Mesh-integrated fixation anchor

Abstract

The application discloses a mesh-integrated fixing anchor, which comprises an anchor body, a flexible mesh, and a connecting belt. The anchor body comprises a needle tip part, a threaded part, and a tail part. The needle tip part is used for penetrating the bone cortex to assist the anchor body to be placed. The threaded part is fixedly connected with the bone in a threaded mode to provide an anti-pulling-out force. The tail part is fixedly connected with the flexible mesh. The flexible mesh is attached to the surface of a fracture block to be reset and is used for forming compression and limiting the fracture block in a reset position through cooperation with the anchor body. One end of the connecting belt is fixedly arranged on the flexible mesh, and the other end of the connecting belt is connected with the tail part of the anchor body. The connecting belt can tighten the flexible mesh.

Description

Technical Field

[0001] This invention relates to the field of orthopedic medical device technology, specifically to an integrated mesh fixation anchor, which is suitable for the reduction and fixation of intra-articular fractures of the olecranon joint of the ulna. Background Technology

[0002] Olecranon fractures are among the most common injuries to the elbow joint, accounting for approximately 10% of upper limb fractures in adults and 18% of proximal forearm fractures. Because the olecranon is a key structure forming the elbow joint, these fractures are considered intra-articular fractures. The core objectives of their treatment are clear and crucial: first, to achieve anatomical reduction of the articular surfaces, ensuring the restoration of the normal anatomical structure of the elbow joint; and second, to provide strong fixation sufficient to support early functional exercises, thereby minimizing the risk of serious sequelae such as elbow stiffness and traumatic arthritis that significantly impact the patient's quality of life.

[0003] In current clinical treatment, there are two main methods for fixing olecranon fractures of the ulna, but both have obvious technical defects and cannot simultaneously meet the multiple clinical needs for fixation effect, safety and postoperative recovery of patients.

[0004] The first method is Kirschner wire tension band (TBW) fixation, which has long been considered the "gold standard" for treating simple transverse olecranon fractures. However, its complication rate in clinical application remains high, mainly due to the following issues: First, the Kirschner wire tail protrudes from the patient's skin, easily causing skin irritation and persistent pain, severely impacting postoperative comfort. Second, the Kirschner wire is prone to displacement or exit after fixation, directly affecting the stability of the fixation. Third, the steel wire used for auxiliary fixation is prone to breakage or loosening, leading to the failure of the entire fixation system and the inability to provide continuous and reliable support for fracture healing. Fourth, the insertion of Kirschner wires can create pin tracts, which are highly susceptible to infection, increasing the patient's treatment risk. These problems collectively result in a 46%-65% rate of secondary surgery to remove internal fixation devices in patients using Kirschner wire tension band fixation, causing not only secondary trauma but also significantly increasing the patient's medical burden. Furthermore, this fixation method is particularly ineffective for comminuted or oblique olecranon fractures, failing to provide sufficient stability to ensure successful fracture healing.

[0005] The second method is plate and screw fixation. For comminuted olecranon fractures, anatomical locking plates can provide relatively stronger mechanical stability, to some extent solving the problem of insufficient fixation of complex fractures by Kirschner wire tension bands. However, this method also has significant drawbacks: Firstly, plate and screw fixation requires a larger surgical procedure, which involves extensive dissection of the periosteum and surrounding soft tissues at the fracture site. This procedure can easily disrupt the blood supply to the fracture ends, and adequate blood supply is a key factor in fracture healing. Damaged blood supply can severely affect the healing speed and quality of the fracture, and may even lead to nonunion. Secondly, as a highly rigid implant, the plate is relatively large, and after implantation, it can easily irritate the surrounding soft tissues, interfering with their normal movement and affecting the recovery of elbow joint function.

[0006] Given the technical bottlenecks of the two traditional fixation methods mentioned above, there is an urgent need in clinical treatment and the medical device market for a new type of olecranon fracture fixation system with high fixation strength, low notch shape, and precise tension adjustment to make up for the shortcomings of existing technologies, provide patients with safer and more effective treatment options, and promote the advancement of olecranon fracture treatment technology. Summary of the Invention

[0007] To address the problems of poor compatibility, insufficient assembly stability, and inability to form an integrated fixation structure in existing internal fixation devices for olecranon fractures, a new integrated mesh fixation anchor is proposed. By optimizing the structure and assembly relationship between the anchor body and the flexible mesh, an integrated fixation structure that conforms to the bone morphology and has strong stability is formed.

