CN110870810A

CN110870810A - Multi-level hole biological ceramic ball artificial eye seat

Info

Publication number: CN110870810A
Application number: CN201811002758.3A
Authority: CN
Inventors: 胡可辉; 万力; 成明
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-08-30
Filing date: 2018-08-30
Publication date: 2020-03-10

Abstract

The invention relates to a porous biological artificial eye holder and a preparation method thereof. The artificial eye seat is made of biological ceramics and is a 10-30mm spheroid, the spherical crown on one side of the artificial eye seat is a dense thin shell with the thickness of 0.2-3mm, the interior and the rest surfaces of the artificial eye seat are provided with uniformly distributed macroscopic holes with the thickness of 0.1-1 mm, more preferably 0.3-1 mm, wherein the macroscopic holes on the surfaces and the interior are communicated with each other, the artificial eye seat further comprises uniformly distributed secondary holes and final holes, the size of the secondary holes is 1-100 mu m, the size of the final holes is smaller than 1 mu m, and the porosity of the artificial eye seat is 60-95%. The porous artificial eye seat is formed by 3D printing, the size of the holes is larger than that of the holes generated by adopting the pore-forming agent, and the shape and the size can be freely designed, so that the porous artificial eye seat is beneficial to the infiltration of new blood vessels and tissues into the porous artificial eye seat. The secondary and final apertures in the prosthetic eye seat of the present invention are small in size and can be used to deliver desired nutrients and the like to the vessels and tissues formed in the macroscopic aperture.

Description

Multi-level hole biological ceramic ball artificial eye seat

Technical Field

The invention relates to a ceramic ball artificial eye holder and a preparation method thereof. More particularly, the invention relates to a bioceramic ball artificial eye seat with multistage holes and a preparation method thereof.

Background

The implantation of the artificial eye seat is a commonly used restoration treatment scheme for restoring the appearance after the removal of the eyeball, and after the implantation of the artificial eye seat, a patient can install an artificial eye piece on the artificial eye seat to restore the appearance to the maximum extent.

The prior art intraocular lens holders can be classified into several categories depending on the material. One is a solid sphere made of a silica gel material; one is porous artificial eye holder made of coral hydroxyapatite; there are also porous prosthetic eye sockets made of polymers.

However, the silica gel artificial eye holder can form a fibrous membrane package around the silica gel artificial eye holder after being implanted, so that the silica gel artificial eye holder is easy to displace and has the problem of immunological rejection. After the porous prosthetic eye seat is implanted, the new blood capillaries and fibrous connective tissues grow slowly to the center of the prosthetic eye seat along the pores of the prosthetic eye seat, so that the displacement of the prosthetic eye seat can be better prevented.

However, although porous prosthetic eye sockets of different materials have such advantages, they are all manufactured through a template method, which has a complicated process, a long process flow, and difficulty in manufacturing due to post-treatment involving a template agent. Furthermore, the large volume of templating agent required for the porous prosthetic eye socket to allow neogenetic tissue infiltration is generally expensive. In addition, when the template method is used, a doctor cannot design a micropore structure, so that the vascularization process after implantation is not controllable, and the quality stability of the eyeball is difficult to ensure. Moreover, the whole shape of the artificial eye holder manufactured by the die can be formed only by cutting, carving or polishing after the die is manufactured, the die opening time is long, the cost is high, and customized manufacturing of different patients cannot be realized.

Accordingly, there remains a need for a new construction of a prosthetic eye mount and a method of making the same.

Disclosure of Invention

The inventor designs a porous artificial eye holder gap structure, a corresponding high-precision photocuring bioceramic slurry formula and a preparation method according to the simulation of the vascularization process in the implanted artificial eye holder and the in-vivo mechanical analysis thereof, and completes the invention based on the design.

The invention aims to provide a hierarchical pore biological ceramic ball artificial eye seat.

The invention also aims to provide a preparation method of the hierarchical pore biological ceramic ball artificial eye seat.

According to an embodiment of the present invention, there is provided a porous prosthetic eye socket characterized in that: the artificial eye seat is prepared by biological ceramics and is a 10-30mm spheroid, the spherical crown at one side of the artificial eye seat is a compact thin shell with the thickness of 0.2-3mm, the interior and the rest surfaces of the artificial eye seat are provided with evenly distributed macroscopic holes with the thickness of 0.1 mm-1 mm, more preferably 0.3 mm-1 mm, wherein the macroscopic holes at the surface and the interior are communicated with each other,

wherein the artificial eye seat further comprises secondary holes and final-stage holes which are uniformly distributed, the size of the secondary holes is 1-100 μm, the size of the final-stage holes is less than 1 μm, and the porosity of the artificial eye seat is 60-95%.

