CN112535553A - Skull repairing plate with composite structure - Google Patents
Skull repairing plate with composite structure Download PDFInfo
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- CN112535553A CN112535553A CN202011451862.8A CN202011451862A CN112535553A CN 112535553 A CN112535553 A CN 112535553A CN 202011451862 A CN202011451862 A CN 202011451862A CN 112535553 A CN112535553 A CN 112535553A
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- porous body
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- outer ring
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/3079—Stepped or enlarged apertures, e.g. having discrete diameter changes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/30—Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
Abstract
The invention provides a skull repairing plate with a composite structure and a preparation method thereof, wherein the skull repairing plate with the composite structure consists of a central entity and an outer ring porous body, and the central entity can ensure that a repairing material has enough mechanical property to resist external impact; the outer ring porous body has a pore structure gradually changed from outside to inside, the periphery of the outer ring porous body is provided with a large pore structure which is favorable for guiding cells to grow inwards, and the inner part of the outer ring porous body is provided with a smaller pore structure which can lead the cells to gather and promote osteogenic differentiation, thereby being favorable for the long-term fixation of the skull plate.
Description
Technical Field
The invention relates to the fields of high polymer materials and biomedical engineering, in particular to a skull repairing plate with a composite structure and a preparation method thereof.
Background
Poly-ether-ether-ketone (PEEK) is one of polyaryletherketone polymers, and due to its good mechanical properties, chemical properties and biocompatibility, PEEK is one of the thermoplastic plastics which are most used in orthopedics and trauma medicine. As a material closest to human bones, PEEK is gradually applied to skull repair, and PEEK mainly has the following three advantages as a skull repair material: first, it is non-magnetic and does not produce artifacts on CT or MRI; secondly, the elastic modulus of the PEEK material is closer to that of human skeleton, and the PEEK material is light in weight, so that the PEEK material is implanted into a patient body to make the patient feel more comfortable; finally, PEEK has good thermal insulation and does not damage brain tissues.
However, PEEK as a biological inert material does not have certain biological activity, and has a risk of loose connection when being implanted into a human body for a long time as a skull repairing material. Research shows that the porous structure of the porous bracket has large specific surface area, can provide wide space for cell adhesion and proliferation, and is beneficial to the regeneration of bone tissues. However, the skull repairing material plays a role in supporting and protecting brain tissues, resists external impact, and needs enough mechanical strength, and the mechanical strength of the PEEK porous scaffold is greatly different from the strength of bone tissues.
Chinese patent CN 103549990A discloses a PEEK skull repairing mesh plate, which is formed by integral injection molding according to the skull condition of a patient, the thickness of the mesh plate can be kept between 0.6 mm and 2mm, and connecting ribs between holes are ensured to be within the range of 0.5 mm to 0.8 mm; the mechanical strength of pure PEEK material is similar to that of human bone tissue, and although the pure PEEK material has a good pore structure, the PEEK grid structure greatly weakens the mechanical strength of PEEK.
Therefore, the optimization of the structural design of the polyetheretherketone skull substitute, the reduction of the production cost and the provision of a skull repair material with excellent mechanical properties and a porous scaffold structure become the problems which need to be solved at present.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a repair material with a composite structure for skull repair and a preparation method thereof.
The invention is realized by the following technical method:
the skull repairing material with the preferable composite structure is composed of a central entity and an outer ring porous body, wherein the outer ring porous body is provided with a communicated pore structure, and the pore structure can promote tissue ingrowth, is favorable for long-term fixation of a skull plate, and is favorable for bone tissue ingrowth from the side surface of a prosthesis and long-term fusion with the tissue.
Reinforcing ribs are fixed between the middle entity of the optimized composite structure plate and the outer ring porous body, the number of the reinforcing ribs is 0-8, and the width of each reinforcing rib is 3-10 mm.
The preferred skull plate with the composite structure has the width of 0-3mm and the porosity of 50-90 percent.
The pore structure of the outer ring porous body is gradually reduced from outside to inside, the maximum pore size is 1500 mu m, and the minimum pore size is 100 mu m; the periphery of the skull plate is provided with a large pore structure which is favorable for guiding cells to grow inwards, and the inner part of the skull plate is provided with a smaller pore structure which can lead the cells to gather and promote osteogenic differentiation, thereby being favorable for the long-term fixation of the skull plate.
The pore-foaming agent of the preferable composite structure plate outer ring porous body is circular sodium chloride particles, the sodium chloride particles are formed by mixing large particles and small particles, the preferable particle size of the large particles is 35 meshes, and the particle size of the small particles is 70 meshes; the round structure and the mixed particles can increase the contact area between the particles, are beneficial to the connectivity of pores and are beneficial to the complete precipitation of the pore-foaming agent.
