EP1148830A1 - Bone screw - Google Patents

Bone screw

Info

Publication number
EP1148830A1
EP1148830A1 EP99900870A EP99900870A EP1148830A1 EP 1148830 A1 EP1148830 A1 EP 1148830A1 EP 99900870 A EP99900870 A EP 99900870A EP 99900870 A EP99900870 A EP 99900870A EP 1148830 A1 EP1148830 A1 EP 1148830A1
Authority
EP
European Patent Office
Prior art keywords
bone screw
screw according
silver coating
compatible material
threadless
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
EP99900870A
Other languages
German (de)
French (fr)
Inventor
Michael Ahrens
Urs Schlegel
Silvia Beer
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.)
AO Technology AG
Original Assignee
Synthes AG Chur
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 Synthes AG Chur filed Critical Synthes AG Chur
Publication of EP1148830A1 publication Critical patent/EP1148830A1/en
Ceased legal-status Critical Current

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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00419—Other metals
    • A61F2310/0052—Coating made of silver or Ag-based alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • 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
    • A61L2300/606—Coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the invention relates to a bone screw according to the preamble of claim 1 and an external fixator with such a bone screw according to claim 16.
  • CH 657 519 BLAETTLER has disclosed a surgical implant completely coated with silver.
  • the silver layer is not applied directly to the carrier material but to an intermediate layer made of copper.
  • the disadvantage of this known device is that silver can have an inhibiting influence on the osteoblasts, depending on the concentration (typically 1.42 ⁇ g / ml), so that a bone screw coated in this way is nevertheless subject to the risks of loosening.
  • Pins have also been proposed, through which a silver-coated plastic tube is pushed down to the depth of the tissue down to the bone.
  • the disadvantage of this device is the lack of sterilizability, which precludes reuse. Since the diameter of the pins is doubled due to the tube being put over them, longer incisions are also required to insert them into the soft tissues, which increases the soft tissue trauma.
  • the invention seeks to remedy this.
  • the invention is based on the problem of creating a bone screw, in particular for use in an external fixator, which prevents the occurrence of infections.
  • the invention solves this problem with a bone screw, which has the features of claim 1.
  • the pins can be used as normal as conventional (uncoated) pins;
  • the pins are reusable after reprocessing and sterilization
  • the bone screw is only partially coated with silver, at least in the soft tissue area to be protected against infections.
  • the threaded part is uncoated, since silver in direct contact with the bone can have an inhibiting effect on the osteoblasts.
  • the rear part of the bone screw which is mechanically stressed by the clamping jaws of the fixator is preferably also uncoated.
  • the silver coating acts as the anode and the steel (or titanium) acts as the cathode.
  • the steel or titanium acts as the cathode.
  • a bactericidal effect mainly occurs on the anode.
  • Current stimulation in bone fractures showed a stimulating effect on the bone cells on the cathode.
  • a further increase in the antibacterial effect of the bone screw according to the invention can be achieved by applying an electric current in low strengths, for example 0.25 microamps.
  • a current of 5 to 20 microamps and approximately 0.8 volts is typically used.
  • the layer thickness of the silver coating is preferably greater than 10 ⁇ and can be applied to the body-compatible material either electrochemically or as a metallic film without an intermediate layer. Another possibility is to stick on the silver coating.
  • the coatings can thus be applied by different methods, e.g. electrochemical (anodizing) using IADB (ion assisted beam deposition using a foil (with conductive or insulating
  • Adhesives The coating-free areas can be covered with stencils.
  • the foils can be applied using a heat-resistant adhesive before sterilization, or sterile directly before insertion by the surgical nurse.
  • the body-compatible material can be steel, titanium, tantalum or niobium. It can also consist of polylactides, polyurethanes, hydroxyapatites, glasses, ceramics or carbon fibers.
  • the threaded front part should be at least 3 mm long to ensure sufficient anchoring in the bone.
  • the threadless back part of the bone screw should be between 2 and 3 cm long, because the drill chuck of the drill used to screw in the pins needs about 2 cm to clamp the pins and another centimeter should remain silver-free so that the silver coating just slightly projects above the skin level, because in addition to the area for the drill chuck, the jaws also cause mechanical abrasion.
