Adjustable fully-flexible loop plate fixation apparatus

Abstract

The present application relates to an adjustable fully-flexible loop plate fixation apparatus, which comprises a fixation loop, a fixation loop ring, and a traction wire, and the three components are all flexible braided fabric. The traction wire passes through the middle and both sides of the fixation loop to form a surrounding tightening structure and extends at one side of the fixation loop to form an 8-shaped adjustable coil, wherein the 8-shaped adjustable coil has an anti-reverse and self-penetrating structure. The surrounding tightening structure and the 8-shaped adjustable coil jointly form the fixation loop ring.

Description

Adjustable fully flexible loop plate fixing device

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application No. 202410355015.3, filed on March 27, 2024, entitled “Adjustable fully flexible tab fixing device,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present application relates to the technical field of medical devices, and in particular to an adjustable fully flexible loop plate fixing device. Background Art

[0004] Existing suspension fixation devices for ligament repair mainly include titanium plate fixation loops and suture coils, which are a combination of metal materials and suture materials. Due to the difference in stiffness between the two materials, the overall stability of the suspension fixation is insufficient. For example, the wear of the suture coils by the metal material can lead to fixation failure, and the hard-hard contact between the metal material and the bone can lead to wiper effect, bungee effect, etc. In addition, due to the poor deformation of metal materials, before surgery, a bone tunnel sufficient for the metal material to pass through needs to be drilled, which causes great damage to the bone. After surgery, the metal feels like a foreign body on the bone surface and has poor biocompatibility. In addition, the coils used in conjunction with the fixation device are mainly adjustable length loops that cannot be adjusted in length or require additional fixation. During the operation, measurements and calculations are required to select the appropriate specifications, or other operations such as knotting and screw implantation are required to assist in fixation, which reduces the efficiency of the operation.

[0005] Although there are technologies that use suture materials for fixation loops, such as CN116869701A, which discloses a deformable body and a fully flexible fixation device containing the deformable body, the flexible anchor of the fixation device is composed of alternating hardened segments and non-hardened segments, and the sutures of the hardened segments are hardened by hot melt. Although this technology uses a suture fixation device, the connection between the hardened and non-hardened segments still poses a risk of wear and failure due to the difference in stiffness. For example, CN114869374A discloses a loop structure used in ligament or tendon injury repair surgery. The length of the loop is not adjustable, and the folding and contraction process of the loop structure after being stressed is uncontrollable. Due to unbalanced force, it is easy to be pulled into the bone tunnel, resulting in fixation failure and surgical failure.

[0006] Summary of the Invention

[0007] One of the purposes of the present application is to provide an adjustable fully flexible loop fixing device with good structural stability to solve the problem that the existing suspended fixing loop is difficult to achieve stable structural forming in a fully flexible state, and the coil length cannot be adjusted or the adjustable coil cannot provide firm support alone.

[0008] To achieve the above-mentioned objectives, the present invention provides an adjustable fully flexible tab fixing device, comprising a fixing tab, a fixing tab ring, and a traction line, all of which are flexible woven fabrics. The fixing tab ring is formed by a traction line that reciprocates through the fixing tab.

[0009] The pull wire is inserted into the upper surface of the fixing loop in the thickness direction to form a tightening wire loop of the fixing loop; it is inserted into and extended into the lower surface of the fixing loop in the thickness direction to form an adjustable coil of the fixing loop. After the tightening wire loop is formed, the two free ends of the pull wire cross each other and intersect with each other to form the adjustable coil. The adjustable coil includes an 8-shaped structure formed by two cross-interspersions.

[0010] The pull wire is provided with a self-locking knot on the upper surface of the fixing loop in the thickness direction. After the adjustable coil is formed, the two free ends are reversely passed through the fixing loop and wound back through the tightening wire ring to form the self-locking knot.

[0011] The traction line is connected to the fixing loop and is used to pull the fixing loop to the surface of the bone cortex.

[0012] According to an embodiment of the first aspect of the present application, the fixing loop includes at least two layers of woven flat belts, which overlap with each other and have at least a length.

