CN112451750B - Multilayer degradable intramedullary nail and manufacturing method thereof - Google Patents

Multilayer degradable intramedullary nail and manufacturing method thereof Download PDF

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CN112451750B
CN112451750B CN202011599258.XA CN202011599258A CN112451750B CN 112451750 B CN112451750 B CN 112451750B CN 202011599258 A CN202011599258 A CN 202011599258A CN 112451750 B CN112451750 B CN 112451750B
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intramedullary nail
layer
middle layer
porosity
pore
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CN112451750A (en
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邵惠锋
年志恒
贺永
段王平
景卓荦
龚友平
刘海强
陈慧鹏
李文欣
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Hangzhou Dianzi University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/028Other inorganic materials not covered by A61L31/022 - A61L31/026
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body

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Abstract

The invention discloses a multilayer degradable intramedullary nail and a manufacturing method thereof. The intramedullary nail consists of 3 parts, namely an outer layer, a middle layer and an inner layer, wherein the outer layer is of a porous structure, the porosity is 35-80%, the pore diameter is 700 micrometers, the middle layer is of a porous structure, the porosity is 10-60%, the pore diameter is 50-300 micrometers, the inner layer is of a porous structure, the porosity is 50-90%, and the pore diameter is 200 micrometers. The inner and outer layers are communicated with each other through the pore canal, the mechanical strength of the middle layer is higher than that of the inner and outer layers, the porosity of the middle layer is lower than that of the inner and outer layers, and the whole intramedullary nail is made of bioactive materials. The intramedullary nail has high mechanical strength, is degradable in vivo, does not need to be taken out by a secondary operation, and has good bioactivity.

