WO2013087096A1 - Endoluminal sleeve device and methods for deploying an endoluminal sleeve in the gi tract - Google Patents

Endoluminal sleeve device and methods for deploying an endoluminal sleeve in the gi tract Download PDF

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Publication number
WO2013087096A1
WO2013087096A1 PCT/EP2011/072637 EP2011072637W WO2013087096A1 WO 2013087096 A1 WO2013087096 A1 WO 2013087096A1 EP 2011072637 W EP2011072637 W EP 2011072637W WO 2013087096 A1 WO2013087096 A1 WO 2013087096A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
wall
endoluminal
lumen
section
Prior art date
Application number
PCT/EP2011/072637
Other languages
French (fr)
Inventor
Mark Steven ZEINER
Mark Steven Ortiz
José M. BERGER
Randy J. Seeley
James W. Voegele
Michael A. Murray
Michele D'arcangelo
Jason Harris
Alessandro Pastorelli
Carrie BENZINGER
David Cagle
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/EP2011/072637 priority Critical patent/WO2013087096A1/en
Publication of WO2013087096A1 publication Critical patent/WO2013087096A1/en

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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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045—Stomach, intestines

Definitions

  • the present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.
  • 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. It was observed that endoluminal
  • Endosleeves in certain regions of the stomach and the duodenum contributed to improve glycemic control and to reduce or eliminate other co-morbidities of obesity. Moreover the lining of parts of the Gl-tract by means of endosleeves provide 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.
  • 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. Therefore, there is a need for improved sleeve devices and procedures for sealing interstices between the lining and the
  • known sleeve devices effectively address the need of selectively preventing the contact of the food flow with a certain length of Gl tract.
  • the known sleeve devices fail to selectively prevent the contact of the food flow with certain regions of the Gl wall, while allowing the food contact with bordering regions of the Gl wall in the same longitudinal position. Therefore, there is a need for improved sleeve devices and procedures for allowing a selective isolation and contact between the Gl wall and a food flow in multiple regions of the Gl tract.
  • 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.
  • an endoluminal sleeve device comprising:
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen and having:
  • compacting means attached to the wall, said compacting means constraining the wall in a transversally folded shape which narrows the cross section along a prevalent portion of
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen and having: a longitudinal extension from a proximal end forming a proximal lumen opening to a distal end forming a distal lumen opening, and
  • the sleeve By reducing the transverse dimensions of the sleeve to a value which is significantly smaller than the diameter of the involved section of intestine during insertion and full longitudinal deployment, the sleeve can more easily advance through the winding path of the intestine and worm its way through sections of intestine which are partially obstructed by residual intestinal contents. This reduces the risk that the sleeve may jib and fold over while it is unfolded und pushed along the intestine. After complete longitudinal deployment of the sleeve, it is then unfolded transversally to gain an expanded cross-section which may match the internal diameter of the intestine or somewhat expand it beyond the physiological dimensions to accommodate the chyme flow and avoid restriction.
  • an endoluminal sleeve device comprising:
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, and
  • END6979 a sleeve sealing portion connected to the wall, said sealing portion having a tubular expansion portion permanently elastically biased in a radially expanded shape, and an annular sealing lip formed at a proximal end of the expansion portion and protruding radially outward from the expansion portion, thereby forming an annular sealing line.
  • the sealing lip is configured to prevent a pull resistant anchoring contact between the expansion portion and surrounding tissue, thereby providing a floating or sliding sleeve sealing portion adapted to slide inside an intestine.
  • the sealing lip is made of a soft and pliable elastomeric material and bendable both in a proximal and a distal direction to allow non traumatic sliding of the sleeve sealing portion within an intestine both in a distal and proximal direction.
  • an endoluminal sleeve device comprising:
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, at least one leak opening formed in said wall remote from the proximal and distal ends, and
  • tissue anchoring portion connected with said wall near said leak opening, said tissue anchoring portion being adapted to securing the wall with the leak opening to a target tissue of intestine for a planned contact between a flow of contents inside the sleeve lumen and said target tissue.
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, and at least one leak opening formed in said wall remote from the proximal and distal ends;
  • END6979 securing the wall with the leak opening directly to the target tissue of intestine for a contact between a flow of contents inside the sleeve lumen and said target tissue.
  • an endoluminal sleeve device comprising:
  • a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, anti backflow means provided at the wall near the proximal lumen opening and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen towards the proximal lumen opening.
  • the sleeve can be e.g. anchored at or below the Cardia of a stomach and prevent upward reflux under normal conditions.
  • Figures 1 through 3 illustrate a method and device for internally lining a section of a Gl tract in accordance with an embodiment
  • Figures 4 through 7 illustrate embodiments of duodenal sleeve devices adapted to implement the method of figures 1 to 3;
  • Figure 8A illustrates a sleeve wall in a transversally folded shape with reduced cross section of the sleeve wall, in accordance with an embodiment
  • Figure 8B illustrates the sleeve wall of figure 8A in a transversally unfolded shape
  • Figure 9A illustrates a sleeve wall in a transversally folded shape with reduced cross section of the sleeve wall, in accordance with a further embodiment
  • Figure 9B illustrates the sleeve wall of figure 8A in a transversally unfolded shape with an increased cross section of the sleeve wall
  • Figures 10A and 10B illustrate method steps and devices for internally lining a section of intestine in accordance with a further embodiment
  • Figures 10C and 10D illustrate method steps and devices for internally lining a section of intestine in accordance with a further embodiment
  • Figures 1 1 through 16 illustrate sealing portions of an endoluminal sleeve in accordance with embodiments of the invention
  • Figures 17 through 20 illustrate expansion tube inserts of sealing portions for an endoluminal sleeve in accordance with embodiments of the invention
  • Figure 21 shows a longitudinal cross-section of a duodenal sleeve with an intermediate sealing and bile capture portion in accordance with an embodiment of the invention
  • Figure 22 is a cross-sectional view according to a sectional plane XXII in figure 21 ;
  • Figure 23 illustrates a duodenal sleeve with an intermediate sealing and bile capture portion in accordance with a further embodiment of the invention
  • Figure 24 illustrates an endoluminal sleeve in accordance with a further embodiment
  • Figure 25 shows a longitudinal cross-section of the sleeve of figure 24 anchored in a section of a Gl tract
  • Figure 26 shows a portion of an internal surface of an endoluminal sleeve in accordance with an embodiment
  • Figure 27 shows a method and devices for internally lining a section of a Gl tract and planned contact of food flow with a selected target tissue of a gastric wall
  • Figure 28 shows a method and devices for internally lining a section of a Gl tract and planned contact of food flow with a selected target tissue at the proximal duodenum;
  • Figure 29 is a cross-sectional view of a portion of an endoluminal sleeve having leak openings in accordance with an embodiment
  • Figure 30 is a cross-sectional view of a portion of an endoluminal sleeve having leak openings in accordance with a further embodiment.
  • END6979 sleeve device 1 for internally lining a section of the Gl tract, particularly a section of duodenum distally from the pylorus or a gastro-intestinal section below the Cardia, comprises a sleeve 2 configured for deployment inside an intestine of a human subject, the sleeve 2 having a wall 8 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, a longitudinal extension from the proximal end 4 to the distal end 6 and a transverse extension defining a cross section of the sleeve 2.
