WO2012072134A1

WO2012072134A1 - An endoluminal lining and a method for endoluminally lining a hollow organ

Info

Publication number: WO2012072134A1
Application number: PCT/EP2010/068665
Authority: WO
Inventors: David Cagle; Mark Steven Ortiz; Michele D'arcangelo; Jason Harris; Edward Anton; Michael A. Murray
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2010-12-01
Filing date: 2010-12-01
Publication date: 2012-06-07
Also published as: CN103237506A; CN103237506B

Abstract

An endoluminal lining (1) for internally lining a hollow organ comprises a flexible tubular sleeve body (3), at least one anchoring portion (6) formed at an end (4) of the sleeve body and provided for the connection of the sleeve body (3) to the hollow organ, a detaching zone (7) formed between the anchoring portion (6) and the sleeve body (3) and a pull-activatable detaching member (8) incorporated in the detaching zone (7) and forming an activating tab (9) such that, upon pulling the activating tab (9), the detaching member (8) causes breakage of the detaching zone (7) and separates the sleeve body (3) from the anchoring portion (6).

Description

"AN ENDOLUMINAL LINING AND A METHOD FOR ENDOLUMINALLY LINING

A HOLLOW ORGAN "

DESCRIPTION

FIELD OF THE INVENTION

The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for internally lining 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.

A known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position. To improve anchoring and stability of the sleeve, it is further known to provide the stent with barbs which penetrate the surrounding tissue.

This notwithstanding, it has been observed that the endoscopic sleeves tend to move inside the Gl tract and migrate away from their initially planned position. US patent n . 7,220,237 B2, Method and device for use in endoscopic organ procedures, to Gannoe et al. describes procedures for internally lining portions of the gastrointestinal tract, using tubular endoluminal sleeves and stapling devices for circumferentially acquiring tissue of the gastric wall and fixating a circular section of the acquired tissue to which an endoluminal sleeve is secured by shape interference.

However, the known methods and devices for endoluminally lining hollow organs, particularly sections of the gastrointestinal tract do not sufficiently address the needs and specific problems arising in case of removal, substitution or relocation of endoluminal sleeves.

Moreover, the known devices and methods do not sufficiently address the need of a good visual control and verification of the correct target site for anchoring the endoluminal sleeves as well as the need of visual control and position verification during removal of endoluminal sleeves.

Accordingly, there is a need for improved devices and procedures for removing endoluminal sleeves from the Gl tract.

SUMMARY OF THE INVENTION

The present invention provides for an improved lining system and method for the transoral, or endoscopic, positioning, anchoring and removal of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, portions of or the entire length of the intestinal tract, etc. , unless specified otherwise. I n 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.

At least part of the above identified needs are met by an endoluminal lining for internally lining a hollow organ, particularly a section of the gastrointestinal tract, the lining comprising a flexible tubular sleeve body extending between a proximal end and a distal end, at least one anchoring portion formed at one of said proximal end and distal end, the anchoring portion being provided for the connection of the sleeve body to the hollow organ, a detaching zone formed between the anchoring portion and the sleeve body and a pull-activatable detaching member incorporated in the detaching zone and having at least one activating tab extending inside the sleeve, wherein the detaching zone and the detaching member are configured such that, upon pulling the activating tab, the detaching member will cause breakage of the detaching zone and separate the sleeve body from the anchoring portion.

This makes it possible, during removal of the endoluminal lining, to precisely separate the sleeve body from the anchoring portion in a predetermined detaching zone of the lining, by simply pulling the activating tab endoluminally from inside the lining.

In accordance with an aspect of the invention, the detaching zone is made weaker than the adjacent anchoring portion and sleeve body, e.g. by perforation or pre- fracturing, such that a tearing force acting on both the detaching zone and the adjacent anchoring portion and tubular sleeve body will cause rupture along a preprogrammed breaking path in the detaching zone.

In accordance with another aspect of the invention, the detaching zone forms a ri n g s h a ped wa l l a n d th e d etach i n g m em ber com pri ses a cutti n g wi re circumferentially extended along the wall and connected with the at least one activating tab such that, upon pulling the activating tab, the cutting wire cuts through the ring wall, thereby detaching the sleeve body from the anchoring portion.

In accordance with another aspect of the invention, the at least one activating tab lays flush against an internal surface of the lining to not obstruct the passage of food through the lined section of the Gl tract.