Description

Multilayer degradable intramedullary nail and manufacturing method thereof
Technical Field
The invention relates to an instrument in the technical field of medical instruments and a manufacturing method thereof, in particular to a multilayer degradable intramedullary nail and a manufacturing method thereof.
Background
At present, many people fracture due to accidents or traffic accidents and need to perform operations, and the treatment by implanting intramedullary nails is a common treatment method in clinic. In consideration of the application environment and action of intramedullary nails, the intramedullary nails need to have high mechanical strength, and the current intramedullary nails commonly used in clinic are mainly made of stainless steel or titanium alloy materials. However, intramedullary nails made of these materials may produce stress shielding effect, so that the fracture part may not be effectively stimulated by stress, and the fracture healing effect may be poor or even fail. Meanwhile, the intramedullary nails made of the materials can slowly release toxic ions or particles after being implanted into a body, and chronic inflammation is caused. Furthermore, once implanted, these intramedullary nails either stay permanently in the body or are surgically removed after bone has been restored, in either case potentially causing complications such as infection or further pain. Moreover, the secondary operation increases the economic burden and pain of the patient.
Therefore, there is a need to produce a high strength degradable intramedullary nail implant which gradually decomposes in the body as the bone heals, which does not require surgical removal, which is non-toxic, which has good bioactivity and which promotes bone healing.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a multi-layer degradable intramedullary nail and a manufacturing method thereof.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a multi-level degradable intramedullary nail is composed of an outer layer, a middle layer and an inner layer, wherein the outer layer is of a porous structure, the porosity is 35-80%, the pore diameter is 700 micrometers, the middle layer is of a porous structure, the porosity is 10-60%, the pore diameter is 50-300 micrometers, the inner layer is of a porous structure, the porosity is 50-90%, the pore diameter is 200-1000 micrometers, the mechanical strength of the middle layer is greater than that of the inner layer and the outer layer, the porosity of the middle layer is lower than that of the inner layer and the outer layer, the multi-level degradable intramedullary nail is made of a bioactive material, the bioactive material is calcium magnesium silicate, the mass percentage of magnesium in the calcium magnesium silicate is 0.2-3.3%, and the multi-level degradable intramedullary nail can also be phosphate or silicate.
Preferably, the pore channels in the outer layer and the inner layer are completely communicated, the pore channel structure can be square, rectangular, parallelogram and the like, the middle layer is a pore channel structure with the inner part communicated along the radial direction, the pore channel structure can be round, square, honeycomb and the like, and the outer layer, the middle layer and the inner layer are communicated with each other through the pore channels. Through the design of the pore structure of the middle layer structure, the middle layer structure has higher mechanical property under the same porosity.
Preferably, holes are formed in the multi-layer degradable intramedullary nail, the diameter of each hole is 1 mm-10 mm, and the number of the holes can be 1, 2 or more.
Furthermore, the holes on the multi-layer degradable intramedullary nail can be in the radial direction or form an angle with the radial direction.
Preferably, the ratio of the cross-sectional diameters of the middle layer and the inner layer of the outer layer of the multi-layer degradable intramedullary nail is (8-7): (6-5): 3-1).
When the intramedullary nail is in practical application, the middle layer with the highest mechanical strength bears most external load, the outer layer of the porous structure is in contact with surrounding bones, along with the increase of implantation time, the intramedullary nail has good bioactivity, can promote the growth of new bone tissues into the inner pore canal of the outer layer structure and is combined with the intramedullary nail to play a role in fixing the intramedullary nail, meanwhile, the intramedullary nail can replace the middle layer to bear a part of external load force, along with the continuous increase of implantation time, the load force borne by the outer layer is more and more, meanwhile, the new bone tissues also grow into the middle layer through the outer layer, although the outer layer and the middle layer are degraded, the mechanical strength of the intramedullary nail is reduced, but the total mechanical strength is increased after the new bone grows into the intramedullary nail.
When the fracture is healed and repaired in the later period, the intramedullary nail is completely degraded without being taken out by a secondary operation. Furthermore, the intramedullary nail can promote the fracture healing due to the good bioactivity. The new bone and the external solution can be led to the inner layer through the pore channels of the outer layer and the middle layer to accelerate the degradation speed of the inner layer, meanwhile, ions released by the inner layer can also flow to the outer layer through the pore channels, and the flow speed of the ions and the degradation speed of the inner layer can be controlled by adjusting the pore size, the porosity and the pore structure in the outer layer and the middle layer.
By adjusting the porosity, the pore diameter and the pore shape structure of the outer layer, the growth speed of the new bone into the outer layer and the degradation speed of the intramedullary nail can be adjusted. By adjusting the porosity, the pore diameter and the pore shape structure of the middle layer, the external load force born by the intramedullary nail and the degradation speed of the intramedullary nail can be adjusted, and the growth speed of new bones into the intramedullary nail is also influenced. The porosity, the aperture and the pore form structure of the inner layer are adjusted, so that the growth speed of the new bone into the intramedullary nail and the degradation speed of the later-stage intramedullary nail can be adjusted.
Preferably, the invention relates to a method for manufacturing the multilayer degradable intramedullary nail, which comprises the following steps:
1) selecting a biological material according to the requirement, and mixing the biological material with a solvent to obtain uniformly dispersed biological ink;
2) respectively designing the structure of 3 parts of the intramedullary nail according to the characteristics and application occasions of the biological ink;
3) adding the biological ink obtained in the step 1) into 3D printing equipment, and performing three-dimensional printing layer by layer to obtain an intramedullary nail blank;
4) processing the intramedullary nail blank, and removing redundant biological ink to obtain a pure intramedullary nail blank with a porous structure;
5) and (3) placing the intramedullary nail blank into a high-temperature furnace for high-temperature calcination, and finally cooling to obtain the multilayer degradable intramedullary nail.
Preferably, the calcination temperature is 1050 deg.CoC-1150oC, the temperature rise speed is 1 to 3 oC/min, and the heat preservation time is 2-4 hours.
Compared with the prior art, the invention has the following advantages:
firstly, the multilayer degradable intramedullary nail manufactured by the invention has high mechanical strength, and makes up for the defects of degradable polymer materials.
