CN102974026A - Arsenic trioxide controllable-releasing balloon and preparing method thereof - Google Patents
Arsenic trioxide controllable-releasing balloon and preparing method thereof Download PDFInfo
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- CN102974026A CN102974026A CN2012103528049A CN201210352804A CN102974026A CN 102974026 A CN102974026 A CN 102974026A CN 2012103528049 A CN2012103528049 A CN 2012103528049A CN 201210352804 A CN201210352804 A CN 201210352804A CN 102974026 A CN102974026 A CN 102974026A
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- arsenic trioxide
- sacculus
- shrinkage pool
- medicament
- controllable release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
Abstract
The invention discloses an arsenic trioxide controllable-releasing drug balloon. The quick water soluble performance of arsenic trioxide is used. The arsenic trioxide and a slow-releasing layer are coated on the surface of the balloon. Even minitype concave holes which restrain releasing of the arsenic trioxide are formed on the slow-releasing layer. The size of the concave holes is adjusted, so that the concave holes are expanded to form micro holes in the process of expanding of the balloon, the facts that the arsenic trioxide is quickly released on a vascular wall and is evenly gathered on the surface of the vascular wall are achieved, quick phagocytosis of a cell is used, proliferation of the cell is avoided, and accordingly the effect that restenosis is avoided is achieved, the balloon can be used for expansion of a percutaneous transluminal coronary angioplasty (PTCA) operation and combination with the PTCA operation and bare stents, and the influence on restenosis caused by drug stent lay-coated materials is lowered.
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 the various diseases such as malignant tumor in the medical research of China.Natural arsenical chemical compound has also had the applicating history in over thousands of year as a kind of medicine in China, 20 century 70s, and 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.The people such as the people such as Zhang Zhuoqi and Shao Jianwei study discovery, and 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 HypercholesterolemicRats, so that the lipid calmness in the liquid is on the endarterium of otherwise smooth, to be piled up by few change more and to form speckle, these specklees gradually increase and cause lumen of artery narrow, blood flow is obstructed, cause heart ischemia, produce angina pectoris, even sudden death.
Percutenous transluminal coro-nary angioplasty (Percutaneous Transluminal Coronary Angioplasty) is a kind of cardiac catheter technology, refer to the coronary artery balloon dilatation, be the most ripe of at present all Coronary Artery Disease Intervention Treatment technology more.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 (Drug Coated Balloon) was a kind of take the delivery device of conduit as sending, and this Objective Concept Harvey Wolinsky carried the mountain in 1991, with the vascular restenosis after the rice prevention blood saccule dilatation.Its mechanism of action is, the hypertrophy that suppresses tunica intima by carrying medicine, the medicine that balloon surface is coated with is when arriving diseased region, make the balloon expandable diseased region by the pressurization dilating sacculus, the medicine that is coated with simultaneously carries out sustained release at this, 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 All Ranges that just 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, find that because of research blood vessel wall after the single contact of paclitaxel obviously will be higher than rapamycin to its picked-up and bioavailability, so the taxol drug sacculus goes on the market as far back as Europe also.2004, Scheller doctor has delivered results of animal 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, the aspect such as restenosis rate and major cardiovascular events 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 pharmacy 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.
As
2O
3It 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, such 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 larger, easily precipitate, therefore so that medicament contg, uniformity after the spraying be 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 simultaneously the risk of clinical treatment, 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, such as patent 20101239216A, 200920205723.X, 200910084768.0,200710150413.8, also have in the sacculus material and participate in ingredient, make it discharge gradually medicine, such 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 the irregular nonplanar structure of tool, to improve Drug absorbability, perhaps adopt three lobes of sacculus self folding or pintongs is folding, form the drug storage chamber at the flap place, such 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, perhaps form the foley's tube in a plurality of chambeies, make it have guidewire lumen, sharp medicine carrying chamber, balloon dilatation chamber is such 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 at present blank out, and medicine is positioned at coating surface, so that drug loss and administration that the medicine of sacculus product self exists in the non-art are uneven, simultaneously, the sacculus sphere structure changes and also increased the risk that product uses in clinical operation, thereby has affected 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 medicinal balloon, 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, with a kind of of bioactive polyurethane, polyester and copolymer thereof or more than one.The sacculus material is that the materials such as nylon, nylon elastomer, Pebax consist of.
