A degradable laminoplasty device

Abstract

The application belongs to the field of medical devices, and particularly relates to an interlamina fixation device and a use method thereof. The defects of long-term implantation of titanium alloy in the prior art are solved, and a new solution is provided for a lamina replantation operation. A 3D-printed degradable zinc alloy material is used, the degradation period of the zinc alloy material is greater than the tissue healing period, and the product is arranged on each side or multiple sides of the vertebra to be installed, the product comprises a fixed plate group and a bone screw, two ends of the fixed plate group are fixed on the vertebra to be installed and the vertebral body, and the fixed plate group is used for fixing the cut part of the vertebra to the vertebral body, the bone screw is arranged at each fixed node, and the product has the advantages of modular assembly, a plurality of fixed plates can be used according to a specific operation plan by a person skilled in the art to realize a stable fixing effect and ensure the fitting degree of an intervention device, the fixed point has multiple design schemes, and the fixed force effect is good.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a biodegradable vertebral laminectomy device and its usage method. Background Technology

[0002] The cervical spine is the smallest of the vertebrae in the entire spine, but it has the greatest flexibility, the highest frequency of movement, and bears the most weight. Its structure is also the most complex and unique, with poor stability, making it most susceptible to injury. Acute and chronic injuries to the cervical spine, especially various cervical spondylosis, have long been common ailments affecting people. The lamina is a crucial component of the posterior structure of the spinal canal, playing a vital role in protecting the spinal cord and maintaining the stability of the cervical spine.

[0003] In situ reimplantation of laminectomy is an effective surgical procedure for treating benign tumors in the spinal canal. It can maintain the integrity of the spinal canal and prevent postoperative scar formation from compressing the spinal cord again and causing neurological symptoms. Based on spinal biomechanics research and long-term clinical observation, it is generally recognized that the posterior structures of the spine play an indispensable role in maintaining spinal stability. Therefore, posterior implantation is the preferred experimental method.

[0004] In existing technologies, the vertebral lamina used is mostly made of non-degradable titanium alloy. In the body fluid environment, titanium alloy will undergo slight corrosion and continuously release metal ions such as titanium and aluminum. Moreover, since titanium alloy has no osteoinductive properties, "malintegration" may occur at the interface with bone tissue during long-term use, and there is also a bleaching effect. Summary of the Invention

[0005] The purpose of this invention is to solve the problem of long-term implantation defects of titanium alloys in the prior art.

[0006] The specific solution of the present invention is as follows: A biodegradable vertebral laminectomy fixation plate is designed using a 3D-printed biodegradable zinc alloy material. The degradation period of the zinc alloy material is longer than the tissue healing period. The product is placed on both sides or multiple sides of the vertebra to be installed. The product includes a fixation plate assembly and bone screws. The two ends of the fixation plate assembly are fixed to the vertebra and vertebral body to be installed, and are used to fix the resected part of the vertebra to the vertebral body. The bone screws are installed at each fixation node. The fixation plate assembly includes a single fixation plate or at least two fixation plates that are assembled together. The end of the fixation plate assembly includes at least three dispersed fixation rings, and bone screws are installed in the fixation rings.

[0007] In specific implementation, the fixation ring includes multiple combined units, and the whole is shaped like a plum blossom. The petals and the flower core are slidably locked together. The curvature of the flower core and petals is designed in advance through the design of the mechanical mechanism. Bone cement is applied between the petals and the vertebral body. The surface of the petals facing the vertebral body is provided with 3D printed honeycomb holes.

[0008] In specific implementation, the sliding clamping includes a lip with a circular cross-section set on the outer edge of the fixing ring, and the petal edge is an open ring with corresponding shape and position. The petal edge can be clamped on the lip to form a gap fit. The petal is 3D printed and the shape and position dimensions are determined according to the designed installation position.

[0009] In a specific implementation, the petals are replaced by multiple triangular plates, with connecting pieces between the triangular plates and a hinged connection between the triangular plates and the connecting pieces.

