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CN115192272A - Irregular porous interbody fusion cage and processing method thereof - Google Patents

Irregular porous interbody fusion cage and processing method thereof Download PDF

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CN115192272A
CN115192272A CN202210864864.2A CN202210864864A CN115192272A CN 115192272 A CN115192272 A CN 115192272A CN 202210864864 A CN202210864864 A CN 202210864864A CN 115192272 A CN115192272 A CN 115192272A
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holes
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CN115192272B (en
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李素丽
赵京生
马凯悦
高状
熊杰
王聪
徐超
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Xi'an Taihui Machinery Technology Co ltd
Xian University of Science and Technology
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Xian University of Science and Technology
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/446Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/3097Designing or manufacturing processes using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]

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  • Health & Medical Sciences (AREA)
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Abstract

The invention discloses a irregular porous interbody fusion cage which comprises a fusion cage body, wherein the fusion cage body comprises an upper surface and a lower surface, two opposite side surfaces between the upper surface and the lower surface are respectively a first side surface and a second side surface, the upper surface and the lower surface both form inclined slope surfaces, a first arc surface is formed between the lower ends of the two inclined slope surfaces, a second arc surface is formed between the higher ends of the two inclined slope surfaces, a plurality of through holes are formed in the upper surface, the lower surface, the first side surface, the second side surface, the first arc surface and the second arc surface of the fusion cage, any two or more through holes in the plurality of through holes are communicated to form a plurality of irregular channels, and the plurality of irregular channels are constructed on the basis of a Tage polygonal lattice. The invention realizes good elasticity of the fusion cage, achieves stable fusion effect, promotes the adhesion of bone cells on a plurality of surfaces of the structure and bone ingrowth, and solves the problems that the structure of the prior intervertebral fusion cage cannot achieve the preset fusion effect and has overhigh settleability.

Description

一种无规则多孔椎间融合器及其加工方法A kind of irregular porous interbody cage and its processing method

技术领域technical field

本发明涉及医疗设备技术领域,尤其涉及一种无规则多孔椎间融合器及其加工方法。The invention relates to the technical field of medical equipment, in particular to a random porous intervertebral cage and a processing method thereof.

背景技术Background technique

脊柱融合己成为脊柱外科的常规技术,广泛应用于腰椎退变、颈椎不稳定、椎间盘损伤和脊柱畸形的治疗。一般来说,脊柱融合手术是实现脊柱稳定和神经减压的有效方法。脊柱融合主要是利用自体骨、异体骨或者人工假体进行植入手术,但由于自体骨的植入会受到自体骨的一些缺点的限制,包括额外的外科创伤、术后并发症(如感染、血肿和供体部位疼痛)的风险增加以及供应有限,目前金属植入物越来越受到医疗领域的青睐,利用椎间融合器来维持椎间间隙高度并减轻神经压迫或刺激,从而使脊柱达到稳定及良好的骨组织生长的效果。Spinal fusion has become a routine technique in spine surgery and is widely used in the treatment of lumbar spine degeneration, cervical spine instability, intervertebral disc injury and spinal deformity. In general, spinal fusion surgery is an effective way to achieve spinal stabilization and nerve decompression. Spinal fusion is mainly the use of autologous bone, allogeneic bone or artificial prosthesis for implantation surgery, but the implantation of autologous bone is limited by some disadvantages of autologous bone, including additional surgical trauma, postoperative complications (such as infection, Due to the increased risk of hematoma and donor site pain) and limited supply, metal implants are increasingly favored in the medical field. Stable and good bone tissue growth effect.

传统机械加工方法无法制造植入物的多孔结构,容易产生应力屏障。而3D打印技术作为一种新兴的前沿技术,不需要传统的刀具、夹具及多道加工工序,利用三维设计数据在一台设备上可快速而精确地制造出任意复杂形状的零件,从而实现“自由制造”,解决应力屏障问题。Traditional machining methods cannot create porous structures of implants, which are prone to stress barriers. As an emerging cutting-edge technology, 3D printing technology does not require traditional tools, fixtures and multiple processing procedures. Using 3D design data, parts of any complex shape can be quickly and accurately manufactured on a single device, so as to achieve " Free to Manufacture", addressing the stress barrier problem.

过去,医疗领域都是利用带螺纹的融合器去促进骨组织融合、生长紧凑,但随着时间的推移,螺纹融合器的沉降率很高,对融合效果有一定的缺陷。国内自主设计融合器结构普遍是部分区域规则的点阵孔径结构并开设大尺寸孔洞,不利于融合器的支撑性和阻碍细胞的物质交换,影响成骨能力,如专利CN111529134A中所设计的融合器结构只是在上下端面和内外弧面开设通孔和窗口,而多孔结构只在其内外弧面某一区域,其余全为实体,可能会存在应力集中现象,导致融合器力学性能与自体骨不匹配造成传力不均匀且不利于融合器多方位进行融合长入。目前无螺纹的椎间融合器也越来越兴起,但是与人体骨骼力学性能相匹配且具有无规则多孔的个性化融合器结构设计研究尚少。In the past, threaded cages were used in the medical field to promote bone tissue fusion and compact growth. However, with the passage of time, the threaded cage has a high sedimentation rate, which has certain defects in the fusion effect. The structure of domestic self-designed cages is generally a regular lattice aperture structure in some areas and large-sized holes are opened, which is not conducive to the support of the cage and hinders the material exchange of cells, which affects the osteogenic ability. For example, the cage designed in the patent CN111529134A The structure only has through holes and windows on the upper and lower end surfaces and the inner and outer arc surfaces, while the porous structure is only in a certain area of the inner and outer arc surfaces, and the rest are all solid, which may cause stress concentration, resulting in the mechanical properties of the cage not matching the autogenous bone. It causes uneven force transmission and is not conducive to fusion and growth of the cage in multiple directions. At present, threadless cages are becoming more and more popular, but there are few studies on the structural design of personalized cages that match the mechanical properties of human bones and have irregular pores.