The polymer-coated surface that is coated on the balloon body has shrinkage pool, and shrinkage pool has the interval to each other, and the arsenic trioxide medicament granule is filled in the shrinkage pool, forms the individual particles group, so that isolated each other between the medicine, as " isolated island ", make 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, preferred arsenic trioxide medicament content is 0.10-2.00ug/mm
2, best arsenic trioxide medicament content is 0.50-1.00ug/mm
2, arsenic trioxide medicament weight is 0.1: 9.9 to 9.9: 0.1 with the ratio of polymer coating weight, and wherein the ratio of the two weight is preferably 0.2-15.0, and the ratio of optimum weight is 0.5-1.5.Loading on arsenic trioxide medicament granule on the polymer coating or its individual particles group's size is 0.01-100.00um, and the preferable particle size size is 0.01-60.00um, and the optimum grain-diameter size is 0.05-50.00um.
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.Sacculus decompression fold is taken out simultaneously, and polymer coating is also together taken out by fold.
The sacculus of arsenic trioxide controllable release of the present invention, its preparation method is as follows:
In balloon body surface spraying one layer of polymeric coating, form the acupuncture shrinkage pool at coating surface, again to coating surface spraying one deck arsenic trioxide medicament granule, make particles filledly to enter in the shrinkage pool, with the laser coating surface of polishing, the arsenic trioxide medicament granule only is retained in the coating shrinkage pool, and evacuation makes the sacculus flap.Wherein, sacculus coating surface shrinkage pool is distributed as 4-8/mm
2, preferred shrinkage pool distributed number is 4-6/mm
2, best shrinkage pool distributed number is 5/mm
2, apart from being 0.08-0.25mm, the spacing of preferred shrinkage pool is 0.10-0.20mm to shrinkage pool to each other, the spacing of best shrinkage pool is 0.10-0.15mm.
In sum, the invention has the beneficial effects as follows: arsenic trioxide controllable release sacculus of the present invention is because balloon body surface coating one layer of polymeric coating, and polymer-coated surface has the shrinkage pool structure, so that its adsorbance to arsenic trioxide medicament improves 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
Labelling and respective name in Fig. 3 part balloon body that is arsenic trioxide controllable release sacculus of the present invention when pressurization 200% and the medication coat enlarged diagram accompanying drawing 3 thereof: 3-shrinkage pool; The 4-polymer coating; 5-arsenic trioxide medicament granule
The specific embodiment
Below in conjunction with embodiment and accompanying drawing, the present invention is done further detailed description, but embodiments of the present invention are not limited to this.
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; so that arsenic trioxide medicament granule or individual particles group are 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 particles filledly to enter in the shrinkage pool, last evacuation makes the molding of sacculus flap.
The sacculus of the arsenic trioxide controllable release for preparing according to the method described above, show that in the balloon pressure testing process its compressive resistance does not change, and sacculus does not occur in the experimentation to break, balloon diameter increases and adds Compressive Strength and claim 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 adds Compressive Strength (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 and is 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 Real-Time Monitoring PBS solution, 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 (8)
1. sacculus with 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. the sacculus of described arsenic trioxide controllable release according to claim 1, it is characterized in that, the sacculus polymer-coated surface has shrinkage pool, shrinkage pool has the interval to each other, the arsenic trioxide medicament granule is filled in the shrinkage pool, forms the individual particles group, so that isolated each other between the medicine, as " isolated island ", make drug controllable release.
3. the sacculus of described arsenic trioxide controllable release according to claim 1 is characterized in that on the described sacculus, arsenic trioxide medicament content is 0.05-5.00ug/mm
2, preferred arsenic trioxide medicament content is 0.10-2.00ug/mm
2, best arsenic trioxide medicament content is 0.50-1.00ug/mm
2Arsenic trioxide medicament weight is 0.1: 9.9 to 9.9: 0.1 with the ratio of polymer coating weight; the ratio of the two weight is preferably 0.2-15.0; wherein the ratio of optimum weight is 0.5-1.5; arsenic trioxide medicament granule or its individual particles group's size is 0.01-100.00um; the preferable particle size size is 0.01-60.00um, and the optimum grain-diameter size is 0.05-50.00um.
