CN203139371U - Balloon with controllably releasable arsenic trioxide - Google Patents
Balloon with controllably releasable arsenic trioxide Download PDFInfo
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- CN203139371U CN203139371U CN201220483575.XU CN201220483575U CN203139371U CN 203139371 U CN203139371 U CN 203139371U CN 201220483575 U CN201220483575 U CN 201220483575U CN 203139371 U CN203139371 U CN 203139371U
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- arsenic trioxide
- sacculus
- balloon
- medicament
- shrinkage pool
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Abstract
The utility model discloses a balloon with controllably releasable arsenic trioxide. A characteristic of the arsenic trioxide, namely quick solution in water, is utilized for coating arsenic trioxide slow release layer on the surface of the balloon. Uniform miniature recess holes which restrain release of the arsenic trioxide are formed on the slow release layer. Through adjusting the dimension of the recess hole, the recess holes are expanded to micro holes in expansion process of the balloon, thereby realizing quick release of the arsenic trioxide on the vessel wall and uniform concentration on the surface of the vessel wall. Quick phagocytosis of the cell is realized for restraining cell histiocytosis, thereby obtaining a function of restraining restenosis. The balloon can be used for expansion of PTCA surgery and is used together with a bare stent, thereby reducing effect of the medicament stent coating material on restenosis.
Description
Technical field
The present invention relates to a kind of medicinal balloon, be specially sacculus of arsenic trioxide controllable release and preparation method thereof, can be used for PTCA operation and bare bracket and unite use.
Background technology
Arsenic trioxide (As
2O
3) be the main component of Chinese medicine arsenicum, it once was used to treat multiple diseases such as malignant tumor in the medical research of China.Big right arsenical chemical compound has also had the applicating history in over thousands of year as a kind of medicine in China, and the seventies in 20th century, the blood internist uses As
2O
3The treatment promyelocytic leukemia has obtained significant curative effect.In recent years As
2O
3Also be used for the treatment of entity tumor.People such as people such as Zhang Zhuoqi and Shao Jianwei discover, it has the effect of antiproliferative, short apoptosis and retardance cell cycle to VSMCs, for may reduce in the body cell quantity in the intravascular stent implant site new intima, to lower inner film thickness significant.
Coronary heart disease (Coronary Atherosclerotic Heart Disease, coronary heart disease) is present the most common a kind of heart disease, how not normal because of self body lipid metabolism, make lipid calmness in the blood on the endarterium of otherwise smooth, become pile up more and form speckle by few that these specklees increase gradually and cause lumen of artery narrow, blood flow is obstructed, cause heart ischemia, produce angina pectoris, even sudden death.
Percutaneous coronary endoluminal vascular plasty (Percutaneous Transluminal Coronary Angioplasty) is a kind of cardiac catheter technology, refers to the coronary artery balloon dilatation more, is the most ripe of all coronary heart disease interventional therapeutic techniques at present.Specifically be by the femoral artery of thigh root or the radial artery on the wrist, through vascular puncture foley's tube, support or other apparatus put into the coronary artery the inside, reach the purpose of removing coronary stricture, rebuild the coronary blood pipe flow.
Medicinal balloon (DrugCoated Balloon) be a kind of be the delivery device of sending with conduit, this concept is proposed in 1991 by Harvey Wolinsky, is used for preventing the vascular restenosis behind the blood vessel balloon dilatation.Its mechanism of action is, suppress the hypertrophy of tunica intima by carrying medicine, balloon surface institute coated drug is when arriving diseased region, make the balloon expandable diseased region by the pressurization dilating sacculus, institute's coated drug continues to discharge at this simultaneously, makes the generation of the abundant ingestion of drugs of blood vessel wall and then inhibition restenosis.The medicinal balloon method needn't be carried out radiotherapy, without polymer or other release tech that continues, the just All Ranges that drug conveying be can reach to sacculus.
At present mostly common medicinal balloon is that paclitaxel and rapamycin are as medication coat, wherein taxol drug is at first to be applied on the medicinal balloon, because the single contact back blood vessel wall of discovering paclitaxel obviously will be higher than rapamycin to its picked-up and bioavailability, so the taxol drug sacculus also goes on the market as far back as Europe.2004, Scheller doctor has delivered zoopery result about the effective prevention of restenosis of medicinal balloon at " Circulation ", the clinical test results of PACCOCATH medicinal balloon, studies show that the taxol drug sacculus compares with common sacculus, late tube chamber lose, aspect such as restenosis rate and main cardiovascular event rate, medicinal balloon all is better than common sacculus.
