WO2013073935A1 - Dispositif pour nettoyer et/ou débrider un implant médical - Google Patents

Dispositif pour nettoyer et/ou débrider un implant médical Download PDF

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Publication number
WO2013073935A1
WO2013073935A1 PCT/NL2012/050776 NL2012050776W WO2013073935A1 WO 2013073935 A1 WO2013073935 A1 WO 2013073935A1 NL 2012050776 W NL2012050776 W NL 2012050776W WO 2013073935 A1 WO2013073935 A1 WO 2013073935A1
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WO
WIPO (PCT)
Prior art keywords
brush plate
implant
bristles
titanium
brush
Prior art date
Application number
PCT/NL2012/050776
Other languages
English (en)
Inventor
Hoshang KAMOSI
Original Assignee
Kamosi Hoshang
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 Kamosi Hoshang filed Critical Kamosi Hoshang
Publication of WO2013073935A1 publication Critical patent/WO2013073935A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A46—BRUSHWARE
    • A46B—BRUSHES
    • A46B13/00—Brushes with driven brush bodies or carriers
    • A—HUMAN NECESSITIES
    • A46—BRUSHWARE
    • A46B—BRUSHES
    • A46B9/00—Arrangements of the bristles in the brush body
    • A46B9/02—Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups
    • A—HUMAN NECESSITIES
    • A46—BRUSHWARE
    • A46B—BRUSHES
    • A46B9/00—Arrangements of the bristles in the brush body
    • A46B9/02—Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups
    • A46B9/025—Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups the bristles or the tufts being arranged in an angled position relative to each other
    • A—HUMAN NECESSITIES
    • A46—BRUSHWARE
    • A46B—BRUSHES
    • A46B9/00—Arrangements of the bristles in the brush body
    • A46B9/02—Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups
    • A46B9/026—Position or arrangement of bristles in relation to surface of the brush body, e.g. inclined, in rows, in groups where the surface of the brush body or carrier is not in one plane, e.g. not flat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/16—Power-driven cleaning or polishing devices
    • A61C17/20—Power-driven cleaning or polishing devices using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/16—Power-driven cleaning or polishing devices
    • A61C17/22—Power-driven cleaning or polishing devices with brushes, cushions, cups, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/16—Power-driven cleaning or polishing devices
    • A61C17/22—Power-driven cleaning or polishing devices with brushes, cushions, cups, or the like
    • A61C17/222—Brush body details, e.g. the shape thereof or connection to handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C17/00—Devices for cleaning, polishing, rinsing or drying teeth, teeth cavities or prostheses; Saliva removers; Dental appliances for receiving spittle
    • A61C17/16—Power-driven cleaning or polishing devices
    • A61C17/22—Power-driven cleaning or polishing devices with brushes, cushions, cups, or the like
    • A61C17/32—Power-driven cleaning or polishing devices with brushes, cushions, cups, or the like reciprocating or oscillating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0089—Implanting tools or instruments

Definitions

  • the present invention relates to a device for cleaning and/or debriding a medical implant comprising a brush.
  • the present invention further relates to a method for cleaning and/or debriding a medical implant comprising the steps of applying said device to the medical implant.
  • Medical implants are frequently implanted into vertebrate animals and humans to restore the architecture and function of the lost tissue and organs.
  • An example of a medical implant is a dental implant.
  • Dental implants are artificial tooth root analogues that are used for the reconstruction of missing teeth and their supporting structures with synthetic substitutes providing a permanent and attractive tooth replacement. They are small metallic anchors placed into the jawbone as replacements for tooth roots. Implants are capable of providing structural function and replacing the natural function provided by natural tissues. Endosseous implants are the most commonly used type of implants, which are surgically placed into the jawbone. Thus, the anatomy of a dental implant consists of a: supra-structure; abutment; and fixture. Whilst metallic dental implants should integrate to the surrounding bone to provide firm attachment (osseointegration) and structural function for supporting the artificial tooth/teeth, the material does not evoke any adverse biologic response. Biocompatibility is the ability of a material to perform with an appropriate host response. This means that the incremented surface corrosion products do not inhibit metabolism, cause adverse reaction or interfere with the viability of the cells surrounding it.
  • Titanium is a very reactive metal and can form a thick adherent oxide layer, which passivates the surface and minimizes corrosion under biological conditions and is extremely stable under physiological conditions.
  • the ability to osseointegrate along with its biocompatibility makes titanium and its alloys very desirable for dental implant.
  • Available dental implants are made of titanium, titanium-zirconium or zirconium/ceramics.
  • Ti-6AL- 4V alloy consists of 6% aluminium, 4% vanadium and is stronger than cpTi with comparable biocompatibility and good resistance to corrosion in the body. Titanium and its alloys are biocompatible when fabricated as implants. They evoke an appropriate response when in contact with tissue and in this case allow the bone to grow right up to the surface. Hydroxyapatite [Ca10 (P04)6 (OH)2] and related calcium phosphate ceramics are biocompatible material which show good bioactivity which promote direct mineralization of the natural bone.
