CN105288823A - Drug eluting balloon system - Google Patents
Drug eluting balloon system Download PDFInfo
- Publication number
- CN105288823A CN105288823A CN201510849564.7A CN201510849564A CN105288823A CN 105288823 A CN105288823 A CN 105288823A CN 201510849564 A CN201510849564 A CN 201510849564A CN 105288823 A CN105288823 A CN 105288823A
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- China
- Prior art keywords
- hirudin
- medicament elution
- paclitaxel
- sacculus
- foley
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- 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.)
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Abstract
The invention discloses a drug eluting balloon system which comprises a balloon catheter and a drug eluting balloon, wherein the balloon catheter is provided with a wire guide cavity arranged along the axial direction; the drug eluting balloon is arranged along the partial length of the balloon catheter and is expanded by virtue of a pressure medium provided by the balloon catheter; the external surface of the balloon body of the drug eluting balloon is provided with a drug coating; the drug coating comprises an inner layer and an outer layer, wherein the inner layer is a taxol and hirudin mixed drug coating, and the outer layer is a hirudin drug coating; a flow channel is also arranged in the wire guide cavity, and the flow channel is arranged at the partial length position of the balloon catheter; and the flow channel is provided with two openings which are respectively formed in two ends of the drug eluting balloon. When the drug eluting balloon system releases drugs, blood flow can not be blocked and drug release can be prolonged to any time, so that the action time of the drugs is increased and the curative effect is improved.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments.More particularly, the present invention relates to a kind of medicament elution balloon system.
Background technology
Percutaneous coronary intervention (pci) (percutaneouscoronaryintervention, PCI) standard treatments of stenosis coronary artery disease has been become, medicament elution sacculus (DEB) can be released into treatment section blood vessel by suppressing the drug conveying of restenosis because of it, do not have again metal to insert thing thus decrease the features such as long-term duplex Antiplatelet therapy (DAPT) simultaneously, being just subject to extensive concern from its birth.But short after balloon dilatation and conventional stent implantation, mid-term, the incidence rate of restenosis reached 5%-60%, seriously limited the development of PCI.Along with to the further investigation of Restenosis after Coronary Interventional Therapy mechanism and the successful research and development of coating stent of medicine (DES), DES prevention of restenosis is made to become possibility.Although so,
Still have the restenosis rate of 10%-20% after inserting DES, part DES does not even reduce the incidence rate of the main adverse events of cardiovascular, and the stent thrombosis of delay more becomes the focus of people's concern.Meanwhile, existing medicinal balloon, is filled by sacculus, drug osmotic in vascular tissue, but due to balloon occlusion blood flow, therefore can only fill about 40 seconds at most, otherwise may cause myocardial ischemia, therefore pharmaceutical release time is limited, treat also limited.
Summary of the invention
An object of the present invention is to solve at least the problems referred to above, and the advantage will illustrated at least is below provided.
A further object of the invention is to provide a kind of medicament elution balloon system, and it is when release medicine, and not blocking blood flow, drug release can extend to random time, adds the action time of medicine, improves therapeutic effect.
In order to realize, according to these objects of the present invention and other advantage, providing a kind of medicament elution balloon system, it is characterized in that, comprising:
Foley's tube, it has the guidewire lumen arranged vertically;
Medicament elution sacculus, its partial-length along foley's tube is arranged and the pressure medium provided by foley's tube and expanding, and the outer surface of described medicament elution sacculus has medication coat;
Wherein, described medication coat comprises internal layer and skin, and described internal layer is the hybrid medicament smear layer of paclitaxel and hirudin; Described skin is hirudin medication coat;
In described guidewire lumen, be also provided with fluid passage, described fluid passage is arranged on the partial-length part of described foley's tube; And described fluid passage has two openings, be separately positioned on the two ends of described medicament elution sacculus.
Preferably, the diameter of described fluid passage is greater than the diameter of described guidewire lumen.
Preferably, described medicament elution sacculus is at outer surface before carrying out coated medicament coating, and the outer surface of described utricule need through low-temperature plasma process; The thickness of described medication coat is the 1/2-1/3 of sacculus utricule thickness.
Preferably, the mass ratio of paclitaxel and hirudin described in the internal layer of described medication coat is 2-3:1, and the weight of described hirudin is for being 1-3ug/mm2; The weight of paclitaxel is 2-6ug/mm2.
Preferably, in described medication coat, the thickness of described internal layer is 3 times of described outer layer thickness.
Preferably, the side of described foley's tube has the exchange mouth interted for seal wire; Described foley's tube also comprises base, and it is arranged on the proximal end of described foley's tube.
