PROGRESSIVE TRACTION ENDOSCOPIC DEVICE
The progressive traction device with a unidirectional adjustment mechanism addresses the complexity of existing devices by simplifying the adjustment process and ensuring stable traction force application for submucosal dissection of digestive tract tumors.
Patent Information
- Application Number
- FR2025002604
- Authority / Receiving Office
- FR · FR
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-07
- Filing Date
- 2025-03-14
- Publication Date
- 2026-02-13
- Estimated Expiration
- 2045-03-14
AI Technical Summary
Existing endoscopic traction devices for resecting superficial tumors of the digestive tract are complex to use due to the intricate adjustment elements, including clamping wires and collars, which complicate the application of traction force.
A progressive traction device with a unidirectional adjustment mechanism, featuring a traction wire embedded in helical windings, allows for a simple and efficient application of a progressive traction force on tumor mucosa, utilizing a unidirectional adjustment element that maintains the traction loop length after a single pulling action.
The device simplifies the use and manufacture of the traction device, enhances adjustment efficiency, and reduces the risk of accidental detachment, while ensuring a stable and progressive traction force during submucosal dissection.
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Abstract
Description
Title of the invention: PROGRESSIVE TRACTION ENDOSCOPIC DEVICE TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to the technical field of endoscopic devices, and more particularly to the technical field of endoscopic traction devices for biological tissue used in the resection of superficial tumors of the digestive tract. STATE OF THE ART
[0002] Endoscopic tissue traction devices are commonly used in the field of digestive endoscopy, particularly for the resection of superficial tumors of the digestive tract. Such devices generally comprise an anchor attached to the superficial tumor and a traction element attached to the digestive tract opposite the superficial tumor to exert traction on it via the anchor.
[0003] Typically, during the resection of superficial tumors of the digestive tract, the practitioner performs a submucosal dissection. This dissection is a complex technique that allows for the semi-invasive resection of superficial tumors. Submucosal dissection consists of separating the tumor mucosa from the rest of the digestive tract wall using a dissecting instrument, with the submucosa serving as the dissection plane.
[0004] This intervention is said to be "semi-invasive" because it respects the organ with relatively short healing times compared to traditional invasive interventions.
[0005] A traction device makes it possible to facilitate submucosal dissection by pulling the mucosa away from the muscle so as to expose the submucosa.
[0006] To achieve this, the anchor is fixed to a portion of the tumor mucosa, or near the tumor mucosa, by means of a removable fixation element (also referred to as a "clip" or "endoscopic clip"), while the traction element is fixed to the opposite wall of the digestive tract so as to exert a traction force on the tumor mucosa. This traction force allows the tumor mucosa to be separated from the rest of the digestive wall and facilitates dissection.
[0007] To facilitate submucosal dissection, a French patent FR 3 134 704 proposed a biological tissue traction device comprising an elastic organ, for example in the shape of a circular ring, a proximal anchor, a distal anchor and a Adjustment device. In this traction device, the two anchors, distal and proximal, are mounted to move relative to the elastic element by means of a proximal traction wire and a distal traction wire connecting the proximal and distal anchors, respectively, to the elastic element. These two anchors are movable between a minimum traction distance and a maximum traction distance. An adjustment device, including a clamp and a tension wire, allows the maximum traction distance to be adjusted between an initial maximum traction distance and a final maximum traction distance, the final maximum traction distance being less than the initial maximum traction distance.
[0008] This device is effective but difficult to use due to the complexity of the adjustment element which includes both a clamping wire and a clamping collar.
[0009] The present invention aims to overcome these drawbacks by proposing an endoscopic progressive traction device allowing the application of a progressive traction force on the tumor mucosa by means of an adjustment mechanism that is simple to use and manufacture.
[0010] The present invention falls within this context. Summary of the invention
[0011] According to a first aspect, the invention relates to a traction device for a biological tissue of the digestive tract comprising: - a traction wire having a first end and a second end; - a support organ intended to be fixed to the digestive tract, away from the biological tissue, and comprising at least one guide through-hole through which the traction wire is mounted sliding; - a unidirectional adjusting device comprising at least one first helical winding through which the traction wire is mounted and embedded; in which the first end of the traction wire is connected, directly or indirectly, to the traction wire at a distance from the second end, so as to form a traction loop of variable length intended to be anchored to the biological tissue; and in which the unidirectional adjustment organ is configured to adjust the length of the traction loop between an initial length and a final length, less than the initial length so as to exert a progressive traction force on the biological tissue. This embodiment improves the adjustment of the traction wire and the efficiency of the traction device. Indeed, according to this embodiment, the unidirectional adjustment element maintains the traction wire length at a desired length after a single pulling action on it. In other words, When the traction wire is pulled, the length of the traction loop decreases, then when the wire is released, the loop length is maintained at the decreased length. This embodiment also simplifies the use and manufacture of the unidirectional adjustment element. For the purposes of this invention, a "unidirectional adjustment element" is understood to mean an element that allows the length of the traction loop to be adjusted in a single direction, thereby reducing the length of the traction loop. In an embodiment where the traction device further includes a hook loop, the unidirectional adjustment element also allows the length of the hook loop to be adjusted in a single direction, thereby reducing the length of the hook loop.
[0012] According to an embodiment of the first aspect of the invention, the first helical winding is formed by a wire with tightly wound turns in the initial state. In one embodiment, the at least one first helical winding is configured to adjust the length of the tension loop between an initial length and a final length shorter than the initial length, and extends along a first longitudinal axis. In another embodiment, the tension wire is embedded in the at least one first helical winding by deforming the first helical winding in at least one direction transverse to the longitudinal axis, preferably in at least one direction substantially perpendicular to the longitudinal axis. These embodiments improve the efficiency of the unidirectional adjustment mechanism.Indeed, thanks to the embedding of the traction wire in the first helical winding by the pre-deformation of this first helical winding, the traction wire can be held firmly in the first helical winding and thus guarantee the anti-return effect of the unidirectional adjusting element. For the purposes of this invention, "initial length" means the length of the traction loop before any traction action is applied to the traction wire. For example, this length corresponds to the length of the traction loop before the traction device is introduced into the digestive tract. For the purposes of this invention, "final length" means the length of the traction loop after one or more traction actions on the traction wire.
[0013] According to one embodiment of the first aspect of the invention, the first end comprises a loop, and the second end is passed through the loop to form said traction loop. This embodiment makes it easier to manufacture the unidirectional adjusting member and to simplify the assembly of the traction wire with the unidirectional adjusting member. Furthermore, this embodiment allows the initial length of the traction loop to be preset before any pulling action is applied to the second end of the traction wire. Indeed, thanks to the loop, the length of the traction loop can be adjusted.
