Disclosure of Invention
The invention aims to provide a irregular porous interbody fusion cage and a processing method thereof, the spine interbody fusion cage with a complex irregular porous structure matched with human skeleton mechanics is printed by utilizing the flexibility of an additive manufacturing and printing process, the structure is prevented from being over-rigid through the organic combination of the structure and materials, the good elasticity of the fusion cage is realized, the stable fusion effect is achieved, the adhesion of bone cells on a plurality of surfaces of the structure and the growth of bones are promoted, and the problems that the structure of the existing interbody fusion cage cannot achieve the preset fusion effect and the settleability is over high are solved.
According to the irregular porous interbody fusion cage and the processing method thereof of the embodiment of the invention,
specifically, an irregular porous interbody fusion cage, includes the fusion cage body, the fusion cage body includes upper surface and lower surface, relative both sides face between upper surface and the lower surface is first cambered surface and second cambered surface respectively, upper surface and lower surface all form slope surface, two form first cambered surface, two between the lower end of slope surface form the second cambered surface between the higher end of slope surface, a plurality of through-holes have all been seted up on upper surface, lower surface, first side, second side, first cambered surface and the second cambered surface of fusion cage, and several arbitrary through-holes in a plurality of through-holes link up and form a plurality of irregular passageways, and a plurality of irregular passageways construct based on the taige polygon crystal lattice.
On the basis of the scheme, the aperture range of the through holes is 0.5mm-1mm.
On the basis of the scheme, a plurality of arris-tooth-shaped anti-skid protrusions are arranged on the upper surface and the lower surface.
On the basis of the scheme, 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.
On the basis of the scheme, the angle range of an included angle formed between extension lines of lower ends of the two inclined slope surfaces is 6-10 degrees, and the angle range of the included angle between the two inclined slope surfaces and the horizontal plane is 3-5 degrees.
On the basis of the scheme, the fusion cage body is of a cashew-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 both arc surfaces.
On the basis of the scheme, the fusion cage body is of a football-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 surfaces.
On the basis of the scheme, the length of the fusion cage body is 20-30mm, the width of the fusion cage body is 10mm, and the height of the fusion cage body is 8-12mm.
On the basis of the scheme, the upper surface and the lower surface of the fusion cage body are made of tantalum alloy materials, and the fusion cage body is made of titanium alloy materials except the upper surface and the lower surface.
A machining method of a random porous interbody fusion cage is suitable for any one random porous interbody fusion cage, and comprises the following steps:
s1: according to image data of CT scanning, reverse engineering reduction is carried out on the spine of a patient by using 3D image generation software, and the STL format is imported into editing processing software to be converted into entity so as to obtain intervertebral space data;
s2: changing the aperture diameter range to be 0.5-1 mm and the density parameter range to be 0.5-0.75mm according to the intervertebral space data obtained in the step S1 based on the Voronoi Thiessen polygonal structure by using computer-aided design software, and designing an aperture structure suitable for bone growth;
s3: importing the aperture structure file in the step S2 into ANSYS in an IGS format, analyzing by using ANSYS finite element simulation, setting cortical bone, cancellous bone and cartilage, wherein the elastic modulus of the cortical bone is 12GPa, the elastic modulus of the cancellous bone is 100MPa, the elastic modulus of the cartilage is 50MPa and the Poisson ratio is 0.3, simulating the elastic modulus of the fusion cage by using material parameters, and adjusting the aperture size and the structure size of the structure;
s4: guiding irregular porous fuser data into slice processing software in an STL format by using an SLM (selective laser melting) technology, wherein the thickness of a slice is 0.02mm, paving a layer of very thin tantalum alloy powder on a substrate of a forming cylinder in the process of starting processing, selectively carrying out laser melting on the current layer by using a high-power laser beam, cooling and solidifying the molten metal powder, reducing the layer thickness height of a processing platform, printing a titanium alloy layer with the thickness of 2mm, paving the tantalum alloy powder on the processed sheet layer by using a roller, scanning a new layer by using the laser beam, stacking layer by layer, and printing the titanium alloy powder again when the processing thickness is 8mm until the whole part is formed;
wherein the process parameters when printing the titanium alloy powder are as follows: the laser power is 230-250W, the scanning speed is 800-1000mm/s, and the scanning interval is 0.1-0.12mm; the process parameters when printing the tantalum alloy powder are as follows: the laser power is 300W-340W, the scanning speed is 1200mm/s, the scanning interval is 0.07mm, the shape of the fusion cage is printed by adopting two alloy materials by utilizing the SLM technology, the length size range of the fusion cage is 25-30mm, and the width size range is 10-15mm;
s5: and (5) grinding and polishing the part obtained in the step (S4) to obtain the required irregular porous fusion device.
