CN110721337A

CN110721337A - Application of zinc-based alloy material, joint open prosthesis and preparation method thereof

Info

Publication number: CN110721337A
Application number: CN201910968900.8A
Authority: CN
Inventors: 戴尅戎; 韩煜; 贾博; 郑玉峰; 张泽川
Original assignee: Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Current assignee: Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Priority date: 2019-10-12
Filing date: 2019-10-12
Publication date: 2020-01-24

Abstract

The invention provides application of a zinc-based alloy material, a joint open prosthesis and a preparation method thereof. The zinc-based alloy is used for preparing joint open prosthesis, and comprises zinc and a second metal, wherein the second metal is selected from at least one of copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 10%. The zinc-based alloy material is used for preparing the joint open prosthesis, antibacterial metal ions are released through continuous degradation of the zinc-based alloy, surrounding infection is controlled, bone is promoted to inhibit osteoclasts, bone loss after joint infection is reduced, and therefore a good foundation is laid for second-stage joint revision. Meanwhile, the zinc-based alloy prosthesis has a simple structure and effectively provides mechanical support to help the joint of a patient move in the course of the spacious placement; the degradation cycle is long, and there is not the condition of prosthesis damage during spacious placement, better satisfying the joint and replacing the demand of putting the art spaciously in the joint renovation after infecting in clinical.

Description

Application of zinc-based alloy material, joint open prosthesis and preparation method thereof

Technical Field

The invention belongs to the field of medical instruments, and relates to application of a zinc-based alloy material, a joint open prosthesis and a preparation method thereof.

Background

In joint replacement surgery, infection after joint replacement is a very important and troublesome problem. At present, joint infection after joint replacement is mainly treated by adopting open placement, namely, the joint is thoroughly cleaned, infected and necrotic tissues are cleared, a joint prosthesis is removed, then, a first-stage bone cement prosthesis is mostly used for open placement, and a second-stage joint revision surgery is carried out. However, in the method, the antibiotic release capacity of the bone cement mixed antibiotic prosthesis is poor, meanwhile, the bone cement prosthesis is not easy to detach, the stress strength is low, the load bearing effect is poor, the knee joint movement of a patient is severely limited in the open period, the functional exercise is difficult to carry out, and the effect is poor.

Therefore, the design of an antibacterial alloy metal prosthesis is a good choice for patients infected after joint replacement.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, it is an object of the present invention to provide a use of a zinc-based alloy material and an articular open prosthesis and a method for the preparation thereof. The zinc-based alloy is used for preparing joint open prosthesis, and comprises zinc and a second metal, wherein the second metal is selected from at least one of copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 10%. The zinc-based alloy material is used for preparing a joint open prosthesis, antibacterial metal ions are released through continuous degradation of the zinc-based alloy, surrounding infection is controlled, bone is promoted to inhibit osteoclasts, bone loss after joint infection is reduced, and therefore a good foundation is laid for second-stage joint revision. Meanwhile, the zinc-based alloy prosthesis has a simple structure and effectively provides mechanical support to help the joint of a patient move in the course of the spacious placement; the degradation cycle is long, the condition of prosthesis damage can not exist during the open placement, and the requirement of joint revision open placement after joint replacement infection in clinic is better satisfied.

In order to achieve the above objects and other related objects, a first aspect of the present invention provides a use of a zinc-based alloy material for preparing a joint open prosthesis, the zinc-based alloy comprising zinc and a second metal, the second metal being at least one selected from copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, wherein the zinc accounts for more than or equal to 90% and less than 100% of the mass fraction of the zinc-based alloy, and the second metal accounts for more than 0% and less than or equal to 10% of the mass fraction of the zinc-based alloy.

Preferably, the mass fraction of zinc in the zinc-based alloy is more than or equal to 95% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 5%.

