CN112451185A

CN112451185A - A kind of high-strength biologically active intervertebral cage and its manufacturing method

Info

Publication number: CN112451185A
Application number: CN202011599971.4A
Authority: CN
Inventors: 邵惠锋; 景卓荦; 贺永; 年志恒; 龚友平; 刘海强; 陈慧鹏; 李文欣
Original assignee: Hangzhou Dianzi University
Current assignee: Hangzhou Dianzi University
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2021-03-09
Anticipated expiration: 2040-12-30
Also published as: CN112451185B

Abstract

The invention discloses a high-strength biologically active intervertebral cage and a manufacturing method thereof. The intervertebral cage is composed of three parts: an outer layer, a middle layer and an inner layer, and the middle layer is wrapped in the outer layer Inside, the inner layer is installed in the middle layer; the outer layer is a soft material; the middle layer is a porous structure, and the inner pores are completely penetrated; the inner layer is the biological activity of two or more porous structures The combination of materials, the internal pores are completely penetrated, it can be a combination of calcium magnesium silicate, silicate, or phosphate, etc., or it can be a biologically active material with some special functions. The middle layer includes an inlet port and a track, the inner layer enters the middle layer through the inlet port, and the inner layer is movably installed on the track. The high-strength biologically active intervertebral cage of the present invention has high mechanical strength, good positional stability, good biological activity, and can also add various functions.

Description

High-strength bioactive intervertebral fusion cage and manufacturing method thereof

Technical Field

The invention relates to an instrument in the technical field of medical instruments and a manufacturing method thereof, in particular to a high-strength bioactive intervertebral fusion cage and a manufacturing method thereof.

Background

With the aging of the population, degenerative diseases of the spine, which mainly cause neck and shoulder pain and pain in the waist and lower extremities, are seriously affecting the work and life of people. Vertebral body fusion between vertebral bodies is one of the main methods for treating degenerative diseases of the spine at present. Through the diligent efforts of researchers, various kinds of interbody cages have been developed in succession and are gradually applied to the clinic. An ideal cage needs to correct spinal deformity, restore normal physiologic curvature, maintain intervertebral space stability, and most importantly promote bone fusion. However, many disadvantages of the current fusion cage include poor biocompatibility of the fusion cage material, collapse of the intervertebral space, late inflammatory response, etc.

With the development of the disciplines of mechanics, materials science, tissue engineering and the like, researchers are studying new intervertebral fusion cages through multidisciplinary intersection, but no matter how the materials of the fusion cages change, the following requirements must be met: the fusion cage has no toxic or side effect in a human body and has better biocompatibility; has suitable biomechanical characteristics; to ensure stability of the intervertebral space and promote bone fusion; after being implanted into a human body, the implant should have a larger fusion area with the upper and lower vertebral bodies and should be closer to the normal physiological curvature of the human body in structure.

Disclosure of Invention

The present invention addresses the above-described deficiencies of the prior art by providing a high strength bioactive interbody fusion cage and a method of making the same.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows: a high strength bioactive interbody cage, said interbody cage is made up of three parts of the outer layer, intermediate layer and inner layer, said intermediate layer is wrapped up in the inside of said outer layer, said inner layer is installed in said intermediate layer;

the outer layer is made of soft materials, can be hydrogel, can also be silica gel and the like;

the middle layer is of a porous structure, and the inner pore passage is completely communicated and can be titanium alloy or PEEK and the like;

the inner layer is a combination of two or more bioactive materials with porous structures, the inner pore channels are completely penetrated, the bioactive materials can be a combination of calcium magnesium silicate, phosphate and the like, and the bioactive materials have some special functions, such as tumor growth inhibition, bone promotion and vascularization promotion.

