CN106267377A - Drug coated balloon catheter - Google Patents
Drug coated balloon catheter Download PDFInfo
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- CN106267377A CN106267377A CN201510276542.6A CN201510276542A CN106267377A CN 106267377 A CN106267377 A CN 106267377A CN 201510276542 A CN201510276542 A CN 201510276542A CN 106267377 A CN106267377 A CN 106267377A
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- medicine
- balloon catheter
- carrier
- acylate
- polyhydric alcohol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
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- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
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- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Materials For Medical Uses (AREA)
Abstract
The drug coated balloon catheter that the present invention relates to includes sacculus and covers the medication coat in balloon surface.Described medication coat includes active medicine and carrier；Described active medicine is paclitaxel, rapamycin, paclitaxel derivant or rapamycin derivative；Described carrier includes that acylate and polyhydric alcohol, the active medicine in described medication coat are 0.5～49 with the mass ratio of carrier, and described acylate is (3～50) with the mass ratio of polyhydric alcohol: 1.Acylate and polyhydric alcohol in medication coat play a role jointly, drug particles particle diameter is less, prevent from being presented to target site prodrug at foley's tube to discharge too early, promote that medicine quickly discharges from balloon surface and absorbed by target tissue, the loss of course of conveying Chinese medicine can be reduced, particles from getting loose, improves coating safety, has again preferable medicine simultaneously and reprints effect.
Description
Technical field
The invention belongs to interventional medical equipment field, be specifically related to drug coated balloon catheter.
Background technology
Cardio-vascular interventional therapeutic field from eighties of last century seventies till now, experienced by three and landmark flies
Jump.Within 1977, the mankind use balloon expandable coronary stricture pathological changes for the first time, and this is first milestone.
Although balloon expandable can eliminate coronary stenosis, but due to the elastical retraction of vascular wall, neointimal hyperplasia
And tube wall inner membrance tear etc. can inspire vascular restenosis, target vessel postoperative 3～6 months restenosis rate be up to 30～
50%.Bare mental stents in 1986 (being called for short: BMS) come out, it is possible not only to eliminate angiostenosis at once,
Greatly reducing the incidence rate of acute reocclusion, it becomes second milestone of interventional therapy simultaneously, but target
The incidence rate of vascular restenosis is still up to 30%.Calendar year 2001 bracket for eluting medicament (vehicle economy S) comes out, and makes
Target vessel restenosis rate is down to 3% hereinafter referred to as the 3rd milestone.
The invention of support is for solving atherosclerosis and Ink vessel transfusing is narrow provides reasonable solution party
Case, makes therapeutic efficiency greatly improve, but occurs in that Ink vessel transfusing and in-stent restenosis simultaneously, for thin vessels,
The shortcomings such as the therapeutic effect of bifurcated vessels and in situ pathological changes etc. is unsatisfactory, owing to accepting patient's number of PCI treatment
Amount rises year by year, and the absolute quantity that the patient of stent restenosis occurs is considerable.Currently for restenosis
The method used includes: the expansion again of simple sacculus, orientation speckle rotary-cut art, turnery art, Ink vessel transfusing are put
Penetrating treatment and repeat stenter to implant etc., existing bare ball capsule and drug stent all have some limitations, naked
The restenosis rate of sacculus is higher, and drug stent is the best for the therapeutic effect of thin vessels and bifurcated vessels,
Both fails to show its preferable effectiveness or safety.
The solution restenosis that appears as of medicament elution sacculus (vehicle economy B) brings new hope.Medicine is washed
De-sacculus is similar with DES, substantially comes from the local drug delivery devices theory based on conduit, passes through ball
The Drug inhibition neointimal hyperplasia that capsule carries, mode and the topical remedy of simply carrying medicine are different for action time.
Medicine-coated balloon is by the medicine of anti-proliferate, such as paclitaxel or rapamycin and the combination of additive
Thing, coating is in balloon surface.In sacculus is transported to lesion vessels wall softened, expansion and blood vessel wall
During film contact, by tear blood vessel wall inner membrance pressurization quickly release, diversion medicaments to local vessel wall.
Medicine plays the effect of anti-angiogenic neointimal hyperplasia in local, thus prevents the vascular restenosis after vascular procedure.
