CN101430311A - Medicine release measuring equipment and method for medicine eluting vascular inner rack - Google Patents
Medicine release measuring equipment and method for medicine eluting vascular inner rack Download PDFInfo
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- CN101430311A CN101430311A CNA2008102330246A CN200810233024A CN101430311A CN 101430311 A CN101430311 A CN 101430311A CN A2008102330246 A CNA2008102330246 A CN A2008102330246A CN 200810233024 A CN200810233024 A CN 200810233024A CN 101430311 A CN101430311 A CN 101430311A
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Abstract
The invention relates to a drug release measuring device and a drug release measuring method which are provided for an endovescular stent. The invention solves the problem that the existing measuring device cannot simulate the condition within a human body or measure the deposition and distribution of the drug on vascular tissues. The method mainly comprises: a buffer solution is prepared; an animal vessel is separated and fixed, the stent is implanted and expanded, and a flow environment within the body is simulated; and samples are collected and tested. The measuring device comprises a reservoir, a silicone tube, a glass tube, a vessel implantation groove, a diaphragm capsule dilatometer, a flow valve, a high pressure gas cylinder and a peristaltic pump, wherein, the reservoir is connected with the vessel container by the glass tube; the vessel implantation groove is connected with the reservoir by the glass tube which contains the diaphragm capsule dilatometer and the flow valve; the reservoirs are connected together by the silicone tube which is provided with the peristaltic pump; the high pressure gas cylinder is connected with the reservoir by the silicone tube. The invention can not only simulate the flow condition within body accurately which can provide better support for the vivo experiment, but also measure the deposition and distribution of the drug on the vascular tissues.
Description
Technical field
The present invention relates to a kind of drug assay method and device thereof, particularly the drug assay method and the device thereof of medication eluting type blood vessel inner support.
Background technology
Along with the raising of China's living standards of the people with enter aging society, atherosclerotic is cardiovascular and cerebrovascular diseases caused more and more higher as cerebral apoplexy and coronary heart disease incidence, and cerebral apoplexy and coronary heart disease constitute compatriots' No.1 killer together.Though the drug therapy kind to such disease is many, but to atherosclerotic plaque disappear and stable effect limited, the percutaneous transluminal angio plasty that the eighties grows up is as the effective means of treatment coronary heart disease, obtained gratifying clinical therapeutic efficacy, but the restenosis rate of postoperative 30%-50% has seriously influenced its late result.The intravascular stenting of Chu Xianing is aided with anti-freezing, Antiplatelet therapy afterwards, reinvent though can suppress blood vessel acute elastic retraction and blood vessel negativity effectively, because of the neointimal hyperplasia due to postoperative vascular smooth muscle cells migration, the propagation still makes the patient of 15%-25% stent restenosis occur.Though many suppressing cell reproduction medicines have been obtained effect preferably in zoopery, in clinical practice, do not reach the curative effect of expection, an important reasons is that the whole body administration is difficult in the drug concentration that the lesion vessels part reaches continuous and effective.The application of bracket for eluting medicament is the revolutionary character progress of Wicresoft's interventional therapy coronary artery disease.With the support is that carrier is to blood vessel local transmission medicine, reduced the spinoff that bare bracket must system's medication be brought, can provide higher drug concentration to arterial tissue simultaneously, and keep time enough, to keep reasonable curative effect, ISR is reduced to below 10%.
The application of topical remedy's slow release method makes bracket for eluting medicament obtain unprecedented success.For bracket for eluting medicament, the detection of drug just seems and is even more important.Drug detects to divide in external detection and the body and detects.Because vitro detection is the basis, and detect the cost height in the body, at present the most of form of using vitro detection of domestic scholars.Conventional method is, support inserted in the conical flask that the ph7.4 damping fluid is housed, and 37 ℃ of shaking table wash-outs detect the dose that discharges in different time points.The weak point of existing method and device is: (1) is simple release in vitro not with in the animal blood vessels access device; (2) do not consider the fluid hydrostatic pressing of human body; (3) can't deposition and the distribution of detection of drugs in vascular tissue.