[0008] An integrated mesh sleeve fixing anchor includes an anchor body, a flexible mesh sleeve, and a connecting strip;

[0009] The anchor body includes a needle tip, a threaded portion, and a tail. The needle tip is used to penetrate the bone cortex to assist in the insertion of the anchor body. The threaded portion forms a fixed connection with the bone to provide pull-out resistance. The tail is fixedly connected to the flexible mesh sleeve.

[0010] The flexible mesh sleeve fits onto the surface of the fracture fragment to be reduced, and, through its cooperation with the anchor body, forms a compression and limiting effect on the fracture fragment at the position to be reduced;

[0011] One end of the connecting strap is fixed to the flexible mesh sleeve, and the other end is connected to the tail of the anchor body. The connecting strap can tighten the flexible mesh sleeve. The tail is provided with a built-in transmission mechanism and a fixing hole. After the connecting strap is locked in one direction through the fixing hole by a tool driven by the built-in transmission mechanism, the flexible mesh sleeve is tightened to a preset tension.

[0012] Preferably, the needle tip is a sharp pyramidal structure, which is a triangular or quadrangular pyramid, giving the needle tip self-tapping ability, allowing it to penetrate the bone cortex without pre-drilling or simply by being guided by a small-diameter guide needle.

[0013] Preferably, the threaded portion is a variable pitch thread structure, which includes a distal thread and a proximal thread, with the distal thread close to the needle tip and the proximal thread close to the tail.

[0014] The distal thread has a greater pitch than the proximal thread, and the distal thread has a smaller tooth depth than the proximal thread. The distal thread is used to form fixation in cancellous bone, and the proximal thread is used to provide pull-out resistance in cortical bone.

[0015] Preferably, the inner surface of the flexible mesh sleeve is fitted to the outer surface of the fracture fragment at the position to be reduced, and a supporting skeleton is provided on the side of the flexible mesh sleeve away from the bone. The supporting skeleton is evenly distributed along the edge and middle of the flexible mesh sleeve to enhance the structural strength of the flexible mesh sleeve.

[0016] Preferably, the flexible mesh is made of a biocompatible material selected from polyetheretherketone, medical titanium alloy or absorbable polymer material, and the elongation of the flexible mesh is not less than 20% to adapt to the curved shape of the bone surface.

[0017] Preferably, the connection between the tail and the flexible mesh sleeve is a pre-connection, which is achieved by injection molding, laser welding or mechanical snap-fit. The tail has a pre-set annular groove, and the edge of the flexible mesh sleeve is provided with an elastic snap-fit ​​part that matches the annular groove. The elastic snap-fit ​​part and the annular groove form an interference fit, so that the anchor body and the flexible mesh sleeve form an integral component.

[0018] Preferably, the tail section is provided with a propulsion control hole and a built-in transmission mechanism. The propulsion control hole is used to cooperate with a tool, and the built-in transmission mechanism includes a worm and a ratchet. The worm meshes with the ratchet. The ratchet is driven to rotate by rotating the propulsion control hole with a special tool, and the flexible mesh sleeve is tightened by a connecting belt.

[0019] Preferably, the flexible mesh sleeve is further provided with tension-adjusting suture holes, through which sutures pass. The sutures are used to weave and connect the flexible mesh sleeves of multiple anchors when multiple anchors work together, so that the flexible mesh sleeves of multiple anchors form a fixation system that covers the entire area, thereby achieving pressure fixation of the fracture fragment surface.

[0020] By adopting the above structure, the present invention has the following technical effects:

[0021] 1. The anchor body and flexible mesh sleeve are integrated into one design. The flexible mesh sleeve conforms to the irregular curved surface of the bone, avoiding the problem of the protruding tail of traditional Kirschner wires and reducing irritation to the triceps tendon and skin. The variable pitch thread section, combined with the self-tapping needle tip section, forms a stable fixation in the cancellous bone and cortical bone respectively, with strong pull-out resistance and high fixation strength.