The core of medicinal balloon play therapeutical effect is medication coat.Due to the anti-proliferate medicine worked
For lipophilic drugs, be insoluble in water, and caking of easily reuniting, form big microgranule, in course of conveying this
The biggest drug microparticles is easily de-by blood punching.If the particle number come off is many, it is easy to cause distal vessels
The complication such as obturation, thrombosis, severe patient can cause amputation.
Summary of the invention
For above-mentioned the deficiencies in the prior art, exploitation is needed to meet following condition medicine-coated balloon: the most permissible
In clinical course or be quickly delivered directly to local tissue area afterwards by active medicine；2. at required target
Position discharges active medicine rapidly in effective and efficient mode, make it possible to penetrate into rapidly target tissue with
Treatment disease；3. medication coat Chinese medicine particle diameter is little, during being delivered to target position and at target position
During treatment, drug particles is de-few by blood punching.
The present invention provides a kind of and has quick medicament release coating and the little medicine of medication coat Chinese medicine particle diameter
Coating ball ductus bursae.Containing active medicine and carrier in the medication coat of this drug coated balloon catheter, this load
Body, for accelerating active medicine rate of release from sacculus, can make medicine discharge also within the shortest period
Rapid osmotic enters the tissue at disease sites, improves ill at vascular system or other body lumens of medicine
Absorbance in tissue, thus realize solving the drug loss in Clinical practice course of conveying and balloon expandable
Medicine is to the quick reprinting at target lesion position afterwards.It addition, designed by formula, reach drug particles particle diameter
Less, and be delivered to during target position and when treating at target position, drug particles is de-by blood punching
Few.
This drug coated balloon catheter, including sacculus with cover at the medication coat of sacculus outer surface, described medicine
Thing coating includes active medicine and carrier；Described active medicine be paclitaxel, rapamycin, paclitaxel derive
Thing or rapamycin derivative；Described carrier includes acylate and polyhydric alcohol, the work in described medication coat
Property medicine and carrier mass ratio be 0.5～49, described acylate and the mass ratio of polyhydric alcohol be (3～
50)∶1。
Described acylate be acetate, benzoate, maleate, succinate, Ascorbate,
Citrate, tartrate, lactate, oxalates, aspartate, nicotinate, gluconate,
One or more in stearate, glutamate, Glu, vanillate or Lactobionate；Described polyhydric alcohol
For at least one in Polyethylene Glycol, trometamol, xylitol, sorbitol, mannitol or amino alcohol.
Described active medicine is 0.5～20 μ g/mm at the content of foley's tube outer surface2。
The material of described foley's tube is nylon, nylon elastomer, PET or polyethylene.
Described foley's tube, for active medicine is transported to the target site of blood vessel or tube chamber, treats blood vessel or pipe
Intracavity narrow, prevent inner membrance or epithelial proliferation；Described blood vessel is coronary artery, peripheral arterial blood vessel
Or cerebral artery vessel；Described tube chamber is esophagus, air flue, intestinal, biliary tract, urinary tract, prostate or nicergoline
Road.
In the medication coat on foley's tube surface of the present invention, carrier is by Lipophilicity material acylate and parent
Aqueous substance polyhydric alcohol forms, and both all produce synergism during medicine conveying and reprinting the two
Accelerate the eluting release of medicine and absorb and greatly reduce conveying finely divided coming off, reducing coating safety.Tool
Body ground, used carrier has the effect that
1, surfactant is made；
First the Lipophilicity material of carrier can be combined with the lipophilic drugs such as rapamycin or paclitaxel, from
And reduce coating surface tension, and be conducive to increasing the hydrophilic of coating, the most beneficially medicine is to group
Knit reprinting；
2, make dispersant interval drug crystal grain, contribute to medicament elution and reprinting；
Lipophilic anti-proliferate medicine is the most mutually assembled, and hydrophilelipophile carrier can be fast owing to having lipotropy
After speed is in combination so that produce interval action between drug molecule, thus greatly reduce and roll into a ball between drug molecule
Poly-probability, it is therefore prevented that large-area reunion between drug molecule, and be gathered on apparatus.The most therefore reduce
The size of drug particles and quantity, further decrease size and the quantity of particles from getting loose, greatly
Improve the safety of coating.
3, as cosolvent, there is Premeabilisation of cells effect, beneficially drug absorption.
