Patent Publication Number: US-2021187153-A1

Title: Adjustable external fixing brace

Description:
This PCT application claims priority and its benefit of the Chinese Patent Application No. 201710945969.X filed on Oct. 12, 2017, entitled “Adjustable External Fixing Brace, Composition of the same, Process for Making the same, and Method of Using the same.” 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to an adjustable external fixing brace, in particular to a versatile flexible mesh plate made from a shape memory material, and belongs to the technical field of external fixation for a broken bone. 
     PRIOR ART 
     In prior art, polycaprolactone (PCL) is often used as an external fixation material for fracture of human bones. Due to the fact that melting point of polycaprolactone is low, the melt strength is sharply reduced for crystal melting happens near the melting point. Like a limp of cement with high viscosity in its softening process, it is difficult for PCL material to have a formation. Due to the above properties of polycaprolactone, it is more difficult for PCL to be used for preparing such a complex structure as orthopedic brace (or called as support or cast). In particular, it is difficult for PCL to use in any injection molding process. In the prior art, a raw solid plate for bone fixing brace is usually formed using thermoplastic material in a process of molding or calendaring, subsequent processing includes such as shearing/cutting, punching, irradiating the punched raw plate, and spraying anti sticking coating on the punched raw plate. In clinical use, the raw plate needs to be further cut according to a patient&#39;s shape of an injured position so as to make his special bone fixing support. Due to the fact that an incision edge of the raw plate is free of anti-sticking coating, adhesion is easy to occur when the special bone fixing support is heated and molded clinically. In addition, in the prior art, the prefabricated holes provided on the versatile plate are uniformly distributed, the holes are too small to change their size and shape according to the needs of different wound position of the patient. Moreover, the holes are too small to facilitate air flowing or bathing on where is braced/supported. 
     WO2014/084425A1 discloses a shape memory mesh plate, which is made in a process as follows: a raw thermoplastic material is softened, molded or woven into a mesh plate in a smelting machine; then the mesh plate is immersed in an anti-sticking liquid, to make the thermoplastic material completely covered by an anti-sticking coating so as to form a layer of anti-sticking shell. A fixing support can be prepared from the mesh plate during its softening. In such a technology, it takes a long time for molding, and it is with a high production cost. 
     In a conventional clinical use, the shape memory mesh plate distributed with large ventilation holes is heated to be softened at temperature of 55-80° C., then is stretched and attached to where a patient&#39;s bone is injured. Finally, the two sides of the mesh plate are connected with each other by means of an enclosing and locking means. Unfortunately, as a large drawback of the prior art, both the anchoring end and the locking end of the enclosing and locking means cannot be rotatable themselves, as a result, in clinical use, after the mesh plate is stretched, it is difficult for the anchoring end and the locking end of the mesh plate to align completely, making difficult to close the outer fixation brace, or making the adjustability worse. 
     Especially, in the prior art, as an intermediate of the medical fixing support, one type of mesh plate is made for the left arm, foot or leg, while another type of mesh plate is made for the right arm, foot or leg. The mesh plate for the left arm, foot or leg cannot be used for the right arm, foot or leg, so that the mass for any type of the mesh plate cannot be increased, thus it is difficult to further reduce the cost and make clinical use more convenient. 
     SUMMARY OF THE INVENTION 
     An object of the invention is to provide an adjustable fixing support, which is one-time formed in injection molding process for a whole mesh plate, does not need to be cut to fit any specific patient&#39;s wounded position, and prevents the mesh plate adhered during use, so that it is simple and quick for a doctor to operate a brace installation in all levels of hospitals. 
     Another object of the present invention is to provide an adjustable fixing support made from a composite material by means of injection molding, which makes it easy to demold after injection molding resulted from the composite material&#39;s new properties, so that the formed mesh plate does not adhere itself in the injection molding process. Therefore, the prior art process (with steps for molding or calendaring for forming a solid raw plate, punching holes on the raw plate, spraying on surfaces of the raw plate so as to have an anti-sticking layer) can be given up. On the other hand, there appears a novel process, in which a homogeneous material is used for directly injection molding of the mesh plate with large air holes and without coating, so that the process is simplified, the production cost is greatly reduced, and comfort feeling of patients is greatly improved. 
     Thus, the present invention is related to a polycaprolactone composite material, whose formula, with components in parts by weight, is: 40-80 wt % of polycaprolactone, 15-55 wt % of filler, and 5-15 wt % of auxiliary materials. A method for preparing the polycaprolactone composite material comprises the following steps: weighing each of components according to the formula of the polycaprolactone composite material, respectively; mixing the weighed components so as to obtain a mixed material; melt extruding and graining the mixed material so as to obtain the polycaprolactone composite material, wherein the melt extruding is performed in process conditions as follows: temperature of a first zone (rear zone) is 130-140° C., temperature of a second zone (middle zone) is 140-150° C., temperature of a third zone (middle zone) is 150-160° C., temperature of a fourth zone (front zone) is 160-170° C., temperature of an injecting nozzle is 170-180° C., residence time is 1-2 min, and pressure is 10-20 MPa; or, temperature of a first zone is 60-130° C., temperature of a second zone is 130-200° C., temperature of a third zone is 150-210° C., temperature of a fourth zone is 160-220° C., temperature of an injecting nozzle is 170-200° C., residence time is 1-5 min, and pressure is 10-100 MPa. 
     The polycaprolactone composite material contains polycaprolactone as a matrix material, as well as filler and lubricant agent for modification of the composite material. The components are synergistic in the melt extrusion process, and the blends react with polycaprolactone molecules to form covalent bonds, so that the interface compatibility between polycaprolactone and other components is improved, and the polycaprolactone composite material is endowed with excellent mechanical properties and anti-sticking performance. According to the method for preparing the polycaprolactone composite material, the raw material can be obtained by mixing all the components according to a formula, then performing a melt extrusion at the appropriate temperature. The preparation method is simple in process, easy to control in condition, low in cost and low in required equipment, so it is suitable for industrial production. 
