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WO2008072065A1 - Procédé de revêtement et/ou d'imprégnation - Google Patents

Procédé de revêtement et/ou d'imprégnation Download PDF

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Publication number
WO2008072065A1
WO2008072065A1 PCT/IB2007/003865 IB2007003865W WO2008072065A1 WO 2008072065 A1 WO2008072065 A1 WO 2008072065A1 IB 2007003865 W IB2007003865 W IB 2007003865W WO 2008072065 A1 WO2008072065 A1 WO 2008072065A1
Authority
WO
WIPO (PCT)
Prior art keywords
protein material
process according
shaped body
covering
organic solvent
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.)
Ceased
Application number
PCT/IB2007/003865
Other languages
English (en)
Inventor
David Maniglio
Claudio Migliaresi
Antonella Motta
Michele Preghenella
Eva Servoli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lincotek Trento SpA
Original Assignee
Eurocoating SpA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Eurocoating SpA filed Critical Eurocoating SpA
Publication of WO2008072065A1 publication Critical patent/WO2008072065A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D13/00—Electrophoretic coating characterised by the process
    • C25D13/04—Electrophoretic coating characterised by the process with organic material
    • 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
    • A61L27/34—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
    • 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

Definitions

  • the invention refers to a covering and/or impregnating method suitable for covering surfaces of a shaped body.
  • these shaped bodies comprise medical or biomedical products, including materials suitable for making implants and prostheses.
  • biocompatible is meant the capacity of a foreign body to be accepted by an organism with which it comes into contact.
  • a good biocompatible material does not cause negative uncontrollable reactions and can therefore be surgically implanted with limited or no contraindications or undesired effects.
  • An implant material must however possess further characteristics, including mechanical properties suitable for the function it has to perform once implanted.
  • mechanical properties suitable for the function it has to perform once implanted In the field of orthopaedic prostheses materials are already used such as metals, alloys, ceramics, polymers and bioglasses.
  • Processes are known for example suitable for covering alloys or metals with a covering suitable for upgrading their biocompatibility and their bioactivity; this covering is, for example, of the ceramic type.
  • the ceramic can be made up of hydroxyapatite or by-products, already used because they are very similar to the biological structure of the bone.
  • Hydroxyapatite is a mineral belonging to the apatite family containing calcium phosphates and represents one of the fundamental components of the bone. Hydroxyapatite thus provides a good bio substrate for the adhesion and the proliferation of the bone cells, allowing the organism to incorporate the prosthesis and promote the formation of new bone tissue.
  • the metal on the other hand provides a support with high mechanical properties.
  • the ceramic undergoes high temperature to make it liquid and then apply it to the prosthesis.
  • the ceramic is sprayed on the prostheses, covering this, and is then subsequently cooled.
  • a first drawback is that the liquefying of the ceramic produces great energy expenditure and the use of extremely costly machinery.
  • a second drawback is that the spray application does not allow uniform spreading of the ceramic: in fact, the deposited layer has variations in thickness on different points of the support.
  • An object of the invention is to upgrade the prior art.
  • Another object of the invention is to develop a process suitable for producing a covering of protein material, that can be reliably, easily and quickly applied and which is cost effective, and has the capacity to favour the adhesion and the proliferation not only of the bone cells, but also of those of other cellular phenotypes, stimulating the formation of new tissue and giving the covered material characteristics of biocompatibility and anti-thrombogenicity.
  • a covering method suitable for covering surfaces of a shaped body, comprising: placing an electrolytic solution containing protein material in an electrochemical cell; producing a difference in potential between electrodes of said electrochemical cell generating a flow of protein material towards at least one of said electrodes; placing said shaped body in said electrochemical cell in such a way that said flow touches said surfaces, covering them with said protein material, characterized in that said protein material comprises fibroin.
  • a shaped body that comprises a covering of protein material, characterized in that said protein material comprises fibroin.
  • a first advantage of the invention is that the covering material is made up of biological material, and therefore similar to the structures of the organism with which it comes into contact.
  • a second advantage of the invention is that the fibroin, in particular, is known for its biocompatibility characteristics, i.e. it is well tolerated by the organism.