发明内容SUMMARY OF THE INVENTION

本发明的一个目的在于提出一种无规则多孔椎间融合器及其加工方法,本发明利用增材制造打印工艺的灵活性,打印出与人体骨骼力学相配的复杂无规则多孔结构的脊柱椎间融合器,通过结构与材料的有机结合,避免结构过刚性,实现融合器良好的弹性,达到稳定融合效果,促进骨细胞在结构多个表面的黏附和骨长入,解决目前椎间融合器的结构达不到预定融合效果和沉降性过高的问题。One object of the present invention is to propose a random porous interbody cage and a processing method thereof. The present invention utilizes the flexibility of the additive manufacturing printing process to print a spinal intervertebral body with a complex and random porous structure that matches the mechanics of human bones. The cage, through the organic combination of structure and material, avoids excessive rigidity of the structure, achieves good elasticity of the cage, achieves a stable fusion effect, promotes the adhesion of bone cells on multiple surfaces of the structure and bone ingrowth, and solves the problem of current intervertebral cages. The structure fails to achieve the predetermined fusion effect and the problem of excessive settlement.

根据本发明实施例的一种无规则多孔椎间融合器及其加工方法,A random porous interbody cage and a processing method thereof according to an embodiment of the present invention,

具体地,一种无规则多孔椎间融合器,包括融合器本体,所述融合器本体包括上表面和下表面,所述上表面和下表面之间的相对两侧面分别为第一弧面和第二弧面,所述上表面和下表面均形成倾斜坡面,两个所述倾斜坡面的较低端之间形成第一弧面,两个所述倾斜坡面的较高端之间形成第二弧面,所述融合器的上表面、下表面、第一侧面、第二侧面、第一弧面和第二弧面上均开设有若干通孔,若干通孔中的任意几个通孔贯通形成若干无规则通道,若干无规则通道基于泰格多边形晶格构建。Specifically, a random porous intervertebral cage includes a cage body, the cage body includes an upper surface and a lower surface, and the opposite sides between the upper surface and the lower surface are a first arc surface and a lower surface, respectively. The second arc surface, the upper surface and the lower surface both form an inclined slope surface, a first arc surface is formed between the lower ends of the two inclined slope surfaces, and a first arc surface is formed between the higher ends of the two inclined slope surfaces The second arc surface, the upper surface, the lower surface, the first side surface, the second side surface, the first arc surface and the second arc surface of the cage are all provided with a number of through holes, and any number of the through holes The holes pass through to form a number of random channels, which are constructed based on the Tiger polygon lattice.

在上述方案的基础上,若干所述通孔的孔径范围为0.5mm-1mm。On the basis of the above solution, the diameter of the plurality of through holes ranges from 0.5 mm to 1 mm.

在上述方案的基础上,所述上表面和下表面上均设置有若干棱齿状的防滑凸起。On the basis of the above solution, a plurality of tooth-shaped anti-skid protrusions are provided on the upper surface and the lower surface.

在上述方案的基础上,两个所述倾斜坡面的较低端之间形成第一侧面,两个所述倾斜坡面的较高端之间形成第二侧面。On the basis of the above solution, a first side surface is formed between the lower ends of the two inclined slope surfaces, and a second side surface is formed between the higher ends of the two inclined slope surfaces.

在上述方案的基础上,两个所述倾斜坡面的较低端的延伸线之间形成的夹角的角度范围为6°-10°,两个所述倾斜坡面与水平面之间的夹角的角度范围均为3°-5°。On the basis of the above solution, the angle range of the included angle formed between the extension lines of the lower ends of the two inclined slope surfaces is 6°-10°, and the included angle between the two inclined slope surfaces and the horizontal plane The angle range is 3°-5°.

在上述方案的基础上,所述融合器本体为类腰果型结构,所述第一弧面的内弧面和第二弧面的内弧面同向设置,所述第一侧面和第二侧面均为弧面。On the basis of the above solution, the cage body is a cashew nut-like structure, the inner arc surface of the first arc surface and the inner arc surface of the second arc surface are arranged in the same direction, and the first side surface and the second side surface are arranged in the same direction. All are arcs.

在上述方案的基础上,所述融合器本体为类橄榄球结构,所述第一弧面的内弧面和第二弧面的内弧面相对设置,所述第一侧面和第二侧面均为弧面。On the basis of the above solution, the cage body is a rugby-like structure, the inner arc surface of the first arc surface and the inner arc surface of the second arc surface are oppositely arranged, and the first side surface and the second side surface are both Arc.

在上述方案的基础上,所述融合器本体的长度为20-30mm,宽度为10mm,高度为8-12mm。On the basis of the above solution, the length of the cage body is 20-30mm, the width is 10mm, and the height is 8-12mm.

在上述方案的基础上,所述融合器本体上表面和下表面采用钽合金材料,所述融合器本体除上表面和下表面外采用钛合金材料。On the basis of the above solution, the upper surface and the lower surface of the cage body are made of tantalum alloy material, and the cage body except the upper surface and the lower surface is made of titanium alloy material.

一种无规则多孔椎间融合器加工方法,适用于任一项所述的一种无规则多孔椎间融合器,包括以下步骤:A method for processing an irregular porous intervertebral cage, applicable to any one of the irregular porous cages, comprising the following steps:

S1:根据CT扫描的影像数据,利用3D图像生成软件对患者脊柱进行逆向工程还原,将STL格式导入编辑处理软件将其实体化,得到椎间隙数据;S1: According to the image data of the CT scan, use the 3D image generation software to reverse engineer the spine of the patient, import the STL format into the editing processing software to materialize it, and obtain the intervertebral space data;

S2:将步骤S1中得到的椎间隙数据,利用计算机辅助设计软件,基于Voronoi泰森多边形结构,改变孔径直径范围为0.5mm-1mm和密度参数范围0.5mm-0.75mm,设计适合骨生长的孔径结构;S2: Using the intervertebral space data obtained in step S1, using computer-aided design software, based on the Voronoi Thiessen polygonal structure, changing the diameter of the aperture to 0.5mm-1mm and the range of density parameters to 0.5mm-0.75mm to design an aperture suitable for bone growth structure;

