CN1827178A - Drug coating-spraying method for drug eluting stent and spraying apparatus therefor - Google Patents
Drug coating-spraying method for drug eluting stent and spraying apparatus therefor Download PDFInfo
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Abstract
This invention is about a process for painting drug elution vas internal support and the painting apparatus. It is a process for painting cardiovascular support and the painting apparatus. This invention solves the problem of heterogeneous painting and great material consumption in current support. The painting preparation processes mainly contain cleaning, drying and spraying to prepare drug coating. The painting apparatus mainly contain: support, nozzle, solution bottle, plastic hose, flow instrument, high-pressure tank, nozzle, ultrasonic atomizer, adjustable rotary table and flume. The downside of the support strut connects with the adjustable rotary table; the solution bottle connects with high-pressure tank by the flow instrument, the ultrasonic atomizer, whose top connects with the solution bottle, is installed in the flume. The uniform drug coating is formed by painting ultrasonic nebulized aerosol fogdrop on the surface of the support of certain movement state. This invention can not only paint heterogeneously and decrease surface roughness of support, but also can greatly save painting material.
Description
Technical field
The present invention relates to a kind of cardiovascular drugs support spraying method and device, particularly medication eluting type blood vessel inner support spraying method and spray equipment thereof.
Background technology
After the operation of blood vessel balloon expandable occurs, utilize intravascular stent treatment infraction property coronary artery disease, be main developing direction always.But support the in-stent restenosis phenomenon can occur after implanting.Behind the implant frame at first vascellum endometrial hyperplasia can appear, the compressing of metal rack can activated blood platelet and macrophage, cytokine and somatomedin also can be had an effect to the propagation of smooth muscle cell simultaneously, add the undesired adjusting of gene and the effect of metalloproteases, and then trigger cell propagation, extracellular matrix reinvent migration with smooth muscle cell, the comprehensive function of these factors has caused serious in-stent restenosis occurring behind the implant frame some months.
Medication eluting type blood vessel inner support coating mainly adopts spraying method, the disclosed application number of domestic existing patent documentation is 200510045668.9, this blood vessel stent drug coating production mainly comprises: the coating of intravascular stent and polymer carrier materials and solvent thereof and medicament mixed, and by the medication coat of electrostatic coating method preparation.Polymer carrier materials comprises: polylactic acid (PLA), polycaprolactone (PCL), poly-Acetic acid, hydroxy-, bimol. cyclic ester (PGA) and one or more copolymers thereof; Solvent comprises acetone, oxolane, chloroform, dichloromethane; Medicine comprises platelet receptor antagonist, rapamycin, paclitaxel, heparin, the full plain A of ring, dactinomycin, dexamethasone, emodin, hirudin.The step of production of coatings mainly comprises the cleaning of intravascular stent, the preparation of coating, preparation, coating drying and the sterilization of medication coat; Electrostatic spraying apparatus mainly comprises spray gun, nozzle, container for paint, electrostatic generator and cable.
The deficiency that existing medication eluting type blood vessel bracket coating process and device thereof exist is: (1) uses traditional spray equipment to spray because bracket geometry is comparatively complicated, occurs easily that material converges or the phenomenon of condensing, the rough surface of support; When (2) spray equipment sprayed, support to be coated with remained static, and this state is not suitable for the spraying of support, can have a strong impact on the medication coat uniformity, a large amount of spraying dead angles usually occurred, and non-uniform areas reaches more than 20%; (3) spraying method is bigger to expending of sprayed on material, and the utilization rate of material is low, only is 5%; (4) spray equipment complex structure.
Summary of the invention
The objective of the invention is at above-mentioned deficiency, a kind of medication eluting type blood vessel inner support spraying method and spray equipment thereof are provided, this apparatus structure is simple, has solved the shortcoming that existing spraying is inhomogeneous, sprayed on material is wasteful.
Medication eluting type blood vessel inner support spraying method of the present invention step in the following order carries out:
(1) cleaning of intravascular stent and sterilization
With bare bracket successively in ethanol, acetone, distilled water ultrasonic cleaning 3-7 minute respectively, then in vacuum drying oven dry 30-60 minute, temperature was 30-50 ℃, utilizes ultra violet lamp 25-30 minute then;
(2) preparation spray solution
After support cleaning and the sterilization, prepared polymer 10-30%, solvent 60-85%, medicine 10-22% is warmed to 25-35 ℃ with the solution after the preparation, utilizes the magnetic agitation instrument to stir mix homogeneously 20-60 minute;
(3) spraying medication coat
The spray solution for preparing is joined in the solution bottle 5, and liquor capacity is the 10-40 milliliter; Open gas cylinder switch 8, adjusting flow instrument 7 carrier gas speed 0.2-1 liters/minute; Open adjustable speed turntable 1 switch, making the support slewing rate remain on per minute 30-60 changes; Connect nebulizer 12 power supplys, the atomizing frequency is the 1600-2500 KHz, atomizing spraying solution; Carrier gas is carried droplet and is deposited on rack surface through behind the nozzle 4, forms uniform medication coat, and spray time is 0.5-2 minute;
(4) coating drying
Propping up after the spraying is placed in the vacuum drying oven, baking temperature 30-50 ℃, 24-48 hour drying time;
(5) dry after-poppet repeats spraying
Dry after-poppet is repeated above (3), (4) step, and multiple number of times is 2-5 time.
