Intervertebral disc fibrous ring repairing device

Abstract

The invention provides an intervertebral disc fibrous ring repairing device, and belongs to the technical field of medical instruments. A round head wire and a mesh; the rivet wire clamping handle is located on the surface of the rivet handle; the rivet is fixedly connected with one side end of the rivet handle; the rivet head is arranged on one side of the rivet; the rivet head hole is formed in the circumferential surface of the rivet head; through the matched design of the rivet and the rivet head, it is ensured that the mesh is accurately anchored to the edge of a vertebral end plate during implantation, displacement or looseness is avoided, the mesh is made of a PET material, biocompatibility and mechanical strength are achieved, fiber ring damage can be effectively closed, and nucleus pulposus is prevented from protruding again. The mesh is uniformly stressed through linkage fixation of the four-corner flat round-head lines and the round-head lines, local stress concentration is avoided, meanwhile, a doctor can accurately control the implantation depth through the scale line design of the rivet handle, and operation errors are reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an intervertebral disc annulus fibrosus repair device. Background Art

[0002] Intervertebral disc anatomy: The human intervertebral disc is composed of three parts: the cartilage endplate, the annulus fibrosus, and the nucleus pulposus. The annulus fibrosus is a multi-layered structure, with the annulus fibers arranged in almost concentric circles. The peripheral fibers are more vertical, and the inclination increases towards the center. The nucleus pulposus is located in the center of the intervertebral disc, and water content can account for 75-90% of the total nucleus pulposus. Pathogenesis: Lumbar disc herniation is one of the more common diseases, mainly due to lumbar disc degeneration, annulus fibrosus rupture, nucleus pulposus compression or the formation of annulus fibrosus gaps. The nucleus pulposus tissue protrudes from the rupture to the back or into the spinal canal, causing irritation or compression of the adjacent spinal nerve roots, resulting in a series of clinical symptoms such as low back pain, numbness and pain in one or both lower limbs. The highest incidence of lumbar disc herniation is in L4-5 and L5-S1, accounting for about 95%. Usually, surgical treatment is required when conservative treatment is ineffective. The surgery usually requires incision of the annulus fibrosus or removal of the nucleus pulposus at the rupture. Currently, whether it's open surgery or minimally invasive discectomy performed under a microscope or endoscope, the annulus fibrosus is generally not repaired after the procedure. This can cause the remaining nucleus pulposus to protrude through the ruptured area, leading to recurrence. Regardless of the method used, discectomy surgery always has a certain recurrence rate, sometimes as high as 27%. Repairing the damaged annulus fibrosus with a disc repair device is an effective measure to reduce postoperative recurrence after discectomy, reducing the postoperative recurrence rate and improving clinical efficacy and patient satisfaction.

[0003] Authorization publication number "CN106063714B" records a fiber ring suturing device for minimally invasive nucleus pulposus removal of lumbar disc herniation, comprising a suture needle body and a suture. The suture needle body comprises a guide wire and a guide sleeve. The guide sleeve is mounted on the guide wire and limited by a limit device on the guide wire; the suture is connected to the guide wire as a whole via a suture connection device. The present invention has a simple and reasonable structure and is easy to operate. It can be applied to the wound suturing process of minimally invasive surgery and can suture damaged surfaces of different shapes. With the cooperation of a endoscopic lens, the entire operation is within the visual range, and the process is safe and controllable. It overcomes the problems of the existing fiber ring suturing process after nucleus pulposus removal under endoscopic lens, which is complicated, time-consuming, inefficient, expensive, and prone to secondary damage.

[0004] Currently, open surgery is mainly used to remove the protruding intervertebral disc tissue that compresses the nerves and the bony structure that has been narrowed by hypertrophic tissue (surgical decompression). This surgery is very invasive and takes a long time for the patient to recover.

[0005] Nucleus pulposus removal is a minimally invasive procedure for patients with lumbar disc herniation who have failed conservative and traditional treatments. It is highly effective and is particularly suitable for those with recurrent lumbar disc herniation. This treatment, which does not require screws or metal rods for fixation, simultaneously removes the nucleus pulposus and removes thickened ligamentum flavum and addresses nerve root canal stenosis caused by facet joint hyperplasia. It is also relatively inexpensive, has a short hospital stay, allows for rapid recovery, and is minimally invasive. However, current discectomy procedures only involve the removal of the herniated nucleus pulposus. This also causes greater damage to the annulus fibrosus, resulting in a larger gap. However, the annulus fibrosus is generally not repaired, leading to a high rate of secondary recurrence and significant pain for patients. Furthermore, scar healing after the initial surgery poses significant challenges for secondary treatment. Therefore, during discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative recurrence and complications. However, current suturing methods, which only allow for single-stitch closure, provide poor sealing of the gap. Summary of the Invention

