WO2013026474A1

WO2013026474A1 - Devices and methods for anchoring an endoluminal sleeve in the gi tract

Info

Publication number: WO2013026474A1
Application number: PCT/EP2011/064461
Authority: WO
Inventors: Michael A. Murray; Mark S. Zeiner; Federico Bilotti; Michele D'arcangelo; Mark Steven Ortiz; Jason Harris; Alessandro Pastorelli; James W. Voegele; Michael J. Stokes
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 GI tract, an anchoring structure (8) with a support ring (9) connected to a proximal sleeve end (4), a plurality of expandable arms (11) hinged to the support ring (9) and movable from a "closed umbrella" configuration to an "open umbrella" configuration,a membrane (15) connected to the arms (11) and extending all around the anchoring structure (8) thereby forming a webbing between adjacent arms (11) and means for locking the arms (11) in the "open umbrella" configuration.

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, - an anchoring structure comprising:

A) a support ring connected to the proximal sleeve end,

B) a plurality of expandable arms having a distal end connected to the support ring and a proximal end extending away from the support ring, the arms being rotatable with respect to the support ring from a closed position in which the proximal ends of the arms are approximated to each other, thereby giving the anchoring structure a collapsed "closed umbrella" shape, to an open position in which the proximal ends of the arms are spaced apart, thereby giving the anchoring structure a spread "open umbrella" shape,

C) a membrane connected to the arms and extending all around the anchoring structure thereby forming a webbing between adjacent arms,

D) means for locking the arms in the open position.

In the collapsed closed position the anchoring structure allows the sleeve device to be endoluminally introduced in the Gl tract, particularly in the stomach and, after expanding the anchoring structure in the open position, the latter interferes with the shape and dimensions of the pyloric sphincter and prevents the sleeve device from migrating distally due to peristaltic forces.

In accordance with an aspect of the invention, all arms of the anchoring structure are linked together such that, during their movement from the closed position to the open position, they move all together and cannot move independently from one another. This enables a uniform expansion of the anchoring structure independently from the position of activation or manipulation of the sleeve device. In accordance with a further aspect of the invention, the anchoring structure comprises means for a shape adjustment thereof in the open position of the arms. Such adjustable shape contributes to a better adaption of the sleeve device to the anatomy of the patient.

In accordance with a yet further aspect of the invention, the activating component comprises an inflatable ring connected to the arms at a distance from the distal arm ends and adapted to be inflated from a retracted ring shape with a reduced circumference (corresponding to the closed position of the arms) to an expanded ring shape with an increased circumference (corresponding to the open position of the arms).

In accordance with a further aspect of the invention, the anchoring structure comprises an activating ring connected with the support ring by foldable hinged segments. The hinged segments are connected with the arms and form a generally straightened shape when unactuated and an outwardly folded shape when actuated by approximating the activating ring towards the support ring. The anchoring structure comprises further at least one snap connector which snap connects or snap ratchet connects the activating ring and the support ring to one another. By approximating the activating ring to the support ring, the hinged segments fold radially outward and move the arms from the closed position to the open position.

In accordance with a further aspect of the invention, the membrane constitutes an end portion of a sleeve wall and is formed as a single piece and without discontinuities with a portion of the sleeve wall distal to the anchoring structure. 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, the device being in a closed configuration;

- Figure 2 illustrates a duodenal sleeve device in accordance with a further embodiment, the device being in an open configuration;

- Figure 3 illustrates an anchoring structure of a duodenal sleeve device in accordance with an embodiment;

- Figure 4 illustrates an anchoring structure of a duodenal sleeve device in accordance with a further embodiment;

- Figure 5 shows a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with an embodiment, in which the dotted lines indicate the closed position of expandable arms;

- Figure 6 shows a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with a further embodiment, in which the dotted lines indicate the closed position of expandable arms and a retaining sheath inserted over the anchoring structure;

- Figures 7 and 8 illustrate a method for endoscopically inserting and anchoring an endoluminal sleeve device in accordance with an embodiment; - Figures 9 and 10 show a partial longitudinal cross-section of an anchoring structure of an endoluminal sleeve device in accordance with a further embodiment, in a closed configuration and in an open configuration;

- Figure 11 illustrates an applier for anchoring an endoluminal sleeve in a Gl tract by applying fastening members to the sleeve and the surrounding tissue in accordance with an aspect of the invention;

- Figure 12 illustrates a method step of applying fastening members to the sleeve and the surrounding tissue by means of the applier in Figure 11 ;