Medication eluting type blood vessel inner support spray equipment, mainly comprise: stent strut 2, support 3, nozzle 4, solution bottle 5, plastic flexible pipe 6, flow instrument 7, gas cylinder switch 8, gas cylinder 9, jet pipe 10, ultrasound atomizer 12, coating 13, it is characterized in that also comprising: adjustable speed turntable 1, tank 11, wherein support 3 is equipped with in stent strut 2 upper ends, the lower end is connected with adjustable speed turntable 1, stent strut 2 is contained in the centre position of adjustable speed turntable 1, in the adjustable speed turntable 1 motor is housed, circuit, fluorescent screen, the side of solution bottle 5 is connected with jet pipe 10, jet pipe 10 is connected with nozzle 4, nozzle 4 is 3-6 centimetre with support 3 distances, the jet pipe 10 of packing in solution bottle 5 bottlenecks, the upper end of jet pipe 10 is connected with plastic flexible pipe 6, plastic flexible pipe 6 is connected with gas cylinder 9 by flow instrument 7, gas cylinder switch 8 is housed above the gas cylinder 9, circular concave station is equipped with in bottom in the tank 11, the centre is circular blind hole, ultrasound atomizer 12 is housed in the hole, the piezoelectric energy-conversion sheet is housed in the ultrasound atomizer 12, drive circuit, the top of ultrasound atomizer 12 is connected with solution bottle 5.
Operation principle of the present invention: the principle of utilizing ultrasonic atomizatio, ultrasonic solution or other mixed solution with matrix material by certain frequency is atomized into diameter at micron-sized gasoloid droplet, the process carrier gas carrying then, and be deposited on the surface of intravascular stent by nozzle, in sedimentary process, support keeps certain kinestate, at last again through super-dry.
The present invention's advantage compared with prior art is:
1, show that from accompanying drawing of the present invention 2 fluorescence distribution is concentrated behind the coating dyeing, brightness is even, has improved the uniformity and the integrity of spraying, has reduced effectively that material converges or the phenomenon of condensing, and reduces surface roughness;
2, the motion mode that support spraying process of the present invention is taked radially to move back and forth and circular motion combines has not only reduced the spraying dead angle effectively, and guaranteed spraying evenly;
3, the spraying coating process of the present invention's employing makes the coating consumption few, and the coating about 30 milliliters can apply 5-8 support, can save coating more than 80%;
4, from accompanying drawing 4 of the present invention as can be seen, spray equipment is simple in structure, has saved production cost.
Description of drawings
The fluorescent staining figure of Fig. 1, medication eluting type blood vessel inner support of the present invention spraying
After photo is nickel-titanium alloy intravascular inner support coated medicament coating among the figure,, utilizes and just putting 200 times of fluorescence microscope (model is OLYMPUS BX51) amplifications through fluorescent staining.
Fig. 2, be to adopt MATLAB to handle the rack surface fluorescence distribution curve that obtains behind the image 1
Show among the figure that the coating fluorescence distribution is concentrated, brightness is even, has proved the uniformity and the integrity of coating.
The afm scan figure of the medication eluting type blood vessel inner support face coat of Fig. 3, the present invention's preparation
Photo is 1.5 * 1.5 microns among the figure
2The surface topography tomograph in zone.The result shows that the coating surface roughness is below 4 nanometers.
The structural representation of Fig. 4, spray equipment of the present invention
In Fig. 4: 1-adjustable speed turntable, 2-stent strut, 3-support, 4-nozzle, 5-solution bottle, 6-plastic flexible pipe, 7-flow instrument, 8-gas cylinder switch, 9-gas cylinder, 10-jet pipe, 11-tank, 12-ultrasonic atomizatio gas, 13-coating.
