WO2015144010A1 - Anterior cervical internal fixation system and preparation method therefor - Google Patents

Abstract

An internal fixation system for the anterior cervical vertebrae and a preparation method therefor. The system comprises a pair of fixing legs (1) arranged oppositely; the ends of the pair of fixing legs (1) are connected by a legs connection rod (2); the other ends of the fixing legs (1) are conical; saw-tooth barbs (5) are arranged on the inside surface of each fixing foot (1); saw-tooth ridges (6) are arranged on two sides of each saw-tooth barb; the middle of the legs connection rod (2) is pierced to form an observation window (3). While the system exerts a distraction force to the two sides of the middle of the observation window (3) of the legs connection rod (2), the two fixing legs (1) continuously press inwards, thus achieving the effect of pressing and fixing a single segment of cervical spine; the system accords with the physiological structural features of the cervical spine, has good conformability, fastens effectively, is simple in structure and easy to put in place and adjust. The preparation method uses single-piece shaping and a degradable magnesium and magnesium alloy matched bioactivity coating, so that the degrading speed of the magnesium and magnesium alloy can be effectively controlled, and injury caused by separation of a screw from a steel plate or removal in a second operation is fully avoided.

Description

Cervical anterior internal fixation system and preparation method thereof Technical field

The invention relates to a medical fixation system and a preparation method thereof, in particular to a cervical anterior internal fixation system and a preparation method thereof.

Background technique

Since Robinson and Cloward in 1961 first introduced the anterior cervical fusion surgery, the surgical approach of anterior cervical plate screw fixation has been widely accepted, especially in the clinical treatment of cervical traumatic fracture, dislocation and degenerative. Cervical diseases and other aspects have been widely used. After the removal of the intervertebral disc, bone graft fusion and internal fixation with cervical anterior plate screws can significantly enhance the stability of the cervical vertebrae and bone graft, reduce the pathological activities that can lead to the formation of pseudoarthrosis, and prevent the loss of intervertebral height. Bone graft fusion, patients can get out of bed early, reducing postoperative complications.

There are many kinds of plate screws fixed, the general steel plate and screws are fixed, the risk of screw dislodge may occur, and the esophagus, trachea, blood vessels and nerves may be damaged; the more advanced is fixed with a locking steel plate screw, the advantage is that the screw and the steel plate are integrated. The steel plate can prevent the screw from exiting. Even if the screw is loose and withdraws from the vertebral body, the screw and the steel plate often move together, and the screw tail does not escape from the steel plate alone, reducing the risk of esophageal damage. In addition, there is also a one-piece steel plate screw system, which is mainly made of titanium and titanium alloy materials. The overall structure completely avoids the risk of nail removal.

However, since the elastic modulus of titanium material is much higher than the elastic modulus of bone, it will destroy the normal stress environment of human bone healing, and the stress shielding effect will not only hinder the rapid formation of osteophytes in the fracture site, but also lead to osteoporosis and the like. Symptoms, when severe, can cause further fractures. In addition, more patients complain of foreign body sensation after esophagus, and even esophageal irritation; even if the above complications do not occur, the survival of the inner plant in the neck brings a lot of psychological burden to many patients. These phases Complications have long plagued spine surgeons.

In the prior art, for the integrated fixation of the cervical vertebra, the following products and patents are mainly involved. MEDICREA company proposed a C-JAWS cervical vertebra pressure fixer, which consists of pure titanium metal T40, a single structure design; patent CN201248760U discloses a cervical anterior memory alloy pressure fixer: including fixed feet and fixed links. The holder is provided with two fixed feet which are approximately symmetrical, the fixed ends of the fixed feet are connected with the fixed link, the angle between the fixed foot and the 2 fixed link is α, 60° ≤ α ≤ 88°, and the fixed sole has an upward end Serrated hook, the material of the holder is made of memory alloy. This technique uses a memory alloy material that does not degrade and requires a second surgical procedure to remove the patient's pain. Patent CN200939166U discloses a shape memory spinal canal forming fixture, which is a shape memory fixer for posterior spinal decompression angioplasty. The utility model is made of a nickel-titanium shape memory alloy, and is composed of a rectangular metal plate and a hook-shaped fixing claw. The middle portion of the rectangular metal plate is arched and curved, and is a stretching portion, the two ends of which are fixed plates, and the fixing claws are respectively disposed at two Below the boundary between the end extension and the fixing plate, the fixing plate is combined with the fixing plate to form a tiger-shaped fixing portion for engaging and fixing the residual ends on both sides of the cut lamina. In use, the nickel-titanium alloy has the characteristic of restoring a specific shape at the set temperature, first softens it at a low temperature of 0 to 4 ° C, bends the stretched portion, opens the fixed portion, and places the residual end of the lamina in the tiger's mouth. Then, the temperature is adjusted to the set temperature to restore the anchor to the original state, and the fixing portion bites and fixes the residual end of the lamina, and the lamina is opened by the extension of the stretching portion, thereby achieving the purpose of decompressing the spinal canal. The technology mainly uses the characteristics of the memory alloy to achieve pressure fixation, and is not degradable, and needs to be taken out twice. Patent CN200810163689.4 proposes a titanium alloy cervical vertebra pressure fixer and a preparation method thereof. The titanium alloy cervical vertebra pressure fixer disclosed in the invention is a U-shaped integral structure, and the two top ends of the U-shaped opening are respectively quadrangular pyramids, U The front and rear sides of the two sides of the font are sawtooth-shaped, and the inner sides of the two sides have small hooks facing the U-shaped bottom, and the bottom of the U-shape has hollowed holes. It is prepared by slow wire cutting, molding and surface treatment. The technology is prepared by forming a titanium alloy, a single structure design, and is molded, easily causing stress concentration and the like, and the titanium alloy is not degradable, and needs to be taken out twice. Patent CN201110234035.8 relates to a cervical anterior road fixation without screws The fixing plate and the fixing method thereof are provided with a viewing hole at a central position of the fixing plate, and a plate-shaped nail is arranged on the fixing plate, and the fixing plate and the plate-shaped nail are an integral structure. The invention has the following problems: a single structure design, a nail foot structure, a titanium alloy material is not degradable, and a foreign matter is strong. Patent CN01214732.X relates to a cervical anterior self-locking fixation device, wherein the two ends of the main steel plate of the device are designed with an integrated toothed wing perpendicular thereto, and the main steel plate is provided with fixing screws, both sides of the toothed wing The edge is designed with inverted teeth, and the end is in the shape of a knife-edge structure, which is not an integral structure.