Also there are some researches show, the clear superiority of medicinal balloon is mainly reflected in the treatment aspect of in-stent restenosis, no matter be the restenosis for the treatment of bare bracket or the restenosis of coating stent of medicine, the advantage of medicinal balloon has all obtained approval, how to make the sacculus medicine that carries as much as possible, guarantee that simultaneously medicine is transported to the blood that is not flowed in the process of diseased region at sacculus and washes away by conduit, become a critical bottleneck of restriction art technology development, the taxol drug sacculus of high dose and the sacculus of newtype drug coating also all research in the middle of, have very important Research Significance.As2O3 is a kind of water soluble drug, owing to there are differences with polymer support dissolubility commonly used, making medicine and carrier present two in spraying process is separated, as CN200510023714.5 patent, the disclosed arsenic trioxide spraying technology of CN1413594A patent, all adopt medicament after carrier mixes in solvent, to spray.But As
2O
3Density is bigger, easily precipitate, therefore make that medicament contg, uniformity after the spraying are restricted, in polymer coating, formed simultaneously irregular passage between the medicine, make the stability of drug release be difficult to control, the inhibition of restenosis is relatively poor, has increased the risk of clinical treatment simultaneously, and is therefore desirable and drug release control effectively medicinal balloon is essential.
Present existing medicinal balloon, the general paclitaxel that adopts more, rapamycin, heparin etc. are as medicine, as patent 20101239216A, 200920205723.X, 200910084768.0,200710150413.8, also have in the sacculus material and participate in ingredient, make it discharge medicine gradually, as international application W08911882A, original and different on the structural design on the spheroid of the sacculus that has, the sacculus outer surface is designed to have concavo-convex nonplanar structure, to improve medicine absorption, perhaps adopt three lobes of sacculus self folding or pintongs is folding, form the drug storage chamber at the flap place, as patent 201010121627.4,200920268650.9, also have the foley's tube agent structure is changed, traditional balloon structure is changed over the foley's tube of eccentric hollow type, perhaps form the foley's tube in a plurality of chambeies, make it have guidewire lumen, sacculus expands chamber and medicine carrying chamber, as patent 201010520201.6,201110261928.1.But above-mentioned patent, in medicine is chosen, all given up arsenic trioxide medicament, make its application in the art still belong to blank out at present, and medicine is positioned at coating surface, makes the medicine of sacculus product self exist drug loss and the administration inequality in the non-art, simultaneously, the sacculus sphere structure changes and also increased the risk that product uses in clinical operation, thereby has influenced the therapeutic effect of product.
Therefore, existing medicinal balloon can't well satisfy the demand of clinical use.As seen, still need a kind of convenient, efficient, medicinal balloon that cost performance is higher in the market, this area.
Summary of the invention
The purpose of this invention is to provide a kind of novel medicament sacculus, relate to medicinal balloon of a kind of arsenic trioxide controllable release and preparation method thereof.
The sacculus of arsenic trioxide controllable release of the present invention mainly comprises: balloon body, be coated in the polymer coating on the balloon body and load on arsenic trioxide medicament on the polymer coating.Be coated in the polymer coating on the balloon body, its material can be the degradability material, also can be the Nondegradable material, and coating material can be polyurethane, have materials such as bioactive polyurethane, polyester or its copolymer.The sacculus material is that materials such as nylon, nylon elastomer, Pebax constitute.
The polymer-coated surface that is coated on the balloon body has shrinkage pool, and shrinkage pool has at interval to each other, and the arsenic trioxide medicament granule is filled in the shrinkage pool, forms the individual particles group, makes to completely cut off each other between the medicine, as " isolated island ", makes drug controllable release.
The sacculus of arsenic trioxide controllable release of the present invention, wherein arsenic trioxide medicament content is 0.05-5.00ug/mm
2, arsenic trioxide medicament weight is 0.1: 9.9 to 9.9: 0.1 with the ratio of polymer coating weight.Loading on arsenic trioxide medicament granule on the polymer coating or its individual particles group's size is 0.01-100.00um.
The sacculus of arsenic trioxide controllable release of the present invention, the sacculus coating surface has the acupuncture shrinkage pool, and the coating surface shrinkage pool is distributed as 4-8/mm
2, apart from being 0.08-0.25mm, sacculus has the vacuum flap to shrinkage pool to each other.
