CN104068956A - High-strength degradable bone fracture binding band and preparation method thereof - Google Patents
High-strength degradable bone fracture binding band and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a high-strength degradable bone fracture binding band and a preparation method of the high-strength degradable bone fracture binding band and belongs to the technical field of medical instruments. The bone fracture binding band is formed by combined preparation of a high-strength orientation fiber band and a randomly arranged fiber film or a random orientation thin film. The degree of crystallinity is increased through a nucleating agent, and the orientation technology is adopted to obtain the high-strength orientation fiber band; the bone fracture binding band is prepared under the condition that the linear speed of a disc-shaped yarn take-up device is greater than or equal to 500 m/min by the adoption of the solution electrospinning technology; the mass percent of a spinning solution is that a degradable polymer accounts for 5-12%, the nucleating agent accounts for 0.5-2%, and a solvent accounts for 86-95%. The orientation fiber band is arranged in a single orientation or double orientations, the random fiber film is sprayed on the surface of the orientation fiber band, or the random orientation thin film is stacked on the orientation fiber band, and then the bone fracture binding band is prepared by means of ultrasonic welding. The tensile strength and tensile modulus of the prepared bone fracture binding band are improved substantially compared with those of a randomly arranged electrostatic spinning film, and the bone fracture binding band has good application prospect with respect to repair and fixation of clinical bone fractures.
Description
Technical field
The invention belongs to technical field of medical instruments, particularly fracture strapping tape of a kind of high-strength degradable and preparation method thereof.
Background technology
Fracture refers to that the seriality of bone structure ruptures wholly or in part.The main cause that fracture occurs mainly contains three kinds of situations: the one, and direct violence, violence directly acts on a certain position of skeleton and causes this fracture, is fractured in injury, often accompanies soft tissue injury in various degree.As wheel clashes into shank, there is fracture of shafts of tibia and fibula in shock place; The 2nd, indirect violence, indirect violence is done the used time to be made to fracture at a distance by longitudinal conduction, leverage or twisting action, while landing as fallen foot from eminence, trunk is because gravity relation is sharply to pre-buckling, vertebral body generation compressibility or the bursting fracture of breast lumbar spine intersection; The 3rd, accumulation property strain, for a long time, repeatedly, slight direct or indirect damage can cause a certain specific part fracture of limbs, claims again fatigue fracture, as remote walking easily causes 1/3 shaft fracture under second and third metatarsal and fibula.
Fracture is the very high clinical case of proportion in the traumatology department, and treatment measure has reset, fixing, rehabilitation training and medicine auxiliary treatment etc.After resetting and to be fixed be one of method of the most often taking of at present treatment fracture, bone injury, aspect fractures, there is good curative effect.Internal fixation device is treatment fracture, the indispensable medical apparatus and instruments of bone wound.
For a long time, the main fracture fixation material of domestic and international clinical employing is the metal materials such as rustless steel, titanium alloy.Adopt metal material to there is the advantages such as the high and technology comparative maturity of good stability, intensity.But, in practical clinical process, find that metal material exists following defect: (1) elastic modelling quantity is large, has produced significant stress shielding in therapeutic process, easily cause osteoporosis, osseous tissue to recover slowly and easily to cause the problems such as secondary fracture; (2) biocompatibility of part metals material is not good enough, causes sometimes inflammatory reaction; (3) after recovery from illness, often need second operation to be taken out, not only strengthened the misery of patient, and increased patient's financial burden.
Along with progress and the development of synthesis of polymer material technology, biological medical degradable macromolecular material and material modified application in bio-medical field thereof are increasingly extensive, and become gradually one of popular domain of domestic and international research and application.Compared with the metal material of non-degraded, degradable high polymer material fracture fixation material has following advantage: the one, along with the prolongation of Implantation Time, material is constantly degraded, and device strength constantly reduces, can effectively reduce or eliminate due to stress-shielding effect cause osteoporosis; The 2nd, do not need second operation to take out, reduce operation spending and reduced patient's misery.But biological medical polymer fracture fixation material weak point is that its hot strength and stretch modulus are far below metal material, can not meet the requirement of fracture fixation under the higher occasion of requirement of strength.Therefore the fracture fixation apparatus that, adopts Biodegradable polymer material to prepare high strength, high-modulus becomes one of the study hotspot in this field.