Preferably, the secondary and final stage apertures are in communication with the macro-apertures.

Preferably, the bioceramic is a material prepared from one or more selected from hydroxyapatite, calcium phosphate, bioglass, calcium sulphate.

Preferably, the dense thin shell may occupy 1/3 to 1/2 of the entire spherical area.

Preferably, small holes or groove lines which are not communicated with the macroscopic holes, the secondary holes and the final stage holes are also arranged on the surface of the compact thin shell. The small hole or groove line is used for helping the adhesiveness between the artificial eye seat and the artificial eye sheet.

Preferably, the spheroid may be a regular sphere, an ellipsoid, a rugby sphere.

The biological ceramic material can increase the biocompatibility of the prosthetic eye seat and reduce inflammation, infection or rejection.

According to another embodiment of the present invention, there is provided a method for preparing the porous prosthetic eye socket, the method including the steps of:

1) carrying out eye socket CT scanning on a patient with eyeball loss to obtain an eye socket three-dimensional data model;

2) forming a blank of the artificial eye seat by adopting the biological ceramic slurry through 3d printing equipment; the blank is a near-spherical body of the three-dimensional data model obtained in the step 1), a spherical crown on one side of the blank is arranged into a compact thin shell with the thickness of 0.2-3mm, and the inner part and the rest surfaces of the blank are arranged into macro holes with the thickness of 0.1-1 mm, more preferably 0.3-1 mm, which are uniformly distributed, wherein the surface and the macro holes in the inner part are communicated with each other, and more preferably, small holes or groove grains which are not communicated with the macro holes can be formed on the surface of the compact thin shell;

3) calcining the artificial eye holder blank with the macroscopic hole at 600 ℃ for 1-4h, thereby removing the pore-forming agent;

4) sintering the artificial eye holder blank calcined in the step 3) at the temperature of 1000-1500 ℃ for 0.5-4h to obtain the required porous artificial eye holder.

Preferably, the bioceramic slurry is a photo-cured bioceramic slurry, and at this time, in the step 2), the bioceramic slurry at the hole forming position is not cured when the blank is formed, and is removed by ultrasonic vibration cleaning and pressure spray gun flushing under the action of a high-solubility solvent, so that a macroscopic hole structure is obtained.

Preferably, the biological ceramic slurry comprises 50-100 parts of biological ceramic, 10-40 parts of nontoxic photosensitive resin, 5-20 parts of pore-forming agent, 1-10 parts of dispersing agent and 0.5-5 parts of sintering aid.

Preferably, the bioceramic comprises a mixture of one or more of hydroxyapatite, calcium phosphate, bioglass, calcium sulphate; the pore-forming agent is one or a mixture of more of PMMA, ammonium bicarbonate, PVA, PVB, carbon powder, graphite powder, graphene and organic fibers.

Preferably, the high-solubility solvent comprises one or more of ethanol, water and a surfactant.

The porous artificial eye seat provided by the invention adopts a 3D printing mode to form designable interconnected holes, and the size of the holes is larger than that of holes generated by adopting a pore-forming agent (namely a template agent), so that the porous artificial eye seat is beneficial to the infiltration of new blood vessels and tissues into the porous artificial eye seat. The secondary and final apertures in the prosthetic eye seat of the present invention are small in size and can be used to deliver desired nutrients and the like to the vessels and tissues formed in the macroscopic aperture.

In addition, the porous prosthetic eye socket of the present invention is shaped based on the patient's orbital data and is sized to fit more closely to each patient.

Drawings

Fig. 1 is a model of an artificial eye seat according to an embodiment of the present invention.

Figure 2 is a photograph of a prosthetic eye holder printed according to the model.

Detailed Description

The present invention will be specifically described below with reference to examples, but the following examples are for illustrative purposes only and are not intended to limit the scope of the present invention.

