A laminar fixation plate system, manufacturing apparatus and manufacturing method

Abstract

The application discloses a lamina fixation plate system, a preparation device and a preparation method, and belongs to the technical field of medical instruments. The system comprises a central main body, two side wings and an adjustable connecting mechanism; the side wings are arranged on the two sides of the central main body respectively, the adjustable connecting mechanism connects the side wings and the central main body and allows the side wings to adjust the position and / or angle relative to the central main body; the adjustable connecting mechanism comprises various structures such as an arc-shaped sliding groove matched with an arc-shaped adjusting block, an elastic neck portion or a sliding hole matched with an adjusting rod; the side wings are provided with inverted taper bone screw holes, and the lower surfaces are provided with anti-skid teeth; the central main body is provided with a detachable drug sustained-release carrier and an auxiliary fixing interface for connecting a nail rod system. The application realizes the accurate adaptation of the side wings and the lamina stump through the adjustable connecting mechanism, enhances the fixing stability through the inverted taper holes and the anti-skid teeth, reduces the revision difficulty through the reversible dismounting design, and integrates the functions of drug sustained release and collaborative connection with the internal fixation system.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a vertebral laminar fixation plate system, preparation equipment, and preparation method. Background Technology

[0002] Laminectomy is a common surgical procedure for treating spinal diseases such as spinal canal tumors and lumbar spinal stenosis. It involves removing part or all of the lamina to relieve compression of the spinal cord or nerve roots. However, this procedure has several drawbacks postoperatively, including a lack of effective barrier protection for the spinal canal contents and decreased stability of the posterior column of the spine, which can easily lead to iatrogenic spinal instability and epidural scar adhesions.

[0003] To reconstruct the anatomical structure of the spinal canal and maintain spinal stability, various laminar fixation systems have emerged clinically. Existing technologies, such as CN102551923B, disclose an artificial lamina comprising an arc-shaped mesh lamina and lateral wings, with screw holes on the lateral wings for fixation. While such products achieve some degree of coverage of lamina defects, the following problems still exist in practical applications:

[0004] Firstly, the fixation stability is insufficient. Existing fixation plates are mostly rigid structures, and their lateral wings do not fit well with the complex and irregular vertebral lamina remnants, resulting in insufficient screw holding force and easy loosening or even plate displacement. At the same time, the screw holes on the lateral wings are mostly straight holes, which makes it difficult to form an effective clamping effect between the lateral wings and the bone surface after the screws are tightened, resulting in poor initial stability.

[0005] Secondly, there is poor individual adaptability. Different patients and different segments of vertebral laminae have significant differences in width and curvature. Traditional fixation plates are usually of fixed size, requiring laborious shaping during surgery or selection of mismatched models, making the operation complex and difficult to achieve precise fit.

[0006] Third, revision surgery is difficult. After implantation, soft tissue can easily grow into the pores on the surface of the fixation plate. Although this is helpful for initial control, the removal process is often extremely difficult during revision surgery due to tissue embedding, which can easily cause dural tears or nerve damage.

[0007] Fourth, insufficient functional integration. Most existing products only provide mechanical shielding and protection, and cannot serve as local drug delivery carriers to inhibit scar formation or promote bone fusion. They are also difficult to integrate with pedicle screw-rod internal fixation systems, thus limiting their comprehensive application in complex cases.

[0008] Therefore, in order to address the above-mentioned technical problems, it is necessary to provide a laminar fixation plate system, preparation equipment, and preparation method.

[0009] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0010] The purpose of this invention is to provide a lamina fixation plate system, preparation equipment, and preparation method, which can solve the problems in the background art.

[0011] To achieve the above objectives, a specific embodiment of the present invention provides the following technical solution:

[0012] A laminar fixation plate system includes a central body, two lateral wings, and an adjustable connecting mechanism. The central body has an upper surface and a lower surface. The two lateral wings are respectively disposed on both sides of the central body for fixed connection with the lamina remnant. The adjustable connecting mechanism connects the lateral wings to the central body and allows the lateral wings to be displaced and / or rotated relative to the central body in at least two degrees of freedom to adapt to the lamina anatomy of different patients.

[0013] In one or more embodiments of the present invention, the adjustable connection mechanism includes a first sliding adjustment unit, the first sliding adjustment unit comprising:

[0014] An arc-shaped groove is provided on the side of the central main body, and an arc-shaped adjusting block is provided at the end of the side wing. The arc-shaped adjusting block is slidably accommodated in the arc-shaped groove and can slide along the length direction of the arc-shaped groove and pivot about the axis of the arc-shaped groove to adjust the extension length and tilt angle of the side wing.