Zinc-based alloys, including but not limited to copper Cu, silver Ag, etc., have antimicrobial properties. Adding single alloy elements such as copper Cu, silver Ag and the like to prepare a binary zinc-based alloy system such as zinc-magnesium alloy, zinc-copper alloy, zinc-silver alloy and the like; and adding two alloy elements to prepare a ternary alloy system, such as zinc silver copper, zinc lithium copper, zinc magnesium copper and the like. In the same way, a multi-element alloy system can be prepared by adding a plurality of different alloy elements.

Zinc promotes the proliferation, differentiation and mineralization of osteoblasts, thereby promoting the bone formation process, and in addition, zinc inhibits the differentiation of osteoclasts, thereby bidirectionally promoting the bone formation process. Zinc element belongs to essential trace elements of human body, 90% of zinc element in human body is stored in muscle and skeleton, is one of the most important elements in the processes of protein synthesis and energy metabolism, and participates in a large amount of physiological reaction processes of human body cell development and growth, gene expression, immune system, nervous system and the like. Meanwhile, the zinc and the zinc alloy have more proper degradation rate, and not only release related metal ions in vivo, but also avoid the influence on the smoothness of the articular surface and the strength of the prosthesis due to too high degradation speed.

Besides the bone-promoting effect of zinc element, the addition of metal ions such as magnesium Mg, copper Cu, silver Ag and the like can endow the alloy with certain antibacterial performance, such as zinc-magnesium, zinc-copper and zinc-silver binary system alloy.

The zinc-based alloy is used for the special joint prosthesis of the first-stage open surgery infected after the joint replacement, inhibits the growth of surrounding bacteria through the antibacterial osteogenesis characteristic of an alloy material, simultaneously regulates the differentiation process of osteogenesis and osteoclasts, avoids further bone injury caused by infection, simultaneously provides joint filling and mechanical support for a patient, helps the patient to move and exercise functions by oneself in the open surgery, and thus lays a good foundation for the second-stage joint revision surgery.

The second aspect of the invention provides a joint open prosthesis, the joint open prosthesis is made of zinc-based alloy, the zinc-based alloy comprises zinc and a second metal, the second metal is at least one selected from copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, wherein the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, such as 90-97.2%, 97.2-99% or more than or equal to 99% and less than 100%, the mass fraction of the second metal in the zinc-based alloy is more than 0 and less than or equal to 10%, such as more than 0 and less than or equal to 1%, 1-2.8% or more than or equal to 2.8% and less than or equal to 10%.

Preferably, the joint open prosthesis comprises a femoral intramedullary unit, a femoral prosthesis unit, a tibial prosthesis unit and a tibial intramedullary unit, wherein the femoral intramedullary unit is matched with a femoral medullary cavity, the femoral intramedullary unit is connected with the femoral prosthesis unit, the femoral prosthesis unit is movably contacted with the tibial prosthesis unit, the tibial prosthesis unit is connected with the tibial intramedullary unit, and the tibial intramedullary unit is matched with the tibial medullary cavity.

More preferably, the joint spacious prosthesis is selected from any one of the following:

1) the joint spaciousness prosthesis one: the femoral prosthesis unit comprises an anterior femoral prosthesis part, a left femoral prosthesis part, a right femoral prosthesis part and a posterior femoral prosthesis part, the anterior femoral prosthesis part and the posterior femoral prosthesis part are arranged on two sides of the left femoral prosthesis part and the right femoral prosthesis part, the femoral intramedullary unit is arranged on the femoral side of the left femoral prosthesis part and the right femoral prosthesis part, the tibial prosthesis unit is provided with a first cavity, and the anterior femoral prosthesis part, the left femoral prosthesis part, the right femoral prosthesis part and the posterior femoral prosthesis part are integrally formed to form an outer surface matched with the first cavity of the tibial prosthesis unit and are in movable contact with the tibial prosthesis unit;

2) and (2) placing a prosthesis II in the joint: the femoral prosthesis unit comprises a femoral prosthesis part, the tibial prosthesis unit is provided with a second cavity, and the femoral prosthesis unit is in movable contact with the tibial prosthesis unit through matching of the outer surface of the femoral prosthesis part and the surface of the tibial prosthesis unit forming the second cavity.