  • the sleeve device 1 further comprises compacting means attached to the wall 8 and constraining the wall 8 in a transversally folded shape (Figures 1 and 2) which narrows the cross section along a prevalent portion of the longitudinal extension of the wall 8 during a longitudinally unfolding of the wall 8 to its full longitudinal extension ( Figure 2).
  • the compacting means can be released when the wall 8 is longitudinally unfolded (Figure 2), thereby allowing the wall 8 to transversally unfold to an expanded cross section (Figure 3).
  • the sleeve 2 can more easily advance through the winding path of the intestine and find its way through sections of intestine which are partially obstructed by residual intestinal contents. This reduces the risk that the sleeve may jib and fold over while it is unfolded und pushed along the intestine. After complete longitudinal deployment of the sleeve 2, it is then unfolded transversally to gain an expanded cross-section which may match the internal diameter of the intestine 9 or somewhat expand it beyond the physiological dimensions to accommodate the chyme flow and avoid restriction.
  • the sleeve wall 8 comprises a plurality of longitudinally extending folds 10 secured along their length by a suture 1 1 which can be pulled out of the wall 8 or dissolved or loosened (by releasing its tension) after the sleeve wall 8 has been fully longitudinally deployed and unfolded, thereby allowing the longitudinal folds 10 to unfold and straighten transversally.
  • the sleeve wall 8 comprises a plurality of longitudinally extending folds 10 secured along their length and tightened to one another by a suture 1 1 which can be pulled out of the wall 8 or dissolved or loosened (by releasing its tension) after the sleeve wall 8 has been fully longitudinally deployed and unfolded.
  • the longitudinal folds 10 can define one or more inextensible inflatable channels 12 ( Figure 6) which have a preferably significantly reduced section with respect to the expanded cross-section of the sleeve 2. This makes it possible to longitudinally deploy the sleeve 2 by inflation of the inflatable channel 12 without expanding the entire sleeve lumen and, hence, without obstructing the intestine with a fully inflated sleeve.
  • the longitudinal folds 10 are preferably configured such that, after removal of the suture 1 1 , the inflatable channel or channels 12 become part of the internal sleeve lumen 3. In this manner, after completion of the longitudinal deployment of the sleeve 2 and removal of the suture 1 1 , the sleeve 2 can be transversally unfolded by simply further inflating the sleeve lumen 3.
  • the above described longitudinal folds are secured and, if provided, connected to one another by means of a dissolvable glue which can be provided instead of the suture 1 1 or in addition to the suture 1 1 .
  • two facing (external or internal) wall 8 surfaces of at least one of the longitudinal folds 10 are glued together to form a non inflatable region of the sleeve 2, thereby reducing the transverse section of the inflated sleeve during longitudinal deployment.
  • the glue can be dissolved after full longitudinal deployment of the sleeve 2, e.g. by exposure of an external fold (Figures 9A, 9B) to the humid intestinal wall or by filling the sleeve lumen 3 with a solvent agent, e.g. water or saline solution, adapted to removes the glue from an internal fold ( Figures 8A, 8B).
  • a solvent agent e.g. water or saline solution
  • the above described longitudinal folds are secured and possibly connected to one another by means of a removable adhesive tape 13 (dashed line in figure 9A) which can be provided instead or in addition to the suture 1 1 and or to the directly applied glue.
  • the adhesive tape 13 additionally seals and reinforces the longitudinal folds 10.
  • the compacting means includes a removable, e.g. dissolvable, auxiliary tube 14 extended along a prevalent portion of the length of the sleeve 2 and adapted to constrain the wall 8 in the transversally folded shape during longitudinal deployment thereof.
  • a removable, e.g. dissolvable, auxiliary tube 14 extended along a prevalent portion of the length of the sleeve 2 and adapted to constrain the wall 8 in the transversally folded shape during longitudinal deployment thereof.
  • FIGS 10A and 10B illustrate an auxiliary tube 14 arranged inside the sleeve lumen 3 and having a diameter which is significantly smaller than the diameter of the sleeve lumen 3.
  • the auxiliary tube 14 defining an internal suction and inflation channel 15 to which a pump 18 can be connected to inject or remove air or other fluid.
  • END6979 and inflation channel 15 comprises a plurality of lateral openings 16 distributed along the length of the sleeve wall 8 and adapted to constrain the wall 8 in the transversally folded shape by suction and to unfold the wall 8 transversally by inflation.
  • the auxiliary tube 14 may be dissolved or otherwise removed from the sleeve 2.
  • the auxiliary tube 14 is inserted externally over the transversally folded sleeve wall 8 and adapted to constrain the sleeve wall 8 in the reduced cross section configuration during insertion and longitudinal deployment of the sleeve wall.
  • the auxiliary tube 14 may be dissolved or otherwise removed from the sleeve 2, thereby allowing the sleeve wall 8 to unfold transversally to its expanded cross- section.
  • the auxiliary tube 14 may have a greater stiffness than the sleeve 2 in order to stiffen the sleeve 2 while it is advanced, e.g. pushed, distally in the Gl tract.
  • the auxiliary tube 14 may have an atraumatic rounded distal tip 17 protruding distally beyond the distal end 6 of the sleeve 2.
  • the above described sleeve device 1 can be advantageously used during a method for endoluminally lining a section of a Gl tract, in which, prior to the insertion of the sleeve 2, the wall 8 is compacted and constrained in a transversally folded shape which narrows the cross section along a prevalent portion of the longitudinal extension of the wall 8. Then, the sleeve 2 is inserted in a target section of the Gl tract and the wall 8 is longitudinally unfolded to its full longitudinal extension while maintaining the wall 8 in the transversally folded shape. Only after the wall 8 has been longitudinally unfolded, it is released from the transversally folded shape such that it can transversally unfold to an expanded cross section.
  • the step of transversally compacting the sleeve wall 8 comprises creating at least one longitudinal fold 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and securing the longitudinal fold 10 by a suture 1 1 , by gluing or by an adhesive tape 13.
  • the step of transversally compacting the sleeve wall 8 comprises creating a plurality of at least two longitudinal folds 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and securing each longitudinal fold 10 separately by an individual suture 1 1 , gluing or by an individual
  • the step of transversally compacting the sleeve wall 8 comprises creating a plurality of at least two longitudinal folds 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and connecting the longitudinal folds 10 to each other by means of suturing, by gluing or by an adhesive tape 13.
  • the step of transversally compacting the sleeve wall 8 comprises applying suction to the sleeve lumen 3 or inserting the sleeve 2 inside an auxiliary tube 14 having a smaller diameter than the transversally unfolded sleeve 2.
  • the step of releasing the wall 8 may comprise one or more of dissolving the suture 1 1 , pulling the suture out of the wall 8, releasing the tension of the suture, but leaving the suture in place (for a future transverse folding and compacting of the sleeve wall 8), dissolving the glue, dissolving the adhesive tape 13, removing the adhesive tape 13 by pulling it away from the wall 8, dissolving or otherwise removing the auxiliary tube 14 from the sleeve wall 8.
  • the step of deploying the sleeve 2 longitudinally comprises forming an inflatable channel 12 by means of the longitudinal folds 10 such that the inflatable channel 12 has a cross section smaller than a cross- section of the transversally unfolded sleeve lumen 3, and inflating the inflatable channel 12.
  • the method may further comprise the step of compacting the sleeve 2 longitudinally, e.g. by folding the sleeve, rolling the sleeve up or by accordion-like folding the sleeve, before inserting the sleeve 2 in the Gl tract.
  • the method may comprise the step of expanding the sleeve 2 transversally from the transversally folded shape to a transversally unfolded shape, e.g. by inflating the sleeve lumen 2.
  • the transversally folded shape of the sleeve wall 8 may have a cross-sectional width (i.e. diameter in case of an approximately circular shape) of between 1 /2 and 1/5, preferably of less than 1/3 of the transversally unfolded cross-sectional width of the sleeve 2.
  • an endoluminal sleeve device 1 comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a
  • the device 1 further comprises a sleeve sealing portion 19 connected to the wall 8 and having a tubular expansion portion 20 permanently elastically biased in a radially expanded shape, and an annular sealing lip 21 formed at a proximal end of the expansion portion 20 and protruding radially outward from the expansion portion 20.
