CN105105872A - Skull replacing apparatus of 3D print and manufacturing method thereof - Google Patents

Abstract

A 3D printed skull replacement device and a preparation method thereof, which relate to a skull replacement device and a preparation method thereof. The present invention aims to solve the problem that the existing cranial substitutes cannot meet the refinement requirements of the patient's defect site, so that the brain tissue is not fully protected, and often causes dysfunction due to mismatch. The device comprises a fixed sheet, a dense layer 1, a dense layer 2 and a transition layer, the fixed sheet and the dense layer 1 are located above the transition layer, the dense layer 2 is located below the transition layer, and the dense layer 1 and the dense layer 2 pass through the transition layer. Layer connection, compact layer 1, transition layer and compact layer 2 have the same shape as the defected skull, and the transition layer is a microscopic truss structure. Methods: 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data of the skull that needs to be replaced; 2: Design a 3D model of the skull replacement structure and print the design model; 3: Modify the surface of the sample sex. The invention is suitable for skull replacement.

Description

A 3D printed skull replacement device and its preparation method

technical field

The invention relates to a skull replacement device and a preparation method thereof, in particular to a 3D printed skull replacement device and a preparation method thereof.

Background technique

As a medium for transmitting external shocks to the brain, the skull plays an important role in maintaining the safety of human life. Injury caused by extrusion and impact of foreign objects on the skull is a common cranial trauma disease in clinical medicine. Worldwide, traumatic brain injury accidents due to vehicle crashes and sports activities account for millions of accidents each year. The cranium cannot be restored after injury, so research on cranial replacements is of paramount importance.

Existing cranial replacements cannot meet the detailed requirements of the patient's defect site, so that the brain tissue is not fully protected, and there are often problems of dysfunction due to mismatch.

Contents of the invention

The purpose of the present invention is to solve the problem that the existing skull substitutes cannot meet the refinement requirements of the patient's defect site, so that the brain tissue is not fully protected, and there are often dysfunctions caused by mismatch, and then provide a 3D printed Skull replacement device and method of making same.

The technical scheme of the present invention is: it comprises fixed sheet, dense layer 1, dense layer 2 and transition layer, fixed sheet and dense layer 1 are positioned at the top of transition layer successively from top to bottom, dense layer 2 is positioned at transition layer The lower part and dense layer 1 and dense layer 2 are connected by a transition layer. The shape of dense layer 1, transition layer and dense layer 2 is the same as that of the defective skull, and the transition layer is a microscopic truss structure.

The present invention also provides a method for manufacturing a 3D printed skull replacement device, the method comprising the following steps:

Step 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data that needs to be replaced;

Step 2: Design a 3D model of the skull replacement structure and print the design model;

Convert the skull data in the image into a three-dimensional model, design a model that completely matches the anatomical shape, structure and mechanical properties of the defective skull, import it into a 3D printing computer program, and use rapid prototyping equipment to build up and bond the printed materials layer by layer. According to the order of dense layer 2, transition layer, dense layer 1, and fixed sheet from bottom to top, the outer edge of the fixed sheet is larger than the outer edge of dense layer 1, and is used to open multiple threaded holes;

Step 3: Perform surface modification on the surface of the dense layer 1, the dense layer 2, and the transition layer. So far, the 3D printing of the skull replacement device is completed.

Compared with the prior art, the present invention has the following effects:

Method advantages:

1. The preparation is fast, and it can be molded within 3-5 hours, and the molding time is shorter than other preparation methods.

2. It is possible to form a substitute that matches the shape and mechanical properties of the patient's defective skull.

3. This method can produce substitutes of any shape. The produced substitutes have strong applicability and can replace any part of the human skull. It is suitable for skull injuries of any shape and size, and can be applied to a wide range of people. .

4. Hydroxyapatite is deposited on the surface of the micro-array structure, the process is simple, the cost is low, and the thickness and shape of the coating are controllable.

Device advantages:

1. The elastic modulus of the replacement material is consistent with that of the skull, which avoids the different strains of the replacement material and the skull under the action of stress, resulting in relative displacement at the contact interface between the metal and the bone, resulting in loosening of the interface and affecting the implanted device function; or cause stress shielding, causing functional degradation or absorption of bone tissue.

2. This type of implant has pores for bone to grow into. The microscopic truss structure layer of the present invention allows adjacent bones to enter the pores during the growth process, so that the real bone and the false bone are integrated.