[0014] According to one embodiment of the first aspect of the invention, the support organ further comprises at least one through-hole for fixation configured to allow fixation of the support organ to the digestive tract via an endoscopic clip or a fixation loop. This embodiment makes it easier to fix the support organ to the wall of the digestive tract.
[0015] According to an embodiment of the first aspect of the invention, the traction device further comprises at least one anchoring loop, preferably at least two anchoring loops, mounted to slide freely in at least one guide through-hole or traction through-hole of the support member and intended to be anchored to the biological tissue. This embodiment improves the distribution of forces on the biological tissue. Indeed, by adding at least one anchor loop, it is possible to add a new, different anchor point, and thus add a tensile force independently of the tensile force exerted by the traction wire.
[0016] According to one embodiment of the first aspect of the invention, the traction wire includes at least one visual marker, preferably the visual marker is a colored section or a ring set on the traction wire. According to one embodiment of the first aspect of the invention, the visual marker is produced by pad printing of the traction wire. These embodiments facilitate adjustment of the traction wire length, thereby improving the handling of the traction device. Furthermore, these embodiments allow identification of when the traction wire length is at its minimum, indicating maximum tightening.
[0017] According to one embodiment of the first aspect of the invention, the traction wire is smooth. By "smooth" is understood, and for the purposes of the present invention, a non-notched traction wire.
[0018] According to an embodiment of the first aspect of the invention, the unidirectional adjustment member comprises a second helical winding, the first helical winding extending along a first longitudinal axis and the second helical winding extending along a second longitudinal axis transverse to the first longitudinal axis, preferably the first longitudinal axis and the second longitudinal axis are substantially orthogonal.
[0019] According to an embodiment of the first aspect of the invention, the second helical winding is made by a wire forming contiguous turns in the initial state.
[0020] According to an embodiment of the first aspect of the invention, the traction wire is mounted embedded in the second helical winding so as to form the traction loop between the first helical winding and the second helical winding and a hook loop of variable length between the second helical winding and the first end of the traction wire, said hook loop being configured to be fixed to the biological tissue; and wherein the second helical winding is configured to adjust the length of the hook loop between an initial length and a final length less than the initial length, so as to secure a removable fixing element to the hook loop.
[0021] According to an alternative embodiment of the first aspect of the invention, the traction device further comprises an anchor which includes a first end configured to be fixed to the support organ and a second end configured to be fixed to the biological tissue; and in which the anchor is mounted embedded in the second helical winding, the second helical winding being configured to adjust the length of the second end between an initial length and a final length less than the initial length, so as to secure a removable fixing element to the second end. These embodiments facilitate the attachment of the unidirectional regulating organ to the biological tissue. In addition, the alternative embodiment allows the unidirectional adjusting member to be kept at a distance from the support member.
[0022] According to an embodiment of the first aspect of the invention, the traction wire, or the anchor, is mounted embedded in the second helical winding by deformation of the second helical winding in at least one direction transverse to the longitudinal axis of the second helical winding, preferably in at least one direction substantially perpendicular to the longitudinal axis of the second helical winding. This embodiment improves the efficiency of the unidirectional adjusting element. Indeed, by embedding the tension wire, or anchor, in the second helical winding through the pre-deformation of this second helical winding, the tension wire, or anchor, can be held firmly within the second helical winding, thus ensuring the anti-reverse effect of the unidirectional adjusting element. Furthermore, a double anti-reverse effect is created, one by the first helical winding and the other by the second helical winding.
[0023] According to an embodiment of the first aspect of the invention, the unidirectional adjustment member further comprises a fastening portion configured to receive the first end of the traction wire so as to form said traction loop or The said attachment loop, preferably the fastening portion of which is a crimping strand, preferably the crimping strand extending from the second helical winding. This embodiment simplifies the creation of the traction loop or the attachment loop by reusing the unidirectional adjustment element.
[0024] According to an alternative embodiment of the first aspect of the invention, in which the unidirectional adjusting member comprises only a first helical winding and a fastening portion configured to receive the first end of the traction wire so as to form said traction loop, preferably the fastening portion is a crimping strand, preferably the crimping strand extends from the first helical winding. This embodiment makes it possible to further simplify the creation of the traction loop or the hook loop by reusing the unidirectional adjustment element.
[0025] According to one embodiment of the first aspect of the invention, the unidirectional adjusting member is configured to be fixed to the support member. This embodiment facilitates the handling of the traction device. Indeed, by attaching the unidirectional adjustment element to the traction device, it is possible to eliminate the need to attach the unidirectional adjustment element to the biological tissue, thus simplifying the device's handling. Furthermore, this embodiment helps to reduce the risks of accidental detachment of the unidirectional adjustment element.
[0026] According to an alternative embodiment of the first aspect of the invention, the unidirectional adjustment member is configured to be fixed to the biological tissue.
[0027] According to a second aspect, the invention relates to a method for assembling a traction device according to the first aspect of the invention, said method comprising at least: - a step of inserting the traction wire into at least one first helical winding of the unidirectional adjusting member; and - a step of embedding the traction wire in the first helical winding.
[0028] According to one embodiment of the second aspect of the invention, the assembly method for the traction device comprises: - a step of inserting the traction wire into at least one first helical winding of the unidirectional adjusting member; - a step of embedding the traction wire in the first helical winding; and - a step of inserting the traction wire into at least one guide hole. In this embodiment, the order of the steps of embedding the traction wire and inserting the traction wire into the guide cross orifice is indifferent.
[0029] According to one embodiment of the second aspect of the invention, the assembly method for the traction device comprises: - a step of inserting the traction wire into at least one first helical winding of the unidirectional adjusting member; - a step of inserting the traction wire into at least one guide hole; - a step of embedding the traction wire in the first helical winding; and - a step of fixing the first end of the traction wire to the unidirectional adjustment organ so as to form a traction loop of variable length intended to be anchored to the biological tissue. In this embodiment, the order of the steps of embedding the traction wire and fixing the first end is indifferent.
[0030] According to an alternative embodiment of the second aspect of the invention, in which the first end of the traction wire includes a loop, the method for assembling the traction device comprises: - a preliminary step of inserting the second end of the traction wire into the loop of the first end of the traction wire so as to form a traction loop of variable initial length intended to be anchored to the biological tissue; - a step of inserting the second end of the traction wire into at least one first helical winding of the unidirectional adjusting member; and - a step of embedding the traction wire in the first helical winding. In this embodiment, the first helical winding is embedded between the loop and the second end of the traction wire. In other words, the first helical winding is located between the loop and the second end of the traction wire. The traction loop is formed by the traction wire located between the first helical winding and the fastening portion.
