Adaptive traction endoscopic device
The adaptive traction device addresses uneven force distribution and handling complexity in existing devices by using a single clamping wire with uniform guide holes and a unidirectional adjustment mechanism, ensuring balanced traction and simplified operation for effective tumor resection.
Patent Information
- Application Number
- PCT/EP2025/072708
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-03-14
- Filing Date
- 2025-08-06
- Publication Date
- 2026-02-12
AI Technical Summary
Existing biological tissue traction devices for submucosal dissection in gastrointestinal endoscopy suffer from uneven traction force distribution, complexity in handling, and increased risk of tangling due to multiple anchors and adjustment mechanisms, leading to inefficiencies and potential detachment during tumor resection.
An adaptive traction device with a single clamping wire passing through uniformly distributed guide holes and a unidirectional adjustment element to ensure balanced force distribution, simplified handling, and reduced tangling, featuring a unidirectional adjustment mechanism to maintain tension wire length and prevent accidental detachment.
The device achieves balanced traction force distribution, simplifies handling, reduces tangling, and enhances the effectiveness of submucosal dissection by maintaining tension without complex clamps, thereby improving the efficiency and safety of tumor resection.
Smart Images

Figure EP2025072708_12022026_PF_FP_ABST
Abstract
Description
Description Title of the invention: Adaptive 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 biological tissue traction devices used in the resection of superficial tumors of the digestive tract. STATE OF THE ART
[0002] Biological tissue traction devices are commonly used in gastrointestinal endoscopy, particularly for the resection of superficial tumors of the digestive tract. Such devices typically include a proximal anchor and an elastic element configured to exert traction.
[0003] Typically, during the resection of superficial tumors of the digestive tract, the surgeon performs a submucosal dissection. This dissection is a complex technique that allows for the semi-invasive removal of superficial tumors. Submucosal dissection involves 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 procedure is described as "semi-invasive" because it respects the organ with relatively short healing times compared to traditional invasive procedures.
[0005] A traction device facilitates submucosal dissection by pulling the mucosa away from the muscle to expose the submucosa. To achieve this, the proximal anchor is fixed to a portion, preferably proximal, of the tumor mucosa using a removable fixation element (also referred to as a "clip" or "endoscopic clip"), while the elastic element is fixed to the opposite wall of the digestive tract to exert a traction force on the mucosa, preferably proximal. tumor. This traction force allows the tumor mucosa to be separated from the rest of the digestive wall and facilitates dissection.
[0006] To further facilitate submucosal dissection, 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 clamp serving as an adjustment mechanism. In this traction device, the two anchors, distal and proximal, are mounted to move relative to the elastic organ by means of a proximal traction wire and a distal traction wire connecting the proximal and distal anchors, respectively, to the elastic organ. These two anchors are movable between a minimum and a maximum traction distance. The adjusting element is attached to the elastic element by means of a removable fastener and includes a tensioning wire. This adjusting element 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. Such a device exposes the submucosa, allowing the dissecting tool to pass through easily throughout the tumor mucosal resection. In other words, this traction device allows the maximum traction distance to be adjusted by reducing it, thereby tightening the proximal and distal traction sutures. Thus, during tumor recession, the freshly dissected portion of the tumor mucosa, no longer connected to the rest of the digestive tract wall and therefore no longer subject to traction, can be re-tensioned to facilitate dissection of the remaining tumor mucosa. This is illustrated in Figures 5 to 8 of the aforementioned French patent.
[0007] The traction device as described in French patent FR 3 134 704 has several drawbacks that the present invention aims to resolve: - The elastic organ does not allow for a balanced distribution of the traction force on the anchoring points of the tumor mucosa by the proximal and distal traction wires, resulting in a non-uniform dissection angle and traction force on the mucosa during the dissection process. Indeed, each traction wire is independent and exerts its own traction force on the tumor mucosa. For example, the proximal traction wire may exert a greater traction force on the tumor mucosa than the distal traction wire, thus creating an imbalance in traction forces. Finally, excessive and unevenly distributed traction force can cause the fixation elements to detach, rendering the device ineffective, and tear the tumor mucosa; - The use of multiple anchors, and therefore multiple separate traction lines, significantly complicates the handling of the traction device and increases the risk of tangling of said lines, particularly when there are at least two anchors. Furthermore, this risk of tangling is exacerbated when the anchors are placed close to one another; - The tensioning of the traction wires is achieved by means of a clamp which includes a cage and a body separate from the traction wires, which slide inside the cage. This configuration also contributes to the complexity of the endoscopic traction device and the risk of tangling; - This device is effective but difficult to use due to the complexity of the adjustment mechanism which includes both a clamp and proximal and distal guides.
[0008] The present invention falls within this context. SUMMARY OF ('INVENTION)
[0009] According to a first aspect, the invention relates to an endoscopic device for adaptive traction of a biological tissue comprising: - a tightening wire (also called "tension wire") comprising a first end and a second end; - an elastic grasping element (also called a "support element") comprising at least one extensible portion, and at least two through-guide holes, preferably the through-guide holes are uniformly distributed over the surface of the grasping element; wherein the first end of the clamping wire passes successively through each through-guide hole so that the clamping wire defines at least two fixation sections, each fixation section being configured to exert a tensile force on the biological tissue. This embodiment allows for a balanced distribution of the traction force on the anchoring points of the biological tissue. Advantageously, this embodiment significantly simplifies the handling of the adaptive traction device. According to one embodiment of the first aspect of the invention, the clamping wire of the adaptive traction device passes through each guide through orifice in the same direction. According to one embodiment of the first aspect of the invention, the elastic gripping element of the adaptive traction device comprises at least three through-guide holes, and each fixing section is located between two adjacent through-guide holes. According to one embodiment of the first aspect of the invention, the clamping wire of the adaptive traction device passes through each guide through orifice only once. According to one embodiment of the first aspect of the invention, the number of fixing sections defined by the clamping wire between two adjacent through guide holes is less than the number of adjustment holes. These embodiments further improve the balanced distribution of traction force on the anchor points, and contribute further to simplifying the handling of the adaptive traction device.
[0010] According to one embodiment of the first aspect of the invention, the adaptive traction device further comprises a unidirectional adjustment element (also called a "unidirectional adjustment member") configured to allow the passage of the clamping wire so as to form a loop of variable length, and configured to adjust the length of said loop between an initial length and a final length less than the initial length. This embodiment improves the adjustment of the tension wire and the effectiveness of the adaptive traction device. According to this embodiment, the unidirectional adjustment element allows for precise adjustment of the tension wire length and the traction force exerted on the biological tissue at the anchor points. Furthermore, this embodiment maintains the tension wire at a desired length and prevents it from sliding in a direction that would increase its length and thus exert traction. adaptive. According to one embodiment of the first aspect of the invention, the first end of the clamping wire is fixed and the second end of the clamping wire is mobile relative to said unidirectional adjustment element, preferably the first end of the clamping wire passes through a first part of the unidirectional adjustment element and is fixed to a second part of the unidirectional adjustment element. According to one embodiment of the first aspect of the invention, the unidirectional adjustment element comprises a first part in the form of a metallic winding and a second part configured to fix the first end of the clamping wire. For example, the metal winding takes the form of a succession of contiguous turns, similar to a spring. According to a preferred embodiment of the first aspect of the invention, the first part of the unidirectional adjustment element extends along a first longitudinal axis, and the second part of the unidirectional adjustment element extends along a second longitudinal axis orthogonal to the first longitudinal axis. These embodiments allow for further improvement in the efficiency of the adaptive traction system.
[0011] According to one embodiment of the first aspect of the invention, the adaptive traction device includes an irreversible assembly element for permanently fixing the unidirectional adjustment element to a removable fixing element itself configured to be removably fixed to the biological tissue. This embodiment improves the positioning of the adaptive traction device and facilitates its use. Indeed, during the application of the adaptive traction device, the unidirectional adjustment element can be permanently fixed to the biological tissue. Thus, the irreversible assembly element reduces the risk of accidental detachment of the unidirectional adjustment element. Furthermore, this embodiment allows the removable fixation element to be pre-positioned near the unidirectional adjustment element before their insertion into the digestive tract, thereby simplifying the handling of the traction device. According to a preferred embodiment of the first aspect of the invention, the irreversible assembly element is a knot, sliding or not, a rivet, or a hook loop. According to a preferred embodiment of the first aspect of the invention, the irreversible assembly element is a hook loop of variable length, preferably formed by the clamping wire or a fixing wire distinct from the clamping wire, said loop being configured to cooperate with at least one removable fixing element. These embodiments make it easier to use the adaptive traction device.
[0012] According to one embodiment of the first aspect of the invention, the irreversible assembly element is configured to be integral with the introduction tool of the adaptive traction device. This embodiment facilitates the handling of the adaptive traction device. In this embodiment, the irreversible assembly element allows for easy attachment of the unidirectional adjustment element to the insertion tool of the adaptive traction device.
[0013] According to one embodiment of the first aspect of the invention, the gripping element of the adaptive traction device comprises a linking element connecting each guide through orifice at a common intersection vertex configured to be fixed to the biological tissue. This embodiment allows for a better balanced distribution of the tensile force on the anchoring points of the biological tissue. According to a preferred embodiment of the first aspect of the invention, the linking element of the adaptive traction device is cross-shaped, the arms of which connect directly or indirectly the guide through-holes at a common intersection vertex configured to be fixed to the biological tissue. "Directly" means that the ends of the arms of the linking element are aligned with the guide through-holes. By "indirectly", it is understood that at least one of the branches of the connecting element is located between two adjacent through-guide ports. According to one embodiment of the first aspect of the invention, the angle formed by two arms of the gripping element is equal to 90 degrees. According to one embodiment of the first aspect of the invention, the gripping element of the adaptive traction device is parallelepiped-shaped and includes four through-guide holes, each through-guide hole being positioned near one of the vertices of the parallelepiped.
[0014] According to one embodiment of the first aspect of the invention, the clamping wire of the adaptive traction device includes coupling elements, such as flexible cylinders fitted onto the clamping wire, allowing the clamping wire to be coupled to removable fastening elements. This embodiment facilitates the attachment of the tightening wire to biological tissue. Furthermore, this embodiment improves the grip on the tightening wire. According to one embodiment of the first aspect of the invention, the coupling elements are made of a metallic material, preferably a metallic material having ferromagnetic properties.
[0015] In one embodiment of the first aspect of the invention, the clamping wire of the adaptive traction device includes at least one visual marker. This embodiment facilitates adjustment of the clamping wire length, thereby improving the handling of the adaptive traction device. Furthermore, this embodiment allows identification of when the clamping wire length is at its minimum, indicating maximum clamping. According to a preferred embodiment of the first aspect of the invention, the visual marker is a ring set on the clamping wire, or a colored section.
[0016] According to one embodiment of the first aspect of the invention, the adaptive traction device comprises a single clamping wire. This embodiment facilitates the handling of the adaptive traction device and eliminates the need for a clamp. Indeed, the clamping wire allows both the application of a traction force to the biological tissue and its subsequent retensioning by a subsequent traction action on the same tissue.