After Lipophilicity carrier is combined with lipophilic drug molecules, because it has hydrophilic, simultaneously as
Every effect, add the specific surface area of coating thus add medicine dissolubility in intercellular substance, accelerate
Medicine arrives the lipid bilayer of target tissue cell membrane, and after medical apparatus and instruments and contact tissue, carrier hydrophilic
Material is discharged rapidly, promotes that medicine discharges during foley's tube inserts target site the most rapidly,
Thus accelerate medicine diffusion in tissue and increase medicine penetrating in tissue, medicine is more easy to be organized
Absorb.
The present invention compared with prior art, has the following advantages and beneficial effect:
(1) containing acylate and polyhydric alcohol, the two inserting at foley's tube in the medication coat of the present invention
During jointly play a role, promote medicine quickly discharge from balloon surface and absorbed by target tissue, simultaneously
Preventing from discharging too early before medicinal balloon catheter is presented to target site, therefore medicinal balloon catheter can produce
Effect reprinted by raw reasonable medicine, reduces size and the quantity of drug particles simultaneously, further subtracts
Lack size and the quantity of particles from getting loose, be greatly improved the safety of coating.
(2) raw material that the foley's tube of the present invention uses is used equally to intravenous injection, safety and biofacies
Capacitive is preferable.
Accompanying drawing explanation
Fig. 1 is embodiment 1～6 and the drug release patterns figure of comparative example 1～4.
Fig. 2 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 1 preparation.
Fig. 3 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 2 preparation.
Fig. 4 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 3 preparation.
Fig. 5 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 4 preparation.
Fig. 6 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 5 preparation.
Fig. 7 is 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle of embodiment 6 preparation.
Fig. 8 is the 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle through comparative example 1 preparation.
Fig. 9 is the 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle through comparative example 2 preparation.
Figure 10 is the 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle through comparative example 3 preparation.
Figure 11 is the 28 days pathological section figures of medicinal balloon catheter far-end skeletal muscle through comparative example 4 preparation.
Detailed description of the invention
Below in conjunction with drawings and Examples, the detailed description of the invention of the present invention is described in further detail, but
Claimed content is not limited thereto.
Embodiment 1
By 250mg paclitaxel, 5.0mg citrate, 0.1mg amino alcohol, 10ml ethanol, 4ml purified water is mixed
Closing preparation coating solution, wherein the mass ratio of active medicine and carrier is 49；By PTA foley's tube (diameter
4mm, long 40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, coating is molten
Liquid precision syringe (being accurate to 2 μ l) drop coating, to the polyester balloon surface after flap, then makes described sacculus
It is dried, repeats drop coating until described balloon surface drug level reaches 20 μ g/mm2, after being dried 24 hours, bag
Dress, ethylene oxide sterilizing.
Embodiment 2
By 11mg rapamycin, 17mg lactate, 5mg mannitol, 7ml ethanol, the mixing of 3ml purified water is joined
Solution processed, wherein the mass ratio of active medicine and carrier is 0.5；By PTA foley's tube (diameter 4mm, length
40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, coating solution is accurate
Syringe (being accurate to 2 μ l) drop coating, on the surface of polyester sacculus, then makes described sacculus be dried, and repeats to drip
It is coated with until described balloon surface drug level reaches 3 μ g/mm2, after being dried 24 hours, packaging, oxirane
Sterilizing.
Embodiment 3
By 120mg paclitaxel, 36mg sodium benzoate, 12mg Macrogol 2000,10ml ethanol, 4ml is pure
Changing water mixed preparing coating solution, wherein the mass ratio of active medicine and carrier is 2.5；By PTA foley's tube
(diameter 4mm, long 40mm) after flap three folding, incites somebody to action in ten thousand grades of clean environments under hundred grades of clean environments
Coating solution spraying equipment sprays to, in the polyester balloon surface after flap, make balloon surface drug level reach
To 3 μ g/mm2, it is dried, packaging, ethylene oxide sterilizing.
Embodiment 4
By 100mg paclitaxel, 50mg sodium benzoate, 5mg Macrogol 2000,10ml ethanol, 4ml purification
Water mixed preparing solution, wherein the mass ratio of active medicine and carrier is 1.82；By PTA foley's tube (diameter
4mm, long 40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, coating is molten
Liquid spraying equipment sprays in the polyester balloon surface after flap, makes balloon surface drug level reach 3 μ g/
mm2, it is dried, packaging, ethylene oxide sterilizing.
Embodiment 5
By 12mg paclitaxel, 20mg magnesium stearate, 4mg Macrogol 2000,10ml ethanol, 4ml purification
Water mixed preparing solution, wherein the mass ratio of active medicine and carrier is 0.5；By PTA foley's tube (diameter
4mm, long 40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, coating is molten
Liquid spraying equipment sprays in the polyester balloon surface after flap, makes balloon surface drug level reach 3 μ g/
mm2, it is dried, packaging, ethylene oxide sterilizing.