[0013] According to any one of the aforementioned embodiments of the first aspect of the present application, the tightening wire loop includes a plurality of wire loops disposed on the fixing loop, the plurality of wire loops being distributed crisscrossly on the load-bearing wall surface of the fixing loop, and being formed by the pulling wire reciprocatingly interlaced on the fixing loop;

[0014] The tightening line loop includes a median line segment and a side line segment;

[0015] The midline segment is the initial insertion segment of the pulling wire on the fixing loop, is arranged in the middle of the length direction of the fixing loop, and extends along the width direction of the fixing loop.

[0016] According to any one of the aforementioned embodiments of the first aspect of the present application, the two free ends of the midline segment pass through the entire thickness of the fixing loop, and after crossing for the first time on the other side of the fixing loop, respectively return through the single-layer woven flat belt of the fixing loop, and then pass through the entire fixing loop again to form the side line segments.

[0017] According to any embodiment of the first aspect of the present application, the adjustable coil includes a non-return structure located at the bottom, and the two free ends of the pulling wire are respectively interlaced with their own wire segments after the first crossing to obtain a non-return structure with two interlocking wire rings.

[0018] According to any of the aforementioned embodiments of the first aspect of the present application, the adjustable coil includes an intersection point located at the upper portion of the anti-return structure, and the two free ends of the puller wire extend after the suture itself passes through a certain length and cross a second time to form the intersection point;

[0019] After crossing, the two free ends are interlaced with each other's initial segments, and then pass through a certain length and then come out to form a complete adjustable coil.

[0020] According to any one of the aforementioned embodiments of the first aspect of the present application, after the adjustable coil is formed, the two free ends of the pull wire pass through the entire thickness of the fixing loop and wrap back through the side line segment to form the self-locking knot.

[0021] According to any one of the aforementioned embodiments of the first aspect of the present application, one of the free ends of the pull line is wrapped around the width direction of the fixing loop to form a U-shaped structure of the pull line, and the pull line and the fixing loop are connected in the same plane.

[0022] According to any of the aforementioned embodiments of the first aspect of the present application, the fixing loop is formed by folding a braided flat belt in half along its width direction, and the longitudinal cross-section is a U-shaped structure;

[0023] Alternatively, the fixing loop is formed by a braided flat belt in a closed loop along its width direction, and the longitudinal axis cross section is an O-shaped structure.

[0024] According to any one of the aforementioned embodiments of the first aspect of the present application, it further includes a loop plate structure, the loop plate structure is connected to the bottom of the adjustable coil, and the anti-return structure is located on the bottom surface of the loop plate structure.

[0025] The fully flexible suture structure is achieved by combining a flexible braided fixation loop, a fixation loop, and a traction cord. This reduces wear and stress concentration caused by differences in stiffness between components, reduces wear of the fixation components on the bone tunnel and surrounding tissue, and alleviates pain for the patient. The fully flexible suture deforms as it passes through the bone tunnel, reducing bone displacement and thus minimizing iatrogenic injury and facilitating postoperative recovery.

[0026] The fixing loop formed by reciprocatingly inserting the fixing loop can form different coils or structures, which is beneficial to the tightening and deformation of the fixing loop and the fixed connection of the implant.

[0027] The tightening wire loop of the fixing loop is formed by reciprocatingly inserting the pulling wire on the outer surface of the fixing loop, which can ensure the stability of the fixing loop in deformation in three-dimensional space.

[0028] After the tightening wire loop is formed, an adjustable coil with a figure-8 structure is formed by extending the free end of the pulling wire to the other side of the fixing loop and crossing it twice and inserting it into itself. This can adjust the length of the coil and improve the anti-return effect of the coil. At the same time, the intersection in the middle of the figure-8 adjustable coil can balance the force of the pulling sutures on both sides, so that the fixing loop always remains perpendicular to the axial tensile force, fully fits the surface of the bone cortex, and achieves stable fixation.

