CN101168073A - Method for preparing electrostatic spinning fiber film-coated vascular inner rack - Google Patents
Method for preparing electrostatic spinning fiber film-coated vascular inner rack Download PDFInfo
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- CN101168073A CN101168073A CN 200710047456 CN200710047456A CN101168073A CN 101168073 A CN101168073 A CN 101168073A CN 200710047456 CN200710047456 CN 200710047456 CN 200710047456 A CN200710047456 A CN 200710047456A CN 101168073 A CN101168073 A CN 101168073A
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Abstract
The invention relates to a process for preparing an internal frame of a blood vessel with electrostatic fiber tectorial. The concrete procedure is that 1, preparing polymer solution or polymer solution with drugs or bioactive elements, 2 preparing to obtain nanometer/ micrometer fiber, 3, forming a fiber film structure on the surface of the internal frame of the blood vessel. The shape of a fabric prepared by the invention imitates the shape of an epimatrix of a natural cell, thereby being beneficial for cells to sticki and breed, moreover, the drugs and active elements such as growth factor can be loaded in the nanometer fiber by an electro-spin to be released slowly, and the internal frame of the blood vessel with electrostatic fiber tectorial has good mechanical function, thereby satisfying the need of clinical releasing. In an implanting area, the invention can effectively support a lesion blood vessel to ensure the smoothness of the lesion blood vessel or can avoid dangers such as blood leakage due to angiomatosis in a diseased region. Simultaneously, the invention is capable of slowing releasing the drugs if necessary.
Description
Technical field
The invention belongs to Wicresoft and hinder intervention medical product field, be specifically related to have the preparation method of electrostatic spinning fiber film-coated endovascular stent.
Background technology
Atherosclerosis is one of major reason that causes heart disease morbidity and death, and this disease makes that arterial lumen is narrow and finally makes blood vessel blockage.Inserting endovascular stent is the important method of treatment cardiovascular disease, and endovascular stent can support stenosis occlusion section blood vessel and keep the tube chamber blood flow unobstructed.But, after support is inserted still the restenosis phenomenon can appear, have a strong impact on therapeutic effect.People mainly adopt coating stent of medicine to suppress the generation of restenosis at present, and the report that utilizes the drug-carrying polymer film to control restenosis is also arranged.Aneurysm is breakneck clinically a kind of angiopathy, can not get mortality rate in the treatment in time month up to 75% if data shows its patient, and five year survival rate only is 17%.Utilize film-coated vascular inner rack can completely cut off the tumor chamber, make the tumor intracavity blood form thrombosis and fleshization gradually, thereby reach the aneurysmal purpose of treatment.
Static spin be one by making polymer solution or fused solution charged, thereby eject and finally make the simple and easy means of nanofiber.The process that whole static spins only needs one and holds the container of polymer solution, the receiving system and the dc static generator of electrostatic spinning fiber.Because high-tension effect, the polymer that sprays from pipette is drawn as fiber.It is the natural or synthetic polymeric fibers of tens nanometers to the hundreds of nanometer that the static spinning technique can prepare diameter, and the material that has successfully prepared nanofiber at present comprises natural or synthetic materials such as chitosan, collagen protein, polyurethane, acid polyethylene, polylactic acid.The nanofiber that electro-spinning obtains has fully effectively imitated the form of extracellular matrix, can promote sticking and rising in value of cell.The superfine fibre that electro-spinning is equipped with in various fields such as medical and health, food, clothing by extensive studies and application.
Summary of the invention
Technical problem to be solved by this invention provides a kind of preparation method of electrostatic spinning fiber film-coated vascular inner rack, this method utilizes the static spinning technique that polymer or the polymer solution that contains ingredient are prepared as nanometer or micron order fiber, and the surface that this fiber is received in endovascular stent formed has certain thickness fibrous membrane; The fibrous membrane for preparing has certain mechanical performance and closely covers on the endovascular stent, can prevent the in-stent restenosis that smooth muscle cell hypertrophy or other effects in support cause effectively, drug-loading fibre can reach the purpose of treatment at the diseased region slow releasing pharmaceutical.