  • the coated surface 0 Aq should preferably make up 10% of the total surface O tot of the bone screw.
  • a preferred development of the invention consists in that the bone screws according to the invention are only partially provided with a silver coating even in the non-threaded shaft part, e.g. with rings alternating in the axial direction.
  • the alternating surface rings made of biocompatible material (e.g. steel) and silver initially cause silver ions to flow out into the soft tissue area. Since the difference in charge decreases with time and the exchanged ions, a predetermined amount of silver ions can be released. Although this embodiment no longer permits the pins to be re-sterilized, it does take account of the requirement for controllable release of silver ions.
  • FIG. 1 shows a schematic illustration of the bone screw according to the invention
  • FIG. 2 shows a further embodiment of the bone screw according to the invention
  • FIG. 3 shows a further embodiment of the bone screw according to the invention.
  • Fig. 4 shows a further embodiment of the bone screw according to the invention.
  • the thread-bearing front part 1 and the threadless rear part 2 are uncoated and only the threadless shaft part 3 lying between them has a silver coating.
  • galvanic currents only occur at the interfaces between the rear part 2 and the threadless shaft part 3 on the one hand and between the threadless shaft part 3 and the front part 1 on the other hand.
  • the bone screw shown in FIG. 2 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3.
  • the threadless shaft part 3 is alternating in the axial direction in the form of rings 4 with a Silver coating.
  • the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
  • the bone screw shown in FIG. 3 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3.
  • the threadless shaft part 3 is provided with longitudinal strips 5 with a silver coating in the axial direction.
  • the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
  • the bone screw shown in FIG. 4 differs from the embodiment according to FIG. 1 only in the design of the threaded front part 1.
  • the front part 1 is either completely coated with silver or only coated with silver on the threads.
  • the version with a front part 1 completely coated with silver is particularly suitable for use on an already infected bone, where a high silver concentration is required.
  • the front part 1 acts as a galvanic element.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The bone screw consists of a biocompatible material with a threaded front part (1), a non-threaded back part (2) and a non-threaded shaft part (3) located in-between said parts. Part OAg of surface Otot of the bone screw is fitted with a silver coating encompassing at least partially the non-threaded shaft part (3). The remaining surface (Otot-OAg) comprising at least the threaded front part (1) is not coated. Said bone screw prevents the occurrence of infections.

Description

KnochenschraubeBone screw
Die Erfindung betrifft eine Knochenschraube gemass dem Oberbegriff des Anspruchs 1 und einen Fixateur externe mit einer solchen Knochenschraube gemass dem Anspruch 16.The invention relates to a bone screw according to the preamble of claim 1 and an external fixator with such a bone screw according to claim 16.
Bei der Verwendung von Fixateur externes in der Chirurgie treten immer noch relativ häufig Infektionen auf, d.h. die durch die Weichteile hindurch in den Knochen implantierten Knochenschrauben - in diesem Zusammenhang auch "pins" genannt - rufen eine Infektion im Weichteilbereich hervor, die auf den Knochen übergreifen kann (sogenannte "Pin tract infection" PTI) .Infections are still relatively common when using external fixators in surgery, i.e. The bone screws implanted through the soft parts in the bones - also referred to in this context as "pins" - cause an infection in the soft tissue area which can spread to the bones (so-called "pin tract infection" PTI).
