WO2000059409A1 - Bone implant device for generating tissue using bone replacement materials and method for producing said bone implant device - Google Patents

Bone implant device for generating tissue using bone replacement materials and method for producing said bone implant device Download PDF

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Publication number
WO2000059409A1
WO2000059409A1 PCT/EP2000/002983 EP0002983W WO0059409A1 WO 2000059409 A1 WO2000059409 A1 WO 2000059409A1 EP 0002983 W EP0002983 W EP 0002983W WO 0059409 A1 WO0059409 A1 WO 0059409A1
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WO
WIPO (PCT)
Prior art keywords
bone
flange
rod elements
flanges
areas
Prior art date
Application number
PCT/EP2000/002983
Other languages
German (de)
French (fr)
Inventor
Franz GÜTLBAUER
Hans-Florian Zeilhofer
Original Assignee
Guetlbauer Franz
Zeilhofer Hans Florian
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 Guetlbauer Franz, Zeilhofer Hans Florian filed Critical Guetlbauer Franz
Publication of WO2000059409A1 publication Critical patent/WO2000059409A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/28—Bones
    • A61F2/2803—Bones for mandibular reconstruction
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    • 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
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    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • 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
    • 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
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Definitions

  • Bone implant device for tissue generation using bone substitute materials and method for producing the
  • the invention relates to a bone implant device for tissue generation using bone substitute materials and a method for producing the bone implant device.
  • bone substitute materials to generate bone tissue, in particular in load-bearing bone areas.
  • Such bone generations are used in oral, maxillofacial and facial surgery and in other operative specialist disciplines, for example for finger bones, hand bones or the like.
  • ceramics with osteoconductive properties such as hydroxylapatite or tricalcium phosphate and / or osteoinductive materials. These materials serve as lead structures at the introduced body parts, the bone substitute material is slowly broken down, at the same time a new bone structure is formed.
  • the previously known materials have the Disadvantage that they are not biomechanically resilient and can therefore only be used in non-supporting bone areas.
  • metallic elements are inserted for the supply of load-bearing bone areas, for example made of titanium alloys or composite materials.
  • Such plates or implants form a foreign body that does not control the formation of new bones in a controlled manner.
  • the contact area between such implants and the bone there are uncontrollable remodeling processes.
  • the biomechanical properties of the implants and the bones differ.
  • the compatibility of such implants is often not given, so that on the one hand germ colonization can occur and on the other hand allergic reactions can be triggered.
  • such implants that remain in the patient's body for long periods of time can cause corrosion processes that are undesirable or questionable from a medical point of view.
  • the invention has for its object to provide a bone implant device and a method for its production, which allows the generation of bone by means of bone replacement materials in load-bearing bone sections with a simple structure and simple, safe applicability.
  • the object is achieved by the features of the main claim and of claim 22, the respective subclaims show further advantageous embodiments of the invention.
  • a bone implant device which has a first and a second flange, each of which can be releasably attached to a bone area, adjacent to a missing or defective bone area. Furthermore, several rod elements are provided according to the invention, which are selectively detachably connected to the flanges.
  • the device according to the invention is distinguished by a number of considerable advantages.
  • the flanges and the rod elements create a support structure that can meet all biomechanical requirements.
  • the support structure is able to absorb and transmit the forces and moments that occur between the two bone areas.
  • This support structure of the bone implant device according to the invention thus forms a stable support structure which, on the one hand, enables bone generation and, on the other hand, allows the patient to strain the bone area during the healing phase.
  • Bone replacement material can be introduced into the interior formed between the flanges and the rod elements, which enables the growth of new bones. This generation effect is not disturbed by occurring loads, since the device absorbs the corresponding forces and / or moments.
  • the selective releasability of the individual rod elements makes it possible, using the device according to the invention, to gradually increase the load-bearing support structure of the device according to the invention with increasing strength of the newly formed bone while maintaining the biomechanical requirements to reduce. Individual bar elements can thus be removed at intervals. This gradually increases the load on the newly formed bone. It is known that bone does not form or only insufficiently in the absence of stress.
  • the device according to the invention thus makes it possible to apply incrementally increasing loads adapted to the new formation process.
  • the respective flange is designed to match the bone region to be connected to the flange.
  • the two bone areas to be connected to the flanges are measured three-dimensionally. This is preferably done using a tomography method. After the exact shape and size of the bone areas have been determined, it is then possible to produce the flange in a precisely fitting manner, for example by means of a shaping or casting process or machining shaping process or by processes which are known from rapid prototyping.
  • the flange can be formed in one piece or in several pieces. In the case of a multi-piece design, it can be assembled appropriately for attachment to the bone areas. In the case of a one-piece design, the flange can have, for example, a U-shaped cross section or can be provided with at least one monitoring area. The shape and shape of the flange should preferably be chosen so that it can be easily and securely pushed or placed onto the bone area during an operation and that it is possible in a simple manner to remove the flange after the new bone has formed. With a multi-piece design of the flange, the individual Areas are removed, in a one-piece design, the flange can be bent or broken open.
  • the bar elements preferably have a circular cross section, but it is possible to dimension the bar elements oval or in some other way.
  • the bar elements can either be in the form of straight bars, but it is also possible to make them helical.