[0017] According to one embodiment of the first aspect of the invention, the fixation section is configured to be fixed directly to the biological tissue. In use, the fixation section is fixed to the biological tissue by means of at least one removable fixation element (also called an "endoscopic clip").
[0018] According to a second aspect, the invention relates to an adaptive traction system comprising: - an adaptive traction device according to the first or fourth aspect of the invention; - at least two removable fixation elements (also called "endoscopic clips") configured to fix the elastic grasping element and / or each fixation section to the biological tissue in a removable manner.
[0019] According to a third aspect, the invention relates to a unidirectional adjustment element (also called a "unidirectional adjustment member"), in particular for its use with the adaptive traction device according to the first or fourth or seventh aspect, configured to allow the passage of a clamping wire so as to form a loop of variable length, and configured to adjust the length of said loop between an initial length and a final length less than the initial length. This embodiment improves the adjustment of the tensioning wire and the effectiveness of an adaptive traction device. In this embodiment, the unidirectional adjustment element allows for precise adjustment of the tensioning wire length and the traction force exerted on the biological tissue at the anchor points, thereby applying adaptive traction. This embodiment also facilitates the use of an endoscopic device for the recession of biological tissue. Indeed, the unidirectional adjustment element allows the wire length to be maintained at a desired length after a brief pulling action. In other words, when the wire is pulled, the loop length decreases, and when the wire is released, the loop length is maintained at the reduced length. According to an embodiment of the third aspect of the invention, the unidirectional adjustment element is configured to cooperate with the clamping wire, the first end of which is fixed and the second end of which is mobile relative to said unidirectional adjustment element, preferably one of the two ends of the clamping wire passes through a first part of the unidirectional adjustment element and is fixed to a second part of the unidirectional adjustment element. According to one embodiment of the third aspect of the invention, the element of unidirectional adjustment includes a first part in the form of a metal winding and a second part configured to fix the first end of the clamping wire. According to a preferred embodiment of the third aspect of the invention, the first part of the unidirectional adjustment element extends along a first longitudinal axis, and the second part of the unidirectional adjustment element extends along a second longitudinal axis, preferably the second longitudinal axis is orthogonal to the first longitudinal axis. It should be noted that the unidirectional adjustment element can be used with any type of endoscopic device for the recession of biological tissue provided that the latter includes at least one wire configured to form a loop.
[0020] According to a fourth aspect, the invention relates to an adaptive traction device according to the first aspect further comprising at least one anchor configured to cooperate with a clamping wire and a gripping element. According to one embodiment of the fourth aspect of the invention, the adaptive traction device according to the second aspect comprises four anchors. According to one embodiment of the fourth aspect of the invention, the anchor of the adaptive traction device according to the second aspect comprises a distal organ, a proximal organ, and a connecting rod. Advantageously, the distal component is configured to be fitted, or fixed, onto the clamping wire and to cooperate with a removable fixing element and / or the unidirectional adjustment element. The proximal component is configured to be fitted, or fixed, onto the gripping element. According to one embodiment of the fourth aspect of the invention, the distal and proximal organs are identical. These embodiments improve the gripping and securing of the adaptive traction device.
[0021] According to a fifth aspect, the invention relates to a method for installing a unidirectional adjustment element (also called a "unidirectional adjustment device") according to the first, third, or fourth aspect of the invention, said method comprising at least: - a step of inserting a clamping wire (also called a "tension wire") into a first part of the unidirectional adjustment element; - a step of attaching one end of the clamping wire to a second part of the unidirectional adjustment element; and - a pre-deformation step, total or partial, of the first part of the unidirectional adjustment element after the insertion of the clamping wire into said first part. According to one embodiment, said installation method further includes a step of inserting the clamping wire into the second part of the unidirectional adjustment element. According to one embodiment of the fifth aspect of the invention, said installation method further includes a pre-deformation step, total or partial, of the second part of the unidirectional adjustment element after the insertion of the clamping wire into said second part. According to one embodiment of the fifth aspect of the invention, during the fixing step, the end of the clamping wire is fixed to the second part of the unidirectional adjustment element by means of crimping, welding, or gluing. According to an embodiment of the fifth aspect of the invention, during the pre-deformation step of the first part and / or the second part, the pre-deformation is carried out by a compression action, preferably over all or part of the length of the part of the unidirectional adjustment element, preferably the compression is carried out by a tool having a jaw with grooves.
[0022] According to a sixth aspect of the invention, the invention relates to a method for installing an irreversible assembly element according to the first aspect of the invention, said method comprising at least: - a step of inserting a clamping wire into a first part of the unidirectional adjustment element; - a step of inserting the clamping wire into a second part of a unidirectional adjustment element and forming a hook loop; - a step of direct or indirect fixing of one end of the clamping wire to the second part of the unidirectional adjustment element; - a pre-deformation stage, total or partial, of the first part of the unidirectional adjustment element subsequent to the insertion of the clamping wire into said first part; - a pre-deformation step of the second part of the unidirectional adjustment element after the insertion of the clamping wire into said second part; - a step involving the insertion of a removable fastening element onto the attachment loop; and - a pulling step on the tightening wire allowing the removable fixing element to be secured with the hook loop. According to an embodiment of the sixth aspect of the invention, during the pre-deformation step of the first part and / or the second part, the pre-deformation is carried out by a compression action, preferably over all or part of the length of the part of the unidirectional adjustment element, preferably the compression is carried out by a tool having a jaw with grooves.
[0023] According to a seventh aspect, the invention relates to a traction device for biological tissue of the digestive tract comprising: - a tension wire (also called "clamping wire") having a first end and a second end; - a support organ (also called "elastic grasping element") 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 adjustment device (also called a "unidirectional adjustment element") comprising at least one first helical winding through which the traction wire is mounted embedded; wherein 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 wherein the unidirectional adjustment device 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 tissue biological. This embodiment improves the adjustment of the traction wire and the efficiency of the traction device. According to this embodiment, the unidirectional adjustment element maintains the traction wire length at a desired length after a brief pulling action. In other words, when the traction wire is pulled, the length of the traction loop decreases, and when the wire is released, the loop length is maintained at the reduced 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 may also allow the length of the hook loop to be adjusted in a single direction, thereby reducing the length of the hook loop.
[0024] According to one embodiment of the seventh aspect of the invention, the first helical winding is formed by a wire with tightly wound turns in the initial state. According to another embodiment of the seventh aspect of the invention, at least one first helical winding is configured to adjust the length of the traction loop between an initial length and a final length shorter than the initial length, and extends along a first longitudinal axis. In one embodiment, the traction wire is embedded in 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, by embedding the tension wire in the first helical winding through the pre-deformation of this first helical winding, the tension wire can be held firmly within the first helical winding, thus ensuring the anti-reverse effect of the unidirectional adjustment mechanism. For the purposes of this invention, "initial length" refers to the 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. By "final length" is meant and for the purposes of the present invention, the length of the traction loop after one or more traction actions on the traction wire.
[0025] According to one embodiment of the seventh aspect of the invention, the first end comprises a loop and the second end is passed inside the loop so as 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 guide, the length of the traction loop can be adjusted.
[0026] According to one embodiment of the seventh 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.
[0027] According to one embodiment of the seventh 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 hole or fixing 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.
[0028] According to one embodiment of the seventh 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 seventh 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.
[0029] According to one embodiment of the seventh 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.
[0030] According to an embodiment of the seventh 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.
[0031] According to one embodiment of the seventh aspect of the invention, the second helical winding is made by a wire forming contiguous turns in the initial state.
[0032] According to one embodiment of the seventh 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.
[0033] According to an alternative embodiment of the seventh aspect of the invention, the traction device further comprises an anchor which includes a first end configured to be fixed to the support member and a second end configured to be fixed to biological tissue; and wherein 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.
[0034] According to one embodiment of the seventh aspect of the invention, the traction wire, or 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.
[0035] According to one embodiment of the seventh 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 said hook loop, preferably the fastening portion is a crimping strand, preferably the crimping strand extends from the second helical winding. This embodiment simplifies the creation of the traction loop or the hook loop by reusing the unidirectional adjustment element.
[0036] According to an alternative embodiment of the seventh 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 fixing 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.
[0037] According to one embodiment of the seventh 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.
[0038] According to an alternative embodiment of the first or third or fourth or seventh aspect of the invention, the unidirectional adjustment member is configured to be fixed to the biological tissue.
[0039] According to one embodiment of the seventh aspect of the invention, the adaptive traction device comprises a single traction wire. This embodiment facilitates the handling of the traction device by eliminating the need for a hose clamp. Indeed, the traction wire allows both the application of a traction force to the biological tissue and its subsequent retraction through a pulling action on the same tissue.
[0040] According to an eighth aspect, the invention relates to a method for assembling a traction device according to the seventh 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.
[0041] According to one embodiment of the eighth aspect of the invention, the assembly method for the traction device comprises: - a step of inserting the traction wire into at least one first winding helical of the unidirectional adjusting organ; - 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.
[0042] According to one embodiment of the eighth 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.
[0043] According to an alternative embodiment of the eighth 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 wire. traction. The traction loop is formed by the traction wire located between the first helical winding and the fixing portion.
[0044] According to an embodiment of the eighth aspect of the invention, in which the unidirectional adjusting member comprises a second helical winding, 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 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.
[0045] According to an embodiment of the eighth 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.
[0046] According to an embodiment of the eighth aspect of the invention, in which the unidirectional adjusting 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 involving the insertion of an endoscopic clip into the hook loop; and - a step of securing the endoscopic clip with the hook loop. In this embodiment, the traction loop is formed by the traction wire located between the helical windings, and the attachment loop is formed by the traction wire located between the second helical winding and the fastening portion. In this embodiment, the order of the steps for embedding the traction wire in the helical windings is irrelevant. 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.
[0047] According to an embodiment of the eighth 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 adjustment mechanism; - 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.
[0048] According to an embodiment of the eighth aspect of the invention, the embedding is achieved by pre-deformation of 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 performed 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.
