WO2013023679A1

WO2013023679A1 - Laparoscopic system for anchoring an endoluminal sleeve in the gi tract

Info

Publication number: WO2013023679A1
Application number: PCT/EP2011/063961
Authority: WO
Inventors: Alessandro Pastorelli
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2011-08-12
Filing date: 2011-08-12
Publication date: 2013-02-21

Abstract

A system (1) for internally lining a section of a Gl tract comprises an endoluminal sleeve (2) with an annular sealing collar (8) formed at the proximal sleeve end (4), an anchoring plug (11) insertable in an otomy (18) in a gastrointestinal wall (19) and adapted to clamp the gastrointestinal wall (19), the anchoring plug (11) being connected to the sealing collar (8) by an elongate flexible tether (9) and adapted to form a pull tie anchor for the sealing collar (2), a laparoscopic applier (14) having a sleeve seat (12) adapted to receive the sleeve (2) in a compacted shape, a pusher (20) operable to push the sleeve (2) from the sleeve seat (12) out of the applier (14), an anchor retainer (15) adapted to retain the anchoring plug (11) and anchor actuating means for switching the anchoring plug (11) from an unactuated shape to a tissue clamping actuated shape.

Description

DESCRIPTION

LAPAROSCOPIC SYSTEM FOR ANCHORING AN ENDOLUMINAL SLEEVE IN THE GI 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 I ndex >=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 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.

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 a system and method for laparoscopically placing an endoluminal, particularly duodenal, sleeve 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 . I n the case of the present i nvention , the surgeon or laparoscopist may insert devices as described below through a laparoscopic access port and the gastrointestinal wall into the stomach or i ntestine as appropriate.

According to an aspect of the invention, there is provided a method for internally lining a section of a Gl tract, particularly of a duodenum, the method comprising:

- providing an endoluminal sleeve with an annular sealing collar formed at a proximal end of the sleeve,

- providing an anchoring plug having a slender unactuated shape, and an actuated shape adapted to clamp tissue,

- connecting the anchoring plug to the sealing collar of the sleeve by means of an elongate flexible tether,

- placing the sleeve in a compacted shape in a sleeve seat formed in a tubular distal end portion of an applier, - attaching the anchoring plug in the unactuated shape to an anchor retainer of the applier;

- laparoscopically accessing an abdominal cavity and creating an otomy in a target anchoring location of a gastrointestinal wall;

- laparoscopically introducing the applier with the attached sleeve and anchoring plug through the otomy to a target sleeve sealing location in the Gl tract, said target sleeve sealing location being distally to the target anchoring location;

- releasing the sealing collar of the sleeve from the sleeve seat in said target sleeve sealing position and releasing the sleeve from the sleeve seat inside the Gl tract;

- withdrawing the applier from the target sleeve sealing location to the otomy in the target anchoring location;

- positioning the anchoring plug in the otomy and fastening the anchoring plug to a Gl wall at the otomy by switching the anchoring plug from the unactuated shape to the actuated shape;

- releasing the anchoring plug from the applier;

- withdrawing the applier from the abdominal cavity.

The method allows to easily and reliably anchor the sleeve within the Gl tract in a position remote from the target sleeve sealing position. It is therefore possible to select the target location for the fixation of the tie anchor in dependency of the resistance of the bodily tissue and of the specific anatomical conditions of the patient. Moreover, the target sealing location can be purposefully selected with regard to optimum sealing characteristics and optimum starting points for the endoluminal lining and without taking account of the suitability of the target sealing location for a pull resistant anchoring of the sleeve.

In accordance with an aspect of the invention, the step of creating an otomy in a target anchoring location comprises creating a gastrotomy in a gastric wall and the step of releasing the sealing collar of the sleeve from the sleeve seat in the target sleeve sealing position comprises releasing the sealing collar of the sleeve within a pyloric sphincter region, particularly within a pyloric antrum.

In accordance with a further aspect of the invention, the method comprises closing the otomy and immobilizing the anchoring plug with respect to the otomy by clamping the anchoring plug to the Gl wall at the otomy.

This allows to retro-anchor the sleeve and to close the otomy in a single step. In accordance with a further aspect of the invention, a distal end of the sleeve can be extended distally within the Gl tract by advancing the applier into the Gl tract distally to the target sleeve sealing location and releasing the distal sleeve end from the applier in a location distal to the target sleeve sealing location.

