WO2013026473A1

WO2013026473A1 - Devices and methods for anchoring an endoluminal sleeve in the gi tract

Info

Publication number: WO2013026473A1
Application number: PCT/EP2011/064460
Authority: WO
Inventors: James W. Voegele; Mark Steven Ortiz; Mark S. Zeiner; Jason Harris; Michele D'arcangelo; Federico Bilotti
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-08-23
Filing date: 2011-08-23
Publication date: 2013-02-28

Abstract

An endoluminal sleeve device (1) for internally lining a section of the GI tract comprises a sleeve (2) configured for deployment inside a duodenum, the sleeve (2) having walls of a flexible material defining a sleeve lumen (3), a proximal end (4) defining a proximal lumen opening (5), and a distal end (6) defining a distal lumen opening (7), the proximal sleeve end (4) forming an anchoring component (8) extending along a circumference of the sleeve, the anchoring component (8) having a collapsed slender transport configuration and a bulky annular deployed configuration having a size that cannot fit through a human pylorus, and a plurality of auxiliary fixation tabs (9) extending from the anchoring component (8).

Description

DESCRIPTION

"DEVICES AND METHODS FOR ANCHORING AN ENDOLUMINAL SLEEVE IN

THE Gl TRACT"

FIELD OF THE INVENTION

The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.

BACKGROUND OF THE INVENTION

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.

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.

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 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 provides an alternative or an additional therapy to traditional therapies of type II diabetes and obesity. Endosleeves may be placed in a brief and less invasive procedure and address the patient's fear of surgery. Contrary to traditional gastric bypass surgery, the result of endoluminal sleeve surgery is reversible and the sleeve can be removed after achievement of the clinical result, but also in case of the occurrence of undesired side effects or clinical complications.

A typical duodenal sleeve device is described in U.S. Pat. No. 7,267,694 where the proximal end of a flexible, floppy sleeve of impermeable material defining a sleeve lumen is endoscopically deployed and anchored with the help of a barbed stent in the pylorus or in the superior section of the duodenum, the stent also ensuring that the proximal lumen opening of the sleeve remains open. Chyme from the stomach enters the proximal lumen opening of the sleeve and passes through the sleeve lumen to the distal lumen opening. Digestive enzymes secreted in the duodenum pass through the duodenum on the outside of the sleeve. The enzymes and the chyme do not mix until the chyme exits from the distal lumen opening of the liner tube. In such a way, the efficiency of the process of digestion of the chyme is diminished, reducing the ability of the gastrointestinal tract to absorb calories from the food.

G.I. Dynamics, Inc., (Watertown, Mass., USA) produces the Endobarrier(R) device that is substantially a duodenal sleeve device configured so that the proximal end of the device is anchored inside the duodenal bulb with the help of a barbed anchoring stent that also keeps the proximal lumen opening open.

In US 2004/0148034 is taught a duodenal sleeve device attached to a funnel, the funnel configured for anchored to the gastric walls inside the gastric cavity in proximity to the lower esophageal sphincter. Food passing the lower esophageal sphincter is directed by the funnel into the proximal lumen opening of the duodenal sleeve device.

In U.S. Pat. No. 7, 121 ,283 is taught a duodenal sleeve device attached to a large stent-like anchoring device that presses outwardly against the pyloric portion of the stomach, the pyloric sphincter and the duodenal bulb.

In known endosleeves, it has been observed that the sleeve devices tend to move inside the Gl tract and migrate away from their original anchoring position.

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. Moreover, known endoluminal sleeve attachment devices and methods are not yet fully satisfying with regard to permitting normal biological events, including vomiting, to occur.

Further fields of desirable improvements related with endoluminal sleeves are their removal from the patient without injuring the involved tissues, the rapidity of deployment and removal of the sleeve, and the repeatability of the sleeve placement.

Accordingly, there is a need for improved devices and procedures for anchoring and sealing an endoluminal, particularly a duodenal sleeve in the Gl tract.

SUMMARY OF THE INVENTION

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.

According to an aspect of the invention, there is provided a duodenal sleeve device, comprising:

- a sleeve configured for deployment inside a duodenum of a human subject, the sleeve having walls of a flexible material defining a sleeve lumen, a proximal end defining a proximal lumen opening, and a distal end defining a distal lumen opening, in which the proximal sleeve end forms an anchoring component extending along a circumference of the sleeve, said anchoring component having a collapsed slender transport configuration and a bulky annular deployed configuration (having a size that cannot fit through a human pylorus) and a plurality of auxiliary fixation tabs extending from the anchoring component.