[0049] According to a ninth aspect, the invention relates to a biological tissue traction system comprising: - an adaptive traction device according to the seventh aspect of the invention; - at least one endoscopic clip (also called "removable fixation element"). BRIEF DESCRIPTION OF THE FIGURES
[0050] 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, including: - [Fig. 1] represents a schematic view of a first aspect of the invention according to one embodiment of the invention; - [Fig. 2] represents a schematic view of the first aspect of the invention according to one embodiment of the invention; - [Fig. 3] represents a schematic top view of the first aspect of the invention as illustrated in [Fig. 2]; - [Fig. 4] represents a schematic front view of the first aspect of the invention as illustrated in [Fig. 2]; - [Fig. 5] represents a schematic view of the second aspect of the invention in use according to an embodiment before adjustment of the clamping wire; - [Fig. 6] represents a schematic view of the second aspect of the invention in use according to an embodiment after adjustment of the clamping wire; - [Fig. 7] represents a schematic view of the third aspect of the invention according to embodiments; - [Fig. 8A], [Fig. 8B], [Fig. 8C], [Fig. 8D], [Fig. 8E] represent schematic views of the third aspect of the invention according to embodiments. - [Fig. 9] represents a schematic view of the fourth aspect of the invention according to one embodiment; - [Fig. 10] represents a functional diagram of the installation process according to the fifth aspect of the invention; - [Fig. 11] represents a functional diagram of the installation process according to the sixth aspect of the invention; - [Fig. 12] represents a schematic view of the seventh aspect of the invention according to one embodiment; - [Fig. 12bis] represents a schematic view of the seventh aspect of the invention according to an embodiment of the invention in which the unidirectional adjusting member is fixed in the through guide orifice by means of a guide loop; - [Fig. 13] represents a schematic view of the third aspect of the invention, or of the unidirectional adjusting member of the seventh aspect of the invention according to an embodiment in which the unidirectional adjusting member comprises a crimping strand; - [Fig. 14] represents a schematic view of the seventh aspect of the invention according to an embodiment of the invention in which the traction device of [Fig. 12] further comprises two anchoring loops; - [Fig. 15] represents a schematic view of the seventh aspect of the invention according to an embodiment of the invention in which the traction wire further comprises a loop; - [Fig. 16] represents a schematic view of the seventh aspect of the invention according to an embodiment of the invention 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. 17] represents a schematic view of the unidirectional adjustment organ illustrated in [Fig. 16] in combination with an endoscopic clip; - [Fig. 18] represents a schematic view of the seventh aspect of the invention according to an embodiment in which the traction device further comprises an anchor, a clamping ring, and two anchoring loops; - [Fig. 19] represents a schematic view of the unidirectional adjustment element of the seventh aspect of the invention illustrated in [Fig. 18]; - [Fig. 20] represents a schematic view of the seventh aspect of the invention according to an embodiment of the invention in which the support member has a parallelepiped shape; - [Fig. 21] represents a schematic view of the seventh aspect of the invention in use according to an embodiment of the invention before adjusting the length of the traction loop; - [Fig. 22] represents a schematic view of the seventh aspect of the invention in use according to an embodiment of the invention after adjusting the length of the traction loop. DETAILED DESCRIPTION OF THE INVENTION
[0051] An adaptive traction device for biological tissue according to an embodiment of the first aspect of the invention is described with reference to [Fig. 1]. The adaptive traction device according to the invention is an endoscopic device.
[0052] Advantageously, the adaptive traction device is configured for use in robotic resection.
[0053] The adaptive traction device 1 shown in this figure includes a clamping wire 2 and an elastic gripping element 5.
[0054] The clamping wire 2 (also called "tension wire") comprises a first end 3 and a second end 4. Advantageously, the clamping wire 2 can be made of polyamide-type polymer, or of nitinol-type shape-memory material. According to one embodiment, the clamping wire 2 has a diameter of between 0.2 mm and 0.5 mm, preferably between 0.2 mm and 0.3 mm. The clamping wire 2 has a length of between 40 mm and 60 mm, preferably between 45 mm and 55 mm. According to the illustrated embodiment, the traction wire 2 is smooth. Advantageously, the tightening wire 2 includes at least one visual marker 30. This visual marker can take the form of a colored section, or a ring set on the tightening wire 2. This visual marker 30 allows, in particular, to indicate to the practitioner the length of the tightening wire 2 remaining during the recession of the tumor mucosa.
[0055] The elastic gripping element 5 (also called "support member"), according to the illustrated embodiment, comprises an extendable part 6, two through guide holes 7, a main opening 22 distinct from the two through guide holes 7, an upper face 25, and a lower face 24. In this example, the elastic gripping element 5 has a ring shape, of thickness e. Preferably the thickness e is between 0.5 mm and 1.5 mm. As illustrated, the gripping element 5 takes the form of a circular ring. Thus, the main opening 22 and the periphery of the gripping element 5 have a circular shape. According to an embodiment not shown, the main opening 22 may have a different shape from the periphery of the gripping element 5. The main opening 22 may be triangular, parallelepiped, or polygonal. The periphery of the gripping element 5 may also be triangular, parallelepiped, or polygonal. However, any other shape known to those skilled in the art may be considered. The main opening 22 has a diameter between 3 mm and 6 mm, preferably between 4 mm and 5 mm. In one embodiment, the elastic gripping element 5 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 elastic gripping element 5 is made of one or more hypoallergenic materials such as polyglecaprone, polybutester, glycomer, polyglactin, polyglyconate, polydioaxanone, or polypropylene. In another embodiment, the elastic gripping element 5 is made of at least two distinct materials. In other words, a first part of the elastic gripping element 5 is made of a first material, and a second part of said gripping element 5 is made of a second material distinct from the first material. For example, the part of the gripping element 5 having the guide holes 7 is made of metal, and the rest of the gripping element 5 is made of an elastic material. In the embodiment shown, the main opening 22 has an eccentric position on the grasping element 5, so that a portion of the grasping element 5 is configured to be fixed to the wall of the digestive tract, in particular by means of a removable fixing element (not shown). This eccentric position of the main opening 22 facilitates deformation of the grasping element 5. However, the main opening 22 may have a central position on the grasping element 5, provided that a portion of the grasping element 5 can be fixed to the wall of the digestive tract, in particular by means of a removable fixing element. These embodiments in particular allow for improved handling of the adaptive traction device 1.
[0056] In the illustrated embodiment, the extendable part 6 corresponds to the entire grasping element 5. According to another embodiment, the extendable part 6 of the grasping element 5 corresponds to a part of the grasping element 5, for example the part of the grasping element 5 configured to be fixed to the wall of the digestive tract. Advantageously, the expandable portion 6 is made of an elastic or flexible material. The expandable portion 6 is configured to deform reversibly along a deformation axis A_ext, said deformation axis A_ext being orthogonal to the wall of the digestive tract when the traction device 1 is attached to said wall. Thus, the expandable portion 6 allows for the indirect application of a traction force to the tumor mucosa when it is attached to the digestive tract wall of a patient. According to the embodiment shown, the deformation axis A_ext also defines an axis of symmetry of the gripping element 5.
[0057] The two guide holes 7 are distributed across the surface of the gripping element 5. As illustrated, the guide holes 7 are spaced apart to ensure a balanced distribution of tensile forces. In other words, each guide hole 7 is distinct from the other guide holes 7. In the illustrated embodiment, one of the two guide holes 7 is on one side of the deformation axis A_ext, while the second guide hole 7 is positioned on the other side of this deformation axis. However, the guide holes 7 can be positioned on the same side of the deformation axis A_ext.
[0058] As illustrated in [Fig. 1], the clamping wire 2 passes successively through each guide through hole 7 so that the clamping wire 2 defines two fixing sections 8. In other words, the first end 3 of the clamping wire 2 passes first through a first guide through hole 7 and then a second guide through hole 7 so that the two ends 3, 4 of the clamping wire 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 clamping wire 2 passes successively through each guide hole 7 in the same direction. For example, this direction corresponds to a movement from the lower face 24 to the upper face 25, or vice versa. In other words, the clamping wire 2 is introduced into the guide hole 7 from the lower face 24, and then emerges from the guide hole 7 from the upper face 25.
[0059] The clamping wire 2 may include coupling elements (not shown) for coupling the clamping wire 2 to removable fastening elements (not shown). For example, the coupling elements are flexible cylinders fitted onto the clamping wire 2. Advantageously, the number of coupling elements is equal to the number of fixing sections 8. In one embodiment, the coupling elements are made of a metallic material, preferably a metallic material with ferromagnetic properties. This embodiment improves the coupling between the coupling elements and the removable fastening elements. According to one embodiment, each coupling element is positioned at the end of each fixing section 8.
[0060] An adaptive traction device for biological tissue according to an embodiment of the invention is now described with reference to [Fig. 2] to [Fig. 4], and [Fig. 7],
[0061] As illustrated in [Fig. 2] to [Fig. 4], and [Fig. 7], the traction device 1 comprises a clamping wire 2, a grasping element 5, a unidirectional adjustment element 9, and an intermediate linking element 15 configured to allow the grasping element 5 to be fixed to the wall of the digestive tract.
[0062] The clamping wire 2 shown in these figures has a similar structure to the clamping wire described in connection with the embodiments of [Fig. 1]. In addition, the clamping wire 2 includes at least two visual markers 30. For example, these visual markers 30 can take the form of successive colored sections, or of rings set on the clamping wire 2 spaced from each other, equidistant or not.
[0063] In this embodiment, the gripping element 5 has a parallelepiped shape, and more particularly a parallelepiped ring shape. As illustrated in [Fig. 2] to [Fig. 4], the gripping element 5 comprises an upper face 25, a lower face 24, four lateral faces 23, a connecting element 13, and four through-hole guides 7. On the other hand, the grasping element 5 has a thickness e. This thickness e is similar to the thickness e described in relation to the embodiments of [Fig. 1]. According to the illustrated embodiment, each lateral face 23 has a concave shape. This embodiment facilitates the deformation of the grasping element 5. 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 during the use of the adaptive traction device 1.
[0064] The four through-hole guides 7 shown in these figures have a structure similar to the through-hole guides described in connection with the embodiments of [Fig. 1], The four guide holes 7 are positioned on the surface of the gripping element 5, such that each guide hole 7 is positioned near one of the vertices of the parallelepiped. In other words, each guide hole 7 is positioned at a cardinal point of the gripping element 5.
[0065] According to an embodiment not illustrated, the four through guide holes 7, each preferably positioned near a vertex of the parallelepiped, extend along the thickness e of the gripping element 5. In other words, in this embodiment, the guide through holes 7 extend in the horizontal plane of the gripping element 5 such that each guide through hole 7 passes through two adjacent lateral faces 23 of the gripping element 5. For example, the horizontal plane corresponds to the plane passing through the gripping element 5 and which is substantially parallel to the lower and upper faces 24, 25. For comparison, in [Fig. 2] to [Fig. 4], the four through-hole guides 7 are defined in the vertical plane of the gripping element 5, and cross the lower face 24 and the upper face 25. The vertical plane of the gripping element 5 corresponds to the plane substantially orthogonal to the horizontal plane of the gripping element 5. This unillustrated embodiment improves the sliding of the clamping wire 2 when it is pulled, thus facilitating the handling of the traction device 1. According to a particular embodiment of this embodiment not illustrated, the diameter of the through guide holes 7 is less than the thickness e of the gripping element 5. According to one embodiment, the four through guide holes 7 extend parallel to the main plane of the gripping element 5. The main plane being the plane along which the gripping element 5 extends.
[0066] The connecting element 13 has a two-pronged cross shape, with the prongs being of equal length. Preferably, the connecting element 13 is made of an elastic material, or a flexible material. According to the illustrated embodiment, the connecting element 13 is configured to deform reversibly along the deformation axis A_ext. According to an embodiment not shown, the connecting element 13 is thermoformed into a desired shape. For example, the thermoformed connecting element has a substantially rounded shape that protrudes from the gripping element 5. Thermoforming the connecting element 13 allows the shape of said connecting element 13 to be maintained throughout the use of the adaptive traction device 1, and thus ensures a balanced distribution of the traction force on the anchoring points of the tumor mucosa. The connecting element 13 is positioned at the center of the gripping element 5 so as to form four quadrants 26 of the same dimension. According to the illustrated embodiment, the connecting element directly links each guide through-hole 7. Thus, one branch of the connecting element 13 links two opposite guide through-holes 7. The connecting element 13 is configured to be fixed to the wall of the digestive tract.