In the prior art, the patent for a biodegradable material for a bone implant is as follows: apatite coating on the screw of the patent 201180034745.4MG, the patent generally relates to a magnesium-based biodegradable implant having a reduced corrosion rate. And a method of making the implant. It is a method for treating the surface of a biodegradable metal implant comprising the steps of providing a dispersion comprising colloidally dispersed apatite and adding the apatite powder to the dispersion to subject the implant to Dispersing the surface of the implant to be treated, wherein the implant comprises a magnesium-based alloy between the implant as the first electrode and the second electrode disposed in the dispersion An AC voltage difference is applied to create plasma electrolytic oxidation on the impregnated surface of the implant such that the impregnated surface is converted to an oxide film that is at least partially formed from colloidally dispersed apatite and apatite powder Covered with apatite. Corrosion results in reduced hydrogen production and improved bone fusion. Patent 201210424063.0 relates to a high-strength absorbable magnesium-based composite orthopedic internal fixator and a preparation method thereof, which mainly comprises a low-porosity porous magnesium alloy matrix with a pore structure and a gradient distribution, and a lower content filled in the pore structure thereof. The polylactic acid polymer material is prepared by high temperature bonding and solidification, wherein the pore structure in the porous magnesium alloy matrix exhibits a gradual decrease in porosity from the surface of the magnesium alloy substrate to the core or from the edge to the center, and the pore size gradually decreases. The gradient distribution is calculated by weight percentage, and the polylactic acid for filling the polymer material accounts for 5% to 49.9% of the total weight, and the porous magnesium alloy matrix accounts for 50.1% to 95% of the total weight. Patent No. 201110081681.5 discloses a metal embracing device for fracture internal fixation which is degradable and absorbable in vivo, which is composed of a single claw type fixing portion or alternately composed of a plurality of claw type fixing portions and a connecting plate. The embracing device is made of degradable metal Made of materials. The embracing device tightly encloses the fracture site by the fixed claws to achieve the alignment of the broken bones; the embracing connector plate connects the claw-shaped fixing portions together and conforms to the shape of the bone. Chinese patent CN101283922A discloses a magnesium alloy bone plate material and an appearance shape for use in orthopedic fixation, and such a bone plate must be used in conjunction with a nail to achieve a fixation effect. The disadvantages of this kind of bone plate are: Firstly, when there are more broken bones or fracture lines in the fracture site, the amount of bone plate or bone nail used will be greatly increased; secondly, the strength of the magnesium alloy is low and cannot be directly When screwing into the bone, it is necessary to first use a hard nail such as stainless steel to tap the screw hole, which increases the difficulty of the doctor's operation and the operation time. Finally, the screwing of the bone nail is another damage to the bone, increasing the original wound area and prolonging. The rehabilitation cycle has increased patient suffering. Therefore, under the premise of satisfying the effect of fracture fixation, how to reduce or even eliminate the use of wedge-shaped fixed ends such as bone screws of magnesium alloys is the key to improving the therapeutic effect of magnesium alloy internal fixation devices. In the clinical practice of fracture treatment, it is often the case that bone fixation is not required or the fracture site cannot be fixed with bone nails. Patent 201010116106.X discloses a self-degrading bioactive metal anchor in the field of biomedical technology made of magnesium or a magnesium alloy, the outer surface of which is optionally provided with a bone-like apatite coating. Patent 201020674925.1 discloses a hollow absorbable metal-magnesium interbody fusion cage made of pure magnesium or a magnesium alloy, the interior being a hollow lumen, the shape of the hollow lumen of the cage and the entire cage The outermost layer has the same shape; the cage is inclined at an angle to the horizontal plane, and the surface is provided with a holding member, and the side wall of the cage is provided with a hole. Patent 201310227538.1 relates to a novel all-bio-controllable degradable bone nail and a method for using the same, which is composed of an outer threaded nail, an inner layer of magnesium alloy screw and a sealant. The main component of the outer threaded nail is carbon dioxide copolymer. The outer threaded nail is made by plastic processing methods such as mixing, granulation, extrusion calendering and punching. The center is made into a threaded hole, and the front end of the nail can have a notch. A standard "cross-shaped" screw is formed in the nut position of the outer threaded nail for inserting it into the bone hole, and the inner threaded nail of the magnesium alloy material may be installed in the threaded hole. The inner and outer 4 layers of screws combined with the exposed parts are coated with a specific content of sealant made of methyl or ethyl carbonate. The three can be used in combination or the outer threaded nail can be used alone as a bone marrow fixing nail. Patent 200780035008.X provides a kind of An implant made of a degradable magnesium alloy or an implant coated with a magnesium alloy and a method of manufacturing such an implant. The implant according to this patent has biodegradable properties and its biodegradability can be easily controlled. In addition, the strength of such an implant and the interface strength to bone tissue are extremely excellent. Mainly about the design of materials. Patent 201210311236.8 discloses a medical degradable magnesium alloy bone fixation screw, which relates to a bone fixation screw, which solves the technical problem that the existing bone fixation screw cannot be degraded. Patent 201180062066.8 discloses a medical implant comprising a biodegradable magnesium-based alloy, at least a portion of which is comprised of magnesium carbonate. A method of making a biocompatible, corrosion-resistant protective skin on a medical implant comprising a magnesium-based alloy, without the specific product being involved. Patent 201080031790.X relates to an implant having a metallic magnesium alloy that is absorbable by the body, wherein the metallic material is a magnesium alloy containing at least 96% by weight of magnesium, at least 1% by weight of manganese and at least 0.5% by weight of at least one rare earth Metal, mainly related to material design.

