WO2012072137A1

WO2012072137A1 - An endoluminal lining system and a method for endoluminally lining a hollow organ

Info

Publication number: WO2012072137A1
Application number: PCT/EP2010/068669
Authority: WO
Inventors: Michele D'arcangelo; Thomas Edward Albrecht; Alessandro Pastorelli; Jason Harris; Edward Anton; Michael A. Murray; Federico Bilotti; Martin Fried
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2010-12-01
Filing date: 2010-12-01
Publication date: 2012-06-07

Abstract

An endoluminal lining system for internally lining a hollow organ, particularly a section of the gastrointestinal tract, comprises an endoluminal docking station (2) with an anchoring flange (3) adapted to be permanently anchored to a wall (4) of the hollow organ and at least one coupling wall (5),at least one tubular lining (6) extending between a proximal end (7) and a distal end (8) and having at least one coupling portion (9) formed near one of the proximal end (7) and distal end (8), wherein the coupling portion is configured to reversibly connect to the coupling wall (5) of the docking station (2).

Description

"AN ENDOLUMINAL LINING SYSTEM 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 positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to "tie off" or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.

Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to severely obese patients (morbid obesity, Body Mass I ndex >=40) due to their complications, including the risk of death, leaving patients who are considered obese or moderately obese with few, if any, interventional options.

In addition to the above described gastrointestinal reduction surgery, endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine.

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 placing and securing endoluminal linings within hollow organs, particularly within the gastrointestinal tract, are not yet satisfactory with regard to a safe and reliable introduction, positioning and anchoring of the sleeve and with regard to the conservation of its planned position. Moreover, the known devices and methods 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 creating sealed or leak tight connection regions between the endoluminal sleeve and the hollow organ in order to obtain a desired flow scheme of the food flow and the flow of bodily fluids, such as gastric juices, bile and pancreatic fluid.

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.

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

SUMMARY OF THE INVENTION

The present invention provides for an improved apparatus and method for the transoral, or endoscopic, positioning and anchoring 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. 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.

At least part of the above identified needs are met by a method for applying a tubular lining to a hollow organ, particularly to a lumen of the gastrointestinal tract, comprising the steps of providing an endoluminal docking station having an anchoring flange and a coupling wall, further providing a tubular lining having a coupling portion for a reversible connection to the coupling wall of the docking station, inserting the docking station endoluminally in the hollow organ and anchoring the anchoring flange of the docking station to the wall of the hollow organ and, subsequently, inserting the lining endoluminally in the hollow organ and connecting the coupling portion of the lining to the coupling wall of the docking station to anchor the lining in the hollow organ.

This makes it possible to configure and optimize the lining for its barrier function and the docking station for the anchoring to the tissue wall. Moreover the reversible connection between the lining and the permanently deployed docking station facilitate the removal and the substitution of the lining within the hollow organ without any need to invasively manipulate the tissue wall.

In accordance with an aspect of the invention, the step of inserting and deploying the docking station comprises

attaching the docking station to an applier such that the anchoring flange is held to overlap at least one fastener of the applier, endoluminally placing the applier with the attached docking station, 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 flange of the docking station into a lumen wall, thereby attaching the docking station to the suitable area of the hollow organ.

This assures a correct relative positioning of the anchoring flange and the fastener. Moreover, the positioning of the docking station on the applier takes place extracorporeally and does not change during endoluminal insertion of the applier and, possibly, during stapling.

In accordance with an aspect of the invention, the method comprises the steps of attaching the tubular lining to an applier in a way that an elongate body portion of the lining is held in a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension, endoluminally placing the applier with the attached tubular lining and an endoscope into the hollow organ, using the endoscope to obtain visibility of the docking station, holding the coupling portion of the lining exposed while moving the coupling portion in engagement with the coupling wall thereby connecting them to one another and, then, pulling the attached tubular lining distally to unfold it from the collapsed configuration to an extended (substantially elongate tu bular shape)configuration.

I n accordance with a further aspect of the invention , the wall of the lumen is partially inverted to create the suitable area for the application of the at least one fastener and, possibly, the fastener is extended to penetrate at least two adjacent layers of tissue arranged by partially inverting the wall of the lumen.

This provides a reliable and resistant anchoring of the docking station in the hollow organ.

In accordance with a further aspect of the invention, after a certain period of time, the tubular lining is removed endoscopically from the docking station and replaced by another tubular lining without invasively manipulating the wall of the hollow organ. I n this way, exhausted or soiled linings can be easily replaced by fresh linings and the total length of the lined section of the Gl tract can be varied by replacing an existing lining with a fresh lining of a different length.

In accordance with a further aspect of the invention, a proximal lining is connected to the docking station and extended proximally therefrom and a distal lining is connected to the docking station and extended distally therefrom. Moreover, a plurality of docking stations may be anchored within the hollow organ at planned distances and a plurality of linings may be arranged to extend in series between said docking stations. This provides a high flexibility of therapy with regard to the selection and modification of the regions in which the contact between the food flow and the Gl tract is prevented.