Summary of the invention
The lower deficiency of strength and modulus that the present invention is directed to Biodegradable high-molecular fracture fixation material, primary and foremost purpose is the preparation method of the fracture strapping tape that a kind of high-strength degradable is provided.The prepared fracture strapping tape of the present invention has replaced the fracture strapping tape of existing metal material, for having high, the degradable novel fracture strapping tape of intensity, and provides corresponding preparation method.A further object of the present invention is the fracture strapping tape of the high-strength degradable that above-mentioned preparation method acquisition is provided.
Object of the present invention is achieved through the following technical solutions: a kind of fracture strapping tape of high-strength degradable, is prepared from by high oriented fibers band and random arrangement fibrous membrane or random orientation Film laminated;
Described high oriented fibers band is prepared by electrostatic spinning by the raw material of following percentage composition: degradable polymer 5～12%, nucleator 0.5～2%, solvent 86～95%; Described high oriented fibers band utilizes directional technology to obtain orientation arrangement structure, and its hot strength is improved largely compared with random orientation fiber.
The thickness of described high oriented fibers band is 0.5～50um, width 2～10mm, fibre diameter 0.02～2.0um, plays the effect of fixedly tying up, and provides and ties up required mechanical strength;
The thickness of described random arrangement fibrous membrane or random orientation thin film is 0.5～40um, length >=4.0mm, width >=4.0mm, plays auxiliary fixation, facilitates fixing broken bone in operation process; Have degradable characteristic, the macromolecular chain in cellulose membrane or thin film is random orientation and arranges.
Described degradable polymer is at least one in polylactic acid (PLA), PGA (PGA) or poly (glycolide-lactide) (PGLA); The number-average molecular weight of described degradable polymer is 50,000～500,000;
Described nucleator is sodium citrate, is preferably medical grade sodium citrate, its purity >=99.0%;
Described solvent is with at least one in hexafluoroisopropanol, dichloromethane or oxolane;
The preparation method of the fracture strapping tape of above-mentioned high-strength degradable, comprises the following steps:
(1) take in the degradable polymer of 5～12 mass parts, solvent that 0.5～2 mass parts nucleator is dissolved in 86～95 mass parts and obtain electrostatic spinning solution I, adopt electrostatic spinning machine to carry out electrostatic spinning, apply spinning under the condition of dish-shaped wire drawing device on-line velocity >=500m/min, then put into vacuum drying oven and process after 24h, preparing thickness is the high oriented fibers band of 0.5～50um, width 2～10mm, fibre diameter 0.02～2.0um;
(2) high oriented fibers band step (1) being prepared is orientated by list respectively or double orientation even structure is arranged the surface that is stacked on random arrangement fibrous membrane or random thin film;
(3) material of heap in step (2) being folded is put into ultrasonic welding machine, adopt the weld mold of some column type or grid type to weld, pressure 1.0MPa, weld interval 1.5s, cool time 2.0s, make the fracture strapping tape (as depicted in figs. 1 and 2) of single orientation or double orientation, obtain the fracture strapping tape of high-strength degradable.
Degradable polymer described in step (1) is at least one in polylactic acid (PLA), PGA (PGA) or poly (glycolide-lactide) (PGLA); Described polylactic acid is preferably Poly-L-lactic acid (PLLA) or dextrorotation polylactic acid (PDLA), and with left-handed monomer or dextrorotation monomer polymerization and the high molecular polymer obtaining, the number-average molecular weight of described polylactic acid is 50,000～500,000; Described PGA is the high molecular polymer obtaining with glycolide monomer polymerization, and the number-average molecular weight of described PGA is 50,000～500,000; Described poly (glycolide-lactide) is for to carry out copolymerization gained high molecular polymer with Acetic acid, hydroxy-, bimol. cyclic ester and two kinds of monomers of lactide, and the number-average molecular weight of described poly (glycolide-lactide) is preferably 50,000～500,000.
Nucleator described in step (1) refers to sodium citrate, is preferably medical grade sodium citrate, its purity >=99.0%;
Described sodium citrate refers to by starchy material and generates citric acid through fermentation, then neutralizes with alkaloids the product that is prepared from gained, purity >=99.0%.Sodium citrate plays Nucleation to degradable polymer, further improves the strength and modulus of strapping tape by improving the degree of crystallinity of material.