Ausgehend von der schon lang bekannten antibakteriellen Wirkung des Silbers wurde in der CH 657 519 BLAETTLER ein vollständig mit Silber beschichtetes chirurgisches Implantat offenbart. Dabei ist die Silberschicht nicht direkt auf dem Trägermaterial sondern auf einer Zwischenschicht aus Kupfer aufgebracht. Der Nachteil dieser bekannten Vorrichtung besteht jedoch darin, dass Silber einen hemmenden Einfluss auf die Osteoblasten, je nach Konzentration (typischerweise 1,42 μg/ml) , ausüben kann, so dass eine solcherart beschichtete Knochenschraube trotzdem der Gefahren einer Lockerung unterworfen ist . Es sind auch Pins vorgeschlagen worden, über welche ein silberbeschichteter Kunststoffschlauch bis in die Tiefe des Gewebes bis zum Knochen vorgeschoben werden. Der Nachteil dieser Vorrichtung besteht in der fehlenden Sterilisierbarkeit , welche eine Wiederverwendung ausschliesst . Da der Durchmesser der Pins durch dem übergestülpten Schlauch verdoppelt wird, sind auch längere Inzisionen zu deren Einführung in die Weichteile erforderlich, was das Weichteiltrauma erhöht.Based on the long-known antibacterial effects of silver, CH 657 519 BLAETTLER has disclosed a surgical implant completely coated with silver. The silver layer is not applied directly to the carrier material but to an intermediate layer made of copper. The disadvantage of this known device, however, is that silver can have an inhibiting influence on the osteoblasts, depending on the concentration (typically 1.42 μg / ml), so that a bone screw coated in this way is nevertheless subject to the risks of loosening. Pins have also been proposed, through which a silver-coated plastic tube is pushed down to the depth of the tissue down to the bone. The disadvantage of this device is the lack of sterilizability, which precludes reuse. Since the diameter of the pins is doubled due to the tube being put over them, longer incisions are also required to insert them into the soft tissues, which increases the soft tissue trauma.
Hier will die Erfindung Abhilfe schaffen. Der Erfindung liegt das Problem zugrunde, eine Knochenschraube, insbesondere zur Verwendung in einem Fixateur externe zu schaffen, welche das Auftreten von Infektionen verhindert.The invention seeks to remedy this. The invention is based on the problem of creating a bone screw, in particular for use in an external fixator, which prevents the occurrence of infections.
Die Erfindung löst die gestellte Aufgabe mit einer Knochenschraube, welche die Merkmale des Anspruchs 1 aufweist.The invention solves this problem with a bone screw, which has the features of claim 1.
Die Hauptvorteile der erfindungsgemässe Knochenschraube sind die folgenden:The main advantages of the bone screw according to the invention are the following:
- die Pins können ganz normal wie herkömmliche (unbeschichtete) Pins eingesetzt werden;- The pins can be used as normal as conventional (uncoated) pins;
- die Pins sind wiederverwendbar nach einer Aufbereitung und Sterilisation) ;- The pins are reusable after reprocessing and sterilization);
- die Infektionsprophylaxe ist bei Medikamentenknappheit (z.B. in Entwicklungsländern) von besonderer Bedeutung. Erfindungswesentlich ist, dass die Knochenschraube nur partiell mit Silber beschichtet ist, und zwar mindestens in dem gegen Infektionen zu schützenden Weichteilbereich. Der Gewindeteil ist unbeschichtet, da Silber im direkten Kontakt mit dem Knochen hemmend auf die Osteoblasten wirken kann. Der durch die Klemmbacken des Fixateur externe mechanisch belastete Hinterteil der Knochenschraube ist vorzugsweise ebenfalls unbeschichtet.- Infection prophylaxis is particularly important when there is a shortage of medication (e.g. in developing countries). It is essential to the invention that the bone screw is only partially coated with silver, at least in the soft tissue area to be protected against infections. The threaded part is uncoated, since silver in direct contact with the bone can have an inhibiting effect on the osteoblasts. The rear part of the bone screw which is mechanically stressed by the clamping jaws of the fixator is preferably also uncoated.
Durch die unterschiedliche Stellung der Elemente Molybdän (- 0,2 V) , Nickel (-0,24 V), Eisen (- 0,447 V), Chrom (0,744 V) und Titan (-1,63 V) im Verhältnis zu Silber (+ 0,8 V) in der elektrochemischen Spannungsreihe ergibt sich für ein FeNi-Trägermaterial (z.B. einen CrNiMo Stahl nach ISO 58/32-1 mit Chrom 16 %, Nickel 13 %, Molybdän 3 % und Eisen 68 %) ein Unterschied von mindestens 1 Volt (bei 1 g Ion gelöst in 1 Liter Lösung bei 25°C) .Due to the different position of the elements molybdenum (- 0.2 V), nickel (-0.24 V), iron (- 0.447 V), chrome (0.744 V) and titanium (-1.63 V) in relation to silver ( + 0.8 V) in the electrochemical series there is a difference of at least for a FeNi carrier material (e.g. a CrNiMo steel according to ISO 58 / 32-1 with chromium 16%, nickel 13%, molybdenum 3% and iron 68%) 1 volt (with 1 g ion dissolved in 1 liter solution at 25 ° C).
