Pedicle screw and method of making same, support seat removal device for pedicle assembly

CN122581876APending Publication Date: 2026-08-18SUZHOU & SCI & TECH DEV
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Patent Information

Application Number
CN202611081925.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-21
Publication Date
2026-08-18

AI Technical Summary

Technical Problem

[0006]本发明的目的在于提供一种椎弓根钉,以解决现有3D打印多孔椎弓根螺钉单一晶格结构疲劳强度不足,且无独立可控通道用于填充增强材料,易出现骨水泥堵塞骨长入孔隙、支撑残留加剧应力集中的问题

Benefits of technology

[0018]本发明的有益效果是:本发明的椎弓根钉的螺纹结构与晶格区径向部分重叠形成互锁结构,提升钉体整体稳定性,在晶格区可设置高孔隙率以匹配人体骨骼模量、减轻应力遮挡,晶格区中部轴向螺旋排布的螺旋通道可定向灌注骨水泥实现内部力学强化。

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Abstract

The present application provides a pedicle screw, which comprises a screw cap, a screw head, a screw body connecting the screw cap and the screw head, the screw body comprises a lattice region arranged radially inside and a threaded structure arranged around the lattice region, the root of the threaded structure is embedded radially inside the lattice region to form an interlocking structure, the lattice region is provided with a spiral channel in the middle part in the radial direction, the spiral channel is arranged in the axial direction in a spiral manner, the spiral channel has an inlet end close to the screw cap and an outlet end close to the screw head, and the screw cap, the screw head and the threaded structure are solid structures. The threaded structure of the pedicle screw of the present application is radially overlapped with the lattice region to form an interlocking structure, the overall stability of the screw body is improved, the high porosity can be arranged in the lattice region to match the modulus of the human skeleton and reduce stress shielding, and the spiral channel arranged in the middle part of the lattice region in the axial direction in a spiral manner can be used for directional injection of bone cement to realize internal mechanical reinforcement.
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Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a pedicle screw and its manufacturing method, and a device for removing the support seat of the pedicle assembly. Background Technology

[0002] Traditional machined solid pedicle screws are the mainstream implant for spinal internal fixation. However, the elastic modulus of the material is much higher than that of human bone tissue, which can easily lead to severe stress shielding after implantation, causing bone resorption and screw loosening in the long term. Conventional solid structures lack bone ingrowth channels and rely solely on mechanical thread engagement for fixation, resulting in a postoperative screw loosening risk of 8% to 15%. The industry has introduced 3D-printed porous pedicle screws, which reduce the elastic modulus through a lattice porous structure and induce bone tissue ingrowth through interconnected pores, improving the biocompatibility between the screw and the vertebral body and effectively alleviating the inherent defects of traditional solid screws.

[0003] Existing 3D-printed porous pedicle screws mostly employ a single-lattice porous structure. If the porosity is increased to more than 50% to meet bone ingrowth requirements, the screw's fatigue strength will significantly decrease, making it difficult to withstand long-term cyclic loads on the human spine and increasing the risk of screw breakage postoperatively. Current improvements only add straight radial reinforcing beams. This structure is a permanent, one-piece molding structure with constant mechanical properties throughout the healing process, failing to meet the differentiated mechanical needs at different stages of bone healing. Furthermore, the straight beam structure has weak capacity to distribute multi-directional spinal loads, resulting in significant stress concentration issues and limited improvement in fatigue resistance.

[0004] Meanwhile, existing porous screws do not have built-in controllable filling channels. In order to improve the strength of the porous area, bone cement is often directly filled in the whole. The bone cement is prone to disorderly seeping into all the lattice pores, blocking the bone ingrowth channels and destroying the biocompatibility of the porous structure.

[0005] In view of this, it is necessary to improve the existing pedicle screws to solve the above problems. Summary of the Invention

[0006] The purpose of this invention is to provide a pedicle screw that solves the problems of insufficient fatigue strength of the single lattice structure of existing 3D printed porous pedicle screws, lack of independent and controllable channels for filling reinforcing materials, easy blockage of bone ingrowth pores by bone cement, and stress concentration caused by residual support.