  • HA- coating of metal implants have been shown to enhance the process of osseointegration with superior properties in terms of interfacial bonding and shear strength, albeit detachment of coating may occur and can be detrimental.
  • Peri-implantitis is an inflammatory reaction in the surrounding tissue of functioning implant, with loss of bone supporting functioning implant (Albrektsson T & Isidor F. 1994)
  • Micro organisms preferentially adhere to implant surfaces and together with a matrix of exo- polysaccharides, proteins and nucleic acids to mature and develop biofilm, on the interfaces between solid surfaces and biological fluids.
  • the extracellular matrix matures as a network of water-soluble and -insoluble glucans protecting them from the host defense mechanisms and antibiotics. It is known that biomaterial-centered infections are extremely resistant to antibiotics as well as host-defense and that they frequently persist until the implanted device is removed.
  • Increased bacterial virulence coupled with locally impaired immune defense due to local or systemic factors may change the latent nature of such chronic infection to a more aggressive infection.
  • the excellent biocompatibility of titanium implants promotes the adsorption of osteoblasts and fibroblasts but also of microbial bi-products.
  • Peri-implantitis can affect the surface of all type of dental implants with an incidence as high as 14.4% (Berglund et al. 2002).
  • Identified associated risk indicators may include: poor oral hygiene, history of periodontitis, uncontrolled diabetes and heavy smoking, coupled with compromised host tissues or immune response.
  • the primary objective of surgical treatment in peri-implantitis is to get access to the implant surface for debridement and decontamination in order to achieve resolution of the inflammatory lesion.
  • Surgical debridement of the infected implant surfaces is often required in order to enhance access to debride and condition the infected implant surfaces and prepare the hard and soft tissues prior to performing the regenerative procedures.
  • the conditions which may require surgical flap debridement in order to expose and prepare the tissues and surfaces prior to regeneration are: periimplantitis, periodontitis lesions, marginal periodontitis, apical periodontitis, furcation defects, apical granulomas and cysts, bone cysts, bone tumours, bone granulomas, bone cancers, (infected) extraction sockets, alveolitis sicca ("dry socket"), cleaning of apicectomy defects, localized osteomyelitis, trauma induced defects, resection or revision of implants, resection or revision of fractures, and removal of temporary bone implants.
  • Surgical therapeutic approaches are undertaken to: eliminate intra-lesion granulation tissues via surgical deregulation; to eradicate interfacial biofilm and residual debris consisting of surgical mechanical and chemical surface debridement; to decontaminate the contaminated exposed interface via surgical surface decontamination techniques; to modify the interface architecture via implantoplasty (to reduce the risk for re-establishments of implant surface biofilm); to eliminate intrabony micro-environmental niche for pathogenic micro-organisms via peripheral tissue resection; to promote the phenomenon of re- osseointegration using surface bio-modifying agents and techniques; and to restore the bone defects caused by destructive pathologic process via regenerative procedures.
  • the implant surfaces are cleansed of these bacteria and their products.
  • Air abrasion and laser treatment have been also frequently used for decontamination of implant surfaces.
  • Albeit due to the implant surface micro-structural features the complete elimination of the biofilm still poses a special challenge.
  • Metal curette instruments prove to leave deep micro-scratches and traces in the most implant surface areas and may contaminate the delicate surface of the medical implant surface by contaminating the material residues when used for debridement of the medical implant surface.
  • the non- biocompatible contamination residues often induce a foreign-body response detrimental to the human tissues.
  • the preserving decontamination methods might be a suitable approach.
  • the soft cleaning brushing tools have also been proved not to serve the purposes with regard to the efficient implant surface debridement. Besides, the risk for remaining the detached or fractured bio-incompatible bristles and/or soft parts into the surrounding soft and hard tissues causing further inflammation, infection and abscess will interfere with the post- debridement surgical healing and regenerative process around the medical implant surfaces.
  • Cleaning devices comprising biocompatible bristles made of the same metallic base material in the form of a rotary brushing- instrument have been utilized to reduce the detrimental physical surface damages during the procedure of the implant surface debridement.
  • European patent application EP 2 437 680 discloses a cleaning device identified as TiBrush.
  • This cleaning device comprises: an elongated base member formed of at least two wires being twisted with each other, and a plurality of bristles fixed between said twisted wires and extending away from said twisted wires, whereby said bristles are positioned in a cleaning section at a first end of said base member; wherein said bristles consist of titanium or a titanium alloy.
  • Prior to use the TiBrush is connected to a surgical hand piece, which during operation lets the brush rotate in a clockwise/counterclockwise direction.
  • the device disclosed in EP 2 437 680 has been found to also damage the implant during cleaning of said implant.
  • a similar device having the same drawbacks as the TiBrush is marketed under the name: TigranTM PeriBrushTM and is an instrument for treating patients with peri-implantitis. This instrument comprises a brush, which rotates during use.
  • the present inventor has identified that the cleaning of the biologically-interfacing implant surfaces are inadequate and unpredictable using the present available mechanical and chemical devices and methods.