[0015] The side of the central body is provided with a limit screw hole above the arc-shaped slide groove. A limit screw is threaded into the limit screw hole, and the lower end of the limit screw abuts against the upper side wall of the arc-shaped adjusting block.

[0016] The end of the side wing is provided with a ball socket, and the end of the arc-shaped adjusting block is fixedly connected with a ball head, which is hinged in the ball socket to allow the side wing to rotate omnidirectionally relative to the arc-shaped adjusting block.

[0017] In one or more embodiments of the present invention, the central body and the side wing are integrally formed, and a pre-bent elastic neck is provided at the connection between the two. The thickness of the elastic neck is less than the thickness of the central body and the side wing, so that the side wing can adjust its angle relative to the central body through elastic deformation.

[0018] In one or more embodiments of the present invention, the adjustable connection mechanism includes a second sliding adjustment unit, the second sliding adjustment unit comprising:

[0019] A sliding hole is provided on the side of the central main body, and an adjusting rod is provided at the end of the side wing. The adjusting rod is slidably accommodated in the sliding hole and can slide along the length direction of the sliding hole to adjust the extension length of the side wing.

[0020] A pair of elastic limiting balls are fixedly connected to the end of the adjusting rod. Multiple limiting grooves are equally spaced along the length direction in the sliding hole. The pair of elastic limiting balls are respectively engaged in the corresponding limiting grooves.

[0021] A pair of guide grooves are provided on the sidewall of the sliding hole along the length direction, and a pair of elastic limiting balls slide along the pair of guide grooves respectively.

[0022] In one or more embodiments of the present invention, at least one bone screw hole is provided on the side wing, the bone screw hole is an inverted conical hole, and the lower surface of the side wing is provided with anti-slip teeth, and the extending direction of the anti-slip teeth intersects the axial direction of the bone screw hole.

[0023] In one or more embodiments of the present invention, the upper surface of the central body is rough or has a microporous structure to facilitate soft tissue adhesion; the lower surface of the central body is smooth or has an anti-adhesion coating.

[0024] The central body is configured with a layered structure, including an inner core layer and an outer functional layer. The inner core layer is made of biodegradable magnesium alloy, and the outer functional layer has a porous structure. The magnesium alloy releases magnesium ions when it degrades in vivo.

[0025] In one or more embodiments of the present invention, a plurality of drug-carrying mechanisms are provided on the central body, and each of the plurality of drug-carrying mechanisms includes a through hole opened through the central body. A drug sustained-release carrier is detachably embedded in the through hole, and the drug sustained-release carrier contains an anti-scarring drug, an anti-inflammatory drug, or a bone growth factor.

[0026] In one or more embodiments of the present invention, the central body is further provided with an auxiliary fixation mechanism, the auxiliary fixation mechanism including auxiliary fixation interfaces opened on the front and rear side walls of the central body, the auxiliary fixation interfaces being used to connect the transverse connecting rod of the posterior spinal fixation system, so that the lamina fixation plate system is integrated into the rod fixation system as a connecting structure; the opening of the auxiliary fixation interface is provided with a sealing plate in a detachable manner.

[0027] An apparatus for preparing a laminectomy system includes:

[0028] A molding die, used for integral molding or separate molding of the central body and side wings;

[0029] A machining unit is used to machine arc-shaped grooves, sliding holes, through holes and / or auxiliary fixing interfaces on the central body;

[0030] A surface treatment unit is used to roughen and smooth the upper and lower surfaces of the central body, respectively.

[0031] An assembly unit is used to assemble the side wings to the central body via an adjustable connecting mechanism, and to install limiting screws, elastic limiting balls, drug sustained-release carriers and / or sealing plates.

[0032] A method for preparing a laminectomy system includes the following steps:

[0033] Step S1: Prepare the blanks of the central body and side wings using a molding die;

[0034] Step S2: The machining unit processes arc-shaped grooves, sliding holes, through holes and / or auxiliary fixing interfaces on the central body;

[0035] Step S3: Roughen the upper surface of the central body and smooth the lower surface using the surface treatment unit;

[0036] Step S4: Assemble the side wings onto the central body via an adjustable connecting mechanism using the assembly unit;

[0037] Step S5: Install the limiting screws, elastic limiting balls, drug sustained-release carriers and / or sealing plates to complete system assembly.