[0031] According to an embodiment of the second aspect of the invention, in which the unidirectional adjusting member comprises a second helical winding, the assembly method of the traction device comprises: - a step of inserting the traction wire into the first helical winding of the unidirectional adjusting member; - a step of inserting the traction wire into the second helical winding of the unidirectional adjusting member, so as to form the traction loop between the first helical winding and the second helical winding; - a step of embedding the traction wire in the first helical winding; and - a step of embedding the traction wire in the second helical winding. In this embodiment, the traction loop is formed by the traction wire located between the two helical windings. In this embodiment, the order of the steps of inserting the traction wire into the second helical winding and embedding the traction wire into the first helical winding is indifferent. In this embodiment, the traction loop is formed by the traction wire located between the first helical winding and the second helical winding.
[0032] According to an embodiment of the second aspect of the invention, in which the unidirectional adjustment member includes a fastening portion, the method for assembling the traction device comprises: - a step of inserting the traction wire into the first helical winding of the unidirectional adjusting member; - a step of attaching the first end of the traction wire to the attachment portion so as to form the traction loop between the first helical winding and the attachment portion; and - a step of embedding the traction wire in the first helical winding. In this embodiment, the traction loop is formed by the traction wire located between the first helical winding and the fastening portion.
[0033] According to an embodiment of the second aspect of the invention, in which the unidirectional adjustment member comprises a second helical winding and a fastening portion, the method for assembling the traction device comprises: - a step of inserting the traction wire into the first helical winding of the unidirectional adjusting member; - a step of inserting the traction wire into the second helical winding of the unidirectional adjusting member, so as to form the traction loop between the first helical winding and the second helical winding; - a step of fixing the first end of the traction wire to the fixing portion so as to form the hook loop between the second helical winding and the fixing portion; - a step of embedding the traction wire in the first helical winding; and - a step of embedding the traction wire in the second helical winding. Optionally, this embodiment also includes: - a step of inserting an endoscopic clip into the hook loop; and - a step of securing the endoscopic clip to the hook loop. In this embodiment, the traction loop is formed by the traction wire located between the helical windings and the hook loop is formed by the traction wire located between the second helical winding and the fixation portion. In this embodiment, the order of the steps for embedding the traction wire in the helical windings is indifferent. In this embodiment, the step of securing the endoscopic clip is carried out by applying a tensile force on the traction wire so as to unidirectionally lengthen the length of the second helical winding and reduce the length of the hook loop.
[0034] According to an embodiment of the second aspect of the invention, in which the traction device comprises an anchor and the unidirectional adjustment member comprises a second helical winding and a fastening portion, the method for assembling the traction device comprises: - a step of inserting the traction wire into the first helical winding of the unidirectional adjusting member; - a step of inserting the first end of the anchor into the second helical winding of the unidirectional adjusting member; - a step of fixing the first end of the traction wire to the fixing portion so as to form the traction loop between the first helical winding and the fixing portion; - a step of fixing a part of the second end of the anchor to the fixing portion so as to form the hook loop between the second helical winding and the fixing portion; - a step of embedding the traction wire in the first helical winding; - a step of embedding the anchor in the second helical winding. Optionally, this embodiment includes: - a step involving the insertion of an endoscopic clip into the anchor loop; and - a step of securing the endoscopic clip to the anchor. In this embodiment, the order of the steps for embedding the traction wire in the helical windings is indifferent. In this embodiment, the step of securing the endoscopic clip is carried out by applying a tensile force to the anchor so as to unidirectionally lengthen the length of the second helical winding and reduce the length of the hook loop. In this embodiment, the traction loop is formed by the traction wire located between the first helical winding and the fastening portion. The anchor loop is formed by the second end of the anchor located between the second helical winding and the fastening portion.
[0035] According to an embodiment of the second aspect of the invention, the embedding is achieved by pre-deforming the first helical winding and / or the second helical winding in at least one direction transverse to the longitudinal axis of the helical winding subject to pre-deformation, preferably in at least one direction substantially perpendicular to the longitudinal axis of the helical winding subject to pre-deformation. For example, the pre-deformation of the first helical winding and / or the second helical winding is carried out by a tool having a jaw with grooves (for example, a crimping tool). By "pre-deformation", it is understood and in the sense of the present invention, the deformation of the first helical winding and / or the second helical winding before any tensile action on the traction wire. BRIEF DESCRIPTION OF THE FIGURES
[0036] Other features and advantages of the invention will become apparent from the following detailed description, by way of non-limiting example, and the accompanying figures, among which: - [Fig.1] represents a schematic view of the first aspect of the invention according to one embodiment; - [Fig.Ibis] represents a schematic view of the first aspect of the invention according to an embodiment in which the unidirectional adjusting member is fixed in the through guide orifice by means of a guide loop; - [Fig.2] represents a schematic view of the unidirectional adjustment element of the first aspect of the invention according to one embodiment; - [[Fig.2bis]] represents a schematic view of the unidirectional adjusting member of the first aspect of the invention according to an embodiment in which the unidirectional adjusting member comprises a crimping strand; - [[Fig.3]] represents a schematic view of the first aspect of the invention according to an embodiment in which the traction device of [Fig.1] further comprises two anchoring loops; - [[Fig.4]] represents a schematic view of the first aspect of the invention according to an embodiment in which the traction wire further comprises a loop; - [[Fig.5]] represents a schematic view of the first aspect of the invention according to an embodiment in which the unidirectional adjustment member is configured to be fixed at the level of the wall of the digestive tract or the tumor mucosa; - [Fig.6] represents a schematic view of the unidirectional adjustment mechanism illustrated in [Fig.5]; - [Fig.7] represents a schematic view of the first aspect of the invention according to an embodiment in which the traction device includes an anchor and a clamping ring; - [[Fig.8]] represents a schematic view of the unidirectional adjustment element of the first aspect of the invention illustrated in [[Fig.7]]; - [Fig.9] represents a schematic view of the first aspect of the invention according to an embodiment in which the support member has a parallelepiped shape; - [[Fig. l]0] represents a schematic view of the first aspect of the invention according to an embodiment before the adjustment of the length of the traction loop; - [[Fig.1]1] represents a schematic view of the first aspect of the invention according to an embodiment after adjusting the length of the traction loop. DETAILED DESCRIPTION OF THE INVENTION
[0037] A traction device for biological tissue of the digestive tract according to an embodiment of the invention is described with reference to [Fig. 1]. The traction device according to the invention is an endoscopic device.
[0038] The traction device 1 shown in this figure comprises a traction wire 2, a support member 3 and a unidirectional adjustment member 4.