In accordance with a yet further aspect of the invention, the at least one activating tab is brightly colored and therefore easily identifiable with an endoscope.

In accordance with a further aspect of the invention, the lining may be anchored and removed by an endoluminal applier having a staple fastening assembly with a cartridge device which houses at least one closed annular row of staples and which forms a first clamping surface, and an anvil which forms a staple forming surface and a second clamping surface facing the first clamping surface. The anvil is movable relative to the cartridge device and is adapted to cooperate with the cartridge device for clamping a ring shaped tissue portion between the first and second clamping surfaces and forming the ends of the staples exiting from the cartridge device. The staple fastening assembly comprises a ring shaped lining seat adapted to receive the lining in a longitudinally compacted (annulus) shape and to hold the anchoring portion of the lining to overlap one of the clamping surfaces and the annular row of staples. The applier comprises a tissue acquisition mechanism having mechanical graspers adapted to acquire a substantially ring shaped tissue portion of the hollow organ in the space between the first and second tissue clamping surfaces, wherein the graspers are further adapted to grasp and pull the at least one activating tab of the lining.

The applier assures a correct relative positioning of the anchoring portion of the lining, the row of staples and the clamping surfaces. Moreover, the positioning of the lining on the lining seat takes place extracorporeal^ and does not change during endoluminal insertion of the applier and during stapling. The gaspers of the tissue acquisition mechanism are adapted to grasp and pull also the activating tab from inside the lining, so that the anchoring and the removal of a lining may be accomplished using the same devices, procedural steps and skills.

In accordance with a further aspect of the invention, the staple fastening assembly of the applier forms a central channel extending longitudinally through the cartridge device and through the anvil and opening laterally into the space between the first and second clamping surfaces, the central channel being adapted for the passage of an endoscope to visualize both the space between the first and second clamping surfaces and the space distally ahead of the staple fastening assembly and , possibly, to slide the applier endoluminally along said endoscope to a target site in the hollow organ.

The applier allows an improved guidance through the Gl tract and continuous visualization by the endoscope received in the central channel, both during endoluminal insertion and withdrawal of the applier, during tissue acquisition and fastening of the staples (when anchoring the lining) and during grasping and pulling the activating tab of the lining intended to be removed.

At least part of the above identified needs are further met by a method for applying and removing a tubular lining from a hollow organ, particularly to a section of the gastrointestinal tract, comprising the steps of providing a lining having a flexible tubular sleeve body, an anchoring portion and a pull-activatable detaching member formed between the anchoring portion and the sleeve body, inserting the lining endoluminally in the hollow organ and anchoring the anchoring portion of the lining to the wall of the hollow organ and, after a period of time, removing the tubular sleeve body from the hollow organ by endoluminally accessing the lining near the anchoring portion, grasping the detaching member and pulling the detaching member to separate the sleeve body from the anchoring portion.

In accordance with an aspect of the invention, the step of pulling the detaching member comprises supporting the anchoring portion and the tubular sleeve body against the direction of pulling the detaching member.

In accordance with a further aspect of the invention, the step of removing the tubular sleeve from the hollow organ comprises pulling the tubular sleeve body through a channel of a transorally placed endoluminal device.

In accordance with a further aspect of the invention, the step of inserting and deploying the lining in the hollow organ comprises attaching the lining to an applier such that the anchoring portion is held to overlap at least one fastener of the applier, endoluminally placing the applier with the attached lining, the fastener and an endoscope into the hollow organ, using the endoscope to obtain visibility of an area suitable for the application of the fastener, applying the fastener to the suitable area of the hollow organ by extending the fastener through the anchoring portion of the lining into a lumen wall, thereby attaching the lining to the suitable area of the hollow organ.

In accordance with an aspect of the invention, the method comprises the steps of attaching the lining to the applier in a way that the tubular sleeve body of the lining is held i n a col la psed (su bstantial ly ri ng shaped ), e. g . wrapped , folded , compressed or rolled up, configuration with regard to a lining longitudinal extension and, after fastening the lining to the hollow organ, pulling the tubular sleeve body to unfold it from the collapsed configuration to an extended (substantially elongate tubular shape) configuration.

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.