[0029] After forming the adjustable coil, the two free ends of the pull cord are threaded back through the fixed loop and wrapped around the tightening loop to form a self-locking knot. The self-locking knot is locked to the upper surface of the fixed loop by the tightening loops on either side of the fixed loop. The degree of coil contraction can be adjusted by tightening the free ends of the self-locking knot, achieving a self-locking function. The self-locking knot structure eliminates the need for knotting during surgery, shortening surgical time. Its strong, anti-loosening properties provide stable and continuous fixation for surgical repair, ensuring the effectiveness of the repair.

[0030] The traction wire can pull the fixation loop through the bone tunnel to the cortical surface of the bone, which can reduce the risk of slippage of the fixation loop and improve the success rate of the operation.

[0031] Other features and advantages of this application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0033] FIG1 is a schematic diagram of the overall structure of the adjustable fully flexible tab fixing device of the present application;

[0034] FIG2 is a schematic diagram of the overall three-dimensional structure of the adjustable fully flexible tab fixing device of the present application;

[0035] FIG3 is a schematic diagram of the overall structure of the fixed loop of the present application;

[0036] FIG4 is a schematic diagram of the connection structure between the pull line and the fixing loop;

[0037] FIG5 is a schematic diagram of the forming process of the anti-return coil on the adjustable coil;

[0038] FIG6 is a schematic diagram of the forming process of the intersection portion on the adjustable coil;

[0039] FIG7 is a schematic diagram of the molding process of the upper coil of the adjustable coil;

[0040] FIG8 is a schematic diagram of the forming process of a self-locking knot;

[0041] FIG9 is a schematic diagram of the steps of the surgical operation in Example 1;

[0042] FIG10 is a schematic structural diagram of the fully flexible loop plate fixing device in Example 2;

[0043] FIG11 is a schematic structural diagram of the fully flexible loop plate fixing device in Example 3.

[0044] Icons: 100-fixing loop; 110-fixing loop plate; 200-fixing loop ring; 210-tightening line loop; 211-median line segment; 212-lateral line segment; 220-adjustable coil; 221-non-return coil; 222-self-locking knot; 300-traction line. DETAILED DESCRIPTION

[0045] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0046] In the description of this application, it should be noted that the terms "inner" and "outer" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or the orientations or positional relationships in which the product of this application is typically placed when in use. These terms are intended solely to facilitate the description of this application and simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" and the like are used solely for distinction and should not be construed as indicating or implying relative importance.

[0047] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed" and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediate medium, or internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0048] The adjustable fully flexible loop plate fixation device in the present application is mainly used for suspending and fixing ligament grafts, utilizing the flexible characteristics of sutures to change the shape of the fixation device assembly, and by providing a tightening wire loop and an adjustable coil structure, the deformation of the fixation loop plate is stabilized, the adjustment of the fixation loop is controllable, and the fixation strength of the overall fixation assembly is increased.

[0049] Referring to FIG1 , in conjunction with FIG2-3 , the adjustable, fully flexible tab fixation device of the present invention comprises a fixing tab 100, a fixing tab ring 200, and a pull cord 300, all made of flexible woven fabric. The fixing tab ring 200 is specifically constructed by sutures reciprocatingly threading through the fixing tab 100. These components, made of flexible woven fabric, form a fully flexible suspension fixation device.

[0050] The fully flexible suture structure can reduce wear and stress concentration caused by stiffness differences between the fixation loop 100, the fixation loop ring 200, and the traction line 300, and can also reduce wear of the fixation components on the bone tunnel and surrounding tissues, thereby reducing pain for the patient.

[0051] The fully flexible suture structure has good deformability and can deform when passing through the bone tunnel, reducing bone displacement, thereby reducing iatrogenic damage and facilitating postoperative recovery.

[0052] The reciprocating interlacing structure of the pulling wire on the upper surface of the fixing loop 100 in the thickness direction constitutes a tightening wire ring 210 of the fixing loop 200. Referring to the structure in the accompanying drawings, the tightening wire ring 210 is arranged on the upper and lower outer surfaces of the fixing loop 100, including a transverse and longitudinal surrounding distribution structure. The tightening wire ring 210 can control the fixing loop 100 to stably perform compression deformation under the tightening tension of the pulling wire, so that the pulling points on the fixing loop 100 are evenly stressed, thereby ensuring the stability of the fixing loop 100 in three-dimensional angle deformation.