For achieving the above object, technical scheme of the present invention is: a kind of preparation method of electrostatic spinning fiber film-coated vascular inner rack,
Concrete implementation step is:
2. prepare polymer solution or contain medicine or contain the polymer solution of bioactive ingredients
A) natural or artificial polymer is dissolved acquisition in solvent and have the uniform solution that concentration is 0.06 grams per milliliter concentration, perhaps
B) natural or artificial polymer and medicine one are coexisted dissolving in the solvent obtains the solution or the suspension of homogeneous, perhaps prepares the solution or the suspension that are mixed into homogeneous behind the solution respectively;
3. prepare the nano/micron fiber
Above-mentioned solution is added in the syringe of electrostatic spinning device, the speed of regulating micro-injection pump be the 0.1-5.0 milliliter/hour, the voltage of regulating high tension generator is the 5000-30000 volt, the receiving range of regulating receiving system is 5.0-30.0 centimetre, obtain fiber 7 fully by electro-spinning, and fiber is received as pipe or membrane structure;
4. the surface of endovascular stent forms the fibrous membrane structure
Endovascular stent is fixed in the rotating shaft, and regulating motor 4, to make slewing rate be 50-6000 rev/min, and the rotation by endovascular stent directly receives electrostatic spinning fiber and becomes the fibrous membrane that is wrapped on the endovascular stent.
In the above-mentioned third step, fibrous membrane or the Guan Jing that obtains in second step can also be made, is pasted and fixed on the outside of endovascular stent; Perhaps will or be adhesively fixed by the direct further suture of fibrous membrane that receives of support.
In above-mentioned second step, syringe also can have single or multiple shower nozzles simultaneously, and the prepared fiber of each shower nozzle can be polymer or the drug-carrying polymer fiber with one or more, obtains different fibers by the blended overlay film product of different proportion; Wherein, single or multiple shower nozzles at different time continuously or be interrupted the preparation fiber and obtain having overlay film product two-layer or that multilamellar is made of two or more fibers.
Natural polymer described in the above-mentioned steps comprise at least collagen protein, gelatin, chitosan, fibrinogenic any; Described artificial polymer comprises any of poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid and related copolymers thereof at least; Described organic solvent comprises any of oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform, one or more compound systems of dimethyl formamide at least; Described medicine comprises any of heparin, rapamycin, paclitaxel, aspirin, prostacyclin at least; Described bioactive ingredients mainly refers to endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin, hepatocyte growth factor.In addition, the endovascular stent that will have an electrostatic spinning fiber film immerses and to have the hygrometric state or the drying that obtain in the solution that comprises described medicine or bioactive ingredients at least and handle back gained endovascular stent.
Physics or the chemical method of endovascular stent through comprising plasma, chemical graft at least that will have electrostatic spinning fiber film modified the film-coated vascular inner rack that obtains to this fibrous membrane.
The endovascular stent that will have electrostatic spinning fiber film is cultivated the complex that obtains being loaded with living cells through cell in vitro.
The invention has the beneficial effects as follows: the fibrous membrane for preparing has certain mechanical performance and closely covers on the endovascular stent, can prevent the in-stent restenosis that smooth muscle cell hypertrophy or other effects in support cause effectively, drug-loading fibre can reach the purpose of treatment at the diseased region slow releasing pharmaceutical.
Description of drawings
Fig. 1 is the fiber film-coated vascular inner rack sketch map;
Fig. 2 is electrostatic spinning fiber preparation and endovascular stent coating sketch map;
Fig. 3 is the overlay film frame sem photograph;
Fig. 4 is the scanning electron microscope enlarged drawing of overlay film fiber on the support.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Concrete implementation step of the present invention is as follows:
1. natural or artificial polymer is dissolved in suitable solvent and obtain to have certain density uniform solution; Or the coexist dissolving in the suitable solvent of natural or artificial polymer and medicine one obtained the solution or the suspension of homogeneous, perhaps prepare the solution or the suspension that are mixed into homogeneous behind the solution respectively;
2. as shown in Figure 2, solution in 1 or 2 is added in the syringe 2, regulate micro-injection pump 1, speed be the 0.1-5.0 milliliter/hour, it is the 5000-30000 volt that adjusting high tension generator 3 makes voltage, it is 5.0-30.0 centimetre that rotating shaft receptor 5 in the adjusting receiving system and dull and stereotyped receptor 6 make receiving range, obtains fiber 7 fully by electro-spinning, and fiber is received as pipe or membrane structure;
3. endovascular stent is fixed on the rotating shaft receptor 5, it is 50-6000 rev/min that adjusting motor 4 makes slewing rate, rotation by endovascular stent directly receives electrostatic spinning fiber becomes the fibrous membrane 10 (Fig. 1 is shown in 3,4) that is wrapped on the endovascular stent 20.
Polymer among the present invention comprises natural and artificial polymer, and natural polymer includes but are not limited to: collagen protein, gelatin, chitosan, Fibrinogen; Artificial polymer includes but are not limited to: poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid and related copolymers thereof; Involved organic solvent includes but are not limited to:: oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform, one or more compound systems of dimethyl formamide; Related medicine is including, but not limited to heparin, rapamycin, paclitaxel, aspirin, prostacyclin; Related bioactive ingredients mainly refers to endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin, hepatocyte growth factor.
