CN115281897A - A metal-ceramic hip joint prosthesis inner lining and its manufacturing method - Google Patents

Abstract

The invention provides a metal-ceramic hip joint prosthesis lining and a manufacturing method thereof, wherein the hip joint prosthesis lining comprises a metal matrix and a ceramic coating positioned on the inner surface of the metal matrix, and the ceramic coating is metallurgically bonded with the metal matrix by adopting a laser cladding technology; the manufacturing method comprises the following steps: A. processing a metal matrix, polishing the inner surface by using abrasive paper, removing an oxide layer, wiping by using alcohol and air-drying; B. cladding a ceramic coating on the inner surface of the metal matrix by using a laser cladding method; C. and (4) performing material reduction processing on the ceramic coating after cladding until the inner lining of the metal-ceramic hip joint prosthesis meets the design requirement. The technical scheme of the invention solves the problems of metal ion precipitation, insufficient wear resistance and easy fragmentation of the ceramic lining of the existing metal hip joint lining.

Description

A metal-ceramic hip joint prosthesis lining and its manufacturing method

technical field

The invention relates to the technical field of medical devices, in particular to a metal-ceramic hip joint prosthesis lining and a manufacturing method thereof.

Background technique

Age-related musculoskeletal disorders are increasing worldwide and prosthetic implantation has become very important. The widespread use of implantable prostheses can help improve the quality of life and help the elderly live a healthy life. Bone substitute materials are very important for repairing damaged bone tissue, stabilizing the broken bone and its structure, providing support and correction, achieving bone healing or fusion, and maintaining the basic health of the human body. Among them, artificial joint replacement technology is one of the most important advances in the field of orthopedics in the 20th century. Among them, hip replacement surgery is the most common. Hip joint prosthesis enables people who used to rely on crutches to walk or even disabled people and patients with joint diseases to be able to work normally. walk.

At present, artificial joint replacement is widely used clinically and has become the best way to treat osteoarthritis. Lining materials are divided into ceramic or polyethylene materials. Polyethylene has been used in artificial hip replacement materials for more than 40 years. The polyethylene-lined prosthesis is characterized by its stable quality and price advantages, low friction coefficient and wear rate, good mechanical properties and biocompatibility, etc. factors are widely used. However, periprosthetic osteolysis and aseptic loosening caused by artificial joint wear debris are the main complications of total hip arthroplasty and the main reason for prosthesis revision. Since the 1970s, ceramic-to-ceramic load-bearing interfaces have been applied to total hip arthroplasty. In addition to higher hardness, better lubricating effect and better wear resistance, ceramic materials also have good biocompatibility and do not release toxic metal ions, especially suitable for young patients with a lot of activity. However, ceramic fragmentation is still a major factor affecting the longevity of ceramic joints. Ceramic fragmentation is a kind of brittle fragmentation, manifested as cracks spreading rapidly under slight energy, and has a clear relationship with local scratches and fine fragmentation, and most of them have no obvious history of trauma. Ceramic fragmentation includes fragmentation of the ceramic femoral head and fragmentation of the ceramic lining. The study found that the fracture rate of the alumina ceramic head was about 2.4% to 2.8%, and the ceramic lining became the main component of ceramic failure, which was mainly related to the impact between the ceramic lining and the femoral prosthesis stem.

And the metal hip joint lining is also widely used in hip joint replacement surgery. The friction interface between the acetabular outer cup of the existing surface hip joint prosthesis and the femoral head prosthesis is a metal "gold-to-gold" interface, although " Compared with other friction interfaces, the friction coefficient of gold-to-gold interface is relatively low, but the "gold-to-gold" interface will lead to the precipitation of metal ions, which will produce adverse biological reactions, including toxic effects on soft tissues near joints, delayed hypersensitivity Allergic reactions, osteolysis, and certain carcinogenicity eventually lead to prosthesis loosening and failure.

Contents of the invention

According to the above-mentioned technical problems of metal ion precipitation, insufficient wear resistance and fragile ceramic lining in the existing metal hip joint lining, a metal-ceramic hip joint prosthesis lining and its manufacturing method are provided. Laser cladding technology cladding ceramic coating on the metal substrate, through the metallurgical combination of metal and ceramic materials, can effectively prevent the precipitation of metal ions, avoid adverse biological reactions, increase wear resistance, and effectively prevent loosening and failure of the prosthesis. At the same time, it can avoid the impact fracture of the ceramic material, prolong the service life of the hip prosthesis, and save the patient from the pain of replacement and repair.