Further more preferably, at least one of the following technical features is also included:

1) in the joint spacious prosthesis I, a patella notch matched with the patella is arranged on the front femoral prosthesis part;

2) in the joint spacious prosthesis I, the inner surface of the anterior femoral prosthesis body is matched with the contacted outer surface of the femur;

3) in the joint spacious prosthesis I, the maximum thickness of the anterior femoral prosthesis part is 5-25 cm;

4) in the joint spacious prosthesis I, the inner surface of the posterior femoral prosthesis body is matched with the outer surface of the contacted femur;

5) in the joint spacious prosthesis I, the maximum thickness of the posterior femoral prosthesis part is 5-25 cm;

6) in the joint spacious prosthesis I, the outer surface of the front femoral prosthesis part, the outer surfaces of the left and right femoral prosthesis parts and the outer surface of the rear femoral prosthesis part are smoothly transited on the same spherical or ellipsoidal curved surface in sequence;

7) in the joint spacious prosthesis I, the maximum thickness of the prosthesis part of the left and right thighbones is 10-50 cm;

8) in the joint spacious prosthesis II, the femoral prosthesis body is spherical or ellipsoidal;

9) in the joint spacious prosthesis II, the maximum thickness of the left side and the right side of the femoral prosthesis part is 10-50 cm;

10) in the joint spacious prosthesis II, the maximum thickness of the front side and the back side of the femoral prosthesis part is 10-50 cm.

Preferably, at least one of the following technical features is also included:

1) the femoral intramedullary unit is coaxial with the femur, and the tibia intramedullary unit is coaxial with the tibia;

2) the tibial prosthetic unit comprises a first tibial prosthetic component and a second tibial prosthetic component of the proximal femoral prosthetic unit, the second tibial prosthetic component being connected to the tibial intramedullary unit, the second tibial prosthetic component being tapered;

3) the joint spacious prosthesis also comprises a femoral transverse nail for fixing the femoral intramedullary unit and the femur.

The third aspect of the invention provides a preparation method of the joint open prosthesis, which is characterized in that a zinc-based alloy is used, and the joint open prosthesis is prepared by a casting process, a cutting process or a 3D printing process, wherein the zinc-based alloy comprises zinc and a second metal, the second metal is selected from at least one of copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0 and less than or equal to 10%.

Different processes are adopted for preparation according to different requirements, for example, detailed operation planning before an operation is adopted, and after joint conditions are determined according to line CT and other examinations of a bone part, joint prostheses with corresponding proper sizes can be prepared according to metal 3D printing of a reconstructed image line. The joint injury size and the bone defect condition after debridement can also be directly measured in the operation, and various standard types of prostheses are selected and prepared according to the condition in the operation.

According to the invention, the zinc-based alloy material is used for preparing the joint open prosthesis, antibacterial metal ions are released through continuous degradation of the zinc-based alloy, surrounding infection is controlled, bone formation and osteoclastogenesis are promoted, bone loss after joint infection is reduced, and thus a good foundation is laid for second-stage joint revision. Meanwhile, the zinc-based alloy prosthesis has a simple structure and effectively provides mechanical support to help the joint of a patient move in the course of the spacious placement; the degradation cycle is long, and there is not the condition of prosthesis damage during spacious placement, better satisfying the joint and replacing the demand of putting the art spaciously in the joint renovation after infecting in clinical. In addition, the joint spacious placement prosthesis comprises a femoral intramedullary unit, a femoral prosthesis unit, a tibial prosthesis unit and a tibial intramedullary unit, wherein the femoral intramedullary unit is matched with a femoral medullary cavity, the femoral intramedullary unit is connected with the femoral prosthesis unit, the femoral prosthesis unit is movably connected with the tibial prosthesis unit, the tibial prosthesis unit is connected with the tibial intramedullary unit, and the tibial intramedullary unit is matched with the tibial medullary cavity, so that the movement of a knee joint during spacious placement is realized, functional exercise is performed, joint filling and mechanical support are provided, a patient can be helped to move and exercise automatically in the spacious placement period, and a good foundation is laid for the joint revision surgery in the second period.

