WO2017140152A1 - Échafaudage vasculaire contenant un enrobage de médicament combiné - Google Patents

Échafaudage vasculaire contenant un enrobage de médicament combiné Download PDF

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Publication number
WO2017140152A1
WO2017140152A1 PCT/CN2016/107020 CN2016107020W WO2017140152A1 WO 2017140152 A1 WO2017140152 A1 WO 2017140152A1 CN 2016107020 W CN2016107020 W CN 2016107020W WO 2017140152 A1 WO2017140152 A1 WO 2017140152A1
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Prior art keywords
drug
coating
composite
coated
stent
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Ceased
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PCT/CN2016/107020
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English (en)
Chinese (zh)
Inventor
张同庆
袁伟
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Danyang Naruicon Nano Technology Co Ltd
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Danyang Naruicon Nano Technology Co Ltd
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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
    • A61L31/02—Inorganic 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
    • 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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/10—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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/06—Coatings containing a mixture of two or more compounds

Definitions

  • the invention relates to a medical instrument, a medicine load bracket formed by loading a functional drug coating on a common stent substrate composed of a common alloy mesh of CoPt and stainless steel.
  • the vascular stent is generally made of an alloy material, such as medical stainless steel, Ta or cobalt-platinum alloy, etc., and the alloy is woven into a net and attached to a balloon and a guiding device.
  • the metal stent can be sent to the vascular lesion to achieve support for the narrow occlusion vessel, reduce the elastic retraction of the blood vessel and reshape the shape, and maintain the lumen of the lumen.
  • U.S. Patent Nos. 4,969,458, 4,733,665, 4,397,762, 4,776,337) Scaffolds of various polymeric materials and degradable materials have also recently been studied.
  • 9204982 discloses a method of drug injection for such stents.
  • the application of rapamycin to the bare stent is applied to the blood vessel, which can effectively inhibit the occurrence of restenosis.
  • drug-coated stents for the study of drugs such as paclitaxel.
  • Loading the drug on the stand is a seemingly easy but actually technical task. It is easy for the average operator to think that if the commonly required drug is applied to the stent, it should be disinfected or have a certain therapeutic effect, but in reality it is far from simple, and the key is the release speed. From the mathematically simple model of drug dissolution, it can be seen that the loadable drug coating is generally at a level of tens of microns thick, and at a fixed solubility, especially in the blood vessels, the blood flows quickly, equal to the drug always facing itself. The unsaturated solution, the release of the drug will be very fast.
  • the drug will release more than 80% over a two-hour period, which is less than the time required for the damaged vessel to heal, so this simple treatment can be used for a little simple disinfection, for the actual blood vessel Repair and restenosis suppression is not helpful. Therefore, researchers all over the world have been using various drug carriers or other physical and chemical techniques to organize drug coatings to form stents in order to achieve sustained drug release. For example, the use of epoxy resin to coat the rapamycin coating on the stent can act as a sustained release of rapamycin in the blood.
  • the sustained release of the drug in such a stent often depends on the specific properties of the drug molecule and the carrier molecule.
  • Cyclodextrin is a commonly used organic molecule and has been used in foods and medicines. As shown in Fig. 1, the molecular structure contains a cyclic structure, and the molecules of the drug can be bound to form a relatively stable state, and the drug molecules can be released in a degraded manner in an aqueous solution.
  • the currently popular drug-loaded stents are mainly single-function drugs. Because of the number of rings in the molecule, there are various cyclodextrins such as ⁇ , ⁇ , and ⁇ , and some have the function of controlling blood sugar and preventing sepsis (European Patent EP1747785).
  • the object of the present invention is to form a composite coating by using a cyclodextrin-loaded drug molecule, and apply the composite coating on a bare alloy stent to form a composite drug-coated vascular stent, and can load a plurality of drugs to form a synergistic effect.
  • a component for controlling blood lipids and blood sugar can be introduced, and the action of the cyclodextrin molecule itself can be combined to control the local vascular microenvironment, thereby improving the healing effect of blood vessels.
  • the use of cyclodextrin may also have the synergistic effect of multiple drugs.
  • the application of vascular stents for anti-stenosis drugs are examples of multiple drugs.
  • the technical scheme of the present invention is: a blood vessel stent containing a composite drug coating, that is, a blood vessel stent functionalized by a novel composite drug coating, and the blood vessel stent base is a commonly used bare metal or alloy (or other scaffold material thereof) in the blood vessel.
  • the stent metal mesh is coated with a composite drug coating.
  • the vascular stent is fixedly applied to the guiding device.
  • the composite drug coating is a single or multiple drug coatings based on cyclodextrin tissue.
  • the composite drug-coated tissue will have a better effect with ⁇ -type cyclodextrin.
  • a blood vessel stent functionalized by a novel composite drug coating wherein the molar ratio of cyclodextrin molecules to drugs in the composite coating is not less than 2:1 and not higher than 20:1.
