阅读说明：本技术 一种增强型腰椎侧路椎间融合器的制备方法 (Preparation method of enhanced lumbar lateral interbody fusion cage ) 是由 王鹏 唐贤华 王大川 吕国玉 李鸿 于 2019-09-03 设计创作，主要内容包括：本发明申请提供了一种增强型腰椎侧路椎间融合器的制备方法,采用以体积份数比10:0.1～3配比的HA/PA66复合材料与辅材粉体所得的医用复合材料进行注塑成型,所制备而成的增强型腰椎侧路椎间融合器,具有较强的抗压和抗冲击强度、力学性能稳定,解决了使用现有腰椎侧路椎间融合器尾端存在断裂风险的技术问题。(The application provides a preparation method of enhanced lumbar lateral interbody fusion cages, wherein the medical composite material prepared from HA/PA66 composite material and auxiliary material powder in a volume part ratio of 10: 0.1-3 is adopted for injection molding, and the prepared enhanced lumbar lateral interbody fusion cages have strong compression strength and impact strength and stable mechanical property, and solve the technical problem that the tail end of the existing lumbar lateral interbody fusion cages HAs fracture risk.)

The preparation method of 1, enhanced lumbar lateral interbody fusion cages is characterized in that medical composite material formed by mixing HA/PA66 composite material particles and auxiliary material powder is adopted for injection molding.

2. The preparation method according to claim 1, wherein the mixing ratio of the HA/PA66 composite material particles to the auxiliary material powder is 10: 0.1-3.

3. The method of claim 1, wherein the injection molding conditions are a temperature of 220 ℃ to 280 ℃ and a pressure of 100MPa to 180 MPa.

4. The method of claim 2, wherein the HA/PA66 composite particles are prepared by an ethanol system method.

5. The preparation method of claim 2, wherein the auxiliary material powder comprises kinds of any one of fiber reinforcement and organosilicon hybrid titanium reinforcement.

6. The preparation method of claim 5, wherein the fiber reinforcement comprises quartz fiber, glass fiber, carbon fiber, modified carbon fiber, short carbon fiber, single-walled carbon nanotube, silicon carbide fiber, silicon nitride fiber, and any or several combinations of BN, TiC, B4C complex phase fiber.

7. The method of claim 5, wherein the silicone hybrid titanium reinforcement has a cage silsesquioxane structure.

8. The method of claim 7, wherein the step of preparing the silicone hybrid titanium reinforcement comprises:

s1, weighing raw materials for later use, wherein the raw materials comprise medical pure titanium powder, absolute ethyl alcohol, ethyl silicate and hydrogen peroxide;

s2, putting medical pure titanium powder into absolute ethyl alcohol, and stirring and dispersing at the rotating speed of 3000-8000 rpm for 0.5-1 h to prepare a titanium powder dispersion liquid;

s3, adding hydrogen peroxide and ethyl silicate into the titanium powder dispersion liquid prepared in the step S2 in sequence, and stirring at the rotating speed of 8000rpm for 3-4.5 h;

s4, filtering the reaction liquid in the step S3, washing a filtered substance by using absolute ethyl alcohol, adding the absolute ethyl alcohol and concentrated hydrochloric acid into the mixture in equal proportion, and stirring the mixture for at least 48 hours at the rotating speed of 4500-5000 rpm;

s5, filtering and collecting precipitates in the mixed and stirred solution obtained in the step S4, washing the precipitates with absolute ethyl alcohol, and recrystallizing the precipitates;

s6, filtering under reduced pressure, and drying at 60-80 ℃ to prepare powder after the liquid material is recrystallized and washed by deionized water in the step S5.

9. The preparation method according to claim 7, wherein the raw material components in the step S1 are configured according to the following parts by volume:

1 part of medical pure titanium powder, namely,

2-4 parts of absolute ethyl alcohol,

3-6 parts of ethyl silicate,

3-6 parts of hydrogen peroxide.

Technical Field

The invention relates to the technical field of orthopedic internal implantation medical equipment, in particular to a preparation method of enhanced lumbar lateral interbody fusion cages.

Background

When the vertebral body bears longitudinal load, the nucleus pulposus expands towards the outer circumference by the good elasticity of the fibrous ring to buffer pressure, thereby realizing the shock absorption function and preventing the human body from vibrating the cranium during walking, bouncing and running.

The side approach lumbar interbody fusion is newer operation methods, which reach a target area from behind the peritoneum by means of special channels, not only can avoid the peeling of the anterior aorta and the vena cava, but also can reduce the injury of posterior muscles, ligaments and nerves.

As described above, since the cage used in the lateral approach lumbar interbody fusion is larger in size and flatter in structure than the conventional cage, higher mechanical stability is required. When the HA/PA66 composite material is adopted to manufacture the lateral approach lumbar interbody fusion cage, the impact strength and toughness of the lateral approach lumbar interbody fusion cage are insufficient, and the tail end of the lateral approach lumbar interbody fusion cage HAs a fracture risk.

Disclosure of Invention

The invention provides a preparation method of enhanced lumbar lateral interbody fusion cages, which solves the technical problem that the tail end of the existing lumbar lateral interbody fusion cage is at fracture risk.

In order to achieve the purpose, the invention provides the following technical scheme:

A method for preparing the reinforced lumbar intervertebral fusion cage includes such steps as mixing HA/PA66 particles with auxiliary powder, and injection moulding.

, mixing the HA/PA66 composite material particles and the auxiliary material powder in a ratio of 10: 0.1-3.