[0053] An adjustable coil 220 is provided on the other side of the fixing loop 100 relative to the tightening wire loop 210. Referring to the accompanying drawings, after the tightening wire loop 210 is formed, the two free ends of the pulling wire cross toward each other and interweave with each other after passing through the entire thickness direction of the fixing loop 100 to form the adjustable coil 220. In the accompanying drawings, the adjustable coil 220 is provided at the lower part of the fixing loop 100, and the adjustable coil 220 includes an 8-shaped structure formed by two cross-interweavings.

[0054] The main purpose of the adjustable coil 220 with a figure-8 structure is to enable the length of the coil for fixing the implant to be freely adjusted, thereby making the surgical process controllable and improving the surgical efficiency.

[0055] A self-locking knot 222 is provided on the upper surface of the fixing loop 100 in the thickness direction. After the adjustable coil 220 is formed at the lower portion of the fixing loop 100, the two free ends of the fixing loop 200 are passed upward through the fixing loop 100 and wrapped around the tightening wire loop 210 to form the self-locking knot 222. The self-locking knot 222 is provided on the upper surface of the fixing loop 100, specifically a self-locking knot 222 with a figure-6 structure. After adjusting the length of the figure-6 coil and tightening the fixing loop 100, the self-locking wire loop is locked to the upper surface of the fixing loop 100 by the tightening wire loops 210 on both sides of the fixing loop 100. At the same time, the degree of coil contraction can be adjusted by tightening the free ends of the figure-6 coil, thereby achieving a self-locking function.

[0056] In the present application, the knot is formed by double force extrusion, which is strong and not easy to slip. The structure of the self-locking knot 222 eliminates the knotting step during surgery, shortens the operation time, and its strong anti-loosening performance can provide stable and continuous fixation for surgical repair, ensuring the effect of surgical repair.

[0057] The traction line 300 is connected to the fixing loop 100 and is used to pull the fixing loop 100 through the bone tunnel to the surface of the bone cortex, thereby reducing the risk of the fixing loop 100 slipping off and improving the success rate of the operation.

[0058] The fixing loop 100 in the present application includes at least two layers of braided flat belts, which overlap with each other and have at least a certain length. Specifically, after assembly, the braided flat belts can form a long strip structure with a certain length, which is conducive to the tightening loop 210 being wrapped around the fixing loop 100 and the adjustable coil 220 being inserted and formed under the fixing loop 100.

[0059] In one configuration, the fixing loop 100 is formed by folding a woven flat belt with a width of 4 mm in half along its width direction, and the overall longitudinal cross-section is U-shaped with an open end and a closed end.

[0060] The structure for pulling the fixing loop 100 is formed by a traction line 300 that is inserted into the fixing loop 100. The traction line 300 is a high-performance non-absorbable 2# suture with a diameter of 0.500-0.599mm. Specifically, one of the free ends of the traction line 300 is wrapped around the closed end of the U-shaped fixing loop 100 and passes through the closed end along the width direction of the fixing loop 100 to form another U-shaped structure composed of the traction line 300. The closed ends of the two U-shaped structures are connected in the same plane, so that the traction line 300 is connected to the fixing loop 100 in the same plane.

[0061] The traction line 300 contacts the fixing loop 100 along its entire width, so that the fixing loop 100 is more evenly stressed when the traction line 300 is pulled through the bone tunnel, thereby reducing the risk of slippage and improving the success rate of the operation.

[0062] The tightening wire loop 210 includes a plurality of wire loops arranged on the fixing loop 100 . Specifically, the plurality of wire loops are crisscrossed on the load-bearing wall of the fixing loop 100 and are formed by a pulling wire reciprocatingly inserted on the fixing loop 100 .

[0063] Furthermore, the tightening wire loop 210 includes a center line segment 211 and a side line segment 212. During the insertion process, the two free ends of the pulling wire are inserted along the width direction of the fixing loop 100 and at the center part of the length direction. A center line segment 211 parallel to the width of the fixing loop 100 is formed on one side surface of the fixing loop 100. This line segment is also the initial insertion line segment of the pulling wire on the fixing loop 100.