Drawings

Fig. 1 is a schematic structural diagram of a first joint spacious prosthesis of the invention.

Fig. 2 is a schematic structural view of the joint open prosthesis I of the present invention.

Fig. 3 is a schematic structural view III of the joint open prosthesis I of the invention.

Fig. 4 is a schematic structural view of a joint open prosthesis two according to the present invention.

FIG. 5 is a schematic structural view of a second joint spacious prosthesis of the invention.

Fig. 6 is a schematic structural view III of a joint open prosthesis II of the present invention.

Reference numerals:

1 femoral intramedullary unit

2 femoral prosthesis unit

21 anterior femoral prosthesis

211 patellar notch

22 left and right femoral prosthesis

23 posterior femoral prosthesis

24 femoral prosthesis spherical component

3 tibial prosthetic unit

31 first chamber

32 second cavity

33 first tibial prosthetic component

34 second tibial prosthetic component

4-shin intramedullary unit

5 femur horizontal penetrating nail

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will become apparent to those skilled in the art from the present disclosure.

It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.

A joint spacious prosthesis comprises a femoral intramedullary unit 1, a femoral prosthesis unit 2, a tibial prosthesis unit 3 and a tibial intramedullary unit 4, wherein the femoral intramedullary unit 1 is matched with a femoral medullary cavity, the femoral intramedullary unit 1 is connected with the femoral prosthesis unit 2, the femoral prosthesis unit 2 is in movable contact with the tibial prosthesis unit 3, the tibial prosthesis unit 3 is connected with the tibial intramedullary unit 4, and the tibial intramedullary unit 4 is matched with the tibial medullary cavity, as shown in figures 1 and 4.

The invention provides a joint spacious prosthesis I, as shown in figure 1, figure 2 and figure 3, the joint spacious prosthesis I comprises a femoral intramedullary unit 1, a femoral prosthesis unit 2, a tibial prosthesis unit 3 and a tibial intramedullary unit 4, the femoral intramedullary unit 1 is matched with a femoral medullary cavity, the femoral prosthesis unit 2 comprises an anterior femoral prosthesis part 21, a left and right femoral prosthesis part 22 and a posterior femoral prosthesis part 23, the anterior femoral prosthesis part 21 and the posterior femoral prosthesis part 23 are arranged at two sides of the left and right femoral prosthesis part 22, the femoral intramedullary unit 1 is arranged at the femoral side of the left and right femoral prosthesis part 22, the tibial prosthesis unit 3 is provided with a first cavity 31, the anterior femoral prosthesis part 21, the left and right femoral prosthesis part 22 and the posterior femoral prosthesis part 23 are integrally formed to form an outer surface matched with the first cavity 31 of the tibial prosthesis unit, and is movably contacted with the tibial prosthesis unit 3, the tibial prosthesis unit 3 is connected with the tibial intramedullary unit 4, and the tibial intramedullary unit 4 is matched with a tibial medullary cavity.

In a preferred embodiment of the first joint spacious prosthesis, the anterior femoral prosthesis member 21 is provided with a patellar notch 211 which matches the patella.

In a preferred embodiment of the first of the above-described articulating prostheses, the inner surface of the anterior femoral prosthesis portion 21 mates with the outer surface of the femur in contact therewith.

In a preferred embodiment of the first joint spacious prosthesis, the maximum thickness of the anterior femoral prosthesis body 21 is 5-25 cm.

In a preferred embodiment of the first of the above-described articulating prostheses, the inner surface of the posterior femoral prosthesis portion 23 mates with the outer surface of the femur in contact therewith.

In a preferred embodiment of the first joint spacious prosthesis, the maximum thickness of the posterior femoral prosthesis part 23 is 5-25 cm.

In a preferred embodiment of the first joint spacious prosthesis, the outer surface of the anterior femoral prosthesis part 21, the outer surfaces of the left and right femoral prosthesis parts 22 and the outer surface of the posterior femoral prosthesis part 23 are smoothly transited on the same spherical or ellipsoidal curved surface in sequence.

