2012136249A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
anchoring
lining
barbs
endoluminal
Prior art date
Application number
PCT/EP2011/055272
Other languages
English (en)
Inventor
Alessandro Pastorelli
Michele D'arcangelo
Mark Ortiz
Michael A. Murray
Scott WOODRUFF
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/EP2011/055272 priority Critical patent/WO2012136249A1/fr
Publication of WO2012136249A1 publication Critical patent/WO2012136249A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F5/0089—Instruments for placement or removal

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.
  • a known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position.
  • metallic expandable structures such as a stent
  • barbs which penetrate the surrounding tissue.
  • the present invention provides for an improved endoluminal lining system and method for the transoral, or endoscopic, positioning and anchoring of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, 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.
  • an endoluminal lining system for internally lining a hollow organ, particularly a section of the gastrointestinal tract, the system comprising a flexible tubular lining extending between a proximal end and a distal end and an anchoring device for fastening the flexible tubular lining in the hollow organ.
  • the anchoring device is provided at one of the proximal end and distal end of the lining and comprises an anchoring ring defining a longitudinal ring axis which is an axis of symmetry of the ring, the ring having a radially external anchoring surface and a plurality of barbs protruding from the anchoring surface.
  • the barbs are inclined with respect to a radial direction to the longitudinal axis such that, upon rotation of the anchoring ring in a first direction about the longitudinal axis, the barbs penetrate into the surrounding tissue and acquire said tissue towards the anchoring surface and, upon rotation of the anchoring ring in a second direction opposite the first direction the barbs are withdrawn from the surrounding tissue.
  • the anchoring device further comprises locking means adapted to prevent the ring from rotating with respect to the surrounding tissue.
  • the locking means comprise at least one fastener adapted to pierce the acquired tissue or tissue adjacent to the acquired tissue and at least one fastener seat formed in the ring and adapted to receive and hold the fastener so that the fastener extends in a transverse direction to the extension of the barbs, preferably in a direction parallel to the longitudinal ring axis.
  • the locking means comprise at least one suture hole formed in the ring and adapted to receive a suture for suturing a portion of the acquired tissue to the ring, thereby preventing the ring from rotating with respect to the acquired tissue about the longitudinal axis.
  • the lining system comprises an endoluminal applier for endoluminally delivering and fastening the anchoring device of the lining system to the hollow organ, the applier comprising a flexible elongate applier shaft and a ring fastening assembly arranged at a distal end of the applier shaft and having a longitudinal axis.
  • the ring fastening assembly comprises a ring holder adapted to engage the ring of the anchoring device by a shape coupling which prevents relative rotation therebetween, a rotation mechanism adapted to rotate the ring holder with respect to the insertion shaft about the longitudinal axis, and a pusher adapted to engage at least one fastener and translatable with respect to the ring holder, wherein the pusher is operable to push the fastener towards the ring holder in a direction parallel to the longitudinal axis.
  • the endoluminal applier allows to perform the ring rotation necessary for the tissue acquisition and the fastener translation necessary for rotationally locking the ring with respect to the acquired tissue by means of a single instrument, i.e. the ring fastening assembly, and without rotating or pushing or pulling the entire applier shaft.
  • FIG. 1 illustrates an endoluminal lining system in accordance with a first embodiment of the invention
  • FIG. 2 illustrates an endolu minal lining system in accordance with a second embodiment of the invention
  • FIG. 3 illustrates a longitudinal cross-section of the lining system of figure 2 during endoluminal fixation within a section of the Gl tract of a patient;
  • FIG. 3A is a perspective illustration of the situation in figure 3, illustrating a "twisting"- type tissue acquisition in accordance with an embodiment of the invention
  • FIG. 4 is a side view of an endoluminal lining system in accordance with a third embodiment of the invention.
  • FIG. 5 illustrates a longitudinal cross-section of the lining system of figure 4 during endoluminal fixation within a section of the Gl tract of a patient
  • FIG. 6 is a side view of an endoluminal lining system in accordance with a fourth embodiment of the invention.