[0064] During the insertion and forming of the midline segment 211, the two free ends of the pulling wire respectively pass through the entire thickness of the fixing loop 100, that is, after passing through the two layers of braided flat tape, they cross the surface of the other side of the fixing loop 100 and then return through the single layer of braided flat tape of the fixing loop 100, thereby forming a longitudinal wire loop in the middle part of the other side of the fixing loop 100. Then, the two free ends of the pulling wire again pass through the two layers of braided flat tape of the entire fixing loop 100 to form the side line segments 212 located on both sides of the length direction of the fixing loop 100.

[0065] The median line segment 211 and the side line segments 212 constitute a tightening line loop 210 formed by the pull line inserted into the upper surface of the fixing loop 100, and the tightening line loop 210 is distributed in a three-point horizontal and vertical staggered manner, so that the pulling point on the fixing loop 100 is evenly stressed, and the cross-cross longitudinal line loop structure of the pull line at the bottom of the fixing loop 100 enables the force of the middle force point of the fixing loop 100 to be evenly transmitted to both sides. As a result, the pull line is tightened in a surrounding manner on the upper and bottom surfaces of the fixing loop 100, ensuring the stability of the deformation of the fixing loop 100 on the horizontal plane.

[0066] The lateral wire loops on both sides of the fixing loop 100 of the pulling wire are respectively inserted into the fixing loop 100 from the bottom upward, passed through the single-layer braided flat belt of the fixing loop 100 and then passed out from the side, and then passed through the fixing loop 100 from the top downward and passed out from the bottom. Passing through the single-layer fixing loop 100 can constrain the relative position of the side line segment 212, that is, the lateral wire loop on the fixing loop 100 and the fixing loop 100, to ensure that the wire loop will not slip to the long side of the fixing loop 100, thereby ensuring the stability of the deformation of the fixing loop 100 in the longitudinal plane.

[0067] Therefore, when the pulling wire is tightened, the fixing loop 100 can generate stable deformation in the entire space under the action of the pulling wire, and the formed three-dimensional structure is fixed to the bone tunnel opening, which is stable and improves the consistency and controllability of the knotting effect.

[0068] The adjustable coil 220 is entirely arranged on the lower side of the fixed loop 100 and includes a non-return structure at the bottom. After the tightening wire loop 210 is formed, the two free ends of the pulling wire passing through the entire fixed loop 100 first cross for the first time. After the first crossing, they are interlaced with their own wire segments to obtain a non-return coil 221 with two interlocking wire loops, which constitutes the specific form of the non-return structure.

[0069] The adjustable coil 220 includes an intersection point located at the upper portion of the non-return coil 221 , and the two free ends of the pull line extend after the suture itself passes through a certain length and cross a second time to form an intersection point located in the middle portion of the adjustable coil 220 ;

[0070] After the second crossing, the two free ends intersect with each other's initial segments, pass through a certain length, and then extend out to form a complete adjustable coil 220 .

[0071] During the forming process of the adjustable coil 220, the two free ends of the pulling wire cross once and each inserts into its own line segment to form the non-return coil 221. Then, each inserts a certain length and then exits from its own line segment. Then, a second cross is made to form an intersection point in the middle of the adjustable coil 220. Then, the two free ends of the pulling wire are inserted into the other section of the fixed loop 200 in the direction after the second cross. Finally, after passing through a certain length, they extend out from the other line segment, completing the forming of the adjustable coil 220.

[0072] The cross-stop structure at the bottom of the 8-shaped adjustable coil 220 ensures that when the adjustable coil 220 is subjected to reverse tension, both sides of the bottom wire loop are evenly stressed, making it difficult for the bottom end to shrink, thereby improving the anti-return effect of the adjustable coil 220.