[0038] Compared with existing technologies, this invention utilizes the synergistic effect of the inverted conical holes and anti-slip teeth on the side wings to generate downward clamping force when the screw is tightened, achieving reliable prestress locking and solving the problem of insecure fixation. Through various methods such as arc-shaped grooves, ball-and-socket joints, flexible neck joints, and adjustable positions, the extension length and fitting angle of the side wings can be flexibly adjusted to perfectly adapt to the vertebral morphology of different patients, avoiding intraoperative shaping. Each connecting structure adopts a reversible disassembly design, combined with a sealing plate to prevent tissue ingrowth and directional microgrooves to guide cell growth, significantly reducing the difficulty of revision surgery. Furthermore, the system integrates a detachable drug carrier, auxiliary fixation interface, and layered side wings, combining local drug delivery, synergistic fixation with the rod-and-screw system, and bioactivity functions, expanding the scope of clinical application. The overall structural design is ingenious, achieving complex functions while considering ease of operation and manufacturing cost. Attached Figure Description

[0039] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0040] Figure 1 This is a schematic diagram of the vertebral plate fixation system in Embodiment 1 of the present invention;

[0041] Figure 2 This is an exploded view of the vertebral lamina fixation plate system in Embodiment 1 of the present invention;

[0042] Figure 3 This is a cross-sectional view of the connection between the central main body and the side wings in Embodiment 1 of the present invention;

[0043] Figure 4 This is a cross-sectional view of the connection between the arc-shaped slide and the arc-shaped adjusting block in Embodiment 1 of the present invention;

[0044] Figure 5 This is a schematic diagram of the vertebral plate fixation system in Embodiment 2 of the present invention;

[0045] Figure 6 This is a cross-sectional view of the vertebral plate fixation system in Embodiment 3 of the present invention;

[0046] Figure 7 This is an exploded view of the vertebral lamina fixation plate system in Embodiment 3 of the present invention;

[0047] Figure 8 For the present invention Figure 7 A schematic diagram at point A in the middle;

[0048] Figure 9 This is a cross-sectional view of the central main body structure in Embodiment 3 of the present invention.

[0049] Explanation of key figure labels:

[0050] 1-Central main body, 2-Side wing, 21-Bone screw hole, 3-First sliding adjustment unit, 31-Arc-shaped slide groove, 32-Arc-shaped adjustment block, 33-Limiting screw hole, 34-Limiting screw, 35-Ball socket, 36-Ball head, 4-Elastic neck, 5-Second sliding adjustment unit, 51-Slide hole, 52-Adjusting rod, 53-Elastic limiting ball, 54-Limiting groove, 55-Guide groove, 6-Drug delivery mechanism, 61-Through hole, 62-Drug sustained-release carrier, 7-Auxiliary fixation mechanism, 71-Auxiliary fixation interface, 72-Sealing plate. Detailed Implementation

[0051] To enable those skilled in the art to better understand the technical solutions in this disclosure, the technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments in this disclosure, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this disclosure.

[0052] like Figures 1 to 9 As shown, a lamina fixation plate system according to an embodiment of the present invention includes a central body 1, two side wings 2, and an adjustable connecting mechanism. The central body 1 has an upper surface and a lower surface. The two side wings are respectively disposed on both sides of the central body 1 for fixed connection with the lamina remnant. The adjustable connecting mechanism connects the side wings 2 to the central body 1. The adjustable connecting mechanism allows the side wings 2 to be displaced and / or rotated relative to the central body 1 in at least two degrees of freedom to adapt to the lamina anatomy of different patients.

[0053] Specifically, the central main body 1 is a butterfly-shaped plate structure with physiological curvature. Its length is arc-shaped to match the physiological curvature of the spine, and its width is arch-shaped to simulate the original vertebral lamina. The overall dimensions of the central main body 1 are designed as follows: length L is 20-40mm (20-30mm for cervical vertebrae, 30-40mm for lumbar vertebrae), width W is 10-20mm, and the main body thickness t1 is 2.0-3.5mm (2.0-2.5mm for titanium alloy, 3.0-3.5mm for PEEK).

[0054] Optionally, the upper surface of the central body 1 is roughened by sandblasting. The sandblasting parameters are: corundum abrasive particle size of 60-80 mesh, sandblasting pressure of 0.4-0.6 MPa, sandblasting distance of 100-150 mm, and the surface roughness Ra value after treatment reaches 3.2-6.3 μm, which is conducive to the adhesion and healing of surrounding muscle and soft tissue. The lower surface is mirror polished, and the surface roughness Ra value after polishing is ≤0.2 μm, in order to reduce friction on the dural sac and postoperative scar adhesion.