The above patents concerning magnesium alloys mainly involve raw materials, surface treatment, and some cages, screws, etc., and are not specifically designed for cervical anterior fixation systems, especially those that do not involve integrated pressure structures.

Summary of the invention

The technical problem to be solved by the invention is to provide a cervical anterior internal fixation system and a preparation method thereof, which conform to the physiological structure characteristics of the cervical vertebra, have good fit and can be effectively fixed, and have a simple structure and are easy to install and adjust.

The technical solution adopted by the present invention to solve the above technical problem is to provide a cervical anterior internal fixation system, comprising a pair of oppositely disposed fixing legs, one end of the pair of fixing legs being connected by a fixed foot link, The other end of the fixing leg is tapered, the inner side of the fixing leg is provided with a serrated hook, the two sides are provided with serrations, and the middle of the fixed leg link is hollowed out to form an observation window.

In the above cervical anterior internal fixation system, the fixed leg and the fixed leg link are integrally formed.

The cervical front anterior internal fixation system, wherein the fixed foot link comprises two connecting arms, The middle portions of the two connecting arms are flared outward to form an observation window, and the two connecting arms are located on the same plane or are slightly convex outward in a curved surface structure.

In the above cervical anterior internal fixation system, the fixed foot link has an overall shape of a diamond shape, an elliptical shape, a central belt with a grooved diamond shape or a central portion of a circular shape.

In the above cervical anterior internal fixation system, the overall cross-sectional shape of the fixed foot is substantially an outer circular inner side rectangular shape, a rectangular shape, a square shape, a trapezoidal shape or an outer circular inner inner trapezoidal shape.

In the above cervical anterior internal fixation system, the other end of the fixing leg is a quadrangular pyramid type.

In the above cervical anterior internal fixation system, the materials of the fixed foot and the fixed foot link are high-purity magnesium or magnesium alloys having a purity of 99% or more.

In the above cervical anterior internal fixation system, the magnesium alloy is ZK60, MB2, AZ31 or M15 magnesium alloy.

In the above cervical anterior internal fixation system, the surface of the fixed foot and the fixed foot link is coated with a bioactive coating containing one or a combination of any one of silicon, calcium and phosphorus.

The above cervical anterior internal fixation system, wherein the silicon bioactive coating has a thickness of 5 to 60 μm.

The present invention further provides a method for preparing the above-mentioned cervical anterior internal fixation system, which comprises the following steps: integrally processing a high-purity magnesium or magnesium alloy to form a fixed foot and a fixed foot link; The foot link is placed in a mixed solution containing silicon salt; a micro-plasma oxidation device is used to generate a bioactive coating containing silicon, calcium or phosphorus on the surface of the fixed foot and the fixed foot link by adjusting the voltage and the soaking time. .

The above method for preparing a cervical anterior internal fixation system, wherein the fixed foot and the fixed foot link are integrally formed on a slow wire cutting processing device.

