FR3160097A1 - Endoscopic medical device for acting on an internal mucosa and comprising at least one notched traction wire and a self-locking knot - Google Patents

Abstract

The invention relates to a medical device usable with an endoscope (20) to perform an incision, traction or dissection action on an internal mucosa (2) to be treated in a body cavity (5) of the digestive tract, said device (1) comprising at least one traction wire (10) having a first proximal portion intended to be anchored in the mucosa (2) using at least one first endoscopic clip (31) and a free end (11) actuable using a manipulation clamp (24) from outside the body cavity (5) to exert a traction force on said wire, characterized in that the traction wire (10) is provided with notches (14), and, at a proximal end (12), with a closed fixing loop (13), and the device (1) comprises at least one traction loop (40) attached on the one hand to the notched traction wire (10) by means of a self-locking knot and on the other part to a second endoscopic clip (32) anchored in another portion of the internal cavity (5), the assembly comprising the notched traction wire (10), the endoscopic clips (31, 32) and the traction loop (40) forming a hoist making it possible to apply a progressive traction force (T) on said mucosa (2) so as to lift it towards the second endoscopic clip (32), the traction loop (40) then acting as a force return pulley. Figure for abstract: Fig. 5

Description

Endoscopic medical device for acting on an internal mucosa and comprising at least one notched traction wire and a self-locking knot Technical field of the invention

The present invention relates to an endoscopic medical device used by an operator performing a digestive endoscopy to act on an internal mucosa of a patient and comprising at least one traction wire.

The invention falls within the field of medical devices and instruments used during therapeutic procedures that can be performed during a digestive endoscopy involving a body cavity of the upper or lower digestive tract, such as the esophagus, stomach, duodenum, rectum or colon.

More particularly, the invention relates to devices, instruments and accessories for carrying out fixation, incision, capture, traction or dissection operations during digestive endoscopy.

Endoscopic submucosal dissection is an interventional endoscopic technique that allows for the single-unit resection of superficial digestive lesions (mucosa to be treated). It consists of progressively cutting, using a dissecting knife (electric scalpel) introduced into the operating channel of an endoscope, the submucosa located under the lesion and separating it from the muscular wall of the digestive tract. To improve the exposure (visibility and access) of the submucosa, two methods are used and can be combined:
- injection of injection solution into the submucosal space, using an injection needle: this has the effect of increasing the volume and therefore the visible thickness of the submucosa, by swelling it;
- Performing traction, which allows the lesion to be pulled in the direction opposite to the muscular wall, to improve exposure of the submucosa.

Generally speaking, improving the exposure of the submucosa improves the safety of the procedure (better visibility of the vessels, distance from the muscular wall) as well as the speed of the procedure.

The traction systems used in submucosal dissection are of two types:
- either based on elastic traction;
- either based on traction by wire manipulated from outside the patient, and possibly associated with a pulley system.

Both types of traction have drawbacks.

Thus, the most widely used elastic traction systems, whether simple or associated with a multi-loop system, have the following main drawbacks:
- on the one hand, a difficulty in setting up the system, linked to the traction force applied by the elastic and against which the endoscope must fight, when fixing it to the wall opposite the lesion;
- on the other hand, an absence of the possibility of being able to observe either the intensity or the direction of the traction force applied to the lesion, when fixing the elastic to the wall opposite the lesion;
- moreover, their use is not possible in large cavities (stomach) given the limited size of the available elastics (dental appliance elastics);
- finally, a loss of effectiveness may be observed during the procedure, linked to the loss of traction capacity of the elastic which returns to its resting shape as the dissection progresses and the lesion rises.

The wire traction system, possibly associated with a pulley, has the following main disadvantages:
- due to the need to use a wire that comes out of the patient and on which the traction force is applied, it can only be used in digestive locations with close access (mainly esophagus, stomach and rectum);
- the procedure requires the temporary removal of the endoscope, and therefore takes some time.

Furthermore, the use of a so-called "multi-loop" system is necessary from a certain size of lesion to be resected. This makes it possible to apply a traction force over a larger surface area of the lesion, to lift the edges (margins) on several sides to increase the surface area of the submucosa, and to limit the risk of torsion of the lesion during dissection.

Document WO2023208930 is known, which describes a multi-loop adaptive endoscopic traction device. This device is effective but has the disadvantages of being quite difficult to set up due to its complexity, and the general disadvantages associated with the elastic traction systems described previously.

Document WO2022190234 is known, which describes a device that attaches around the end of the endoscope and allows traction to be applied to an element of the digestive tract. This device does not pass through the operating channel, cannot be released into the digestive tract and does not use any wire or endoscopic clip.