[0055] Secondly, the central main body 1 can be configured as a layered structure, including an inner core layer 11 and an outer functional layer 12. The inner core layer 11 is made of a biodegradable magnesium alloy (such as a Mg-Zn-Ca alloy), and the outer functional layer 12 is a porous structure (a porous titanium alloy layer formed by 3D printing, with a porosity of 60%-80% and a pore size of 300-500 μm). When the magnesium alloy degrades in vivo, it slowly releases magnesium ions, which have multiple biological effects such as promoting osteogenic growth, anti-inflammation, and antibacterial properties, thus benefiting bone healing and preventing infection. The porous structure of the outer functional layer 12 facilitates bone tissue ingrowth, achieving biological fixation. In vitro cell experiments show that this layered structure can promote osteoblast proliferation and increase ALP activity by 30%-50%.

[0056] Side wings 2 are located on both sides of the central body 1 and are used for fixed connection with the lamina remnant. Bone screw holes 21 are provided on the side wings 2. The bone screw holes 21 are inverted conical holes (larger at the top and smaller at the bottom), with a taper angle α of 60°-90°, preferably 75°, matching the taper of the head of a standard lamina fixation screw (such as a 3.5mm diameter cortical bone screw). The lower surface of the side wings 2 (the contact surface with the lamina) is provided with anti-slip teeth. The anti-slip teeth are pyramidal or blade-shaped protrusions with a height of 0.3-0.5mm and a tooth spacing of 0.8-1.2mm. The extension direction of the anti-slip teeth intersects the axial direction of the bone screw holes 21. When the lamina fixation screw (not shown in the figure) is screwed into the vertebra through the inverted conical hole, a tightening torque of 1.5-2.5 N·m is recommended. The screw head applies a downward oblique pressure to the hole wall, forcing the anti-slip teeth on the lower surface of the side wings 2 to embed into the bone surface, forming a pre-stress lock, significantly enhancing initial stability.

[0057] like Figure 1 and Figure 2 As shown, a plurality of drug-carrying mechanisms 6 are provided on the central body 1. Each drug-carrying mechanism 6 includes a through-hole 61 formed in the central body 1, into which a drug-releasing carrier 62 is detachably embedded. The through-hole 61 is preferably a countersunk hole with internal threads. The drug-releasing carrier 62 is a matching externally threaded cylinder, made of a biodegradable polymer (such as PLGA, molecular weight 50,000-100,000) or porous hydroxyapatite. The drug-releasing carrier 62 is filled with an anti-scarring drug (such as mitomycin C, loading amount 0.5-2.0 mg), an anti-inflammatory drug (such as dexamethasone, loading amount 1.0-3.0 mg), or a bone growth factor (such as BMP-2, loading amount 0.1-0.5 mg). The release rate of the carrier 62 can be controlled by adjusting the molecular weight of the polymer, the lactic acid / glycolic acid ratio, or the pore size, with a designed release cycle of 4-12 weeks. After implantation, the medication is slowly released locally, which can effectively inhibit scar tissue proliferation in the laminectomy area or promote bone graft fusion.

[0058] Figure 1 and Figure 2As shown, the central body 1 is also equipped with an auxiliary fixation mechanism 7, which includes auxiliary fixation interfaces 71 located on the anterior and posterior side walls of the central body 1. The auxiliary fixation interfaces 71 can be grooves, through holes, or ear-like structures, used to connect the transverse connecting rods (not shown in the figure) of the posterior spinal internal fixation system. The dimensions of the auxiliary fixation interfaces 71 match the connectors of the standard transverse connecting rods; for example, if a connecting rod with a diameter of 5.5mm or 6.0mm is used, the corresponding inner diameter of the interface is 5.6-6.1mm. For patients requiring simultaneous pedicle screw-rod internal fixation, this system can be connected to the screw-rod system via the transverse connecting rods, making the laminar fixation plate part of the entire posterior fixation system, acting as a bridge and providing stability, thus enhancing the overall mechanical stability of the structure. A detachable sealing plate 72 is provided at the opening of the auxiliary fixation interface 71. The sealing plate 72 is a medical-grade silicone or PEEK sheet with a thickness of 0.5-1.0mm, connected to the interface via snaps or threads, used to prevent soft tissue ingrowth when the interface is not in use.

