CN204050424U - A kind of medicinal balloon - Google Patents
A kind of medicinal balloon Download PDFInfo
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- CN204050424U CN204050424U CN201320725784.5U CN201320725784U CN204050424U CN 204050424 U CN204050424 U CN 204050424U CN 201320725784 U CN201320725784 U CN 201320725784U CN 204050424 U CN204050424 U CN 204050424U
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Abstract
This utility model belongs to medical instruments field, is specifically related to a kind of medicinal balloon.Medicinal balloon of the present utility model comprises double-layered balloon, and its superficies are coated with the biodegradable polymer layer of water solublity bottom and drug containing successively.Medicinal balloon of the present utility model has following beneficial effect: in the process of its outer balloon expandable, have the solution such as normal saline ooze out from balloon wall, dissolved water dissolubility bottom, thus controls the release of the biodegradable polymer layer of drug containing; This polymeric layer evenly can discharge medicine to whole pathological tissues for a long time, maintains drug level enough around sick cell within considerable time; Biodegradable polymer layer (thin film) also can comprise adhesive, makes it stick to blood vessel and has certain toughness, can not rupture because of external force such as the compressing of blood vessel, torsions as support.
Description
Technical field
This utility model belongs to medical instruments field, is specifically related to a kind of medicinal balloon.
Background technology
Angiostenosis is morbidity and main causes of death, and therapeutic modality the most frequently used at present adopts bracket for eluting medicament (DES) interventional therapy.DES is coated on rack surface after being mixed with polymeric matrix by medicine, forms topical remedy's slow releasing system.When after stenter to implant blood vessel, medicine meeting slow release continued for several weeks, to time several months, adds the supporting role of upper bracket, effectively can treat the narrow or inaccessible of blood vessel, is one of the most conventional at present and the most effective intervention apparatus.But DES also has many weak points, such as, polymer can produce local chronic inflammatory reaction; The existence of support needs Long-term Anti antiplatelet drug treatment; Medication coat skewness; After Thrombosis in sten, should not implant frame etc. again.
In order to overcome above-mentioned deficiency, especially seek to solve in-stent restenosis, lower Extremity Arterial Diseases, vascular bifurcation place and thin vessels the problem such as narrow time a kind of novel product--the medicament elution sacculus (DEB) that has been born.DEB technology is a kind of balloon reconstruction of improvement, sacculus, at sacculus outer surface medication, is delivered to lesion locations by conduit by this technology, and (0-2min) discharges medicine within the blink of balloon expandable, play blood vessel dilating, treat narrow or inaccessible effect.Even if lesion vessels generation restenosis blocks, also carry out Retreatment by DEB.
But current medicinal balloon requires that the medicine being used for the treatment of disease must have such effect: namely reached the object of curing the disease by single-bolus high-dose administration, repeat administration is nonessential.This greatly limits the selection of medicine, and after disposable heavy dose of administration, medicine enters blood circulation and easily causes acute toxic reaction.
Current biodegradable stent part overcomes the limiting factor of traditional DES, and the reaction that can not cause inflammation, with endothelialization is difficult again, can discharge medicine lentamente relative to DEB.But because its release limited area, and the factors such as the support strength of support is undesirable, easy fracture, can not produce a desired effect.So, be necessary the feature of the feature that comprehensive medicinal balloon Chinese medicine evenly discharges and the medium-term and long-term slow releasing of drug stent, thus develop a kind of newly containing medicine coating.
