CN103705324A - Blood vessel coating support and preparation method for blood vessel coating support - Google Patents
Blood vessel coating support and preparation method for blood vessel coating support Download PDFInfo
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- CN103705324A CN103705324A CN201310752335.4A CN201310752335A CN103705324A CN 103705324 A CN103705324 A CN 103705324A CN 201310752335 A CN201310752335 A CN 201310752335A CN 103705324 A CN103705324 A CN 103705324A
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Abstract
The invention provides a preparation method for a blood vessel coating support. The preparation method comprises the steps of enabling a central spindle to coaxially penetrate through a cavity of a blood vessel support body, wherein the shore hardness D of the surface layer of the central spindle or the whole central spindle is smaller than 60 or larger than 86; changing a gap formed between the outer surface of the central spindle and the inner wall of the blood vessel support until the central spindle and the blood vessel support are in gapless contact or partial contact; coating the blood vessel support body with coating liquid; removing the central spindle. According to the preparation method, the coating support with the outer wall and the side wall coated with coatings, and the inner wall coated with no coating or incontinuous coatings can be prepared, and the inner wall coating amount of the blood vessel coating support is effectively controlled.
Description
Technical field
The invention belongs to implanted medical device field, be specifically related to a kind of preparation method and blood vessel coating bracket of blood vessel coating bracket.
Background technology
Intravascular stent is a kind of blood vessel implant, has expansiveness, after implantation, can play the effect of radial support, makes myocardial revascularization.The rack body structure of existing intravascular stent as shown in Figure 1, the cylindrical tube structure with inner chamber 02 that it consists of cradling piece 01, cradling piece 01 is fenestral fabric.Cradling piece 01 cross section comprises cradling piece outer wall 03, sidewall 04, inwall 05, as shown in Figure 2.
The preparation of intravascular stent is to be mainly prepared from by cutting and work out two kinds of modes at present, by the support after cutting or weaving, all need through polishing or polishing repeatedly, cleaning process, so that cradling piece 01 surface is relatively smooth, thereby reduce the damage of support to blood vessel wall, also be conducive to the spraying of coating, but after above-mentioned technical process, conventionally can make bracket edge have certain chamfering, or cradling piece wall is fluted, thereby make cradling piece cross section present irregular shape, if any certain chamfering or irregular square, trapezoidal, circular, oval, polygon.By after support implantable intravascular, because can making vascular damaged, support implantation process can cause vessel wall inflammation reaction, thereby cause smooth muscle cell proliferation, still have a certain proportion of vascular restenosis and occur, thereby weakened the support blood vessels that support plays, make blood transport unimpeded effect.
The generation occurring in order to overcome vascular restenosis, has developed drug stent.At present drug stent is to cover the polymer coating that one deck contains active constituents of medicine on the cradling piece 01 of rack body as shown in Figure 1, suppresses the generation of vascular restenosis by active ingredient.But when concrete application, only have support outer wall to contact with blood vessel wall with sidewall, the medicine that support outer wall and sidewall discharge can play the effect that suppresses the pre-preventing restenosis of blood vessel of blood vessel wall neointimal hyperplasia by intravasation wall, the medicine of rack inner wall cannot play the effect that suppresses neointimal hyperplasia, can be released into blood on the contrary, be circulated to whole body, other organs are played to side effect, also can suppress support endothelialization in addition, increase thrombotic risk.Therefore, be necessary to provide a kind of preparation method of coating bracket to reduce or avoid rack inner wall seal coat.
Summary of the invention
The blood vessel coating bracket preparation method that the present invention's one technical scheme provides comprises the steps: that top layer or whole shore hardness D are less than to 60 mandrel to be run through in the cavity of intravascular stent body coaxially; Change the gap of outer surface and the described intravascular stent inwall of described mandrel, until both seamless contacts; Coating solution is sprayed to described intravascular stent body; With remove described mandrel.
The blood vessel coating bracket preparation method that another technical scheme of the present invention provides comprises the steps: mandrel to run through coaxially in the cavity of intravascular stent body, and described mandrel top layer or whole shore hardness D are greater than 86; Change the gap of outer surface and the described intravascular stent inwall of described mandrel, until both part contacts; Coating solution is sprayed to described intravascular stent body; With remove described mandrel.
In one embodiment of the invention, can there is elastic deformation in described top layer, and external diameter is greater than the internal diameter of described intravascular stent body, described mandrel is run through in described cavity coaxially and changes the outer surface of described mandrel comprise with the gap of described intravascular stent inside: the described mandrel that stretches the extremely external diameter of described mandrel is less than described internal diameter; Described mandrel is connected to described intravascular stent body coaxially; Remove stretching action to described mandrel and recover deformation.
In one embodiment of the invention, described outside diameter of mandrel roughly mates with the internal diameter of described intravascular stent body, the gap of the outer surface of the described mandrel of described change and described intravascular stent inside comprises: the intravascular stent body that is through with described mandrel is placed in to reagent and soaks, until described mandrel top layer is expanded to that described mandrel outer surface contacts with the interior wall seamless of intravascular stent body or part contact after from described reagent, take out.
In one embodiment of the invention, described outside diameter of mandrel is slightly less than the internal diameter of described intravascular stent body, and the outer surface of the described mandrel of described change and the gap of described intravascular stent inwall comprise along intravascular stent body described in the radial compression of described intravascular stent body.
In one embodiment of the invention, described coating solution is sprayed at described this external surface of intravascular stent with ultrasonic spraying coating process, and ultrasonic power is 0.5～1.5w.
In one embodiment of the invention, the internal diameter of described blood vessel coating bracket body is not equal to the radius of curvature of described blood vessel coating bracket inner body wall.
It is worth mentioning that, before mandrel is run through in described cavity coaxially, also can in outer wall, inwall and the sidewall of described intravascular stent body, form coating by least one wall, be that the preparation method of the blood vessel coating bracket that provides of one embodiment of the invention is included in coating surface and sprays aforementioned coating solution again, the coating that this coating solution forms is the first coating, and the coating (being pre-formed the coating at intravascular stent body surface) that this first coating covers is the second coating.That is to say, this second coating is between this first coating and this intravascular stent body.Preferably, described coating covers whole outer surfaces (being outer wall, inwall and sidewall) of described intravascular stent body.