According to a further aspect of the invention, the method can be implemented by a laparoscopic system for internally lining a section of a Gl tract, particularly of a duodenum, the system comprising:

- an endoluminal sleeve configured for deployment inside a Gl tract, particularly inside a duodenum of a human subject, the sleeve having a wall of a flexible material defining a sleeve lumen, a proximal end defining a proximal lumen opening, a distal end defining a distal lumen opening, and an annular sealing collar formed at the proximal sleeve end,

- an anchoring plug having a slender unactuated shape in which the anchoring plug is insertable in an otomy in a gastrointestinal wall and an actuated shape adapted to clamp the gastrointestinal wall, thereby closing the otomy and immobilizing the anchoring plug with respect to the otomy,

wherein the anchoring plug is connected to the sealing collar of the sleeve by means of an elongate flexible tether and adapted to form a pull tie anchor for the sealing collar,

- a laparoscopic applier having:

A) an elongate insertion shaft;

B) a sleeve seat formed in a tubular distal end portion of the insertion shaft and adapted to receive the sleeve in a compacted shape,

B) a pusher slidably arranged inside the distal end portion of the insertion shaft and operable to push the sleeve from the sleeve seat distally out of the applier,

C) an anchor retainer adapted to retain the anchoring plug in an unactuated shape and means for releasing the anchoring plug from the anchor retainer,

D) anchor actuating means for switching the anchoring plug from the unactuated shape to the actuated shape.

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 4 illustrate a method and devices for laparoscopically lining a section of a Gl tract, particularly of a duodenum, in accordance with an embodiment of the invention;

- Figures 5 and 6 illustrate devices and method steps for fixating an anchoring plug to a target anchoring location in a gastric wall in accordance with an embodiment;

- Figure 7 is an enlarged view of an anchoring plug of the laparoscopic lining system in accordance with an embodiment;

- Figures 8 and 9 illustrate devices and method steps for fixating an anchoring plug to a target anchoring location in a gastric wall in accordance with a further embodiment;

DETAILED DESCRIPTION OF EMBODIMENTS

Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, a method for internally lining a section of a Gl tract, particularly of a duodenum, the method comprises:

- providing an endoluminal sleeve 2 with an annular sealing collar 8 formed at a proximal end 4 of the sleeve 2,

- providing an anchoring plug 11 having a slender unactuated shape (Figure 5), and an actuated shape (Figure 6) adapted to clamp tissue,

- connecting the anchoring plug 11 to the sealing collar 8 of the sleeve 2 by means of an elongate flexible tether 9,

- placing the sleeve 2 in a compacted shape in a sleeve seat 12 formed in a tubular distal end portion 13 of an applier 14,

- attaching the anchoring plug 1 1 in the unactuated shape to an anchor retainer 15 of the applier 14;

- laparoscopically accessing an abdominal cavity 17 and creating an otomy 18 in a target anchoring location of a gastrointestinal wall 19;

- laparoscopically introducing the applier 14 with the attached sleeve 2 and anchoring plug 11 through the otomy 18 to a target sleeve sealing location in the Gl tract, said target sleeve sealing location being distally to the target anchoring location;

- releasing the sealing collar 8 of the sleeve 2 from the sleeve seat 12 in the target sleeve sealing position and releasing the sleeve 2 from the sleeve seat 12 inside the Gl tract; - withdrawing the applier 14 from the target sleeve sealing location to the otomy 18 in the target anchoring location;

- positioning the anchoring plug 1 1 in the otomy 18 and fastening the anchoring plug 1 1 to a Gl wall 19 at the otomy 18 by switching the anchoring plug 11 from the unactuated shape to the actuated shape;

- releasing the anchoring plug 11 from the applier 14;

- withdrawing the applier 14 from the abdominal cavity 17 (Figures 1 through 4). The method allows to easily and reliably anchor the sleeve 2 within the Gl tract in a position remote from the target sleeve sealing location. It is therefore possible to select the target location for the fixation of the tie anchor in dependency of the resistance of the bodily tissue and of the specific anatomical conditions of the patient. Moreover, the target sealing location can be purposefully selected with regard to optimum sealing characteristics and optimum starting points for the endoluminal lining and without taking account of the suitability of the target sealing location for a pull resistant anchoring of the sleeve.