In accordance with a further aspect of the invention, the coupling portion of the lining and the coupling wall are magnetically connected to one another. This facilitates both a coupling operation which doesn't require particular movements by the applier and a mutual self alignment of the lining coupling portion with respect to the coupling wall of the docking station.

In accordance with a yet further aspect of the invention, the method comprises the steps of holding the docking station on the applier in a radially compacted or collapsed shape during endoluminal placement and, after fastening the docking station to the hollow organ, expanding the docking station radially, thereby allowing it to adapt to the dimension of the hollow organ and to follow its radial movements, e.g. peristalsis, at least within certain limits.

At least part of the above identified needs are also met by an endoluminal lining system for i nternal ly l i n i ng a h ol low organ , particu larly a section of the gastrointestinal tract, the system comprising an endoluminal docking station with an anchoring flange adapted to be permanently anchored to a wall of the hollow organ and at least one coupling wall, and at least one tubular lining extending between a proximal end and a distal end, the lining having at least a coupling portion near one of the proximal end and distal end, wherein the coupling wall and the coupling portion are configured to reversibly connect to each other.

I n accordance with a further aspect of the invention , the coupling wall of the docking station and the coupling portion of the lining are magnetically attracted to each other.

I n accordance with another aspect of the invention , the docking station is deformable from a radially collapsed shape to a radially expanded shape, thereby reducing its bulk during transoral introduction into the hollow organ and adapting its shape and dimension to the dimension and natural movements, e.g. peristalsis, of the hollow organ.

In accordance with another aspect of the invention, the anchoring flange of the docking station comprises a plurality of holes or weakened points for the passage of one or more fasteners, such as staples, for the fixation of the docking station to the wall of the hollow organ. This makes it possible to make the anchoring flange of a resistant, e.g. semi-rigid material and to fixate it to the l umen wall using conventional surgical staples.

I n accordance with a yet further aspect of the invention, the docking station comprises a distal coupling wall for the connection of a distally extending lining, and a proximal coupling wall for the connection of a proximally extending lining, wherein the distal coupling wall is formed on a distal side of the docking station and the proximal coupling wall is formed on a proximal side of the docking station opposite the distal side with respect to the anchoring flange. This provides a high flexibility of therapy with regard to the selection and modification of the regions in which the contact between the food flow and the Gl tract is prevented.

In accordance with a further aspect of the invention, the coupling portion of the lining comprises orientation means which invite and allow the coupling portion to connect to the coupling wall of the docking station in only one predetermined orientation. The orientation means may comprise magnets or shape connectors which prevent the coupling portion from engaging the coupling wall with a mutual orientation different from the predetermined one.

In accordance with a further aspect of the invention, the lining system comprises 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 station seat adapted to receive the docking station, possibly in a radially collapsed shape, and to hold the anchoring flange of the docking station to overlap one of said clamping surfaces and said annular row of staples.

This assures a correct relative positioning of the anchoring flange, the row of staples and the clamping surfaces. Moreover, the positioning of the docking station on the station seat takes place extracorporeal^ and does not change during endoluminal insertion of the applier and during stapling.

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 and during fastening of the staples.

In accordance with a yet further aspect of the invention, the endoluminal applier or a further endoluminal sleeve applier is provided with a lining seat which is adapted to receive the tubular lining in a longitudinally compacted (substantially annulus) shape with regard to a lining longitudinal extension and to expose the coupling portion of the lining and orient the coupling portion to face the coupling wall of the docking station.

This assures a correct relative positioning and enables an easy coupling of the lining with the docking station. Moreover, the positioning of the lining on the lining seat takes place extracorporal ly and does not change during endoluminal insertion of the applier and, possibly, during coupling.

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

- Figures 1 and 2 illustrate a docking station of an endoluminal lining system in a retracted and expanded shape;

- Figure 3 is a perspective view of a docking station in accordance with a further embodiment;

- Figure 4 is a perspective sectional view of the docking station of figure 3;

- Figures 5 and 6 show the docking station of figure 3 in a radially retracted shape;

- Figure and 2 illustrate a docking station of an endoluminal lining system in a retracted and expanded shape;

- Figure 7 is a perspective sectional view of the docking station of figure 3 in an activated anchoring configuration;

- Figure 8 is a side view of the docking station of figure 3, which engages a lumen wall in an activated anchoring configuration;

- Figure 9 shows single components of the endoluminal linig system in accordance with an embodiment;

- Figures 10 and 1 1 illustrate the endoluminal lining system of figure 9 deployed in a section of the Gl tract;

- Figure 12 is a partial side view of an endoluminal applier equipped with the tubular lining to be connected to the docking station in accordance with an embodiment;

- Figure 1 3 is a partial side view of an endoluminal applier equipped with the docking station in accordance with an embodiment;