Certainly, also can spray after the above coating solution (forming the first coating) at described intravascular stent body, at described the first coating surface, form again coating.That is to say this first coating of all or part of covering of this second coating.In certain embodiments, this second coating also covers described inwall completely.
The present invention's one technical scheme also provides a kind of blood vessel coating bracket, comprise blood vessel coating bracket body and the first coating that is formed at described blood vessel coating bracket body outer wall and sidewall, described blood vessel coating bracket also comprises the second coating, described the second coating is positioned at described the first coating surface, or between described the first coating and described this external surface of intravascular stent.
This second coating can partly cover the outer surface of described intravascular stent body.Preferably, described the second coating covers described outer surface (being outer wall, sidewall and inwall) completely.
In one embodiment of the invention, described the first coating also covers the part inwall of blood vessel coating bracket body.
In one embodiment of the invention, the internal diameter of described blood vessel coating bracket body is not equal to the radius of curvature of described blood vessel coating bracket inner body wall, coating on described inwall comprises some subregions, between each subregion, is spaced from each other, and the coating on this inwall is meaning discontinuous coating.
In an embodiment of the present invention, described the first coating and the second coating can be all medication coat; Or described the first coating is medication coat, described the second coating is non-medication coat; Or described the first coating and the second coating can be all non-medication coat.When the first coating and the second coating are all medication coat, the medicine of the non-inhibition support of the medicament selection endothelialization in described the second coating.
In one embodiment of the invention, described the first coating and the second coating can be polymer coatings.This polymer coating can accelerate the degraded of intravascular stent body in human body.For example, when this intravascular stent body is ferroalloy (comprising pure iron and alloy thereof) matrix, this polymer can be the polyester that contains carboxyl, such as polylactic acid and derivant thereof.Type of polymer in this first coating and the second coating can be different.
In one embodiment of the invention, this first coating is medication coat, and this second coating is polymer coating.
In one embodiment of the invention, the thickness of described coating is 2～50 microns.
Compared with prior art, blood vessel coating bracket preparation method provided by the invention can be by controlling contacting of mandrel surface and intravascular stent inner body wall two contact surfaces, and can prepare outer wall in conjunction with traditional spraying coating process, sidewall has coating, the blood vessel coating bracket that inside coating is controlled, make this blood vessel coating bracket inwall without coating or be formed with discontinuous coating, its method can be controlled the coating amount of blood vessel coating bracket inwall flexibly, technique is simple, condition is easy to control, and the blood vessel coating bracket yields of acquisition is high.
The blood vessel coating bracket obtaining by above-mentioned blood vessel coating bracket preparation method is because its inwall is without coating or be formed with discontinuous coating, effectively reduce the amount of this blood vessel coating bracket inside coating, therefore, when this intravascular stent is coating stent of medicine, by after its built-in blood vessel, can both play the effect that suppresses vascular restenosis, can not suppress again support endothelialization or bring other side effect.
Accompanying drawing explanation
Fig. 1 is the rack body structural representation of existing intravascular stent;
Fig. 2 is that the rack body shown in Fig. 1 is perpendicular to the cross-sectional view of its axis;
Fig. 3 is the process chart of embodiment of the present invention blood vessel coating bracket preparation method;
Fig. 4 is in embodiment of the present invention blood vessel coating bracket preparation method, and to be shore hardness D be arranged in the state diagram in the hollow cavity of intravascular stent body lower than the mandrel of 60 rubber or flexible plastic to skin-material;
Fig. 5 is mandrel its schematic diagram contacting with the interior wall seamless of intravascular stent body after immersion treatment expands in Fig. 4;
Fig. 6 is the enlarged drawing that the cradling piece of Fig. 5 medium vessels rack body contacts with mandrel seamless surface;
Fig. 7 sprays medication coat liquid by the structural representation of the dry medication coat forming on the cradling piece of the intravascular stent body shown in Fig. 5; Wherein, at the inwall of cradling piece without medication coat;
Fig. 8 is in embodiment of the present invention blood vessel coating bracket preparation method, intravascular stent body 1 through press hold processing after its inwall and shore hardness D higher than the structure for amplifying schematic diagram of 86 mandrel Surface Contact face;
Fig. 9 is that Fig. 8 is along the sectional view of A-A;
Figure 10 is that Fig. 8 is along the sectional view of B-B;
Figure 11 is that Fig. 8 is along the sectional view of C-C;
Figure 12 sprays medication coat liquid by the structural representation of the dry medication coat forming on the cradling piece of the intravascular stent body shown in Fig. 8; Wherein, the inwall at cradling piece is formed with discontinuous medication coat;
Figure 13 be the embodiment of the present invention 3 blood vessel coating bracket preparation method medium vessels rack bodies 1 through press hold processing after the structure for amplifying schematic diagram of its cradling piece inwall and mandrel Surface Contact face;
Figure 14 sprays medication coat liquid by the structural representation of the dry medication coat forming on the cradling piece of the intravascular stent body shown in Figure 13; Wherein, the inwall at cradling piece is formed with discontinuous medication coat;
Figure 15 is that the medication coat liquid in embodiment of the present invention blood vessel coating bracket preparation method adopts ultrasonic spraying coating process schematic diagram;
Figure 16 is the schematic diagram of the blood vessel coating bracket that provides of the embodiment of the present invention 5;
Figure 17 is the schematic diagram of the blood vessel coating bracket that provides of the embodiment of the present invention 6.
The specific embodiment
In order to make object of the present invention, technical scheme and technique effect clearer, below in conjunction with drawings and Examples, the present invention is further elaborated.Should be appreciated that specific embodiment described herein, only in order to explain the present invention, is not intended to limit the present invention.
