CN104874090A - Novel drug eluting balloon catheter - Google Patents
Novel drug eluting balloon catheter Download PDFInfo
- Publication number
- CN104874090A CN104874090A CN201510124482.6A CN201510124482A CN104874090A CN 104874090 A CN104874090 A CN 104874090A CN 201510124482 A CN201510124482 A CN 201510124482A CN 104874090 A CN104874090 A CN 104874090A
- Authority
- CN
- China
- Prior art keywords
- drug
- medicine
- balloon catheter
- hydrophilelipophile
- carried coat
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000003814 drug Substances 0.000 title claims abstract description 144
- 229940079593 drug Drugs 0.000 title claims abstract description 59
- 229920000642 polymer Polymers 0.000 claims abstract description 27
- 238000011068 loading method Methods 0.000 claims abstract description 16
- 238000004140 cleaning Methods 0.000 claims description 38
- 238000000576 coating method Methods 0.000 claims description 25
- 238000005516 engineering process Methods 0.000 claims description 25
- 239000011248 coating agent Substances 0.000 claims description 22
- 150000002148 esters Chemical class 0.000 claims description 18
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 16
- 239000002202 Polyethylene glycol Substances 0.000 claims description 13
- 229920001223 polyethylene glycol Polymers 0.000 claims description 13
- 229920001221 xylan Polymers 0.000 claims description 13
- 150000004823 xylans Chemical class 0.000 claims description 13
- 229920001503 Glucan Polymers 0.000 claims description 11
- TWNIBLMWSKIRAT-VFUOTHLCSA-N levoglucosan Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@H]2CO[C@@H]1O2 TWNIBLMWSKIRAT-VFUOTHLCSA-N 0.000 claims description 11
- 239000007921 spray Substances 0.000 claims description 11
- 239000002253 acid Substances 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 9
- 229920001661 Chitosan Polymers 0.000 claims description 8
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 7
- 238000004804 winding Methods 0.000 claims description 7
- 229920002101 Chitin Polymers 0.000 claims description 6
- 229930012538 Paclitaxel Natural products 0.000 claims description 6
- 229920000375 Poly(ethylene glycol)-block-poly(ε−caprolactone) methyl ether Polymers 0.000 claims description 6
- 229960001592 paclitaxel Drugs 0.000 claims description 6
- 229950008882 polysorbate Drugs 0.000 claims description 6
- 229920000136 polysorbate Polymers 0.000 claims description 6
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims description 6
- 150000003904 phospholipids Chemical class 0.000 claims description 5
- 229960000446 abciximab Drugs 0.000 claims description 3
- ZAHRKKWIAAJSAO-UHFFFAOYSA-N rapamycin Natural products COCC(O)C(=C/C(C)C(=O)CC(OC(=O)C1CCCCN1C(=O)C(=O)C2(O)OC(CC(OC)C(=CC=CC=CC(C)CC(C)C(=O)C)C)CCC2C)C(C)CC3CCC(O)C(C3)OC)C ZAHRKKWIAAJSAO-UHFFFAOYSA-N 0.000 claims description 3
- QFJCIRLUMZQUOT-HPLJOQBZSA-N sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 claims description 3
- 229960002930 sirolimus Drugs 0.000 claims description 3
- 241001597008 Nomeidae Species 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 239000010410 layer Substances 0.000 abstract description 51
- 238000000034 method Methods 0.000 abstract description 18
- 239000003640 drug residue Substances 0.000 abstract description 8
- 239000011247 coating layer Substances 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 230000000694 effects Effects 0.000 description 15
- 238000005507 spraying Methods 0.000 description 13
- 239000012876 carrier material Substances 0.000 description 11
- 239000000463 material Substances 0.000 description 11
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 10
- 210000004204 blood vessel Anatomy 0.000 description 8
- 238000010828 elution Methods 0.000 description 8
- 230000003902 lesion Effects 0.000 description 8
- 239000002987 primer (paints) Substances 0.000 description 8
- 238000002474 experimental method Methods 0.000 description 7
- 229910052756 noble gas Inorganic materials 0.000 description 7
- 230000002000 scavenging effect Effects 0.000 description 7
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 229910052786 argon Inorganic materials 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 210000001519 tissue Anatomy 0.000 description 5
- 238000013461 design Methods 0.000 description 4
- 239000003960 organic solvent Substances 0.000 description 4
- 230000001575 pathological effect Effects 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- 210000000709 aorta Anatomy 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000003618 dip coating Methods 0.000 description 3
- 230000002500 effect on skin Effects 0.000 description 3
- 238000000605 extraction Methods 0.000 description 3
- 229910052754 neon Inorganic materials 0.000 description 3
- GKAOGPIIYCISHV-UHFFFAOYSA-N neon atom Chemical compound [Ne] GKAOGPIIYCISHV-UHFFFAOYSA-N 0.000 description 3
- 238000011587 new zealand white rabbit Methods 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- KKJUPNGICOCCDW-UHFFFAOYSA-N 7-N,N-Dimethylamino-1,2,3,4,5-pentathiocyclooctane Chemical compound CN(C)C1CSSSSSC1 KKJUPNGICOCCDW-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- 229920002988 biodegradable polymer Polymers 0.000 description 2
- 239000004621 biodegradable polymer Substances 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 2
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 241000283977 Oryctolagus Species 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 229920002614 Polyether block amide Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 238000005530 etching Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 239000008206 lipophilic material Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000003754 machining Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 239000013047 polymeric layer Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000007086 side reaction Methods 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Abstract
The invention provides a novel drug eluting balloon catheter. The novel drug eluting balloon catheter comprises a catheter body, a balloon body (1) and a balloon surface (2) and further comprises a hydrophilic and lipophilic bottom layer (3) and a drug loading coating layer (4). The hydrophilic and lipophilic bottom layer (3) is arranged on the upper surface of the balloon surface (2), the drug loading coating layer (4) is arranged on the upper surface of the hydrophilic and lipophilic bottom layer (3), and the drug loading coating layer (4) is composed of polymer and drug. The novel drug eluting balloon catheter has the advantages of simple structure, simple production process and procedures, low drug loss during delivery and low drug residues on the balloon after interventional operation.
