WO2015070814A1 - Ballonnet à élution médicamenteuse et procédé de fabrication - Google Patents

Ballonnet à élution médicamenteuse et procédé de fabrication Download PDF

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Publication number
WO2015070814A1
WO2015070814A1 PCT/CN2014/091292 CN2014091292W WO2015070814A1 WO 2015070814 A1 WO2015070814 A1 WO 2015070814A1 CN 2014091292 W CN2014091292 W CN 2014091292W WO 2015070814 A1 WO2015070814 A1 WO 2015070814A1
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WO
WIPO (PCT)
Prior art keywords
drug
balloon
layer
adhesive
polymer layer
Prior art date
Application number
PCT/CN2014/091292
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English (en)
Chinese (zh)
Inventor
张鹏
张琳琳
郭芳
王长松
史增佐
李中华
罗七一
Original Assignee
微创心脉医疗科技（上海）有限公司
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Publication date
Application filed by 微创心脉医疗科技（上海）有限公司 filed Critical 微创心脉医疗科技（上海）有限公司
Publication of WO2015070814A1 publication Critical patent/WO2015070814A1/fr

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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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/148—Materials at least partially resorbable by the body

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a drug balloon and a preparation method thereof.
  • vascular stenosis is the leading cause of morbidity and mortality.
  • the most common treatment currently used is drug-eluting stent (DES) interventional therapy.
  • DES is a drug that is mixed with a polymer matrix and applied to the surface of the stent to form a local drug slow release system.
  • the drug When the stent is implanted into the blood vessel, the drug will be slowly released for several weeks to several months. Together with the support of the stent, it can effectively treat the stenosis or occlusion of the blood vessel. It is one of the most commonly used and most effective interventional devices.
  • DES also has many shortcomings. For example, the polymer will produce a local chronic inflammatory reaction; the presence of the stent requires long-term antiplatelet therapy; the drug coating is unevenly distributed; after stent thrombosis, it is not suitable to implant the stent again.
  • DEB drug-eluting balloon
  • the current degradable stent partially overcomes the limitations of traditional DES, does not cause inflammatory reactions and re-endothelialization, and can release drugs slowly relative to DEB. But because of its release surface The product is limited, and the support strength of the stent is not ideal, and it is easy to break, and the expected effect cannot be achieved. Therefore, it is necessary to synthesize a uniform drug release in the drug balloon and a long-term slow release in the drug stent to develop a new drug-containing coating.
  • WO 2012/039884 A1 discloses a transferable polymer coating by dissolving a water-soluble material and a degradable polymer on a surface of a conventional balloon, respectively, and then immersing the entire coating in an aqueous solution for a period of time to dissolve the water solubility of the inner layer.
  • the material forms a structure in which a layer of degradable polymer is nested outside the balloon.
  • the disadvantages of the invention are: (1) the inner layer water-soluble material is tightly coated by the outer layer degradable polymer, and it is difficult for water molecules to cross the outer layer barrier. In many cases, the inner layer water-soluble material cannot be immersed for a long time.
  • the polymer layer is a very thin film, which does not support the support like a stent, and does not actively adhere to the wall once the balloon is withdrawn. After the release, the film remaining on the inner wall of the blood vessel is easily washed away by the bloodstream, and not only does not serve the purpose of treating the disease, but even causes severe blood vessel embolism.
  • Chinese Patent Application No. 200610025200.8 discloses a double-layer balloon catheter in which an inner balloon in the two-layer balloon functions to expand a blood vessel, and an outer balloon is made of a unique microporous membrane, which can be treated.
  • the acting gene or drug is infiltrated by the outer balloon into the blood vessel wall and the target organ.
  • the invention effectively overcomes the loss of the drug during the delivery of the contrast catheter, reduces the system toxicity, but does not achieve the purpose of long-term sustained release.
  • the present invention contemplates a coating of a drug balloon that is combined with a special double layer balloon.
  • the inner balloon is first angioplasty, then the outer balloon expansion.
  • a solution such as physiological saline oozes out from the pores of the outer balloon wall to dissolve the water-soluble underlayer, so that the action of the underlayer changes from the connecting layer to the lubricating layer, and the drug-containing degradable polymer layer (film) ) detaches from the surface of the outer balloon and withdraws the balloon from the body.
  • the drug-containing degradable polymer layer uniformly releases the drug throughout the lesion over a period of minutes to months.
  • the degradable polymer layer (film) may further comprise an adhesive which adheres to the inner wall of the blood vessel and has a certain toughness, and does not break like a stent due to an external force such as compression or torsion of the blood vessel, and does not fall off from the lesion.