[0022] 2. The flexible mesh and anchor body are pre-connected as an integrated structure at the factory, eliminating the need for intraoperative assembly and avoiding the weak links in the connection between traditional sutures and anchors. At the same time, the self-tapping design of the needle tip reduces the pre-drilling steps and shortens the operation time.

[0023] 3. The tension adjustment mechanism can apply continuous, stable and quantifiable pressure to the fracture ends, and the one-way locking groove prevents tension loss. No knotting is required, avoiding the uncertainty caused by traditional suture knotting, and improving the reliability and standardization of fixation effect.

[0024] 4. It adopts a universal anchor body, which can selectively achieve fixation or tension adjustment functions according to surgical needs, and is suitable for various types of olecranon fractures such as simple transverse fractures, comminuted fractures, and oblique fractures, thus broadening the scope of application.

[0025] 5. Reduce the need for secondary surgeries due to fixation failure, hardware irritation, etc., thereby reducing secondary trauma and medical costs for patients. At the same time, the low-trauma design reduces damage to the blood supply to the fracture ends and promotes fracture healing. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0027] Figure 2 This is a schematic diagram of the connecting strip in the present invention;

[0028] Figure 3 This is a bottom view in this invention;

[0029] Figure 4 This is a schematic diagram of the anchor body in this invention;

[0030] Figure 5 This is a side view of the anchor body in this invention;

[0031] Figure 6 This is a sectional view of the tail of the anchor body in this invention;

[0032] Figure 7 This is a schematic diagram showing the locking of the tightening control terminal and the rotating tightening shaft in this invention;

[0033] Figure 8 This is a top view of the flexible mesh sleeve in this invention;

[0034] Figure 9 This is a schematic diagram of the application of the present invention to a fracture site. Detailed Implementation

[0035] The integrated mesh sleeve fixing anchor provided in this embodiment consists of two core components: the anchor body module and the flexible mesh sleeve module. The anchor body module is further disassembled into the tip, threaded part, and tail part according to function and location, as detailed below:

[0036] Anchor body module 1

[0037] like Figure 1-4 As shown, the anchor body 1 is the rigid support component of the device, which undertakes the basic functions of penetrating bone, stabilizing and anchoring, and adjusting tension. It is made of biocompatible metal materials, such as medical titanium alloy, and is integrally molded. All sub-components are seamlessly connected to ensure overall mechanical strength.

[0038] The needle tip 11 is a penetration and self-tapping positioning component located at the foremost end of the anchor body 1, serving as the pilot structure for anchor implantation into the bone. Designed as a sharp pyramidal structure similar to a Kirschner wire, specifically a triangular or quadrangular pyramid, with sharpened edges, it possesses strong self-tapping capabilities. This structure allows the anchor body 1 to penetrate the hard cortical bone of the olecranon of the ulna without pre-drilling or with guidance only from a small-diameter guide needle, reducing bone damage and thermal injury caused by traditional drilling while ensuring accurate implantation.

[0039] The threaded portion 12, a multi-regional adaptation and pull-out resistant fixation component, is located behind the needle tip 11, connecting the needle tip 11 and the tail 13. After implantation, it penetrates the cancellous and cortical bone regions of the olecranon process of the ulna, serving as the core guarantee for anchoring stability. This structure employs a variable-pitch thread structure that transitions from sparse to dense, divided into two sections.

[0040] The distal thread, near the needle tip 11, has a slightly wider pitch and shallower thread depth, adapting to the porous structure of cancellous bone. This shallow grip prevents cancellous bone fragmentation and achieves initial stable fixation. The proximal thread, near the tail 13, has a denser pitch and deeper thread depth, adapting to the dense structure of cortical bone. This deep engagement provides strong pull-out resistance, preventing anchor displacement or dislodgement. The needle tip 11, through its variable pitch design from sparse to dense, adapts to different bone density areas, balancing fixation stability and bone protection.