The sacculus of arsenic trioxide controllable release of the present invention, in process of expansion, only there is arsenic trioxide medicament to discharge fast in the short time, after sacculus is delivered to lesions position, when the sacculus pressurization is not less than 6atm, the arsenic trioxide medicament burst size is no less than 40% of its total content, and when the sacculus pressurization was not less than 10atm, the arsenic trioxide medicament burst size was no less than 80% of its total content, when the sacculus pressurization was not less than 14atm, the arsenic trioxide medicament burst size was not less than 90% of its total content.
The sacculus of arsenic trioxide controllable release of the present invention, the polymer coating of balloon body surface coated is owing to have certain ductility and drawing property of bullet, can be in company with balloon body together expansion in the pressurization process of expansion, the shrinkage pool of polymer-coated surface is enlarged by tearing under this situation, the arsenic trioxide medicament granule that wraps up in the shrinkage pool is released in the blood vessel, is absorbed by blood vessel wall.When sacculus decompression fold was drawn back, polymer coating was also together taken out by fold.
In sum, the invention has the beneficial effects as follows: arsenic trioxide controllable release sacculus of the present invention is because balloon body surface applied one layer of polymeric coating, and polymer-coated surface has the shrinkage pool structure, make its adsorbance to arsenic trioxide medicament improve greatly, and guaranteed in the sacculus course of conveying, the entrained medicine of sacculus is reduced greatly by the loss rate that blood washes away, and effectively arrives diseased region and plays therapeutical effect.Can be effective to the PCTA operation and unite use with bare bracket.
Description of drawings
Fig. 1 is arsenic trioxide controllable release balloon body structural representation of the present invention
Fig. 2 is balloon body and the medication coat enlarged diagram thereof of arsenic trioxide controllable release sacculus of the present invention
Labelling and respective name in the accompanying drawing 2: 1-arsenic trioxide medicament and polymer coating; The 2-balloon body
Fig. 3 is arsenic trioxide controllable release sacculus of the present invention at 200% o'clock part balloon body of pressurization and medication coat enlarged diagram thereof
Labelling and respective name in the accompanying drawing 3: 3-shrinkage pool; The 4-polymer coating; 5-arsenic trioxide medicament granule
Below in conjunction with embodiment and accompanying drawing, the present invention is done detailed description further, but embodiments of the present invention are not limited thereto.
The specific embodiment
Extremely shown in Figure 3 referring to Fig. 2; the sacculus outer surface of arsenic trioxide controllable release sacculus of the present invention is coated with polymer coating; polymer-coated surface has the shrinkage pool structure; this shrinkage pool structure is by special shrinkage pool pin pinprick gained; filled up the arsenic trioxide medicament granule in the shrinkage pool; make arsenic trioxide medicament granule or individual particles group just as " isolated island ", so that the controllable release of medicine.
A kind of preparation method of above-mentioned arsenic trioxide controllable release sacculus, adopt spraying method to the outer surface of spheroid spraying polymer coating of sacculus, coating layer thickness is 0.08-0.12mm, form the acupuncture shrinkage pool on coating table surface, the diameter of shrinkage pool is 1-50um, the shrinkage pool degree of depth is 0.001-0.05mm, it is 0.1: 9.9 to 9.9: 0.1 proportional arrangement arsenic trioxide medicament granule according to the ratio of arsenic trioxide medicament weight and polymer coating weight, with drug particles spray-on coating surface, make and particles filledly go in the shrinkage pool, last evacuation makes the molding of sacculus flap.
The sacculus of Zhi Bei arsenic trioxide controllable release according to the method described above, show that in the balloon pressure testing process its compressive resistance does not change, and sacculus does not take place in the experimentation to break, balloon diameter increases with pressurization intensity and claims linear increment relevant, illustrate that product of the present invention can satisfy that PTCA performs the operation and the support implant surgery in to the performance requirement of foley's tube.Related data such as table 1.