In accordance with an embodiment, the step of creating the otomy 18 in the target anchoring location comprises creating a gastrotomy in a gastric wall and the step of releasing the sealing collar 8 of the sleeve 2 from the sleeve seat 12 in the target sleeve sealing position comprises cannulating a pylorus 16 with a distal tip of the applier 14 and releasing the sealing collar 8 of the sleeve 2 within a pyloric sphincter region, particularly within a pyloric antrum.

In accordance with a further embodiment, the method comprises closing the otomy 18 and immobilizing the anchoring plug 11 with respect to the otomy 18 by clamping the anchoring plug 1 1 to the Gl wall 19 at the otomy 18. This allows to retro-anchor the sleeve 2 and to close the otomy 18 in a single step.

In accordance with an embodiment, the sleeve 2 can be released from the sleeve seat 12 by distally advancing a pusher 20 inside the distal end portion 13 of the applier 14 thereby pushing the sleeve 2 from the sleeve seat 12 distally out of the applier 14. When it is desired to not displace the sleeve 2 with respect to the surrounding anatomy during expulsion, the applier 14 or only its distal end portion 13 can be gradually proximally withdrawn from the deployment site while the pusher 20 is distally advanced so the relative position between the surrounding anatomy and the pusher 20 and sleeve 2 remain substantially unchanged during expulsion of the sleeve 2. In accordance with a further embodiment, the anchoring plug 11 may be permanently elastically biased in the actuated shape. In this case, the anchoring plug 1 1 can be inserted in the unactuated shape in the tubular distal end portion 13 of the applier 14 in a position proximal to the sleeve 2.

In this case the tubular end portion 13 retains the anchoring plug 1 1 in the unactuated shape and the anchoring plug 1 1 can be pushed out of the applier 14 by the same pusher 20 that previously expelled the sleeve 2. After leaving the tubular end 13 portion of the applier, the anchoring plug 11 will automatically elastically switch in the actuated shape, thereby clamping the gastric or duodenal wall 19 around the otomy 18. The plug 1 1 may be gradually released from the applier so that a distal plug portion is expanded at the distal side of the otomy (inside the stomach) and subsequently a proximal plug portion is expanded at a proximal side of the otomy (outside the stomach).

In a preferred embodiment, the anchoring plug 1 1 is arranged within the tubular distal end portion 13 of the applier 14 proximally to the sleeve 2 and the pusher 20 is arranged proximally to the anchoring plug 1 1 and, for releasing the sleeve 2 from the applier 14, the pusher 20 is moved distally by a first distance such that the sleeve 2 is expelled from a distal end of the applier 14 and the anchoring plug 1 1 is displaced distally near the distal end of the applier. For subsequently releasing the anchoring plug 1 1 , the pusher 20 is moved further distally by a second distance such that the anchoring plug 11 is expelled from the distal end of the applier 14. Also in this embodiment, when it is desired to not displace the plug 1 1 with respect to otomy during expulsion, the applier 14 or only its distal end portion 13 can be gradually proximally withdrawn through the otomy while the pusher 20 is distally advanced so the relative position between the otomy and the pusher 20 and plug 1 1 remain substantially unchanged during expulsion of the plug 1 1.

In accordance with a further embodiment of the method, a distal end 6 of the sleeve 2 can be extended distally within the Gl tract by advancing the applier 14 into the Gl tract distally to the target sleeve sealing location and releasing the distal sleeve end 6 from the applier 14 distally to the target sleeve sealing location.

For this purpose, the sleeve 2 may be e.g. gradually expelled from the applier 14 starting with the distal sleeve end 6 at a location distal to the target sleeve sealing location and moving the applier 14 (while gradually expelling the sleeve 2) proximally towards the target sleeve sealing location. The thus extended sleeve 2 can be further extended distally in the Gl tract by the action of peristalsis or by a ballast weight (not shown) connected to the distal sleeve end 6.

The described method can be implemented by a laparoscopic system 1 for internally lining a section of a Gl tract, particularly of a duodenum, the system 1 comprising:

- an endoluminal sleeve 2 configured for deployment inside a Gl tract, particularly inside a duodenum of a human subject, the sleeve having a wall of a flexible material defining a sleeve lumen 3, a proximal end 4 defining a proximal lumen opening 5, a distal end 6 defining a distal lumen opening 7, and an annular sealing collar 8 formed at the proximal sleeve end 4,

- an anchoring plug 11 having a slender unactuated shape in which the anchoring plug 1 1 is insertable in an otomy 18 in a gastrointestinal wall 19 and an actuated shape adapted to clamp the gastrointestinal wall 19, thereby closing the otomy 18 and immobilizing the anchoring plug 11 with respect to the otomy 18, wherein the anchoring plug 1 1 is connected to the sealing collar 8 of the sleeve 2 by means of an elongate flexible tether 9 and adapted to form a pull tie anchor for the sealing collar 2.

