WO2009104168A2 - Implants biomédicaux anti-pathogènes, méthodes et trousses avec matériau photocatalytiquement actif - Google Patents

Implants biomédicaux anti-pathogènes, méthodes et trousses avec matériau photocatalytiquement actif Download PDF

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Publication number
WO2009104168A2
WO2009104168A2 PCT/IB2009/050715 IB2009050715W WO2009104168A2 WO 2009104168 A2 WO2009104168 A2 WO 2009104168A2 IB 2009050715 W IB2009050715 W IB 2009050715W WO 2009104168 A2 WO2009104168 A2 WO 2009104168A2
Authority
WO
WIPO (PCT)
Prior art keywords
photocatalytically active
implant
biomedical implant
light
active material
Prior art date
Application number
PCT/IB2009/050715
Other languages
English (en)
Other versions
WO2009104168A3 (fr
Inventor
Maria STRÖMME
Ken Welch
Håkan ENGQVIST
Original Assignee
Stroemme Maria
Ken Welch
Engqvist Haakan
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 Stroemme Maria, Ken Welch, Engqvist Haakan filed Critical Stroemme Maria
Priority to US12/918,698 priority Critical patent/US20100331978A1/en
Priority to EP09713082A priority patent/EP2254609A2/fr
Publication of WO2009104168A2 publication Critical patent/WO2009104168A2/fr
Publication of WO2009104168A3 publication Critical patent/WO2009104168A3/fr

Links

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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • 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
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/62—Encapsulated active agents, e.g. emulsified droplets
    • A61L2300/624—Nanocapsules
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/63—Crystals