DESCRIPTION OF THE DRAWINGS

- Figure 1 illustrates a tubular lining after anchoring and full extension within a section of the Gl tract;

- Figure 2 illustrates different possible positions of a tubular lining within the Gl tract of a patient;

- Figure 3 is a perspective longitudinal section of a lining anchored in a section of the Gl tract in accordance with an embodiment;

- Figure 4 is a perspective partial view of a lin i ng i n accordance with an embodiment;

- Figure 4A, 4B and 4C are schematic views of a detaching member of the lining in accordance with embodiments of the invention;

- Figure 5 is a perspective partial view of a lining in accordance with a further embodiment;

- Figures 6 and 7 illustrate an especially adapted endoluminal applier equipped with a lining to be anchored in a hollow organ in a closed and open configuration; - Figure 8 illustrates the transoral introduction of the applier of figure 6 to the duodenum;

- Figures 9 through 1 1 illustrate steps of a method for endoluminally removing the lining from the Gl tract by means of the applier of figure 6.

- Figures 12 through 14 illustrate steps of a method for endoluminally positioning and anchoring the lining in a target site of the Gl tract by means of the applier of figure 6.

DETAILED DESCRIPTION OF EMBODIMENTS

Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views, figures 1 to 5 depict an endoluminal lining 1 for internally lin ing a hollow organ , particu larly a section of th e gastrointestinal tract 2. The lining 1 comprises a flexible tubular sleeve body 3 extending between a proximal end 4 and a distal end 5 and at least one anchoring portion 6 formed at one of said proximal end 4 and distal end 5. The anchoring portion 6 is provided for the connection, e.g. by stapling, of the sleeve body 3 to the hollow organ. A detaching zone 7 is formed between the anchoring portion 6 and the sleeve body 3 and a pull-activatable detaching member 8 is incorporated in the detaching zone 7 and forms at least one activating tab 9 extending inside the lining 1 . The detaching zone 7 and the detaching member 8 are configured such that, upon pulling the activating tab 9, the detaching member 8 will cause breakage of the detaching zone 7 and separate the sleeve body 3 from the anchoring portion 6. This makes it possible, during removal of the endoluminal lining, to precisely separate the sleeve body from the anchoring portion in a predetermined detaching zone of the lining, by simply pulling the activating tab endoluminally from inside the lining.

In accordance with an embodiment, the detaching zone 7 forms an annular wall which is made weaker than the adjacent annular or tubular anchoring portion 6 and sleeve body 3, such that a tearing force acting on both the detaching zone 7 and the adjacent anchoring portion 6 and sleeve body 3 will cause rupture along a preprogrammed breaking path in the detaching zone 7.

For this purpose, the detach ing zone 7 may comprise a perforation or pre- fracturing 10.

Alternatively or additionally, the detaching member 8 may comprises a cutting wire 1 1 circumferentially extended along the ring wall 12 of the detaching zone 7 and connected with the at least one activating tab 9 such that, upon pulling the activating tab 9, the cutting wire 1 1 cuts through the ring wall 12, thereby detaching the sleeve body 3 from the anchoring portion 6. Particularly, the cutting wire 1 1 may be extended on an external surface 13 of the annular wall 12 and one or both end portions of the cutting wire 1 1 , which form the activating tabs 9, extend through the wall 12 and emerge from an internal surface 14 thereof. A protection layer or stripe 15 may be provided on the external surface 13, which covers the cutting wire 1 1 and isolates it from the surrounding tissue of the hollow organ.

In accordance with an embodiment, the annular wall 12 may be stiffened against radial inward deformation, e.g. by means of a rigid stiffening ring 1 6 arranged adjacent to the cutting wire 1 1 and adapted to resist the pulling force transmitted by the cutting wire 1 1 to the detaching zone 7 in order to preserve the shape of the detaching zone 7 during cutting. The stiffening ring 16 provides a substantially rigid support which helps the cutting wire 1 1 to accomplish a precise and clean cut through the annular wall 12. The stiffening ring 16 may be made of plastic or metal plate, wire or mesh material integrated in the detaching zone 7 or attached, e.g. glued, to its internal 14 or external surface 13.

In accordance with embodiments, both end portions 17, 18 of the cutting wire 1 1 may be extended through a strangling ring 19 and connected to a common activating tab 9 or to two different activating tabs 9 (Figure 4A) so that, during pulling the common activating tab 9 or both activating tabs 9, the cutting wire 1 1 is tightened and, during cutting, strangles the annular wall 12 against the strangling ring 19.

Alternatively, one end portion 1 7 of the cutting wire 1 1 is tensile resistant connected to a strangling ring 19 and the opposite end portion 18 of the cutting wire 1 1 is extended through the strangling ring 19 and connected to an activating tab 9 (Figure 4B) so that, during pulling the only activating tab 9, the cutting wire 1 1 is tightened and, during cutting, tears the annular wall 12 and strangles the latter against the strangling ring 19.