- Figures 1 4 and 1 5 illustrate the applier of figure 13 in a closed and open configuration;

- Figure 16 illustrates the transoral introduction of the applier of figure 2 to the duodenum;

- Figure 17 is a close up view of the applier in a closed configuration inside a lumen;

- Figure 18 illustrates a method step in which the applier is opened after positioning in the target location in the Gl tract;

- Figure 19 is a close up view of the applier in the opened configuration inside a lumen;

- Figure 20 illustrates an especially adapted applier and a method for acquiring tissue of the hollow organ to which the docking station of the lining system is intended to be fastened in accordance with an embodiment;

- Figure 21 illustrates the applier in a closed configuration in which the acquired tissue and an anchoring flange of the docking station is clamped between an anvil and a cartridge device of the applier ready for the application of the fasteners; - Figure 22 is a perspective sectional view of a docking station anchored to a target location of the hollow organ in accordance with an embodiment;

- Figures 23 and 24 are sectional views illustrating a deployed lining system before and after coupling the lining to the docking station;

- Figure 25 illustrates the lining system after anchoring and full extension within a section of the Gl tract;

- Figure 26 illustrates a further embodiment of the method, in which the docking station is anchored by the applier directly below the Lower Esophageal Sphincter (LES) to create a gastro-jejunal lining or a gastric lining from the LES down to the pylorus; - Figure 27 illustrates different possible positions of the tubular lining within the Gl tract of a patient;

- Figures 28 and 29 are top and side views of a further embodiment of a docking station of an endoluminal lining system in a retracted shape;

- Figures 30 and 31 are top and side views of the docking station in figure 28 in and expanded shape;

- Figure 32 illustrates the applier in accordance with a further embodiment in an open configuration. DETAILED DESCRIPTION OF EMBODIMENTS

Referring to the drawings where like numerals denote like anatomical structures and components th rou ghout th e severa l views , fig u res 1 to 1 1 depict an endoluminal lining system for internally lining a hollow organ, particularly a section of the gastrointestinal tract 1 . The system comprises an endoluminal docking station 2 with an anchoring flange 3 adapted to be permanently anchored to a wall 4 of the hollow organ and at least one coupling wall 5. The system further comprises at least one tubular lining 6 which extends between a proximal end 7 and a distal end 8 and has at least one coupling portion 9 near one of the proximal end 7 and distal end 8, wherein the coupling portion is configured to reversibly connect to the coupling wall 5 of the docking station 2.

In accordance with an embodiment (Figures 1 , 2, 23, 24), the docking station 2 comprises a ring shaped magnetic plate 10 forming both the anchoring flange 3 and the coupling wall 5 and the coupling portion 9 of the lining 6 comprises a magnetically attractable ring 1 1 arranged at one or both of the proximal and distal ends 7, 8 and magnetically connectible to the magnetic plate 10.

Alternatively, the coupling wall and the coupling portion may form mechanical connectors, such as bayonet or snap on connectors (not illustrated)

In accordance with an embodiment, the docking station 2 may be deformable from a radially collapsed shape (figure 1 ) to a radially expanded shape (figure 2), thereby reducing its bulk during transoral introduction into the hollow organ and adapting its shape and dimension to the dimension and natural movements, e.g. peristalsis, of the hollow organ 1.

I n order to allow for the radial contraction and expansion , in the exemplary embodiment of figures 1 and 2, the anchoring flange 3 or the magnetic plate 10 may comprise a plurality of rigid or semi-rigid fastening portions 12 adapted to be fastened to the lumen wall and a plurality of arch shaped flexible links 13 formed between the fastening portions 12 and extending inside a circumference defined by the fastening portions 12. By elastically deforming from a closed arch shape (figure 1 ) to an open arch shape (figure 2) and vice versa, the flexible links 13 allow the above said radial retraction and expansion of the anchoring flange 3 needed e.g. during endoluminal transportation of the docking station, peristalsis and to prevent the risk of obstruction during passage of chime through the docking station.

In accordance with a further embodiment, the anchoring flange 3 of the docking station 2, particularly the fastening portions 1 3 may comprise holes 14 or weakened points for the passage of one or more fasteners, such as staples 15, for the fixation of the docking station 2 to the wall 4 of the hollow organ 1 . For example, each individual fastening portion 12 may define two staple passage holes 14 for receiving the two legs of respectively one individual staple.

This makes it possible to make the anchoring flange of a resistant, e.g. semi-rigid 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 resistant flange material.

In accordance with a further embodiment, the docking station 2 comprises a distal coupling wall 5' for the connection of a distally extending lining 6, and a proximal coupling wall 5" for the connection of a proximally extending lining 6, wherein the distal coupling wall 5' extend distally from the anchoring flange 3 and the proximal coupling wall 5" extends proximally from the anchoring flange 3 opposite the distal coupling wall 5'. This provides a high flexibility of therapy with regard to the selection and modification of the regions in which the contact between the food flow and the Gl tract is prevented.