Embodiment 6
By 96mg paclitaxel, 40mg sodium stearate, 10mg Macrogol 2000,10ml ethanol, 4ml purification
Water mixed preparing solution, wherein the mass ratio of active medicine and carrier is 1.92；By PTA foley's tube (diameter
4mm, long 40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, coating is molten
Liquid spraying equipment sprays in the polyester balloon surface after flap, makes balloon surface drug level reach 3 μ g/
mm2, it is dried, packaging, ethylene oxide sterilizing.
Comparative example 1
By 50mg paclitaxel, 20mg Iopromide, 5ml ethanol mixed preparing solution；By PTA foley's tube
(diameter 4mm, long 40mm) after flap three folding, incites somebody to action in ten thousand grades of clean environments under hundred grades of clean environments
Coating solution spraying equipment sprays in the polyester balloon surface after flap, makes the coating drug concentration be
3μg/mm2, naturally dry 24 hours, packaging, ethylene oxide sterilizing.
Comparative example 2
By 100mg paclitaxel, 0.5mg sodium benzoate, 0.5mg sorbitol, 10ml ethanol, 4ml purified water is mixed
Closing preparation solution, wherein the mass ratio of active medicine and carrier is 100；By PTA foley's tube (diameter 4mm,
Long 40mm) after flap three folding, under hundred grades of clean environments, coating solution is sprayed in ten thousand grades of clean environments
Equipment sprays in the polyester balloon surface after flap, makes balloon surface drug level reach 3 μ g/mm2, dry
Dry, packaging, ethylene oxide sterilizing.
Comparative example 3
By 75mg paclitaxel, 0.74mg sodium citrate, 0.26mg cetomacrogol 1000,10ml ethanol, 4ml
Purified water mixed preparing solution, wherein the mass ratio of active medicine and carrier is 75；PTA foley's tube is (straight
Footpath 4mm, long 40mm) in ten thousand grades of clean environments after flap three folding, by coating under hundred grades of clean environments
Solution spraying equipment sprays to, in the polyester balloon surface after flap, make balloon surface drug level reach
3μg/mm2, it is dried, packaging, ethylene oxide sterilizing.
Comparative example 4
By 4.4mg rapamycin, 3.7mg sodium acetate, 18.3mg mannitol, 8ml ethanol, 3ml purified water is mixed
Closing preparation solution, wherein the mass ratio of active medicine and carrier is 0.2；By PTA foley's tube (diameter 4mm,
Long 40mm) in ten thousand grades of clean environments after flap three folding, under hundred grades of clean environments, by coating solution essence
Close syringe (being accurate to 2 μ l) drop coating, on the surface of polyester sacculus, then makes described sacculus be dried, and repeats
Drop coating is until described balloon surface drug level reaches 3 μ g/mm2, after being dried 24 hours, packaging, epoxy second
Alkane sterilizing.
Course of conveying loss simulation test
Carry out course of conveying loss simulation test with the target vessel of pig arteria coronaria blood vessel simulation coronary artery system, survey
Try before sacculus is full, i.e. foley's tube inserts and moves to the dose loss during target site.
Respectively by embodiment 1～6 and the foley's tube of comparative example 1～4 preparation insert in in-vitro simulated blood vessel model.
In simulated blood vessel system, the flotation time is 90 seconds, then takes out conduit.HPLC is utilized to analyze on foley's tube
Remaining medicine, HPLC test condition is: Japan's Shimadzu LC-20A high performance liquid chromatograph, chromatographic column:
Aglilent ZOBAX SB-C184.6 × 250mm, 5um, flow phase: methanol: acetonitrile: water=230:360:410,
Column temperature: 30 DEG C, UV-detector, detects wavelength 227nm, flow velocity: 1.0ml/min.
HPLC measurement result is as shown in table 1:
Table 1 course of conveying loss simulation test result
Table 1 result shows: compared with the medicine-coated balloon that comparative example 1 is not added with carrier, the medicine of the present invention
Sacculus, during moving to Intertherapy site, decreases medicine loss in vascular system, says
Cohesive force between foley's tube and the medication coat of the bright present invention is bigger.And compared with comparative example 2～4 medicine
Loss amount is the most suitable.