By retrieval, Chinese utility model patent " a kind of medicament slow release determinator of drug-eluting stent ", application number is 200620163943.7, open day on January 2nd, 2008.This utility model discloses the device that a kind of medicament slow release of simulating human body blood vessel drug eluting wash-out support is measured, and is made of silicone tube, constant flow pump, conical flask, liquid release medium, and silicone tube is built-in with drug-eluting stent; Silicone tube one end is connected with the feed flow silicone tube, and the other end of feed flow silicone tube inserts in the conical flask, is provided with constant flow pump in the feed flow silicone tube; The other end of silicone tube is connected with liquid-return silica gel tube, and the other end of liquid-return silica gel tube inserts in the conical flask, is provided with to detect the hole on liquid-return silica gel tube.This utility model has 3 above-mentioned weak points equally.
Summary of the invention
Purpose of the present invention is exactly at above-mentioned deficiency, a kind of drug assay method and device of drug eluting vascular inner support are provided, solve existing determinator accurately the interior situation of analogue body, can't measure the problem that medicine deposits and distributes in vascular tissue.
The drug determinator of the medication eluting type blood vessel inner support that the present invention proposes mainly comprises: first and second reservoir, gas cylinder, first, second, third and fourth silicone tube, peristaltic pump, first and second glass tube, support implantable port, blood vessel are inserted groove, target blood, support, sample tap, bellows pressure instrument, flow valve etc.First reservoir is connected with first and second silicone tubes simultaneously, the first silicone tube other end is connected with gas cylinder, gas is fed first reservoir, second silicone tube is connected with peristaltic pump, peristaltic pump is input to the damping fluid in first reservoir in second reservoir of top by the 3rd silicone tube, second reservoir below is connected with the 4th silicone tube and first glass tube, the first glass tube lower end is connected with the target blood that the blood vessel of below is inserted in the groove, intravascular stent is arranged in the target blood, the target blood other end connects second glass tube, be connected with on second glass tube in the bellows pressure instrument, second glass tube links to each other with first reservoir by flow valve.The 4th silicone tube lower end is inserted in first reservoir, keeps the liquid level of second reservoir and the drop height between the target blood.
The present invention further proposes to use the drug assay method of said apparatus, and step is carried out in the following order:
(1) preparation of damping fluid
The damping fluid cumulative volume is 100-250ml, and glucose content is 1.5-2.5g/L, and the anhydrous slufuric acid content of magnesium is 0.13-0.16g/L, and potassium phosphate content is 0.12-0.18g/L, and KCE content is 0.3-0.5g/L, and sodium chloride content is 6-8g/L;
(2) separation of animal blood vessels and fixing
Cut the thoracic cavity open after new zealand white rabbit, air embolism method are put to death, isolate aorta pectoralis or abdominal aorta, remove unnecessary manadesma and fat, intercepting 2-4cm is fixed in blood vessel and inserts in the groove between two glass tubes;
(3) support is implanted and expansion
Use the drug stent transmission system that bracket for eluting medicament is implanted in the target blood that fixes, balloon expandable stent is expanded 3-6 time to diameter 3-4mm;
(4) flowing environment in the analogue body
The damping fluid that configures is added in the reservoir, and whole determinator places 37 ℃, in the environment of 100% humidity; Open gas cylinder, O in the gas cylinder
2Content is 80-98%, CO
2Content is 2%-20%; Open peristaltic pump, the maintenance flow is 20-60ml/min; The vertical height of regulating between reservoir and the target blood is 80-120cm;
(5) sampling and detection
Take out support, deposition and the distribution of detection of drugs in vascular tissue respectively at a plurality of time points in the 96h.
This method is with the part of animal blood vessels as determinator, the damping fluid that oxygen and similar blood of human body are provided to blood vessel is to keep its activity, certain fluid hydrostatic pressing is provided simultaneously, more perfectly the true environment in the analogue body can be measured deposition and the distribution of medicine in vascular tissue simultaneously.
Description of drawings
Fig. 1 is the structural representation of this determinator.
