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WO2015189716A1 - Valve cardiaque prothétique mécanique résistante à la thrombose - Google Patents

Valve cardiaque prothétique mécanique résistante à la thrombose Download PDF

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Publication number
WO2015189716A1
WO2015189716A1 PCT/IB2015/052690 IB2015052690W WO2015189716A1 WO 2015189716 A1 WO2015189716 A1 WO 2015189716A1 IB 2015052690 W IB2015052690 W IB 2015052690W WO 2015189716 A1 WO2015189716 A1 WO 2015189716A1
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WIPO (PCT)
Prior art keywords
valve
mechanical
inr
patients
nano
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Ceased
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PCT/IB2015/052690
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English (en)
Inventor
Seyedhossein OJAGHIHAGHIGHI
Akram MIKAEILPOUR
Hamidreza MORTEZABAGI
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/306Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/047Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/082Inorganic materials
    • A61L31/088Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L33/00Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/02Use of inorganic materials
    • A61L33/022Metal or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L33/00Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/02Use of inorganic materials
    • A61L33/027Other specific inorganic materials not covered by A61L33/022 or A61L33/025
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16HGEARING
    • F16H47/00Combinations of mechanical gearing with fluid clutches or fluid gearing
    • F16H47/02Combinations of mechanical gearing with fluid clutches or fluid gearing the fluid gearing being of the volumetric type
    • F16H47/04Combinations of mechanical gearing with fluid clutches or fluid gearing the fluid gearing being of the volumetric type the mechanical gearing being of the type with members having orbital motion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/12Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/20Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves

Definitions

  • thromboembolic event is one of the most important complications of mechanical heart valves. It may be manifested as thrombosis (figure 1) and result in obstruction or severe insufficiency of the valve or even systemic emboli (mainly cerebral).
  • thromboembolic events increases within three first months after surgery, replacement of mitral valve, and other risk factors of thromboembolism (atrial fibrillation, left ventricular dysfunction, left atrial enlargement, and past history of thromboembolism). For this reason, all patients with mechanical valves have to take anticoagulants mainly Warfarin all over their life. Desired INR limit varies in these patients and it should be considered in prescribing medicine. However, it is not easy considering severe food and medicinal interactions in decrease or increase of warfarin effect, unpredictability of its effect from one person to another and even in different times in one person, and severe variation of INR. Then increase of INR may lead to hemorrhage complications including gastrointestinal, cerebral and other organs.
  • the present invention aims at making mechanical heart valves using Nano technology through adding Nano-materials of Ti0 2 and Si0 2 or ZnO to all surfaces of mechanical valve including leaflets and their surrounding ring.
  • Creating superhydrophobia, establishing negative charge and creating Nanowire pattern it significantly decreases the time and area of contact between valve surfaces and blood cells, platelets and protein molecules which prevents their accumulation on the different parts of the valve such as leaflets and valve ring, subsequently nor thrombosis and neither its severe mentioned complications are occurred therefore there will be no need to prescribe anticoagulant (warfarin).
  • Bileaflet mechanical valve is the most applicable prosthetic valve. Appropriate prosthetic valve is selected for every patient considering different factors.
  • Biological valves do not require long-term treatment with anticoagulants. In comparison with mechanical ones, however, they are less durable and used in older-than-65-years patients, women in reproductive ages, patients with lower life expectancy, and when it is not possible to establish appropriate level of anticoagulants. In the rest cases, mechanical valves are used.
  • Nanowire patterns on surface of a material using Nano- materials such as Ti0 2 and Si0 2 and establishing negative charge may lead to severe superhydrophobia and significant decreases of contact time and area with other materials and considerable decrease of its adhesion.
  • following measures are taken in two stages:
  • Ti0 2 nanowires (dimension: 30-60nm) are dressed up on the mentioned layers with a regular Nano-pattern using Electrophoretic Deposition or each of the mentioned methods such that maximum thickness of the mentioned two layers does not exceed lOOnm. (figure 4)
  • Nano pattern results in forming of two kinds of barrier at Nano scale (10 ⁇ 9 ) in order to prevent thrombosis at the surface of leaflets or ring.
  • Non-conductivity of silicon or ZnO Nanowires creates an electrical barrier in all surfaces of different parts of mechanical valve through accumulation of negative charge at Nano pattern surface. Since protein molecules of coagulation factors and wall of blood cells have negative charges too, they repel each other so they will not adhere and accumulate which is mandatory to thrombosis formation.
  • the invention may be ideally used in following cases:

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Inorganic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne une valve cardiaque prothétique mécanique résistante à la thrombose qui est un équipement médical technique. La thromboembolie est une des complications les plus importantes des valves mécaniques disponibles qui peuvent apparaître sous la forme d'une formation de caillot sur la valve, son dysfonctionnement, une insuffisance ou une sténose sévère, et une embolie systémique (principalement cérébrale). Par conséquent, ces patients doivent utiliser des anticoagulants, en particulier la warfarine, pendant toute leur vie. Le rapport international normalisé (INR) diffère chez ces patients et il doit être pris en compte dans la prise de médicaments. Cependant, cela n'est pas facile compte tenu des interférences sévères entre aliments et médicaments dans la diminution ou l'augmentation des effets de la warfarine, l'imprévisibilité de ses effets d'une personne à une autre et même à des temps différents chez la même personne, et la variation importante de l'INR. De plus, l'augmentation de l'INR peut conduire à une hémorragie dans différentes parties du corps comprenant le système digestif et le cerveau. De plus, un INR non thérapeutique peut conduire à créer des conditions pour des complications thrombo-emboliques et la vie du patient est menacée dans les deux cas. Par conséquent, les changements continus d'INR constituent le prédicteur indépendant le plus efficace d'un taux de survie réduit chez les patients porteurs de valve cardiaque mécanique. Au moyen de la nanotechnologie, des propriétés des nanomatériaux et du développement d'un revêtement avec des nanofils de dioxyde de silicium (SiO2) ou d'oxyde de zinc (ZnO) et de dioxyde de titane (TiO2), ce plan vise à créer une superhydrophobie ainsi que des barrières électrique et mécanique dans la couche la plus externe de toutes les surfaces de la valve étant en contact avec la circulation sanguine et à prévenir l'accumulation de cellules sanguines (plaquettes, érythrocytes et leucocytes) et de protéines (filaments de fibrine) et la thrombose. De cette manière, les événements thrombo-emboliques et la colonisation de bactéries sur la valve prothétique et l'infection de la prothèse sont prévenus mais il n'est pas nécessaire de consommer des anticoagulants tels que la warfarine.
PCT/IB2015/052690 2014-06-09 2015-04-14 Valve cardiaque prothétique mécanique résistante à la thrombose Ceased WO2015189716A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IR13933002830 2014-06-09
IR139350140003002830 2014-06-09

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WO2015189716A1 true WO2015189716A1 (fr) 2015-12-17

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022083758A1 (fr) * 2020-10-23 2022-04-28 吉林启明皓月生物科技有限公司 Matériau anticoagulant pour valvule cardiaque artificielle, procédé de préparation s'y rapportant et utilisation associée
WO2022083759A1 (fr) * 2020-10-23 2022-04-28 吉林启明皓月生物科技有限公司 Matériau de valve cardiaque artificielle anticoagulation et anticalcification, son procédé de préparation et son application
WO2024140222A1 (fr) * 2022-12-30 2024-07-04 深圳市健心医疗科技有限公司 Structure de feuillet valvulaire, procédé de préparation de structure de feuillet valvulaire et prothèse valvulaire

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4935030A (en) 1985-06-17 1990-06-19 Medtronic, Inc. Mechanical heart valve prosthesis
WO2001030274A1 (fr) 1999-10-22 2001-05-03 Gunze Limited Valve cardiaque mecanique et procede de production
WO2005042646A2 (fr) * 2003-10-30 2005-05-12 Applied Medical Resources Corporation Traitement et modifications de surfaces faisant appel a des materiaux nanostructures
US6896700B2 (en) 2003-06-06 2005-05-24 Tamkang University Tri-leaflet mechanical heart valve
US20060204738A1 (en) * 2003-04-17 2006-09-14 Nanosys, Inc. Medical device applications of nanostructured surfaces
WO2010022107A2 (fr) * 2008-08-18 2010-02-25 The Regents Of The University Of California Revêtements nanostructurés superhydrophobes, superoléophobes et/ou superhomniphobes, procédés de fabrication et applications associés
US20110091510A1 (en) * 2008-04-30 2011-04-21 University Of Florida Research Foundation, Inc. Nanorod materials and methods of making and using same
US20110223212A1 (en) * 2008-09-19 2011-09-15 Innovative Surface Technologies Inc. Drug eluting superhydrophobic coatings
US8470026B2 (en) 2010-10-26 2013-06-25 National Taiwan Ocean University Mechanical heart valve apparatus

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4935030A (en) 1985-06-17 1990-06-19 Medtronic, Inc. Mechanical heart valve prosthesis
WO2001030274A1 (fr) 1999-10-22 2001-05-03 Gunze Limited Valve cardiaque mecanique et procede de production
US20060204738A1 (en) * 2003-04-17 2006-09-14 Nanosys, Inc. Medical device applications of nanostructured surfaces
US6896700B2 (en) 2003-06-06 2005-05-24 Tamkang University Tri-leaflet mechanical heart valve
WO2005042646A2 (fr) * 2003-10-30 2005-05-12 Applied Medical Resources Corporation Traitement et modifications de surfaces faisant appel a des materiaux nanostructures
US20110091510A1 (en) * 2008-04-30 2011-04-21 University Of Florida Research Foundation, Inc. Nanorod materials and methods of making and using same
WO2010022107A2 (fr) * 2008-08-18 2010-02-25 The Regents Of The University Of California Revêtements nanostructurés superhydrophobes, superoléophobes et/ou superhomniphobes, procédés de fabrication et applications associés
US20110223212A1 (en) * 2008-09-19 2011-09-15 Innovative Surface Technologies Inc. Drug eluting superhydrophobic coatings
US8470026B2 (en) 2010-10-26 2013-06-25 National Taiwan Ocean University Mechanical heart valve apparatus

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022083758A1 (fr) * 2020-10-23 2022-04-28 吉林启明皓月生物科技有限公司 Matériau anticoagulant pour valvule cardiaque artificielle, procédé de préparation s'y rapportant et utilisation associée
WO2022083759A1 (fr) * 2020-10-23 2022-04-28 吉林启明皓月生物科技有限公司 Matériau de valve cardiaque artificielle anticoagulation et anticalcification, son procédé de préparation et son application
WO2024140222A1 (fr) * 2022-12-30 2024-07-04 深圳市健心医疗科技有限公司 Structure de feuillet valvulaire, procédé de préparation de structure de feuillet valvulaire et prothèse valvulaire

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