     To this end, in accordance with the first aspect of the present invention, there is provided an adjustable external fixation brace, characterized in that the outer fixation brace is one-time formed by an injection molding process (on the other hand, in the prior art, the outer fixation brace is molded or calendered into a solid plate, followed by cutting to raw products, perforating on each raw product, the spraying antibonding agent on surfaces of each raw product), so as to form a shape memory mesh plate distributed with large ventilation holes (in the prior art, however, the ventilation holes are regular small holes); and the raw material of the mesh plate is doped with an anti-sticking agent. 
     Preferably, the ventilation holes (openings for air flowing) are macropores (large size holes) which have at least one of the following features: a hole having an arc transition; a span of at least greater than the thickness of the mesh plate (preferably less than 50 times of the thickness, more preferably less than 30 times of the thickness); a ratio of maximum span to minimum span is 1:1 to 40:1 (preferably 1:1 to 30:1, more preferably 1:1 to 20:1); the minimum transition radius is 10 degrees; the minimum transition radius is 0.5 mm; the width of any rib between two large openings is at least greater than the thickness of the mesh plate (preferably greater than 1.5 times of the thickness, more preferably greater than 2 times of the thickness); and a sum of the areas (breathable area) occupied by the ventilation holes is 7-70%, preferably 20-70%, more preferably 29-60%, and most preferably 30-55% of the total area of the external fixing brace (i.e. a case or a support). 
     Preferably, the shape memory mesh plate has at least one of the following features: a thickness of at least 1.5 mm (preferably 4-6 or 4-8 mm, more preferably 5 mm); a thickness for a special portion (contacting a certain joint or bony protrusion in use) of the mesh plate is made thinner; and in a special area, there is arranged a hole (as a circular, oval-shaped, generally triangular, peach-shaped, etc.) pre-arranged for the thumb, etc. 
     Preferably, the anti-sticking agent may be a single or composite anti-adhesive that prevents the shape memory mesh plate from sticking during injection molding to facilitate removal from the mold. 
     Preferably, the adjustable external fixation brace is used for, but not limited to, a patient&#39;s injured position requiring rehabilitation as follows: hand, upper limb, lower limb, neck, chest, waist, or foot. 
     Preferably, adjacent the two sides, parallel to the longitudinal direction, of the adjustable outer fixing support are provided with a snap-fit means of the enclosing and locking means, which can be bonded on, inserted into, or integrated with the shape memory mesh plate; the thickness of the snap-fit means can be substantially the same as that of the shape memory mesh plate; and the enclosing and locking means can be a backstop buckle structure, a nylon buckle belt structure, a button structure, a tenon structure, or a waistband structure with combination of a fixing needle and a hole. 
     According to the second aspect of the present invention, there is provided an adjustable external fixation brace, characterized in that it is made from a modified high molecular material, comprising an anti-sticking agent selected from the group consisting of polycaprolactone, polypropylene, polyethylene, calcium carbonate, glass fibers, monoalkoxy titanate coupling agents, graft polypropylene, graft polyethylene, polyethylene wax, calcium stearate, stearamide, vegetable oil, the blends thereof, and the combinations thereof. 
     In accordance with the third aspect of the present invention, there is provided a process for making an adjustable external fixing support, characterized in that the process comprises the following steps: injection molding a blend containing an anti-sticking agent and components selected from the group consisting of polycaprolactone, polypropylene, polyethylene, calcium carbonate, glass fiber, monoalkoxy titanate coupling agent, grafted polypropylene, grafted polyethylene, polyethylene wax, calcium stearate, stearic amide, vegetable oil, and combination thereof; and one-time forming a shape memory mesh plate with large air holes. 
     In accordance with the fourth aspect of the present invention, there is provided a method for using an adjustable external fixation brace, characterized in that heating at 70-80° C. so as to soften a shape memory mesh plate, which is made from a modified high molecular material, and is distributed with large openings; directly contacting the shape memory mesh plate on the patient&#39;s injured position, or stretching the shape memory mesh plate to a proper size according to requirements, and surrounding it around the patient&#39;s wounded position; closing the cleavage between the two sides of the shape memory mesh plate by means of the enclosing and locking means; and cooling the shaped mesh plate to temperature below 60° C., thus self-hardening the shaped mesh plate, setting the shaped mesh plate, making the shaped mesh plate formed, making the shaped mesh plate subjected to hold any weight, so as to function the shaped mesh plate as an external fixing brace. 
     According to the fifth aspect of the present invention, there is provided an adjustable external fixation brace, characterized in that it is a plate with large through holes. According to the design, it is facilitated to directly inspect wound recovering progress, and prevent from occurring complications after trauma. It is the large through holes arranged on the mesh plate that make the skin in the injured position good for air flows and quick-drying after taking a shower, so as to improve the health condition of the patient&#39;s skin at the injured position, prevent pruritus, and avoid occurrence of dermatitis. And by prearranging the big holes of the mesh plate, it makes the brace light in weight. 
     In accordance with the sixth aspect of the present invention, there is provided an adjustable external fixation brace, characterized in that the fixing brace is always matched with the enclosing and locking means which are adjustable and easy to be disassembled. In this case, in the whole recovering course, a clamping tightness of the brace can be adjusted at any time according to swelling condition where the patient is wounded, so that suitable compression on the corresponding soft tissue is maintained, so as to keep a very good fixing effect of the brace. 
     According to the invention, the thermoplastic memory material is adopted, its tensile property is good, any angle and deformation in any direction can be generated, and in particular, the net like structure has better stretchability. In this case, one type of the mesh plate can be extensively used for different patients, fat or thin. Therefore, types of the mesh plate are reduced, production cost for any type of the mesh plate is reduced, and the purchased number of types of the mesh plate by any hospital is also reduced. 
