CN111281616A

CN111281616A - Full-hip metal cup prosthesis and manufacturing method thereof

Info

Publication number: CN111281616A
Application number: CN202010167821.XA
Authority: CN
Inventors: 史春宝; 许奎雪; 史文超; 史春生; 任宏志
Original assignee: Beijing Chunlizhengda Medical Instruments Co Ltd
Current assignee: Beijing Chunlizhengda Medical Instruments Co Ltd
Priority date: 2020-03-11
Filing date: 2020-03-11
Publication date: 2020-06-16
Anticipated expiration: 2040-03-11
Also published as: CN111281616B

Abstract

The invention relates to a full hip metal cup prosthesis and a manufacturing method thereof. The 3D printing tantalum metal bone trabecula is a tantalum net adopting 3D printing, inner holes of the tantalum net adopt 3D printing, the hole diameters of the inner holes are 200-400 mu m respectively, and the thickness of the inner holes is 1 mm. The outer side surface of the tantalum net is a porous structure with the aperture of 600-800 mu m and the thickness of 2 mm. The full hip metal cup prosthesis is closer to the bone than any other prosthesis metal in the aspects of physical property and mechanical property, is very beneficial to the occurrence of osteoinduction, and can quickly and widely enable soft tissues to infiltrate and firmly attach; and has high load strength and low elastic modulus, thereby allowing the stress shielding to be minimized under physiological load conditions, and the surface of the tantalum material has excellent biocompatibility; the preparation method is simple, has low cost, is beneficial to implementation and clinical application, and is suitable for the requirements of patients.

Description

Full-hip metal cup prosthesis and manufacturing method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a full hip metal cup prosthesis and a manufacturing method thereof.

Background

A total hip metal cup prosthesis is a surgical implant used to replace the acetabular component of a human hip joint. At present, cement type and biological type metal outer cups are commonly used in the prior art, wherein the cement type is filled and fixed by bone cement, and the biological type is a process of spraying titanium powder or sintering titanium beads on the surface. The metal outer cup is combined with a femoral stem and a ball head for use in hip joint total hip replacement surgery. The total acetabular prosthesis structure in the prior art is formed by connecting and combining a metal outer cup and an inner liner through taper, and has the advantages of convenience in processing, short development period and the like.

Although the prior art total hip metal cup can replace the acetabulum part of the hip joint, a plurality of defects are found in the actual use, so that the total hip metal cup cannot achieve the optimal use effect in the actual application, and the defects can be summarized as follows:

1. surface treatment of the metal outer cup: the prior full hip metal outer cup adopts the processes of spraying emery, spraying titanium, spraying HA, sintering titanium beads and the like on the surface. As a result, although the surface reaches a certain roughness, the coating is absorbed and falls off, and the problems of undesirable bone ingrowth caused by micromotion of the titanium beads and the bone or infection, operative revision and the like caused by the falling of the titanium beads exist.

2. Titanium alloy 3D prints metal outer cup bone trabecula structure. Titanium and titanium alloys have good mechanical strength and biocompatibility, and are the preferred materials for orthopedic implants and dental implants. The titanium is subjected to surface biological modification, so that the integration capability of the titanium and host bones can be obviously enhanced. However, titanium has the defects of poor mechanical property, easy physiological corrosion and the like, and the clinical success rate of titanium is influenced.

3. There is a 3D printing tantalum trabecula cushion, and will lean on the bone nail with the metal cup components of a whole that can function independently to be fixed in the acetabular bone, though have the better bone of titanium alloy trabecula and grow into the effect, nevertheless have the prosthesis not hard up and because of two body structural design, the bone grows into the problem such as the effect is not good and the operation is renovated.

Disclosure of Invention

The invention aims to provide a full hip metal cup prosthesis, which at least aims to solve the technical problems of enhancing various physicochemical characteristics of prosthesis materials and improving bone ingrowth effect, and is suitable for the needs of patients.