Because existing blood vessel drug eluting coating bracket is mostly generally to adopt full coat preparing technology to be prepared from, cause this blood vessel coating bracket inwall, outer wall and sidewall all to have medication coat.Wherein, the existing medication coat of inwall can be released in blood, is circulated to whole body, and other organs are played to side effect, also can suppress in addition the endothelialization of blood vessel coating bracket, increases thrombotic risk.Therefore,, if can the medication coat of blood vessel coating bracket inwall be control effectively, can effectively overcome the existing deficiency of existing blood vessel coating bracket.
Based on above-mentioned reason, the embodiment of the present invention provides the blood vessel coating bracket preparation method that can effectively control inwall medication coat.The method technological process as shown in Figure 3, refers to Fig. 4-15 simultaneously, and it comprises the steps:
S01. obtain intravascular stent body 1 and mandrel 2: obtain the intravascular stent body 1 of grid hollow tubular and the mandrel 2 matching with the hollow cavity 11 of intravascular stent body 1;
S02. mandrel 2 is arranged in coaxially in the hollow cavity 11 of intravascular stent body 1, and control the contact condition of both contact surfaces: the mandrel obtaining in step S01 2 is worn and is arranged in the hollow cavity 11 of intravascular stent body 1, mandrel 2 outer surfaces are contacted or part contact with the interior wall seamless of intravascular stent body 1;
S03. on intravascular stent body 1, prepare medication coat 3: the hollow cavity 11 that medication coat liquid is sprayed in S02 is equipped with on the intravascular stent body 1 of mandrel 2, drying removes mandrel 2 after processing, obtain blood vessel coating bracket, and the inwall of described blood vessel coating bracket is without medication coat 3 or be formed with discontinuous medication coat 3.
Particularly, in above-mentioned steps S01, hollow cavity 11 form fit of mandrel 2 and intravascular stent body 1, therefore, it can be arranged in the hollow cavity 11 of intravascular stent body 1, and can realize the contact condition of the inwall of these mandrel 2 outer surfaces and intravascular stent body 1 by regulating the factors such as its diameter and surperficial soft or hard, as realize the seamless contact of two contact surfaces or part contact.Therefore, this mandrel 2 has following embodiment at least:
As the first embodiment of the present invention, the shore hardness D that this mandrel 2 comprises mandrel body 22 and is coated on mandrel body 22 surfaces is lower than 60 top layer 21.This top layer 21 can be rubber or flexible plastic or other flexible materials and makes, and its structure is mandrel 2 structures as shown in Figure 4.Wherein, this mandrel body 22 can be to be prepared from by metal, pottery or duroplasts.
As the second embodiment of the present invention, this mandrel 2 is prepared from as rubber or flexible plastic one lower than 60 material by shore hardness D.
As the third embodiment of the present invention, this mandrel 2 is prepared from higher than 86 material one by shore hardness D.In specific embodiment, this mandrel 2 is prepared from higher than 86 metal, pottery or plastic or other material by shore hardness D.
As the 4th kind of embodiment of the present invention, the shore hardness D that this mandrel 2 comprises mandrel body 22 and is coated on mandrel body 22 surfaces is higher than 86 material layer 21, and its structure is as mandrel 2 structures shown in Fig. 4.In specific embodiment, this shore hardness D is prepared from by metal, pottery or plastic or other material higher than 86 material layer 21.Wherein, this mandrel body 22 can be to have metal, pottery or duroplasts to be prepared from.
It should be understood that in the first and second embodiment of mandrel 2, shore hardness D is shore hardness D≤60 lower than 60 mathematic(al) representation.The mandrel 2 of this first and second embodiment can be realized these mandrel 2 surfaces and contact with the interior wall seamless of intravascular stent body 1.In the third and fourth embodiment of mandrel 2, shore hardness D is shore hardness D >=86 higher than 86 mathematic(al) representation.The mandrel 2 of this third and fourth embodiment is because its surperficial hardness is relatively large, and because intravascular stent body 1 inboard wall groove 124 is or/and the existence of chamfering 125, as shown in Fig. 8-10, after mandrel 2 surfaces contact with intravascular stent body 1 inwall, between two tactile faces, have part gap, two contact surfaces are part contacts.
In addition, under the instruction of the embodiment of the present invention, adopt the mandrel of other structures also within embodiment of the present invention scope of disclosure.
In this step S01, intravascular stent body 1 is grid hollow tubular.The cylindrical tube structure with inner chamber 11 that this concrete intravascular stent body 1 consists of cradling piece 12, cradling piece 12 is fenestral fabric.Cradling piece 12 cross sections comprise cradling piece outer wall 121, sidewall 122, inwall 123, the as shown in Figure 7 structure of cradling piece 12.Wherein, the outer wall 121 of all cradling pieces 12 has formed the outer surface of intravascular stent body 1, and the inwall 123 of all cradling pieces 12 has formed the inner surface of intravascular stent body 1.
For the embodiment of the present invention, there is certain chamfering intravascular stent body 1 at suitable especially cradling piece 12 edges of selecting, or suitable especially cradling piece 12 cross sections of selecting are irregular circle, ellipse, trapezoidal, square etc. intravascular stent body 1, be at least not exclusively overlap from the circular arc of the intravascular stent body 1 internal diameter intravascular stent bodies 1 of (radius of curvature and the shelf inner diameter that are inwall are different) of part cradling piece 12 inwalls.That is to say that blood vessel coating bracket preparation method embodiment of the present invention is particularly suitable for forming medication coat 3 on such intravascular stent body 1 that to be at least part cradling piece 12 inwalls not exclusively overlap with the circular arc of intravascular stent body 1 internal diameter.