     According to the invention, the mesh plate with large size holes made by the one-time injection molding process does not have any punching process, so no waste and leftover materials are generated, and no coating procedure is needed. In this case, without additional coating, any adhesion is avoided, so the production efficiency is high, and the manufacturing cost is low. 
     According to the invention, the mesh plate is an intermediate of the fixing support which is made from a thermoplastic material with good processing performance (suitable for injection molding), certain ductility and non-adhesion, and which is injected and molded into products for different human body portions (hands, limbs, neck, chest, waist or feet). 
     According to the present invention, the mesh plate has arranged some large size holes that facilitate enjoy fresh air; the mesh plate consists of a single piece or multiple pieces; the mesh plate has different enclosing and locking means; a pattern and thickness on a special portion of the mesh plate can be different to other portions of the mesh plate, e.g. thickness of the mesh plate corresponding to ulnar stem, talar, etc. is less than or equal to the thickness of other portions of the mesh plate; and so on. 
     According to the invention, the mesh plate can be stretched or deformed in any way to correspond to the injured position of the human body fracture, so as to obtain an external fixing brace with different shapes or different spatial orientations. No cropping is required at the two sides of the mesh plate. The mesh plate cannot stick one portion to another in use. The mesh plate is made from the same chemical material, except the enclosing and locking means, and the surface of the mesh plate does not need to be coated or impregnated with other substances. After being enclosed by the enclosing and locking means, a fixing brace with an irregular barrel shape suitable for the external shape of the wounded limb portion of the human body can be formed. The mesh plate can be used to fix all possible positions of human body, such as neck, chest, limbs, etc. The fastening tightness of the fixing brace can be adjusted at will according to the swelling change at the affected position with respect to the fracture. It is convenient to disassemble the fixing brace, so that the external injury treatment and nursing of the affected position are facilitated. The material of the mesh plate does not absorb water, so the fixing brace can wear even in bathing. 
     The invention overcomes the prejudice of the traditional technology, has no respect to the traditional process, is not limited by the traditional material selection, but instead opens the innovation, selects a new material, a new technology, a new style and a new structure, provides a rehabilitation support which is lower in manufacturing cost, simpler in manufacturing process, more convenient for doctors to use, safer and more comfortable to wear by patients, and more suitable for fracture fixation according to the anatomy of a human body. 
     According to the invention, at the anchoring end and the locking end of the enclosing and locking means, the pins or posts themselves can be freely rotated to facilitate the clinical use. Regardless of how the mesh plates are stretched, the corresponding anchoring end and the locking end can be completely aligned with each other through adaptive steering adjustment, so that the enclosing of the external fixing support becomes easy, and its adjustability is excellent. 
     According to the invention, as an intermediate product for forming the medical fixing support, it is no longer to separately prepare the mesh plate used for the left arm, foot or leg and that used for the right arm, foot or leg, so that a versatile mesh plate is formed and can be used both for the left arm and the right arm, both for the left foot or leg and for the right foot or leg, therefore a batch of any type of the mesh plate can be improved, the cost for making the mesh plate is further reduced, and clinical use of the mesh plate is facilitated. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of an adjustable external fixation brace in an intermediate state in accordance with one embodiment of the present invention. 
         FIGS. 2 a -2 b    are schematic views of an adjustable external fixation brace in a broken bone supporting state of the embodiment as shown in  FIG. 1 . 
         FIGS. 3 a -3 e    are schematic views of several kinds of enclosing and locking means of the adjustable external fixation brace according to embodiments of the present invention. 
         FIG. 4  is a wrist fixing brace, a variation of the arm fixing brace as shown in  FIGS. 1-3 . 
         FIG. 5  is a schematic view of the enclosing and locking means of an adjustable external fixing brace in accordance with an embodiment of the present invention. 
         FIG. 6  is a schematic view of the assembled structure of the enclosing and locking means as shown in  FIG. 5 . 
         FIG. 7A  is a schematic view of the disassembled structure of the anchoring end of the enclosing and locking means as shown in  FIG. 6 . 
         FIG. 7B  is a schematic view of the disassembled structure of the locking end of the enclosing and locking means as shown in  FIG. 6 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The invention provides a thermoplastic material capable of injection molding a complex structural medical brace (support or cast), wherein the thermoplastic material has low-temperature thermoplastic properties, is of ductility, and is free of any adhesion during clinical use. According to some embodiments of the present invention, the thermoplastic material comprises: a main material such as polycaprolactone; an auxiliary material such as polyethylene or polypropylene; a coupling agent such as an oxytitanate coupling agent; a grafting agent such as graft polypropylene or graft polyethylene; and a lubricant such as polyethylene wax, calcium stearate, stearamide or vegetable oil. 
     In order to more clearly understand the technical problems, technical solutions, and beneficial effects to be solved by the present invention, a more detailed description of the invention will be made as follows, taken in conjunction with the accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. According to the embodiment of the invention, a polycaprolactone composite material with good interface compatibility and excellent mechanical properties between polycaprolactone and fibers is provided. The polycaprolactone composite material comprises components in percentage by weight as the following formula: 40-80 wt % of polycaprolactone, 15-55 wt % of filler, and 5-15 wt % of auxiliary materials. 
     In particular, the polycaprolactone is a matrix component. In their melt extrusion process, the molecules of the polycaprolactone and other components, especially lubricant, are synergistic, so that the interface problem between the polycaprolactone and the filler is improved, and the mechanical properties of the polycaprolactone composite material are endowed. To further exhibit an interfacial compatibility between the polycaprolactone and the filler, a further detailed description of the invention will be made with respect to the formulation and preparation method of the examples of the polycaprolactone composite. 
     