In order to achieve the purpose, the invention provides a full hip metal cup prosthesis which comprises a 3D printed tantalum metal bone trabecula and a titanium alloy metal cup, wherein the 3D printed tantalum metal bone trabecula and the titanium alloy metal cup are brazed together through silver brazing metal accessories.

The 3D printing tantalum metal bone trabecula is a tantalum net adopting 3D printing, an inner hole of the tantalum net adopts 3D printing, the hole diameter of the inner hole is 200-400 mu m respectively, and the thickness of the inner hole is 1 mm.

The outer side surface of the tantalum net is of a porous structure with the aperture of 600-800 mu m and the thickness of 2 mm. The compressive strength of the porous tantalum net is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%.

The porous tantalum mesh is capable of binding free radicals.

The material used for 3D printing is preferably spherical tantalum powder with the particle size of 15-45 microns; the purity of the spherical tantalum powder is more than 99.9 percent, the oxygen content is less than 500ppm, the sphericity is more than 90 percent, and the Hall flow rate is less than 10s/50 g.

The laser positive defocusing light spot during 3D printing is 135 micrometers, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W; the temperature of the substrate is preferably 100 ℃.

The titanium alloy metal cup is a machined titanium alloy metal cup, and the surface of the titanium alloy metal cup is provided with the micro threads, so that the titanium alloy metal cup is more firmly brazed with the tantalum mesh.

Preferably, after the 3D printed tantalum metal bone trabecula and the titanium alloy metal cup are brazed together, 5-degree self-locking bone nails can be used for reinforcement in order to increase the firmness of the prosthesis and avoid micromotion and assist short-term bone ingrowth in the operation process.

The invention also provides a manufacturing method of the total hip metal cup prosthesis, which comprises the following steps:

firstly, 3D prints tantalum metal bone trabecula: according to CT scanning data of a patient, importing the obtained format file into a 3D printer for 3D printing to obtain a porous tantalum net; the pore diameters of the inner holes of the porous tantalum net are respectively 200-400 mu m, and the thickness is 1 mm; the outer side surface is a porous structure with the aperture of 600-800 μm and the thickness of 2 mm; the compressive strength of the porous tantalum net is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%; the porous tantalum mesh is capable of binding free radicals; the material for 3D printing is preferably spherical tantalum powder with the particle size of 15-45 microns, the purity of the spherical tantalum powder is more than 99.9%, the oxygen content is less than 500ppm, the sphericity is more than 90%, and the Hall flow rate is less than 10s/50 g; the positive defocusing spot of the laser is 135 μm, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W; the temperature of the substrate is preferably 100 ℃;

secondly, machining a titanium alloy metal cup: the titanium alloy metal cup is processed into a shape and a size matched with the 3D printed tantalum metal bone trabecula, and meanwhile, the surface of the titanium alloy metal cup is processed with micro threads, so that the titanium alloy metal cup is more firmly brazed with a tantalum mesh;

thirdly, brazing: and brazing the 3D printed tantalum metal bone trabecula and the machined titanium alloy metal cup together through silver brazing metal accessories.

Advantageous effects

Compared with the prior art, the invention has the beneficial effects that:

first, the present invention is a 3D printed tantalum metal trabecular bone structure, the trabecular metal in cellular structure closely resembles cancellous bone structure and is closer to bone in physical and mechanical properties than any other prosthetic metal.

Secondly, the unique, high-porosity and trabecular bone-like structure of the tantalum metal trabecula is very beneficial to the occurrence of osteoinduction, and can quickly and widely infiltrate and firmly attach soft tissues; and has high load strength and low elastic modulus, thereby allowing the stress shielding to be minimized under physiological load conditions, and the tantalum material surface has excellent biocompatibility.

