DE102006044415B4 - Titanium-containing implant for temporary implantation - Google Patents

Titanium-containing implant for temporary implantation Download PDF

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Publication number
DE102006044415B4
DE102006044415B4 DE102006044415A DE102006044415A DE102006044415B4 DE 102006044415 B4 DE102006044415 B4 DE 102006044415B4 DE 102006044415 A DE102006044415 A DE 102006044415A DE 102006044415 A DE102006044415 A DE 102006044415A DE 102006044415 B4 DE102006044415 B4 DE 102006044415B4
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Prior art keywords
titanium
implant
implantation
roughness
containing implant
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Expired - Fee Related
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DE102006044415A
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German (de)
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DE102006044415A1 (en
Inventor
Bernhard Gottwald
Thomas Krock
Dr. Fischer Hans-Joachim
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Aap Implantate AG
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Aap Implantate AG
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    • 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
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium 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
    • 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
    • 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
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/009—Special surfaces of prostheses, e.g. for improving ingrowth for hindering or preventing attachment of biological tissue
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30672—Features concerning an interaction with the environment or a particular use of the prosthesis temporary
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30932—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for retarding or preventing ingrowth of bone tissue
    • 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
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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

Abstract

Titanhaltiges Implantat zur temporären Implantation, mit einer Oberfläche, welche für die Dauer der Implantation im Kontakt mit organischem Material eines Organismus steht, dadurch gekennzeichnet, dass die Rauigkeit der Oberfläche durch Keramofinish oder elektrolytisch galvanische Behandlung einen Ra-Parameter von Ra ≤ 0,05 μm und einen Rt-Parameter von Rt ≤ 0,7 μm aufweist.Titanium-containing implant for temporary implantation, having a surface which is in contact with organic material of an organism for the duration of the implantation, characterized in that the roughness of the surface by ceramic finishing or electrolytic galvanic treatment has an Ra parameter of Ra ≤ 0.05 μm and an Rt parameter of Rt ≦ 0.7 μm.

Description

Die Erfindung bezieht sich auf ein titanhaltiges Implantat zur temporären Implantation, mit einer Oberfläche, welche für die Dauer der Implantation im Kontakt mit organischem Material eines Organismus steht.The invention relates to a titanium-containing implant for temporary implantation, with a surface which is in contact with organic material of an organism for the duration of the implantation.

Titanhaltige Implantate können beispielsweise aus Reintitan oder Titanlegierungen bestehen. Derartige Implantate finden Verwendung sowohl als Dauerimplantate, beispielsweise als künstliche Hüftgelenkpfannen, als auch als temporäre Implantate, beispielsweise als Osteosyntheseplatten. Titan als Werkstoff zeichnet sich durch seine gute Biokompatibilität aus. Für Dauerimplantate ist es vorteilhaft, wenn das Implantat und das umgebende organische Material, beispielsweise Bindegewebe oder Knochensubstanz, eine besonders feste Verbindung miteinander eingehen. Ohne diese feste Verbindung kann das Gewebe an Dauerimplantaten einer ständigen mechanischen Irritation ausgesetzt sein und sich in Folge dessen entzünden. Zur Erhöhung der Affinität zwischen dem eingesetzten Implantat und dem das Implantat umgebenen Organismus ist es üblich, die Oberfläche des Implantats zu behandeln. Aus dem Stand der Technik sind hierfür beispielsweise beschichtende oder die Oberfläche aufrauende Methoden bekannt. Zum Aufrauen der Oberfläche werden beispielsweise Sandstrahl- oder Säureätzverfahren eingesetzt. Als Beschichtungen sind beispielsweise Kollagenbeschichtungen bekannt.Titanium-containing implants may for example consist of pure titanium or titanium alloys. Such implants are used both as permanent implants, for example as artificial hip joint pans, as well as temporary implants, for example as osteosynthesis plates. Titanium as a material is characterized by its good biocompatibility. For permanent implants, it is advantageous if the implant and the surrounding organic material, for example connective tissue or bone substance, form a particularly strong connection with one another. Without this tight connection, the tissue on permanent implants may be subject to constant mechanical irritation and, as a result, become inflamed. To increase the affinity between the implant used and the organism surrounding the implant, it is common practice to treat the surface of the implant. For example, coating or roughening methods are known from the prior art. For roughening the surface, for example, sandblasting or acid etching methods are used. For example, collagen coatings are known as coatings.

Der Erfindung liegt die Aufgabe zugrunde, ein titanhaltiges Implantat zur temporären Implantation anzugeben, das ein Anwachsen von umgebendem organischem Material verhindert.The invention has for its object to provide a titanium-containing implant for temporary implantation, which prevents the growth of surrounding organic material.

Die Aufgabe wird erfindungsgemäß dadurch gelöst, dass die Rauigkeit der Oberfläche durch Keramofinish oder elektrolytisch galvanische Behandlung einen Ra-Parameter von Ra ≤ 0,05 μm und einen Rt-Parameter von Rt ≤ 0,7 μm aufweist.The object is achieved in that the roughness of the surface by Keramofinish or electrolytic galvanic treatment has a R a -Parameter of R a ≤ 0.05 microns and an R t -Parameter of R t ≤ 0.7 microns.

Die Glattheit der Oberfläche allein reicht aus, um die Aufgabe zu lösen. Das erfindungsgemäße Implantat ist an seiner Oberfläche nicht chemisch verändert oder beschichtet, so dass Untersuchungen zur Verträglichkeit entfallen können. Die Glattheit der Oberfläche kann von dem Verwendungszweck des Implantats abhängig gemacht werden.The smoothness of the surface alone is enough to solve the task. The implant according to the invention is not chemically modified or coated on its surface, so that compatibility studies can be dispensed with. The smoothness of the surface may be dependent on the intended use of the implant.

