WO2013185830A1

WO2013185830A1 - Devices and methods for anchoring an endoluminal sleeve in the gi tract

Info

Publication number: WO2013185830A1
Application number: PCT/EP2012/061376
Authority: WO
Inventors: Matthias Tschoep; Thomas Edward Albrecht; Jason Harris; Taylor Aronhalt; Mark Steven ZEINER; Michael A. Murray; Michele D'arcangelo; Mark Steven Ortiz
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2012-06-14
Filing date: 2012-06-14
Publication date: 2013-12-19

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), a gastric band (8) adapted to be locked in a closed annulus shape around a stomach (10) and to restrict an internal lumen of the stomach (10), in which the proximal sleeve end (4) forms an anchoring component (12) extending along a circumference of the sleeve (2) and adapted to be connected with the gastric band (8) through a gastric wall (11) of the stomach (10).

Description

"DEVICES AND METHODS FOR ANCHORING AN ENDOLUMINAL SLEEVE IN THE Gl

TRACT"

DESCRIPTION

FIELD OF THE INVENTION

[0001 ] 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

[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. The gastric band procedure would be available to moderately obese patients, but has a generally reduced efficacy against weight loss.

[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 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.

[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] 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.

[0007] US 2004/0148034 discloses 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.

[0008] U.S. Pat. No. 7,121 ,283 discloses 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.

[0009] 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.

[0010] The objective of the present invention is therefore to provide devices and methods which address the shortcomings of the discussed prior art. A particular object of the invention is to provide improved devices and procedures for anchoring an endoluminal, particularly a duodenal sleeve in the Gl tract.

SUMMARY OF THE INVENTION

[001 1 ] The present invention provides for an endoluminal, particularly duodenal, sleeve device and method for the transoral, or endoscopic, positioning 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, and for anchoring the sleeve device by means of a mixed approach involving both endoscopy and laparoscopy.

[0012] 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,

- a gastric band adapted to be locked in a closed annulus shape around a stomach of the human subject and to restrict an internal lumen of the stomach,

in which the proximal sleeve end forms an annular anchoring component extending along a circumference of the sleeve and adapted to be connected with said gastric band through a gastric wall of said stomach.

[0013] The combination of a duodenal sleeve with a gastric band that can be connected to the duodenal sleeve through a gastric wall of a patient addresses both the need of increasing weight loss efficacy of the gastric band and improving positioning of the duodenal sleeve within the Gl tract.

[0014] In accordance with an aspect of the invention, the anchoring component and the gastric band are connected by laparoscopically stitching a suture through the gastric band the anchoring component and a portion of gastric wall interposed between the anchoring component and the gastric band.

[0015] 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 anchored within a stomach and extended inside the duodenum of a patient in accordance with an embodiment of the invention;

- Figure 2 shows a detail of a duodenal sleeve device anchored within the stomach in accordance with a further embodiment;

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

- Figure 4 illustrates a further developed embodiment of the sleeve device in Figure 3;

- Figure 5 illustrates a sleeve device anchored inside the stomach and extended within the duodenum in accordance with a further embodiment;

- Figure 6 illustrates a detail of a sleeve device anchored inside the stomach in accordance with a yet further embodiment;

- Figure 7 illustrates a detail of a sleeve device anchored inside the stomach in accordance with a further embodiment;

- Figures 8 and 9 illustrate a further developed embodiment of the sleeve device in Figure 1 ;

- Figure 10 illustrates a detail of a sleeve device in accordance with a further embodiment; - Figure 1 1 illustrates a detail of a sleeve device anchored inside the stomach in accordance with a yet further embodiment;

- Figures 12 and 13 illustrate method steps of a procedure which combines a duodenal sleeve device with a Magenstrasse & Mill gastroplasty.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 1 TO 1 1

[0016] 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, comprises a sleeve 2 configured for deployment inside a duodenum 9 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.