  • the shape of the rods depends on the one hand on the forces to be transferred, on the other hand on the local conditions and the possibility of removing the rods one after the other in individual surgical steps.
  • the first flange has fixed bearings for the rod elements. It is thus possible to pre-assemble the rod elements on the first flange.
  • the second flange is preferably equipped with bearings that allow axial play of the rod elements, so that they can be pushed on or plugged on accordingly. It is understood that suitable fixing means are provided around the ends of the rod elements also to be firmly connected to the second flange.
  • flanges there are various possibilities for connecting the flanges to the bone areas.
  • means for screwing can be provided. It is possible to insert screws into the bone area through recesses in the flanges.
  • the flanges can also be fixed using continuous screws.
  • gluing the flanges to the bone areas Since the flanges are manufactured very precisely to the dimensions of the bone areas, it is also possible to push them onto the bone areas and clamp them. Another possibility is to manufacture the flanges from a memory alloy which, after assembly, for example by heat, fits exactly on the bone areas.
  • bone replacement material is introduced into the interior formed by the rod elements and the flanges.
  • holding means for the bone replacement materials are arranged in the interior. These can be film-like, net-like, granular, gel-like and / or grid-like. It is particularly advantageous if the holding means are made from biodegradable material. It is then not necessary to remove the holding means again.
  • Both the flanges and the rod elements can, for example, be made from biocompatible titanium alloys. However, there are also a variety of other material compositions.
  • the bone implant device according to the invention is thus manufactured to match the bone to be newly formed and the bone areas adjacent to the defective area.
  • the flanges are preferably dimensioned using a 3D method in order to ensure an exact fit of the flanges.
  • the number, arrangement and size of the bar elements are determined based on the loads that occur.
  • the sequence of the rod elements to be removed step by step is determined in order to be able to apply a sufficient load which promotes bone growth during the generation of the defective bone. After the bone has been completely generated, the device according to the invention is removed. There are therefore no disruptive or negative implants remaining in the patient's body.
  • the bone implant device according to the invention makes it possible to keep the bone replacement materials in the desired shape during the generation process.
  • the forces and moments to be transmitted are determined using a method of the finite elements.
  • the bone implant device can then transmit the compressive forces, tensile forces, torsional forces and shear forces that occur.
  • rod elements made of metallic materials. fen manufacture, while other rod elements can be made of resorbable materials, such as polylactides. The latter variant is advantageous if, for operational reasons, special difficulties could arise when removing individual rod elements.
  • the resorbable rod elements can serve as additional support for the bone replacement materials, without these rod elements subsequently having to be surgically removed.
  • Calcium hydroxyapatite cement or phase-pure beta or alpha-calcium calcium phosphate ceramics can be used as bone replacement materials.
  • the support structure formed by the bone implant device according to the invention can be adapted in the simplest manner to the respective operative conditions within the scope of the invention.
  • the shape and arrangement of the bar elements can be varied over a wide range. Due to the helical design of the rod elements, it is possible, for example, to attach them with their ends offset by 180 ° to the respective flange. It is therefore not necessary to have direct access to the rear part of the bone to remove the rod elements. This can be particularly advantageous in the treatment of jawbones, in order not to burden the patient unnecessarily.
  • FIG. 1 shows a simplified, perspective view of a bone implant device according to the invention for connecting two bone areas
  • FIG. 2 shows a simplified illustration of the bone implant device according to the invention in association with a lower jaw represented by finite elements
  • FIG. 3 is a sectional view taken along the line III-III of FIG. 2,
  • Fig. 4 is a sectional view taken along the line IV-IV of Fig. 2, and
  • first flange 1 and 2 each show a first flange 1 and a second flange 2, which are placed on a first bone area 3 and a second bone area 4, respectively.
  • the flanges 1 and 2 can be fastened by means of schematically illustrated screws 11.
  • the two flanges 1 and 2 are connected by means of a multiplicity of rod elements 5.
  • the first flange 1 has bearings 7 which can be in the form of recesses or bores. It is thus possible to insert the rod elements 5 into the first flange 1 by means of a press fit. Alternatively, a screw connection is also possible. It is understood that further other types of fastening can be selected within the scope of the invention.
  • the other end of the rod elements 5 is attached to the second flange 2. For this purpose, this also has corresponding bearings 7.
  • the flanges can have a U-shaped shape.
  • bone replacement material 10 which is held by holding means 9, is inserted into the interior formed by the rod elements 5.
  • holding means can be designed, for example, in the form of a film.
  • the flange can have different thickness ranges.
  • contact areas 8 are provided which bear against the bone area 4, so that the flange is not braced against the bone area 4 over its entire inner surface.
  • the flanges and the rod elements can be preassembled in such a way that a flange is non-positively connected to the rod elements and is axially displaceable at the other end of the rod elements by a certain range for easier sliding on the bone ends.
  • These ends of the rod elements are designed such that after the device according to the invention has been introduced by means of axial push a positive connection with the other flange is reached. If the load permits, the rod ends in the inner region, that is to say in the region facing away from the body surface, are not or only partially non-positively connected to the respective flange in order to make it easier to remove these rod elements.
  • the bar elements can be arranged either in a straight line and opposite one another or offset by up to 180 °.
  • the use of the invention on a lower jaw bone has been described.
  • the invention is not limited to oral, maxillofacial and facial surgery, rather it can also be used in other areas of the human or animal skeleton, for example in the case of hand or finger bones, in the area of the bone bone or the like.