- Figure 13 illustrates an endoluminal sleeve anchored in a duodenum by means of the devices and methods illustrated in figures 1 1 and 12;

- Figures 14 and 15 show sleeve fastening members in accordance with embodiments of the invention;

- Figure 16 illustrates an applier and method for anchoring an endoluminal sleeve in a Gl tract by applying fastening members to the sleeve and the surrounding tissue in accordance with a further embodiment;

- Figures 17 and 18 illustrate an applier, a clip and a method for anchoring an endoluminal sleeve in a Gl tract by applying the clip to the sleeve and to the surrounding tissue in accordance with a yet further embodiment;

- Figures 19 to 21 illustrate an applier, a double T-tag fastener and a method for anchoring an endoluminal sleeve in a Gl tract by applying the double T-tag fastener to the sleeve and to the surrounding tissue in accordance with a yet further embodiment of the invention;

- Figure 22 illustrates a method for anchoring an endoluminal sleeve in a Gl tract by applying T-tag fasteners to the sleeve and to the surrounding tissue and purse string tightening the T-tag fasteners in accordance with a yet further embodiment of the invention;

- Figures 23 through 26 illustrate a method and devices for holding a distal portion of an endoluminal sleeve within a Gl tract in accordance with a further aspect of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 1 TO 10

Referring to the drawings in which 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 device 1 has further an anchoring structure 8 comprising:

A) a support ring 9 connected to the proximal sleeve end 4,

B) a plurality of expandable arms 1 1 having a distal end 13 connected to the support ring 9 and a proximal end 14 extending away from the support ring 9, the arms 1 1 being rotatable with respect to the support ring 9 from a closed position (Figure 1) in which the proximal ends 14 of the arms 1 1 are approximated to each other, thereby giving the anchoring structure 8 a collapsed "closed umbrella" shape, to an open position (Figure 2) in which the proximal ends 14 of the arms 1 1 are spaced apart, thereby giving the anchoring structure 8 a spread "open umbrella" shape,

C) a membrane 15 connected to the arms 1 1 and extending all around the anchoring structure 8 thereby forming a webbing between adjacent arms 11 ,

D) means for locking the arms 1 1 in the open position.

In the collapsed closed position (Figure 1) the anchoring structure 8 allows the sleeve device 1 to be endoluminally introduced in the Gl tract, particularly in the stomach 10 and, after expanding the anchoring structure 8 in the open position (Figure 2), the latter interferes with the shape and dimensions of the pyloric sphincter 16 and prevents the sleeve device 1 from migrating distally due to peristaltic forces.

In accordance with an embodiment of the invention, all arms 11 of the anchoring structure 8 are linked together such that, during their movement from the closed position to the open position, they move all together and cannot move independently from one another. This enables a uniform expansion of the anchoring structure 8 independently from the position of activation or manipulation of the sleeve device 1.

For this purpose and for the purpose of locking the arms 1 1 in the open position, the sleeve device 1 may comprise an activating component 17 which is connected to all arms 1 1 and guided to move with respect to the support ring 9 such that the relative movement of the activating component 17 with respect to the support ring 9 moves the arms 1 1 from the closed position to the open position and vice versa. In accordance with an embodiment, the activating component 17, e.g. an activating ring or bushing, is rotatably supported by the support ring 9 and forms cam portions which engage the arms 1 1 in a manner to generate the movement of the arms 1 1 from the closed position to the open position and vice versa.

In accordance with a further embodiment, the activating component 17, e.g. an activating ring or bushing, is slidably supported by the support ring 9 and coupled with the arms 11 in a manner that a relative translation between the activating component 17 and the support ring 9 in a sleeve longitudinal (proximal-distal) direction generates the movement of the arms 11 from the closed position to the open position and vice versa (compare Figure 5).

In accordance with a further embodiment, the activating component 17 and the support ring 9, which may also be embodied as a bushing or tube section, form at least one latching seat 18 and a corresponding latching tooth 19 adapted to snap engage and to lock the arms 11 in the open position.

Advantageously, a plurality of latching seats 18 may be provided for a snap engagement of the latching tooth 19 in multiple relative positions of the activating component 17 with respect to the support ring 9, thereby allowing a shape adjustment of the anchoring structure in the open position of the arms 1 1. Such adjustable shape contributes to a better adaption of the sleeve device 1 to the anatomy of the patient.