[0007] To achieve the above objectives, the present invention provides a pedicle screw, which includes a screw head, a screw cap, and a screw body connecting the screw cap and the screw head. The screw body includes a lattice region arranged radially inside and a threaded structure arranged around the lattice region. The root of the threaded structure is radially embedded inside the lattice region to form an interlocking structure. A helical channel is provided in the radial center of the lattice region. The helical channel is arranged helically along the axial direction and has an inlet end near the screw cap and an outlet end near the screw head. The screw cap, screw head, and threaded structure are solid structures.

[0008] As a further improvement of the present invention, the number of spiral channels is greater than or equal to two.

[0009] As a further improvement of the present invention, the pedicle screw is manufactured by 3D printing.

[0010] As a further improvement of the present invention, the lattice region includes a first lattice layer close to the spiral channel on both radial sides and a second lattice layer away from the spiral channel on both radial sides, wherein the porosity of the first lattice layer is less than the porosity of the second lattice layer.

[0011] As a further improvement of the present invention, the porosity of the first lattice layer is 25%~30%, and the porosity of the second lattice layer is 40%~50%.

[0012] As a further improvement of the present invention, the line diameter of the first lattice layer is 80~100μm, and the line diameter of the second lattice layer is 150~200μm.

[0013] This invention also provides a pedicle screw assembly support removal device. The pedicle screw assembly obtained by printing is connected to the support seat through a support wire on a threaded structure. The pedicle screw assembly support removal device is used to remove the support seat on the printed pedicle screw assembly to obtain the pedicle screw as described above. The screw head has a recessed fixing groove. The pedicle screw assembly support removal device includes:

[0014] A clamping member that clamps the nail body axially, with the nail head located above the clamping member, the clamping member being used to restrict downward movement of the pedicle assembly; A limiting shaft is inserted into the fixing groove to restrict the circumferential rotation of the pedicle assembly; A cutting component, the cutting component comprising a rotating body and a cutting portion disposed on the rotating body; A driving component, which is connected to the cutting component to drive the cutting component to rotate circumferentially and cause the cutting part to cut the support wire.

[0015] As a further improvement of the present invention, both sides of the rotating body are provided with cutting portions, and the driving component is a bidirectional rotating motor.

[0016] As a further improvement of the present invention, the cutting part includes a plurality of blades spaced apart in the vertical direction, and the driving member includes a driving motor connected to the cutting member and an axial driving structure for driving the driving motor to move up and down in the vertical direction.

[0017] The present invention also provides a method for manufacturing a pedicle screw, the method comprising the following steps: S1: The pedicle assembly was prepared using 3D printing. S2: Provides a support removal device for the pedicle assembly as described above, using a clamping member to hold the nail body so that the limiting shaft is inserted into the fixing groove; S3: The driving component drives the cutting component to rotate and cut the support wire, causing the pedicle screw to separate from the support seat; S4: Grind off the remaining part of the support wire on the threaded structure to obtain the pedicle screw.

[0018] The beneficial effects of the present invention are: the threaded structure of the pedicle screw of the present invention overlaps with the radial part of the lattice region to form an interlocking structure, which improves the overall stability of the screw body; high porosity can be set in the lattice region to match the modulus of human bones and reduce stress shielding; the spiral channels arranged axially in the middle of the lattice region can be directionally injected with bone cement to achieve internal mechanical strengthening. Attached Figure Description

[0019] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a side view of the pedicle screw assembly of the present invention before the support seat is removed; Figure 2 This is a top view of the pedicle screw assembly of the present invention before the support seat is removed; Figure 3 This is a side perspective structural diagram of the pedicle screw of the present invention; Figure 4 yes Figure 3 Schematic diagram of the cross-sectional structure of AA; Figure 5 This is a side view of the pedicle screw of the present invention; Figure 6 This is a schematic diagram of the structure of the pedicle assembly support seat removal device of the present invention during operation; Figure 7This is a schematic diagram of the cutting component of the pedicle assembly support seat removal device of the present invention; Figure 8 This is a top view schematic diagram of part of the structure of the pedicle assembly support seat removal device of the present invention during operation; Figure 9 This is a schematic diagram of the pedicle screw of the present invention after the support seat is removed; Figure 10 This is a flowchart of the method for manufacturing the pedicle screw of the present invention.

