WO2014087414A1 - Endoprothèse cardiovasculaire à base de titane métallique avec une surface nanostructurée et procédé pour la fabriquer - Google Patents

Endoprothèse cardiovasculaire à base de titane métallique avec une surface nanostructurée et procédé pour la fabriquer Download PDF

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WO2014087414A1
WO2014087414A1 PCT/IN2012/000788 IN2012000788W WO2014087414A1 WO 2014087414 A1 WO2014087414 A1 WO 2014087414A1 IN 2012000788 W IN2012000788 W IN 2012000788W WO 2014087414 A1 WO2014087414 A1 WO 2014087414A1
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Prior art keywords
stent
stents
titanium
endovascular prosthesis
smooth muscle
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PCT/IN2012/000788
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English (en)
Inventor
Deepthy Deepthy Menon Krishnaprasad Chennazhi Sreerekha Pr. Chandini C. Mohan. V Nair
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Amrita Vishwa Vidya Peetham University
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Priority to PCT/IN2012/000788 priority Critical patent/WO2014087414A1/fr
Publication of WO2014087414A1 publication Critical patent/WO2014087414A1/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
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified 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
    • 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

Definitions

  • nanostructured titania layer that promotes superior endothelialization
  • nanotexturing of stents involves subjecting the metallic surface to hydrothermal
  • This invention describes a medical device, which may be used for example, as a vascular (stent, heart valves), endotracheal or prostatic device.] BACKGROUND OF THE INVENTION
  • Cardiovascular diseases results from arterial narrowing due to the accumulation of fatty deposits on the arterial wall, which restricts blood flow through the vessel.
  • Percutaneous transluminal angioplasty referred to commonly as angioplasty, helps to enlarge the lumen of the affected artery by radial hydraulic expansion.
  • the vessel restenoses chronically or closes down acutely, negating the positive effects of angioplasty procedure [1].
  • vascular smooth muscle cells in the artery wall undergo hyperproliferation and invade and spread into the inner vessel lining, making the vessels susceptible to complete blockage when a local blood clotting occurs, leading to the death of tissues.
  • Stents are elongated tubular metallic structures, with either solid or lattice-like walls, and can either be balloon expandable or self-expanding. With the stent in place, restenosis may or may not be inhibited, but the degree of blockage would be reduced due to the structural strength of the stent opposing the inward force of any restenosis, thus maintaining the patency of the vessel.
  • an endoluminal prosthesis device ultimately helps to repair, replace or correct a damaged blood vessel.
  • the prosthesis can help rectify a variety of defects including stenosis of the vessel, thrombosis, occlusion or an aneurysm.
  • the stents deployed in conditions of artherosclerosis or other diseased states demands that the stent material be appropriately biocompatible, hemocompatible as well as mechanically durable. This necessitates the use of metals including titanium (Ti), 316L stainless steel (SS - medical grade), Nitinol (an alloy of Nickel and Titanium) and Cobalt-Chromium (CoCr), for vascular stenting applications [3].
  • the stent material can induce allergic reactions in a significant percentage of patient population, as in the most commonly used Nickel containing materials such as Nitinol and even medical grade 3 6L SS, which contains nearly 12% Nickel.
  • Titanium and its alloys are well known for its biocompatibility, corrosion resistance, toughness, durability, etc., making it an ideal material for vascular stents.
  • in-stent restenosis is a known problem associated with using bare metal stents, eventually leading to thrombosis. This occurs due to excessive vascular smooth muscle cell (VSMC) proliferation as a result of injury at the time of stent implantation and dysfunction of endothelial cells (ECs).
  • VSMC vascular smooth muscle cell
  • drug-eluting stents appear to be a significant step forward in the treatment of coronary artery disease, there is concern regarding the long terms risk of sub-acute thrombosis associated with drug eluting stents [4].
  • drug coated stents are considerably more expensive than uncoated stents, and may be unnecessary for a relatively large percentage of angioplasty patients in which they are implanted, being prescribed mainly in cases to avoid quick, undesirable and adverse reactions soon after implantation.