The technical means adopted in the present invention are as follows:

A metal-ceramic hip joint prosthesis inner lining comprises a metal base and a ceramic coating on the inner surface of the metal base, and the ceramic coating is metallurgically combined with the metal base by laser cladding technology.

Further, the metal substrate is titanium alloy, stainless steel or cobalt-chromium-molybdenum alloy.

Further, the ceramic coating is zirconia, alumina, alumina-zirconia eutectic ceramics or titanium carbide.

The present invention also provides a method for manufacturing a metal-ceramic hip joint prosthesis lining, which specifically includes the following steps:

A. Process the metal substrate, and polish the inner surface with sandpaper to remove the oxide layer, then wipe with alcohol and air dry;

B. Cladding a ceramic coating on the inner surface of the metal substrate by laser cladding;

C. Carry out material reduction processing on the cladding ceramic coating until the metal-ceramic hip joint prosthesis lining meets the design requirements and the thickness of the ceramic coating is at least 0.5 mm.

Further, the metal substrate processing method in step A may adopt milling, turning or additive manufacturing technology.

Further, the inner diameter of the metal base is 28.5-30 mm.

Further, the thickness of the ceramic coating after subtractive machining in step C is 0.5-2 mm.

Further, in step B, the process parameters adopted by the laser cladding method are: laser power of 800-1400W, scanning speed of 1-4mm/s, powder feeding amount of 0.5-2.88g/min.

Further, step A specifically includes: processing the metal substrate, and polishing the inner surface with sandpaper to remove the oxide layer, then wiping with absolute ethanol and air-drying, and then clamping and fixing the metal substrate on the positioning device;

Step B specifically includes the following steps:

B-1: Connect the additive deposition heat source, additive feeding device and additive shielding gas tank to the additive deposition head for laser cladding respectively, and load the powder for laser cladding into the additive feeding device;

B-2: Adjust the position of the metal substrate through the positioning device, so that the plane where the inner surface of the metal substrate is located is perpendicular to the laser direction emitted by the additive deposition head;

B-3: Adjust the position of the laser spot emitted by the additive deposition head on the inner surface of the metal substrate, and adjust the size of the laser spot so that the laser is focused on the inner surface of the metal substrate. In the initial state, the defocus amount Z of the laser is controlled within ± within 3mm;

B-4: The inert gas is delivered to the additive deposition head through the additive shielding gas tank, and the air pressure of the additive shielding gas tank is controlled at 0.5-0.7MPa;

B-4: Start the additive deposition heat source and additive feeding device, provide laser for the additive deposition head through the additive deposition heat source, provide laser cladding powder for the additive deposition head through the additive feeding device, and control the additive through the manipulator The movement trajectory of the deposition head, and at the same time control the positioning device to drive the metal substrate to rotate at a constant speed. Under the conditions of laser power of 800-1400W, scanning speed of 1-4mm/s, and powder feeding amount of 0.5-2.88g/min, the additive material can be controlled. The deposition head performs laser cladding on the inner surface of the metal substrate to obtain a ceramic coating.

Further, the material reduction method adopted in step C is grinding, turning or milling.

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

1. The metal-ceramic hip joint prosthesis lining provided by the present invention and its manufacturing method can improve the wear resistance of the hip joint prosthesis lining, and the ceramic coating is clad on the hip joint prosthesis lining by using laser cladding technology Finally, its surface is more wear-resistant than the "gold-on-gold" hip prosthesis, which can prevent metal ions from entering the human body and is beneficial to human health.

2. The metal-ceramic hip joint prosthesis lining provided by the present invention can effectively improve the impact resistance of the hip joint prosthesis, effectively prevent the hip joint lining from breaking, and prolong the service life of the product.

3. The metal-ceramic hip joint prosthesis lining provided by the present invention improves the bonding strength between the metal substrate and the ceramic coating through the metallurgical combination of metal and ceramics, and the thermal stress between the coating and the metal substrate is low, and the coating The quality is good, and there are no defects such as cracks.

Based on the above reasons, the present invention can be widely promoted in the field of hip joint lining.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description These are some embodiments of the present invention. For those skilled in the art, other drawings can also be obtained according to these drawings without any creative effort.

Fig. 1 is a flow chart of the manufacturing method of the metal-ceramic hip joint prosthesis lining of the present invention.

Fig. 2 is a schematic diagram of the working state of the acetabular cup of the present invention.