[0010] In a specific implementation, the edge of the petal is provided with a fine hole through which the suture thread can pass, and the corresponding groove below the fixing plate assembly is provided for the suture thread to pass through.

[0011] In practice, the thickness of the end of the fixing plate group is greater than the thickness of the middle of the fixing plate group.

[0012] Alternatively, the structure of the fixing plate assembly can be replaced by a base plate and a top plate, with the base plate covering the installation area and the top plate covering the end of the fixing rod assembly, and a ratchet toothed mating surface with a self-locking function provided between the base plate and the top plate.

[0013] In specific implementation, a dovetail groove-shaped sliding connection is provided between the top plate and the bottom plate.

[0014] This design also includes a method of using a lamina, employing the aforementioned biodegradable lamina reimplantation surgical fixation plate, comprising the following steps: (1) Data collection: Case data and diagnostic data of patients involving fixation plate structures and joint structures requiring curvature deformation; (2) Printing: Using 3D printing equipment and zinc alloy materials to print fixation plates and bone screws; (3) Assembly: The equipment is assembled and debugged during the operation; In step (3), bone nails are provided at the ends of the fixation plate assembly, and the fixation plate assembly and the vertebrae are fitted together in a consistent shape and position.

[0015] The fixation plate assembly has through holes on the outer petal edge of the fixation ring. Before the bone screw is installed, the suture is knotted and passed through the through holes, then through the bottom of the fixation plate assembly, and finally removed from the bone screw hole, so as to drive the petal and the vertebra to form a fastening.

[0016] The beneficial effects of this invention are as follows: The material is made of zinc alloy, including the bone screw, which is biodegradable and the degradation products can be metabolized and absorbed by the human body. The degradation period is longer than the tissue healing period. In addition, the material itself has good biocompatibility and is not likely to cause obvious local inflammatory reactions after implantation. Especially suitable for postoperative repair of spinal canal tumors. Compared with existing technologies, this application provides a brand-new technical concept. By reimplanting and fixing the resected part in situ, the resected part is perfectly integrated into the cervical spine, which is conducive to rapid repair and greatly reduces the use of prostheses.

[0017] Combined with 3D printing technology, the overall shape fits perfectly with the surface of the vertebral body in the affected segment, increasing the stress-bearing area and reducing stress concentration at the connection points. Further improvements were made to the structure of the auxiliary positioning device, making it more modular and targeted. At the same time, as an auxiliary positioning and fixation device, its fixation and positioning effect is better and the postoperative prognosis cost is lower. The design of the fixing plate has been improved in particular to address the characteristics of the explanation process. In the specific implementation process, a design with thicker ends and thinner middle can be adopted to provide support strength throughout the degradation process, effectively preventing the fixing plate assembly from collapsing in the middle and achieving a good and effective prognosis. Attached Figure Description

[0018] Figure 1 This diagram illustrates the usage status of the present application. Figure 2 A schematic diagram of the structure of this application is shown. Figure 3 A schematic diagram of another preferred embodiment of this application is shown. Figure 4 This is a perspective view of the reimplantation surgical device of the present invention; Figure 5 yes Figure 4 The front view of the structure shown; Figure 6 yes Figure 4 Top view of the structure shown; Figure 7 yes Figure 4 Left view of the structure shown; Figure 8 This is a schematic diagram of the fixing ring portion in another embodiment; Figure 9 This is a schematic diagram of the working structure of the ratchet teeth in another embodiment; Figure 10 This is a schematic diagram of the petal structure in yet another embodiment; In the attached diagram: 1. Fixation plate assembly; 2. Bone screw mounting hole; 3. Fixation ring; 4. Petal; 5. Vertebra to be installed; 6. Vertebrae; 7. Suture; 8. Dovetail groove; 9. Base plate; 10. Top plate. Detailed Implementation

[0019] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention. Example 1

[0020] A biodegradable lamina reimplantation surgical fixation plate, see [link to relevant documentation]. Figures 1 to 3 The product is made of 3D-printed biodegradable zinc alloy material, the degradation period of which is longer than the tissue healing period. The product is installed on both sides or multiple sides of the vertebra 5 to be installed. The product includes a fixation plate assembly 1 and bone screws. The two ends of the fixation plate assembly 1 are fixed to the vertebra 5 and vertebral body 6 to be installed, and are used to fix the removed part of the vertebra to the vertebral body 6. The bone screws are installed at each fixation node. The fixation plate assembly 1 includes a whole fixation plate or at least two fixation plates with an assembly relationship. The end of the fixation plate assembly 1 includes at least three dispersed fixation rings 3, and bone screws are installed in the fixation rings 3.

