Endoscopic medical device for acting on an internal mucosa and comprising at least one barbed traction wire and a self-locking knot
The medical device with a notched traction wire and self-locking knot system addresses the limitations of existing endoscopic traction systems by providing adjustable and constant tension, ensuring safe and efficient mucosal manipulation during digestive endoscopy.
Patent Information
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2024-03-12
- Publication Date
- 2026-03-13
AI Technical Summary
Existing endoscopic traction systems for digestive endoscopy, such as elastic and wire-based systems, face challenges including complexity in setup, inability to adjust traction force, limited applicability to large cavities, and loss of effectiveness during procedures, making them impractical and unsafe for handling and versatile use.
A medical device with a notched traction wire and self-locking knot system, allowing for progressive and adjustable traction force application using endoscopic clips, ensuring the wire remains taut and maintains tension without manual intervention, suitable for both small and large lesions.
Enables safe, precise, and versatile manipulation of mucosal tissues by maintaining constant traction force, facilitating effective dissection and resection procedures with ease of use and applicability across various digestive tract locations.
Smart Images
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Abstract
Description
Title of the invention: Endoscopic medical device for acting on an internal mucosa and comprising at least one barbed traction wire and a self-locking knot. Technical field of the invention
[0001] 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.
[0002] 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.
[0003] More particularly, the invention relates to devices, instruments and accessories enabling fixation, incision, capture, traction or dissection operations to be carried out during a digestive endoscopy. Previous technique
[0004] Endoscopic submucosal dissection is an interventional endoscopy technique that allows for the en bloc resection of superficial digestive lesions (the mucosa to be treated). It consists of progressively cutting, using a dissecting knife (electrocautery) inserted into the working channel of an endoscope, the submucosa located beneath the lesion and separating it from the muscular wall of the digestive tract. To improve exposure (visibility and access) of the submucosa, two methods are used and can be combined: - the 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 opposite direction to the muscle wall, to improve exposure of the submucosa.
[0005] In general, improving exposure of the submucosa improves the safety of the procedure (better visibility of vessels, distance from the muscle wall) as well as the speed of the procedure.
[0006] Traction systems used in submucosal dissection are of two types: - either based on elastic traction; - either based on traction by a wire manipulated from outside the patient, and possibly associated with a pulley system.
[0007] Both of these types of traction have disadvantages.
[0008] Thus, the most commonly used elastic traction systems, whether simple or associated with a multi-loop system, have the following main disadvantages: - 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, there is no possibility of observing either the intensity or the direction of the traction force applied to the lesion, when the elastic is fixed to the wall opposite the lesion; - Furthermore, their use is not possible in large cavities (stomach) given the limited size of the elastics available (dental appliance elastics); - Finally, a loss of effectiveness may be observed during the procedure, related to the loss of traction capacity of the elastic which returns to its resting shape as the dissection progresses and the lesion is lifted.
[0009] The wire traction system possibly associated with a pulley has the following main disadvantages: - because of 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 (primarily esophagus, stomach and rectum); - the procedure requires the temporary removal of the endoscope, and therefore takes some time.
[0010] Furthermore, the use of a so-called "multi-loop" system is necessary for lesions exceeding a certain size to be resected. This allows a traction force to be applied over a larger area of the lesion, lifting its edges on several sides to increase the exposure area of the submucosa, and helps to limit the risk of lesion torsion during dissection.
[0011] Document WO2023208930, which describes a multi-loop adaptive endoscopic traction device, is known. This device is effective but has the disadvantages of being rather difficult to set up due to its complexity, and the general disadvantages associated with elastic traction systems described previously.
[0012] Document WO2022190234 is known, describing a device that attaches around the tip of the endoscope and allows traction to be applied to an element of the digestive tract. This device does not pass through the working channel, cannot be released into the digestive tract, and uses neither wire nor endoscopic clip.
[0013] EP3998024 is known to describe a traction system using several loops attached to one another, instead of a traction wire, the purpose of which is to allow for several traction lengths. There is no gradual adjustment of the traction.
[0014] Document WO2021113232A1 is known, which describes in very broad terms a traction system using two clips and a traction band. It makes no mention of progressive adjustment of the traction.