Preferably, described medicament elution sacculus is prepared by the following method:
Step one, gets paclitaxel and the hirudin of formula ratio, prepares paclitaxel and hirudin solution;
Step 2, utilizes airless spraying to add ultrasonic atomization technology and described paclitaxel and hirudin solution is coated on described balloon surface.The medication coat weight range of described sacculus is 0.2-50ug/mm2.
Preferably, the preparation of described paclitaxel and hirudin solution comprises: the Iirudo-seu-whitmania essence getting formula ratio, adds methanol dissolve according to the ratio of 6-8mg/ml, adds the paclitaxel of formula ratio after dissolving.
The present invention at least comprises following beneficial effect: medicament elution balloon system of the present invention comprises a special fluid passage, described fluid passage can through described medicament elution sacculus utricule distal end portion and proximal end, ensure medicament elution sacculus after expansion, before and after utricule, still have fluid to pass through; Avoid blood flow to be blocked, extend the TPER of sacculus; Fluid passage of the present invention is all provided with opening in the utricule both sides of described medicament elution sacculus, and described fluid passage and described guidewire lumen share a cavity, does not affect the folding dress of sacculus.The outer surface of described medicament elution sacculus, through low-temperature plasma process, can allow balloon surface form hydrogen bond, increase surface energy, increase macromolecule and the adhesion of medicine such as between hirudin.Intermediate layer is actual drug active layer, and outermost layer adopts water miscible hirudin, and in the process of medicinal balloon Ink vessel transfusing conveying, protection intermediate layer is not washed away by blood; Intermediate layer is made up of fat-soluble core drug paclitaxel and water miscible hirudin, hirudin can as the carrier of paclitaxel, simultaneously, when drug release, hirudin first dissolves, make medicine layer form cellular, add the bonded area of fat-soluble paclitaxel and vascular tissue, promote drug absorption.
Part is embodied by explanation below by other advantage of the present invention, target and feature, part also will by research and practice of the present invention by those skilled in the art is understood.
Accompanying drawing explanation
Fig. 1 is the structural representation of medicament elution balloon system of the present invention;
Fig. 2 is the cross section structure schematic diagram of medicament elution balloon system of the present invention.
Detailed description of the invention
Below in conjunction with accompanying drawing, the present invention is described in further detail, can implement according to this with reference to description word to make those skilled in the art.
Should be appreciated that used hereinly such as " to have ", other element one or more do not allotted in " comprising " and " comprising " term or the existence of its combination or interpolation.
As depicted in figs. 1 and 2, the invention provides a kind of medicament elution balloon system, it comprises:
Foley's tube 6, it has the guidewire lumen 5 arranged vertically;
Medicament elution sacculus 1, its partial-length along foley's tube is arranged and the pressure medium provided by foley's tube and expanding, and utricule 101 outer surface of described medicament elution sacculus 1 has medication coat 102,103;
Wherein, described medication coat 102,103 comprises internal layer 102 and outer 103, and described internal layer 102 is the hybrid medicament smear layer of paclitaxel and hirudin; Described outer 103 is hirudin medication coat;
In described guidewire lumen 5, be also provided with fluid passage 4, described fluid passage 4 is arranged on the partial-length part of described foley's tube 6; And described fluid passage 4 has two openings 2,3, be separately positioned on the two ends of described medicament elution ball/1.Described fluid passage 4, for when described medicament elution sacculus fills, endovascular blood continues circulation by fluid passage, prolong drug release time, improves therapeutic effect.Meanwhile, at medicament elution sacculus utricule 101 surface-coated medication coat 102,103, filled, drug osmotic in vascular tissue by medicament elution sacculus.
The internal layer 102 of described medication coat is actual drug active layer, and outer 103 adopt water miscible hirudin, and in the process of medicinal balloon Ink vessel transfusing conveying, protection internal layer 102 does not wash away by blood; Internal layer 102 is made up of fat-soluble core drug paclitaxel and water miscible hirudin, hirudin can as the carrier of paclitaxel, simultaneously, when drug release, hirudin first dissolves, make medicine layer form cellular, add the bonded area of fat-soluble paclitaxel and vascular tissue, promote drug absorption.
Wherein in an embodiment, as shown in Figure 1, the diameter of described fluid passage 4 is greater than the diameter of described guidewire lumen 5.Described fluid passage 4 shares a cavity with described guidewire lumen 5, and the cavity of described fluid passage 4 is greater than the cavity of guidewire lumen 5, thus, described fluid passage 4 all arranges opening at the two ends of described medicament elution sacculus 1, blood not only can form circumference, simultaneously when carrying out folding dress, the expanded state of sacculus can not be affected.