[0021] This design also includes a method of using a lamina, employing the aforementioned biodegradable lamina reimplantation surgical fixation plate, comprising the following steps: (1) Data collection: Case data and diagnostic data of patients involving fixation plate structures and joint structures requiring curvature deformation; (2) Printing: The fixation plate assembly 1 and bone screws were printed using 3D printing equipment and zinc alloy materials; (3) Assembly: The equipment is assembled and debugged during the operation; In step (3), bone nails are provided at the end of the fixation plate assembly 1, and the fixation plate assembly 1 and the vertebrae are fitted together in a consistent shape and position.

[0022] The fixation plate assembly 1 has a through hole on the edge of the outer petal 4 of the fixation ring 3. Before the bone screw is installed, the suture 7 is knotted and passed through the through hole, then through the bottom of the fixation plate assembly 1 and out of the bone screw hole, so as to drive the petal 4 and the vertebra to form a fastening.

[0023] like Figure 1 As shown, this application discloses a fixation device for vertebral laminectomy, which adopts a solution that is completely different from the prior art. The whole structure is a thin sheet structure with undulations in shape according to the shape of the vertebral body 6 surface. With the help of 3D printing technology, it can be perfectly matched with the surface of the patient's cervical spine, thereby achieving thinness and stability.

[0024] This application is particularly suitable for postoperative repair of spinal canal tumors. Spinal canal tumors usually require surgical removal, which inevitably involves removing part of the vertebrae to expose the tumor. This application reimplantes the removed vertebrae in situ and then fixes them tightly with a fixation plate. This method can preserve the integrity of the vertebrae to the maximum extent, fully preserve the osteoinductive properties of the bone tissue, and the shape of the joint surface can also be highly matched, which can accelerate the healing cycle.

[0025] The fixation plate is used to fix the removed vertebral bone to the vertebral body 6. The two end plates of the fixation plate are connected into a whole by a flat connecting strip in the middle. The end plates are fixed to the removed vertebral bone and the vertebral body 6 respectively. After fixation, the two parts are stably connected together. Those skilled in the art can use multiple fixation plates to achieve a stable fixation effect according to the specific surgical plan.

[0026] like Figure 2 As shown, the endplate is not a flat plate, but rather a shape that perfectly matches the surface of vertebral body 6. It is formed using 3D printing technology, allowing it to be molded to match the incision location and the surface shape of vertebral body 6 in different patients. Based on this, the thickness of the endplate can be greatly reduced, alleviating or eliminating the feeling of a foreign body, while also increasing the contact area with bone tissue. The stress is fully distributed, making it less prone to loosening due to concentrated stress.

[0027] More importantly, the fixation plate in this embodiment is biodegradable as a whole. Of course, the degradation period is longer than the bone healing period. During the bone healing process, it maintains an effective fixation effect. After complete degradation, it no longer requires a second surgery to remove it.

[0028] Furthermore, this application can also be combined with porous structures or drug delivery mechanisms to achieve better treatment results for more difficult cases.

[0029] Another preferred embodiment, such as Figure 3 As shown, the width of the endplate is similar to that of the connecting plate, and the area in the vertebral part is smaller, which is conducive to the implementation of the planned preoperative plan.