[0015] Finally, document WO2020251715A1 describes in very broad terms a traction system using two clips and an extensible filament.
[0016] In summary, elastic traction systems are the most widely used because they are relatively easy to manufacture. 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.
[0017] However, there remain many disadvantages to using prior art systems which are not sufficiently practical, easy to handle, safe and versatile.
[0018] The invention thus relates more specifically to an endoscopic device allowing the application of a traction force on a wire whose force 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.
[0019] The invention can, for example, be used during endoscopic submucosal dissection procedures, that is, therapeutic endoscopic procedures whose purpose is the en bloc resection of a superficial lesion of the digestive mucosa. However, it is by no means limited to this application and can be used for all procedures performed endoscopically on the digestive tract. Presentation of the invention
[0020] The present invention aims to remedy these drawbacks with a completely innovative approach.
[0021] To this end, according to a first aspect, the present invention relates to a medical device usable with an endoscope to perform, during 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, stomach, duodenum, rectum or 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 manipulator 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 apart from each other, and, at a proximal end, with a closed fastening loop, and - the device further comprises at least one traction loop attached on one side to the notched traction wire by means of a self-locking knot, between the first portion and the distal end, and on the other side 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 allowing a progressive traction force to be applied, according to 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-returning pulley.
[0022] This solution allows for safe manipulation of the mucosa being treated because the traction action is maintained by the tension of the barbed traction wire and the traction loop, which create an anti-return force using the barbs and the self-locking knot. The practitioner can thus perform the necessary manipulations precisely, without having to worry about the tension of the barbed traction wire, which can be repeatedly tightened by pulling on it from outside the patient's body, for example, to gradually lift the mucosa as the endoscopic procedure is performed. The combination of the barbs on the traction wire and the traction loop firmly anchored in the body cavity creates a kind of lifting mechanism in which the traction wire remains constantly taut.
[0023] The invention is implemented according to the embodiments and variants set out below, which are to be considered individually or according to any technically feasible combination.
[0024] 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.
[0025] Thanks to this solution, the serrated traction wire cannot fully relax because the self-locking knot of the traction loop will maintain it under tension, thus preventing the surface of the mucosa being treated from collapsing and returning to its initial position. The specific orientation of the serrations creates a safety mechanism against retraction, so that the practitioner does not need to manually maintain tension on the free end of the traction wire to keep it taut and pulling on the mucosa being treated.
[0026] Preferably, the notches of the notched traction wire are in the form of fine points / spines spaced apart along said wire in the manner of an ear of wheat.
[0027] This simple design solution makes it possible to achieve an effective anti-return force.
[0028] According to a preferred embodiment of the present invention, the traction wire Notched has notches along most of its length, and preferably along its entire length.
[0029] This solution allows the traction loop to be placed at different locations on the notched traction wire.
[0030] 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 far apart from each other of said adjustment loop to form a multi-loop device, said fixation loops being further intended to be hooked by means of first endoscopic clips to the mucosa to be treated at locations far apart from each other to distribute the traction force exerted on the latter.
[0031] This solution makes it possible to act on large and / or elongated lesions with a single device.
[0032] According to one 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 the level of 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 freely to said notched traction wire at locations far apart from each other of said adjustment loop to form a multi-clip device, said first endoscopic clips being further intended to be hooked to the mucosa to be treated at locations far apart from each other to distribute the traction force exerted on the latter.
[0033] According to another particular embodiment, in addition, a terminal traction loop is connected on one side to the closed fixation loop and on the other side to the serrated traction wire by a self-locking knot. The distal end of the serrated traction wire is passed inside said terminal traction loop, and the proximal portion is closed upon itself at the latter so as to form an adjustment loop of variable length. Several fixation loops, for example two to six, preferably three to four, are freely connected to said traction wire. notched in locations far apart from each other of said adjustment loop to form a multi-loop device, said fixation loops being further intended to be hooked by means of first endoscopic clips to the mucosa to be treated in locations far apart from each other to distribute the traction force exerted on the latter.