[0039] The traction wire 2 comprises a first end 5 and a second end 6. Advantageously, the traction wire 2 can be made of a polyamide-type polymer or a shape-memory material such as nitinol. This type of material is particularly suitable for surgical use since it allows the traction wire 2 to have little or no interaction with biological tissues. According to one embodiment, the traction wire 2 has a diameter of between 0.1 mm and 0.5 mm, preferably a diameter of between 0.1 mm and 0.25 mm. The traction wire 2 has a length of between 40 mm and 60 mm, preferably a length of between 45 mm and 55 mm. According to the illustrated embodiment, the traction wire 2 is smooth. Advantageously, the traction wire 2 includes at least one visual marker 7. As illustrated in [Fig. 1], the visual marker 7 is a ring set onto the traction wire 2. According to an embodiment not shown, the visual marker 7 is a colored section. This visual marker 7 allows the practitioner to see the remaining length of traction wire during resection of the tumor mucosa.
[0040] As shown in [Fig. 1], the traction wire 2 further comprises a grasping element 16. In the example shown, the grasping element 16 is a loop. This loop 16 is located at the second end 6 of the traction wire 2. Advantageously, the grasping element 16 is configured for use in robotic resection. These embodiments allow for easy manipulation and adjustment of the traction wire 2 by a practitioner or a robot. Thus, the traction device 1 is particularly suitable for operations performed directly by a practitioner or via a robot. Furthermore, these embodiments allow the second end 6 of the traction wire 2 to protrude from the unidirectional adjustment member 4 throughout the use of the traction device 1. In other words, the gripping element 16 prevents the second end 6 from fully penetrating the unidirectional adjustment member 4.
[0041] According to one embodiment, the gripping element 16 is an element added to the traction wire 2. In other words, the gripping element 16 is initially independent of the traction wire 2 and is attached to the latter by any means or method of attachment known to those skilled in the art, such as, for example, crimping or gluing. In this embodiment, the gripping element 16 is either made of metal, or a metal alloy, for medical use, or of a material similar or identical to the traction wire 2. According to an alternative embodiment, the gripping element 16 is formed from the second end 6 of the traction wire. In this embodiment, the gripping element 16 is made of a material similar or identical to the traction wire 2.
[0042] The support member 3, according to the illustrated embodiment, comprises a through-hole for guidance 8 and a through-hole for fastening 9. The support member 3 also comprises an upper face 11 and a lower face 12. In this example, the support member 3 has a ring shape of thickness e. Preferably, the thickness e is between 0.5 mm and 1.5 mm. As illustrated, the support member 3 is in the form of a ring with a through-hole for mounting 9 and a through-hole for guidance in its periphery. In other words, the support member 3 has two distinct holes: the through-hole for mounting 9 and the through-hole for guidance 8. As illustrated, the support member 3 is in the form of a circular ring. Thus, the through-hole for mounting 9 and the periphery of the support member 3 are circular. The same is true for the through-hole for guidance 8, which is also circular.
[0043] According to an embodiment not illustrated, the guide through orifice 8 and / or the fixing through orifice 9 have a different shape from the periphery of the fixing member 3. Similarly, the guide through orifice 8 may have a different shape from the fixing through orifice 9.
[0044] For example, the guide through-hole 8 and the fixing through-hole 9 may be triangular, parallelepiped, or polygonal in shape. The periphery of the support member 3 may be triangular, parallelepiped, or polygonal. However, any other shape known to a person skilled in the art may be considered. The guide through hole 8 has a diameter between 1 mm and 2 mm. The fixing through hole 9 has a diameter between 3 mm and 6 mm, preferably between 4 mm and 5 mm.
[0045] According to one embodiment, the support member 3 is made of an elastic material, a flexible material, metal, a composite material, or any other suitable material known to those skilled in the art. Preferably, the support member 3 is made of one or more hypoallergenic materials such as polyglecaprone, polybutester, glycomer, polyglactin, polyglyconate, polydioaxanone, or polypropylene. In another embodiment, the support member 3 is made of at least two distinct materials. In other words, a first part of the support member 3 is made of a first material, and a second part of said support member 3 is made of a second material distinct from the first material. For example, the part of the support member 3 having the guide hole 8 is made of metal, and the rest of the support member 3 is made of an elastic material. This embodiment ensures the integrity of the guide through orifice 8.
[0046] In the illustrated embodiment, the through-hole for fixation 9 has an eccentric position on the support member 3, so that a portion of the support member 3 is configured to be fixed to the wall of the digestive tract, in particular by means of a removable fixation element (not shown), such as an endoscopic clip or a fixation loop. This eccentric position of the through-hole for fixation 9 facilitates deformation of the support member 3. However, the through-hole for fixation 9 may have a central position on the support member 3, provided that a portion of the support member 3 can be fixed to the wall of the digestive tract, in particular by means of an endoscopic clip. These embodiments improve the handling of the traction device 1.
[0047] According to an embodiment not illustrated, the support member 3 further comprises an extendable part. The extensible part of the support organ 3 corresponds to a part of the support organ 3, such as the part of the support organ 3 configured to be fixed to the wall of the digestive tract. Advantageously, the extensible portion is made of an elastic or flexible material. The extensible portion is configured to deform reversibly along a deformation axis A_ext, the deformation axis A_ext being substantially orthogonal to the wall of the digestive tract when the traction device 1 is attached to the wall of the digestive tract. Thus, the extensible part allows an indirect traction force to be exerted on the tumor mucosa when the extensible part is attached to the digestive wall of a patient.
[0048] The unidirectional adjusting member 4 comprises at least one first helical winding 13. As illustrated in [Fig.2], the unidirectional adjusting member 4 comprises a first helical winding 13, a second helical winding 14 and a connecting element 15 (not visible in [Fig.1]) joining the first winding 13 and the second winding 14.
[0049] The first helical winding 13 and the second helical winding 14 take the form of wires forming tightly wound turns in the initial state, similar to tension springs. For example, the first and second windings 13, 14 are made of metal, or a metal alloy, for medical use. Initially, the first helical winding 13 has a length between 2 mm and 5 mm, preferably between 2.5 mm and 3.5 mm. The second helical winding 14 and the connecting element 15 have a length between 0.5 mm and 3 mm, preferably between 0.5 mm and 1.5 mm. For the purposes of this invention, "initial state" means the state of the first and second helical windings 13 and 14 before any tensile force is applied to the traction wire 2. Initially, the turns of the first helical winding and / or the second helical winding are joined. In the final state, the elongation factor of the first helical winding 13 is between 1 and 5. According to one embodiment, the elongation factor of the first helical winding is greater than 1, 1.2, 1.5, 1.8, 2, 3 or even greater than 4. The elongation factor of the second helical winding 14 is between 1 and 5.According to one embodiment, the elongation factor of the second helical winding is greater than 1, 1.2, 1.5, 1.8, 2, 3 or greater than 4. By "final state", it is understood and within the meaning of the present invention, the state of the first and second helical windings 13, 14 after several tensile actions on the tensile wire 2. In the final state, the turns of the first helical winding and / or the second helical winding are no longer contiguous. For the purposes of this invention, "elongation factor" means the ratio between the final length and the initial length of a helical winding. Advantageously, the first and second windings 13, 14 have an inner diameter of between 0.2 mm and 1 mm, preferably between 0.2 mm and 0.3 mm. The first and second windings 13, 14 may have an outer diameter of between 0.4 mm and 1 mm, preferably between 0.5 mm and 0.8 mm, and even more preferably an outer diameter of between 0.6 mm and 0.7 mm.