Fig. 3 is a schematic diagram of the position of the inner liner of the hip joint prosthesis of the present invention in the acetabular cup.

In the figure: 1. Additive protective gas tank; 2. Additive heat source; 3. Additive feeding device; 4. Additive deposition head; 5. Metal substrate; 6. Positioning device; 7. Workbench; 8. Acetabular Cup; 8-1, hole structure cup; 8-2, derived interlayer; 8-3, lining; 9, femoral head; 10, bone stem.

Detailed ways

It should be noted that, in the case of no conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and examples.

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments It is only some embodiments of the present invention, but not all embodiments. The following description of at least one exemplary embodiment is merely illustrative in nature and in no way taken as limiting the invention, its application or uses. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

It should be noted that the terminology used here is only for describing specific embodiments, and is not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural, and it should also be understood that when the terms "comprising" and/or "comprising" are used in this specification, they mean There are features, steps, operations, means, components and/or combinations thereof.

The relative arrangements of components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise. At the same time, it should be clear that, for the convenience of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the authorized description. In all examples shown and discussed herein, any specific values should be construed as exemplary only, and not as limitations. Therefore, other examples of the exemplary embodiment may have different values. It should be noted that like numerals and letters denote like items in the following figures, therefore, once an item is defined in one figure, it does not require further discussion in subsequent figures.

In the description of the present invention, it should be understood that orientation words such as "front, back, up, down, left, right", "horizontal, vertical, vertical, horizontal" and "top, bottom" etc. indicate the orientation Or positional relationship is generally based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description. In the absence of a contrary description, these orientation words do not indicate or imply the device or element referred to. It must have a specific orientation or be constructed and operated in a specific orientation, so it should not be construed as limiting the scope of the present invention: the orientation words "inside and outside" refer to inside and outside relative to the outline of each part itself.

For the convenience of description, spatially relative terms may be used here, such as "on ...", "over ...", "on the surface of ...", "above", etc., to describe the The spatial positional relationship between one device or feature shown and other devices or features. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, devices described as "above" or "above" other devices or configurations would then be oriented "beneath" or "above" the other devices or configurations. its underlying device or construction". Thus, the exemplary term "above" can encompass both an orientation of "above" and "beneath". The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.

In addition, it should be noted that the use of words such as "first" and "second" to define components is only for the convenience of distinguishing corresponding components. To limit the protection scope of the present invention.

Example 1

As shown in Figures 2-3, the present invention provides a metal-ceramic hip joint prosthesis lining, including a metal base and a ceramic coating on the inner surface of the metal base, and the ceramic coating adopts laser cladding technology Metallurgically bonded to the metal matrix.

Further, the metal substrate is titanium alloy, stainless steel or cobalt-chromium-molybdenum alloy.

Further, the ceramic coating is zirconia, alumina, alumina-zirconia eutectic ceramics or titanium carbide.

Further, the thickness of the ceramic coating is at least 0.5 mm.

Preferably, the thickness of the ceramic coating is 0.5-2 mm.

When in use, the inner liner 8-3 of the present invention, as the innermost layer of the acetabular cup 8, is in direct contact with the femoral head 9 at one end of the stem 10, and the acetabular cup 8 includes a hole structure cup 8-1 from outside to inside. , the derived interlayer 8-2 and the inner liner 8-3 of the present invention, wherein the hole structure cup 8-1 and the derived interlayer 8-2 constitute the acetabulum, which is used to be embedded in the human bone during use, and the described in the present invention The inner lining 8-3 is used to connect the femoral head 9 and the acetabulum, and plays the role of reducing friction and positioning. The inner lining 8-3 of the present invention can improve the metal matrix and ceramics through the metallurgical combination of metal and ceramics. The bonding strength of the coating, and the thermal stress between the coating and the metal substrate is low, the quality of the coating is good, and there are no defects such as cracks, which can effectively improve the impact resistance of the hip joint prosthesis and effectively prevent hip joint internal damage. The cracking of the lining prolongs the service life of the product; the ceramic material used can avoid the precipitation of metal ions, which can not only improve the wear resistance of the lining of the hip joint prosthesis, but also prevent metal ions from entering the human body, which is beneficial to human health.

