WO2015189716A1 - Valve cardiaque prothétique mécanique résistante à la thrombose - Google Patents
Valve cardiaque prothétique mécanique résistante à la thrombose Download PDFInfo
- 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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- WO
- WIPO (PCT)
- Prior art keywords
- valve
- mechanical
- inr
- patients
- nano
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
-
- 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
- A61L31/082—Inorganic materials
- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
-
- 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/02—Use of inorganic materials
- A61L33/022—Metal 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/02—Use of inorganic materials
- A61L33/027—Other specific inorganic materials not covered by A61L33/022 or A61L33/025
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16H—GEARING
- F16H47/00—Combinations of mechanical gearing with fluid clutches or fluid gearing
- F16H47/02—Combinations of mechanical gearing with fluid clutches or fluid gearing the fluid gearing being of the volumetric type
- F16H47/04—Combinations 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
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials 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:
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- 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.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IR13933002830 | 2014-06-09 | ||
| IR139350140003002830 | 2014-06-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2015189716A1 true WO2015189716A1 (fr) | 2015-12-17 |
Family
ID=83230871
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2015/052690 Ceased WO2015189716A1 (fr) | 2014-06-09 | 2015-04-14 | Valve cardiaque prothétique mécanique résistante à la thrombose |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2015189716A1 (fr) |
Cited By (3)
| 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)
| 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 |
-
2015
- 2015-04-14 WO PCT/IB2015/052690 patent/WO2015189716A1/fr not_active Ceased
Patent Citations (9)
| 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)
| 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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