Document EP3998024 is known, which describes a traction system using several loops attached to each other, instead of the traction wire, the purpose of which is to allow several traction lengths. There is no progressive adjustment of the traction.

Document WO2021113232A1 is known, which describes in a very broad manner a traction system using two clips and a traction band. There is no mention of progressive adjustment of the traction.

Finally, document WO2020251715A1 describes in a very broad manner a traction system using two clips and an extensible filament.

In summary, elastic traction systems are the most widely used because they are relatively easy to perform. They are perfectly suited for small lesions. However, for larger lesions, their main drawbacks are a possible loss of effectiveness during the procedure and a relative complexity of installation.

However, there are still many disadvantages in using prior art systems which are not sufficiently practical, easy to handle, safe and versatile.

The invention thus relates more specifically to an endoscopic device allowing the application of a traction force to a wire, the force of which can be adjusted progressively, between at least two elements of the wall of the digestive tract, to which it will be fixed by means of endoscopic clips.

The invention can, for example, be used during endoscopic submucosal dissection procedures, i.e. therapeutic endoscopic procedures whose aim is the monobloc resection of a superficial lesion of the digestive mucosa. However, it is absolutely not limited to this application and can be used for all procedures performed by endoscopy of the digestive tract.

Presentation of the invention

The present invention aims to overcome these drawbacks with a completely innovative approach.

To this end, according to a first aspect, the present invention relates to a medical device usable with an endoscope to carry out, during a digestive endoscopy, an action of fixation, incision, traction or dissection on a surface of an internal mucosa to be treated, called a lesion, of a body cavity of the upper or lower digestive tract, such as the esophagus, the stomach, the duodenum, the rectum or the colon, said device comprising for this purpose at least one traction wire having a first proximal portion intended to be anchored in the mucosa to be treated using at least one first endoscopic clip and an opposite distal/free end actuable in particular using a manipulation clamp passing through an operating channel of said endoscope and manipulated from outside the body cavity to exert a traction force on said wire, characterized in that:
- the traction wire is provided, over at least part of its length, with a series of radially projecting notches spaced from each other, and, at a proximal end, with a closed fixing loop, and
- the device further comprises at least one traction loop attached on the one hand to the notched traction wire by means of a self-locking knot, between the first portion and the distal end, and on the other hand to a second endoscopic clip anchored in another portion of the internal cavity substantially facing the mucosa to be treated, the assembly comprising at least the notched traction wire, the endoscopic clips and the traction loop forming a hoist making it possible to apply a progressive traction force, depending on the position of the notches along the notched traction wire where the traction loop is attached, on said mucosa to be treated so as to lift it locally substantially in the direction of the second endoscopic clip, the traction loop then acting as a force return pulley.

This solution allows the mucosa to be treated to be acted on safely because the traction action on the latter is maintained by the tension of the notched traction wire and the traction loop, which create a non-return force using the notches and the self-locking knot. The practitioner can thus carry out the necessary manipulations with precision, without having to worry about the tension of the notched traction wire, which can be (re)tensioned repeatedly by pulling on it from outside the patient's body, for example to gradually lift the mucosa as the endoscopic procedure is carried out by the practitioner. The combination of the traction wire's notches and the traction loop firmly anchored in the body cavity thus creates a sort of lifting hoist in which the traction wire remains permanently taut.

The invention is implemented according to the embodiments and variants set out below, which are to be considered individually or in any technically effective combination.

Advantageously, the notches are oriented externally around the notched traction wire unidirectionally in the same direction and form as many self-locking anti-recoil stops for the traction loop, so that the traction force exerted on the wire can only be in one direction.

Thanks to this solution, the notched traction wire cannot completely relax because the self-locking knot of the traction loop will keep it under tension, which prevents the surface of the mucosa to be treated from sagging and returning to its initial position. The particular orientation of the notches thus makes it possible to create an anti-return safety device so that the practitioner does not need to maintain tension on the free end of the traction wire himself to keep it taut and pull on the mucosa to be treated.

Preferably, the notches of the notched traction wire are in the form of fine points/thorns spaced from each other along said wire in the manner of an ear of wheat.

This simple design solution achieves an effective anti-reverse force.

According to a preferred embodiment of the present invention, the notched traction wire comprises notches over most of its length, and preferably over its entire length.

This solution allows the traction loop to be placed at different locations on the notched traction wire.

According to a particular embodiment of the present invention, the distal end of the notched traction wire is passed inside the closed fixation loop and the proximal portion is closed on itself so as to form an adjustment loop of variable length, and several fixation loops, for example two to six, preferably three to four, are freely connected to said notched traction wire at locations distant from each other of said adjustment loop to form a multi-loop device, said fixation loops being furthermore intended to be attached by means of first endoscopic clips to the mucosa to be treated at locations distant from each other to distribute the traction force exerted on the latter.