  • the uncontrolled rotary action of the brushed in the deep and narrow intra-bony defects may cause further damage to the healthy peri-implant bone.
  • the rotary debriding action of the metal brushes in the deep bony defects may also transfer the pathogenic macro-organisms along with the other disrupted biofilm products and contaminants into the cancellous bone and circulating blood causing adverse biological effect in the form localized inflammatory and infectious process as well as systemic bacteremia especially in medically compromised patients.
  • the objective of the present invention is to provide for an improved device for cleaning and/or debridement of the medical implant comprising a brush and an improved method for cleaning and/or debridement of the medical implant comprising the steps of applying said device to the medical implant.
  • a device as identified by the preamble further comprising a brush comprised of at least a brush plate and bristles wherein the brush plate is curved along one imaginary axis extending parallel to the surface of the brush plate, such that the brush plate has a concave surface and the bristles are located at the concave surface of the brush plate.
  • the imaginary axis is positioned above the center of and extends parallel to the surface of the brush plate and is orientated in parallel to the implant when the device is in use.
  • the device according to the present invention has sufficient physical hardness, elasticity module, tensile strength which allow for the efficient elimination of the biofilm from the surface of the medical implant surface without causing any adverse physical impact on the implant surfaces and/or biological effect on the surrounding tissues.
  • the device according to the present invention eliminates the detrimental physical/chemical influences on the implants surfaces; prevents the adverse biological impacts exerted on the surrounding localized soft and hard tissues; minimizes the adverse systemic health sequel via blood circulation; and enhances the effectiveness and predictability of the therapeutic strategies implemented in the treatment of peri-implantitis lesions.
  • the device according to the present invention is preferably shaped such that it gently but thoroughly debrides the whole implant surface, especially the inner parts of the implant threads while otherwise left minimally affected by means of hand or rotary brush according to the prior art.
  • the tangential brushing action is designed to debride the organic and inorganic debris in a circumferential pattern, with a gentle but optimized polishing effect on the implant surface topography.
  • the non-traumatizing rear surface of a device according to the present invention applying the oscillating movements eliminates the risk for emergence of systemic bacteremia caused by the spread of dissolved and disrupted biofilm products into the peri-implant healthy hard and soft tissue environment and their vascular supply.
  • the device according to the present invention optimizes peri-implant debridement, decontamination and irrigation without exerting any adverse physical impact on the peri- implant surface texture, or any biological impact on the peri-implant bone and mucosa.
  • the device according to the present invention can also be referred to as peri-implant ultrasound debridement device (PIUS-DD).
  • PIUS-DD peri-implant ultrasound debridement device
  • the term "dental implant” implies the scope of any device designed and manufactured to be implanted into the oral cavity of the vertebrate animals, in particular a mammal such as human, during the tooth restoration procedure.
  • the device further comprises a linking component for linking and preferably detachably connecting to the device, a device that can oscillates at ultra sound frequency, preferably said oscillating device is a piezo-electric oscillating apparatus.
  • the device further comprises an ultra sound oscillating apparatus for oscillating the brush plate with bristles at an ultra sound frequency, preferably said oscillating device is a piezo-electric oscillating apparatus.
  • Such an apparatus can oscillate the device according to the present invention in the range of 20-30kHz.
  • Said linking component is preferably of such a length that the total length of the device is equal or more than 20mm or equal or less than 30mm, and preferably the length ranges from 20mm to 30mm.
  • the implant is a medical implant, preferably a dental implant and more preferred a root implant.
  • the linking component is a shaft, preferably said shaft is comprised of or coated with stainless steel.
  • the bristles are made of an alloy, and preferably a titanium alloy. The contact point(s) of the device is (are) worn down/abraded during operation of the device. The possible trace elements released to the surrounding tissues do not trigger any adverse biological response in the form of foreign body reaction.
  • titanium particles even in high levels seem not to cause any cytotoxicity.
  • the concave surface defines a cavity for receiving the dental implant
  • the brush plate is provided with bristles near or on at least one edge, said bristles extending diagonally away from said edge and away from the brush plate or in case the bristles are placed near the edge of the brush plate to beyond the brush plate.
  • these brushes are placed at or near the edge opposing the edge to which the shaft is connected.
  • the bristles are attached to the brush plate.
  • the bristles are connected to the brush plate by laser welding.
  • other ways of attaching the bristles to the plate can also be used.
  • the bristles are distributed on the plate such that one or several bristles are clustered together on at least one spot and that one or several of these clusters are positioned at regular intervals along the brush plate.
  • a single layer makes up both the concave and convex surface of the brush plate whereby the concave surface provided with bristles is receiving the dental implant.
  • the brush plate is comprised of at least 2 layers, wherein a first layer makes up the concave surface of the brush plate and a second layer makes up at least part of the convex surface of the brush plate, preferably the brush plate consist of 2 layers.
  • the bristles form part of the second layer or are attached to the second layer and extend through holes in the first layer. This allows for the bristles to be firmly fixed to the brush plate minimizing or even preventing the loss of bristles during operation of the device.
