CN110123491B - Artificial acetabulum liner based on titanium alloy porous framework and manufacturing method thereof - Google Patents
Artificial acetabulum liner based on titanium alloy porous framework and manufacturing method thereof Download PDFInfo
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- CN110123491B CN110123491B CN201910350974.5A CN201910350974A CN110123491B CN 110123491 B CN110123491 B CN 110123491B CN 201910350974 A CN201910350974 A CN 201910350974A CN 110123491 B CN110123491 B CN 110123491B
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- 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
- A61F2/32—Joints for the hip
- A61F2/34—Acetabular cups
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction
Abstract
The invention discloses an artificial acetabulum liner based on a titanium alloy porous skeleton and a manufacturing method thereof, wherein the method comprises the following steps: preparing a porous skeleton structure of the titanium alloy hip joint lining by using titanium alloy powder; providing peroxide and ultra-high molecular weight polyethylene powder, and uniformly mixing the peroxide and the ultra-high molecular weight polyethylene powder to prepare a composite master batch; and filling the composite master batch into the holes of the framework structure through hot pressing to obtain the artificial acetabulum liner based on the titanium alloy porous framework. The invention solves the problem that the hip joint lining in the prior art is easy to cause artificial joint failure such as dissolution of peripheral bones of the joint, aseptic loosening and the like due to abrasion.
Description
Technical Field
The invention relates to the technical field of orthopedic implants, in particular to an artificial acetabulum liner based on a titanium alloy porous framework and a manufacturing method thereof.
Background
With the increase in the average life span of humans, the aging of the population has been one of the challenges facing the world. The rapid increase in the aging population entails a large increase in the number of patients with orthopedic joint diseases, and artificial hip replacement is considered to be the best and most common surgical procedure for treating end-stage orthopedic joint diseases. The artificial hip joint comprises an acetabulum component, a femoral head component and a femoral stem component. The acetabulum assembly comprises an acetabulum cup and an acetabulum liner, wherein the femoral head and the acetabulum liner form a movable interface of the artificial joint. In the current market of orthopedic implants, metal or ceramic is generally used as an artificial femoral head, and polyethylene is used as an acetabular liner. However, as the metal or ceramic femoral head and the polyethylene lining are continuously rubbed by the artificial joint movement after the operation, the polyethylene lining can generate more or less wear particles or particles, thereby causing a series of artificial joint failure problems such as the dissolution of the peripheral bone of the joint and the aseptic loosening. Although the problem of artificial joint failure exists under the current technical conditions, the hip revision surgery can achieve better clinical effect. However, the hip revision surgery is expensive and has many surgical complications, which causes great pain and economic burden to the patient.
Accordingly, the prior art is yet to be improved and developed.
Disclosure of Invention
In view of the defects of the prior art, the invention aims to provide an artificial acetabulum liner based on a titanium alloy porous framework and a manufacturing method thereof, and aims to solve the problems that the conventional hip joint liner is easy to cause artificial joint failure such as dissolution of bones around joints, aseptic loosening and the like due to abrasion.
The technical scheme of the invention is as follows:
a method for manufacturing an artificial acetabulum liner based on a titanium alloy porous skeleton comprises the following steps:
preparing a porous skeleton structure of the titanium alloy hip joint lining by using titanium alloy powder;
providing peroxide and ultra-high molecular weight polyethylene powder, and uniformly mixing the peroxide and the ultra-high molecular weight polyethylene powder to prepare a composite master batch;
and filling the composite master batch into the holes of the framework structure through hot pressing to obtain the artificial acetabulum liner based on the titanium alloy porous framework.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous framework comprises the following steps of forming a porous framework structure, wherein the pore diameter of holes of the porous framework structure is 0.8-0.9 mm, and the hole spacing is 1-1.2 mm.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous framework comprises the following step of preparing a titanium alloy porous framework, wherein the peroxide is dicumyl peroxide.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous skeleton comprises the following steps of mixing dicumyl peroxide and ultrahigh molecular weight polyethylene powder according to a ratio of 1:2, and mixing uniformly.
The preparation method of the artificial acetabulum liner based on the titanium alloy porous skeleton comprises the step of adding an antioxidant when mixing peroxide and ultrahigh molecular weight polyethylene powder uniformly.