The invention has the beneficial effects that:
(1) The invention is a threadless irregular porous structure, breaks through the structure of the traditional fusion cage, can prevent high settleability due to the threadless structure, is not taken out after the operation, and is simple and convenient for the operation; the bionic human skeleton with the irregular porous structure can increase the contact area of bone tissues, promote the growth of the bone tissues and accelerate the fusion efficiency, and simultaneously ensure that the mechanical property of the human bone tissues is met and the fusion effect of the fusion device is improved by combining the structure and the material under the condition of high aperture ratio;
(2) The processing method of the irregular porous interbody fusion cage utilizes a rapid forming technology, can realize the printing of different materials at different positions due to the unique structure of the irregular porous interbody fusion cage, enhances the contact friction between the upper surface and the lower surface of the interbody fusion cage and the spine by utilizing the advantage of high friction coefficient of a tantalum material, improves the implantation stability, can still meet the requirement of mechanical property under the condition of large aperture ratio by adopting titanium alloy at the rest parts, and can print the interbody fusion cages with different specifications according to the CT intervertebral space data of different patients to realize personalized customization.
Detailed Description
The present invention will now be described in further detail with reference to the accompanying drawings.
Example 1
As shown in fig. 1-8, specifically, an irregular porous interbody fusion cage, includes the fusion cage body, the fusion cage body includes upper surface 1 and lower surface 2, the relative both sides face between upper surface 1 and the lower surface 2 is first side 7 and second side 8 respectively, upper surface 1 and lower surface 2 all form slope surface, two form first cambered surface 3 between the lower end of slope surface, two form second cambered surface 4 between the higher end of slope surface, a plurality of through-holes 5 have all been seted up on upper surface 1, lower surface 2, first side 7, second side 8, first cambered surface 3 and the second cambered surface 4 of fusion cage, and arbitrary two or more through-holes 5 in a plurality of through-holes 5 link up and form a plurality of irregular passageways, and a plurality of irregular passageways are based on the construction of taige polygon crystal lattice.
This kind of structure of integration ware body is based on taisen polygon lattice, form by a plurality of spaces taisen structure combination, irregular fretwork porous structure, the whorless, not only can reach good compression elastic modulus, still be favorable to bone tissue to grow into, promote the osseous cell to fuse, conveniently implant, realize individualized customization, simultaneously go up, lower surface 2 sets up to certain angle of slope, it is crooked to do benefit to postoperative patient's vertebra, utilize SLM printing technique to realize fusing different materials of ware different position printing, and simultaneously, inside and outside are porous fretwork structure entirely, the whorless, have good biocompatibility, can induce bone to grow into, be favorable to improving spinal fusion rate and bone regeneration, reach more stable fusion effect.
Preferably, the aperture range of the plurality of through holes 5 is 0.5mm-1mm.
Wherein the porous structure with the pore diameter of 0.5-0.75mm and the density of 0.6-0.75 mm is suitable for people with the bone density T value between-1 and 1; the porous structure with the pore diameter of 0.75-1mm and the density of 0.5-0.6 mm is suitable for people with the bone density T value less than-1.
As shown in figures 3-4, a plurality of ridge-tooth-shaped anti-slip protrusions 6 are arranged on the upper surface 1 and the lower surface 2, so that the unevenness is increased, and the fusion cage is prevented from slipping off after being implanted.
As shown in fig. 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 upper ends of the two inclined slope surfaces.
The angle range of an included angle A between extension lines of the lower ends (namely, the front bulges) of the two inclined slope surfaces is 6-10 degrees, and the angle range of an included angle C between the two inclined slope surfaces and a horizontal plane is 3-5 degrees.
Preferably, the angle of the included angle a formed between the extension lines of the lower ends (i.e. the front convex) of the two inclined slope surfaces is 6 °, the angle of the included angle C formed between the two inclined slope surfaces and the horizontal plane is 3 °, so as to ensure that the fusion cage can avoid the bending movement of the spine after being implanted, and therefore the upper surface 1 and the lower surface 2 are set to have a certain inclination angle, and the angle is helpful for recovering the physiological curvature of the lumbar.
As shown in fig. 4 and 6, the cage body is of 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 both arc surfaces.
As shown in fig. 5 and 7, the fusion cage body is of 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 oppositely arranged, and the first side surface 7 and the second side surface 8 are both arc surfaces.
In actual use, the two shapes need to be selected according to the intervertebral space obtained by CT scanning, and the side surfaces of the fusion cage with the two structures are designed into circular arc surfaces which can adapt to the internal structure of the human vertebral body.