[0067] Advantageously, a person skilled in the art will appreciate that the connecting element 13 can be a separate part from the gripping element 5, which will subsequently be assembled with said gripping element 5 by any known means of assembly. of the person in the profession. The connecting element 13 can result directly from the manufacture of the gripping element 5. In other words, and by way of example, during the manufacture of the gripping element 5, the latter can undergo a bore allowing the connecting element 13 to be formed.
[0068] According to the illustrated embodiment, the clamping wire 2 passes successively through each guide through hole 7 so that the clamping wire 2 defines a fixing section 8 between each adjacent guide through hole 7, i.e. at least three fixing sections 8 in total. In other words, the first end 3 of the clamping wire 2 passes through each of the four guide through holes 7 so that the two ends 3, 4 of the clamping wire 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 clamping wire 2 passes successively through each of the four guide holes 7 in the same direction. For example, this direction corresponds to a movement from the lower face 24 to the upper face 25, or vice versa. In other words, the clamping wire 2 is introduced into the guide hole 7 from the lower face 24, and then emerges from the guide hole 7 from the upper face 25.
[0069] Each fixation section 8 is configured to be fixed to the biological tissue. For example, in use, each fixation section 8 is fixed to the biological tissue via a removable fixation element.
[0070] As illustrated in [Fig. 2] to [Fig. 4], the clamping wire 2 comprises three coupling elements 14. In this example, the coupling elements 14 are flexible cylinders fitted onto the clamping wire 2. Moreover, these coupling elements 14 are made of a metallic material having ferromagnetic properties. Each of the three coupling elements 14 is positioned at the end of a fixing section 8. The coupling elements 14 allow the clamping wire 2 to be coupled to removable fixing elements (not shown).
[0071] As detailed above, the adaptive traction device 1 can be used with at least one removable fixing element (also called "endoscopic clip") thus forming a traction system according to the second aspect of the invention.
[0072] The unidirectional adjusting element 9 (also called the "unidirectional adjusting member") is illustrated in [Fig. 3] to [Fig. 6], This unidirectional adjustment element 9 according to the third aspect of the invention is described more particularly in [Fig. 7]. It comprises a first part 10 (also called "first helical winding"), a second part 11 (also called "second helical winding"), and a connecting element 27 allowing the first part 10 to be joined to the second part 11. The first part 10 and the second part 11 take the form of a metallic winding, such as a succession of contiguous turns, similar to a spring. In the embodiment shown, the connecting element 27 takes the form of a metal cylinder. Initially, the first part 10 has a length between 2 mm and 5 mm, preferably between 2.5 mm and 3.5 mm, while the second part 11 and the connecting element 27 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 parts 10 and 11 before any pulling action is applied to the pulling wire 2. Initially, the turns of the first part and / or the second part are joined. In the final state, the elongation factor of the first part 10 is between 1 and 5. According to one embodiment, the elongation factor of the first part is greater than 1, 1.2, 1.5, 1.8, 2, 3 or even greater than 4. The elongation factor of the second part 11 is between 1 and 5. According to one embodiment, the elongation factor of the second part 11 is greater than 1, 1.2, 1.5, 1.8, 2, 3 or even greater than 4. By "final state", for the purposes of this invention, is understood the state of the first and second parts 10, 11 after several tensile actions on the clamping wire 2. In the final state, the turns of the first part and / or the second part 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 part. Advantageously, the first and second parts 10, 11 have an inner diameter of between 0.2 mm and 1 mm, preferably between 0.2 mm and 0.5 mm, and preferably between 0.2 mm and 0.3 mm. The first and second parts 10, 11 may have an outer diameter of between 0.4 mm and 1 mm, preferably between 0.5 mm and 0.8 mm, and preferably between 0.6 mm and 0.7 mm. As represented in [Fig. 7], the first part 10 extends along a first longitudinal axis A_long1, and the second part 11 extends along a second longitudinal axis A_long2 orthogonal to the first longitudinal axis A_long1. Thus, the first part 10 is orthogonal to the second part 10. The unidirectional adjustment element 9 allows the first and second ends 3, 4 of the clamping wire 2 to be joined to form a loop of variable length, ranging from an initial length to a final length shorter than the initial length. In the example shown, the first end 3 passes through the first part 10, then through each of the four guide holes 7 as explained previously, and is then attached to the second part 11. The first end 3 is attached to the second part 11 by any means or method of attachment described below, or known to those skilled in the art. According to an embodiment not illustrated, the first end 3 is first fixed to the second part 11, for example by crimping, welding or gluing, then the second end 4 passes through each guide through hole 7 as explained previously, then passes through the first part 10 so that the second end 4 protrudes from the first part 10. The second end 4 can slide inside the first part 10. Advantageously, the second end 4 has a gripping element (not shown), such as a knot or loop, to prevent the second end 4 from fully penetrating the first part 10, while ensuring a better grip on the second end 4. Thus, the second end 4 always protrudes from the first part 10. The first part 10 is configured to allow the clamping wire 2 to slide in a single direction. According to an embodiment not shown, the first part 10 is pre-deformed, totally or partially, after the insertion of the clamping wire 2 into it. This embodiment also facilitates deformation longitudinal of the first part 10 when the clamping wire 2 is pulled, and thus improve the unidirectional effect (also referred to under the terminology "anti-return") of the unidirectional adjusting element 9.
[0073] It should be noted that the unidirectional adjustment element 9 can be used with any type of endoscopic device for the recession of biological tissue provided that the latter includes at least one wire configured to form a loop.
[0074] On the other hand, the unidirectional adjusting element 9 can be manufactured from a single piece, or as three separate parts, namely the first and second parts 10, 11 and the connecting element 27, assembled together. For example, the assembly of the three parts 10, 11, 27 is carried out by gluing, welding, or any other means or method of assembly known to a person skilled in the art.
[0075] The adaptive traction device 1, according to the first aspect, may include an intermediate connecting element 15 (also called a "fixing loop") in the form of a circular ring. Advantageously, the intermediate connecting element is made of an elastic material, a flexible material, or a metallic material. According to one embodiment, the intermediate connecting element 15 is made of a material similar to the material of the gripping element 5. As illustrated in [Fig. 2] to [Fig. 4], the intermediate connecting element 15 is positioned at the level of the connecting element 13. Preferably, the intermediate connecting element 15 is positioned at the center of the connecting element 13. Preferably, the intermediate connecting element 15 is positioned at the intersection of the branches of the connecting element 13. The intermediate connecting element 15 is configured to allow the grasping element 5 to be fixed to the wall of the digestive tract.
[0076] The operation of the adaptive traction device 1 shown in [Fig. 5] and [Fig. 6] will now be explained.
[0077] In these figures, the adaptive traction device 1 is similar to the adaptive traction device 1 described in connection with [Fig. 2] to [Fig. 4]. In addition, the adaptive traction device 1 includes five removable fixing elements 12. As illustrated, the removable fixation elements 12 are endoscopic clips familiar to those skilled in the art. Typically, endoscopic clips are configured to attach to biological tissue by pinching said biological tissue between their jaws.
[0078] During a recession surgery of a tumorous mucosa in the digestive tract, the adaptive traction device 1 is introduced into the digestive tract near the tumorous mucosa. Furthermore, during the introduction of the adaptive traction device 1 into the digestive tract, the clamping wire 2 is at its initial length.
[0079] As shown in [Fig. 5] and [Fig. 6], the digestive tract 29 comprises a lower digestive wall 16, an upper digestive wall (not shown) opposite the lower digestive wall 16, and a tumor mucosa 17 located on the lower digestive wall 16.
[0080] Initially, the grasping element 5 is fixed to the upper digestive wall via the intermediate connecting element 15 and a removable fixation element (not shown), which allows the intermediate connecting element 15 to be fixed to said upper digestive wall. At this stage, no traction force is exerted on the tumor mucosa 17, nor on the digestive tract 29.
[0081] Once the grasping element 5 is fixed to the upper digestive wall, each of the three fixation sections 8 is fixed to the tumor mucosa 17 by means of the removable fixation elements 12, thus defining three anchoring points on the tumor mucosa 17. As shown in [Fig. 5] and [Fig. 6], the fixation sections 8 are uniformly distributed on the surface of the tumor mucosa 17. Furthermore, the positioning of the removable fixation elements 12 on the fixation sections 8 is facilitated by the coupling elements 14. As for the unidirectional adjustment element 9, it is fixed to the lower digestive wall 16 by means of one of the five removable fixation elements 12. In some cases, the unidirectional adjustment element 9 can be fixed to the tumor mucosa instead of the digestive wall. At this stage, no tensile force is exerted on the tumor mucosa 17, nor on the digestive tract 29.
[0082] In a second step, once the three fixing sections 8 and the unidirectional adjusting element 9 are fixed in their respective positions, the second end 4 of the clamping wire 2 is pulled in a direction D1 causing a The length of the clamping wire 2 decreases from an initial length. Direction D1 corresponds to a movement from the connecting element 27 towards the end of the first part 10 located opposite the connecting element 27. Pulling the clamping wire 2 along direction D1 causes a deformation of the first part 10 along the first longitudinal axis A_long1. Thus, when the clamping wire 2 is pulled, the length of the first part 10 increases. Furthermore, the longitudinal deformation of the first part 10 prevents the clamping wire 2 from sliding in the opposite direction, which would cause its length to increase. Furthermore, reducing the length L of the clamping wire 2 causes tension in said wire 2. This exerts tensile forces on the upper digestive tract wall and on the tumor mucosa 17. Under the effect of these tensile forces, the grasping element 5 and / or the connecting element 13 may deform. On the other hand, thanks to the adaptive traction device 1, the tensile forces are distributed evenly across the anchoring points of the tumor mucosa 17.
[0083] Subsequently, in order to separate the tumor mucosa 17 from the lower digestive wall 16, an initial dissection of the tumor mucosa 17 is performed using a dissecting tool 28. As this initial dissection progresses, the traction forces exerted on the tumor mucosa 17 decrease, particularly in the freshly dissected portion. Indeed, this dissected portion of the tumor mucosa 17 is no longer attached to the lower digestive wall 16 and can obstruct the angle of dissection.
[0084] To ensure a sufficient dissection angle when dissecting the remaining tumor mucosa 17, which is not separated from the lower digestive wall 16, the tightening wire 2 is re-tensioned by pulling on its second end 4, in the direction D1. This again applies traction forces to the tumor mucosa 17, allowing for a sufficient dissection angle. This facilitates the passage of the dissecting tool 28 and the retraction of the tumor mucosa. Furthermore, the unidirectional adjustment element 9 allows the length of the clamping wire 2 to be maintained constant during dissection operations. A simple pulling action on the second end 4 in the direction D1 allows the length L. Thus, the length of the clamping wire 2 decreases from an initial length to a final length less than the initial length.
[0085] These steps of separating the tumor mucosa 17 from the lower digestive wall 16 by dissection and of retaining the tightening wire 2 are repeated successively until the complete recession of the tumor mucosa 17 from the lower digestive wall 16.