The method for manufacturing the artificial acetabulum liner based on the titanium alloy porous framework comprises the following steps of: filling the composite master batch into the hole of the porous skeleton structure through hot pressing, and removing the redundant composite master batch outside the hole to form a lining surface for contacting with the femoral head.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous framework comprises the following steps of carrying out hot pressing at the temperature of 170-180 ℃ and under the pressure of 10-12 MPa.
The method for manufacturing the artificial acetabulum lining based on the titanium alloy porous framework further comprises the following steps after the step of manufacturing the porous framework structure of the titanium alloy hip joint lining by using titanium alloy powder: and annealing and disinfecting the porous skeleton structure of the titanium alloy hip joint lining.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous framework comprises the following steps of annealing, wherein the annealing is vacuum annealing heat treatment, the protective gas is argon, and the heat treatment temperature is 800-850 ℃.
The manufacturing method of the artificial acetabulum liner based on the titanium alloy porous skeleton comprises the step of carrying out combined treatment on hydrogen peroxide and low-temperature plasma.
According to the method for manufacturing the artificial acetabulum liner based on the titanium alloy porous skeleton, in the step of manufacturing the porous skeleton structure of the titanium alloy hip joint liner by using the titanium alloy powder, the titanium alloy powder is subjected to checkerboard scanning and printing by using a 3D printer according to a three-dimensional CAD model of a target hip joint liner to manufacture the porous skeleton structure of the titanium alloy hip joint liner.
An artificial acetabulum liner based on a titanium alloy porous skeleton is manufactured by the method.
Has the advantages that: according to the invention, the titanium alloy powder is firstly used for preparing the porous skeleton structure of the hip joint lining, then the mixed master batch obtained by mixing the peroxide and the ultra-high molecular weight polyethylene powder is filled in the holes of the porous skeleton structure through a hot pressing method, so that an inner concave lining surface in contact with the femoral head and an outer convex lining surface in contact with the acetabular cup are formed, the ultra-high molecular weight polyethylene and the peroxide are crosslinked under the action of hot pressing, the creep elongation of the ultra-high molecular weight polyethylene can be greatly reduced, the wear resistance is better, the generation of abrasive dust is reduced, meanwhile, the holes distributed on the skeleton structure provide accommodating spaces for polyethylene particles, metal particles and bone cement particles generated by abrasion, the polyethylene particles, the metal particles and the bone cement particles are prevented from entering the surrounding bone tissues, the generation of related diseases is prevented, and the service life of the acetabular.
Drawings
FIG. 1 is a schematic flow chart of a preferred embodiment of a method for manufacturing an artificial acetabular liner based on a titanium alloy porous skeleton according to the invention;
FIG. 2 is a schematic view of a porous framework structure;
FIG. 3 is a graph of an annealing process;
fig. 4 is a structural schematic diagram of the artificial acetabular liner based on the titanium alloy porous skeleton.
Detailed Description
The invention provides an artificial acetabulum liner based on a titanium alloy porous framework and a manufacturing method thereof, and the invention is further described in detail below in order to make the purpose, technical scheme and effect of the invention clearer and more clear. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The invention relates to a method for manufacturing an artificial acetabulum liner based on a titanium alloy porous skeleton, which comprises the following steps of:
s1, preparing a porous skeleton structure of the titanium alloy hip joint lining by using titanium alloy powder;
s2, providing peroxide and ultra-high molecular weight polyethylene powder, and uniformly mixing the peroxide and the ultra-high molecular weight polyethylene powder to prepare a composite master batch;
and S3, filling the composite master batch into the holes on the porous skeleton structure through hot pressing to obtain the artificial acetabulum liner based on the titanium alloy porous skeleton.