In the exemplary embodiment of figures 3 to 1 1 , the docking station 2 comprises a generally tubular, possibly single piece, body 16, defining a tubular distal coupling wall portion 5' and a tubular proximal coupling wall portion 5", as well as the anchoring flange or ring 3 which may be formed by a plurality of fastening plates 17 arranged or formed between the distal and proximal coupling wall portions 5', 5" and foldable (along folding lines 18 which extend transversal to a tubular body longitudinal extension) to engage the lumen wall 4 to which the docking station is intended to be fastened. As described before with reference to the embodiment of figures 1 and 2, the fastening plates 17 may be adapted to be stapled to a ring of lumen wall and, for this purpose, they may define staple passage holes 14 or weakened staple passage zones. Alternatively, the foldable fastening plates 17 may be provided with magnetic or snap engagement means or similar locking means for holding them in the folded tissue clamping configuration (figure 8).

The tubular body 16 may be provided with a plurality of longitudinal folding lines 19 which separate adjacent semi-rigid or rigid wall sections 20 (which are not intended to deform during use) and allow the tubular body 16 to be deformed from a radially retracted zigzag cross-sectional shape to an expanded substantially circular cross- sectional shape and vice versa.

I n this embodiment, the coupling features of the docking station 2, such as magnetic zones or pads 21 , or mechanical latches are arranged in the non- deformable wall sections 20 and cooperate with corresponding coupling features of the coupling portion 9 of the lining 6, such as magnetic zones or pads 22, or mechanical latches. The coupling portion 9 may also be substantially tubular and at least partially insertable into the tubular coupling wall portions 5', 5".

As illustrated in figure 1 1 , the lining 6 may have two coupling portions 9', 9", arranged respectively near the distal and proximal end thereof.

In accordance with a further embodiment, the coupling portion 9 of the lining 6 comprises orientation means which invite and allow the coupling portion 9 to connect to the coupling wall 5 of the docking station 2 in only one predetermined orientation. The orientation means may comprise magnets (particularly the same magnets acting as couplers) or shape connectors which prevent the coupling portion from engaging the coupling wall 5 with an orientation different from the predetermined one.

This is particularly advantageous in case of linings 6 provided with additional lumens 23 for an isolated flow of bodily fluids (e.g. bile, pancreatic juices, gastric juices) with respect to chime and to the lumen wall. Such a lining 6 may be adapted to selectively couple to the docking station 2 in a manner to align or misalign the additional lumens 23 with corresponding apertures (not illustrated) in the docking station 2 in order to selectively direct the flow of bodily fluids, e.g.:

- from the interstice between the lining and the hollow organ into the lining,

- from an additional lining lumen of a proximal lining into a distal lining,

- from an additional lining lumen of a proximal lining into an additional lining lumen of a distal lining,

- from an additional lining lumen of a proximal lining into an interstice between a distal lining and the hollow organ.

The lining system may further comprise an endoluminal applier 24 for anchoring the docking station 2 to the hollow organ 4, particularly to a section of the Gl tract of a patient. The applier 24 has a staple fastening assembly 25 with a cartridge device 26 which houses at least one closed annular row of staples 15 and whose distal end surface forms a first clamping surface 27, and an anvil 28 which forms a staple forming surface 29 and a second clamping surface 30 facing the first clamping surface 27. The anvil 28 is movable relative to the cartridge device 26 and adapted to cooperate with the cartridge device 26 for clamping a ring shaped tissue portion 31 between the first and second clamping surfaces 27, 30 and forming the ends of the staples 15 exiting from the cartridge device 26. The staples 15 may comprise titanium staples intended to permanently remain anchored in the stapled tissue ring or, time dependently biodegradable or bioabsorbable staples for a temporary anchoring of the docking station 2 in the hollow organ.

The staple fastening assembly 25 comprises a station seat 32 adapted to receive the docking station 2, possibly in a radially collapsed shape, and to hold the anchoring flange 3 of the docking station 2 to overlap one of said clamping surfaces 27, 30 and said annular row of staples 15.

This assures a correct relative positioning of the anchoring flange, the row of staples and the clamping surfaces. Moreover, the positioning of the docking station on the station seat takes place extracorporeal^ and does not change during the endoluminal insertion of the applier and during firing of the staples.

The station seat 32 may comprise holding pins 33 arranged in the second clamping surface 30 of the anvil 28 and adapted to hold the anchoring portion 12 in its correct position until it is withdrawn from the anvil by an external force, e.g. during withdrawal of the anvil 28 from the anchored sleeve docking station 2.

In accordance with an embodiment, the holding pins 33 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 flange 3 in its radially retracted shape. Alternatively, a clamping edge (not illustrated) may be provided near the second clamping surface 30 of the anvil 28 to hold the anchoring portion 12 in its correct position, in which the clamping edge is elastically supported or magnetically biased in order to resiliency hold the anchoring flange 3 and allow a relatively easy detachment of the latter.