[0086] The unidirectional adjustment element 9 according to an embodiment of the invention is now described with reference to [Fig. 8A] to [Fig. 8E]. In these figures, the unidirectional adjustment element 9 is similar to the unidirectional adjustment element 9 described in relation to [Fig. 2] to [Fig. 4], and [Fig. 7]. Thus, the clamping wire 2 passing through the first part 10 as described previously is shown, and embodiments in relation to the second part 11 will be detailed more precisely below.
[0087] According to the embodiment shown in Figure 8A, the adaptive traction device 1 includes a clamping ring 31. Advantageously, this clamping ring 31 has dimensions greater than the second part 11 of the unidirectional adjustment element 9. The clamping ring 31 is made of a material similar to that of the unidirectional adjustment element 9. Advantageously, the clamping ring 31 has a diameter greater than the inner diameter of the second part 11. As shown in this figure, the clamping ring 31 is positioned at one end of the second part 11 such that the clamping ring 31 can abut against this end. The clamping ring 31 abuts against the end of the second part 11 when a tensile force is applied to the clamping wire 2. The clamping ring 31 is attached to the first end 3, which protrudes from the second part 11, by any means of attachment known to those skilled in the art. For example, the clamping ring 31 is attached to the first end 3 by means of crimping, welding, or gluing. Thus, the clamping ring 31 ensures that the first end 3 remains protruding from the second part 11, even when the clamping wire 2 is pulled.
[0088] According to the embodiment shown in [Fig. 8B], the first end 3 of the clamping wire 2 is attached to the second part 11 of the unidirectional adjusting element 9 by any fastening method known to those skilled in the art. For example, the first end 3 is attached to the second part 11 by means of crimping, welding, or gluing. Preferably, the first end 3 is attached near the end of the second part 11 located opposite the connecting element 27. Alternatively, the first end 3 may be attached to the connecting element 27.
[0089] According to the embodiment shown in [Fig. 8C], the adaptive traction device 1 comprises a clamping ring 31, and a removable fixing element 12. Advantageously, this clamping ring 31 has dimensions greater than the second part 11 of the unidirectional adjustment element 9. The clamping ring 31 is made of a material similar to that of the unidirectional adjustment element 9. As shown in this figure, the clamping ring 31 is positioned at one end of the second part 11 such that the clamping ring 31 can abut against this end. The clamping ring 31 abuts against the end of the second part 11 when a tensile force is applied to the clamping wire 2. The clamping ring 31 is configured to allow the clamping wire 2 to slide inside said clamping ring 31. As illustrated in [Fig. 8C], the first end 3 of the clamping wire 2 passes through the clamping ring 31, then a hook loop 32 is formed, and finally the first end 3 is attached to the clamping ring 31 by any means of attachment known to a person skilled in the art, including those mentioned previously. The hook loop 32 is configured to cooperate with the removable fastening element 12. According to one embodiment, the second part 12 is pre-deformed, totally or partially, before any tensile action on the clamping wire 2. For example, the pre-deformation is carried out by a compression action, preferably over all or part of the length along the longitudinal axis A_long2. The compression can be carried out by a tool having a jaw with grooves. When the clamping wire 2 is pulled in a direction D2, it slides inside the clamping ring 31, which comes to rest against the second part 11, causing a decrease in the length of the fastening loop 32. The direction D2 corresponds to a movement from the connecting element 27 towards the end of the second part 11 located opposite the connecting element 27. Thus, when the removable fastening element 12 is fitted into the fastening loop 32, the decrease in the length of the fastening loop 32 secures the removable fastening element 12 to the fastening loop 32. In addition, this embodiment improves the stability of the fixation of the unidirectional adjustment element to the wall of the digestive tract or tumor mucosa.
[0090] According to the embodiment shown in [Fig. 8D], a hook loop 32 is formed at the first end 3, and then the first end 3 is attached to the second part 11 by any fastening means known to those skilled in the art, including those mentioned previously. Alternatively, the first end 3 can be attached to the connecting element 27. The hook loop 32 is configured to cooperate with a removable fastening element (not shown). According to one embodiment, the second part 12 is pre-deformed, totally or partially, before any tensile action on the clamping wire 2. For example, the pre-deformation is carried out by a compression action, preferably over all or part of the length along the longitudinal axis A_long2. The compression can be carried out by a tool having a jaw with grooves. When the tensioning wire 2 is pulled in the direction D2, the length of the attachment loop 32 decreases. Thus, when a removable fastener is fitted onto the attachment loop 32, the reduction in the length of the attachment loop 32 secures the fitted removable fastener to said attachment loop 32. This embodiment also makes it possible to improve the stability of the fixation of the unidirectional adjustment element to the wall of the digestive tract or the tumor mucosa.
[0091] According to the embodiment shown in [Fig. 8E], the adaptive traction device 1 further comprises a fixing wire 33 separate from the clamping wire 2 (not illustrated in this figure), and a clamping ring 35. The fixing wire 33 is similar to the clamping wire 2, and the clamping ring 35 is similar to the clamping ring 31. As shown in this figure, the clamping ring 35 is positioned at one end of the second part 11 such that the clamping ring 35 can abut against this end. The clamping ring 35 abuts against the end of the second part 11 when a tensile force is applied to the fastening wire 33. In addition, the fixing wire 33 comprises a first end 36 and a second end 37. The first end 36 of the fixing wire 33 passes through the second part 11, then the clamping ring 35, a hook loop 34 is then formed, then the first end 36 passes again successively through the clamping ring 35 and the second part 11. The hook loop 34 thus formed is configured to cooperate with a removable fixing element (not shown). Advantageously, the attachment loop 34 can replace a distal component of an anchor (not shown). Furthermore, the fastening wire 33 can replace a connecting rod of said anchor. The first and second ends 36, 37 are fixed to the gripping element 5 (not shown), or to an anchor (not shown) as will be described below. In this embodiment, the second part 12 is pre-deformed, totally or partially, before any tensile action is applied to the fixing wire 33. For example, the pre-deformation is achieved by a compression action, preferably over all or part of the length along the longitudinal axis A_long2. The compression can be achieved by a tool having a jaw with grooves. When at least one end of the fastening wire 33 is pulled in the direction D2, the fastening wire 33 slides inside the clamping ring 35 which comes to rest against the second part 11 causing a reduction in the length of the hook loop 34. Thus, when a removable fastening element is fitted at the hook loop 34, the reduction in the length of the hook loop 34 makes it possible to secure the fitted removable fastening element with said hook loop 34. According to an embodiment not illustrated, the first end 36 is fixed to the clamping ring 35, without again passing through the second part 11 of the unidirectional adjustment element 9. The operation is then similar to the embodiment described in connection with [Fig. 8C].
[0092] According to an embodiment not shown, after the formation of the hook loop 34, the first end 36 is fixed on the second part 11, in a manner similar to the embodiment described in connection with [Fig. 8D]. Thus, the use of a clamping ring 35 can be avoided.
[0093] The adaptive traction device 1 described in relation to [Fig. 1] to [Fig. 8E] comprises a single tensioning wire 2, thus significantly simplifying the handling of the traction device. Such an adaptive traction device 1 eliminates the need for a hose clamp and anchors.
[0094] An adaptive traction device for biological tissue according to an embodiment according to the fourth of the invention is now described with reference to [Fig. 9].
[0095] The adaptive traction device 1 of the fourth aspect of the invention is similar to the adaptive traction device 1, according to the first aspect of the invention, described in relation to [Fig. 2] to [Fig. 4], and [Fig. 7]. In addition, the adaptive traction device 1 comprises four anchors 18. Each anchor 18 comprises a distal organ 19, a proximal organ 21, and a connecting rod 20 for connecting the distal organ 19 to the proximal organ 21. The proximal organ 21 is configured to be fitted onto the grasping element 5, for example, at the level of a quadrant 18. The distal organ 21 is configured to be fitted onto the clamping wire 2 and to cooperate with a removable fixing element 12 and / or the unidirectional adjustment element 9. The distal and proximal organs 19, 21 take the form of circular rings. However, any other ring shape may be considered provided that it allows cooperation with the gripping element 5 and / or the removable fixing element 12 and / or the unidirectional adjustment element 9. Advantageously, the distal and proximal parts 19, 21 are made of metal, plastic, latex, or any other suitable material known to those skilled in the art. Preferably, the distal and proximal parts 19, 21 are made of one or more hypoallergenic materials such as polyglecaprone, polybutester, glycomer, polyglactin, polyglyconate, polydioaxanone, polypropylene. According to one embodiment, the distal and proximal organs 19, 21 comprise a surface coating made of one or more hypoallergenic materials of the type described previously. In one embodiment, the connecting rod 20 is made of a flexible or elastic material. The connecting rod 20 is configured to deform when the tensioning wire 2 is applied. These embodiments of the connecting rod 20 facilitate the tensioning of the tensioning wire 2. As shown in [Fig. 9], each proximal organ 21 is nested within a distinct quadrant 26. In other words, a proximal organ 21 is nested within a single quadrant 26. In addition, each distal organ 19 is fitted at a separate fixing section 8 or at the unidirectional adjustment element 9. In other words, a distal organ 19 is fitted either onto a fixing section 8 or onto the unidirectional adjustment element 9.
[0096] Steps in the installation process according to an embodiment of the fifth aspect of the invention are described with reference to [Fig. 10]. This figure also corresponds to an embodiment of the eighth aspect of the invention. Indeed, the eighth aspect of the invention relates to a method for installing the traction device of the seventh aspect of the invention, and more particularly for installing the tension wire (also called the "traction wire") with the unidirectional adjustment element (also called the "unidirectional adjustment member").
[0097] The functional diagram of the process shown in [Fig. 10] includes an insertion step 100, a fixing step 101, and a pre-deformation step 102.
[0098] During the insertion step 100, the clamping wire 2 is inserted into the first part 10 of the unidirectional adjusting element 9. According to one embodiment, the second end 4 is inserted into the first part 10, so that the second end 4 protrudes from the first part 10.
[0099] This insertion step 100 also corresponds to the insertion of the tension wire (also called "clamping wire") of the eighth aspect of the invention.
[0100] During the fastening step 101, the clamping wire 2 is fixed directly or indirectly to the second part 11, by any known means or method of fastening, such as those mentioned previously. By "fixed directly to the second part", it is understood and in the sense of the invention, a fixing according to the embodiments described in relation to [Fig. 8B] and [Fig. 8D], By "fixed indirectly to the second part", it is understood and in the sense of the invention, a fixing according to the embodiments described in relation to [Fig. 8A] and [Fig. 8C],
[0101] According to one embodiment, during steps 100, 101, the first end 3 of the clamping wire 2 first passes through the first part 10 and is then fixed directly or indirectly to the second part 11.
[0102] Following these steps 100, 101, the tightening wire 2 forms a hook loop 32 of variable length.