WO2012/039884 A1 discloses a kind of transferable polymer coating, by water-soluble material and degradable polymer are coated in common balloon surface respectively, then whole coating is immersed a period of time in aqueous solution, dissolve the water-soluble material of nexine, thus form the structure of a nested biodegradable polymer layer outside sacculus.The shortcoming of this invention is: (1) nexine water-soluble material is tightly wrapped quilt by outer degradable polymer, and hydrone is difficult to cross outer barrier, even if soak for a long time in a lot of situation, internal layer water-soluble material can not dissolve; On the other hand, even if the water-soluble material of nexine dissolves, its aqueous solution is also difficult to flow out, although this kind of solution has certain lubricity under having water existent condition, once after coating drying, again by sacculus and outer adhesion with hydrone completely; (2) even if by immersion treatment, nexine is completely removed, and does not have entity to be connected between balloon wall with biodegradable polymer layer, and in processing procedure that this directly causes that the folding pressure in drug coat and later stage is held etc., the movement of polymeric layer, even comes off; (3) in addition, polymeric layer is a very thin skim, do not have the supporting role as support, also can not be initiatively adherent, once after sacculus withdraws from, the thin film residing in blood vessel place is easy to be washed away by blood flow, does not only have the object of disease therapy, even causes serious blood vessel embolism.
Chinese invention patent application No.200610025200.8 discloses a kind of double-layered balloon catheter, in two-layer sacculus, internal layer sacculus plays the effect of blood vessel dilating, and outer sacculus is made up of the microporous membrane of uniqueness, the gene of therapeutical effect or medicine can will be played by outer sacculus osmosis on blood vessel wall, target organ.This invention effectively overcomes the loss of medicine in angiography catheter in course of conveying, reduces system toxicity, but does not reach the object of long-acting slow-release.
Summary of the invention
In order to solve an above difficult problem, this utility model devises a kind of coating of medicinal balloon, and this coating coordinates special double-layered balloon.During operation, first internal layer sacculus carries out angioplasty, then outer balloon expandable.In the process, the solution such as normal saline ooze out from the aperture of outer balloon wall, dissolved water dissolubility bottom, thus make the effect of bottom become lubricating layer from articulamentum, the biodegradable polymer layer (thin film) of drug containing departs from from the surface of outer sacculus, then is withdrawn from by sacculus external.The biodegradable polymer layer of drug containing evenly discharged medicine at whole diseased region within the several minutes time to the several months.Biodegradable polymer layer (thin film) also can comprise adhesive, makes it stick to blood vessel and has certain toughness, can not rupture, also can not come off from diseased region because of external force such as the compressing of blood vessel, torsions as support.
Specifically, this utility model provides a kind of medicinal balloon, comprises double-layered balloon, it is characterized in that, the outer balloon surface of described double-layered balloon is provided with coating, and described coating comprises the biodegradable polymer layer of water solublity bottom and drug containing successively.
According to this utility model, described medicine is scattered in biodegradable polymer layer, or is separately coated with one deck medicine layer on biodegradable polymer layer.
According to this utility model, the biodegradable polymer layer of described drug containing is further containing adhesive.In this case, described biodegradable polymer layer is the Rotating fields comprising biodegradable polymer, adhesive and medicine, or comprises the double-decker of three's combination in any, or is the three-decker be coated with respectively.
According to this utility model, a described Rotating fields is by after biodegradable polymer, adhesive and medicine blending, is coated on together on water solublity bottom.
According to this utility model, described double-decker can combination in any, as long as after combination, comprise biodegradable polymer, adhesive and medicine just.Such as, described double-decker can be that degradable polymer and adhesive form a Rotating fields, and medicine forms separately another Rotating fields, or degradable polymer forms separately a Rotating fields, and adhesive and medicine form another Rotating fields, or degradable polymer and adhesive form a Rotating fields, and medicine and adhesive form another Rotating fields, or degradable polymer and medicine form a Rotating fields, and adhesive forms separately a Rotating fields, or degradable polymer, adhesive and medicine form a Rotating fields, and adhesive and/or medicine and/or degradable polymer form another Rotating fields etc.
According to this utility model, described three-decker can arrange in random order, such as, is biodegradable polymer structure sheaf, adhesive structure sheaf and medicines structure layer successively.
Those skilled in the art can understand, no matter be double-decker or three-decker, in order to ensure that bilayer or three-decker adhere to blood vessel, containing the structure sheaf of adhesive be exposed in whole or in part outside, to dissolve at water solublity bottom, can contact with blood vessel after release.