Preferably, the middle layer of the high-strength bioactive intervertebral fusion device comprises an inlet and a track, the inner layer enters the middle layer through the inlet, the inner layer is movably mounted on the track, the whole structure of the middle layer can be hollowed according to the requirements of application occasions, the topology structure of the whole structure is optimized, the fusion device is lighter on the premise of meeting the use requirements, and the middle layer is used for bearing external loads.

Preferably, the porosity of the middle layer is 30-60%, the pore diameter is 50-500 microns, and the pore form structure can be square, rectangular, parallelogram, spherical and the like;

preferably, the entry opening and the track in the intermediate layer constitute one unit, and the number of the units may be 1, 2, or more. In practical application, the number of the units is determined according to the structure of the middle layer and the required number of the inner layers, and the positions of the units in the middle layer are determined according to the structure of the middle layer.

Preferably, the porosity of the inner layer of the high-strength bioactive intervertebral fusion device is 30-90%, the pore diameter is 200-1000 microns, the thickness is 0.3-5 mm, the pore form structure can be a grid square, a rectangle, a parallelogram and the like, and the inner layer structure can be a plurality of bioactive materials.

Preferably, the external shape of the inner layer of the high-strength bioactive intervertebral fusion device is the same as that of the inlet of the middle layer, and can be triangular, circular and the like, the external shape of the inner layer is matched with the cross-sectional shape of the track, the size of the inner layer is slightly smaller than that of the inlet, and the inner layer can enter the inner part of the middle layer through the inlet. Through the design of entry port special construction, the inlayer can only reach inside the intermediate level through the entry port under a position state, and after the inlayer entered into the intermediate level inside, the inlayer can follow the intraformational track cooperation of intermediate level, guarantees that the inlayer is a relatively stable position state inside the intermediate level, for example when the shape of inlayer is triangle-shaped, orbital cross sectional shape is the V type, when the shape of inlayer is circular, orbital cross sectional shape is the semicircle type, when a plurality of inlayers entered into on the track, the inlayer can carry out horizontal migration on the track to hardly come out from the entry port, guarantee that the inlayer is inside the intermediate level always.

In practical application, the outer layer is wrapped outside the middle layer, so that the hard material can be prevented from directly contacting with surrounding hard bones to cause abrasion. The mechanical strength of the intermediate layer can be adjusted by adjusting the porosity, the pore diameter and the pore form structure of the intermediate layer. The degradation speed and the ion release speed of the biological material can be controlled by adjusting the porosity, the pore diameter, the pore form structure and the porosity of the middle layer. By adjusting the number of inner layers or the number of materials of the same structure in one unit, the release amount of ions can be controlled, so that the fusion device has better functions. By adjusting the material of the inner layer, the fusion device can have different functions or integrate multiple functions, such as tumor inhibition, vascularization promotion, bone regeneration promotion and the like.

Preferably, the present invention relates to a method for manufacturing the high-strength bioactive intervertebral fusion cage, comprising the steps of:

1) respectively selecting the material types of the middle layer, the outer layer and the inner layer according to application occasions;

2) designing the structure of the intermediate layer according to the application occasions and the material characteristics of the intermediate layer, and then manufacturing the intermediate layer by using equipment;

3) designing the structure of the outer layer according to the structure of the middle layer and the material characteristics of the outer layer, and then manufacturing the outer layer;

4) designing the structure of the inner layer according to the application occasion and the material characteristics of the inner layer, mixing the inner layer material with a solvent to respectively obtain uniformly dispersed biological ink, and then manufacturing a plurality of inner layer blanks by using 3D printing equipment;

5) respectively placing the inner layer blanks into a high-temperature furnace for high-temperature calcination, and cooling to obtain a plurality of inner layer structures;

6) placing a plurality of inner-layer structures on a track sequentially through the inlet openings of the middle layers;

7) and (3) wrapping the intermediate layer structure containing the inner layer by using the outer layer to obtain the high-strength bioactive intervertebral fusion device.

Preferably, the calcination temperature is 950%^oC-1150^oC, the temperature rising speed is 1 to 3^oCMin, and the heat preservation time is 1-6 hours.

