CN104857615A - Novel dual-layer drug balloon catheter - Google Patents
Novel dual-layer drug balloon catheter Download PDFInfo
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- CN104857615A CN104857615A CN201410066921.8A CN201410066921A CN104857615A CN 104857615 A CN104857615 A CN 104857615A CN 201410066921 A CN201410066921 A CN 201410066921A CN 104857615 A CN104857615 A CN 104857615A
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- drug
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- sacculus
- balloon catheter
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Abstract
The invention relates to a minimally-invasive intervention medical instrument, particularly to a dual-layer drug balloon catheter used for quickly releasing drugs at a focus part in a blood vessel. The dual-layer drug balloon catheter comprises an inner-layer balloon, an outer-layer microporous drug releasing membrane, a catheter body, developing rings and a connecting piece, wherein the outer-layer microporous drug releasing membrane and a straight section of the inner-layer balloon are connected through gluing or laser welding, and a drug storage balloon is formed; the balloon and the catheter body are connected through laser welding; the two developing rings are arranged on the catheter body and can mark out the straight section of the balloon; the connecting piece is a 6% standard Luer taper; liquid drugs or growth factors are stored in the drug storage balloon, when the balloon is full, micropores of the outer-layer microporous drug releasing membrane are expanded under the pressure of the inner-layer balloon, and the drugs in the drug storage balloon are quickly and accurately released via the expanded micropores; the balloon can quickly release the drugs at the stenosis part of the blood vessel while expanding the stenosis part, so that blood is prevented from gathering at the diseased part, and the probability of restenosis is greatly decreased; besides, the dual-layer drug balloon catheter has the advantages of simple structure, convenience in operation, high drug-loading capacity and the like.
Description
Technical field
The present invention relates to Micro trauma interventional medical device, particularly relate to a kind of novel double-layer medicinal balloon catheter for carrying out rapid delivery of pharmaceuticals at Ink vessel transfusing focal part.
Background technology
New era of coronary heart disease vascular treatment again has been started in the appearance of Coronary Artery Disease Intervention Treatment, and one of significant challenge that postoperative restenosis is it to be faced.The generation of restenosis not only causes the recurrence of angina pectoris symptom, needs myocardial revascularization relief of symptoms again, also can cause acute coronary artery syndrome at some patients.Peripheral blood vessel, its sickness rate has obvious rising in recent years, common as arteriosclerosis obliterans, arteriovenous thrombosis, aneurysm etc.; Peripheral blood vessel has very high disability rate.
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, take Neointimal formation as feature.In the bracket for eluting medicament epoch, narrowly in support still have generation, and once occur lacking effective processing method.In the drug stent of restenosis, superpose another drug stent 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 the blood vessel wall of coated with drug in specific region, this topical remedy of place is made to concentrate and not cause systemic side effects.
The advantage of medicine carrying sacculus comprises: 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; Without polymer carrier, reduce chronic inflammatory reaction and advanced thrombus formation; Without metallic framework, save the original anatomic form of blood vessel, in process thin vessels and bifurcated lesions process, 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 by covering at common foley's tube the sacculus that one deck is installed with micropore outward, and this sacculus connects its independent cavity, forms the conduit containing two-layer sacculus, three cavitys.In two-layer sacculus, internal layer sacculus plays blood vessel dilating, and outer sacculus is made up of the microporous membrane of uniqueness, can be endosmosis or be applied on blood vessel wall, target organ by outer sacculus by playing the gene of therapeutical effect or medicine.The balloon structure of the releasable medicaments that above-mentioned patent relates to is complicated, and manufacture difficulty is high, and owing to cannot learn the amount of left drug in tube chamber in operation, accurately cannot control the burst size of medicine to lesions position.
Chinese patent CN101785900A discloses a kind of medicinal balloon catheter and preparation method thereof.The sacculus outer surface of this medicinal balloon catheter is the irregular nonplanar structure of tool, this medicinal balloon catheter adopts Ultra-Violet Laser grinding sacculus outer surface, sacculus outer surface is made to form the irregular nonplanar structure of tool, 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, can sacculus be damaged, the pressure of sacculus is reduced; And owing to being still the physical action that absorption affinity is lower between balloon surface and medicine, medicine can not being changed and easily come off and the shortcoming such as drug loading is little.
Summary of the invention
In order to solve the problems referred to above of prior art, the object of this invention is to provide a kind of novel double-layer medicinal balloon catheter, having structure simple, easy to operate, drug loading is large, the accurate feature of drug release.