The pore-foaming agent of the preferable composite structure plate outer ring porous body is round sodium chloride particles, and the round sodium chloride particles are prepared from water, vegetable oil, glutinous rice flour and sodium chloride crystals. Preparing glutinous rice flour and water into paste, adding vegetable oil, pouring NaCl particles, stirring for 5 minutes by a stirrer at 1000 rpm, heating the oil temperature to 80 ℃, after stirring, screening spherical sodium chloride particles from the oil, cleaning in isopropanol, drying, and screening.
The upper surface and the lower surface of the optimized composite structure plate are provided with wave structures, and the wave structures accord with the physiological characteristics of human skull.
The preferred composite structure skull plate has evenly distributed drainage holes in the middle solid hole part of the composite structure plate.
The preferable composite structure plate is characterized in that the intermediate solid and the reinforcing ribs are firstly pressed and formed, and the outer ring porous body is filled and formed for pressing.
The preferable composite structure plate is characterized in that the outer ring porous body is of a three-layer composite structure, namely the upper layer and the lower layer are compact layers, and the middle layer is a porous layer.
Compared with the prior art, the invention has the beneficial effects that:
1. the skull plate with the composite structure is formed by combining the middle entity and the outer ring porous body, the middle entity and the outer ring porous body are fixed by the reinforcing ribs, on one hand, the skull plate is ensured to have enough mechanical property, and on the other hand, the pore structure of the outer ring porous body can promote bone tissues to grow in from the side surface, so that the long-term fusion of a prosthesis and the skull plate is facilitated;
2. the outer ring porous body of the skull plate with the composite structure provided by the invention has a gradually-changed pore structure, the large pore structure on the periphery is favorable for guiding cells to grow inwards, and the small pore structure in the composite structure can enable the cells to gather and promote osteogenic differentiation, so that the long-term fixation of the skull plate is facilitated.
Drawings
1-middle solid part; 2-an outer race porous body portion; 3-reinforcing ribs;
FIG. 1 is a composite structural panel having a random arrangement of pore structures;
FIG. 2 is a composite structural panel having a graded pore structure;
FIG. 3 the elution rate of porogens over time;
FIG. 4 results of in vitro cell proliferation experiments.
The following describes in further detail embodiments of the present invention with reference to the accompanying drawings. It should be understood that these examples are for illustrative purposes and are not intended to limit the scope of the present invention. The conditions used in the examples may be further adjusted according to the conditions of the particular manufacturer, and the conditions not specified are generally the conditions in routine experiments.
Example 1:
preparing a spherical pore-foaming agent: preparing 10g of glutinous rice flour and 2g of water into paste, adding vegetable oil, adding 50g of NaCl crystal particles with the particle size of 70 meshes, stirring for 5 minutes by using a stirrer at 1000 rpm, heating the oil temperature to 80 ℃, after stirring, screening spherical sodium chloride particles from the oil, cleaning in isopropanol, drying, then screening, and screening out spherical sodium chloride with the particle size of 600 mu m.
Preparing powder: the pure polyether-ether-ketone material is a raw material of a middle solid structure and a reinforcing rib; mixing spherical sodium chloride particles and polyether-ether-ketone powder in a ratio of 3: 7 as a raw material of the outer ring porous body.
Molding: pressing the middle solid part and 6 reinforcing ribs into a flat plate by adopting a powder pressing forming method, and filling powder of the porous body; then sintering is carried out at a temperature of 380 ℃ for 1 h.
Bending and shaping: heating the whole plate in a muffle furnace at 300 ℃ for 10 min; and (4) carrying out shaping and cutting treatment on a mouldless forming machine according to the skull prefabricated model with artificial defect.
And (3) pore-foaming agent precipitation: and (3) placing the shaped plate in an ultrasonic cleaning machine for cleaning, setting the temperature at 50 ℃, carrying out water bath for 10h, and taking out and drying the plate to obtain the skull repairing plate with the composite structure, wherein the precipitation rate of the pore-forming agent along with the time is shown in figure 3.
Example 2:
preparing a spherical pore-foaming agent: preparing 10g of glutinous rice flour and 2g of water into paste, adding vegetable oil, adding 50g of NaCl crystal particles with the particle sizes of 70 meshes and 50 meshes, stirring for 5 minutes by using a stirrer at 1000 rpm, heating the oil temperature to 80 ℃, after stirring, screening spherical sodium chloride particles from the oil, cleaning in isopropanol, drying, then screening, and screening out spherical sodium chloride with the particle sizes of 600 mu m and 200 mu m.
Preparing powder: the pure polyether-ether-ketone material is a raw material of a middle solid structure and a reinforcing rib; mixing 600 mu m spherical sodium chloride particles and 200 mu m spherical sodium chloride particles with polyether ether ketone powder in a ratio of 3: 7 as a raw material of the outer ring porous body.
