CN201543095U - Medicine-coated balloon - Google Patents

Medicine-coated balloon Download PDF

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Publication number
CN201543095U
CN201543095U CN200920205723XU CN200920205723U CN201543095U CN 201543095 U CN201543095 U CN 201543095U CN 200920205723X U CN200920205723X U CN 200920205723XU CN 200920205723 U CN200920205723 U CN 200920205723U CN 201543095 U CN201543095 U CN 201543095U
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China
Prior art keywords
sacculus
medication coat
tube
balloon
medicine
Prior art date
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.)
Expired - Lifetime
Application number
CN200920205723XU
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Chinese (zh)
Inventor
董超
李云林
周亮
斯科特·阿多尼诺
雪莉·帕克
史蒂夫·罗兰德
艾克·吉曼
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ORBUSNEICH MEDICAL APPLIANCE (SHENZHEN) CO Ltd
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ORBUSNEICH MEDICAL APPLIANCE (SHENZHEN) CO Ltd
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Priority to CN200920205723XU priority Critical patent/CN201543095U/en
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Publication of CN201543095U publication Critical patent/CN201543095U/en
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Abstract

The utility model discloses a medicine-coated balloon. The technical problems to be solved are as follows: the structure of the medicine-coated balloon can become simple, medicine can be released in a short time, the released amount can be fixed, moreover, the restenosis rate can be reduced, and the occurrence of thrombosis can be avoided. In order to solve the technical problems, the utility model adopts the following technical scheme that: the medicine-coated balloon comprises a proximal catheter needle holder and a distal balloon, a thermal-shrinkable tube, a hypotube and a balloon catheter are sequentially connected between the catheter needle holder and the balloon, the balloon wraps the distal opening of the balloon catheter and is communicated with the cavities of the proximal hypotube and the thermal-shrinkable tube, the surface of the balloon is coated with medicine coating, and the balloon catheter is provided with a side hole, which is communicated with the cavities of the proximal hypotube and the thermal-shrinkable tube. Compared with the prior art, since the outside of the balloon is coated with the medicine coating, the technique is simple, the medicine coating can be released and absorbed by the blood vessel shortly after being contacted with the wall of the blood vessel, so that the restenosis and thrombosis of the blood vessel can be prevented.