[0017] The sleeve device 1 further comprises a gastric band 8 adapted to be locked in a closed annulus shape around a stomach 10 of the human subject and to restrict an internal lumen of the stomach 10.

[0018] The proximal sleeve end 4 forms an annular anchoring component 12 extending along a circumference of the sleeve 2 and adapted to be connected with the gastric band 8 through a gastric wall 1 1 of the stomach 10.

[0019] The combination of the duodenal sleeve 2 inside the stomach and the gastric band 8 outside the stomach and that can be connected to one another through the gastric wall increases the weight loss efficacy with respect to a gastric band procedure alone and significantly improves the positioning and anchoring of the duodenal sleeve within the Gl tract.

[0020] In accordance with an embodiment (Figure 1 ), the anchoring component 12 and the gastric band 8 can be connected by a connecting structure which is extended through the gastric band 8, the anchoring component 12 and a portion of gastric wall 1 1 interposed between the anchoring component 12 and the gastric band 8. The connecting structure 13 may include a suture which is stitched through the anchoring component 12, gastric wall 1 1 and gastric band 8 either endoscopically from inside the stomach 10 or laparoscopically from the peritoneal space outside the stomach 10 or in a mixed endoscopic-laparoscopic approach from both sides of the gastric wall 1 1 .

[0021 ] Alternatively, the connecting structure 13 may include staples, rivets or T-tags which may be applied by the methods described in connection with the suture.

[0022] In order to ease the application of the connecting structure 13 and to assure a correct relative position between the gastric band 8 and the anchoring component 12, at least one or both of the gastric band 8 and the anchoring component 12 may define through holes 14 in predetermined positions and adapted to receive the connecting structure 12, e.g. a suture, staples or rivets. The predefined through holes 14 further allow the connecting structure 12 to extend through the gastric band 8 and through the anchoring component 12 without the risk of piercing inflatable portions thereof which will be described further below.

[0023] In accordance with an embodiment (Figure 2), a plurality of barbs 15 may protrude outward from the anchoring component 12 in order to pierce into or through the gastric wall 1 1 . The anchoring component 12 can be configured and positioned such that the barbs 15 may pierce through the gastric wall 1 1 into the gastric band 8, thereby coupling them together. Alternatively, the barbs 15 may be provided proximally to the gastric band 8 and extend radially beyond an internal diameter of the gastric band 8 such that the barbs 15 can be made to pierce into an esophageal tissue 19 (with the gastric band 8 applied around the cardia) or into the gastric wall 1 1 and at the same time loop lashed by the gastric band 8 against distal displacement.

[0024] With regard to all described embodiments, the gastric band 8 may have one or more inflatable portions 16 which can be inflated and deflated e.g. by injecting an inflation fluid (saline, C0₂) through an inflation duct 17. With the gastric band 8 locked in a ring shape by means of an appropriate closing device 18, the inflatable portion 16 allows adjustment of the internal diameter of the gastric band 8 and, hence, of the restriction of the internal lumen of the stomach 10 and of the shape relationship and latching capabilities between the gastric band 8 and the sleeve anchoring component 12. [0025] In accordance with an embodiment (Figure 3), the anchoring component 12 comprises a proximal anchoring ring 20 having a first external diameter and a distal anchoring ring 21 provided distally to the proximal anchoring ring 20 and having a second external diameter which may be equal to the first external diameter. The gastric band 8 is adapted to be arranged between the proximal and distal anchoring rings 20, 21 and has an internal diameter smaller than the first and second external diameters. In this manner the anchoring component 12 can be locked from both sides to a constriction created in the gastric wall or in the esophageal wall by the gastric band 8 and cannot migrate distally or proximally from the planned anchoring location.