  • the present invention provides a drug balloon comprising a double-layer balloon, characterized in that a coating layer is provided on the outer balloon surface of the double-layer balloon, and the coating sequentially comprises a water-soluble primer layer. And a biodegradable polymer layer containing the drug.
  • the drug is dispersed in the biodegradable polymer layer, or the drug-containing biodegradable polymer layer comprises a further coating of a drug layer over the biodegradable polymer layer.
  • the drug-containing biodegradable polymer layer further contains an adhesive.
  • the drug-containing biodegradable polymer layer is a layer structure comprising a biodegradable polymer, an adhesive and a drug, or a double layer structure comprising any combination of a polymer, an adhesive and a drug, Or a three-layer structure in which a polymer, an adhesive, and a drug are separately coated.
  • the one-layer structure is obtained by blending a biodegradable polymer, an adhesive and a drug together on a water-soluble underlayer.
  • the two-layer structure may be arbitrarily combined as long as it includes a biodegradable polymer, an adhesive, and a drug.
  • the two-layer structure may be a structure in which a degradable polymer and an adhesive form a structure, and the drug alone constitutes another layer structure, or the degradable polymer separately constitutes a layer structure, and the adhesive and the drug constitute another layer structure, Or the degradable polymer and the adhesive form a structure, and the drug and the adhesive constitute another structure, or the degradable polymer and the drug form a structure, and the adhesive separately constitutes a structure, or a degradable polymer, an adhesive And the drug constitutes a layer of structure, while the adhesive and / or drug and / or degradable polymerization The object constitutes another layer structure or the like.
  • the three-layer structure may be arranged in any order, for example, in turn, a biodegradable polymer structural layer, an adhesive structural layer, and a drug structural layer.
  • the adhesive-containing structural layer is exposed in whole or in part to dissolve in the water-soluble bottom layer. It can be in contact with the inner wall of the blood vessel after release.
  • the present invention also provides a method of preparing a drug balloon comprising providing a double layer balloon, making a water soluble primer layer on the outer balloon surface thereof, and then forming a biodegradable polymer layer containing the drug and optionally an adhesive.
  • the biodegradable polymer layer may be attached to the inner wall of the blood vessel of the lesion area to release the drug for a period of several minutes to several months.
  • the double-layered balloon is completely identical to the balloon disclosed in Chinese Patent Application No. 200610025200.8.
  • the water-soluble bottom layer also known as the hydrophilic bottom layer, has a certain adhesive strength in the anhydrous state, and is used for connecting the surface of the balloon and the degradable polymer layer containing the drug and the optional adhesive; Dissolved to form a lubricating layer to smoothly release the degradable polymer layer.
  • the water-soluble materials include natural water-soluble polymers such as starch, cellulose, vegetable gum and animal glue; modified starch and modified cellulose; carboxymethyl starch, acetic acid starch, hydroxymethyl cellulose, and carboxymethyl Chemically modified natural polymers such as cellulose; synthetic polymers such as polyacrylamide (PAM), hydrolyzed polyacrylamide (HPAM), and polyvinylpyrrolidone (PVP).
  • the biodegradable polymer layer containing the drug and optionally the adhesive can be rapidly degraded or dissolved, for example, even a few days after surgery, for example, 5 minutes to 24 hours after surgery. In other cases, the degradable polymer layer may degrade or dissolve slowly, for example from 5 days to 6 months. In this process, the degradable polymer layer is attached to the inner wall of the diseased vessel until the drug is completely absorbed or the coating is completely degraded. Thickness of the drug-containing degradable polymer layer The degree can be appropriately adjusted depending on the desired degradation time, generally less than 10 ⁇ m, for example, 0.2 ⁇ m to 9 ⁇ m or 0.5 ⁇ m to 8.5 ⁇ m.
  • the biodegradable polymer may be polyhydroxyalkanoate (PHA), polyhydroxybutyrate compound, poly(glycerol-sebacic acid), polypeptide, polylactic acid (PLA), etc. poly- ⁇ - A hydroxy acid compound, a polyglycolic acid (PGA), a polylactic acid-glycolic acid copolymer (PLGA), a polydioxanone, a polylactic acid-polyethylene oxide copolymer, hyaluronic acid or the like.
  • PHA polyhydroxyalkanoate
  • PHA polyhydroxybutyrate compound
  • poly(glycerol-sebacic acid) polypeptide
  • PLA polylactic acid
  • PLA polylactic acid
  • poly- ⁇ - A hydroxy acid compound a polyglycolic acid (PGA), a polylactic acid-glycolic acid copolymer (PLGA), a polydioxanone, a polylactic acid-polyethylene oxide copolymer, hyaluronic acid or the like