In the above-mentioned third step, fibrous membrane or the Guan Jing that obtains in second step can also be made, is pasted and fixed on the outside of endovascular stent; Perhaps will or be adhesively fixed by the direct further suture of fibrous membrane that receives of support.
In above-mentioned second step, syringe also can have single or multiple shower nozzles simultaneously, and the prepared fiber of each shower nozzle can be polymer or the drug-carrying polymer fiber with one or more, obtains different fibers by the blended overlay film product of different proportion; Wherein, single or multiple shower nozzles at different time continuously or be interrupted the preparation fiber and obtain having overlay film product two-layer or that multilamellar is made of two or more fibers.
Physics or the chemical method of endovascular stent through comprising plasma, chemical graft at least that will have electrostatic spinning fiber film modified the film-coated vascular inner rack that obtains to this fibrous membrane.
The endovascular stent that will have electrostatic spinning fiber film is cultivated the complex that obtains being loaded with living cells through cell in vitro.
Embodiment:
Example one:
The trifluoroethanol solution of preparation P (LLA-CL), concentration is 0.06 grams per milliliter, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.5 milliliters/hour, voltage is 15.0 kilovolts, receiving range is 20.0 centimetres, and motor speed is 50 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter P (LLA-CL) fibrous membrane.
Example two:
Preparation P (LLA-CL) concentration is 0.06 grams per milliliter, heparin concentration is the mixed solution of 0.0006 grams per milliliter, solvent for use is that volume ratio is oxolane/water compounded solvents of 10: 1, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.5 milliliters/hour, and voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, motor speed is 500 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter the P that is loaded with heparin (LLA-CL) fibrous membrane.
Example three:
Preparation PLLA concentration is 0.06 grams per milliliter, rapamycin concentrations is the mixed solution of 0.0012 grams per milliliter, solvent for use is an acetone, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.5 milliliters/hour, and voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, motor speed is 1000 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter the P that is loaded with rapamycin (LLA-CL) fibrous membrane.
Example four:
Preparation PCL concentration is 0.06 grams per milliliter, paclitaxel concentration is the mixed solution of 0.0006 grams per milliliter, solvent for use is a chloroform, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.0 milliliters/hour, and voltage is 20.0 kilovolts, and receiving range is 20.0 centimetres, motor speed is 2000 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter the PCL fibrous membrane that is loaded with paclitaxel.
Example five:
The preparation gelatin concentration is 0.06 grams per milliliter, heparin concentration is the mixed solution of 0.02 grams per milliliter, solvent for use is that volume ratio is trifluoroethanol/water compounded solvents of 9: 11, regulating the micro-injection pump rate is 0.5 milliliter/hour, voltage is 30.0 kilovolts, receiving range is 30.0 centimetres, and motor speed is 500 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.15 millimeter the gelatin fiber film that is loaded with heparin.
Example six:
Preparation P (LLA-CL) concentration is 0.06 grams per milliliter, aspirin concentration is the mixed solution of 0.0006 grams per milliliter, solvent for use is a chloroform, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.0 milliliters/hour, and voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, motor speed is 1000 rev/mins, is coated with thickness after 30 minutes on the endovascular stent and is about 0.10 millimeter the P that is loaded with aspirin (LLA-CL) fibrous membrane.
Example seven:
Preparation PCL concentration is 0.06 grams per milliliter, prostacyclin concentration is the mixed solution of 0.0006 grams per milliliter, solvent for use is a chloroform, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.0 milliliters/hour, and voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, motor speed is 1000 rev/mins, obtains being coated with the endovascular stent that certain thickness is loaded with the PCL fibrous membrane of prostacyclin after 30 minutes.
Example eight:
The trifluoroethanol solution of preparation P (LLA-CL), concentration is 0.06 grams per milliliter, endovascular stent is fixed in the rotating shaft, regulating the micro-injection pump rate is 1.5 milliliters/hour, voltage is 15.0 kilovolts, and receiving range is 20.0 centimetres, and motor speed is 50 rev/mins, be coated with certain thickness P (LLA-CL) fibrous membrane after a period of time on the endovascular stent, through making or bonding this film that makes further is fixed on the support.
Example nine:
The hexafluoroisopropanol solution of preparation P (LLA-CL), concentration is 0.06 grams per milliliter, regulating the micro-injection pump rate is 1.5 milliliters/hour, voltage is 15.0 kilovolts, receive with the stainless steel tube that rotates, receiving range is 20.0 centimetres, and motor speed is 6000 rev/mins, can obtain wall thickness from stainless steel tube after 30 minutes and be about 0.10 millimeter P (LLA-CL) fiber pipe, this pipe is fixed on the endovascular stent that promptly obtains having electrostatic spinning fiber film on the endovascular stent.
