CN105664342A - Drug sustained-release balloon - Google Patents
Drug sustained-release balloon Download PDFInfo
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- CN105664342A CN105664342A CN201410672004.4A CN201410672004A CN105664342A CN 105664342 A CN105664342 A CN 105664342A CN 201410672004 A CN201410672004 A CN 201410672004A CN 105664342 A CN105664342 A CN 105664342A
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- sacculus
- slow release
- medicine
- medicament slow
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Abstract
The invention relates to minimal invasion medical equipment, in particular to a drug sustained-release balloon used at an intra-vascular lesion part. The device is composed of a balloon body and a drug sustained-release system. The drug sustained-release system is composed of a polymer layer, a protection layer and a drug sustained-release layer. The balloon surface structure is composed of a balloon body surface, the polymer layer, the protection layer and the drug sustained-release layer from the inside to the outside. When the balloon swells and expands at the vasculopathy part, the protection layer and the polymer layer fall off. The drug sustained-release layer is attached to a vascular wall. Medicine in the drug sustained-release layer slowly releases the vasculopathy part. The protection layer helps prevent medicine in the sustained-release layer from taking away and wasting during blood flow. While the narrow part of a blood vessel is expanded, medicine slowly acts upon the lesion part following quick release of medicine. In the meantime, medicine in the sustained-release layer is prevented from taking away and wasting during blood flow due to effect of the protection layer. The possibility of re-narrowing is greatly decreased. The drug sustained-release balloon is advantaged by being simple in structure, convenient in operation and large in medicine-loading capacity.
Description
Technical field
The present invention relates to Micro trauma interventional medical device, particularly relate to a kind of for carrying out medicament slow release sacculus at Ink vessel transfusing focal part.
Background technology
The appearance of Coronary Artery Disease Intervention Treatment has been started new era of coronary heart disease vascular treatment again, and one of significant challenge that postoperative restenosis is it to be faced. Restenosis not only results in the recurrence of angina pectoris symptom, it is necessary to myocardial revascularization relief of symptoms again, also can cause acute coronary artery syndrome at some patients. The application of support reduces restenosis rate, but brings another stubborn problem: in-stent restenosis. In-stent restenosis is a kind of Pathologic process, and the performance on histology is different from restenosis, with Neointimal formation for feature. In the bracket for eluting medicament epoch, narrow in support still have generation, and once occur lacking effective processing method. In the drug stent of restenosis, another drug stent of superposition can make restenosis rate subsequently up to 43%. New apparatus and therapeutic strategy continue to bring out and are intended to capture this difficult problem in recent years, and medicine carrying sacculus is wherein one of more promising technology.
The medicine carrying sacculus combined of traditional Balloon Angioplasty and advanced medicament elution technology, its unique construction avoids the side reaction caused by metal frame and polymer carrier, by coated with drug in the blood vessel wall of specific region, this topical remedy of place concentration is made not cause systemic side effects.
The advantage of medicine carrying sacculus includes: being uniformly distributed of particular blood vessel wall region medicine; The high concentration of topical remedy and the part-time application in a week, do not affect long-term healing process; Carrier without polymer, reduces chronic inflammatory reaction and advanced thrombus is formed; Without metallic framework, save the original anatomic form of blood vessel, in processing thin vessels and bifurcated lesions process, it is to avoid the impact on blood flow patterns; Shorten the course for the treatment of of Antiplatelet therapy.
Chinese patent CN101045175A discloses a kind of double-layered balloon catheter, and it is installed with the sacculus of micropore by being cladded with lid layer at common foley's tube, and this sacculus connects the cavity that it is independent, forms the conduit containing two-layer sacculus, three cavitys.In two-layer sacculus, internal layer sacculus plays the effect of expansion blood vessel, and outer layer sacculus is made up of unique microporous membrane, can by endosmosis by outer layer sacculus to the gene or medicine that play therapeutical effect or be applied on blood vessel wall, target organ. The balloon structure of the releasable medicaments that above-mentioned patent relates to is complicated, and manufacture difficulty is high, and owing to the amount of left drug in tube chamber cannot be learnt in operation, it is impossible to lesions position is accurately controlled the burst size of medicine.