Bei dieser Anordnung wirkt die Silberbeschichtung als Anode und der Stahl (oder Titan) als Kathode. Bei Versuchen mit Bakterien konnte gezeigt werden, dass eine bakterizide Wirkung überwiegend an der Anode auftritt. Strom-Stimulation bei Knochenfrakturen zeigten eine stimulierende Wirkung auf die Knochenzellen an der Kathode .With this arrangement, the silver coating acts as the anode and the steel (or titanium) acts as the cathode. Experiments with bacteria have shown that a bactericidal effect mainly occurs on the anode. Current stimulation in bone fractures showed a stimulating effect on the bone cells on the cathode.
Eine weitere Steigerung der antibakteriellen Wirkung der erfindungsgemässen Knochenschraube kann durch Applikation eines elektrischen Stromes in geringen Stärken, z.B. 0,25 Mikroampere erzielt werden. Typischerweise wird eine Stromstärke von 5 bis 20 Mikroampere und ca. 0,8 Volt verwendet. Einerseits erfolgt dadurch eine bakterizide Abgabe von Silberionen, anderseits wird das Osteoblastenwachstum im Bereich des - mit Silber unbeschichteten - Gewindes (Titan) stimuliert.A further increase in the antibacterial effect of the bone screw according to the invention can be achieved by applying an electric current in low strengths, for example 0.25 microamps. A current of 5 to 20 microamps and approximately 0.8 volts is typically used. On the one hand this results in a bactericidal release of silver ions, on the other hand the osteoblast growth is stimulated in the area of the thread (titanium) which is not coated with silver.
Die Schichtdicke der Silberbeschichtung ist vorzugsweise grösser als 10 μ ist und kann entweder elektrochemisch oder als metallische Folie zwischenschichtfrei auf dem körperverträglichen Material aufgebracht werden. Eine andere Möglichkeit besteht darin die Silberbeschichtung aufzukleben. Die Beschichtungen können somit nach unterschiedlichen Verfahren aufgebracht werden, z.B. elektrochemisch (Eloxieren) mittels IADB (ion assisted beam deposition mittels einer Folie (mit leitenden oder isolierendenThe layer thickness of the silver coating is preferably greater than 10 μ and can be applied to the body-compatible material either electrochemically or as a metallic film without an intermediate layer. Another possibility is to stick on the silver coating. The coatings can thus be applied by different methods, e.g. electrochemical (anodizing) using IADB (ion assisted beam deposition using a foil (with conductive or insulating
Klebstoffen) . Die beschichtungsfreien Bereiche können dabei durch Schablonen abgedeckt werden.Adhesives). The coating-free areas can be covered with stencils.
Die Folien können vor der Sterilisation mittels eines hitzebeständigen Klebstoffes aufgebracht werden, oder steril direkt vor der Insertion durch die Op-Schwester .The foils can be applied using a heat-resistant adhesive before sterilization, or sterile directly before insertion by the surgical nurse.
Das körperverträgliche Material kann Stahl, Titan, Tantal oder Niob sein. Es kann auch aus Polylactiden, Polyurethanen, Hydroxyapatiten, Gläsern, Keramiken oder Kohlefasern bestehen.The body-compatible material can be steel, titanium, tantalum or niobium. It can also consist of polylactides, polyurethanes, hydroxyapatites, glasses, ceramics or carbon fibers.
Der gewindetragende Vorderteil sollte mindestens 3 mm lang sein um eine genügende Verankerung im Knochen zu gewährleisten. Der gewindelose Hinterteil der Knochenschraube sollte zwischen 2 und 3 cm lang sein, da das Bohrfutter des zum Eindrehen der Pins verwendeten Bohrers etwa 2 cm benötigt um die Pins festzuklemmen und ein weiterer Zentimeter silberfrei bleiben sollte, damit die Silberbeschichtung das Hautniveau gerade etwas überragt, da neben dem Bereich für das Bohrfutter auch die Klemmbacken mechanischen Abrieb verursachen.The threaded front part should be at least 3 mm long to ensure sufficient anchoring in the bone. The threadless back part of the bone screw should be between 2 and 3 cm long, because the drill chuck of the drill used to screw in the pins needs about 2 cm to clamp the pins and another centimeter should remain silver-free so that the silver coating just slightly projects above the skin level, because in addition to the area for the drill chuck, the jaws also cause mechanical abrasion.