The sleeve device can be endoluminally inserted in a stomach with the anchoring component being in the slender transport configuration and, once arrived inside the stomach, the anchoring component can be deformed to the bulky deployed configuration which prevents the proximal sleeve end from passing distally through the pylorus. Additionally, the auxiliary fixation tabs can be fastened to plications of the gastric wall in a plurality of auxiliary fixation points around the circumference of the proximal sleeve end. In this way, the annular bulky shape of the deployed anchoring component locks the sleeve device within the stomach and transmits distal peristaltic pulling forces as uniformly distributed load along to the gastric wall, while the auxiliary fixation tabs prevent the proximal sleeve end from undesired tilting and rotation. Moreover, during digestive local movements of the gastric wall section against which the anchoring component abuts, the auxiliary fixating tabs accomplish temporarily the anchoring function against distal peristalsis pull and contribute to keep the proximal sleeve end in contact with the gastric wall, thereby improving sealing.

In accordance with an aspect of the invention, the anchoring component comprises a coil which can change shape from an extended free-ended string shape adapted for transoral or transnasal transportation thereof into the stomach, to a coiled annular configuration adapted to shape connect with the stomach such as to provide an anchor for the proximal sleeve end.

In accordance with a further aspect of the invention, the anchoring component comprises a ring which can change shape from a flattened ovalised shape adapted for transoral or transnasal transportation thereof into the stomach, to a circular configuration adapted to shape connect with the stomach such as to provide an anchor for the proximal sleeve end.

In accordance with a further aspect of the invention, the individual tabs may be loop shaped with an internal opening bridged by a fixation web which is adapted to be received in a plication pocket formed between two interconnected gastric wall plications. In accordance with a yet further aspect of the invention, the tabs are rigid and have a preset elongate curved shape which contributes to better adapt to the gastric anatomy and to shape locking of the sleeve device 1 within the stomach.

In accordance with a yet further aspect of the invention, the tabs can be plastically irreversibly deformed but their resistance against plastic deformation is greater than the physiological forces involved in gastric movements.

In accordance with a further aspect of the invention, a method is provided for endoluminally lining a portion of the Gl tract, the method comprising endoluminally inserting the sleeve device while the anchoring portion is in its slender transport shape, then deforming the anchoring portion inside the stomach to its deployed bulky shape having a size that cannot fit through a human pylorus, then fastening the auxiliary fastening tabs to plications in the gastric wall.

In accordance with a further aspect of the invention, the method comprises forming a plication such that an open pocket is formed in the gastrointestinal wall, and connecting the auxiliary fixating tab with the plication by extending a section of the tab through the plication pocket.

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

- Figure 1 illustrates a duodenal sleeve device in accordance with an embodiment of the invention;

- Figure 2 shows the duodenal sleeve device anchored within the stomach and extended inside the duodenum of a patient;

- Figure 3 illustrates a detail of a sleeve device anchored inside the stomach in accordance with an embodiment;

- Figure 4 illustrates a sleeve device anchored inside the stomach and extended within the duodenum in accordance with a further embodiment;

- Figure 5 illustrates a detail of a sleeve device anchored inside the stomach in accordance with a further embodiment;

- Figures 6 and 7 illustrate a sleeve device in accordance with an embodiment in a collapsed transport shape and in an expanded bulky deployed shape; - Figure 8 illustrates the sleeve device of figure 6 anchored inside the stomach and extended within the duodenum;

- Figure 9 is a cross-sectional view of a gastric plication attachment method and devices for anchoring the sleeve device within the stomach in accordance with an embodiment;

- Figures 10 and 11 illustrate a gastric plication attachment method and devices for anchoring the sleeve device within the stomach in accordance with a further embodiment;

- Figures 12 to 14 illustrate a flange shaped proximal mounting portion of an endoluminal sleeve in accordance with a further embodiment of the invention;

- Figure 15 is a side view of a flange shaped proximal mounting portion of an endoluminal sleeve in accordance with a further embodiment;

- Figure 16 is a side view of a flange shaped proximal mounting portion of an endoluminal sleeve in accordance with a yet further embodiment;