[0020] Reference numerals: 100, Pedicle assembly; 1, Pedicle nail; 11, Nail head; 111, Fixing groove; 12, Nail head; 13, Nail body; 131, Lattice region; 1311, First lattice layer; 1312, Second lattice layer; 1313, Spiral channel; 1314, Inlet end; 1315, Outlet end; 132, Threaded structure; 1321, Interlocking structure; 2, Support seat; 3, Support wire; 200, Support seat removal device for pedicle assembly; 201, Clamping component; 202, Limiting shaft; 203, Cutting component; 2031, Rotating body; 2032, Cutting section; 2033, Blade; 204, Driving component. Detailed Implementation

[0021] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0023] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, the technical features involved in the different embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0024] like Figures 1 to 9 As shown, the present invention provides a pedicle screw 1, which includes a screw head 11, a screw head 12, and a screw body 13 connecting the screw head 11 and the screw head 12. The screw body 13 includes a lattice region 131 arranged radially inside and a threaded structure 132 arranged around the lattice region 131. The root of the threaded structure 132 is radially embedded inside the lattice region 131 to form an interlocking structure 1321. The lattice region 131 has a helical channel 1313 in the radial middle. The helical channel 1313 is arranged helically in the axial direction. The helical channel 1313 has an inlet end 1314 near the screw head 11 and an outlet end 1315 near the screw head 12. The screw head 11, the screw head 12, and the threaded structure 132 are solid structures.

[0025] The lattice region 131 is in the shape of a hollow column, and the spiral channel 1313 is located in the middle of the lattice region 131 along the thickness direction, that is, the spiral channel 1313 is formed by the lattice region 131.

[0026] In this embodiment, the threaded structure 132 and the radial portion of the lattice region 131 overlap and interlock, and the root of the thread is embedded inside the lattice, eliminating the risk of separation between the thread and the porous lattice interface, greatly improving the overall structural stability of the nail body 13. While ensuring high porosity, elastic modulus close to human bones, and reducing stress shielding, it effectively improves the defects of insufficient strength of a single porous structure.

[0027] A spiral channel 1313 with an axial through-hole is provided in the middle of the lattice region 131, which can be used to directionally inject bioactive bone cement. The bone cement is only retained in the spiral channel 1313 and will not diffuse disorderly and block the pores of the outer lattice. The bone ingrowth channel of the lattice region 131 is completely preserved, taking into account both mechanical enhancement and biointegration performance.

[0028] The spiral channel 1313 is arranged spirally along the axial direction to form a built-in spiral reinforcement skeleton, which can evenly distribute the multi-directional cyclic load of the spine, improve the shortcomings of traditional straight reinforcement beams that cannot adapt to multi-directional forces and stress concentration, significantly improve the overall fatigue resistance and shear resistance of the screw, and reduce the risk of screw breakage after surgery.

[0029] The spiral channel 1313 can gradually degrade with the bone cement in the later stages, realizing the temporal evolution of the screw's mechanical properties: in the early stage of implantation, the bone cement provides high-strength support to meet the initial fixation requirements of the surgery; after bone healing, the cement degrades, the overall modulus of the screw is further reduced, reducing long-term stress shielding and adapting to the mechanical needs of different stages of bone healing.

