1. A preparation method of an artificial eye platform based on a beta-tcp material is characterized by comprising the following steps:

acquiring patient data by using a three-dimensional scanner and establishing a digital model;

(II) carrying out computer-aided design on the prosthesis form of the artificial eye, typesetting and exporting STL data;

(III) importing the STL data into a 3D printer;

printing, spraying and molding an oval artificial eye platform with the same design by taking beta-tcp ink slurry with the solid phase content of 30-60% as a raw material and taking slurry consisting of nano sodium carbonate particles, an auxiliary solvent and a dispersing agent as a supporting raw material;

washing the soluble support material with water;

sixthly, sintering according to a set curve sintering process after airing to obtain the artificial eye platform;

and (seventhly) inspecting finished products.

2. The method as claimed in claim 1, wherein the β -tcp ink slurry comprises β -tcp nanoparticles, an auxiliary solvent, and a binder.

3. The method as claimed in claim 1, wherein in step one, the primary modeling is performed by using an alginate impression, and then the digital model is built on a computer using data obtained by a three-dimensional scanner.

4. The method as claimed in claim 1, wherein the anterior portion of the ocular prosthesis has a hole for receiving the eye plate, and the posterior sphere portion is made of polygonal lattice.

5. The method as claimed in claim 1, wherein the ocular prosthesis table has a front eye plate receiving hole and a rear ball portion having a lattice structure of uniform density formed by interconnected trusses.

6. The method for preparing the artificial eye platform based on the beta-tcp material, as claimed in claim 1, wherein the sintering process with the set curve in the sixth step comprises:

a sintering curve is formulated according to the compact temperature of the beta-tcp material at 1450 ℃, a heat preservation curve and a heating speed are changed, the temperature is raised from room temperature to 100 ℃, then the heat preservation is carried out, the heating speed is 1-5 ℃, and the heat preservation time is 3 h; heating from 100 ℃ to 350 ℃, wherein the heating rate is 1-4 ℃, and keeping the temperature for 5 h; heating from 350 ℃ to 500 ℃, wherein the heating rate is 1-4 ℃, and keeping the temperature for 3 h; heating from 500 ℃ to 800 ℃, wherein the heating rate is 1-3 ℃, keeping the temperature for 4h, heating from 800 ℃ to 1450 ℃, wherein the heating rate is 1-3 ℃, and keeping the temperature for 5 h;

then, the temperature is reduced from 1450 ℃ to 800 ℃ at the speed of 1 ℃ to 3 ℃, and the temperature is preserved for 3 hours; keeping the temperature for 2 hours from 800 ℃ to 500 ℃ at the cooling speed of 1 ℃ to 5 ℃; keeping the temperature for 1h from 500-300 ℃ at the cooling speed of 1-5 ℃; the temperature is reduced from 300 ℃ to normal temperature at a speed of 1-5 ℃.

7. The method for preparing a beta-tcp material-based prosthetic eye table according to claim 1, wherein in the seventh step, the finished product inspection comprises: vibrating the product at the frequency of 300 times per minute, and discharging the defective products with internal sound.

8. The method for preparing the artificial eye platform based on the beta-tcp material, which is characterized in that in the step seven, the finished product inspection comprises the following steps: and (4) putting the product into water in sequence by using a drainage method to observe whether the volume of the discharged liquid is within the volume value range of the standard good product.

9. The method for preparing a beta-tcp material-based prosthetic eye table according to claim 1, wherein in the seventh step, the finished product inspection comprises: and (5) flushing the product by using a water gun with the pressure of more than or equal to 3 kilopascals to remove the defective products with broken residues.

Background

The artificial eye implantation is a main treatment method for reconstruction and reshaping of eye sockets of patients with eye diseases after eye extirpation for various reasons in clinic. The enucleation is a common means for treating absolute glaucoma, various serious eye traumas, intraocular malignant tumors, eyeball atrophy and other diseases, and after the enucleation, no eyeball, orbital syndrome, ptosis, lacrimation, poor appearance and serious influence on appearance can be finally caused due to tissue atrophy, scar contraction and the like, and children even influence the development of the orbit, the maxillofacial region and other complications, so that long-term mental and psychological burden is brought to patients. The artificial eye is implanted to prevent the atrophy of intraorbital tissues and fill the volume loss of the removed eyeball, so that the appearance of the face is improved, and the complications are prevented.