The system 1 further comprises a laparoscopic applier 14 having an elongate insertion shaft 21 , a sleeve seat 12 formed in a tubular distal end portion 13 of the insertion shaft 21 and adapted to receive the sleeve 2 in a compacted shape, a pusher 20 slidably arranged inside the distal end portion 13 of the insertion shaft 21 and operable to push the sleeve 2 from the sleeve seat 12 distally out of the applier 14, an anchor retainer 15 adapted to retain the anchoring plug 1 1 in the unactuated shape and means for releasing the anchoring plug 11 from the anchor retainer 15, as well as anchor actuating means for switching the anchoring plug 11 from the unactuated shape to the actuated shape.

I n accordance with an embodiment, the anchoring plug 11 comprises a first compression portion 22 and an adjacent second compression portion 23 adapted to give the anchoring portion 22 a rivet or double flange like actuated shape. In the exemplary embodiment shown in figures 5 through 7, the anchoring plug 11 comprises proximal 24, center 25, and distal disks 26 connected respectively by proximal and distal foldable hinged arms 27 that give the anchoring plug 11 a generally cylindrical shape when unactuated and the above said rivet shape or double flange shape when actuated. The proximal 24, center 25, and distal disks 26 may be permanently elastically biased towards each other, i.e. towards the actuated configuration, and the anchoring plug 1 1 can be retained in the unactuated cylindrical shape as long as it remains inserted inside the tubular laparoscopic applier 14. After expulsion of the anchoring plug 1 1 from the applier 14, the elastic preload approximates the proximal 24, center 25, and distal disks 26 towards each other, thereby folding the hinged arms 27 to the actuated shape in which the folded hinged arms 27 engage the Gl wall from both sides of the otomy 18 (Figures 6, 7).

In accordance with a further embodiment, the anchoring plug 11 may comprise an arresting member 28 adapted to lock the proximal 24, center 25, and distal disks 26 in the approximated actuated position, e.g. by snap coupling or by snap ratchet coupling.

Moreover, a dedicated anchoring plug applier 29 may be provided which is insertable in the tubular laparoscopic applier 14 and which has an elongate implement portion, a handle connected to the implement portion, an actuating member engaged to one of the disks 24, 25, 26 of the anchoring plug 1 1 and adapted approximate the disks to each other, and a control coupled to the handle and configured to cause movement of the actuating member, and thus causing the interposed hinged arms 27 of the anchoring plug 11 to fold in the actuated shape. In accordance with a yet further exemplary embodiment, the dedicated anchoring plug applier 29 may be slidably housed inside the tubular laparoscopic applier 14 and form the pusher 20.

Alternatively, the compression portions 22, 23 of the anchoring plug 11 may comprise first and second inflatable ring shaped balloons 30 (Figure 8, 9) which can be connected by an insufflating line 31 to an extracorporeal insufflating pump (not shown).

In accordance with a yet further embodiment, a first marker 32 which can be visualized, for instance a radio opaque region, is provided at the anchoring plug 11 between the compression portions 22, 23 and further markers 33 may be provided adjacent to the compression portions 22, 23 opposite the first marker. These markers 32, 33 help localizing the compression portions 22, 23 and facilitate a correct positioning of the anchoring plug 11.

In accordance with a yet further embodiment, the sealing collar 11 itself may be elastically expandable from a collapsed shape in which the sealing collar can be received inside the sleeve seat 12 of the applier 14, to an expanded shape adapted to leak tight engaging the Gl wall 19.