As shown in Figure 1, the present invention also provides a method for manufacturing a metal-ceramic hip joint prosthesis lining, which specifically includes the following steps:

A. Process the metal substrate 5, and polish the inner surface with sandpaper to remove the oxide layer, then wipe with alcohol and air dry;

B. Cladding a ceramic coating on the inner surface of the metal substrate 5 by using a laser cladding method;

C. Carry out material reduction processing on the cladding ceramic coating until the metal-ceramic hip joint prosthesis lining meets the design requirements and the thickness of the ceramic coating is at least 0.5mm.

Further, the processing method of the metal base 5 in step A may adopt milling, turning or additive manufacturing technology.

Furthermore, the inner diameter of the metal base 5 is 28.5-30 mm, which is 0.5-2 mm larger than the final inner diameter of the metal lining processed in the prior art, and the outer diameter is the same as 36 mm.

Further, the thickness of the ceramic coating after subtractive machining in step C is 0.5-2 mm.

Further, in step B, the process parameters adopted by the laser cladding method are: laser power is 800-1400W, scanning speed is 1-4mm/s, powder feeding amount is 0.5-2.88g/min; The metal-ceramic hip joint prosthesis lining structure prepared under the above method will not crack.

Further, step A specifically includes: processing the metal base 5, and polishing the inner surface with sandpaper to remove the oxide layer, then wiping with absolute ethanol and air-drying to remove surface impurities, oil, etc., and then clamping and fixing the metal base on the positioning device 6 ;

Step B specifically includes the following steps:

B-1: Connect the additive deposition heat source 2, the additive feeding device 3 and the additive shielding gas tank 1 to the additive deposition head 4 for laser cladding respectively, and load the powder for laser cladding into the additive feeding device 3 ;

B-2: adjust the position of the metal base 5 through the positioning device 6, so that the plane where the inner surface of the metal base 5 is located is perpendicular to the laser direction emitted by the additive deposition head 4;

B-3: Adjust the position of the laser spot emitted by the additive deposition head 4 on the inner surface of the metal substrate 5, and adjust the size of the laser spot so that the laser is focused on the inner surface of the metal substrate. The defocus amount Z of the laser in the initial state is controlled Within the range of ±3mm;

B-4: The inert gas is delivered to the additive deposition head 4 through the additive shielding gas tank 1, so that the laser cladding process is carried out under the protection of the inert gas, and the air pressure of the additive shielding gas tank 1 is controlled at 0.5-0.7MPa;

B-4: Start the additive deposition heat source 2 and the additive feeding device 3, provide laser for the additive deposition head 4 through the additive deposition heat source 2, and provide laser cladding powder for the additive deposition head 4 through the additive feeding device 3 , control the movement trajectory of the additive deposition head 4 through the manipulator, and at the same time control the positioning device 6 to drive the metal substrate 5 to rotate at a constant speed, when the laser power is 800-1400W, the scanning speed is 1-4mm/s, and the powder feeding amount is 0.5-2.88g /min, control the additive deposition head 4 to perform laser cladding on the inner surface of the metal substrate 5 to obtain a ceramic coating.

Further, the material reduction method adopted in step C is grinding, turning or milling.

Further, in this embodiment, the laser is used as the additive heat source 2, the TiC powder is used as the powder for laser cladding (ie ceramic coating), the positioning device 6 is a precision electric turntable, and the additive feeding device 3 is a coaxial powder feeding device .

Preferably, the additive heat source 2 adopts FCL 2000 fiber laser, the additive deposition head 4 adopts an AK190 SERIES-6KW laser processing head, and the additive feeding device 3 adopts an RC-PGF intelligent powder feeder to control the trajectory of the additive deposition head 4 The manipulator adopts the manipulator of GP 180 or MH 12 model.

Further, step B-1 also includes sifting the powder for laser cladding, placing it in a drying oven at 100-120° C. for more than 4 hours, and loading it into the additive feeding device 3 after cooling.

Preferably, the speed of the additive feeding device 3 is 0.2r/min, and the outlet flow is set to 6L/min; the laser power provided by the additive heat source 2 is 1200W; the outlet flow of the additive shielding gas tank 1 is set to 8L/min, inert The gas is high-purity argon.

Further, the trajectory of the manipulator is controlled by the preset program input in the YRC 1000 control cabinet, the scanning speed of the additive deposition head 4 is controlled to be 1mm/s during laser cladding, and the interlayer lift is set to 1mm.