  • a third advantage is supported by various studies that have shown that the amino acid sequences of fibroin favour cell adhesion and proliferation, prompting the regeneration of the tissues close to the implant site and cellular colonisation.
  • a further advantage of the invention is that the method can be easily applied on metal- based prostheses or implant materials or which in any case comprise conducting materials or, again, also on non-conducting porous materials.
  • Another advantage of the invention is that the covering, once the protein material has deposited, can be stabilised to upgrade its mechanical characteristics.
  • a further advantage of the invention is that the covering of protein material can be made variably porous according to specific requests to upgrade its predisposition to cellular colonisation, and thus favour specific processes.
  • An additional advantage of the invention is that uniform coverings of protein material are also obtained on irregular surfaces; in particular, porous shaped bodies can be obtained impregnated with fibroin on which the inner surface cavities are also covered with protein material.
  • Another advantage is that conductor bodies of any shape and size can be covered.
  • a further advantage of the invention is that the entire process is performed with low energy expenditure and without using costly machinery.
  • Another advantage of the invention is that the covering of protein material can be associated with additives of various kinds, including biologically active molecules such as cellular growth and adhesion factors, or drugs.
  • Another advantage is that depositing protein material on a rigid surface allows to overcome the problems related to the sensitivity of the cells to local rigidity, creating a softer layer on which the cells can proliferate and in which nutrients and metabolic substances can spread.
  • a further advantage of the invention is that the covering of protein material can comprise other proteins besides fibroin or other natural or synthetic molecules with electric charge in non-null solution.
  • the method according to the invention entails placing an electrolytic solution containing protein material, dissolved or in suspension, in an electrochemical cell.
  • This protein material has electrophoretic properties, meaning it has the capacity to move in the electrolytic solution towards an electrode with an appropriate charge.
  • the electrochemical cell comprises a generator able to produce a difference of potential between the electrodes.
  • the electrodes of the electrochemical cell are made up of electric conductor bodies made, for example, with metals, graphite, conducting oxides, conducting polymers and any conducting material, and suitable for being immersed in the electrolytic solution.
  • the protein material After having produced an adequate electric field, the protein material starts to migrate towards the electrode with appropriate charge, generating a flow of protein material towards this; this flow is therefore the upshot of the movement of all the charged molecules in the electrolytic solution towards the opposite electrode.
  • the placing is further provided of a shaped body immersed in the electrolytic solution and placed between the electrodes or in any case in such a way that the flow of protein material laps or cuts into or touches its surfaces, covering these with the protein material.
  • the weak chemical interactions that are established are, for example: Van der Waals forces, hydrogen bonds, dipole moments, hydrophobic or electrostatic interactions.
  • the shaped body is a product substantially, but not only, intended for medical or biomedical use, such as for example supports for cell cultivation, implant materials and prostheses.
  • the shaped body on which to make the deposition is made up of an electric conducting material, it can itself represent one of the two electrodes, allowing the direct deposit of the fibroin on the surface of the shaped body; in this case therefore, it is enough to place the shaped body in the solution and this will act as an electrode and its counter-electrode, both connected to the respective poles of the battery.
  • This method thus permits covering metal prostheses or prostheses made up of any conducting material by simply replacing the electrode on which deposition occurs with the prosthesis.
  • the deposition of fibroin is obtained by placing at least one portion of the shaped body in a substantially transversal position with respect to the direction of migration of the protein material; in migrating, the molecules in solution encounter the surface of the shaped body and deposit on this.
  • one of the two electrodes can be fitted, completely or partially, inside the shaped body, before being removed or also left inside the shaped body at the end of the covering process.
  • the shaped body comprises a porous matrix
  • the flow of protein material can also migrate inside the pores and the cavities thus impregnating the shaped body; in fact, the fibroin also covers the surface of the inner interstices, obtaining a porous material impregnated with fibroin with excellent biological properties.