  • Recent studies revealed that for patients in which a drug-ccated stent was implanted after stenosis of a coronary vessel, the mortality rate is higher than for patients who were treated with an uncoated metal stent.
  • the object of the present invention is to provide a stent, with which the risk of restenosis is reduced without having to use antiproliferative active substances.
  • a feasible approach to improving the above mentioned pitfalls of metallic stents is to provide a biocompatible metal surface that specifically promotes rapid endothelialization and blood compatibility, and simultaneously inhibit high smooth muscle cell proliferation. Such a biocompatible surface would also help to minimize or avoid any adverse foreign body responses. This can be achieved by providing appropriate surface treatments to the metallic stent surface, such as surface coatings and/or surface modifications [6].
  • the surfaces with tunable nanoscale surface features can also exhibit varied wetting characteristics (such as hydrophilicity), which in turn affect the cellular interaction with the biomaterial as well as its blood compatibility.
  • a desirable cellular response on nanostructured surfaces can lead to stronger biointegration with adjacent tissues, thereby increasing both lifetime and bonding between appropriate tissues and implant surfaces.
  • a nanostructured stent surface can attach endothelial cells more easily than a smooth one, resulting in an accelerated endothelialisation process. The so formed endothelial layer is very smooth, thereby largely preventing thrombus formation and restenosis.
  • the endothelium forming over the stent should maintain its native functionality, capable of releasing antithrombogenic factors as well as factors inhibiting smooth muscle proliferation. Also, any surface coating or treatment provided should be completely adherent to the metal surface.
  • US Patent No: 2008/0147167A1 describes a method for producing a stent coated with a layer of noble metal oxide over the substrate composed of a less noble metal, to improve the biocompatibility and antiproliferative characteristics [20].
  • the noble metal oxide layer such as iridium oxide and the less noble alloy or metal such as titanium or niobium or platinum enriched medical grade stainless steel.
  • US20090118813 disclosure relates to patterned endoprostheses that can facilitate selective endothelialization of the endoprosthesis surface [21].
  • the endoprosthesis can have a patterned coating, wliich can be formed of materials such as titanium oxide, titanium nitride or iridium oxide.
  • the patterned coating is suggested to aid in enhanced endothelialization and decreased adhesion and proliferation of smooth muscle cells, which can thereby reduce restenosis.
  • PCT Publication No. WO 99/07308 discloses stents wherein a portion of. a stent supporting structure is encapsulated with a thin flexible coating made of a polymer which can be used as a carrier for supporting therapeutic agents and drugs.
  • a polymer which can be used as a carrier for supporting therapeutic agents and drugs.
  • bioerodable polymers are used as drug delivery coatings, porosity is variously claimed to aid tissue ingrowth, make the erosion of the polymer more predictable, or regulate/ enhance the rate of drug release, as, for example, disclosed in U.S. Pat. Nos. 2010031232, 7901451 [22,23].
  • the non-encapsulated portions of the stents form porous exteriors rendering them more biocompatible while reducing blood clots.
  • the said stents have the disadvantage that they are complicated to manufacture and expensive.
  • the above mentioned products have the drawback that the implant surfaces are provided with various kinds of coatings which can ultimately cause structural instabilities upon implantation and also is produced through stringent routes.
  • the present invention focuses on producing a stable bioactive patterned stent surface that is easy to manufacture and economically viable, particularly favoring the endothelialization process with reduced smooth muscle proliferation and platelet adhesion.
  • NaOH alkaline conditions
  • the present invention utilizes this novel, versatile technique to produce an endovascular metallic device (stent) that aims at rectifying the causes responsible for restenosis after stent implantation, without the incorporation of any antiproliferative pharmaceutical agents. It follows that for successful interventional use, the stent should possess characteristics of relatively non-allergenic reaction, resistance to vessel recoil, sufficient thinness to rriinimize obstruction to flow of blood and biocompatibility to vessel, which can all be met through the use of nanostructured stents.
  • vascular st nt applications for eg. cardiovascular, neurovascular peripheral vascular stents
  • metallic titanium possessing uniform nanostructural surface topography of distinct morphology.