In accordance with a yet further embodiment, both end portions 1 7, 1 8 of the cutting wire 1 1 are placed through the annular wall 12 to overlap each other and connected to a common activating tab 9 or to two different activating tabs 9 (Figure 4C) so that, during pulling the common activating tab 9 or both activating tabs 9, the cutting wire 1 1 cuts through the annular wall 12 without tightening.

In order not to obstruct the passage of food or chime through the lining 1 , the at least one activating tab 9 is arranged to lay flush against the internal surface 13 of the lining 1 and, to this end, may be detachably glued to the annular wall 12.

Moreover, the activating tab 9 may be brightly colored, e.g . green or blue, in contrast with the color of the inside of the lining and therefore easily identifiable with an endoscope. The activating tab 9 may comprise a roughened and preferably deformable, e.g. rubber, polyethylene or silicone, portion which can be easily grasped without slipping away. The activating tab 9 may also form a ring or noose to facilitate grasping or latching of the detaching member 8 during removal of the sleeve body 3.

I n the exemplary embodiment shown in figure 5, the detaching member 8 comprises a pull resistant tearing stripe 20 extending about the circumference of the annular wall 12 and connected thereto in a region distal to the weakened zone 10. Upon pulling the activating tab 9, the tearing stripe 20 rips the weakened zone 10 thereby detaching the tubular sleeve body 3 from the anchoring portion 6. Advantageously, the detaching zone 7 is configured such that the detaching member 8 remains connected to the sleeve body 3 after detaching it from the anchoring portion 6. In this way the detached sleeve body 3 can be further manipulated and removed from the body by acting on the activating tabs 9 which are already held by an endoluminal instrument and, hence, under control.

In accordance with an embodiment, the anchoring portion 6 of the lining 1 may comprise holes or locally weakened points for the passage of one or more fasteners, such as staples 24, for the fixation of the lining 1 to the wall of the hollow organ 2. For example, the anchoring portion 6 may define a plurality of pairs of staple passage holes 37 (Figure 5) for receiving the two legs of respectively one individual staple.

This makes it possible to make the anchoring portion 6 of a resistant, e.g. semirigid material and to fixate it to the lumen wall using conventional surgical staples which need not be adapted to penetrate through the entire thickness of the comparatively resistant material.

The hitherto described lining 1 may be advantageously anchored and removed by an endoluminal applier 21 having a staple fastening assembly 22 with a cartridge device 23 which houses at least one closed annular row of staples 24 and which forms a first clamping surface 25, and an anvil 26 which forms a staple forming surface 27 and a second clamping surface 28 facing the first clamping surface 25. The anvil 26 is movable relative to the cartridge device 23 and is adapted to cooperate with the cartridge device 23 for clamping a ring shaped tissue portion 29 between the first 25 and second 28 clamping surfaces and forming the ends of the staples 24 exiting from the cartridge device 23. The staple fastening assembly 22 comprises a ring shaped lining seat 30 adapted to receive the lining 1 i n a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and to hold the anchoring portion 6 of the lining 1 to overlap one of the clamping surfaces 25, 28 and the annular row of staples 24. The applier 21 comprises a tissue acquisition mechanism having mechanical graspers 31 adapted to acquire the ring shaped tissue portion 29 of the hollow organ in the clamping space 32 between the first and second clamping surfaces 25, 28, wherein the graspers 31 are further adapted to grasp and pull the at least one activating tab 9 of the lining 1.

The thus configured applier 21 can hence be used for endoluminally positioning and anchoring the sleeve 1 and also for removing the sleeve body 3 of a previously placed lining. During endoluminal positioning and deploying, the applier 21 assures a correct relative positioning of the anchoring portion 6 of the lining 1 , the row of staples 24 and the clamping surfaces 25, 28. The positioning of the lining 1 on the lining seat 30 can take place extracorporeal^ and does not change during endoluminal insertion of the applier 21 and during stapling. The gaspers 31 of the tissue acquisition mechanism are adapted to grasp and acquire the tissue in preparation of the fastening of the lining 1 to the hollow organ and the same graspers 31 are arranged and adapted pull the activating tab 9 during removal of the sleeve body. Therefore, the anchoring and the removal of a lining can be accomplished using the same devices, procedural steps and skills.