[0026] In accordance with an embodiment, the proximal anchoring ring 20 and the distal anchoring ring 21 are connected by an inextensible, e.g. flexible tubular, spacer 22 having a constant length, such that the gastric band 8 can be trapped between the proximal and distal rings 20, 21 without however pulling the proximal and distal rings 20, 21 towards each other or clamping the gastric wall tissue against the gastric band 8.

[0027] In a further embodiment (Figure 4) the proximal anchoring ring 20 and the distal anchoring ring 21 are connected by an elastically extensible or length adjustable tightening member 23, e.g. an elastic tubular wall portion or a plurality of tethers, such that the gastric band 8 can be trapped and tightened or clamped between the proximal and distal rings 20, 21 . This assures an improved sealing of the lined lumen and secures the entire assembly in place and prevents the proximal and distal rings 20, 21 from turning over sideways. Tightening of the tightening member can be accomplished by means of a grasper which is e.g. fed through the working channel of an endoscope.

[0028] One concern with the anchoring assembly in figures 3 and 4 is that the proximal and distal anchoring rings 20, 21 should be tightly mated with the gastric band 8 through the gastric wall 1 1 to prevent relative axial movement. However, if the mating is too tight, the gastric tissue may become over compressed with the risk of ischemia or even necrosis. It is therefore desirable to maintain the closely positioned relationship of the anchoring rings and the gastric band without excessively compressing the gastric wall tissue.

[0029] In an embodiment (Figure 5) the anchoring component 12 forms only one single proximal anchoring ring 20 having an external diameter greater than an internal diameter of the gastric band, such that the proximal anchoring ring 20 can be placed inside the stomach proximally to the gastric band 8 placed externally around the stomach and the sleeve 2 can be extended from the proximal anchoring ring 20 distally through the gastric lumen constricted by the gastric band 8. In this manner the proximal end 4 of the sleeve 2 can be loop lashed by the gastric band 8 against distal displacement.

[0030] The proximal and/or distal anchoring rings 20, 21 can be semi-rigid or segmented and may have a collapsed slender transport configuration and a bulky annular deployed configuration.

[0031 ] In accordance with a yet further embodiment (Figure 6) which can be combined with the previously described examples, one of the gastric band 8 and the anchoring component 12 may comprise a magnetic substance 24 and the other one of the gastric band 8 and the anchoring component 12 may comprise a magnetically attractable substance in order to provide a magnetic connection thereof through the gastric wall 1 1 .

[0032] In an exemplary embodiment (Figure 7), the anchoring component 12 of the sleeve 2 forms a proximally widened funnel 25 having an external diameter greater than an internal diameter of the gastric band 8, such that the funnel 25 can be placed inside the stomach proximally to the gastric band 8 arranged externally around the stomach and the sleeve 2 can be extended from the funnel 25 distally through the gastric lumen constricted by the gastric band 8. In this manner the proximal end 4 of the sleeve 2 can be loop lashed by the gastric band 8 against distal displacement.

[0033] In a further development of the embodiment described in connection with Figure 1 , the gastric band 8 may form a plurality of fixating tabs 26 (Figures 8, 9) which protrude preferably from a radially internal wall of the gastric band 8 and which are adapted to receive the above described connecting structure 13, e.g. stitched suture, staples, rivets, t-tags, etc. The fixating tabs 26 may be made of a fiber reinforced sheet material.

[0034] In order to reinforce also the region of the sleeve anchoring component 12 intended to receive (or to be pierced through by) the connecting structure 13, the anchoring component 12 may include a (e.g. woven) fiber reinforced region 27 (Figures 10, 1 1 ). The suture or fastener can be driven from the peritoneal cavity through the fixating tab 26 of the gastric band 8, the gastric wall 1 1 and the fiber reinforced region 27 of the sleeve 2 and locked thereto by knotting, t-tag unfolding or staple deformation.