  • a compound drug coating that can contain multiple functional components, such as lipid-lowering, limiting stenosis, controlling blood pressure, limiting blood components, etc., such as simvastatin, aspirin, urethane, paclitaxel, rapamycin Etc., such as simvastatin / aspirin mixed coating.
  • functional components such as lipid-lowering, limiting stenosis, controlling blood pressure, limiting blood components, etc.
  • simvastatin, aspirin, urethane, paclitaxel, rapamycin Etc. such as simvastatin / aspirin mixed coating.
  • the amount of the drug refers to the amount of the three mixed drugs.
  • a method for preparing a vascular stent containing a composite drug coating wherein a typical composite drug coating liquid manufacturing process is: dissolving a cyclodextrin in a mixture of ethanol and water, and then dissolving the drug therein and heating to 40 - 80 ° C, and hold for a while until uniform.
  • the mass of the cyclodextrin is between 2 and 20 times the mass of the drug.
  • a vascular stent functionalized by a novel composite drug coating the typical manufacturing process is that the metal stent substrate is fixed and maintained at 60 ⁇ 10 ° C, and the composite drug coating liquid is dripped on the stent substrate to dry, repeating 3- 10 drops to a thickness of 10 to 100 microns; or immersing the metal stent in a composite drug coating liquid, then drying to form a coating, repeated several times to the desired coating thickness.
  • the stent is substantially fixed to the balloon and the guide to form a complete surgical product, a composite coated stent.
  • the present invention is a blood vessel stent functionalized with a novel composite drug coating.
  • the novel composite coating is a single or multiple drug coating based on cyclodextrin tissue, especially gamma cyclodextrin, which may be used to inhibit restenosis, control blood lipids, blood sugar, blood pressure or control blood pressure.
  • a drug such as one or more of blood drugs such as simvastatin, aspirin, urethane, paclitaxel, and rapamycin.
  • the stent is delivered into the blood vessel to observe the slow release of the drug for several weeks, and has the effect of improving the vascular microenvironment around the stent, achieving better blood vessel healing and maintaining smooth postoperative operation.
  • the coating obtained by the invention can organize a plurality of functional drugs and realize long-term sustained release of the drug in the blood, and the effect of assisting blood vessel repair has been verified in animal experiments.
  • Figure 1 is a typical configuration of a cyclodextrin molecule
  • Figure 2 contains a composite coated vascular stent photograph (length scale 25mm);
  • Figure 3 shows the drug sustained release effect of the composite coated stent, the x-axis is time, the y-axis is the drug content that has been released, and 1 is 100%;
  • FIG. 4 Comparison of repair effects of pig hind leg blood vessels, (a): control group, (b): effect diagram of the present invention.
  • the metal mesh is secured to the balloon and guide to form a stent system assembly.
  • a typical coating liquid is produced by dissolving the cyclodextrin in a mixture of alcohol and water, then dissolving the drug in it and heating it to 40-80 degrees Celsius for more than one hour.
  • the number of molecules of cyclodextrin is between 2 and 20 times the number of drug molecules.
  • a typical composite coated stent is manufactured by fixing and holding the metal stent at 60 ° C, dropping the coating liquid onto the stent, and repeatedly dropping it to a thickness of 10 to 100 ⁇ m or soaking the metal stent. In the liquid, it is post-baked to form a coating.
  • the stent is secured to the balloon and the guide to form a composite coated stent.
  • Figure 2 is a vascular stent we made.
  • the composition of the coating was measured by Raman spectroscopy. From the Raman spectroscopy and infrared identification results, the encapsulated molecules still showed the aspirin and simvastatin Raman. Characteristics, which support the efficacy of our molecular drugs may be effectively maintained.
  • the stent was immersed in physiological saline, and the drug release amount of simvastatin was measured by an ultraviolet spectrophotometer.
  • Figure 3 we also show the effect of drug release directly on the stent. We can see that the drug smeared the bare stent for only two hours and released 80% of all doses (the shortest light curve).
  • the bare stent and the composite coated stent were implanted into the blood vessels of the hind legs of the experimental pigs, and the full-term feeding was carried out to check the blood vessel growth at the stent. It was found that there was a half-probability of blood flow obstruction after the bare stent was used, and the angiogram after the blockage was as shown in Fig. 4(a).
  • the stent coated with this method has no blockage at present, which will ensure the smooth flow of blood flow.
  • Figure 4(b) has a lower probability of blockage than the use of a single drug alone.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un échafaudage vasculaire contenant un enrobage de médicament combiné et son procédé de préparation. L'échafaudage vasculaire comprend un maillage métallique constitué d'un métal nu ou d'un alliage, et un enrobage de médicament combiné appliqué sur le maillage métallique. L'enrobage de médicament combiné est un enrobage d'un ou de plusieurs médicaments basé sur une structure de cyclodextrine. Le rapport molaire entre des molécules de cyclodextrine et ledit médicament dans l'enrobage est supérieur ou égal à 2:1 et inférieur ou égal à 20:1. Les médicaments dans l'enrobage sont des médicaments ayant des effets d'inhibition de la resténose et de régulation des lipides sanguins, de la glycémie ou de la tension artérielle.
PCT/CN2016/107020 2016-02-15 2016-11-24 Échafaudage vasculaire contenant un enrobage de médicament combiné Ceased WO2017140152A1 (fr)