[0041] The tail section 13 is an integrated component for connection, adjustment, and locking. Located at the rearmost end of the anchor body 1 and exposed on the outer side of the bone surface, it serves as the functional integrated end for connecting the flexible mesh sleeve 2 and achieving tension control. This structure is a dedicated structure for fixed connection with the flexible mesh sleeve 2. It includes an advance control hole and a built-in micro worm gear and ratchet structure. The advance control hole is a dedicated tool; in this embodiment, a micro torque wrench is used. The cross-sectional shape can be hexagonal, star-shaped, or internally triangular, ensuring a stable connection between the tool and the anchor. This converts the rotational force of the tool into the tightening force of the flexible mesh sleeve 2.

[0042] It can be seen that the tail section 13 is both the fixed base of the flexible net sleeve 2 and the control center for tension adjustment, realizing the three-in-one function of connection, adjustment and locking.

[0043] Flexible mesh module

[0044] The flexible mesh sleeve 2 serves as the flexible fit and multi-directional force-bearing core of the device, undertaking the functions of reducing soft tissue irritation, dispersing fixation stress, and transmitting compressive tension. It is made of biocompatible flexible materials, such as polyetheretherketone (PEEK) and absorbable polymer materials, and its structure is as follows:

[0045] The main mesh sleeve is a component that adapts to the curved surface of the fracture fragment and supports the low notch. It covers the surface of the olecranon fracture fragment of the ulna, adhering to the bone surface on the inner side and corresponding to the triceps tendon and skin on the outer side.

[0046] The main mesh sleeve has a flexible mesh structure with a mesh density that balances flexibility and structural strength. The inner surface of the flexible mesh sleeve 2 conforms to the outer surface of the fracture fragment at the reduction position. The inner surface is designed according to the anatomical morphology of the olecranon of the ulna, which can perfectly adapt to the irregular curved surface of the fracture fragment. Through cooperation with the anchor body 1, it forms a compression and restraint on the fracture fragment at the reduction position. On the outer side of the mesh sleeve, away from the bone surface, a supporting skeleton 21 is added. The supporting skeleton 21 is evenly distributed along the edge and middle of the mesh sleeve, such as in a grid or radial pattern, and is made of fine-diameter metal wire, such as titanium alloy wire, to enhance the mesh sleeve's resistance to collapse. This minimizes irritation to the triceps tendon and skin above, solves the pain point of the protruding tail of traditional Kirschner wires, and at the same time forms a multi-directional force-bearing area to distribute the pressure at the fracture ends.

[0047] The connecting band 3 on the flexible mesh sleeve 2 serves as a tension transmission and coordinating fixation component. One end is integrally formed with the main body of the mesh sleeve, and the other end is used to cooperate with the locking mechanism of the tail 13. This component is a high-strength flexible strip or line structure, with its width designed according to tension requirements and a smooth surface to reduce frictional wear with the anchor locking groove. As a bridge for tension transmission, it transmits the tightening force generated by the adjustment mechanism of the tail 13 to the main body of the mesh sleeve, achieving pressure fixation of the fracture ends. The connecting band 3 tightens the flexible mesh sleeve 2. One end of the connecting band is pre-installed on the flexible mesh sleeve 2, and the other end passes through the hole at the tail of the anchor. During the operation, rotating the tail of the anchor with a tool will tighten the connecting band 3, thereby tightening the flexible mesh sleeve 2 and providing better pressure fixation of the fracture surface. The anchor does not need to be connected to the flexible mesh sleeve 2 through the connecting band 3; the connecting band 3 only serves to tighten the flexible mesh sleeve 2.

[0048] The above components are assembled through pre-connection and built-in integration to form a collaborative whole, ensuring simplified surgical procedures and improved fixation reliability. The specific assembly relationship is as follows:

[0049] The anchor body 1 is integrally formed and seamlessly connected. The tip 11, threaded part 12, and tail 13 are assembled by integral forging and precision machining to form a three-in-one structure.

[0050] First, a rough blank of the anchor body 1 is formed by metal forging. Then, the pyramid of the tip 11, the variable pitch thread of the threaded part 12, and the push control hole 4 of the tail 13 are formed by CNC machining. There are no joints at the connection of each component to avoid the risk of breakage caused by stress concentration.

[0051] The anchor body 1 is integrally molded to ensure sufficient mechanical strength, which can withstand the rotational force during implantation, the pull-out force after fixation, and the torque force during tension adjustment.