Description
Technical field
The present invention designs a kind of medical apparatus and instruments, a kind of newtype drug eluting sacculus that especially a kind of interventional therapy cardiovascular disease uses.
Background technology
Medicine eluting balloon catheter is that conventional balloon plasty and advanced medicament elution technology combine, the instant-free of medicine eluting balloon catheter medicine when interventional therapy, the side reaction that the prolonged stay avoiding metal rack and polymer carrier causes, the one being metal rack angioplasty is effectively supplementary, implant in Vascular Restenosis after Balloom process at drug stent and there is good application, show its superiority gradually, but the medicine that medicament elution sacculus also also exists medical surfaces a large amount of loss and cause the low and PTCA or and STENTS of medicine carrying drug ratio when pathological tissues to still have some drugs to be attached to balloon surface (being about 10-20%) because of the existence of surface combination power in intervention procedure, affect the problem of drug release.Therefore, how realizing medicine on medicament elution sacculus in lesion locations release at regular time and quantity, is one of key factor realizing medicinal balloon therapeutic effect.
CN101785900A discloses a kind of medicinal balloon, in this patent, balloon design becomes outer surface is the irregular nonplanar structure of tool, at groove part and the flat part coated medicament of sacculus outer surface, by the indwelling effect of groove, reduce the loss of medicine in course of conveying.The method adopts the reeded mould of tool, in sacculus forming process, directly make sacculus have groove outward appearance, but balloon surface drug residue is higher after the groove indwelling effect of the method also can cause treatment, affect drug utilization efficiency, on the other hand, the method is higher to sacculus molding technology, and especially Mould Machining required precision is too harsh.
Chinese patent CN200951251A discloses a kind of double-deck medicine eluting foley's tube, and this medicine eluting balloon catheter covers the sacculus of one deck with micropore at sacculus outer surface, and described outer sacculus is prepared by materials such as PE, PC, PEBAX.It adopts laser boring or etching technique to make micropore, and equally also because of the skin effect of micropore, can increase the drug residue on Post operation medicinal balloon surface, and this technique needs expensive instrument and equipment, complex technical process, is not suitable for suitability for industrialized production.
In addition, Chinese patent CN103990221A discloses a kind of medicament elution balloon-system, described polymeric layer contains medicine or medicine and additive, and disclose a kind of fabric extracted, this bottom forms vesicular texture after extraction, the adhesion of medicine layer and balloon surface can be reduced, be bonded in blood vessel wall after medicine layer monoblock or flaking can be made.But, still there is the problem of a large amount of loss in intervention procedure in this patent, in technique, it extracts after selecting coating spraying again, extraction process is complicated, extracts solvent used and also may cause damage to medication coat, after extraction, organic solvent remaining on sacculus is also the problem that need solve, and be bonded in the medicine layer of lamellar in blood vessel wall and fall block and come off, there is the risk causing thrombosis, even threat to life.
Chinese patent CN204050424U discloses a kind of medicinal balloon, this medicinal balloon adopts double-layered balloon, sacculus outer surface is coated with the biodegradable polymer layer of water solublity bottom and drug containing successively, its skin is when expanding, have the solution such as normal saline to ooze out from balloon wall, dissolved water dissolubility bottom, thus the release controlling the biodegradable polymer layer of drug containing.This balloon structure is complicated, and normal saline injects balloon wall, on the one hand complex manufacturing, and solution is difficult to be retained in balloon wall steadily in the long term on the other hand, once there be solution to ooze out, and will badly damaged coating integrity.
Therefore, need to provide a kind of medicine eluting balloon catheter, not only can reduce the loss of course of conveying Chinese medicine, reduce postoperative medicine remaining in balloon surface, improve drug use efficiency, and processing technique is simple, use safety, be applicable to suitability for industrialized production.
Summary of the invention
In order to solve the problems of the technologies described above, the invention provides a kind of newtype drug eluting foley's tube, it is simple that this medicine eluting balloon catheter has structure, and production process is simple, the loss of course of conveying Chinese medicine is few, and after intervene operation the feature of medicine less residue on sacculus.
A kind of medicine eluting balloon catheter, comprise conduit, balloon body 1 and balloon surface 2, it is characterized in that, also comprise hydrophilelipophile bottom 3 and drug-carried coat 4, described hydrophilelipophile bottom 3 is positioned at above balloon surface 2, and drug-carried coat 4 is positioned at above hydrophilelipophile bottom 3, and described drug-carried coat 4 is made up of polymer and medicine.