The activating component 17 and the support ring 9 may form auxiliary latching seats and auxiliary latching teeth (not shown) adapted to snap engage each other and to hold the arms 11 in the closed position.

Alternatively or additionally, the arms 1 1 may be permanently elastically biased in the closed position, thereby increasing the resistance against an undesired accidental expansion of the anchoring structure 8 or completely obviating the need of auxiliary latching means.

In accordance with a further embodiment of the invention (Figures 3, 4), the activating component comprises an inflatable ring 20 connected to the arms 1 1 at a distance from the distal arm ends 13 and adapted to be inflated from a retracted ring shape with a reduced circumference (corresponding to the closed position of the arms 11) to an expanded ring shape with an increased circumference (corresponding to the open position of the arms 1 1). The inflation of the inflatable ring can be accomplished by an endoscopic inflation syringe or by a detachable inflation line 21 extending from the inflatable ring 20 and connectable to an extracorporeal insufflating pump (not illustrated).

In accordance with an embodiment, a solidifying agent may be arranged inside the inflatable ring 20, which solidifying agent is adapted to solidify after reaction with an insufflating fluid, thereby locking the inflatable ring 20 in the expanded shape.

Alternatively, a solidifying agent may be mixed with an insufflating fluid before injection thereof into the inflatable ring 20.

In the exemplary embodiment in Figure 3 the inflatable ring 20 is arranged at the proximal arm ends 14, while in the embodiment in Figure 4 the inflatable ring 20 is arranged near a middle region of the arms 1 1.

In accordance with a further exemplary embodiment (Figures 9 and 10) , the activating component 17 comprises an activating ring 23 connected with the support ring 9 by foldable hinged segments 24. The hinged segments 24 are connected with the arms 11 and form a generally straightened shape when unactuated and an outwardly folded shape when actuated by approximating the activating ring 23 towards the support ring 9. The activating component 17 comprises at least one snap connector 25, 26 which snap connects or snap ratchet connects the activating ring 23 and the support ring 9 to one another. By approximating the activating ring 23 to the support ring 9, the hinged segments 24 fold radially outward and move the arms 1 1 from the closed position (Figure 9) to the open position (Figure 10).

In accordance with an embodiment, a distal hinged segment 27 of the hinged segments 24 may be formed by a distal end portion of the arms 1 1 to simplify the anchoring structure 8.

In accordance with a further embodiment (Figure 6), the arms 1 1 may be permanently elastically biased in the open position and temporarily held in the closed position by a tubular sheath 29 inserted over the anchoring structure 8. By cutting the sheath 29 or by withdrawing the sheath 29 from the anchoring structure 8, the arms 1 1 are released to move from the closed position to the open position where the arms 11 are locked either by the elastic preload only or by means of additional mechanical latching means, e.g. by snap latching means.

In accordance with a further embodiment, the anchoring structure 8 may comprise barbs 28 which are exposed and protrude outward when the arms 1 1 are in the open position to pierce surrounding tissue and further improve anchoring of the sleeve device 1 , and which barbs 28 may be covered by the anchoring structure 8 when the arms 1 1 are in the closed position to protect the mouth and esophagus and to avoid trauma during endoluminal introduction of the sleeve device in the Gl tract.

In accordance with an embodiment, the membrane 15 may be stretchable or foldable and extends all around the anchoring structure 8. In the open position of the anchoring structure 8, the membrane 15 creates a funnel shaped proximal opening 5 of the sleeve 2 and provides a sealing contact between the proximal sleeve end 4 and the surrounding tissue, e.g. a gastric wall 12. The membrane 15 may be grafted from an elastomeric material or from a silicone rubber film, e.g. from a Silastic® silicone mold commercialized by DOW CORNING®.

In accordance with a further embodiment, the membrane 15 constitutes an end portion of a sleeve wall 22 and is formed monolithically, i.e. as a single piece and without discontinuities, with a portion of the sleeve wall 22 distal to the anchoring structure 8.

The support ring 9 may be embodied as a short cylindrical tube section made of semi-rigid plastic material and connected to the sleeve 2 by means of an adhesive or by molding.

The distal ends 13 of the arms 1 1 may be rotatably connected to the support ring 9 by means of hinges or, alternatively, distal ends 13 of the arms 11 may be rigidly connected to the support ring 9 and form a flexible hinge region, e.g. a film hinge, near the support ring 9, so that the arms 1 1 can rotate with respect to the support ring 9 by flexure of the flexible hinge region.