S3:将步骤S2的孔径结构文件以IGS格式导入ANSYS,利用ANSYS有限元仿真进行分析,设置皮质骨、松质骨和软骨,皮质骨弹性模量为12GPa,松质骨弹性模量为100MPa,软骨弹性模量为50MPa和泊松比0.3的材料参数模拟融合器弹性模量,调整结构孔径大小,调整结构尺寸;S3: Import the aperture structure file of step S2 into ANSYS in IGS format, use ANSYS finite element simulation for analysis, set cortical bone, cancellous bone and cartilage, cortical bone elastic modulus is 12GPa, cancellous bone elastic modulus is 100MPa, The material parameters of cartilage elastic modulus of 50MPa and Poisson's ratio of 0.3 simulate the elastic modulus of the cage, adjust the size of the structure aperture, and adjust the structure size;

S4:利用SLM技术,将无规则多孔融合器数据以STL格式导入至切片处理软件,切层厚度为0.02mm,开始加工过程中,在成形缸的基板上先铺上一层很薄的钽合金粉末,高功率激光束对当前层进行选择性激光熔化,熔化的金属粉末冷却固化后,加工平台降低一个层厚高度,打印出厚度2mm的钛合金层后用滚筒在加工好的片层之上铺好钽合金粉末,激光束开始扫描新一层,如此层层叠加,加工厚度为8mm处时再次换成钛合金粉末进行打印,直至整个零件成形;S4: Using SLM technology, import the random porous fusion device data into the slice processing software in STL format, and the slice thickness is 0.02mm. In the process of starting the processing, a thin layer of tantalum alloy is firstly spread on the substrate of the forming cylinder Powder, high-power laser beam performs selective laser melting on the current layer. After the molten metal powder is cooled and solidified, the processing platform is lowered by one layer thickness, and a titanium alloy layer with a thickness of 2mm is printed out with a roller on the processed layer. After the tantalum alloy powder is laid, the laser beam starts to scan a new layer, so that the layers are superimposed, and when the processing thickness is 8mm, the titanium alloy powder is replaced again for printing, until the whole part is formed;

其中打印钛合金粉末时的工艺参数:激光功率为230-250W、扫描速度为800-1000mm/s、扫描间距为0.1-0.12mm;打印钽合金粉末时的工艺参数:激光功率为300W-340W、扫描速度为1200mm/s、扫描间距为0.07mm,利用SLM技术采用两种合金材料打印融合器的形状,且融合器长度尺寸范围是25-30mm,宽度尺寸范围是10-15mm;Among them, the process parameters when printing titanium alloy powder: the laser power is 230-250W, the scanning speed is 800-1000mm/s, and the scanning distance is 0.1-0.12mm; the process parameters when printing tantalum alloy powder: the laser power is 300W-340W, The scanning speed is 1200mm/s, the scanning distance is 0.07mm, and the shape of the fusion cage is printed by using two alloy materials using SLM technology, and the length and size of the cage are in the range of 25-30mm, and the width of the cage is in the range of 10-15mm;

S5:将步骤S4中得到的零件进行打磨及抛光,得所需无规则多孔融合器。S5: grinding and polishing the parts obtained in step S4 to obtain the desired random porous fusion device.

本发明的有益效果是:The beneficial effects of the present invention are:

(1)本发明为无螺纹的无规则多孔结构,打破传统融合器的结构,无螺纹可防止高沉降性,术后不再取出,简便手术操作;无规则多孔结构仿生人体骨骼,不仅可以增加骨组织的接触面积,促进骨组织长入,加快融合效率,同时保证在高孔径率情况下,通过结构与材料的相结合,满足人体骨组织力学性能,提高融合器的融合效果;(1) The present invention is an irregular porous structure without threads, which breaks the structure of traditional cages. No threads can prevent high subsidence, and it is no longer removed after surgery, which is convenient for surgical operations; the bionic human bones with irregular porous structures can not only increase the The contact area of bone tissue promotes the ingrowth of bone tissue, accelerates the fusion efficiency, and at the same time ensures that in the case of high pore size, the combination of structure and material can meet the mechanical properties of human bone tissue and improve the fusion effect of the cage;

(2)本发明无规则多孔椎间融合器加工方法利用快速成型技术,由于无规则多孔椎间融合器的独特结构,可实现不同位置的不同材料的打印,利用钽材料的高摩擦系数的优点增强融合器上、下表面与脊柱接触的摩擦,提高植入稳定性,其余部位采用钛合金可以保持在大孔径率的情况下仍然满足力学性能要求,根据不同患者的CT椎间隙数据打印不同规格的融合器,实现个性化定制。(2) The processing method of the random porous intervertebral cage of the present invention uses the rapid prototyping technology. Due to the unique structure of the random porous intervertebral cage, the printing of different materials at different positions can be realized, and the advantages of the high friction coefficient of the tantalum material are used. The friction between the upper and lower surfaces of the cage in contact with the spine is enhanced to improve the stability of implantation. Titanium alloy is used for the rest of the cage to maintain a large aperture ratio and still meet the mechanical performance requirements. Different specifications are printed according to the CT intervertebral space data of different patients. Fusion device to achieve personalized customization.

附图说明Description of drawings

附图用来提供对本发明的进一步理解,并且构成说明书的一部分,与本发明的实施例一起用于解释本发明,并不构成对本发明的限制。在附图中:The accompanying drawings are used to provide a further understanding of the present invention, and constitute a part of the specification, and are used to explain the present invention together with the embodiments of the present invention, and do not constitute a limitation to the present invention. In the attached image:

图1为本发明提出的一种无规则多孔椎间融合器(类腰果型)的结构示意图;Fig. 1 is the structural representation of a kind of irregular porous intervertebral cage (like cashew nut type) proposed by the present invention;

图2为本发明提出的一种无规则多孔椎间融合器(类橄榄球型)的结构示意图;Fig. 2 is the structural representation of a kind of irregular porous intervertebral cage (rugby-like type) proposed by the present invention;

图3为图2的左视图;Fig. 3 is the left side view of Fig. 2;

图4为图2的右视图;Fig. 4 is the right side view of Fig. 2;

图5为图1的局部剖视图;Fig. 5 is the partial sectional view of Fig. 1;

图6为图2的局部剖视图;Fig. 6 is the partial sectional view of Fig. 2;

图7为图1的模型图;Fig. 7 is the model diagram of Fig. 1;

图8为图2的模型图;Fig. 8 is the model diagram of Fig. 2;

图9为本发明一种无规则多孔椎间融合器加工方法的SLM技术制备方法示意图;9 is a schematic diagram of a SLM technology preparation method of a method for processing a random porous interbody cage of the present invention;

具体实施方式Detailed ways

现在结合附图对本发明作进一步详细的说明。The present invention will now be described in further detail with reference to the accompanying drawings.