Wherein bottom 3 is for having the polymer material layer of hydrophilelipophile performance, and as shown in Figure 1, the existing hydrophilic group of polymeric material has lipophilic group again.Bottom forms a sealing coat between drug-carried coat and sacculus, because of medicine and balloon surface because skin effect adhesion is stronger, the medicine of drug-carried coat can be avoided to contact with balloon surface, reduce medicine layer adhesion, be beneficial to the quick release of medicine layer, and the drug residue of medicine because causing with the skin effect of sacculus can be reduced, primer should have hydrophilelipophile performance, primer can be Polyethylene Glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-stearate, phospholipid, gather one or more in citrate.Underlayer thickness is preferably 0.1-2 μm, and bottom can not be too thick, blocked uply affects the overall transportation performance of medicinal balloon, the excessively thin effect not reaching isolation sacculus and medicine.
(wherein Mv is viscosity-average molecular weight to the preferred Mv>50K of described bottom hydrophilelipophile Polymer average molecular weights, K is unit of quantity " thousand "), the hydrophilelipophile polymer hydrophilicity of this Range molecular weight reduces, as difficult drop-off during bottom, especially when medicinal balloon coating has multiple structure, can guarantee that in the medicinal balloon treatment short time, (sacculus opens rear 1min) bottom is difficult to dissolve, and better stability can be kept at short notice, if bottom local shedding, that easily causes drug-loaded layer falls block, affect the reprinting of medicine to pathological tissues.Wherein, more preferably 70K<Mv<150K, because when molecular weight is excessive, polymer is large in endovascular viscosity, affects blood flow, easy artery-clogging, jeopardizes patient vitals's health.
Precedence technique scheme of the present invention; also comprise one deck hydrophilelipophile top layer 5; top layer is polymer material layer; top layer is wrapped in drug-carried coat surface, forms layer protective layer, can reduce the loss of medicine in course of conveying on drug-carried coat surface; when sacculus is transported to lesion locations; top layer is dissolved completely substantially, and do not affect again the release of medication coat Chinese medicine while reaching protection drug-carried coat, skin-material should have good lipophilic hydrophilicity.Because medicine eluting balloon catheter needs the blood vessel through a section longer to arrive narrow location in course of conveying; now medicine often loses in a large number after blood flow washes away; not only cause medicine carrying drug ratio when pathological tissues low; and easily cause toxic and side effects; the effect of protection medication coat can be played in top layer in medicinal balloon course of conveying, can not affect again release when medicine reaches lesion locations.Skin-material can be Polyethylene Glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-hard acid esters, phospholipid, one or more in poly-citrate.Skin depth is 0.1-2 μm, and top layer is not blocked up, and when medicinal balloon arrives transfer position, top layer is difficult to dissolving and completes, and top layer is too thin is difficult to the effect reaching protection medicine layer.
Drug-carried coat 4 carrier material and top layer 5 material are hydrophilelipophile polymer, the preferred Mv<40K of mean molecule quantity, drug-carried coat needs to discharge completely in 1min after sacculus is opened, and needs polymer to have good hydrophilic, therefore requires that polymer has lower molecular weight; Top layer plays a part to protect medication coat in sacculus course of conveying, and meanwhile, when sacculus is transported to lesion locations, top layer will be dissolved completely, and therefore also should there be better dissolubility on top layer, also requires lower molecular weight.Wherein, more preferably 1K<Mv<40K.
Drug-carried coat 4 carrier material is the mixed layer of hydrophilelipophile polymer and medicine.Described drug-carried coat is positioned in the middle of top layer and bottom, and the carrier material of drug-carried coat has Lipophilicity, and after guaranteeing that sacculus is adherent, medicine timely and effectively can be discharged into blood vessel wall.The drug loading of drug-carried coat is preferably 1-5 μ g/mm
2coating layer thickness is preferably 1-50 μm, the drug loading of above-mentioned each drug-carried coat and thickness are the preferable range of great many of experiments, the drug loading of each drug-carried coat is unsuitable too high, too high meeting produces larger side effect to human body, too lowly do not reach therapeutic effect, each drug-carried coat thickness is unsuitable excessive, otherwise can affect the fastness that coating combines.In addition, drug-carried coat be preferably coated on sacculus open after whole effectively support scopes, the coating and tapering, sacculus two ends does not have, in order to avoid affect the medicament contg of sacculus entirety.
The carrier material of drug-carried coat and medicine such as one or more medicines in paclitaxel, rapamycin and derivant, abciximab etc. fully mix, be dissolved in methanol, ethanol, acetone, dichloromethane, acetonitrile, oxolane, the mode adopting spraying, dip-coating, coating or flap to inject by coating load to balloon surface.The carrier material of drug-carried coat is one or both in Polyethylene Glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-stearate, phospholipid, poly-citrate, the preferred Mv<40K of mean molecule quantity, more preferably 1K<Mv<40K.
Drug-carried coat is made up of one or more carrier materials above-mentioned and medicine, and the carrier material of drug-carried coat is preferably identical with bottom, and the part by weight of preferred medicine and carrier material is 1:10-10:1.Wherein, the preferred polymer molecular weight of the present invention, drug loading, component and coating layer thickness can guarantee that medicine also effectively can be reprinted to blood vessel wall in 1min in safe release; The kind of medicine and content also can reach the effect for the treatment of vascular lesion.
Higher molecular weight material selected by bottom, reduces the hydrophilic of primer, can reduce sacculus when opening, dissolve the coating caused fall block risk because of bottom local material.Drug-carried coat and top layer require that molecular weight is little, and hydrophilic is better, are beneficial to sacculus and open rear medicine and can be discharged into lesion locations timely and effectively.
The present invention further provides a kind of preparation method of medicine eluting balloon catheter, comprising:
First the surface of sacculus adopts the pretreatment of plasma cleaning technology, then sprays one deck bottom, thickness 0.1-2 μm;
Spray drug-carried coat again, thickness is 1-50 μm, and drug loading is 1 μ g/mm
2-5 μ g/mm
2;
After coating drying, folding, spray one deck top layer again after winding, thickness is 0.1-2 μm.