[0030] In this embodiment, the system comprises a fixation plate and matching bone screws, both made of advanced biodegradable composite materials. Its design essence lies in the precise matching of the material's degradation kinetics with the biological process of bone tissue healing in the human body. After implantation, the fixation plate initially provides robust mechanical support, and subsequently its degradation rate is essentially synchronized with the growth rate of new bone tissue. Ultimately, the entire implant completely degrades, and its degradation products are harmless small molecules (such as water and carbon dioxide) that can be naturally metabolized and absorbed by the body, eliminating the need for a second surgery to remove it. This achieves an ideal transformation from a "permanent foreign body" to a "temporary scaffold" and then to "autologous tissue."

[0031] The core function of the fixation plate is to achieve a stable bridging and fusion between the resected vertebral fragment and the main vertebral body 6. Its main structure consists of two end plates attached to the bone surface and an integrated central connecting strip. This connecting strip is flat, ensuring axial stiffness while reducing the overall profile and minimizing irritation to surrounding soft tissues. During surgery, bone screws are used to firmly fix the end plates to the resected bone fragment and the adjacent healthy vertebral body 6, forming a rigid, integrated connection that effectively maintains intervertebral height and alignment, creating a stable biomechanical environment for bone healing. Example 2

[0032] The installation principle of this embodiment is the same as that of embodiment 1. The specific difference is that the fixing ring 3 includes multiple combined units and is shaped like a plum blossom. The petals 4 are slidably locked to the flower core. The curvature of the flower core and petals 4 is designed in advance through the design of the mechanical mechanism. Bone cement is applied between the petals 4 and the vertebral body 6. The surface of the petals 4 facing the vertebral body 6 is provided with 3D printed honeycomb holes.

[0033] The sliding clamp includes a lip with a circular cross-section set on the outer edge of the fixing ring 3. The edge of the petal 4 is an open ring with a corresponding shape and position. The edge of the petal 4 can be clamped on the lip to form a gap fit. The petal 4 is 3D printed and its shape and position are determined according to the designed installation position.

[0034] In this embodiment, to adapt to different vertebral body morphologies and surgical needs, the fixation plate adopts a unique modular design. Its basic shape is a biomimetic plum blossom shape, consisting of a central "flower core" unit and multiple surrounding "petal" units assembled through a precision clamping structure such as hinges or deformable rivets. The key advantage of this design lies in its preoperative adjustability: surgeons can pre-adjust the relative curvature and angle between the "flower core" and "petal" units using a simple mechanical adjustment mechanism based on the patient's CT data. This allows the fixation plate to better conform to the individualized vertebral surface anatomy, achieving personalized matching and improving adhesion and fixation effectiveness.

[0035] The system boasts a high degree of design flexibility. The quincunx structure can be derived into a mesh-like structure formed by multiple triangular plate units hinged together at nodes, providing isotropic mechanical support. Furthermore, the "petal 4" unit, with its larger enclosing area, distributes adaptive adjustment capabilities across key nodes of the entire fixed plate, enabling more precise biomechanical control. Example 3

[0036] The installation principle of this embodiment is the same as that of embodiment 1. The specific difference is that the petal 4 is replaced by multiple triangular plates, and a connecting piece is provided between the triangular plates. A hinged connection is provided between the triangular plates and the connecting piece.

[0037] The edge of the petal 4 has a small hole through which the suture 7 can pass, and the lower part of the corresponding fixing plate assembly 1 has a groove through which the suture 7 passes. The thickness of the end of the fixing plate assembly 1 is greater than the thickness of the middle of the fixing plate assembly. Example 4

[0038] The installation principle of this embodiment is the same as that of embodiment 1. The specific difference is that the structure of the fixing plate group 1 is replaced by a base plate 9 and a top plate 10. The base plate 9 covers the installation area, and the top plate 10 covers the end of the fixing rod group. The base plate 9 and the top plate 10 are provided with a ratchet toothed mating surface with self-locking function.

[0039] The top plate 10 and the bottom plate 9 are connected by a dovetail groove 8-type sliding groove.

[0040] The design aims to ensure that the strength at the ends is always greater than that in the middle, providing excellent support. Simultaneously, the dovetail groove connection and ratchet-toothed mating surfaces effectively enable rapid installation of multi-layered structures and self-locking around the installation circumference. This significantly improves surgical precision and saves surgical time.