  • the bristles extend from the brush plate substantially perpendicular to the concave surface of the brush plate.
  • the length of the bristles ranges from 1 to 2.5 millimeters.
  • the brush further comprises a holder, holding the brush plate.
  • the brush plate is held by the holder such that the brush plate is curved along one axis extending parallel to the surface of the brush plate such that the brush plate has a concave surface and the bristles are located at the concave surface of the brush plate.
  • the holder provides for the curvature of the brush plate.
  • the holder is further provided with the linking component.
  • the device is for use in the prevention and/or treatment of a condition selected from the group consisting of: periimplant mucositis, periimplantitis, periodontitis lesions, marginal periodontitis, apical periodontitis, dental furcation defects, apical granulomas and dental cysts, bone cysts, bone tumours, bone granulomas, bone cancers, (infected) extraction sockets, alveolitis sicca (“dry socket”), cleaning of apicectomy defects, localized osteomyelitis, trauma induced defects, resection or revision of implants, resection or revision of fractures, and removal of temporary bone implants.
  • a condition selected from the group consisting of: periimplant mucositis, periimplantitis, periodontitis lesions, marginal periodontitis, apical periodontitis, dental furcation defects, apical granulomas and dental cysts, bone cysts, bone tumours, bone granulomas, bone
  • the invention further relates to a method for cleaning and/or debriding a medical implant comprising the steps of applying a device comprising a brush comprised of at least a brush plate and bristles wherein the brush plate is curved along one axis extending parallel to the surface of the brush plate, such that the brush plate has a concave surface and the bristles are located at the concave surface of the brush plate, preferably according to the present invention to a medical implant in such a way that at least some of the bristles contact the implant and letting the device oscillate at an ultra sound frequency.
  • a single layer could makes up both the inner concave and outer convex surface of the brush plate whereby the inner concave surface provided with bristles is receiving the dental implant.
  • the method according to the present invention further comprises the step of reflecting the gum in order to gain access to the dental implant, said step precedes the step of applying the device to the implant.
  • the debridement/decontamination method may further advocate the adjunctive use of chemical demineralization agents by applying the agent to the implant.
  • chemical demineralization agents can improve the removal of the mineralized bacterial toxins, bi-products, matured extra- celluar matrix and smear layers from the root/implant surfaces.
  • a number of chemical agents including acid citric, tetracycline hydrochloride, EDTA, phosphoric acid, maleic acid and lactic acid can be used during the procedure of chemical debridement and preparation for the regenerative procedures on the dental and implant surfaces.
  • the adjunct use and action of such chemical conditioning may prevail cell attachment, re- osseointegration and would healing.
  • Adjunct chemical debridement may be enhanced using Citric acid and/or H202 by facilitating the removal of proteins.
  • a concentration of H202 in the range of 2-4%, or about 3% by weight is preferred.
  • Adjunct chemical debridement and decontamination may be enhanced using citric acid by facilitating the removal of proteins and biofilm cells (Ntrouka et al. 201 1).
  • the use of citric acid solutions (PH1) at different concentrations has been advocated for the removal of proteins and biofilm cells on the contaminated implant surfaces in particular HA-coated implant surfaces. (Dennison et al. 1994).
  • the adjunct chemical debridement by means of non-toxic neutrally-buffered EDTA (17%- 25%; PH7 for 2 min.) can be used to: facilitate removal of biofilm and to enhance the effectiveness of mechanical debridement procedure without inhibiting the fibroblast and the cells including progenitor cells in the vicinity of the alveolar bone may be available.
  • EDTA has also been shown to functionalize a naturally-oxidized titanium surface.
  • the present inventor has found that, it is beneficial to apply adjunct chemical agents during the mechanical debridement according to the present invention followed by intermittent profuse saline irrigation during and after the process of mechanical debridement in order to optimize disruption, dissolution and elimination of the biofilm from the contaminated implant surfaces, and to reestablish the titanium surface biocompatibility perquisite for the process of re-osseointegration.
  • the device according to the present invention is for the intra-surgical debridement of metallic medical implant surfaces subjected to peri-implant contamination in the form of bacterial biofilm, debris, calculus and/or fibrous tissue.
  • the invented device is also for the intra-surgical debridement of all medical implant surfaces made of or coated by biocompatible hydroxyapatite [Ca10 (P04)6 (OH)2] and related calcium phosphate ceramics subjected to peri-implant contamination in the form of bacterial biofilm, debris, calculus and/or fibrous tissue.
  • the invented device further removes the debris from the abutments, cement remnants, bacterial biofilm, debris, calculus, or fibrous tissues in the vicinity of dental implants.
  • the invented piezon ultrasound device can be applied on the medical and dental metallic implants driven by a piezon Ultrasound unit to facilitate access and enhance debridement within both narrow and wide, shallow and deep peri-implant defects caused by peri-implantitis.
  • the invented device can gently but thoroughly debride the whole implant surface, especially the inner parts of the implant threads while otherwise left minimally affected by means of hand or rotary brush.