On the basis of the scheme, the length L of the fusion cage body is 20-30mm, the width B of the fusion cage body is 10-15mm, and the height of the fusion cage body is 8-12mm.
Example 2
The utility model provides an irregular porous intervertebral space fuses ware, fuse ware body upper surface 1 and lower surface 2 and adopt tantalum alloy material, fuse the ware body and all adopt titanium alloy material except upper surface 1 and lower surface 2 to the different mechanical properties and the structure of two kinds of materials cooperate, realize the elastic modulus and the mechanical properties that suit with human bone tissue.
Specifically, the upper surface 1 and the lower surface 2 (each 2 mm) are made of tantalum alloy, and the stability of implantation is achieved by utilizing the high friction coefficient of the tantalum alloy, so that the tantalum alloy is prevented from slipping after being implanted. The middle part (6 mm) of the fusion cage is made of titanium alloy material, accounts for 60 percent of the total volume, and the fusion cage still ensures the compatibility of the mechanical property under the condition of keeping 80 percent of aperture ratio.
The upper, middle and lower different positions of the fusion cage structure respectively use tantalum alloy, titanium alloy and tantalum alloy materials, and the high friction coefficient of the tantalum alloy is used for improving the surface friction of the fusion cage, so that the self-body bone mechanical performance can be met, and the fusion cage can achieve a better fixing effect.
Wherein the titanium-tantalum alloy ratio is 1:13:1.
example 3
As shown in fig. 9, a method for manufacturing a random porous interbody cage, which is suitable for use in the random porous interbody cage according to embodiment 1 or 2, comprises the steps of:
s1: according to image data of CT scanning, 3D image generation software (such as Mimics software) is used for carrying out reverse engineering reduction on the spine of a patient, and the STL format is led into editing processing software (such as Geomagic software) to be converted into solid so as to obtain intervertebral space data;
s2: changing the aperture range to be 0.5-1 mm and the density parameter range to be 0.5-0.75mm by using computer aided design software (such as Materialise 3-matic software) according to the intervertebral disc space data obtained in the step S1 and based on the Voronoi Thiessen polygonal structure, and designing an aperture structure suitable for bone growth;
s3: importing the aperture structure file in the step S2 into ANSYS in an IGS format, analyzing by using ANSYS finite element simulation, setting cortical bone, cancellous bone and cartilage, wherein the elastic modulus of the cortical bone is 12GPa, the elastic modulus of the cancellous bone is 100MPa, the elastic modulus of the cartilage is 50MPa and the Poisson ratio is 0.3, simulating the elastic modulus of the fusion cage by using material parameters, and adjusting the aperture size and the structure size of the structure;
s4: guiding irregular porous fuser data into slice processing software in an STL format by using an SLM (selective laser melting) technology, wherein the thickness of a slice is 0.02mm, paving a layer of very thin tantalum alloy powder on a substrate of a forming cylinder in the process of starting processing, selectively carrying out laser melting on the current layer by using a high-power laser beam, cooling and solidifying the molten metal powder, reducing the layer thickness height of a processing platform, printing a titanium alloy layer with the thickness of 2mm, paving the tantalum alloy powder on the processed sheet layer by using a roller, scanning a new layer by using the laser beam, stacking layer by layer, and printing the titanium alloy powder again when the processing thickness is 8mm until the whole part is formed;
the process parameters when printing the titanium alloy powder are as follows: the laser power is 230-250W, the scanning speed is 800-1000mm/s, and the scanning interval is 0.1-0.12mm; the process parameters when printing the tantalum alloy powder are as follows: the laser power is 300W-340W, the scanning speed is 1200mm/s, the scanning interval is 0.07mm, the shape of the fusion cage is printed by adopting two alloy materials by utilizing the SLM technology, the size range of the length L of the fusion cage is 25-30mm, and the size range of the width B of the fusion cage is 10-15mm;
s5: and (5) grinding and polishing the part obtained in the step (S4) to obtain the required irregular porous fusion device.