- Figure 17 is a side view of a flange shaped proximal mounting portion of an endoluminal sleeve in accordance with a yet further embodiment;

- Figure 18 is a perspective view of a flange shaped proximal mounting portion of an endoluminal sleeve in accordance with a yet further embodiment;

- Figures 19 and 20 illustrate cross-sections of flange shaped mounting portions of an endoluminal sleeve in accordance with embodiments;

- Figure 21 illustrates a reinforcing ring of a flange shaped mounting portion for an endoluminal sleeve in accordance with an embodiment;

- Figure 22 is a cross-section of a connecting region of the reinforcing ring in figure 21 ;

- Figure 23 illustrates the endoluminal sleeve of figures 12 to 14 with the flange shaped mounting portion placed in an antrum of a stomach.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 1 TO 11 Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, an endoluminal sleeve device 1 for internally lining a section of the Gl tract, particularly a section of duodenum distally from the pylorus, comprises a sleeve 2 configured for deployment inside a duodenum of a human subject, the sleeve 2 having walls of a flexible material defining a sleeve lumen 3, a proximal end 4 defining a proximal lumen opening 5, and a distal end 6 defining a distal lumen opening 7. The proximal sleeve end 4 forms an anchoring component extending along a circumference of the sleeve, said anchoring component having a collapsed slender transport configuration and a bulky annular deployed configuration having a size that cannot fit through a human pylorus, and a plurality of auxiliary fixation tabs 9 extending from the anchoring component 8.

The sleeve device 1 can be endoluminally inserted in a stomach 10 with the anchoring component 8 being in the slender transport configuration and, once arrived inside the stomach 10, the anchoring component 8 can be deformed to the bulky deployed configuration which prevents the proximal sleeve end 4 from passing distally through the pylorus 16. Additionally, the auxiliary fixation tabs 9 can be fastened to plications 11 of the gastric wall 12 in a plurality of auxiliary fixation points around the circumference of the proximal sleeve end 4. In this way, the annular bulky shape of the deployed anchoring component 8 locks the sleeve device 1 within the stomach 10 and transmits distal peristaltic pulling forces as uniformly distributed load along to the gastric wall 12, while the auxiliary fixation tabs 9 prevent the proximal sleeve end 4 from undesired tilting and rotation. Moreover, during digestive local movements of the gastric wall section against which the anchoring component 8 abuts, the auxiliary fixating tabs 9 accomplish temporarily the anchoring function against distal peristalsis pull and contribute to keep the proximal sleeve end 4 in contact with the gastric wall 12, thereby improving sealing.

In accordance with an embodiment, the anchoring component 8 comprises a coil which can change shape from an extended free-ended string shape adapted for transoral or transnasal transportation thereof into the stomach 10, to a coiled annular configuration adapted to shape connect with the stomach 10 such as to provide an anchor for the proximal sleeve end 4.

In accordance with embodiments, the coil can comprise a sequence of rigid segments which are linked to one another by elastic or shape memory or phase changeable material links. Additionally or alternatively, the coil can be snap rigidizable i n its coi led deployed shape, e. g . by means of m utually snap connectable initially free ends and/or by a pull string 13 activatable rigidizing mechanism.

The free-ended string shape of the coil in the transport configuration provides an extremely slender structure which can be easily and mini-invasively moved through the mouth down the esophagus into the stomach or pushed through an endoluminally or laparoscopically inserted insertion tube. The coil can be slidably received inside a circumferentially extending tubular pocket 14 formed at the proximal sleeve end 4 in order to facilitate deformation of the coil from the slender configuration to the bulky coiled configuration and a slidable uniform distribution of the sleeve wall along the circumference of the deployed coil.

In accordance with a further embodiment, the anchoring component 8 comprises a ring which can change shape from a flattened ovalised shape adapted for transoral or transnasal transportation thereof into the stomach 10, to a circular configuration adapted to shape connect with the stomach 10 such as to provide an anchor for the proximal sleeve end 4.

In accordance with embodiments, the ring can be made from elastic material, from thermally activatable shape memory material, phase change material or it may comprise a sequence of rigid segments which are linked to one another by elastic or shape memory or phase changeable material links. Additionally or alternatively, the ring can be rigidizable in its circular deployed shape, e.g. by means of a cinching string 13 mechanism or by one or more locking segments formed from heat shrinking material, e.g. a heat shrinking membrane covering parts or the total of the anchoring component 8.