The above method for preparing a cervical anterior internal fixation system, which further comprises grinding, polishing and cleaning the fixed and fixed foot links after cutting and forming.

The above method for preparing a cervical anterior internal fixation system, wherein the plasma oxidation device has a voltage range of 450-500 V, and the soaking time ranges from 1 to 30 min.

The above method for preparing a cervical anterior internal fixation system, wherein the mixed solution containing a silicon salt is a mixture of Na2SiO3·9H2O, Na3PO4·12H2O and NaF, Na2SiO3·9H2O, Na3PO4·12H2O, KF and (CH3COO)2Ca A mixture of H2O or a mixture of K2SiO3·9H2O, K3PO4·12H2O and NaF.

Compared with the prior art, the present invention has the following beneficial effects: the cervical anterior internal fixation system and the preparation method thereof provided by the technical solution of the present invention, the external fixation force is applied at the middle of the inner side of the observation window of the fixed foot link; It is continuously compressed to the inside to achieve the effect of pressing and fixing the single-segment cervical vertebra. It conforms to the physiological structure of the cervical vertebrae, has good fit and can achieve effective and strong fixation, eliminating the cumbersome installation steps and the nut fixing adjustment time. The operation time is short, the patient's pain is relieved, the radiation time of the patient and the doctor is reduced, and the surgical trauma is small. Compared with the ordinary nail plate system, the fixation by the pressure and the slight elasticity contribute to the early healing of the bone. In particular, the present invention adopts a degradable magnesium and magnesium alloy material and processes an integrated anterior cervical internal fixation system. As the bone heals, the magnesium alloy is continuously degraded without secondary surgery; the magnesium alloy has a modulus of elasticity higher than that of titanium alloy, stainless steel, etc. The material is closer to the human bone tissue, reducing the stress shielding effect; and the preparation of the bioactive silicon-containing coating on the surface of the magnesium alloy can effectively control the degradation rate of the magnesium alloy; using the integrated processing method; completely avoiding the possibility of separation of the screw and the steel plate Moreover, the risk of the screw coming out of the steel plate alone and damaging the esophagus is not occurred; the integral processing and molding realizes the simultaneous synchronous degradation of the steel plate and the screw, and effectively realizes the high-strength fixing function of the early stage after the cervical anterior system implantation, and It can degrade overall within a set time, effectively conduct bone growth, reduce the patient's foreign body sensation, and finally achieve complete degradation and complete recovery of cervical vertebrae.

DRAWINGS

1(a), (b), (c), and (d) are a front view, a left side view, a top view, and a three-dimensional structure of a cervical anterior internal fixation system of a rectangular fixed foot and an elliptical link according to an embodiment of the present invention. ;

2(a), (b), (c), and (d) are a front view, a left side view, and a top view of a cervical anterior internal fixation system of an outer circular inner rectangular fixed leg and an elliptical link according to an embodiment of the present invention. And a three-dimensional structure diagram;

3(a), (b), (c), (d) are a front view, a left side view of a cervical anterior internal fixation system of a rectangular fixed foot and an elliptical connecting rod with a micro convex arc according to an embodiment of the present invention; Top view and schematic view of the three-dimensional structure;

Figure 4 (a), (b), (c), (d) is a front view of the cervical anterior internal fixation system of the outer circular inner rectangular fixed foot and the elliptical connecting rod with micro convex arc in the embodiment of the present invention , left view, top view and schematic view of the three-dimensional structure;

5(a), (b), (c), and (d) are a front view, a left side view, a top view, and a three-dimensional structure of a cervical anterior internal fixation system for a rectangular fixed foot and a circular link according to an embodiment of the present invention. ;

6(a), (b), (c), and (d) are a front view, a left side view, and a top view of a cervical anterior internal fixation system of an outer circular inner rectangular fixed leg and a circular link according to an embodiment of the present invention; And a three-dimensional structure diagram;

Figure 7 (a), (b), (c), (d) are a front view, a left side view of a cervical anterior internal fixation system of a rectangular fixed foot and a circular connecting rod with a micro convex arc according to an embodiment of the present invention; Top view and schematic view of the three-dimensional structure;

Figure 8 (a), (b), (c), (d) is a front view of the cervical anterior internal fixation system of the outer circular inner rectangular fixed foot and the circular convex link with micro convex arc in the embodiment of the present invention , left view, top view and schematic view of the three-dimensional structure;

9(a), (b), (c), and (d) are a front view, a left side view, a top view, and a perspective view of a cervical anterior internal fixation system of a rectangular fixed foot and a diamond shaped link according to an embodiment of the present invention;

10(a), (b), (c), and (d) are a front view, a left side view, a top view, and a cervical anterior internal fixation system of the outer circular inner rectangular fixed leg and the diamond shaped link according to the embodiment of the present invention; Schematic diagram of three-dimensional structure;

11(a), (b), (c), and (d) are a front view, a left side view, and a top view of a cervical anterior internal fixation system of a rectangular fixed leg and a diamond-shaped connecting rod with a micro convex arc according to an embodiment of the present invention; And a three-dimensional structure diagram;