[0103] During the pre-deformation step 102, the first part 10 is partially deformed. In other words, only a part of the first part is deformed. This pre-deformation makes it easier to deform the longitudinal deformation of the first part 10 when the clamping wire 2 is pulled in the direction D1, and thus improve the unidirectional effect of the unidirectional adjusting element 9. Thus, when the clamping wire 2 is pulled, the first part 10 deforms, as described previously, and prevents the clamping wire 2 from sliding in the opposite direction which would cause an increase in length. According to one embodiment, the first part 10 is totally deformed. Advantageously, the first part 10 is deformed by a compression action along the first longitudinal axis A_long1. For example, the pre-deformation of the first part 10 is carried out by a tool having a jaw with grooves.
[0104] This pre-deformation step 102 also corresponds to the step of embedding the traction wire in the first helical winding (also called "first part") of the unidirectional adjusting member (also called "unidirectional adjusting element").
[0105] Steps in the installation process according to an embodiment of the sixth aspect of the invention are described with reference to [Fig. 12],
[0106] The functional diagram of the process shown in [Fig. 12] includes two insertion steps 200, 201, one fixing step 202, two pre-deformation steps 203, 204, one insertion step 205, and one traction step 206.
[0107] During the insertion step 200, the clamping wire 2 is inserted into the first part 10 of the unidirectional adjusting element 9. According to one embodiment, the second end 4 is inserted into the first part 10, so that the second end 4 protrudes from the first part 10.
[0108] During the insertion step 201, the clamping wire 2 is inserted into the second part 10 of the unidirectional adjustment element 9. Furthermore, during this insertion step 201, the clamping wire 2 forms a hook loop 32 of variable length.
[0109] During the fastening step 202, the clamping wire 2 is fixed directly or indirectly to the second part 11, by any known means or method of fastening, such as those mentioned previously. By "fixed directly to the second part", it is understood and in the sense of the invention, a fixing according to the embodiments described in relation to [Fig. 8B] and [Fig. 8D], By "fixed indirectly to the second part", it is understood and in the sense of the invention, a fixing according to the embodiments described in relation to [Fig. 8A] and [Fig. 8C],
[0110] During the pre-deformation step 203, the first part 10 is partially deformed. In other words, only a portion of the first part is deformed. According to one embodiment, the first part 10 is fully deformed. Advantageously, the first part 10 is deformed by a compression action along the first longitudinal axis A_long1. For example, the pre-deformation of the first part 10 is carried out by a tool having a jaw with grooves.
[0111] During the pre-deformation step 204, the second part 11 is partially deformed. In other words, only a part of the second part is deformed. According to one embodiment, the second part 11 is totally deformed. Advantageously, the second part 11 is deformed by a compression action along the second longitudinal axis A_long2. For example, the pre-deformation of the second part 11 is carried out by a tool having a jaw with grooves.
[0112] It should be noted that the order of the two pre-deformation steps 203 and 204 is arbitrary. For example, pre-deformation step 204 can be carried out before pre-deformation step 203.
[0113] During the insertion step 205, a removable fastening element 12 is inserted at the level of the hook loop 32. This insertion on the hook loop 32 is similar to the insertion of a removable fastening element 12 on a fastening section 8 as described previously.
[0114] During the traction step 206, the clamping wire 2 is pulled, causing a decrease in the length of the hook loop 32 and a longitudinal deformation of the second part 11 similar to the deformation of the first part 10 described above. For example, the clamping wire 2 is pulled in the direction D2 described previously. On the other hand, this pulling action is carried out on the end of the clamping wire 2 located opposite the hook loop 32. The second part 11, thus deformed, prevents the tightening wire 2 from sliding in a direction that would cause an increase in the length of the hook loop 32. Thus, the removable fastening element 12 is attached to the hook loop 32.
[0115] According to an embodiment not shown, during steps 201 to 206, a fastening wire 33 is used instead of the tightening wire 2. In this case, the fastening wire 33 forms a hook loop 34 of variable length. This embodiment corresponds to the embodiment described in connection with [Fig. 8E].
[0116] A traction device for biological tissue of the digestive tract according to an embodiment of the seventh aspect of the invention is described with reference to [Fig. 12]. The traction device according to the invention is an endoscopic device.
[0117] Advantageously, the traction device is configured for use in robotic resection.
[0118] The traction device 1 shown in this figure includes a traction wire 2 (also called "clamping wire"), a support member 5 (also called "elastic gripping element") and a unidirectional adjustment member 9 (also called "unidirectional adjustment element").
[0119] The tension wire 2, or clamping wire, comprises a first end 3 and a second end 4. Advantageously, the traction wire 2 can be made of polyamide-type polymer or nitinol-type shape-memory material. 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 30. As illustrated in [Fig. 12], the visual marker 30 is a ring set on the traction wire 2. According to an embodiment not shown, the visual marker 30 is a colored section. This visual marker 30 allows the practitioner to be indicated the length of traction thread remaining during the resection of the tumor mucosa.
[0120] As shown in [Fig. 12], the traction wire 2 further comprises a gripping element 38. In the example shown, the gripping element 5 is a loop. This loop 38 is located at the second end 4 of the traction wire 2. Advantageously, the grasping element 38 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 well-suited for operations performed directly by a practitioner or via a robot. Furthermore, these embodiments allow the second end 4 of the traction wire 2 to protrude from the unidirectional adjusting member 9 throughout the use of the traction device 1. In other words, the gripping element 38 prevents the second end 6 from fully penetrating the unidirectional adjusting member 9.
[0121] In one embodiment, the gripping element 38 is an element added to the traction wire 2. In other words, the gripping element 38 is initially independent of the traction wire 2 and is attached to it by any means or method of attachment known to those skilled in the art, such as crimping or gluing. In this embodiment, the gripping element 38 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 38 is formed from the second end 4 of the traction wire. In this embodiment, the gripping element 38 is made of a material similar or identical to the traction wire 2.
[0122] The support member 5 (also called the "elastic gripping element"), according to the illustrated embodiment, includes a guide through hole 7 and a fixing through hole 39. The support member 5 also includes an upper face 11 and a lower face 12. In this example, the support member 5 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 5 is in the form of a ring with a through-hole for mounting 39 and a through-hole for guidance in its periphery. In other words, the support member 5 has both the through-hole for mounting 39 and the through-hole for guidance 7. As illustrated, the support member 5 is in the form of a circular ring. Thus, the through-hole for mounting 39 and the periphery of the support member 5 are circular. The same is true for the through-hole for guidance 7, which is also circular.
[0123] According to an embodiment not illustrated, the guide through-hole 7 and / or the fixing through-hole 38 have a different shape from the periphery of the support member 5. Similarly, the guide through hole 7 may have a different shape from the fixing through hole 39.
[0124] For example, the guide hole 8 and the fixing hole 9 may be triangular, parallelepiped, or polygonal. 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 7 has a diameter between 1 mm and 2 mm. The fixing through hole 39 has a diameter between 3 mm and 6 mm, preferably between 4 mm and 5 mm.
[0125] According to one embodiment, the support element 5 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 element 5 is made of one or more hypoallergenic materials such as polyglecaprone, polybutester, glycomer, polyglactin, polyglyconate, polydioaxanone, or polypropylene. In another embodiment, the support member 5 is made of at least two distinct materials. In other words, a first part of the support member 5 is made of a first material, and a second part of said support member 5 is made of a second material distinct from the first material. For example, the part of the support member 5 having the guide hole 7 is made of metal, and the rest of the support member 5 is made of an elastic material. This embodiment ensures the integrity of the guide through orifice 7.
[0126] In the embodiment shown, the through-hole for fixation 38 has an eccentric position on the support member 5, so that a portion of the support member 5 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 39 facilitates deformation of the support member 5. However, the through-hole for fixation 39 may have a central position on the support member 5, provided that a portion of the support member 5 can be fixed to the wall of the digestive tract, in particular by means of a clip. endoscopic. These embodiments allow for improved handling of the traction device 1.
[0127] According to an embodiment not illustrated, the support member 5 further includes an extendable part. The extensible part of the support organ 5 corresponds to a part of the support organ 5, such as the part of the support organ 5 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 fixed to the digestive tract wall. Thus, the extensible portion allows for the indirect application of a traction force to the tumor mucosa when it is fixed to the digestive tract wall of a patient.
[0128] The unidirectional adjusting member 9, or unidirectional adjusting element, comprises at least one first helical winding 10 (also called the "first part"). As illustrated in [Fig. 13], the unidirectional adjusting member 9 comprises a first helical winding 10, a second helical winding 11 (also called the "second part") and a connecting element 27 (not visible in [Fig. 12]) joining the first winding 10 and the second winding 11.
[0129] The first helical winding 10 and the second helical winding 11 take the form of wires forming tightly wound turns in the initial state, similar to tension springs. For example, the first and second windings 10, 11 are made of metal, or a metal alloy, for medical use. Initially, the first helical winding 10 has a length between 2 mm and 5 mm, preferably between 2.5 mm and 3.5 mm. The second helical winding 11 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 10 and 11 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 10 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 greater than 4. The elongation factor of the second helical winding 11 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 10, 11 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 10, 11 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 10, 11 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.
[0130] The first helical winding 10 extends along a first longitudinal axis A_long1, and the second helical winding 11 extends along a second longitudinal axis A_long2 substantially orthogonal to the first longitudinal axis A_long1. Thus, the first helical winding 10 is substantially orthogonal to the second helical winding 11.
[0131] The unidirectional adjusting member 9 allows the first end 3 of the traction wire 2 to be connected, directly or indirectly, to the traction wire 2 at a distance from the second end 4 so as to form a traction loop of variable length. Indeed, in the example illustrated in [Fig. 12], the first end 3 of the traction wire 2 passes through the first helical winding 10, the guide through-hole 7, and is fixed to the second helical winding 11. The first end 3 is fixed to the second helical 11 by any means or method of fixing described below, or known to a person skilled in the art.
[0132] According to another embodiment, the first end 3 is fixed to the second helical winding 11, for example by crimping, welding or gluing, the traction wire 2 passes through the guide hole 7, and through the first helical winding 10 so that the second end 4 protrudes from the first helical winding 10.
[0133] The first helical winding 10 is configured to allow the traction wire 2 to slide in a single direction.
[0134] In this embodiment, the unidirectional adjusting member 9 further includes a fastening portion configured to receive the first end 3 of the traction wire 2. For example, the fastening portion is a crimping strand 41. Advantageously, the crimping strand 41 extends from the second helical winding 11, preferably the crimping strand 41 extends from the second helical winding 11 parallel to the second longitudinal axis A_long2 and along the second helical winding 11.
[0135] According to an embodiment not shown, the first helical winding 10 is pre-deformed, totally or partially. Thus, the traction wire 2 is embedded in the first helical winding 10 of the unidirectional adjusting member 9. For example, the first helical winding 10 is pre-deformed in a direction transverse to the first longitudinal axis A_long1, preferably in a direction substantially perpendicular to the longitudinal axis A_long1. By "transverse", it is understood and in the sense of the present invention, any straight line secant to the longitudinal axis A_long1 forming an angle with this longitudinal axis A_long1 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 10 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 9. This pre-deformation of the first helical winding 10 is achieved by a compression action along the longitudinal axis A_long1, that is to say by deformation of the first helical winding 10 in a direction transverse to the longitudinal axis A_long1, preferably in a direction substantially perpendicular to the longitudinal axis A_long1. For example, the pre-deformation of the first helical winding 10 is carried out by a tool having a jaw with grooves (for example, a crimping tool).