[0052] The anchor body 1 and the flexible mesh sleeve 2 are pre-connected as a single unit, eliminating weak points. The assembly of the tail 13 and the flexible mesh sleeve 2 is the core of the integrated design, employing a pre-connection method before shipment, rather than intraoperative assembly, to form a complete component. The tail 13 has a pre-set annular groove, and the edge of the flexible mesh sleeve 2 has a matching elastic snap-fit. Mechanical pressure is used to press the snap-fit ​​into the groove, forming an interference fit to ensure a firm and secure connection without loosening. The assembly relationship is as follows: Figure 6 The location of point g is shown in the diagram.

[0053] By using the above assembly method, the weak links in the temporary connection between sutures and anchors during surgery in traditional techniques, such as suture slippage and loosening of knots, are completely eliminated. At the same time, the surgical procedure is simplified, and there is no need to assemble anchors and mesh during surgery.

[0054] Tail 13 Adjustment mechanism and connecting belt 3

[0055] The adjustment mechanism of the tail section 13, the rotating tightening shaft 6 and the tightening control terminal 9, are dynamically adapted to the connecting belt 3 of the flexible mesh sleeve 2. Tension adjustment and locking are achieved through a movable meshing structure. The specific cooperation relationship is as follows:

[0056] The rotating tightening shaft 6, as the transmission core of the entire tightening mechanism, is located at the center of the tail 13 and is arranged along the radial direction of the tail 13, that is, the vertical direction after the anchor is implanted into the bone. The structure is cylindrical and is a key component connecting the power input and tension transmission.

[0057] The tightening control terminal 9 is also located at the center of the tail 13. It has a cylindrical structure and is assembled perpendicularly to the rotating tightening shaft 6. It is embedded inside the tail 13 and is adapted to the position of the subsequent fixing hole 7 to facilitate the transmission of power to drive the connecting belt 3 to tighten.

[0058] The fixing hole 7 is located at the bottom of the tightening control terminal 9. The hole is a rectangular or elliptical through-hole, its diameter matching the width of the connecting strap 3 of the flexible mesh sleeve 2, allowing the connecting strap 3 to pass through smoothly. This hole penetrates the side wall of the tail 13, its inner side adjacent to the tightening control terminal 9, and its outer side connecting to the connecting strap 3 of the flexible mesh sleeve 2, serving as a channel connecting the inner and outer mesh sleeves of the mechanism. Figure 5 Point a shown is a through hole in the side wall of the anchor, through which the wire harness passes into the interior of the anchor.

[0059] The advance control hole 4 is located on the end face of the tail 13, that is, the top face away from the bone. The inner shape of the hole is designed as an inner hexagon, which is compatible with the head of the torque wrench. As an interface for the external tool access mechanism, it is directly exposed on the end face of the tail 13 for the operator's convenience.

[0060] The tightening control hole 5 is arranged on the end face of the tail 13 and is located beside the propulsion control hole 4, or exists as an auxiliary hole coaxial with the propulsion control hole 4. Its hole diameter is slightly smaller than that of the propulsion control hole 4. Its internal structure is adapted to the rotating tightening shaft 6 and is integrated on the end face of the tail 13. It forms a main hole and auxiliary hole matching relationship with the propulsion control hole 4 to assist in the adjustment and locking of tension.

[0061] Both ends of the connecting belt 3 are fixed to the device structure, and the fixation is completed through pre-connection and mechanism locking. The specific process is described as follows:

[0062] 1. One end of connecting strap 3: pre-connected to the main body of flexible mesh sleeve 2, and fixed at the factory;

[0063] One end of the connecting strap 3 is fixed to the main body of the flexible mesh sleeve 2 by integral molding or pre-connection. It is already formed as a whole at the factory and there is no need to tie the end during the operation.