  • the expansion portion 20 presses the sealing lip 21 radially against the surrounding tissue, thereby establishing an annular sealing line between the sealing lip 21 and the tissue.
  • the sealing lip 21 pushes the surrounding tissue locally radially away from the tubular expansion portion 20 or at least decreases a contact pressure between the tissue and the tubular expansion portion 20.
  • This particular configuration of the sealing lip 21 prevents a pull resistant anchoring contact between the expansion portion 20 and a surrounding tissue, thereby providing a floating or sliding sleeve seal which allows the sealing portion to slide inside an intestine.
  • a floating seal configuration reduces the local stress applied to the tissue of the Gl tract at the sealing portion 19 and assures a reliable leak prevention also during and after dislocations of the sleeve 2 inside a Gl tract.
  • the sealing lip 21 is made of a soft and pliable elastomeric material and bendable with respect to the tubular expansion portion 20 both in a proximal and a distal direction to allow non traumatic sliding of the sleeve sealing portion 19 within an intestine both in a distal and proximal direction.
  • the sleeve device 1 may additionally comprise an anchoring portion 22 (dashed line in figure 15) connected e.g. by means of a tether 43 with the sleeve wall 8 or the sealing portion 19 and adapted to anchor the sleeve 2 inside a target section of the Gl tract without necessarily accomplishing a sealing function.
  • an anchoring portion 22 dashed line in figure 15
  • the sealing portion 19 may be arranged at the proximal sleeve end 4 and can be e.g. positioned distal of the pylorus, while the anchoring portion 22 can be placed inside the stomach.
  • the sealing lip can have a shape, e.g. a proximally widening funnel shape (compare figures 1 1 , 12, 13 and 15), which widens radially during distal flexure and narrows radially during proximal flexure with respect to the tubular expansion portion 20, so that a proximal retrograde motion of the sealing portion 19 inside the intestine is at least somewhat hindered, while a distal motion thereof is allowed to occur more easily.
  • a proximally widening funnel shape (compare figures 1 1 , 12, 13 and 15)
  • the sealing lip 21 has undulations in an axial (or longitudinal) direction 23 of the sealing portion 19 and an external surface with a continuous convex shape, thereby preventing the formation of concavities in a radial direction 24 which might lead to undesired leakage between the sleeve and the Gl wall.
  • the tubular expansion portion 20 comprises an undulated or zigzag shaped wall which adapts to a large range of diameters of intestinal wall and which can be easily transversally compacted during placement.
  • the tubular expansion portion 20 comprises a helix shaped expansion and sealing rip 24 formed on an external surface 25 of the expansion portion 20 and which is adapted to bias the expansion portion 20 permanently radially outward and to engage a surrounding tissue along an additional helix shaped sealing line.
  • the tubular expansion portion 20 comprises a net of interconnected expansion and sealing rips 26 formed on the external surface 25 of the expansion portion 20 and adapted for a tight engagement of surrounding tissue.
  • Figures 17 through 19 illustrate possible embodiments of inserts 44 which may be incorporated in the tubular expansion portion 20 in order to permanently bias it outward.
  • the inserts 44 may comprise multiple interconnected undulated rings ( Figures 17, 18), multiple interconnected plane rings (figure 19) or an elastic tube with a plurality of weakening holes (figure 20).
  • the tubular expansion portion of the sleeve sealing portion 19 defines an internal surface 28 in communication with a secondary sleeve lumen 27 (e.g. formed by an additional sleeve wall 29 which may extend parallel to or be coaxially arranged about the sleeve wall 8) adapted to drain digestive secretions such as for example biliopancreatic juices.
  • a secondary sleeve lumen 27 e.g. formed by an additional sleeve wall 29 which may extend parallel to or be coaxially arranged about the sleeve wall
  • the sealing portion 19 may comprise a semi-rigid or rigid connecting ring 30 or tube arranged radially inside the tubular expansion portion 20 and connected to the tubular expansion portion 20 by at least one, preferably at least two collapsible arms 31 adapted to allow a radial deformation of the tubular expansion portion 20 without deforming the connecting ring 30.
  • This makes it possible to adapt the sealing portion 19 to different intestinal lumen dimensions and to accommodate peristalsis without interfering with the diameter of the sleeve lumen 3.
  • sealing portion 19 may be arranged distally of a sphincter of ODDI in order to provide a seal against leakage of biliopancreatic secretions between the sleeve device 1 and the duodenal wall and with the additional purpose of selectively draining the biliopancreatic secretions separate from both the intestinal wall and, possibly, of selectively preventing and/or promoting a contact between a chyme flow inside the sleeve lumen 3 and the captured biliary fluid.
  • the collapsible arms 31 are inclined with respect to a longitudinal axis 32 of the sealing portion 19 such that a radial deformation of the expansion portion 20 brings about a (substantially cantilever type) flexure of the collapsible arms 31 which doesn't generate substantial compression in a local longitudinal direction of the arms 31 .
  • Such a flexure of the collapsible arms 31 may be further improved by forming flexure hinges 33 at both ends of the arms 31 .
  • an endoluminal sleeve device 1 comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a wall 8 of a flexible material, the wall 8 defining a sleeve lumen 3, a proximal end 4 forming a proximal lumen opening 5 and a distal end 6 forming a distal lumen opening 7.
  • the sleeve device 1 further includes at least one leak opening 34 formed in the wall 8 remote from the proximal and distal ends 4, 6, and a tissue anchoring portion 35 connected with the wall 8 near said leak opening 34.
  • the tissue anchoring portion 35 may include:
  • the tissue anchoring portion 35 is adapted to fasten the wall 8 near the leak opening 34 to a target tissue of intestine for a selective contact between a flow of contents inside the sleeve lumen 3 and the target tissue.
  • the leak openings 34 formed in the wall 8 of the sleeve allow a contact between chyme flow and Gl wall tissue in selected positions along a circumference of a target section of Gl tract, e.g. in one or more specific regions of the stomach (Figure 27) or of the proximal duodenum (Figure 28).
  • the tissue anchoring portion 35 is arranged within a distance of less than 5 cm, preferably less than 2 cm from the leak opening 34.
  • the leak opening 34 comprises a selectively permeable shield 36 adapted to allow the passage of only one or more predetermined nutrients, e.g. fats, through the leak openings 34.
  • the leak openings 34 may have an adjustable size, e.g. thanks to a shield member 37 slidably connected to the sleeve wall 8 and adapted to adjustably overlap the leak openings 34 ( Figures 29, 30).
  • an endoluminal sleeve device 1 comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a wall 8 of a flexible material, the wall 8 defining a sleeve lumen 3, a proximal end 4 forming a proximal lumen opening 5 and a distal end 6 forming a distal lumen opening 7.
  • the device 1 further comprises anti backflow means 39 provided at the wall 8 near the proximal lumen opening 5 and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen 3 towards the proximal lumen opening 5.
  • anti backflow means 39 provided at the wall 8 near the proximal lumen opening 5 and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen 3 towards the proximal lumen opening 5.
  • the sleeve 2 can be e.g. anchored at or below the Cardia of a stomach and will prevent upward reflux under normal conditions.
  • the anti backflow means 39 can comprise a one way valve, e.g. a flapper valve 40, which allows a passage of contents in a distal direction (i.e. introduction of food into the proximal lumen opening 5), but prevents a proximal backflow of contents.
  • a flapper valve 40 which allows a passage of contents in a distal direction (i.e. introduction of food into the proximal lumen opening 5), but prevents a proximal backflow of contents.
  • the anti backflow means 39 can be embodied by a stepped internal surface 41 of the sleeve wall 8, said stepped surface 41 having a plurality of circumferentially extending distally facing risers 42 adapted to slow down and lessen an undesired proximal reflux inside the sleeve 2.
  • 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
  • END6979 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.
  • 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.
  • END6979 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.
  • a programmed tearing line e.g. a perforation
  • 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.