[0006] The purpose of the present invention is to provide an intervertebral disc annulus fibrosus repair device, which aims to solve the problem in the existing technology that currently mainly adopts open surgery to remove the protruding intervertebral disc tissue that compresses the nerves and the bony structure that is narrowed by the hypertrophic tissue (surgical decompression). The surgery is traumatic and the patient's recovery time is long. The current discectomy only removes the protruding nucleus pulposus. While removing the nucleus pulposus, the intervertebral disc annulus fibrosus is damaged to a greater extent, that is, the annulus fibrosus gap is larger, but the intervertebral disc annulus fibrosus is generally not repaired. There is a high secondary recurrence rate after surgery, which brings great pain to the patient. At the same time, the scar healing of the annulus fibrosus after one operation also brings great challenges to secondary treatment. Therefore, when performing discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative recurrence and postoperative complications; this suturing method can only complete single-needle suturing, and the sealing of the rupture is very poor.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] An intervertebral disc annulus fibrosus repair device, comprising:

[0009] round-top wire and mesh;

[0010] A rivet wire clamping handle, the rivet wire clamping handle being located on the surface of the rivet handle;

[0011] a rivet, the rivet being fixedly connected to one side end of the rivet handle;

[0012] a rivet head, the rivet head being arranged on one side of the rivet;

[0013] a rivet head hole, the rivet head hole being opened on the circumferential surface of the rivet head;

[0014] Four square-cornered flat round-head wires, each of which is fixedly connected to the surface of the mesh;

[0015] Four round-head wires, each of which is fixedly connected to one side end of the four flat round-head wires at the four corners;

[0016] The four-cornered flat round head wire is sleeved inside the rivet head and fixed by a wire passing through the side wall thereof. The mesh is used to seal the damaged intervertebral disc gap.

[0017] As a preferred solution of the present invention, the material of the mesh is polyethylene terephthalate, and its mesh density structure design meets the requirements of biocompatibility, strength and flexibility.

[0018] As a preferred solution of the present invention, the rivet head and the rivet cooperate with each other to implant the rivet into the bottom hole at the edge of the spinal vertebral end plate.

[0019] As a preferred solution of the present invention, the four-corner flat round-head wire and the round-head wire are used for connection, traction and fixation to achieve the repair of the annulus fibrosus.

[0020] As a preferred solution of the present invention, the mesh is fixed to the fiber ring by four-corner flat round-head wires and round-head wires to close the damaged gap.

[0021] As a preferred solution of the present invention, the implantation depth of the rivet is controlled by making the scale line on the rivet handle flush with the back surface.

[0022] As a preferred solution of the present invention, the mesh is fixed by tightening the webbing to provide a stable repair environment.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] 1. The coordinated design of the rivet and rivet head ensures precise anchoring at the vertebral endplate edge during implantation, preventing displacement or loosening. The mesh is made of PET, a material with both biocompatibility and mechanical strength, effectively sealing annular fibrosus damage and preventing re-herniation of the nucleus pulposus. The coordinated fixation of the four-cornered flat round-head wires and the round-head wire ensures uniform mesh loading, avoiding localized stress concentrations. The graduated lines on the rivet handle allow the surgeon to precisely control the implant depth, minimizing surgical errors. The overall structure provides secure fixation while adapting to spinal motion, reducing the risk of postoperative complications. The adjustable webbing tightening mechanism allows the mesh to dynamically conform to the annular defect, providing a stable repair environment and avoiding the excessive restraint or loosening associated with traditional suturing techniques. The low-friction design of the flat round-head wires reduces irritation to surrounding soft tissues, while the microporous structure of the PET mesh facilitates nutrient penetration and promotes natural regeneration of the annulus fibrosus. Compared to traditional open repair, this device offers simpler operation, less invasiveness, and faster postoperative recovery. Long-term follow-up has demonstrated lower re-herniation rates and higher patient satisfaction, demonstrating significant clinical advantages.

[0025] 2. As a key component in sealing the gap in a damaged intervertebral disc, the mesh's rational design and excellent performance can effectively prevent further protrusion of disc material and promote the repair and healing of the annulus fibrosus. The mesh's material and structure adapt to the physiological movement of the intervertebral disc, providing a stable environment for the repair of the annulus fibrosus.

[0026] 3. The use of knot-free anchors not only simplifies surgical procedures but also improves fixation reliability. They can be accurately implanted into the bottom hole at the edge of the spinal vertebral endplate, providing strong fixation force and ensuring that the annulus fibrosus remains in a stable position during the repair process. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings:

[0028] Figure 1 This is a structural diagram of a rivet implantation surgical tool of the present invention;

[0029] Figure 2 This is a diagram of the mesh structure of the present invention;

[0030] Figure 3 This is an enlarged view of the rivet in the present invention;

[0031] Figure 4 An enlarged view of the rivet head in the present invention;

[0032] Figure 5 This is the mesh loading diagram of the present invention.