In a preferred embodiment of the first joint spacious prosthesis, the maximum thickness of the left and right femoral prosthesis portions 22 is 10-50 cm.

In a preferred embodiment of the first joint prosthesis, the tibial prosthesis unit 3 comprises a first tibial prosthesis member 33 and a second tibial prosthesis member 34 close to the femoral prosthesis unit, the second tibial prosthesis member 34 is connected with the tibial intramedullary unit 4, and the second tibial prosthesis member 34 is conical, so that the installation is convenient, the fitting with the surrounding tissues is tight, and no dead space is left.

In a preferred embodiment of the first articulation prosthesis, the articulation prosthesis further comprises a femoral transverse nail 5 for fixing the femoral intramedullary unit 1 to the femur.

The invention provides a joint spacious prosthesis II, as shown in fig. 4, fig. 5 and fig. 6, the joint spacious prosthesis comprises a femoral intramedullary unit 1, a femoral prosthesis unit 2, a tibial prosthesis unit 3 and a tibial intramedullary unit 4, the femoral intramedullary unit 1 is matched with a femoral medullary cavity, the femoral intramedullary unit 1 is connected with the femoral prosthesis unit 2, the femoral prosthesis unit 2 comprises a femoral prosthesis part 24, the tibial prosthesis unit 3 is provided with a second cavity 32, the femoral prosthesis unit 2 is in movable contact with the tibial prosthesis unit 3 through matching of the outer surface of the femoral prosthesis part 24 and the surface of the tibial prosthesis unit forming the second cavity 32, the tibial prosthesis unit 3 is connected with the tibial intramedullary unit 4, and the tibial intramedullary unit 4 is matched with the tibial medullary cavity.

In a preferred embodiment of the second joint spacious prosthesis, the femoral prosthesis part 24 is spherical or ellipsoidal, has simple shape, does not leave a dead space, is convenient for joint movement, is beneficial to disassembly, and is more suitable for temporary prostheses after joint infection.

In a preferred embodiment of the second joint spacious prosthesis, the maximum thickness of the left and right sides of the femoral prosthesis part 24 is 10-50 cm.

In a preferred embodiment of the second joint spacious prosthesis, the maximum thickness of the femoral prosthesis part 24 is 10-50 cm.

In a preferred embodiment of the joint open prosthesis II, the femoral intramedullary unit 1 is coaxial with the femur and the tibial intramedullary unit 4 is coaxial with the tibia.

In a preferred embodiment of the second joint prosthesis, the tibial prosthesis unit 3 comprises a first tibial prosthesis member 33 and a second tibial prosthesis member 34 close to the femoral prosthesis unit, the second tibial prosthesis member 34 is connected with the tibial intramedullary unit 4, and the second tibial prosthesis member 34 is conical, so that the installation is convenient, the fitting with the surrounding tissues is tight, and no dead space is left.

In a preferred embodiment of the second joint spacious prosthesis, the joint spacious prosthesis further comprises a femoral transverse nail 5 for fixing the femoral intramedullary unit 1 to the femur.

In a preferred embodiment of the first joint open prosthesis and the second joint open prosthesis, the material of the joint open prosthesis is preferably zinc-based alloy, the zinc-based alloy comprises zinc and a second metal, the second metal is at least one selected from copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, wherein the mass fraction of zinc in the zinc-based alloy is greater than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is greater than 0 and less than or equal to 10%.

In a preferred embodiment of the joint open prosthesis I and II, the mass fraction of zinc in the zinc-based alloy is more than or equal to 95% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 5%.

When in use, the joint spacious prosthesis is arranged in the joint spacious prosthesis after the infection prosthesis is removed and the wound is thoroughly debrided according to the condition of a patient, and the joint spacious prosthesis is taken out to replace the conventional joint prosthesis after the infection inhibition condition is stable.