  • the product based on surface modified titanium has been tested in vitro to demonstrate good endothelialization, with reduced smooth muscle cell proliferation, excellent blood compatibility and minimal platelet adhesion.
  • Fig. 1 Schematic representation of the Ti endovascular prosthesis (stent in this case)
  • A Outer diameter
  • B inner diameter
  • C Hole horizontal length
  • D Hole Vertical width
  • E Strut width.
  • FIG. 2 Representative scanning electron micrograph images of the nanostructures generated on the stent implant by hydrothermal modification shown at different magnifications in (i), (ii) and (iii).
  • A Ti implant surface before hydrothermal treatment; and hydrothermally modified Ti implants with nanostructural features
  • B Structure A
  • C Structure B
  • D Structure C and
  • E Control polished Ti
  • FIG. 3 Contact angle measured on nanostructured Ti surface (A) Structure A (B) Structure B (C) Structure C in comparison to (D) control surface.
  • Fig. 4 Graph showing cell viability analysis using Alamar blue assay on various surfaces at 24, 72 and 120 h, with control polished surface as control (A) Enhanced cell viability of HUVECs (B) Decreased viability of SMC; Statistical significance was assessed relative to control nanopolished Ti for each nanostructure with * and ** denoting p ⁇ 0.05, and p ⁇ 0.01 versus control respectively.
  • FIG.5 Scanning electron micrographs and Actin fluorescent staining of HUVECs proliferation at two different incubation periods on various Ti surfaces - Structure A, Structure B, Structure C and control have been labeled as A, B, C and D respectively.
  • (Ai to Di) SEM morphology analysis at 24 h (Aii to Dii) Fluorescent analysis at 24 h (Aiii to Diii) SEM morphology analysis at 72 h and (Aiv to Div) Fluorescent analysis at 72 h.
  • Arrows indicates the philopodial extensions of cell proliferation on the nanosurfaces.
  • FIG. 6 Scanning electron micrographs and Actin fluorescent staining of SMCs proliferating on various surfaces - Structure A, Structure B, Structure C and control have been represented as A, B, C and D respectively.
  • Higher magnification SEM micrographs are shown in inset on the right side. Arrows shown in the figure indicate the rounded SMCs as a result of nanomodification; Magnification: 60X
  • FIG. 8 Functionality analysis of SMC cultured on various Ti samples using Smooth muscle calponin and smooth muscle a-actin staining at 48 h
  • A Structure A
  • B Structure B
  • C Structure C
  • D Control using confocal microscopy. Red-calponin; Green-Smooth muscle actin.
  • Right panel shows the merged images of SMA and Calponin; Magnification: 63X.
  • Fig. 9 Blood compatibility studies on various Ti surfaces using (A) Hemolysis assay (B) SEM image of platelet adhesion [i- Structure A, ii- Structure B, ii- Structure C, iv- Structure D, v- Positive control (lower magnification), vi- Positive control (higher magnification)] (C) Platelet aggregation by cell counter and D) Platelet activation by flow cytometry.
  • A Hemolysis assay
  • B SEM image of platelet adhesion [i- Structure A, ii- Structure B, ii- Structure C, iv- Structure D, v- Positive control (lower magnification), vi- Positive control (higher magnification)]
  • C Platelet aggregation by cell counter and D) Platelet activation by flow cytometry.
  • biocompatible component any component that is intended for long or short-term contact with biological tissues and also which does not induce any adverse biological response of the tissue is encompassed by the term "biocompatible component” or “biocompatibility” of the material.
  • biocompatible component is an implant such as cardiovascular, orthopaedic, or dental implants.
  • the term "implant” includes within its scope any device that is intended to be implanted into a human body and that can serve the purpose of replacing the anatomy and/ or restoring any normal function of the body.
  • endovascular prostheses can be a medical device that is tubular (e.g., a stent) and/or balloon extendable.
  • endoprosthesis refers to stent prototypes created through laser cutting.
  • nanosurface modification refers to the process of surface modification wherein the metallic surface is treated chemically by one or many means to achieve a homogeneous / uniform surface topography with structural features in the nanoscale with dimensions ranging from 1 - 500 nm.