In above-mentioned steps S02, the inwall two contact surface contact conditions that mandrel 2 wore and be arranged in mode in the hollow cavity 11 of intravascular stent body 1 and mandrel 2 outer surfaces and intravascular stent body 1 are different different according to selected mandrel 2 hardness.When the concrete material of the skin 21 when mandrel 2 or the integral material of mandrel 2 are shore hardness D lower than 60 rubber or flexible plastic or other materials, this mandrel 2 is surperficial contacts with the interior wall seamless of intravascular stent body 1; When the shore hardness D of mandrel 2 is higher than 86 time, these mandrel 2 surfaces partly contact with inwall two contact surfaces of intravascular stent body 1.Therefore the mode that, mandrel 2 wears and is arranged in the hollow cavity 11 of intravascular stent body 1 at least has following several embodiment:
The first embodiment, as Figure 4-Figure 6, when mandrel 2 is the first embodiment in above-mentioned steps S01, while being mandrel 2 top layer 21 that comprises mandrel body 22 and be coated on mandrel body surface for shore hardness D lower than 60 rubber or flexible plastic layer or other materials, first mandrel 2 is arranged in the hollow cavity 11 of intravascular stent body 1, now, as shown in Figure 4, there is not seamless contact with intravascular stent body 1 inwall in the outer surface of mandrel 2 to both states.Both are soaked in to reagent as in normal heptane, expanded in top layer 21, until top layer 21, expand until mandrel 2 outer surfaces take out after contacting with the interior wall seamless of intravascular stent body 1, top layer 21 after taking-up contacts as shown in Figure 5,6 with the interior wall seamless of intravascular stent body 1, particularly, cradling piece 12 inwalls and the top layer 21 of intravascular stent body 1 form contact interface 23 closely, and both edges 24 do not have gap.
The second embodiment, embodiment is basic identical with this first, difference is when mandrel 2 being placed in to reagent together with intravascular stent body 1 soaking or afterwards, the outer surface of intravascular stent body 1 is pressed to the effect of holding (also can not apply this radial force) along radially applying of this intravascular stent body 1 simultaneously, to reduce intravascular stent body 1 internal diameter, make top layer 21 with the inwall of intravascular stent body 1 as seamless contact the shown in Fig. 5,6.
The third embodiment, when mandrel is the second embodiment of mandrel 2 in above-mentioned steps S01, be that mandrel 2 integral materials are while being shore hardness D lower than 60 rubber or flexible plastic, first the rubber of mandrel 2 or flexible plastic are carried out to stretcher strain, reduce mandrel 2 diameters, mandrel 2 is passed after the hollow cavity 11 of intravascular stent body 1, remove stretching action, mandrel 2 distortion are restored, its outer surface contacts with the interior wall seamless of intravascular stent body 1, when in this embodiment, mandrel 2 is through hollow cavity 11 and the contact condition of removing the inwall of mandrel 2 outer surfaces and intravascular stent body 1 after stretching action respectively as Fig. 4, contact condition shown in 5.Wherein, the interior wall seamless contact condition of cradling piece 12 of removing top layer after stretching action 21 and intravascular stent body 1 is contact condition as shown in Figure 6, and cradling piece 12 forms contact interface 23 closely with top layer 21, and both edges 24 do not have gap.
The 4th kind of embodiment, basic identical with this third embodiment, after difference is to remove and to mandrel 2 stretching actions, its distortion is restored, also comprise the outer surface of intravascular stent body 1 is applied to the step of pressing the effect of holding, to reduce intravascular stent body 1 internal diameter, make top layer 21 with the inwall of intravascular stent body 1 as seamless contact the shown in Fig. 5,6.
The 5th kind of embodiment, when mandrel 2 is third and fourth embodiment of mandrel 2 in above-mentioned steps S01, the shore hardness D of this mandrel was higher than 86 o'clock, first mandrel 2 is arranged in the hollow cavity 11 of intravascular stent body 1, again intravascular stent body 1 outer surface is pressed and held processing, in pressure, hold processing procedure medium vessels rack body 1 stressed and be out of shape, its internal diameter is reduced, and present irregularly shaped.When removing, press after the external force of holding, because intravascular stent body 1 size rebounds to some extent, again because the hardness of mandrel 2 is relatively high, although the inwall of macroscopic view intravascular stent body 1 and mandrel 2 outer surfaces seamless contact seemingly, but examine under a microscope, there is gap in the inwall of intravascular stent body 1 and mandrel 2 outer surfaces, both are part contacts.Particularly, as shown in Figure 8, groove 124 or chamfering 125 because cradling piece 12 exists, make its inwall contact and have gap with mandrel 2 outer surfaces to the state enlarged drawing that cradling piece 12 inwalls of intravascular stent body 1 contact with mandrel 2 outer surfaces.Wherein, known along A-A sectional view 9 in Fig. 8, due to the existence of cradling piece 12 grooves 124, make cradling piece 12 inwalls at this place contact and have gap with mandrel 2 outer surfaces; Known along B-B cross section Figure 10 in Fig. 8, due to the existence of cradling piece 12 chamferings 125, make cradling piece 12 inwalls at this place contact and have gap with mandrel 2 outer surfaces; Known along C-C cross section Figure 11 in Fig. 8, because cradling piece 12 inwall is herein smooth, therefore, cradling piece 12 inwalls at this place are seamless contacts with mandrel 2 outer surfaces, do not have gap.
To sum up, when the shore hardness D of mandrel 2 top layers or integral body is less than 60, by preceding method, can make the outer surface of mandrel 2 and the interior wall seamless of intravascular stent body 1 contact; When the shore hardness D of mandrel 2 top layers or integral body is greater than 86, by preceding method, can make the outer surface of mandrel 2 contact with the inner wall section of intravascular stent body 1.
In above-mentioned steps S03, after medication coat liquid is sprayed on the intravascular stent body 1 after above-mentioned steps S02 processes, medication coat liquid can stick to outer wall and the sidewall of intravascular stent body 1, that is to say outer wall and the sidewall that can stick to cradling piece 12.Simultaneously, if the inwall of intravascular stent body 1 is seamless contacts with the outer surface of mandrel 2, two surfaces of so seamless contact have stoped entering of this medication coat liquid, after medication coat liquid is dry, thereby avoid forming medication coat 3 at intravascular stent body 1 inwall, as shown in Figure 7, and only at cradling piece 12 outer walls 121 and the sidewall 122 of intravascular stent body 1, form medication coats 3, wall 123 does not have the formation of medication coat 3 within it, that is to say that inwall at blood vessel coating bracket is without medication coat 3.