Chinese patent CN101785900A discloses a kind of medicinal balloon catheter and preparation method thereof. The sacculus outer surface of this medicinal balloon catheter is for having irregular nonplanar structure, this medicinal balloon catheter adopts Ultra-Violet Laser grinding sacculus outer surface, make sacculus outer surface be formed and have irregular nonplanar structure, due to the concavo-convex nonplanar structure of sacculus outer wall surface, make Drug absorbability in surface. The preparation method complex process of the medicinal balloon catheter that above-mentioned patent relates to, and owing to using laser to carry out balloon surface etching, sacculus can be damaged, make the pressure of sacculus reduce; And owing to remaining as absorption affinity between balloon surface and medicine relatively low physical action, it is impossible to the shortcoming such as change that medicine is easy to fall off and drug loading is little.
Summary of the invention
In order to solve the problems referred to above of prior art, it is an object of the invention to provide a kind of medicament slow release sacculus, there is simple in construction, easy to operate, feature that drug loading is big.
To achieve these goals, the technical solution adopted in the present invention is:
A kind of medicament slow release sacculus comprises sacculus body and drug sustained release system composition, and wherein drug sustained release system drug sustained release system is made up of polymeric layer, protective layer and medicament slow release layer. Described balloon surface structure structure from the inside to the outside is sacculus surface, polymeric layer, protective layer and medicament slow release layer. When sacculus full distending at vascular lesion place; protective layer and polymeric layer come off; medicament slow release layer note invests blood vessel wall, and the slow vasotropic lesion release of medicine in medicament slow release layer, protective layer avoids the medicine in medicament slow release layer be pulled away in the flow process of blood and lose.
Further, medicament slow release layer of the present invention is made up of Lac and the medicine of loose structure, Lac, medicine and carbamide or PVP are configured to certain proportion and are dissolved in ethanol, the mode adopting ultrasonic atomization spraying is sprayed at the surface of protective layer, after drying whole sacculus is placed in water, by the carbamide in Lac or PVP solution modeling, forming the loose structure of drug containing, the thickness of its layer is 0.001mm ~ 0.01mm; Medicine passes through hole slow releasing.
Further, polymeric layer of the present invention is cellulose polyethylene, adopts the mode of ultrasonic spray to be sprayed at the outer surface of sacculus body, and its thickness is 0.001mm ~ 0.01mm.
Further, described protective layer of the present invention is Lac, adopts the mode of ultrasonic spray to be sprayed at the outer surface of polymeric layer, and its thickness is 0.001mm ~ 0.01mm, and sacculus is when lesion fills and opens, and protective layer separates with polymeric layer.
Further, the medicine in medicament slow release layer of the present invention is paclitaxel or rapamycin or derivatives thereof, and its content is 1ug/mm2~3ug/mm2。
Further, sacculus body of the present invention adopts Low Temperature Plasma Treating, and increasing surface can so that it is have good adhesion with described polymeric layer.
Further, the described ball capsule diameters of the present invention is 2mm ~ 30mm, and length is 20mm ~ 300mm.
The invention has the beneficial effects as follows: while expansion angiostenosis position, also can after rapid delivery of pharmaceuticals, medicine slowly acts on lesion; Simultaneously as the effect of protective layer, it is to avoid the medicine in medicament slow release layer is pulled away in the flow process of blood and loses, and greatly reduces the probability of restenosis; In addition the present invention also has the advantages such as simple in construction, easy to operate, drug loading is big.
Accompanying drawing explanation
In order to be illustrated more clearly that the embodiment of the present invention or technical scheme of the prior art, the accompanying drawing used required in embodiment or description of the prior art will be briefly described below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skill in the art, under the premise not paying creative work, it is also possible to obtain other accompanying drawing according to these accompanying drawings.