12(a), (b), (c), and (d) are front views of a cervical anterior internal fixation system of an outer circular inner rectangular fixed leg and a diamond-shaped connecting rod with a micro convex arc according to an embodiment of the present invention, Left view, top view and schematic view of the three-dimensional structure;

Figure 13 is a schematic view showing the shape of a fixed foot link according to an embodiment of the present invention;

Figure 14 is a schematic view showing the overall cross-sectional shape of a fixing leg according to an embodiment of the present invention;

15(a) and (b) are schematic views showing the effect of the cervical anterior internal fixation system before and after the cervical vertebrae are opened and pressurized;

Figure 16 (a), (b) is a schematic view showing the force of fixing the foot connecting rod and fixing the foot after the cervical anterior internal fixation system is opened and pressurized;

17 is a schematic view showing a preparation process of a cervical anterior internal fixation system according to the present invention;

Figure 18 is a surface topography and surface coating energy spectrum of a silicon-containing bioactive coating on a magnesium alloy surface;

Fig. 19 is a graph showing the dynamic potential polarization curves before and after the MB2 magnesium alloy coating.

In the picture:

1-fixed foot; 2-fixed foot link; 3-view window; 4-end; 5--toothed hook; 6-saw tooth; 7-joint arm.

detailed description

The invention will now be further described with reference to the drawings and embodiments.

1(a), (b), (c), and (d) are a front view, a left side view, a top view, and a three-dimensional structure of a cervical anterior internal fixation system of a rectangular fixed foot and an elliptical link according to an embodiment of the present invention. .

Referring to FIG. 1 , a cervical anterior internal fixation system provided by the present invention includes a pair of oppositely disposed fixing legs 1 . One end of a pair of fixing legs 1 is connected by a fixed leg link 2 , and the other end portion 4 of the fixing leg 1 is Cone type, the inner side of the fixed foot 1, that is, the side facing the other fixed leg, provided with a saw The tooth hooks 5 are provided with serrations 6 on both sides of each of the fixed legs 1, and the intermediate hollow of the fixed foot links 2 forms an observation window 3.

The cervical anterior internal fixation system provided by the invention has a fixed foot 1 and a fixed foot link 2 which are made of a high-purity magnesium or magnesium alloy of a degradable material, such as 99.999% pure magnesium or a magnesium alloy such as ZK60, MB2, AZ31 or M15. The surfaces of the fixed foot 1 and the fixed foot link 2 are coated with a bioactive coating (not shown) containing one or a combination of any one of silicon, calcium, phosphorus, and the thickness of the bioactive coating is 5- 60 μm. It can effectively control the degradation rate of magnesium alloy. Due to the unique in vivo degradation properties of magnesium, it can avoid the removal of the second operation and alleviate the suffering of the patient; magnesium is the positive ion in the human body after potassium, and the human body needs a large amount. The adult needs more than 350mg per day. The magnesium ion released by magnesium alloy is not only harmless to the human body, but also a common factor of many enzymes. It is also a key element of energy transport, storage and utilization. It can regulate and stabilize the structure of RNA and DNA, regulate cell growth and maintain cell membrane structure. It plays an important role; excess magnesium can be excreted through the urine and has good safety. Compared with titanium alloy and stainless steel, medical magnesium alloy material has better biomechanical compatibility, elastic modulus is about 45GP, close to human bone (10-30GP), stress shielding effect is small; density is 1.7-1.9g /cm ³ or so, similar to human bone density (l.75g/cm ³ ), much lower than the density of Ti6Al4V (4.47g/cm ³ ); its specific strength, specific stiffness, processing performance is good, in line with the ideal The mechanical properties of the bone plate are required; in addition, magnesium also has the effect of bone conduction. However, since the degradation of magnesium leads to an increase in the concentration of magnesium ions in the blood, it is particularly important to control the degradation of the magnesium alloy so that the magnesium ion concentration is within a reasonable range acceptable to the human body. The surface modification control degradation rate is a good one. method.

The cervical anterior internal fixation system provided by the invention can integrally form the fixed foot 1 and the fixed foot link 2; the possibility of separation of the screw and the steel plate is completely avoided, and the screw alone is removed from the steel plate and the esophagus is damaged. Risk; the other anatomical and compressible structure design conforms to the physiological structure characteristics of the cervical vertebrae, and the fit is good and the effective and firm fixation is achieved; the integrated processing and molding realizes the simultaneous synchronous degradation of the steel plate and the screw, and effectively realizes the cervical anterior cervical system implantation. Early high-strength solid The function can be degraded in a set time, effectively inhibiting the growth of bone, reducing the foreign body sensation of the patient, and finally achieving complete degradation and complete recovery of the cervical vertebrae.

In addition, the complicated installation steps and the nut fixing adjustment time can be eliminated, the operation time is short, the patient's pain is relieved, the radiation time of the patient and the doctor is reduced, and the surgical trauma is small, compared with the ordinary nail plate system, and fixed by pressure, small Elasticity contributes to the early healing of the bone.