When the framework structure of the hip joint lining is prepared by using titanium alloy, holes are arranged on the framework structure, namely the framework structure is in a spongy porous structure, then a composite master batch consisting of peroxide and ultra-high molecular weight polyethylene is filled in the holes in a hot pressing mode, the ultra-high molecular weight polyethylene can be melted and pressed into the holes under the hot pressing action, so that an inner concave lining surface which is in contact with a femoral head is formed together with an inner concave surface of the framework structure made of the titanium alloy and used for bearing the femoral head, and an outer convex lining surface which is in contact with the acetabular cup is formed together with an outer convex surface of the framework structure made for bearing the acetabular cup; and the hot pressing effect can make the polyethylene with ultrahigh molecular weight and peroxide carry out cross-linking reaction, the creep elongation of the polyethylene with ultrahigh molecular weight can be greatly reduced, the wear resistance is better, the generation of abrasive dust is reduced, and meanwhile, holes distributed on the framework structure provide accommodation space for polyethylene particles, metal particles and bone cement particles generated by abrasion, so that the polyethylene particles, the metal particles and the bone cement particles are prevented from entering surrounding bone tissues to cause the generation of related diseases, and the service life of the acetabulum lining is greatly prolonged.
Specifically, in step S1, the titanium alloy powder is subjected to checkerboard scanning and printing by using a 3D printer according to the three-dimensional CAD model of the target hip joint lining, and obviously, holes are arranged in the three-dimensional CAD model, that is, on the target hip joint lining, and holes are arranged on the inner concave surface of the skeleton structure printed in this way. Preferably, as shown in fig. 2, a mesh with evenly distributed holes is printed according to the three-dimensional CAD model of the target hip joint lining according to the cross-shaped structural units, so that the holes of the skeleton structure can be formed by the gaps between the adjacent cross-shaped structural units after printing. The pore diameter of the pores is 0.8-0.9 mm (for example, 0.88 mm), and the pore spacing is 1-1.2 mm (for example, 1.08 mm), so that the porous framework has sufficient mechanical properties and sufficient space for subsequent hot pressing.
More specifically, in step S1, the designed three-dimensional CAD model of the hip joint lining is converted into an STL file, and then the STL file is imported into a Selective Laser Melting (SLM) printer dedicated for metal materials, and titanium alloy powder Ti-6Al-4V (TC 4) is placed in the printer to perform checkerboard scanning printing, so as to obtain the framework structure of the hip joint lining made of titanium alloy. Wherein, the printing process is carried out under protective gases such as argon, and the process parameters are set in the printing process as follows: the laser speed is 1200-1300mm/s, the laser power is 300-350W, and the laser scanning gap is 0.09 mm.
The titanium alloy powder can be Ti-6Al-4V (TC 4), the tensile strength mechanics of the titanium alloy powder is more than or equal to 440MPa, the yield strength is more than or equal to 230 MPa, the elongation is more than or equal to 5%, and the chemical components are shown in Table 1:
TABLE 1
| Element(s) | Al | V | Si | Fe | C | N | H | O | Ti |
| Mass content (%) | 6.02 | 4 | 0.04 | 0.15 | 0.05 | 0.03 | 0.01 | 0.14 | Balance of |
Preferably, the particle size of the titanium alloy powder is 15-53um, namely, the requirement of a 3D printing process can be well met.
Further, after step S1, the method further includes: and annealing and sterilizing the porous skeleton structure of the titanium alloy hip joint lining, wherein the internal stress of the formed skeleton structure can be eliminated through annealing, and the sterilization effect can be achieved through sterilizing. Preferably, the annealing treatment is vacuum annealing heat treatment, because air is difficult to be directly exhausted, air can be exhausted by inert gas such as argon and the like, then the inert gas is extracted, and then the annealing heat treatment is carried out, wherein the heat treatment temperature is 800 plus 850 ℃, the cooling mode is furnace cooling, the specific process curve is shown in figure 2, the temperature is increased to 800 ℃ at constant speed within 2.5h, the moisture is preserved for 4h, then the furnace cooling is carried out to 80 ℃, and then the air cooling is carried out. Preferably, the sterilization treatment is a combination treatment of hydrogen peroxide and low-temperature plasma, and the hydrogen peroxide and the low-temperature plasma are combined to improve the sterilization effect. More preferably, ultrasonic treatment is also performed before the sterilization treatment, the ultrasonic treatment is performed to remove raw material, i.e., titanium alloy particles, attached to the surface of the print, and the ultrasonic treatment time is 2 hours.