If the inwall of intravascular stent body 1 is that part contacts with the outer surface of mandrel 2, as the 5th kind of embodiment in step S02 above, between two surfaces of part contact, there is gap, in follow-up spray treatment process, medication coat liquid can be by intravascular stent body 1 inboard wall groove and mandrel 2 between the gap of formation or/and the formed gap of chamfering between the inwall of intravascular stent body 1 and mandrel 2, as enter in the gap at chamfering 125 places in Fig. 9 further groove 124 places and Figure 10 and in dry run, form medication coat 3, meanwhile, medication coat liquid also can be prevented from entering the seamless contact portion between the inwall of intravascular stent body 1 and the outer surface of mandrel 2, seamless contact portion as shown in figure 11.Therefore, to be dried after and remove after mandrel 2, this is seamless, and contact portion does not have the formation of medication coat 3, in the gapped part of two contact surfaces, form medication coat 3, thereby make to be formed with discontinuous medication coat 3 on cradling piece 12 inwalls 123 of intravascular stent body 1, as shown in Figure 12,14.Certainly, now at cradling piece 12 outer walls 121 of intravascular stent body 1 and sidewall 122, form medication coats 3.
In this step S03, the mode that the medication coat liquid mode on intravascular stent body 1 that is sprayed at preferably sprays sprays, concrete can select ultrasonic spraying coating process spraying medication coat liquid, its technique as shown in figure 15, according to the method for step S02 above by mandrel 2 through in intravascular stent body 1 and make that inwall two contact surfaces of mandrel 2 outer surfaces and intravascular stent body 1 are seamless to be contacted or after part contacts, mandrel 2 one end are fixed on turning cylinder 4, by turning cylinder 4, drive intravascular stent bodies 1 to rotate and move around along the axis direction of mandrel 2.For spraying the nozzle 5 of medication coat liquid, be fixed on directly over intravascular stent body 1, medication coat liquid is processed through ultrasonic atomizing device 6 ultrasonic atomizatios after nozzle 5 sprays again, and the medication coat liquid of atomization is sprayed on intravascular stent body 1.Because the medication coat liquid drop after atomization is very little, easily enter intravascular stent body 1 each position after above-mentioned steps S02 processes, as entered in the inwall and the gap between mandrel 2 outer surfaces of the intravascular stent body 1 in the third embodiment of step S02 above, outer wall, the sidewall that therefore can obtain intravascular stent body 1 have medication coat, and inwall has the blood vessel coating bracket of discontinuous medication coat.Wherein, the discontinuous medication coat of inwall can refer to, this medication coat comprises some subregions spaced apart from each other; Also can refer to, medication coat only has one, and does not cover this inwall completely.
The amount that this medication coat liquid is sprayed on intravascular stent body 1 can be controlled according to the needs of actual production, in a preferred embodiment, this medication coat liquid amount on intravascular stent body 1 that is sprayed at is that the thickness that processing to be dried forms medication coat 3 is afterwards 2～30 μ m.
In this step S03 Chinese medicine coating solution, contain active constituents of medicine and/or polymer.In a preferred embodiment, the solute mass concentration of this medication coat liquid is 0.1～20%, and this preferred concentration is conducive to the spraying of this medication coat liquid, is particularly conducive to spraying.Wherein, while containing active constituents of medicine in this medication coat liquid, it is that 2～30 μ g/mm(are in stent length that the content of this active constituents of medicine is preferably content in medication coat 3)
In specific embodiment, this active constituents of medicine is one or more complex in anti-hamartoplasia class medicine, anti-platelet drug, antithrombotic formation class medicine, anti-inflammatory response class medicine; Wherein, anti-hamartoplasia class medicine can but be not only rapamycin, paclitaxel etc., anti-platelet drug can but be not only cilostazol (Cilostazol), antithrombotic form class medicine can but be not only heparin, anti-inflammatory response class medicine can but be not only dexamethasone.
In another specific embodiment, when medication coat liquid contains polymer, this polymer is the homopolymer of lactide, Acetic acid, hydroxy-, bimol. cyclic ester, ε-caprolactone or the copolymer of the two or three's copolymer; Or polybutyl methacrylate, cellulose family, at least one in polyvidon, polyvinyl alcohol, polymethyl methacrylate, gelatin, arabic gum.
This contains active constituents of medicine and polymer preferred kind can prevent that vascular restenosis from occurring preferably, is beneficial to the endothelialization of blood vessel coating bracket, guarantees that blood fortune is unimpeded.
In another specific embodiment, the solvent of medication coat liquid is at least one in oxolane, dichloromethane, chloroform, ethyl acetate, dimethyl formamide, chloroform, trichloroethane.Can certainly select can dissolved substance active component and/or other solvents of polymer.
In this step S03, the object of the dried after spray treatment is the dry medication coat 3 that forms of medication coat liquid that makes to stick on intravascular stent body 1, and the mode of its dried can adopt conventional drying mode, as normal temperature drying or oven dry.After processing to be dried, the taking-up mode of mandrel 2 is according to the hardness of the surfacing of mandrel 2 or to be arranged in mode in intravascular stent body 1 according to mandrel 2 different and different, as being while being arranged in intravascular stent body 1 according to the mode of first and second kind of embodiment in step S02 above when mandrel 2, in dried process, the top layer 21 expanding can lose the solvent of absorption and cause its reduced to be restored, therefore after, dry, can directly extract mandrel 2 out; When mandrel 2 is while being arranged in intravascular stent body 1 according to the mode of third and fourth kind of embodiment in step S02 above, after processing to be dried, again mandrel 2 is applied to external pulling force, mandrel 2 deformed diameter are diminished, now directly this mandrel 2 is extracted out from the hollow cavity 11 at intravascular stent body 1; When mandrel 2 is, while being arranged in intravascular stent body 1 according to the mode of the 5th kind of embodiment in step S02 above, after processing to be dried, directly mandrel 2 to be applied to external force, directly this mandrel 2 is extracted out from the hollow cavity 11 at intravascular stent body 1.