Compared with the prior art, the invention has the following advantages:

firstly, the surface structure of the high-strength bioactive intervertebral fusion device manufactured by the invention is soft and is not easy to abrade with the contact part.

Secondly, the high-strength bioactive intervertebral fusion device manufactured by the invention has good bioactivity in vivo and can promote bone regeneration and repair.

Thirdly, the invention can manufacture the high-strength bioactive intervertebral fusion cage with multiple functions, and meets the complex and changeable practical application requirements.

Fourthly, the method for manufacturing the high-strength bioactive intervertebral fusion cage is convenient to operate and low in manufacturing cost.

Drawings

FIG. 1 is a schematic flow chart of a method of manufacturing a high strength bioactive intervertebral cage according to the present disclosure;

FIG. 2 is a schematic view of a high strength bioactive intervertebral cage of the present invention;

fig. 3 is a partial schematic view of a high strength bioactive intervertebral cage of the present invention.

Detailed Description

The following examples are given for the detailed implementation and specific operation of the present invention, but the scope of the present invention is not limited to the following examples.

As shown in figure 2, the high-strength bioactive intervertebral fusion device comprises an outer layer, a middle layer and an inner layer, wherein the middle layer is wrapped inside the outer layer, and the inner layer is arranged inside the middle layer;

the outer layer is made of soft material, which can be hydrogel or silica gel;

the middle layer is of a porous structure, and the inner pore passage is completely penetrated, and can be titanium alloy, PEEK (polyether ether ketone) and the like;

The intermediate level of above-mentioned high strength biological activity interbody fusion cage includes inlet port and track, and above-mentioned inlayer passes through inside above-mentioned inlet port gets into the intermediate level, and above-mentioned inlayer movable mounting is on above-mentioned track, and above-mentioned intermediate level is according to the needs of application scenario, and whole structure can carry out the fretwork and handle, optimizes through carrying out topological structure to whole structure, can make the fusion cage lighter under the prerequisite that satisfies the operation requirement, and the effect in intermediate level is used for bearing external load.

The porosity of the middle layer is 30-60%, the pore diameter is 50-500 microns, and the pore form structure can be square, rectangular, parallelogram, spherical and the like;

the inlet and the track in the intermediate layer form a unit, and the number of the units can be 1, 2 or more. In practical application, the number of the units is determined according to the structure of the middle layer and the required number of the inner layers, and the positions of the units in the middle layer are determined according to the structure of the middle layer.

The porosity of the inner layer of the high-strength bioactive interbody fusion cage is 30-90%, the pore diameter is 200-1000 microns, the thickness is 0.3-5 mm, the pore form structure can be a grid square, a rectangle, a parallelogram and the like, and the inner layer structure can be a plurality of various bioactive materials.

The external shape of the inner layer of the high-strength bioactive intervertebral fusion device is the same as that of the inlet of the middle layer and can be triangular, circular and the like, the external shape of the inner layer is matched with the cross section shape of the track, the size of the inner layer is slightly smaller than that of the inlet, and the inner layer can enter the inner part of the middle layer through the inlet. Through the design of inlet port structure, above-mentioned inlayer can only reach inside the intermediate level through the inlet port under a position state, when the inlayer enters into the inside back in intermediate level, the inlayer can follow the intraformational track cooperation in above-mentioned intermediate level, guarantee that the inlayer is a relatively stable position state in the intermediate level inside, for example when the shape of inlayer is triangle-shaped, orbital cross sectional shape is the V type, when the shape of inlayer is circular, orbital cross sectional shape is the semicircle type, when a plurality of inlayers enter into on the track, the inlayer can carry out horizontal migration on the track, and hardly come out from the inlet port, guarantee that the inlayer is inside the intermediate level all the time.