This solution allows action on large and/or elongated lesions with a single device.

According to an alternative embodiment of the present invention, the distal end of the notched traction wire is passed inside the closed fixation loop and the proximal portion is closed on itself at its closed fixation loop so as to form an adjustment loop of variable length, and several first endoscopic clips, for example two to six, preferably three to four, are directly connected in a free manner to said notched traction wire at locations distant from each other of said adjustment loop to form a multi-clip device, said first endoscopic clips being furthermore intended to be attached to the mucosa to be treated at locations distant from each other to distribute the traction force exerted on the latter.

According to another particular embodiment, in addition to a terminal traction loop connected on the one hand to the closed fixation loop and on the other hand to the notched traction wire by a self-locking knot, the distal end of the notched traction wire is passed inside said terminal traction loop and the proximal portion is closed on itself at the latter so as to form an adjustment loop of variable length, and several fixation loops, for example two to six, preferably three to four, are freely connected to said notched traction wire at locations distant from each other of said adjustment loop to form a multi-loop device, said fixation loops being moreover intended to be attached by means of first endoscopic clips to the mucosa to be treated at locations distant from each other to distribute the traction force exerted on the latter.

According to a variant, the device further comprises a terminal traction loop connected on the one hand to the closed fixation loop and on the other hand to the notched traction wire by a self-locking knot, the distal end of the notched traction wire is passed inside said terminal traction loop and the proximal portion is closed on itself at the latter so as to form an adjustment loop of variable length, and several first endoscopic clips, for example two to six, preferably three to four, are directly connected in a free manner to said notched traction wire at locations distant from each other of said adjustment loop to form a multi-clip device, said first endoscopic clips being furthermore intended to be attached to the mucosa to be treated at locations distant from each other to distribute the traction force exerted on the latter.

Advantageously, the notched traction wire has a diameter of between approximately 0.15 mm and 0.4 mm and a length of between approximately 4 cm and 45 cm.

According to a particularly interesting aspect of the present invention, each traction loop is constituted by a ring of wire forming a self-locking knot called a “lark’s head” knot closed around the notched traction wire.

Preferably, each pull loop is made of a surgical suture thread, preferably braided, having a diameter of between about 0.15 mm and 0.4 mm.

According to a particular characteristic of the present invention, each traction loop and each fixing loop have a different color and/or contrast from the notched traction wire.

Preferably, each pull loop measures about 4 mm to 10 mm in diameter.

Advantageously, the traction loop is positioned between approximately 10 mm and 30 mm from the distal/free end of the barbed traction wire.

According to a particular characteristic, each fixing loop measures approximately 3 mm to 10 mm in diameter.

Preferably, each fixing loop consists of a closed wire ring inside which passes the notched traction wire along which it can slide freely.

Brief description of the figures

Other advantages, aims and characteristics of the present invention emerge from the following description given, for explanatory and non-limiting purposes, with reference to the appended drawings, in which:

FIG. 1 there FIG. 1 is a schematic side view of a device according to the present invention, before use using an endoscope,

FIG. 2 there FIG. 2 is a side view of the device of the FIG. 1 in a first stage of use,

FIG. 3 there FIG. 3 is a side view of the device of the FIG. 1 in a second stage of use,

FIG. 4 there FIG. 4 is a side view of the device of the FIG. 1 in a third stage of use,

FIG. 5 there FIG. 5 is a side view of the device of the FIG. 1 in a fourth stage of use,

FIG. 6 there FIG. 6 is a side view of the device of the FIG. 1 in a fifth stage of use,

FIG. 7 there FIG. 7 is a side view of the device of the FIG. 1 in a sixth stage of use,

FIG. 8 there FIG. 8 is a side view of the device of the FIG. 1 in a seventh stage of use,

FIG. 9 there FIG. 9 is a detail view of a traction loop of the device of figures 1 to 8,

FIG. 10 there FIG. 10 is an enlarged view of the detail of the FIG. 9 ,

FIG. 11 there FIG. 11 is a side view of a first variant embodiment of the device of figures 1 to 8,

FIG. 12 there FIG. 12 is a side view of the device of the FIG. 11 in a first stage of use,

FIG. 13 ] there FIG. 13 is a side view of the device of the FIG. 11 in a second stage of use,

FIG. 14 there FIG. 14 is a front view of the figure of the device of the FIG. 11 in a third stage of use,

FIG. 15 there FIG. 15 is a side view of the device of the FIG. 11 in a fourth stage of use,