4. the sacculus of described arsenic trioxide controllable release according to claim 1, it is characterized in that, be delivered to lesions position at sacculus, when 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.
5. the sacculus of described arsenic trioxide controllable release according to 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 polyurethane, with a kind of of bioactive polyurethane, polyester and copolymer thereof or more than one.
6. according to the sacculus of claim 1 described arsenic trioxide controllable release, it is characterized in that, described sacculus, the sacculus material is nylon, perhaps nylon elastomer, the perhaps material such as Pebax.
7. the preparation method of described arsenic trioxide controllable release sacculus according to claim 1-6, it is characterized in that, comprise following treatment step, in balloon body surface laser spraying one layer of polymeric coating, form the acupuncture shrinkage pool at coating surface, spray again the arsenic trioxide granule, it is packed in the shrinkage pool, laser polishing coating surface, evacuation makes the sacculus flap.
8. the preparation method of arsenic trioxide controllable release sacculus according to claim 7 is characterized in that, sacculus coating surface shrinkage pool is distributed as 4-8/mm
2, preferred shrinkage pool distributed number is 4-6/mm
2, best shrinkage pool distributed number is 5/mm
2, apart from being 0.08-0.25mm, the spacing of preferred shrinkage pool is 0.10-0.20mm to shrinkage pool to each other, the spacing of best shrinkage pool is 0.10-0.15mm.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012103528049A CN102974026A (en) | 2012-09-21 | 2012-09-21 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
| PCT/CN2013/080528 WO2014044082A1 (en) | 2012-09-21 | 2013-07-31 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012103528049A CN102974026A (en) | 2012-09-21 | 2012-09-21 | Arsenic trioxide controllable-releasing balloon and preparing method thereof |
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| CN102974026A true CN102974026A (en) | 2013-03-20 |
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| WO (1) | WO2014044082A1 (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN104174110A (en) * | 2013-05-23 | 2014-12-03 | 微创心脉医疗科技（上海）有限公司 | Medicine balloon and preparation method thereof |
| CN107261300A (en) * | 2016-04-04 | 2017-10-20 | 美敦力心血管股份有限公司 | Foley's tube and the method for covering medical sacculus |
| CN108325050A (en) * | 2018-03-28 | 2018-07-27 | 周胜华 | A kind of novel cyclic sacculus and its application method |
| CN108348347A (en) * | 2015-11-17 | 2018-07-31 | 森蒂恩特控股有限公司 | Device and method for enhancing drug delivery |
| CN114010917A (en) * | 2021-11-05 | 2022-02-08 | 广东博迈医疗科技股份有限公司 | Double-medicine administration balloon |
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| 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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- 2013-07-31 WO PCT/CN2013/080528 patent/WO2014044082A1/en active Application Filing
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| CN101161300A (en) * | 2007-11-27 | 2008-04-16 | 北京美中双和医疗器械有限公司 | Arsenic trioxide medicament elution bracket |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN104174110A (en) * | 2013-05-23 | 2014-12-03 | 微创心脉医疗科技（上海）有限公司 | Medicine balloon and preparation method thereof |
| CN108348347A (en) * | 2015-11-17 | 2018-07-31 | 森蒂恩特控股有限公司 | Device and method for enhancing drug delivery |
| CN107261300A (en) * | 2016-04-04 | 2017-10-20 | 美敦力心血管股份有限公司 | Foley's tube and the method for covering medical sacculus |
| CN108325050A (en) * | 2018-03-28 | 2018-07-27 | 周胜华 | A kind of novel cyclic sacculus and its application method |
| CN114010917A (en) * | 2021-11-05 | 2022-02-08 | 广东博迈医疗科技股份有限公司 | Double-medicine administration balloon |
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| Publication number | Publication date |
|---|---|
| WO2014044082A1 (en) | 2014-03-27 |
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Application publication date: 20130320 |