So kann beispielsweise die vorgesehene Implantatierungsdauer und das vorgesehene umgebende organische Material berücksichtigt werden. Erfindungsgemäß ist eine Rauigkeit vorgesehen, die Rauigkeitsparameter von Ra ≤ 0.05 μm und Rt ≤ 0.7 μm aufweist.For example, the planned implantation duration and the intended surrounding organic material can be taken into account. According to the invention, a roughness is provided which has roughness parameters of R a ≦ 0.05 μm and R t ≦ 0.7 μm.

Dabei entspricht der R.-Wert dem arithmetischen Mittel der Abweichung von der Mittellinie des Profils. Dieser Wert wird auch als mittlere Rauigkeit bezeichnet. Der Rt-Wert ist ein Maß für die Rauigkeitstiefe.The R. value corresponds to the arithmetic mean of the deviation from the center line of the profile. This value is also called average roughness. The R t value is a measure of the roughness depth.

Diese Rauigkeitswerte sind signifikant kleiner als Rauigkeitswerte gängiger Titanimplantate. Der Stand der Technik, wie er beispielsweise durch die WO 2004/008984A1 , die WO 2004/008983 A1 , die WO 2005/004941 A1 , die EP 0 388 576 A1 und das DE 20 2005 002 450 U1 offenbart wird, weist Rauigkeitswerte in der Größenordnung von 250 nm bis 20 nm auf.These roughness values are significantly smaller than roughness values of common titanium implants. The state of the art, as exemplified by the WO 2004 / 008984A1 , the WO 2004/008983 A1 , the WO 2005/004941 A1 , the EP 0 388 576 A1 and the DE 20 2005 002 450 U1 has roughness values on the order of 250 nm to 20 nm.

Die derartig geringe Rauigkeit des erfindungsgemäßen Implantats wird durch Keramofinish oder elektrolytisch galvanische Methoden erreichen.The thus low roughness of the implant according to the invention is achieved by ceramic finishing or electrolytic galvanic methods.

Im Folgenden wird die Erfindung anhand eines Ausführungsbeispiels schematisch in einer Zeichnung gezeigt.In the following, the invention will be shown schematically with reference to an embodiment in a drawing.

Dabei zeigt dieIt shows the

1 ein Diagramm einer Profilanalyse der Oberfläche eines Titanimplantats gemäß dem Stand der Technik, und die 1 a diagram of a profile analysis of the surface of a titanium implant according to the prior art, and the

2 ein Diagramm einer Profilanalyse der Oberfläche eines erfindungsgemäßen Titanimplantats. 2 a diagram of a profile analysis of the surface of a titanium implant according to the invention.

Claims (1)

Titanhaltiges Implantat zur temporären Implantation, mit einer Oberfläche, welche für die Dauer der Implantation im Kontakt mit organischem Material eines Organismus steht, dadurch gekennzeichnet, dass die Rauigkeit der Oberfläche durch Keramofinish oder elektrolytisch galvanische Behandlung einen Ra-Parameter von Ra ≤ 0,05 μm und einen Rt-Parameter von Rt ≤ 0,7 μm aufweist.Titanium-containing implant for temporary implantation, having a surface which is in contact with organic material of an organism for the duration of the implantation, characterized in that the roughness of the surface by ceramic finish or electrolytic galvanic treatment has an R a parameter of R a ≤ 0, 05 μm and an R t parameter of R t ≤ 0.7 μm.
DE102006044415A 2006-09-18 2006-09-18 Titanium-containing implant for temporary implantation Expired - Fee Related DE102006044415B4 (en)

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1398664B1 (en) * 2010-03-09 2013-03-08 Sintea Plustek S R L PROSTHESIS WITH DIFFERENTIATED BIOLOGICAL RESPONSE
CA2803262C (en) * 2010-07-09 2018-09-11 Synthes Usa, Llc Self-detaching layer for easy implant removal

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0388576A1 (en) * 1989-03-23 1990-09-26 Institut Straumann Ag Metallic implant
WO2004008984A1 (en) * 2002-07-19 2004-01-29 Astra Tech Ab An implant and a method for treating an implant surface
WO2004008983A1 (en) * 2002-07-19 2004-01-29 Astra Tech Ab An implant and a method for treating an implant surface
WO2005004941A1 (en) * 2003-07-08 2005-01-20 Poligrat Gmbh Cementable endoprostheses
DE202005002450U1 (en) * 2005-02-16 2005-07-07 Oraltronics Dental Implant Technology Gmbh Jaw implant suitable for insertion in bone is (partly) provided with homogeneous nanostructurized surface with specified surface topography and consists e.g. of titanium or alloy

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0388576A1 (en) * 1989-03-23 1990-09-26 Institut Straumann Ag Metallic implant
WO2004008984A1 (en) * 2002-07-19 2004-01-29 Astra Tech Ab An implant and a method for treating an implant surface
WO2004008983A1 (en) * 2002-07-19 2004-01-29 Astra Tech Ab An implant and a method for treating an implant surface
WO2005004941A1 (en) * 2003-07-08 2005-01-20 Poligrat Gmbh Cementable endoprostheses
DE202005002450U1 (en) * 2005-02-16 2005-07-07 Oraltronics Dental Implant Technology Gmbh Jaw implant suitable for insertion in bone is (partly) provided with homogeneous nanostructurized surface with specified surface topography and consists e.g. of titanium or alloy

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