FIG. 16 there FIG. 16 is a front view of the FIG. 15 ,

FIG. 17 there FIG. 17 is a side view of the device of the FIG. 11 in a fifth stage of use,

FIG. 18 there FIG. 18 is a side view of the device of the FIG. 11 in a sixth stage of use,

FIG. 19 there FIG. 19 is a front view of the FIG. 18 ,

FIG. 20 there FIG. 20 is a side view of the device of the FIG. 11 in a seventh of use,

FIG. 21 there FIG. 21 is a side view of an alternative embodiment of the device of Figures 11 to 20,

FIG. 22 there FIG. 22 is a side view of the device of the FIG. 21 in a first stage of use,

FIG. 23 there FIG. 23 is a side view of the device of the FIG. 21 in a second stage of use,

FIG. 24 there FIG. 24 is a side view of the device of the FIG. 21 in a third stage of use,

FIG. 25 there FIG. 25 is a front view of the figure of the device of the FIG. 21 in a fourth stage of use,

FIG. 26 there FIG. 26 is a side view of the device of the FIG. 21 in a fifth stage of use,

FIG. 27 there FIG. 27 is a side view of the device of the FIG. 21 in a sixth stage of use,

FIG. 28 there FIG. 28 is a side view of the device of the FIG. 21 in a seventh stage of use,

FIG. 29 there FIG. 29 is a side view of the device of the FIG. 21 in an eighth stage of use,

FIG. 30 there FIG. 30 is a side view of an alternative embodiment of the device of Figures 21 to 29, and

FIG. 31 there FIG. 31 is a side view of an alternative embodiment of the device of Figures 11 to 20.

Figures 1 to 31 represent different embodiments of a medical device 1 in accordance with the present invention used by an operator carrying out a therapeutic digestive endoscopy procedure relating for example to a body cavity 5 (or natural conduit) of the upper or lower digestive tract of a patient (not shown), such as the esophagus, the stomach, the duodenum, the rectum or the colon.

This description is given without limitation, each characteristic of an embodiment being able to be combined with any other characteristic of any other embodiment.

It should be noted, from now on, that the figures are not necessarily to scale, without this hindering their understanding.

The device 1 typically comprises a non-extensible (non-elastically deformable along its length) notched traction wire 10 intended to be inserted by means of an endoscope 20 of known type into the digestive tract 5 of the patient to carry out operations of fixation, incision, traction or dissection of a mucosa 2 to be treated, in particular of a lesion of the inner wall 6 of said digestive tract 5 of the patient. It is not necessary for this traction wire to be sterile.

For this purpose, the endoscope 20 comprises a proximal end 21 for manipulation by a practitioner such as a gastroenterological surgeon, an operating channel 22 through which it is possible to pass accessories, some of which will be described in relation to the invention, and a distal end 23 through which said accessories emerge so that they can be manipulated from outside the digestive tract 5 by said practitioner.

The notched traction wire 10 has a first proximal portion 16 ending in a proximal end 12 intended to be hooked locally in the mucosa to be treated 2 of the digestive tract 5 using at least one first endoscopic clip 31, and a distal/free end 11 opposite the proximal end 12 and actuable in particular using a manipulation clamp 24 passing through the operating channel 22 of the endoscope 20.

For this purpose, the notched traction wire 10 has, at its proximal end 12, a closed (or terminal) attachment loop 13 to which a first endoscopic clip 31 can be attached. The notched traction wire 10 is similar to a surgical suture thread, but it does not need to be sterile. It has an ideal diameter of between approximately 0.15 mm (USP 4-0) and 0.4 mm (USP 1-0), and a length of between approximately 4 cm and 45 cm depending on its use.

As illustrated by the FIG. 9 and 10, the notched traction wire 10 is provided, over a majority of its length and preferably over its entire length, with notches 14 materialized by points/thorns arranged around said wire and projecting radially outwardly from the latter. These points 14 are all spaced apart by a zone 15 and oriented in the same direction so that the notched traction wire 10 forms a sort of giant and elongated wheat ear, each point/thorn of which forms an anti-recoil notch, the usefulness of which will be explained later.

When implanted in the digestive tract 5, the notched traction wire 10 is also equipped with a traction loop 40 which is in the form of a ring made with a thread similar to a surgical suture thread, but which is not necessarily sterile, connected around the notched wire 10 by forming a lark's head knot 42 tight at the level of the prominent notches 14.

As can be seen in the zoomed view of the FIG. 10 , the strands constituting this knot 42 are preferably, but not necessarily, tightened in spaces 15 between two spines 14 of the notched traction wire 10. When this knot 42 is made correctly by the practitioner, it allows the wire to be pulled according to the arrow G while the spines 14 block any sliding of the notched traction wire 10 in the knot 42 in the direction of the arrow D.