Described biodegradable polymer layer can be attached to the blood vessel of lesion region, within the time do not waited to the several months for several minutes, discharge medicine.
Disclosed in described double-layered balloon and Chinese invention patent application No.200610025200.8, sacculus is completely the same.
Described water solublity bottom, also known as hydrophilic bottom layer, has certain adhesion strength under anhydrous state, for connecting the biodegradable polymer layer of balloon surface and drug containing and optional adhesive; Can dissolve rapidly once meet water, form lubricating layer, thus smoothly biodegradable polymer layer is discharged.Described water-soluble material comprises the water-soluble macromolecules such as starch based, cellulose, plant gum, animal glue; Modified starch and modified cellulose; The chemically modified natural polymerses such as carboxymethyl starch, acetic starch, hydroxy methocel, carboxymethyl cellulose; The synthetic polymers such as polyacrylamide (PAM), hydrolyzed polyacrylamide (HPAM), polyvinylpyrrolidone (PVP).
The biodegradable polymer layer of described drug containing and optional adhesive is capable of being fast degraded or dissolve, and such as several days after surgery even less, such as postoperative 5 minutes to 24 hours again.In yet some other cases, described biodegradable polymer layer can slowly be degraded or dissolve, such as from 5 days to 6 months not etc.In this process, biodegradable polymer layer combination medicine is attached to lesion vessels inwall until medicine is completely absorbed or coating is degradable.The thickness of biodegradable polymer layer can make the appropriate adjustments according to required degradation time, is generally less than 10 μm, such as, and 0.2 μm-9 μm or 0.5 μm-8.5 μm.
Described biodegradable polymer can be polyhydroxyalkanoate (PHA), poly butyric ester type compound, poly-poly-alpha-hydroxy acid compounds, polyglycolic acid (PGA), Poly(D,L-lactide-co-glycolide (PLGA), PPDO, polylactic acid-polyethylene oxide copolymer, the hyaluronic acid etc. such as (glycerol-decanedioic acid), polypeptide, polylactic acid (PLA).
Polymeric layer can be adhered to blood vessel tissue place by described adhesive, prevent from coming off, comprise gelatin, starch, agar, mannan, alginic acid, polyacrylic acid, polyacrylate adhesive, dextrin, methylcellulose, methyl vinyl ether, the copolymer of maleic anhydride, arabic gum, tragcanth, karaya, tracasol, cyanoacrylate adhesive, polyurethane tackifier, organosilicon series adhesive, fibrin adhesive, sea-mussel mucin adhesive etc.
Described medicine is antithrombotic, propagation, antiinflammatory, antiinflammatory, anti-proliferate, antitumor, resisting mitosis, T suppression cell, have cell toxicant, angiogenesis inhibitor, anti-restenosis, suppression microtubule, metastasis or antithrombotic material, be preferably acemetacin, aescine, aminopterin, antimycoin, arsenic trioxide, Aristolochic Acid, aspirin, little ?alkali, ginkgol, rapamycin and derivant thereof, paclitaxel, Docetaxel, antibiotic (particularly actinomycin D), hormone, antibody curing cancer drug.
This utility model solves that the drug absorption time existed in conventional medicament sacculus is short, and absorbtivity is low, the problem that individual variation is large.After intervene operation, polymeric layer carried drug adhesion and evenly discharge medicine within the time that diseased region did not wait from 5 minutes-6 months.