The staple fastening assembly 25 forms a central channel 34 extending longitudinally through the cartridge device 26 and through the anvil 28 and opening laterally into a clamping space 35 between the first and second clamping surfaces 27, 30. The central channel 34 is adapted for the passage of an endoscope 36 to enable visualization of both the clamping space 35 and the space distally ahead of the staple fastening assembly 25 and, possibly, to slide the entire applier 24 or at least the staple fastening assembly 25 endoluminally along the endoscope 36 to a target site in the hollow organ 4 or to guide the entire applier 24 or at least the staple fastening assembly 25 by means of the endoscope 36 endoluminally to said target site.

The thus configured applier 24 allows an improved guidance through the Gl tract and continuous visualization by the endoscope 36 received in the central channel 34, both during endoluminal insertion and withdrawal of the applier 24 and during fastening the staples 15 to anchor the docking station 2.

In accordance with embodiments, the endoscope 36 can be a flexible standard endoscope or a component of the applier 24 especially configured to fit in the central channel 34 thereof and to perform, additional to visualization and guidance, further functions of the applier, such as e.g. tissue acquisition which will be described further below.

In accordance with an embodiment, the staple fastening assembly 25 is provided at a distal end 37 of a flexible hollow shaft 38 through which the central channel 34 extends proximally to a proximal aperture thereof (not shown in the figures) and which can be completely inserted over the endoscope 36.

Alternatively, only the staple fastening assembly 25 of the applier 24 is adapted to receive the endoscope 36 within the central channel 34 and to be guided by the endoscope 36 to the target site for anchoring the docking station 2 and the flexible shaft 38 may be adapted to extend laterally of the endoscope 36 shaft. However, the cartridge device 26 with the first clamping surface 27 and the anvil 28 with the second clamping surface 30 define both a complete closed annulus around the central channel 34 so that a continuous annular staple line is obtainable by a single tissue clamping and staple firing step.

The anvil 28 is translatably connected to the cartridge device 26 by at least one, preferably two diametrically opposite anvil shafts 39 slidably received in one or more guide holes 40 of the cartridge device 26 and connected with a moving mechanism adapted to move the anvil 28 relative to the cartridge device 26. The guide holes 40 and the anvil shafts 39 are arranged in a region between the central channel 34 and the staple row, i.e. radially external of the central channel 34 and radially internal of the annular staple row, thereby allowing complete endoscope access and visualization also during anvil approximation and clamping of the acquired tissue. The anvil shafts 39 can have a very limited circumferential extension to not obstruct the visualization of the tissue clamping space 35.

The anvil shafts 25 comprise preferably hollow tubular profiles with a high torque resistance for a given external dimension and their total circumferential extension with regard to a longitudinal axis of the applier 1 is less than 100°, preferably less than 60° , even more preferably less than 45° , i n order to leave sufficient unobstructed space between the shafts 39 to allow the clamping space 35 to be comfortably visualized and accessed from the central channel 34.

In accordance with an embodiment, the applier 24 comprises a tissue acquisition mechanism 41 adapted to acquire a substantially ring shaped tissue portion 31 of the hollow organ 4 in the clamping space 35 between the first and second clamping surfaces 27, 30. The tissue acquisition mechanism 41 may be arranged in the staple fastening assembly 25 between the central channel 34 and the row of staples 15, i.e. radially external of the central channel 34 and radially internal of the annular row of staples 15. In this way, the central channel 34 is not obstructed by the tissue acquisition mechanism 41 and allows unobstructed access and visualization by the endoscope 36 also during tissue acquisition. Alternatively, the tissue acquisition mechanism 41 and the endoscope 36 may be configured to be received together and contemporaneously in the central channel 34, e.g . by passing the tissue acquisition mechanism 41 through an instrument channel 42 of the endoscope 39 while the endoscope 39 is received in the central channel 34 of the staple fastening assembly 25. In accordance with embodiments, the tissue acquisition mechanism 41 may comprise mechanical gaspers or suction means. Figure 20 shows an exemplary embodiment, in which at least one, preferably a plurality of pairs of graspers 43 are arranged and operable to move from the clamping space 35 radially outward and grasp opposite portions of tissue of the hollow organ 4 and pull the grasped portions of tissue into the clamping space 35, for instance by partial or complete withdrawal of the graspers 43 inside the cartridge device 26. The graspers 43 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 24 or near a proximal end portion of the endoscope 36.

In accordance with an embodiment, the staple fastening assembly 25 of the same endoluminal applier 24 or a further endoluminal applier (not illustrated) comprises a ring shaped lining seat 44 adapted to receive and hold the tubular lining 6 in a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and to expose and orient the coupling portion 9, 9', 9" of the lining 6 so that it faces the coupling wall 5 of the docking station 2.