[0073] The intersection point located in the middle of the 8-shaped adjustable coil 220 can limit unilateral displacement of the sutures on both sides when the fixed loop 200 is pulled in the forward direction to shrink the coil. Regardless of whether the coil is subjected to positive or reverse pulling force, the fixed loops 200 on both sides are subjected to balanced force, so that the fixed loop 100 always remains perpendicular to the axial tensile force, fully fits the bone cortical surface, and achieves stable fixation.

[0074] After the first crossover, the two free ends of the puller wire intersect with each other's wire segments for a certain length. After the second crossover, the two free ends of the puller wire intersect with each other's wire segments for a certain length, forming four self-threading structures of the adjustable coil 220. When the coil is stretched in the positive direction by the puller wire, the four self-threading structures contract, thereby adjusting the coil length.

[0075] After the adjustable coil 220 is formed, the two free ends of the pull wire are passed through the entire thickness of the fixing loop 100 and looped back through the side wire segment 212 to form a self-locking knot 222 .

[0076] Specifically, the self-locking knot 222 is formed on the upper plane of the fixing loop 100 and has a 6-shaped structure. After adjusting the length of the 6-shaped self-locking coil and tightening the fixing loop 100, the self-locking wire loop is locked to the upper surface of the fixing loop 100 by the wire loops on both sides of the fixing loop 100, that is, by the side wire segments 212. At the same time, the degree of coil contraction can be adjusted by tightening the free end of the 6-shaped self-locking coil to achieve the self-locking function.

[0077] Since the knot is formed by double force extrusion, it is strong and not easy to slip. The setting of the self-locking knot 222 eliminates the knotting step during surgery and shortens the operation time. Its strong anti-loosening performance can provide stable and continuous fixation for surgical repair, ensuring the effect of surgical repair.

[0078] Based on the above structure and molding process, the entire fixed loop 200 is divided into upper and lower parts by the plane of the fixed loop 100. The fixed loop 200 located in the lower part of the fixed loop 100 has an 8-shaped adjustable coil structure. The pulling structure of this part is formed by the pulling wire interlacing through the U-shaped fixed loop 100 and the pulling wire and its own wire segments. The fixed loop 200 located in the upper part of the fixed loop 100 is the tightening wire loop 210. During the molding process, the fixed loop 200 first forms the tightening wire loop 210, and then forms the adjustable coil 220.

[0079] Specifically: First, the pulling line is inserted along the width direction of the fixing loop 100 and at the center of the length direction, forming a line segment parallel to the width on one surface of the U-shaped fixing loop 100, and the free ends of the two sutures located on the other end surface of the U-shaped fixing loop 100 cross and pass back into the U-shaped fixing loop 100 again, thereby forming a longitudinal loop in the middle of the fixing loop 100 and two transverse loops on both sides of the fixing loop 100. The formation of this part is shown in Figure 4.

[0080] 5-7 , the lower coil in the figure-8 adjustable coil structure is formed by the pull wire extending from below the plane of the fixed loop 100 and threading itself through it. The middle intersection is formed by the pull wires on both sides interlacing with each other along the diagonal direction and then interlacing with each other's initial ends. The upper coil is formed by the pull wires passing upward back through the fixed loop 100.

[0081] Finally, the free ends of the pulling wires pass through the sides of the two horizontal loops formed by the pulling wires and the fixing loops 100 and pass through the horizontal loops from top to bottom to form a 6-shaped self-locking knot 222. The formation of the self-locking knot 222 is shown in FIG. 8 .

[0082] Different embodiments are used below to further illustrate the different components of the adjustable fully flexible tab fixing device of the present application.

[0083] Example 1

[0084] 1-3 , the adjustable fully flexible tab fixing device in this embodiment is composed of a fixing tab 100 , a fixing tab ring 200 , and a traction line 300 . The fixing tab 100 and the traction line 300 are connected in a double U-shaped sleeve, and the fixing tab ring 200 is connected to the fixing tab 100 by interlacing and encircling. The midpoint of the pull wire is the midpoint of segment 1. Starting from the center point O on the upper surface of the fixing loop 100, the pull wire passes through the fixing loop 100 or the pull wire structure itself in sequence from 1 to n, where n is a positive integer greater than 1. At the same time, segment n and segment n' are circularly symmetrical about the longitudinal axis perpendicular to the upper surface of the fixing loop 100 where point O is located. When the pull wire is inserted and connected on the fixing loop 100, the contact position of the traction wire 300 and the fixing loop 100 is always in contact, and the pull wire does not pass through the structure of the traction wire 300 or the contact gap between the traction wire 300 and the fixing loop 100.