Currently, the more commonly used artificial eye platforms include: hydroxyapatite eye holder, calcium phosphate bioceramic artificial eye holder, polyethylene artificial eye holder, high-density porous polyethylene artificial eye holder, bioactive material artificial eye holder, allogeneic bone artificial eye holder, silica gel artificial eye holder, etc. The complications of various artificial eye seats after being implanted are still not few, and the most common complications comprise the defects of postoperative conjunctiva rupture, eye seat exposure, implant rejection, vascularization delay, poor human tissue compatibility, partial material under-stability and the like, so that the problems of exposure, infection, rejection and the like of an artificial eye platform exist for a long time. Traditional artificial eye processing need through the loaded down with trivial details technology such as back mould, moulding-die, the shaping of polishing, color, if the artificial eye passes through alginate material and fills patient's eye die, then makes the model through the gypsum, and has certain hardness requirement to the gypsum when sculpture gypsum model, intensity of labour is big. And the polishing and coloring are both manually operated, which increases the risk of product damage. In addition, the ocular prosthesis table on the market usually has standard specifications and cannot be customized according to the requirements of patients, so that the fitting degree of the ocular prosthesis and the patients is reduced, the patients feel unsuitable when using the ocular prosthesis table, and the risk of transplantation failure is increased. In the processing process of the product, manual operation is needed in most of time, and impurities in the artificial eye can be increased by frequently contacting the outside, so that the human body can generate rejection. The basic function of the artificial eye platform is to be able to be integrated into the human body, so the surface needs to have a concave structure for the nerves and blood vessels to climb, the existing artificial eye platform structure has a four-hole spherical artificial eye platform, a mesh type artificial eye platform and the like, the artificial eye platforms can only be processed on the surface, the interior cannot be structurally constructed by manual means, and the artificial eye platform products printed by 3D in the published documents only imitate the basic structure of the prior art, without substantial breakthrough, such as patent publication No. CN109087387A, an individualized 3D printed multifunctional artificial eye seat and a preparation method thereof and the like.

Disclosure of Invention

The invention aims to solve the problems and provides a method for preparing an artificial eye platform based on a beta-tcp material, which utilizes the characteristics of high stability and high human tissue compatibility of the beta-tcp material to prepare a unique artificial eye suitable for each patient by a 3D printing method. The artificial eye platform has the characteristics of high stability, high biocompatibility, rapid vascularization promotion, shape matching degree increase, postoperative complications reduction, effective improvement of the implantation success rate of the artificial eye, long-term usability and the like after use.

The technical problem of the invention is mainly solved by the following technical scheme: a preparation method of an artificial eye platform based on a beta-tcp material is characterized by comprising the following steps:

acquiring patient data and establishing a digital model by using a three-dimensional scanner.

And (II) carrying out computer-aided design on the prosthesis form of the artificial eye, typesetting and exporting STL data.

And (III) importing the STL data into the 3D printer.

And (IV) printing, spraying and molding the oval artificial eye platform with the same design by using beta-tcp ink slurry with the solid phase content of 30-60% as a raw material and using slurry consisting of nano sodium carbonate particles, an auxiliary solvent and a dispersing agent as a supporting raw material.

And (V) washing the soluble supporting material by water.

And (VI) sintering according to a set curve sintering process after airing to obtain the artificial eye table.

And (seventhly) inspecting finished products.

In the fourth step, the β -tcp ink slurry preferably comprises the nano β -tcp particles, the auxiliary solvent, and the binder.

The method for preparing the artificial eye platform based on the beta-tcp material is preferably that in the first step, the primary modeling is carried out by using an alginate material impression, and then a digital model is established on a computer by using data obtained by a three-dimensional scanner.