Concrete, first the present invention carries out pretreatment to balloon surface, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as argon, neon etc., and power is 10KHz-100KHz, pressure during cleaning in work chamber is 0.01atm-0.3atm, and scavenging period is 5-30min;
Bottom 3 preparation technology: the carrier material weighing certain mass, and be dissolved in organic solvent, leave standstill, to be dissolved completely after, obtain primer coating liquid, then adopt dip-coating or spraying or coating processes, make balloon surface form one deck carrier material coating, through room temperature vacuum drying, obtain the foley's tube with bottom.
Drug-carried coat preparation technology: weigh the carrier material of certain mass and medicine, and be dissolved in organic solvent, is then coated in bottom surface by the employing dip-coating of configuration medicine carrying spray coating liquor or spraying or coating processes, and the thickness controlling drug-carried coat is in aforementioned range.
After drying to be coated, sacculus is folded, winding, and further on the preparation top layer, surface of drug-carried coat, identical with bottom preparation technology for top layer preparation technology.
Plasma cleaning technology minimizing interfacial effect is adopted to affect the adhesion of coating, and the physical impact effect of plasma, make balloon surface become more coarse, increase the fastness that coating is combined with balloon surface.Adopt optimizing technology parameters both can ensure the cleaning of balloon surface impurity completely, the long-time physical impact balloon surface of plasma can be avoided again, affect the mechanical property of sacculus.
Multilayer medicine eluting coatings sacculus of the present invention has following effect:
(1) bottom can reduce medicine and directly contacts with balloon surface, reduces through residual in balloon surface of PTCA or and STENTS medicine, and when making sacculus arrive lesion locations, the release of medicine reaches maximization, by the therapeutic effect optimization of medicine; Meanwhile, adopt multilayer medicine of the present invention to design, can guarantee drug-carried coat and bottom in conjunction with fastness;
(2) drug loss of medicament elution sacculus in course of conveying can be reduced in top layer, prevents ingredient from discharging too early in blood;
(3) the present invention is compared with monolayer drug-carried coat, has Drug bioavailability high, and toxic and side effects is little, and when being combined with bottom of the present invention and top layer, beneficial effect is more remarkable.
(4) the present invention also has structure simply in addition, and easy to process, qualification rate is high, is suitable for large-scale production.
Accompanying drawing explanation
Fig. 1 hydrophilelipophile polymer architecture schematic diagram
Fig. 2 contains the medicament elution sacculus coating structure figure of bottom, drug-carried coat
Fig. 3 contains the medicament elution sacculus coating structure figure on bottom, drug-carried coat and top layer
Fig. 4 contains the medicament elution sacculus drug release profiles on bottom, drug-carried coat and top layer
Wherein, 1 is balloon body, and 2 is balloon surface, and 3 is bottom, and 4 is drug-carried coat, and 5 is top layer.
Detailed description of the invention
Explain invention below in conjunction with specific embodiments and accompanying drawing, but the present invention is not limited only to this.
Embodiment 1
As shown in Figure 2, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as argon, power 50KHz, pressure during cleaning in work chamber is 0.1atmatm, and scavenging period is 10min.Then with the lipophilic Polyethylene Glycol of tool good hydrophilic for primer (as shown in Figure 1, the existing hydrophilic group of polymeric material has lipophilic group again), then the Polyethylene Glycol bottom that molecular weight is 70K is sprayed, thickness 1 μm, spray the drug-carried coat of Polyethylene Glycol that one deck molecular weight is 15K and paclitaxel mixing again, drug loading is 2.5 μ g/mm
2, thickness is 10 μm; After coating drying, finally fold.
Embodiment 2
As shown in Figure 3, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as neon, and power is 10KHz, pressure during cleaning in work chamber is 0.01atm, and scavenging period is 5min.Then with the poly-hard acid esters of Lipophilicity for primer (as shown in Figure 1, the existing hydrophilic group of polymeric material has lipophilic group again), spraying one deck molecular weight is the poly-hard acid esters bottom of 51K, thickness 2 μm, spray the drug-carried coat of hard acid esters that one deck molecular weight is 5K and paclitaxel mixing again, drug loading is 1 μ g/mm
2, thickness is 50 μm; After coating drying, folding, spraying one deck molecular weight after winding is again 2K polyglycerin ester top layer, and thickness is 2 μm.
Embodiment 3
As shown in Figure 3, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as argon, and power is 50KHz, pressure during cleaning in work chamber is 0.1atm, and scavenging period is 10min.Then with the hydrophilic glucosan of lipophilic for primer (as shown in Figure 1, the existing hydrophilic group of polymeric material has lipophilic group again), spraying one deck molecular weight is the glucosan bottom of 150K, thickness 0.1 μm, spray the drug-carried coat that one deck molecular weight is 39K glucosan and rapamycin mixing again, drug loading is 2.5 μ g/mm
2, thickness is 1 μm; After coating drying, folding, finally spraying one deck molecular weight again after winding is that 39K gathers citrate top layer, and thickness is 0.1 μm.