Molding: pressing the middle solid part and 6 reinforcing ribs into a flat plate by adopting a powder pressing forming method, adding 600 mu m of sodium chloride and polyether-ether-ketone mixed particles into the powder of the porous body according to an outer ring, and adding 200 mu m of sodium chloride and polyether-ether-ketone mixed particles into an inner ring for filling; then sintering is carried out at a temperature of 380 ℃ for 1 h.
Bending and shaping: heating the whole plate in a muffle furnace at 300 ℃ for 10 min; and (4) carrying out shaping and cutting treatment on a mouldless forming machine according to the skull prefabricated model with artificial defect.
And (3) pore-foaming agent precipitation: and (3) putting the shaped plate into an ultrasonic cleaning machine for cleaning, setting the temperature to be 50 ℃, carrying out water bath for 10 hours, taking out and drying to prepare the skull plate with the composite structure, wherein the outer ring porous body is of the gradually-changed pore structure.
In vitro cell experiments: respectively sterilizing a pure PEEK plate and the composite structure plates manufactured in the embodiment 1 and the embodiment 2; example 2 a plate was soaked with BMP, the material was added to a cell culture plate, and proliferation of each of the above groups of cells was measured for 1, 3, and 7 days by the CCK-8 method; the OD at 450nm was read by the microplate reader and the results are shown in Table 1.
Example 3:
preparing a spherical pore-foaming agent: preparing 10g of glutinous rice flour and 2g of water into paste, adding vegetable oil, adding 50g of NaCl crystal particles with the particle size of 70 meshes, stirring for 5 minutes by using a stirrer at 1000 rpm, heating the oil temperature to 80 ℃, after stirring, screening spherical sodium chloride particles from the oil, cleaning in isopropanol, drying, then screening, and screening out spherical sodium chloride with the particle size of 600 mu m.
Preparing powder: the pure polyether-ether-ketone material is of a middle solid structure; mixing spherical sodium chloride particles and polyether-ether-ketone powder in a ratio of 3: 7 as a raw material of the outer ring porous body.
Molding: pressing the middle solid part into a flat plate by adopting a powder pressing forming method, and filling the powder of the porous body; then sintering is carried out at a temperature of 380 ℃ for 1 h.
Bending and shaping: heating the whole plate in a muffle furnace at 300 ℃ for 10 min; and (4) carrying out shaping and cutting treatment on a mouldless forming machine according to the skull prefabricated model with artificial defect.
And (3) pore-foaming agent precipitation: and (3) putting the shaped plate into an ultrasonic cleaning machine for cleaning, setting the temperature to be 50 ℃, carrying out water bath for 10 hours, taking out, and drying to obtain the skull plate with the composite structure.
Claims (10)
1. The utility model provides a skull repair panel with composite construction which characterized in that: the skull repairing plate with the composite structure is composed of a central entity, reinforcing ribs and an outer ring porous body, wherein the outer ring porous body is provided with a communicated pore structure, and the pore structure can promote tissue growth and is beneficial to long-term fixation of the skull plate.
2. The composite structural board as claimed in claim 1, wherein the intermediate body of the composite structural board and the outer porous body are fixed by reinforcing ribs, the number of the reinforcing ribs is 0-8, and the width of the reinforcing ribs is 3-10 mm.
3. The composite structural sheet as claimed in claim 1 or 2, wherein the outer ring porous body has a width of 0 to 3cm and a porosity of 50 to 90%.
4. The composite structural panel as claimed in claim 1, wherein the outer porous body has a pore structure gradually decreasing from the outside to the inside, and the pore size is at most 1500 μm and at least 100 μm.
5. A porous body as claimed in claim 1 or 3 having a pore structure of circular sodium chloride, the circular sodium chloride particles being a mixture of large and small particle sizes, the large particle size being 35 mesh and the small particle size being 70 mesh.
6. A porous body pore structure as claimed in claim 1 or 5, wherein the circular sodium chloride is prepared from water, vegetable oil, glutinous rice flour, sodium chloride crystals.
7. A composite structural panel according to claim 1, wherein the upper and lower surfaces of the panel have a wave-like configuration.
8. The composite structural panel according to claim 1, wherein the central solid portion of the composite structural panel has drainage holes uniformly distributed therein.
9. The composite structural panel as claimed in claim 1, wherein the intermediate body and the reinforcing ribs are formed by compression molding, and the outer porous body is formed by filling and then compression molding.
10. The composite structural sheet according to claim 1, wherein the outer porous body has a three-layer composite structure, i.e., the upper and lower layers are dense layers and the intermediate layer is a porous layer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011451862.8A CN112535553B (en) | 2020-12-12 | 2020-12-12 | Skull repairing plate with composite structure |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011451862.8A CN112535553B (en) | 2020-12-12 | 2020-12-12 | Skull repairing plate with composite structure |
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| CN112535553A true CN112535553A (en) | 2021-03-23 |
| CN112535553B CN112535553B (en) | 2021-12-07 |
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2020
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| CN112535553B (en) | 2021-12-07 |
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