In the method for preparing the artificial eye platform based on the beta-tcp material, preferably, a sense eye piece mounting hole is arranged at the right front part of the artificial eye platform, and the rear spherical part is composed of a polygonal crystal lattice.

In the method for preparing the artificial eye platform based on the beta-tcp material, preferably, the front part of the artificial eye platform is provided with a sense eye piece mounting hole, and the rear sphere part is a grid structure with uniform density formed by mutually connected trusses.

Preferably, the sintering process for setting the curve in the sixth step includes:

a sintering curve is formulated according to the compact temperature of the beta-tcp material at 1450 ℃, a heat preservation curve and a heating speed are changed, the temperature is raised from room temperature to 100 ℃, then the heat preservation is carried out, the heating speed is 1-5 ℃, and the heat preservation time is 3 h; heating from 100 ℃ to 350 ℃, wherein the heating rate is 1-4 ℃, and keeping the temperature for 5 h; heating from 350 ℃ to 500 ℃, wherein the heating rate is 1-4 ℃, and keeping the temperature for 3 h; heating from 500 ℃ to 800 ℃, the heating rate is 1-3 ℃, keeping the temperature for 4h, heating from 800 ℃ to 1450 ℃, the heating rate is 1-3 ℃, and keeping the temperature for 5 h.

Then, the temperature is reduced from 1450 ℃ to 800 ℃ at the speed of 1 ℃ to 3 ℃, and the temperature is preserved for 3 hours; keeping the temperature for 2 hours from 800 ℃ to 500 ℃ at the cooling speed of 1 ℃ to 5 ℃; keeping the temperature for 1h from 500-300 ℃ at the cooling speed of 1-5 ℃; the temperature is reduced from 300 ℃ to normal temperature at a speed of 1-5 ℃.

Preferably, in the step seven, in the preparation method of the artificial eye platform based on the beta-tcp material, the finished product inspection comprises the following steps: vibrating the product at the frequency of 300 times per minute, and discharging the defective products with internal sound.

Preferably, in the step seven, in the preparation method of the artificial eye platform based on the beta-tcp material, the finished product inspection comprises the following steps: and (4) putting the product into water in sequence by using a drainage method to observe whether the volume of the discharged liquid is within the volume value range of the standard good product.

Preferably, in the step seven, in the preparation method of the artificial eye platform based on the beta-tcp material, the finished product inspection comprises the following steps: and (5) flushing the product by using a water gun with the pressure of more than or equal to 3 kilopascals to remove the defective products with broken residues.

As an alternative to the human eye, safety and comfort are essential. According to the technical scheme, the alginate material impression is used for primary modeling, and then a digital model is established on a computer by using data obtained by a three-dimensional scanner, so that manpower and material resources consumed by gypsum model making are saved. The artificial eye that 3D printed can make corresponding size's individual artificial eye platform through scanning every implant eye socket shape, and the laminating adapts to the eye socket, reduces and walks to position after the transplantation and drops the risk such as.

The human body is very likely to reject foreign substances. The beta-tricalcium phosphate has good biodegradability, biocompatibility and biological nontoxicity, and after the beta-tricalcium phosphate is implanted into a human body, even the degraded Ca and P can enter a living body circulatory system to form new bones without pyrogen and denaturation, the beta-tricalcium phosphate has no irritation to muscles and skin, is suitable for the climbing and growth of biological soft tissues, and increases the stability of the artificial eye after transplantation. When the artificial eye table is formed, the front part of the artificial eye table is directly formed into a circular hole groove with an inward recess so as to meet the fixation of an artificial eye sheet, and the specific shape of the back part is mainly established according to a specific model obtained by 3D scanning so as to meet the personalized requirement.

The method utilizes the lattice-shaped artificial eye platform printed by high-precision 3D to be communicated with the internal space of the artificial eye platform, has better nerve climbing property and can realize permanent biological integration in vivo. Because the internal through hole structure is constructed, the weight is lighter, the surface shape of the crystal lattice adopts a polygon, and the integral pressure resistance of the artificial eye table is ensured. Even complex lattice structures, due to the water-soluble support material, the structural integrity can be ensured by heating and rinsing in a water bath. The porosity can effectively reduce the surface roughness, and is between Ra 1-3.