Embodiment 4
As shown in Figure 3, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as neon, and power is 100KHz, pressure during cleaning in work chamber is 0.3atm, and scavenging period is 30min.Then with the hydrophilic chitosan of lipophilic for primer (as shown in Figure 1, the existing hydrophilic group of polymeric material has lipophilic group again), spraying one deck molecular weight is 200K chitosan bottom, thickness 0.2 μm, spray the drug-carried coat that one deck molecular weight is 20K xylan alcohol and abciximab mixing again, drug loading is 5 μ g/mm
2, thickness is 6 μm; After coating drying, folding, finally spraying one deck molecular weight again after winding is 10K xylan alcohol top layer, and thickness is 0.8 μm.
Contrast experiment 1
First the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopts plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as argon, power 50KHz, pressure during cleaning in work chamber is 0.1atmatm, and scavenging period is 10min.And then spraying the drug-carried coat of polyglycerin ester that molecular weight is 50K and paclitaxel mixing, drug loading is 2.5 μ g/mm
2, thickness is 18 μm; After coating drying, finally fold.
Contrast and experiment
For verifying the drug loss of the medicine eluting balloon catheter of above-mentioned embodiment in course of conveying, the above-mentioned foley's tube folding pressure held is conveyed into the ventral aorta assigned address of about 2.0 ± 0.5 kilograms New Zealand white rabbit, after abundant moistening, pressurising is opened, and foley's tube is placed in lesion locations and keeps about 1 minute, then sacculus is taken out, survey remaining drug residue rate on sacculus, and measure the medicament contg reprinted in new zealand rabbit ventral aorta at the appointed time, remain according to this and calculate the loss rate of medicine at course of conveying.
For the situation that checking medicine is absorbed by tissue, in the bone tremulous pulse of the New Zealand white rabbit that above-mentioned sacculus is implanted, pressurising balloon expandable under 16atm, keep pressure 1 minute, sacculus is taken out in decompression, and blood is died suddenly after washing away 1 hour white rabbit, surveys the drug residue rate organized on drug concentration and sacculus.
For organizing medicine absorbance, dissecting and obtaining balloon expandable place blood vessel, after grinding, being settled to 2ml, then using and survey hplc determination drug in solution content, and computation organization's drug absorption rate.
For sacculus drug residue rate, take out the sacculus that uses, shear and be settled to 2ml, then use survey hplc determination drug in solution content after grind, and calculating drug residue rate.
More than detect chromatograph of liquid service condition to be:
Detector: UV-detector;
Chromatographic column: SB-Aq C
185 μm of 250 × 4.6mm;
Mobile phase: methanol: acetonitrile: water=23:41:36;
Column temperature: 30 DEG C;
Determined wavelength: 227nm;
Flow velocity: 1.5 ml/min;
Sample size: 10 μ L.
| Embodiment | Course of conveying Chinese medicine loss rate | Organize medicine absorbance | Medicine residual rate on sacculus |
| Embodiment 1 | 36％ | 21.5％ | 9％ |
| Embodiment 2 | 29％ | 23.8％ | 11％ |
| Embodiment 3 | 28％ | 24.2％ | 10％ |
| Embodiment 4 | 32％ | 26.2％ | 11％ |
| Contrast experiment 1 | 53％ | 10.3％ | 15％ |
Contrast experiment 2
As shown in Figure 3, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, adopt plasma cleaning technology, cleaning sacculus surface irregularities, preferentially described plasma cleaning adopts noble gas, such as argon, and power is 50KHz, pressure during cleaning in work chamber is 0.1atm, and scavenging period is 10min.Then one deck Polyethylene Glycol bottom is sprayed, thickness 1 μm, then the drug-carried coat of the poly-hard acid esters of spraying and paclitaxel mixing, drug loading is 2.5 μ g/mm
2, thickness is 15 μm; After coating drying, folding, finally spray one deck xylan alcohol top layer again after winding, thickness is 1 μm.
According to above-mentioned preparation method and following table molecular weight, Polyethylene Glycol, poly-hard acid esters and xylan alcohol prepare bottom, drug-carried coat and top layer respectively, and the following different molecular weight of corresponding use prepares medicinal balloon 1-8.
In addition, according to above-mentioned preparation method and following table molecular weight, use non-hydrophilic lipophilic materials PLGA, and low-molecular-weight PVP prepares bottom, poly-hard acid esters and drug-carried coat prepared respectively by xylan alcohol and top layer obtains sacculus 9 and 10.
| Sacculus is numbered | Bottom molecular weight (K) | Drug-carried coat molecular weight (K) | Surface molecules amount (K) |
| 1 | 31 | 0.1 | 0.1 |
| 2 | 41 | 0.5 | 0.5 |
| 3 | 51 | 1 | 1 |
| 4 | 71 | 20 | 20 |
| 5 | 101 | 30 | 30 |
| 6 | 151 | 39 | 39 |
| 7 | 201 | 50 | 50 |
| 8 | 301 | 100 | 100 |
| 9 | 101 | 30 | 30 |
| 10 | 20 | 0.1 | 0.1 |
Contrast and experiment
For medicine eluting balloon catheter different molecular weight coating loss in course of conveying of proving and comparisom experiment 2, the above-mentioned foley's tube folding pressure held is conveyed into the ventral aorta assigned address of about 2.0 ± 0.5 kilograms New Zealand white rabbit, after abundant moistening, pressurising is opened, and foley's tube is placed in lesion locations and keeps about 1 minute, then take out sacculus, measure the weight of corresponding Polyethylene Glycol, glucosan and xylan alcohol hydrophilelipophile polymer in remaining bottom, drug-carried coat and top layer on sacculus.