The joint spacious prosthesis of the invention is shown in figure 1, mainly comprises a femoral intramedullary unit 1, a femoral prosthesis unit 2, a tibial prosthesis unit 3, a tibial intramedullary unit 4 and a femoral transverse nail 5, wherein the femoral intramedullary unit 1 is firstly installed during installation, then the femoral transverse nail 5 is used for fixing the femoral intramedullary unit 1 to the femoral shaft by adopting a positioner, the femoral prosthesis unit 2 is installed below, and the tibia adopts the matched tibial prosthesis unit 3 and tibial intramedullary unit 4.

The joint spacious prosthesis of the invention adopts a spherical prosthesis or an ellipsoidal prosthesis, namely a femur prosthesis body 24 as shown in figure 2, and mainly comprises a femur intramedullary unit 1, a femur prosthesis unit 2, a tibia prosthesis unit 3 and a tibia intramedullary unit 4, wherein the femur intramedullary unit 1 is fixed in the femur marrow during installation, the femur prosthesis unit 2 is installed, and the tibia prosthesis unit 3 and the tibia intramedullary unit 4 are matched and suitable below.

Wherein, the diameter of the femoral intramedullary unit can be 1 cm-4 cm, the length is 3 cm-30 cm, and the size of the femoral medullary cavity is matched to fit the medullary cavity of a patient as a standard; the diameter of the femoral transverse nail can be 0.5 cm-1 cm, the length is 1 cm-4 cm, and the femoral transverse nail is matched with the intramedullary rod for fixation; the maximum thickness of the anterior femoral prosthesis part and the maximum thickness of the posterior femoral prosthesis part can be respectively 5 cm-25 cm, the maximum thickness of the left femoral prosthesis part and the right femoral prosthesis part can be 5 cm-25 cm, the maximum thickness of the left femoral prosthesis part and the right femoral prosthesis part of the tibial prosthesis unit is 10 cm-50 cm according to the size of the femur of a patient, and the maximum thickness of the front side and the rear side is 10 cm-50 cm.

Example 1

The zinc-based alloy selected by the invention is tested for electrochemical performance and corrosion performance according to the following standard procedures

1.1 electrochemical testing

The tests were carried out in Hank's solution at room temperature using an electrochemical workstation (Autolab, Metrohm, Switzerland). A three-electrode system employing a platinum electrode-Saturated Calomel Electrode (SCE) was used for electrochemical testing. Open-circuit potential (OCP) monitoring was performed for 5400 seconds for each sample. Electrochemical Impedance Spectroscopy (EIS) was measured at 10mV and a measurement frequency of 10⁵Hz to 10^-2Under the conditions of (1). The Potentiodynamic polarization test (Potentiodynamic polarization test) was subsequently carried out at a rate of 1mV/s, the test area being 0.2826cm²

At least five measurements were made per sample set. By means of Linear fit and TafelThe extrapolarization method analyzes the corrosion parameters of the negative and positive portions of the polarization curve, including Open Circuit Potential (OCP), corrosion potential (Ecorr) and corrosion current density (icorr).

1.2 immersion test

The soaking experiments were carried out in Hank's solution at 37 ℃. The pH of the solution was recorded by a pH meter (MettlerFiveEasy pH FE20K) at different time points during soaking. After removal of the corrosion products, the weight loss of the samples was measured on an electronic balance (XS105, mettletelerdo), with a measurement sensitivity of 0.1mg, with five measurements being carried out on average per group. The in vitro corrosion rate was calculated according to the following formula: c ═ Δ m/ρ At, where C is the corrosion rate in mm/year, Δ m is the weight loss, ρ is the density of the material, a is the surface area of the initial soak, and t is the time of implantation.

Some of the test results are shown in table 1.

TABLE 1 electrochemical parameters of zinc alloy (37. + -. 0.2 ℃ C.)