Compared with the prior art, the invention has the beneficial effects that: the oxalate printing die can be accelerated in production speed by 3d scanning, the labor intensity is reduced, the labor cost is reduced, and errors caused by the deformation of the printing die in gypsum can be avoided; the injection is carried out according to the requirement, no redundant material is wasted, the material utilization rate is improved, the personalized product which is fit with the outline of the eye socket of the patient can be customized and printed, and the comfort and the stability after the transplantation are further improved; the risk of artificial touch pollution to the artificial eye is reduced, and the success rate of the product is higher; manufacturing a lattice structure (pore) suitable for soft tissue to climb and grow in, and strengthening the combination of the prosthesis and the human body; the polygonal lattice structure inside the sphere reduces the weight of the prosthesis and maintains the high compressive strength of the prosthesis.

Drawings

Fig. 1 is a schematic diagram of an application state structure of the present invention.

FIG. 2 is a partial schematic view of a sphere-forming crystal structure of the ocular prosthesis table of the present invention.

In the figure: 1. artificial eye platform, 101 crystalline lens, 2 artificial eye piece.

Detailed Description

The technical scheme of the invention is further specifically described by the following embodiments and the accompanying drawings.

The embodiment provides a method for preparing an artificial eye platform based on a beta-tcp material, which comprises the following steps:

acquiring patient data and establishing a digital model by using a three-dimensional scanner. Firstly, an alginate material impression is utilized, after the basic ocular prosthesis data of a patient are obtained clinically, a three-dimensional scanner is used for scanning the artificial eye impression, then a digital model is built on a computer and is corrected, and the data such as actual eye socket, eye fundus and the like of the patient can be compared clinically during correction. The alginate material belongs to a hydrocolloid impression material with irreversible elasticity, the dispersion medium of the alginate material is water, the alginate material has good fluidity, elasticity and plasticity (beneficial to obtaining a clear outline in an eye under slight pressure), the chemical property is stable, the setting time is 3-5min, the strength after setting is good, the shape of the impression material cannot be changed due to small temperature change, the accuracy of the impression material is ensured, the shape of the impression material is prevented from being changed due to the temperature difference between a tray and a human body, and the alginate material has certain hydrophobicity and can prevent the surface of the impression material from being blurred due to the body fluid in the eye. By scanning the oxalate impression in 3D, the production speed can be increased, labor costs can be reduced, and errors caused by the deformation of the impression in the plaster can be avoided.

And (II) carrying out computer-aided design on the prosthesis form of the artificial eye, typesetting and exporting STL data.

And (III) importing the STL data into the 3D printer. And importing the exported repairing STL data into a ceramic jet 3D printer to finish typesetting and customizing a support retainer in a Netfabb design platform, and performing jet forming after design to obtain the artificial eye platform prosthesis with the size consistent with the original model. Because the artificial eye holder formed by the ceramic slurry has shrinkage after sintering, 10-20% of shrinkage is reserved.

And (IV) taking beta-tcp ink slurry with the solid phase content of 30-60 percent as a raw material, wherein the ceramic slurry consists of nano beta-tricalcium phosphate particles, an auxiliary solvent (mainly glycol ether mixture) and a binding agent (mixture of lipid and hydrocarbon organic matters). The elliptical artificial eye table 1 which is formed by printing, spraying and forming and is consistent with the design is used as a supporting raw material by slurry consisting of nano sodium carbonate particles, an auxiliary solvent and a dispersing agent. (note: the ellipse here is a one-way view, in fact an ellipsoid).