Abstract

An endoluminal sleeve device (1) for internally lining a section of the Gl tract comprises a sleeve (2) having a longitudinal extension and a transverse extension defining a cross section of the sleeve (2), compacting means attached to the sleeve (2) and constraining a sleeve wall (8) in a transversally folded shape which narrows the cross section of the wall (8) along a prevalent portion of the longitudinal extension during longitudinally deploying the wall (8) to its full longitudinal extension, wherein the compacting means can be released when the wall (8) is longitudinally unfolded, thereby allowing the wall (8) to transversally unfold from said narrowed cross-section to an expanded cross section.

Description

DESCRIPTION
"ENDOLUMINAL SLEEVE DEVICE AND METHODS FOR DEPLOYING AN
ENDOLUMINAL SLEEVE IN THE Gl TRACT"
FIELD OF THE INVENTION
[0001 ] The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.
BACKGROUND OF THE INVENTION
[0002] In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to "tie off" or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or 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.
[0003] Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to severely obese patients (morbid obesity, Body Mass Index >=40) due to their complications, including the risk of death, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
[0004] In addition to the above described gastrointestinal reduction surgery, 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. It was observed that endoluminal
END6979 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. Moreover the lining of parts of the Gl-tract by means of endosleeves provide 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.
[0005] 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.
[0006] Known endosleeves and sleeve placement procedures have the drawback that the transverse dimension of the sleeve wall which is intended to fully occupy the intestine and to provide a possibly large internal sleeve lumen for the passage of intestinal contents, often jeopardizes a correct longitudinal deployment of the sleeve within the Gl tract. The somewhat cumbersome sleeve tends to hinder itself whilst unfolding and advancing longitudinally inside the winding intestine. Particularly in case of partial restriction of the Gl tract by residual intestinal contents, the sleeve tends to "jib" and to eventually fold over, so that deployment need to be started from the beginning. Therefore, there is a need for improved sleeve devices and procedures for the longitudinal deployment of endoluminal sleeves within a Gl tract.
[0007] 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. Therefore, there is a need for improved sleeve devices and procedures for sealing interstices between the lining and the
END6979 Gl wall.
[0008] With regard to the lining function of endoluminal sleeves which focuses on an isolation of the food flow from the gastrointestinal wall, known sleeve devices effectively address the need of selectively preventing the contact of the food flow with a certain length of Gl tract. However, the known sleeve devices fail to selectively prevent the contact of the food flow with certain regions of the Gl wall, while allowing the food contact with bordering regions of the Gl wall in the same longitudinal position. Therefore, there is a need for improved sleeve devices and procedures for allowing a selective isolation and contact between the Gl wall and a food flow in multiple regions of the Gl tract.
[0009] Further fields of desirable improvements related with endoluminal sleeves are their suitability for allowing normal physiological events to occur, such as e.g. preventing permanent gastroesophageal reflux and/or allowing vomiting, especially when the sleeve device is placed in the stomach at the cardia.
SUMMARY OF THE INVENTION
[0010] 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. In the case of the present invention, 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.
[001 1 ] According to an aspect of the invention, there is provided an endoluminal sleeve device, comprising:
a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen and having:
a longitudinal extension from a proximal end forming a proximal lumen opening to a distal end forming a distal lumen opening, and
a transverse extension defining a cross section of the sleeve,
compacting means attached to the wall, said compacting means constraining the wall in a transversally folded shape which narrows the cross section along a prevalent portion of
END6979 the longitudinal extension of the wall during a longitudinally unfolding of the wall to its full longitudinal extension, wherein said compacting means can be released when the wall is longitudinally unfolded, thereby allowing the wall to transversally unfold to an expanded cross section.
[0012] According to a further aspect of the invention, there is provided method for endoluminally lining a section of a Gl tract, the method comprising:
providing a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen and having: a longitudinal extension from a proximal end forming a proximal lumen opening to a distal end forming a distal lumen opening, and
a transverse extension defining a cross section of the sleeve,
compacting and constraining the wall in a transversally folded shape which narrows the cross section along a prevalent portion of the longitudinal extension of the wall;
inserting the sleeve and longitudinally unfolding the wall to its full longitudinal extension within the target section of the Gl tract while maintaining the wall in the transversally folded shape;
after the wall has been longitudinally unfolded, releasing the wall from the transversally folded shape such that the wall can transversally unfold to an expanded cross section.
[0013] By reducing the transverse dimensions of the sleeve to a value which is significantly smaller than the diameter of the involved section of intestine during insertion and full longitudinal deployment, the sleeve can more easily advance through the winding path of the intestine and worm its way through sections of intestine which are partially obstructed by residual intestinal contents. This reduces the risk that the sleeve may jib and fold over while it is unfolded und pushed along the intestine. After complete longitudinal deployment of the sleeve, it is then unfolded transversally to gain an expanded cross-section which may match the internal diameter of the intestine or somewhat expand it beyond the physiological dimensions to accommodate the chyme flow and avoid restriction.
[0014] According to a further aspect of the invention which may be implemented in combination with the previously described features, there is provided an endoluminal sleeve device, comprising:
a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, and
END6979 a sleeve sealing portion connected to the wall, said sealing portion having a tubular expansion portion permanently elastically biased in a radially expanded shape, and an annular sealing lip formed at a proximal end of the expansion portion and protruding radially outward from the expansion portion, thereby forming an annular sealing line.
[0015] In accordance with an aspect of the invention, the sealing lip is configured to prevent a pull resistant anchoring contact between the expansion portion and surrounding tissue, thereby providing a floating or sliding sleeve sealing portion adapted to slide inside an intestine.
[0016] In accordance with a further aspect of the invention, the sealing lip is made of a soft and pliable elastomeric material and bendable both in a proximal and a distal direction to allow non traumatic sliding of the sleeve sealing portion within an intestine both in a distal and proximal direction.
[0017] In accordance with a yet further aspect of the invention which may be implemented in combination with one or more of the previously described features, there is provided an endoluminal sleeve device, comprising:
a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, at least one leak opening formed in said wall remote from the proximal and distal ends, and
a tissue anchoring portion connected with said wall near said leak opening, said tissue anchoring portion being adapted to securing the wall with the leak opening to a target tissue of intestine for a planned contact between a flow of contents inside the sleeve lumen and said target tissue.
[0018] In accordance with a further aspect of the invention which may be implemented in combination with one or more of the previously described features, there is provided a method for internally lining a section of a Gl tract, the method comprising:
providing a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, and at least one leak opening formed in said wall remote from the proximal and distal ends;
deploying the sleeve within a section of the Gl tract and positioning the leak opening at a target tissue of intestine;
END6979 securing the wall with the leak opening directly to the target tissue of intestine for a contact between a flow of contents inside the sleeve lumen and said target tissue.
[0019] By providing leak openings remote from both the distal end proximal sleeve end and securing the sleeve wall to the surrounding intestinal wall directly at or near the leak openings, a precise and purposeful contact between the chyme flow inside the sleeve lumen and selected portions of Gl wall can be established and the risk of undesired dislocations of the leak openings away from their intended position is obviated. Moreover, the leak openings formed in the wall of the sleeve allow a contact between chyme flow and Gl wall tissue in selected positions along a circumference of a target section of Gl tract, e.g. a specific region of the stomach.
[0020] In accordance with a yet further aspect of the invention which may be implemented in combination with one or more of the previously described features, there is provided an endoluminal sleeve device, comprising:
a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen, a proximal end forming a proximal lumen opening and a distal end forming a distal lumen opening, anti backflow means provided at the wall near the proximal lumen opening and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen towards the proximal lumen opening. By partially obstructing a proximal backflow at the proximal lumen opening, the sleeve can be e.g. anchored at or below the Cardia of a stomach and prevent upward reflux under normal conditions.
[0021 ] These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
Figures 1 through 3 illustrate a method and device for internally lining a section of a Gl tract in accordance with an embodiment;
Figures 4 through 7 illustrate embodiments of duodenal sleeve devices adapted to implement the method of figures 1 to 3;
Figure 8A illustrates a sleeve wall in a transversally folded shape with reduced cross section of the sleeve wall, in accordance with an embodiment;
Figure 8B illustrates the sleeve wall of figure 8A in a transversally unfolded shape with
END6979 an increased cross section of the sleeve wall;
Figure 9A illustrates a sleeve wall in a transversally folded shape with reduced cross section of the sleeve wall, in accordance with a further embodiment;
Figure 9B illustrates the sleeve wall of figure 8A in a transversally unfolded shape with an increased cross section of the sleeve wall;
Figures 10A and 10B illustrate method steps and devices for internally lining a section of intestine in accordance with a further embodiment;
Figures 10C and 10D illustrate method steps and devices for internally lining a section of intestine in accordance with a further embodiment;
Figures 1 1 through 16 illustrate sealing portions of an endoluminal sleeve in accordance with embodiments of the invention;
Figures 17 through 20 illustrate expansion tube inserts of sealing portions for an endoluminal sleeve in accordance with embodiments of the invention;
Figure 21 shows a longitudinal cross-section of a duodenal sleeve with an intermediate sealing and bile capture portion in accordance with an embodiment of the invention;
Figure 22 is a cross-sectional view according to a sectional plane XXII in figure 21 ;