In the step S2, the peroxide and the ultra-high molecular weight polyethylene powder are mixed to obtain the composite master batch, and the mixing process is only physical mixing, and the peroxide and the ultra-high molecular weight polyethylene need to be uniformly mixed, so that the ultra-high molecular weight polyethylene is uniformly crosslinked through peroxide groups in the peroxide in the subsequent hot pressing process, and the polyethylene crosslinking effect is better improved.
The ultra-high molecular weight polyethylene (UHMWPE) generally refers to polyethylene having a molecular weight of 100 ten thousand or more, and preferably 120 ten thousand or more. Wherein an antioxidant such as antioxidant 1076 is added when mixing the peroxide and the ultra high molecular weight polyethylene powder to prevent the polyethylene from being oxidized to affect the crosslinking quality at the subsequent hot pressing. Preferably, the peroxide is dicumyl peroxide (DCP). More preferably, dicumyl peroxide is mixed with ultra-high molecular weight polyethylene powder 1:2, and mixing uniformly.
Specifically, in step S2, a certain amount of dicumyl peroxide and an antioxidant 1076 are uniformly mixed at 60 ℃ with a small amount of absolute ethanol, UHMWPE powder is added according to a ratio of 1:2, stirred for about 30min and further ultrasonically dispersed and uniformly mixed, and finally, excessive absolute ethanol is volatilized through slight heating drying to prepare the ultrahigh molecular weight polyethylene/dicumyl peroxide mixed master batch containing dicumyl peroxide.
In step S3, the composite master batch is hot pressed and filled into the hole of the porous skeleton structure, the ultra-high molecular weight polyethylene is melted under the action of hot pressing and pressed into the hole to fill the hole, and then the redundant composite master batch outside the hole is removed by using a cutter, so that an inner concave lining surface contacting with the femoral head and an outer convex lining surface contacting with the acetabular cup can be formed together with the titanium alloy skeleton structure, i.e., the outer convex lining surface and the inner concave lining surface are doped with the ultra-high molecular weight polyethylene and the titanium alloy, and are contacted with the femoral head and the acetabular cup to bear pressure. In addition, the hot pressing effect can enable the polyethylene with ultrahigh molecular weight to carry out crosslinking reaction with peroxide, greatly reduce the creep elongation of the polyethylene with ultrahigh molecular weight and have better wear resistance. Preferably, the hot pressing temperature is 170-180 ℃ and the pressure is 10-12 MPa.
Specifically, in step S3, the porous skeleton is first placed in a mold, and the skeleton is attached to the mold, and then the mixed masterbatch is added into the mold, where the masterbatch has a volume 2 times that of the skeleton, and is uniformly filled above the concave-inward surface, and the mold is subjected to heat treatment before pressing, and the pressing process parameters are as follows: the pressure is 10-12MPa, the pressing time is about 20 minutes, and the pressing temperature is 175 ℃. And then cutting the acetabulum lining prototype after the hot pressing treatment by using a cutter to obtain the shape of the acetabulum lining, wherein the shape structure is shown in figure 4, the inner concave lining surface in contact with the femoral head and the outer convex lining surface in contact with the acetabulum cup are doped and distributed with ultra-high molecular weight polyethylene 100 and titanium alloy 200, and then the final artificial acetabulum lining based on the titanium alloy porous framework can be obtained by performing high-temperature sterilization treatment for more than 3 times and plasma sterilization treatment which is the same as the steps.
Based on the method, the invention also provides an artificial acetabulum liner based on the titanium alloy porous framework, wherein the artificial acetabulum liner is manufactured by the method.
Through detection, the ultrahigh molecular weight polyethylene provided by the invention is subjected to peroxide crosslinking treatment, so that the creep elongation is greatly reduced, the ultrahigh molecular weight polyethylene has better wear resistance, and the generation of abrasive dust is reduced; the metal 3D printing technology and the ultrahigh molecular polyethylene crosslinking technology are combined, and the viscous abrasion is reduced by more than 50% compared with the existing pure polyethylene acetabulum liner.