实施例1Example 1

如图1-8所示,具体地,一种无规则多孔椎间融合器,包括融合器本体,所述融合器本体包括上表面1和下表面2,所述上表面1和下表面2之间的相对两侧面分别为第一侧面7和第二侧面8,所述上表面1和下表面2均形成倾斜坡面,两个所述倾斜坡面的较低端之间形成第一弧面3,两个所述倾斜坡面的较高端之间形成第二弧面4,所述融合器的上表面1、下表面2、第一侧面7、第二侧面8、第一弧面3和第二弧面4上均开设有若干通孔5,若干通孔5中的任意两个或多个通孔5贯通形成若干无规则通道,若干无规则通道基于泰格多边形晶格构建。As shown in Figures 1-8, specifically, a random porous interbody cage includes a cage body, the cage body includes an upper surface 1 and a lower surface 2, and the upper surface 1 and the lower surface 2 are between the upper surface 1 and the lower surface 2. The opposite sides between the two sides are the first side 7 and the second side 8 respectively, the upper surface 1 and the lower surface 2 both form an inclined slope, and a first arc surface is formed between the lower ends of the two inclined slopes 3. A second arc surface 4 is formed between the higher ends of the two said inclined slopes, and the upper surface 1, lower surface 2, first side surface 7, second side surface 8, first arc surface 3 and The second arc surface 4 is provided with a plurality of through holes 5 , any two or more of the through holes 5 in the plurality of through holes 5 pass through to form a plurality of random channels, and the plurality of random channels are constructed based on the Tiger polygon lattice.

融合器本体的这种结构是基于泰森多边形晶格,由多个空间泰森结构组合形成,无规则的镂空多孔结构,无螺纹,不仅可以达到良好的压缩弹性模量,还有利于骨组织长入,促进骨细胞融合,方便植入,实现个性化定制,同时上、下表面2设置为倾斜一定角度,利于术后患者的脊椎弯曲,利用SLM打印技术实现融合器不同位置打印不同材料,同时,内部和外部全为多孔的镂空结构、无螺纹,具有良好生物相容性、能诱导骨长入,有利于提高脊柱融合率和骨再生,达到更加稳定的融合效果。This structure of the cage body is based on the Thiessen polygonal lattice, which is formed by the combination of multiple spatial Thiessen structures. The irregular hollow porous structure and no threads can not only achieve a good compressive elastic modulus, but also benefit the bone tissue. It grows in, promotes bone cell fusion, facilitates implantation, and realizes personalized customization. At the same time, the upper and lower surfaces 2 are set to be inclined at a certain angle, which is conducive to the curvature of the spine of patients after surgery. SLM printing technology is used to print different materials at different positions of the cage. At the same time, the interior and exterior are all porous hollow structures without threads, which have good biocompatibility and can induce bone ingrowth, which is beneficial to improve the rate of spinal fusion and bone regeneration, and achieve a more stable fusion effect.

优选的,若干所述通孔5的孔径范围为0.5mm-1mm。Preferably, the diameter of the plurality of through holes 5 ranges from 0.5 mm to 1 mm.

其中,孔径为0.5-0.75mm,密度为0.6mm-0.75mm的多孔结构适合骨密度T值在-1和1之间的人群;孔径直径为0.75-1mm,密度为0.5mm-0.6mm的多孔结构适合骨密度T值小于-1的人群。Among them, the porous structure with a pore diameter of 0.5-0.75mm and a density of 0.6mm-0.75mm is suitable for people with a bone density T value between -1 and 1; the porous structure with a pore diameter of 0.75-1mm and a density of 0.5mm-0.6mm The structure is suitable for people with a bone mineral density T value of less than -1.

如图3-4所示,所述上表面1和下表面2上均设置有若干棱齿状的防滑凸起6,增大不平整度,防止融合器植入后滑落。As shown in Figures 3-4, the upper surface 1 and the lower surface 2 are provided with a plurality of tooth-shaped anti-skid protrusions 6 to increase the unevenness and prevent the cage from slipping off after implantation.

如图3-4所示,两个所述倾斜坡面的较低端之间形成第一弧面3,两个所述倾斜坡面的较高端之间形成第二弧面4。As shown in Figures 3-4, a first arc surface 3 is formed between the lower ends of the two inclined slope surfaces, and a second arc surface 4 is formed between the higher ends of the two inclined slope surfaces.

两个所述倾斜坡面的较低端(即前凸)的延伸线之间的夹角A的角度范围为6°-10°,两个所述倾斜坡面与水平面之间的夹角C的角度范围均为3°-5°。The angle range of the included angle A between the extension lines of the lower ends (that is, the front convexity) of the two sloped slopes is 6°-10°, and the included angle C between the two sloped slopes and the horizontal plane The angle range is 3°-5°.

优选的,两个所述倾斜坡面的较低端(即前凸)的延伸线之间形成的夹角A的角度为6°,两个所述倾斜坡面与水平面之间形成的夹角C的角度均为3°,为保证融合器植入后避免脊柱的弯曲活动行为,故上表面1和下表面2设置成一定的倾斜角度,该角度有助于恢复腰椎生理曲度。Preferably, the angle A formed between the extension lines of the lower ends (that is, the front convexity) of the two inclined slopes is 6°, and the angle formed between the two inclined slopes and the horizontal plane is 6°. The angle of C is 3°. In order to avoid the bending behavior of the spine after the cage is implanted, the upper surface 1 and the lower surface 2 are set to a certain inclination angle, which is helpful to restore the physiological curvature of the lumbar spine.