Figure 23 illustrates a duodenal sleeve with an intermediate sealing and bile capture portion in accordance with a further embodiment of the invention;
Figure 24 illustrates an endoluminal sleeve in accordance with a further embodiment; Figure 25 shows a longitudinal cross-section of the sleeve of figure 24 anchored in a section of a Gl tract;
Figure 26 shows a portion of an internal surface of an endoluminal sleeve in accordance with an embodiment;
Figure 27 shows a method and devices for internally lining a section of a Gl tract and planned contact of food flow with a selected target tissue of a gastric wall;
Figure 28 shows a method and devices for internally lining a section of a Gl tract and planned contact of food flow with a selected target tissue at the proximal duodenum;
Figure 29 is a cross-sectional view of a portion of an endoluminal sleeve having leak openings in accordance with an embodiment;
Figure 30 is a cross-sectional view of a portion of an endoluminal sleeve having leak openings in accordance with a further embodiment.
DETAILED DESCRIPTION OF EMBODIMENTS
[0022] Referring to the drawings 1 through 10B where like numerals denote like anatomical structures and components throughout the several views, an endoluminal
END6979 sleeve device 1 for internally lining a section of the Gl tract, particularly a section of duodenum distally from the pylorus or a gastro-intestinal section below the Cardia, comprises a sleeve 2 configured for deployment inside an intestine of a human subject, the sleeve 2 having a wall 8 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, a longitudinal extension from the proximal end 4 to the distal end 6 and a transverse extension defining a cross section of the sleeve 2. The sleeve device 1 further comprises compacting means attached to the wall 8 and constraining the wall 8 in a transversally folded shape (Figures 1 and 2) which narrows the cross section along a prevalent portion of the longitudinal extension of the wall 8 during a longitudinally unfolding of the wall 8 to its full longitudinal extension (Figure 2).
[0023] The compacting means can be released when the wall 8 is longitudinally unfolded (Figure 2), thereby allowing the wall 8 to transversally unfold to an expanded cross section (Figure 3).
[0024] By reducing the transverse dimensions of the sleeve 2 to a value which is significantly smaller than the diameter of the involved section of intestine during insertion and full longitudinal deployment, the sleeve 2 can more easily advance through the winding path of the intestine and find its way through sections of intestine which are partially obstructed by residual intestinal contents. This reduces the risk that the sleeve may jib and fold over while it is unfolded und pushed along the intestine. After complete longitudinal deployment of the sleeve 2, it is then unfolded transversally to gain an expanded cross-section which may match the internal diameter of the intestine 9 or somewhat expand it beyond the physiological dimensions to accommodate the chyme flow and avoid restriction.
[0025] In accordance with an embodiment (Figures 5, 7), the sleeve wall 8 comprises a plurality of longitudinally extending folds 10 secured along their length by a suture 1 1 which can be pulled out of the wall 8 or dissolved or loosened (by releasing its tension) after the sleeve wall 8 has been fully longitudinally deployed and unfolded, thereby allowing the longitudinal folds 10 to unfold and straighten transversally.
[0026] In accordance with a further embodiment (Figures 4, 6), the sleeve wall 8 comprises a plurality of longitudinally extending folds 10 secured along their length and tightened to one another by a suture 1 1 which can be pulled out of the wall 8 or dissolved or loosened (by releasing its tension) after the sleeve wall 8 has been fully longitudinally deployed and unfolded.
END6979 [0027] The longitudinal folds 10 can define one or more inextensible inflatable channels 12 (Figure 6) which have a preferably significantly reduced section with respect to the expanded cross-section of the sleeve 2. This makes it possible to longitudinally deploy the sleeve 2 by inflation of the inflatable channel 12 without expanding the entire sleeve lumen and, hence, without obstructing the intestine with a fully inflated sleeve.
[0028] The longitudinal folds 10 are preferably configured such that, after removal of the suture 1 1 , the inflatable channel or channels 12 become part of the internal sleeve lumen 3. In this manner, after completion of the longitudinal deployment of the sleeve 2 and removal of the suture 1 1 , the sleeve 2 can be transversally unfolded by simply further inflating the sleeve lumen 3.
[0029] In accordance with a further embodiment, the above described longitudinal folds are secured and, if provided, connected to one another by means of a dissolvable glue which can be provided instead of the suture 1 1 or in addition to the suture 1 1 .
[0030] In accordance with an embodiment (Figures 8A, 9A) two facing (external or internal) wall 8 surfaces of at least one of the longitudinal folds 10 are glued together to form a non inflatable region of the sleeve 2, thereby reducing the transverse section of the inflated sleeve during longitudinal deployment. Also in this case, the glue can be dissolved after full longitudinal deployment of the sleeve 2, e.g. by exposure of an external fold (Figures 9A, 9B) to the humid intestinal wall or by filling the sleeve lumen 3 with a solvent agent, e.g. water or saline solution, adapted to removes the glue from an internal fold (Figures 8A, 8B). A non limiting example of a dissolvable glue is cyanoacrylate.
[0031 ] In accordance with a further embodiment, the above described longitudinal folds are secured and possibly connected to one another by means of a removable adhesive tape 13 (dashed line in figure 9A) which can be provided instead or in addition to the suture 1 1 and or to the directly applied glue. The adhesive tape 13 additionally seals and reinforces the longitudinal folds 10.
[0032] In accordance with a further embodiment (Figures 10A, 10B, 10C, 10D) the compacting means includes a removable, e.g. dissolvable, auxiliary tube 14 extended along a prevalent portion of the length of the sleeve 2 and adapted to constrain the wall 8 in the transversally folded shape during longitudinal deployment thereof.
[0033] Figures 10A and 10B illustrate an auxiliary tube 14 arranged inside the sleeve lumen 3 and having a diameter which is significantly smaller than the diameter of the sleeve lumen 3. The auxiliary tube 14 defining an internal suction and inflation channel 15 to which a pump 18 can be connected to inject or remove air or other fluid. The suction
END6979 and inflation channel 15 comprises a plurality of lateral openings 16 distributed along the length of the sleeve wall 8 and adapted to constrain the wall 8 in the transversally folded shape by suction and to unfold the wall 8 transversally by inflation. After completion of the longitudinal deployment and the transverse deployment of the sleeve 2, the auxiliary tube 14 may be dissolved or otherwise removed from the sleeve 2.
[0034] In accordance with a further embodiment (Figures 10C, 10D), the auxiliary tube 14 is inserted externally over the transversally folded sleeve wall 8 and adapted to constrain the sleeve wall 8 in the reduced cross section configuration during insertion and longitudinal deployment of the sleeve wall. After completion of the longitudinal deployment of the sleeve 2, the auxiliary tube 14 may be dissolved or otherwise removed from the sleeve 2, thereby allowing the sleeve wall 8 to unfold transversally to its expanded cross- section.
[0035] In both embodiments (Figures 10A, 10B, 10C, 10D), The auxiliary tube 14 may have a greater stiffness than the sleeve 2 in order to stiffen the sleeve 2 while it is advanced, e.g. pushed, distally in the Gl tract. For the same purpose, the auxiliary tube 14 may have an atraumatic rounded distal tip 17 protruding distally beyond the distal end 6 of the sleeve 2.
[0036] The above described sleeve device 1 can be advantageously used during a method for endoluminally lining a section of a Gl tract, in which, prior to the insertion of the sleeve 2, the wall 8 is compacted and constrained in a transversally folded shape which narrows the cross section along a prevalent portion of the longitudinal extension of the wall 8. Then, the sleeve 2 is inserted in a target section of the Gl tract and the wall 8 is longitudinally unfolded to its full longitudinal extension while maintaining the wall 8 in the transversally folded shape. Only after the wall 8 has been longitudinally unfolded, it is released from the transversally folded shape such that it can transversally unfold to an expanded cross section.
[0037] In accordance with an embodiment, the step of transversally compacting the sleeve wall 8 comprises creating at least one longitudinal fold 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and securing the longitudinal fold 10 by a suture 1 1 , by gluing or by an adhesive tape 13.
[0038] In accordance with a further embodiment, the step of transversally compacting the sleeve wall 8 comprises creating a plurality of at least two longitudinal folds 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and securing each longitudinal fold 10 separately by an individual suture 1 1 , gluing or by an individual
END6979 adhesive tape 13.
[0039] In accordance with a yet further embodiment, the step of transversally compacting the sleeve wall 8 comprises creating a plurality of at least two longitudinal folds 10 in the sleeve wall 8 along a substantial part of the length of the sleeve 2 and connecting the longitudinal folds 10 to each other by means of suturing, by gluing or by an adhesive tape 13.
[0040] Alternatively, the step of transversally compacting the sleeve wall 8 comprises applying suction to the sleeve lumen 3 or inserting the sleeve 2 inside an auxiliary tube 14 having a smaller diameter than the transversally unfolded sleeve 2.
[0041 ] In accordance with embodiments, the step of releasing the wall 8 may comprise one or more of dissolving the suture 1 1 , pulling the suture out of the wall 8, releasing the tension of the suture, but leaving the suture in place (for a future transverse folding and compacting of the sleeve wall 8), dissolving the glue, dissolving the adhesive tape 13, removing the adhesive tape 13 by pulling it away from the wall 8, dissolving or otherwise removing the auxiliary tube 14 from the sleeve wall 8.
[0042] In accordance with a further embodiment, the step of deploying the sleeve 2 longitudinally comprises forming an inflatable channel 12 by means of the longitudinal folds 10 such that the inflatable channel 12 has a cross section smaller than a cross- section of the transversally unfolded sleeve lumen 3, and inflating the inflatable channel 12.
[0043] The method may further comprise the step of compacting the sleeve 2 longitudinally, e.g. by folding the sleeve, rolling the sleeve up or by accordion-like folding the sleeve, before inserting the sleeve 2 in the Gl tract.
[0044] In accordance with a further embodiment, the method may comprise the step of expanding the sleeve 2 transversally from the transversally folded shape to a transversally unfolded shape, e.g. by inflating the sleeve lumen 2.
[0045] With regard to all described device and method embodiments, the transversally folded shape of the sleeve wall 8 may have a cross-sectional width (i.e. diameter in case of an approximately circular shape) of between 1 /2 and 1/5, preferably of less than 1/3 of the transversally unfolded cross-sectional width of the sleeve 2.
[0046] In accordance with a further embodiment (Figures 14 through 23) of the invention which may be implemented in combination with or without the previously described features, there is provided an endoluminal sleeve device 1 comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a