Example 1

Adopting hydroxyapatite: tricalcium phosphate: mixing 20nm-500nm powder with bioglass of 4:2:1 to obtain 50 parts of biological ceramic material, mixing 40 parts of acrylic resin monomer to obtain photosensitive resin binder, 5 parts of PMMA to obtain pore-forming agent, 2 parts of polymethyl cellulose to obtain dispersing agent, and 1 part of MgO to obtain sintering aid, uniformly mixing by using a mixer, and defoaming to obtain biological ceramic slurry for 3D printing.

Modeling of the artificial eye base is carried out by using the data of the eye socket scanned by the patient, wherein the model of the artificial eye base is a regular sphere with the diameter of 25mm, the spherical cap with the height of 10mm on one side is a compact thin shell with the thickness of 1mm, and the inner part and the rest surface are provided with uniformly distributed holes with the thickness of 0.3mm to 1mm, and the holes are communicated with each other. The model is shown in fig. 1.

The prepared biological ceramic slurry is used for printing the artificial eye holder by adopting an Autocera type 3D printer which is manufactured by Beijing ten-dimensional science and technology Limited liability company and can be used for photocuring forming. And obtaining a 3D printing blank after printing, photocuring and ultrasonic cleaning.

The blank is calcined at the temperature of 600 ℃ for 3h, and then sintered at the temperature of 1300 ℃ for 2h to obtain the finally prepared artificial eye holder, and the prepared artificial eye holder is shown in figure 2.

Example 2

An ellipsoid with a polar radius larger than the equatorial radius is used as the model of the artificial eye socket, and the spherical cap with a height of 6mm from one pole is a compact thin shell with a thickness of 2mm, and the inner part and the rest of the surface have uniformly distributed holes of 0.1mm to 0.8mm, which are interconnected.

Except for the differences of these models, the prosthetic eye seat was prepared in the same manner as described in example 1.

Example 3

The prosthetic eye socket was prepared in the same manner as described in example 1, using a 1:1 mixed powder of bioglass and calcium sulfate as a raw material of bioceramic powder. And keeping the final sintering temperature at 1200 ℃ for 1 h.

Claims

1. A porous prosthetic eye mount, comprising: the artificial eye seat is prepared by biological ceramics and is a 10-30mm spheroid, the spherical crown at one side of the artificial eye seat is a compact thin shell with the thickness of 0.2-3mm, the interior and the rest surfaces of the artificial eye seat are provided with evenly distributed macroscopic holes with the thickness of 0.1 mm-1 mm, more preferably 0.3 mm-1 mm, wherein the macroscopic holes at the surface and the interior are communicated with each other,

2. The multi-aperture prosthetic eye socket of claim 1, wherein the secondary and final apertures are in communication with the macro-apertures.

3. The porous prosthetic eye socket according to claim 1, wherein the bioceramic is a material prepared from one or more selected from hydroxyapatite, calcium phosphate, bioglass, calcium sulphate.

4. The porous prosthetic eye seat according to claim 1, wherein the dense shell may occupy 1/3 to 1/2 of the entire spherical area, preferably there is also a fine pore or groove pattern on the dense shell surface that does not interconnect the macro-, secondary-and final-stage pores.

5. The porous prosthetic eye socket according to claim 1, wherein the spheroid can be a regular sphere, an ellipsoid, a rugby sphere.

6. A method for preparing a porous prosthetic eye socket, comprising the steps of:

7. The method according to claim 6, wherein the bioceramic slurry is a photo-cured bioceramic slurry, and in the case of step 2), the bioceramic slurry at the hole forming positions during blank formation is not cured and is subsequently removed by ultrasonic vibration cleaning and pressure lance flushing under the action of a highly soluble solvent, thereby obtaining a macroscopic pore structure.

8. The method as claimed in claim 6, wherein the bio-ceramic slurry comprises 50-100 parts of bio-ceramic, 10-40 parts of nontoxic photosensitive resin, 5-20 parts of pore-forming agent, 1-10 parts of dispersing agent and 0.5-5 parts of sintering aid component.

9. The method of claim 6, wherein the bioceramic comprises a mixture of one or more of hydroxyapatite, calcium phosphate, bioglass, calcium sulphate; the pore-forming agent is one or a mixture of more of PMMA, ammonium bicarbonate, PVA, PVB, carbon powder, graphite powder, graphene and organic fibers.

10. The method of claim 7, wherein the high-solubility solvent comprises one or more of ethanol, water and a surfactant.