[0030] In this embodiment, the screw head 12, screw cap 11, and thread structure 132 are all made of solid material. The solid material can significantly improve the basic mechanical strength of the screw surgical operation end and the vertebral body occlusion site. On the one hand, the solid structure of the screw cap 11 can stably match various spinal surgical instruments. During the operation, it is not easy to deform or slip during screwing, spreading and other operations, ensuring the reliability of the surgical operation. On the other hand, the solid segment of the screw head 12 can achieve rapid and stable puncture anchoring in the early stage of implantation. The peripheral solid thread and the lattice region 131 radially overlap and interlock. The high rigidity of the solid thread forms a reliable mechanical holding force, avoiding the problem of easy wear and breakage of porous threads. While the porous lattice region is responsible for matching the bone elastic modulus and inducing bone ingrowth, the solid component bears the main operating load and the initial fixation load. The whole takes into account biocompatibility and structural rigidity, effectively reducing the risk of intraoperative damage and early postoperative fixation failure.

[0031] The number of spiral channels 1313 is greater than or equal to two. Multiple spiral channels 1313 can further disperse the internal load of the nail body 13, and simultaneously improve the uniformity of bone cement filling and the overall fatigue resistance. In this embodiment, the number of spiral channels 1313 is two.

[0032] The pedicle screw 1 is manufactured using 3D printing. The 3D printing process allows for the customization of lattice pore parameters and the layout of the helical channels 1313, adapting to the different skeletal anatomy characteristics of patients. Furthermore, it enables the integrated molding of the solid body, lattice, and helical channels 1313, simplifying the manufacturing process.

[0033] The lattice region 131 includes a first lattice layer 1311 along both radial sides close to the spiral channel 1313 and a second lattice layer 1312 along both radial sides away from the spiral channel 1313, wherein the porosity of the first lattice layer 1311 is less than the porosity of the second lattice layer 1312.

[0034] In this embodiment, the lattice region 131 is divided into a first lattice layer 1311 with lower porosity adjacent to the spiral channel 1313 and a second lattice layer 1312 with higher porosity on the outside, forming a gradient lattice structure with differentiated pores. The first lattice layer 1311 with lower porosity is more compact and can form a barrier to prevent the slurry from seeping outward and blocking the second lattice layer 1312 on the outside for bone ingrowth when bone cement is poured. This preserves the osteogenic space of the outer porous structure. At the same time, the gradient pore arrangement can guide the air bubbles generated during casting to be quickly discharged along the spiral channel 1313, reduce air bubble defects in the channel, ensure that the inner spiral channel 1313 is filled densely, and take into account both the internal mechanical strengthening effect and the bio-integration function of the outer lattice.

[0035] In this embodiment, the porosity of the first lattice layer 1311 is 25%~30%, and the porosity of the second lattice layer 1312 is 40%~50%. Limiting the porosity of the first lattice layer 1311, which is adjacent to the spiral channel 1313, to 25%~30% significantly reduces the lattice interconnection aperture, forming a dense, impermeable barrier that prevents bone cement powder clusters from permeating outwards and avoids clogging the outer lattice. The porosity of the outer second lattice layer 1312 is set to 40%~50%, ensuring both structural mechanical strength and high air permeability. During bone cement injection, air bubbles in the channel can quickly pass through the second lattice layer 1312 and be discharged, eliminating casting bubble defects. Simultaneously, the high porosity of the second lattice layer 1312 allows for sufficient pore space for human bone tissue ingrowth, balancing internal impermeability and air venting with long-term bone integration effects.

[0036] In this embodiment, the line diameter of the first lattice layer 1311 is 80~100μm, and the line diameter of the second lattice layer 1312 is 150~200μm.

[0037] The first lattice layer 1311 uses a finer lattice line diameter of 80~100μm, which can form dense and uniform micropores at a low porosity of 25%~30%, with the equivalent pore size controlled within 5μm. This effectively blocks the penetration of bone cement flow units, since the effective flow unit of bone cement is 5~10μm. This setting of the equivalent pore size can enhance the seepage prevention effect. In addition, the thickness of the first lattice layer 1311 is about 100μm.

[0038] The second lattice layer 1312 uses a coarser lattice wire diameter of 150~200μm, which can form a large-size air passage of 30~80μm under a high porosity of 40%~50%, ensuring smooth gas discharge. At the same time, the coarser wire diameter can improve the overall structural strength of the outer lattice and prevent the high-porosity lattice from breaking under stress. The combination of coarse and fine wire diameters with double-layer gradient porosity can simultaneously achieve the triple functions of seepage prevention, air discharge, and structural reinforcement.