The specific embodiment
Medication eluting type blood vessel inner support spraying method of the present invention is step in the following order:
(1) with respectively ultrasonic cleaning 4 minutes in ethanol, acetone, distilled water successively of bare bracket, in vacuum drying oven dry 45 minutes then, temperature was 45 ℃, utilizes ultra violet lamp at last 30 minutes;
(2) preparation spray solution
After support cleaning and the sterilization, prepared polymer 15%, solvent 70%, the solution of medicine 15% is warmed to 30 ℃ with the solution after the preparation, utilizes the magnetic agitation instrument to stir mix homogeneously 40 minutes;
(3) spraying medication coat
The spray solution for preparing is joined in the solution bottle 5, and liquor capacity is 30 milliliters; Open gas cylinder switch 8, regulate flow instrument 7 carrier gas speed at 0.3 liter/minute; Open adjustable speed turntable 1 switch, making the support slewing rate remain on per minute 55 changes; Connect nebulizer 12 power supplys, the atomizing frequency is 1700 KHz, the atomizing coating material solution; Carrier gas is carried droplet and is deposited on rack surface through behind the nozzle 4, forms uniform medication coat, and spray time is 1 minute;
(4) coating drying
Propping up after the spraying is placed in the vacuum drying oven 45 ℃ of baking temperatures, 24 hours drying times;
(5) dry after-poppet repeats spraying
Dry after-poppet is repeated above (3), (4) step, and multiple number of times is 3 times.
Medication eluting type blood vessel inner support spray equipment, mainly comprise: adjustable speed turntable 1, stent strut 2, support 3, nozzle 4, solution bottle 5, plastic flexible pipe 6, flow instrument 7, gas cylinder switch 8, gas cylinder 9, jet pipe 10, tank 11, ultrasound atomizer 12, coating 13, wherein support 3 is equipped with in stent strut 2 upper ends, the lower end is connected with adjustable speed turntable 1, stent strut 2 is contained in the centre position of adjustable speed turntable 1, in the adjustable speed turntable 1 motor is housed, circuit, fluorescent screen, the side of solution bottle 5 is connected with jet pipe 10, jet pipe 10 is connected with nozzle 4, nozzle 4 is 3-6 centimetre with support 3 distances, the jet pipe 10 of packing in solution bottle 5 bottlenecks, the upper end of jet pipe 10 is connected with plastic flexible pipe 6, plastic flexible pipe 6 is connected with gas cylinder 9 by flow instrument 7, gas cylinder switch 8 is housed above the gas cylinder 9, circular concave station is equipped with in bottom in the tank 11, the centre is circular blind hole, ultrasound atomizer 12 is housed in the hole, the piezoelectric energy-conversion sheet is housed in the ultrasound atomizer 12, drive circuit, the top of ultrasound atomizer 12 is connected with solution bottle 5.Nozzle 4 is an inverted tubaeform, and jet pipe 10 is the circular glass pipe, and tank 11 is cylindrical, and the first half of solution bottle 5 is cylindrical, and Lower Half is conical.
According to the selected parameters of composite factors such as the kind of the required medication coat of support, drug loading, mechanical performance, slow release characteristic, functional character, preparation medication eluting type blood vessel inner support.
Embodiment
Dexamethasone medication eluting type blood vessel inner support spraying method step in the following order carries out:
(1) the selection of material 316L type stainless steel stent, ultrasonic cleaning 4 minutes in ethanol, acetone, distilled water successively, in vacuum drying oven dry 45 minutes then, baking temperature was 45 ℃, utilizes ultra violet lamp to carry out disinfection in 30 minutes at last;
(2) preparation spray solution
After support cleaning and the sterilization, preparation polylactic acid 15%, acetone 70%, the solution of dexamethasone 15% is warmed to 30 ℃ with the solution after the preparation, utilizes the magnetic agitation instrument to stir mix homogeneously 40 minutes;
(3) spraying medication coat
The spray solution for preparing is joined in the solution bottle 5 30 milliliters of liquor capacities; Open gas cylinder switch 8, regulate flow instrument 7 carrier gas speed at 0.3 liter/minute; Open adjustable speed turntable 1 switch, making the support slewing rate remain on per minute 55 changes; Connect nebulizer 12 power supplys, the atomizing frequency is 1700 KHz, the atomizing coating material solution; Carrier gas is carried droplet and is deposited on rack surface through behind the nozzle 4, forms uniform medication coat, and spray time is 1 minute;
(4) coating drying
Propping up after the spraying is placed in the vacuum drying oven 45 ℃ of baking temperatures, 24 hours drying times;
(5) dry after-poppet repeats spraying
Dry after-poppet is repeated above (3), (4) step, and multiple number of times is 3 times.