[0035] Figure 1 1 illustrates an exemplary non-limiting embodiment, which combines the features described in connection with figures 1 , 8, 9, 10 with inflatable proximal and distal anchoring rings 20, 21 . Additionally, also the gastric band 12 may be inflatable to adjust its internal diameter and to create a cushion which reduced adverse effects of the gastric wall compression.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 12 TO 13

[0036] Figure 12 illustrates a method in which a Magenstrasse & Mills procedure is performed and additionally, a gastric sleeve 2 is anchored within the stomach 10.

[0037] The Magenstrasse & Mills alteration of the stomach anatomy may be performed to create a gastric sleeve 30 configured as a long narrow tube fashioned from the lesser curvature 31 of the stomach which conveys food from the esophagus 19 to the antral mill 32, with the advantage that normal antral grinding of solid food and antro-pyloro-duodenal regulation of gastric emptying and secretion are preserved. By the same procedure a gastric pouch portion 28 and a region 29 which is distal to the gastric pouch portion 28 and constricted with respect to the latter is obtained. An anchoring component 12 having a greater external diameter than the passage diameter of the constricted region 29 can be advantageously placed within the gastric pouch portion 28 and connected to the sleeve, e.g. by tethers, so that the sleeve is prevented from migrating distally.

[0038] For the sake of completeness, the so called Magenstrasse ("street of the stomach") and Mill Operation (MM) for creating a gastric sleeve 30 and the above said gastric pouch portion 28 can be created by the following method. In accordance with an embodiment, a midline epigastric incision and mechanical upward retraction of the rib cage or, alternatively, a plurality of laparoscopic access ports or a single-site access device could be used to provide access to the upper stomach and esophagus. A gastric tube, preferably a naso-gastric tube is endoluminally inserted through the nose and the esophagus into the stomach and with its tip down into the duodenum to define the shape and dimension of the gastric sleeve 30. Alternatively, an endoscope or bougie may be used orally. A laparoscopic or open surgery circular stapler can be used to create a circular defect 32 in the gastric antrum 33, preferably close beyond the incisura angularis and about 5 to 6 cm from the pylorus 34.

[0039] Alternatively, a linear cutter designed to only staple and cut at the distal portion of the jaw assembly may be used to create a 'button-hole' defect in the gastric antrum.

[0040] A relatively wide passage (constricted region 29) must be left between the circular defect 32 and the greater curvature 35 to enable unobstructed flow of fluid from the excluded body (gastric pouch portion 28) of the stomach 10 into the antrum 33. It is therefore preferable to use a small circular stapler with a staple line diameter of about 1 cm - 1 ,5 cm for the creation of the circular defect 19.

[0041 ] After removal of the circular "doughnut" of gastric wall, a laparoscopic or open-surgery linear stapler can be used to create the "Magenstrasse"-type gastric sleeve 30 by dividing the stomach 10 completely from the circular defect 32 in the antrum 33 to the angle of HIS or at least proximate thereto. The free stapled edges of stomach 10 can be over-sutured with running absorbable sutures to reinforce the staple lines and ensure hemostasis. [0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] In some embodiments, the proximal end of the sleeve may be flared and may define a funnel-like structure.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051 ] 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.

[0052] 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.

[0053] 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),

- a gastric band (8) adapted to be locked in a closed annulus shape around a stomach (10) and to restrict an internal lumen of the stomach (10),

in which the proximal sleeve end (4) forms an anchoring component (12) extending along a circumference of the sleeve (2) and adapted to be connected with the gastric band (8) through a gastric wall (1 1 ) of the stomach (10).

2. Endoluminal sleeve device (1 ) according to claim 1 , comprising a connecting structure (13) adapted to be extended through the gastric band (8), through the anchoring component (12) and through a portion of gastric wall (1 1 ) interposed between the anchoring component (12) and the gastric band (8).

3. Endoluminal sleeve device (1 ) according to claim 2, wherein the connecting structure (13) is selected in the group consisting of a suture, staples, rivets and T-tags.