In accordance with an embodiment, the staple fastening assembly 22 forms a central channel 33 extending longitudinally through the cartridge device 23 and through the anvil 26 and opening laterally into the clamping space 32 between the first and second clamping surfaces 25, 28. The central channel 33 is adapted for the passage of an endoscope 34 to enable visualization of both the clamping space 32 and the space distally ahead of the staple fastening assembly 22 and, possibly, to slide the entire applier 21 or at least the staple fastening assembly 22 endoluminally along the endoscope 34 to a target site in the hollow organ 2 or to guide the entire applier 21 or at least the staple fastening assembly 22 by means of the endoscope 34 endoluminally to such target site.

The thus configured applier 21 allows an improved guidance through the Gl tract and continuous visualization by the endoscope 34 received in the central channel 33, both during endoluminal insertion and withdrawal of the applier 21 , during tissue acquisition and fastening of the staples (when anchoring the lining) and during grasping and pulling the activating tab of the lining intended to be removed. In accordance with embodiments, the endoscope 34 can be a flexible standard endoscope or a component of the applier 21 especially configured to fit in the central channel 33 thereof and to perform, additional to visualization and guidance, the above described grasping and pulling functions.

In accordance with an embodiment, the staple fastening assembly 22 may be provided at a distal end 35 of a flexible hollow shaft 36 through which the central channel 33 extends proximally to a proximal aperture thereof (not shown in the figures) and which can be completely inserted over the endoscope 34. Alternatively, only the staple fastening assembly 22 of the applier 21 is adapted to receive the endoscope 34 within the central channel 33 and to be guided by the endoscope 34 to the target site for anchoring the lining 1 and the flexible shaft 36 may be adapted to extend laterally of the endoscope shaft 36. However, the cartridge device 23 with the first clamping surface 25 and the anvil 26 with the second clamping surface 28 define both a complete closed annulus around the central channel 33 so that a continuous annular staple line is obtainable by a single tissue clamping and staple firing step.

The graspers 31 are arranged to grasp the activating tab 9 and pull it into the clamping space 32 between the cartridge device 23 and the anvil 26 and, possibly, from the clamping space 32 further into the central channel 33 through which the detached sleeve body 3 can be removed transorally from the body without any contact with the Gl tract proximal of the anchoring site.

The applier may be further configured in a way that, during pulling the activating tab 9 of the lining 1 , the anvil 26 can be or is approximated towards the cartridge device 23, without however clamping the detaching member 8, so that a support is provided against which the detaching zone 7 of the lining 1 abuts while it is ripped or cut through.

The graspers 31 may be arranged in the staple fastening assembly 22 between the central channel 33 and the row of staples 24, i.e. radially external of the central channel 33 and radially internal of the annular row of staples 24. In this way, the central channel 33 is not obstructed by the graspers 31 and allows unobstructed access and visualization by the endoscope 34 during tissue acquisition and also during sleeve removal. Alternatively, the graspers 31 and the endoscope 34 may be configured to be received together and contemporaneously in the central channel 33, e.g. by passing the grasper or graspers 31 through an instrument channel 38 of the endoscope 34 while the endoscope 34 is received in the central channel 38 of the staple fastening assembly 22.

The graspers 31 can be connected through one or more acquisition activation movement transmitters with an extracorporeal acquisition activation mechanism provided e.g. at a proximal handle portion of the applier 21 or near a proximal end portion of the endoscope 34.

Figures 12 through 14 illustrate a method of anchoring the lining 1 to the hollow organ, using the applier 21 , in which at least one, preferably a plurality of pairs of graspers 31 are arranged and operable to move from the clamping space 32 radially outward and grasp opposite portions of tissue of the hollow organ and pull the grasped portions of tissue into the clamping space 32, for instance by partial or complete withdrawal of the graspers 31 inside the cartridge device 23.

Analogously, figures 9 through 1 1 illustrate a method of removing the sleeve body 3 from the hollow organ, using the same applier 21 , in which at least one grasper 31 is arranged and operable to move from the clamping space 32 radially outward and grasp the activating tab 9 and pull the grasped activating tab 9 into the clamping space 32, for instance by partial or complete withdrawal of the graspers 31 inside the cartridge device 23.

In accordance with an embodiment, the lining seat 30 may comprise holding pins 39 arranged in the second clamping surface 28 of the anvil 26 and adapted to hold the anchoring portion 6 in its correct position until it is withdrawn from the anvil by an external force, e.g. during withdrawal of the anvil 26 from the anchored sleeve 1 .