As shown in fig. 1, it is a flow chart of the manufacturing method of the high strength bioactive intervertebral fusion device of the present invention, comprising the following steps:

The above calcination temperatureDegree of 950^oC-1150^oC, the temperature rising speed is 1 to 3^oCMin, and the heat preservation time is 1-6 hours.

Example 1

The manufacturing method of the intervertebral fusion device with the functions of resisting tumor, promoting osteogenesis and promoting vascularization for the lumbar intervertebral fusion comprises the following steps:

1) selecting titanium alloy as a material of the middle layer, silica gel as a material of the outer layer, calcium magnesium silicate with the magnesium content of 1.6 percent as an inner layer material A, calcium silicate material containing strontium as an inner layer material B, calcium silicate material containing copper as an inner layer material C, and calcium silicate material with anti-tumor drugs as an inner layer material D;

2) designing the outline of a titanium alloy intermediate layer according to the mechanical properties required by the interbody fusion cage and the material properties of the titanium alloy, wherein the internal porosity is 30%, the pore diameter is 100 microns, the pore-shaped structure is in a grid shape, 2 units are arranged in the intermediate layer and are respectively arranged on the uppermost surface and the lowermost surface of the intermediate layer, the shape of an inlet is triangular, the cross section of a track is in a V shape, then guiding the designed intermediate layer structure model into metal 3D printing equipment, and stacking layer by layer through a selective laser melting process to obtain the titanium alloy intermediate layer structure;

3) according to the upper and lower surface structures of the middle layer and the material characteristics of the silica gel, the structure of the outer layer is designed to be the same as the upper and lower surface structures of the middle layer, the size of the structure is slightly smaller than that of the upper and lower surface structures of the middle layer, the silica gel can be firmly wrapped outside the middle layer, and then the structure of the outer layer of the silica gel is manufactured by a pouring method;

4) 4 structures of the inner layer are respectively designed according to the anti-tumor property, the bone regeneration property, the vascularization promoting property and the repair property required by the application occasion and the properties of four materials, the porosity of the inner layer A is 60 percent, the pore diameter is 500 micrometers, the pore form structure is a grid square, the porosity of the inner layer B is 50 percent, the pore diameter is 400 micrometers, the pore form structure is a grid square, the porosity of the inner layer C is 50 percent, the pore diameter is 400 micrometers, the pore form structure is a grid square, the porosity of the inner layer D is 60 percent, the pore diameter is 700 micrometers, the pore form structure is a grid square, the four inner layers are triangles with the same follow-in inlet, but the size of the triangles is 0.5mm smaller than the enter-in inlet, the shape and the size of the inner layers are just matched with the cross-section shape and the size of the rail, the four inner layer materials are respectively mixed with the solvent to obtain the uniformly dispersed biological inks A and, c and D, guiding the structural model of the inner layer into 3D printing equipment, and then respectively obtaining inner layer blanks A, B, C and D by utilizing the 3D printing equipment in a layer-by-layer overlapping mode;

5) putting the inner layer blank A into a high-temperature furnace, and passing through 1150^oCalcining at high temperature for 4 hr, cooling to obtain inner layer A, putting inner layer blank B in high-temperature furnace, and passing through 1100 deg.C^oCalcining the C at high temperature for 4 hours, cooling to obtain an inner layer B, putting the inner layer blank C into a high-temperature furnace, and passing through 1100 DEG C^oCalcining the C at high temperature for 4 hours, cooling to obtain an inner layer C, putting the inner layer blank D into a high-temperature furnace, and passing through 1100 DEG C^oCalcining the C at high temperature for 4 hours, cooling to obtain an inner layer D, soaking the inner layer D in a solution containing the anti-tumor drug for several times, and drying to obtain the inner layer D carrying the anti-tumor drug;