       
         
           
               
             
               
                 TABLE 1 
               
               
                   
               
               
                 Content (wt %) of components in some embodiments of the present invention. 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
               
               
               
            
               
                 Component\Example No.: 
                 1 
                 2 
                 3 
                 4 
                 5 
                 6 
                 7 
                 8 
                 9 
                 10 
                 11 
                 12 
               
               
                   
               
               
                 Polycaprolactone 
                 40 
                 40 
                 40 
                 40 
                 45 
                 45 
                 50 
                 50 
                 50 
                 50 
                 55 
                 55 
               
               
                 Polypropylene 
                 48 
                   
                 4 
                   
                 35 
                 25 
                 25 
                   
                 25 
                   
                 23 
                   
               
               
                 Polyethylene 
                   
                 50 
                 44 
                 50 
                 10 
                 20 
                   
                 15 
                   
                 15 
                   
                 23 
               
               
                 Calcium Carbonate 
                   
                   
                   
                   
                   
                   
                   
                 15 
                 15 
                 15 
                 4 
                 5 
               
               
                 Glass Fiber 
                   
                   
                   
                   
                   
                   
                 15 
                 8 
                   
                 8 
                 10 
                 10 
               
               
                 Monoalkoxy Titanate Coupling Agent 
                 1 
                 1 
                 1 
                 1 
                   
                   
                   
                 1 
                   
                 1 
                 1 
                   
               
               
                 Grafted Polypropylene 
                 4 
                   
                 4 
                   
                 1.5 
                 1.5 
                 4 
                   
                 4 
                   
                   
                   
               
               
                 Grafted Polyethylene 
                   
                 2 
                   
                 2 
                 1.5 
                 1.5 
                   
                 2 
                   
                 2 
                 2 
                 2 
               
               
                 Polyethylene Wax 
                 7 
                   
                 7 
                   
                   
                   
                   
                 4 
                   
                 4 
                 2 
                 2 
               
               
                 Calcium stearate 
                   
                 7 
                   
                 7 
                   
                   
                   
                 2 
                 5 
                 2 
                 2 
                   
               
               
                 Stearamide 
                   
                   
                   
                   
                 7 
                 7 
                   
                 3 
                   
                 3 
                   
                 2 
               
               
                 Vegetable Oil 
                   
                   
                   
                   
                   
                   
                 6 
                   
                 1 
                   
                 1 
                 1 
               
               
                   
               
               
                 Component\Example No.: 
                 13 
                 14 
                 15 
                 16 
                 17 
                 18 
                 19 
                 20 
                 21 
                 22 
                 23 
                 24 
               
               
                   
               
               
                 Polycaprolactone 
                 55 
                 55 
                 60 
                 60 
                 60 
                 60 
                 65 
                 65 
                 65 
                 65 
                 70 
                 70 
               
               
                 Polypropylene 
                 23 
                   
                   
                 15 
                   
                 15 
                 10 
                   
                 10 
                   
                   
                   
               
               
                 Polyethylene 
                   
                 23 
                 20 
                   
                 20 
                   
                   
                 15 
                   
                 15 
                 10 
                 10 
               
               
                 Calcium Carbonate 
                 10 
                 10 
                 3 
                 3 
                 9 
                 15 
                 8 
                 5 
                 10 
                 6 
                 2 
                 10 
               
               
                 Glass Fiber 
                 4 
                 5 
                 9 
                 15 
                 3 
                 3 
                 10 
                 5 
                 8 
                 5 
                 10 
                 2 
               
               
                 Monoalkoxy Titanate Coupling Agent 
                 1 
                   
                 1 
                   
                 1 
                   
                   
                   
                   
                   
                   
                   
               
               
                 Grafted Polypropylene 
                   
                   
                   
                 3 
                   
                 3 
                 2 
                   
                 2 
                   
                   
                   
               
               
                 Grafted Polyethylene 
                 2 
                 2 
                 2 
                   
                 2 
                   
                   
                 3 
                   
                 3 
                 3 
                 3 
               
               
                 Polyethylene Wax 
                 2 
                 2 
                   
                 3 
                 1.5 
                 1.5 
                   
                   
                 2.5 
                 2 
                 2 
                 2 
               
               
                 Calcium stearate 
                 2 
                   
                 3 
                 1 
                 2.5 
                 1.5 
                   
                 3 
                 1.5 
                 3 
                   
                   
               
               
                 Stearamide 
                   
                 2 
                 1 
                   
                 0.5 
                 0.5 
                 3 
                 4 
                 0.5 
                 0.5 
                   
                 2 
               
               
                 Vegetable Oil 
                 1 
                 1 
                 1 
                   
                 0.5 
                 0.5 
                 2 
                   
                 0.5 
                 0.5 
                 3 
                 1 
               
               
                   
               
            
           
         
       
     
     Performance Tests: 
     Samples of the polycaprolactone composite material prepared in Examples 1-24 above are tested for related performance using the ASTM D-790 test standard. 
     Where test method each related property for is as follows: 
     Elongation at Break: 
     Samples of the tested material: pressed into Type I; 
     Spline Size (mm): Length×End Width×Thickness=(150±3)×(10±0.3)×(4±0.3); 
     Tensile Speed: 50 mm/min. 
     Molding Time: 
     Injection molding is performed with polycaprolactone composite in Color Plate Injection Molding Plant. 
     Equipment Model: SSF 380-III, 
     Parameters: Nozzle Temperature=160° C.;
         First Segment Temperature=160° C.;   Second Segment Temperature=160° C.       

     Time for normally completing formation: counted in case of spraying a release agent. 
     Flexural Strength and Flexural Modulus: 
     Test standard: ASTM D-790; 
     Length×End Width×Thickness=(150±3)×(10±0.3)×(3±0.3); 
     Bending speed: 20 mm/min. 
     The test results of the related performances of the polycaprolactone composite samples prepared in Examples 1-24 above are shown in Table 2, respectively. 
     