[0085] The surgical procedure in this embodiment is shown in Figure 9. Taking the anterior cruciate ligament repair of the knee joint as an example: the fixation loop 100 is stretched through the bone tunnel to the cortical bone surface by the traction wire 300. By stretching the wire loop on the self-locking knot 222 and adjusting the coil length, the graft is pulled to the appropriate position in the bone tunnel. The coil is tightened to compress the fixation loop 100 into a knot. Then, the wire end on the self-locking knot 222 is stretched to tighten the self-locking knot 222, achieving a stable structure without knotting and with the knot not loosening. Finally, the excess traction wire is cut to complete the suspension fixation of the ligament repair.

[0086] Example 2

[0087] A fully flexible knot-free suspension fixing loop 100 assembly, as shown in FIG10 , is basically the same as Example 1, except that the fixing loop 100 is formed by a braided flat belt in a closed loop along its width direction, and the longitudinal cross-section is an O-shaped structure.

[0088] Example 3

[0089] The adjustable fully flexible tab fixing device in this embodiment, as shown in FIG11 , has the same basic structure as that of Embodiment 1, except that a fixing tab 110 is added to the bottom of the adjustable coil 220 formed by the pull wire, and the two interlaced loops of the pull wire are located on the bottom surface of the fixing tab 110 .

[0090] The surgical procedure in this embodiment is as follows, taking the tibiofibular syndesmotic ligament repair as an example: the fixation loop 100 is stretched by the traction line 300 and passes through the fibular and tibial tunnels to reach the cortical bone surface of the tibia. The fixation loop 110 remains on the cortical bone surface of the fibular side. By stretching the loop of the self-locking knot 222 and adjusting the coil length, the tibiofibular syndesmotic ligament is completely repositioned. The fixation loop 100 is pressed against the cortical bone surface of the tibia and contracted into a knot. Then, the end of the thread on the self-locking knot 222 is stretched to completely lock the self-locking knot 222. The excess traction line is cut off, and the tibiofibular syndesmotic ligament repair is completed.

[0091] It is important to point out that this solution, combined with the suspension fixation method used in ligament repair surgery, achieves the following technical effects through the structural design of the all-suture loop fixation device:

[0092] 1. Fully flexible: Compared with metal fixation loops or fixation loops with partially hardened sutures, all components of this solution are made of flexible sutures. This can reduce the risk of wear between components and on the bone tunnel and surrounding tissues, alleviate the problem of uneven stress distribution caused by stiffness differences, and provide stable and long-lasting fixation. At the same time, the fully flexible fixation loop can deform to pass through the bone tunnel with a smaller diameter, reducing the required diameter of the bone tunnel and reducing iatrogenic damage.

[0093] 2. Deformation consistency: The interconnection design between the pull cord and the fixed loop ensures that the deformation of the fixed loop caused by the contraction of the pull cord is stable and consistent, solving the problem of uncontrollable deformation of the flexible fixed loop and the problem of unbalanced structural deformation and failure when subjected to force.

[0094] 3. Adjustable self-locking coil: This eliminates the need for intraoperative measurement, calculation, and selection of the appropriate size of the loop for non-adjustable coils. It also eliminates the need for additional knotting or screw implantation for auxiliary fixation of adjustable coils. A knot can be formed by tightening the self-locking wire loop and the self-locking wire end in sequence. The self-locking knot is fixed by the reverse force of the double-layer coil, making it firm and non-slip. It provides stable and effective support, improves surgical precision and flexibility, and significantly shortens surgical time. The structural design of the full-suture loop reduces the number of surgical steps, improves surgical efficiency, and reduces the risk of complications caused by surgery. Its fully flexible nature reduces wear on the sutures and surrounding tissues, balances overall stress, and reduces the risk of failure due to stress concentration. Its deformable nature reduces the diameter of the bone tunnel required for implantation, reduces iatrogenic damage, and reduces the volume of the fixation loop after implantation, reducing the foreign body sensation and the risk of complications.