Example 2

For one example of infection after knee joint replacement, after a conventional antibiotic-resistant treatment is applied before an operation, a Zn-1Ag alloy (Ag 1 wt%, UTS 300MPa, YS 250MPa and elongation more than 50%) is used for preparing the first joint open prosthesis according to joint and prosthesis conditions by metal 3D printing. And (3) performing a conventional operation, completely cleaning the wound after reaching the joint layer, removing peripheral necrotic tissues, removing the infected joint prosthesis, replacing the infected joint prosthesis with a degradable antibacterial metal prosthesis, and fixing antibiotic bone cement. The prosthesis can effectively provide mechanical support while providing joint filling to prevent contracture of surrounding tissues, and meanwhile, metal ions released to the periphery by the prosthesis inhibit the growth of surrounding bacteria, thereby being beneficial to infection control; it also promotes osteogenesis, inhibits osteoclastic activity, and reduces bone loss.

Example 3

Aiming at the infection with bone destruction after knee joint replacement, after the conventional antibiotic treatment is performed before the operation, Zn-0.8Li-2.0Ag alloy (Li 0.8 wt%, Ag 2 wt%, UTS 440MPa, YS 350MPa, and elongation rate > 80%) is adopted to process and prepare the joint open-position prosthesis II according to the conditions of the joint and the prosthesis, the femoral prosthesis adopts a prosthesis with a handle, and the prosthesis with a proper model can be selected according to the conditions in the operation after various models are prepared in advance. The conventional operation is performed, the wound is thoroughly cleaned after the artificial bone reaches the joint layer surface, the surrounding necrotic tissue is cleared, the infected joint prosthesis is removed, the degradable antibacterial metal prosthesis is replaced, the femoral bone marrow is opened, the femoral prosthesis is inserted, the prosthesis handle transverse nail is driven in according to the positioner, the femoral prosthesis is fixed on the femoral segment, the stress of the distal joint surface of the femur is reduced, the mechanical support is provided, the further bone destruction is prevented, the metal ions released to the periphery of the prosthesis inhibit the growth of surrounding bacteria, and the infection control is facilitated; it also has effects in promoting osteogenesis, inhibiting osteoclast activity, balancing bone, and repairing damaged bone.

In conclusion, the present invention effectively overcomes various disadvantages of the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. The application of the zinc-based alloy material is characterized in that the zinc-based alloy is used for preparing joint open prosthesis, the zinc-based alloy comprises zinc and a second metal, the second metal is selected from at least one of copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, wherein the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0 and less than or equal to 10%.

2. Use of a zinc-based alloy material according to claim 1, characterized in that the mass fraction of zinc in the zinc-based alloy is more than or equal to 95% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 5%.

3. The joint open prosthesis is characterized in that the joint open prosthesis is made of zinc-based alloy, the zinc-based alloy comprises zinc and second metal, the second metal is at least one selected from copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, the mass fraction of zinc in the zinc-based alloy is more than or equal to 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is more than 0% and less than or equal to 10%.

4. The joint open prosthesis of claim 3, wherein the zinc is greater than or equal to 95% and less than 100% by mass of the zinc-based alloy, and the second metal is greater than 0% and less than or equal to 5% by mass of the zinc-based alloy.

5. The joint spacious prosthesis of claim 3, which comprises a femoral intramedullary unit (1), a femoral prosthesis unit (2), a tibial prosthesis unit (3) and a tibial intramedullary unit (4), wherein the femoral intramedullary unit (1) is matched with a femoral medullary cavity, the femoral intramedullary unit (1) is connected with the femoral prosthesis unit (2), the femoral prosthesis unit (2) is movably contacted with the tibial prosthesis unit (3), the tibial prosthesis unit (3) is connected with the tibial intramedullary unit (4), and the tibial intramedullary unit (4) is matched with a tibial medullary cavity.