  • the debridement is undertaken by gentle maneuvering the bristles tangential and circumferential to the exposed implant surface in order to disrupt and eliminate the organic and inorganic debris, with an optimized polishing effect on the implant surface topography.
  • the gentle brushing action of the device according to the present invention removes the surface debris in a tangential circumferential pattern with optimized polishing effect.
  • the invented device facilitates an atraumatic access to the narrow angular intra-bony defects causing no risk for peri-implant tissue trauma compared to the rotary instruments.
  • the device and the method according to the present invention may be used for the prevention and/or treatment of numerous pathologic conditions affecting the soft-hard tissues interfaces in the oral cavity.
  • Such hard and soft tissues which need decontamination in order to restore their biomechanical functions, and will benefit from may be treated by this invention are teeth and bone structures, periodontal tissues, peri-apical tissues, and peri- implant tissues.
  • the device and the method of the invention may be used for the prevention and/or treatment of numerous pathologic conditions consisting peri-implant mucositis, exposed implants, ailing implants, and peri-implantitis.
  • the device and the method of the invention may be applied for the prevention, alleviation and/or treatment of numerous pathologic conditions, in particular of periodontitis, marginal periodontitis, peri-apical osteitis, dental apical periodontitis, dental furcation defects, dental apical granulomas and dental cysts, bone cysts, bone tumours, bone granulomas, bone cancers, (infected) extraction sockets, alveolitis sicca (“dry socket”), endodontic -periodontal lesions in need of debridement, localized osteomyelitis, trauma induced defects, resection or revision of fractures, fenestrated and dehisced implants in need of revision and augmentation.
  • the device of the invention may be used for the cleaning of the extraction alveoli sockets or more generally the removal of unwanted soft and/or hard tissue.
  • Titanium, titanium alloys, zirconium and zirconium alloys are most suitable material for constructing dental implants due to the fact these metallic implant materials have been proved to be the most biocompatible and corrosion resistant in body fluids, and resist the bacterial adhesion while have excellent mechanical and physical properties.
  • Dental implants are often manufactured using a metal alloy.
  • almost all the dental implants are made of titanium, titanium-zirconium alloys or zirconium oxide/ceramics.
  • alloy refers to a metallic material, which contains a base metal and at least one alloying component, where the "base metal” is intended to mean the primary constituent of the alloy, and the “alloying component” is intended to mean the component, which is added to the base metal in order to form the alloy. Therefore, the term “titanium alloy” is intended to mean an alloy comprising "titanium” as “base metal” and at one other metal as “alloying component”.
  • Said shaft preferably consists of a solid material, made of titanium, titanium alloy or stainless still.
  • the device shaft preferably consists of stainless still, titanium, or titanium alloy, whereby titanium alloy refers to a metallic material, which here contains "titanium” as the "base metal” which is intended to mean the primary constituent of the alloy, and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • titanium alloy refers to a metallic material, which here contains "titanium” as the "base metal” which is intended to mean the primary constituent of the alloy, and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • the device shaft may consist of a titanium alloy, whereby the titanium alloy comprises titanium as base metal, and aluminum and vanadium as alloying components.
  • the titanium alloy may comprise of about 94.5% titanium, about 3% aluminum, and about 2.5% vanadium.
  • the shaft has a maximum length, which is equal or more than 15mm or equal or less than 22mm.
  • the length of the shaft varies from 15mm to 22mm.
  • the insertion length of the device shaft is equal or more than 3mm or equal or less than 10mm.
  • the cross section geometry of device shaft may be changed from the shaft insertion points (device head) towards the shaft tip say from a round shape to an oval, square, or rectangular formed geometry.
  • the diameter of the device shaft is equal or more than 0.3mm or equal or less than 0.55mm .
  • the diameter of the device shaft may be reduced from the device shaft insertion points or shaft head towards the shaft tip from equal or less than 0.55mm to equal or more than 0.3mm.
  • the device “core” is a part of the device which holds/protects/forms the device brush plate and preferably consists of stainless still, titanium, or titanium alloy described as above.
  • the device core maximum height is equal to or more than 0.5 mm or equal or less than 2mm.
  • the diameter of the device core is equal or 0.2 mm more than the device plate [R].
  • the device "brush plate” height may vary from 2mm to 12mm technically designed and manufactured to optimally adapt the defect depth and implant length.
  • the concave brush plate surface which receives the implant is provided with bristles near or on at least one edge, the bristles extent diagonally away from the edge and away from the brush plate or in case the bristles are placed near the edge to beyond the brush plate which present with sharp brush edges that provide a good "brushing edge” that effectively cleans away deep-sitting inflamed/infected soft-tissue and hard debris /calculus from the defect area without damaging the sound viable bone or other hard tissues.
  • the device brush plate consists of pure, unalloyed titanium.
  • the brush plate may be of titanium selected from the group consisting of 4 graded titanium categories, consisting of: titanium grade 1 , titanium grade 2, titanium grade 3, and titanium grade 4 according to ASTM F67. These types of titanium are sometimes also denoted as "commercially pure" titanium.