Take out the sacculus used, be immersed in the organic solvent of soluble polymer, then distinguish the content of Polyethylene Glycol (sacculus 9 and 10 measures PLGA and PVP respectively), glucosan and xylan alcohol hydrophilelipophile polymer in abstraction and quantification balloon surface, and calculate residual quantity and corresponding residual rate:
| Sacculus is numbered | Bottom residual rate | Drug-carried coat residual rate | Top layer residual rate |
| 1 | 61％ | 8.9％ | 0％ |
| 2 | 72％ | 9.3％ | 0％ |
| 3 | 80％ | 9.5％ | 0％ |
| 4 | 91％ | 10.6％ | 0％ |
| 5 | 93％ | 12.5％ | 0％ |
| 6 | 95％ | 14.6％ | 0.9％ |
| 7 | 97％ | 26.3％ | 8.1％ |
| 8 | 98％ | 72％ | 46％ |
| 9 | 99％ | 35％ | 3％ |
| 10 | 48％ | 5.8％ | 0％ |
| Embodiment 1 | 89％ | 9.2％ | — |
As seen from the above table, as bottom hydrophilelipophile polymer molecular weight Mv<50K, bottom comes off seriously, and the bottom of drug containing does not come off, and not only can not improve therapeutic effect, even blocks minute blood vessel end, jeopardizes patient vitals's health.As drug-carried coat molecular weight >40K, drug-carried coat polymer residue is high, and drug Transformation rate is low; And when being less than 1K, easily causing drug-carried coat to be dissolved in course of conveying in blood and lose comparatively greatly, and actual reprinting of medicine arrives the also few of blood vessel wall.As surface molecules amount >40K, top layer polymer residue rate is also higher, is unfavorable for drug release; When being less than 1K, top layer is easily dissolved, and is delivered in cardiac procedure the effect not having protection drug-carried coat at intervene operation.
Inventor studies discovery, as bottom molecular weight Mv>50K, when drug-carried coat and top layer Mv<40K, can reduce underlying polymer loss, and improve the drug release of drug-carried coat.And for hydrophilelipophile polymer, such as Polyethylene Glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-hard acid esters, poly-citrate, have similar technique effect.
In addition, known with upper table as shown in Figure 4, newtype drug eluting foley's tube drug release process design sketch, wherein the present invention's preferred bottom hydrophilelipophile polymer molecular weight 70K<Mv<150K, and preferably drug-carried coat and top layer hydrophilelipophile polymer molecular weight 1K<Mv<40K, bottom local is obviously without coming off, that can not cause drug-loaded layer falls block, improve the reprinting of medicine to pathological tissues, drug release effect is especially remarkable.
Above-described embodiment is the present invention's preferably embodiment; but embodiments of the present invention are not restricted to the described embodiments; change, the modification done under other any does not deviate from spirit of the present invention and principle, substitute, combine, simplify; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (11)
1. a medicine eluting balloon catheter, comprise conduit, balloon body (1) and balloon surface (2), it is characterized in that, also comprise hydrophilelipophile bottom (3) and drug-carried coat (4), described hydrophilelipophile bottom (3) is positioned at above balloon surface (2), and drug-carried coat (4) is positioned at above hydrophilelipophile bottom (3), and described drug-carried coat (4) is made up of polymer and medicine.
2. medicine eluting balloon catheter according to claim 1, it is characterized in that, described bottom (3) is made up of one or more in hydrophilelipophile polymer poly ethylene glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-hard acid esters, phospholipid, poly-citrate etc.
3. medicine eluting balloon catheter according to claim 1 or 2, it is characterized in that, described bottom (3) hydrophilelipophile Polymer average molecular weights Mv>50K, is preferably 70K<Mv<150K.
4. medicine eluting balloon catheter according to the arbitrary claim of claim 1-3, is characterized in that, also comprises one deck hydrophilelipophile top layer (5).
5. medicine eluting balloon catheter according to the arbitrary claim of claim 1-4, it is characterized in that, described drug-carried coat (4) and/or top layer (5) are made up of one or more in hydrophilelipophile polymer poly ethylene glycol, PEG-PCL, polysorbate, xylan alcohol, polyglycerin ester, chitosan, chitin, glucosan, poly-hard acid esters, phospholipid, poly-citrate etc.
6. medicine eluting balloon catheter according to claim 4 or 5, it is characterized in that, described drug-carried coat (4) and top layer (5) hydrophilelipophile Polymer average molecular weights Mv<40K, be preferably 1K<Mv<40K.
7. medicine eluting balloon catheter according to the arbitrary claim of claim 1-6, is characterized in that, described bottom (3) thickness is 0.1-2 μm, and described drug-carried coat (4) thickness is 1-50 μm.
8. medicine eluting balloon catheter according to the arbitrary claim of claim 4-6, is characterized in that, described top layer (5) thickness is 0.1-2 μm.
9. medicine eluting balloon catheter according to the arbitrary claim of claim 1-8, is characterized in that, described medicine is one or more medicines in paclitaxel, rapamycin and derivant, abciximab etc.
10. medicine eluting balloon catheter according to the arbitrary claim of claim 1-9, is characterized in that, described drug-carried coat (4) drug loading is 1-5 μ g/mm
2.