Table 1 Φ 2.25mm arsenic trioxide controllable release sacculus resistance test data
| Sacculus pressurization intensity (ATM) | 2.25mm diameter behind the sacculus pressurized (mm) |
| 6 | 2.25 |
| 8 | 2.32 |
| 10 | 2.37 |
| 12 | 2.42 |
| 14 | 2.46 |
| 16 | 2.51 |
| 18 | 2.56 |
| 20 | 2.60 |
Under PBS solution dynamic flow state, detecting the drug release effect of arsenic trioxide controllable release sacculus finds, when PBS circulates speed when being 50cm/s, sacculus as under the PBS dynamic environment, is carried out the linearity pressurization to it, and pressing speed is 4atm/30s, continue 2.5min pressing time, the medicament contg of arsenic trioxide changes in the monitoring PBS solution in real time, is compiled into arsenic trioxide medicament and discharges scale, and is as shown in table 2.
The vitro drug release situation of table 2 arsenic trioxide controllable release sacculus
| The balloon expandable pressurization | PBS Chinese medicine content | Release amount of medicine |
| 6atm | 71.3ug | 40.4％ |
| 8atm | 123.6ug | 70.2％ |
| 10atm | 143.0ug | 81.3％ |
| 12atm | 155.4ug | 88.1％ |
| 14atm | 160.1ug | 91.0％ |
Product of the present invention not only can be applicable to also can be applicable to the support implant surgery in the PTCA operation.
Claims (7)
1. sacculus that has the arsenic trioxide controllable release, it is characterized in that, the sacculus of described arsenic trioxide controllable release comprises: the polymer coating that balloon body, arsenic trioxide medicament and control arsenic trioxide medicament discharge, wherein polymer-coated surface has shrinkage pool, only has arsenic trioxide to discharge fast in process of expansion.
2. according to the sacculus of the described arsenic trioxide controllable release of claim 1, it is characterized in that the sacculus polymer-coated surface has shrinkage pool, shrinkage pool has at interval to each other, the arsenic trioxide medicament granule is filled in the shrinkage pool, forms independently " isolated island " particle swarm, makes between the medicine isolated each other.
3. according to the sacculus of the described arsenic trioxide controllable release of claim 1, it is characterized in that on the described sacculus, arsenic trioxide medicament content is 0.05-5.00ug/mm
2, arsenic trioxide medicament weight is 0.1: 9.9 to 9.9: 0.1 with the ratio of polymer coating weight, arsenic trioxide medicament granule or its individual particles group's size is 0.01-100.00um.
4. according to the sacculus of the described arsenic trioxide controllable release of claim 1, it is characterized in that, the polymer coating of balloon surface, its material can be the degradability material, also can be the Nondegradable material, coating material can be a kind of in polyurethane or its copolymer.
5. according to the sacculus of the described arsenic trioxide controllable release of claim 1, it is characterized in that, described sacculus, the sacculus material is nylon, perhaps nylon elastomer, perhaps material such as Pebax.
6. arsenic trioxide controllable release sacculus according to claim 1 is characterized in that the sacculus polymer-coated surface has the acupuncture shrinkage pool, and sacculus has the vacuum flap.
7. arsenic trioxide controllable release sacculus according to claim 6 is characterized in that, sacculus coating surface shrinkage pool is distributed as 4-8/mm
2, shrinkage pool distance to each other is 0.08-0.25mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201220483575.XU CN203139371U (en) | 2012-09-21 | 2012-09-21 | Balloon with controllably releasable arsenic trioxide |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201220483575.XU CN203139371U (en) | 2012-09-21 | 2012-09-21 | Balloon with controllably releasable arsenic trioxide |
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| CN203139371U true CN203139371U (en) | 2013-08-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201220483575.XU Expired - Lifetime CN203139371U (en) | 2012-09-21 | 2012-09-21 | Balloon with controllably releasable arsenic trioxide |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102974026A (en) * | 2012-09-21 | 2013-03-20 | 北京美中双和医疗器械有限公司 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
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2012
- 2012-09-21 CN CN201220483575.XU patent/CN203139371U/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102974026A (en) * | 2012-09-21 | 2013-03-20 | 北京美中双和医疗器械有限公司 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
| WO2014044082A1 (en) * | 2012-09-21 | 2014-03-27 | 北京美中双和医疗器械有限公司 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 101500 Miyun Industrial Development Zone, Beijing science and technology road, No. 48 Patentee after: AMSINOMED MEDICAL Co.,Ltd. Address before: 101500 Miyun Industrial Development Zone, Beijing science and technology road, No. 48 Patentee before: BEIJING AMSINO MEDICAL Co.,Ltd. |
|
| CP01 | Change in the name or title of a patent holder | ||
| CX01 | Expiry of patent term |
Granted publication date: 20130821 |
|
| CX01 | Expiry of patent term |