Definitions

  • the present invention is directed to antipathogenic biomedical implants employing photocatalytically active material which exhibits an antipathogenic effect upon irradiation with light.
  • the invention is further directed to methods and kits for providing antipathogenic biomedical implants and to methods for reducing pathogens on a biomedical implant.
  • Infections surrounding skin- or bone-penetrating material are a significant health problem for patients and society, with accompanying major treatment costs.
  • Typical treatments of such infections often include massive doses of systemic antibiotics which risk both complications for the patient and development of antibiotic resistant bacteria.
  • the problem of infection is especially pronounced for implants that penetrate the skin, including but not limited to otology implants, catheters, orthopedic implants and dental implants, and for cosmetic materials penetrating the skin, including piercing jewelry and the like. Infection can arise around both permanent implants and temporary implants.
  • Methods to reduce the occurrence of infections around implants include administration of systemic antibiotics; local delivery of antibiotics via the implant surface (see Hildebrand et al, "Surface coatings for biological activation and functionalization of medical devices," Surface & Coatings Technology, 200:6318-6324 (2006); US Patent No. 7,175,611; Clinical Implant Dentistry and Related Research, 7 (2): 105-111 (2005); and US Patent No. 6,902,397); coating of implants with bactericidal materials, typically platinum, iridium, gold, silver, mercury, copper, iodine, and alloys, compounds and oxides thereof (see US Patent No.
  • the invention is directed to a method for reducing pathogens on a biomedical implant, the method comprising irradiating light on a biomedical implant installed in a patient, wherein the biomedical implant is installed in a position such that the photocatalytically active filler is arranged to receive light irradiated from an external source, the irradiated light being of a wavelength and intensity effective to activate the photocatalytically active filler.
  • the antipathogenic biomedical implants of the present invention comprise at least about 1 weight percent of a photocatalytically active material which exhibits an antipathogenic effect upon irradiation with light.
  • a photocatalytically active material comprises one or more of TiO 2 , ZnO, ZnS, (X-Fe 2 O 3 , WO 3 , SrTiO 3 , K 4 Nb 6 O 17 , CdS, and oxides with perovskite structure (perovskite oxides).
  • the photocatalytically active material comprises crystalline titanium dioxide.
  • the photocatalytically active material as a filler in a matrix material may be arranged in a surface layer of the biomedical implant or may be contained throughout the structure of the implant.
  • the implant is formed throughout its structure of a matrix material comprising at least about 1 weight percent of a photocatalytically active filler which exhibits an antipathogenic effect upon irradiation with light, wherein the photocatalytically active filler is arranged in the matrix material in the implant to receive light irradiated from an external light source.
  • the valence band of this material is positioned very close to the valence band of anatase but the conduction band is about 0.2 eV lower in energy than that of the anatase material, meaning that the driving force for superoxide formation is not as strong as for the anatase phase.
  • UV light see Ibafiez et al., Journal of Photochemistry and Photobiology A: Chemistry, 157(l):81-85 (2003).
  • Surfaces coated with titanium dioxide show antibacterial and self-cleaning characteristics related to the photocatalytic properties of titanium dioxide in the anatase form (see Pelizzetti et al, Nouv. J. Chim., 8:547-550 (1984); Pelizzetti et al, Heterogeneous Photocatalysis, J. Wiley and Sons (1989); Pelizzetti et al, Adv. Colloid and Interf.
  • the implant may include additives to enhance the photocatalytic activity.
  • additives to enhance the photocatalytic activity include sodium perborate, magnesium silicate, and citric acid. These ingredients particularly serve to enhance the photocatalytic activity of photocatalytically active material such as titanium dioxide when the material is exposed to light.
  • the photocatalytically active material comprises TiO 2 nanoparticles with a major portion of the particles, i.e. greater than about 50% by weight, being below about 100 nm in size and wherein a majority, i.e. greater than about 50% by weight, of the particles which are less than 100 nm in size are of the anatase phase.
  • TiO 2 nanoparticles may be produced by sol-gel, solid state diffusion or molecular assembly techniques.
  • the filled matrix material may be arranged at a surface of the implant structure or may be employed throughout the implant structure.
  • the matrix material is employed throughout the structure of the implant and the photocatalytically active filler is arranged in the matrix in at least a surface layer of the biomedical implant.
  • the photocatalytically active filler is arranged in the matrix throughout the structure of the biomedical implant.
  • the filler particles can be porous as discussed above or non-porous and of any shape, including powders, granules or the like.
  • the filler is added to an unhardened biomaterial such as an injectable m-sztw-setting or hardening polymer.
  • an injectable m-sztw-setting or hardening polymer such as an injectable m-sztw-setting or hardening polymer.
  • Such polymers include, but are not limited to, polyurethane, silicone polymers, polyethylene, bisphenol-A diglycidylether methacrylate (in szYw-hardening), polymethylmethacrylate, and glass polyalkenoate cements, optionally in combination with X-ray opacity additives such as barium sulfate and zirconium dioxide.
  • the photocatalytically active filler can also be added to combinations of injectable polymers and ceramics, e.g. combinations of calcium aluminate and glass ionomer cements as well.
  • the photocatalytically active filler comprises crystalline titanium dioxide filler particles. Such particles are commercially available from powder manufacturers or companies, for example, Sigma Aldrich, Degussa and Strem.
  • the photocatalytically active material comprises TiO 2 nanoparticles of anatase phase. These particles may be made by e.g. sol-gel techniques, or they may be purchased from a nanoparticle manufacturer.
  • the pathogenicidal activity of TiO 2 to longer wavelengths (visible light) may be obtained via the addition of e.g. solid solutions into the crystalline phases, examples of solid solutions including nitrogen ions.
  • a photocatalytically active material as described is employed as a filler material for an implant for use in dentistry, wherein the implant may be in the form of e.g. restoratives, temporary fillings, cements, adhesives, base and liners.
  • Yet another specific area for employing a photocatalytically active material as described is as a filler material for an implant in orthopedics.
  • the implant material in the vicinity of the photocatalytically active material should have a high transparency to the light used for photocatalytic activation.
  • the components should be transparent to UV-A light, i.e. light with a wave length between 400 and 315 nm.
  • the photocatalytically active material is deposited as a coating on an implant substrate.
  • implant substrate materials include titanium, stainless steel, cobalt chromium alloys, tantalum, polyurethane, silicon, polyethylene, aluminum oxide, zirconium dioxide, hydroxymethyl- methacrylate, polymethylmethacrylate, and the like.
  • the photocatalytically active material is deposited on the implant substrate with a coating thickness suitably above about 5 nm and below about 1 mm, and in a specific embodiment, the coating thickness is less than about 100 micrometer.
  • the coating can be deposited using any deposition method, and preferable, the deposition method employs a maximum temperature below 800 0 C, and preferably employs a maximum temperature below about 400 0 C.
  • Non-limiting examples of deposition methods include sol-gel methods, physical vapor deposition (including sputtering, arc evaporation and cathodic evaporation), and chemical vapor deposition.
  • the gradient composition may comprise less than about 90 % of the thin film coating thickness. In a further embodiment, the gradient composition comprises at least about 10 % of the thin film coating thickness. In a specific embodiment, the gradient composition has a thickness of greater than about 7 nm, more specifically greater than about 15 nm, and even more specifically greater than about 40 nm, and/or a thickness less than about 30 micrometers, more specifically less than about 1 micrometer, and even more specifically less than about 200 nm. In a further specific embodiment, the gradient composition has a thickness of from about 40 nm to 200 nm.
  • the photocatalytically active material is arranged in the biomedical implant to receive light irradiated from an external light source, i.e., external to the implant, and the method comprises irradiating the biomedical implant with light of a wavelength and intensity effective to activate the photocatalytically active material.
  • the light source for illumination of the photocatalytically active material to obtain an antipathogenic effect can be stationary, portable, handheld, or in any other configuration. In a specific embodiment, the light source is handheld.
  • Exemplary light sources include, but are not limited to, an incandescent lamp, a gas discharge lamp, a halogen lamp, a fluorescent lamp, a laser, a light-emitting diode, or any combinations thereof.
  • the intensity reaching the area to be treated is typically above 0.1 mW cm 2 , and, in more specific embodiments, is above 0.5 mW cm 2 , above 1 mW cm “2 , or above 5 mW cm “2 .
  • the UV light emitted from the sun and reaching the surface of the earth is about 1 mW cm "2
  • the total effect emitted from a normal incandescent lamp is about 0.07 microW.
  • the illumination dose needed for efficient treatment is strongly dependent on the photocatalytic efficiency of the active material. The stronger photocatalyst used and the larger its total surface area, the lower the dose of illumination with photons in the proper wavelength range will be needed.
  • the implants may be irradiated prior to their installation in a patient to reduce the bioburden encountered in the implant installation.
  • a biomedical implant for example dental implants or endosseous implants in general, before surgical utilization can be irradiated with light of a wavelength and intensity effective to activate the photocatalytically active filler. The thus irradiated implant can then be installed in a patient with a reduced bioburden and therefore a reduced risk of infection.
  • Yet another example of the present invention comprises a photocatalytically active antipathogenic material coating on Hoffman instruments.
  • Non-limiting examples of the use of coatings or filler particles of the photocatalytically active antipathogenic material in an implant according to the invention in dentistry include: in situ hardening materials, periodontology, treatment of caries lesions and dental implants.
  • the photocatalytically active material is also bone- bioactive.
  • Non-limiting examples of the use of coatings or filler particles of the photocatalytically active antipathogenic material in an implant according to the invention in orthopedics include, e.g., fracture fixation, spine devices, and prostheses, and craniomaxilliofacial devices.