11. 1 kinds of medicinal balloon preparation methoies, it is characterized in that: medicine eluting balloon catheter composition according to the arbitrary claim of claim 1-10, first the surface of sacculus adopts the pretreatment of plasma cleaning technology, then sprays one deck bottom (3), thickness 0.1-2 μm; Spray drug-carried coat (4) again, thickness is 1-50 μm, and drug loading is 1 μ g/mm
2-5 μ g/mm
2; After coating drying, folding, spray one deck top layer (5) after winding again, thickness is 0.1-2 μm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510124482.6A CN104874090A (en) | 2015-03-20 | 2015-03-20 | Novel drug eluting balloon catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510124482.6A CN104874090A (en) | 2015-03-20 | 2015-03-20 | Novel drug eluting balloon catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104874090A true CN104874090A (en) | 2015-09-02 |
Family
ID=53941928
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510124482.6A Pending CN104874090A (en) | 2015-03-20 | 2015-03-20 | Novel drug eluting balloon catheter |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104874090A (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107243109A (en) * | 2016-03-29 | 2017-10-13 | 深圳市信立泰生物医疗工程有限公司 | The not foley's tube of blocking blood flow |
| CN107376030A (en) * | 2017-08-09 | 2017-11-24 | 乐普（北京）医疗器械股份有限公司 | A kind of preparation method of medicinal balloon, the medicinal balloon being prepared and its application |
| CN109966564A (en) * | 2017-12-28 | 2019-07-05 | 先健科技(深圳)有限公司 | Carry medicine ball capsule and preparation method thereof |
| CN110292701A (en) * | 2019-06-27 | 2019-10-01 | 山东瑞安泰医疗技术有限公司 | A kind of medicine eluting balloon catheter and preparation method thereof |
| CN111032101A (en) * | 2017-09-21 | 2020-04-17 | 泰尔茂株式会社 | Drug coating and method of forming the same |
| CN111035815A (en) * | 2020-01-10 | 2020-04-21 | 卢静 | Medical tracheal catheter, tracheal catheter coating and preparation method thereof |
| WO2020103667A1 (en) * | 2018-11-23 | 2020-05-28 | 上海微创医疗器械（集团）有限公司 | Drug eluting balloon and balloon catheter |
| CN112370638A (en) * | 2020-12-04 | 2021-02-19 | 上海康德莱医疗器械股份有限公司 | Medicine balloon |
| CN114146231A (en) * | 2020-09-07 | 2022-03-08 | 上海鸿脉医疗科技有限公司 | Drug balloon and preparation method thereof |
| CN115337523A (en) * | 2021-05-12 | 2022-11-15 | 先健科技(深圳)有限公司 | Medicine balloon and preparation method thereof |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040111144A1 (en) * | 2002-12-06 | 2004-06-10 | Lawin Laurie R. | Barriers for polymeric coatings |
| CN101610798A (en) * | 2007-10-19 | 2009-12-23 | 美国乐通公司 | The drug release coating of medical apparatus and instruments |
| US7645504B1 (en) * | 2003-06-26 | 2010-01-12 | Advanced Cardiovascular Systems, Inc. | Coatings for implantable medical devices comprising hydrophobic and hydrophilic polymers |
| US20110137243A1 (en) * | 2007-09-06 | 2011-06-09 | Abbott Cardiovascular Systems Inc. | Coating On A Balloon Device |
| US20120165786A1 (en) * | 2010-06-30 | 2012-06-28 | Chappa Ralph A | Lipid coating for medical devices delivering bioactive agent |
| US20130345629A1 (en) * | 2010-12-04 | 2013-12-26 | Alexander Rübben | Coating and coating method for the balloon of a balloon catheter, and balloon catheter with coated balloon |
| CN103611212A (en) * | 2013-11-21 | 2014-03-05 | 先健科技(深圳)有限公司 | Drug balloon preparation method |
| WO2014163097A1 (en) * | 2013-04-01 | 2014-10-09 | テルモ株式会社 | Balloon catheter for drug administration and process for producing same |
| CN204840617U (en) * | 2015-03-20 | 2015-12-09 | 深圳市信立泰生物医疗工程有限公司 | Novel medicine elution sacculus pipe |
-
2015
- 2015-03-20 CN CN201510124482.6A patent/CN104874090A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040111144A1 (en) * | 2002-12-06 | 2004-06-10 | Lawin Laurie R. | Barriers for polymeric coatings |
| US7645504B1 (en) * | 2003-06-26 | 2010-01-12 | Advanced Cardiovascular Systems, Inc. | Coatings for implantable medical devices comprising hydrophobic and hydrophilic polymers |
| US20110137243A1 (en) * | 2007-09-06 | 2011-06-09 | Abbott Cardiovascular Systems Inc. | Coating On A Balloon Device |
| CN101610798A (en) * | 2007-10-19 | 2009-12-23 | 美国乐通公司 | The drug release coating of medical apparatus and instruments |
| US20120165786A1 (en) * | 2010-06-30 | 2012-06-28 | Chappa Ralph A | Lipid coating for medical devices delivering bioactive agent |
| US20130345629A1 (en) * | 2010-12-04 | 2013-12-26 | Alexander Rübben | Coating and coating method for the balloon of a balloon catheter, and balloon catheter with coated balloon |
| WO2014163097A1 (en) * | 2013-04-01 | 2014-10-09 | テルモ株式会社 | Balloon catheter for drug administration and process for producing same |
| CN103611212A (en) * | 2013-11-21 | 2014-03-05 | 先健科技(深圳)有限公司 | Drug balloon preparation method |
| CN204840617U (en) * | 2015-03-20 | 2015-12-09 | 深圳市信立泰生物医疗工程有限公司 | Novel medicine elution sacculus pipe |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107243109A (en) * | 2016-03-29 | 2017-10-13 | 深圳市信立泰生物医疗工程有限公司 | The not foley's tube of blocking blood flow |