In summary, the artificial acetabulum liner based on the titanium alloy porous skeleton and the manufacturing method thereof provided by the invention firstly make the porous skeleton structure of the hip joint liner by using titanium alloy powder, then filling a mixed master batch obtained by mixing peroxide and ultra-high molecular weight polyethylene powder into the holes by a hot pressing method, thereby forming an inner concave lining surface contacted with the femoral head and an outer convex lining surface contacted with the acetabular cup, crosslinking the ultra-high molecular polyethylene and peroxide under the action of hot pressing, greatly reducing the creep elongation of the ultra-high molecular polyethylene, having better wear resistance, reducing the generation of abrasive dust, meanwhile, the holes distributed on the skeleton structure provide accommodation space for polyethylene particles, metal particles and bone cement particles generated by abrasion, so that the polyethylene particles, the metal particles and the bone cement particles are prevented from entering surrounding bone tissues to cause generation of related diseases, and the service life of the acetabulum lining is greatly prolonged.
It is to be understood that the invention is not limited to the examples described above, but that modifications and variations may be effected thereto by those of ordinary skill in the art in light of the foregoing description, and that all such modifications and variations are intended to be within the scope of the invention as defined by the appended claims.
Claims (10)
1. A method for manufacturing an artificial acetabulum liner based on a titanium alloy porous skeleton is characterized by comprising the following steps:
preparing a porous skeleton structure of the titanium alloy hip joint lining by using titanium alloy powder;
providing peroxide and ultra-high molecular weight polyethylene powder, and uniformly mixing the peroxide and the ultra-high molecular weight polyethylene powder to prepare a composite master batch;
filling composite master batch into the hole of the skeleton structure through hot pressing, so that the composite master batch and the inner concave surface of the skeleton structure for bearing the femoral head form an inner concave lining surface which is contacted with the femoral head, and meanwhile, the composite master batch and the outer convex surface of the skeleton structure for bearing the acetabular cup form an outer convex lining surface which is contacted with the acetabular cup, namely the artificial acetabular liner based on the titanium alloy porous skeleton is prepared.
2. The method for manufacturing the artificial acetabulum liner based on the titanium alloy porous framework according to claim 1, wherein the pore diameter of the pores of the porous framework structure is 0.8-0.9 mm, and the pore spacing is 1-1.2 mm.
3. The method for manufacturing the artificial acetabular liner based on the titanium alloy porous skeleton according to claim 1, wherein the peroxide is dicumyl peroxide.
4. The method for manufacturing the artificial acetabular liner based on the titanium alloy porous skeleton according to claim 3, wherein the ratio of dicumyl peroxide to the ultra-high molecular weight polyethylene powder is 1:2, and mixing uniformly.
5. The method for manufacturing the artificial acetabulum liner based on the titanium alloy porous skeleton according to claim 1, wherein an antioxidant is further added when the peroxide and the ultra-high molecular weight polyethylene powder are mixed uniformly.
6. The method for manufacturing the artificial acetabulum liner based on the titanium alloy porous skeleton according to claim 1, wherein the hot pressing temperature is 170-180 ℃ and the pressure is 10-12 MPa.
7. The method for manufacturing the artificial acetabular liner based on the titanium alloy porous skeleton according to claim 1, wherein after the step of manufacturing the porous skeleton structure of the titanium alloy hip joint liner by using titanium alloy powder, the method further comprises the following steps: and annealing and disinfecting the porous skeleton structure of the titanium alloy hip joint lining.
8. The method for manufacturing the artificial acetabular liner based on the titanium alloy porous skeleton according to claim 7, wherein the disinfection treatment is a combination treatment of hydrogen peroxide and low-temperature plasma.
9. The method for manufacturing the artificial acetabular liner based on the titanium alloy porous skeleton according to claim 1, wherein in the step of manufacturing the porous skeleton structure of the titanium alloy hip joint liner by using the titanium alloy powder, the titanium alloy powder is subjected to checkerboard scanning and printing by using a 3D printer according to a three-dimensional CAD model of a target hip joint liner to manufacture the porous skeleton structure of the titanium alloy hip joint liner.
10. An artificial acetabulum liner based on a titanium alloy porous skeleton, which is characterized by being manufactured by the method according to any one of claims 1 to 9.
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| CN111134905B (en) * | 2019-12-30 | 2021-12-07 | 云南省第一人民医院 | Artificial hip joint and preparation method thereof |
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