In accordance with an embodiment, the arms 11 may be connected to the support ring 9 by injection molding as a monolithic unit or, alternatively, by gluing or welding or overmolding.

The arms 1 1 may have a curved shape such as to define an olive shaped or ellipsoid shaped or conical framework with a rounded or truncated tip in the closed position of the arms 1 1 and a dome or cap shaped framework in their open position.

In accordance with a further embodiment, the anchoring structure 8 may be configured to receive the sleeve 2 in a compacted, e.g. folded or rolled, configuration inside a receiving space defined by the membrane 15 and arms 1 1 and the closed position. This facilitates the introduction of the device 1 to the target site in the Gl tract and protects the sleeve 2 from unfolding or tangling as long as the anchoring structure 8 remains closed.

In accordance with a preferred method implementation of the invention, the sleeve device 1 is endoluminally introduced in the stomach 10, the anchoring structure is then expanded to seat inside the distal antrum and bear against the pylorus 16, and the sleeve is distally extended inside the duodenum.

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 1 1 TO 22

In accordance with a further aspect of the invention (Figures 11 to 22) methods and devices are provided for anchoring an endoluminal sleeve 2 within a gastrointestinal tract by applying fastening members 30, 31 , 32, 33 to both a proximal rim or flange 34 of the sleeve 2 and to the surrounding tissue 35 at a target anchoring location in the Gl tract.

The sleeve 2 used for the anchoring method may have 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 and the proximal rim or flange 34 formed at the proximal sleeve end 4.

The sleeve is endoluminally inserted in the Gl tract, e.g. in the duodenum 36, and the proximal sleeve rim 34 is positioned in the target anchoring location, e.g. in the antrum or in the proximal duodenum immediately distally of the pylorus 16. Then, a plurality of portions of the sleeve rim 34 are approximated to adjacent portions of surrounding tissue 35 of the Gl wall. The approximated sleeve rim 34 portions and tissue 35 portions are then connected to each other by attaching each one of a plurality of fastening members 30, 31 , 32, 33 to respectively a pair of approximated tissue 35 and sleeve rim 34 portions. In this manner, the sleeve rim 34 can be anchored to the surrounding tissue 35 in a plurality of anchoring points around its circumference.

In accordance with an embodiment, the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed by applying suction to both the sleeve rim 34 and the tissue 35.

In accordance with a further embodiment, the step of applying the fastening mem bers m ay com prise applyi ng a pl u ral ity of the fasteni ng mem bers simultaneously and in different positions at the sleeve rim 34. Moreover, also the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed simultaneously in different positions at the sleeve rim 34.

In accordance with an alternative embodiment, the step of applying the fastening members may comprise applying a plurality of the fastening members sequentially one after the other in different positions at the sleeve rim 34 and, analogously, also the step of approximating the sleeve rim 34 portions and tissue 35 portions may be performed sequentially in different positions at the sleeve rim 34.

In accordance with an embodiment (Figures 11 to 13), there may be provided an applier 37 having a flexible hollow shaft 38 which is insertable over an endoscope 39 and a distal applier head 40 which forms a plurality of (e.g. four) acquisition cavities 41 at different circumferential positions. Each acquisition cavity 41 comprises at least one suction aperture 42 connected by a suction duct to an extracorporeal suction pump (not shown) and adapted to acquire, by suction, adjacent tissue and sleeve portions into the acquisition cavity 41. I n each acquisition cavity 41 a fastener applier 43 is provided which is adapted to apply the fastening member to the acquired tissue 35 and sleeve rim 34 portions.

In accordance with an embodiment (Figures 12, 14, 15) the fastening member may comprise a split ring fastener 30 starting as a relatively straight piece of material preferably sharpened to a very fine point at one end. The fastener applier 43 has a curved forming member 44 and a driver 45. The free end of the curved forming member 44 may be offset from the other or driving end attached to the applier 37 and driver 45. The straight fastener 30 is driven by the driver 45 through the curved forming member 44 to the free end so that the sharpened point of the fastener 30 is immediately adjacent the sleeve rim 34 and tissue 35 to be joined. As the fastener 30 is curved, it is directed so the pointed end engages the sleeve rim 34 and tissue 35 to be joined. The fastener 30 is continued to be driven in a circular configuration through the sleeve rim 34 and tissue 35. As the fastener 30 is curved back on itself to form a ring or loop (Figure 14) or multiple loop (Figure 15), the sleeve rim 34 and tissue 35 that have been engaged are held together.