  • the matrix if made of electric conducting material, can itself be the electrode, otherwise it can be placed between the two electrodes.
  • the electrolytic solution is made up of water in which is dissolved a quantity of fibroin between 0.1% and 15%; it has been ascertained that the best results are obtained with concentrations of fibroin of around 1%.
  • To the electrolytic solution can also be added proteins different to fibroin or other different molecules to obtain a covering of mixed protein material.
  • the power generator maintains a difference in potential between the electrodes between 0 and 40 V, nevertheless this interval can be extended according to need.
  • Increase in voltage is matched by an increase in the deposition speed but also in the production of gas bubbles or other undesired effects, for example, the formation of a non-uniform covering, deriving from the presence of these bubbles or from alterations of the components used in the process; for this reason, the best difference in potential is between 1 V and 5 V.
  • the pH of the solution determines the direction of the migration of the protein material in solution; in particular, when the process occurs in a pH value interval between 6 and 7, the fibroin migrates towards the positive electrode.
  • the electro-deposition process occurs at room temperature.
  • the distance between the two electrodes can vary from just a few millimetres to several centimetres, bearing in mind that the shorter the distance, the higher the deposition speed.
  • the number and the shape of the electrodes that can be immersed in the solution can vary.
  • the start of the power generator produces an electric current deriving from the passing of the electrons exchanged with the electrodes in the processes and reductions of the molecules and/or of the ions present in solution, as is supported by the continuous flow of these molecules and/or ions towards the electrodes.
  • the quantity of deposited protein material therefore depends on different variables such as: applied voltage, concentration and volume (for very small volumes, an impoverishment of the reagents can occur) of the initial solution, pH, electrode material and their distance.
  • the covering of the protein material obtained after deposition on the shaped body can be stabilised to make it stable and insoluble in water, and if necessary dry it by means of drying or freeze-drying. It is known that, in its soluble form, fibroin is found in the random coil and a-helical structures, which can also remain at the time of deposition on the shaped conductor body.
  • the transformation can be induced of the fibroin towards the ⁇ sheet shape by treating this covering with an organic solvent, i.e. by immersing the surface of a conductor body covered with fibroin in a solution containing water and at least one organic solvent in a percentage between 20% and 100% (normally between 60% and 80%) for a predetermined time interval between 1 and 24 hours.
  • This organic solvent is for example a hydrophilic alcohol such as methanol.
  • the covering of protein material can be stabilised by treating it with water vapour, meaning placing the covered shaped bodies in an environment saturated with water vapour for a predetermined time interval such as to induce the crystallisation of the fibroin, and which is normally between 1 and 24 hours. After depositing the fibroin, the covering of protein material can undergo a freeze- drying process.
  • the deposited protein material undergoes a transformation from a more or less compact gel to a sponge with controlled porosity.
  • This covering sponge shape besides being preferable to the gel one for certain uses, can increase practicality and make its preservation easier in conditions of sterility.
  • the freeze-drying technique is used; the covering temperature of protein material is lowered to -2O 0 C or -80 0 C freezing the liquid component, and then the ice thus obtained is sublimated under vacuum.
  • the covering of protein material can be sterilised using any of the chemical or physical means known to the technician in the field such as, for example ⁇ rays.
  • Fibroin is a protein obtained by separation and purification from the cocoon of the larva of a number of organisms, such as, for example Bombyx mori.
  • fibroin can be used taken from various breeds of Bombyx mori, from other lepidopters, from anthropods, from genetically modified organisms and in general from other biological or synthetic sources.
  • fibroin in a support for the cellular growth or implant, whether this is used for cell growth in vitro or in vivo or for the regeneration of tissues, improves the support's capacity to ensure the proliferation of the cells themselves without causing an immune reaction or extending the inflammatory reaction; this effect is thought to be determined by amino acid sequences favourable to the adhesion and the activation of the cellular metabolism.
  • the covering of protein material can be associated, for purposes of improving the biological characteristics, with additives comprising biologically active molecules, including cellular growth or adhesion factors, or antibiotics, anti-inflammatories, etc...