4. Endoluminal sleeve device (1 ) according to claim 2, in which at least one of the gastric band (8) and the anchoring component (12) defines a plurality of through holes (14) distributed along a circumference thereof and adapted to receive the connecting structure (12).

5. Endoluminal sleeve device (1 ) according to any one of the preceding claims, comprising a plurality of barbs (15) protruding outward from the anchoring component (12), said barbs (15) extending radially beyond an internal diameter of the gastric band (8) and being configured to pierce through the gastric wall (1 1 ) into the gastric band (8).

6. Endoluminal sleeve device (1 ) according to any one of the preceding claims, in which the gastric band (8) has one or more inflatable portions (16) which allow adjustment of an internal diameter of the gastric band (8).

7. Endoluminal sleeve device (1 ) according to any one of the preceding claims, in which the anchoring component (12) comprises a proximal anchoring ring (20) having a first external diameter and a distal anchoring ring (21 ) provided distally to the proximal anchoring ring (20) and having a second external diameter, wherein the gastric band (8) is adapted to be arranged between the proximal and distal anchoring rings (20, 21 ) and has an internal diameter smaller than the first and second external diameters.

8. Endoluminal sleeve device (1 ) according to claim 7, in which the proximal anchoring ring (20) and the distal anchoring ring (21 ) are connected by an elastically extensible tightening member (23).

9. Endoluminal sleeve device (1 ) according to claim 7, in which the proximal anchoring ring (20) and the distal anchoring ring (21 ) are connected by a length adjustable tightening member (23).

10. Endoluminal sleeve device (1 ) according to any one of claims 1 to 6, wherein the anchoring component (12) forms a single proximal anchoring ring (20) having an external diameter greater than an internal diameter of the gastric band (8), such that the sleeve (2) can be loop lashed by the gastric band (8) against distal displacement.

11. Endoluminal sleeve device (1 ) according to any one of claims 7 to 10, in which the anchoring ring (20, 21 ) has a collapsed slender transport configuration and a bulky annular deployed configuration.

12. Endoluminal sleeve device (1 ) according to any one of the preceding claims, in which one of the gastric band (8) and the anchoring component (12) comprises a magnetic substance and the other one of the gastric band (8) and the anchoring component (12) comprises a magnetically attractable substance adapted to provide a magnetic connection of the gastric band (8) and the anchoring component (12) through the gastric wall (1 1 ).

13. Endoluminal sleeve device (1 ) according to any one of claims 2 to 12 , in which the gastric band (8) may form a plurality of fixating tabs (26) adapted to receive the connecting structure (13).

14. Endoluminal sleeve device (1 ) according to claim 7, in which the proximal and distal anchoring rings (20, 21 ) are inflatable.

15. Method for internally lining a section of a Gl tract, comprising:

- deploying a sleeve (2) inside a stomach and 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 (12) extending along a circumference of the sleeve,

- locking a gastric band (8) in a closed annulus shape around the stomach (10), thereby restricting an internal lumen of the stomach (10),

- placing the proximal sleeve end (4) with the anchoring component (12) inside the stomach, - connecting the gastric band (8) with said anchoring component (12) through a gastric wall

(1 1 ) of the stomach (10).

16. Method according to claim 15, comprising placing the anchoring component (12) proximal with respect to the gastric band (8) and loop lashing the proximal sleeve end (4) by said gastric band (8) against distal dislocation.

17. Method for internally lining a section of a Gl tract, comprising:

- creating in a stomach a gastric pouch portion (28) and a region (29) which is distal to the gastric pouch portion (28) and constricted with respect to gastric pouch portion (28),

- deploying a sleeve (2) inside the stomach and 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),

- placing an anchoring component (12) within the gastric pouch portion (28), the anchoring component (12) having a greater external diameter than a passage diameter of the constricted region (29),

- connecting the anchoring component (12) through the constricted region (29) with said sleeve (2) to prevent the sleeve (2) from migrating distally.