In accordance with the described methods and devices, the applier 14 carrying the sleeve 2, the tether 9 and the anchoring plug 1 1 can be introduced in the abdominal cavity 17 through a laparoscopic access port (not shown) and placed through the otomy 18 in the gastric wall or in the intestinal wall. The applier 14 can have a distal pointed tip adapted to create the otomy 18 when being forced through the wall of the intestine or of the stomach. Alternatively, the otomy 18 may be created with a standard laparoscopic cutting instrument or with a piercing needle routed through the internal channel of the applier 14. The applier 14 is then advanced inside the Gl tract until its distal end is positioned in a region of the Gl tract distal to the target sleeve sealing location, i.e. the intended location for positioning the sealing collar 8 of the sleeve 2. Then the pusher 20 is operated to expel the sleeve 2 from the applier 14, starting with the distal sleeve end 6 and gradually expelling the sleeve, while proximally withdrawing the applier 14 until the distal applier tip is positioned at the target sleeve sealing location. Then the pusher 20 is further moved to expel also the sealing collar 8 of the sleeve and deploy the sealing collar 8 in the target sleeve sealing location.

Upon releasing the sealing collar 8 from the sleeve seat 12 of the applier 14, the sealing collar 8 expands elastically to leak tight adhere against the surrounding tissue wall of the target sleeve sealing location.

Subsequently, the applier 14 is withdrawn further proximally until the distal applier end is near the otomy 18, where the anchoring plug 11 (which is connected to the sealing collar 8 of the sleeve 2 by the at least one tether 9) is released and actuated, thereby retro-anchoring the sleeve 2 and closing the otomy 18. Eventually the applier 14 is withdrawn from the abdominal cavity 17 through the laparoscopic access port which is then closed by known suturing or glueing techniques.

In order to remove the sleeve 2 from the Gl tract, the anchoring plug 1 1 can be again laparoscopically reached and detached from the otomy 18, e.g. by switching the anchoring plug 1 1 back to its unactuated shape, then the sleeve 2 (which is still attached to the anchoring plug 1 1 by tether 9) can be pulled out of the Gl tract by pulling the anchoring plug 1 1 proximally into a tubular laparoscopic device, removing the tubular laparoscopic device from the patient, closing the otomy 18 and the laparoscopic access port.

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.

I n some em bodi ments , 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 incl ude 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. I n 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.

I n 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 addresses 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. A method for internally lining a section of a Gl tract, particularly of a duodenum, the method comprising:

- providing an endoluminal sleeve (2) with an annular sealing collar (8) formed at a proximal end (4) of the sleeve (2),

- connecting the sealing collar (8) to an anchoring plug (1 1 ) by means of an elongate flexible tether (9),

- placing the anchoring plug (1 1) with the tether (9) and sleeve (2) in a compacted shape in an applier (14),

- laparoscopically accessing an abdominal cavity (17) and creating an otomy (18) in a target anchoring location of a gastrointestinal wall (19);

- laparoscopically introducing the applier (14) carrying the sleeve (2), anchoring plug (11) and tether (9) through the otomy (18) to a target sleeve sealing location in the G l tract, said target sleeve sealing location being distally to the target anchoring location;

- releasing the sealing collar (8) of the sleeve (2) from the applier (14) in the target sleeve sealing location and releasing the sleeve (2) from the applier (14) inside the Gl tract;

- withdrawing the applier (14) from the target sleeve sealing location to the otomy (18) in the target anchoring location;

- positioning the anchoring plug (1 1) in the otomy (18) and fastening the anchoring plug (11) to the Gl wall (19) at the otomy (18);

- releasing the anchoring plug (1 1) from the applier (14);

- withdrawing the applier (14) from the abdominal cavity (17).

2. Method according to claim 1 , in which the anchoring plug (1 1 ) has a slender unactuated shape and an actuated shape adapted to clamp tissue, and wherein the anchoring plug (1 1 ) is fastened to the Gl wall (19) at the otomy (18) by switching the anchoring plug (1 1 ) from the unactuated shape to the actuated shape.

3. Method according to claim 1 or 2, comprising creating said otomy (18) in a gastric wall and releasing the sealing collar (8) of the sleeve (2) within a pyloric antrum.

4. Method according to clai m 1 , comprising closing the otomy (18) and immobilizing the anchoring plug (1 1) with respect to the otomy (18) by clamping the anchoring plug (1 1) to the Gl wall (19) at the otomy (18).

5. Method according to claim 1 or 2, wherein the step of releasing the sleeve (2) comprises moving a pusher (20) inside the distal end portion (13) of the applier (14) in a distal direction with respect to the distal end portion (13), thereby releasing the sleeve (2) distally out of the applier (14).