Wherein in an embodiment, as shown in Figure 2, described medicament elution sacculus is at utricule 101 outer surface before carrying out coated medicament coating, and the outer surface of described utricule 101 need through low-temperature plasma process; The thickness of described medication coat 102,103 is the 1/2-1/3 of sacculus capsule/101 thickness.The outer surface of described medicament elution sacculus adopts low-temperature plasma treatment technology, and activation macromolecule layer, increases the adhesion between macromolecule and medicine.Low-temperature plasma can allow utricule 101 surface of medicament elution sacculus form hydrogen bond, increases surface energy, and if hirudin formation adhesion.
Wherein in an embodiment, described in the internal layer 102 of described medication coat, the mass ratio of paclitaxel and hirudin is 2-3:1, and the weight of described hirudin is for being 1-3ug/mm2; The weight of paclitaxel is 2-6ug/mm2.Described medication coat can also add tanshinone IIA or hormone such as prednisone etc., and the concentration of wherein said tanshinone IIA is 7-9mg/ml; The concentration of described prednisone is 0.05-2mg/ml; Described medicament elution sacculus can also use slow-released carrier such as Ultravist or carbamide etc.Described Ultravist concentration is 0.1mmol/L, and described urea concentration is 10mmol/L.
Wherein in an embodiment, as shown in Figure 2, in described medication coat, the thickness of described internal layer is 3 times of described outer layer thickness.
Wherein in an embodiment, as shown in Figure 2, the side of described foley's tube has the exchange mouth interted for seal wire; Described foley's tube also comprises base, and it is arranged on the proximal end of described foley's tube.
Wherein in an embodiment, described medicament elution sacculus is prepared by the following method:
Step one, gets paclitaxel and the hirudin of formula ratio, prepares paclitaxel and hirudin solution;
Step 2, utilizes airless spraying to add ultrasonic atomization technology and described paclitaxel and hirudin solution is coated on described balloon surface.The medication coat weight range of described sacculus is 0.2-50ug/mm2.
Wherein in an embodiment, the preparation of described paclitaxel and hirudin solution comprises: the Iirudo-seu-whitmania essence getting formula ratio, adds methanol dissolve according to the ratio of 6-8mg/ml, adds the paclitaxel of formula ratio after dissolving.The described paclitaxel prepared according to this ratio and hirudin solution are distributed in sacculus utricule surface with being more conducive to medication coat uniform composition, and medication coat composition can be made to be attached to sacculus utricule surface more firmly simultaneously.
The solution that the medication coat of described medicament elution sacculus can also contain corresponding medicine by spraying or dipping completes, or other prepares the method for coating.In the medication coat of described medicament elution sacculus, heterogeneity can be layered distribution, also can be uniformly distributed, and optimum is dispersed distribution.
Here the number of devices illustrated and treatment scale are used to simplify explanation of the present invention.The application of medicament elution sacculus of the present invention, modifications and variations be will be readily apparent to persons skilled in the art.
Although embodiment of the present invention are open as above, but it is not restricted to listed in description and embodiment utilization, it can be applied to various applicable the field of the invention completely, for those skilled in the art, can easily realize other amendment, therefore do not deviating under the general concept that claim and equivalency range limit, the present invention is not limited to specific details and illustrates here and the legend described.
Claims (8)
1. a medicament elution balloon system, is characterized in that, comprising:
Foley's tube, it has the guidewire lumen arranged vertically;
Medicament elution sacculus, its partial-length along foley's tube is arranged and the pressure medium provided by foley's tube and expanding, and the outer surface of described medicament elution sacculus has medication coat;
Wherein, described medication coat comprises internal layer and skin, and described internal layer is the hybrid medicament smear layer of paclitaxel and hirudin; Described skin is hirudin medication coat;
In described guidewire lumen, be also provided with fluid passage, described fluid passage is arranged on the partial-length part of described foley's tube; And described fluid passage has two openings, be separately positioned on the two ends of described medicament elution sacculus.
2. medicament elution balloon system as claimed in claim 1, it is characterized in that, the diameter of described fluid passage is greater than the diameter of described guidewire lumen.
3. medicament elution balloon system as claimed in claim 2, it is characterized in that, described medicament elution sacculus is at outer surface before carrying out coated medicament coating, and the outer surface of described utricule need through low-temperature plasma process; The thickness of described medication coat is the 1/2-1/3 of sacculus utricule thickness.
4. medicament elution balloon system as claimed in claim 3, it is characterized in that, the mass ratio of paclitaxel and hirudin described in the internal layer of described medication coat is 2-3:1, and the weight of described hirudin is for being 1-3ug/mm
2; The weight of paclitaxel is 2-6ug/mm
2.