Thirdly, the porous tantalum metal bone trabecula is in a three-dimensional communicated pore structure, the porosity is 75-85%, the pore diameter is 200-400 μm respectively, and the thickness is 1 mm; the outer side surface is a porous structure with the aperture of 600-800 μm and the thickness of 2 mm; the pore size is 400-600 μm. The porosity of the porous tantalum metal bone trabecula is higher than that of a CoCr sintered body (30-50%) and a titanium fiber net (40-50%), and the excellent mechanical property of the porous tantalum metal bone trabecula is determined by a high-porosity structure. Firstly, the maximum bending strength of the porous tantalum reaches 110MPa, and sufficient physiological support can be provided for new bone tissues; secondly, the friction coefficient of the material and a bone group is 40-80% higher than that of the traditional metal implant material, the material is favorable for being combined with host bones, and the initial stability is enhanced; moreover, the elastic modulus is about 3GPa, is between that of cortical bone (12-18GPa) and that of cancellous bone (0.2-0.5GPa), is obviously lower than that of titanium alloy and cobalt-chromium alloy, and can effectively reduce stress shielding effect and facilitate bone tissue remodeling due to the elastic modulus matched with human bone tissue.

Fourth, the preparation method of the total hip metal cup prosthesis is simple, low in cost, beneficial to implementation and clinical application, and suitable for the needs of patients.

Drawings

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention.

Fig. 1 is a schematic structural view of a total hip metal cup prosthesis according to the present invention.

Fig. 2 is a top view of a total hip metal cup prosthesis according to the present invention.

FIG. 3 is an enlarged partial schematic view of a titanium alloy metal cup according to the present invention.

Fig. 4 is a schematic structural diagram of a 3D printed tantalum metal trabecular bone according to the present invention.

Fig. 5 is a schematic structural view of a silver brazing filler metal accessory according to the present invention.

Fig. 6 is a schematic structural view of the metal cup bone nail of the present invention.

Detailed Description

The present invention is described in more detail below to facilitate an understanding of the present invention.

As shown in fig. 1 to 6, the total hip metal cup prosthesis comprises a 3D printed tantalum metal bone trabecula 1 and a titanium alloy metal cup 2, wherein the 3D printed tantalum metal bone trabecula 1 and the titanium alloy metal cup 2 are brazed together through silver brazing metal accessories.

The 3D printing tantalum metal bone trabecula 1 is a tantalum net adopting 3D printing, inner holes of the tantalum net adopt 3D printing, the hole diameters of the inner holes are 200-400 mu m respectively, and the thickness of the inner holes is 1 mm. The outer side surface is a porous structure with the aperture of 600-800 μm and the thickness of 2mm (see figure 4 for details);

the compressive strength of the porous tantalum net is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%.

The porous tantalum mesh is capable of binding free radicals.

The material used for 3D printing is preferably spherical tantalum powder with the particle size of 15-45 mu m.

The purity of the spherical tantalum powder is more than 99.9 percent, the oxygen content is less than 500ppm, the sphericity is more than 90 percent, and the Hall flow rate is less than 10s/50 g.

Preferably, after the 3D printed tantalum metal bone trabecula 1 and the titanium alloy metal cup 2 are brazed together, in order to increase the firmness of the prosthesis and avoid micromotion and assist short-term bone ingrowth, 5-degree self-locking bone nails (metal cup bone nails) can be used for reinforcement.

In summary, the invention provides a full hip metal cup prosthesis, which adopts a 3D printing and brazing process of a surface tantalum bone trabecula, enhances the surface roughness and is beneficial to bone ingrowth. According to the invention, the hole inside the tantalum mesh is printed in a 3D mode, the hole diameters are respectively 200-400 microns, the thickness is 1mm, and the tantalum mesh is more firm after being brazed with the titanium alloy metal cup; the outer side surface has the aperture of 600-800 μm and the thickness of 2mm, which is beneficial to the fixation of the implant and the growth of new bone tissue. The compressive strength of the porous tantalum net provided by the invention is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%. Meanwhile, the material can be combined with free radicals, so that the oxidation resistance rate of the prosthesis material is improved, and the long-term curative effect of the prosthesis material is prolonged.