[0064] 2. The other end of the connecting strap 3: Automatic tightening and one-way locking are achieved through a tightening mechanism, replacing knotting;

[0065] The other end of the connecting strap 3 needs to pass through the tightening mechanism of the tail 13. Through the coordinated action of the push control hole 4, the rotating tightening shaft 6, the tightening control terminal 9, and the fixing hole 7 within the mechanism, tightening and locking are completed. The specific steps are as follows:

[0066] Step 1: Inserting the connecting strap 3 into the mechanism. Pass the free end of the connecting strap 3, i.e., the end not connected to the main body of the mesh sleeve, through the fixing hole 7 of the tail 13. The anchor body 1 has holes on its exterior, such as... Figure 5 As shown at point a, the connecting strap 3 passes through the hole and then wraps around the fixing hole 7 of the tightening control terminal 9. It will not fall off but can keep the connecting strap 3 in a pullable state.

[0067] Step 2: Tool-driven tightening. The surgeon connects the torque wrench to the advance control hole 4 and rotates the tool to drive the tightening control terminal 9 to rotate; the tightening control terminal 9 achieves stable rotation through the threaded track 8 on the outer surface of the anchor body 1, driving the rotating tightening shaft 6 to rotate synchronously.

[0068] Step 3: As Figure 6-8 As shown, the connecting band 3 is tightened and locked. The connecting band 3 is fixed to the fixing hole 7 of the tightening control terminal 9. As it is rotated, the connecting band 3 is gradually pulled, causing the flexible mesh sleeve 2 to contract and press against the fracture site to be reduced. When the fracture reduction is confirmed to be satisfactory by imaging and the tension reaches the preset value, the rotating tool is stopped. The one-way toothed structure of the tightening control terminal 9 and the rotating tightening shaft 6 forms a reverse locking mechanism, similar to a ratchet mechanism, to prevent the connecting band 3 from loosening in the opposite direction. At this time, the tension of the connecting band 3 is stably maintained and there is no need to fix it by knotting.

[0069] The flexible mesh sleeve 2 in this embodiment is also provided with tension adjustment seam holes 22. These tension adjustment seam holes 22 can be used to realize the coordinated operation of multiple anchors, as follows:

[0070] like Figure 9 As shown, the anchor selection and division of labor are as follows: 2-3 anchors are used, with different functions: fixed anchors (c) and adjusting anchors (b). Fixed anchors (c) provide basic anchoring in the stable areas on both sides of the fracture, while adjusting anchors (b) are responsible for applying pressure in the core area of ​​the fracture. General-purpose anchors can switch functions. First, the fracture is reduced and temporarily fixed. Then, fixed anchors (c) are implanted sequentially, ensuring proper fit of the mesh sleeve and adjusting anchors (b), leaving room for adjustment. The flexible mesh sleeves (2) pre-connected at the factory of each anchor are overlapped to form a full-area coverage mesh. Sutures (d) are then woven together through tension adjusting suture holes (22), making the multi-anchor mesh sleeve an integrated system. After all anchors are fixed, tension is provided between all anchors via sutures (d), ultimately achieving stable fixation and pressure on the increased fracture area.

[0071] In this embodiment, the flexible mesh sleeve 2 is designed to prevent deformation, shrinkage, misalignment, or shrinkage during use through the following structure:

[0072] 1. The flexible mesh sleeve 2 body fits the curved surface of the fractured bone fragments, laying the foundation for uniform stress distribution.

[0073] The flexible mesh 2 is designed as a flexible mesh and incorporates a supporting skeleton 21 structure to maximally conform to the irregular curved surface of the fracture fragments and provide a strong, multi-directional stress-bearing area. This design, based on the mesh's own structure, prevents stress concentration caused by poor fit.

[0074] Bionic curved surface adaptation eliminates localized gaps. The inner surface of the flexible mesh sleeve 2 is custom-designed based on the anatomical morphology of the olecranon of the ulna, i.e., its irregular curved surface. After implantation, it can completely conform to the surface of the fracture fragment, without wrinkles or gaps. This surface contact replaces the point contact of traditional sutures, allowing the stress at the fracture ends to be evenly transmitted to the anchor through the flexible mesh sleeve 2, avoiding deformation of the flexible mesh sleeve 2 caused by localized stress concentration.