Solvent described in step (1) is with at least one in hexafluoroisopropanol, dichloromethane or oxolane;
As preferred embodiment, in step (2), on high oriented fibers band, cover another random arrangement fibrous membrane or random thin film;
Random arrangement fibrous membrane described in step (2) is prepared by following methods:
The concentration that degradable polymer is become with solution allocation is the electrostatic spinning solution II of 5～8wt%, to being fixed with the dull and stereotyped wire drawing device surface spray webbing of high oriented fibers band, spray webbing thickness 0.5～20um, then puts into vacuum drying oven and processes 24h, obtains random arrangement fibrous membrane;
Described degradable polymer is at least one in polylactic acid (PLA), PGA (PGA) or poly (glycolide-lactide) (PGLA); The number-average molecular weight of described degradable polymer is 50,000～500,000;
Described solvent is with at least one in hexafluoroisopropanol, dichloromethane or oxolane;
Random thin film described in step (2) is prepared by following methods:
Taking degradable polymer as raw material, adopt the method for hot-forming or melt spinning to prepare the random thin film that thickness is 15～20um;
Described degradable polymer is at least one in polylactic acid (PLA), PGA (PGA) or poly (glycolide-lactide) (PGLA); The number-average molecular weight of described degradable polymer is 50,000～500,000.
The fracture strapping tape of the high-strength degradable that above-mentioned preparation method obtains as internal fixation device the reparation of clinical fracture and fixing aspect application.
The present invention has following advantage and effect with respect to prior art:
(1) sodium citrate is a kind of safety non-toxic, wide material sources, biodegradation material, by becoming nuclear effect to improve the degree of crystallinity of polylactic acid, PGA and poly (glycolide-lactide), can effectively improve the strength and modulus of material, sodium citrate decomposes and becomes citric acid in human body, further decomposes and changes carbon dioxide and water into;
(2) compared with non-orientation biodegradable fiber material, the present invention by directional technology with become strapping tape prepared by nuclear technology to there is excellent strength and modulus, can meet the high strength requirement of fracture operation when fixing;
(3) compared with metal strapping strand, strapping tape of the present invention has biodegradable performance, and along with the prolongation of Implantation Time, the mechanical property of guipure reduces gradually, finally resolve into that tissue can absorb or eliminable low-molecular-weight component, after healing, do not need second operation;
(4) strapping tape is designed to length and width >=4.0mm planar band, has avoided single piece of metal guipure in operation process, to operate the deficiencies such as not convenient, operating time is long;
(5) mechanical property of orientation fibers band is well below metal material, and its thickness and degree of orientation scalable, avoids the problems such as the excessive stress shielding causing of Strength of Metallic Materials, in clinical operation, is with a wide range of applications.
Brief description of the drawings
Fig. 1 is the structural representation of single orientation fracture strapping tape in the present invention;
Fig. 2 is the structural representation of double orientation fracture strapping tape in the present invention;
Fig. 3 is the structural representation of the some column type weld mold in ultrasonic welding mould in the present invention;
Fig. 4 is the structural representation of the grid type weld mold in ultrasonic welding mould in the present invention;
Wherein: 1 high oriented fibers band, 2 random arrangement fibrous membranes or random orientation thin film, 3 posts, 4 grids.
Specific embodiment
embodiment 1
(1) accurately weighing number-average molecular weight is 200,000 Poly-L-lactic acid (PLLA) 12g and citric acid 0.5g, dissolve in the hexafluoroisopropanol of 87.5g, adopt electrostatic spinning machine to carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 500m/min, to prepare thickness be that 0.5um, width are the high oriented fibers band (as shown in the high oriented fibers band 1 in Fig. 1 or Fig. 2) of 2mm, fibre diameter 1～2um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) above-mentioned orientation fibers band is evenly arranged in to the dull and stereotyped wire drawing device surface of electrostatic spinning machine, be dissolved in taking number-average molecular weight as 100,000 PLLA and in hexafluoroisopropanol, be made into the spinning solution of concentration as 5wt%, to being fixed with the dull and stereotyped wire drawing device surface spray webbing of orientation fibers band, spray webbing thickness 0.5um, then puts into vacuum drying oven and processes 24h(random arrangement fibrous membrane as shown in Figures 1 and 2);
(3) above-mentioned strapping tape is put into ultrasonic welding machine, adopt grid type weld mold (to see accompanying drawing 4, described grid type weld mold comprises equally distributed grid 4 structures) weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made the fracture strapping tape (as Fig. 1) of single orientation.