3. The hydroxyapatite coating has a similar structure and composition to bone, and has good biocompatibility and activity. The hydroxyapatite coating deposited on the surface of the metal substrate not only retains the mechanical properties of the metal substrate, but also takes into account the compatibility and biological activity of the coating. It is conducive to the attachment and growth of tissue cells and promotes osseointegration.

Description of drawings

Fig. 1 is a schematic diagram of the damaged skull structure to be manufactured by the method of the present invention; Fig. 2 is a schematic diagram of the structure of the present invention; Fig. 3 is a bottom view of Fig. 2; Fig. 4 is an enlarged view of Fig. 2 at A.

Detailed ways

Specific Embodiment 1: This embodiment is described with reference to FIGS. 1 to 4 . A 3D printed skull replacement device in this embodiment includes a fixation piece 4 , a dense layer 1 , a dense layer 2 , and a transition layer 3 . The fixed sheet 4 and the compact layer 1 are located above the transition layer 3 from top to bottom, the compact layer 2 is located below the transition layer 3 and the compact layer 1 and the compact layer 2 are connected through the transition layer 3, and the compact layer 2 is located below the transition layer 3. Strain layer 1, transition layer 3, and compact layer 2 2 have the same shape as the defective skull, and transition layer 3 is a microscopic truss structure.

The connection between the present embodiment and the skull during use is installed on the outer periphery of the fixing piece 4 through a plurality of bolts, so as to realize the connection between the skull and the present embodiment.

Specific embodiment two: this embodiment is described in conjunction with Fig. 2 to Fig. 4, and present embodiment it also comprises active coating 5, and active coating 5 is deposited on the outside of tight layer one 1, dense layer two 2 and transition layer 3 On the surface. Such setting not only preserves the mechanical properties of the metal matrix, but also takes into account the compatibility and biological activity of the coating. The other composition and connection relationship are the same as those in the first embodiment.

Specific Embodiment 3: This embodiment is described with reference to FIG. 2 . The active coating 5 of this embodiment is a hydroxyapatite coating. Such setting is conducive to the attachment and growth of tissue cells and promotes osseointegration. Other compositions and connections are the same as those in the second embodiment.

Specific Embodiment 4: This embodiment is described with reference to FIG. 2 . The thickness of the active coating 5 in this embodiment is 30-50 μm. Such setting can induce bone tissue to rapidly grow toward it so that the implant and the surrounding bone tissue form chemical bonds. Other compositions and connections are the same as those in Embodiment 2 or 3.

Embodiment 5: This embodiment is described with reference to FIG. 2 to FIG. 3 . In this embodiment, a plurality of threaded holes 6 are provided on the outer edge of the fixing piece 4 . Such setting facilitates connection with other bones of the human body. Other compositions and connections are the same as in Embodiment 4.

Embodiment 6: This embodiment is described with reference to FIGS. 2 to 4 . The area of the fixing piece 4 in this embodiment is larger than that of the skull, and the fixing piece 4 is a curved surface fixing piece. Such setting facilitates docking with other bones. Other compositions and connections are the same as those in Embodiment 5.

Specific Embodiment 7: This embodiment is described in conjunction with Fig. 1 to Fig. 4, a method for manufacturing a 3D printed skull replacement device in this embodiment, the method includes the following steps:

Step 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data that needs to be replaced;

Step 2: Design a 3D model of the skull replacement structure and print the design model;

Convert the skull data in the image into a three-dimensional model, design a model that completely matches the anatomical shape, structure and mechanical properties of the defective skull, import it into a 3D printing computer program, and use rapid prototyping equipment to build up and bond the printed materials layer by layer. According to the order of dense layer 2 2, transition layer 3, dense layer 1, and fixed sheet 4 from bottom to top, the outer edge of fixed sheet 4 is larger than the outer edge of dense layer 1, and is used to set up multiple layers. 6 threaded holes;

Step 3: Carry out surface modification to the surfaces of dense layer 1, dense layer 2 2, and transition layer 3. So far, the 3D printing of the skull replacement device is completed.

Surface modification (deposition of a biomimetic layer - hydroxyapatite on the surface of the sample):

(1) In an argon atmosphere, soak in 37% HCl solution for 90 minutes at 50°C; then soak for 60 minutes at 40°C.

(2) Ultrasonic cleaning with distilled water to remove surface oxides, the cleaning temperature is 40°C, and the cleaning time is 50 minutes

(3) Soak in 10mol/L NaOH solution for 24h, the temperature is controlled at 60°C,

(4) The sample was washed with distilled water and dried at 100°C.