In-vitro simulated test
Make target vessel simulator in vitro with pig arteria coronaria blood vessel and carry out in-vitro simulated test.
Respectively by embodiment 1～6 and the PTA foley's tube of comparative example 1～4 preparation insert in simulation target blood vessel, right
Sacculus liquid is charged to about 12atm.Transition percentage of elongation (that is: the ratio of balloon diameter and blood vessel diameter) be about 1.10～
1.20.Medicine is transported in target tissue in the liquid of 30～60 seconds fills the time, is then exitted by foley's tube
And take out from in-vitro simulated test system, collect target vessel tissue.By tissue extraction and HPLC, analyze
The remaining dose retained on medicament contg in molecular target tissue and sacculus, ibid, result is such as test condition
Shown in table 2.
The in-vitro simulated test result of table 2
As shown in Table 2: compared with the medicine-coated balloon that comparative example 1 is not added with carrier, the medicine ball of the present invention
Capsule is during ductal ectasia, and the absorbance of medicine is increased by vascular tissue, compared with comparative example 2～4,
The absorbance of medicine is also increased by vascular tissue, and absorbance is relevant with the mass ratio of carrier with active medicine.
Particles from getting loose is tested
In vitro under simulation test (purified water, 37 DEG C, 300ml/min) environment, simulation conveying, expand ball
Capsule, eluting balloon surface, the detection microgranule that comes off of medication coat, by particulate instrument detection come off micro-
Grain size and number.And by the specific size of microscopic method Observe and measure large scale microgranule (＞ 100 μm)
And pattern.
Table 3 in-vitro simulated particles from getting loose test result
As shown in Table 3: compared with the medicine-coated balloon of comparative example 1～4, the medicinal balloon of the present invention is at conduit
In simulaed path process of expansion, particles from getting loose level to get well far away (maximum particle diameter chi compared to comparative example 1～4
Very little smaller, each size range particle number is fewer than it).It is hereby understood that the size of particles from getting loose and quantity with
The mass ratio of active medicine and carrier, and the mass ratio between carrier also has significant relationship, implements in the present invention
Less drug particle size and less particles from getting loose quantity can be obtained in the range of example.
Drug release test
Test the loss amount of medicine during sacculus is full.
By embodiment 1～6 and the foley's tube of comparative example 1～4 preparation in healthy miniature pig body, peripheral arterial
Vasodilation, respectively at 30min, 24h, 7 day, follows up a case by regular visits to after 28 days, takes ball and expands section blood vessel, cleans up,
Medicament contg is measured: drug release patterns is as shown in Figure 1 in HPLC.
Fig. 1 result shows: compared with the drug coated balloon catheter (comparative example 1～4) not having carrier,
Effect reprinted by the medicinal balloon catheter medicine of the present invention and bioavailability substantially to be got well.Furtherly
Bright, the present invention prepares medicinal balloon catheter drug release effect relatively comparative example and substantially to get well.
Safety research is tested
On the femoral artery,superficial of healthy miniature pig left and right, use the medicinal balloon catheter of embodiment 1～6 preparation respectively
Carry out 1:(1.1～1.2 with the medicinal balloon catheter of comparative example 1～4 preparation) vasodilation, take out remote after 28 days
End skeletal muscle tissue, paraffin section prepares (RM2235 type paraffin slicing machine, Leica company of Germany), application
Optical microscope (DM2500 type micrometering system, Leica company of Germany) and image analysis software are carried out
Graphical analysis, observes vascular thrombosis in skeletal muscle, occlusion condition and ischemia, and Skeletal Muscle Cell is downright bad
Etc. complication.
Result shows: through the medicinal balloon catheter of the present invention after vasodilation, its far-end skeletal muscle group
Knit and do not find any change (Fig. 2～Fig. 7), the most do not find thrombosis, ischemia and necrocytosis etc. also
Send out disease；The medicinal balloon catheter of comparative example 2～4 is after vasodilation, and ball expands section blood vessel, far-end skeletal muscle
Tissue does not finds any change (Fig. 9～11), does not finds thrombosis, ischemia and necrocytosis etc. also yet
Send out disease；And after vasodilation, it is found that partial occlusion (Fig. 8) through the medicinal balloon catheter of comparative example 1,
And periinfarct tissue cell necrosis phenomenon.Illustrating further, it is micro-that the present invention prepares medicinal balloon catheter
Abscission is less, safer.