[0034] According to one variant, the device further includes a terminal traction loop connected on one side to the closed fixation loop and on the other side to the serrated traction wire by a self-locking knot, the distal end of the serrated traction wire is passed inside said terminal traction loop and the proximal portion is closed on itself at the level of 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 freely to said serrated traction wire at locations far apart from each other of said adjustment loop to form a multi-clip device, said first endoscopic clips being further intended to be hooked to the mucosa to be treated at locations far apart from each other to distribute the traction force exerted on the latter.
[0035] 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.
[0036] According to a particularly interesting aspect of the present invention, each traction loop is made up of a ring of wire forming a self-locking knot known as a "lark's head" knot closed around the notched traction wire.
[0037] Preferably, each traction loop is made of surgical suture thread, preferably braided, having a diameter of between approximately 0.15 mm and 0.4 mm.
[0038] According to a particular feature of the present invention, each traction loop and each fastening loop has a different colour and / or contrast to the notched traction wire.
[0039] Preferably, each traction loop measures approximately 4 mm to 10 mm in diameter.
[0040] Advantageously, the traction loop is positioned between approximately 10 mm and 30 mm from the distal / free end of the notched traction wire.
[0041] According to a particular feature, each fastening loop measures approximately 3 mm to 10 mm in diameter.
[0042] Preferably, each fastening 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
[0043] Other advantages, purposes and features of the present invention will become apparent from the following description, given for explanatory purposes and in no way as a limitation, with reference to the accompanying drawings, in which:
[0044] [Fig-1] [Fig.1] is a schematic side view of a device conforming to the present invention, before use with an endoscope,
[0045] [Fig.2] [Fig.2] is a side view of the device of [Fig.1] in a first stage of use,
[0046] [Fig.3] [Fig.3] is a side view of the device of [Fig.1] in a second stage of use,
[0047] [Fig.4] [Fig.4] is a side view of the device of [Fig.1] in a third stage of use,
[0048] [Fig.5] [Fig.5] is a side view of the device of [Fig.1] in a fourth stage of use,
[0049] [Fig.6] [Fig.6] is a side view of the device of [Fig.1] in a fifth stage of use,
[0050] [Fig.7] [Fig.7] is a side view of the device of [Fig.1] in a sixth stage of use,
[0051] [Fig.8] [Fig.8] is a side view of the device of [Fig.1] in a seventh stage of use,
[0052] [Fig.9] [Fig.9] is a detail view of a traction loop of the device shown in Figures 1 to 8,
[0053] [Fig. 10] [Fig. 10] is an enlarged view of the detail of [Fig. 9],
[0054] [Fig. 11] [Fig. 11] is a side view of a first variant embodiment of the arrangement of figures 1 to 8,
[0055] [Fig. 12] [Fig. 12] is a side view of the device of [Fig. 11] in a first stage of use,
[0056] [Fig. 13] [Fig. 13] is a side view of the device of [Fig. 11] in a second stage of use,
[0057] [Fig. 14] [Fig. 14] is a front view of the device figure of [Fig. 11] in a third stage of use,
[0058] [Fig. 15] [Fig. 15] is a side view of the device of [Fig. 11] in a fourth stage of use,
[0059] [Fig. 16] [Fig. 16] is a front view of [Fig. 15],
[0060] [Fig. 17] [Fig. 17] is a side view of the device of [Fig. 11] in a fifth step of use,
[0061] [Fig. 18] [Fig. 18] is a side view of the device of [Fig. 11] in a sixth stage of use,
[0062] [Fig. 19] [Fig. 19] is a front view of [Fig. 18],
[0063] [Fig. 20] [Fig. 20] is a side view of the device of [Fig. 11] in a seventh of use,
[0064] [Fig.21] [Fig.21] is a side view of an alternative embodiment of the device figures 11 to 20,
[0065] [Fig.22] [Fig.22] is a side view of the device of [Fig.21] in a first usage step,
[0066] [Fig.23] [Fig.23] is a side view of the device of [Fig.21] in a second stage of use,
[0067] [Fig. 24] [Fig. 24] is a side view of the device of [Fig. 21] in a third usage step,
[0068] [Fig. 25] [Fig. 25] is a front view of the figure of the device in [Fig. 21] a fourth stage of use,
[0069] [Fig. 26] [Fig. 26] is a side view of the device of [Fig. 21] in a fifth step of use,
[0070] [Fig. 27] [Fig. 27] is a side view of the device of [Fig. 21] in a sixth usage step,
[0071] [Fig. 28] [Fig. 28] is a side view of the device of [Fig. 21] in a seventh usage step,
[0072] [Fig. 29] [Fig. 29] is a side view of the device of [Fig. 21] in an eighth usage step,
[0073] [Fig. 30] [Fig. 30] is a side view of an alternative embodiment of the device figures 21 to 29, and
[0074] [Fig. 31] [Fig. 31] is a side view of an alternative embodiment of the device figures 11 to 20. Description of the implementation methods
[0075] Figures 1 to 31 represent different embodiments of a medical device 1 according to the present invention used by an operator performing a therapeutic digestive endoscopy procedure, for example, on a body cavity 5 (or natural conduit) of the upper or lower digestive tract of a patient (not shown), such as the esophagus, stomach, duodenum, rectum or colon.