The wear resistance test was carried out on the hip joint prosthesis liner made of only TC4 titanium alloy and the hip joint prosthesis liner with TC4 titanium alloy metal matrix and TiC ceramic coating prepared by the method provided by the present invention. The test results are as follows As shown in the table:

It can be seen that the wear quality of the hip joint prosthesis liner provided by the present invention is 10.6% of that of the hip joint prosthesis liner made of only TC4 titanium alloy, and the metallurgical combination of metal and ceramic materials can effectively prevent metal ion Precipitation avoids adverse biological reactions, and at the same time significantly increases wear resistance, effectively preventing prosthesis loosening and failure, and can avoid impact and crushing of ceramic materials, prolonging the service life of the hip joint prosthesis.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still be Modifications are made to the technical solutions described in the foregoing embodiments, or equivalent replacements are made to some or all of the technical features; these modifications or replacements do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. A metal-ceramic hip joint prosthesis inner lining, is characterized in that, comprises metal substrate and the ceramic coating that is positioned at described metal substrate inner surface, and described ceramic coating adopts laser cladding technology and described metal substrate metallurgy combined. 2 . The metal-ceramic hip joint prosthesis lining according to claim 1 , wherein the metal matrix is titanium alloy, stainless steel or cobalt-chromium-molybdenum alloy. 3. The metal-ceramic hip joint prosthesis lining according to claim 1, wherein the ceramic coating is zirconia, alumina, alumina-zirconia eutectic ceramics or titanium carbide. 4. A method for manufacturing a metal-ceramic hip joint prosthesis inner lining, characterized in that it specifically comprises the following steps: A. Process the metal substrate, and polish the inner surface with sandpaper to remove the oxide layer, then wipe with alcohol and air dry; B. Cladding a ceramic coating on the inner surface of the metal substrate by laser cladding; C. Carry out material reduction processing on the cladding ceramic coating until the metal-ceramic hip joint prosthesis lining meets the design requirements and the thickness of the ceramic coating is at least 0.5 mm. 5. The manufacturing method of the metal-ceramic hip joint prosthesis lining according to claim 4, characterized in that the metal substrate processing method in step A can adopt milling, turning or additive manufacturing technology. 6. The manufacturing method of the metal-ceramic hip joint prosthesis lining according to claim 4, characterized in that the inner diameter of the metal base is 28.5-30 mm. 7 . The method for manufacturing the metal-ceramic hip joint prosthesis lining according to claim 4 , wherein the thickness of the ceramic coating is 0.5-2 mm after subtractive processing in step C. 8 . 8. The manufacturing method of the metal-ceramic hip joint prosthesis lining according to claim 4, characterized in that, in step B, the process parameters used in the laser cladding method are: the laser power is 800-1400W, and the scanning The speed is 1-4mm/s, and the powder feeding volume is 0.5-2.88g/min. 9. according to the manufacture method of metal-ceramic hip joint prosthesis lining as claimed in claim 4, it is characterized in that, Step A specifically includes: processing the metal substrate, and polishing the inner surface with sandpaper to remove the oxide layer, then wiping with absolute ethanol and air-drying, and then clamping and fixing the metal substrate on the positioning device; Step B specifically includes the following steps: B-1: Connect the additive deposition heat source, additive feeding device and additive shielding gas tank to the additive deposition head for laser cladding respectively, and load the powder for laser cladding into the additive feeding device; B-2: Adjust the position of the metal substrate through the positioning device, so that the cut surface of the inner surface of the metal substrate is perpendicular to the laser direction emitted by the additive deposition head; B-3: Adjust the position of the laser spot emitted by the additive deposition head on the inner surface of the metal substrate, and adjust the size of the laser spot so that the laser is focused on the inner surface of the metal substrate. In the initial state, the defocus amount Z of the laser is controlled within ± within 3mm; B-4: The inert gas is delivered to the additive deposition head through the additive shielding gas tank, and the air pressure of the additive shielding gas tank is controlled at 0.5-0.7MPa; B-4: Start the additive deposition heat source and additive feeding device, provide laser for the additive deposition head through the additive deposition heat source, provide laser cladding powder for the additive deposition head through the additive feeding device, and control the additive through the manipulator The movement trajectory of the deposition head, and at the same time control the positioning device to drive the metal substrate to rotate at a constant speed. Under the conditions of laser power of 800-1400W, scanning speed of 1-4mm/s, and powder feeding amount of 0.5-2.88g/min, the additive material can be controlled. The deposition head performs laser cladding on the inner surface of the metal substrate to obtain a ceramic coating. 10. The manufacturing method of the metal-ceramic hip joint prosthesis lining according to claim 4, characterized in that the material reduction method used in step C is grinding, turning or milling.

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