[0039] like Figures 6 to 9As shown, since porous structures require extensive support during 3D printing, manual removal of these supports can easily leave impurities and disrupt lattice connectivity, further exacerbating stress concentration and hindering the large-scale clinical application of porous pedicle screws. Therefore, this invention also provides a device for removing the support seat 2 of a pedicle assembly 100. The pedicle assembly 100 obtained through printing is connected to the support seat 2 via a support wire 3 on a threaded structure 132. The device for removing the support seat 2 of the pedicle assembly 100 is used to remove the support seat 2 on the printed pedicle assembly 100 to obtain the pedicle screw 1. The screw head 11 has a recessed fixing groove 111. The device for removing the support seat 2 of the pedicle assembly 100 includes: A clamping member 201 clamps the nail body 13 axially, the nail head 12 is located above the clamping member 201, and the clamping member 201 is used to restrict the downward movement of the pedicle assembly 100; A limiting shaft 202 is inserted into the fixing groove 111 to restrict the circumferential rotation of the pedicle assembly 100. The cutting component 203 includes a rotating body 2031 and a cutting portion 2032 disposed on the rotating body 2031. A driving member 204 is connected to the cutting member 203 to drive the cutting member 203 to rotate circumferentially and cause the cutting part 2032 to cut the support wire 3.

[0040] This device achieves circumferential locking by axial positioning of clamping component 201 and insertion of limiting shaft 202 into fixing groove 111 of nail head 12, which can completely fix the 3D printed pedicle component 100. During the processing, the nail body 13 will not slide up or down or deflect circumferentially, ensuring that the cutting part 2032 is accurately aligned with the support wire 3 on the outside of the thread, avoiding the positioning deviation problem caused by screw shaking when manually grinding and prying.

[0041] The rotating body 2031 is arranged around the nail body 13, and the cutting part 2032 is arranged on the side of the rotating body 2031 facing the nail body 13. The support wire 3 is only arranged on the outside of the thread. The cutting part 203 is driven by the driving part 204 to perform circumferential rotation cutting, which only cuts the support wire 3 on the outside of the thread. It will not contact or scrape the solid thread profile, thus avoiding the defects of random breakage and pulling damage to the thread structure 132 when the support is removed manually. It completely preserves the solid structural strength and surgical anchoring performance of the thread.

[0042] The support wire 3 is equipped with preset stress concentration breakpoints. Under external force, the support wire 3 breaks precisely at the stress concentration point, preventing irregular tearing and eliminating the transmission of fracture stress to the root of the thread, which could cause thread chipping or lattice structure cracking, thus ensuring the overall molding quality of the pedicle screw 1. The stress concentration breakpoints on the support wire 3 are preset during printing and can be either weak points or bending points.

[0043] The pedicle assembly 100 support seat 2 removal device relies on the drive component 204 to provide standardized power, replacing manual removal operations, uniformly controlling the cutting force, number of rotations and feed stroke, eliminating product defects caused by uneven manual operation force and differences in operation techniques, greatly improving batch processing consistency, while reducing manual operation costs and shortening support removal time.

[0044] Cutting sections 2032 are provided on both circumferential sides of the rotating body 2031, and the driving component 204 is a bidirectional rotating motor. The bidirectional rotating motor drives the rotating body 2031 to rotate forward and in reverse. During forward rotation, one cutting section 2032 cuts the outer support wire 3 of the thread; during reverse rotation, the other cutting section 2032 simultaneously participates in the cutting operation. This enables bidirectional reciprocating cutting to clean the support wire 3, which not only speeds up the cutting efficiency of the support wire 3 and shortens the overall dismantling time, but also balances the cutting force, avoiding uneven load and excessive local wear on the rotating body 2031 caused by continuous cutting on one side. Simultaneously, the bidirectional alternating cutting can remove residual support debris from all directions, preventing debris from getting stuck in the thread gaps or lattice pores, completely protecting the thread profile and internal gradient lattice structure, and further improving the product molding qualification rate after support removal.