In accordance with an embodiment, the holding pins 39 may be elastically biased in a protracted position in which they protrude out of the second clamping surface to engage and , possibly, hold the anchoring portion 6 in its correct position. Advantageously, the anchoring portion 6 has a radially deformable ring shape and is held by the lining seat 30 in a radially retracted shape to facilitate endoluminal insertion.

Alternatively, a clamping edge (not illustrated) may be provided near the second clamping surface 28 of the anvil 26 to hold the anchoring portion 6 in its correct position, in which the clamping edge is elastically supported or magnetically biased in order to resiliency hold the anchoring portion 6 and allow a relatively easy detachment of the latter.

The applier 21 comprises an anvil moving mechanism connected through one or more flexible anvil movement transmitters with an extracorporeal anvil movement activation mechanism provided e.g. at a proximal handle portion of the applier 21 , as well as a staple driving mechanism adapted to drive the staples 24 distally out of the staple slots and against the staple forming surface of the anvil.

Also the staple driving mechanism is connected through one or more flexible driving movement transmitters with an extracorporeal staple firing mechanism provided e.g. at a proximal handle portion of the applier. Both the anvil movement transmitters and the driving movement transmitters are arranged inside the flexible shaft 36.

The lining 1 may be formed of any suitable biocompatible graft material such as polyester or PTFE, rubber, Teflon, Nylon, Dacron, polyethylene, polystyrene, polyurethane, polyethylene terephtalate, etc.

DETAILED DESCRIPTION OF A METHOD OF LINING A HOLLOW ORGAN AND

REMOVING THE LINING FROM THE HOLLOW ORGAN

A clinical work-up, including a physical and mental assessment of the patient may be performed to determine whether a transoral deployment and anchoring of an endosleeve is clinically indicated. This assessment may include inspecting the esophagus and stomach of the patient to determine whether any contraindications exist for undertaking the procedure such as ulcerations, obstructions, or other cond itions that may precl ude treatment. Once the assessment has been completed, either in an operating room with the patient under general anesthesia, or in an endoscopy suite with the patient under sedation, the operator can prepare the applier 21 with the, possibly radially retracted, lining 1 placed over the lining seat 30, as shown in FIG. 6, and slide the applier 21 over the endoscope 34 to guide it under endoscopic visualization down the patient's esophagus and stomach to a target location in the Gl tract, e.g. in the duodenum. Once in place, the physician uses the endoscope 34 placed in the central channel of the applier 21 to view and select an area suitable for the application of the fastener, i.e. the staples. FIGS. 12 through 14 illustrate the following method steps and action of the applier within the target section of intestine.

Once the applier is positioned in the selected anatomical location, the staple fastening assembly is opened by distal movement of the anvil, to expose the clamping space to the surrounding tissue within the duodenum and the tissue acquisition graspers 31 may be activated and tissue may be drawn into the clamping space in an entirely circumferential manner or a su bstantially circumferential manner, i.e., at least partially about the circumference of the applier at some point less than 360 degrees relative to a longitudinal axis of the applier. The entire tissue acquisition step may be directly endoscopically visualized thanks to the central channel opening into the clamping space.

After the desired amount of tissue has been acquired into the clamping space, anvil 26 and cartridge device 23 may be moved towards one another such that the acquired tissue ring is clamped therebetween. The staple driving mechanism of applier 21 is then actuated to engage the annular closed row of staples or fastening element through the acquired tissue ring and through the anchoring portion 6 of the lining 1 which is arranged on the anvil to overlap the second clamping surface and the staple position, thereby fastening the lining 1 in place in a circumferential fashion. Subsequently, the ring shaped anchoring place can be directly endoscopically visualized by passing the endoscope 34 distally through the anvil. Then, applier 21 is removed. In doing so, the anvil of the applier 21 is carefully pulled through the newly-created ring or plication of stapled tissue and anchoring portion of the lining, leaving the latter in place. Then, the tubular sleeve body 3 can be pulled distally to unfold it from the collapsed configuration to an extended substantially elongate tubular shape configuration.

After a certain period of time, the tubular lining may be endoluminally removed from the hollow organ by endoluminally inserting the applier 21 in the above described manner and placing it inside the lining near the anchoring portion.

Once in place, the physician uses the endoscope 34 placed in the central channel of the applier 21 to identify the colored activating tab or tabs 9

FIGS. 9 through 1 1 illustrate the following method steps and action of the applier within the target section of intestine.