[0050] As shown in [Fig. 2], the first helical winding 13 extends along a first longitudinal axis A_longl, and the second helical winding 14 extends along a second longitudinal axis A_long2 substantially orthogonal to the first longitudinal axis A_longl. Thus, the first helical winding 13 is substantially orthogonal to the second helical winding 14.
[0051] The unidirectional adjusting member 4 allows the first end 5 of the traction wire 2 to be connected, directly or indirectly, to the traction wire 2 at a distance from the second end 6 so as to form a traction loop of variable length. Indeed, in the example illustrated in [Fig. 1], the first end 5 of the traction wire 2 passes through the first helical winding 13, the guide through-hole 8, and is fixed to the second helical winding 14. The first end 5 is fixed to the second helical 14 by any means or method of fixing described below, or known to a person skilled in the art.
[0052] According to another embodiment, the first end 5 is fixed to the second helical winding 14, for example by crimping, welding or gluing, the traction wire 2 passes through the guide through orifice 8, and through the first helical winding 13 so that the second end 6 protrudes from the first helical winding 13.
[0053] The first helical winding 13 is configured to allow the traction wire 2 to slide in a single direction.
[0054] According to an embodiment not shown, the first helical winding 13 is pre-deformed, totally or partially. Thus, the traction wire 2 is embedded in the first helical winding 13 of the unidirectional adjusting member 4. For example, the first helical winding 13 is pre-deformed in a direction transverse to the first longitudinal axis A_longl, preferably in a direction substantially perpendicular to the longitudinal axis A_longl. By "transverse", it is understood and in the sense of the present invention, any straight line secant to the longitudinal axis A_longl forming an angle with this longitudinal axis A_longl between 45° and 135°, preferably an angle between 70° and 110°, preferably an angle between 80° and 100°. This embodiment also makes it easier to facilitate the longitudinal deformation of the first helical winding 13 when the traction wire 2 is pulled, and thus to improve the unidirectional effect (also referred to under the term "anti-return") of the unidirectional adjusting member 4. This pre-deformation of the first helical winding 13 is achieved by a compression action along the longitudinal axis A_longl, that is to say by deformation of the first helical winding 13 in a direction transverse to the longitudinal axis A_longl, preferably in a direction substantially perpendicular to the longitudinal axis A_longl. For example, the pre-deformation of the first helical winding 13 is carried out by a tool having a jaw with grooves (for example, a crimping tool).
[0055] The unidirectional adjusting member 4 can be made from a single piece, or in the form of three separate parts, respectively the first and second helical windings 13, 14 and the connecting element 15, which are assembled together. For example, the assembly of the three parts 13, 14, 15 is carried out by bonding, by welding, or by any other means or method of assembly known to those skilled in the art.
[0056] As shown in [Fig. 1], the unidirectional adjusting member 4 is fixed at the level of the guide through orifice 8. This fastening can be achieved by inserting the unidirectional adjusting member 4 into the guide hole 8. In other words, since the support member 3 is made of an elastic material, it is possible to temporarily deform the guide hole 8 to insert the unidirectional adjusting member 4 into it. This temporary deformation can be achieved by passing the unidirectional adjusting member through the guide hole 8. According to another embodiment, the unidirectional adjusting member 4 is fixed by means of a sleeve or a wire. According to another embodiment, the unidirectional adjusting member 4 is fixed by means of a special imprint in the support member 3. For example, this imprint is made by a special molding of the support member. These embodiments make it possible to limit the risks of dislodging the unidirectional adjustment element from the support element, and thus to improve the reliability of the traction device.
[0057] [Fig. 1bis] represents a variant of the embodiment of the invention illustrated in [Fig. 1]. In this embodiment, compared to the traction device described in [Fig. 1], the traction device further comprises a guide loop 36. Advantageously, the guide loop 36 is configured to be mounted in the through-hole for fastening 9 or in the through-hole for guiding 8. In the case where the guide loop 36 is mounted in the through fixing hole 9, this guide loop 36 can serve as a through guide hole 8. The guide loop 36 can be made of the same material as the traction wire 2.
[0058] As illustrated in this figure, the guide loop 36 is further configured to fix the unidirectional adjusting member to the guide through orifice 8 of the support member 3. The guide loop 36 can be fixed to the unidirectional adjusting member 4 by crimping, knotting, or any other means within the reach of a person skilled in the art. For example, the crimping of the guide loop 36 with the unidirectional adjusting member 4 is carried out at the connection element 15 of the unidirectional adjusting member 4.
[0059] Fig. 2bis represents a variant of the embodiment of the unidirectional adjusting member 4 illustrated in Fig. 2. In this embodiment, the unidirectional adjusting member 4 further includes a fastening portion configured to receive the first end 5 of the traction wire 2. For example, the fastening portion is a crimping strand 35. Advantageously, the crimping strand 35 extends from the second helical winding 14, preferably the crimping strand 35 extends from the second helical winding 14 parallel to the second longitudinal axis A_long2 and along the second helical winding 14.
[0060] Figure 3 represents another embodiment of the invention. In this embodiment, compared to the traction device described in Figure 1, the traction device 1 further comprises two anchoring loops 17. This embodiment improves the distribution of forces on the biological tissue. Indeed, by adding two anchoring loops 17, it is possible to add two new, different anchoring points, and thus add traction forces independent of the traction force exerted by the traction wire 2. Thus, the overall traction force exerted by the traction device 1 is greater on the surface of the tumor mucosa to be resected.
[0061] Advantageously, the anchor loops 17 are made of the same material as the traction wire 2.
[0062] As illustrated, the anchor loops 17 are mounted in the pull-through hole 9 by any method or means known to a person skilled in the art. According to an embodiment not illustrated, the anchor loops 17 are mounted in the guide through hole 8.
[0063] The anchor loops 17 are mounted to slide freely in the traction through hole 9. In other words, the movement of the anchor loops 17 can take place over the entire circumference of the traction through hole 9, without hindrance.