As shown in figure 1, the fusion cage structure of this embodiment is based on the polygonal irregular porous structure of taisen, for satisfying the fusion effect of human motion demand and backbone, designs two kinds of structural shapes and is "kidney" shape and "football" shape respectively, can induce the diversified income of osseous tissue, reaches the fast, good effect of fusing of going into of growing into, simultaneously, does not design helicitic texture, not only conveniently implants, avoids the high settleability after implanting moreover. See fig. 1 and 2. The length L and height H of the two cage structures of this embodiment are both 25mm and 10mm, and the width B is 10mm and 15mm, respectively. The side surfaces of the fusion cage with the two structures are designed into the inner structure of a circular arc curved surface which can adapt to the vertebral body of a human body, the upper surface 1 and the lower surface 2 are provided with a plurality of tooth-shaped convex surfaces, friction is increased, the upper surface 1 and the lower surface 2 (each 2 mm) adopt tantalum alloy materials except the friction which is structurally increased, thereby the high friction coefficient of the tantalum alloy is utilized to achieve the stability of implantation, and the fusion cage is prevented from slipping after implantation. The middle part (6 mm) is shown in figures 3 and 4, and both adopt titanium alloy materials, account for 60 percent of the total volume, and the fusion cage still ensures the compatibility of the mechanical property under the condition of 80 percent of porosity. As shown in figure 2, in order to ensure that the bending movement behavior of the spine is avoided after the fusion cage is implanted, the upper surface 1 and the lower surface 2 are arranged to have certain inclination angles, the front convex angle formed by the two surfaces is 6 degrees, and the included angles between the upper inclined slope surface and the horizontal plane are both 3 degrees, which is beneficial to recovering the physiological curvature of the lumbar.
The invention relates to a specific embodiment of a processing method of a irregular porous interbody fusion cage, which comprises the following steps as shown in figures 1-9:
(1) The doctor carries out CT scanning on the spine of the patient to obtain CT image data of the patient, utilizes Mimics software to carry out reverse engineering reduction on the spine of the patient, and introduces the STL format into Geomagic to realize the STL format, so as to obtain intervertebral space data.
(2) The approximate shape of the fusion cage is designed according to the intervertebral space data, and a porous structure suitable for bone growth is designed by utilizing Materialise 3-matic software and changing the aperture (0.5 mm-1 mm) and the density parameter (0.5 mm-0.75 mm) based on the Voronoi Thiessen polygonal structure.
(3) And importing the file into ANSYS in an IGS format, analyzing by using finite element simulation, setting the elastic modulus of a cortical bone (with the elastic modulus of 12 GPa), a cancellous bone (with the elastic modulus of 100 MPa) and a cartilage (with the elastic modulus of 50 MPa) and a Poisson ratio of 0.3 for simulating the elastic modulus of the fusion cage, adjusting the pore size of the structure, and realizing the hollow porous structures with different pore diameters so as to adapt to people with different bone densities.
(4) Aiming at different crowds, the length and the size range are set to be 25-30mm according to the irregular porous structure; the width dimension ranged from 10-15mm, and the irregular porous fusion device was introduced into the slice processing software in STL format using SLM printing technique as in FIG. 8, with a slice thickness of 0.02mm. In the process of starting processing, a layer of very thin tantalum alloy powder with the thickness of 0.03mm is firstly paved on a substrate of a forming cylinder, a high-power laser beam selectively carries out laser melting on the current layer, after the molten metal powder is cooled and solidified, a processing platform is lowered by one layer thickness height, a titanium alloy layer with the thickness of 2mm is printed, the tantalum alloy powder is paved on the processed sheet layer by a roller, the laser beam starts to scan a new layer, the layer is overlapped layer by layer, and the titanium alloy powder is changed to be printed when the processing thickness is 8mm until the whole part is formed. Wherein the process parameters when printing the titanium alloy powder are as follows: the laser power is 230W, the scanning speed is 1000mm/s, and the scanning interval is 0.12mm; the process parameters when printing the tantalum alloy powder are as follows: the laser power is 300W, the scanning speed is 1200mm/s, and the scanning interval is 0.07mm.
(5) And (5) grinding and polishing the part obtained in the step (4) to obtain the required part.
In some embodiments, the random multi-hole intersomatic cage has a length of 25mm, a width of 10mm, a height of 10mm, a lordotic angle of 6 °, a pore size of 0.75mm, and a density of 0.5mm.
In some embodiments, the random multi-hole intersomatic cage has a length of 25mm, a width of 10mm, a height of 10mm, a lordotic angle of 6 °, a pore size of 0.5mm, and a density of 1mm.
In some embodiments, the random multi-hole intersomatic cage has a length of 30mm, a width of 15mm, a height of 10mm, a lordotic angle of 6 °, a pore size of 1mm, and a density of 0.5mm.
The irregular porous interbody fusion cage and the preparation method thereof adopt the porous structure of the bionic bone, have no screw thread on the whole, are an integral model of the irregular porous structure, can enable the contact surface of the fusion cage and the spine to be more compact, accelerate the growth and migration of bone tissues from a plurality of surfaces of the fusion cage, accelerate the fusion effect, avoid high settleability caused by the existence of the screw thread, and do not need to fill bone materials in the fusion cage in the operation, thereby simplifying the operation of the operation.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.