Claims (4)
1, a kind of medication eluting type blood vessel inner support spraying method is characterized in that: endovascular stent eluting medicine spraying method step in the following order carries out:
(1) cleaning of intravascular stent and sterilization
With bare bracket successively in ethanol, acetone, distilled water ultrasonic cleaning 3-7 minute respectively, then in vacuum drying oven dry 30-60 minute, temperature was 30-50 ℃, utilizes ultra violet lamp 25-30 minute then;
(2) preparation spray solution
After support cleaning and the sterilization, prepared polymer 10-30%, solvent 60-85%, medicine 10-22% is warmed to 25-35 ℃ with the solution after the preparation, utilizes the magnetic agitation instrument to stir mix homogeneously 20-60 minute;
(3) spraying medication coat
The spray solution for preparing is joined in the solution bottle (5), and liquor capacity is the 10-40 milliliter; Open gas cylinder switch (8), adjusting flow instrument (7) carrier gas speed 0.2-1 liter/minute; Open adjustable speed turntable (1) switch, making the support slewing rate remain on per minute 30-60 changes; Connect nebulizer (12) power supply, the atomizing frequency is the 1600-2500 KHz, atomizing spraying solution; Carrier gas is deposited on rack surface after carrying droplet process nozzle (4), forms uniform medication coat, and spray time is 0.5-2 minute;
(4) coating drying
Propping up after the spraying is placed in the vacuum drying oven, baking temperature 30-50 ℃, 24-48 hour drying time;
(5) dry after-poppet repeats spraying
Dry after-poppet is repeated above (3), (4) step, and multiple number of times is 2-5 time.
2, by the described medication eluting type blood vessel inner support of claim 1 spraying method, it is characterized in that: endovascular stent eluting medicine spraying method step in the following order carries out:
(1) respectively ultrasonic cleaning 4 minutes in ethanol, acetone, distilled water successively of bare bracket, in vacuum drying oven dry 45 minutes then, temperature was 45 ℃, utilizes ultra violet lamp at last 30 minutes;
(2) preparation spray solution
After support cleaning and the sterilization, prepared polymer 15%, solvent 70%, the solution of medicine 15% is warmed to 30 ℃ with the solution after the preparation, utilizes the magnetic agitation instrument to stir mix homogeneously 40 minutes;
(3) spraying medication coat
The spray solution for preparing is joined in the solution bottle (5), and liquor capacity is 30 milliliters; Open gas cylinder switch (8), regulate 0.3 liter/minute of flow instrument (7) carrier gas speed; Open adjustable speed turntable (1) switch, making the support slewing rate remain on per minute 55 changes; Connect nebulizer (12) power supply, the atomizing frequency is 1700 KHz, atomizing spraying solution; Carrier gas is deposited on rack surface after carrying droplet process nozzle (4), forms uniform medication coat, and spray time is 1 minute;
(4) coating drying
Propping up after the spraying is placed in the vacuum drying oven 45 ℃ of baking temperatures, 24 hours drying times;
(5) dry after-poppet repeats spraying
Dry after-poppet is repeated above (3), (4) step, and multiple number of times is 3 times.
3, a kind of medication eluting type blood vessel inner support spray equipment, mainly comprise: stent strut (2), support (3), nozzle (4), solution bottle (5), plastic flexible pipe (6), flow instrument (7), gas cylinder switch (8), gas cylinder (9), jet pipe (10), ultrasound atomizer (12), coating (13), it is characterized in that also comprising: adjustable speed turntable (1), tank (11), wherein support (3) is equipped with in stent strut (2) upper end, the lower end is connected with adjustable speed turntable (1), stent strut (2) is contained in the centre position of adjustable speed turntable (1), the adjustable speed turntable is equipped with motor in (1), circuit, fluorescent screen, the side of solution bottle (5) is connected with jet pipe (10), jet pipe (10) is connected with nozzle (4), nozzle (4) is 3-6 centimetre with support (3) distance, the jet pipe (10) of packing in solution bottle (5) bottleneck, the upper end of jet pipe (10) is connected with plastic flexible pipe (6), plastic flexible pipe (6) is connected with gas cylinder (9) by flow instrument (7), gas cylinder switch (8) is housed above the gas cylinder (9), circular concave station is equipped with in bottom in the tank (11), the centre is circular blind hole, ultrasound atomizer (12) is housed in the hole, ultrasound atomizer is equipped with the piezoelectric energy-conversion sheet in (12), drive circuit, the top of ultrasound atomizer (12) is connected with solution bottle (5).
4, by the described medication eluting type blood vessel inner support of claim 3 spray equipment, it is characterized in that nozzle (4) is an inverted tubaeform, jet pipe (10) is the circular glass pipe, and tank (11) is cylindrical, the first half of solution bottle (5) is cylindrical, and Lower Half is conical.
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