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WO1997028760A1 - Moyen de fixation en forme de vis ou de broche pour osteosynthese - Google Patents

Moyen de fixation en forme de vis ou de broche pour osteosynthese Download PDF

Info

Publication number
WO1997028760A1
WO1997028760A1 PCT/CH1997/000040 CH9700040W WO9728760A1 WO 1997028760 A1 WO1997028760 A1 WO 1997028760A1 CH 9700040 W CH9700040 W CH 9700040W WO 9728760 A1 WO9728760 A1 WO 9728760A1
Authority
WO
WIPO (PCT)
Prior art keywords
roughness
bone
surface roughness
osteosynthesis
screw
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CH1997/000040
Other languages
German (de)
English (en)
Inventor
Wilfried Schilli
Martin Schug
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.)
Institut Straumann AG
Original Assignee
Institut Straumann AG
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 Institut Straumann AG filed Critical Institut Straumann AG
Priority to AU26127/97A priority Critical patent/AU2612797A/en
Publication of WO1997028760A1 publication Critical patent/WO1997028760A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • 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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • 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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30838—Microstructures
    • 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
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • 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
    • A61F2002/30906—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth shot- sand- or grit-blasted
    • 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
    • A61F2002/30925—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth etched
    • 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

Definitions

  • the invention relates to a surgically inserted thorn or screw-shaped fastening means for use in osteosynthesis for the union of fractured, repositioned bone parts, the fastening means being set mono- or bicortical and solely effecting or additionally serving to hold together the bone parts Fixing connection part.
  • This concerns the maxillo-craniofacial osteosynthesis and the osteosynthesis of other small bone fragments, e.g. in hand and foot surgery.
  • the invention relates to the fixation of permanent implants in all areas with a low fixation depth in the bone, e.g. implantable hearing aids, epitheses and small joints. In principle, all those areas of application come into consideration where long screws are not required or cannot be used because of increased risk.
  • the mandrel-shaped or screw-shaped fastening means - the most typical form is the small fragment screw - is initially referred to as a bone screw in order to shorten the use of language.
  • the conventional bone screws used for this are with a See fine or coarse thread or a combined thread; otherwise the threaded part has a smooth surface, which is a quality criterion.
  • the bone screws consist of corrosion-free, biocompatible metal, whereby titanium has proven particularly useful in the field of small fragment supply.
  • mini-osteosynthesis systems consisting of pure titanium in situ on account of the improved biocompatibility of the material (cf. Edwards, TJC, David, DJ: A comparative study of miniplates used in the treatment of mandibular fractures. Plast. Reconstr. Surg. 97: 1150 (1996).
  • screwed-in bone screws must have good anchoring, both with regard to tearing out and unscrewing, the risk of loosening due to unscrewing becoming smaller with increasing number of screws when fixing a bone plate.
  • Adequate anchorage of the screw is generally achieved if the screw has a greater length and is bicortical, i.e. is screwed continuously through the bone, with which the screw thread engages on both sides of the bone in the firmer corticalis.
  • a screw is known from WO-A-94 16636, in which a modified outer diameter and a pitch decreasing towards the screw head is provided over the length of the threaded part (similar to WO-A-91 09572).
  • the flank angle of the thread plays a special role in CH-A-681 595.
  • CH-A-681 957 and EP-A-0 491 211 proposes special geometries of the threaded part.
  • the invention is based on the problem of using a mandrel-shaped or screw-shaped fastening means, in particular in the diameter dimension of approximately ⁇ 2.5 mm and, for example, a length of 2 to 3 times the diameter to create increased secondary stability.
  • the screws must be able to be subjected to a functional load immediately after the operation, that is, in the critical initial phase of osteosynthesis, sufficient primary stability and accompanying Fracture healing also ensure a solid secondary stability, since usually no additional immobilization of the fracture can be considered. This means that it is also important to increase the pull-out strength, which among other things determines the quality of the secondary stability.