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un procédé approprié pour le revêtement de surfaces d'un corps façonné comprenant les étapes suivantes: la placement d'une solution électrolytique contenant un matériau à base de protéine dans une cellule électrochimique ; la production d'une différence en potentiel entre des électrodes de la cellule électrochimique entraînant la génération d'un écoulement du matériau à base de protéine vers au moins une des électrodes ; le placement du corps façonné dans la cellule électrochimique de sorte que l'écoulement entre en contact avec les surfaces en les recouvrant du matériau à base de protéine, le matériau à base de protéine comprenant de la fibroïne.
PCT/IB2007/003865 2006-12-12 2007-12-10 Procédé de revêtement et/ou d'imprégnation Ceased WO2008072065A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMO20060404 ITMO20060404A1 (it) 2006-12-12 2006-12-12 Metodo di ricopertura e/o impregnazione
ITMO2006A000404 2006-12-12

Publications (1)

Publication Number Publication Date
WO2008072065A1 true WO2008072065A1 (fr) 2008-06-19

Family

ID=39296037

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/003865 Ceased WO2008072065A1 (fr) 2006-12-12 2007-12-10 Procédé de revêtement et/ou d'imprégnation

Country Status (2)

Country Link
IT (1) ITMO20060404A1 (fr)
WO (1) WO2008072065A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1153551A (en) * 1967-06-15 1969-05-29 Jun Mizuguchi Method and apparatus for Obtaining Electro-Deposited Shaped Articles from Fibrous Protein Fibrils
US4264422A (en) * 1979-04-26 1981-04-28 Kureha Kagaku Kogyo Kabushiki Kaisha Method for producing shaped articles by electrodepositional shaping from fibrous substance having electrophoretic property and apparatus for same
US4294677A (en) * 1978-11-17 1981-10-13 Kureha Kagaku Kogyo Kabushiki Kaisha Method for electrodepositing a protein onto an ion-exchange membrane
DE19811900A1 (de) * 1998-03-18 1999-09-23 Feinchemie Gmbh Sebnitz Biokompatibles Kompositmaterial
WO2001025403A2 (fr) * 1999-10-01 2001-04-12 Consorzio Per Gli Studi Universitari Substrat bio-artificiel pour la production de tissus et organes animaux, en particulier humains
US6440427B1 (en) * 1991-06-17 2002-08-27 Biovitrum Ab Tissue treatment composition comprising fibrin or fibrinogen and biodegradable and biocompatible polymer
WO2003022909A1 (fr) * 2001-09-11 2003-03-20 Consorzio Per Gli Studi Universitari Procede de preparation d'hydrogels de fibroine de soie

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1153551A (en) * 1967-06-15 1969-05-29 Jun Mizuguchi Method and apparatus for Obtaining Electro-Deposited Shaped Articles from Fibrous Protein Fibrils
US4294677A (en) * 1978-11-17 1981-10-13 Kureha Kagaku Kogyo Kabushiki Kaisha Method for electrodepositing a protein onto an ion-exchange membrane
US4264422A (en) * 1979-04-26 1981-04-28 Kureha Kagaku Kogyo Kabushiki Kaisha Method for producing shaped articles by electrodepositional shaping from fibrous substance having electrophoretic property and apparatus for same
US6440427B1 (en) * 1991-06-17 2002-08-27 Biovitrum Ab Tissue treatment composition comprising fibrin or fibrinogen and biodegradable and biocompatible polymer
DE19811900A1 (de) * 1998-03-18 1999-09-23 Feinchemie Gmbh Sebnitz Biokompatibles Kompositmaterial
WO2001025403A2 (fr) * 1999-10-01 2001-04-12 Consorzio Per Gli Studi Universitari Substrat bio-artificiel pour la production de tissus et organes animaux, en particulier humains
WO2003022909A1 (fr) * 2001-09-11 2003-03-20 Consorzio Per Gli Studi Universitari Procede de preparation d'hydrogels de fibroine de soie

Also Published As

Publication number Publication date
ITMO20060404A1 (it) 2008-06-13

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