As described in connection with the coiled anchoring component, also the ring anchoring component 8 can be slidably received inside a circumferentially extending tubular pocket 14 formed at the proximal sleeve end 4 in order to facilitate deformation of the ring from the slender configuration to the bulky circular configuration and a slidable uniform distribution of the sleeve wall along the circumference of the deployed ring. The endoluminal or laparoscopic insertion of the sleeve device with a ring shaped anchoring component can be performed by the method described above in connection with the coil shaped anchoring component.

In accordance with an embodiment, the auxiliary fixating tabs 9 are positioned at a constant angular pitch along the circumference of the proximal sleeve end 4. In order to increase the stretch resistance of the auxiliary fixating tabs 9, the latter can be grafted from a fiber reinforced material.

In accordance with a further embodiment, the individual tabs 9 may be loop shaped (Figures 10, 1 1) with an internal opening bridged by a fixation web 15 which is adapted to be received in a plication pocket 17 formed between two interconnected gastric wall plications 11.

In accordance with a yet further embodiment, the tabs 9 are rigid and have a preset elongate curved shape which contributes to better adapt to the gastric anatomy and to shape locking of the sleeve device 1 within the stomach 10.

In accordance with a yet further embodiment, the tabs 9 can be plastically irreversibly deformed but their resistance against plastic deformation is greater than the physiological forces involved in gastric movements.

For the purpose of cooperating with the anchoring component 8 to shape lock the sleeve device 1 within the stomach 10, the rigid or plastically deformable tabs 9 may be rigidly connected with the anchoring component 8 or their connection with the anchoring component 8 can be rigidized by a (e.g. pull-string activatable) locking mechanism.

In accordance with a further embodiment (Figures 1 , 4), the auxiliary fixation tabs 9 comprise a plurality of tabs 9 having different lengths or being length adjustable by means of a length adjusting device 18 which adjustably connects a proximal tab portion 19 intended to be connected to the gastric wall 12 and a distal tab portion 20 connected to the anchoring component 8.

In accordance with an exemplary embodiment (Figure 7) a flapper valve is provided in the wall of sleeve 2 which is adapted to open when a retro flow pressure exceeds a preset value, thereby permitting a retro-flow of gastrointestinal contents.

In accordance with a further embodiment, a method is provided for endoluminally lining a portion of the Gl tract, the method comprising endoluminally inserting the sleeve device 1 while the anchoring portion 8 is in its slender transport shape, then deforming the anchoring portion 8 inside the stomach 10 to its deployed bulky shape having a size that cannot fit through a human pylorus, then fastening the auxiliary fastening tabs 9 to plications 1 1 in the gastric wall 12.

In accordance with embodiments, the plications 1 1 may be created endoluminally by accessing the stomach 10 through the mouth or nose and the esophagus. Possible methods and devices for the creation of the gastric wall plications 1 1 are described in US6,773,441 whose content is incorporated herein in its entirety. In accordance with a further embodiment, the plications 1 1 are created and affixed by applying a plication fastener 22 to a gastric wall fold and the auxiliary tabs 9 are attached to the thus created plication 11 by means of the same plication fastener 22.

In an embodiment (Figures 8, 9), the step of affixing the plication 11 and the step of attaching the auxiliary tabs 9 to the plication 11 are performed contemporaneously by driving the plication fastener 22 through both the tab 9 and the gastric wall fold. Advantageously, the plication fasteners 22 are extended through or into the muscularis layer of the gastric wall fold to prevent ripping out and increase durability of the attachment.

Plication fasteners 22 may comprise e.g. staples (applied by endoluminal circular, semi-circular or toro-type staplers), expandable baskets, T-tags or H-fasteners and include surgical pledgets and may be constructed from any biocompatible material, such as, but not limited to, stainless steel, cobalt chromium, titanium, alloys of such metals, biocompatible polymers, soluble polymers, non-soluble polymers, swellable polymers, absorbable polymers, suture material, bioresorbable suture, bioabsorbable suture, combinations thereof, or the like.

In accordance with a further embodiment (Figures 10, 1 1) the method comprises forming a plication 11 such that an open pocket 17 is formed in the gastrointestinal wall, and connecting the auxiliary fixating tab 9 with the plication 1 1 by extending a section of the tab 9 through the plication pocket 17.