[0059] Example 1

[0060] like Figures 1 to 4 As shown, the adjustable mechanism includes a first sliding adjustment unit 3.

[0061] The first sliding adjustment unit 3 includes an arc-shaped groove 31, an arc-shaped adjustment block 32, a limiting screw 34, and a ball-and-socket joint. The arc-shaped groove 31 is located on both sides of the central main body 1 and has an arc-shaped dovetail groove structure. The radius of curvature R of the arc-shaped groove 31 is designed according to the anatomical curvature of the human vertebral lamina, and is specifically divided into three specifications: R=25-35mm for the cervical spine segment, R=35-45mm for the thoracic spine segment, and R=45-60mm for the lumbar spine segment. In clinical use, the doctor selects the central main body with the corresponding radius of curvature based on the patient's preoperative imaging measurements. The arc-shaped adjustment block 32 is located at the end of the side wing 2, and its arc-shaped cross-section matches the arc-shaped cross-section of the arc-shaped groove 31. It can be slidably accommodated within the arc-shaped groove 31. At the same time, the arc-shaped adjustment block 32 can also rotate at a small angle along its arc surface within the arc-shaped groove 31 to adjust the angle of the side wing 2. When the arc-shaped adjusting block 32 slides and / or rotates along the arc-shaped groove 31, the extension length and tilting angle of the side wing 2 change continuously at the same time, realizing the coupled adjustment of width and angle.

[0062] A limiting screw hole 33 is provided on the side of the central main body 1 above the arc-shaped slide groove 31. A limiting screw 34 is threaded into the limiting screw hole 33. The limiting screw 34 is an M2-M3 tapered set screw made of titanium alloy or medical-grade stainless steel. The lower end of the limiting screw 34 abuts against the upper side wall of the arc-shaped adjusting block 32. After the side wing is adjusted to the correct position, tighten the limiting screw 34. It is recommended to tighten the torque to 0.3-0.5 N·m to lock the arc-shaped adjusting block 32 within the arc-shaped slide groove 31 and prevent postoperative displacement. The tapered tip of the limiting screw 34 will form a micro-indentation on the surface of the arc-shaped adjusting block 32 when tightened, further enhancing the anti-slip effect.

[0063] To achieve more flexible angle adjustment, a ball joint 35 is provided at the end of the side wing 2, and a ball head 36 is fixedly connected to the end of the arc-shaped adjustment block 32. The ball head 36 is hinged in the ball joint 35, which allows the side wing 2 to rotate omnidirectionally relative to the arc-shaped adjustment block 32. Through the cooperation of the arc-shaped groove and the ball joint, this embodiment achieves independent adjustment of width and angle, which can accurately adapt to the anatomical shape of different patients.

[0064] Example 2

[0065] like Figure 5 As shown, the main difference between this embodiment and Embodiment 1 lies in the different implementation methods of the adjustable connecting mechanism.

[0066] In this embodiment, the central body 1 and the side wings 2 are integrally molded, and a pre-bent elastic neck 4 is provided at the connection between them. The thickness t2 of the elastic neck 4 is less than the thickness of the central body 1 and the side wings 2. The length L2 of the elastic neck 4 is 3-6 mm, and the width is consistent with the width of the root of the side wings. The material of the elastic neck 4 is a titanium alloy with superelasticity (such as TiNi shape memory alloy, whose elastic modulus is about 40-60 GPa and superelastic strain can reach 8%) or PEEK with a certain degree of flexibility (elastic modulus is about 3-4 GPa).

[0067] The pre-bending angle of the elastic neck 4 is 5-10 degrees, simulating the natural curvature of the lamina. During the procedure, the surgeon does not need to perform complex mechanical adjustments; simply pressing the lateral wing 2 with the needle holder causes the elastic neck 4 to undergo elastic deformation, changing the angle of the lateral wing 2 relative to the central body 1. The amount of deformation is controlled within the range of 0-3mm, corresponding to an angle change range of 5-10 degrees. Due to the elastic properties of the material, after the external force is removed, the lateral wing 2 remains stable in its new position, with a rebound rate of less than 5%, achieving adaptive fit with the lamina remnant.

[0068] This embodiment simplifies the "mechanical joint" into a "material joint," utilizing the elastic properties of the material to achieve angle adjustment. This structure has no moving parts, eliminates the risk of wear, and has a simple manufacturing process (one-time injection molding or forging), significantly reducing costs.

[0069] Example 3

[0070] like Figures 6 to 9 As shown, this embodiment provides another adjustable connection mechanism—the second sliding adjustment unit 5.