embodiment 2
(1) accurately weighing number-average molecular weight is 300,000 dextrorotation polylactic acid (PDLA) 5g and sodium citrate 1g, be dissolved in dichloromethane, then carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 700m/min, to prepare thickness be that 10um, width are the high oriented fibers band that 5mm, fibre diameter are 0.1～1.0um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) by above-mentioned PDLA fabric strip respectively along the horizontal and vertical dull and stereotyped wire drawing device surface that is evenly arranged in electrostatic spinning machine, be dissolved in taking number-average molecular weight as 100,000 PDLA and in dichloromethane, be made into the spinning solution of concentration as 8wt%, to being fixed with the dull and stereotyped wire drawing device surface spray webbing of orientation fibers band, spray webbing thickness 20um, then puts into vacuum drying oven and processes 24h;
(3) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopt some column type weld mold (to see accompanying drawing 3, described some column type weld mold includes multiple somes posts 3 structures) weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made the fracture strapping tape of single orientation.
embodiment 3
(1) accurately weighing number-average molecular weight is 200,000 PGA 8g and sodium citrate 1.5g, be dissolved in the oxolane of 90.5g, then carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 850m/min, to prepare thickness be that 25um, width are the high oriented fibers band that 10mm, fibre diameter are 0.1～1.0um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) by above-mentioned orientation fibers band respectively along the horizontal and vertical dull and stereotyped wire drawing device surface that is evenly arranged in electrostatic spinning machine, be dissolved in taking number-average molecular weight as 50,000 PGA and in oxolane, be made into the spinning solution of concentration as 5wt%, adopt electrostatic spinning machine at dull and stereotyped wire drawing device surface spray webbing, after reaching 10um, spray webbing thickness suspends spray webbing, above-mentioned strapping tape is turned over, also spray webbing 10um thickness on another side, then puts into vacuum drying oven and processes 24h;
(3) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopt grid type weld mold (seeing accompanying drawing 4) to weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made that orientation fibers is clipped in the middle, the fracture strapping tape of double orientation.
embodiment 4
(1) accurately weighing number-average molecular weight is 300,000 PLGA 6g and sodium citrate 2g, be dissolved in 92g hexafluoroisopropanol/dichloromethane mixed solvent (80:20), then adopt electrostatic spinning machine to carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 1000m/min, to prepare thickness be that 50um, width are the high oriented fibers band that 5mm, fibre diameter are 0.05～0.5um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) PLGA taking number-average molecular weight as 80,000, as raw material, adopts hot-forming method to prepare the PGLA thin film that thickness is 15um (random orientation thin film as shown in Figures 1 and 2);
(3) first spread a PLGA thin film, then by orientation fibers band respectively along horizontal and vertical its surface that is evenly arranged in, cover a PLGA thin film in the above;
(4) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopts a some column type mould (seeing accompanying drawing 3) to weld, and pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made that orientation fibers is clipped in the middle, the fracture strapping tape of double orientation.
embodiment 5
(1) accurately weighing number-average molecular weight is 200,000 PGA 5g and sodium citrate 1g, be dissolved in and in 94g hexafluoroisopropanol/oxolane mixed solvent (60:40), be made into the solution that concentration is 5wt%, then adopt electrostatic spinning machine to carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 1200m/min, to prepare thickness be that 20um, width are the high oriented fibers band that 5mm, fibre diameter are 0.02～0.4um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) PLLA taking number-average molecular weight as 150,000, as raw material, adopts melt spinning method to prepare the PLLA non-woven fabrics that thickness is 15um left and right;
(3) first spread a PLLA non-woven fabrics, then by PLLA fabric strip respectively along horizontal and vertical its surface that is evenly arranged in, cover a PLLA non-woven fabrics in the above;
(4) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopt grid pad mould (seeing accompanying drawing 4) to weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made that orientation fibers is clipped in the middle, the fracture strapping tape of double orientation.