Secondly, the method for manufacturing the multilayer degradable intramedullary nail is convenient to operate and low in manufacturing cost.
Thirdly, the multilayer degradable intramedullary nail manufactured by the invention can be continuously absorbed in vivo without secondary operation for extraction.
Fourthly, the multilayer degradable intramedullary nail manufactured by the invention has good bioactivity and can promote fracture healing.
Drawings
FIG. 1 is a schematic structural view of a multi-layered degradable intramedullary nail of the present invention;
fig. 2 is a schematic flow chart of the manufacturing method of the multi-layer degradable intramedullary nail of the present invention.
Detailed Description
The following examples are given for the detailed implementation and specific operation of the present invention, but the scope of the present invention is not limited to the following examples.
As shown in figure 1, the multi-level degradable intramedullary nail comprises an outer layer 4, a middle layer 1 and an inner layer 2, wherein the outer layer is of a porous structure, the porosity is 35-80%, the pore diameter is 700 micrometers, the middle layer is of a porous structure, the porosity is 10-60%, the pore diameter is 50-300 micrometers, the inner layer is of a porous structure, the porosity is 50-90%, the pore diameter is 1000 micrometers, the mechanical strength of the middle layer is greater than that of the inner layer and the outer layer, the porosity of the middle layer is lower than that of the inner layer and the outer layer, the multi-level degradable intramedullary nail is made of a bioactive material, the bioactive material is calcium magnesium silicate, the mass percentage of magnesium in the calcium magnesium silicate is 0.2-3.3%, and the bioactive material can also be phosphate or silicate.
The pore channels in the outer layer and the inner layer are completely communicated, the pore channel structure can be square, rectangular, parallelogram and the like, the middle layer is a pore channel structure 3 with the inner part communicated along the radial direction, the pore channel structure can be round, square, honeycomb and the like, and the outer layer, the middle layer and the inner layer are communicated with each other through the pore channels. Through the design of the pore structure of the middle layer structure, the middle layer structure has higher mechanical property under the same porosity.
Above-mentioned multi-level degradable intramedullary nail is equipped with the hole, and the diameter of this hole is 1mm ~10mm, can be 1, 2 or more.
The holes on the multi-level degradable intramedullary nail can be in the radial direction or form an angle with the radial direction.
The ratio of the cross-sectional diameters of the middle layer and the inner layer of the outer layer of the multi-layer degradable intramedullary nail is (8-7): (6-5): 3-1). When the intramedullary nail is in practical application, the middle layer with the highest mechanical strength bears most external loads, the outer layer of the porous structure is in contact with surrounding bones, and with the increase of implantation time, as the intramedullary nail has good bioactivity, the intramedullary nail can promote the growth of new bone tissues to the inner pore canal of the outer layer structure, and is combined with the intramedullary nail to play a role in fixing the intramedullary nail. Meanwhile, the middle layer can be replaced to bear a part of external load force, the load force borne by the outer layer is increased along with the increase of the implantation time, and meanwhile, the new bone tissue grows into the middle layer through the outer layer. When the fracture is healed and repaired in the later period, the intramedullary nail is completely degraded without being taken out by a secondary operation. Furthermore, the intramedullary nail can promote the healing of fracture due to the good bioactivity. The new bone and the external solution can be led to the inner layer through the pore channels of the outer layer and the middle layer, the degradation speed of the inner layer is accelerated, meanwhile, ions released by the inner layer can also flow to the outer layer through the pore channels, and the flow speed of the ions and the degradation speed of the inner layer can be controlled by adjusting the pore sizes, the porosity and the pore structures in the outer layer and the middle layer.
By adjusting the porosity, the pore diameter and the pore shape structure of the outer layer, the growth speed of the new bone into the outer layer and the degradation speed of the intramedullary nail can be adjusted. By adjusting the porosity, the pore diameter and the pore shape structure of the middle layer, the external load force born by the intramedullary nail and the degradation speed of the intramedullary nail can be adjusted, and the growth speed of new bones into the intramedullary nail is also influenced. The porosity, the aperture and the pore form structure of the inner layer are adjusted, so that the growth speed of the new bone into the intramedullary nail and the degradation speed of the later-stage intramedullary nail can be adjusted.
Fig. 2 is a schematic flow chart of the manufacturing method of the multi-layered degradable intramedullary nail of the present invention, which comprises the following steps:
1) selecting a biological material according to the requirement, and mixing the biological material with a solvent to obtain uniformly dispersed biological ink;
2) respectively designing the structure of 3 parts of the intramedullary nail according to the characteristics and application occasions of the biological ink;
3) adding the biological ink obtained in the step 1) into 3D printing equipment, and performing three-dimensional printing layer by layer to obtain an intramedullary nail blank;
4) processing the intramedullary nail blank, and removing redundant biological ink to obtain a pure intramedullary nail blank with a porous structure;
5) and (3) placing the intramedullary nail blank into a high-temperature furnace for high-temperature calcination, and finally cooling to obtain the multilayer degradable intramedullary nail.
The calcination temperature is 1050oC-1150oC, the temperature rise speed is 1 to 3 oC/min, and the heat preservation time is 2-4 hours.
Example 1
The intramedullary nail used for repairing the tibial fracture is manufactured as follows:
1) uniformly mixing calcium magnesium silicate powder with the magnesium content of 1.5% with a photosensitive resin solution to obtain uniformly dispersed biological ink;
2) designing the structure of the intramedullary nail according to the shrinkage characteristic of a three-dimensional structure formed by biological ink after high-temperature calcination and the mechanical characteristic required by femoral fracture repair, wherein the pore diameter of the outer layer is 500 microns, the porosity is 60%, the pore diameter of the middle layer is 150 microns, the porosity is 30%, the pore diameter of the inner layer is 600 microns, the porosity is 80%, and the section diameter ratio of the outer layer, the middle layer and the inner layer is 8:6: 1;
3) adding the biological ink obtained in the step 1) into a 3D printer, introducing a designed three-dimensional model of the intramedullary nail into the 3D printer, printing the intramedullary nail by the 3D printer according to set parameters, and superposing the three-dimensional printing layers to obtain an intramedullary nail blank which is the same as the designed model;
4) processing the intramedullary nail blank, and removing redundant biological ink to obtain a pure intramedullary nail blank with a porous structure;
5) placing the intramedullary nail blank into a high-temperature furnace, passing through 1100oAnd C, calcining at high temperature for 3 hours, and cooling to obtain the multilayer degradable intramedullary nail, wherein the schematic diagram of the internal structure is shown in figure 2.