6) placing 1 inner layer D on a track through an inlet on the upper surface of the middle layer, inclining the middle layer to enable the inner layer D to move to the other end of the track along the track, then flatly placing the middle layer, enabling the inner layer A to be placed on the track through the inlet, inclining the middle layer again, enabling the inner layer A to move to the other end of the track and be in contact with the inner layer D, continuing to operate in such a way, sequentially placing the inner layers C, B, B, C, A and D until the 8 inner layer structures are positioned on the track on the upper surface of the middle layer according to the sequence of DACBBCAD, then overturning the middle layer, adding the inner layer structures into the inlet on the lower surface of the middle layer, filling the track on the lower surface with the 8 inner layer structures as the operation process of adding the inner layer structures into the upper surface, and finally obtaining the middle layer loaded with the;

7) respectively wrapping the upper surface and the outer surface of the intermediate layer obtained in the step 6) by using the silica gel obtained in the step 3) to obtain the high-strength bioactive intervertebral fusion device, wherein the structural schematic diagram of the key part is shown in fig. 3.

Claims

1. a high-strength biologically active intervertebral cage is characterized in that, described intervertebral cage is made up of three parts of outer layer, middle layer and inner layer, and described middle layer is wrapped inside described outer layer, the inner layer is mounted within the intermediate layer;

The outer layer is a soft material, such as hydrogel or silica gel;

The intermediate layer is a porous structure, and the internal pores are completely penetrated, which is titanium alloy or PEEK, etc.;

The inner layer is a combination of two or more bioactive materials with porous structures, and the internal pores are completely penetrated, which is a combination of calcium magnesium silicate, silicate, or phosphate, or the bioactive material has some functions. , including tumor growth inhibition, vascularization and osteogenesis;

The middle layer of the high-strength biologically active intervertebral cage includes an access port and a track, the inner layer enters the interior of the middle layer through the access port, and the inner layer is movably installed on the track;

The porosity of the intermediate layer is 30-60%, the pore diameter is 50-500 microns, and the pore morphological structure is square, rectangular, parallelogram or spherical;

The inlet and the track in the intermediate layer form a unit, and the unit is at least one or more.

2. The high-strength biologically active intervertebral cage according to claim 1, wherein the inner layer of the high-strength biologically active intervertebral cage has a porosity of 30-90%, and a pore diameter of 200-1000 Micron, the thickness is 0.3~5mm, and the pore shape structure is grid square, rectangle, parallelogram.

3. The high-strength bioactive intervertebral cage according to claim 1, wherein the outer shape of the inner layer of the high-strength bioactive intervertebral cage is the same as the shape of the inlet port of the middle layer ; The outer shape of the inner layer matches the cross-sectional shape of the track, the size of the inner layer is slightly smaller than the size of the inlet port, and the inner layer can enter the interior of the intermediate layer through the inlet port.

4. a kind of manufacture method of high-strength bioactive intervertebral cage according to claim 1, is characterized in that, comprises the following steps:

1) Select the material types of the middle layer, outer layer and inner layer according to the application;

2) Design the structure of the intermediate layer according to the application and the material properties of the intermediate layer, and then use the equipment to manufacture the intermediate layer;

3) According to the structure of the middle layer and the material properties of the outer layer, design the structure of the outer layer, and then manufacture the outer layer;

4) Design the structure of the inner layer according to the application and the material properties of the inner layer, mix the inner layer material with the solvent to obtain a uniformly dispersed bio-ink, and then use 3D printing equipment to manufacture multiple inner layer blanks;

5) Put the inner layer blanks into a high temperature furnace for high temperature calcination, and obtain multiple inner layer structures after cooling;

6) Place multiple inner layer structures on the track through the entrance of the middle layer in sequence;

7) Wrap the middle layer structure including the inner layer with the outer layer to obtain a high-strength bioactive intervertebral cage.

5. the manufacture method of high-strength biologically active intervertebral cage according to claim 4, is characterized in that, described calcination temperature is 950 ^o C-1150 ^o C, and the heating rate is 1-3 ^o C/min, The holding time is 1-6 hours.