[0045] The cutting part 2032 includes a plurality of blades 2033 spaced apart in the vertical direction, and the driving member 204 includes a driving motor connected to the cutting member 203 and an axial driving structure for driving the driving motor to move up and down in the vertical direction.

[0046] In this embodiment, the pedicle assembly 100 is first completely locked and positioned by the clamping member 201 and the limiting shaft 202. The axial drive structure drives the drive motor and the cutting member 203 to move downward as a whole, so that the multiple sets of vertically spaced blades 2033 are aligned with the support wires 3 at different heights. The bidirectional rotation motor drives the rotating body 2031 to rotate circumferentially, and the multiple blades 2033 simultaneously cut the support wires 3 at the corresponding heights. After a single cut is completed, the axial drive structure drives the cutting member 203 to move up and down back and forth, and repeatedly cuts in conjunction with the bidirectional rotation, cutting off all the support wires 3 layer by layer to complete the dismantling.

[0047] It can also be used in conjunction with a bidirectional rotating motor to achieve gradual cutting from both sides inwards.

[0048] Multiple sets of vertically spaced cutting blades 2033 can simultaneously cut support wires 3 at different heights, and can handle multiple layers of support in a single rotation, greatly improving cutting efficiency; the axial drive structure drives the cutting part 203 to rise and fall vertically, which can adapt to the height position of all support wires 3 within the entire length of the nail body 13, with full coverage and no residue; the lifting feed combined with circumferential rotation composite cutting causes the support wires 3 to break neatly along the preset stress break point, with uniform force, avoiding pulling damage to the threads and lattice structure.

[0049] like Figure 10 As shown, the present invention also provides a method for manufacturing a pedicle screw 1, the method comprising the following steps: S1: The pedicle component 100 is prepared by 3D printing; the solid nail head 12, solid nail cap 11, nail body 13 with solid thread structure 132, lattice region 131 with high and low porosity layers inside the nail body 13, and axial spiral channel 1313 in the middle of the lattice are formed simultaneously. During printing, only the curved support wire 3 with stress concentration breakpoint is set on the outside of the thread structure 132. The pedicle nail 1 body and the bottom support seat 2 are connected by the support wire 3 to complete the integrated printing of the blank.

[0050] S2: A device for removing the support base 2 of the pedicle assembly 100 is provided. A clamping member 201 clamps the nail body 13, allowing the limiting shaft 202 to be inserted into the fixing groove 111. In this embodiment, the printed pedicle assembly 100 is loaded into the device. The clamping member 201 supports and clamps the nail body 13 axially, restricting the downward sliding of the pedicle assembly 100. Then, the limiting shaft 202 is inserted into the fixing groove 111 recessed in the nail head 11, locking the circumferential degree of freedom of the pedicle assembly 100 and achieving complete screw fixation without deviation. In this embodiment, the fixing groove 111 is a hexagonal groove.

[0051] S3: The driving component 204 drives the cutting component 203 to rotate and cut the support wire 3, so that the pedicle screw 1 is separated from the support seat 2. In this embodiment, the bidirectional rotating motor is started to drive the rotating body 2031 with multiple layers of spaced blades 2033 and cutting parts 2032 on both sides to rotate circumferentially. At the same time, the axial driving structure drives the cutting component 203 to move up and down in the vertical direction. Multiple sets of blades 2033 are aligned with the support wires 3 on the outside of the thread layer by layer to perform bidirectional reciprocating cutting. The support wires 3 are precisely cut along the preset stress concentration break point, so that the pedicle screw 1 body is completely separated from the bottom support seat 2.

[0052] S4: Grind off the remaining part of the support wire 3 on the thread structure 132 to obtain the pedicle screw 1. Lightly and finely grind the small amount of support wire 3 remaining on the outer wall of the thread to remove small protruding debris from the thread surface, and finally obtain the finished pedicle screw 1 with complete structure, no thread damage, and unobstructed lattice channels.