The cervical anterior internal fixation system of the present invention has a fixed leg link 2 including two connecting arms 7, and the intermediate portions of the two connecting arms 7 are laterally flared to form an observation window 3, and the two connecting arms 7 are located on the same plane. (As shown in FIG. 1 , FIG. 2 , FIG. 5 , FIG. 6 , FIG. 9 and FIG. 10 , the plane is substantially perpendicular to the extending direction of the fixing leg 1 ) or slightly convex outward to form a curved surface structure ( FIG. 3 . 4, 7, 8, 11, and 12, the middle portion of the curved surface structure slightly protrudes away from the fixed leg 1). The fixation system has an elastic function and can be distracted to serve as a single-segment cervical compression fixation. The micro-arc surface structure is designed to make the fixation system better fit to the cervical vertebra, thereby minimizing the body's foreign body sensation after implantation, and the overall shape of the fixed foot link 2 can be approximated as a diamond shape (Fig. 9- 12 and Figure 13 (a)), elliptical (as shown in Figure 1-4 and Figure 13 (b)), the central belt with the grooved diamond (as shown in Figure 13 (c)) or the middle Round (as shown in Figures 5-8 and 13(d)).

The cervical anterior internal fixation system provided by the present invention has an end portion 4 of the fixing leg 1 preferably a quadrangular pyramid, and the overall cross section of the fixing leg 1 (ie, a section perpendicular to the extending direction of the two fixing legs 1) is substantially circular outward. Inner rectangle (as shown in Figure 2, Figure 4, Figure 6, Figure 8, Figure 10, Figure 12 and Figure 14 (a)), rectangle (Figure 1, Figure 3, Figure 5, Figure 7, Figure 9, Figure 11 and Figure 14 (b)), square (as shown in Figure 14 (c)), trapezoid (as shown in Figure 14 (d)) or outside circular trapezoid (as shown in Figure 14 (e)) .

The cervical anterior internal fixation system provided by the present invention has a specific structural design by changing the shape of the fixed foot 1 and the fixed foot link 2, as shown in FIG. 1-12, respectively.

In Fig. 1, the fixed leg 1 has a rectangular cross-sectional shape, and the fixed leg link 2 has an elliptical shape as a whole. As shown in Fig. 1(a), the end portion 4 of the fixing leg is a quadrangular pyramid; the fixed leg link 2 includes two connecting arms 7, and the intermediate portions of the two connecting arms 7 are laterally flared to form an observation window 3, two The connecting arms 7 are located on the same plane.

2 is basically the same as the design of FIG. 1, except that the cross-sectional shape of the fixed leg 1 is an outer circular inner inner rectangle as shown in FIG. 2(a).

3 is basically the same as the design in FIG. 1, except that the fixed foot link 2 has a micro convex arc design, that is, the two connecting arms 7 are slightly convex in a direction away from the fixed leg 1 to form a curved surface structure, as shown in FIG. 3 ( b) shown.

4 is basically the same as the design in FIG. 2, except that the fixed leg link 2 has a micro convex arc design, and similarly, the two connecting arms 7 constitute a fixed leg link 2 which is slightly convex outward and has a curved surface structure. As shown in Figure 4 (b).

The cross-sectional shape of a pair of fixing legs 1 in FIG. 5 is rectangular, as shown in FIG. 5(a), the end portion 4 of the fixing leg is a quadrangular pyramid design, the inner side has a serrated hook 5, and the two sides are serrations 6; The middle portion of the rod 2 has a circular design, and the fixed foot link 2 includes two connecting arms 7, and the intermediate portions of the two connecting arms 7 are laterally flared to form an observation window 3, and the two connecting arms 7 are located on the same plane.

6 is basically the same as the design in FIG. 5, except that the cross-sectional shape of the fixed leg 1 is an outer circular inner inner rectangle as shown in FIG. 6(a).

7 is basically the same as the design of FIG. 5, except that the fixed foot link 2 has a micro convex arc design as shown in FIG. 7(b).

8 is substantially the same as the design of FIG. 6, except that the fixed foot link 2 has a micro convex arc design as shown in FIG. 8(b).

In Fig. 9, a pair of fixing legs 1 has a rectangular cross section, and the fixed leg link 2 has a diamond design as a whole. As shown in Fig. 9(a), the end portion 4 of the fixing leg is a quadrangular pyramid, and the inner side has a serrated hook 5. The two sides are serrations 6, and the fixed foot link 2 comprises two connecting arms 7, the intermediate portions of which are laterally flared to form a viewing window 3, the two connecting arms 7 being in the same plane.

The embodiment of Fig. 10 is substantially the same as the embodiment of Fig. 9, except that the cross-sectional shape of the fixed leg 1 is a design of the outer circular inner side rectangle, as shown in Fig. 10(a).

The embodiment of Figure 11 is substantially identical to the embodiment of Figure 9, except that the fixed foot link 2 has a micro-bump design as shown in Figure 11(b).

The embodiment of Figure 12 is substantially identical to the embodiment of Figure 10, except that the fixed foot link 2 has a micro-bump design as shown in Figure 12(b).