[0033] In the figure: 1. Round head wire; 2. Four-corner flat round head wire; 3. Mesh; 4. Rivet handle; 5. Rivet wire handle; 6. Rivet; 7. Rivet head; 8. Rivet head hole. DETAILED DESCRIPTION

[0034] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0035] Example 1

[0036] See also Figure 1-Figure 5 , the present invention provides the following technical solutions:

[0037] An intervertebral disc annulus fibrosus repair device, comprising:

[0038] Round head wire 1 and mesh 3;

[0039] A rivet wire clamping handle 5 is located on the surface of the rivet handle 4;

[0040] Rivet 6, rivet 6 is fixedly connected to one side end of the rivet handle 4;

[0041] A rivet head 7 is provided on one side of the rivet 6;

[0042] A rivet head hole 8 is provided on the circumferential surface of the rivet head 7;

[0043] Four square flat round-head wires 2, all of which are fixedly connected to the surface of the mesh 3;

[0044] Four round-head wires 1, the four round-head wires 1 are respectively fixedly connected to one side end of four square flat round-head wires 2;

[0045] The four-corner flat round head wire 2 is sleeved in the rivet head 7 and fixed by a wire passing through the side wall thereof. The mesh 3 is used to seal the damaged intervertebral disc gap.

[0046] After the mesh 3 is initially positioned in the damaged area through the four-corner flat round-head wire 2, the mesh 3 can cover the intervertebral disc gap and provide basic support for subsequent fixation. After the mesh 3 is initially positioned, the rivet 6 is inserted into the intervertebral disc tissue so that the rivet head 7 passes through the center hole of the four-corner flat round-head wire 2. The four-corner flat round-head wire 2 will be limited by the circumferential surface of the rivet head 7 and locked by the fixing wire through the rivet head hole 8. After the rivet 6 is fully implanted, the operator holds the rivet handle 4 and tightens the fixing wire with the rivet wire clamping handle 5. The four-corner flat round-head wire 2 will fit tightly with the rivet head 7, and at the same time drive the mesh 3 to generate radial tension to achieve a firm fit with the annulus fibrosus tissue. After the round-head wires 1 at the four corners are fixed by the corresponding rivets, the mesh 3 forms a three-dimensional tension structure, which can completely block the damaged gap and maintain a mechanical distribution consistent with the physiological curvature, and finally achieve anatomical reconstruction and functional repair of the annulus fibrosus. The mesh 3 is a key component for sealing the gap of the damaged intervertebral disc. Its reasonable design and good performance can effectively prevent the further protrusion of the material in the intervertebral disc and promote the repair and healing of the annulus fibrosus. The material and structure of the mesh 3 can adapt to the physiological movement of the intervertebral disc and provide a stable environment for the repair of the annulus fibrosus. The use of the knot-free anchor 6 not only simplifies the surgical operation, but also improves the reliability of fixation. It can be accurately implanted into the bottom hole at the edge of the spinal vertebral end plate, providing a strong fixing force to ensure that the annulus fibrosus maintains a stable position during the repair process.

[0047] For details, please refer to Figure 1-Figure 5 The material of the mesh 3 is polyethylene terephthalate, and its mesh structure design meets the requirements of biocompatibility, strength and flexibility.

[0048] In this embodiment, the polyethylene terephthalate and mesh structure design meet the requirements. It should have good biocompatibility to avoid causing an immune response after implantation in the human body. At the same time, it also needs to have sufficient strength and flexibility to adapt to the physiological movement of the intervertebral disc and effectively prevent further protrusion of the material in the intervertebral disc, ensuring that the mesh 3 can effectively seal the damage and will not break or shift due to spinal movement.

[0049] For details, please refer to Figure 1-Figure 5 The rivet head 7 and the rivet 6 cooperate with each other to implant the rivet 6 into the bottom hole at the edge of the spinal vertebral end plate.

[0050] In this embodiment: rivet 6 serves as a fixed anchor point, and its design conforms to the anatomical structure of the vertebral endplate to ensure stability and no loosening after implantation. The special shape of the rivet head 7 can enhance the anchoring force and prevent postoperative displacement. Bottom hole implantation means that the rivet 6 is precisely fixed in the area with harder vertebral bone, thereby improving long-term stability.

[0051] For details, please refer to Figure 1-Figure 5 The four-corner flat round-head wire 2 and the round-head wire 1 are used for connection, traction and fixation to achieve the repair of the fiber ring.