[0064] Figure 4 represents another embodiment of the invention. In this embodiment, compared to the traction device described in relation to Figures 1 to 3, the traction wire 2 further comprises a loop 18 located at the first end 5, and the unidirectional adjustment member 4 comprises only a first helical winding 13.
[0065] Advantageously, the guide 18 is a loop similar to the gripping element 16. Thus, the embodiments relating to the gripping element 16 are also applicable to the guide 18.
[0066] As illustrated in [Fig.4], the second end 6 of the traction wire 2 is passed inside the loop 18 so as to form the traction loop. This embodiment allows the initial length of the traction loop to be preset before any traction action is applied to the second end 6 of the traction wire 2. Indeed, thanks to the loop 18, the initial length of the traction loop can be adjusted. For example, this adjustment is made before the traction wire 2 is fixed to the tumor mucosa using endoscopic clips (not shown).
[0067] A traction device according to another embodiment of the invention is described with reference to [Fig.5] and [Fig.6].
[0068] In this embodiment, and contrary to the traction device 1 described in connection with [Fig.1] to [Fig.3], the unidirectional adjustment member 4 is fixed at the level of the wall of the digestive tract or the tumor mucosa, and not at the level of the through-hole guiding 8 of the support member 3. This embodiment facilitates the assembly of the traction device 1 while ensuring greater freedom in the placement of the unidirectional adjustment member 4.
[0069] Detail A shown in [Fig. 5] is now described in relation to [Fig. 6]. In this embodiment, compared to the traction device described in relation to [Fig. 1] to [Fig. 3], the traction device 1 further comprises a clamping ring 29 and an endoscopic clip 24. Advantageously, this clamping ring 29 has at least one dimension larger than the internal diameter of the second helical winding 14 of the unidirectional adjustment member 4. The clamping ring 31 is made of a material similar or identical to that of the unidirectional adjusting member 4.
[0070] As shown in this figure, the clamping ring 29 is positioned at one end of the second winding 14 so that the clamping ring 29 can come to rest against this end when a pulling action is performed on the pulling wire 2.
[0071] The clamping ring 29 is configured to allow the traction wire 2 to slide inside said clamping ring 29. As illustrated in [Fig. 6], the first end 5 of the traction wire 2 passes through the clamping ring 29, a hook loop 28 is formed, and the first end 5 is fixed to the clamping ring 29 by any fastening means known to those skilled in the art, including those mentioned previously. The clamping loop 28 is configured to cooperate with the endoscopic clip 24. When the traction wire 2 is pulled in a direction Dl, the latter slides inside the clamping ring 29 which comes to rest against the second helical winding 14 causing a reduction in the length of the hook loop 28. The direction Dl corresponds to a pulling movement allowing the clamping ring 29 to come to rest against the second winding 14. Thus, when the endoscopic clip 24 is fitted at the level of the hook loop 28, the reduction in the length of the hook loop 28 allows the endoscopic clip 24 to be secured with the hook loop 28. In addition, this embodiment improves the stability of the fixation of the unidirectional adjustment organ 4 to the wall of the digestive tract or the tumor mucosa.
[0072] A traction device according to another embodiment of the invention is described with reference to [[Fig.7]], [Fig.8] and [Fig.9]. In this embodiment, with respect to the traction device described in connection with [[Fig.5]], the traction device 1 comprises an anchor 30 and a clamping ring 34. For example, the anchor 30 is a secondary traction wire, this secondary traction wire is made of a material similar or identical to the traction wire 2. Thus, the anchor 30 is flexible. The anchor 30 allows the unidirectional adjustment element 4 to be maintained at a distance, for example at a predetermined maximum distance, from the support element 3 throughout the resection operation and facilitates the fixation of the adjustment element 4 to the biological tissue. Furthermore, the anchor 30 eliminates the need for the clamping ring 29 and the attachment loop 28.
[0073] The anchor 30 comprises a first end 33, an intermediate section 32, and a second end 31 of adjustable length.
[0074] The first end 33 is configured to be fixed to the support member 3, for example, at the through fixing hole 9. The second end 31 of variable length is configured to be fixed to the biological tissue by means of an endoscopic clip (not shown).
[0075] The first and second ends 31, 33 of the anchor 30 take the form of loops.
[0076] As shown in [Fig.7], the first end 33 of the anchor 30 is fixed at the through fixing hole 9. On the other hand, the intermediate section 32 passes through the second helical winding 14 of the unidirectional adjusting member 4 in place of the traction wire 2. The first end 5 of the traction wire 2 is then fixed to the second winding 14 by means of the clamping ring 34. The second end 6 of the traction wire 2 passes through the first helical winding 13 so as to protrude from the first helical winding 13.
[0077] The anchor 30 is mounted embedded in the second helical winding 14 of the unidirectional adjusting member 4. For example, the second helical winding 14 is pre-deformed in a direction transverse to the second longitudinal axis A_long2, preferably in a direction substantially perpendicular to the longitudinal axis A_long2. This pre-deformation of the second winding 14 is achieved by a compression action along the longitudinal axis A_long2, that is to say by deformation of the second winding 14 in a direction transverse to the longitudinal axis A_long2, preferably in a direction substantially perpendicular to the longitudinal axis A_long2. For example, the pre-deformation of the second winding 14 is carried out by a tool having a jaw with grooves (for example, a crimping tool).
[0078] When the unidirectional adjustment member 4 is moved along the direction D2, the length of the second end 31 will decrease, thus allowing an endoscopic clip (not shown) to be secured with this second end 31. The direction D2 corresponds to a pulling movement from the second end 31 towards the first end 33. Furthermore, during the movement of the unidirectional adjusting member 4 along the intermediate section 32 of the anchor 30, the second winding 14 will deform irreversibly along the second longitudinal axis A_long2. During this movement, the length of the second winding 14 will increase. In addition, the longitudinal deformation of the second winding 14 prevents the unidirectional adjustment member 4 from sliding in the opposite direction, which would cause an increase in the length of the second end 31 of the anchor 30, and therefore a detachment of the endoscopic clip from the second end 31.
[0079] Detail B shown in [Fig. 7] is now described in relation to [Fig. 8]. The unidirectional adjusting member 4 illustrated in this figure corresponds to the directional member 4 described previously, in relation to [Fig. 7].
[0080] The unidirectional adjusting member 4 further includes a fastening portion configured to receive the first end 5 of the traction wire 2. The fastening portion is also configured to receive a part of the second end 31 of the anchor 30. For example, the fixing portion is a 35 crimp strand (not visible on [Fig.7]).
[0081] As illustrated in [Fig. 8], the crimping strand 35 extends from the second helical winding 14, preferably the crimping strand 35 extends from the second helical winding 14 parallel to the second longitudinal axis A_long2 and along the second helical winding 14.