  • hydrophilid treatment refers to a chemical technique of surface modification of the metal, wherein the metals are treated in a sealed autoclave at elevated temperature and pressure, in a chemical environment offered by alkaline solution and in certain cases a combination with suitable chelating agent, thereby providing a roughened nanotexture to the implant surface.
  • endothelialization refers to the capability of implanted endovascular prosthesis to promote adhesion and proliferation of endothelial cells to cover the embodiment.
  • 'inhibiting restenosis means reducing the extent of restenosis observed following a vascular injury at the time of stent deployment, which is measured by average percentage reduction in the stenosis rate at a selected time following stent placement, e.g., 1-6 months.
  • blood compatibility refers to the ability of the vascular implant in direct contact with blood to inhibit blood hemolysis; platelet adhesion, aggregation and activation; inhibit blood coagulation and clotting; provide minimal immunogenecity.
  • the present invention is focussed on development of a medical device for treating abnormalities of the cardiovascular system. Those with ordinary skill in the art will appreciate that the below described invention can be applied to other implantable medical devices.
  • the present invention relates to the development of implantable medical devices, which can be endovascular prosthesis (stents) based on nanosurface modified metals or metal alloys of titanium.
  • implantable medical devices which can be endovascular prosthesis (stents) based on nanosurface modified metals or metal alloys of titanium.
  • the presently preferred process is performed through the following sequence of steps: (i) tube processing from ingot (ii) laser cutting of tube (iii) mechanical and chemical finishing (iv) electropolishing (v) vacuum annealing; and (vi) hydrothermal processing in alkaline conditions for nanosl_ractaring.
  • Fig 1. is a perspective view of the endoprosthesis (stent) of an expanded hollow tubular self-supporting structure.
  • the embodiment In its expanded state, the embodiment has got an outer diameter of about 3-4 mm and a total length of 10-20 mm.
  • the tubular stent In the laser cutting process, the tubular stent is provided with an array of through-holes or openings through sidewall, defined and bounded by struts or links that enables stent expansion at the target site.
  • a conventional laser with narrow beam enables the precise cutting or opening to form a latticework sidewall following a programmable pattern.
  • Lattice sidewall has a pattern of interconnected struts by creating a series of longitudinally repeating diamond shaped openings parallel to the longitudinal axis.
  • Step 1 Surface cleaning of the mechanically coarsened, chemically finished, vacuum annealed Ti implant surface through successive ultrasonication in acetone and distilled water.
  • Step 2 Treatment of the cleaned Ti implant in alkaline medium in an autoclave kept inside a high temperature furnace with programmable temperature controller to vary the temperature in the range of 100-300° C for different time intervals (1-10 hrs).
  • Step 3 Drying of the hydrothermally treated Ti implant samples in a medically sterile environment and sterile sealing to obtain the finished product.
  • Fig. 2 gives electron micrographs of the varying surface features of Ti stent prototype.
  • the above said processes fabricated on the metallic stent prototype (Fig. 2A) resulted in nanostructures with variable morphology, labelled as (B) Structure A (C) Structure B and (D) Structure C. These nanostructures are compared with conventional polished surfaces labelled as ( ⁇ ) Control.
  • Structure A obtained through hydrothermal processing of the stent has a foliate or leaf like 2D construct, formed of more or less flat, broad nanocues of width in the range of 135 ⁇ 43.3 nm and crevices in between, of dimensions 117 ⁇ 21.5 nm.
  • Structure B discloses an architecture where, the Titania nanostructures form relatively organised pores with diameter varying as 109 ⁇ 42.2 nm. Pores are well defined by an outer wall separating each pore with thickness of approximately 55.8 ⁇ 10.5 nm.
  • Structure C shows nanofeatures presenting a 1-D, more or less vertically aligned rod like morphology, with diameters of 114 ⁇ 10.2 nm, with distance between the two features in the range of 146 ⁇ 71.3 nm.
  • the features are distributed uniformly as an array of nanostructures over the surface.