       
         
           
               
             
               
                 TABLE 2 
               
               
                   
               
               
                 Test Results According to Some Embodiments of the Invention 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
               
               
               
               
               
               
               
               
               
            
               
                 Component\Example No.: 
                 1 
                 2 
                 3 
                 4 
                 5 
                 6 
                 7 
                 8 
                 9 
                 10 
                 11 
                 12 
               
               
                   
               
               
                 Elongation at Break (%) 
                 1.5 
                 1.5 
                 1.5 
                 1.5 
                 1.7 
                 1.7 
                 1.8 
                 1.8 
                 1.8 
                 1.8 
                 2.1 
                 2 
               
               
                 Molding Time (s) 
                 120 
                 120 
                 120 
                 120 
                 130 
                 130 
                 140 
                 140 
                 140 
                 140 
                 160 
                 160 
               
               
                 Flexural Strength (MPa) 
                 115 
                 115 
                 115 
                 115 
                 110 
                 110 
                 110 
                 110 
                 110 
                 110 
                 104 
                 105 
               
               
                 Flexural Modulus (MPa) 
                 4100 
                 4150 
                 4100 
                 4103 
                 3820 
                 3800 
                 3515 
                 3510 
                 3515 
                 3510 
                 3340 
                 3345 
               
               
                   
               
               
                 Component/Example No.: 
                 13 
                 14 
                 15 
                 16 
                 17 
                 18 
                 19 
                 20 
                 21 
                 22 
                 23 
                 24 
               
               
                   
               
               
                 Elongation at Break (%): 
                 2.1 
                 2 
                 2.2 
                 2.3 
                 2.2 
                 2.2 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
                 2.5 
                 2.5 
               
               
                 Molding Time (s) 
                 160 
                 160 
                 180 
                 180 
                 180 
                 180 
                 200 
                 200 
                 200 
                 200 
                 230 
                 230 
               
               
                 Flexural Strength (MPa) 
                 104 
                 105 
                 101 
                 100 
                 101 
                 100 
                 95 
                 96 
                 95 
                 96 
                 94 
                 94 
               
               
                 Flexural Modulus (MPa) 
                 3340 
                 3345 
                 3230 
                 3256 
                 3230 
                 3256 
                 3010 
                 3015 
                 3010 
                 3015 
                 2890 
                 2890 
               
               
                   
               
            
           
         
       
     
     From the above examples, through modification of polycaprolactone composite material, it can be seen that the mechanical property and the anti-sticking property of the polycaprolactone composite samples are effectively improved. The above samples are only preferred embodiments of the invention, but do not limit the invention. Any modification, equivalent replacement and improvement made in the invention and principles shall be included in the scope of protection of the invention. 
     Test methods and related parameters can also be as follows: 
     Elongation at Break: 
     Test standard: GB 1040-92; 
     The samples: pressed into an I-shaped; 
     Spline size (mm):
         length=156±3;   end width=20±0.2;   intermediate parallel length=60±0.5;   intermediate parallel width=10±0.2; and   thickness=4±0.2;       

     Stretching speed: 50 mm/min. 
     Tensile Strength: 
     Test standard: ASTM D-638; 
     The samples: type I; 
     Spline size (mm):
         Length×End Width×Thickness=(176±2)×(12.6±0.2)×(3.05±0.2);       

     Stretching speed: 50 mm/min±10%. 
     Flexural Strength and Flexural Modulus: 
     Test standard: ASTM D-790; 
     Sample size (mm):
         length=127±1;   width=12.7±0.2;   thickness=3.2±0.2;       

     Bending speed: 20 mm/min. 
     Molding Time: 
     Injection molding is performed with polycaprolactone composite in Color Plate Injection to 
     Molding Plant. 
     Equipment Model: SSF 380-III, 
     Parameters: Nozzle Temperature=160° C.;
         First Segment Temperature=160° C.;   Second Segment Temperature=160° C.       