To achieve these goals, the technical solution adopted in the present invention is:
A kind of novel double-layer medicinal balloon catheter, comprises internal layer sacculus, outer micropore drug releasing membrane according, catheter body, developing ring and connector; Outer micropore drug releasing membrane according is connected through gluing or laser weld with the flat segments of internal layer sacculus, forms drug reservoirs; Sacculus and catheter body adopt the mode of laser weld to be connected; Containing two developing rings on catheter body, signable go out the flat segments of sacculus; Connector is 6% standard luer fittings; Liquid medicine or somatomedin are stored in drug reservoirs, and when sacculus fills, outer micropore drug releasing membrane according is under the pressure of internal layer sacculus, and micropore is expanded, and the medicine in drug reservoirs is discharged fast and accurately by the micropore of expansion;
Further, the micro-pore diameter of outer micropore drug releasing membrane according of the present invention is preferably 3 ~ 100um;
Further, the micro-porosity of outer micropore drug releasing membrane according of the present invention is 10 ~ 70%;
Further, internal layer balloon diameter of the present invention 2 ~ 35mm, length 20 ~ 300mm
Further, the material of internal layer sacculus of the present invention is nylon (PA) or polyether block amide (PEBAX);
Further, the material of outer micropore drug releasing membrane according of the present invention is polyether block amide (PEBAX) or polyurethane (PU):
Further, drug reservoirs ectonexine of the present invention is coated with hydrophilic coating;
Further, drug reservoirs of the present invention can load rapamycin, paclitaxel, somatomedin;
The invention has the beneficial effects as follows: while blood vessel dilating narrow positions, also can carry out rapid delivery of pharmaceuticals to it, avoid blood to assemble at diseased region, greatly reduce the probability of restenosis; In addition the present invention also has the advantages such as structure is simple, easy to operate, drug loading is large.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, be briefly described to the accompanying drawing used required in embodiment or description of the prior art 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 prerequisite not paying creative work, other accompanying drawing can also be obtained according to these accompanying drawings.
Below in conjunction with drawings and Examples, the present invention is further described.
Fig. 1 is overall structure schematic diagram of the present invention.
Fig. 2 is drug reservoirs structural representation.
Fig. 3 is the schematic cross-section of catheter body.
1. catheter body, 2. connector, 3. sacculus fills interface, 4. guide wire exit openings, 5. balloon proximal junction point, 6. near-end developing ring, 7. internal layer sacculus, 8. outer micropore drug releasing membrane according proximal connection point, 9. outer micropore drug releasing membrane according, 10. outer micropore drug releasing membrane according distal attachment points, 11. far-end developing rings, 12. balloon distal junction points, 13. is most advanced and sophisticated, 14. drug reservoirses, 15. internal layer balloon cavities, 16. guidewire lumen, 17. sacculus fill chamber.
Detailed description of the invention
Referring now to accompanying drawing, the invention will be further described.
A kind of novel double-layer medicinal balloon catheter mainly comprises internal layer sacculus 7, outer micropore drug releasing membrane according 9, catheter body 1, developing ring 6 and 11, connector 2.
Described outer micropore drug releasing membrane according 9, adopt the microporous membrane that polyether block amide (PEBAX) or polyurethane (PU) are made, micro-pore diameter is preferably 3 ~ 100um, and micro-porosity is 10 ~ 70%; Micropore drug releasing membrane according is connected through gluing or laser weld with the flat segments of internal layer sacculus, forms drug reservoirs 14; The ectonexine of micropore drug releasing membrane according 9 is all containing hydrophilic coating; Rapamycin, paclitaxel or somatomedin etc. can be loaded in drug reservoirs 14.
Described catheter body 1 is double lumen tube, and material is polyether block amide (PEBAX), and one of them tract is by 0.035 inch or 0.018 inch or 0.014 inch of seal wire; Described sacculus body 8 and catheter body 1 adopt the mode of laser weld to be connected.Described developing ring 6 and 11 is the thin-walled ring that platinumiridio or platinum or gold are made, and developing ring 6 and 11 is individually fixed on the catheter body 1 at the most two ends of flat segments of internal layer sacculus 7, and developing ring is visible under X-ray, in operation signable go out the position of sacculus.Described connector 2 is breeches joint, and fill interface 3 containing sacculus, it is 6% standard luer fittings, in operation process, by pump by full for internal layer sacculus 7 expansion; The other end of connector 2 is guide wire exit openings 4, and it is also 6% standard luer fittings, and seal wire runs through catheter body by this mouth, also carries out visualization by this mouthful of injection of contrast medium.