From the above, blood vessel coating bracket preparation method provided by the invention can be by controlling contacting of mandrel 2 surfaces and intravascular stent body 1 inwall two contact surfaces, and can prepare outer wall in conjunction with traditional spraying coating process, sidewall has medication coat, and inwall is without medication coat or be formed with the controlled blood vessel coating bracket of inwall medication coat of discontinuous medication coat.And be particluarly suitable for forming the controlled medication coat of inwall on this class intravascular stent body 1 that to be at least part cradling piece 12 inwalls not exclusively overlap with the circular arc of intravascular stent body 1 internal diameter.
Correspondingly, the embodiment of the present invention also provides blood vessel coating bracket, and this blood vessel coating bracket can adopt blood vessel coating bracket preparation method mentioned above to prepare.Therefore, this blood vessel coating bracket comprises intravascular stent body and is combined in the coating on this intravascular stent body surface and side, wherein, the intravascular stent body 1 of the structure of intravascular stent body as shown in Fig. 4,5, and at this intravascular stent body 1 inwall without medication coat 3 or be coated with discontinuous medication coat 3, as shown in Fig. 7,12 and 14.Wherein, this medication coat 3 can be to consist of the first coating and the second coating, and the second coating is coated with the appearance with the first coating.
The material of this medication coat 3 is also as active constituents of medicine and/or polymer in medication coat liquid mentioned above, and in a preferred embodiment, the thickness of this medication coat 3 is 2～30 μ m.When this medication coat 3 contains active constituents of medicine, it is 2～30 μ g/mm that the content of this active constituents of medicine is preferably content in medication coat.
Due at this blood vessel coating bracket inwall without medication coat or be formed with discontinuous medication coat, effectively reduce the amount of the medication coat of this blood vessel coating bracket inwall, therefore, entered after blood vessel, can both play the effect that suppresses vascular restenosis, can not suppress again support endothelialization or bring other side effect.
By specific embodiment, embodiment of the present invention blood vessel coating bracket and preparation method thereof is described further below.
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S11: preparation one mandrel 2, as shown in Figure 4, this mandrel 2 is comprised of stainless steel bar 22 and the silicone rubber tube 21 that is coated on stainless steel bar 22 surfaces, and the shore hardness D value of silicone rubber is 50, and these mandrel 2 external diameters are 0.9mm; Metal rack body in simultaneously providing is as shown in Figure 4 intravascular stent body 1, and its internal diameter is 1.0mm, and the cross section of its cradling piece 12 is that edge has the trapezoidal of chamfering;
S12: put into together after normal heptane soaks 2min and take out after mandrel 2 being arranged in the hollow cavity 11 of metal rack body 1, silicone rubber expands after absorbing normal heptane, metal rack body 1 size constancy, thereby silicone rubber tube 21 outer walls are contacted with the interior wall seamless of cradling piece 12 of metal rack body 1, as shown in Figure 5, micro-Microscopic observation cradling piece 12 inwalls evenly embed silicone rubber tube 21 outer surfaces, form the interface 13 of seamless contact, the edge 14 that cradling piece 12 contacts with mandrel 2 does not have gap, as shown in Figure 6.
S13: metal rack body 1 and mandrel 2 are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body 1 top after nozzle 5 ejection again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, by the metal rack body 1 after spraying together with mandrel 2 at air drying 5min at least, after the normal heptane volatilization of absorption in silicone rubber tube 21, external diameter diminishes, take off mandrel 2, cradling piece 12 outer walls 121 that obtain, sidewall 122 is formed with medication coat 3, inwall 123 is without the one side coating blood vessel coating bracket of medication coat 3, as shown in Figure 7.Wherein, medication coat solution is the tetrahydrofuran solution that contains rapamycin, and the content of rapamycin is 5%; Ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Through medication coat solution spraying, at the thickness of cradling piece 12 outer walls 121, the formed medication coat 3 of sidewall 122, be 20 μ m.
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S21 a: metallic blood vessel bracket is provided, and internal diameter is 10mm, preparation one mandrel 2, this mandrel 2 for the polytetrafluoroethylene (PTFE) that external diameter is slightly less than metal rack body internal diameter excellent, the shore hardness D of this PTFE rod is 90; The structure of this metal rack body is as metal rack body 1 in embodiment 1;
S22: after mandrel 2 being arranged in the hollow cavity 11 of metal rack body, the metal rack body that is equipped with mandrel 2 is put into and pressed the machine of holding to press to hold processing, metal rack body diameter diminishes and PTFE mandrel 2 size constancies, because PTFE mandrel 2 is harder, pressure is held rear metal rack body dimension rebound phenomenon, and cradling piece 12 cross sections of metal rack body can present irregular shape, although macroscopical cradling piece 12 inwalls are that the outer wall seamless of mandrel 2 contacts with PTFE rod, but examine under a microscope, there is gap in metal rack inner body wall and PTFE rod outer wall, as shown in Figure 8, AA from Fig. 8, BB, CC does sectional view in tri-positions, see respectively Fig. 9, 10, 11.There is groove 124 in AA place cradling piece 12 inwall mid portions, and still has gap after mandrel 2 Surface Contacts; There is the damaged of certain chamfering 125 in cradling piece 12 edges, BB place, after contacting, also has gap with mandrel 2, and CC place cradling piece 12 inwalls contact completely with mandrel 2 surfaces just;
S23: metal rack body and mandrel 2 are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body top after nozzle 5 ejections again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, metal rack body after spraying is put into the dry at least 10min of baking oven of 30～60 ℃ together with mandrel 2, take out PTFE rod, cradling piece 12 outer walls that obtain, sidewall is formed with medication coat 3, inwall is formed with the blood vessel coating bracket of discontinuous medication coat 3, as shown in figure 12.Wherein, medication coat solution is to contain polymer and the heparin mixture that mass ratio is 4:6, and wherein the quality percentage composition of polymer is 5%; Ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Through medication coat solution spraying, at cradling piece 12 outer walls, sidewall and part inwall, the thickness of formed medication coat 3 is about 50 μ m.