END6979 wall 8 of a flexible material, the wall 8 defining a sleeve lumen 3, a proximal end 4 forming a proximal lumen opening 5 and a distal end 6 forming a distal lumen opening 7. The device 1 further comprises a sleeve sealing portion 19 connected to the wall 8 and having a tubular expansion portion 20 permanently elastically biased in a radially expanded shape, and an annular sealing lip 21 formed at a proximal end of the expansion portion 20 and protruding radially outward from the expansion portion 20. During a use of the sleeve device 1 inside a Gl tract, the expansion portion 20 presses the sealing lip 21 radially against the surrounding tissue, thereby establishing an annular sealing line between the sealing lip 21 and the tissue. However, at the same time, the sealing lip 21 pushes the surrounding tissue locally radially away from the tubular expansion portion 20 or at least decreases a contact pressure between the tissue and the tubular expansion portion 20.
[0047] This particular configuration of the sealing lip 21 prevents a pull resistant anchoring contact between the expansion portion 20 and a surrounding tissue, thereby providing a floating or sliding sleeve seal which allows the sealing portion to slide inside an intestine. Such a floating seal configuration reduces the local stress applied to the tissue of the Gl tract at the sealing portion 19 and assures a reliable leak prevention also during and after dislocations of the sleeve 2 inside a Gl tract.
[0048] In accordance with an embodiment, the sealing lip 21 is made of a soft and pliable elastomeric material and bendable with respect to the tubular expansion portion 20 both in a proximal and a distal direction to allow non traumatic sliding of the sleeve sealing portion 19 within an intestine both in a distal and proximal direction.
[0049] In accordance with an embodiment, the sleeve device 1 may additionally comprise an anchoring portion 22 (dashed line in figure 15) connected e.g. by means of a tether 43 with the sleeve wall 8 or the sealing portion 19 and adapted to anchor the sleeve 2 inside a target section of the Gl tract without necessarily accomplishing a sealing function.
[0050] The sealing portion 19 may be arranged at the proximal sleeve end 4 and can be e.g. positioned distal of the pylorus, while the anchoring portion 22 can be placed inside the stomach.
[0051 ] In accordance with a further embodiment, the sealing lip can have a shape, e.g. a proximally widening funnel shape (compare figures 1 1 , 12, 13 and 15), which widens radially during distal flexure and narrows radially during proximal flexure with respect to the tubular expansion portion 20, so that a proximal retrograde motion of the sealing portion 19 inside the intestine is at least somewhat hindered, while a distal motion thereof is allowed to occur more easily.
END6979 [0052] In accordance with an embodiment (Figure 14) the sealing lip 21 has undulations in an axial (or longitudinal) direction 23 of the sealing portion 19 and an external surface with a continuous convex shape, thereby preventing the formation of concavities in a radial direction 24 which might lead to undesired leakage between the sleeve and the Gl wall.
[0053] In accordance with an embodiment (Figures 1 1 , 15, 16), the tubular expansion portion 20 comprises an undulated or zigzag shaped wall which adapts to a large range of diameters of intestinal wall and which can be easily transversally compacted during placement.
[0054] In accordance with a further embodiment (Figure 12), the tubular expansion portion 20 comprises a helix shaped expansion and sealing rip 24 formed on an external surface 25 of the expansion portion 20 and which is adapted to bias the expansion portion 20 permanently radially outward and to engage a surrounding tissue along an additional helix shaped sealing line.
[0055] In accordance with a yet further embodiment (Figure 13), the tubular expansion portion 20 comprises a net of interconnected expansion and sealing rips 26 formed on the external surface 25 of the expansion portion 20 and adapted for a tight engagement of surrounding tissue.
[0056] Figures 17 through 19 illustrate possible embodiments of inserts 44 which may be incorporated in the tubular expansion portion 20 in order to permanently bias it outward. The inserts 44 may comprise multiple interconnected undulated rings (Figures 17, 18), multiple interconnected plane rings (figure 19) or an elastic tube with a plurality of weakening holes (figure 20).
[0057] In accordance with a further embodiment (Figures 21 through 23) the tubular expansion portion of the sleeve sealing portion 19 defines an internal surface 28 in communication with a secondary sleeve lumen 27 (e.g. formed by an additional sleeve wall 29 which may extend parallel to or be coaxially arranged about the sleeve wall 8) adapted to drain digestive secretions such as for example biliopancreatic juices.
[0058] For the connection with the sleeve wall 8, the sealing portion 19 may comprise a semi-rigid or rigid connecting ring 30 or tube arranged radially inside the tubular expansion portion 20 and connected to the tubular expansion portion 20 by at least one, preferably at least two collapsible arms 31 adapted to allow a radial deformation of the tubular expansion portion 20 without deforming the connecting ring 30. This makes it possible to adapt the sealing portion 19 to different intestinal lumen dimensions and to accommodate peristalsis without interfering with the diameter of the sleeve lumen 3. A
END6979 thus configured sealing portion 19 may be arranged distally of a sphincter of ODDI in order to provide a seal against leakage of biliopancreatic secretions between the sleeve device 1 and the duodenal wall and with the additional purpose of selectively draining the biliopancreatic secretions separate from both the intestinal wall and, possibly, of selectively preventing and/or promoting a contact between a chyme flow inside the sleeve lumen 3 and the captured biliary fluid.
[0059] In accordance with an embodiment the collapsible arms 31 are inclined with respect to a longitudinal axis 32 of the sealing portion 19 such that a radial deformation of the expansion portion 20 brings about a (substantially cantilever type) flexure of the collapsible arms 31 which doesn't generate substantial compression in a local longitudinal direction of the arms 31 . Such a flexure of the collapsible arms 31 may be further improved by forming flexure hinges 33 at both ends of the arms 31 .
[0060] In accordance with a yet further embodiment (Figures 26 through 30) which may be implemented in combination with one or more of the previously described features, there is provided an endoluminal sleeve device 1 , comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a wall 8 of a flexible material, the wall 8 defining a sleeve lumen 3, a proximal end 4 forming a proximal lumen opening 5 and a distal end 6 forming a distal lumen opening 7. The sleeve device 1 further includes at least one leak opening 34 formed in the wall 8 remote from the proximal and distal ends 4, 6, and a tissue anchoring portion 35 connected with the wall 8 near said leak opening 34. The tissue anchoring portion 35 may include:
a portion (of the wall 8) emulating the internal shape of a section of Gl tract, e.g. of the stomach, adapted to connect to the latter by shape coupling,
a stent,
a clamping portion,
a suture,
an adhesive surface portion.
[0061 ] The tissue anchoring portion 35 is adapted to fasten the wall 8 near the leak opening 34 to a target tissue of intestine for a selective contact between a flow of contents inside the sleeve lumen 3 and the target tissue.
[0062] By providing the leak openings 34 remote from both the distal end proximal sleeve ends 4, 6 and securing the sleeve wall 8 to the surrounding intestinal wall directly at or near the leak openings 34, a precise and purposeful contact between the chyme flow inside the sleeve lumen 3 and selected portions of Gl wall can be established and the risk
END6979 of undesired dislocations of the leak openings 34 away from their intended position is obviated. Moreover, the leak openings 34 formed in the wall 8 of the sleeve allow a contact between chyme flow and Gl wall tissue in selected positions along a circumference of a target section of Gl tract, e.g. in one or more specific regions of the stomach (Figure 27) or of the proximal duodenum (Figure 28).
[0063] In accordance with an embodiment, the tissue anchoring portion 35 is arranged within a distance of less than 5 cm, preferably less than 2 cm from the leak opening 34.
[0064] In accordance with an embodiment, the leak opening 34 comprises a selectively permeable shield 36 adapted to allow the passage of only one or more predetermined nutrients, e.g. fats, through the leak openings 34.
[0065] In accordance with a further embodiment, the leak openings 34 may have an adjustable size, e.g. thanks to a shield member 37 slidably connected to the sleeve wall 8 and adapted to adjustably overlap the leak openings 34 (Figures 29, 30).
[0066] In accordance with a yet further embodiment of the invention (Figures 24, 25, 26, 28) which may be implemented in combination with one or more of the previously described features, there is provided an endoluminal sleeve device 1 , comprising a sleeve 2 configured for deployment inside an intestine 9 of a human subject, the sleeve 2 having a wall 8 of a flexible material, the wall 8 defining a sleeve lumen 3, a proximal end 4 forming a proximal lumen opening 5 and a distal end 6 forming a distal lumen opening 7. The device 1 further comprises anti backflow means 39 provided at the wall 8 near the proximal lumen opening 5 and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen 3 towards the proximal lumen opening 5. By partially obstructing a proximal backflow at the proximal lumen opening, the sleeve 2 can be e.g. anchored at or below the Cardia of a stomach and will prevent upward reflux under normal conditions.
[0067] The anti backflow means 39 can comprise a one way valve, e.g. a flapper valve 40, which allows a passage of contents in a distal direction (i.e. introduction of food into the proximal lumen opening 5), but prevents a proximal backflow of contents.
[0068] Alternatively or additionally, the anti backflow means 39 can be embodied by a stepped internal surface 41 of the sleeve wall 8, said stepped surface 41 having a plurality of circumferentially extending distally facing risers 42 adapted to slow down and lessen an undesired proximal reflux inside the sleeve 2.
[0069] 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
END6979 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.
[0070] The diameter of the sleeve lumen may be substantially constant along the entire length of the liner tube. Although any suitable luminal diameter may be used, in some embodiments, 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.
[0071 ] In some embodiments, the proximal end of the sleeve may be flared and may define a funnel-like structure.
[0072] 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. Generally, 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.
[0073] 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). In some embodiments, 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.
[0074] 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. In addition, sleeve may further include components that inhibit twisting or kinking of the sleeve itself. In one embodiment, 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. In other embodiments, the stiffening elements may be in spiral shape or extending lengthwise along at least a portion of the sleeve.
[0075] In an implantation method, 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.
END6979 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.
[0076] In this way 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.
[0077] Particularly, devices and procedures have been described which improve the longitudinal deployment of endoluminal sleeves. Moreover, devices and procedures have been described which reduce the risk of an undesired leakage of the partially digested food flow in the interstice between the lumen wall and the sleeve. At least some of the described devices and procedures allow a selective isolation and contact between the Gl wall and a food flow in multiple regions of the Gl tract.
[0078] Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.
END6979