The traction loop 40 is made with a different color from that of the notched traction wire 10 in order to be able to distinguish it.

The wire constituting the traction loop 40 is non-extensible (non-elastically deformable) and has a diameter of between 0.15 mm (USP 4-0) and 0.4 mm (USP 1-0). This loop typically has a "before knotting" diameter of between approximately 4 mm and 10 mm and is knotted to the serrated traction wire 10 at a distance of between approximately 10 mm and 30 mm from its distal/free end 11.

Figures 2 to 8 illustrate seven steps of implantation and use of the device 1 according to the present invention, according to the following chronology:

The practitioner, after having inserted the endoscope 20 into the digestive tract 5 of the patient, locates the mucosa 2 to be treated 2. The practitioner then makes an incision 3 around the mucosa 2 to be treated, for example using a knife (electric scalpel) introduced through the lumen 22 of the endoscope 20 and placed at its distal end 23. Then, the practitioner positions the device 1 of the present invention close to the lesion 2, as illustrated in the FIG. 3 .

The practitioner brings the wire 10 inside the digestive tract 5 and connects its proximal end 12 to the mucosa 2 to be treated using a first endoscopic clip 31 of known type, one of the jaws of which is inserted into the closed fixation loop 13 before being fixed in said mucosa 2, as illustrated by the FIG. 3 .

Once the endoscopic clip 31 is released and securely attached to the mucosa 2 to be treated, the practitioner attaches the traction loop 40, previously tied around the notched traction wire 10, to the inner wall 6 of the natural duct 5 using a second endoscopic clip 32, one of the jaws of which is inserted into the traction loop 40 before being anchored in said wall 5, as illustrated by the FIG. 4 It will be noted that in this embodiment, the traction loop 40 is placed slightly upstream of the mucosa 2 to be treated, and in particular relative to the first endoscopic clip 31.

The practitioner then grasps the free distal end 11 of the notched traction wire 10 using forceps 24 passing through the operating channel 22 of the endoscope 20 in order to exert a traction force on said wire, according to the arrows T. The assembly constituted by the notched traction wire 10, the traction loop 40 and the first and second endoscopic clips 31 and 32 thus forms a lifting hoist which makes it possible, as the traction force T increases, to pull on the first endoscopic clip 31 in order to locally lift the mucosa 2 to be treated, as illustrated by the FIG. 5 . The traction loop 40, in particular its lark's head knot 42, being blocked in translation by the notches 14 of the thorn-shaped wire (ears), this traction force T is maintained without the practitioner needing to exert tension on the notched traction wire 10 using the manipulation clamp 24. Thus, the thorns 14 of the notched traction wire 10 create a non-return stop (self-locking effect of the knot 42) which blocks the latter and prevents it from sliding in the traction loop 40 against the arrows T, that is to say in the direction of the arrow D. We thus speak of a knot 42 with a unidirectional self-locking effect.

Indeed, as illustrated by the FIG. 6 , the manipulation forceps 24 are detached from the distal end 11 of the notched traction wire 10 (which becomes free again) and the traction force T remains, which allows for example the practitioner to carry out a dissection of the mucosa 2 to be treated at the level of the incision 3 using a suitable instrument (dissection knife) passing through the operating channel 22 of the endoscope 20.

The practitioner can again exert a traction force T on the notched traction wire 10 by grasping its distal end 11 using the clamp 24 passing through the operating channel 22 of the endoscope 20, which has the effect of sliding said wire 10 in the traction loop 40 (according to the arrow G of the FIG. 10 ), which remains firmly anchored in the inner wall 6 of the digestive tract 5. This new traction force makes it possible to lift the mucosa 2 to be treated again, as illustrated in the FIG. 7 We are therefore talking about progressive adjustable traction with anti-return effect achieved using knot 42 with self-locking effect.

The practitioner can then again withdraw the manipulation forceps 24 to release the distal end 11 of the notched traction wire 10 without the traction force T decreasing, which allows him to act on the mucosa 2 to be treated to continue or complete the dissection, as illustrated by the FIG. 8 .

Once the dissection has been carried out, the practitioner removes the second endoscopic clip 32 from the inner wall 6 of the digestive tract 5 as well as the device 1, then extracts the mucosa 2.

According to a so-called “multi-loop” (or multi-polar) embodiment illustrated by figures 11 to 20, the distal end 11 of the notched traction wire 10 is passed, at its proximal portion 16, inside the closed fixing loop 13, so as to create a larger loop, the length of which is variable, called “adjustment loop” 17.