  • Figure 7 illustrates a longitudinal cross-section of the lining system of figure 6 during endoluminal fixation within a section of the Gl tract of a patient
  • FIG. 8 illustrates an endoluminal applier for endoluminally inserting and anchoring the lining system in a target site in a hollow organ, wherein the applier carries a lining and anchoring ring as illustrated in figure 3;
  • FIG. 9 illustrates an endoluminal applier for endoluminally inserting and anchoring the lining system in a target site in a hollow organ, wherein the applier carries a lining and anchoring ring as illustrated in figures 4 and 5;
  • FIG. 10 illustrates an endoluminal applier for endoluminally inserting and anchoring the lining system in a target site in a hollow organ, wherein the applier carries a lining and anchoring ring as illustrated in figures 6 and 7;
  • FIGS. 1 1 and 12 illustrate different possible positions of the endoluminal lining within the Gl tract of a patient.
  • figure 1 depicts an endoluminal lining system for internally lining a hollow organ 1 , particularly a section of the gastrointestinal tract.
  • the system comprises a flexible tubular lining 2 extending between a proximal end 3 and a distal end 4 and an anchoring device 5 for fastening the flexible tubular lining 2 in the hollow organ 1 .
  • the anchoring device 5 is provided at one of the proximal end 3 and distal end 4 of the lining and comprises an anchoring ring 6 defining a central passage opening 7 and developing about a longitudinal axis 8 of the anchoring device 5, which is an axis of symmetry of the ring 6.
  • the anchoring ring 6 has a radially external anchoring surface 9 and a plurality of barbs 10 arranged in the anchoring surface 9 and operable to protrude from the anchoring surface 9 radially outward and inclined with respect to a radial direction to the longitudinal axis 8.
  • the barbs 10 penetrate into the surrounding tissue 1 1 of the hollow organ 1 and acquire and attract said tissue 1 1 towards the anchoring surface 9 and, upon rotation of the anchoring ring 6 in a second direction opposite the first direction the barbs 10 are withdrawn from the surrounding tissue 1 1 and allow the tissue 1 1 to detach from the anchoring surface 9.
  • the anchoring device 5 comprises locking means adapted to prevent the anchoring ring 6 from rotating with respect to the surrounding tissue 1 1.
  • the barbs 10 may be movable between a rest position in which free pointed ends of the barbs are retracted inside the anchoring ring 6, and an activated position in which the barbs are protracted to extend outside the anchoring ring 6. This allows the lining system to be inserted endoluminally with the barbs retracted and to protract the barbs 10 only after positioning of the anchoring ring 6 in the planned anchoring site.
  • a moving mechanism may be provided in the anchoring ring 6 for actively moving the barbs 10 from the rest position inside the anchoring ring 6 to the activated position outside the anchoring surface 9.
  • the barbs 10 may be permanently elastically biased to the activated position and a releasable barb retaining mechanism may be provided at the anchoring ring 6 which is adapted to retain the barbs in the rest position during endoluminal insertion of the lining system and to release the barbs to elastically protract in the activated position after positioning of the anchoring ring 6 in the planned anchoring site inside the hollow organ 1 .
  • a detachable or otherwise removable protective sheath may be provided to protect the surrounding tissue from the barbs 10 during endoluminal insertion of the lining system.
  • the protective sheath is withdrawn from the anchoring ring 6 after its positioning in the anchoring site, in order to expose the barbs to the surrounding tissue.
  • the locking means comprise at least one suture hole 15 formed in the anchoring ring 6 and adapted to receive a suture 16 for suturing a portion of the acquired tissue 1 1 to the anchoring ring 6, thereby preventing the anchoring ring 6 from rotating about the longitudinal axis 8 with respect to the acquired tissue 1 1 .
  • the locking means comprise at least one pin or needle fastener 12 adapted to pierce the acquired tissue 1 1 or neighbor tissue 13 adjacent to the acquired tissue 1 1 and at least one fastener seat 14 formed in the anchoring ring 6 and adapted to receive and hold the fastener 12 so that the fastener 12 extends in a transverse direction to the extension of the barbs 10, preferably in a direction parallel to the longitudinal ring axis 8.