Claims (5)
1. a drug coated balloon catheter, including sacculus with cover at the medication coat of sacculus outer surface, its
Being characterised by, described medication coat includes active medicine and carrier；Described active medicine is paclitaxel, thunder handkerchief
Mycin, paclitaxel derivant or rapamycin derivative；Described carrier includes acylate and polyhydric alcohol, institute
The mass ratio stating the active medicine in medication coat and carrier is 0.5～49, described acylate and polyhydric alcohol
Mass ratio is (3～50): 1.
Drug coated balloon catheter the most according to claim 1, it is characterised in that described acylate
For acetate, benzoate, maleate, succinate, Ascorbate, citrate, tartaric acid
Salt, lactate, oxalates, aspartate, nicotinate, gluconate, stearate, glutamic acid
At least one in salt, vanillate, Lactobionate；Described polyhydric alcohol be Polyethylene Glycol, trometamol,
At least one in xylitol, sorbitol, mannitol, amino alcohol.
Drug coated balloon catheter the most according to claim 1, it is characterised in that described acylate
For benzoate；Described polyhydric alcohol is Polyethylene Glycol.
Drug coated balloon catheter the most according to claim 1, it is characterised in that described active medicine
Content at sacculus outer surface is 0.5～20 μ g/mm2。
5. according to the drug coated balloon catheter described in any one of Claims 1 to 4, it is characterised in that institute
The material stating foley's tube is nylon, nylon elastomer, PET or polyethylene.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510276542.6A CN106267377A (en) | 2015-05-26 | 2015-05-26 | Drug coated balloon catheter |
| PCT/CN2016/080746 WO2016188303A1 (en) | 2015-05-26 | 2016-04-29 | Drug coating layer balloon catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510276542.6A CN106267377A (en) | 2015-05-26 | 2015-05-26 | Drug coated balloon catheter |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106267377A true CN106267377A (en) | 2017-01-04 |
Family
ID=57393806
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510276542.6A Pending CN106267377A (en) | 2015-05-26 | 2015-05-26 | Drug coated balloon catheter |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN106267377A (en) |
| WO (1) | WO2016188303A1 (en) |
Cited By (8)
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| CN108261569A (en) * | 2016-12-31 | 2018-07-10 | 先健科技(深圳)有限公司 | The preparation method of medicinal 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 |
| CN110201243A (en) * | 2019-07-09 | 2019-09-06 | 科睿驰（深圳）医疗科技发展有限公司 | A kind of combination drug coating foley's tube and preparation method thereof |
| CN111249536A (en) * | 2020-01-15 | 2020-06-09 | 山东瑞安泰医疗技术有限公司 | Novel drug eluting balloon catheter and preparation method thereof |
| WO2020258834A1 (en) * | 2019-06-27 | 2020-12-30 | 山东瑞安泰医疗技术有限公司 | Drug-eluting balloon catheter and preparation method therefor |
| CN112933301A (en) * | 2019-11-26 | 2021-06-11 | 上海微创医疗器械（集团）有限公司 | Medicine-carrying implantation medical apparatus and preparation method thereof |
| CN113117220A (en) * | 2021-04-14 | 2021-07-16 | 深圳市赛禾医疗技术有限公司 | Medicine balloon catheter, medicine balloon catheter system and control method thereof |
| CN116350859A (en) * | 2023-06-01 | 2023-06-30 | 北京久事神康医疗科技有限公司 | Drug-coated balloon catheter and preparation method thereof |
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| 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 |
| WO2020258834A1 (en) * | 2019-06-27 | 2020-12-30 | 山东瑞安泰医疗技术有限公司 | Drug-eluting balloon catheter and preparation method therefor |
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| CN110201243B (en) * | 2019-07-09 | 2021-10-26 | 科睿驰（深圳）医疗科技发展有限公司 | Composite drug coating balloon catheter and preparation method thereof |
| CN112933301A (en) * | 2019-11-26 | 2021-06-11 | 上海微创医疗器械（集团）有限公司 | Medicine-carrying implantation medical apparatus and preparation method thereof |
| CN112933301B (en) * | 2019-11-26 | 2023-01-24 | 上海微创医疗器械（集团）有限公司 | Medicine-carrying implantation medical apparatus and preparation method thereof |
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| CN116350859A (en) * | 2023-06-01 | 2023-06-30 | 北京久事神康医疗科技有限公司 | Drug-coated balloon catheter and preparation method thereof |
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