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CN201610085845.4A CN105561406A (zh) 2016-02-15 2016-02-15 一种含复合药物涂层的血管支架
CN201610085845.4 2016-02-15

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105561406A (zh) * 2016-02-15 2016-05-11 丹阳纳瑞康纳米科技有限公司 一种含复合药物涂层的血管支架
CN114521996A (zh) * 2022-01-19 2022-05-24 株洲茂物医疗科技有限公司 一种复合药物支架及其制备方法

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WO2008002434A2 (fr) * 2006-06-26 2008-01-03 Boston Scientific Scimed, Inc. Dispositifs médicaux pour libération d'agents thérapeutiques de faible solubilité
CN101573149A (zh) * 2006-11-06 2009-11-04 彼鲁兹实验室公司 从多孔基体制备可植入假体的方法和相关的假体及其应用
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WO2010141667A1 (fr) * 2009-06-03 2010-12-09 Case Western Reserve University Système et procédé de délivrance d'un agent thérapeutique
CN105561406A (zh) * 2016-02-15 2016-05-11 丹阳纳瑞康纳米科技有限公司 一种含复合药物涂层的血管支架

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US8187620B2 (en) * 2006-03-27 2012-05-29 Boston Scientific Scimed, Inc. Medical devices comprising a porous metal oxide or metal material and a polymer coating for delivering therapeutic agents
ZA200904416B (en) * 2007-01-30 2010-08-25 Hemoteq Ag Biodegradable vascular support
CN105031748B (zh) * 2015-08-03 2018-06-26 苏州康力丰纳米科技有限公司 一种可控缓释的阿司匹林金属复合材料制备

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001074401A2 (fr) * 2000-03-31 2001-10-11 Supergen, Inc. Complexes de camptothecine
CN101080247A (zh) * 2004-11-15 2007-11-28 里尔科技大学Saic 用于逐步释放和延迟释放治疗分子的改善吸收性能的具有环糊精的生物材料
WO2008002434A2 (fr) * 2006-06-26 2008-01-03 Boston Scientific Scimed, Inc. Dispositifs médicaux pour libération d'agents thérapeutiques de faible solubilité
CN101573149A (zh) * 2006-11-06 2009-11-04 彼鲁兹实验室公司 从多孔基体制备可植入假体的方法和相关的假体及其应用
CN101686949A (zh) * 2007-04-20 2010-03-31 纳瓦拉公司科学与技术研究所 包含环糊精和生物活性分子的纳米颗粒及其用途
WO2010141667A1 (fr) * 2009-06-03 2010-12-09 Case Western Reserve University Système et procédé de délivrance d'un agent thérapeutique
CN105561406A (zh) * 2016-02-15 2016-05-11 丹阳纳瑞康纳米科技有限公司 一种含复合药物涂层的血管支架

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