[0076] This description is given by way of non-limiting attribution, each feature of one embodiment being able to be combined with any other feature of any other embodiment.
[0077] It is noted from the outset that the figures are not necessarily to scale, without this affecting their understanding.
[0078] 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 of an endoscope 20 of a known type in the patient's digestive tract 5 to perform fixation, incision, traction, or dissection of a mucosa 2 to be treated, in particular a lesion of the inner wall 6 of said digestive tract 5 of the patient. This traction suture does not need to be sterile.
[0079] The endoscope 20 has for this purpose 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.
[0080] 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 to the proximal end 12 and operable in particular using a manipulation clamp 24 passing through the working channel 22 of the endoscope 20.
[0081] To this end, the barbed traction thread 10 has, at its proximal end 12, a closed (or terminal) fixation loop 13 to which a first endoscopic clip 31 can be attached. The barbed traction thread 10 is similar to a surgical suture, 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.
[0082] As illustrated by [Fig. 9] and 10, the notched traction wire 10 is provided, over most of its length and preferably along its entire length, with notches 14 materialized by points / spines arranged around said wire and projecting radially outwards from it. These points 14 are all spaced by a zone 15 and oriented in the same direction so that the notched traction wire 10 forms a kind of giant, elongated ear of wheat, each point / spine of which forms an anti-recoil notch, the purpose of which will be explained later.
[0083] During its implantation in the digestive tract 5, the barbed 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 barbed wire 10 by forming a lark's head knot 42 tightened at the level of the prominent notches 14.
[0084] As can be seen in the zoomed view of [Fig. 10], the strands constituting this knot 42 are preferably, but not necessarily, tightened in spaces 15 between two thorns 14 of the serrated traction wire 10. When this knot 42 is correctly tied by the practitioner, it allows the wire to be pulled along arrow G while the thorns 14 blocks any sliding of the notched traction wire 10 in the knot 42 in the direction of arrow D.
[0085] 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.
[0086] The wire forming the traction loop 40 is non-stretchable (non-elastically deformable) and has a diameter between 0.15 mm (USP 4-0) and 0.4 mm (USP 1-0). This loop typically has a "before knotting" diameter between approximately 4 mm and 10 mm and is knotted to the serrated traction wire 10 at a distance between approximately 10 mm and 30 mm from its distal / free end 11.
[0087] Figures 2 to 8 illustrate seven steps of implantation and use of the device 1 according to the present invention, in the following chronological order:
[0088] The practitioner, after inserting the endoscope 20 into the patient's digestive tract 5, locates the mucosa 2 to be treated. The practitioner then makes an incision 3 around the mucosa 2 to be treated, for example with a knife (electric scalpel) introduced through the light 22 of the endoscope 20 and placed at its distal end 23. Next, the practitioner positions the device 1 of the present invention near the lesion 2, as illustrated in [Fig.3].
[0089] 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 whose jaws is inserted into the closed fixation loop 13 before being fixed in said mucosa 2, as illustrated by [Fig.3].
[0090] Once the endoscopic clip 31 is released and firmly anchored in the mucosa 2 to be treated, the practitioner attaches the traction loop 40, previously knotted around the barbed traction thread 10, to the inner wall 6 of the natural canal 5 using a second endoscopic clip 32, one of whose jaws is inserted into the traction loop 40 before anchoring itself in said wall 5, as illustrated in [Fig. 4]. It should be noted that in this embodiment, the traction loop 40 is positioned slightly proximal to the mucosa 2 to be treated, and in particular relative to the first endoscopic clip 31.