US2009/0018389 whose content is incorporated herein in its entirety, describes methods and devices for creating the above said open plication pockets 17. In some embodiments, an endoscopic treatment device is introduced into the stomach 10 of a patient without creating an incision in the patient. Then the gastric wall 12 is manipulated with an end effecter of the endoscopic device and a first plication 1 1 and an adjacent second plication 11 ' are formed in the gastric wall 12. Then, the first plication 1 1 is coupled with the second plication 11 ' to thereby form a double plication wherein the open pocket 17 is formed between the first plication 1 1 and the second plication 11 ' (Figures 10 and 11).

In accordance with a further embodiment, multiple plications 1 1 or a continuous annular plication ridge is formed along a circumference in the stomach 10 and the tabs 9 are attached to the plications 1 1 or to the continuous ridge in a plurality of point distributed around the circumference of the proximal sleeve end 4.

In accordance with a yet further embodiment, the sleeve device may be positioned and anchored such that the proximal sleeve end 4 is positioned at the cardia near the EG junction for allowing normal physiological events such as wretching and vomiting to occur.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 12 TO 23 Referring to Figures 12 to 23, an endoluminal sleeve device 1 for internally lining a section of the Gl tract, particularly a section of duodenum distally from the pylorus 16, comprises a sleeve 2 configured for deployment inside a duodenum of a human subject, the sleeve 2 having a wall of a flexible material defining a sleeve lumen 3, a proximal end 4 defining a proximal lumen opening 5, and a distal end 6 defining a distal lumen opening 7. The proximal sleeve end 4 forms a mounting portion 23 having a tubular bushing 24 with a proximal flange 26 of annular disk shape formed at a proximal end of the bushing 24 and intended to rest against the antrum 27 of the stomach 10, while the bushing 24 seats inside the pylorus 16 (Figure 23).

In accordance with an embodiment, the proximal flange 26 lays in a plane perpendicular to a longitudinal axis 25 of the bushing 24 and may have an external diameter of 40mm to 70mm, preferably of 55mm to 65mm and an internal diameter of 10mm to 30mm, preferably of 25mm to 30mm, as well as a plate thickness of between 2mm and 4mm, preferably of about 2,5mm.

The proximal flange 26 may be made of silicone and may comprise, at its outer circumference, a substantially rigid reinforcement ring 31 , e.g. a non deformable rigid metal ring.

The bushing 24 diameter may be equal to the proximal flange 26 internal diameter and the length of the bushing may be from 10mm to 20mm, preferably about 15mm. The bushing 24 may be rigid or semi-rigid and may be made of silicone. The bushing 24 may have a substantially circular cylindrical shape (Figures 14, 16, 17 and 18) or an hourglass shape with a proximally widened tubular proximal bushing section 28, a distally widened tubular distal bushing section 29, and a narrowed intermediate bushing section 30 (Figure 15).

Even though the proximal flange 26 prevents the mounting portion 23 from passing through the pylorus 16 and the sleeve from migrating distally, there remains a risk that the sleeve 2 migrates proximally into the stomach 10. Such a proximal migration of sleeve 2 can be prevented by providing a ballast weight (not shown) at a distal sleeve end 6, so that gravitational forces and intestinal peristalsis hold the sleeve distally extended within the duodenum. Alternatively, an additional distal flange 32 may be formed at a distal end section 33 of the bushing 24 distally to the proximal flange 26, wherein the distal flange 32 is intended to be seated from the duodenal (distal) side against the distal pyloric sphincter 16 (Figures 15 to 18). In accordance with an embodiment, the distal flange 32 lays in a plane perpendicular to the longitudinal axis 25 of the bushing 24 and may have an external diameter smaller than the external diameter of the proximal flange 26, as well as a plate thickness of between 2mm and 4mm, preferably of about 2,5mm. The distal flange 32 may be made of silicone and may (but need not necessarily) comprise, at its outer circumference, a reinforcement ring (not shown), e.g. an elastically deformable metal ring.

In accordance with embodiments, the distal flange 32 may have an adjustable outer diameter and may be substantially rigid or, alternatively, collapsible to facilitate insertion thereof through the pyloric sphincter.

In accordance with a further embodiment (Figure 18), the distal flange 32 may form one or more drain holes 34 adapted to drain the ring space (from bileopancreatic secretions) defined between the bushing 24 and the proximal and distal flanges 26, 32.