Below in conjunction with drawings and Examples, the present invention is further described.
Fig. 1 is the schematic diagram of the present invention.
Fig. 2 is the drug sustained release system schematic diagram of the present invention.
Fig. 3 is the formation schematic diagram of medicament slow release layer.
Wherein, 1 is drug sustained release system, and 2 is sacculus body, and 3 is medicament slow release layer, and 4 is protective layer, and 5 is polymeric layer, and 6 is balloon surface, and 7 is Lac molecule, and 8 is porogen molecule, and 9 is the hole formed after urea molecule dissolves, and 10 is drug molecule.
Detailed description of the invention
Referring now to accompanying drawing, the invention will be further described.
A kind of medicament slow release sacculus comprises sacculus body 2, polymeric layer 5, and drug sustained release system 1 forms, and wherein drug sustained release system is made up of protective layer 4 and medicament slow release layer 3.
Described medicament slow release sacculus structure from the inside to the outside is sacculus surface 6, polymeric layer 5, protective layer 4 and medicament slow release layer 3; when sacculus at vascular lesion place, open by full tympanites; owing to polymeric layer 5 and protective layer 4 exist obvious interfacial tension; polymeric layer 5 and protective layer 4 come off; medicament slow release layer 3 note invests blood vessel wall; the slow vasotropic lesion release of medicine 10 in medicament slow release layer 3, protective layer 4 avoids the medicine 10 of in medicament slow release layer 3 be pulled away in the flow process of blood and lose.
Described medicament slow release layer 3 is made up of medicine 10 and water-fast porous Lac 7; during manufacture; medicine 10, Lac 7 are configured to certain proportion are dissolved in ethanol with porogen 8 carbamide or PVP; the mode adopting ultrasonic atomization spraying is sprayed at the surface of protective layer 4; after drying whole sacculus is placed in water; by porogen 8 carbamide in Lac or PVP solution modeling; again through negative pressure cold drying; forming the internal porous sustained-release layer containing medicine 10 of a kind of Lac, the thickness of medicament slow release layer 5 is 0.001mm ~ 0.01mm.
Described polymeric layer 5 is cellulose polyethylene material, during manufacture, is dissolved in solvent, adopts the mode of ultrasonic spray to be sprayed at sacculus surface 6, by negative pressure cold drying, forms polymeric layer one layer fine and close, and thickness is 0.001mm ~ 0.01mm.
Medicine 10 in described medicament slow release layer 5 is paclitaxel or rapamycin or derivatives thereof, and content controls as 1ug/mm2~3ug/mm2。
Described sacculus body 2 adopts Low Temperature Plasma Treating, and increasing surface can so that it is have good adhesion with described polymeric layer 5, reduces the sacculus loss when Ink vessel transfusing passes through.
Described ball capsule diameters is 2mm ~ 30mm, and length is 20mm ~ 300mm.
The specific embodiment of the present invention.Such as taxadol slow release system, the diameter of sacculus is 5mm, and length is 140mm, processing 3 minutes at low temperature plasma intracavity, the polyvinyl cellulose solution that will prepare, with ultrasonic spray nozzle, uniformly spray in balloon surface, negative pressure cold drying will be used, form polymeric layer; The Lac solution atomization even application prepared is in polymeric layer, and by the paclitaxel prepared, Lac, urea liquid atomization even application in polymeric layer, negative pressure cold drying, being formed containing medication amount is the slow release layer of 2ug/mm2; It is placed on again in aqueous solution, places 30 ~ 180 minutes, negative pressure cold drying, make medicament slow release sacculus.
Referring to Fig. 1, the clinical detailed description of the invention that the present invention is described. The situation of lesion vessels is first assessed before using, select medicament slow release sacculus and the catheter sheath of suitable dimension, seal wire is implanted diseased region by catheter sheath, guidewire proximal is inserted along the most advanced and sophisticated hole of medicament slow release sacculus, be pushed forward into sacculus until angiostenosis diseased region; When needing, can withdrawing from seal wire, the guide wire exit openings along connector injects contrast solution, in order to observe diseased region; Seal wire is reinserted again after completing radiography; Filled Balloon is to the nominal pressure of sacculus; After 30 ~ 60 seconds, medicine discharges completely, and it is flat that startup pump evacuation makes sacculus receive completely, then withdraws from sacculus.