  • the features can vary to include rods, needles, pits, pores, mesh, spheres, and/or polygonal shapes such as triangles, squares, rectangles, diamonds, and hexagons depending on the processing conditions.
  • An endovascular prosthesis of any desired shapes and sizes (for example, Ti or other metallic stents with prosthesis si2es ranging from 1 mm to 46 mm) can be processed to achieve the nanosurface features.
  • the features can be ordered or non-ordered, clustered or non-clustered, in phase or out-of-phase, parallel or non-parallel.
  • a specific set of nanostructures have been selected for the in vitro analysis.
  • the surface modifications or topographies created on a particular substrate of the embodiment can be sensed by the cells as they adhere. Many factors, such as differences in surface energy gradients, hydrophobicity, hydrophilicity, charge, and/ or pH is supposed to affect cell adhesion and these properties are affected by topological and/ or chemical surface patterns. In some embodiments, surface modification can result in space confinements affecting the local solute concentration, cell wettability and protein exchange. Some embodiments show superior cellular adhesion and function on hydrophilic surfaces because of enhanced competitive binding and bioactivity of adhesion proteins such as fibronectin on hydrophilic surfaces, and/or an increased cellular ability to modify their interfacial proteins. The degree of hy ⁇ drophilicity/phobicity was estimated through contact angle measurements.
  • a distinct feature of the present invention relates to the observation that nanosurface modification, of the kind produced by the hydrothermal process described, provided substantially improved in vitro biocompatibility, with enhanced endothelialisation and improved cellular functions, decreased adhesion of other cells such as smooth muscle cells, platelets, and/or monocytes in comparison to unmodified metallic surfaces.
  • Cell proliferation studies revealed that all the developed nanostructure modified surfaces showed significantly enhanced cellular adhesion and proliferation than polished Ti after 1, 3 and 5 days of in-vitro culture using alamar blue assay (Fig 4).
  • Enhanced proliferation was observed on Structure A in comparison to control-polished titanium and odier nanostructured implants.
  • VSMC viability was badly affected, showing a significandy reduced VSMC proliferation with respect to the control polished surface.
  • an embodiment with nanosurface modification can influence the expression of SMC differentiation markers that helps to maintain the differentiated state of VSMCs, promoting a non-proliferative contractile phenotype.
  • Staining of VSMCs on various modified and unmodified surfaces using intracellular SMC specific markers such as smooth muscle -actin (SMaA) and calponin suggest their efficacy as successful endovascular prosthesis (for eg. stents).
  • VASCULAR STENTS E.G., CORONARY STENTS, AORTIC STENTS, PERIPHERAL VASCULAR STENTS, NEUROVASCULAR STENTS

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un procédé de préparation d'endoprothèses métalliques biocompatibles à base de titane ayant une couche de titane nanostructurée qui favorise une endothélialisation supérieure, avec inhibition simultanée de la prolifération des cellules de muscle lisse et de l'adhésion des plaquettes, destinée à une utilisation spécifique dans des applications cardiovasculaires. Le procédé de nanotexturisation des endoprothèses implique la soumission de la surface métallique à un traitement hydrothermique dans des conditions alcalines à températures élevées. Cette invention décrit un dispositif médical qui peut être utilisé comme dispositif vasculaire (endoprothèse, valvules cardiaques) ou endotrachéal ou prostatique.
PCT/IN2012/000788 2012-12-03 2012-12-03 Endoprothèse cardiovasculaire à base de titane métallique avec une surface nanostructurée et procédé pour la fabriquer WO2014087414A1 (fr)

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Cited By (3)

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Publication number Priority date Publication date Assignee Title
WO2018029166A1 (fr) 2016-08-09 2018-02-15 Jožef Stefan Institute Procédé de revêtement d'un dispositif médical, en particulier d'une endoprothèse vasculaire
US10420860B2 (en) 2015-01-09 2019-09-24 Kondapavulur T. VENKATESWARA-RAO Coatings, materials, and devices with biohealing properties
EP4049690A1 (fr) 2021-02-25 2022-08-31 Jozef Stefan Institute Procédé de traitement de métaux médicaux et leurs alliages

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