[0082] The first end 5 of the traction wire 2 and a section of the second end 31 of the anchor 30 are fixed to the crimping strand 35 by means of the crimping ring 34.
[0083] A traction device 1 according to another embodiment of the invention is now described with reference to [Fig.9].
[0084] The traction device 1 includes a traction wire 2, a support member 3, a unidirectional adjustment member 4, and a fastening loop 19 configured to allow the attachment of the support member 3 to the wall of the digestive tract.
[0085] The traction wire 2 shown in this figure has similar or identical structural characteristics to the traction wire described in relation to the embodiments of the previous figures.
[0086] In this embodiment, the support member 3 has a parallelepiped shape, and more particularly a parallelepiped ring shape. As illustrated, the support member 3 comprises an upper face 11, a lower face 12, four through guide holes 8, four lateral faces 20, and a connecting element 21. On the other hand, the support member 3 has a thickness e. The thickness e is similar or identical to the thickness e described in relation to the embodiments of [Fig. 1]. According to the illustrated embodiment, each lateral face 20 has a concave shape. This embodiment facilitates the deformation of the support member 3. Advantageously, each edge at the junction between two adjacent lateral faces has a chamfer. These embodiments help to limit the risk of injury to the wall of the digestive tract when using traction device 1.
[0087] The four through-guide ports 8 shown in this figure have similar or identical dimensions to the through-guide ports described in relation to the embodiments of the previous figures. The four through-hole guides 8 are positioned on the surface of the support member 3, such that each through-hole guide 8 is positioned near one of the vertices of the parallelepiped. In other words, each through-hole guide 8 is positioned at a cardinal point of the support member 3. This arrangement of the through-guide holes allows for a better distribution of traction forces on the tumor mucosa to be resected.
[0088] According to an embodiment not illustrated, the four through-guide orifices 8, each positioned near a vertex of the parallelepiped, extend according the thickness e of the support member 3. In other words, in this embodiment, the through guide holes 8 extend in the horizontal plane of the support member 3 such that each through guide hole 8 passes through two adjacent lateral faces 20 of the unidirectional adjusting member 4.
[0089] The connecting element 21 has a two-pronged cross shape, with the prongs being of equal length. Preferably, the connecting element 21 is made of an elastic material, or of a flexible material. According to the illustrated embodiment, the connecting element 21 is configured to deform reversibly along the deformation axis A_ext. According to an embodiment not shown, the connecting element 21 is thermoformed into a desired shape. For example, the thermoformed connecting element has a substantially rounded shape that protrudes from the support organ 3. Thermoforming the connecting element 21 allows the shape of said connecting element 21 to be maintained throughout the use of the traction device 1, and thus ensures a balanced distribution of the traction force on the anchoring points of the tumor mucosa. The connecting element 21 is positioned at the center of the support member 3 so as to form four quadrants 22 of the same size. According to the illustrated embodiment, the connecting element 21 directly connects each guide through-hole 8. Thus, one branch of the connecting element 21 connects two opposite guide through-holes 8. The linking element 21 is configured to be fixed to the wall of the digestive tract.
[0090] Advantageously, those skilled in the art will appreciate that the connecting element 21 can be a separate part from the support member 3, which will subsequently be assembled with said support member 3 by any means of assembly known to those skilled in the art. The connecting element 21 can be a direct result of the manufacture of the support member 3. In other words, and by way of example, during the manufacture of the support member 3, the latter can undergo a boring to form the connecting element 21.
[0091] According to the illustrated embodiment, the traction wire 2 passes successively through each guide through orifice 8 so that the traction wire 2 defines a fixing section 22 between each adjacent guide through orifice 8, i.e. a total of four fixing sections 22. In other words, the first end 5 of the traction wire 2 passes through each of the four guide through orifices 8 so that the two ends 5,6 of the traction wire 2 can be joined, thus forming a loop of length, which can vary between an initial length and a final length less than the initial length. In the illustrated embodiment, the traction wire 2 passes successively through each of the four guide holes 8 in the same direction. For example, this direction corresponds to a pulling motion from the lower face 12 to the upper face 11. In other words, the traction wire 2 is introduced into the guide hole 8 from the lower face 12, and then emerges from the guide hole 8 from the upper face 11.
[0092] As illustrated in [[Fig.9]], the traction wire 2 comprises four coupling elements 23. In this example, the coupling elements 23 are flexible cylinders fitted onto the traction wire 2. Moreover, these coupling elements 23 are made of a metallic material having ferromagnetic properties. According to one embodiment, the coupling elements 23 are crimped or slidably mounted on the traction wire 2. Each of the four coupling elements 23 is positioned at the end of a fixing section 22. The coupling elements 23 allow the traction wire 2 to be coupled to endoscopic clips (not shown). It should be noted that these coupling elements 23 can be used in the implementation methods described in connection with the previous figures.
[0093] The unidirectional adjusting member 4 has the same embodiments as those described in connection with the previous figures. As presented, the unidirectional adjusting member 4 is fixed at one of the through guide ports 8 according to one of the means or methods of fixing described previously.
[0094] The fastening loop 19 takes the form of a circular ring. Advantageously, the fastening loop 19 is made from an elastic material, a flexible material, or a metallic material. According to one embodiment, the fastening loop 19 is made of a material similar or identical to that of the support member 3. As illustrated in [[Fig.9]], the fastening loop 19 is positioned at the level of the connecting element 21. Preferably, the fastening loop 19 is positioned at the center of the connecting element 21. Preferably, the fastening loop 19 is positioned at the intersection of the branches of the connecting element 21. The fixation loop 19 is configured to allow the support organ 3 to be fixed to the wall of the digestive tract.
[0095] The operation of the adaptive traction device 1 will now be explained in relation to [Fig.10] and [Fig.11].
[0096] The adaptive traction device 1 is identical to the adaptive traction device 1 described in connection with [Fig. 1]. In addition, the traction device 1 comprises four endoscopic clips 24. Typically, endoscopic clips 24 are configured to attach to biological tissue by pinching said biological tissue between their jaws.
[0097] During a resection operation of a tumorous mucosa of a digestive tract, the traction device 1 is introduced into the digestive tract in close proximity to the tumorous mucosa.
[0098] As shown in [Fig.10] and [Fig.11], the digestive tract 25 comprises a lower digestive wall 26, an upper digestive wall (not shown) opposite the lower digestive wall 26, and a tumor mucosa 27 located on the lower digestive wall 26.
[0099] Initially, the support organ 3 is fixed to the upper digestive wall by means of an endoscopic clip (not shown) positioned in the through fixation orifice 9. At this stage, no traction force is exerted on the tumor mucosa 27, nor on the digestive tract 25.