如图4和6所示,所述融合器本体为类腰果型结构,所述第一弧面3的内弧面和第二弧面4的内弧面同向设置,所述第一侧面7和第二侧面8均为弧面。As shown in Figures 4 and 6, the cage body is a cashew-like structure, the inner arc surface of the first arc surface 3 and the inner arc surface of the second arc surface 4 are arranged in the same direction, and the first side surface 7 and the second side surface 8 are arc surfaces.

如图5和7所示,所述融合器本体为类橄榄球结构,所述第一弧面3的内弧面和第二弧面4的内弧面相对设置,所述第一侧面7和第二侧面8均为弧面。As shown in FIGS. 5 and 7 , the cage body is a football-like structure, the inner arc surface of the first arc surface 3 and the inner arc surface of the second arc surface 4 are arranged opposite to each other, and the first side surface 7 and the second arc surface are opposite to each other. Both side surfaces 8 are arc surfaces.

实际使用中,两种形状需根据CT扫描得出的椎间隙来进行选择,该两种结构的融合器侧面都设计为圆弧曲面可以适应人体椎体的内部结构。In actual use, the two shapes need to be selected according to the intervertebral space obtained by CT scanning. The sides of the cages of the two structures are designed as arc surfaces, which can adapt to the internal structure of the human vertebral body.

在上述方案的基础上,所述融合器本体的长度L为20-30mm,宽度B为10-15mm,高度为8-12mm。On the basis of the above solution, the length L of the cage body is 20-30 mm, the width B is 10-15 mm, and the height is 8-12 mm.

实施例2Example 2

一种无规则多孔椎间隔融合器,所述融合器本体上表面1和下表面2采用钽合金材料,所述融合器本体除上表面1和下表面2之外均采用钛合金材料,以两种材料的不同力学属性和结构相配合,实现与人体骨组织相适应的弹性模量和力学性能。An irregular porous intervertebral spacer cage, the upper surface 1 and the lower surface 2 of the cage body are made of tantalum alloy material, and the cage body is made of titanium alloy material except the upper surface 1 and the lower surface 2, and the two are made of titanium alloy. The different mechanical properties and structures of these materials are matched to achieve elastic modulus and mechanical properties that are compatible with human bone tissue.

具体地,上表面1、下表面2(各2mm)采用钽合金材料,利用钽合金的高摩擦系数从而达到植入的稳定,防止植入后滑落。其中间部位(6mm)均采用钛合金材料,占总体积的60%,保持融合器在80%孔径率的情况下仍然保证力学性能的相适应。Specifically, the upper surface 1 and the lower surface 2 (2 mm each) are made of tantalum alloy material, and the high friction coefficient of tantalum alloy is used to achieve stable implantation and prevent slipping after implantation. The middle part (6mm) is made of titanium alloy material, accounting for 60% of the total volume, and the mechanical properties of the cage are still ensured when the aperture ratio is 80%.

在融合器结构得上、中、下不同位置分别利用钽合金、钛合金、钽合金材料,利用钽合金得高摩擦系数提高融合器表面摩擦,不仅可以满足自体骨得力学性能同时融合器达到较好的固定效果。Tantalum alloy, titanium alloy and tantalum alloy material are used in different positions of the upper, middle and lower parts of the cage structure. The high friction coefficient of tantalum alloy improves the surface friction of the cage. Good fix.

其中,钛钽合金配比为1:13:1。Among them, the ratio of titanium-tantalum alloy is 1:13:1.

实施例3Example 3

如图9所示,一种无规则多孔椎间融合器加工方法,适用于实施例1或2所述的一种无规则多孔椎间融合器,包括以下步骤:As shown in Figure 9, a method for processing an irregular porous intervertebral cage, which is applicable to the irregular porous intervertebral cage described in Embodiment 1 or 2, includes the following steps:

S1:根据CT扫描的影像数据,利用3D图像生成软件(如Mimics软件)对患者脊柱进行逆向工程还原,将STL格式导入编辑处理软件(如Geomagic软件)将其实体化,得到椎间隙数据;S1: According to the image data of CT scan, use 3D image generation software (such as Mimics software) to reverse engineer the spine of the patient, import the STL format into editing and processing software (such as Geomagic software) to materialize it, and obtain intervertebral space data;

S2:将步骤S1中得到的椎间隙数据,利用计算机辅助设计软件(如Materialise 3-matic软件),基于Voronoi泰森多边形结构,改变孔径范围为0.5mm-1mm和密度参数范围0.5mm-0.75mm,设计适合骨生长的孔径结构;S2: Use computer-aided design software (such as Materialise 3-matic software) to change the intervertebral space data obtained in step S1, based on the Voronoi Thiessen polygonal structure, to change the aperture range to 0.5mm-1mm and the density parameter range to 0.5mm-0.75mm , design a pore structure suitable for bone growth;

S3:将步骤S2的孔径结构文件以IGS格式导入ANSYS,利用ANSYS有限元仿真进行分析,设置皮质骨、松质骨和软骨,皮质骨弹性模量为12GPa,松质骨弹性模量为100MPa,软骨弹性模量为50MPa和泊松比0.3的材料参数模拟融合器弹性模量,调整结构孔径大小,调整结构尺寸;S3: Import the aperture structure file of step S2 into ANSYS in IGS format, use ANSYS finite element simulation for analysis, set cortical bone, cancellous bone and cartilage, cortical bone elastic modulus is 12GPa, cancellous bone elastic modulus is 100MPa, The material parameters of cartilage elastic modulus of 50MPa and Poisson's ratio of 0.3 simulate the elastic modulus of the cage, adjust the size of the structure aperture, and adjust the structure size;