[0136] The unidirectional adjusting member 9 can be made from a single piece, or from three separate parts, namely the first and second helical windings 10, 11 and the connecting element 27, which are assembled together. For example, the assembly of the three parts 10, 11, 27 is carried out by bonding, welding, or any other means or method of assembly known to those skilled in the art.
[0137] As shown in [Fig.12], the unidirectional adjusting member 9 is fixed at the level of the guide through orifice 7. This fastening can be achieved by inserting the unidirectional adjusting member 9 into the guide hole 7. In other words, since the support member 5 is made of an elastic material, it is possible to temporarily deform the guide hole 7 to insert the unidirectional adjusting member 9 into it. This temporary deformation can be achieved by passing the unidirectional adjusting member through the guide hole 7. According to another embodiment, the unidirectional adjusting member 9 is fixed by means of a sleeve or a wire. According to another embodiment, the unidirectional adjusting member 9 is fixed by means of a special imprint in the support member 5. 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.
[0138] Fig. 12bis represents a variant of the embodiment of the invention illustrated in Fig. 12. In this embodiment, compared to the traction device described in Fig. 12, the traction device further comprises a guide loop 40. Advantageously, the guide loop 40 is configured to be mounted in the through fixing hole 39 or in the through guide hole 7. In the case where the guide loop 40 is mounted in the fixing through hole 39, this guide loop 40 can serve as a guide through hole 7. The guide loop 40 can be made of the same material as the traction wire 2.
[0139] As illustrated in this figure, the guide loop 40 is further configured to fix the unidirectional adjusting member to the guide through orifice 7 of the support member 5. The guide loop 40 can be attached 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 guide loop 40 is crimped to the unidirectional adjusting member 9 at the connection point 27 of the unidirectional adjusting member 9.
[0140] Figure 14 represents another embodiment of the invention. In this embodiment, compared to the traction device described in Figure 12, the traction device 1 further comprises two anchoring loops 42. This embodiment improves the distribution of forces on the biological tissue. Indeed, by adding two anchoring loops 42, 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.
[0141] Advantageously, the anchor loops 42 are made of the same material as the traction wire 2.
[0142] As illustrated, the anchor loops 42 are mounted in the through fixing hole 39 by any method or means known to a person skilled in the art. According to an embodiment not illustrated, the anchor loops 42 are mounted in the guide through hole 7.
[0143] The anchor loops 42 are mounted to slide freely in the through fixing hole 39. In other words, the movement of the anchor loops 42 can be made over the entire circumference of the through fixing hole 39, without hindrance.
[0144] Figure 15 represents another embodiment of the invention. In this embodiment, with respect to the traction device described in connection with Figure 15, 12] to [Fig. 14], the traction wire 2 further includes a loop 43 located at level of the first end 3, and the unidirectional adjusting member 4 comprises only a first helical winding 10.
[0145] Advantageously, the loop 43 is a loop similar to the gripping element 38. Thus, the embodiments relating to the gripping element 38 are also applicable to the loop 43.
[0146] As illustrated in [Fig. 15], the second end 4 of the traction wire 2 is passed inside the loop 43 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 4 of the traction wire 2. Indeed, thanks to the loop 43, 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).
[0147] The traction device 1 described in relation to [Fig. 12], [Fig. 12bis], [Fig. 14] to [Fig. 16] comprises a single traction wire 2, thus significantly facilitating the handling of the traction device. Such a traction device 1 eliminates the need for a hose clamp and anchors.
[0148] A traction device according to another embodiment of the invention is described with reference to [Fig. 16] and [Fig. 17],
[0149] In this embodiment, and contrary to the traction device 1 described in connection with [Fig. 12] to [Fig. 14], the unidirectional adjustment member 9 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 of the guide 7 of the support member 5. This embodiment facilitates the assembly of the traction device 1 while ensuring greater freedom in the placement of the unidirectional adjustment member 9.
[0150] Detail A shown in [Fig. 16] is now described in relation to [Fig. 17]. In this embodiment, compared to the traction device described in relation to [Fig. 12] to [Fig. 14], the traction device 1 further comprises a clamping ring 31 and an endoscopic clip 12. Advantageously, this clamping ring 31 has at least one dimension greater than the internal diameter of the second helical winding 11 of the unidirectional adjustment member 9. The clamping ring 31 is made of a material similar or identical to that of the unidirectional adjusting member 9.
[0151] As shown in this figure, the clamping ring 31 is positioned at one end of the second winding 11 so that the clamping ring 31 can come to rest against this end when a pulling action is performed on the pulling wire 2.
[0152] The clamping ring 31 is configured to allow the traction wire 2 to slide inside said clamping ring 31. As illustrated in [Fig. 17], the first end 5 of the traction wire 2 passes through the clamping ring 31, forming a hook loop 32, and the first end 3 is attached to the clamping ring 31 by any means of attachment known to those skilled in the art, including those mentioned previously. The hook loop 32 is configured to cooperate with the endoscopic clip 12. When the traction wire 2 is pulled in a direction D1, it slides inside the clamping ring 31, which abuts against the second helical winding 11, causing a decrease in the length of the hook loop 32. The direction D1 corresponds to a pulling movement that allows the clamping ring 31 to abut against the second winding 11. Thus, when the endoscopic clip 12 is fitted into the hook loop 32, the reduction in the length of the hook loop 32 allows the endoscopic clip 12 to be secured with the hook loop 32. In addition, this embodiment improves the stability of the fixation of the unidirectional adjustment organ 9 to the wall of the digestive tract or the tumor mucosa.
[0153] A traction device according to another embodiment of the first or fourth or seventh aspect of the invention is described with reference to [Fig. 18], [Fig. 19] and [Fig. 20], In this embodiment, compared to the traction device described in connection with [Fig. 16], the traction device 1 comprises an anchor 18 and a clamping ring 35. For example, anchor 18 is a secondary traction wire, this secondary traction wire is made of a material similar or identical to traction wire 2. Thus, anchor 18 is flexible. The anchor 18 allows the unidirectional adjustment element 9 to be maintained at a distance, for example at a predetermined maximum distance, from the support element 5 throughout the resection operation and facilitates the fixation of the adjustment element 9 to the biological tissue. Furthermore, the anchor 18 eliminates the need for the clamping ring 31 and the attachment loop 32.
[0154] The anchor 18 comprises a first end 21, an intermediate section 20, and a second end 19 of adjustable length.
[0155] The first end 21 is configured to be fixed to the support member 5, for example, at the through fixing hole 39. The second end 19 of variable length is configured to be fixed to the biological tissue by means of an endoscopic clip (not shown).
[0156] The first and second ends 21, 19 of the anchor 18 take the form of loops.
[0157] As shown in [Fig. 18], the first end 19 of the anchor 18 is fixed at the through fixing hole 39. On the other hand, the intermediate section 20 passes through the second helical winding 11 of the unidirectional adjusting member 9 in place of the traction wire 2. The first end 3 of the traction wire 2 is then fixed to the second winding 11 by means of the clamping ring 35. The second end 4 of the traction wire 2 passes through the first helical winding 3 so as to protrude from the first helical winding 3.
[0158] The anchor 18 is mounted embedded in the second helical winding 11 of the unidirectional adjusting member 9. For example, the second helical winding 11 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 11 is achieved by a compression action along the longitudinal axis A_long2, that is to say by deformation of the second winding 11 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 11 is carried out by a tool having a jaw with grooves (for example, a crimping tool).
[0159] When the unidirectional adjustment member 9 is moved along the direction D2, the length of the second end 19 will decrease, thus allowing an endoscopic clip (not shown) to be attached to this second end 19. The direction D2 corresponds to a pulling movement from the second end 19 to the first end 21. Furthermore, during the movement of the unidirectional adjusting member 9 along the intermediate section 20 of the anchor 18, the second winding 11 will deform irreversibly along the second longitudinal axis A_long2. During this movement, the length of the second winding 11 will increase. In addition, the longitudinal deformation of the second winding 11 prevents the unidirectional adjustment member 9 from sliding in the opposite direction, which would cause an increase in the length of the second end 19 of the anchor 18, and therefore a detachment of the endoscopic clip from the second end 19.
[0160] Detail B shown in [Fig. 18] is now described in relation to [Fig. 19]. The unidirectional adjusting member 9 illustrated in this figure corresponds to the directional member 9 described previously, in relation to [Fig. 18].
[0161] The unidirectional adjusting member 9 further includes a fixing portion configured to receive the first end 3 of the traction wire 2. The fixing portion is also configured to receive a part of the second end 19 of the anchor 18. For example, the fastening portion is a crimping strand 41 (not visible on [Fig. 18]).
[0162] As illustrated in [Fig. 19], the crimping strand 41 extends from the second helical winding 11, preferably the crimping strand 41 extends from the second helical winding 11 parallel to the second longitudinal axis A_long2 and along the second helical winding 11.
[0163] The first end 3 of the traction wire 2 and a section of the second end 19 of the anchor 18 are fixed to the crimping strand 41 by means of the crimping ring 35.
[0164] A traction device 1 according to another embodiment of the invention is now described with reference to [Fig. 20],
[0165] The traction device 1 includes a traction wire 2, a support member 5, a one-way adjusting member 9, and a fixing loop 15 (also called an "intermediate linking element") configured to allow the fixing of the support member 5 to the wall of the digestive tract.
[0166] 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.
[0167] In this embodiment, the support member 5 has a parallelepiped shape, and more particularly a parallelepiped ring shape. As illustrated, the support member 5 comprises an upper face 25, a lower face 24, four through guide holes 7, four lateral faces 23, and a connecting element 13. On the other hand, the support member 5 has a thickness e. The thickness e is similar or identical to the thickness e described in connection with the embodiments of [Fig. 12]. According to the illustrated embodiment, each lateral face 23 has a concave shape. This embodiment facilitates the deformation of the support member 5. 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 the traction device 1.
[0168] The four through-guide ports 7 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 7 are positioned on the surface of the support member 5, such that each through-hole guide 7 is positioned near one of the vertices of the parallelepiped. In other words, each through-hole guide 7 is positioned at a cardinal point of the support member 5. This arrangement of the through-guide holes allows for a better distribution of traction forces on the tumor mucosa to be resected.
[0169] According to an embodiment not illustrated, the four through-guide holes 7, each preferably positioned near a vertex of the parallelepiped, extend along the thickness e of the support member 5. In other words, in this embodiment, the through-guide holes 7 extend in the horizontal plane of the support member 5 so that each through-guide hole 7 passes through two adjacent lateral faces 23 of the support member 5. For example, the horizontal plane corresponds to the plane passing through the support member 5 and which is substantially parallel to the lower and upper faces 24, 25. For comparison, in [Fig. 20], the four through-guide ports 7 are defined in the vertical plane of the support member 5, and pass through the lower face 24 and the upper face 25. The vertical plane of the support member 5 corresponds to the plane substantially orthogonal to the horizontal plane of the support member 5. This unillustrated embodiment improves the sliding of the traction wire 2 when it is pulled, thus facilitating the handling of the traction device 1. According to a particular embodiment of this embodiment not illustrated, the diameter of the through guide holes 7 is less than the thickness e of the support member 5. According to one embodiment, the four through guide ports 7 extend parallel to the main plane of the support member 5. The main plane is the plane along which the support member 5 extends.