[0053] The manufacturing method of the pedicle screw 1 first involves 3D printing a pedicle component 100 with a gradient lattice and spiral channels 1313, and setting support wires 3 only on the outer side of the threads. Then, a special removal device is used to axially clamp and circumferentially lock the screw. The support wires 3 are precisely cut by a bidirectional liftable multi-blade cutting part 2033 to separate the screw body 13 from the support seat 2. Finally, only a small amount of residual wire is lightly ground to remove it. The entire process avoids pulling and grinding damage to the threads and internal porous lattice structure during manual removal of the support, and fully preserves the structural advantages of the screw in preventing air penetration, bone ingrowth, and mechanical reinforcement. The standardized machining process can unify the post-processing technology, effectively improving the quality and production efficiency of mass production.

[0054] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0055] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A pedicle screw, characterized in that: The pedicle screw includes a screw head, a screw body, and a screw body connecting the screw head and the screw body. The screw body includes a lattice region arranged radially inside and a threaded structure surrounding the lattice region. The root of the threaded structure is radially embedded inside the lattice region to form an interlocking structure. The lattice region has a helical channel in the radial middle. The helical channel is arranged helically in the axial direction. The helical channel has an inlet end near the screw head and an outlet end near the screw head. The screw head, screw body, and threaded structure are solid structures.

2. The pedicle screw according to claim 1, characterized in that: The number of spiral channels is greater than or equal to two.

3. The pedicle screw according to claim 1, characterized in that: The pedicle screws were manufactured using 3D printing.

4. The pedicle screw according to claim 1, characterized in that: The lattice region includes a first lattice layer along both radial sides close to the helical channel and a second lattice layer along both radial sides away from the helical channel, wherein the porosity of the first lattice layer is less than that of the second lattice layer.

5. The pedicle screw according to claim 4, characterized in that: The porosity of the first lattice layer is 25%~30%, and the porosity of the second lattice layer is 40%~50%.

6. The pedicle screw according to claim 4 or 5, characterized in that: The diameter of the first lattice layer is 80~100μm, and the diameter of the second lattice layer is 150~200μm.

7. A device for removing the support seat of a pedicle assembly, wherein the pedicle assembly obtained by printing is connected to a support seat via a support wire on a threaded structure, the device for removing the support seat on the printed pedicle assembly to obtain the pedicle screw as described in any one of claims 1-6, wherein the screw head is provided with a recessed fixing groove, characterized in that: The pedicle assembly support removal device includes: A clamping member that clamps the nail body axially, with the nail head located above the clamping member, the clamping member being used to restrict downward movement of the pedicle assembly; A limiting shaft is inserted into the fixing groove to restrict the circumferential rotation of the pedicle assembly; A cutting component, the cutting component comprising a rotating body and a cutting portion disposed on the rotating body; A driving component, which is connected to the cutting component to drive the cutting component to rotate circumferentially and cause the cutting part to cut the support wire.

8. The pedicle assembly support removal device according to claim 7, characterized in that: The rotating body has cutting sections on both sides in the circumferential direction, and the driving component is a bidirectional rotating motor.

9. The pedicle assembly support removal device according to claim 7 or 8, characterized in that: The cutting part includes multiple blades spaced apart in the vertical direction, and the driving component includes a drive motor connected to the cutting component and an axial drive structure for driving the drive motor to move up and down in the vertical direction.

10. A method for manufacturing a pedicle screw, characterized in that: The method for manufacturing the pedicle screw includes the following steps: S1: The pedicle assembly was prepared using 3D printing. S2: Provides a support seat removal device for the pedicle assembly as described in any one of claims 7-9, using a clamping member to clamp the nail body so that the limiting shaft is inserted into the fixing groove; S3: The driving component drives the cutting component to rotate and cut the support wire, causing the pedicle screw to separate from the support seat; S4: Grind off the remaining part of the support wire on the threaded structure to obtain the pedicle screw.