[0100] Once the support organ 3 is fixed to the upper digestive wall, the traction loop defined by the traction wire 2 is fixed to the tumor mucosa 27 by means of the endoscopic clips 24, thus defining anchoring points. As shown in [[Fig. 10]] and [[Fig. 11]], the endoscopic clips 24 are uniformly distributed over the surface of the tumor mucosa 27. At this stage, no traction force is exerted on the tumor mucosa 27, nor on the digestive tract 25.
[0101] Subsequently, once the traction loop is fixed to the tumor mucosa 27, a traction force can be applied to the second end 6 of the traction wire 2, notably by means of the loop 16, in a direction D3 causing a decrease in the length of the traction wire 2 from an initial length. The direction D3 corresponds to a pulling movement from the connecting element 15 towards the end of the first helical winding 13 located opposite the connecting element 15. Pulling the tension wire 2 along direction D3 causes irreversible deformation of the first helical winding 13 along the first longitudinal axis A_longl. Thus, when tension wire 2 is pulled, the length of the first winding 13 increases. Furthermore, the longitudinal deformation of the first winding 13 along the first longitudinal axis A_longl prevents tension wire 2 from sliding in the opposite direction, which would cause its length to increase. Furthermore, the decrease in the length of the traction wire 2 causes tension in said traction wire 2. Thus, traction forces are exerted on the upper digestive wall and on the tumor mucosa 27. Under the effect of these traction forces, the supporting organ 3 can deform.
[0102] Subsequently, in order to separate the tumor mucosa 27 from the lower digestive wall 26, an initial dissection of the tumor mucosa 27 is performed using a dissecting tool 10. As this initial dissection progresses, the traction forces exerted on the tumor mucosa 27 decrease, particularly in the freshly resected portion. Indeed, this resected portion of the tumor mucosa 27 is no longer attached to the lower digestive wall 26 and can obstruct the angle of dissection.
[0103] To ensure a sufficient dissection angle when dissecting the remaining tumor mucosa 27 not separated from the lower digestive wall 26, the traction wire 2 is re-tensioned by pulling on the loop 16 in the direction D3. This again applies traction forces to the tumor mucosa 27, allowing for a sufficient dissection angle. This facilitates, in particular, the passage of the dissecting tool 10 and the resection of the tumor mucosa. Furthermore, the one-way adjustment mechanism 4 maintains a constant length of the traction wire 2 during dissection. A simple pulling action on the loop 16 in the direction D3 allows the length to be varied. Thus, the length of the traction wire 2 decreases from an initial length to a final length shorter than the initial length.
[0104] These steps of separating the tumor mucosa 27 from the lower digestive wall 26 by dissection and of tensioning the traction wire 2 are repeated successively until the complete resection of the tumor mucosa 27 from the lower digestive wall 26.
Claims
Demands
1. Traction device (1) for a biological tissue of the digestive tract comprising: - a traction wire (2) having a first end (5) and a second end (6); - a support member (3) intended to be fixed to the digestive tract, at a distance from the biological tissue, and comprising at least one guide through-hole (8) through which the traction wire (2) is slidably mounted; - a unidirectional adjustment member (4) comprising at least one first helical winding (13) through which the traction wire (2) is mounted embedded; in which the first end (5) of the traction wire (2) is connected, directly or indirectly, to the traction wire (2) at a distance from the second end (6), so as to form a traction loop of variable length intended to be anchored to the biological tissue;and wherein the unidirectional adjustment member (4) is configured to adjust the length of the traction loop between an initial length and a final length less than the initial length, so as to exert a progressive traction force on the biological tissue.
2. Device (1) according to claim 1, wherein the first helical winding (13) is made by a wire forming contiguous turns in the initial state.
3. Device (1) according to claim 1 or claim 2, wherein the at least one first helical winding (13) is configured to adjust the length of the traction loop between an initial length and a final length less than the initial length, and extends along a first longitudinal axis (A_longl) and the traction wire (2) is embedded in the at least one first helical winding (13) by deformation of the at least one first helical winding (13) in at least one direction transverse to the longitudinal axis (A_longl), preferably in at least one direction substantially perpendicular to the longitudinal axis (A_longl).
4. Device (1) according to any one of claims 1 to 3, wherein the first end (5) comprises a loop (18) and the second end (6) is passed inside the loop (18) so as to form said traction loop.
5. Device (1) according to any one of claims 1 to 4, wherein the support member (3) further comprises at least one through-hole for fixation (9) configured to permit fixation of the support member (3) to the digestive tract via an endoscopic clip (24) or a fixation loop (19).
6. Device according to any one of claims 1 to 5, further comprising at least one anchoring loop (17), preferably at least two anchoring loops (17), mounted to slide freely in at least one guide through-hole (8) or traction through-hole (9) of the support member (3) and intended to be anchored to the biological tissue.
7. Device (1) according to any one of claims 1 to 6, wherein the traction wire (2) comprises at least one visual marker (7), preferably the visual marker (7) is a coloured section extending along a portion of the traction wire or a ring set on the traction wire (2).
8. Device (1) according to any one of claims 1 to 7, wherein the traction wire (2) is smooth.
9. Device (1) according to any one of claims 1 to 8, wherein the unidirectional adjusting member (4) comprises a second helical winding (14), the first helical winding (13) extending along a first longitudinal axis (A_longl) and the second helical winding (14) extending along a second longitudinal axis (A_long2) transverse to the first longitudinal axis, preferably the first longitudinal axis (A_longl) and the second longitudinal axis (A_long2) are substantially orthogonal.
10. Device (1) according to claim 9, wherein the traction wire (2) is mounted embedded in the second helical winding (14) so as to form the traction loop between the first helical winding (13) and the second helical winding (14), and a hook loop (28) of variable length between the second helical winding (14) and the first end (5) of the traction wire (2), said hook loop (28) being configured to fix the unidirectional adjustment member (4) to the biological tissue; and wherein the second helical winding (14) is configured to adjust the length of the hook loop (28) between a length initial and a final length less than the initial length, so as to secure a removable fixing element (24) to the hook loop (28).
11. Device (1) according to claim 9, further comprising an anchor (30) which includes a first end (33) configured to be fixed to the support organ (3) and a second end (31) configured to be fixed to the biological tissue; and in which the anchor (30) is mounted embedded in the second helical winding (14), the second helical winding (14) being configured to adjust the length of the second end (31) between an initial length and a final length less than the initial length, so as to secure a removable fixing element (24) to the second end (31).
12. Device (1) according to any one of claims 9 to 11, wherein the unidirectional adjusting member (4) further comprises a fastening portion configured to receive the first end (5) of the traction wire (2) so as to form said traction loop or said hook loop (28), preferably the fastening portion is a crimping strand (35).
Citation Information
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