[0091] The practitioner then grasps the free distal end 11 of the barbed traction wire 10 with forceps 24 passing through the working channel 22 of the endoscope 20 in order to exert a traction force on said wire, as indicated by arrows T. The assembly consisting of the barbed traction wire 10, the traction loop 40, and the first and second endoscopic clips 31 and 32 thus forms a lifting hoist which, as the traction force T increases, allows the first endoscopic clip 31 to be pulled in order to locally lift the mucosa 2 to be treated, as illustrated in [Fig. 5]. The traction loop 40, in particular its lark's head knot 42, being blocked in translation by the spiky (ear-shaped) barbs 14 of the wire, 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 barbs 14 of the notched traction wire 10 create an anti-return stop (self-locking effect of the knot 42) which block the latter and prevent it from sliding in the traction loop 40 against the arrows T, i.e. in the direction of the arrow D. We thus speak of knot 42 with unidirectional self-locking effect.
[0092] Indeed, as illustrated in [Fig.6], the manipulation clamp 24 is 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 perform a dissection of the mucosa 2 to be treated at the level of the incision 3 using a suitable instrument (dissecting knife) passing through the working channel 22 of the endoscope 20.
[0093] The practitioner can again apply a traction force T to the serrated traction wire 10 by grasping its distal end 11 with the forceps 24 passing through the working channel 22 of the endoscope 20. This causes the wire 10 to slide into the traction loop 40 (as indicated by arrow G in [Fig. 10]), which remains firmly anchored in the inner wall 6 of the digestive tract 5. This renewed traction force allows the mucosa 2 to be treated to be lifted again, as illustrated in [Fig. 7]. This is referred to as progressive adjustable traction with an anti-return effect, achieved using the self-locking knot 42.
[0094] The practitioner can then again remove the manipulation clamp 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 [Fig.8].
[0095] 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 he extracts the mucosa 2.
[0096] According to a variant embodiment called "multi-loop" (or multipolar) illustrated by figures 11 to 20, the distal end 11 of the notched traction wire 10 is passed, at the level of its proximal portion 16, inside the closed fixation loop 13, so as to create a larger loop, the length of which is variable, called "adjustment loop" 17.
[0097] Between two and six fastening loops 41, for example three, are pre-positioned around the notched traction wire 10 before forming the adjustment loop 17, so as to form a "multi-loop" device. These fastening loops 41 can slide freely along the adjustment loop 17 of the notched traction wire 10, but they are preferably evenly spaced around the perimeter of this adjustment loop 17, which is substantially in the shape of a circle. less regular, so as to distribute the traction force exerted on the mucosa 2 during the detachment of the latter.
[0098] These (multi) fixation loops 41 are each made of a thread similar to a surgical suture thread, but this thread does not need to be sterile. This thread is preferably a different color from that of the barbed 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).
[0099] Each fastening loop 41 has a diameter between approximately 3 mm and 10 mm, and is non-extensible (non-elastically deformable).
[0100] The implantation and operation of this variant embodiment are identical to that which 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 (such as the jaws of a jaw). These first clips 31 are brought and hooked 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 serrated traction wire 10 can be pulled (traction T) by its free end 11 with the forceps 24 passing through the working channel 22 of the endoscope 20 ([Fig.18] to 19) then released so that the practitioner can perform his dissection ([Fig.20]).The unidirectional self-locking knot 42 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].
[0101] Figures 21 to 29 illustrate another variant of a multipolar type embodiment in which the first endoscopic clips 31 are anchored directly into the mucosa 2 to be treated, without the intermediate presence of the fixation loops 4L. 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 to 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 mucosa 2 in locations far from each other and their distribution along the adjustment loop 17 allows the traction force exerted on the mucosa 2 to be distributed.