  • the adhesive can adhere the polymer layer to the inner wall tissue of the blood vessel to prevent shedding, including gelatin, starch, agar, mannan, alginic acid, polyacrylic acid, polyacrylate adhesive, dextrin, methyl cellulose. , methyl vinyl ether, copolymer of maleic anhydride, gum arabic, scutellaria gum, paulownia gum, locust bean gum, cyanoacrylate adhesive, polyurethane adhesive, silicone adhesive, fibrin Adhesive, mussel mucin adhesive, etc.
  • the drug is antithrombotic, proliferative, anti-inflammatory, anti-inflammatory, anti-proliferative, anti-tumor, anti-mitotic, cytostatic, cytotoxic, anti-angiogenic, anti-restenosis, inhibition of microtubule, anti-metastatic or antithrombotic Substance, preferably acemetacin, aescin, aminopterin, antimycotics, arsenic trioxide, aristolochic acid, aspirin, berberine, ginkgo phenol, rapamycin and its derivatives, paclitaxel, docei Paclitaxel, antibiotics (especially actinomycin-D), hormones, and antibody-based cancer drugs.
  • the invention solves the problems that the absorption time of the medicine in the traditional drug balloon is short, the absorption amount is low, and the individual difference is large.
  • the polymer layer carries the drug to the lesion and uniformly releases the drug from 5 minutes to 6 months.
  • the drug balloon of the invention has the following beneficial effects: (1) the coating is combined with a special double-layer balloon, and a solution such as physiological saline is exuded from the balloon wall during the expansion of the outer balloon to dissolve the water-soluble bottom layer. It converts the connection function into a lubrication function to control the release of the drug-containing degradable polymer layer; (2) the polymer layer can uniformly release the drug to the entire diseased tissue for a long time, and maintain sufficient surrounding of the diseased cells for a long period of time.
  • degradable polymer layer may also contain Adhesive, which is more conducive to adhesion to the inner wall of the blood vessel and has certain toughness, and will not break like a stent due to external forces such as compression and torsion of the blood vessel; (4) no stent exists in the human body for a long time, and the coating can be relatively short. Degradation or dissolution in time does not affect re-endothelialization; (5) Compared with the conventional drug-eluting balloon technique, the present invention reduces the amount of drug loss, increases the amount of drug absorption, requires less drug loading, and has less toxicity to the system.
  • FIG. 1 is a schematic view showing a cross-sectional structure of a drug balloon after an inner balloon is expanded according to an embodiment of the present invention.
  • the inner balloon acts as an angioplasty, in which case the degradable polymer layer remains firmly bonded to the outer wall of the balloon.
  • FIG. 2 is a schematic view showing a cross-sectional structure of a drug balloon according to an embodiment of the present invention, in which the inner and outer balloons are expanded.
  • its expansion fluid such as saline
  • saline can penetrate the pores in the outer wall of the balloon to dissolve the water-soluble bottom layer, thereby degrading the polymer layer containing the drug and optional adhesive. Separated from the balloon.
  • FIG. 3 is a schematic structural view of a longitudinal section of a drug balloon according to an embodiment of the present invention.
  • FIG. 4 is a schematic structural view of a drug balloon in a process of withdrawing a balloon according to an embodiment of the present invention. As shown, the balloon is withdrawn from the body and a layer of degradable polymer containing the drug and optional adhesive adheres to the inner wall of the blood vessel, releasing the drug to adjacent tissue over a period of minutes to months of dissolution or degradation.
  • a double-layered balloon was prepared according to the method described in Chinese Patent Application No. 200610025200.8 owned by the present applicant.
  • PVP polyvinylpyrrolidone
  • IPA isopropyl alcohol
  • PLGA polylactic acid-glycolic acid copolymer
  • THF tetrahydrofuran
  • the thickness of the degradable polymer layer was 6 ⁇ m.
  • a double-layered balloon was prepared according to the method described in Chinese Patent Application No. 200610025200.8 owned by the present applicant.
  • the thickness of the degradable polymer layer including the drug layer was 8.5 ⁇ m in total.
  • the isolated porcine artery vascular segment which is similar in diameter to the balloon, was immediately immersed in pig blood supplemented with anticoagulant, kept at 37 ° C, and the drug balloon was passed through the 6F catheter in a folded state for 1 minute, then the balloon entered the blood vessel.
  • the inner balloon first expands (12 atm) to achieve the purpose of blood vessel formation, and then the outer balloon is infused with physiological saline, and the water-soluble bottom layer dissolves and disappears (about 1 minute) to withdraw the balloon, and the degradable polymer layer forms a
  • the layer film adheres to the inner wall of the blood vessel.
  • the drug balloon entered the lumen of the latex hose in a folded state, and the inner balloon first expanded (12 atm). Then, the outer balloon is infused with physiological saline, and after the water-soluble bottom layer dissolves and disappears (about 1 minute), the balloon is withdrawn, and the polymer layer is degraded to form a film adhered to the inner cavity of the latex tube, and the latex tube is degradable.
  • PBS constant temperature phosphate buffer