As above-mentioned, after internal layer sacculus is connected with catheter body, the surfaces externally and internally coating hydrophilic coating of outer micropore drug releasing membrane according, more outer micropore drug releasing membrane according is connected with internal layer sacculus, connect while can load rapamycin, paclitaxel or somatomedin etc., then carry out sacculus fold.
The specific embodiment of the present invention.As 0.035 inch of godet system, catheter body 1 external diameter is 1.8mm, and one of them tract internal diameter is 1.0mm, and another tract is the half-moon-shaped tract that internal diameter is greater than 0.5mm, and the external diameter of internal layer sacculus 7 is 6.0mm, and length is 100mm; Internal layer sacculus and catheter body adopt laser weld to be connected, outer micropore drug releasing membrane according micro-pore diameter is 25um, micro-porosity is 45%, outer microtube sacculus hole drug releasing membrane according adopts gluing mode to be connected with internal layer sacculus, while outer microtube sacculus hole drug releasing membrane according is bonding with internal layer sacculus, be loaded into paclitaxel solution; Catheter body distal end adopts most advanced and sophisticated forming machine to carry out most advanced and sophisticated molding, and half-moon-shaped tract is closed, and forms the tip 11 that external diameter is 1.2mm, length is 5mm.
The specific embodiment of the present invention.As 0.018 inch of godet system, catheter body external diameter is 1.4mm, and one of them tract internal diameter is 0.55mm, and another tract is the half-moon-shaped tract that internal diameter is greater than 0.5mm, and the external diameter of sacculus body 8 is 3.0mm, and length is 100mm; Internal layer sacculus and catheter body adopt laser weld to be connected; Outer micropore drug releasing membrane according micro-pore diameter is 25um, micro-porosity is 45%, outer microtube sacculus hole drug releasing membrane according adopts gluing mode to be connected with internal layer sacculus, while outer microtube sacculus hole drug releasing membrane according is bonding with internal layer sacculus, is loaded into paclitaxel solution; Catheter body distal end adopts most advanced and sophisticated forming machine to carry out most advanced and sophisticated molding, and half-moon-shaped tract is closed, and forms that external diameter is 0.7mm, length is the tip of 5mm.
Referring to Fig. 1, clinical detailed description of the invention of the present invention is described.The situation of preoperative first radiography assess lesion blood vessel, select foley's tube and the catheter sheath of suitable dimension, select suitable position puncture vessel, seal wire is inserted diseased region by catheter sheath, the hole of guidewire proximal along the tip of foley's tube is inserted, is pushed forward into foley's tube until angiostenosis diseased region; When needing, seal wire can be withdrawn from, along the guide wire exit openings injecting contrast liquid of connector, to observe diseased region; Reinsert seal wire again after completing radiography, pump filled interface with the sacculus of connector and is connected, primer pump until sacculus nominal pressure more than; After 30 ~ 60 seconds, medicine discharges completely, and primer pump evacuation makes sacculus bounce back completely, then withdraws from foley's tube.
To the above-mentioned explanation of the disclosed embodiments, professional and technical personnel in the field are realized or uses the present invention.To be apparent for those skilled in the art to the multiple amendment of these embodiments, General Principle as defined herein can without departing from the spirit or scope of the present invention, realize in other embodiments.Therefore, the present invention can not be restricted to these embodiments shown in this article, but will meet the widest scope consistent with principle disclosed herein and features of novelty.
Claims (8)
1. a novel double-layer medicinal balloon catheter, comprises internal layer sacculus, outer micropore drug releasing membrane according, catheter body, developing ring and connector;
It is characterized in that, described outer micropore drug releasing membrane according is connected through gluing or laser weld with the flat segments of internal layer sacculus, forms drug reservoirs; Liquid medicine or somatomedin are stored in drug reservoirs, and when sacculus fills, outer micropore drug releasing membrane according is under the pressure of internal layer sacculus, and micropore is expanded, and the medicine in drug reservoirs is discharged fast by the micropore of expansion.
2. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, the micro-pore diameter of described outer micropore drug releasing membrane according is preferably 3 ~ 100um.
3. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, the micro-porosity of described outer micropore drug releasing membrane according is 10 ~ 70%.
4. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, described internal layer balloon diameter 2 ~ 35mm, length 20 ~ 300mm.
5. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, the material of described internal layer sacculus is nylon (PA) or polyether block amide (PEBAX).
6. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, the material of described outer micropore drug releasing membrane according is polyether block amide (PEBAX) or polyurethane (PU).
7. a kind of novel double-layer medicinal balloon catheter according to claim 1, is characterized in that, described drug reservoirs ectonexine is coated with hydrophilic coating.
8. a kind of novel double-layer medicinal balloon catheter according to claim 1, it is characterized in that, described drug reservoirs can load rapamycin, paclitaxel, somatomedin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410066921.8A CN104857615A (en) | 2014-02-26 | 2014-02-26 | Novel dual-layer drug balloon catheter |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410066921.8A CN104857615A (en) | 2014-02-26 | 2014-02-26 | Novel dual-layer drug balloon catheter |
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| CN104857615A true CN104857615A (en) | 2015-08-26 |
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| CN201410066921.8A Pending CN104857615A (en) | 2014-02-26 | 2014-02-26 | Novel dual-layer drug balloon catheter |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079951A (en) * | 2015-09-22 | 2015-11-25 | 傅国胜 | Perfusion medicine balloon |
| CN106178138A (en) * | 2016-09-07 | 2016-12-07 | 上海申淇医疗科技有限公司 | A kind of medicinal balloon |
| CN107303406A (en) * | 2016-04-21 | 2017-10-31 | 青岛智辰生物科技有限公司 | A kind of sacculus dilating catheter |
| CN107616855A (en) * | 2017-08-24 | 2018-01-23 | 黑龙江正康生物技术股份有限公司 | The portable injection device of bionical tick worm absorption type live vaccine |
| CN108355230A (en) * | 2018-03-09 | 2018-08-03 | 鼎科医疗技术（苏州）有限公司 | More seal wire medicine balloon dilating catheters and its application method |
| 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 |
| CN109414571A (en) * | 2016-11-17 | 2019-03-01 | 脉科私人有限公司 | A kind of medicament elution sacculus |
| CN110732078A (en) * | 2019-11-14 | 2020-01-31 | 昆山金泰医疗科技有限公司 | Balloon |
| CN112274745A (en) * | 2020-10-29 | 2021-01-29 | 合肥达米医疗科技有限公司 | Double-layer bag double-cavity bronchial catheter |
| CN108355230B (en) * | 2018-03-09 | 2024-04-26 | 鼎科医疗技术（苏州）有限公司 | Multi-guidewire drug balloon dilation catheter and method of use thereof |
-
2014
- 2014-02-26 CN CN201410066921.8A patent/CN104857615A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079951A (en) * | 2015-09-22 | 2015-11-25 | 傅国胜 | Perfusion medicine balloon |
| CN107303406A (en) * | 2016-04-21 | 2017-10-31 | 青岛智辰生物科技有限公司 | A kind of sacculus dilating catheter |
| CN106178138A (en) * | 2016-09-07 | 2016-12-07 | 上海申淇医疗科技有限公司 | A kind of medicinal balloon |
| CN109414571A (en) * | 2016-11-17 | 2019-03-01 | 脉科私人有限公司 | A kind of medicament elution sacculus |
| CN109414571B (en) * | 2016-11-17 | 2021-10-08 | 脉科私人有限公司 | Medicine elution sacculus |
| CN107616855A (en) * | 2017-08-24 | 2018-01-23 | 黑龙江正康生物技术股份有限公司 | The portable injection device of bionical tick worm absorption type live vaccine |
| CN108355230A (en) * | 2018-03-09 | 2018-08-03 | 鼎科医疗技术（苏州）有限公司 | More seal wire medicine balloon dilating catheters and its application method |
| CN108355230B (en) * | 2018-03-09 | 2024-04-26 | 鼎科医疗技术（苏州）有限公司 | Multi-guidewire drug balloon dilation catheter and method of use thereof |
| 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 |
| CN110732078A (en) * | 2019-11-14 | 2020-01-31 | 昆山金泰医疗科技有限公司 | Balloon |
| CN110732078B (en) * | 2019-11-14 | 2022-05-13 | 昆山金泰医疗科技有限公司 | Balloon |
| CN112274745A (en) * | 2020-10-29 | 2021-01-29 | 合肥达米医疗科技有限公司 | Double-layer bag double-cavity bronchial catheter |
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Application publication date: 20150826 |
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| WD01 | Invention patent application deemed withdrawn after publication |