Described above to the disclosed embodiments, makes professional and technical personnel in the field be capable of or uses the present invention. The multiple amendment of these embodiments be will be apparent from for those skilled in the art, and generic principles defined herein can without departing from the spirit or scope of the present invention, realize in other embodiments. Therefore, the present invention is not intended to be limited to the embodiments shown herein, and is to fit to the widest scope consistent with principles disclosed herein and features of novelty.
Claims (7)
1. a medicament slow release sacculus comprises sacculus body, polymeric layer and drug sustained release system composition;
It is characterized in that, drug sustained release system is made up of protective layer and medicament slow release layer, and described balloon surface structure is sacculus surface, polymeric layer, protective layer and medicament slow release layer from the inside to the outside; When sacculus full distending at vascular lesion place; protective layer and polymeric layer come off; medicament slow release layer note invests blood vessel wall, and the slow vasotropic lesion release of medicine in medicament slow release layer, protective layer avoids the medicine in medicament slow release layer be pulled away in the flow process of blood and lose.
2. a kind of medicament slow release sacculus according to claim 1; it is characterized in that; described medicament slow release layer is made up of Lac and the medicine of loose structure; Lac, medicine and porogen carbamide or PVP are configured to certain proportion and are dissolved in ethanol; the mode adopting ultrasonic atomization spraying is sprayed at the surface of protective layer, is placed in water by whole sacculus after drying, by the porogen carbamide in Lac or PVP solution modeling; forming the loose structure of drug containing, the thickness of its layer is 0.001mm ~ 0.01mm.
3. a kind of medicament slow release sacculus according to claim 1, it is characterised in that described polymeric layer is cellulose polyethylene, adopts the mode of ultrasonic spray to be sprayed at the outer surface of sacculus body, and its thickness is 0.001mm ~ 0.01mm.
4. a kind of medicament slow release sacculus according to claim 1, it is characterised in that described protective layer is Lac, adopts the mode of ultrasonic spray to be sprayed at the outer surface of polymeric layer, and its thickness is 0.001mm ~ 0.01mm.
5. a kind of medicament slow release sacculus according to claim 1, it is characterised in that the medicine in described medicament slow release layer is paclitaxel or rapamycin or derivatives thereof, and its content is 1ug/mm2 ~ 3ug/mm2.
6. a kind of medicament slow release sacculus according to claim 1, it is characterised in that described sacculus body adopts Low Temperature Plasma Treating, and increasing surface can so that it is have good adhesion with described polymeric layer.
7. a kind of medicament slow release sacculus according to claim 1, it is characterised in that described ball capsule diameters is 2mm ~ 30mm, and length is 20mm ~ 300mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410672004.4A CN105664342A (en) | 2014-11-22 | 2014-11-22 | Drug sustained-release balloon |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410672004.4A CN105664342A (en) | 2014-11-22 | 2014-11-22 | Drug sustained-release balloon |
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| CN105664342A true CN105664342A (en) | 2016-06-15 |
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| CN201410672004.4A Pending CN105664342A (en) | 2014-11-22 | 2014-11-22 | Drug sustained-release balloon |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108261569A (en) * | 2016-12-31 | 2018-07-10 | 先健科技(深圳)有限公司 | The preparation method of medicinal balloon |
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- 2014-11-22 CN CN201410672004.4A patent/CN105664342A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108261569A (en) * | 2016-12-31 | 2018-07-10 | 先健科技(深圳)有限公司 | The preparation method of medicinal balloon |
| CN108261569B (en) * | 2016-12-31 | 2021-01-22 | 先健科技(深圳)有限公司 | Preparation method of medicine balloon |
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Application publication date: 20160615 |