| CN107376030A (en) * | 2017-08-09 | 2017-11-24 | 乐普（北京）医疗器械股份有限公司 | A kind of preparation method of medicinal balloon, the medicinal balloon being prepared and its application |
| CN107376030B (en) * | 2017-08-09 | 2020-08-07 | 乐普（北京）医疗器械股份有限公司 | Preparation method of drug balloon, prepared drug balloon and application thereof |
| CN111032101A (en) * | 2017-09-21 | 2020-04-17 | 泰尔茂株式会社 | Drug coating and method of forming the same |
| US11660429B2 (en) | 2017-09-21 | 2023-05-30 | Terumo Kabushiki Kaisha | Drug coating layer and method for forming same |
| CN109966564A (en) * | 2017-12-28 | 2019-07-05 | 先健科技(深圳)有限公司 | Carry medicine ball capsule and preparation method thereof |
| CN109966564B (en) * | 2017-12-28 | 2022-11-18 | 先健科技(深圳)有限公司 | Drug-loaded balloon and preparation method thereof |
| WO2020103667A1 (en) * | 2018-11-23 | 2020-05-28 | 上海微创医疗器械（集团）有限公司 | Drug eluting balloon and balloon catheter |
| CN111214748A (en) * | 2018-11-23 | 2020-06-02 | 上海微创医疗器械（集团）有限公司 | Drug eluting balloon and balloon catheter |
| CN110292701A (en) * | 2019-06-27 | 2019-10-01 | 山东瑞安泰医疗技术有限公司 | A kind of medicine eluting balloon catheter and preparation method thereof |
| CN110292701B (en) * | 2019-06-27 | 2021-11-16 | 山东瑞安泰医疗技术有限公司 | Drug eluting balloon catheter and preparation method thereof |
| CN111035815A (en) * | 2020-01-10 | 2020-04-21 | 卢静 | Medical tracheal catheter, tracheal catheter coating and preparation method thereof |
| CN114146231A (en) * | 2020-09-07 | 2022-03-08 | 上海鸿脉医疗科技有限公司 | Drug balloon and preparation method thereof |
| WO2022048270A1 (en) * | 2020-09-07 | 2022-03-10 | 上海鸿脉医疗科技有限公司 | Drug balloon and preparation method therefor |
| CN112370638A (en) * | 2020-12-04 | 2021-02-19 | 上海康德莱医疗器械股份有限公司 | Medicine balloon |
| CN115337523A (en) * | 2021-05-12 | 2022-11-15 | 先健科技(深圳)有限公司 | Medicine balloon and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN104874090A (en) | Novel drug eluting balloon catheter | |
| CN104511084A (en) | Balloon catheter | |
| US9974931B2 (en) | Pharmaceutical-coated medical products, the production thereof and the use thereof | |
| CN204840617U (en) | Novel medicine elution sacculus pipe | |
| CN104394898B (en) | Balloon surface coating | |
| CN102847200B (en) | A method for preparing electrostatically self-assembled drug carried layer | |
| JP2018529484A (en) | Medical device coated with drug | |
| CN106237395B (en) | A kind of medicine-coated balloon and preparation method thereof | |
| KR20120098624A (en) | Use of compositions to coat catheter balloons and coated catheter balloons | |
| CN203138758U (en) | Combined medical device composed of drug-coated balloon and bracket | |
| KR20090045916A (en) | Manufacture, method and use of drug-eluting medical devices for permanently keeping blood vessels open | |
| WO2011071629A1 (en) | Hydrophobic therapueutic agent and solid emulsifier coating for drug coated balloon | |
| EP3030274B1 (en) | Method of treating peripheral artery diseases in lower limbs | |
| CN101511420A (en) | Catheter for cell delivery | |
| CN103800987B (en) | Medical balloon and preparation method thereof | |
| CN102940543A (en) | Combined medical instrument formed by drug coated balloon and stent | |
| KR20120036627A (en) | Drug-eluting balloon catheter multilayer coating with drug-embeded nanoparticles and polymers and preparation method thereof | |
| CN107485777A (en) | A kind of preparation method of the controllable medicinal balloon catheter of crystal, the medicinal balloon catheter being prepared and its application | |
| CN106178233A (en) | The preparation method of medicine balloon dilating catheter and flap winding sacculus | |
| JP2017521114A (en) | Treatment of peripheral arterial disease of the lower limb | |
| CN104661692A (en) | Balloon surface coating for valvuloplasty | |
| JP2015217260A (en) | Medical device | |
| CN101195048A (en) | Compound medicament washing bracket and method for preparing the same | |
| CN115192780A (en) | Rapamycin drug balloon and preparation method and application thereof | |
| CN203017550U (en) | Medical balloon |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| CB02 | Change of applicant information |
Address after: 518118, No. five, No. 1, great industrial zone, Ping Shan, Guangdong, Shenzhen Applicant after: SHENZHEN SALUBRIS BIOMEDICAL ENGINEERING Co.,Ltd. Address before: Baoan District Xixiang street Shenzhen city Guangdong province 518102 115 City District 1 factories Applicant before: SHENZHEN SALUBRIS BIOMEDICAL ENGINEERING Co.,Ltd. |
|
| CB02 | Change of applicant information | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: 518118 No.1, Guihua 5th Road, Pingshan District, Shenzhen City, Guangdong Province Applicant after: Shenzhen Xinlitai Medical Equipment Co.,Ltd. Address before: 518118 No.1, Guihua 5th Road, Pingshan District, Shenzhen City, Guangdong Province Applicant before: SHENZHEN SALUBRIS BIOMEDICAL ENGINEERING Co.,Ltd. |
|
| CB02 | Change of applicant information |