[0041] 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 foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A biodegradable lamina reimplantation surgical device, characterized in that: The product is made of 3D-printed biodegradable zinc alloy material. The degradation cycle of the zinc alloy material is longer than the tissue healing cycle. The product is installed on both sides or multiple sides of the vertebra (5) to be installed. The product includes a fixation plate assembly (1) and bone screws. The two ends of the fixation plate assembly (1) are fixed to the vertebra (5) and vertebral body (6) to be installed, and are used to fix the removed part of the vertebra to the vertebral body (6). The bone screws are installed at each fixation node. The fixation plate assembly (1) includes a whole fixation plate or at least two fixation plates with an assembly relationship. The end of the fixation plate assembly (1) includes at least three dispersed fixation rings (3), in which bone screws are installed.

2. The biodegradable lamina reimplantation surgical device as described in claim 1, characterized in that: The fixation ring (3) includes multiple combined units, and the whole is in the shape of a plum blossom. The petals (4) are slidably locked to the flower core. The curvature of the flower core and the petals (4) is designed in advance through the design of the mechanical mechanism. Bone cement is applied between the petals (4) and the vertebral body (6). The surface of the petals (4) facing the vertebral body (6) is provided with 3D printed honeycomb holes.

3. The biodegradable lamina reimplantation surgical device as described in claim 2, characterized in that: The sliding clamp includes a lip with a circular cross-section set on the outer edge of the fixing ring (3), and the edge of the petal (4) is an open ring with corresponding shape and position. The edge of the petal (4) can be clamped on the lip to form a gap fit. The petal (4) is 3D printed and the shape and position dimensions are determined according to the designed installation position.

4. The biodegradable lamina reimplantation surgical device as described in claim 3, characterized in that: The petal (4) is replaced by multiple triangular plates, with connecting pieces between the triangular plates and a hinged connection between the triangular plates and the connecting pieces.

5. The biodegradable lamina reimplantation surgical device as described in claim 4, characterized in that: The petal (4) has a small hole on its edge through which the suture line (7) can pass, and the corresponding fixing plate assembly (1) has a groove below it through which the suture line (7) can pass.

6. The biodegradable lamina reimplantation surgical device as described in claim 5, characterized in that: The thickness of the end of the fixing plate group (1) is greater than the thickness of the middle of the fixing plate group.

7. The biodegradable lamina reimplantation surgical device as described in claim 5, characterized in that: The structure of the fixing plate group (1) is replaced by a bottom plate (9) and a top plate (10). The bottom plate (9) covers the installation area, and the top plate (10) covers the end of the fixing rod group. The bottom plate (9) and the top plate (10) are provided with a ratchet toothed mating surface with self-locking function.

8. The biodegradable lamina reimplantation surgical device as described in claim 1, characterized in that: The top plate (10) and the bottom plate (9) are connected by a dovetail groove (8) type sliding groove.

9. A method of using a laminectomy reimplantation surgical device, comprising using the biodegradable laminectomy reimplantation surgical device as described in claim 1, characterized in that, Includes the following steps: (1) Data collection: Case data and diagnostic data of patients involving fixation plate structures and joint structures requiring curvature deformation; (2) Printing: The fixation plate assembly (1) and bone screws are printed using 3D printing equipment and zinc alloy materials; (3) Assembly: The equipment is assembled and debugged during the operation; (4) In step (3), the end of the fixation plate assembly (1) is provided with bone nails, and the fixation plate assembly (1) and the vertebrae are fitted together in a consistent shape and position.

10. The method of using the lamina as described in claim 9, characterized in that: The fixation plate assembly (1) has a through hole on the edge of the petal (4) outside the fixation ring (3). Before the bone screw is installed, the suture (7) is knotted and passed through the through hole, passing under the fixation plate assembly (1) and then taken out from the bone screw hole, so as to drive the petal (4) and the vertebra to form a fastening.

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