5. medicament elution balloon system as claimed in claim 4, it is characterized in that, in described medication coat, the thickness of described internal layer is 3 times of described outer layer thickness.
6. medicament elution balloon system as claimed in claim 5, is characterized in that, the side of described foley's tube has the exchange mouth interted for seal wire; Described foley's tube also comprises base, and it is arranged on the proximal end of described foley's tube.
7. the medicament elution balloon system as described in any one of claim 1-6, is characterized in that, described medicament elution sacculus is prepared by the following method:
Step one, gets paclitaxel and the hirudin of formula ratio, prepares paclitaxel and hirudin solution;
Step 2, utilizes airless spraying to add ultrasonic atomization technology and described paclitaxel and hirudin solution is coated on described balloon surface.The medication coat weight range of described sacculus is 0.2-50ug/mm
2.
8. medicament elution balloon system as claimed in claim 7, it is characterized in that, the preparation of described paclitaxel and hirudin solution comprises: the Iirudo-seu-whitmania essence getting formula ratio, adds methanol dissolve according to the ratio of 6-8mg/ml, adds the paclitaxel of formula ratio after dissolving.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510849564.7A CN105288823A (en) | 2015-11-27 | 2015-11-27 | Drug eluting balloon system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510849564.7A CN105288823A (en) | 2015-11-27 | 2015-11-27 | Drug eluting balloon system |
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| Publication Number | Publication Date |
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| CN105288823A true CN105288823A (en) | 2016-02-03 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510849564.7A Pending CN105288823A (en) | 2015-11-27 | 2015-11-27 | Drug eluting balloon system |
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| CN (1) | CN105288823A (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237485A (en) * | 2016-08-29 | 2016-12-21 | 恒壹（北京）医疗科技有限公司 | A kind of medicine-coated balloon dilating catheter and preparation method thereof |
| CN106310495A (en) * | 2016-08-22 | 2017-01-11 | 苗立夫 | Perfusion and dilation balloon system |
| CN108261569A (en) * | 2016-12-31 | 2018-07-10 | 先健科技(深圳)有限公司 | The preparation method of medicinal balloon |
| CN108742959A (en) * | 2018-04-21 | 2018-11-06 | 李皇德 | A kind of blood saccule, balloon-stent drug release device and its medicine release method |
| CN109172876A (en) * | 2018-09-21 | 2019-01-11 | 杭州巴泰医疗器械有限公司 | It is a kind of to ease up the newtype drug bracket of Slow release coating simultaneous with rapid delivery of pharmaceuticals |
| 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 |
| CN110051917A (en) * | 2018-01-18 | 2019-07-26 | 上海微创医疗器械（集团）有限公司 | Sacculus dilating catheter |
| CN110201242A (en) * | 2016-02-08 | 2019-09-06 | 祥丰医疗私人有限公司 | A kind of medical device |
| CN115569240A (en) * | 2022-09-15 | 2023-01-06 | 辽宁垠艺生物科技股份有限公司 | Medicine coating plastic capsule and preparation method thereof |
| US11559671B2 (en) | 2016-02-08 | 2023-01-24 | Orbusneich Medical Pte. Ltd. | Drug eluting balloon |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110201242A (en) * | 2016-02-08 | 2019-09-06 | 祥丰医疗私人有限公司 | A kind of medical device |
| US11559671B2 (en) | 2016-02-08 | 2023-01-24 | Orbusneich Medical Pte. Ltd. | Drug eluting balloon |
| CN106310495A (en) * | 2016-08-22 | 2017-01-11 | 苗立夫 | Perfusion and dilation balloon system |
| CN106237485A (en) * | 2016-08-29 | 2016-12-21 | 恒壹（北京）医疗科技有限公司 | A kind of medicine-coated balloon dilating catheter and preparation method thereof |
| 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 |
| 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 |
| CN110051917A (en) * | 2018-01-18 | 2019-07-26 | 上海微创医疗器械（集团）有限公司 | Sacculus dilating catheter |
| CN108742959A (en) * | 2018-04-21 | 2018-11-06 | 李皇德 | A kind of blood saccule, balloon-stent drug release device and its medicine release method |
| CN109172876A (en) * | 2018-09-21 | 2019-01-11 | 杭州巴泰医疗器械有限公司 | It is a kind of to ease up the newtype drug bracket of Slow release coating simultaneous with rapid delivery of pharmaceuticals |
| CN115569240A (en) * | 2022-09-15 | 2023-01-06 | 辽宁垠艺生物科技股份有限公司 | Medicine coating plastic capsule and preparation method thereof |
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Application publication date: 20160203 |
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