Between two and six fixing loops 41, for example three, are previously placed around the notched traction wire 10 before forming the adjustment loop 17, so as to form a “multi-loop” device. These fixing loops 41 can slide freely along the adjustment loop 17 of the notched traction wire 10 but they are preferably spaced regularly around the perimeter of this adjustment loop 17 which takes substantially the form of a more or less regular circle, so as to distribute the traction force exerted on the mucosa 2 during the detachment of the latter.

These (multi) fixation loops 41 are each made of a thread similar to a surgical suture thread, but it is not necessary for this thread to be sterile. This thread has a color preferentially different from that of the notched traction thread 10 in order to distinguish it from the latter, and its diameter is between approximately 0.15 mm (USP 4-0) and 0.4 mm (USP 1-0).

Each fixing loop 41 has a diameter of between approximately 3 mm and 10 mm, and are non-extensible (non-elastically deformable).

The implantation and operation of this variant embodiment are identical to what has been described in relation to figures 2 to 8, with the difference that the three fixation loops 41 are each connected to a first endoscopic clip 31 anchored to the mucosa 2 to be treated by penetration (like the bits of a jaw). These first clips 31 are brought and attached one by one to the fixation loops 41 to be anchored in the mucosa 2 to be treated (see figures 13 to 16) then the traction loop is anchored by the second endoscopic clip in the inner wall 6 of the digestive tract 5 opposite the mucosa 2 to be treated ( FIG. 17 ), slightly upstream of the latter, so that the notched traction wire 10 can be pulled (traction T) by its free end 11 using the clamp 24 passing through the operating channel 22 of the endoscope 20 ( FIG. 18 at 19) then released so that the practitioner can carry out his dissection ( FIG. 20 ). The knot 42 with unidirectional self-locking effect works in the same way as before, by allowing the notched traction wire 10 to slide in the traction loop in the direction of arrow G and by blocking this sliding in the direction of arrow D, in accordance in particular with FIG. 10 .

Figures 21 to 29 illustrate another alternative embodiment of the multipolar type in which the first endoscopic clips 31 are anchored directly in the mucosa 2 to be treated, without the intermediate presence of the fixing loops 41. Thus, it is the notched traction wire 10, and in particular the proximal portion 16 forming the adjustment loop 17, which allows the first endoscopic clips 31 both to be held on said notched traction wire 10, while being able to slide along the latter (in the space defined between the jaws of each first endoscopic clip), and to be firmly anchored in the mucosa 2 to be treated by penetration (like the jaws of a jaw). Here again, the multitude of anchoring zones of the first endoscopic clips 31 in the mucosa 2 in locations distant from each other and their distribution along the adjustment loop 17 makes it possible to distribute the traction force exerted on the mucosa 2.

The implantation and operation of this embodiment variant, illustrated by figures 22 to 29, are identical to what has been described in relation to figures 12 to 20, with the difference that the three fixation loops 41 are absent and the first endoscopic clips 31 are anchored directly in the mucosa 2 to be treated, and that one of the clips 31, positioned at the proximal pole of the lesion 2, also hooks the terminal fixation loop 13 in order to concentrate the traction force at this level. The knot 42 with unidirectional self-locking effect operates in the same way as before, by allowing the notched traction wire 10 to slide in the traction loop in the direction of the arrow G ( FIG. 10 ) and blocking this sliding in the direction of arrow D.

There FIG. 30 illustrates an alternative embodiment of figures 21 to 29 in which a terminal traction loop 50, similar to the traction loop 40, is tied around the notched traction wire 10 to form a self-locking knot and is connected to the closed fixing loop 13. More precisely, the free distal end 11 of the notched traction wire 10 is passed inside this terminal traction loop 50 and the proximal portion 16 is closed on itself at the latter so as to form an adjustment loop 17 of variable length.

As for the solution of figures 21 to 29, the first fixing clips are directly attached to the notched traction wire 10. This solution makes it possible to prevent the closed fixing loop 17 from widening because the thorns 14 of the notched traction wire 10 act as a non-return stop for the terminal traction loop 50 (same functionality as the knot 42 with unidirectional self-locking effect of the traction loop 40).

There FIG. 31 illustrates an alternative embodiment of figures 11 to 20 in which a terminal traction loop 50, similar to the traction loop 40, is tied around the notched traction wire 10 to form a self-locking knot and is connected to the closed fixing loop 13. More precisely, the free distal end 11 of the notched traction wire 10 is passed inside this terminal traction loop 50 and the proximal portion 16 is closed on itself at the latter so as to form an adjustment loop 17 of variable length.