S4:利用SLM技术,将无规则多孔融合器数据以STL格式导入至切片处理软件,切层厚度为0.02mm,开始加工过程中,在成形缸的基板上先铺上一层很薄的钽合金粉末,高功率激光束对当前层进行选择性激光熔化,熔化的金属粉末冷却固化后,加工平台降低一个层厚高度,打印出厚度2mm的钛合金层后用滚筒在加工好的片层之上铺好钽合金粉末,激光束开始扫描新一层,如此层层叠加,加工厚度为8mm处时再次换成钛合金粉末进行打印,直至整个零件成形;S4: Using SLM technology, import the random porous fusion device data into the slice processing software in STL format, and the slice thickness is 0.02mm. In the process of starting the processing, a thin layer of tantalum alloy is firstly spread on the substrate of the forming cylinder Powder, high-power laser beam performs selective laser melting on the current layer. After the molten metal powder is cooled and solidified, the processing platform is lowered by one layer thickness, and a titanium alloy layer with a thickness of 2mm is printed out with a roller on the processed layer. After the tantalum alloy powder is laid, the laser beam starts to scan a new layer, so that the layers are superimposed, and when the processing thickness is 8mm, the titanium alloy powder is replaced again for printing, until the whole part is formed;

其中打印钛合金粉末时的工艺参数:激光功率为230-250W、扫描速度为800-1000mm/s、扫描间距为0.1-0.12mm;打印钽合金粉末时的工艺参数:激光功率为300W-340W、扫描速度为1200mm/s、扫描间距为0.07mm,利用SLM技术采用两种合金材料打印融合器的形状,且融合器长度L尺寸范围是25-30mm,宽度B尺寸范围是10-15mm;Among them, the process parameters when printing titanium alloy powder: the laser power is 230-250W, the scanning speed is 800-1000mm/s, and the scanning distance is 0.1-0.12mm; the process parameters when printing tantalum alloy powder: the laser power is 300W-340W, The scanning speed is 1200mm/s, the scanning distance is 0.07mm, and the shape of the fusion cage is printed by using two alloy materials using SLM technology, and the length L of the cage is 25-30mm, and the width B size is 10-15mm;

S5:将步骤S4中得到的零件进行打磨及抛光,得所需无规则多孔融合器。S5: grinding and polishing the parts obtained in step S4 to obtain the desired random porous fusion device.

如图1所示,本实施例的融合器结构是基于泰森多边形的无规则多孔结构,为满足人体运动需求和脊柱的融合效果,设计两种结构形状分别为“肾”形和“橄榄球”形,能诱导骨组织多方位长入,达到长入快、融合好的效果,同时,不设计螺纹结构,不仅方便植入,而且避免植入后的高沉降性。见图1、图2本实施例中两种融合器结构的长度L和高度H均为25mm和10mm,宽度B分别为10mm和15mm。该两种结构的融合器侧表面都设计为圆弧曲面可以适应人体椎体的内部结构,上表面1、下表面2都设置多个齿形凸面,增加摩擦,除了在结构上增加摩擦外,上表面1、下表面2(各2mm)采用钽合金材料,利用钽合金的高摩擦系数从而达到植入的稳定,防止植入后滑落。其中间部位(6mm)如图3、图4所示,均采用钛合金材料,占总体积的60%,保持融合器在80%孔隙率的情况下仍然保证力学性能的相适应。如图2所示,为保证融合器植入后避免脊柱的弯曲活动行为,故上表面1和下表面2设置成一定的倾斜角度,两表面形成的前凸角为6°,上、下倾斜坡面与水平面夹角均为3°,有助于恢复腰椎生理曲度。As shown in Figure 1, the structure of the cage of this embodiment is a random porous structure based on Thiessen polygons. In order to meet the needs of human movement and the fusion effect of the spine, two structural shapes are designed as "kidney" and "rugby". It can induce the ingrowth of bone tissue in multiple directions, and achieve the effect of fast ingrowth and good fusion. At the same time, no thread structure is designed, which is not only convenient for implantation, but also avoids high subsidence after implantation. 1 and 2 , the length L and height H of the two cage structures in this embodiment are both 25 mm and 10 mm, and the width B is 10 mm and 15 mm, respectively. The side surfaces of the cages of the two structures are designed as arc curved surfaces to adapt to the internal structure of the human vertebral body. The upper surface 1 and the lower surface 2 are provided with a plurality of tooth-shaped convex surfaces to increase friction. In addition to increasing friction in structure, The upper surface 1 and the lower surface 2 (2mm each) are made of tantalum alloy material, and the high friction coefficient of tantalum alloy is used to achieve stable implantation and prevent slipping after implantation. The middle part (6mm) is shown in Figure 3 and Figure 4, all of which are made of titanium alloy, accounting for 60% of the total volume, and the mechanical properties of the cage are still ensured when the porosity is 80%. As shown in Figure 2, in order to avoid the bending behavior of the spine after the cage is implanted, the upper surface 1 and the lower surface 2 are set to a certain inclination angle, the lordosis angle formed by the two surfaces is 6°, and the upper and lower surfaces are inclined. The angle between the slope and the horizontal is 3°, which helps to restore the physiological curvature of the lumbar spine.

本发明所述的无规则多孔椎间融合器加工方法一具体实施例,如图1-9所示,步骤如下:A specific embodiment of the method for processing an irregular porous intervertebral cage according to the present invention is shown in Figures 1-9, and the steps are as follows:

(1)医生对患者的脊柱进行CT扫描,得到患者CT影像数据,利用Mimics软件对患者脊柱进行逆向工程还原,将STL格式导入Geomagic将其实体化,得到椎间隙数据。(1) The doctor performs a CT scan on the patient's spine to obtain the patient's CT image data, uses the Mimics software to reverse engineer the patient's spine, and imports the STL format into Geomagic to materialize it to obtain the intervertebral space data.

(2)根据椎间隙数据设计融合器大致形态,利用Materialise 3-matic软件,基于Voronoi泰森多边形结构,改变孔径(0.5mm-1mm)和密度参数(0.5mm-0.75mm),设计适合骨生长的多孔结构。(2) Design the approximate shape of the cage according to the intervertebral space data, use the Materialise 3-matic software, based on the Voronoi Thiessen polygon structure, change the aperture (0.5mm-1mm) and density parameters (0.5mm-0.75mm), and design it suitable for bone growth. porous structure.