[0071] The second sliding adjustment unit 5 includes a sliding hole 51 disposed on the side of the central main body 1, and an adjustment rod 52 disposed at the end of the side wing 2. The adjustment rod 52 is slidably accommodated in the sliding hole 51 and can slide along the length direction of the sliding hole 51 to adjust the extension length of the side wing 2. The fitting clearance between the sliding hole 51 and the adjustment rod 52 is 0.02-0.05mm, and the sliding resistance is less than 5N.

[0072] A pair of elastic limiting balls 53 are fixedly connected to the end of the adjusting rod 52. The elastic limiting balls 53 are made of an elastic material (such as medical-grade silicone rubber). Multiple limiting grooves 54 are evenly spaced along the length of the sliding hole 51. The limiting grooves 54 are arc-shaped or V-shaped, with a depth of 0.3-0.6 mm and a spacing of 2-4 mm between adjacent limiting grooves, corresponding to the adjustment positions of the side wing extension length. A pair of elastic limiting balls 53 are respectively engaged in the corresponding limiting grooves 54. When the adjusting rod 52 slides, the elastic limiting balls 53, under the action of elastic force, sequentially pass through each limiting groove 54 and engage with the corresponding limiting groove 54 after reaching the target position. The change in resistance during engagement is obvious, producing a clear "click" feel, achieving position locking.

[0073] A pair of guide grooves 55 are formed along the length of the side wall of the sliding hole 51, and a pair of elastic limiting balls 53 slide along the pair of guide grooves 55 respectively. The function of the guide grooves 55 is to guide the movement direction of the elastic limiting balls 53 and prevent the adjusting rod 52 from deflecting or rotating during the sliding process.

[0074] The locking reliability test of this embodiment shows that under axial tension, the disengagement force of the elastic limiting ball 53 and the limiting groove 54 is ≥50N, which is much greater than the tension that may be borne under physiological load (about 10-20N), which is sufficient to ensure that there is no displacement after surgery.

[0075] When using the lamina fixation plate system of the present invention, the appropriate central body 1 is first selected according to the patient's preoperative imaging measurement results (such as the width of the lamina defect and the curvature of the lamina stump), and the position and angle of the two side wings 2 are pre-adjusted through the adjustable connecting mechanism.

[0076] Adjustment process: In Embodiment 1, by sliding the arc-shaped adjusting block 32 along the arc-shaped groove 31, the extension length and tilt angle of the side wing 2 can be adjusted simultaneously, achieving a coupling adaptation of width and curvature; by the omnidirectional rotation of the ball head 36 within the ball socket 35, the contact angle between the side wing 2 and the vertebral lamina remnant can be further fine-tuned. In Embodiment 2, by pressing the side wing 2 to cause elastic deformation of the elastic neck 4, continuous angle adjustment can be achieved. In Embodiment 3, by pushing the adjusting rod 52 to cause the elastic limiting ball 53 to sequentially engage with the limiting groove 54 at different positions, a step-by-step adjustment of the extension length can be achieved.

[0077] Fixation process: After adjustment, tighten the limiting screw 34 or insert the elastic limiting ball 53 into the limiting groove 54 to lock the lateral wing 2 relative to the central body 1. Then, screw the laminar fixation screw through the inverted conical bone screw hole 21 on the lateral wing 2 into the lamina remnant. During tightening, the screw head applies downward pressure to the wall of the inverted conical hole, forcing the anti-slip teeth on the lower surface of the lateral wing 2 to embed into the bone surface, forming a pre-stressed lock, thereby firmly fixing the entire system to the lamina defect area.

[0078] Functional implementation: After fixation, the central main body 1 is suspended above the dural sac. Its smooth lower surface 14 prevents adhesion to the dura mater, while its rough upper surface 13 promotes soft tissue healing. If a drug-releasing carrier 62 is implanted, it can slowly release medication locally after surgery to inhibit scar formation or promote bone fusion. Connecting the auxiliary fixation interface 71 to the pedicle screw-rod system can further enhance overall stability.

[0079] Revision procedure: If a second revision surgery is required, the procedure can be performed in reverse. First, unscrew the laminar fixation screws, then loosen the limiting screw 34 or forcefully pull out the adjusting rod 52 to disengage the elastic limiting ball 53 from the limiting groove 54. This allows the lateral wing 2 to be separated from the central body 1, and the entire system can be removed. Because the sealing plate 72 prevents soft tissue from growing into the connection interface, there is no need to deal with embedded tissue during revision, reducing the difficulty and risk of the surgery.