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S31 a: mandrel 2 is provided, and internal diameter is 4.5mm, and the metal rack body as shown in Figure 4, internal diameter is 5mm, and intravascular stent body 1, and this mandrel 2 is stainless steel bar, and its external diameter is slightly less than the internal diameter of metal rack body;
S32: after mandrel 2 being arranged in the hollow cavity of metal rack body, the metal rack body that is equipped with mandrel is put into and pressed the machine of holding to press to hold processing, metal rack body diameter diminishes and stainless steel bar size constancy, because stainless steel bar is harder, pressure is held rear metal rack body dimension rebound phenomenon, and cradling piece 12 cross sections of metal rack body can present irregular shape, examine under a microscope, metal rack inner body wall and stainless steel bar are that mandrel 2 outer walls exist gap, as shown in figure 13, particularly, cradling piece 12 inwalls occur that chamfering 125 appears in groove 124 and its,
S33: metal rack body and mandrel 2 are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body top after nozzle 5 ejections again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, metal rack body after spraying is put into the dry at least 5min of baking oven of 30～60 ℃ together with mandrel 2, take out PTFE rod, cradling piece 12 outer walls that obtain, sidewall is formed with medication coat 3, inwall is formed with the blood vessel coating bracket of discontinuous medication coat 3, as shown in figure 14.Wherein, medication coat solution is the mixture that contains polymer and rapamycin, and its mass content percentage composition is 1%; Ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Coating layer thickness through medication coat solution spraying on cradling piece is about 35 μ m.
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S41: preparation one mandrel, this mandrel is that external diameter is the butadiene rubber pipe of the shore hardness D50 of 3.1mm; Metal rack body in simultaneously providing is as shown in Figure 4 intravascular stent body 1, and its internal diameter is 3.0mm;
S42: the mandrel of butadiene rubber pipe is carried out to stretch processing, its outside dimension is diminished, after making in its hollow cavity that is arranged in metal rack body when following lower than 3.0mm, remove the external force of stretching action, make butadiene rubber pipe outside dimension return to original size, metal rack inner body wall contacts with the outer wall seamless of butadiene rubber pipe, micro-Microscopic observation discovery, and metal rack body cradling piece inwall evenly embeds butadiene rubber pipe outer wall;
S43: metal rack body and butadiene rubber tube core axle are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body 1 top after nozzle 5 ejection again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, when medication coat thickness reaches 15 μ m, stop spraying, after again butadiene rubber pipe being applied stretching external force and stretched, from metal rack body cavity, take out, obtain the cradling piece outer wall of metal rack body, sidewall has medication coat, inwall is without the blood vessel coating bracket of medication coat.Wherein, medication coat solution is the ethyl acetate solution containing 3% polylactic acid and 3% rapamycin; Ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Through medication coat solution spraying, at the coating layer thickness of cradling piece, be about 20 μ m.
Embodiment 5
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S51: provide a mandrel 2 and as shown in Figure 4 in internal diameter be that 1.6mm metal rack body is intravascular stent body 1; Wherein, this mandrel 2 comprises that diameter is the rustless steel cylindrical body of 1.3mm, at periphery, coat after lubricating oil, the politef that is 0.01mm by thickness (PTFE) thin film is evenly rolled in rustless steel periphery, the shore hardness of this PTFE film is 30, through multilamellar PTFE film, be wound around, until the gross thickness of rustless steel periphery PTFE film is at least 0.2mm;
S52: after mandrel being arranged in the hollow cavity of metal rack body, the metal rack body that is equipped with mandrel is put into and pressed the machine of holding to press to hold processing, metal rack body diameter diminishes until seamless contact of PTFE thin film of its inwall and mandrel, examine under a microscope, the cradling piece cross section of metal rack body is the irregular square with chamfering, and metal rack inner body wall has evenly embedded on PTFE film;
S53: metal rack body and mandrel are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body 1 top after nozzle 5 ejection again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, after spraying contact, take off stainless steel column, then by the stretcher strain of PTFE film, thereby make it separated with rack inner wall, the metal rack body outer wall and the sidewall that obtain have medication coat, and inwall does not have the blood vessel coating bracket of medication coat.Wherein, medication coat solution is the polylactic acid solution that contains mass percentage concentration 0.1%～15%, and in another embodiment, this polylactic acid solution is 0.1%～10%; Ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Through medication coat solution spraying, at the coating layer thickness of cradling piece, be about 5 μ m.
Outer wall and the sidewall of embodiment 5 preparations are had to the first coating, inwall does not have the one side coating bracket of the first coating, directly be fixed on turning cylinder 4, support tube intracavity spindle-less, then evenly sprays whole cradling piece, and spray solution is containing polylactic acid 0.5%, after spraying finishes, obtain having the support of two layers of coatings, at the first coating surface, be also formed with the second coating (polymer coating), and the second coating covers outer wall, inwall and the sidewall of this one side coating bracket.Final support outer wall total coating thickness approximately 15 μ m, spraying instrument parameter is with embodiment 5.
Embodiment 7
A kind of blood vessel coating bracket and preparation method thereof, this blood vessel coating bracket preparation method is as follows:
S71: it is that 1.2mm metal rack body is intravascular stent body 1 that internal diameter is provided; Support is directly fixed on spraying instrument rotating shaft 4, whole support is sprayed, spray solution contains 0.5% polylactic acid, obtains the support that inside and outside wall all has the second coating, and the second coating layer thickness is 10～15 μ m.