15(a) and (b) are schematic views showing the effect of the cervical anterior internal fixation system before and after the cervical vertebrae are opened and pressurized; and Figs. 16(a) and (b) are the cervical anterior internal fixation system of the present invention. The force diagram of the fixed foot link and the fixed foot after pressing.

Referring to Figures 15 and 16, the cervical anterior cervical internal fixation system according to the present invention, when in use, applies a force to both sides in the middle of the observation window of the fixed foot link while the two fixed legs are continuously compressed inward. Thereby achieving the effect of pressing and fixing the single-segment cervical vertebra.

17 is a schematic view showing the preparation process of the cervical anterior internal fixation system of the present invention.

With continued reference to FIG. 17, the method for preparing a cervical anterior internal fixation system provided by the present invention includes the following steps:

Step S1: integrally forming a high-purity magnesium or magnesium alloy to form a fixed leg 1 and a fixed leg link 2. Specifically, the fixed leg 1 and the fixed leg link 2 can be integrally formed on the slow wire cutting processing device, and the fixed leg 1 and the fixed leg link 2 after cutting and forming can be ground, polished and cleaned.

Step S2: The fixed leg 1 and the fixed leg link 2 after machining and surface cleaning are placed in a mixed solution containing a silicon salt. The mixed solution containing the silicon salt may be a mixture of Na ₂ SiO ₃ ·9H ₂ O, Na ₃ PO ₄ ·12H ₂ O and NaF, Na ₂ SiO ₃ ·9H ₂ O, Na ₃ PO ₄ ·12H ₂ O a mixture of KF and (CH ₃ COO) ₂ Ca·H ₂ O, or a mixture of K ₂ SiO ₃ ·9H ₂ O, K ₃ PO ₄ ·12H ₂ O and NaF. Here, although the mixed solution containing a silicon salt is exemplified, the present invention is not limited thereto, and any suitable mixed solution may be employed as long as the surface of the fixed leg and the fixed leg link can be made in the subsequent step S3. A bioactive coating layer containing one or a combination of any one of silicon, calcium, and phosphorus may be produced.

Step S3: using a micro-plasma oxidation device, by adjusting the voltage and the processing time, a bioactive coating containing one or a combination of any one of silicon, calcium, and phosphorus is formed on the surfaces of the fixed leg and the fixed leg link. Specifically, bioactive coatings of different thicknesses (5-60 μm) can be prepared by adjusting the voltage (450-500 V) and the soaking time (1-30 Min) to control the magnesium degradation time. As shown in Fig. 18, the abscissa of Fig. 18 represents energy, the unit is KeV, and the ordinate represents the intensity of X-rays, and the unit is KCnt. From the surface topography of the coating, the uniformity of the coating is good, and the spectrum shows the coating. The layer is mainly composed of silicon, oxygen and magnesium, and contains a small amount of fluorine and sodium. A large number of studies have shown that the silicon-containing coating can significantly improve the biological activity, so the silicon bioactive coating of the invention has good biological activity and uses plasma. Technically, the coating of the present invention has a high bonding strength. As shown in Fig. 19, the abscissa Current is the self-corrosion current density, the ordinate Polarity is the self-corrosion potential, the unit is volt, the curve 1 is the pre-coating polarization curve, and the curve 2 is the post-coating polarization curve, from the polarization. Curve analysis of corrosion resistance, before and after the coating, the self-corrosion potential increased from -1.491V to -1.310V, and the self-corrosion current density decreased significantly, indicating that the corrosion resistance was significantly improved, indicating that the degradation performance can be controlled.

Here are a few specific implementations:

Example 1

The three-dimensional software is used to design the outer structure of the integrated cervical anterior internal fixation system. The MB2 magnesium alloy material is processed and formed on the slow wire cutting processing equipment, and then ground, polished and cleaned to obtain a preliminary preparation of the integrated cervical anterior approach. Fixed system. In a mixed solution of 14 g/l Na ₂ SiO ₃ ·9H ₂ O, 1 g/l Na ₃ PO ₄ ·12H ₂ O, 0.5 g/l NaF, the above-mentioned preliminary preparation of the integrated cervical vertebrae was performed at a voltage of 470 V using a plasma oxidation apparatus. The in-situ fixing system was treated for 5 minutes, and a silicon-containing coating having a thickness of 15 μm was prepared on the surface.

Example 2

The three-dimensional software is used to design the above-mentioned integrated structure of the integrated cervical anterior internal fixation system. The pure magnesium material is processed and formed on the slow wire cutting processing equipment, and then ground, polished and cleaned to obtain a preliminary preparation of the integrated cervical anterior internal fixation. system. In a mixed solution of 12 g/l Na ₂ SiO ₃ ·9H ₂ O, 0.5 g/l Na ₃ PO ₄ ·12H ₂ O, 0.5 g/l KF, 11 g/l (CH ₃ COO) ₂ Ca·H ₂ O, The above-prepared integrated cervical anterior internal fixation system was treated with a plasma oxidation apparatus at a voltage of 450 V for 6 minutes, and a silicon-containing coating having a thickness of 10 μm was prepared on the surface thereof.