(3)将文件以IGS格式导入ANSYS,利用有限元仿真进行分析,设置皮质骨(弹性模量12GPa)、松质骨(弹性模量100MPa)和软骨(弹性模量50MPa)和泊松比0.3的材料参数模拟融合器弹性模量,调整结构孔径大小,实现不同孔径的镂空多孔结构,以适应不同骨密度人群。(3) Import the file into ANSYS in IGS format, use finite element simulation for analysis, set cortical bone (elastic modulus 12GPa), cancellous bone (elastic modulus 100MPa) and cartilage (elastic modulus 50MPa) and Poisson's ratio 0.3 The material parameters simulate the elastic modulus of the cage, adjust the pore size of the structure, and realize the hollow porous structure with different pore sizes to adapt to people with different bone densities.

(4)针对不同人群,依据不规则多孔结构设置长度尺寸范围是25-30mm;宽度尺寸范围是10-15mm,利用SLM技术打印技术如图8,将无规则多孔融合器以STL格式导入至切片处理软件,切层厚度为0.02mm。开始加工过程中,在成形缸的基板上先铺上一层很薄的钽合金粉末,厚度为0.03mm,高功率激光束对当前层进行选择性激光熔化,熔化的金属粉末冷却固化后,加工平台降低一个层厚高度,打印出厚度2mm的钛合金层后用滚筒在加工好的片层之上铺好钽合金粉末,激光束开始扫描新一层,如此层层叠加,加工厚度为8mm处时再次换成钛合金粉末进行打印,直至整个零件成形。其中打印钛合金粉末时的工艺参数:激光功率为230W、扫描速度为1000mm/s、扫描间距为0.12mm;打印钽合金粉末时的工艺参数:激光功率为300W、扫描速度为1200mm/s、扫描间距为0.07mm。(4) For different groups of people, according to the irregular porous structure, the length and size range is 25-30mm; Processing software, slice thickness is 0.02mm. In the process of starting the processing, a thin layer of tantalum alloy powder with a thickness of 0.03mm is firstly laid on the substrate of the forming cylinder. The high-power laser beam performs selective laser melting on the current layer. After the molten metal powder is cooled and solidified, the processing The platform is lowered by one layer height, and a titanium alloy layer with a thickness of 2mm is printed. After the tantalum alloy powder is spread on the processed layer with a roller, the laser beam starts to scan a new layer, so that the layers are superimposed, and the processing thickness is 8mm Then switch to titanium alloy powder again and print until the whole part is formed. Among them, the process parameters when printing titanium alloy powder: the laser power is 230W, the scanning speed is 1000mm/s, and the scanning distance is 0.12mm; the process parameters when printing tantalum alloy powder: the laser power is 300W, the scanning speed is 1200mm/s, the scanning The pitch is 0.07mm.

(5)将步骤(4)得到的零件进行打磨及抛光,得所需零件。(5) grinding and polishing the parts obtained in step (4) to obtain the required parts.

在一些实施例中,无规则多孔椎间融合器的长度为25mm,宽度为10mm,高度为10mm,前凸角6°,孔径0.75mm,密度0.5mm。In some embodiments, the random porous cage is 25mm in length, 10mm in width, 10mm in height, 6° in lordosis, 0.75mm in aperture, and 0.5mm in density.

在一些实施例中,无规则多孔椎间融合器的长度为25mm,宽度为10mm,高度为10mm,前凸角6°,孔径0.5mm,密度1mm。In some embodiments, the random porous cage has a length of 25 mm, a width of 10 mm, a height of 10 mm, a lordosis angle of 6°, a hole diameter of 0.5 mm, and a density of 1 mm.

在一些实施例中,无规则多孔椎间融合器的长度为30mm,宽度为15mm,高度为10mm,前凸角6°,孔径1mm,密度0.5mm。In some embodiments, the random porous cage has a length of 30 mm, a width of 15 mm, a height of 10 mm, a lordosis angle of 6°, a hole diameter of 1 mm, and a density of 0.5 mm.

本发明的无规则多孔椎间融合器及其制备方法采用仿生骨的多孔结构,其整体无螺纹,为无规则多孔结构一体模型,可以使融合器与脊椎接触面更加紧密,加速骨组织从融合器多个面进行生长迁移,加快融合效果,避免由于存在螺纹导致很高的沉降性,并且术中不需要在融合器中填充骨材料,简化了手术的操作。The random porous intervertebral cage of the present invention and the preparation method thereof adopts the porous structure of bionic bone, and the whole has no threads, and is an integrated model of the irregular porous structure, which can make the contact surface between the cage and the vertebrae tighter, and accelerate the fusion of bone tissue from The cage can grow and migrate on multiple surfaces, speed up the fusion effect, avoid high subsidence caused by the existence of threads, and do not need to fill the cage with bone material during the operation, which simplifies the operation of the operation.

以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。The above description is only a preferred embodiment of the present invention, but the protection scope of the present invention is not limited to this. The equivalent replacement or change of the inventive concept thereof shall be included within the protection scope of the present invention.

Claims (9)