After drying, the samples were immersed in SBF solution, kept at 37°C in a water bath, and the solution was replaced every 2 days. After soaking and culturing for 21 days, they were taken out, washed with distilled water and dried in an oven.

The method for forming the hydroxyapatite coating on the surface of the device is not limited to the above-mentioned methods, and may be a sol-gel method, a micro-arc oxidation method, and the like. Surface modification is not limited to hydroxyapatite coatings but can be other coatings.

Printing process:

Using the metal 3D printer M270 of German EOS company, the parameters during use are:

Process parameters: laser power 170W, scanning speed 1250mm/s, spot size 100μm, oxygen content <0.1, layer thickness 30μm, scanning distance 60μm

Post-treatment of the processed sample: cyclic heat treatment in an argon protective atmosphere to release thermal stress (heat treatment at 680°C for 4 hours, then cooling); ultrasonically clean the surface of the sample with isopropanol, then clean it with double distilled water and dry it in air to dry.

Embodiment 8: This embodiment is described with reference to FIG. 1 to FIG. 4 . The printing materials in Step 2 of this embodiment are titanium alloy powder, metal powder, ceramic powder, plastic and cell tissue. Such setting can have good biocompatibility and good mechanical properties. Other compositions and connections are the same as those in Embodiment 7.

Ninth specific embodiment: This embodiment will be described with reference to FIG. 1 to FIG. 4 . The transition layer 3 in step 2 of this embodiment is a micro-array truss structure layer. In the actual use process, other microstructures such as pyramid structure, hollow polyhedron structure, and extremely small curved surface structure can be used, so that the adjacent bones will enter the pores during the growth process, so that the real bone and the false bone will form. One body, the patient's bones can recover as soon as possible. Other compositions and connections are the same as those in Embodiment 8.

Claims (9)

1. A 3D printed skull replacement device, characterized in that: it comprises a fixed sheet (4), a compact layer (1), a dense layer two (2) and a transition layer (3), and a fixed sheet (4) The dense layer one (1) is located above the transition layer (3) from top to bottom, the dense layer two (2) is located below the transition layer (3), and the dense layer one (1) and the dense layer two ( 2) Connected through the transition layer (3), the compact layer one (1), transition layer (3) and compact layer two (2) have the same shape as the defective skull, and the transition layer (3) is a microscopic truss structure. 2. The skull substitute device of a kind of 3D printing according to claim 1, is characterized in that: it also comprises active coating (5), and active coating (5) is deposited on compact layer one (1), compact Layer two (2) and the outer surface of the transition layer (3). 3. A 3D printed skull replacement device according to claim 2, characterized in that: the active coating (5) is a hydroxyapatite coating. 4. A 3D printed skull substitute device according to claim 3, characterized in that: the thickness of the active coating (5) is 30-50 μm. 5. A 3D printed skull replacement device according to claim 4, characterized in that: the outer edge of the fixing piece (4) is provided with a plurality of threaded holes (6). 6. A 3D printed skull replacement device according to claim 5, characterized in that: the area of the fixation piece (4) is larger than that of the skull, and the fixation piece (4) is a curved surface fixation piece. 7. A method for manufacturing a 3D printed skull replacement device according to claim 1, characterized in that: the method comprises the following steps: Step 1: Perform 3D imaging on the damaged skull to determine the geometric dimensions and parameters of the skull, and obtain the original data that needs to be replaced; Step 2: Design a 3D model of the skull replacement structure and print the design model; Convert the skull data in the image into a three-dimensional model, design a model that completely matches the anatomical shape, structure and mechanical properties of the defective skull, import it into a 3D printing computer program, and use rapid prototyping equipment to build up and bond the printed materials layer by layer. According to the order from bottom to top: dense layer 2 (2), transition layer (3), dense layer 1 (1), fixed piece (4), the outer edge of the fixed piece (4) is larger than the dense layer An outer edge of one (1) is used for opening a plurality of threaded holes (6); Step 3: Carry out surface modification to the surface of dense layer 1 (1), dense layer 2 (2) and transition layer (3), so far, the 3D printing of the skull replacement device is completed. 8. A 3D printed skull replacement device and its preparation method according to claim 7, characterized in that: the printing materials in step 2 are titanium alloy powder, metal powder, ceramic powder, plastic and cell tissue. 9. A 3D printed skull replacement device and its preparation method according to claim 8, characterized in that: the transition layer (3) in step 2 is a micro-array truss structure layer.