  • the locking means may comprise a fastening ring 17 having a central passage opening which can be aligned with the passage opening 7 of the anchoring ring 6 for the passage of the contents, e.g. food or chime, once the lining is anchored in the hollow organ 1 , e.g. the jejunum.
  • the fastening ring 17 is initially separate from the anchoring ring 6 and supports a plurality of uniformly circumferentially distributed needle or pin fasteners 12 arranged in a frontal surface 18 of the fastening ring 17 and protruding in an axial direction parallel to the longitudinal axis 8 towards the anchoring ring 6.
  • the anchoring ring 6 forms a plurality of fastener seats 14, e.g. internally stepped or riffled holes provided in a back surface 19 of the anchoring ring 6, intended to face towards the fastening ring 17 during application of the anchoring device 5.
  • the fastener seats 14 are positioned and shaped to receive the pin or needle fasteners 12 by means of a snap-on shape coupling or interference fit, thereby holding the fasteners 12 (which are preferably straight) oriented transversely with respect to the barbs 10 and, preferably, parallel to the longitudinal axis 8.
  • the lining 2 and anchoring device 5 with the barbs 10 retracted in the rest position are endoscopically inserted through the mouth, esophagus, stomach and duodenum to the planned anchoring site, e.g. a section of the jejunum. Then, the anchoring ring 6 is positioned so that the longitudinal axis 8 coincides substantially with a longitudinal direction of the intestine and the barbs 10 are exposed by actively moving or releasing them from the rest position to the protracted activated position outside the anchoring surface 9.
  • the anchoring ring 6 With the barbs 10 activated , the anchoring ring 6 is rotated about the longitudinal axis 8 in the first direction so that the barbs pierce the surrounding tissue 1 1 ( Figure 3) and make it slide towards a base of the barbs and the anchoring surface 9.
  • the anchoring ring 6 By further rotating the anchoring ring 6 in the first direction, the neighbor tissue 13 adjacent to the tissue 1 1 pierced by the barbs 10 is twisted and narrowed and, hence, pulled over the back surface 19 of the anchoring ring 6. It is now possible to move the fastening ring 17 parallel to the longitudinal axis 8 towards and in engagement with the anchoring ring 6.
  • the pin or needle fasteners 12 By pushing the fastening ring 17 and the anchoring ring 6 together, the pin or needle fasteners 12 pierce through the twisted neighbor tissue 13 arranged over the back surface 19 of anchoring ring 6 and are received by the fastener seats 14. In this way, any backward rotation of the anchoring ring 6 with respect to the surrounding tissue 1 1 is effectively prevented and the anchoring device of the lining system is reliably fixated in the planned anchoring site of the intestine. In this configuration the pin or needle fasteners 12 act both as anti-rotation means and, together with the barbs 10, as tissue retaining means.
  • the locking means comprise a fastening ring 20 having a central passage opening aligned with the passage opening 7 of the anchoring ring 6 for the passage of the contents, e.g. food or chime, once the lining is anchored in the hollow organ 1 , e.g. the jejunum.
  • the fastening ring 20 is inseparably connected to the anchoring ring 6 and translatable parallel to the longitudinal axis 8 from an open position ( Figure 4) to a closed position ( Figure 5).
  • the fastening ring 20 supports a plurality of uniformly circumferentially distributed needle or pin fasteners 12 arranged in a frontal surface 18 of the fastening ring 20 and protruding in an axial direction parallel to the longitudinal axis 8 towards the anchoring ring 6.
  • the anchoring ring 6 comprises a circumferential groove 21 formed in the anchoring surface 9, wherein the barbs 10 are arranged in the groove 21 and may be retractable inside the groove 21 (rest position) and protractible outside the groove 21 (activated position). In this configuration, by rotating the anchoring ring 6 in the first direction the surrounding tissue 1 1 is pierced and slides along the barbs into the groove 21 .
  • the anchoring ring 6 further forms a plurality of fastener seats 14, e.g. internally stepped or riffled holes provided in a back surface 19 of the anchoring ring 6 and facing toward the fastening ring 20.