In accordance with an embodiment, the lining seat 44 is formed in the anvil 28 and comprises a distal containment wall 45 (Figure 12) against which the collapsed and "packed" tubular lining 6, i.e. an endoluminal sleeve, rests so that it keeps its collapsed and "packed" shape until the lining 6 is pulled or pushed distally over the containment wall 45 or the containment wall 45 is bent down or broken away by an external force, e.g. during withdrawal of the anvil 28 from the coupled lining 6. In accordance with an embodiment, the lining seat 44 may be configured so that, by closing the staple fastening assembly 25, at least part of the lining 6 is forcedly pushed distally over the containment wall 45 and out of the lining seat 44.

Moreover, the earlier described holding pins 33 and clamping edges are preferably adapted to hold also the coupling portion 9 in its correct position with respect to the anvil.

As already mentioned above, the applier 24 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 24, as well as a staple driving mechanism adapted to drive the staples 15 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 38.

In accordance with a further embodiment (Figures 28 through 31 ), the docking station 2 or the anchoring flange 3 forms a ring shaped plate 46 having a generally wavy shape, preferably but not necessarily constituted by two opposite peaks 47 and two opposite valleys 48 angularly spaced at about 90° and forming a two- peaks-two-valleys-wave. The wavy shape of the plate 46 may be obtained by a locally stepped or otherwise offset configuration which "oscillates" about the wavy shape. The plate 46 is elastically deformable from the wavy shape (figure 29) to a flattened shape (figure 31 ), in which a passage opening 49 of the plate 46 in the flattened shape is greater than the passage opening 49 of the plate 46 in the wavy shape.

This allows to retract the applier 24 more comfortably from the anchoring site and to withdraw the anvil 28 through the stapled tissue ring and anchoring flange which can now radially expand (from the wavy shape to a flattened shape) and which would be otherwise somewhat stiff. Moreover, the anchored docking station can follow within certain limits the physiological expansion and retraction movement of the intestine, e.g. during peristalsis.

Figure 32 illustrates an exemplary embodiment of the applier 24 adapted to deploy a docking station 2 whose anchoring flange has a wavy shape as described hereinbefore. In this embodiment, the first clamping surface 27 of the cartridge device 26 and the second clamping surface 30 (which provides the staple forming surface) of the anvil 28 have a generally wavy shape, preferably but not necessarily constituted by two opposite peaks 50 and two opposite valleys 51 angularly spaced at about 90° and forming a two-peaks-two-valleys-wave. The wavy shape of the clamping surfaces 27, 30 may be obtained by a locally stepped or otherwise offset configuration which "oscillates" about the wavy shape. Particularly, the stepped first clamping surface 27 is composed of a series of lands 52 and risers 53, wherein the lands 52 are perpendicular to the longitudinal axis X of the staple fastening assembly 25 and the exit openings of the staple 15 slots are defined in the lands 52. Analogously, also the second clamping surface 30 of the anvil is composed of a series of lands 54 and risers 55, wherein the lands 54 are perpendicular to the longitudinal axis X of the staple fastening assembly 25 and the staple forming recesses are defined in the lands 54.

In both the first clamping surface 27 and the second clamping surface 30, the lands 52, 54 define with the risers 53, 55 an obtuse angle in order to reduce local tissue tensioning during clamping and stapling.

All staple guide slots may extend in a substantially normal direction to the corresponding lands 52 and parallel with respect to the longitudinal axis X.

As a result, all staples 15 housed in the guide slots may be in parallel alignment with respect to the staple drive direction of the staple driving mechanism which may, hence coincide with the longitudinal axis X.

In order to limit the diameter of the staple fastening assembly, the described wavy and stepped shape of the clamping surfaces 27, 30 deviates from a hypothetical circular reference shape in a plane perpendicular to the longitudinal axis X only in a direction normal to that plane, such that the projection of the first clamping surface 27 and the second clamping surface 30, as well as the annular line defined by the at least one row of staples 15 onto that plane is circular.

In this embodiment, the anchoring flange 3 of the docking station 2 may be held to overlap one of the first and second clamping surfaces 27, 30 and the annular row of staples 15 by the same features and methods previously described. Additionally or alternatively, the anchoring flange 3 may be detachably fixated to the wavy or stepped wavy clamping surface by an adhesive such that it is kept in the same wavy or stepped wavy shape as the clamping surfaces.

Particularly, the shape of the ring shaped plate 46 is complementary to the shape of the clamping surfaces.

DETAILED DESCRIPTION OF A METHOD FOR ANCHORING THE TUBULAR LINING WITHIN A 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 24 with the radially retracted docking station placed over the station seat, as shown in FIG. 15, and slide the applier 24 over the endoscope 36 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 36 placed in the central channel of the applier 24 to view and select an area suitable for the application of the fastener, i.e. the staples.