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un ballonnet à élution médicamenteuse et son procédé de fabrication. Le ballonnet à élution médicamenteuse comprend un ballonnet à deux couches, dont la surface extérieure est séquentiellement revêtue d'un substrat hydrosoluble et d'une couche polymère biodégradable contenant un médicament. Pendant le processus de dilatation du ballonnet, une solution saline physiologique et des solutions associées suintent par la paroi du ballonnet et dissolvent le substrat hydrosoluble, contrôlant ainsi la libération de la couche polymère dégradable contenant le médicament.
PCT/CN2014/091292 2013-11-15 2014-11-17 Ballonnet à élution médicamenteuse et procédé de fabrication WO2015070814A1 (fr)

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CN201310572145.4A CN104623740B (zh) 2013-11-15 2013-11-15 一种药物球囊及其制备方法
CN201310572145.4 2013-11-15

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10195311B2 (en) 2009-12-18 2019-02-05 Interface Biologics, Inc. Local delivery of drugs from self assembled coatings
CN109966564A (zh) * 2017-12-28 2019-07-05 先健科技(深圳)有限公司 载药球囊及其制备方法
CN112402702A (zh) * 2020-12-04 2021-02-26 上海康德莱医疗器械股份有限公司 一种药物涂层组合物以及一种药物涂层球囊
US11059859B2 (en) 2017-07-05 2021-07-13 Jiangyin Usun Pharmaceutical Co., Ltd. Anti-inflammatory use of peptide
EP3884987A4 (fr) * 2018-11-23 2022-01-05 Shanghai MicroPort Medical (Group) Co., Ltd. Ballonnet d'élution de médicament et cathéter à ballonnet
EP3974007A1 (fr) * 2016-04-04 2022-03-30 Medtronic Vascular Inc. Ballonnet revêtu de médicament
US11318232B2 (en) 2018-05-22 2022-05-03 Interface Biologics, Inc. Compositions and methods for delivering drugs to a vessel wall
CN115227880A (zh) * 2017-05-05 2022-10-25 优敦力公司 用于体腔的药物涂布球囊导管
CN115990295B (zh) * 2023-02-14 2024-04-30 上海朗迈医疗器械科技有限公司 粘接型聚乳酸类植入体、制备方法及器械