Die beschichtete Oberfläche 0Aq sollte vorzugsweise 10 % der gesamten Oberfläche Otot der Knochenschraube ausmachen.The coated surface 0 Aq should preferably make up 10% of the total surface O tot of the bone screw.
Eine bevorzugte Weiterbildung der Erfindung besteht darin, dass die erfindungsgemässen Knochenschrauben auch im gewindelosen Schaftteil nur partiell mit einer Silberbeschichtung versehen sind, z.B. mit in axialer Richtung alternierenden Ringen. Die alternierenden Oberflächen-Ringe aus biokompatiblen Material (z.B. Stahl) und Silber bewirken initial ein Ausströmen von Silberionen in den Weichteilbereich. Da der Ladungsunterschied mit der Zeit und den ausgetauschten Ionen abnimmt, kann eine im voraus bestimmte Menge Silberionen abgegeben werden. Diese Ausführungsform lässt zwar eine Resterilisierung der Pins nicht mehr zu, trägt aber dafür der Forderung einer kontrollierbaren Abgabe von Silberionen Rechnung.A preferred development of the invention consists in that the bone screws according to the invention are only partially provided with a silver coating even in the non-threaded shaft part, e.g. with rings alternating in the axial direction. The alternating surface rings made of biocompatible material (e.g. steel) and silver initially cause silver ions to flow out into the soft tissue area. Since the difference in charge decreases with time and the exchanged ions, a predetermined amount of silver ions can be released. Although this embodiment no longer permits the pins to be re-sterilized, it does take account of the requirement for controllable release of silver ions.
Die Erfindung und Weiterbildungen der Erfindung werden im folgenden anhand der teilweise schematischen Darstellungen mehrerer Ausführungsbeispiele noch näher erläutert. s zeigen :The invention and further developments of the invention are explained in more detail below on the basis of the partially schematic representations of several exemplary embodiments. s show:
Fig. 1 eine schematische Darstellung der erfindungs- gemässen Knochenschraube;1 shows a schematic illustration of the bone screw according to the invention;
Fig. 2 eine weitere Ausführungsform der erfindungsgemässen Knochenschraube;2 shows a further embodiment of the bone screw according to the invention;
Fig. 3 eine weitere Ausführungsform der erfindungsgemässen Knochenschraube; und3 shows a further embodiment of the bone screw according to the invention; and
Fig. 4 eine weitere Ausführungsform der erfindungsgemässen Knochenschraube .Fig. 4 shows a further embodiment of the bone screw according to the invention.
Bei der in Fig. 1 dargestellten Knochenschraube sind der gewindetragende Vorderteil 1 und der gewindelosen Hinterteil 2 unbeschichtet und nur der dazwischen liegende gewindelose Schaftteil 3 trägt eine Silberbeschichtung. Bei dieser Ausführung treten nur an den Grenzflächen zwischen Hinterteil 2 und gewindelosem Schaftteil 3 einerseit sowie zwischen gewindelosem Schaftteil 3 und Vorderteil 1 anderseits galvanische Ströme auf .In the bone screw shown in FIG. 1, the thread-bearing front part 1 and the threadless rear part 2 are uncoated and only the threadless shaft part 3 lying between them has a silver coating. In this embodiment, galvanic currents only occur at the interfaces between the rear part 2 and the threadless shaft part 3 on the one hand and between the threadless shaft part 3 and the front part 1 on the other hand.