Example 3

The three-dimensional software is used to design the above-mentioned integrated structure of the integrated cervical anterior internal fixation system. The MB15 magnesium alloy material is processed and formed on the slow wire cutting processing equipment, and then ground, polished and cleaned to obtain a preliminary preparation of the integrated cervical anterior approach. Fixed system. In a mixed solution of 15 g/l K ₂ SiO ₃ ·9H ₂ O, 2 g/l K ₃ PO ₄ ·12H ₂ O, 0.5 g/l NaF, the above-prepared integrated cervical vertebrae were prepared at a voltage of 500 V using a plasma oxidation apparatus. The in-situ fixing system was treated for 15 minutes, and a silicon-containing coating having a thickness of 35 μm was prepared on the surface.

While the present invention has been described in its preferred embodiments, the present invention is not intended to be limited thereto, and the present invention may be modified and improved without departing from the spirit and scope of the invention. The scope of protection is defined by the terms of the claims.

Claims (15)

1. A cervical anterior internal fixation system, comprising: a pair of oppositely disposed fixing legs (1), one end of the pair of fixing feet (1) being connected by a fixed foot link (2), the fixing The other end of the foot (1) is tapered, the inner side of the fixing leg (1) is provided with a serrated hook (5), and the two sides are provided with serrations (6), and the middle of the fixed leg link (2) is hollowed out An observation window (3) is formed.
2. The cervical anterior cervical internal fixation system according to claim 1, wherein the fixed leg (1) and the fixed leg link (2) are integrally formed.
3. The cervical anterior cervical internal fixation system according to claim 1, wherein said fixed foot link (2) comprises two connecting arms (7), and a middle portion of said two connecting arms (7) is adjacent The side opening forms the observation window (3), and the two connecting arms (7) are located on the same plane or slightly convex in a direction away from the fixing leg (1) to form a curved surface structure.
4. The cervical anterior cervical internal fixation system according to claim 3, wherein the fixed foot link (2) has an overall shape of a rhombus shape, an elliptical shape, a central portion with a grooved diamond shape, or a central portion having a circular shape.
5. The cervical anterior cervical internal fixation system according to claim 1, wherein the fixed cross-sectional shape of the fixing leg (1) is substantially an outer circular inner side rectangular shape, a rectangular shape, a square shape, a trapezoidal shape or an outer circular inner inner trapezoidal shape.
6. The cervical anterior internal fixation system according to claim 1 or 5, wherein the other end of the fixing leg has a quadrangular pyramid shape.
7. The cervical anterior internal fixation system according to claim 1, wherein the material of the fixing leg (1) and the fixed leg link (2) are high-purity magnesium or magnesium alloys having a purity of 99% or more.
8. The cervical anterior cervical internal fixation system according to claim 7, wherein the magnesium alloy is a ZK60, MB2, AZ31 or M15 magnesium alloy.
9. The cervical anterior internal fixation system according to claim 1, wherein the surface of the fixing leg (1) and the fixed leg link (2) is coated with one or more of silicon, calcium and phosphorus. Ren A combination of biologically active coatings.
10. The cervical anterior cervical internal fixation system according to claim 9, wherein the bioactive coating has a thickness of 5 to 60 μm.
11. A method for preparing a cervical anterior cervical internal fixation system according to any one of claims 1 to 10, comprising the steps of:

    Forming a fixed foot (1) and a fixed foot link (2) integrally with a high-purity magnesium or magnesium alloy;

    Soak the fixed foot (1) and the fixed foot link (2) in a mixed solution containing silicon salt; use plasma oxidation equipment to adjust the voltage and soak time, at the fixed foot (1) and the fixed foot link (2 The surface of the substrate produces a bioactive coating comprising one or a combination of any one of silicon, calcium, phosphorus.
12. The method for preparing a cervical anterior internal fixation system according to claim 11, wherein the fixed leg (1) and the fixed leg link (2) are integrally formed on the slow wire cutting processing device.
13. The method for preparing a cervical anterior internal fixation system according to claim 12, further comprising: grinding, polishing and cleaning the fixed foot (1) and the fixed foot link (2) after the cutting.
14. The method of preparing a cervical anterior internal fixation system according to claim 12, wherein the plasma oxidation device has a voltage range of 450-500 V, and the soaking time ranges from 1 to 30 min.
15. The method for preparing a cervical anterior internal fixation system according to claim 11, wherein the mixed solution containing the silicon salt is Na ₂ SiO ₃ ·9H ₂ O, Na ₃ PO ₄ ·12H ₂ O and NaF. a mixed solution of Na ₂ SiO ₃ ·9H ₂ O, Na ₃ PO ₄ ·12H ₂ O, KF and (CH ₃ COO) ₂ Ca·H ₂ O, or K ₂ SiO ₃ ·9H ₂ O, K ₃ A mixture of PO ₄ ·12H ₂ O and NaF.

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