The invention still takes the HA/PA66 composite material as the main body, and the main body material is toughened through the selection of auxiliary materials and the control of the addition amount of the auxiliary materials, so as to ensure that the composite material HAs reasonable impact strength and toughness and avoid the tail end of the manufactured lumbar interbody fusion cage passing through the lateral approach from being broken.

, the injection molding conditions are 220-280 deg.C and 100-180 MPa.

Tables 1-5 provide the effect of injection molding conditions on the appearance and mechanics of standard injection molded specimens. Wherein, the standard injection molding test sample strips of 80cm multiplied by 10cm multiplied by 4cm and 10cm multiplied by 4cm are respectively adopted to carry out the impact resistance test and the compression resistance test.

As can be seen from the table, the optimum injection molding conditions of the medical composite material are as follows: the temperature is 220-280 ℃, the pressure is 100-180 Mpa, the glue injection speed is 4-50%, the pressure maintaining time is 4-10 s, and the cooling time is 10-30 s.

, HA/PA66 composite material particles are prepared by an ethanol system method with a mature process.

, the auxiliary material powder comprises any of fiber reinforcement and organic silicon hybrid titanium reinforcement.

, the fiber reinforcement comprises quartz fiber, glass fiber, carbon fiber, modified carbon fiber, short carbon fiber, single-walled carbon nanotube, silicon carbide fiber, silicon nitride fiber, and any or several combinations of BN, TiC, B4C complex phase fiber.

Table 6 provides the effect of fiber reinforcement composition on the mechanical properties of the fuser samples. Wherein, the standard injection molding sample is an injection molding lumbar vertebrae lateral way interbody fusion cage with the specification of 26cm multiplied by 10cm multiplied by 12 cm.

, the silicone hybrid titanium reinforcement has a cage silsesquioxane structure as shown in FIG. 1.

The cage-like silsesquioxane has natural nanoscale and regular spatial structure, and is stable in structure and property and friendly to human body; the peripheral substituent group is easy to design so as to carry out polymerization and activation according to actual needs, thereby obtaining the modified material with higher mechanical strength and bioactivity.

Table 7 provides the effect of silicone hybrid titanium reinforcement content on the mechanical properties of the fuser samples. It is known from comparison with table 6 that the compressive strength of the organosilicon hybrid titanium reinforcement is substantially up to the level of the fiber reinforcement, and the impact resistance is significantly better than the fiber reinforcement. In addition, the substituent group has easy design, so that the artificial intervertebral disc is more suitable for serving as an interbody fusion cage and other human implants, the rejection reaction risk is reduced, and the fusion degree of the implants and the human body is improved.

, the preparation of the organic silicon hybrid titanium reinforcement comprises the following steps:

s1, weighing raw materials for later use, wherein the raw materials comprise medical pure titanium powder, absolute ethyl alcohol, ethyl silicate and hydrogen peroxide;

s2, putting medical pure titanium powder into absolute ethyl alcohol, and stirring and dispersing at the rotating speed of 3000-8000 rpm for 0.5-1 h to prepare a titanium powder dispersion liquid;

s3, adding hydrogen peroxide and ethyl silicate into the titanium powder dispersion liquid prepared in the step S2 in sequence, and stirring at the rotating speed of 8000rpm for 3-4.5 h;

s4, filtering the reaction liquid in the step S3, washing a filtered substance by using absolute ethyl alcohol, adding the absolute ethyl alcohol and concentrated hydrochloric acid into the mixture in equal proportion, and stirring the mixture for at least 48 hours at the rotating speed of 4500-5000 rpm;

s5, filtering and collecting precipitates in the mixed and stirred solution obtained in the step S4, washing the precipitates with absolute ethyl alcohol, and recrystallizing the precipitates;

s6, filtering under reduced pressure, and drying at 60-80 ℃ to prepare powder after the liquid material is recrystallized and washed by deionized water in the step S5.

, preparing the raw material components in the step S1 according to the following volume parts:

1 part of medical pure titanium powder, namely,

2-4 parts of absolute ethyl alcohol,

3-6 parts of ethyl silicate,

3-6 parts of hydrogen peroxide.

Table 8 provides the silicone hybrid titanium reinforcement part formulation and its effect on the mechanical properties of the composite.

Drawings

In order to more clearly illustrate some technical solutions of the present invention, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

FIG. 1 is a schematic structural view of an organosilicon hybrid titanium reinforcement according to the present invention;

FIG. 2 is a schematic structural diagram of example 8 of the present invention;

fig. 3 is a schematic structural diagram of embodiment 9 of the present invention.

Reference numerals: 1. implanting the end; 2. a tail end; 3. a clamping hole; 4. a front side wall; 5. a rear side wall; 6. bone grafting holes; 7. a middle spacer rib; 8. positioning holes; 9. a protrusion; 10. a clamping groove.

Detailed Description

In the following, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the claimed embodiments. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

The following disclosure provides many different embodiments or examples for implementing different configurations of embodiments of the present application. In order to simplify the disclosure of the embodiments of the present application, the components and arrangements of the specific examples are described below. Of course, they are merely examples and are not intended to limit the claimed embodiments. Moreover, embodiments of the present application may repeat reference numerals and/or reference letters in the various examples, which have been repeated for purposes of brevity and clarity and do not in themselves dictate a relationship between the various embodiments and/or arrangements discussed. In addition, while the embodiments of the present application provide examples of various specific processes and materials, one of ordinary skill in the art will recognize applications of other processes and/or uses of other materials.

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.