In accordance with a further embodiment, the fastener 30 may be permanently elastically biased in a split ring or split coiled shape 31 , as illustrated in Figures 14 and 15 and received inside the fastener applier 43 in a temporarily straightened shape, so that when the fastener 30 is driven out of the fastener applier 43 and through the approximated sleeve rim 34 and tissue 35, it elastically bends back in its original split ring or split coiled shape.

Each fastener applier 43 may receive a plurality of fasteners 30 and the distal applier head 40 may be rotated inside the Gl tract and sequentially apply groups of fasteners 30 in different circumferential positions of the sleeve rim 34.

In accordance with a further embodiment (Figure 16), a flexible applier comprising a fastener applier 43 as described in connection with figures 11 and 12 is routed through an instrument channel 46 of an endoscope 39 and receives a plurality of fastening members 30 which are sequentially applied to the previously approximated sleeve rim 34 and tissue 35 portions.

In accordance with an embodiment (Figures 17, 18), the step of applying the fastening members to the approximated sleeve rim 34 and tissue portions 35 may comprise applying a clip 33 having opposite jaws 47 adapted to permanently clamp the sleeve rim 34 portion and the tissue portion 35 together. In this case the step of approximating the sleeve rim 34 portions and the tissue portions 35 may comprise pulling, e.g. by suction, a sleeve rim 34 portion and an adjacent tissue portion 35 together between the opened jaws 47 of the clip 33.

The clip 33 itself may be a single piece clip in elastic or shape memory material, e.g. Nitinol. The clip 33 in shape memory material may have an open position below a transition temperature and a closed position above the transition temperature, wherein the transition temperature is above room temperature but below human body temperature. In this case, the clip 33 can be activated by exposing it inside the Gl tract to the body temperature. Prior to activation, the clip 33 may be actively cooled to avoid an undesired phase transition before deployment of the clip.

Alternatively, the phase transition of the clip 33 may be triggered by actively heating the clip during its application to the sleeve rim 34 and tissue 35 portions. In this case, the transition temperature of the clip 33 may also be higher than the human body temperature and the clip material is configured that after cooling down to body temperature the closed shape is maintained.

In order to actively heat the clip 33, a clip applier 48 may comprise electric, inductive or conductive heating means or a separate endoscopic heating device may be used.

Active heating of the clips 33 has the further advantage of allowing to selectively heating individual clips in order to better control the fastening position and time. The clip 33 may be a single piece clip or a clip with two opposite jaws 47 which are hinged together and elastically biased to the closed configuration by an elastic spring or by a shape memory material as described above. In accordance with a further embodiment (Figures 19-22), the step of applying the fastening member to the approximated tissue portion 35 and sleeve rim 34 portion may comprise loading a double T-tag fastener 32 inside a hollow needle 49 and piercing the hollow needle 49 through the approximated tissue portion 35 and sleeve rim 34 portion, then expelling a first anchoring end 50 of the double T-tag fastener 32 at a first side of the approximated tissue and sleeve rim portions, then withdrawing the hollow needle 49 from the approximated tissue and sleeve rim portions and expelling a second anchoring end 51 of the double T-tag fastener 32 at an opposite second side of the approximated tissue and sleeve rim portions, thereby fastening them together.

In accordance with a yet further embodiment (Figure 22), the step of applying the fastening member to the approximated tissue portion 35 and sleeve rim 34 portion may comprise applying T-tag fasteners 52 to different pairs of approximated tissue 35 and sleeve rim 34 portions, the T-tag fasteners 52 having a suture 53 extending therefrom, and knotting together the sutures 53 of the applied T-tag fasteners 52 and purse string like tightening the sutures 53. Also in this case the T-tag fasteners can be applied by means of the hollow needle 49 (Figures 19, 21) and the tissue end sleeve rim portions can be approximated by means of a suction cup 54 (Figure 19) or acquisition cavity 41 (as shown in Figure 1 1).

DETAILED DESCRIPTION OF EMBODIMENTS OF FIGURES 23 TO 26

In accordance with a yet further aspect of the invention (Figures 23 to 26) there is provided a method and system for holding a distal portion of sleeve 2 in place. The system comprises an elastic ring 55 which has a coiled compacted shape (Figure 26) and which can be elastically deformed in an expanded annular shape, wherein the expanded annular shape of ring 55 can be locked by a mutual (shape-) coupling of its two free ends 56, 57. The system further comprises an endoluminal ring applier 58 having a flexible insertion shaft 59 and a ring fastening head 60 arranged at a distal end 61 of shaft 59. The ring fastening head 60 comprises an annular ring seat 62 adapted to receive the elastic ring 55 in the compacted shape, and a ring spreading mechanism 63 comprising a central slider 64 movable by a moving mechanism with respect to the ring seat 62 and a plurality of two or more rigid spreading rods 65 having a proximal end hinged to the central slider 64 and a distal end hinged to the ring seat 62, such that a translation of the central slider 64 with respect to the ring seat 62 changes the angle between the spreading rods 65 and the slider 64, thereby radially expanding or retracting the ring seat 62.