embodiment 6
(1) accurately weighing number-average molecular weight is 500,000 PGA 5g and sodium citrate 0.8g, be dissolved in the hexafluoroisopropanol of 84.5g, then adopt electrostatic spinning machine to carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 800m/min, to prepare thickness be that 20um, width are the high oriented fibers band that 5mm, fibre diameter are 0.1～1.0um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) PGA taking number-average molecular weight as 150,000, as raw material, adopts melt spinning method to prepare the PGA non-woven fabrics that thickness is 20um;
(3) first spread a PGA non-woven fabrics, then by PGA fabric strip respectively along horizontal and vertical its surface that is evenly arranged in, cover a PGA non-woven fabrics in the above;
(4) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopt grid type weld mold (seeing accompanying drawing 4) to weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made that orientation fibers is clipped in the middle, the fracture strapping tape of double orientation.
comparative example 1
(1) accurately weighing number-average molecular weight is 200,000 PGA 8g, be dissolved in the oxolane of 92g, then carry out electrostatic spinning, adopt that under the condition that dish-shaped wire drawing device, on-line velocity are 850m/min, to prepare thickness be that 25um, width are the high oriented fibers band that 10mm, fibre diameter are 0.1～1.0um, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) by above-mentioned orientation fibers band respectively along the horizontal and vertical dull and stereotyped wire drawing device surface that is evenly arranged in electrostatic spinning machine, be dissolved in taking number-average molecular weight as 50,000 PGA and in oxolane, be made into the spinning solution of concentration as 5wt%, adopt electrostatic spinning machine at dull and stereotyped wire drawing device surface spray webbing, after reaching 10um, spray webbing thickness suspends spray webbing, above-mentioned strapping tape is turned over, also spray webbing 10um thickness on another side, then puts into vacuum drying oven and processes 24h;
(3) material of above-mentioned heap being folded is put into ultrasonic welding machine, adopt grid type weld mold (seeing accompanying drawing 4) to weld, pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made that orientation fibers is clipped in the middle, the fracture strapping tape of double orientation.
comparative example 2
(1) Poly-L-lactic acid that is 200,000 by number-average molecular weight (PLLA) is dissolved in and in hexafluoroisopropanol, is made into the solution that concentration is 8wt%, then adopt electrostatic spinning machine to carry out electrostatic spinning, adopting dull and stereotyped wire drawing device to prepare thickness is the random orientation PLLA fibrous membrane that 20um, fibre diameter are 0.2～1.0um, cutting into width is the PLLA fabric strip of 5mm, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) above-mentioned PLLA fabric strip is evenly arranged in to the dull and stereotyped wire drawing device surface of electrostatic spinning machine, be dissolved in taking number-average molecular weight as 100,000 PLLA and in hexafluoroisopropanol, be made into the spinning solution of concentration as 5wt%, adopt electrostatic spinning machine at dull and stereotyped wire drawing device surface spray webbing, spray webbing thickness 20um, make randomly-oriented fracture strapping tape, then put into vacuum drying oven and process 24h.
comparative example 3
(1) PGA that is 200,000 by number-average molecular weight is dissolved in and in hexafluoroisopropanol, is made into the solution that concentration is 8wt%, then adopt electrostatic spinning machine to carry out electrostatic spinning, adopt dull and stereotyped wire drawing device to prepare the PGA fibrous membrane of random lapping, being prepared into thickness is that 20um, fibre diameter are 0.2～1.0um fabric strip, then cutting into width is the PGA fabric strip of 5mm, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) by above-mentioned PGA fabric strip respectively along the horizontal and vertical dull and stereotyped wire drawing device surface that is evenly arranged in electrostatic spinning machine, be dissolved in taking number-average molecular weight as 50,000 PGA and in hexafluoroisopropanol, be made into the spinning solution of concentration as 6wt%, adopt electrostatic spinning machine at dull and stereotyped wire drawing device surface spray webbing, spray webbing thickness 20um, make randomly-oriented fracture strapping tape, then put into vacuum drying oven and process 24h.