Die in Fig. 2 dargestellte Knochenschraube weicht nur in der Gestaltung des gewindelosen Schaftteil 3 von der Ausführung gemass Fig. 1 ab. Der gewindelosen Schaftteil 3 ist in axialer Richtung alternierend in Form von Ringen 4 mit einer Silberbeschichtung versehen. Bei dieser Ausführung liegt das galvanische Element im Bereich des gewindelosen Schaftteils 3 ; es bewirkt ein gleichmassiges Ausströmen von Silberionen als Infektionsprophylaxe .The bone screw shown in FIG. 2 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3. The threadless shaft part 3 is alternating in the axial direction in the form of rings 4 with a Silver coating. In this embodiment, the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
Die in Fig. 3 dargestellte Knochenschraube weicht nur in der Gestaltung des gewindelosen Schaftteil 3 von der Ausführung gemass Fig. 1 ab. Der gewindelosen Schaftteil 3 ist in axialer Richtung mit Längsstreifen 5 mit einer Silberbeschichtung versehen. Bei dieser Ausführung liegt das galvanische Element im Bereich des gewindelosen Schaftteils 3; es bewirkt ein gleichmassiges Ausströmen von Silberionen als Infektionsprophylaxe .The bone screw shown in FIG. 3 differs from the embodiment according to FIG. 1 only in the design of the threadless shaft part 3. The threadless shaft part 3 is provided with longitudinal strips 5 with a silver coating in the axial direction. In this embodiment, the galvanic element lies in the area of the threadless shaft part 3; it causes an even flow of silver ions as a prophylaxis against infection.
Die in Fig. 4 dargestellte Knochenschraube weicht nur in der Gestaltung des gewindetragenden Vorderteils 1 von der Ausführung gemass Fig. 1 ab. Der Vorderteil 1 ist hier entweder vollständig mit Silber beschichtet oder nur auf den Gewindegängen mit Silber beschichtet . Die Ausführung mit einem vollständig mit Silber beschichteten Vorderteil 1 eignet sich speziell zur Anwendung bei einem bereits infizierten Knochen, wo eine hohe Silberkonzentration gefragt ist. Bei der Ausführung mit den silberbeschichteten Gewindegängen (der Kerndurchmesser besteht aus Titan) wirkt der Vorderteil 1 als galvanisches Element . The bone screw shown in FIG. 4 differs from the embodiment according to FIG. 1 only in the design of the threaded front part 1. The front part 1 is either completely coated with silver or only coated with silver on the threads. The version with a front part 1 completely coated with silver is particularly suitable for use on an already infected bone, where a high silver concentration is required. In the version with the silver-coated threads (the core diameter consists of titanium), the front part 1 acts as a galvanic element.

Claims

Patentansprüche claims
1. Knochenschraube aus einem körperverträglichen Material mit einem gewindetragenden Vorderteil (1) , einem gewindelosen Hinterteil (2) und einen dazwischen liegenden gewindelosen Schaftteil (3) , dadurch gekennzeichnet, dass1. Bone screw made of a body-compatible material with a thread-supporting front part (1), a threadless rear part (2) and an threadless shaft part (3) lying in between, characterized in that
A) ein Teil 0A„ der Oberfläche Otot der Knochenschraube mit einer Silberbeschichtung versehen ist und mindestens teilweise den gewindelosen Schaftteil (3) umfasst; undA) a part 0 A "of the surface O tot the bone screw is provided with a silver coating and at least partially comprises the threadless shaft part (3); and
B) die übrige Oberfläche (Otot - 0Aq) , welche mindestens den gewindetragenden Vorderteil (1) umfasst, unbeschichtet ist.B) the remaining surface (O tot - 0 Aq ), which comprises at least the threaded front part (1), is uncoated.
2. Knochenschraube nach Anspruch 1, dadurch gekennzeichnet, dass die Schichtdicke der Silberbeschichtung grösser als 10 μ ist.2. Bone screw according to claim 1, characterized in that the layer thickness of the silver coating is greater than 10 μ.
3. Knochenschraube nach Anspruch 1 oder 2 , dadurch gekennzeichnet, dass die Silberbeschichtung elektrochemisch auf dem körperverträglichen Material aufgebracht ist.3. Bone screw according to claim 1 or 2, characterized in that the silver coating is applied electrochemically to the body-compatible material.
4. Knochenschraube nach Anspruch 1 oder 2 , dadurch gekennzeichnet, dass die Silberbeschichtung als metallische Folie auf dem körperverträglichen Material aufgebracht ist.4. Bone screw according to claim 1 or 2, characterized in that the silver coating is applied as a metallic foil on the body-compatible material.