The moving mechanism my comprise a push and/or pull mechanism which is activatable by an extracorporeal plunger 66 arranged at a proximal end of the applier 58 and which may be elastically biased in a position in which the ring seat 62 is radially retracted to allow endoluminal insertion of the applier 58 inside the Gl tract and inside the sleeve 2 as well as endoluminal withdrawal therefrom.

After endoluminal positioning of the applier 58 with the ring fastening head 60 in a target ring fastening location inside the sleeve 2, the plunger 66 can be activated to spread the spreading rods 65 and, hence, expand the ring seat 62. The expanded ring seat 62 widens the elastic ring 55 to the expanded shape in which the ring 55 engages the sleeve 2 internally and presses the sleeve 2 against the lumen of the Gl tract to hold it firmly in position. When the expanded shape of the ring 55 is achieved, its free ends 56, 57 connect to one another and lock the ring 55 in the expanded shape. It is now possible to retract the ring seat 62, e.g. by releasing the plunger 66 so that the moving mechanism can elastically return to its rest position, which allows withdrawal of the applier from the sleeve 2 and from the Gl tract of the patient.

In accordance with a further embodiment, the distal sleeve portion can be attached to the elastic ring 55 prior to its insertion in the Gl tract and the distal sleeve portion can be inserted and positioned in its planned position by means of the applier 58 before deploying the elastic ring 55.

The elastic ring 55 can stabilize the position of a distal sleeve portion and hold its lumen wide open to prevent blockage.

Positioning of the ring fastening head 60 and deployment of the elastic ring 55 can be monitored and visualized by means of a scope (not shown) passed through an internal channel 67 formed in the applier 58 insertion shaft 59.

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 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. Endoluminal sleeve device (1) for internally lining a section of the Gl tract, comprising:

- a sleeve (2) configured for deployment inside a Gl tract, 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),

- an anchoring structure (8) comprising:

A) a support ring (9) connected to the proximal sleeve end (4),

B) a plurality of expandable arms (1 1 ) having a distal end (13) connected to the support ring (9) and a proximal end (14) extending away from the support ring (9), the arms (1 1) being rotatable with respect to the support ring (9) from a closed position in which the proximal ends (14) of the arms (1 1) are approximated to each other, thereby giving the anchoring structure (8) a "closed umbrella" shape, to an open position in which the proximal ends (14) of the arms (1 1) are spaced apart, thereby giving the anchoring structure (8) a spread "open umbrella" shape,

C) a membrane (15) connected to the arms (1 1 ) and extending all around the anchoring structure (8) thereby forming a webbing between adjacent arms (11),

D) means for locking the arms (1 1) in the open position.

2. Endoluminal sleeve device (1) according to claim 1 , in which all arms (1 1) of the anchoring structure (8) are linked together such that they move all together and cannot move independently from one another.

3. Endoluminal sleeve device (1) according to claim 1 or 2, comprising an activating component (17) connected to all arms (1 1) and guided to move with respect to the support ring (9) such that the relative movement of the activating component (17) with respect to the support ring (9) moves the arms (1 1) from the closed position to the open position and vice versa.

4. Endoluminal sleeve device (1) according to claim 3, in which the activating component (17) and the support ring (9) form at least one latching seat (18) and a corresponding latching tooth (19) adapted to snap engage each other and to lock the arms (11) in the open position.

5. Endoluminal sleeve device (1) according to claim 4, comprising a plurality of said latching seats (18) for a snap engagement of the latching tooth (19) in multiple positions of the activating component (17) with respect to the support ring (9).

6. Endoluminal sleeve device (1) according to any one of claims 3 to 5, wherein the activating component (17) is rotatably supported by the support ring (9) and forms cam portions which engage the arms (1 1) and move the arms (1 1) from the closed position to the open position and vice versa in response to a rotation of the activating component (17).