[0080] The present invention also provides a preparation apparatus for preparing the above-mentioned laminar fixation plate system, comprising:

[0081] Molding mold: Used for one-piece molding or separate molding of the central body 1 and side wings 2. Depending on the different materials and structural designs, injection molds (for PEEK materials) or precision casting molds (for titanium alloy materials) can be used.

[0082] Machining unit: Used to machine arc-shaped grooves 31, sliding holes 51, through holes 61, and / or auxiliary fixing interfaces 71 on the central body 1. The machining unit can be a CNC machining center, an EDM machine, or a laser processing equipment to ensure the dimensional accuracy and surface quality of each structure.

[0083] Surface treatment unit: used to roughen and smooth the upper surface 13 and lower surface 14 of the central body 1, respectively. Roughening can be performed by sandblasting, acid etching or plasma spraying; smoothing can be performed by mechanical polishing, electrochemical polishing or coating.

[0084] Assembly unit: Used to assemble the side wings 2 onto the central body 1 via an adjustable connecting mechanism, and to install the limiting screws 34, elastic limiting balls 53, drug sustained-release carriers 62 and / or sealing plates 72. The assembly unit can be a semi-automatic assembly line or a robotic assembly workstation to ensure assembly accuracy and consistency.

[0085] The present invention also provides a method for preparing the above-mentioned laminar fixation plate system, comprising the following steps:

[0086] Step S1: Prepare the blanks of the central body 1 and the side wings 2 using a molding die. For the one-piece molding scheme (such as in Example 2), the central body and the side wings are formed in the same die; for the separate molding scheme (such as in Examples 1 and 3), the central body and the side wings are formed separately. After molding, deburring, cleaning, and drying are performed. Cleaning is done using an ultrasonic cleaner with anhydrous ethanol or deionized water as the cleaning solution. The cleaning time is 10-15 minutes, and the drying temperature is 60-80℃ for 2-4 hours.

[0087] Step S2: Machining the arc-shaped groove 31, sliding hole 51, through hole 61, and / or auxiliary fixing interface 71 on the central body 1 using the machining unit. According to design requirements, appropriate machining processes are adopted to ensure dimensional accuracy and surface quality. Dimensional inspection is performed after machining, using a coordinate measuring machine (CMM) for random checks; the pass rate for critical dimensions must reach over 99%.

[0088] Step S3: The upper surface 13 of the central body 1 is roughened and the lower surface 14 is smoothed using the surface treatment unit. The treated surfaces must meet the design requirements, with an upper surface roughness Ra value of 3.2-6.3 μm and a lower surface roughness Ra value ≤0.2 μm. The surface roughness is measured using a surface roughness meter.

[0089] Step S4: Assemble the side wings 2 onto the central body 1 via the assembly unit using the adjustable connecting mechanism. For Embodiment 1, screw the arc-shaped adjusting block 32 into the arc-shaped sliding groove 31 from the side; for Embodiment 3, insert the adjusting rod 52 into the sliding hole 51 and push it to the target position. After assembly, perform sliding resistance testing and locking reliability testing. The sliding resistance is ≤5N, and the unlocking force after locking is ≥50N.

[0090] Step S5: Install the limiting screw 34, elastic limiting ball 53, drug sustained-release carrier 62, and / or sealing plate 72 to complete system assembly. The assembled system requires functional testing to ensure smooth movement and reliable locking of all adjustment mechanisms. The final product undergoes sterilization using ethylene oxide (EO) or gamma irradiation.

[0091] It will be apparent to those skilled in the art that this disclosure is not limited to the details of the exemplary embodiments described above, and that this disclosure can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of this disclosure is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within this disclosure. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0092] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A laminectomy system, characterized in that, include: The central main body has an upper surface and a lower surface; Two side wings are respectively located on both sides of the central main body for fixed connection with the vertebral lamina remnant; as well as An adjustable connecting mechanism connects the side wings to the central body; The adjustable connection mechanism allows the flanks to be displaced and / or rotated in at least two degrees of freedom relative to the central body to accommodate the vertebral anatomical morphology of different patients.