[0052] In this embodiment: the four-corner flat round-head wire 2 is designed to be flat, which can reduce the stimulation to the surrounding soft tissue and enhance the locking effect with the rivet head 7. The round-head wire 1 provides additional traction, which is convenient for adjusting the position of the mesh 3 during the operation so that it fits tightly to the damaged part of the fiber ring. The connection and fixing functions ensure that the mesh 3 can be evenly stressed to avoid excessive local stress leading to repair failure.

[0053] For details, please refer to Figure 1-Figure 5 The mesh 3 is fixed to the fiber ring through the four-corner flat round-head wire 2 and the round-head wire 1 to close the damaged gap.

[0054] In this embodiment: four-point fixation allows the mesh 3 to evenly cover the damaged area, preventing deflection or wrinkles caused by single-point fixation, not only preventing nucleus pulposus protrusion, but also promoting the natural healing of the annulus fibrosus tissue. By adjusting the tension of the round-head wire 1, the mesh 3 can adapt to defects of different sizes.

[0055] For details, please refer to Figure 1-Figure 5 The implantation depth of the rivet 6 is controlled by making sure that the scale line on the rivet handle 4 is flush with the back surface.

[0056] In this embodiment: precise depth control is provided to avoid problems such as damage to the vertebral body caused by excessive implantation or poor fixation caused by excessive shallow implantation. The rivet 6 is ensured to be completely embedded in the bone flush with the back surface, reducing friction or irritation of the protruding part on the surrounding tissue. The doctor can intuitively judge the implantation position, reduce dependence on X-rays during surgery, and shorten the operation time.

[0057] For details, please refer to Figure 1-Figure 5 The mesh 3 is fixed by tightening the webbing to provide a stable repair environment.

[0058] In this embodiment: the adjustable sutures or locking devices enable the mesh 3 to dynamically adapt to the tension and relaxation changes of the annulus fibrosus. After fixation, the mesh 3 will not loosen due to spinal movement, while allowing micro-movement to avoid stress shielding effects, promote healing, and provide a stable mechanical environment that helps regenerate annulus fibrosus tissue and reduces the risk of recurrence.

[0059] The working principle and usage process of the present invention are as follows: four four-corner flat round-head wires 2 are respectively passed through the four corners of the mesh 3 and fixed, the free ends of the four-corner flat round-head wires 2 are inserted into the rivet head holes 8 of the rivet heads 7, and locked by threading through the side walls. The round-head wire 1 is connected to the four-corner flat round-head wires 2 to provide additional traction to adjust the position of the mesh 3. The rivet handle 4 is operated to implant the rivet 6 into the vertebra so that the mesh 3 covers the gap in the fiber ring and is tensioned. The suture line is fixed by the rivet wire clamping handle 5 to ensure that the mesh 3 fits stably.

[0060] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. An intervertebral disc annulus fibrosus repair device, characterized by: include: Round head wire (1) and mesh (3); A rivet wire gripping handle (5), wherein the rivet wire gripping handle (5) is located on the surface of the rivet handle (4); A rivet (6), wherein the rivet (6) is fixedly connected to one side end of the rivet handle (4); a rivet head (7), the rivet head (7) being arranged on one side of the rivet (6); A rivet head hole (8), wherein the rivet head hole (8) is formed on the circumferential surface of the rivet head (7); Four square-cornered flat round-head wires (2), each of the four square-cornered flat round-head wires (2) being fixedly connected to the surface of the mesh (3); Four round-head wires (1), the four round-head wires (1) being fixedly connected to one side end of four four-corner flat round-head wires (2); The four-cornered flat round head wire (2) is sleeved inside the rivet head (7) and fixed by a wire passing through its side wall, and the mesh (3) is used to seal the damaged intervertebral disc gap.

2. The intervertebral disc annulus fibrosus repair device according to claim 1, characterized in that: The material of the mesh (3) is polyethylene terephthalate, and its mesh density structure design meets the requirements of biocompatibility, strength and flexibility.

3. The intervertebral disc annulus fibrosus repair device according to claim 2, characterized in that: The rivet head (7) and the rivet (6) cooperate with each other and are used to implant the rivet (6) into the bottom hole at the edge of the spinal vertebral end plate.

4. The intervertebral disc annulus fibrosus repair device according to claim 3, characterized in that: The four-corner flat round-head wire (2) and the round-head wire (1) are used for connection, pulling and fixing to achieve the repair of the annulus fibrosus.

5. The intervertebral disc annulus fibrosus repair device according to claim 4, characterized in that: The mesh (3) is fixed to the fiber ring via four-corner flat round-head wires (2) and round-head wires (1) to close the damaged gap.

6. The intervertebral disc annulus fibrosus repair device according to claim 5, characterized in that: The implantation depth of the rivet (6) is controlled by making the scale line on the rivet handle (4) flush with the back surface.

7. The intervertebral disc annulus fibrosus repair device according to claim 6, characterized in that: The mesh (3) is fixed by tightening the webbing to provide a stable repair environment.

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