Medicinal balloon of the present utility model has following beneficial effect: (1) its coating coordinates special double-layered balloon, in the process of outer balloon expandable, have the solution such as normal saline ooze out from balloon wall, dissolved water dissolubility bottom makes it change lubricating function into by linkage function, thus controls the release of the biodegradable polymer layer of drug containing; (2) polymeric layer evenly can discharge medicine to whole pathological tissues for a long time, maintains drug level enough around sick cell within considerable time; (3) biodegradable polymer layer (thin film) also can contain adhesive, thus is more conducive to stick to blood vessel and has certain toughness, can not rupture because of external force such as the compressing of blood vessel, torsions as support; (4) without support long-term existence in human body, coating can be degraded or dissolve within the relatively short time, does not affect endothelialization again; (5) relative to traditional medicament elution balloons technique, this utility model reduces drug loss amount, and increase drug absorption, required drug loading is little, little to system toxicity.
Accompanying drawing explanation
In order to more clearly describe the technical solution of the utility model, briefly introduce below in conjunction with accompanying drawing.Obviously, these accompanying drawings are only some detailed description of the invention that this utility model is recorded.This utility model includes but not limited to these accompanying drawings.
A kind of medicinal balloon that Fig. 1 provides for this utility model embodiment, the Structure of cross section schematic diagram after its internal layer balloon expandable.As shown in the figure, internal layer sacculus can play the effect of angioplasty, and now biodegradable polymer layer is still incorporated into sacculus outer wall securely.Wherein 101: medicine; 102: water solublity bottom; 103: double-layered balloon; And 104: biodegradable polymer layer.
A kind of medicinal balloon that Fig. 2 provides for this utility model embodiment, its ectonexine sacculus all expand after Structure of cross section schematic diagram.As shown in the figure, when outer balloon expandable, it expands liquid (as normal saline) and can pass through the aperture of sacculus outer wall thus dissolved by water solublity bottom, thus drug containing is separated with sacculus with the biodegradable polymer layer of optional adhesive.Wherein 201: medicine; 203: double-layered balloon; And 204: biodegradable polymer layer.
A kind of medicinal balloon longitudinal section structural representation that Fig. 3 provides for this utility model embodiment.Wherein 302: water solublity bottom; 303: biodegradable polymer layer; And 305: balloon wall.
A kind of medicinal balloon that Fig. 4 provides for this utility model embodiment withdraws from the structural representation in process at sacculus.As shown in the figure, sacculus is withdrawn from body, and the biodegradable polymer layer of drug containing and optional adhesive adheres to blood vessel, several minutes to the several months not wait dissolving or degradation time in adjacent tissue release medicine.Wherein 403: biodegradable polymer layer; 406: blood vessel; And 407: double-layered balloon.
Detailed description of the invention
In order to understand this utility model further, below in conjunction with embodiment, preferred version of the present utility model is described.These describe the feature and advantage just illustrating this utility model medicinal balloon, and unrestricted protection domain of the present utility model.
Embodiment 1
1. double-layered balloon preparation
A double-layered balloon is prepared according to the described method of Chinese invention patent application No.200610025200.8.
2. coating preparation
Take 2g polyvinylpyrrolidone (PVP, molecular weight 10,000), join in 5ml isopropyl alcohol (IPA) solution, fully stir until PVP dissolves completely.Expanded by double-layered balloon internal layer, immerse in above-mentioned solution, then dry in 40 DEG C of baking ovens, form water solublity bottom, it is 30.109mm. that calliper records sacculus middle part external diameter
Take 2g Poly(D,L-lactide-co-glycolide (PLGA) (50/50), 0.01g cyanoacrylate and 300mg paclitaxel are dissolved in 10ml oxolane (THF) solution, fully stir until all the components dissolves completely.Then the sacculus scribbling water solublity bottom is immersed in above-mentioned solution, dry in 40 DEG C of baking ovens, repeat immersion 3 times.After drying, recording sacculus middle part external diameter at calliper is 30.121mm.
Known by calculating, the thickness of biodegradable polymer layer is 6 μm.
Embodiment 2
1. double-layered balloon preparation
Method according to Chinese invention patent application No.200610025200.8, prepares a double-layered balloon.
2. coating preparation
Take 2g PVP (molecular weight 10,000), join in 5ml IPA solution, fully stir until PVP dissolves completely.Expanded by double-layered balloon internal layer, immerse in above-mentioned solution, then dry in 40 DEG C of baking ovens, form water solublity bottom, it is 30.109mm that calliper records sacculus middle part external diameter.