2. The laminectomy system according to claim 1, characterized in that, The adjustable connection mechanism includes a first sliding adjustment unit, the first sliding adjustment unit comprising: An arc-shaped groove is provided on the side of the central main body, and an arc-shaped adjusting block is provided at the end of the side wing. The arc-shaped adjusting block is slidably accommodated in the arc-shaped groove and can slide along the length direction of the arc-shaped groove and pivot about the axis of the arc-shaped groove to adjust the extension length and tilt angle of the side wing. The side of the central body is provided with a limit screw hole above the arc-shaped slide groove. A limit screw is threaded into the limit screw hole, and the lower end of the limit screw abuts against the upper side wall of the arc-shaped adjusting block. The end of the side wing is provided with a ball socket, and the end of the arc-shaped adjusting block is fixedly connected with a ball head, which is hinged in the ball socket to allow the side wing to rotate omnidirectionally relative to the arc-shaped adjusting block.

3. The laminectomy system according to claim 1, characterized in that, The central body and the side wings are integrally formed, and a pre-bent elastic neck is provided at the connection between the two. The thickness of the elastic neck is less than the thickness of the central body and the side wings, so that the side wings can adjust their angle relative to the central body through elastic deformation.

4. The laminectomy system according to claim 1, characterized in that, The adjustable connection mechanism includes a second sliding adjustment unit, the second sliding adjustment unit comprising: A sliding hole is provided on the side of the central main body, and an adjusting rod is provided at the end of the side wing. The adjusting rod is slidably accommodated in the sliding hole and can slide along the length direction of the sliding hole to adjust the extension length of the side wing. A pair of elastic limiting balls are fixedly connected to the end of the adjusting rod. Multiple limiting grooves are equally spaced along the length direction in the sliding hole. The pair of elastic limiting balls are respectively engaged in the corresponding limiting grooves. A pair of guide grooves are provided on the sidewall of the sliding hole along the length direction, and a pair of elastic limiting balls slide along the pair of guide grooves respectively.

5. A laminectomy system according to any one of claims 1-4, characterized in that, At least one bone screw hole is provided on the side wing. The bone screw hole is an inverted conical hole. The lower surface of the side wing is provided with anti-slip teeth, and the extending direction of the anti-slip teeth intersects the axial direction of the bone screw hole.

6. A laminectomy system according to claim 5, characterized in that, The upper surface of the central body is rough or has a microporous structure to promote soft tissue adhesion; the lower surface of the central body is smooth or has an anti-adhesion coating. The central body is configured with a layered structure, including an inner core layer and an outer functional layer. The inner core layer is made of biodegradable magnesium alloy, and the outer functional layer has a porous structure. The magnesium alloy releases magnesium ions when it degrades in vivo.

7. The laminectomy system according to claim 1, characterized in that, The central body is provided with multiple drug-carrying mechanisms, each of which includes a through hole that is opened through the central body. A drug sustained-release carrier is detachably embedded in the through hole. The drug sustained-release carrier contains an anti-scarring drug, an anti-inflammatory drug, or a bone growth factor.

8. A laminectomy system according to claim 1, characterized in that, The central body is also provided with an auxiliary fixation mechanism, which includes auxiliary fixation interfaces opened on the front and rear side walls of the central body. The auxiliary fixation interfaces are used to connect the transverse connecting rods of the posterior spinal fixation system, so that the lamina fixation plate system is integrated into the rod fixation system as a connecting structure. The opening of the auxiliary fixation interface is provided with a sealing plate in a detachable manner.

9. A device for preparing a laminectomy system, characterized in that, For preparing a laminectomy system as described in any one of claims 1-8, comprising: A molding die, used for integral molding or separate molding of the central body and side wings; A machining unit is used to machine arc-shaped grooves, sliding holes, through holes and / or auxiliary fixing interfaces on the central body; A surface treatment unit is used to roughen and smooth the upper and lower surfaces of the central body, respectively. An assembly unit is used to assemble the side wings to the central body via an adjustable connecting mechanism, and to install limiting screws, elastic limiting balls, drug sustained-release carriers and / or sealing plates.

10. A method for preparing a laminar fixation plate system, used to prepare a laminar fixation plate system as described in any one of claims 1-8, characterized in that, Includes the following steps: Step S1: Prepare the blanks of the central body and side wings using a molding die; Step S2: The machining unit processes arc-shaped grooves, sliding holes, through holes and / or auxiliary fixing interfaces on the central body; Step S3: Roughen the upper surface of the central body and smooth the lower surface using the surface treatment unit; Step S4: Assemble the side wings onto the central body via an adjustable connecting mechanism using the assembly unit; Step S5: Install the limiting screws, elastic limiting balls, drug sustained-release carriers and / or sealing plates to complete system assembly.

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