Claims

1. Endoluminal sleeve device (1 ) for internally lining a section of the Gl tract, comprising:
- a sleeve (2) configured for deployment inside a duodenum, the sleeve (2) having a wall (8) of a flexible material defining a sleeve lumen (3), a longitudinal extension from a proximal end (4) defining a proximal lumen opening (5) to a distal end (6) defining a distal lumen opening (7), and a transverse extension defining a cross section of the sleeve (2),
- compacting means attached to the wall (8) and constraining the wall (8) in a transversally folded shape which narrows the cross section of the wall (8) along a prevalent portion of the longitudinal extension during longitudinally deploying the wall (8), wherein said compacting means can be released when the wall (8) is longitudinally unfolded, thereby allowing the wall (8) to transversally unfold from said narrowed cross- section to an expanded cross section.
2. Endoluminal sleeve device (1 ) according to claim 1 , in which the sleeve wall (8) comprises a plurality of longitudinally extending folds (10) secured along their length by said compacting means.
3. Endoluminal sleeve device (1 ) according to claim 2, in which the longitudinal folds (10) are tightened to one another inside the sleeve lumen (3) by said compacting means.
4. Endoluminal sleeve device (1 ) according to claim 2 or 3, in which the longitudinal folds (10) define one or more inextensible inflatable channels (12) having a preferably significantly reduced section with respect to the expanded cross-section of the sleeve (2).
5. Endoluminal sleeve device (1 ) according to claim 4, wherein, during unfolding the longitudinal folds (10), the inflatable channel (12) becomes part of the internal sleeve lumen (3), such that after releasing the compacting means, the sleeve (2) can be transversally unfolded by inflating the sleeve lumen (3).
6. Endoluminal sleeve device (1 ) according to any one of the preceding claims, wherein said compacting means are selected in the group of:
- a suture (1 1 ) which can be pulled out of the wall (8),
- a suture (1 1 ) which can be loosened by releasing its tension,
- a suture (1 1 ) which can be dissolved,
- a dissolvable glue,
- an adhesive tape which can be removed from the wall (8).
7. Endoluminal sleeve device (1 ) according to claim 4, wherein two facing surface portions of one of the longitudinal folds (10) are glued together to form a non inflatable region of the sleeve (2), thereby reducing the transverse section of the inflated sleeve during
END6979 longitudinal deployment.
8. Endoluminal sleeve device (1 ) according to claim 1 , wherein the compacting means comprises an auxiliary tube (14) extended along a prevalent portion of the length of the sleeve (2), said auxiliary tube (14) being removably attached to the sleeve wall (8) and constrains the wall (8) in said transversally folded shape during longitudinal deployment of the sleeve (2).
9. Endoluminal sleeve device (1 ) according to claim 8, wherein the auxiliary tube (14) has a diameter which is significantly smaller than the diameter of the sleeve lumen (3) and defines an internal suction and inflation channel (15) to which a pump (18) can be connected for injection or suction of a fluid, wherein the auxiliary tube (14) is arranged inside the sleeve lumen (3) and the suction and inflation channel (15) comprises a plurality of lateral openings (16) distributed along the length of the sleeve wall (8) and adapted to constrain the wall (8) in the transversally folded shape by suction and to unfold the wall (8) transversally by inflation.
10. Endoluminal sleeve device (1 ) according to claim 8, wherein the auxiliary tube (14) is inserted externally over the transversally folded sleeve wall (8) and adapted to constrain the sleeve wall (8) in a reduced cross section configuration during longitudinal deployment of the sleeve wall (8).
11. Endoluminal sleeve device (1 ) according to claim 9 or 10, wherein the auxiliary tube (14) is dissolvable.
12. Endoluminal sleeve device (1 ) according to claim 9 or 10, wherein the auxiliary tube (14) has a greater stiffness than the sleeve (2) and a rounded distal tip (17) protruding distally beyond the distal end (6) of the sleeve (2).
13. Endoluminal sleeve device (1 ) according to claim 2, the wall (8) defines one or more leak openings for a selective contact between contents inside the sleeve lumen (3) and a surrounding intestinal wall tissue, said longitudinal folds being formed such that they cover said leak openings.
14. A method for endoluminally lining a section of a Gl tract, the method comprising:
- providing a sleeve configured for deployment inside an intestine of a human subject, the sleeve having a wall of a flexible material, the wall defining a sleeve lumen and having:
- a longitudinal extension from a proximal end forming a proximal lumen opening to a distal end forming a distal lumen opening, and
- a transverse extension defining a cross section of the sleeve,
- compacting and constraining the wall in a transversally folded shape which narrows the
END6979 cross section along a prevalent portion of the longitudinal extension of the wall;
- inserting the sleeve and longitudinally unfolding the wall to its full longitudinal extension within the target section of the Gl tract while maintaining the wall in the transversally folded shape;
- after the wall has been longitudinally unfolded, releasing the wall from the transversally folded shape such that the wall can transversally unfold to an expanded cross section.
15. Method according to claim 14, wherein the step of transversally compacting the sleeve wall (8) comprises creating at least one longitudinal fold (10) in the sleeve wall (8) along a substantial part of the length of the sleeve (2) and temporarily securing the longitudinal fold (10) by one of a suture, a glue and an adhesive tape.
16. Method according to claim 14, comprising securing each longitudinal fold (10) separately.
17. Method according to claim 14, comprising connecting the longitudinal folds (10) to each other by one of a suture, a glue and an adhesive tape.
18. Method according to claim 14, wherein the step of transversally compacting the sleeve wall (8) comprises applying suction to the sleeve lumen (3).
19. Method according to claim 14, wherein the step of transversally compacting the sleeve wall (8) comprises inserting the sleeve (2) inside an auxiliary tube (14) having a smaller diameter than the transversally unfolded sleeve (2).
20. Method according to claim 15, wherein the step of releasing the wall (8) comprises one of:
- dissolving the suture (1 1 ),
- pulling the suture (1 1 ) out of the wall (8),
- releasing a tension of the suture (1 1 ), but leaving the suture in place,
- dissolving the glue,
- dissolving the adhesive tape (13)
- removing the adhesive tape (13) by pulling the tape away from the wall (8).
21. Method according to claim 19, wherein the step of releasing the wall (8) comprises dissolving the auxiliary tube (14).
22. Method according to claim 15, wherein the step of deploying the sleeve (2) longitudinally comprises forming an inflatable channel (12) by means of the longitudinal folds (10) and inflating the inflatable channel (12).
23. Method according to claim 22, comprise the step of transversally expanding the previously longitudinally unfolded sleeve (2) from the transversally folded shape to a
END6979 transversally unfolded shape by inflating sleeve lumen (2).
24. Endoluminal sleeve device (1 ) for internally lining a section of the Gl tract, comprising:
- a sleeve (2) configured for deployment inside a duodenum, the sleeve (2) having a wall (8) 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),
- a sleeve sealing portion (19) connected to the wall 8 and having a tubular expansion portion (20) permanently elastically biased in a radially expanded shape, and an annular sealing lip (21 ) formed at a proximal end of the expansion portion (20) and protruding radially outward from the expansion portion (20).
25. Endoluminal sleeve device (1 ) according to claim 24, wherein the sealing lip (21 ) is adapted to hold surrounding tissue locally radially away from the tubular expansion portion (20), thereby reducing a contact pressure between the tissue and the tubular expansion portion (20).
26. Endoluminal sleeve device (1 ) according to claim 24, wherein the sealing lip (21 ) is made of a soft and pliable elastomeric material and bendable with respect to the tubular expansion portion (20) both in a proximal and a distal direction to allow sliding of the sleeve sealing portion (19) within an intestine in a distal and proximal direction.
27. Endoluminal sleeve device (1 ) according to any one of claims 24 to 26, comprising an anchoring portion (22) connected with the sleeve (2) and adapted to anchor the sleeve (2) inside the Gl tract at a distance from the sealing portion (19).
28. Endoluminal sleeve device (1 ) according to any one of claims 24 to 27, wherein the sealing lip has a shape which widens radially during distal flexure and narrows radially during proximal flexure with respect to the tubular expansion portion (20), thereby allowing a distal sliding motion and slowing a proximal retrograde motion of the sealing portion (19) inside the intestine.
29. Endoluminal sleeve device (1 ) according to any one of claims 24 to 28, wherein sleeve sealing portion (19) comprises a connecting ring (30) arranged radially inside the tubular expansion portion (20) and connected to the tubular expansion portion (20) by at least two collapsible arms (31 ) adapted to allow a radial deformation of the tubular expansion portion (20) without deforming the connecting ring (30).
30. Endoluminal sleeve device (1 ) according to claim 29, wherein the collapsible arms (31 ) are inclined with respect to a longitudinal axis (32) of the sealing portion (19) such that a radial deformation of the expansion portion (20) brings about a flexure of the collapsible arms (31 ) which doesn't generate substantial compression in a local
END6979 longitudinal direction of the arms (31 ).
31. Endoluminal sleeve device (1 ) according to claim 30, in which flexure hinges (33) are formed at both ends of the arms (31 ).
32. Endoluminal sleeve device (1 ) for internally lining a section of the Gl tract, comprising: - a sleeve (2) configured for deployment inside a duodenum, the sleeve (2) having a wall
(8) 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),
- at least one leak opening (34) formed in the wall (8) remote from the proximal and distal ends (4, 6),
- a tissue anchoring portion (35) connected with the wall (8) near said leak opening (34).
33. Endoluminal sleeve device (1 ) according to claim 32, in which the tissue anchoring portion (35) comprises one of:
- a portion of the wall (8) emulating the internal shape of a section of Gl tract and adapted to connect to the Gl tract by shape coupling,
- a stent,
- a clamping portion,
- a suture,
- an adhesive surface portion.
34. Endoluminal sleeve device (1 ) according to claim 32 or 33, in which the tissue anchoring portion (35) is arranged within a distance of less than 5 cm from the leak opening (34).
35. Endoluminal sleeve device (1 ) according to any one of claims 32 to 34, in which the leak opening (34) comprises a selectively permeable shield (36) adapted to allow the passage of only one or more predetermined nutrients through the leak opening (34).
36. Endoluminal sleeve device (1 ) according to any one of claims 32 to 35, in which the leak opening (34) has an adjustable size.
37. Endoluminal sleeve device (1 ) for internally lining a section of the Gl tract, comprising:
- a sleeve (2) configured for deployment inside a duodenum, the sleeve (2) having a wall (8) 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),
- anti backflow means (39) provided at the wall (8) near the proximal lumen opening (5) and configured to partially obstruct a proximal backflow of contents from inside the sleeve lumen (3) towards the proximal lumen opening (5).
38. Endoluminal sleeve device (1 ) according to claim 38, wherein the anti backflow means
END6979 (39) comprise a one way flapper valve (40) which allows a passage of contents in a distal direction but prevents a proximal backflow of contents.
39. Endoluminal sleeve device (1 ) according to claim 37 or 38, wherein the anti backflow means (39) comprise the a stepped internal surface (41 ) of the sleeve wall (8), said stepped surface (41 ) having a plurality of circumferentially extending distally facing risers (42) adapted to slow down and lessen an undesired proximal reflux inside the sleeve (2).
END6979
PCT/EP2011/072637 2011-12-13 2011-12-13 Endoluminal sleeve device and methods for deploying an endoluminal sleeve in the gi tract WO2013087096A1 (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015198936A (en) * 2014-04-05 2015-11-12 レックス メディカル リミテッド パートナーシップ Duodenum sleeve for treating obesity
EP2604223B1 (en) * 2011-12-15 2016-06-29 Cook Medical Technologies LLC Anti-leakage prosthesis
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
EP3054860A4 (en) * 2013-10-10 2017-08-23 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
US10779979B2 (en) 2013-10-10 2020-09-22 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US11406522B2 (en) 2016-11-09 2022-08-09 Boston Scientific Scimed, Inc. Deployable sleeves and related methods