Claims (3)

1. A multi-level degradable intramedullary nail is characterized in that the intramedullary nail consists of 3 parts, namely an outer layer, a middle layer and an inner layer;
the outer layer is of a porous structure, the porosity is 35-80%, the pore diameter is 100-700 microns, the middle layer is of a porous structure, the porosity is 10-60%, the pore diameter is 50-300 microns, the inner layer is of a porous structure, the porosity is 50-90%, and the pore diameter is 200-1000 microns;
the mechanical strength of the middle layer is greater than that of the inner layer and the outer layer, the porosity of the middle layer is lower than that of the inner layer and the outer layer, and the middle layer is made of bioactive materials;
the bioactive material is calcium magnesium silicate or phosphate, wherein the mass percent of magnesium in the calcium magnesium silicate is 0.2-3.3%;
the pore channels in the outer layer and the inner layer are completely communicated, and the pore channel structure is square, rectangular or parallelogram;
the middle layer is a pore channel structure with the inner part communicated along the radial direction, and the pore channel structure is round, square or honeycomb;
the outer layer, the middle layer and the inner layer are communicated with each other through pore channels;
the multi-level degradable intramedullary nail is provided with more than one hole, and the diameter of the hole is 1 mm-10 mm.
2. The multi-layered degradable intramedullary nail of claim 1, wherein the holes of the multi-layered degradable intramedullary nail are designed radially or at an angle to the radial direction.
3. The multi-level degradable intramedullary nail of claim 1, wherein the ratio of the cross-sectional diameters of the middle layer and the inner layer of the outer layer of the multi-level degradable intramedullary nail is (8-7): (6-5): 3-1).
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CN102908672A (en) * 2012-10-30 2013-02-06 东南大学 High-strength absorbable magnesium substrate composite orthopedic fixing device and preparation method thereof
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