Take 2g PLGA (50/50), 0.01g cyanoacrylate is dissolved in 10mlTHF solution, fully stirs until all the components dissolves completely.The sacculus scribbling water solublity bottom is continued to immerse in above-mentioned solution, then dry in 40 DEG C of baking ovens, repeat immersion 2 times, bone dry.Finally, adopting ultrasonic spraying technology to spray one deck paclitaxel at polymer layer surface, for guaranteeing effective bonding of polymer coating and blood vessel, not spraying medicine in the length of each reserved 1mm in these coating two ends.It is 30.126mm that calliper records sacculus middle part external diameter.
Known by calculating, the thickness comprising the biodegradable polymer layer of medicine layer adds up to 8.5 μm.
Embodiment 3
Get the isolated pig arterial blood pipeline section close with balloon diameter, immerse immediately in the Sanguis sus domestica adding anticoagulant, keep 37 DEG C of constant temperature, medicinal balloon keeps 1 minute by 6F conduit in a folded configuration, then sacculus intravasation inner chamber, first internal layer sacculus expands the object that (12atm) reaches angioplastic, then outer sacculus saline injection, after water solublity bottom dissolves and disappears, (about 1 minute) withdraws from sacculus, and biodegradable polymer layer forms thin film and sticks to blood vessel place.
Separately get the latex flexible pipe close with balloon diameter, immerse 37 DEG C of constant temperature phosphate buffer (PBS, pH=7.4) in, medicinal balloon enters latex flexible pipe inner chamber in a folded configuration, first internal layer sacculus is expanded (12atm), then outer sacculus saline injection, after water solublity bottom dissolves and disappears, (about 1 minute) withdraws from sacculus, biodegradable polymer layer forms thin film and sticks to latex tubing inner chamber, what this latex tubing and degradable films are placed in medicament dissolution instrument turns basket, dissolution medium is the constant temperature PBS (pH=7.4) of 37 DEG C ± 0.5 DEG C, rotating speed is 100 revs/min, after sampling process in 1 hour, HPLC testing drug stripping situation.As a result, biodegradable polymer layer was at first 24 hours release about 40% medicines.
The explanation of above embodiment just understands core concept of the present utility model for helping.Should be understood that; for the ordinary skill in the art; under the prerequisite not departing from this utility model principle, some improvement and modification can also be carried out to the medication coat of this utility model sacculus, but these improve and modification also falls in the scope of this utility model claim request protection.
Claims (6)
1. a medicinal balloon, comprises double-layered balloon, it is characterized in that, the outer balloon surface of described double-layered balloon is provided with coating, and described coating comprises the biodegradable polymer layer of water solublity bottom and drug containing successively.
2. medicinal balloon as claimed in claim 1, it is characterized in that, described medicine is scattered in biodegradable polymer layer, or is separately coated with one deck medicine layer on biodegradable polymer layer.
3. medicinal balloon as claimed in claim 1 or 2, it is characterized in that, described water solublity bottom is made up of water-soluble material.
4. medicinal balloon as claimed in claim 1 or 2, it is characterized in that, the thickness of described biodegradable polymer layer is less than 10 μm.
5. medicinal balloon as claimed in claim 4, it is characterized in that, the thickness of described biodegradable polymer layer is 0.2 μm-9 μm.
6. the medicinal balloon as described in claims 5, is characterized in that, the thickness of described biodegradable polymer layer is 0.5 μm-8.5 μm.