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un implant biomédical antipathogène constitué dans toute sa structure d'un matériau matriciel comprenant au moins 1% en poids d'une charge photocatalytiquement active qui à un effet anti-pathogène lorsqu'elle est irradiée par de la lumière. Cette charge photocatalytiquement active est agencée dans le matériau matriciel de l'implant de manière à recevoir la lumière irradiée par une source lumineuse extérieure. Dans un autre mode de réalisation, un implant biomédical anti-pathogène comprend au moins 1% en poids d'un matériau photocatalytiquement actif qui présente un effet antipathogène lorsqu'il est irradié par de la lumière, ce matériau étant agencé dans l'implant de manière à recevoir la lumière irradiée par une source lumineuse extérieure. L'invention concerne également des méthodes de fourniture d'un implant biomédical ant-pathogène, des méthodes permettant de limiter les agents pathogènes sur un implant médical, des méthodes permettant d'atténuer la bio contamination lors de la mise en place d'un implant biomédical, et des trousses de fourniture d'implants bio médicaux antipathogènes.
PCT/IB2009/050715 2008-02-22 2009-02-20 Implants biomédicaux anti-pathogènes, méthodes et trousses avec matériau photocatalytiquement actif WO2009104168A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US12/918,698 US20100331978A1 (en) 2008-12-17 2009-02-20 Antipathogenic Biomedical Implants, Methods and Kits Employing Photocatalytically Active Material
EP09713082A EP2254609A2 (fr) 2008-02-22 2009-02-20 Implants biomédicaux anti-pathogènes, méthodes et trousses avec matériau photocatalytiquement actif

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SE0800423-6 2008-02-22
SE0800423 2008-02-22
US13830008P 2008-12-17 2008-12-17
US61/138,300 2008-12-17

Publications (2)

Publication Number Publication Date
WO2009104168A2 true WO2009104168A2 (fr) 2009-08-27
WO2009104168A3 WO2009104168A3 (fr) 2010-06-10

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PCT/IB2009/050715 WO2009104168A2 (fr) 2008-02-22 2009-02-20 Implants biomédicaux anti-pathogènes, méthodes et trousses avec matériau photocatalytiquement actif

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EP (1) EP2254609A2 (fr)
WO (1) WO2009104168A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200087797A1 (en) * 2018-09-13 2020-03-19 Brandon Strahin Modified oxide surface treatment layer for alloys and corresponding methods

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000057932A2 (fr) * 1999-03-31 2000-10-05 The Brigham And Women's Hospital, Inc. Materiaux chirurgicaux nanocomposites et leur procede de production

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000057932A2 (fr) * 1999-03-31 2000-10-05 The Brigham And Women's Hospital, Inc. Materiaux chirurgicaux nanocomposites et leur procede de production

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TSUANG ET AL.: "Studies of Photokilling of Bacteria Using Titanium Dioxide Nanoparticles" ARTIF ORGANS, vol. 32, no. 2, 5 February 2008 (2008-02-05), XP002576175 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200087797A1 (en) * 2018-09-13 2020-03-19 Brandon Strahin Modified oxide surface treatment layer for alloys and corresponding methods
US11773494B2 (en) * 2018-09-13 2023-10-03 The University Of Akron Modified oxide surface treatment layer for alloys and corresponding methods

Also Published As

Publication number Publication date
WO2009104168A3 (fr) 2010-06-10
EP2254609A2 (fr) 2010-12-01

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