Embodiment
Referring to Fig. 1, the drug determinator of this medication eluting type blood vessel inner support comprises that first reservoir 1, gas cylinder 2, first silicone tube 3, second silicone tube 4, peristaltic pump 5, the 3rd silicone tube 6, second reservoir 7, first glass tube 8, blood vessel insert groove 10, target blood 11, support 12, bellows pressure instrument 14, flow valve 15, second glass tube 16; First reservoir 1 is connected with first and second silicone tubes 3 simultaneously, 4, first silicone tube, 3 other ends are connected with gas cylinder 2, gas is fed first reservoir 1, be connected with peristaltic pump 5 on second silicone tube 4, peristaltic pump 5 is input to the damping fluid in first reservoir 1 in second reservoir 7 of top by the 3rd silicone tube 6, second reservoir, 7 belows are connected with the 4th silicone tube 17 and first glass tube 8, first glass tube, 8 lower ends are connected with the target blood 11 that the below blood vessel is inserted in the groove 10, on first glass tube 8 support implantable port 9 is arranged, implant in the target blood 11 intravascular stent 12 is arranged, blood vessel is inserted sample tap 13 on the groove 10, target blood 11 other ends distribute and connect second glass tube 16, being connected with bellows pressure instrument 14, the second glass tubes 16 on second glass tube 16 links to each other with first reservoir 1 by flow valve 15.The 4th silicone tube 17 lower ends are inserted in first reservoir 1, keep the liquid level of second reservoir 7 and the drop between the target blood 11 within a certain height.First reservoir 1, second reservoir 7 and blood vessel are inserted groove 10 and are cylindrical, and the internal diameter of first, second, third and fourth silicone tube 3,4,6,17, first and second glass tube 8,16 is 3mm.
The drug assay method of endovascular stent of the present invention step in the following order carries out:
(1) preparation of damping fluid
The damping fluid cumulative volume is 150ml, and glucose content is 2g/L, and the anhydrous slufuric acid content of magnesium is 0.141g/L, and potassium phosphate content is 0.16g/L, and KCE content is 0.35g/L, and sodium chloride content is 6.9g/L;
(2) separation of animal blood vessels and fixing
New zealand white rabbit, the air embolism method is cut the thoracic cavity open after putting to death, and isolates aorta pectoralis, removes unnecessary manadesma and fat, and intercepting 3cm is fixed in the two ends that blood vessel is inserted glass tube in the groove 10;
(3) support is implanted and expansion
Use the drug stent transmission system that bracket for eluting medicament 12 is implanted in the target blood 11 that fixes, balloon expandable stent is expanded 3-6 time to diameter 3-4mm;
(4) flowing environment in the analogue body
The damping fluid that configures is added in first reservoir 1, and whole determinator places 37 ℃, in the environment of 100% humidity; Open gas cylinder 2, O in the gas cylinder
2Content is 95%, CO
2Content is 5%; Open peristaltic pump 5, the maintenance flow is 60ml/min; The liquid level and the vertical height between the blood vessel of regulating second reservoir 7 are 100cm;
(5) sampling and detection
Take out support respectively at 2h, 4h, 8h, 24h, 48h, 96h, deposition and the distribution of detection of drugs in vascular tissue.
Claims (4)
1, a kind of drug determinator of medication eluting type blood vessel inner support, it is characterized in that described device comprises that first reservoir (1), gas cylinder (2), first silicone tube (3), second silicone tube (4), peristaltic pump (5), the 3rd silicone tube (6), second reservoir (7), first glass tube (8), blood vessel insert groove (10), target blood (11), support (12), bellows pressure instrument (14), flow valve (15), second glass tube (16) and the 4th silicone tube (17); Described first reservoir (1) connects first and second silicone tubes (3) (4) simultaneously, first silicone tube (3) other end is connected with gas cylinder (2), gas is fed first reservoir (1), be connected with peristaltic pump (5) on second silicone tube (4), peristaltic pump (5) is input to the damping fluid in first reservoir (1) in second reservoir (7) of top by the 3rd silicone tube (6), second reservoir (7) below is connected with the 4th silicone tube (17) and first glass tube (8), first glass tube (8) lower end is connected with the target blood (11) that the below blood vessel is inserted in the groove (10), support implantable port (9) is arranged on first glass tube (8), implant in the target blood (11) intravascular stent (12) is arranged, blood vessel is inserted sample tap (13) on the groove (10), target blood (11) other end connects second glass tube (16), be connected with bellows pressure instrument (14) on second glass tube (16), second glass tube (16) links to each other with first reservoir (1) by flow valve (15); The 4th silicone tube (17) lower end is inserted in first reservoir (1), keeps the liquid level of second reservoir (7) and the drop height between the target blood (11).