[0095] It should be noted that, unless there is any conflict, the features in the embodiments of this application can be combined with each other.

[0096] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. An adjustable fully flexible tab fixing device, wherein: The invention comprises a fixing loop, a fixing loop ring and a pulling wire, all of which are made of flexible braids, wherein the fixing loop ring is formed by the pulling wire reciprocatingly inserted on the fixing loop; The pull wire is inserted into the upper surface of the fixing loop in the thickness direction to form a tightening wire loop of the fixing loop; it is inserted into and extended into the lower surface of the fixing loop in the thickness direction to form an adjustable coil of the fixing loop. After the tightening wire loop is formed, the two free ends of the pull wire cross each other and intersect with each other to form the adjustable coil. The adjustable coil includes an 8-shaped structure formed by two cross-interspersions. The two free ends of the pulling wire are respectively interlaced with their own wire segments after the first crossing, thereby forming a non-return structure with two interlocking wire loops; The adjustable coil includes an intersection point located on the upper portion of the anti-return structure, and the two free ends of the pull line extend after the suture itself passes through a certain length and cross a second time to form the intersection point; After the second crossing, the two free ends intersect with each other's initial segments, pass through a certain length, and then come out to form a complete adjustable coil; The pull wire is provided with a self-locking knot on the upper surface of the fixing loop in the thickness direction. After the adjustable coil is formed, the two free ends are reversely passed through the fixing loop and wound back through the tightening wire ring to form the self-locking knot. The traction line is connected to the fixing loop and is used to pull the fixing loop to the surface of the bone cortex.

2. The adjustable fully flexible tab fixing device according to claim 1, wherein: The fixing loop includes at least two layers of woven flat belts, which overlap with each other and have at least a length.

3. The adjustable fully flexible tab fixing device according to claim 2, wherein: The tightening wire loop includes a plurality of wire loops arranged on the fixing loop, the plurality of wire loops are distributed crisscrossly on the load-bearing wall surface of the fixing loop, and are formed by the pulling wire reciprocatingly inserted on the fixing loop; The tightening line loop includes a median line segment and a side line segment; The midline segment is the initial insertion segment of the pulling wire on the fixing loop, is arranged in the middle of the length direction of the fixing loop, and extends along the width direction of the fixing loop.

4. The adjustable fully flexible tab fixing device according to claim 3, wherein: The two free ends of the midline segment pass through the entire thickness of the fixing loop, and after crossing for the first time on the other side of the fixing loop, they respectively pass back through the single-layer woven flat belt of the fixing loop and then pass out from the side, and then again pass down from the top of the fixing loop through the entire fixing loop to form the side line segments.

5. The adjustable fully flexible tab fixing device according to claim 1, wherein: The adjustable coil includes a non-return structure located at the bottom.

6. The adjustable fully flexible tab fixing device according to claim 3, wherein: After the adjustable coil is formed, the two free ends of the pulling wire pass through the entire thickness of the fixing loop and wind back through the side line segments to form the self-locking knot.

7. The adjustable fully flexible tab fixing device according to claim 1, wherein: One of the free ends of the pulling line is looped back through the width direction of the fixing loop to form a U-shaped structure of the pulling line, and the pulling line and the fixing loop are connected in the same plane.

8. The adjustable fully flexible tab fixing device according to claim 2, wherein: The fixing loop is formed by folding a braided flat belt in half along its width direction, and the longitudinal cross section is a U-shaped structure; Alternatively, the fixing loop is formed by a braided flat belt in a closed loop along its width direction, and the longitudinal axis cross section is an O-shaped structure.

9. The adjustable fully flexible tab fixing device according to claim 5, wherein: It also includes a loop plate structure, which is connected to the bottom of the adjustable coil, and the anti-return structure is located on the bottom surface of the loop plate structure.

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