[0102] The installation and operation of this variant embodiment, illustrated by Figures 22 to 29, are identical to what has been described in relation to Figures 12 to 20, The only difference is that the three fixation loops 41 are absent, and the first endoscopic clips 31 are anchored directly into the mucosa 2 to be treated. 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 that level. The unidirectional self-locking knot 42 functions in the same way as before, by allowing the serrated traction wire 10 to slide in the traction loop in the direction of arrow G ([Fig. 10]) and by locking this sliding in the direction of arrow D.
[0103] Figure 30 illustrates an alternative embodiment of Figures 21 to 29 in which a terminal traction loop 50, similar to traction loop 40, is knotted around the notched traction wire 10 to form a self-locking knot and is connected to the closed fixation loop 13. More specifically, 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 over itself at the level of the latter so as to form an adjustment loop 17 of variable length.
[0104] As with the solution in Figures 21 to 29, the first fixing clips are directly attached to the serrated traction wire 10. This solution prevents the closed fixing loop 17 from widening because the thorns 14 of the serrated traction wire 10 act as a backstop for the terminal traction loop 50 (same functionality as the knot 42 with unidirectional self-locking effect of the traction loop 40).
[0105] Figure 31 illustrates an alternative embodiment of Figures 11 to 20 in which a terminal traction loop 50, similar to traction loop 40, is knotted around the notched traction wire 10 to form a self-locking knot and is connected to the closed fixation loop 13. More specifically, 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 over itself at the level of the latter so as to form an adjustment loop 17 of variable length.
[0106] As with the solution in Figures 11 to 20, between two and six fixation loops 41, for example three, are pre-positioned around the serrated 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 fixation loops and function in the same way as described previously. This solution prevents the closed fixation loop 17 from widening because the barbs 14 of the serrated traction wire 10 act as a non-return stop for the terminal traction loop 50 (the same functionality as the unidirectional self-locking knot 42 of the traction loop 40).
[0107] 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 working channel of the endoscope, it is therefore usable for example throughout the digestive tract without withdrawal of the endoscope; - the device of the present invention is compatible with an operating channel of 3.2mm in diameter (slim colonoscopes); - the device of the present invention offers a major innovation which consists of being able to perform very easily an adjustable and progressive traction, as well as an anti-recoil effect guaranteeing excellent traction to be able to act safely on the lesion; - Traction adjustment is possible under the practitioner's visual control; - there is no constraint when fixing the traction loop, which allows for 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 constraint on the distance between the lesion and the point of attachment of the traction loop so that it is also usable 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 small and large lesions.
[0108] It must be clearly understood that the detailed description of the object of the Invention, given solely by way of illustration, does not in any way constitute a limitation, technical equivalents also being included in the scope of the present invention.
[0109] Thus, other forms of knots for making the traction loop 40 are conceivable provided that they are easy to make, reliable, that they allow both the sliding in one direction of the notched traction wire 10 and the locking of the latter by the anti-recoil notches 14 when the traction force is transmitted to the mucosa 2 to be treated in order to lift it locally.
[0110] Similarly, other forms of serrated traction wires are conceivable, for example a wire having a longitudinal succession known as "in a rosary" of radial protuberances in the form of barrels, cylinders, washers or balls, or even truncated cones all oriented in the same way (i.e. with the largest part of the cone acting as a stop against return for the traction loop), each time preferably spaced apart, in the manner of a weighted / weighted fishing line, provided that the functions of progressive traction (according to the position of the traction loop along the wire) and of maintaining the tension of the serrated traction wire, using the traction loop, the notches and the endoscopic clips, are accomplished.
[0111] The traction loop 40 can be placed upstream, at the zenith or downstream of the mucosa 2 to be treated.
[0112] Finally, the number of first endoscopic clips 31 and / or fixation 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 required to lift and detach the mucosa.
[0113] 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 barbed wire / traction loop / second endoscopic clip assembly to withstand the necessary traction. In this case, the practitioner implants 2 or even 3 devices and actuates them simultaneously to lift the mucosa 2 to be treated without risk of a second endoscopic clip detaching.
Claims
Demands
1. A medical device (1) usable with an endoscope (20) to perform, during digestive endoscopy, an action of fixation, incision, traction or dissection 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, stomach, duodenum, rectum or 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 forceps (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,of a series of radially projecting notches (14) spaced apart, and, at a proximal end (12), of a closed fixation loop (13), and - the device (1) further comprises at least one traction loop (40) attached on one side 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 side 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) being adapted to form a hoist allowing the application of a progressive traction force (T), depending on the position of the notches (14) along the notched traction wire (10) where the loop is attached traction (40),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-returning pulley.