     Time for normally completing formation is counted in case of spraying a release agent. 
     According to the test result, a medical fixing support with complex structure can be manufactured through injection molding by adopting the composite material formula provided by the invention. Especially, according to the present invention, the process for one time product formation is simple, the production cycle is short, the production cost is low, the clinical use is simple, any further cutting the product to meet usage of any specific patient is avoided, the clinical patient comfort feeling for wearing the product is greatly improved, and adhesion during heating and shaping operation in clinical use is prevented. 
     According to the present invention, by blending with some fillers, the raw material to make medical fixing support becomes to have better processing and forming performance, making possible to form a complex structure by performing an injection molding process. And the prepared product has certain ductility and is free of adhesion during clinical use. 
     The invention does not use any traditional process, nor is limited by traditional material selections, but selects a new material, a new process, a new pattern and a new structure, so that the manufacturing cost becomes lower, and the manufacturing process becomes simpler. In addition, it is more convenient for doctors to use the invented product, and it is safer for patients to wear the invented product, and it is more suitable for the fixing support for broken bone rehabilitation to be placed on the fracture position following the anatomy of the human body. 
       FIG. 1  is a structural view of an adjustable external fixation brace in an intermediate state in accordance with one embodiment of the present invention.  FIG. 2 a    is a structural view of the embodiment in usage status as shown in  FIG. 1 .  FIG. 2 b    is another structural view of the embodiment in usage state as shown in  FIG. 1 . 
       FIG. 1  shows a raw product of brace/support  10  for adjustably enclosing and fixing on a position of a broken bone externally. Its raw material contains an anti-sticking agent. A shape memory mesh plate  12 , or an intermediate of the brace  10 , is formed one-time by a molding process, having a series of different shaped large openings  11  fully distributed on the mesh plate  12 . This is completely different from prior art. In prior art, a method for producing a mesh plate comprises the steps as follows: forming a solid plate through a vulcanization process; applying an anti-sticking agent on surfaces of the solid plate; punching through holes on the solid plate; then cutting edges of the plate to obtain the needed shape plate. Moreover, in the lag prior art, only a regular array of small holes can be formed, large openings (especially random-shaped large openings) cannot be formed. Random shaped large openings are conducive to obtain isotropy of the formed mesh plate, so that the structural strength of the shape memory mesh plate  12  can be ensured by any stretching deformation of the shape memory mesh plate  12  in any direction. The regular array of large openings instead of small holes in the prior art does not maintain good isotropy, i.e., it is possible to destroy the intermediate of the medical fixing brace by stretching the mesh plate in certain directions. 
     As shown in  FIGS. 1-2 , the irregular shaped large hole or opening  11  has a transition arc  13  whose minimum transition radius is 0.5 mm and minimum transition fillet is 10 degrees. 
     Span B is at least greater than thickness t, preferably less than 50 times of the thickness, and more preferably less than 30 times of the thickness. 
     The ratio of maximum span L to minimum span B is 1:1 to 40:1, preferably 1:1 to 30:1, and more preferably 1:1 to 20:1. 
     The width b of any rib between two adjacent large openings  11  is at least greater than the thickness of the mesh plate, preferably greater than 1.5 times of the thickness, and more preferably greater than 2 times of the thickness. 
     The sum of the areas occupied by the large openings  11  is 25-98%, preferably 27-80%, more preferably 29-60%, and most preferably 30-55% of the full area of the shape memory mesh plate  12 . 
     The shape memory mesh plate  12  has a thickness of at least 3 mm, preferably 4-6 mm, and more preferably 5 mm. For example, the thickness of the portion  14  contacting to the wrist bone in use is thinner than the other portions; and a particular shaped oval hole  15  corresponding to the thumb is pre-arranged on a suitable portion of the mesh plate. The oval hole  15  may be in a shape of a peach, ellipse, generally triangular, etc. depending on actual needs. 
     The anti-sticking agent may be a single or composite anti-adhesive that prevents the shape-memory mesh plate  12  from sticking during the molding process to facilitate removal from the mold. 
     As shown in  FIG. 1 , the adjustable external fixing brace  10  is used for rehabilitation of a patient&#39;s arm. In other embodiments, the concepts of the present invention are equally applicable to a brace for fixing on a position of limbs, chest, neck, waist, hand, foot, etc. where has a broken bone. 
     Adjacent to the two sides, parallel to longitudinal direction, of the adjustable outer fixing support  10  are provided with a plurality of snap-fit means of the enclosing and locking means  16 , which may be adhered to, inserted into, or integral with the shape-memory mesh plate  12 . The thickness of snap-fit means of the enclosing and locking means  16  may be substantially the same as that of the shape-memory mesh plate  12 . 
     In the embodiment as shown in  FIG. 3 a   , the enclosing and locking means  16  may be a snap-in configuration. The enclosing and locking means  16  mounted on one side of the shape-memory mesh plate  12  has a check strap  161 . There are provided with straight teeth  163  on the check strap  161 . The enclosing and locking means  16 , which is mounted on the other side of the shape memory mesh plate  12 , is provided with a slot  162  and a check rod  164 . The slot  162  is provided to make the check strap  161  pass through thereof and make the rod  164  engagement with one of the straight teeth  163 , so that the check strap  161  cannot be pulled back to facilitate locking of the enclosing and locking means  16 . However, when the rod  164  is manually turned away, the check strap  161  can freely drawback to facilitate relaxation of the enclosing and locking means  16 . 
     In the embodiment as shown in  FIG. 3 b   , the enclosing and locking means  16  may be a nylon tape structure. The enclosing and locking means  16  mounted on one side of the shape memory mesh plate  12  is provided with a nylon seat  161  having nylon upright piles  163  thereon. The enclosing and locking means  16 , which is mounted on the other side of the shape memory mesh plate  12 , is provided with a nylon strap  162  provided with nylon loops  164 . If making the nylon upright piles  163  and the nylon loops  164  bond together, the enclosing and locking means  16  is locked. When the nylon loops  164  are manually pulled apart from the nylon upright piles  163 , the enclosing and locking means  16  is released. 
     In the embodiment as shown in  FIG. 3 c   , the enclosing and locking means  16  may be a button structure. The enclosing and locking means  16  mounted on one side of the shape memory mesh plate  12  is provided with a button seat  161  having barbed teeth  163  thereon. The enclosing and locking means  16 , which is mounted on the other side of the shape memory mesh plate  12 , is provided with a button  162  on which hooks  164  are provided. When the hooks  164  are snapped onto the teeth  163 , the connection device  16  is locked. When the button  162  is pulled apart manually from the button seat  161 , the enclosing and locking means  16  is released. 