comparative example 4
(1) PLGA that is 200,000 by number-average molecular weight is dissolved in and in hexafluoroisopropanol, is made into the solution that concentration is 8wt%, then adopt electrostatic spinning machine to carry out electrostatic spinning, adopt dull and stereotyped wire drawing device to prepare the PLGA fibrous membrane of random lapping, being prepared into thickness is that 20um, fibre diameter are 0.1～2.0um random orientation fabric strip, cut into the fabric strip that width is 5mm, then put into vacuum drying oven and process 24h, its mechanical experimental results is in table 1, and degradation property result is by table 2;
(2) by above-mentioned PLGA fabric strip respectively along the horizontal and vertical dull and stereotyped wire drawing device surface that is evenly arranged in electrostatic spinning machine, be dissolved in taking number-average molecular weight as 200,000 PGAL and in hexafluoroisopropanol, be made into the spinning solution of concentration as 6wt%, adopt electrostatic spinning machine at dull and stereotyped wire drawing device surface spray webbing, spray webbing thickness 20um, make randomly-oriented fracture strapping tape, then put into vacuum drying oven and process 24h.
The mechanical property testing result of the strapping tape that above-described embodiment and comparative example obtain is as shown in table 1:
From the test result of table 1, comparative example 1 adopts directional technology to prepare orientation fibers band, and its hot strength and stretch modulus are far away higher than random arrangement fiber.Add sodium citrate (seeing embodiment 3) after-drawing strength and modulus and further improve, elongation at break decreases.Illustrate that orientation technology can improve the intensity of strapping tape, can further improve its intensity by adding sodium citrate nucleation.
Because the intensity of fracture strapping tape is mainly determined by orientation fibers, adopt hot strength and the elongation at break of tensile testing machine test differently-oriented directivity, to characterize the mechanical property of strapping tape.Above-mentioned strapping tape is immersed in simulated body fluid (PBS) solution of 37 DEG C, hot strength after 60 days, 120 days and 180 days and the variation of elongation at break are soaked in test respectively, evaluate its degradation property, and the performance test results is as shown in table 2:
As known from Table 2, strapping tape soaks 60 days in PBS solution, and hot strength and elongation at break only have slight decline, soaks after 120 days, and hot strength and elongation at break decline and be less than 20%, illustrate at the initial stage of union of fracture and can play good fixation.Soak after 180 days, hot strength and elongation at break reduce by 40～60%, and performance exceedes the about half of decay, illustrates that strapping tape has good degradability, and adding sodium citrate nucleator does not affect substantially on degradation property.
Above-described embodiment is preferably embodiment of the present invention; but embodiments of the present invention are not restricted to the described embodiments; other any do not deviate from change, the modification done under spirit of the present invention and principle, substitutes, combination, simplify; all should be equivalent substitute mode, within being included in protection scope of the present invention.
Claims (10)
1. a fracture strapping tape for high-strength degradable, is characterized in that: be prepared from by high oriented fibers band and random arrangement fibrous membrane or random orientation Film laminated;
Described high oriented fibers band is prepared by electrostatic spinning by the raw material of following percentage composition: degradable polymer 5～12%, nucleator 0.5～2%, solvent 86～95%;
The thickness of described high oriented fibers band is 0.5～50um, width 2～10mm, fibre diameter 0.02～2.0um;
The thickness of described random arrangement fibrous membrane or random orientation thin film is 0.5～40um, length >=4.0mm, width >=4.0mm.
2. the fracture strapping tape of high-strength degradable according to claim 1, is characterized in that: described nucleator is sodium citrate, purity >=99.0%.
3. the fracture strapping tape of high-strength degradable according to claim 1, is characterized in that: described degradable polymer is at least one in polylactic acid, PGA or poly (glycolide-lactide); The number-average molecular weight of described degradable polymer is 50,000～500,000;
Described solvent is with at least one in hexafluoroisopropanol, dichloromethane or oxolane.
4. the preparation method of the fracture strapping tape of the high-strength degradable described in claim 1～3 any one, is characterized in that comprising the following steps:
(1) take in the degradable polymer of 5～12 mass parts, solvent that 0.5～2 mass parts nucleator is dissolved in 86～95 mass parts and obtain electrostatic spinning solution I, adopt electrostatic spinning machine to carry out electrostatic spinning, apply spinning under the condition of dish-shaped wire drawing device on-line velocity >=500m/min, then put into vacuum drying oven and process after 24h, preparing thickness is the high oriented fibers band of 0.5～50um, width 2～10mm, fibre diameter 0.02～2.0um;
(2) high oriented fibers band step (1) being prepared is orientated by list respectively or double orientation even structure is arranged the surface that is stacked on random arrangement fibrous membrane or random thin film;
(3) material of heap in step (2) being folded is put into ultrasonic welding machine, adopts the weld mold of some column type or grid type to weld, and pressure 1.0MPa, weld interval 1.5s, cool time, 2.0s, made the fracture strapping tape of high-strength degradable.