[0170] The connecting element 13 has a two-pronged cross shape, with the prongs being of equal length. Preferably, the connecting element 13 is made of an elastic material, or a flexible material. According to the illustrated embodiment, the connecting element 13 is configured to deform reversibly along the deformation axis A_ext. According to an embodiment not shown, the connecting element 13 is thermoformed into a desired shape. For example, the thermoformed connecting element has a substantially rounded shape projecting from the support member 5. The Thermoforming of the linking element 13 allows the shape of said linking element 13 to be maintained throughout the use of the traction device 1, and thus to ensure a balanced distribution of the traction force on the anchoring points of the tumor mucosa. The connecting element 13 is positioned at the center of the support member 5 so as to form four quadrants 26 of the same size. According to the illustrated embodiment, the connecting element 13 directly connects each guide through-hole 7. Thus, one branch of the connecting element 13 connects two opposite guide through-holes 7. The linking element 13 is configured to be fixed to the wall of the digestive tract.
[0171] Advantageously, a person skilled in the art will appreciate that the connecting element 13 may be a separate part from the support member 5 which, subsequently, will be assembled with said support member 3 by any means of assembly known to a person skilled in the art. The connecting element 13 can result directly from the manufacture of the support member 5. In other words, and by way of example, during the manufacture of the support member 5, the latter can undergo a bore allowing the connecting element 13 to be formed.
[0172] According to the illustrated embodiment, the traction wire 2 passes successively through each guide through orifice 7 so that the traction wire 2 defines a fixing section 8 between each adjacent guide through orifice 7, i.e. a total of four fixing sections 8. In other words, the first end 3 of the traction wire 2 passes through each of the four guide through orifices 7 so that the two ends 3,4 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 7 in the same direction. For example, this direction corresponds to a pulling motion from the lower face 24 to the upper face 25, or vice versa. In other words, the traction wire 2 is introduced into the guide hole 7 from the lower face 24, and then emerges from the guide hole 7 from the upper face 25.
[0173] Each fixation section 8 is configured to be fixed to the biological tissue. For example, each fixation section 8 is fixed to the biological tissue via an endoscopic clip.
[0174] As illustrated in [Fig. 20], the traction wire 2 comprises four coupling elements 14. In this example, the coupling elements 14 are flexible cylinders fitted onto the traction wire 2. Moreover, these coupling elements 14 are made of a metallic material having ferromagnetic properties. According to one embodiment, the coupling elements 14 are crimped or slidably mounted on the traction wire 2. Each of the four coupling elements 14 is positioned at the end of a fixing section 8. The coupling elements 14 allow the traction wire 2 to be coupled to endoscopic clips (not shown). It should be noted that these coupling elements 14 can be used in the implementation methods described in connection with the previous figures.
[0175] The unidirectional adjusting member 9 has the same embodiments as those described in connection with the previous figures. As presented, the unidirectional adjusting member 9 is fixed at one of the guide through holes 7 according to one of the means or methods of fixing described previously.
[0176] The fastening loop 15 takes the form of a circular ring. Advantageously, the fastening loop 15 is made from an elastic material, a flexible material, or a metallic material. According to one embodiment, the fastening loop 15 is made of a material similar or identical to that of the support member 5. As illustrated in [Fig. 20], the fastening loop 15 is positioned at the level of the connecting element 13. Preferably, the fastening loop 15 is positioned at the center of the connecting element 13. Preferably, the fastening loop 15 is positioned at the intersection of the branches of the connecting element 113. The fixation loop 15 is configured to allow the support organ 3 to be fixed to the wall of the digestive tract.
[0177] The operation of the adaptive traction device 1 will now be explained in relation to [Fig. 21] and [Fig. 22].
[0178] The adaptive traction device 1 is identical to the adaptive traction device 1 described in connection with [Fig. 12]. In addition, the traction device 1 includes four endoscopic clips 12. Typically, endoscopic clips 12 are configured to attach to biological tissue by pinching said biological tissue between their jaws.
[0179] During a resection 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.
[0180] As shown in [Fig. 21] and [Fig. 22], the digestive tract 29 comprises a lower digestive wall 16, an upper digestive wall (not shown) opposite the lower digestive wall 16, and a tumor mucosa 17 located on the lower digestive wall 16.
[0181] Initially, the support organ 5 is fixed to the upper digestive wall by means of an endoscopic clip (not shown) positioned in the through fixation orifice 39. At this stage, no traction force is exerted on the tumor mucosa 17, nor on the digestive tract 29.
[0182] Once the support organ 5 is fixed to the upper digestive wall, the traction loop defined by the traction wire 2 is fixed to the tumor mucosa 17 by means of the endoscopic clips 12, thus defining anchor points. As shown in [Fig. 21] and [Fig. 22], the endoscopic clips 12 are uniformly distributed over the surface of the tumor mucosa 17. At this stage, no traction force is exerted on the tumor mucosa 17, nor on the digestive tract 29.
[0183] Subsequently, once the traction loop is fixed to the tumor mucosa 17, traction can be applied to the second end 4 of the traction wire 2, notably via the loop 38, in a direction D3, causing a decrease in the length of the traction wire 2 from an initial length. Direction D3 corresponds to a pulling motion from the connecting element 27 towards the end of the first helical winding 10 located opposite the connecting element 27. Pulling the tension wire 2 along direction D3 causes irreversible deformation of the first helical winding 10 along the first longitudinal axis A_long1. Thus, when tension wire 2 is pulled, the length of the first winding 10 increases. Furthermore, the longitudinal deformation of the first winding 10 along the first longitudinal axis A_long1 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 17. Under the effect of these traction forces, the supporting organ 5 can deform.
[0184] Subsequently, in order to separate the tumor mucosa 17 from the lower digestive wall 16, an initial dissection of the tumor mucosa 17 is performed using a dissecting tool 28. As this initial dissection progresses, the traction forces exerted on the tumor mucosa 17 decrease, particularly in the freshly resected portion. Indeed, this resected portion of the tumor mucosa 17 is no longer attached to the lower digestive wall 16 and can obstruct the dissection angle.
[0185] To ensure a sufficient dissection angle when dissecting the remaining tumor mucosa 17, which is not separated from the lower digestive wall 26, the traction wire 2 is re-tensioned by pulling on the loop 38, in the direction D3. This re-applies traction forces to the tumor mucosa 17, allowing for a sufficient dissection angle. This, in particular, facilitates the passage of the dissecting tool 28 and the resection of the tumor mucosa. Furthermore, the unidirectional adjustment mechanism 9 maintains a constant length of the traction wire 2 during dissection. A simple pulling action on the loop 38 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.
[0186] These steps of separating the tumor mucosa 17 from the lower digestive wall 16 by dissection and tensioning the traction wire 2 are repeated successively until complete resection of the tumor mucosa 17 of the lower digestive wall 16.|
Claims
Demands
1. Adaptive traction device (1) for a biological tissue of the digestive tract comprising: - a traction wire (2) having a first end (3) and a second end (4); - a support organ (5) intended to be fixed to the digestive tract, away from the biological tissue, and comprising at least one through-hole guide (8) through which the traction wire (2) is mounted sliding; - a unidirectional adjustment member (9) comprising at least a first helical winding (10) through which the traction wire (2) is mounted embedded; in which the first end (3) of the traction wire (2) is connected, directly or indirectly, to the traction wire (2) at a distance from the second end (4), so as to form a traction loop of variable length intended to be anchored to the biological tissue; and in which the unidirectional adjustment member (9) 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. Adaptive traction device (1) according to claim 1, wherein the first helical winding (10) is made by a wire forming contiguous turns in the initial state.
3. Adaptive traction device (1) according to claim 1 or claim 2, wherein the at least one first helical winding (10) 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_long1) and the traction wire (2) is embedded in the at least one first helical winding (10) by deformation of the at least one first helical winding (10) in at least one direction transverse to the longitudinal axis (A_long1), preferably in at least one direction substantially perpendicular to the longitudinal axis (A_long1).
4. Adaptive traction device (1) according to any one of claims 1 to 3, wherein the first end (3) comprises a pass-through (43) and the second end (4) is passed inside the loop (43) so as to form said traction loop.
5. Adaptive traction device (1) according to any one of claims 1 to 4, wherein the support member (5) further comprises at least one through-hole fixation port (39) configured to permit fixation of the support member (5) to the digestive tract via an endoscopic clip (12) or a fixation loop (15).
6. Adaptive traction device (1) according to any one of claims 1 to 5, further comprising at least one anchoring loop (42), preferably at least two anchoring loops (42), mounted to slide freely in at least one guide through-hole (7) or traction through-hole (39) of the support member (5) and intended to be anchored to the biological tissue.
7. Adaptive traction device (1) according to any one of claims 1 to 6, wherein the traction wire (2) comprises at least one visual marker (30), preferably the visual marker (30) is a coloured section extending along a portion of the traction wire or a ring set on the traction wire (2).
8. Adaptive traction device (1) according to any one of claims 1 to 7, wherein the traction wire (2) is smooth.
9. An adaptive traction device (1) according to any one of claims 1 to 8, wherein the unidirectional adjustment member (9) comprises a second helical winding (11), the first helical winding (10) extending along a first longitudinal axis (A_long1) and the second helical winding (11) extending along a second longitudinal axis (A_long2) transverse to the first longitudinal axis, preferably the first longitudinal axis (A_long1) and the second longitudinal axis (A_long2) are substantially orthogonal.
10. An adaptive traction device (1) according to claim 9, wherein the traction wire (2) is mounted embedded in the second helical winding (11) so as to form the traction loop between the first helical winding (10) and the second helical winding (11), and a hook loop (32) of variable length between the second helical winding (11) and the first end (3) of the traction wire (2), said hook loop (32) being configured to fix the unidirectional adjustment element (9) to the biological tissue; and wherein the second helical winding (11) is configured to adjust the length of the hook loop (32) between an initial length and a length final length less than the initial length, so as to secure a removable fixing element (12) to the hook loop (32).
11. An adaptive traction device (1) according to claim 9, further comprising an anchor (18) which includes a first end (21) configured to be fixed to the support organ (5) and a second end (19) configured to be fixed to the biological tissue; and in which the anchor (18) is mounted embedded in the second helical winding (11), the second helical winding (11) being configured to adjust the length of the second end (19) between an initial length and a final length less than the initial length, so as to secure a removable fixing element (12) to the second end (19).
12. Adaptive traction device (1) according to any one of claims 9 to 11, wherein the unidirectional adjustment member (9) further comprises a fastening portion configured to receive the first end (3) of the traction wire (2) so as to form said traction loop or said hook loop (32), preferably the fastening portion is a crimping strand (41).
13. Adaptive traction device (1) according to any one of claims 1 to 12, comprising a single traction wire (2).
14. A biological tissue traction system comprising: - an adaptive traction device (1) according to any one of claims 1 to 13; - at least one endoscopic clip (12).
Citation Information
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