FIGS. 16 through 23 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 mechanism, either vacuum or mechanical grasping, may be activated and tissue may be drawn into the clamping space in an entirely circumferential manner or a substantially 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 28 and cartridge device 26 may be moved towards one another such that the acquired tissue ring is clamped therebetween. The staple driving mechanism of applier 24 is then actuated to engage the an n ular closed row of staples or fastening element through the acquired tissue ring and through the anchoring flange 3 of the docking station 2 which is arranged on the anvil to overlap the second clamping surface and the staple position, thereby fastening the docking station 2 in place in a circumferential fashion. Subsequently, the ring shaped anchoring place can be d irectly endoscopically visualized by passi ng the endoscope 36 distally through the anvil. Then, applier 24 is removed. In doing so, the anvil of the applier 24 is carefully pulled through the newly-created ring or plication of stapled tissue and anchoring flange of the docking station, leaving the latter in place. The docking station is now released to radially expand and to follow the movement of the lumen wall. Then, the applier is extracorporeal^ equipped with the lining 6 and endoluminally inserted in the hollow organ (as described in relation with the deployment of the docking station) and the coupling portion of the lining is (e.g. magnetically orientated and) connected to the coupling wall of the docking station without any need to invasively manipulate the tissue wall. Then, the attached tubular lining 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 can be endoluminally removed from the docking station and replaced by another tubular lining without invasively manipulating the wall of the hollow organ. In this way, exhausted or soiled linings can be easily replaced by fresh linings and the total length of the lined section of the Gl tract can be varied by replacing an existing lining with a fresh lining of a different length.

In order to create very long endoluminal barriers and to gain high flexibility of therapy with regard to the selection and modification of the regions in which the contact between the food flow and the Gl tract is prevented, two or more docking stations are anchored within the hollow organ at planned distances and a plurality of linings are arranged to extend in series between said docking stations.

In this way a bypass conduit is created 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 lining or 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 system for internally lining a hollow organ, particularly a section of the gastrointestinal tract, the system comprising:

- an endoluminal docking station (2) with an anchoring flange (3) adapted to be permanently anchored to a wall (4) of the hollow organ and at least one coupling wall (5),

- at least one tubular lining (6) extending between a proximal end (7) and a distal end (8) and having at least one coupling portion (9) formed near one of the proximal end (7) and distal end (8), wherein the coupling portion is configured to reversibly connect to the coupling wall (5) of the docking station (2).

2. System according to claim 1 , in which the docking station (2) comprises a ring shaped magnetic plate (10) forming both the anchoring flange (3) and the coupling wall (5), and the coupling portion (9) comprises a magnetically attractable ring (1 1 ).

3. System according to claim 1 , in which the docking station (2) is elastically deformable from a radially collapsed shape to a radially expanded shape.

4. System according to claim 3, in which the anchoring flange (3) comprises a plurality of substantially rigid fastening portions (12) adapted to be fastened to the lumen wall and a plurality of arch shaped flexible links (13) formed between the fastening portions (12) and extending radially inside a circumference defined by the fastening portions (12).

5. System according to claim 1 , in which the anchoring flange (3) comprises holes (14) for the passage of fasteners (15).

6. System according to claims 4 and 5, in which each individual fastening portion (12) define two staple passage holes (14) for receiving the two legs of respectively one individual staple.

7. System according to any preceding claim, in which the docking station (2) comprises a distal coupling wall (5') for the reversible connection of a distally extending lining (6), and a proximal coupling wall (5") for the reversible connection of a proximally extending lining (6), said distal coupling wall (5') extending distally from the anchoring flange (3) and said proximal coupling wall (5") extending proximally from the anchoring flange (3) opposite the distal coupling wall (5').

8. System according to any preceding claim, in which the docking station (2) comprises a tubular body (16) defining a tubular distal coupling wall portion (5'), a tubular proximal coupling wall portion (5") and a plurality of fastening plates (17) formed between the distal and proximal coupling wall portions (5\ 5") and foldable to clamp an adjacent lumen wall (4) therebetween, said fastening plates (17) being lockable in the folded tissue clamping shape.

9. System according to claim 8, in which the fastening plates (17) are adapted to be stapled to the clamped lumen wall and define passage holes (14) for the passage of the legs of surgical staples.

10. System according to claim 8 or 9, in which said tubular body (16) forms a plurality of longitudinal folding lines (19) which separate adjacent rigid wall sections (20) such that the tubular body (16) is deformable from a radially retracted zigzag cross-sectional shape to a radially expanded shape.

11. System according to claim 10, in which magnetic zones (21 ) are arranged in the rigid wall sections (20).

12. System according to claim 8, in which the coupling portion (9) of the lining (6) is tubular and insertable into the tubular coupling wall portions (5', 5").

13. System according to any one of the preceding claims, in which the lining (6) has two coupling portions (9' , 9") arranged respectively near the distal and proximal end.

14. System according to any one of the preceding claims, in which the coupling portion (9) of the lining (6) comprises orientation means which invite and allow the coupling portion (9) to connect to the coupling wall (5) in only one predetermined orientation.