As for the solution of figures 11 to 20, between two and six fixing loops 41, for example three, are previously placed around the notched traction wire 10 before forming the adjustment loop 17, so as to form a “multi-loop” device. The first endoscopic clips 31 are then attached to these fixing loops and operate in the same way as described previously. This solution makes it possible to prevent the closed fixing loop 17 from widening because the spines 14 of the notched traction wire 10 act as a non-return stop for the terminal traction loop 50 (same functionality as the knot 42 with unidirectional self-locking effect of the traction loop 40).

The advantages of the pre-designed and ready-to-use device of the present invention include the following:
- the device of the present invention passes through the operating channel of the endoscope, it can therefore be used, for example, throughout the digestive tract without removing the endoscope;
- the device of the present invention is compatible with a 3.2mm diameter operating channel (slim colonoscopes);
- the device of the present invention proposes a major innovation which consists of being able to very easily carry out adjustable and progressive traction, as well as an anti-recoil effect guaranteeing excellent traction to be able to act in complete safety on the lesion;
- traction adjustment is possible under the control of the practitioner's vision;
- there is no constraint when fixing the traction loop, which allows zenithal fixation, upstream or downstream of the lesion to be treated;
- the device of the present invention is simple to set up and use;
- there is no distance constraint between the lesion and the point of fixation of the traction loop so that it can also be used in large cavities (stomach);
- single-loop and multi-loop (or multipolar) versions are possible so that the device of the present invention is suitable for both small and large lesions.

It should be clearly understood that the detailed description of the subject of the Invention, given solely for the purpose of illustration, does not constitute a limitation in any way, the technical equivalents also being included within the scope of the present invention.

Thus, other forms of knots for making the traction loop 40 are conceivable provided that they are easy to make, reliable, and that they allow both the sliding in a single direction of the notched traction wire 10 and the blocking of the latter by the anti-recoil notches 14 when the traction force is transmitted to the mucosa 2 to be treated to lift it locally.

Similarly, other forms of notched traction wires are conceivable, for example a wire having a longitudinal succession called "in a string" of radial protuberances in the form of barrels, cylinders, washers or even balls, or even truncated cones all oriented in the same way (i.e. with the largest part of the cone acting as a non-return stop for the traction loop), each time preferably spaced apart, in the manner of a weighted/sealed fishing line, as long as the functions of progressive traction (depending on the position of the traction loop along the wire) and maintenance of the tension of the notched traction wire, using the traction loop, the notches and the endoscopic clips, are accomplished.

The traction loop 40 can be placed upstream, at the zenith or downstream of the mucosa 2 to be treated.

Finally, the number of first endoscopic clips 31 and/or fixing loops 41 can be modified, in particular according to the size of the mucosa 2 to be treated, for example if the latter is relatively long and/or wide in order to distribute the traction force necessary to lift and detach the mucosa.

Several similar devices 1 can also be implanted in the duct so as to operate in parallel in cases where the mucosa has too large a surface area (too long and/or too wide) and/or is too thick for a single toothed wire/traction loop/second endoscopic clip assembly to withstand the necessary traction. In this case, the practitioner implants 2 or even 3 devices and operates them simultaneously to lift the mucosa 2 to be treated without the risk of a second endoscopic clip coming loose.

Claims (16)