  • fasteners of the generic type the surface of which coming into contact with the bone at least partially has an additional specific surface roughness generated, have significantly better secondary stability.
  • Macro profiling in the form of a thread or at least in principle regular depressions and / or elevations eg ribs, grooves, webs, knobs, honeycombs
  • Macro profiling in the form of a thread or at least in principle regular depressions and / or elevations (eg ribs, grooves, webs, knobs, honeycombs); 2. an in principle irregular macro roughness, which was generated, for example, by corundum blasting; and 3. an in principle irregular micro-roughness, which was generated for example by chemical surface treatment.
  • the mandrel-shaped or screw-shaped fastening means provided for use in osteosynthesis, for the union of fractured bone parts and those repositioned in a surgical procedure, has a head part and a shaft attached to it.
  • the shaft can be provided entirely or partially with threads or other textures; several differently designed, separate, textured sections are also possible. A thread could have a self-tapping part.
  • the shaft is designed to be inserted monocortically or bicortically in the bones to be healed.
  • the three structures namely the macro-profiling and the macro-roughness and the micro-roughness, can be provided in a variety of mixed forms as well as superimposed or alternating alternately, both axially and radially on the shaft. It would be conceivable that the thread flanks and the core surface of the shaft are differently macro and micro-rough.
  • the fastening means either alone holds the bone parts together, or additional connecting parts are fixed by means of this fastening part.
  • Such connecting parts are in particular extramedullary bone plates, as are used, for example, for fractures on extremities or on the skull.
  • the the Repositioning - possibly under constant contact pressure - stabilizing implants are generally removed from the body again in a further surgical step after the bone has healed. Taking advantage of the material-related, advantageous biocompatibility and the now improved secondary stability, the previously necessary revision of the fastener can be omitted.
  • a surface roughness and thus enlargement is specifically produced on the shaft of the mandrel-shaped or screw-shaped fastening means located in the bone, as a result of which biological anchoring (secondary stability) can only be achieved in the bone.
  • the surface roughness preferably consists of a macro and a micro roughness. Part of the macro roughness can be generated by material application, e.g. using the T_itanplasma-3_ ⁇ ray method (TPS).
  • TPS T_itanplasma-3_ ⁇ ray method
  • the roughness can also advantageously be produced by mechanical and / or chemical and / or thermal treatment in the form of material displacement and / or material removal that goes deep into the base material.
  • the macro roughness is e.g. can be produced by single- or multi-phase grinding treatment of the relevant shaft surface; irradiation with solid particles can also be considered. Corundum has proven itself as an abrasive.
  • the micro roughness is e.g. generated by chemical treatment as an etching process. In this respect, the principle
  • the anchoring can also be further increased if the surface roughness is introduced in a direction-oriented manner. In order to produce this alignment, the irradiation is carried out at an adequate angle.
  • mini-osteosynthesis screws made of pure titanium with three different surfaces (smooth, TPS-coated, SLA-treated) in defined bone specimens made of pig bone; Measurement of the maximum torque and the ratio of screwing in to loosening torque;

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

Abstract

Le moyen de fixation présenté, notamment une vis pour os, utilisable en ostéosynthèse, est caractérisé en ce qu'on confère à la tige qui vient en prise, de façon monocorticale ou bicorticale, avec les fragments osseux à lier, une rugosité en surface supplémentaire. Le moyen de fixation est destiné à assurer directement la stabilisation des fragments, ou encore à fixer des éléments de jonction, par exemple, une lame osseuse. La rugosité de surface peut être produite par addition ou, de préférence, par déplacement ou enlèvement de matière. On aura alors principalement recours à un sablage au moyen de particules solides et/ou à un traitement d'attaque. Le moyen de fixation selon l'invention permet, pour la première fois, lorsqu'il est utilisé également sous forme d'une vis à petits fragments, d'obtenir une osséo-intégration, rendant inutile toute révision du moyen de fixation. Comme matériau approprié, on utilise principalement le titane ou un alliage à base de titane.
PCT/CH1997/000040 1996-02-09 1997-02-10 Moyen de fixation en forme de vis ou de broche pour osteosynthese Ceased WO1997028760A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU26127/97A AU2612797A (en) 1996-02-09 1997-02-10 Pin or screw-like securing device for osteosynthesis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH352/96 1996-02-09
CH35296 1996-02-09