Description

The medication coat sacculus
Technical field
This utility model relates to a kind of medical apparatus and instruments, particularly a kind of medication coat sacculus that is used for expanding the various pipelines of tissue.
Background technology
At present, percutaneous transluminal coronary angioplasty (PCI) is the most topmost intervention technology of treatment coronary atherosclerotic luminal stenosis, Chinese invention patent ZL03815912.0, ZL200410040075.9 disclose the various sacculus of its use, but, therefore PCI postoperative 3-6 month restenosis rate has limited this broad application up to 30%-50%.For overcoming its deficiency, new techniques such as laser angioplasty, coronary plaque rotary-cut art and turnery art have released one after another the eighties, these new techniques have remedied the deficiency of PCI in some aspects, but do not reduce restenosis rate, and coronary stent is inserted Clinical application, is an impressive progress of intervention property cardiology, and it has increased the safety of PCI, obviously reduced the restenosis rate of PCI, about 70% coronary heart disease patient's interventional therapy has been used support at present.But, it does not overcome the restenosis problem fully, the appearance of coating stent of medicine makes us see hope, and the selected coating medicine of this product is mainly antitumor drug, cell migration inhibitor, anti-inflammatory drug, immunosuppressant and antithrombotic reagent etc.Wherein the coating stent of medicine of application cell growth cycle inhibitor has been obtained preliminary satisfactory result, and Chinese invention patent ZL200410018039.2, ZL200610096840.8 disclose several relevant coating stent of medicine.But, by clinical practice in recent years, find in the drug stent postoperative support thrombosis to take place, this fatefulue complication, seriously perplexing the doctor who is engaged in the work of cardiovascular interventional therapy, how can avoid the generation of thrombosis when reducing restenosis rate, be the problem that is worth further investigation.
Summary of the invention
The purpose of this utility model provides a kind of medication coat sacculus, and the technical problem that solve is to make it simple in structure, and medicine can short-term discharges and burst size is fixed, and reduces restenosis rate and avoid the generation of thrombosis.
For solving the problems of the technologies described above, this utility model adopts following technical scheme: a kind of medication coat sacculus, comprise the conduit needle stand of near-end and the sacculus of far-end, be connected with heat-shrink tube, hypotube and foley's tube in turn between described conduit needle stand and the sacculus, described sacculus is coated on the foley's tube distal openings and with the hypotube of near-end and the tube chamber of heat-shrink tube and is communicated with, scribble medication coat on the surface of described sacculus, be provided with side opening on foley's tube, side opening is communicated with the hypotube of near-end and the tube chamber of heat-shrink tube.
The length of foley's tube of the present utility model is 10-100mm, and external diameter is 1-10mm.
The length of sacculus of the present utility model is 10-100mm, and the diameter after the expansion is 1-100mm.
Medication coat of the present utility model is even formula or the non-homogeneous formula distributed architecture of thickness 3-13 μ m.
Medication coat of the present utility model adopts everolimus, paclitaxel, tacrolimus, phosphocholine, pimecrolimus, dexamethasone or derivatives thereof or polymer coating.
Conduit needle stand of the present utility model adopts polyamine fat or polycarbonate material structure.
Heat-shrink tube of the present utility model adopts the polyolefine material structure.
Hypotube of the present utility model adopts the stainless steel material structure.
Foley's tube of the present utility model adopts medical nylon, PET, PVC or polycarbonate material structure.
Sacculus of the present utility model is a loose structure, adopts nylon or block polyetheramides resin material.
This utility model compared with prior art adopts to scribble medication coat in the outside of sacculus, and technology is simple, contacts at short notice can discharge and allow the blood vessel absorption after the blood vessel wall, prevents vascular restenosis and avoids thrombosis.
Description of drawings
Fig. 1 is a structural representation of the present utility model.
The specific embodiment
Below in conjunction with drawings and Examples this utility model is described in further detail.As shown in Figure 1, medication coat sacculus of the present utility model is by the conduit needle stand 1 of near-end, the heat-shrink tube 2 of connecting duct needle stand 1, the hypotube 3 that connects heat-shrink tube 2, the foley's tube 7 that connects hypotube 3, the sacculus 5 that connects the far-end of foley's tube 7 is formed, described sacculus 5 is coated on foley's tube 7 distal openings and with the hypotube 3 of near-end and the tube chamber of heat-shrink tube 2 and is communicated with, the length of sacculus 5 is 10-100mm, scribbling thickness on the surface of sacculus 5 is the medication coat 6 of 3-13 μ m, sacculus 5 expansion back diameters are 1-100mm, on foley's tube 7, be provided with side opening 4, side opening 4 is communicated with the hypotube 3 of near-end and the tube chamber of heat-shrink tube 2, the total length of described foley's tube 7 is 30-1500mm, and external diameter is 1-10mm.
Conduit needle stand 1 of the present utility model adopts polyamine fat or polycarbonate material.
Heat-shrink tube 2 of the present utility model adopts polyolefine material.
Hypotube 3 of the present utility model adopts stainless steel material.
Foley's tube 7 of the present utility model adopts medical nylon, PET, PVC or polycarbonate material.
Sacculus of the present utility model is the nylon or the block polyetheramides resin material through surface treatment modes such as () plasmas of cellular structure, helps discharging adhering to short-term of drug molecule.