     In the embodiment as shown in  FIG. 3 d   , the enclosing and locking means  16  may be a tongue-and-tenon structure. The enclosing and locking means  16  mounted on one side of the shape-memory mesh plate  12  is provided with a female connector  161  having a plurality of stepped grooves  163  in a row. The enclosing and locking means  16 , which is mounted on the other side of the shape memory mesh plate  12 , is provided with a male connector  162  with a trapezoidal head  164 . When the trapezoidal head  164  is inserted into one of stepped grooves  163 , the enclosing and locking means  16  is locked. When the trapezoidal head  164  is manually loosened, the enclosing and locking means  16  is also released. 
     In the embodiment as shown in  FIG. 3 e   , the enclosing and locking means  16  may be a belt with a fixing pin and a series of holes. The enclosing and locking means  16  mounted on one side of the shape-memory mesh plate  12  is provided with a belt fixing end  161  with a fixing needle  163  thereon. The enclosing and locking means  16 , which is mounted on the other side of the shape memory mesh plate  12 , is provided with a needle receiving end  162  of the belt which is provided with a series of holes  164 . When the fixing needle  163  is inserted into one of holes  164 , the enclosing and locking means  16  is locked. When manually taking the fixing needle  163  out of the certain hole  164 . the enclosing and locking means  16  is released. 
     According to the invention, the adjustable external fixing support is made from a modified high-molecular material which is selected from the group consisting of polycaprolactone, polypropylene/polyethylene, calcium carbonate, glass fiber, oxytitanate coupling agent, grafted polypropylene, grafted polyethylene, polyethylene wax, calcium stearate, stearamide, vegetable oil, a blend thereof, or a combination thereof. 
     According to the invention, the adjustable external fixing support is made by the injection molding process, in which the shape memory mesh plate with the large openings distributed thereon is formed in a mold at one time. The molding raw material itself contains the anti-sticking agent, so that the product no longer needs to be coated with the anti-sticking agent on surfaces thereof. In addition, the raw material is selected from the group consisting of polycaprolactone, polypropylene/polyethylene, calcium carbonate, fiberglass, oxytitanate coupling agent, graft polypropylene, graft polyethylene, polyethylene wax, calcium stearate, stearamide, vegetable oil, blends thereof, or combinations thereof. 
     According to the invention, when the adjustable external fixing support is used by a doctor, firstly, a shape memory mesh plate, which is distributed with large openings and made from a modified high-molecular material, is heated to soften at the temperature of 70-80° C. (or 60-70° C. for softening); then temperature of the shape memory mesh plate distributed with large openings thereon is cooled to 65° C. (preferably less than 60° C., more preferably less than 50° C.) within 15 minutes (preferably 12 minutes, more preferably 10 minutes), then the doctor can encompass the mesh plate on the wounded site where the patient needs to be fixed, with stretching and deforming to make the shape memory mesh plate with distributed large openings fitted to where the patient is injured; then the two cross edges of the shape memory mesh plate distributed with large openings are connected together. 
     The adjustable external fixation brace according to the present invention employs a thermoplastic memory and degradable material selected from the group consisting of polycaprolactone, polypropylene/polyethylene, calcium carbonate, glass fibers, oxytitanate coupling agents, graft polypropylene, graft polyethylene, polyethylene wax, calcium stearate, stearamide, vegetable oil, blends thereof, and combinations thereof. The mixed raw materials are subjected to injection molding, so that a shape memory mesh plate with large-holes is formed at one time. Preferably, a curing agent, a rigid reinforcing agent and the like are also added into the mixed raw material. 
       FIG. 4  shows a wrist fixation brace having a structure very similar to the arm fixing support as shown in  FIGS. 1-3 , and any illustration will not be repeated hereafter. 
     The invention relates to a support for fixing a position of an injured bone. The support is made by an injection molding. The fixing support is made from a homogeneous shape memory modified material, so it is stretchable and can be deformed to have a spatial curved surface. The fixing support has no coating. The modified material comprises the following components in percentage by weight: 40 to 80% of polycaprolactone, 15 to 55% of filler, and 2.6 to 14.5% of auxiliary materials. As an intermediate of the fixing support, a mesh plate according to the invention is arranged with large air holes, and hollowed-out areas account for 7-70% of the total area of the mesh plate. Recovering of the wound can be inspected directly though the large-holes, so any complication after trauma can be avoided. The enclosing and locking means according to the invention is adjustable, so that the clamping tightness of the fixing brace can be adjusted at any time in the wound recovering period, to enjoy both maintenance of suitable compression on soft tissue and good fixing effect. It is convenient for the doctor to take care of the postoperative wound for the enclosing and locking means is easy to disassemble. During wearing the fixing brace, it is necessary to further modify the formed mesh plate according to a current size of position of the broken bone of the patient, so it is simple and convenient for the doctor to take the shape changed mesh plate as the updated fixing brace. The material according to the invention does not absorb water and has no pad structure, so it is quick in drying after bathing, and it is good in comfort for the wearer. As a result, the health of skin is greatly improved for the skin of the wounded site can enjoy fresh air and even bathing, and any pruritus and dermatitis can be avoided. The external fixing brace according to the invention can be used for bone support of the upper limb, the neck, the chest, the waist, the lower limb and the like. 
     In the embodiment as shown in  FIG. 5 , snap-fit means  101 ,  102  are mounted on both sides of the mesh plate  100  adjacent its lateral edges, respectively. The snap-fit means  101 ,  102  are each provided with an anchoring end head  103  and a fixing end head  104 , respectively, that can be rotatable with respect to the connecting band  105  of the mesh plate  100 . In clinical use, the mesh plate  100  is shaped such that its inner surface I surrounds the patient&#39;s injury. And on the outer surface O, the anchor end  106  of the connecting band  105  is fixed within the anchoring end head  103 , and the fixing end  107  of the connecting band  105  is fixed within the connecting end head  104 , thereby enclosing the mesh plate  100 . 
       FIG. 6  is a partially enlarged schematic view of a finally positioned and assembled structure of the snap-fit means  101 ,  102 . And  FIGS. 7A-7B  are schematic exploded views of the positioning and mounting structure of the snap-fit means  101 ,  102 . 
     As shown in  FIGS. 5-6, 7A and 7B , according to the first aspect of the present invention, there is provided a medical fixation brace, which is reshaped from a mesh plate  100  provided with a plurality of large vents, and it is injection molded from a shape memory material; on the front and back surfaces O, I, a plurality of step holes  99 ,  98  for mounting the snap-fit means  101 ,  102  are symmetrically arranged along each side of the mesh plate  100  adjacent to its lateral edge, or a plurality of step holes  99 ,  98  for mounting the snap-fit means are provided on at least one surface thereof; at the step holes  99 ,  98 , the thickness of the mesh plate  100  is thinned; and the step holes  99 ,  98  are assembled with parts  111 ,  110  for mounting the end heads. 
     Preferably, the snap-fit means  101 ,  102  is provided with a snap-fit seat  110  and a snap-fit post  119 ; the snap-fit seat  110  is disposed within the mounting pocket/step hole  98  provided on one side I of the mesh plate  100 , and the snap-fit post  119  is rotatably inserted into the snap-fit seat  110  from the outer surface O of the mesh plate  100 , and cannot be drawn out of the snap-fit seat  110 . 