Once the applier is positioned in the correct location for grasping the activating tab 9, the staple fastening assembly is opened by distal movement of the anvil, to expose the clamping space to the surrounding lining and the graspers 31 are operated to grasp the activating tabs and pull them into the clamping space, while the anvil and cartridge device may act as support against which the lining abuts whilst the detaching member, e.g. a cutting wire cuts through the detaching zone and separates the sleeve body from the anchoring portion. The entire detaching step may be directly endoscopically visualized thanks to the central channel opening into the clamping space.

It is now possible to pull the entire sleeve body into the central channel of the applier and out of the body without any contact between the soiled sleeve body and the Gl tract proximal to the anchoring site. Since the sleeve body remains attached to the activating tabs, the graspers, which still hold the activating tabs, can be pulled proximally into the central channel of the applier and out of the patients body, so that the removed sleeve body is dragged behind. In this way a bypass conduit may be purposefully created and removed 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 procedures and devices help to mimic the effects of gastric bypass in resolution of type 2 diabetes and facilitating weight loss, improve glycemic control and reduce or eliminate other co-morbidities of severe obesity. Moreover, the described procedures and devices may be advantageously used in conjunction with other therapeutic regimes for the treatment of type 2 diabetes and its co-morbidities and address the patients fear of invasive surgery. Last but not least, the described procedures and devices allow a reversible procedure with an easy removal and replacement of the endoluminal sleeve once the desired effect has been achieved or a modification of the endoluminal lining is desired.

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. An endoluminal lining (1 ) for internally lining a hollow organ, particularly a section of the gastrointestinal tract (2), the lining (1 ) comprising:

- a flexible tubular sleeve body (3) extending between a proximal end (4) and a distal end (5),

- at least one anchoring portion (6) formed at one of said proximal end (4) and distal end (5) and provided for the connection of the sleeve body (3) to the hollow organ,

- a detaching zone (7) formed between the anchoring portion (6) and the sleeve body (3), and

- a pull-activatable detaching member (8) incorporated in said detaching zone (7), said detaching member forming at least one activating tab (9) extending inside the lining (1 ), wherein said detaching member (8) is configured such that, upon pulling the activating tab (9), the detaching member (8) causes breakage of the detaching zone (7) and separates the sleeve body (3) from the anchoring portion (6).

2. An endoluminal lining (1 ) according to claim 1 , in which the detaching zone (7) forms an annular wall which is made weaker than the adjacent anchoring portion (6) and sleeve body (3), such that a tearing force acting on both the detaching zone (7) and the adjacent anchoring portion (6) and sleeve body (3) will cause rupture along a preprogrammed breaking path in the detaching zone (7).

3. An endoluminal lining (1 ) according to claim 2, in which the detaching zone (7) comprises a pre-fractured line (10).

4. An endoluminal lining (1 ) according to claim 1 or 2, in which the detaching member (8) comprises a cutting wire (1 1 ) circumferentially extended along a ring wall (12) of the detaching zone (7).

5. An endoluminal lining (1 ) according to claim 4, in which the cutting wire (1 1 ) is extended on an external surface (13) of the annular wall (12) and one or both end portions of the cutting wire (1 1 ) extend through the ring wall (12) and emerge from an internal surface (14) thereof.

6. An endoluminal lining (1 ) according to claim 4 or 5, in which the annular wall 12 is stiffened against radial inward deformation by means of a rigid stiffening ring (16) arranged adjacent to the cutting wire (1 1 ).

7. An endoluminal lining (1 ) according to any one of claims 4 to 6, in which two opposite end portions (17, 18) of the cutting wire (1 1 ) extend through a strangling ring (19) and are connected to at least one activating tab (9) such that, during pulling the activating tab (9), the cutting wire (1 1 ) strangles and cuts the annular wall (12) against the strangling ring (19).

8. An endoluminal lining (1 ) according to any one of claims 4 to 6, in which one end portion (17) of the cutting wire (1 1 ) is tensile resistant connected to a strangling ring (19) and an opposite end portion (18) of the cutting wire (1 1 ) is extended through the strangling ring (19) and connected to the activating tab (9) so that, during pulling the activating tab (9), the cutting wire (1 1 ) cuts and strangles the annular wall (12) against the strangling ring (19) and, after completion of the cut, pulls also the strangling ring itself.