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030040804A1 (en) * 2001-08-27 2003-02-27 Stack Richard S. Satiation devices and methods
WO2004080336A2 (en) * 2003-03-12 2004-09-23 Synecor, Llc Method and apparatus for modifying the exit orifice of a satiation pouch
US20050085923A1 (en) * 2002-12-02 2005-04-21 Gi Dynamics, Inc. Anti-obesity devices
US7267694B2 (en) 2002-12-02 2007-09-11 Gi Dynamics, Inc. Bariatric sleeve
WO2008030403A1 (en) * 2006-09-02 2008-03-13 Synecor, Llc Intestinal sleeves and associated deployment systems and methods
US20100256775A1 (en) * 2009-04-03 2010-10-07 Metamodix, Inc. Modular gastrointestinal prostheses
WO2010128495A1 (en) * 2009-05-07 2010-11-11 Rainbow Medical Ltd. Gastroretentive duodenal pill
US20110004228A1 (en) * 2009-07-01 2011-01-06 E2 Llc Systems and Methods for Treating Obesity and Type 2 Diabetes
WO2011073970A1 (en) * 2009-12-18 2011-06-23 Vysera Biomedical Limited A gastrointestinal implant device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030040804A1 (en) * 2001-08-27 2003-02-27 Stack Richard S. Satiation devices and methods
US20050085923A1 (en) * 2002-12-02 2005-04-21 Gi Dynamics, Inc. Anti-obesity devices
US7267694B2 (en) 2002-12-02 2007-09-11 Gi Dynamics, Inc. Bariatric sleeve
WO2004080336A2 (en) * 2003-03-12 2004-09-23 Synecor, Llc Method and apparatus for modifying the exit orifice of a satiation pouch
WO2008030403A1 (en) * 2006-09-02 2008-03-13 Synecor, Llc Intestinal sleeves and associated deployment systems and methods
US20100256775A1 (en) * 2009-04-03 2010-10-07 Metamodix, Inc. Modular gastrointestinal prostheses
WO2010128495A1 (en) * 2009-05-07 2010-11-11 Rainbow Medical Ltd. Gastroretentive duodenal pill
US20110004228A1 (en) * 2009-07-01 2011-01-06 E2 Llc Systems and Methods for Treating Obesity and Type 2 Diabetes
WO2011073970A1 (en) * 2009-12-18 2011-06-23 Vysera Biomedical Limited A gastrointestinal implant device

Cited By (12)

* 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
EP2604223B1 (en) * 2011-12-15 2016-06-29 Cook Medical Technologies LLC Anti-leakage prosthesis
US10092388B2 (en) 2011-12-15 2018-10-09 Cook Medical Technologies Llc Anti-leakage prosthesis
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
EP3054860A4 (en) * 2013-10-10 2017-08-23 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US10433998B2 (en) 2013-10-10 2019-10-08 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US10779979B2 (en) 2013-10-10 2020-09-22 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US11559300B2 (en) 2013-10-10 2023-01-24 Nitinotes Ltd. Endoluminal sleeve gastroplasty
US11690745B2 (en) 2013-10-10 2023-07-04 Nitinotes Ltd. Endoluminal sleeve gastroplasty
JP2015198936A (en) * 2014-04-05 2015-11-12 レックス メディカル リミテッド パートナーシップ Duodenum sleeve for treating obesity
US11406522B2 (en) 2016-11-09 2022-08-09 Boston Scientific Scimed, Inc. Deployable sleeves and related methods

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