2. Device (1) according to claim 1, characterized in that the notches (14) are oriented externally around the notched traction wire (10) in a unidirectional manner in the same direction and form as many self-locking anti-recoil stops for the traction loop (40), so that the tensile force (T) exerted on the wire (10) can only be in one direction.
3. 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 / spines spaced apart along said wire (10) in the manner of an ear of wheat.
4. Device (1) according to any one of claims 1 to 3, characterized in that the notched traction wire (10) has notches (14) over most of its length, and preferably over its entire length.
5. Device (1) according to any one of claims 1 to 4, characterized in that: - the distal end (11) of the serrated traction wire (10) is passed inside the closed fixation loop (13) and the proximal portion (16) is closed on itself 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 serrated traction wire (10) at locations far apart from each other of said adjustment loop (17) to form a multi-loop device, said fixation loops (41) being further intended to be hooked by means of first endoscopic clips (31) to the mucosa (2) to be treated at locations far apart from each other to distribute the traction force (T) exerted on the latter.
6. A device (1) according to any one of claims 1 to 4, characterized in that: - the distal end (11) of the serrated traction wire (10) is passed inside the closed fixation loop (13) and the proximal portion (16) is closed upon itself at its closed fixation 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 and freely connected to said serrated traction wire (10) at locations far apart from each other on said adjustment loop (17) to form a multi-clip device, said first endoscopic clips (31) being further intended to be hooked to the mucosa (2) at treat in locations far apart from each other to distribute the tensile force (T) exerted on the latter.
7. Device (1) according to any one of claims 1 to 4, characterized in that it further comprises a terminal traction loop (50) connected on one side to the closed fixation loop (13) and on the other side to the serrated traction wire (10) by a self-locking knot, the distal end (11) of the serrated traction wire (10) is passed inside the terminal traction loop (50) and the proximal portion (16) is closed on itself at the level of 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 serrated traction wire (10) at locations far apart from each other of said adjustment loop (17) to form a multi-loop device,said fixation loops (41) are also intended to be attached by means of first endoscopic clips (31) to the mucosa (2) to be treated at locations far apart from each other in order to distribute the traction force (T) exerted on the latter.
8. Device (1) according to any one of claims 1 to 4, characterized in that it further comprises a terminal traction loop (50) connected on one side to the closed fixation loop (13) and on the other side to the serrated traction wire (10) by a self-locking knot, the distal end (11) of the serrated traction wire (10) is passed inside the terminal traction loop (50) and the proximal portion (16) is closed on itself at the level of 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 and freely connected to said serrated traction wire (10) at locations far apart from each other of said adjustment loop (17) to form a multi-clip device,said first endoscopic clips (31) being further intended to be attached to the mucosa (2) to be treated at locations far apart from each other in order to distribute the traction force (T) exerted on the latter.
9. Device (1) according to any one of claims 1 to 8, characterized in that the notched traction wire (10) comprises a diameter between approximately 0.15 mm and 0.4 mm and a length between approximately 4 cm and 45 cm.
10. Device (1) according to any one of claims 1 to 9, characterized in that each traction loop (40) is made up of a wire ring forming a self-locking knot (42) known as a "lark's head" knot closed around the notched traction wire (10).
11. Device according to any one of claims 1 to 10, characterized in that each traction loop (40) is made of a surgical suture thread, preferably braided, having a diameter of between about 0.15 mm and 0.4 mm.
12. Device (1) according to any one of claims 1 to 11, characterized in that each traction loop (40) and each fastening loop (41) have a different colour and / or contrast to the notched traction wire (10).
13. 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.
14. 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).
15. Device (1) according to any one of claims 1 to 14, characterized in that each fastening loop (41) measures approximately 3 mm to 10 mm in diameter.
16. Device (1) according to any one of claims 1 to 15, characterized in that each fastening loop (41) is made up of a closed wire ring inside which passes the notched traction wire (10) along which it can slide freely.