7. Endoluminal sleeve device (1) according to anyone of claims 3 to 5, wherein the activating component (17) is slidably supported by the support ring (9) and coupled with the arms (1 1) in a manner that a relative translation between the activating component (17) and the support ring (9) in a sleeve longitudinal direction moves the arms (11) from the closed position to the open position and vice versa.

8. Endoluminal sleeve device (1) according to claim 3, wherein the actuating component (17) comprises an inflatable ring (20) connected to the arms (1 1) at a distance from the distal arm ends (13) and inflatable from a retracted ring shape with a reduced circumference to an expanded ring shape with an increased circumference.

9. Endoluminal sleeve device (1) according to claim 8, in which a solidifying agent is arranged inside the inflatable ring (20), said solidifying agent being adapted to solidify after reaction with an insufflating fluid, thereby locking the inflatable ring (20) in the expanded ring shape.

10. Endoluminal sleeve device (1) according to claim 9, wherein the inflatable ring (20) is arranged at the proximal ends (14) of the arms (1 1).

11. Endoluminal sleeve device (1) according to any one of claims 3 to 5, wherein the activating component (17) comprises an activating ring (23) connected with the support ring (9) by foldable hinged segments (24), said hinged segments (24) being connected with the arms (1 1) and form a generally straightened shape when unactuated and an outwardly folded shape when actuated by approximating the activating ring (23) towards the support ring (9).

12. Endoluminal sleeve device (1) according to claim 1 1 , wherein a distal hinged segment (27) of the hinged segments (24) is formed by a distal end portion of the arms (1 1).

13. Endoluminal sleeve device (1) according to any one of claims 3 to 5, wherein the arms (11) are permanently elastically biased in the closed position.

14. Endoluminal sleeve device (1) according to any one of the preceding claims, in which said anchoring structure (8) forms barbs (28), said barbs (28) being covered by the anchoring structure (8) when the arms (11) are in the closed position and said barbs being exposed to protrude outward when the arms (11) are in the open position.

15. Endoluminal sleeve device (1) according to any one of the preceding claims, in which the membrane (15) and the arms (1 1 ) in the closed position define an internal receiving space which receives and holds the sleeve (2) in a compacted configuration.

16. Method for anchoring an endoluminal sleeve (2) within a gastrointestinal tract, 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 a sleeve rim (34) formed at the proximal sleeve end

(4),

the method comprising:

- endoluminally inserting the sleeve (2) in the Gl tract and positioning the sleeve rim (34) in a target anchoring location;

- approximating a plurality of portions of the sleeve rim (34) to adjacent portions of surrounding tissue (35) of the Gl wall by applying suction to both the sleeve rim (34) and the tissue (35);

- attaching a plurality of individual fastening members (30, 31 , 32, 33) to the pairs of approximated tissue (35) and sleeve rim (34) portions.

17. Method according to claim 16, in which the step of applying the fastening members comprises applying the plurality of the fastening members simultaneously and in a plurality of different positions at the sleeve rim (34) and the step of approximating the sleeve rim (34) portions and tissue (35) portions by suction is performed simultaneously in a plurality of different positions at the sleeve rim (34).

18. Method according to claim 17, comprising:

- providing an applier (37) having a hollow flexible shaft (38) and a distal applier head (40) forming a plurality of acquisition cavities (41) at different circumferential positions, each acquisition cavity (41) forming a suction aperture (42) connected by a suction duct to an extracorporeal suction pump, and a fastener applier (43) arranged in each acquisition cavity (41);

- inserting an endoscope (39) through hollow shaft of the applier (37) and introducing the applier with the endoscope to the target anchoring location; - positioning the acquisition cavities (41) of the applier (37) so that each acquisition cavity (41) covers both a portion of the sleeve rim and a portion of the surrounding tissue;

- acquiring the tissue and sleeve rim portions together into the acquisition cavities (41) by applying suction through the suction apertures (42);

- while still applying suction, applying the fastening members by the fastener appliers (43) to the acquired tissue (35) and sleeve rim (34) portions from inside the acquisition cavities (41).

19. Method according to claim 18, wherein the fastening member comprises a split ring fastener (30) starting as a straightened piece of material with a sharpened tip and the fastener applier (43) has a curved forming member (44) and a driver (45) and wherein the step of applying the fastening member comprises:

- driving the straight fastener (30) by the driver (45) through the curved forming member (44) so the sharpened tip pierces the approximated sleeve rim (34) and tissue (35) portions and the fastener (30) is driven in a circular configuration.