6. Method according to claim 5, comprising:

- permanently elastically biasing the anchoring plug (11) in the actuated shape;

- inserting the anchoring plug (1 1) in the unactuated shape in the tubular distal end portion (13) of the applier (14) in a position proximal to the sleeve (2);

- releasing the anchoring plug (1 1 ) from the applier (14) and fastening the anchoring plug (1 1) at the otomy (18) by pushing the anchoring plug (1 1) with the same pusher (20) that previously expelled the sleeve (2).

7. Method according to claim 5 or 6, comprising:

- during a distal movement of the pusher (20) with respect to said distal end portion (13) of the applier (14), withdrawing the distal end portion (13) proximally with respect to the surrounding anatomy.

8. Method according to claim 6, comprising:

- arranging the anchoring plug (1 1) within the tubular distal end portion (13) of the applier (14) proximally to the sleeve (2) and arranging the pusher (20) proximally to the anchoring plug (11), and

- releasing the sleeve (2) from the applier (14) by moving the pusher (20) distally by a first distance sufficient to expel the sleeve (2) from a distal end of the applier (14), and

- releasing the anchoring plug (1 1) from the applier (14) by moving the pusher (20) further distally by a second distance such that the anchoring plug (1 1) is expelled from the distal end of the applier (14).

9. Method according to claim 1 , comprising:

- extending a distal end (6) of the sleeve (2) distally within the Gl tract by advancing the applier (14) into the Gl tract distally of the target sleeve sealing location and releasing the distal sleeve end (6) from the applier (14) distally of the target sleeve sealing location.

10. Method according to claim 9, comprising moving the applier (14) proximally towards the target sleeve sealing location while gradually expelling sleeve (2).

11. System (1) for internally l ining a section of a G l tract, the system (1) comprising:

- an endoluminal sleeve (2) configured for deployment inside a Gl tract, particularly 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), a distal end (6) defining a distal lumen opening (7), and an annular sealing collar (8) formed at the proximal sleeve end (4),

- an anchoring plug (1 1) having a slender unactuated shape in which the anchoring plug (11) is insertable in an otomy (18) in a gastrointestinal wall (19) and an actuated shape adapted to clamp the gastrointestinal wall (19), the anchoring plug (1 1) being connected to the sealing collar (8) by an elongate flexible tether (9) and adapted to form a pull tie anchor for the sealing collar (2),

- a laparoscopic applier (14) having an elongate insertion shaft (21), a sleeve seat (12) formed in a tubular distal end portion (13) of the insertion shaft (21) and adapted to receive the sleeve (2) in a compacted shape, a pusher (20) slidably arranged inside the distal end portion (13) of the insertion shaft (21) and operable to push the sleeve (2) from the sleeve seat (12) distally out of the applier (14), an anchor retainer (15) adapted to retain the anchoring plug (11) in the unactuated shape and means for releasing the anchoring plug (11) from the anchor retainer (15),

- anchor actuating means for switching the anchoring plug (1 1) from the unactuated shape to the actuated shape.

12. System (1) according to claim 1 1 , in which the anchoring plug (1 1) comprises a first compression portion (22) and an adjacent second compression portion (23) adapted to give the anchoring portion (22) a rivet like actuated shape.

13. System (1) according to claim 12, in which the anchoring plug (1 1) comprises an arresting member (28) adapted to lock the first and second compression portions (22, 23) in the actuated position.

14. System (1 ) according to claim 1 3, in which the arresting member (28) comprises a snap coupler.

15. System (1) according to claim 13, in which the arresting member (28) comprises a snap ratchet coupler.

16. System (1) according to claim 12 or 16, in which the compression portions (22, 23) comprise first and second inflatable ring shaped balloons (30).

17. System (1 ) according to any one of claims 1 1 to 15, in which the anchoring plug (1 1) is permanently elastically biased in the actuated shape.

18. System (1) according to claim 11 , in which the sealing collar (11) is elastically expandable from a collapsed shape in which the sealing collar can be received inside the sleeve seat (12) of the applier (14), to an expanded shape adapted to leak tight engaging the Gl wall (19).

19. System (1 ) according to claim 12, in which a first visualization marker (32) is provided at the anchoring plug (1 1) between the compression portions (22, 23).

20. System (1 ) according to claim 18, in which further markers (33) may be provided adjacent to the compression portions (22, 23) opposite the first marker.