[0075] The supporting framework 21 is reinforced to maintain the shape of the flexible mesh 2. A uniformly distributed supporting framework 21 is added to the outer side of the flexible mesh 2, away from the fracture fragment. The framework 21 is made of fine-diameter metal wire, such as medical-grade titanium alloy wire, and is distributed in a grid or radial pattern. The supporting framework 21 does not affect the flexible fit of the flexible mesh 2, and provides anti-collapse support under stress, preventing the flexible mesh 2 from localizing or deforming due to tension, ensuring that the entire mesh always maintains a shape that conforms to the fracture fragment.

[0076] 2. Multiple anchors work together to form a multi-point uniform force-bearing system, avoiding the disruption of the flexible mesh caused by single-point tension.

[0077] The fixation system typically uses 2-3 anchors, including a fixed anchor (c) and an adjusting anchor (b). The anchors are arranged in a triangular or linearly symmetrical pattern, forming multi-point fixation around the fracture ends. Their specific functions are as follows:

[0078] Anchor distribution adapts to stress requirements: Fixed anchor c is implanted in the stable bone area on both sides of the fracture end, and adjustable anchor b is implanted in the core stress area directly above the fracture end. The anchor spacing is designed according to the size of the flexible mesh sleeve 2 to ensure that the edges and middle of the flexible mesh sleeve 2 can be stably fixed by the anchors, avoiding unilateral traction deformation of the flexible mesh sleeve 2 due to uneven anchor distribution.

[0079] Synchronous tension transmission ensures balanced stress distribution across the flexible mesh sleeve 2: The flexible mesh sleeve 2 is pre-connected to the tails 13 of all anchors at the factory. When the adjusting anchor b applies tension via the tightening mechanism, the tension is synchronously transmitted to all anchors through the mesh structure of the flexible mesh sleeve 2, resulting in multi-point synchronous stress distribution. This design avoids the disordered state of localized tightness and looseness in other areas of the flexible mesh sleeve 2 caused by traditional single-anchor pulling, ensuring uniform tension distribution across the entire mesh.

[0080] 3. Synchronized design of tension control mechanism to avoid overstretching or local tension imbalance.

[0081] Quantitative tension adjustment to avoid excessive traction: The surgeon can control the tension according to the fracture reduction requirements by connecting a special miniature torque wrench to the advance control hole 4 at the tail 13, such as setting a torque value of 3 N·m. This quantifiable adjustment replaces the experience-based tension of traditional knot tying, avoiding excessive local contraction of the flexible mesh sleeve 2 due to excessive tension, or loosening and disorder of the flexible mesh sleeve 2 due to insufficient tension.

[0082] Unidirectional locking and synchronous force application maintain stable tension: When the tension reaches the preset value, the unidirectional locking groove of the tail 13 will automatically lock the connecting strip 3 of the flexible net sleeve 2 to prevent tension loss; at the same time, because the flexible net sleeve 2 is pre-connected with multiple anchors, the tension after locking will be evenly maintained in the entire net, and the flexible net sleeve 2 will not be locally loose or tight due to the tension change of a single anchor, ensuring that the flexible net sleeve 2 is always in a state of uniform force application and stable shape.

[0083] 4. The flexible mesh sleeve 2 is pre-connected to the anchor nails to prevent displacement of the flexible mesh sleeve 2 due to loose connection points.

[0084] The connection points are evenly distributed and have reliable strength: the pre-connection between the flexible net sleeve 2 and the tail 13 adopts a mechanical snap-fit ​​method. The connection points are evenly distributed along the tail 13, rather than single-point connection, and the connection strength is consistent with the main body of the flexible net sleeve 2, so as to avoid the partial detachment or overall disorder of the flexible net sleeve 2 due to the breakage of local connection points.

[0085] The absence of intraoperative assembly reduces human error, as the flexible mesh sleeve 2 and anchors do not require temporary assembly during surgery, unlike the knotted connection of traditional sutures and anchors. This avoids intraoperative manipulations such as misaligned knots or weak connections that could lead to uneven stress on the flexible mesh sleeve 2. Furthermore, the pre-connection eliminates weak points at the traditional suture-anchor connection, ensuring that the flexible mesh sleeve 2 maintains a stable connection with the anchors under stress, preventing the entire mesh from becoming unusable due to loose connections.