2, press the drug determinator of the described medication eluting type blood vessel inner support of claim 1, it is characterized in that described first reservoir (1), second reservoir (7) and blood vessel insert groove (10) and be cylindrical, the internal diameter of first, second, third and fourth silicone tube (3) (4) (6) (17), first and second glass tube (8) (16) is 3mm.
3, use the drug determinator of claim 1 or 2 described medication eluting type blood vessel inner supports to measure the method for drug, it is characterized in that method carries out according to the following steps:
(1) preparation of damping fluid
The damping fluid cumulative volume is 100-250ml, and glucose content is 1.5-2.5g/L, and the anhydrous slufuric acid content of magnesium is 0.13-0.16g/L, and potassium phosphate content is 0.12-0.18g/L, and KCE content is 0.3-0.5g/L, and sodium chloride content is 6-8g/L;
(2) separation of animal blood vessels and fixing
Isolate aorta pectoralis or the abdominal aorta of animal, remove unnecessary manadesma and fat, 2-4cm is as target blood in intercepting, is fixed in blood vessel and inserts between two glass tubes in the groove (10);
(3) support is implanted and expansion
Use the drug stent transmission system that bracket for eluting medicament (12) is implanted in the target blood (11) that fixes, to diameter 3-4mm, expand 3-6 time with balloon expandable stent;
(4) flowing environment in the analogue body
The damping fluid that configures is added in first reservoir (1), whole determinator is placed 37 ℃, in the environment of 100% humidity; Open gas cylinder (2), O in the gas cylinder
2Content is 80-98%, CO
2Content is 2%-20%; Open peristaltic pump (5), the maintenance flow is 20-60ml/min; The vertical height of regulating between second reservoir (7) and the target blood (11) is 80-120cm;
(5) sampling and detection
Take out bracket for eluting medicament (12), deposition and the distribution of detection of drugs in vascular tissue respectively at a plurality of time points in the 96h.
4, by the drug assay method of the described medication eluting type blood vessel inner support of claim 3, the drug assay method that it is characterized in that endovascular stent step in the following order carries out:
(1) preparation of damping fluid
The damping fluid cumulative volume is 150ml, and glucose content is 2g/L, and the anhydrous slufuric acid content of magnesium is 0.141g/L, and potassium phosphate content is 0.16g/L, and KCE content is 0.35g/L, and sodium chloride content is 6.9g/L;
(2) separation of animal blood vessels and fixing
Cut the thoracic cavity open after new zealand white rabbit air embolism method put to death, isolate aorta pectoralis, remove unnecessary manadesma and fat, intercepting 3cm is fixed in blood vessel and inserts between two glass tubes in the groove (10);
(3) support is implanted and expansion
Use the drug stent transmission system that bracket for eluting medicament (12) is implanted in the target blood (11) that fixes, balloon expandable stent is expanded 3-6 time to diameter 3-4mm;
(4) flowing environment in the analogue body
The damping fluid that configures is added in first reservoir (1), and whole determinator places 37 ℃, in the environment of 100% humidity; Open gas cylinder (2), O in the gas cylinder
2Content is 95%, CO
2Content is 5%; Open peristaltic pump (5), the maintenance flow is 60ml/min; Regulating the liquid level of second reservoir (7) and the vertical height between the target blood (11) is 100cm;
(5) sampling and detection
Take out support respectively at 2h, 4h, 8h, 24h, 48h, 96h,, deposition and the distribution of detection of drugs in vascular tissue.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810233024 CN101430311B (en) | 2008-11-11 | 2008-11-11 | Medicine release measuring equipment and method for medicine eluting vascular inner rack |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810233024 CN101430311B (en) | 2008-11-11 | 2008-11-11 | Medicine release measuring equipment and method for medicine eluting vascular inner rack |
Publications (2)
| Publication Number | Publication Date |
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| CN101430311A true CN101430311A (en) | 2009-05-13 |
| CN101430311B CN101430311B (en) | 2013-07-31 |