1.一种无规则多孔椎间融合器,包括融合器本体,所述融合器本体包括上表面和下表面,所述上表面和下表面之间的相对两侧面分别为第一侧面和第二侧面,所述上表面和下表面均形成倾斜坡面,两个所述倾斜坡面的较低端之间形成第一弧面,两个所述倾斜坡面的较高端之间形成第二弧面,其特征在于,所述融合器的上表面、下表面、第一侧面、第二侧面、第一弧面和第二弧面上均开设有若干通孔,若干通孔中的任意两个或多个通孔贯通形成若干无规则通道,若干无规则通道基于泰格多边形晶格构建。1. a random porous intervertebral cage, comprising a cage body, the cage body comprises an upper surface and a lower surface, and the opposite sides between the upper surface and the lower surface are respectively the first side and the second On the side, both the upper surface and the lower surface form an inclined slope, a first arc is formed between the lower ends of the two inclined slopes, and a second arc is formed between the higher ends of the two inclined slopes It is characterized in that the upper surface, the lower surface, the first side, the second side, the first arc surface and the second arc surface of the cage are provided with several through holes, and any two of the several through holes are provided with a plurality of through holes. A plurality of through holes are connected to form a plurality of random channels, and the plurality of random channels are constructed based on a Tiger polygon lattice. 2.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,若干所述通孔的孔径范围为0.5mm-1mm。2 . The random porous interbody cage according to claim 1 , wherein the diameters of the plurality of through holes range from 0.5 mm to 1 mm. 3 . 3.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,所述上表面和下表面上均设置有若干棱齿状的防滑凸起。3 . The random porous interbody cage according to claim 1 , wherein a plurality of tooth-shaped anti-skid protrusions are provided on the upper surface and the lower surface. 4 . 4.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,两个所述倾斜坡面的较低端的延伸线之间形成的夹角的角度范围为6°-10°,两个所述倾斜坡面与水平面之间的夹角的角度范围均为3°-5°。4. The random porous interbody cage according to claim 1, wherein the angle of the included angle formed between the extension lines of the lower ends of the two inclined slope surfaces is 6°-10° °, the angle range of the included angle between the two inclined slope surfaces and the horizontal plane is 3°-5°. 5.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,所述融合器本体为类腰果型结构,所述第一弧面的内弧面和第二弧面的内弧面同向设置,所述第一侧面和第二侧面均为弧面。5. A kind of irregular porous intervertebral cage according to claim 1, characterized in that, the cage body is a cashew-like structure, the inner arc of the first arc surface and the inner arc of the second arc The inner arc surfaces are arranged in the same direction, and the first side surface and the second side surface are both arc surfaces. 6.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,所述融合器本体为类橄榄球结构,所述第一弧面的内弧面和第二弧面的内弧面相对设置,所述第一侧面和第二侧面均为弧面。6. The random porous intervertebral cage according to claim 1, wherein the cage body is a rugby-like structure, the inner arc of the first arc surface and the inner arc of the second arc surface The arc surfaces are oppositely arranged, and the first side surface and the second side surface are both arc surfaces. 7.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,所述融合器本体的长度为20-30mm,宽度为10-15mm,高度为8-12mm。7 . The random porous interbody cage according to claim 1 , wherein the cage body has a length of 20-30 mm, a width of 10-15 mm, and a height of 8-12 mm. 8 . 8.根据权利要求1所述的一种无规则多孔椎间融合器,其特征在于,所述融合器本体上表面和下表面采用钽合金材料,所述融合器本体除上表面和下表面外采用钛合金材料。8. The random porous intervertebral cage according to claim 1, wherein the upper surface and the lower surface of the cage body are made of tantalum alloy material, and the cage body is made of tantalum alloy except for the upper surface and the lower surface. Made of titanium alloy. 9.一种无规则多孔椎间融合器加工方法,适用于权利要求1-8任一项所述的一种无规则多孔椎间融合器,其特征在于,包括以下步骤:9. A method for processing an irregular porous intervertebral cage, applicable to a kind of irregular porous intervertebral cage according to any one of claims 1-8, characterized in that, comprising the following steps: S1:根据CT扫描的影像数据,利用3D图像生成软件对患者脊柱进行逆向工程还原,将STL格式导入编辑处理软件将其实体化,得到椎间隙数据;S1: According to the image data of the CT scan, use the 3D image generation software to reverse engineer the spine of the patient, import the STL format into the editing processing software to materialize it, and obtain the intervertebral space data; S2:将步骤S1中得到的椎间隙数据,利用计算机辅助设计软件,基于Voronoi泰森多边形结构,改变孔径直径范围为0.5mm-1mm和密度参数范围0.5mm-0.75mm,设计适合骨生长的孔径结构;S2: Using the intervertebral space data obtained in step S1, using computer-aided design software, based on the Voronoi Thiessen polygonal structure, changing the diameter of the aperture to 0.5mm-1mm and the range of density parameters to 0.5mm-0.75mm to design an aperture suitable for bone growth structure; S3:将步骤S2的孔径结构文件以IGS格式导入ANSYS,利用ANSYS有限元仿真进行分析,设置皮质骨、松质骨和软骨,皮质骨弹性模量为12GPa,松质骨弹性模量为100MPa,软骨弹性模量为50MPa和泊松比0.3的材料参数模拟融合器弹性模量,调整结构孔径大小,调整结构尺寸;S3: Import the aperture structure file of step S2 into ANSYS in IGS format, use ANSYS finite element simulation for analysis, set cortical bone, cancellous bone and cartilage, cortical bone elastic modulus is 12GPa, cancellous bone elastic modulus is 100MPa, The material parameters of cartilage elastic modulus of 50MPa and Poisson's ratio of 0.3 simulate the elastic modulus of the cage, adjust the size of the structure aperture, and adjust the structure size; S4:利用SLM技术,将无规则多孔融合器数据以STL格式导入至切片处理软件,开始加工过程中,在成形缸的基板上先铺上一层很薄的钽合金粉末,高功率激光束对当前层进行选择性激光熔化,熔化的金属粉末冷却固化后,打印出钛合金层后在加工好的片层之上铺好钽合金粉末,激光束开始扫描新一层,如此层层叠加,之后再次换成钛合金粉末进行打印,直至整个零件成形;S4: Using SLM technology, import the data of the random porous fusion device into the slicing processing software in STL format. In the process of starting the processing, a thin layer of tantalum alloy powder is firstly spread on the substrate of the forming cylinder, and the high-power laser beam The current layer is selectively laser melted. After the molten metal powder is cooled and solidified, the titanium alloy layer is printed and the tantalum alloy powder is laid on the processed sheet. The laser beam starts to scan a new layer, and the layers are superimposed. Switch to titanium alloy powder again for printing until the entire part is formed; S5:将步骤S4中得到的零件进行打磨及抛光,得所需无规则多孔融合器。S5: grinding and polishing the parts obtained in step S4 to obtain the desired random porous fusion device.
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