Publications (1)

Publication Number Publication Date
WO1997028760A1 true WO1997028760A1 (fr) 1997-08-14

Family

ID=4185071

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH1997/000040 Ceased WO1997028760A1 (fr) 1996-02-09 1997-02-10 Moyen de fixation en forme de vis ou de broche pour osteosynthese

Country Status (2)

Country Link
AU (1) AU2612797A (fr)
WO (1) WO1997028760A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999013700A2 (fr) 1999-01-12 1999-03-25 Lipat Consulting Ag Structure superficielle pour implant intraosseux
WO2003030957A1 (fr) * 2001-10-11 2003-04-17 Straumann Holding Ag Implants osteophiles

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3605123A (en) * 1969-04-29 1971-09-20 Melpar Inc Bone implant
FR2610512A1 (fr) * 1987-02-06 1988-08-12 Cuilleron J Procede et moyens d'ancrage d'elements d'implants visses dans les tissus osseux et les elements d'implants obtenus
US4865603A (en) * 1988-02-04 1989-09-12 Joint Medical Products Corporation Metallic prosthetic devices having micro-textured outer surfaces
EP0388576A1 (fr) * 1989-03-23 1990-09-26 Institut Straumann Ag Implant métallique
US5098434A (en) * 1990-11-28 1992-03-24 Boehringer Mannheim Corporation Porous coated bone screw
WO1994009717A1 (fr) * 1992-10-28 1994-05-11 Astra Aktiebolag Appareil de fixation pour systeme d'implant dentaire
EP0701803A1 (fr) * 1994-02-03 1996-03-20 Ao-Forschungsinstitut Davos Dispositif médical implantable dans des organismes vivants

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3605123A (en) * 1969-04-29 1971-09-20 Melpar Inc Bone implant
FR2610512A1 (fr) * 1987-02-06 1988-08-12 Cuilleron J Procede et moyens d'ancrage d'elements d'implants visses dans les tissus osseux et les elements d'implants obtenus
US4865603A (en) * 1988-02-04 1989-09-12 Joint Medical Products Corporation Metallic prosthetic devices having micro-textured outer surfaces
EP0388576A1 (fr) * 1989-03-23 1990-09-26 Institut Straumann Ag Implant métallique
US5098434A (en) * 1990-11-28 1992-03-24 Boehringer Mannheim Corporation Porous coated bone screw
WO1994009717A1 (fr) * 1992-10-28 1994-05-11 Astra Aktiebolag Appareil de fixation pour systeme d'implant dentaire
EP0701803A1 (fr) * 1994-02-03 1996-03-20 Ao-Forschungsinstitut Davos Dispositif médical implantable dans des organismes vivants

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999013700A2 (fr) 1999-01-12 1999-03-25 Lipat Consulting Ag Structure superficielle pour implant intraosseux
WO1999013700A3 (fr) * 1999-01-12 1999-11-25 Lipat Consulting Ag Structure superficielle pour implant intraosseux
US6554867B1 (en) 1999-01-12 2003-04-29 Lipat Consulting Ag Surface structure for intraosseous implant
WO2003030957A1 (fr) * 2001-10-11 2003-04-17 Straumann Holding Ag Implants osteophiles
CN100366300C (zh) * 2001-10-11 2008-02-06 斯特劳曼控股公司 亲骨型植入物

Also Published As

Publication number Publication date
AU2612797A (en) 1997-08-28

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