In accordance with a yet further embodiment (Figure 17), the tubular bushing 24 forms a rigid proximal end section 35 carrying the proximal flange 26, a rigid distal end section 33 carrying the distal flange 32 and a flexible intermediate section 35. In this embodiment, the rigid proximal and distal sections of the tubular bushing 24 prevent the proximal and distal flanges from tilting and the flexible intermediate section can follow the narrowing and widening movements of the pyloric sphincter. The sleeve 2 and its mounting portion 23 may comprise a radio-opaque wire 35 (e.g. silver or steel wire) extending along the entire length of the sleeve 2 and adapted to be visualized by radiography or fluoro-imaging or, alternatively, ultrasound responsive material incorporated in the sleeve wall and in the mounting portion and adapted to be visualized by ultrasound.

Figures 19 to 21 illustrate exemplary embodiments of the flange reinforcement ring 31. The reinforcement ring 31 may comprise a Nitinol wire 37 which allows a severe deformation of the proximal flange 26 during endoluminal insertion in the Gl tract and which returns to the expanded shape after release in the target anchoring location in the antrum 27. The Nitinol wire 37 may be arranged in a single loop (Figure 19) or in an overlapping loop (Figure 20) and free ends of the wire can be connected to each other to stiffen the reinforcement ring 31 and to avoid the formation of kinking points.

For this purpose a triple lumen peripheral tube 36 (Figures 21 , 22) may be arranged at an outer circumference of the proximal flange 26 and/or distal flange 32, the tube 36 defining three circumferentially extended lumens 38 one of which receives a complete 360° loop of the Nitinol wire 37 and the other two lumens 38 receive the overlapping two free end sections of the wire 37. Opposite free ends of the triple lumen tube 36 may be inserted and held together by an overtube section 39.

The sleeve 2 itself is sufficiently flexible to follow the curvature of the duodenum. Further, in some embodiments the walls of the sleeve are sufficiently flexible and/or collapsible to allow duodenal peristalsis to drive chyme through the lumen of the sleeve. Sufficient collapsibility of the walls of the sleeve prevents continuous intimate contact of the outer surface of the sleeve with the duodenal mucosa, avoiding damage to the duodenal mucosa and allowing digestive secretions not collected into the sleeve lumen to pass through the duodenal lumen outside the sleeve lumen.

In some embodiments, at least a portion of the wall of a sleeve may be porous or semipermeable to allow entry of digestive secretions into the sleeve lumen and/or to allow the flow of fluids and digested matter out of the sleeve lumen.

In some embodiments, at least a portion of the wall of a sleeve may be impermeable, analogous to the Endobarrier(R) by Gl Dynamics Inc, Watertown, Mass., USA and as described in U.S. Pat. No. 7,267,694 which is included by reference as if fully set forth herein.

The diameter of the sleeve lumen may be substantially constant along the entire length of the liner tube. 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.

In some embodiments, 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. 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.

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.

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.

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. 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.

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.

Particularly, the described devices and procedures obviate undesired migration of the sleeve away from its original anchoring position and address the need of reliable sealing of the lined lumen. Moreover, some embodiments of the described devices and methods are beneficial with regard to permitting normal biological events, including vomiting, to occur.

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.

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 walls of a flexible material defining a sleeve lumen (3), a proximal end (4) defining a proximal lumen opening (5), and a distal end (6) defining a distal lumen opening

(7) , the proximal sleeve end (4) forming an anchoring component (8) extending along a circumference of the sleeve, said anchoring component (8) having a collapsed slender transport configuration and a bulky annular deployed configuration having a size that cannot fit through a human pylorus,

- a plurality of auxiliary fixation tabs (9) extending from the anchoring component

(8) .

2. Endoluminal sleeve device (1) according to claim 1 , in which the auxiliary fixating tabs (9) are positioned at a constant angular pitch along the circumference of the proximal sleeve end (4).

3. Endoluminal sleeve device (1) according to claim 1 or 2, in which the tabs (9) are loop shaped with an internal opening bridged by a fixation web (15).

4. Endoluminal sleeve device (1) according to claim 1 , in which the tabs (9) are rigid and have a preset elongate curved shape.

5. Endoluminal sleeve device (1) according to claim 1 , in which the tabs (9) are plastically deformable but their resistance against plastic deformation is greater than the physiological forces involved in gastric movements.