  • the brush plate maximum length is equal or more than [1/8 to 5/8 x 6.28mm] or equal or less than [1/8 to 5/8 x 34.54mm] determined by the implant diameter, bristle length, and the size of the defect.
  • the lateral profile shape of the device brush plate could be modified from a "straight" form to a "curved” form so that it could adapt to the lateral profile/ cross section of the contaminated medical/dental implants when subjected to the mechanical decontamination procedure.
  • the design and the manufacturing of the device according to the present invention can be performed to adapt the specific design and profile of each implant system, according to its type, size, shape, and alongside the implant body.
  • the device invented is designed to gently but thoroughly debride the whole implant surface, especially the inner parts of the implant threads while otherwise left minimally affected by means of hand or rotary brush, and further to the claim that, the tangential oscillating action of the device will remove the organic and inorganic debris in a circumferential pattern, with a gentle but optimized polishing effect compatible to the implant surface topography.
  • the shape and size of the brush plate may vary according to the implant system, implant type and implant size to best accommodate the 3-dimensional defect implant surface morphology.
  • the shape of the brush plate may vary according to the defect type to best accommodate the 3-dimensional defect morphology. Therefore, these designs may vary from narrow to wide base, and from cylindrical to conical spade-shaped tip.
  • the shape of the brush plate may vary longitudinally from straight to curved, and curved to straight, alongside the proximal (top) to distal (end) part of the brush plate.
  • the shape of the brush plate may vary from proximal (top) to distal (end) side so that the cylindrical shoulder of the plate could transform to a more conical spade-shaped tip to follow the implant profile.
  • the device brush plate to which the bristles are connected may consist of titanium, or titanium alloy described as above.
  • the brush plate preferably consists of titanium alloy, whereby titanium alloy refers to a metallic material, which contains a base metal and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • titanium alloy refers to a metallic material, which contains a base metal and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • the brush plate consists of a titanium alloy, whereby the titanium alloy comprises titanium as base metal, and aluminum and vanadium as alloying components.
  • the titanium alloy may comprise of about 94.5% titanium, about 3% aluminum, and about 2.5% vanadium.
  • the device brush plate may consist of pure, unalloyed titanium.
  • the brush plate may be of titanium selected from the group consisting of 4 graded titanium categories, consisting of: titanium grade 1 , titanium grade 2, titanium grade 3, and titanium grade 4 according to ASTM F67.
  • the bristles of the device according to the present invention are manufactured using the same or similar titanium/titanium alloy material biocompatible to the delicate metallic implant surface material for the purpose of cleaning/debridement/decontamination in order to avoid any physical damage, scratches or metallic contamination, while making the action of the mechanical debridement most efficiently and harmlessly.
  • the hardness degree of the bristle material corresponds to the hardness degree of the titanium implant surface. Due to the fact that the metallic bristles are made of the "biocompatible" titanium/titanium alloy materials, in case of dislodged fractured bristles, abrasion particles, lost material residues, there would be no risk for the metal contamination or triggering of adverse biological effect or inflammation, but healing of particles with the medical implants.
  • the device according to the present invention is also suitable for debridement of the zirconium and zirconium alloys since the hardness of zirconium and zirconium alloys are similar to that of titanium and titanium alloys.
  • the bristles do not leave any bio-compromising contaminants on the treated surface, as titanium is a bio-inert material, which does not provoke any adverse biological effect or foreign body reaction, and does not hamper the implant treatment outcome.
  • the bristles have a maximum length of at least 1.0 mm, and preferably a maximum length of 2.5mm.
  • the device bristles' diameter, number and distribution and length are determined according to the size, design, macro-structure (e.g. screw pitch/indentation- depth/width/design/sequence) within the exposed implant surfaces.
  • macro-structure e.g. screw pitch/indentation- depth/width/design/sequence
  • the bristles preferably consist of titanium or titanium alloy, whereby titanium alloy refers to a metallic material, which contains a base metal and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • titanium alloy refers to a metallic material, which contains a base metal and at least one alloying component selected from the group consisting of: zirconium, tantalum, hafnium, niobium, aluminum, vanadium, molybdenum, chrome, cobalt, magnesium, iron, gold, silver, copper, mercury, tin and zink.
  • the bristles may consist of a titanium alloy, whereby the titanium alloy comprises titanium as base metal, and aluminum and vanadium as alloying components.
  • the titanium alloy may comprise of about 94.5% titanium, about 3% aluminum and about 2.5% vanadium.
  • the bristles may consist of a titanium alloy, whereby the titanium alloy comprises Titanium- 6 Aluminum- 4 Vanadium (Ti6AI4V) alloy according to ASTM F136 and /or (Ti6AL4V) alloy according to ASTM F1472.
  • Ti6AI4V Titanium- 6 Aluminum- 4 Vanadium
  • ASTM F136 and /or (Ti6AL4V) alloy according to ASTM F1472.
  • the bristles may consist of a titanium alloy selected from the group consisting of a Titanium- 6 Aluminum- 7 Niobium (Ti6AI7Nb) alloy according to ASTM F1295, a Titanium-13 Niobium- 13 Zirconium (Ti13Nb13Zr) alloy according to ASTM F1813.