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CN104922735B (zh) * 2015-06-24 2017-03-22 浙江巴泰医疗科技有限公司 一种药物球囊的制备方法
CN106974896A (zh) * 2016-05-10 2017-07-25 北京德立福瑞医药科技有限公司 一种含有疏水性化疗药物纳米颗粒和纤维蛋白胶的抗肿瘤剂
CN106178138A (zh) * 2016-09-07 2016-12-07 上海申淇医疗科技有限公司 一种药物球囊
CN107088259A (zh) * 2017-06-09 2017-08-25 上海心至医疗科技有限公司 一种药物球囊及其制备方法
CN108057168B (zh) * 2017-11-08 2021-06-29 普霖医疗科技(广州)有限公司 一种药物球囊的制备方法
CN109985280B (zh) * 2017-12-29 2022-06-21 先健科技(深圳)有限公司 药物球囊及其制备方法
CN209790103U (zh) * 2018-04-21 2019-12-17 李皇德 一种血管球囊，球囊支架药物释放装置
CN108744233A (zh) * 2018-06-28 2018-11-06 山东吉威医疗制品有限公司 一种药物球囊扩张导管及其工艺
JP7315658B2 (ja) * 2018-08-01 2023-07-26 ボストン サイエンティフィック サイムド，インコーポレイテッド 薬物放出コーティング組成物
CN108852578B (zh) * 2018-09-04 2024-05-28 常州至善医疗科技有限公司 一种可自然降解的植入物
CN110170076A (zh) * 2019-03-18 2019-08-27 苏州恒瑞宏远医疗科技有限公司 头端可洗脱微导管
CN112370638A (zh) * 2020-12-04 2021-02-19 上海康德莱医疗器械股份有限公司 一种药物球囊
CN112354070A (zh) * 2020-12-04 2021-02-12 上海康德莱医疗器械股份有限公司 一种药物球囊的制备方法及其制得的药物球囊
CN115040300A (zh) * 2021-03-09 2022-09-13 常州至善医疗科技有限公司 一种体内植入物的封闭和释放结构
CN117222446A (zh) * 2021-04-12 2023-12-12 业聚医疗器械(深圳)有限公司 可扩张球囊导管
CN114073813A (zh) * 2021-11-12 2022-02-22 威高奋威健康科技发展(上海)有限公司 一种改进的药物涂覆医疗球囊导管

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CN203017550U (zh) * 2012-11-08 2013-06-26 上海微创医疗器械（集团）有限公司 医用球囊
CN204050424U (zh) * 2013-11-15 2014-12-31 微创心脉医疗科技（上海）有限公司 一种药物球囊

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CN101045175B (zh) * 2006-03-29 2012-07-04 微创医疗器械(上海)有限公司 双层球囊导管
WO2012039884A1 (fr) * 2010-09-23 2012-03-29 Boston Scientific Scimed, Inc. Ballonnet revêtu de médicament doté d'un revêtement transférable
CN103249435A (zh) * 2010-12-21 2013-08-14 百多力股份公司 作为导管材料的聚酰胺/聚乙烯吡咯烷酮(pa/pvp)聚合物混合物
WO2012166819A1 (fr) * 2011-05-31 2012-12-06 Micell Technologies, Inc. Système et procédé de formation de revêtement transférable à élution de médicament, libéré dans le temps

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10195311B2 (en) 2009-12-18 2019-02-05 Interface Biologics, Inc. Local delivery of drugs from self assembled coatings
EP3974007A1 (fr) * 2016-04-04 2022-03-30 Medtronic Vascular Inc. Ballonnet revêtu de médicament
CN115227880A (zh) * 2017-05-05 2022-10-25 优敦力公司 用于体腔的药物涂布球囊导管
US11059859B2 (en) 2017-07-05 2021-07-13 Jiangyin Usun Pharmaceutical Co., Ltd. Anti-inflammatory use of peptide
CN109966564A (zh) * 2017-12-28 2019-07-05 先健科技(深圳)有限公司 载药球囊及其制备方法
CN109966564B (zh) * 2017-12-28 2022-11-18 先健科技(深圳)有限公司 载药球囊及其制备方法
US11318232B2 (en) 2018-05-22 2022-05-03 Interface Biologics, Inc. Compositions and methods for delivering drugs to a vessel wall
EP3884987A4 (fr) * 2018-11-23 2022-01-05 Shanghai MicroPort Medical (Group) Co., Ltd. Ballonnet d'élution de médicament et cathéter à ballonnet
CN112402702A (zh) * 2020-12-04 2021-02-26 上海康德莱医疗器械股份有限公司 一种药物涂层组合物以及一种药物涂层球囊
CN115990295B (zh) * 2023-02-14 2024-04-30 上海朗迈医疗器械科技有限公司 粘接型聚乳酸类植入体、制备方法及器械

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