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| CN 200810233024 Expired - Fee Related CN101430311B (en) | 2008-11-11 | 2008-11-11 | Medicine release measuring equipment and method for medicine eluting vascular inner rack |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101976528A (en) * | 2010-09-09 | 2011-02-16 | 华南理工大学 | Biomechanical experiment simulation device for implantation of intravascular stent |
| CN102564857A (en) * | 2012-01-18 | 2012-07-11 | 复旦大学 | Device for measuring nonlinear mechanical property of blood vessel |
| FR2973146A1 (en) * | 2011-03-25 | 2012-09-28 | Arts | Test bench for testing in-vitro behavior of active pro-healing stent, has centrifugal pump including output connected to supply pipe for feeding test-tubes, where test-tubes are connected to return fluid collector |
| CN102721796A (en) * | 2012-06-27 | 2012-10-10 | 浙江省中医药研究院 | Experimental device for simulating local drug release behavior of medicine and application thereof |
| CN103018413A (en) * | 2011-09-20 | 2013-04-03 | 中国中医科学院中药研究所 | Drug absorption apparatus |
| EP2779144A1 (en) * | 2013-03-12 | 2014-09-17 | Université de Mons | Device for simulating blood flow |
| CN104677785A (en) * | 2013-12-02 | 2015-06-03 | 上海微创医疗器械（集团）有限公司 | Insoluble particle testing system |
| DE102015008050A1 (en) | 2015-06-19 | 2016-12-22 | Technische Universität Ilmenau | Arrangement in the form of a model system for the reproduction of maternal and fetal pulse curves for non-invasive transabdominal plethysmography |
| CN110675717A (en) * | 2019-10-10 | 2020-01-10 | 吉林大学 | Bionic equipment for simulating vascular stenosis and thrombus |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5271898A (en) * | 1993-05-03 | 1993-12-21 | Medtronic, Inc. | Apparatus for testing blood/biomaterials/device interactions and characteristics |
| US5670708A (en) * | 1996-04-02 | 1997-09-23 | Endura-Tec Systems Corporation | High frequency intravascular prosthesis fatigue tester |
| WO2005033671A1 (en) * | 2003-10-08 | 2005-04-14 | Haemoprobe B.V. | Method and device for in vitro simulation of an in vivo fluid flow |
| CN100361636C (en) * | 2005-06-29 | 2008-01-16 | 东南大学 | Extracorporeal test device and method for the dilation performance of saccule dilating intravascular rack |
| CN201000449Y (en) * | 2006-12-31 | 2008-01-02 | 重庆大学 | Medicine slow release testing device for medicine eluted frame |
| CN201075079Y (en) * | 2007-10-11 | 2008-06-18 | 上海交通大学 | Device for simulating biological medical material external dynamic erosion |
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2008
- 2008-11-11 CN CN 200810233024 patent/CN101430311B/en not_active Expired - Fee Related
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101976528A (en) * | 2010-09-09 | 2011-02-16 | 华南理工大学 | Biomechanical experiment simulation device for implantation of intravascular stent |
| FR2973146A1 (en) * | 2011-03-25 | 2012-09-28 | Arts | Test bench for testing in-vitro behavior of active pro-healing stent, has centrifugal pump including output connected to supply pipe for feeding test-tubes, where test-tubes are connected to return fluid collector |
| CN103018413A (en) * | 2011-09-20 | 2013-04-03 | 中国中医科学院中药研究所 | Drug absorption apparatus |
| CN103018413B (en) * | 2011-09-20 | 2015-03-18 | 中国中医科学院中药研究所 | Drug absorption apparatus |
| CN102564857A (en) * | 2012-01-18 | 2012-07-11 | 复旦大学 | Device for measuring nonlinear mechanical property of blood vessel |
| CN102564857B (en) * | 2012-01-18 | 2015-07-29 | 复旦大学 | Device for measuring nonlinear mechanical property of blood vessel |
| CN102721796A (en) * | 2012-06-27 | 2012-10-10 | 浙江省中医药研究院 | Experimental device for simulating local drug release behavior of medicine and application thereof |
| EP2779144A1 (en) * | 2013-03-12 | 2014-09-17 | Université de Mons | Device for simulating blood flow |
| CN104677785A (en) * | 2013-12-02 | 2015-06-03 | 上海微创医疗器械（集团）有限公司 | Insoluble particle testing system |
| DE102015008050A1 (en) | 2015-06-19 | 2016-12-22 | Technische Universität Ilmenau | Arrangement in the form of a model system for the reproduction of maternal and fetal pulse curves for non-invasive transabdominal plethysmography |
| CN110675717A (en) * | 2019-10-10 | 2020-01-10 | 吉林大学 | Bionic equipment for simulating vascular stenosis and thrombus |
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| CN101430311B (en) | 2013-07-31 |
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