  • a titanium alloy selected from the group consisting of a Titanium- 6 Aluminum- 7 Niobium (Ti6AI7Nb) alloy according to ASTM F1295, a Titanium-13 Niobium- 13 Zirconium (Ti13Nb13Zr) alloy according to ASTM F1813.
  • the device bristles may consist of pure, unalloyed titanium.
  • the bristles may be of titanium selected from the group consisting of 4 graded titanium categories, consisting of: titanium grade 1 , titanium grade 2, titanium grade 3, and titanium grade 4 according to ASTM F67.
  • Figure 1 depicts a front view of a device according to the present invention.
  • Figure 2 depicts a top view of a device according to the present invention.
  • Figure 3 depicts a detailed view of a brush plate.
  • Figure 4 depicts a detailed view of a brush plate
  • Figure 5 depicts a device according to the present invention installed on a holding device
  • the device depicted in figure 1 has a brush (1) comprised of a curved brush plate (2) and bristles (3).
  • the bristles are substantially perpendicular to the brush plate (2).
  • a shaft (4) is shown which is connected to the holder (5).
  • Further bristles (9) are shown. These bristles (9) are provide at or near the edge of the concave surface of the brush (1).
  • the bristles (9) are not placed on the concave surface but at the bottom side (10) of the brush (1).
  • These bristles (9) extent diagonally away from said edge and away from the brush plate (2) to beyond the brush plate (2) and substantially towards the axis (6 in figure 2).
  • the bristles (1) are located in such a way that several bristles are grouped together in clusters. These clusters in figure 1 are regularly spaced apart and divided over the concave surface (7) of the brush (1).
  • Figure 2 shows the device from the top, viewed along the axis (6) and shaft (4).
  • the brush plate (2) is curved along one axis (6 in figure 2) extending parallel to the surface of the brush plate (2), such that the brush plate (2) has a concave surface (7) and the bristles (3) are located at the concave surface (7) of the brush plate (2). Further the cavity (13) for receiving the dental implant is indicated.
  • Figure 3 shows a close up of the brush (1) wherein the brush plate (2) is comprised of at least 2 layers (1 1 , 12), wherein a first layer makes up the concave surface (7) of the brush plate (2) and a second layer makes up at least part of the convex surface (8) of the brush plate (2).
  • the bristles (3) are for example welded to layer 12 and extend through holes in layer 11.
  • Figure 4 also shows a close up of the brush (1) but from a different point of view compared to the close up of figure 3.
  • Figure 4 shows more clearly that the bristles (9) are provided to the bottom side (10) of the brush (1).
  • Figure 5 shows a the device as depicted in the previous figures (part A) wherein the shaft is connected to a holder piece (part B). This holder piece on its turn can be connected to a hand piece (not depicted) generating ultra-sound waves and regulated via a piezoelectric oscillating apparatus.
  • This Example describes a procedure for using the device according to the present invention.
  • the instrument holder is inserted into the hand piece, tightened initially by hand and then by a driver.
  • the device is inserted on the instrument holder, tightened initially by hand and then by a driver.
  • the position of the device and the adjustment of the irrigation and power should provide adequate irrigation at the top of the device.
  • prosthetic supra-structure be removed, and implant cover screws are replaced prior to the debridement/decontaminations involved in the treatment of exposed and contaminated dental implant surfaces and peri-implant lesions as a result of peri- implantitis.
  • the implant-bound granulation tissues at the defect entrance is removed whilst further vision and access for instrumentation and chemical decontamination of exposed contaminated implant surface is obtained.
  • Initial gross mechanical debridement of the exposed implant surface is carried out using the device according to the present invention at a lower power output.
  • the possible minor residual bone-bound granulation tissues, unsupported bone sequesters, and disrupted biofilm particles are irrigated and eliminated using sterile saline or physiological NaCI solution.
  • the initial gross mechanical surface debridement facilitates and enhances access and availability for adjunct chemical agents.
  • adjunct chemical debridement/decontamination/conditioning of exposed contaminated implant surfaces promote peri-implant bone defect-fill and re-osseointegration as a result of optimal and effective elimination of the biofilm from the exposed contaminated dental implant surfaces.
  • Secondary fine mechanical debridement of exposed implant surface is carried out using the device according to the present invention at a higher power output in order to eliminate the biofilm residues in the deepest parts/macro-porosities implant surfaces.
  • the possible minor residual bone-bound granulation tissues and disrupted biofilm particles are irrigated and eliminated using sterile saline or physiological NaCI solution.
  • Intra-marrow penetration is performed to stimulate bleeding and promote fibrin stabilization
  • An appropriate regeneration technique is performed and passive wound adaptation, closure and stability is achieved.
  • PIUS-DD peri-implant ultrasound debridement device
  • the power setting is adjusted to: the instrument design and dimensional specification, indication of use according to the defect morphology and implant surface characteristic, and the stage of implant surface debridement procedure.