Medical device (1) usable with an endoscope (20) to carry out, during a digestive endoscopy, a fixing, incision, traction or dissection action on a surface of an internal mucosa (2) to be treated, called a lesion, of a body cavity (5) of the upper or lower digestive tract, such as the esophagus, the stomach, the duodenum, the rectum or the colon, said device (1) comprising for this purpose at least one traction wire (10) having a first proximal portion (16) intended to be anchored in the mucosa (2) to be treated using at least one first endoscopic clip (31) and an opposite distal/free end (11) actuable in particular using a manipulation clamp (24) passing through an operating channel (22) of said endoscope (20) and manipulated from outside the body cavity (5) to exert a traction force on said wire,
characterized in that :
- the traction wire (10) is provided, over at least part of its length, with a series of radially projecting notches (14) spaced from each other, and, at a proximal end (12), with a closed fixing loop (13), and
- the device (1) further comprises at least one traction loop (40) attached on the one hand to the notched traction wire (10) by means of a self-locking knot (42), between the first portion (16) and the distal end (11), and on the other hand to a second endoscopic clip (32) anchored in another portion of the internal cavity (5) substantially facing the mucosa (2) to be treated, the assembly comprising at least the notched traction wire (10), the endoscopic clips (31, 32) and the traction loop (40) forming a hoist making it possible to apply a progressive traction force (T), depending on the position of the notches (14) along the notched traction wire (10) where the traction loop (40) is attached, on said mucosa (2) to be treated so as to lift it locally substantially in the direction of the second endoscopic clip (32), the traction loop (40) then acting as a force return pulley. Device (1) according to claim 1, characterized in that the notches (14) are oriented externally around the notched traction wire (10) unidirectionally in the same direction and form as many self-locking anti-recoil stops for the traction loop (40), so that the traction force (T) exerted on the wire (10) can only be exerted in one direction. Device (1) according to claim 2, characterized in that the notches (14) of the notched traction wire (10) are in the form of fine points/thorns spaced from each other along said wire (10) in the manner of an ear of wheat. Device (1) according to any one of claims 1 to 3, characterized in that the notched traction wire (10) comprises notches (14) over most of its length, and preferably over its entire length. Device (1) according to any one of claims 1 to 4, characterized in that :
- the distal end (11) of the notched traction wire (10) is passed inside the closed fixing loop (13) and the proximal portion (16) is closed on itself so as to form an adjustment loop (17) of variable length, and
- several fixing loops (41), for example two to six, preferably three to four, are freely connected to said notched traction wire (10) at locations distant from each other of said adjustment loop (17) to form a multi-loop device, said fixing loops (41) being further intended to be attached by means of first endoscopic clips (31) to the mucosa (2) to be treated at locations distant from each other to distribute the traction force (T) exerted on the latter. Device (1) according to any one of claims 1 to 4, characterized in that :
- the distal end (11) of the notched traction wire (10) is passed inside the closed fixing loop (13) and the proximal portion (16) is closed on itself at the level of its closed fixing loop (13) so as to form an adjustment loop (17) of variable length, and
- several first endoscopic clips (31), for example two to six, preferably three to four, are directly connected in a free manner to said notched traction wire (10) at locations distant from each other of said adjustment loop (17) to form a multi-clip device, said first endoscopic clips (31) being furthermore intended to be attached to the mucosa (2) to be treated at locations distant from each other to distribute the traction force (T) exerted on the latter. Device (1) according to any one of claims 1 to 4, characterized in that it further comprises a terminal traction loop (50) connected on the one hand to the closed fixation loop (13) and on the other hand to the notched traction wire (10) by a self-locking knot, the distal end (11) of the notched traction wire (10) is passed inside the terminal traction loop (50) and the proximal portion (16) is closed on itself at the latter so as to form an adjustment loop (17) of variable length, and several fixation loops (41), for example two to six, preferably three to four, are freely connected to said notched traction wire (10) at locations distant from each other of said adjustment loop (17) to form a multi-loop device, said fixation loops (41) being moreover intended to be attached by means of first endoscopic clips (31) to the mucosa (2) to be treated in locations distant from each other to distribute the traction force (T) exerted on the latter. Device (1) according to any one of claims 1 to 4, characterized in that it further comprises a terminal traction loop (50) connected on the one hand to the closed fixation loop (13) and on the other hand to the notched traction wire (10) by a self-locking knot, the distal end (11) of the notched traction wire (10) is passed inside the terminal traction loop (50) and the proximal portion (16) is closed on itself at the latter so as to form an adjustment loop (17) of variable length, and several first endoscopic clips (31), for example two to six, preferably three to four, are directly connected in a free manner to said notched traction wire (10) at locations distant from each other of said adjustment loop (17) to form a multi-clip device, said first endoscopic clips (31) being moreover intended to be attached to the mucosa (2) to be treated in locations distant from each other to distribute the tensile force (T) exerted on the latter. Device (1) according to any one of claims 1 to 8, characterized in that the notched traction wire (10) has a diameter of between approximately 0.15 mm and 0.4 mm and a length of between approximately 4 cm and 45 cm. Device (1) according to any one of claims 1 to 9, characterized in that each traction loop (40) is constituted by a ring of wire forming a self-locking knot (42) called a “lark’s head” knot closed around the notched traction wire (10). Device according to any one of claims 1 to 10, characterized in that each traction loop (40) is made from a surgical suture thread, preferably braided, having a diameter of between approximately 0.15 mm and 0.4 mm. Device (1) according to any one of claims 1 to 11, characterized in that each traction loop (40) and each fixing loop (41) have a different color and/or contrast from the notched traction wire (10). Device (1) according to any one of claims 1 to 12, characterized in that each traction loop (40) measures approximately 4 mm to 10 mm in diameter. Device according to any one of claims 1 to 13, characterized in that the traction loop (40) is positioned between approximately 10 mm and 30 mm from the distal/free end (11) of the notched traction wire (10). Device (1) according to any one of claims 1 to 14, characterized in that each fixing loop (41) measures approximately 3 mm to 10 mm in diameter. Device (1) according to any one of claims 1 to 15, characterized in that each fixing loop (41) is constituted by a closed wire ring inside which passes the notched traction wire (10) along which it can slide freely.