[0086] In summary, this technical solution constructs an integrated system that provides stable fit, multi-point force application, tension control, and secure connection through a complete chain design of the flexible mesh sleeve 2 structure, including anchor distribution and tension control connection methods. Furthermore, the curved surface adaptation of the flexible mesh sleeve 2 and its compression with the skeleton 21 ensure that it fits the fracture fragments and maintains their shape; the symmetrical distribution of multiple anchors creates multi-point uniform force application, avoiding single-point traction; quantitative and controllable tension adjustment and synchronous locking maintain the overall tension balance of the mesh; and the pre-connected integrated structure at the factory eliminates displacement caused by loose connection points, meeting clinical usage requirements.

Claims

1. An integrated fixing anchor for a mesh sleeve, characterized in that, include: Anchor body (1), flexible mesh sleeve (2), connecting strip (3); The anchor body (1) includes a needle tip (11), a threaded part (12) and a tail (13). The needle tip (11) is used to penetrate the bone cortex to assist the anchor body (1) in insertion. The threaded part (12) forms a threaded connection with the bone to provide pull-out resistance. The tail (13) is fixedly connected to the flexible mesh sleeve (2). The flexible mesh sleeve (2) fits against the surface of the fracture fragment to be reduced, and forms a compression limit on the fracture fragment at the position to be reduced by cooperating with the anchor body (1); One end of the connecting band (3) is fixed to the flexible mesh sleeve (2), and the other end is connected to the tail (13) of the anchor body (1). The tail (13) is provided with a built-in transmission mechanism and a fixing hole (7). After the connecting band (3) is locked in one direction through the fixing hole (7) by the tool driving the built-in transmission mechanism, the flexible mesh sleeve (2) is tightened to the preset tension. The connection between the tail (13) and the flexible mesh sleeve (2) is a pre-connection, which is achieved by mechanical engagement. The tail (13) has a pre-set annular groove, and the edge of the flexible mesh sleeve (2) is provided with an elastic snap-fit ​​part that is adapted to the annular groove. The elastic snap-fit ​​part and the annular groove form an interference fit. The anchor body (1) and the flexible mesh sleeve (2) form an integral component. The tail (13) is provided with a push control hole (4), which is used to cooperate with a tool. The built-in transmission mechanism includes a rotating tightening shaft (6) and a tightening control terminal (9). The rotating tightening shaft (6) meshes with the tightening control terminal (9). By rotating the push control hole (4) with a special tool, the tightening control terminal (9) is driven to rotate, thereby driving the connecting belt (3) to tighten the flexible mesh sleeve (2).

2. The integrated mesh-anchor of claim 1, wherein, The needle tip (11) is a pyramidal structure, which is a triangular pyramid or a quadrangular pyramid.

3. The integrated mesh-anchor of claim 1, wherein, The threaded portion (12) is a variable pitch thread structure, which includes a distal thread and a proximal thread. The distal thread is close to the needle tip (11), and the proximal thread is close to the tail (13). The distal thread has a greater pitch than the proximal thread, and the distal thread has a smaller tooth depth than the proximal thread. The distal thread is used to form fixation in cancellous bone, and the proximal thread provides pull-out resistance in cortical bone.

4. The integrated mesh-anchor of claim 1, wherein, The inner surface of the flexible mesh sleeve (2) is attached to the outer surface of the fracture fragment at the position to be reduced. The flexible mesh sleeve (2) is provided with a support frame (21) on the side away from the bone. The support frame (21) is evenly distributed along the edge and middle of the flexible mesh sleeve (2) to enhance the structural strength of the flexible mesh sleeve (2).

5. The integrated mesh-anchor of claim 1, wherein, The flexible mesh sleeve (2) is made of a biocompatible material, which is selected from polyether ether ketone, medical titanium alloy or absorbable polymer material, and the elongation of the flexible mesh sleeve (2) is not less than 20%.

6. The integrated mesh-anchor of claim 1, wherein, The flexible mesh sleeve (2) is also provided with tension adjustment suture holes (22) on its surface. Sutures pass through the tension adjustment suture holes (22). The sutures are used to weave and connect the flexible mesh sleeve (2) of each anchor when multiple anchors work together, so that the flexible mesh sleeve (2) of multiple anchors forms a fixation system that covers the entire area and achieves pressure fixation of the fracture fragment surface.

Images