The structure of the artificial eye platform is shown in fig. 1 and fig. 2, in which the artificial eye platform 1, the crystalline lens 101 and the artificial eye sheet 2 are shown, and the 3D printed product of the embodiment is mainly the artificial eye platform 1. The front part of the artificial eye table 1 is provided with an installation hole of an artificial eye piece 2, the back sphere part is an ellipsoid, and the ellipsoid of the artificial eye table 1 is composed of polygonal lattices with uniform density in unit volume, namely a crystalline lens 101; or a grid structure with uniform density in unit volume formed by interconnected trusses; but can be in other structural forms such as honeycombs with uniform density in unit volume.

And (V) washing the soluble supporting material by water. The tray after completing the printing of the artificial eye platform is placed in a soft water circulation box at the temperature of 20-40 ℃, and is circulated at the speed of 20-100L per hour to dissolve the supporting protective layers on the surface and the bottom, so that the artificial eye platform is separated from the tray. The separated artificial eye platform is taken out and put into another water circulation box to be continuously cleaned until the conductivity in the water box is measured, and the cleaning is considered to be finished when the conductivity is kept within the range of 100-200 and does not change any more.

And (3) placing the cleaned artificial eye platform in an environment with the room temperature of 20-80 ℃ and the humidity of 0-50% for airing.

And (VI) sintering according to a set curve sintering process after drying to obtain the artificial eye table 1.

The sintering curve is changed according to the sintering curve of the beta-tcp material, the compacting temperature of the beta-tcp material is about 1450, the heat preservation curve is changed, and the temperature rise speed is changed to adjust the integral sintering effect.

The method comprises the following specific steps: heating from room temperature to 100 deg.C, and maintaining at 1-5 deg.C for 3h to evaporate water.

Heating from 100 ℃ to 350 ℃, wherein the heating rate is 1-4 ℃, and the temperature is kept for 5 hours, and impurities are evaporated in the stage.

Heating from 350 ℃ to 500 ℃, wherein the heating rate is 1-4 ℃, and keeping the temperature for 3 h; heating from 500 ℃ to 800 ℃, wherein the heating rate is 1-3 ℃, and keeping the temperature for 4 h; raising the temperature from 800 ℃ to 1450 ℃, wherein the temperature raising rate is 1-3 ℃, and the temperature is kept for 5 hours. The gradient temperature rise of the three stages is to prevent the temperature change from being heated too fast to form cracks unevenly.

Keeping the temperature for 3h from 1450-800 ℃ at the cooling speed of 1-3 ℃; keeping the temperature for 2 hours from 800 ℃ to 500 ℃ at the cooling speed of 1 ℃ to 5 ℃; keeping the temperature for 1h from 500-300 ℃ at the cooling speed of 1-5 ℃; the temperature is reduced from 300 ℃ to normal temperature at the speed of 1-5 ℃, and the temperature is reduced at high temperature with small change, so that cracking is prevented.

Due to the complexity and the particularity of the lattice structure, compared with other products, the long heat preservation strategy and the low temperature change rate are adopted, internal moisture impurities and the like are fully volatilized, and the heat preservation time is prolonged, so that the interior is uniformly heated and compacted. The temperature change rate at high temperature is reduced, and the product is ensured not to crack.

And (seventhly) inspecting finished products.

The following methods are mainly used:

and calculating the standard deviation for good products within a certain range according to the estimated volume of the modeling software.

And observing the surface of the product, checking whether the product is broken or sunken, and removing defective products.

Vibrating the product at 300 times per minute to listen to the sound, or to listen to the sound with the internal damage.

Put into aquatic observation exhaust liquid volume in the yields volume value in with the drainage method with the product in turn, can judge whether product is inside to produce swell, bubble or structure disappearance.

And (5) flushing the product by using a water gun with the pressure of 5 kilopascals, and observing whether the broken residues can be flushed out, wherein the inner part of the flushed residues is slightly broken or not firm enough.

The complete quality product is obtained by the sequence and the combined application of the methods.

The above embodiments are illustrative of the present invention, and are not intended to limit the present invention, and it is obvious that those skilled in the art can make various modifications and simple reasoning on the embodiments without departing from the spirit and scope of the embodiments of the present invention, and any simple modified processes, methods, etc. of the present invention belong to the protection scope of the present invention.