     Preferably, the snap-fit seat  110  is provided with an elastically expandable check barrel  114 . The snap-fit post  119  is provided with a check head  112  with a stop face  117 . The resiliently check barrel  114  retracts radially after the check head  112  of the snap post  119  traverses the check barrel  114 , such that the end face  118  of the check barrel  114  comes into contact with the stop face  117  of the check barrel  114  of the check head  112 , but the snap-fit post  119  can rotate arbitrarily within a 360 degree range within the check barrel  114 . 
     Preferably, the snap-fit post  119  is further provided with a head portion  103 ,  104 , which is provided with a channel  120 ,  121  which is a channel for fixing the anchoring end  122  of the strap  105 , and/or a channel for gearing into the locking end  123  of the strap  105 . 
     Preferably, the channel used to stop the anchoring end  122  of the strap  105  is a step square hole, while the channel used to gear into the fixing end  123  of the strap  105  is provided with a stop tongue  124 . Preferably, the stop tongue  124  is provided with a stop tooth  125 . 
     Preferably, the check barrel  114  is disposed at a central portion of the snap mount  110 , which includes a base plate, the check barrel  114  is disposed in the center of the base plate, being perpendicular to the base plate. Preferably, the side wall of the check barrel  114  is provided with at least one slit along its parent line. 
     Preferably, a guiding sleeve or guiding rod  115  perpendicular to the base plate is symmetrically provided on both sides of the check barrel  114  with respect to the longitudinal direction of the base plate. 
     Preferably, there is further provided with a snap flap  111 . In the center of the snap flap  111 , there is provided with a central bore  126  that mates with the outer peripheral surface of a support cylinder  113  of the check barrel  114 . Both sides of the snap flap  111  are symmetrically provided with a guiding rod or guiding sleeve  116  that is perpendicular to the snap flap  111 . The guiding rod or guiding sleeve  116  mates with the guiding sleeve or guiding rod  115 . 
     Preferably, the thickness of the base plate outside the guiding sleeve or guiding rod  115  is not greater than the thickness of the base plate inside between the two guiding sleeves or guiding rods  115  with respect to the longitudinal direction of the base plate. The outer diameter of one end of the check barrel  114  away from the base plate is not smaller than the outer diameter of the check barrel  114  adjacent to the other end of the base plate. The check barrel  114  is connected with the base plate through the support cylinder  113 . The included angle formed between the outer side wall of the check barrel  114  and the inner side wall of the support cylinder  113  is an acute angle. 
     Preferably, the sum of the height of the check barrel  114  and the height of the check head  112  is not greater than the height of the support cylinder  113 . 
     Preferably, the material of the mesh plate comprises 40-75 wt % of polycaprolactone, 18-50 wt % of filler, and 7-10 wt % of auxiliary materials. Preferably the material further comprises a coupling agent. In the mesh plate with large ventilation holes, the hollowed-out areas account for 7-70% of the total area of the mesh plate. 
     According to the second aspect of the present invention, there is provided a fixing support which has large ventilation holes thereon, is formed by injection molding, and is made from a shape memory material, in which a blended raw material comprises polycaprolactone, filler and auxiliary materials (preferably, with respect to compositions, the raw material comprises 40-75 wt % of polycaprolactone, 18-50 wt % of a filler, and 7-10 wt % of an auxiliary material; preferably, the raw material further comprises a coupling agent); with the large ventilation holes, the hollowed-out areas account for 7-70% of the total area of the fixing support; and the enclosing and locking means is capable of being disassembled and capable of adjusting the locking tightness thereof. 
     Preferably, the filler is polypropylene and/or polyethylene; and/or, the filler is calcium carbonate and/or glass fiber. 
     Preferably, the coupling agent is monoalkoxy titanate; the auxiliary material is grafted polypropylene and/or grafted polyethylene; and/or, the auxiliary material is polyethylene wax, calcium stearate, stearamide, and/or vegetable oil. 
     Preferably, the adjustable outer fixing support is provided with a snap-fit means adjacent to the two edges parallel to longitudinal axis of the fixing support; the snap-fit means can be adhered on/inserted into the shape memory mesh plate or integrated with the shape memory mesh plate; the thickness of the snap-fit means can be approximately the same as that of the shape memory mesh plate; the enclosing and locking means can be a backstop buckle structure, a nylon adhesive tape structure, a button structure, a mortise and tenon structure, or a waistband type structure with a fixing needle and a series of receiving holes. 
     In accordance with the third aspect of the present invention, there is provided a method for making a fixation brace, comprising the steps of: weighing the components, respectively, according to the polycaprolactone composite formulation; mixing the weighed components to obtain a mixed material; making melt extrusion and granulation on the mixed material to obtain the polycaprolactone composite material; wherein in the melt extrusion, a first zone (rear zone) temperature is 130-140° C., a second zone (middle zone) temperature is 140-150° C., a third zone (middle zone) temperature is 150-160° C., a fourth zone (front zone) temperature is 160-170° C., an injecting nozzle temperature is 170-180° C., a residence time is 1-2 min, and a pressure is 10-20 MPa. 
     Preferably, the composite material is subjected to drying treatment before pre-mixing, in which the drying temperature is 30-50° C.; the materials are melted and blended at 20-80 rpm; then the cast strip is extruded, and granulation is carried out for further melt molding. 
     Preferably, the outer fixing support is one-time formed in an injection molding process to obtain a shape memory mesh plate with irregularly shaped large openings; and the raw material is doped with an anti-sticking agent. 
     Preferably, the anti-sticking agent is selected from the group consisting of polyethylene wax, calcium stearate, stearamide, and vegetable oil. 
     According to the fourth aspect of the present invention, there is provided a method for using an adjustable external fixation brace, characterized in that a shape memory mesh having large vents is heated at 70-80° C. for softening; stretching is performed according to the size of position of broken bone of the patient so as to suitable for putting the mesh plate on a site where the patient&#39;s bone needs to be fixed; then a cleavage formed between the two side edges of the mesh plate is connected together with a plurality of the enclosing and locking means. 
     In accordance with the fifth aspect of the present invention, there is provided a usage of an adjustable external fixation brace, characterized in that the adjustable external fixation brace is used for, but is not limited to, any patient&#39;s position requiring rehabilitation, i.e. hand (including fingers, palm, wrist), upper limb portions, neck, chest, waist, lower limb portions, or feet (including ankle, sole, toes). 
     Having disclosed concepts according to the aspects of the present inventive, it will be apparent to those skilled in the art from this disclosure that various improvements, substitutions, additions, modifications, variations, and the like can be made to the disclosed embodiments of the present invention without departing from the scope of protection as defined by the appended claims.