5. the preparation method of the fracture strapping tape of high-strength degradable according to claim 4, is characterized in that: the degradable polymer described in step (1) is at least one in polylactic acid, PGA or poly (glycolide-lactide); The data molecular weight of described degradable polymer is 50,000～500,000;
Nucleator described in step (1) is sodium citrate, purity >=99.0%;
Solvent described in step (1) is with at least one in hexafluoroisopropanol, dichloromethane or oxolane.
6. the preparation method of the fracture strapping tape of high-strength degradable according to claim 5, is characterized in that: described polylactic acid is Poly-L-lactic acid or dextrorotation polylactic acid.
7. the preparation method of the fracture strapping tape of high-strength degradable according to claim 4, is characterized in that: in step (2), on high oriented fibers band, cover another random arrangement fibrous membrane or random thin film.
8. the preparation method of the fracture strapping tape of high-strength degradable according to claim 4, is characterized in that: the random arrangement fibrous membrane described in step (2) is prepared by following methods:
The concentration that degradable polymer is become with solution allocation is the electrostatic spinning solution II of 5～8wt%, to being fixed with the dull and stereotyped wire drawing device surface spray webbing of high oriented fibers band, spray webbing thickness 0.5～20um, then puts into vacuum drying oven and processes 24h, prepares random arrangement fibrous membrane;
Described degradable polymer is at least one in polylactic acid, PGA or poly (glycolide-lactide); The number-average molecular weight of described degradable polymer is 50,000～500,000;
Described solvent is with at least one in hexafluoroisopropanol, dichloromethane or oxolane.
9. the preparation method of the fracture strapping tape of high-strength degradable according to claim 4, is characterized in that: the random thin film described in step (2) is prepared by following methods:
Taking degradable polymer as raw material, adopt the method for hot-forming or melt spinning to prepare the random thin film that thickness is 15～20um;
Described degradable polymer is at least one in polylactic acid, PGA or poly (glycolide-lactide); The number-average molecular weight of described degradable polymer is 50,000～500,000.
The fracture strapping tape of the high-strength degradable described in claim 1～3 any one as internal fixation device the reparation of clinical fracture and fixing aspect application.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107285396A (en) * | 2016-04-12 | 2017-10-24 | 杭州中润惠民环保科技有限公司 | A kind of degradable PLA water filtering elements |
| WO2020182863A1 (en) * | 2019-03-11 | 2020-09-17 | Xeltis Ag | Electrospun polymer assemblies for medical implant applications |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102908668A (en) * | 2012-11-09 | 2013-02-06 | 无锡中科光远生物材料有限公司 | Preparation method of induced growth type absorbable patch |
| CN102921050A (en) * | 2012-11-09 | 2013-02-13 | 无锡中科光远生物材料有限公司 | Preparation method of anti-adhesion fibrous membrane with hemostatic function |
| CN103611197A (en) * | 2013-11-15 | 2014-03-05 | 无锡中科光远生物材料有限公司 | Method for preparing nano-fiber-based guided bone regeneration membrane |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102908668A (en) * | 2012-11-09 | 2013-02-06 | 无锡中科光远生物材料有限公司 | Preparation method of induced growth type absorbable patch |
| CN102921050A (en) * | 2012-11-09 | 2013-02-13 | 无锡中科光远生物材料有限公司 | Preparation method of anti-adhesion fibrous membrane with hemostatic function |
| CN103611197A (en) * | 2013-11-15 | 2014-03-05 | 无锡中科光远生物材料有限公司 | Method for preparing nano-fiber-based guided bone regeneration membrane |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107285396A (en) * | 2016-04-12 | 2017-10-24 | 杭州中润惠民环保科技有限公司 | A kind of degradable PLA water filtering elements |
| WO2020182863A1 (en) * | 2019-03-11 | 2020-09-17 | Xeltis Ag | Electrospun polymer assemblies for medical implant applications |
| CN113557041A (en) * | 2019-03-11 | 2021-10-26 | 谢尔蒂斯股份公司 | Electrospun polymeric components for medical implant applications |
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