15. System according to any preceding claim, in which the lining (6) defines at least one additional lumen (23) for an isolated flow of bodily fluids and the lining (6) is adapted to selectively couple to the docking station (2) in a manner to position the additional lumens (23) with respect to corresponding apertures in the docking station (2) to selectively direct the flow of bodily fluids.

16. System according to any preceding claim, comprising an endoluminal applier (24) for anchoring the docking station (2) to the hollow organ (4), said applier (24) having:

- a staple fastening assembly (25) with a cartridge device (26) which houses at least one closed annular row of staples (15) and forms a first clamping surface (27), an anvil (28) forming a staple forming surface (29) and a second clamping surface (30) facing the first clamping surface (27), the anvil (28) being adapted to cooperate with the cartridge device (26) for clamping a ring shaped tissue portion (31 ) between the first and second clamping surfaces (27, 30) and forming the ends of the staples (15) exiting from the cartridge device (26),

wherein said staple fastening assembly (25) comprises a station seat (32) adapted to receive the docking station (2) and hold the anchoring flange (3) of the docking station (2) to overlap one of said clamping surfaces (27, 30) and said annular row of staples (15).

17. System according to claim 16, in which said station seat (32) is adapted to hold the docking station (2) in a radially retracted shape and release the docking station (2) to expand radially.

18. System according to claim 16, in which said staple fastening assembly (25) forms a central channel (34) extending longitudinally through the cartridge device (26) and through the anvil (28) and opening laterally into a clamping space (35) between the first and second clamping surfaces (27, 30), the central channel (34) being adapted for the passage of an endoscope (36) to enable visualization of both the clamping space (35) and the space distally ahead of the staple fastening assembly (25) and to slide the entire staple fastening assembly (25) along the endoscope (36).

19. System according to claim 16, in which said staple fastening assembly (25) comprises a ring shaped lining seat (44) adapted to receive and hold the tubular lining (6) in a collapsed annulus shape and to expose and orient the coupling portion (9, 9', 9") of the lining (6) so that it faces the coupling wall (5) of the docking station (2).

20. System according to claim 16, in which said first clamping surface (27) and said second clamping surface (30) have a globally wavy shape (35, 36).

21. System according to claim 20, in which said wavy shape is formed by a stepped configuration of said first and second clamping surfaces (27, 30).

22. System according to claim 20 or 21 , in which said anchoring flange (3) forms a ring shaped plate (46) having a wavy shape complementary to the wavy shape of said clamping surfaces (27, 30) and being elastically deformable to a flattened shape, in which a passage opening (49) of the plate (46) in the flattened shape is greater than said passage opening (49) of the plate (46) in the wavy shape.

23. A method for applying a tubular lining to a hollow organ, particularly to a lumen of the gastrointestinal tract, the method comprising the steps of:

- providing an endoluminal docking station having an anchoring flange and a coupling wall and further providing a tubular lining having a coupling portion for a reversible connection to the coupling wall of the docking station,

- inserting the docking station endoluminally in the hollow organ and anchoring the anchoring flange of the docking station to the wall of the hollow organ, and

- subsequently, inserting the lin ing endolu minally in the hollow organ and connecting the coupling portion of the lining to the coupling wall of the docking station to anchor the lining in the hollow organ.

24. Method according to claim 23, in which the step of inserting and anchoring the docking station comprises:

- extracorporeal^ attaching the docking station to an applier such that the anchoring flange is held to overlap at least one fastener of the applier,

- endoluminally placing the applier with the attached docking station, 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 flange of the docking station into a wall of the hollow organ.

25. Method according to claim 23, in which the step of inserting and coupling the lining comprises:

- attaching the tubular lining to an applier in a way that an elongate body portion of the lining is held in a compacted ring shape,

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

- using the endoscope to obtain visibility of the previously anchored docking station,

- holding the coupling portion of the lining exposed while moving the coupling portion in engagement with the coupling wall, thereby connecting them to one another,

- pulling the attached tubular lining distally to unfold the lining from the compacted shape to an extended elongate tubular shape.

26. Method according to claim 23, in which the wall of the hollow organ is partially inverted to create the suitable area for the application of the at least one fastener and the fastener is extended to penetrate at least two adjacent layers of tissue arranged by partially inverting the wall of the hollow organ.

27. Method according to claim 23, in which after a certain period of time, the tubular lining is removed endoscopically from the docking station and replaced by another tubular lining without invasively manipulating the wall of the hollow organ.

28. Method according to claim 23, in which a proximal lining is connected to the docking station and extended proximally therefrom and a distal lining is connected to the docking station and extended distally therefrom. Method according to claim , in which a plurality of docking stations is anchored within the hollow organ at planned distances and a plurality of linings are arranged to extend in series between said docking stations.

29. Method according to claim 23, in which the coupling portion of the lining and the coupling wall of the docking station are magnetically connected to one another.

30. Method according to claim 23, comprising the steps of holding the docking station on the applier in a radially compacted shape during endoluminal placement and, after fastening the docking station to the hollow organ, releasing the docking station to expand radially.