9. An endoluminal lining (1 ) according to any one of claims 4 to 6, in which two opposite end portions (1 7, 1 8) of the cutting wire (1 1 ) are placed through the annular wall (12) to overlap each other and connected to said at least one activating tab (9) so that, during pulling the activating tab (9), the cutting wire (1 1 ) cuts through the annular wall (12) without tightening it.

10. An endoluminal lining (1 ) according to any one of the preceding claims, in which the activating tab (9) is arranged to lay flush against an internal surface (13) of the lining (1 ).

11. An endoluminal lining (1 ) according to any one of the preceding claims, in which the activating tab (9) is brightly colored in contrast with the color of the inside of the lining (1 ).

12. An endoluminal lining (1 ) according to claim 2, in which the detaching member (8) comprises a pull resistant tearing stripe (20) extended about the circumference of the annular wall (12) and connected thereto in a region distal to said weakened zone (10), said tearing stripe (20) being configured to rip the weakened zone (10) in response of pulling the activating tab (9).

13. An endoluminal lining (1 ) according to any one of the preceding claims, in which the detaching zone (7) is configured such that the detaching member (8) remains connected to the sleeve body (3) after its separation from the anchoring portion (6).

14. An endoluminal lining system, comprising the lining (1 ) according to any one of the preceding claims, and

an endoluminal applier (21 ) having:

- a staple fastening assembly (22) with a cartridge device (23) housing at least one closed annular row of staples (24) and forming a first clamping surface (25), and an anvil (26) forming a staple forming surface (27) and a second clamping surface (28) facing the first clamping surface (25), the anvil (26) being movable relative to the cartridge device (23) and adapted to cooperate with the cartridge device (23) for clamping a tissue portion (29) between the first (25) and second (28) clamping surfaces and forming the ends of the staples (24) exiting from the cartridge device (23),

- an annular lining seat (30) adapted to receive the lining (1 ) in a collapsed configuration with regard to a lining longitudinal extension an d to hold th e anchoring portion (6) of the lining (1 ) to overlap one of the clamping surfaces (25, 28) and the annular row of staples (24),

- at least one grasper (31 ) adapted to acquire the tissue portion (29) of the hollow organ in the clamping space (32) between the first and second clamping surfaces (25, 28) and to grasp and pull the at least one activating tab (9) of the lining (1 ).

15. An endoluminal lining system according to claim 14, in which said staple fastening assembly (22) forms a central channel (33) extending longitudinally through the cartridge device (23) and through the anvil (26) and opening laterally into the clamping space (32) between the first and second clamping surfaces (25, 28), said at least one grasper (31 ) being adapted to pull said activating tab (9) into said central channel (33).

16. A method for applying and removing a tubular lining from a hollow organ, particularly to a section of the gastrointestinal tract, the method comprising the steps:

- providing a lining having a flexible tubular sleeve body, an anchoring portion and a pull-activatable detaching member formed between the anchoring portion and the sleeve body,

- inserting the lining endoluminally in the hollow organ and anchoring the anchoring portion of the lining to the wall of the hollow organ, and

- after a period of time, removing the tubular sleeve body from the hollow organ by endoluminally accessing the lining near the anchoring portion , grasping the detaching member and pulling the detaching member to separate the sleeve body from the anchoring portion.

17. A method according to claim 16, in which the step of pulling the detaching member comprises supporting the anchoring portion and the tubular sleeve body against the direction of pulling the detaching member.

18. A method according to claim 16, in which the step of removing the tubular sleeve from the hollow organ comprises pulling the tubular sleeve body through a channel of a transorally placed endoluminal device.

19. A method according to claim 16, in which the step of anchoring the lining in the hollow organ comprises:

- attaching the lining to an applier such that the anchoring portion is held to overlap at least one fastener of the applier,

- endoluminally placing the applier with the attached lining, the fastener and an endoscope into the hollow organ,

- using the endoscope to obtain visibility of an area suitable for the application of the fastener,

- applying the fastener to the suitable area of the hollow organ by extending the fastener through the anchoring portion of the lining into a lumen wall, thereby attaching the lining to the suitable area of the hollow organ.

20. A method according to claim 19, comprising:

- attaching the lining to the applier in a way that the tubular sleeve body of the lining is held in a collapsed configuration with regard to a lining longitudinal extension, and

- after fastening the lining to the hollow organ, pulling the tubular sleeve body to unfold it from the collapsed configuration to an extended elongate tubular shape.