6. The joint spacious prosthesis of claim 5, wherein the joint spacious prosthesis is selected from any one of the following:

1) the joint spaciousness prosthesis one: the femoral prosthesis unit (2) comprises an anterior femoral prosthesis body (21), a left femoral prosthesis body, a right femoral prosthesis body (22) and a posterior femoral prosthesis body (23), the anterior femoral prosthesis body (21) and the posterior femoral prosthesis body (23) are arranged on two sides of the left femoral prosthesis body and the right femoral prosthesis body (22), the femoral intramedullary unit (1) is arranged on the femoral side of the left femoral prosthesis body and the right femoral prosthesis body (22), the tibial prosthesis unit (3) is provided with a first cavity (31), and the anterior femoral prosthesis body (21), the left femoral prosthesis body, the right femoral prosthesis body (22) and the posterior femoral prosthesis body (23) are integrally formed to form an outer surface matched with the first cavity (31) of the tibial prosthesis unit and are in movable contact with the tibial prosthesis unit (3);

2) and (2) placing a prosthesis II in the joint: femoral prosthesis unit (2) include femoral prosthesis portion (24), tibial prosthesis unit (3) are equipped with second cavity (32), femoral prosthesis unit (2) through the surface of femoral prosthesis portion (24) with form the matching of the tibial prosthesis unit surface of second cavity (32) with tibial prosthesis unit (3) movable contact.

7. The joint open prosthesis of claim 6, further comprising at least one of the following technical features:

1) in the joint spacious prosthesis I, a patella notch (211) matched with a patella is arranged on the front femoral prosthesis part (21);

2) in the joint spacious prosthesis I, the inner surface of the anterior femoral prosthesis part (21) is matched with the contacted outer surface of the femur;

3) in the joint spacious prosthesis I, the maximum thickness of the anterior femoral prosthesis part (21) is 5-25 cm;

4) in the joint spacious prosthesis I, the inner surface of the posterior femoral prosthesis part (23) is matched with the outer surface of the contacted femur;

5) in the joint spacious prosthesis I, the maximum thickness of the posterior femoral prosthesis part (23) is 5-25 cm;

6) in the joint spacious prosthesis I, the outer surface of the front femoral prosthesis part (21), the outer surfaces of the left and right femoral prosthesis parts (22) and the outer surface of the rear femoral prosthesis part (23) are smoothly transited on the same spherical or ellipsoidal curved surface in sequence;

7) in the joint spacious prosthesis I, the maximum thickness of the left and right femoral prosthesis parts (22) is 10-50 cm;

8) in the joint spacious prosthesis II, the femoral prosthesis part (24) is spherical or ellipsoidal;

9) in the joint spacious prosthesis II, the maximum thickness of the left side and the right side of the femoral prosthesis part (24) is 10-50 cm;

10) in the joint spacious prosthesis II, the maximum thickness of the front and back sides of the femoral prosthesis part (24) is 10-50 cm.

8. The joint articulation open prosthesis according to any of the claims 5 to 7, characterized in that it further comprises at least one of the following technical features:

1) the femoral intramedullary unit (1) is coaxial with the femur, and the tibial intramedullary unit (4) is coaxial with the tibia;

2) the tibial prosthetic unit (3) comprises a first tibial prosthetic element (33) and a second tibial prosthetic element (34) of a proximal femoral prosthetic unit, the second tibial prosthetic element (34) being connected to the tibial intramedullary unit (4), the second tibial prosthetic element (34) being tapered;

3) the joint spacious prosthesis also comprises a femoral transverse nail (5) which is used for fixing the femoral intramedullary unit (1) and the femur.

9. The method for preparing an articular open prosthesis according to any one of claims 3 to 7, characterized in that the articular open prosthesis is prepared by a casting process, a cutting process or a 3D printing process by using a zinc-based alloy, the zinc-based alloy comprises zinc and a second metal, the second metal is selected from at least one of copper, silver, magnesium, lithium, manganese, strontium, calcium, yttrium, gadolinium and dysprosium, wherein the mass fraction of zinc in the zinc-based alloy is not less than 90% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is not less than 0% and not more than 10%.

10. The method for preparing the joint open prosthesis of claim 9, wherein the mass fraction of zinc in the zinc-based alloy is greater than or equal to 95% and less than 100%, and the mass fraction of the second metal in the zinc-based alloy is greater than 0% and less than or equal to 5%.