  • the device should be driven at a range of low to a medium power setting, up to maximum of 70% output:
  • the power output is adjusted and reduced in direct proportion to the increased granulation size during the initial gross debridement procedure.
  • the power output is adjusted and reduced in direct proportion to the increased surface area of the PIUS-DD bristle plate
  • the power output is adjusted and reduced in direct proportion to the increased PIUS-DD working length
  • the insertion length of the PIUS-DD adjusted suing the laser-marked rings of the shaft end should be used to establish an optimal acoustic streaming on the device tip during the ultrasound oscillation at the selected power output.
  • the device should be driven at a rage of maximum to a medium irrigation flow rate setting, down to a minimum of 70% output:
  • the continuous irrigation is regulated until an acoustic streaming effect is reached.
  • Adequate profuse continuous irrigation is applied using sterile saline or ringer solution in order to: a) avoid overheating of the device resulting in peri-implant tissue thermal damage and necrosis; b) establish an efficient acoustic streaming resulting in disruption of biofilm and bacterial bu-products with the implant surface macro-porosities; c) improve the irrigation and wash-out effect of the disrupted debris particles; and d) avoid any mechanical deformation or fracture of PIUS-DD bristles and other parts.
  • the titanium bristles of the device should be kept in and light close contact with implant surface without excessive force while gentle brushing movements should be applied tangential to the exposed implant surface.

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  • Health & Medical Sciences (AREA)
  • Dentistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

Les implants médicaux sont fréquemment implantés dans des êtres humains et des animaux vertébrés pour rétablir l'architecture et la fonction de tissus et d'organes perdus. Un exemple d'implant médical est l'implant dentaire. Les implants dentaires sont des équivalents artificiels de racine de dent qui sont utilisés pour la reconstruction d'une dent manquante et leurs structures de soutien, avec des substituts synthétiques fournissant un élément de remplacement de dent permanent et attractif. Ce sont de petits ancrages métalliques placés dans la mâchoire pour remplacer les racines des dents. Les implants peuvent avoir une fonction structurelle et remplacer la fonction naturelle assurée par les tissus naturels. Les implants endo-osseux sont le type d'implants le plus utilisé, lesquels sont placés chirurgicalement dans la mâchoire. Par conséquent, l'anatomie d'un implant dentaire est composée de : une supra-structure ; un appui ; et un élément de fixation. La présente invention porte sur un dispositif pour nettoyer et/ou débrider un implant dentaire comprenant une brosse. La présente invention porte également sur un procédé pour nettoyer et/ou débrider un implant dentaire comprenant les étapes d'application dudit dispositif à l'implant médical.
PCT/NL2012/050776 2011-11-15 2012-11-05 Dispositif pour nettoyer et/ou débrider un implant médical WO2013073935A1 (fr)

Applications Claiming Priority (2)

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NL1039169A NL1039169C2 (en) 2011-11-15 2011-11-15 Peri-implant ultrasound debridement device (pius-dd).
NL1039169 2011-11-15

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WO2013073935A1 true WO2013073935A1 (fr) 2013-05-23

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Cited By (5)

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WO2015175018A1 (fr) * 2014-05-16 2015-11-19 Robert T. Bock Consultancy, Llc. Brosse à dents à ultrasons à portée étendue spatialement améliorée
US10219878B2 (en) 2016-11-08 2019-03-05 Christopher R. Goodman Dental implantoplasty tool for preventing peri-implantis in dental implants
EP3294191A4 (fr) * 2015-04-06 2019-03-20 Mmlf Llc Système de nettoyage dentaire et son procédé d'utilisation
US10758639B2 (en) * 2014-10-02 2020-09-01 Polypid Ltd. Methods for the treatment of peri-implantitis
WO2023206311A1 (fr) * 2022-04-29 2023-11-02 李岩峰 Brosse en titane de nettoyage de type environnant pour surface d'implant et son procédé d'utilisation

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015175018A1 (fr) * 2014-05-16 2015-11-19 Robert T. Bock Consultancy, Llc. Brosse à dents à ultrasons à portée étendue spatialement améliorée
CN106456301A (zh) * 2014-05-16 2017-02-22 罗伯特.T.伯克咨询有限责任公司 空间改进扩展传播超声波牙刷
CN106456301B (zh) * 2014-05-16 2019-08-23 罗伯特.T.伯克咨询有限责任公司 空间改进扩展传播超声波牙刷
US10758639B2 (en) * 2014-10-02 2020-09-01 Polypid Ltd. Methods for the treatment of peri-implantitis
EP3294191A4 (fr) * 2015-04-06 2019-03-20 Mmlf Llc Système de nettoyage dentaire et son procédé d'utilisation
US10219878B2 (en) 2016-11-08 2019-03-05 Christopher R. Goodman Dental implantoplasty tool for preventing peri-implantis in dental implants
WO2023206311A1 (fr) * 2022-04-29 2023-11-02 李岩峰 Brosse en titane de nettoyage de type environnant pour surface d'implant et son procédé d'utilisation

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