  • the fastener seats 14 are positioned and shaped to hold the pin or needle fasteners 12 by means of shape coupling, thereby connecting the fastening ring 20 inseparably with the anchoring ring 6.
  • fastener seats 14 extend (in the longitudinal direction of axis 8) transversally through the circumferential groove 21 and guide the pin or needle fasteners 12, in the closed position, to extend through said circumferential groove 21.
  • the lining 2 and anchoring device 5 with the barbs 10 retracted in the circumferential groove 21 or covered by a protective sheath are endoscopically inserted through the mouth, esophagus, stomach and duodenum to the planned anchoring site, e.g. a section of the jejunum. Then, the anchoring ring 6 with the attached fastening ring 20 is positioned so that the longitudinal axis 8 coincides substantially with a longitudinal direction of the intestine and the barbs 10 are exposed by actively moving or releasing them from the rest position to the protracted activated position outside the anchoring surface 9.
  • the anchoring ring 6 With the barbs 10 activated, the anchoring ring 6 is rotated about the longitudinal axis 8 in the first direction so that the barbs pierce the surrounding tissue 1 1 and make it slide towards a base of the barbs inside the groove 21 . It is now possible to push the fastening ring 20 from the open position to the closed position. By pushing the fastening ring 20 and the anchoring ring 6 together, the pin or needle fasteners 12 pierce through the surrounding tissue 1 1 arranged inside the circumferential groove 21 of anchoring ring 6 and are locked in the closed position by the fastener seats 14 (Figure 5).
  • the pin or needle fasteners 12 act both as anti-rotation means and, together with the barbs 10, as tissue retaining means.
  • Figures 6 and 7 illustrate a further exemplary embodiment, in which the anchoring ring 6 and the fastening ring 20 are substantially shaped as described in connection with figure 4 and 5, but initially separate and adapted to be connected by moving the fastening ring 20 parallel to the longitudinal axis 8 towards and in engagement with the anchoring ring 6.
  • the pin or needle fasteners 12 By pushing the fastening ring 20 and the anchoring ring 6 together, the pin or needle fasteners 12 pierce through the surrounding tissue 1 1 arranged in the groove 21 of anchoring ring 6 and are received by the fastener seats 14.
  • the lining system comprises a lining seat 22 arranged at the anchoring ring 6 and adapted to receive and hold the pliable tubular lining 2 in a packed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension.
  • the lining seat 22 may cooperate with the locking means, i.e. with the pin or needle fasteners 12 to release the lining 2 and, possibly to push at least a portion of the lining 2 distally out of the lining seat 22, when the locking means are activated (e.g. when the fasteners 12 are received by the fastener seats 14 in the closed position).
  • the anchoring device 5 may be grafted at least partially of bioabsorbable material and the anchoring ring 6 and fastening ring 17, 20 may be substantially rigid. At least part of the anchoring device 5 may be protected by a protective sheath during endoluminal insertion in the hollow organ 1 .
  • the lining system comprises an endoluminal applier 23 ( Figures 8, 9, 10) for endoluminally delivering and fastening the anchoring device 5 of the lining system to the hollow organ 1 .
  • the applier 23 comprises a flexible elongate applier shaft 24 extending from a proximal handle (not illustrated) and a distal shaft end 26 at which a ring fastening assembly 25 is provided.
  • the ring fastening assembly 25 defines a longitudinal assembly axis 27 and comprises a ring holder 28 adapted to detachably engage the anchoring ring 6 of the anchoring device 5 by means of shape coupling which prevents relative rotation therebetween, and a rotation mechanism 29 operable to rotate the ring holder 28 with respect to the applier shaft 24 about the assembly axis 27.
  • the ring fastening assembly 25 further comprises a pusher 30 translatable parallel to the assembly axis 27 with respect to the ring holder 28 and adapted to engage at least one fastener 12, 17, 20 and operable to push the fastener axially towards the ring holder 28.