6. Endoluminal sleeve device (1) according to claim 4 or 5, in which the tabs (9) are rigidly connected with the anchoring component (8).

7. Endoluminal sleeve device (1) according to claim 1 , in which the auxiliary fixation tabs (9) are length adjustable by means of a length adjusting device (18) which adjustably connects a proximal tab portion (19) intended to be connected to the gastric wall (12) and a distal tab portion (20) connected to the anchoring component (8).

8. Endoluminal sleeve device (1) according to any preceding claim, in which the anchoring component (8) comprises a ring that can be rigidized in its circular deployed shape.

9. Endoluminal sleeve device (1) according to any preceding claim, in which the anchoring component (8) is slidably received inside a circumferentially extending tubular pocket (14) formed at the proximal sleeve end (4).

10. Endoluminal sleeve device (1) according to any preceding claim, in which a flapper valve is provided in the sleeve (2).

11. Method for endolumi nal ly lini ng a portion of the G l tract, the method comprising:

- endoluminally creating plications (1 1) in a gastric wall by accessing a stomach

(10) through the esophagus,

- endoluminally inserting a sleeve device (1) in the stomach (10) while holding an annular proximal sleeve end (4, 8) in a slender transport shape,

- deforming the proximal sleeve end (4, 8) inside the stomach (10) to a deployed bulky shape having a size that cannot fit through a human pylorus,

- extending auxiliary fixation tabs (9) from the proximal sleeve end (4, 8) and fastening the tabs (9) to the plications (1 1) in the gastric wall (12),

12. Method according to claim 11 , comprising:

- creating and affixing said plications (1 1) by applying a plication fastener (22) to a gastric wall fold;

- connecting the auxiliary tabs (9) to the plications (1 1) by means of said same plication fasteners (22).

13. Method according to claim 12, comprising:

- driving the plication fastener (22) in a single step through both the tab (9) and the gastric wall fold.

14. Method according to claim 11 , comprising:

- forming said plication (11 , 1 1 ') such that an open pocket (17) is formed in the gastric wall, and

- extending a section of the tab (9) through the open pocket (17).

15. Method according to claim 14, comprising:

- forming a first plication (1 1) and an adjacent second plication (11 ') in the gastric wall (12),

- forming the open pocket (17) between the first plication (1 1 ) and the second plication (1 1 ') by coupling the first plication (1 1) with the second plication (11 ').

16. Method according to claim 15, comprising:

- extending the section of the tab (9) as a closed loop between the first plication

(1 1) and the second plication (1 1 ') before coupling the first plication (1 1) with the second plication (1 1 ').

17. Method according to any one of claims 1 1 to 16, in which the proximal sleeve end (4) with a proximal sleeve lumen opening (5) is positioned in the stomach (10) at the cardia near the EG junction.

18. 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 walls of a flexible material defining a sleeve lumen (3), a proximal end (4) defining a proximal lumen opening (5), and a distal end (6) defining a distal lumen opening (7), the proximal sleeve end (4) forming a mounting portion (23) having a tubular bushing (24) with a proximal flange (26) of annular disk shape, the tubular bushing being intended to extend inside a pylorus (16) when the proximal flange (26) rests against the antrum (27) of a stomach (10).

19. Endoluminal sleeve device (1) according to claim 18, in which the proximal flange (26) extends in a plane perpendicular to a longitudinal axis (25) of the bushing (24).

20. Endoluminal sleeve device (1) according to claim 18 or 19, wherein the proximal flange (26) comprises at an outer circumference a substantially rigid reinforcement ring (31).

21. Endoluminal sleeve device (1) according to claim 18, wherein an additional distal flange (32) is formed at a distal end section (33) of the bushing (24) distally to the proximal flange (26).

22. Endoluminal sleeve device (1) according to claim 21 , wherein the distal flange (32) has an adjustable outer diameter.

23. Endoluminal sleeve device (1) according to claim 21 , wherein the distal flange (32) forms a drain hole (34) adapted to drain a ring space defined between the bushing (24) and the proximal and distal flanges (26, 32).

24. Endoluminal sleeve device (1) according to claim 21 , wherein the tubular bushing (24) forms a rigid proximal end section (35) carrying the proximal flange (26), a rigid distal end section (33) carrying the distal flange (32) and a flexible intermediate section (35).

25. Endoluminal sleeve device (1) according to claim 20, wherein the bushing (24) is rigid.