5. Knochenschraube nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass der gewindetragende Vorderteil (1) mindestens 3 mm lang ist. 5. Bone screw according to one of claims 1 to 4, characterized in that the threaded front part (1) is at least 3 mm long.
6. Knochenschraube nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass der gewindelose Hinterteil (2) unbeschichtet ist.6. Bone screw according to one of claims 1 to 7, characterized in that the threadless rear part (2) is uncoated.
7. Knochenschraube nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass der gewindelose Hinterteil (2) zwischen 2 und 3 cm lang ist.7. Bone screw according to one of claims 1 to 6, characterized in that the unthreaded rear part (2) is between 2 and 3 cm long.
8. Knochenschraube nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass das körperverträglichen Material Stahl, Titan, Tantal oder Niob ist.8. Bone screw according to one of claims 1 to 7, characterized in that the body-compatible material is steel, titanium, tantalum or niobium.
9. Knochenschraube nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass das körperverträglichen Material zur folgenden Gruppe von Materialien gehört:9. Bone screw according to one of claims 1 to 7, characterized in that the body-compatible material belongs to the following group of materials:
Polylactide, Polyurethane, Hydroxyapatite, Gläser, Keramik oder Kohlefasern.Polylactides, polyurethanes, hydroxyapatites, glasses, ceramics or carbon fibers.
10. Knochenschraube nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass die beschichtete Oberfläche 0Aq mindestens 10 % der gesamten Oberfläche Otot der Knochenschraube ausmacht .10. Bone screw according to one of claims 1 to 9, characterized in that the coated surface 0 Aq makes up at least 10% of the total surface O tot of the bone screw.
11. Knochenschraube nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die Silberbeschichtung zwischenschichtfrei auf dem körperverträglichen Material aufgebracht ist . 11. Bone screw according to one of claims 1 to 10, characterized in that the silver coating is applied without an intermediate layer on the body-compatible material.
12. Knochenschraube nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die Silberbeschichtung mittels eines Klebstoffes auf dem körperverträglichen Material aufgebracht ist .12. Bone screw according to one of claims 1 to 10, characterized in that the silver coating is applied to the body-compatible material by means of an adhesive.
13. Knochenschraube nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, dass der gewindelosen Schaftteil (3) nur partiell mit einer Silberbeschichtung versehen ist.13. Bone screw according to one of claims 1 to 12, characterized in that the threadless shaft part (3) is only partially provided with a silver coating.
14. Knochenschraube nach Anspruch 13, dadurch gekennzeichnet, dass der gewindelosen Schaftteil (3) in axialer Richtung alternierend in Form von Ringen (4) mit einer Silberbeschichtung versehen ist.14. Bone screw according to claim 13, characterized in that the threadless shaft part (3) is alternately provided in the axial direction in the form of rings (4) with a silver coating.
15. Knochenschraube nach Anspruch 13, dadurch gekennzeichnet, dass der gewindelosen Schaftteil (3) in axialer Richtung mit Längsstreifen (5) mit einer Silberbeschichtung versehen ist.15. Bone screw according to claim 13, characterized in that the threadless shaft part (3) is provided in the axial direction with longitudinal strips (5) with a silver coating.
16. Fixateur externe mit einer Knochenschraube nach einem der Ansprüche 1 bis 15. 16. External fixator with a bone screw according to one of claims 1 to 15.
EP99900870A 1999-02-04 1999-02-04 Bone screw Ceased EP1148830A1 (en)

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PCT/CH1999/000049 WO2000045724A1 (en) 1999-02-04 1999-02-04 Bone screw

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JP (1) JP4230668B2 (en)
AU (1) AU757391B2 (en)
CA (1) CA2360904C (en)
WO (1) WO2000045724A1 (en)
ZA (1) ZA200000450B (en)

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ZA200000450B (en) 2000-09-06
AU757391B2 (en) 2003-02-20
JP4230668B2 (en) 2009-02-25
CA2360904A1 (en) 2000-08-10
AU2044699A (en) 2000-08-25
US20020029043A1 (en) 2002-03-07
US6663634B2 (en) 2003-12-16
WO2000045724A1 (en) 2000-08-10
JP2002536048A (en) 2002-10-29

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