  • the endoluminal applier 23 allows to rotate the anchoring ring 6 for the tissue acquisition and to drive the fasteners 12 in the tissue 1 1 , 13 and into the anchoring ring 6 for rotationally locking the ring 6 with respect to the acquired tissue. All these functions are accomplished by means of a single instrument, i.e. the ring fastening assembly 25, and without rotating or pushing or pulling the entire applier shaft 24.
  • the pusher 30 may form an annular fastening ring seat 32 adapted to detachably hold the fastening ring 17, 20 if provided.
  • the ring fastening assembly 25 comprises a barb activating mechanism 33 adapted to co-operate with the barb moving mechanism of the anchoring ring 5 received by the ring holder 28 and operable to move the barbs 10 from the rest position in the activated position or to release the barbs 10 to allow them to snap in the activated position.
  • the barb activating mechanism 33 may comprise an activating tooth 34 arranged near the ring holder 28 and acting on a corresponding activating button 35 of the barb movement mechanism.
  • the barb activating mechanism 33 may comprise a protection slider adapted to slide a protection casing 36 with respect to the ring holder 28 from a first position in which the protection casing covers the anchoring ring 6 received by the ring holder 28, to a second position in which the protection casing 36 exposes the anchoring ring 6.
  • the applier 23 may further comprise an instrument channel 31 extending longitudinally through the ring fastening assembly 25
  • the instrument channel 31 is adapted to slidingly receive an endoscope 37 to visualize the space distally ahead of the ring fastening assembly 25 and, possibly, to slide the applier 23 endoluminally along the endoscope 37 to the lining anchoring site in the hollow organ 1 .
  • the ring holder 28 comprises ring releasing means which detach the ring holder 28 from the anchoring ring 6 when the force transmitted by the ring holder 28 to the anchoring ring 6 exceeds a predetermined target value sufficient for an adequate locking pressure between the pin or needle fasteners 12 and the anchoring ring 6.
  • the ring releasing means can be adapted to force dependency separate the ring holder 28 from the anchoring ring 6 by resilient radially inward retraction or deformation of the ring holder 28 or by force dependency breaking the ring holder 28 in predetermined breaking points.
  • the rotating mechanism 29 is connected through one or more flexible rotation transmitters with an extracorporeal rotation activation mechanism provided e.g. at the proximal handle portion of the applier 23.
  • the pusher 30 is connected through one or more flexible pushing movement transmitters with an extracorporeal pushing mechanism provided e.g. at the proximal handle portion of the applier 23.
  • the ring holder 28 is connected through one or more flexible pulling movement transmitters with an extracorporeal pushing mechanism provided e.g. at the proximal handle portion of the applier 23, so that the ring holder 28 can be pulled towards a stationary pusher 30.
  • the barb activating mechanism 33 may comprise one or more flexible activating movement transmitters connected to an extracorporeal barb activator button provided e.g. at the proximal handle portion of the applier 23.
  • the rotation movement transmitters, the pushing movement transmitters and the barb activating movement transmitters are arranged inside the flexible applier shaft 24.
  • a clinical work-up including a physical and mental assessment of the patient may be performed to determine whether a transoral deployment and anchoring of an endoluminal lining is clinically indicated.
  • This assessment may include inspecting the esophagus and stomach of the patient to determine whether any contraindications exist for undertaking the procedure such as ulcerations, obstructions, or other conditions that may preclude treatment.
  • the operator can prepare the applier 23 with the anchoring device 5 with the attached lining 3 placed over the ring fastening assembly 25, as shown in FIGs 8, 9, 10.
  • the anchoring ring 6 is attached by detachable shape coupling to the ring holder 28 and the fastening ring 17, 20 (if provided) or fasteners 12 are brought in engagement with the pusher 30.
  • the barbs may be retracted in their rest position or covered by the protection casing 36.
  • the endoscope 37 is moved over the endoscope 37 and guided under endoscopic visualization down the patient's esophagus and stomach to a target location in the Gl tract, e.g. in the duodenum.
  • the physician uses the endoscope 37 placed in the instrument channel 31 of the applier 23 to view and select an area suitable for the application of the lining 2.