Medication coat 6 of the present utility model adopts everolimus (Everolimus), paclitaxel (Paclitaxel), tacrolimus (Tacrolimus), phosphocholine (Zotarolimus), pimecrolimus (Pimecrolimus), dexamethasone (Dexamethasone) or derivatives thereof or polymer coating, also can be single anti-proliferative drug coating, also can be the hybrid medicament smear layer of two or more anti-hypertrophy and anti-inflammatory response, employing applies processing at sacculus with solution spraying method or solution dipping method by the solution that medicine and pharmaceutical carrier disposed, and described medication coat 6 can be even formula or non-homogeneous formula distributed architecture.
Medication coat 6 of the present invention has three kinds of coating ways: 1. equally distributed medication coat; 2. the potted medication coat that treated balloon surface is carried out on the surface; 3. hybrid medicament smear layer, micromolecule wherein is a hydrophilic particle, can promote macromolecular drug adhere to and short-term discharges.
Coating way of the present utility model is: this medication coat can adopt the solution that is disposed by medicine and pharmaceutical carrier to apply processing at the arteria coronaria sacculus with solution spraying method or solution dipping method, after applying evenly sacculus placed air or use hot blast mode or evacuation mode solvent flashing, standby behind the product ethane via epoxyethane sterilization, the thickness of medication coat is 3-13 μ m on the sacculus, sacculus discharges medication amount, determined with infiltration rate after human vas contacts by medicinal mixture, can be by the concentration of drug solution, coating solution what and coating process are controlled.
Animal experiment shows, anti-proliferative drug can make the apoptosis of contact with it as cytotoxin, and endotheliocyte and smooth muscle cell are no exception, but various cell is not quite similar to the tolerance degree of medicine: smooth muscle cell to medicine than the endotheliocyte sensitivity.Animal experiment shows, sacculus of the present utility model can continue to reduce new intima and form, prevent restenosis, simultaneously because the sacculus coating is only understood short term contact to blood vessel wall, do not influence normal endothelialization process, avoided the generation of tardy property thrombosis, this new method has some advantage: need not radiotherapy, without polymer or other release tech that continues.This technology can make medicine be transported to damage tremulous pulse All Ranges.
Drug mechanism of the present utility model: (1) fat-soluble anti-proliferative drug can be absorbed by vascular tissue rapidly, and this type of lasting release is also inessential concerning the inflammatory reaction process that suppresses restenosis; (2) the medicine short-term exposes and can obviously block the early stage hypertrophy startup factor, anti-proliferative drug is retained in balloon surface, up to balloon expandable, in process of expansion, medicine is extruded in the narrow blood vessel wall, enough medicine dissolutions also are penetrated into blood vessel wall, medicine only gives in the of short duration process of expansion of sacculus, can dissolve rapidly and disappear, can the divide a word with a hyphen at the end of a line blood vessel place of damage of endotheliocyte and CFU-GM thereof, like this blood vessel again endothelialization just do not suppressed because these CFU-GM that enter pathological changes are from the pathological changes downstream; do not expose medicine before the pathological changes far-end, so these cells maintenance proper splitting functions.
Embodiment of the present utility model is as follows:
Embodiment 1: configuration paclitaxel coating solution (100% paclitaxel is dissolved in the chloroformic solution), with spraying process solution is coated on the sacculus, and spray density is 0.25ug/mm at every turn 2, spraying altogether four times, final medicine density is 1ug/mm on the sacculus 2, blow 10 seconds of sacculus with solvent evaporates with hot blast then, folding sacculus, the sterilization of final product package sterilization.According to zoopery, when carrying out arteria coronaria vasodilation with this kind sacculus, instant medicament contg is 50-150ug in the animal blood vessels wall of operation back, medicament contg is less than 50ug in the blood, medicament contg is 25-100ug after 24 hours, medicament contg is less than 100ug in the blood, can effectively prevent the formation of vascular restenosis.
Embodiment 2: configuration sirolimus coating solution (80% sirolimus is dissolved in the acetone soln), with spraying process solution is coated on the sacculus, each spraying density is 0.75ug/mm2, spray altogether four times, final medicine density is 3ug/mm2 on the sacculus, blow 10 seconds of sacculus with solvent evaporates with hot blast then, folding sacculus, the sterilization of final product package sterilization.According to zoopery, when carrying out arteria coronaria vasodilation with this kind sacculus, instant medicament contg is 50-250ug in the animal blood vessels wall of operation back, medicament contg is less than 100ug in the blood, medicament contg is 25-150ug after 24 hours, medicament contg is less than 50ug in the blood, can effectively prevent the formation of vascular restenosis.
Embodiment 3: configuration paclitaxel coating solution (70% paclitaxel coating solution+30%smart polymer is dissolved in the chloromethane aldehyde solution), with spraying process solution is coated on the sacculus, each spraying density is 0.75ug/mm2, spray altogether four times, final medicine density is 3ug/mm2 on the sacculus, blow 10 seconds of sacculus with solvent evaporates with hot blast then, folding sacculus, the sterilization of final product package sterilization.According to zoopery, when carrying out arteria coronaria vasodilation with this kind sacculus, instant medicament contg is 50-250ug in the animal blood vessels wall of operation back, medicament contg is less than 100ug in the blood, medicament contg is 25-150ug after 24 hours, medicament contg is less than 50ug in the blood, can effectively prevent the formation of vascular restenosis.