Example ten:
The hexafluoroisopropanol solution of preparation PLGA, concentration is 0.08 grams per milliliter, regulating the micro-injection pump rate is 1.0 milliliters/hour, voltage is 15.0 kilovolts, is that 20.0 centimeters receive with flat board in distance, can obtain having certain thickness fibrous membrane after 30 minutes, this film be made or is bonded in the endovascular stent that promptly obtains having electrostatic spinning fiber film on the endovascular stent.
Claims (6)
1. the preparation method of an electrostatic spinning fiber film-coated vascular inner rack is characterized in that, concrete implementation step is:
(1) preparation polymer solution or contain medicine or contain the polymer solution of bioactive ingredients
1) natural or artificial polymer is dissolved acquisition in solvent and have the uniform solution that concentration is 0.06 grams per milliliter concentration, perhaps
2) natural or artificial polymer and medicine one are coexisted dissolving in the solvent obtains the solution or the suspension of homogeneous, perhaps prepares the solution or the suspension that are mixed into homogeneous behind the solution respectively;
(2) prepare the nano/micron fiber
Above-mentioned solution is added in the syringe (2) of electrostatic spinning device, the speed of regulating micro-injection pump (1) be the 0.1-5.0 milliliter/hour, the voltage of regulating high tension generator (3) is the 5000-30000 volt, the receiving range of regulating receiving system (5,6) is 5.0-30.0 centimetre, obtain fiber (7) fully by electro-spinning, and fiber is received as pipe or membrane structure;
(3) surface of endovascular stent forms the fibrous membrane structure
Endovascular stent is fixed in the rotating shaft (5), and regulating motor (4), to make slewing rate be 50-6000 rev/min, and the rotation by endovascular stent directly receives electrostatic spinning fiber and becomes the fibrous membrane (10) that is wrapped on the endovascular stent (20).
2. the preparation method of electrostatic spinning fiber film-coated vascular inner rack according to claim 1 is characterized in that, in the above-mentioned third step, fibrous membrane or the Guan Jing that obtains in second step can also be made, is pasted and fixed on the outside of endovascular stent; Perhaps will or be adhesively fixed by the direct further suture of fibrous membrane that receives of support.
3. the preparation method of electrostatic spinning fiber film-coated vascular inner rack according to claim 1, it is characterized in that, in above-mentioned second step, syringe (2) also can have single or multiple shower nozzles simultaneously, the prepared fiber of each shower nozzle can be polymer or the drug-carrying polymer fiber with one or more, obtains different fibers by the blended overlay film product of different proportion; Wherein, single or multiple shower nozzles at different time continuously or be interrupted the preparation fiber and obtain having overlay film two-layer or that multilamellar is made of two or more fibers.
4. according to the preparation method of claim 1 or 3 described electrostatic spinning fiber film-coated vascular inner racks, it is characterized in that, the natural polymer described in the above-mentioned steps comprise at least collagen protein, gelatin, chitosan, fibrinogenic any; Described artificial polymer comprises any of poly-Acetic acid, hydroxy-, bimol. cyclic ester, polylactide, polycaprolactone, polyglycolic acid and related copolymers thereof at least; Described organic solvent comprises any of oxolane, hexafluoroisopropanol, acetone, trifluoroethanol, dichloromethane, chloroform, one or more compound systems of dimethyl formamide at least; Described medicine comprises any of heparin, rapamycin, paclitaxel, aspirin, prostacyclin at least; Described bioactive ingredients mainly refers to endothelial cell growth factor (ECGF), basic fibroblast growth factor, nerve growth factor, bone morphogenetic protein, glial growth factor, transforming growth factor, epidermal growth factor, platelet-derived somatomedin, hepatocyte growth factor.In addition, the endovascular stent that will have an electrostatic spinning fiber film immerses and to have the hygrometric state or the drying that obtain in the solution that comprises described medicine or bioactive ingredients at least and handle back gained endovascular stent.
5. the preparation method of electrostatic spinning fiber film-coated vascular inner rack according to claim 1, it is characterized in that, physics or the chemical method of endovascular stent through comprising plasma, chemical graft at least that has electrostatic spinning fiber film can also be modified the film-coated vascular inner rack that obtains to this fibrous membrane in the above-mentioned steps.
6. the preparation method of electrostatic spinning fiber film-coated vascular inner rack according to claim 1 is characterized in that, the endovascular stent that has electrostatic spinning fiber film can also be cultivated the complex that obtains being loaded with living cells through cell in vitro in the above-mentioned steps.
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| CN110575607A (en) * | 2019-10-07 | 2019-12-17 | 江苏暖阳医疗器械有限公司 | Medicine balloon |
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