20. Method according to claim 18, wherein:

- the fastening member is permanently elastically biased in a split ring shape (30; 31) and received inside the fastener applier (43) in a temporarily straightened shape,

- when the fastening member is driven out of the fastener applier (43) and through the approximated sleeve rim (34) and tissue (35), the fastening member elastically bends back in its original split ring shape.

21. Method according to claim 18, wherein each fastener applier (43) receives a plurality of fastening members (30) and the applier head (40) is rotated inside the Gl tract and sequentially applies groups of fastening members (30) in different circumferential positions of the sleeve rim (34).

22. Method according to claim 16, in which the step of applying the fastening members comprises applying the plurality of the fastening members sequentially in different positions at the sleeve rim (34) and the step of approximating the sleeve rim (34) portions and tissue (35) portions is performed sequentially in different positions at the sleeve rim (34).

23. Method according to claim 16, in which:

- the step of applying the fastening members comprises applying a clip (33) having opposite jaws (47) which permanently clamp the sleeve rim (34) portion and the tissue portion 35 together;

- the step of approximating the sleeve rim (34) portions and the tissue portions (35) comprises pulling, by suction, the sleeve rim (34) portion and the adjacent tissue portion (35) together between the opened jaws(47) of the clip (33).

24. Method according to claim 16, in which the step of applying the fastening members comprises:

- loading a double T-tag fastener (32) inside a hollow needle (49);

- piercing the hollow needle (49) through the approximated tissue (35) portion and sleeve rim (34) portion,

- expelling a first anchoring end (50) of the double T-tag fastener (32) from a tip of the hollow needel at a first side of the approximated tissue and sleeve rim portions, then withdrawing the hollow needle (49) from the approximated tissue and sleeve rim portions and expelling a second anchoring end (51) of the double T-tag fastener (32) from the tip of the hollow needle at an opposite second side of the approximated tissue and sleeve rim portions.

25. Method according to claim 16, in which the step of applying the fastening members comprises:

- applying T-tag fasteners (52) to different pairs of approximated tissue (35) and sleeve rim (34) portions, the T-tag fasteners (52) having a suture (53) extending therefrom,

- knotting together the sutures (53) of the applied T-tag fasteners (52) and purse string like tightening the sutures (53).

26. System for anchoring an endoluminal sleeve (2) in a Gl tract, the system comprising:

- split ring fasteners (30) starting as a straightened piece of material with a sharpened tip and deformable in a circular configuration,

- an applier (37) having a hollow flexible shaft (38) adapted for insertion over an endoscope (39), an applier head (40) arranged at a distal end of the shaft (38) and forming a plurality of acquisition cavities (41) at different circumferential positions, each acquisition cavity (41) forming a suction aperture (42) connected by a suction duct to a suction pump and operable to acquire a portion of the sleeve (2) and an adjacent portion of surrounding tissue in the acquisition cavity (41), and a fastener applier (43) arranged in each acquisition cavity (41) and adapted to drive the split ring fasteners (30) into the acquired portions of sleeve (2) and tissue to hold them together,

wherein the fastener applier (43) has a curved forming member (44) and a driver (45) adapted to drive the straight split ring fastener (30) through the curved forming member (44) so the fastener (30) is deformed in a circular configuration when exiting the fastener applier (43).

27. System for holding a portion of an endoluminal sleeve (2) in place within a Gl tract, the system comprising:

- an elastic ring (55) having a coiled compacted shape and an expanded annular shape and two free ends (56, 57) adapted to connect to each other when the elastic ring (55) is in the expanded annular shape, thereby locking the ring (55) in said expanded annular shape;

- an endoluminal ring applier (58) having a flexible insertion shaft (59) and a ring fastening head (60) arranged at a distal end (61) of insertion shaft (59), the ring fastening head (60) having an annular ring seat (62) adapted to receive the elastic ring (55) and a ring spreading mechanism (63) adapted to radially expand and retract the ring seat (62).

28. System according to claim 27, wherein the ring spreading mechanism (63) comprises a central slider (64) movable by a moving mechanism with respect to the ring seat (62) and a plurality of rigid spreading rods (65) having a proximal end hinged to the central slider (64) and a distal end hinged to the ring seat (62), such that a translation of the central slider (64) with respect to the ring seat (62) changes the angle between the spreading rods (65) and the slider (64), thereby radially expanding or retracting the ring seat (62).

29. System according to claim 27 or 28, wherein the sleeve portion is attached to the elastic ring (55).