Claims (10)

1. medication coat sacculus, comprise the conduit needle stand (1) of near-end and the sacculus (5) of far-end, be connected with heat-shrink tube (2) in turn between described conduit needle stand (1) and the sacculus (5), hypotube (3) and foley's tube (7), it is characterized in that: described sacculus (5) is coated on foley's tube (7) distal openings and with the hypotube (3) of near-end and the tube chamber of heat-shrink tube (2) and is communicated with, scribble medication coat (6) on the surface of described sacculus (5), be provided with side opening (4) on foley's tube (7), side opening (4) is communicated with the hypotube (3) of near-end and the tube chamber of heat-shrink tube (2).
2. medication coat sacculus according to claim 1 is characterized in that: the length of described foley's tube (7) is 10-100mm, and external diameter is 1-10mm.
3. medication coat sacculus according to claim 2 is characterized in that: the length of described sacculus (5) is 10-100mm, and the diameter after the expansion is 1-100mm.
4. medication coat sacculus according to claim 3 is characterized in that: described medication coat (6) is even formula or the non-homogeneous formula distributed architecture of thickness 3-13 μ m.
5. medication coat sacculus according to claim 4 is characterized in that: described medication coat (6) adopts everolimus, paclitaxel, tacrolimus, phosphocholine, pimecrolimus, dexamethasone or derivatives thereof or polymer coating.
6. medication coat sacculus according to claim 5 is characterized in that: described conduit needle stand (1) adopts polyamine fat or polycarbonate material structure.
7. medication coat sacculus according to claim 6 is characterized in that: described heat-shrink tube (2) adopts the polyolefine material structure.
8. medication coat sacculus according to claim 7 is characterized in that: described hypotube (3) adopts the stainless steel material structure.
9. medication coat sacculus according to claim 8 is characterized in that: described foley's tube (7) adopts medical nylon, PET, PVC or polycarbonate material structure.
10. medication coat sacculus according to claim 9 is characterized in that: described sacculus (5) is a loose structure, adopts nylon or block polyetheramides resin material.
CN200920205723XU 2009-09-29 2009-09-29 Medicine-coated balloon Expired - Lifetime CN201543095U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Application Number Priority Date Filing Date Title
CN200920205723XU CN201543095U (en) 2009-09-29 2009-09-29 Medicine-coated balloon

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102553062A (en) * 2010-12-27 2012-07-11 微创医疗器械(上海)有限公司 Drug conveying device
CN103316382A (en) * 2013-05-10 2013-09-25 张金萍 Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof
CN109223267A (en) * 2018-11-22 2019-01-18 山东吉威医疗制品有限公司 A kind of non-polymer coating drug stent system and manufacture craft

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102553062A (en) * 2010-12-27 2012-07-11 微创医疗器械(上海)有限公司 Drug conveying device
CN102553062B (en) * 2010-12-27 2015-10-28 微创心脉医疗科技(上海)有限公司 A kind of delivery device
CN103316382A (en) * 2013-05-10 2013-09-25 张金萍 Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof
CN103316382B (en) * 2013-05-10 2014-12-17 张金萍 Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof
CN109223267A (en) * 2018-11-22 2019-01-18 山东吉威医疗制品有限公司 A kind of non-polymer coating drug stent system and manufacture craft

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Granted publication date: 20100811