S72: provide mandrel 2 to comprise that diameter is the rustless steel cylindrical body of 1.0mm, at periphery, coat after lubricating oil, the politef that is 0.01mm by thickness (PTFE) thin film is evenly rolled in rustless steel periphery, the shore hardness of this PTFE film is 30, through multilamellar PTFE film, be wound around, until the gross thickness of rustless steel periphery PTFE film is at least 0.2mm;
S73: after mandrel being arranged in the hollow cavity of the cated metal rack body that S71 prepares, the metal rack body that is equipped with mandrel is put into and pressed the machine of holding to press to hold processing, metal rack body diameter diminishes until seamless contact of PTFE thin film of its inwall and mandrel, examine under a microscope, the cradling piece cross section of metal rack body is the irregular square with chamfering, and metal rack inner body wall has evenly embedded on PTFE film;
S74: metal rack body and mandrel are fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4 driven rotary and along the axial direction of turning cylinder 4, move around, medication coat solution by be fixed on metal rack body 1 top after nozzle 5 ejection again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, after spraying contact, take off stainless steel column, then by the stretcher strain of PTFE film, thereby make it separated with rack inner wall, the metal rack body obtaining has two layers of coatings, the second coating is polymer coating, be distributed in the inwall of rack body, outer wall and sidewall, the first coating is medication coat, and the first coating is only distributed in outer wall and sidewall, the outer wall and the sidewall that are whole support have medication coat, inwall only has polymer coating and there is no medication coat.This medication coat solution is the polylactic acid that contains mass percentage concentration 3% and 3% rapamycin, and ultrasonic spraying equipment is that model is the ultrasonic spraying instrument of Medicoat2000, and its ultrasonic power is set to 0.5～1.5w; Through medication coat solution spraying, at the coating layer thickness of the outer wall of cradling piece, be about 20 μ m.
Comparative example
Obtain as the intravascular stent body in embodiment 1, cavity body does not wear mandrel therein, but directly this intravascular stent body is directly fixed on turning cylinder 4 as shown in figure 15, by turning cylinder 4, drive with the speed rotation of 100～300r/min and along the axial direction of turning cylinder 4 and move around, medication coat solution by be fixed on metal rack body 1 top after nozzle 5 ejection again through ultrasonic atomizing device 6 ultrasonic atomizatios, drop on rack surface, metal rack body after spraying 1 is dry, the blood vessel coating bracket surfaces externally and internally obtaining has uniform coating.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, all any modifications of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., within all should being included in protection scope of the present invention.
Claims (14)
1. a blood vessel coating bracket preparation method, comprises the steps:
Mandrel is run through coaxially in the cavity of intravascular stent body, described mandrel top layer or whole shore hardness D are less than 60;
Change the gap of outer surface and the described intravascular stent inwall of described mandrel, until both seamless contacts;
Coating solution is sprayed to described intravascular stent body; With
Remove described mandrel.
2. a blood vessel coating bracket preparation method, comprises the steps:
Mandrel is run through coaxially in the cavity of intravascular stent body, described mandrel top layer or whole shore hardness D are greater than 86;
Change the gap of outer surface and the described intravascular stent inwall of described mandrel, until both part contacts;
Coating solution is sprayed to described intravascular stent body; With
Remove described mandrel.
3. blood vessel coating bracket preparation method as claimed in claim 1 or 2, it is characterized in that, before described preparation method is also included in mandrel is run through in described cavity coaxially, in outer wall, inwall and the sidewall of described intravascular stent body, at least one wall forms coating.
4. blood vessel coating bracket preparation method as claimed in claim 1 or 2, is characterized in that, described preparation method is also included in the coating surface formation coating that described coating solution forms.
5. blood vessel coating bracket preparation method as claimed in claim 1 or 2, it is characterized in that: elastic deformation can occur on described top layer, and external diameter is greater than the internal diameter of described intravascular stent body, described mandrel is run through in described cavity coaxially and changes the outer surface of described mandrel comprise with the gap of described intravascular stent inside: the described mandrel that stretches the extremely external diameter of described mandrel is less than described internal diameter; Described mandrel is connected to described intravascular stent body coaxially; Remove stretching action to described mandrel and recover deformation.
6. blood vessel coating bracket preparation method as claimed in claim 1 or 2, it is characterized in that, described outside diameter of mandrel roughly mates with the internal diameter of described intravascular stent body, the gap of the outer surface of the described mandrel of described change and described intravascular stent inside comprises: the intravascular stent body that is through with described mandrel is placed in to reagent and soaks, until described mandrel top layer is expanded to that described mandrel outer surface contacts with the interior wall seamless of intravascular stent body or part contact after from described reagent, take out.
7. blood vessel coating bracket preparation method as claimed in claim 1 or 2, it is characterized in that: described outside diameter of mandrel is slightly less than the internal diameter of described intravascular stent body, the outer surface of the described mandrel of described change and the gap of described intravascular stent inwall comprise along intravascular stent body described in the radial compression of described intravascular stent body.
8. blood vessel coating bracket preparation method as claimed in claim 1 or 2, is characterized in that, described coating solution is sprayed at described this external surface of intravascular stent with ultrasonic spraying coating process, and ultrasonic power is 0.5～1.5w.
9. blood vessel coating bracket preparation method as claimed in claim 1 or 2, is characterized in that, the internal diameter of described blood vessel coating bracket body is not equal to the radius of curvature of described blood vessel coating bracket inner body wall.
10. a blood vessel coating bracket, comprise blood vessel coating bracket body and the first coating that is formed at described blood vessel coating bracket body outer wall and sidewall, it is characterized in that, described blood vessel coating bracket also comprises the second coating, described the second coating is positioned at described the first coating surface, or between described the first coating and described this external surface of intravascular stent.
11. blood vessel coating brackets as claimed in claim 10, it is characterized in that, the internal diameter of described blood vessel coating bracket body is not equal to the radius of curvature of described blood vessel coating bracket inner body wall, and the coating on described inwall comprises some subregions, between each subregion, is spaced from each other.
12. blood vessel coating brackets as claimed in claim 10, is characterized in that, described the first coating also covers the part inwall of described blood vessel coating bracket body.
13. blood vessel coating brackets as claimed in claim 12, is characterized in that, described the second coating covers at least one wall in described outer wall, sidewall and inwall.
14. blood vessel coating brackets as described in claim 11-13 any one, is characterized in that, described the first coating and the second coating are all medication coat; Or described the first coating is medication coat, described the second coating is non-medication coat; Or described the first coating and the second coating are all polymer coating.
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