A kind of cervical intervertebral fusion device and its preparation method

A fusion device and cervical spine technology, which is applied in the field of cervical intervertebral fusion device and its preparation, can solve the problems of insufficient bone-material interface bonding strength, low mechanical strength, loose bone implant, etc., to achieve migration and value-added, good long-term Fixing effect, enhancing the effect of mechanical locking

Active Publication Date: 2019-04-23
JILIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the traditional intervertebral fusion still has certain limitations: 1) The titanium alloy intervertebral fusion is mainly made of Ti6Al4V (CN 105796214 A), although its strength is high, its elastic modulus (110GPa) is much higher than that of natural bone ( Cortical bone is about 3-12GPa), there is a metal-bone interface problem, which will produce stress shielding, resulting in bone resorption and implant loosening
2) The elastic modulus of polyether ether ketone intervertebral fusion is close to that of vertebral cortical bone, which avoids stress shielding, but it and titanium alloy are biologically inert materials, and bone tissue can only be attached to the surface of the material and cannot enter its interior To achieve good osseointegration, resulting in insufficient bone-material interface bonding strength, prone to loosening
However, its mechanical strength is low, and the inherent brittleness of the material itself makes it easy to break during surgical operations

Method used

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  • A kind of cervical intervertebral fusion device and its preparation method
  • A kind of cervical intervertebral fusion device and its preparation method
  • A kind of cervical intervertebral fusion device and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Silver-containing porous titanium alloy scaffold

[0027] Use Unigraphics software to design and build a three-dimensional graphic, input the model data into the powder laser sintering rapid prototyping equipment, and add alloy powder to the equipment for sintering and molding, and make a silver-containing porous titanium alloy bracket with grooves on the surface and through holes on the side; Among them, the alloy powder components are aluminum 7%, vanadium 5%, carbon 0.3%, iron 0.4%, silver 0.3%, and the rest is titanium.

[0028] The silver-containing porous titanium alloy stent described in this embodiment has a specification of: regular pores, an average pore diameter of 300 μm, and a porosity of 40%; a diameter (D) of 12 mm and a height (H) of a cylinder of 5 mm, with an arc-shaped concave surface. The groove depth (h) is 1mm, the upper surface is a slope of 3° (the angle shown in b), in order to maintain the physiological curvature of the cervical spine, and ...

Embodiment 2

[0032] (1) Silver-containing porous titanium alloy scaffold

[0033] Use Unigraphics software to design and build a three-dimensional graphic, input the model data into the powder laser sintering rapid prototyping equipment, and add alloy powder to the equipment for sintering and molding, and make a silver-containing porous titanium alloy bracket with grooves on the surface and through holes on the side; Among them, the alloy powder components are aluminum 5%, vanadium 3%, carbon 0.1%, iron 0.1%, silver 0.1%, and the rest is titanium.

[0034] The silver-containing porous titanium alloy stent described in this embodiment has specifications: regular pores, an average pore diameter of 500 μm, and a porosity of 50%; a diameter (D) of 14 mm, a height (H) of a cylinder of 10 mm, and a surface groove depth (h) is 5mm, and the upper surface is an inclined plane of 4° (the angle shown in b), so as to maintain the physiological curvature of the cervical spine, and the diameter (d) of t...

Embodiment 3

[0037] Example 3 In vitro rhBMP-2 release experiment

[0038] Soak the silver-containing cervical intervertebral fusion device prepared in Example 2 in phosphate buffer (pH=7) and shake it on a shaker at a constant temperature of 37°C, suck out 100 μL of the soaking solution every 5 days, and follow the rhBMP-2 ELISA kit (R&D ) instructions, measure the rhBMP-2 content in the soaking solution, repeat the above experiment three times, and calculate the average value. The results showed that the cumulative release of rhBMP-2 in the silver-containing cervical intervertebral fusion cage showed a gentle increasing trend, and the release time could be extended to about 35 days, as shown in Table 1.

[0039] Table 1 The cumulative release of rhBMP-2 in silver-containing cervical intervertebral fusion cages at different times

[0040] time / day

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Abstract

The invention relates to a cervical intervertebral fusion device and a preparation method thereof, belonging to the field of spinal fusion and internal fixation. In the present invention, model data is first input into powder laser sintering rapid prototyping equipment according to design requirements, alloy powder is added into the equipment for sintering and molding, and a porous titanium alloy bracket with grooves on the surface and through holes on the side is produced. Then, the bone powder or demineralized bone matrix dry powder loaded with recombinant human bone morphogenetic protein-2 is loaded on the pores and surface grooves of the porous titanium alloy scaffold through ultrasonic or vibration reaction to obtain a silver-containing cervical intervertebral fusion device. The silver-containing cervical intervertebral fusion device obtained by the present invention not only has pores in the internal structure, but also has grooves on the surface, which can attach more bone powder or decalcified bone matrix loaded with recombinant human bone morphogenetic protein-2, so as to promote the induction of bone tissue to grow into the pores, enhance The mechanical locking of the porous titanium alloy implant can achieve better long-term fixation effect; while the side of the porous titanium alloy stent is provided with a through central hole, which is conducive to promoting blood circulation and dissipating blood stasis.

Description

technical field [0001] The invention belongs to the field of spinal fusion and internal fixation, and in particular relates to a cervical intervertebral fusion device and a preparation method thereof. Background technique [0002] Intervertebral disc herniation and cervical instability caused by cervical disc degeneration are common clinical spinal surgery diseases, and anterior cervical decompression, fusion and internal fixation is the most commonly used surgical method. There are two main types of materials commonly used in intervertebral fusion: ① bone graft materials, including autologous bone blocks and allogeneic bone grafts; ② alternative materials, namely intervertebral fusion cages. In the past, autologous bone block transplantation was often used for intervertebral fusion, but the complications in the autologous bone extraction area were as high as 10%-20%, including residual pain, infection, and sensory disturbance in the bone extraction area. Although bone allo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/44
CPCA61F2/30942A61F2/4455C22C14/00B22F3/11B33Y10/00B33Y70/00A61F2002/30968A61F2002/3097A61F2002/30784A61F2002/3006B22F2999/00A61F2002/30943B22F10/28Y02P10/25
Inventor 吴敏飞赵冠杰张善勇矫健航
Owner JILIN UNIV
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