  • the barbs 10 of the anchoring ring 5 are exposed to the surrounding tissue 1 1 within the duodenum by operating the barb activating mechanism and, possibly, sliding the protection casing 36 away from the anchoring ring 6.
  • the ring rotation mechanism may be activated to rotate the ring holder 25 together with the anchoring ring 6 in the first direction and pierce and twist the surrounding tissue 1 1 :
  • the tubular lining attached to the anchoring ring 6 can be now released or pulled distally to unfold it from the collapsed configuration to an extended substantially elongate tubular shape configuration.
  • the distal end 4 of the lining 2 may be provided with an inertial mass adapted to promote unfolding of the lining due to gravity or with a rigid or semi-rigid ring element adapted to be moved distally by the intestinal peristalsis.
  • the applier 23 is endoluminally removed from the patient. Removal of the lining 2 from the hollow organ can be accomplished by separating, e.g.
  • 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 help to mimic the effects of gastric bypass in resolution of type 2 diabetes and facilitating weight loss, improve glycemic control and reduce or eliminate other co-morbidities of severe obesity.
  • the described devices and procedures may be advantageously used in conjunction with other therapeutic regimes for the treatment of type 2 diabetes and its co-morbidities and address the patients fear of invasive surgery.
  • the described procedures and devices allow a reversible procedure with an easy removal and replacement of the endoluminal lining or sleeve once the desired effect has been achieved or a modification of the endoluminal lining is desired.

Abstract

L'invention porte sur un système de revêtement endoluminal pour revêtir de manière interne un organe creux (1), lequel système de revêtement endoluminal comprend un revêtement tubulaire (2) souple et un dispositif d'ancrage (5) pour fixer le revêtement (2) dans l'organe creux (1). Le dispositif d'ancrage (5) comprend un anneau d'ancrage (6) formant une surface d'ancrage (9) radialement externe, une pluralité de barbelures (10) agencées dans la surface d'ancrage (9) et aptes à faire saillie à partir de la surface d'ancrage (9) radialement vers l'extérieur et inclinées par rapport à une direction radiale de l'axe longitudinal (8) de telle sorte que, lors d'une rotation de l'anneau d'ancrage (6) dans une première direction autour de l'axe longitudinal (8), les barbelures (10) pénètrent dans le tissu (11) environnant et acquièrent ledit tissu (11) vers la surface d'ancrage (9). En outre, des moyens de verrouillage sont prévus pour empêcher une rotation relative entre l'anneau d'ancrage et le tissu environnant.
PCT/EP2011/055272 2011-04-05 2011-04-05 Système de revêtement endoluminal et procédé de revêtement endoluminal d'un organe creux WO2012136249A1 (fr)

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US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
EP3240503A4 (fr) * 2014-12-29 2018-07-25 Bfkw, Llc Fixation de dispositif intraluminal
US10182901B2 (en) 2011-05-20 2019-01-22 Bfkw, Llc Intraluminal device and method of fixation
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
US10786380B2 (en) 2007-02-14 2020-09-29 Bfkw, Llc Bariatric device and method
US11013629B2 (en) 2014-12-29 2021-05-25 Bfkw, Llc Fixation of intraluminal device
US11020213B2 (en) 2014-12-29 2021-06-01 Bfkw, Llc Fixation of intraluminal device
US11642234B2 (en) 2004-10-15 2023-05-09 Bfkw, Llc Bariatric device and method

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US11129703B2 (en) 2011-05-20 2021-09-28 Bfkw, Llc Intraluminal device and method of fixation
WO2014159186A1 (fr) * 2013-03-14 2014-10-02 Endo Pharmaceuticals Inc. Dispositif d'anastomose urétrale
US10307280B2 (en) 2013-08-28 2019-06-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
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EP3240503A4 (fr) * 2014-12-29 2018-07-25 Bfkw, Llc Fixation de dispositif intraluminal
AU2015374326B2 (en) * 2014-12-29 2020-05-21 Bfkw, Llc Fixation of intraluminal device
US10682219B2 (en) 2014-12-29 2020-06-16 Bfkw, Llc Fixation of intraluminal device
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