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| CN201320725784.5U CN204050424U (en) | 2013-11-15 | 2013-11-15 | A kind of medicinal balloon |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201320725784.5U CN204050424U (en) | 2013-11-15 | 2013-11-15 | A kind of medicinal balloon |
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| CN204050424U true CN204050424U (en) | 2014-12-31 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104623740A (en) * | 2013-11-15 | 2015-05-20 | 微创心脉医疗科技（上海）有限公司 | Medicine balloon and preparation method thereof |
| CN107928877A (en) * | 2017-12-19 | 2018-04-20 | 大连海事大学 | A kind of wound dressing and its production method based on gas oxygen supply |
| CN108339159A (en) * | 2017-01-24 | 2018-07-31 | 青岛智辰生物科技有限公司 | Medicine coating and preparation method 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 |
| CN109985280A (en) * | 2017-12-29 | 2019-07-09 | 先健科技(深圳)有限公司 | Medicinal balloon and preparation method thereof |
| CN110141760A (en) * | 2019-06-05 | 2019-08-20 | 山东百多安医疗器械有限公司 | A kind of surface carries the vertebral plasty dilating sacculus and preparation method thereof of medicine |
| WO2020103667A1 (en) * | 2018-11-23 | 2020-05-28 | 上海微创医疗器械（集团）有限公司 | Drug eluting balloon and balloon catheter |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104623740A (en) * | 2013-11-15 | 2015-05-20 | 微创心脉医疗科技（上海）有限公司 | Medicine balloon and preparation method thereof |
| CN108339159A (en) * | 2017-01-24 | 2018-07-31 | 青岛智辰生物科技有限公司 | Medicine coating and preparation method thereof |
| CN107928877A (en) * | 2017-12-19 | 2018-04-20 | 大连海事大学 | A kind of wound dressing and its production method based on gas oxygen supply |
| CN109985280A (en) * | 2017-12-29 | 2019-07-09 | 先健科技(深圳)有限公司 | Medicinal balloon and preparation method thereof |
| CN109985280B (en) * | 2017-12-29 | 2022-06-21 | 先健科技(深圳)有限公司 | Drug balloon and preparation method 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 |
| WO2020103667A1 (en) * | 2018-11-23 | 2020-05-28 | 上海微创医疗器械（集团）有限公司 | Drug eluting balloon and balloon catheter |
| CN110141760A (en) * | 2019-06-05 | 2019-08-20 | 山东百多安医疗器械有限公司 | A kind of surface carries the vertebral plasty dilating sacculus and preparation method thereof of medicine |
| CN110141760B (en) * | 2019-06-05 | 2021-10-08 | 山东百多安医疗器械股份有限公司 | Centrum forming expansion balloon with drug loaded on surface and preparation method thereof |
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| C14 | Grant of patent or utility model | ||
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| CP01 | Change in the name or title of a patent holder |
Address after: No. 3399 Lane 1, Kangxin Highway, Pudong New District, Shanghai, 201318 Patentee after: SHANGHAI MICROPORT ENDOVASCULAR MEDTECH Co.,Ltd. Address before: No. 3399 Lane 1, Kangxin Highway, Pudong New District, Shanghai, 201318 Patentee before: MICROPORT ENDOVASCULAR (SHANGHAI) Co.,Ltd. |
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| CP03 | Change of name, title or address | ||
| CP03 | Change of name, title or address |
Address after: No. 3399 Lane 1, Kangxin Highway, Pudong New District, Shanghai, 201321 Patentee after: Shanghai minimally invasive heart pulse medical technology (Group) Co.,Ltd. Address before: No.1, Lane 3399, Kangxin Road, Pudong New Area, Shanghai, 201318 Patentee before: SHANGHAI MICROPORT ENDOVASCULAR MEDTECH Co.,Ltd. |
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Effective date of registration: 20210324 Address after: Room 101, No.1, Lane 3399, Kangxin Road, Pudong New Area, Shanghai, 201321 Patentee after: Shanghai Hongmai Medical Technology Co.,Ltd. Address before: No. 3399 Lane 1, Kangxin Highway, Pudong New District, Shanghai, 201321 Patentee before: Shanghai minimally invasive heart pulse medical technology (Group) Co.,Ltd. |
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Granted publication date: 20141231 |