And according to CT scanning data of the patient, importing the obtained format file into a 3D printer for 3D printing to obtain the porous tantalum net.

The material for 3D printing is preferably spherical tantalum powder with the particle size of 15-45 microns, the purity of the spherical tantalum powder is greater than 99.9%, the oxygen content is less than 500ppm, the sphericity is greater than 90, and the Hall flow rate is less than 10s/50 g. The positive defocusing spot of the laser is 135 μm, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W; the temperature of the substrate is preferably 100 ℃. GB/T1964-1996 is adopted to test the mechanical property of the porous tantalum net, and the result shows that the compressive strength reaches more than 180MPa and the elastic modulus reaches more than 15 GPa. The porosity of the porous tantalum net is measured by GB/T5163-2006 and reaches over 75%.

The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations of the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.

Claims

1. The full hip metal cup prosthesis is characterized by comprising a 3D printed tantalum metal bone trabecula and a titanium alloy metal cup, wherein the 3D printed tantalum metal bone trabecula and the titanium alloy metal cup are brazed together through silver brazing metal accessories.

2. The total hip metal cup prosthesis according to claim 1, wherein the 3D printed tantalum metal trabecular bone is a 3D printed tantalum mesh, the inner holes of the tantalum mesh are 3D printed, the hole diameters of the inner holes are respectively 200 μm-400 μm, and the thickness is 1 mm.

3. The total hip metal cup prosthesis according to claim 2, wherein the outer surface of the tantalum mesh is a porous structure with a pore size of 600 μm to 800 μm and a thickness of 2 mm.

4. The total hip metal cup prosthesis according to claim 2 or 3, wherein the porous tantalum mesh has a compressive strength of 120 to 180MPa, an elastic modulus of 10 to 20GPa, and a porosity of 75 to 85%.

5. The total hip metal cup prosthesis according to claim 2, wherein said porous tantalum mesh is capable of binding free radicals.

6. The total hip metal cup prosthesis according to claim 2, wherein the 3D printing uses spherical tantalum powder of 15-45 μm; the purity of the spherical tantalum powder is more than 99.9 percent, the oxygen content is less than 500ppm, the sphericity is more than 90 percent, and the Hall flow rate is less than 10s/50 g.

7. The total hip metal cup prosthesis according to claim 2, wherein the laser positive defocus spot during 3D printing is 135 μ ι η, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W; the temperature of the substrate was 100 ℃.

8. The total hip metal cup prosthesis according to claim 1, wherein the titanium alloy metal cup is a machined titanium alloy metal cup, and the surface of the titanium alloy metal cup is provided with micro threads so as to be more firmly brazed with the tantalum mesh.

9. The total hip metal cup prosthesis according to claim 1, wherein said 3D printed tantalum metal trabecular bone and titanium alloy metal cup are brazed together and reinforced with 5 ° self-locking bone pins.

10. The method of making a total hip metal cup prosthesis according to any of claims 1 to 9, comprising the steps of:

firstly, 3D prints tantalum metal bone trabecula: according to CT scanning data of a patient, importing the obtained format file into a 3D printer for 3D printing to obtain a porous tantalum net; the pore diameters of the inner holes of the porous tantalum net are respectively 200-400 mu m, and the thickness is 1 mm; the outer side surface is a porous structure with the aperture of 600-800 μm, and the thickness of the porous structure is 2 mm; the compressive strength of the porous tantalum net is 120-180 MPa, the elastic modulus is 10-20 GPa, and the porosity is 75-85%; the porous tantalum mesh is capable of binding free radicals; the 3D printing material is spherical tantalum powder with the particle size of 15-45 microns, the purity of the spherical tantalum powder is more than 99.9%, the oxygen content is less than 500ppm, the sphericity is more than 90, and the Hall flow rate is less than 10s/50 g; the positive defocusing spot of the laser is 135 μm, the speed is 150mm/s, the line spacing is 0.5mm, and the power is 250W; the temperature of the substrate is preferably 100 ℃;