Abstract

The invention relates to a bone implant device for generating tissue using bone replacement materials and to a method for producing the same. The inventive device comprises a first (1) and a second flange (2), each of which can be detachably fixed to an area of bone (3, 4), and several rod elements (5) which are connected to the flanges (1, 2) in such a way that they are selectively detachable.

Description

Knochenimplantatvorrichtung zur Gewebegenerierung mittels Knochenersatzmaterialien sowie Verfahren zur Herstellung der Bone implant device for tissue generation using bone substitute materials and method for producing the
KnochenimplantatvorrichtungBone implant device
BesehreibungDescription
Die Erfindung betrifft eine Knochenimplantatvorrichtung zur Gewebegenerierung mittels Knochenersatzmaterialien sowie ein Verfahren zur Herstellung der Knochenimplantatvorrichtung.The invention relates to a bone implant device for tissue generation using bone substitute materials and a method for producing the bone implant device.
Aus dem Stand der Technik ist es bekannt, mittels Knochenersatzmaterialien Knochengewebe, insbesondere in lasttragenden Knochenbereichen zu generieren. Derartige Knochengenerierungen werden in der Mund-, Kiefer- und Gesichtschirurgie und in anderen operativ tätigen Fachdisziplinen, beispielsweise für Fingerknochen, Handknochen oder ähnliches verwandt. Dabei werden beispielsweise Keramiken mit osteokonduktiven Eigenschaften, wie etwa Hydroxylapatit oder Trikalziumphosphat und/oder osteoinduktive Materialien eingesetzt. Diese Materialien dienen an den eingebrachten Körperstellen als Leitstrukturen, das Knochenersatzmaterial wird langsam abgebaut, gleichzeitig erfolgt die Bildung einer neuen Knochenstruktur. Die bisher bekannten Materialien weisen den Nachteil auf, daß sie biomechanisch nicht belastbar sind und deshalb nur in nicht tragenden Knochenbereichen eingesetzt werden können.It is known from the prior art to use bone substitute materials to generate bone tissue, in particular in load-bearing bone areas. Such bone generations are used in oral, maxillofacial and facial surgery and in other operative specialist disciplines, for example for finger bones, hand bones or the like. For example, ceramics with osteoconductive properties, such as hydroxylapatite or tricalcium phosphate and / or osteoinductive materials, are used. These materials serve as lead structures at the introduced body parts, the bone substitute material is slowly broken down, at the same time a new bone structure is formed. The previously known materials have the Disadvantage that they are not biomechanically resilient and can therefore only be used in non-supporting bone areas.
Für die Versorgung von Last tragenden Knochenbereichen werden nach dem Stand der Technik metallische Elemente eingefügt, beispielsweise aus Titanlegierungen oder Verbundwerkstoffen. Derartige Platten oder Implantate bilden jedoch einen Fremdkörper, der nicht in kontrollierter Weise die Neubildung von Knochen. Es ergeben sich insbesondere im Kontaktbereich zwischen derartigen Implantaten und dem Knochen nicht kontrollierbare Umbauvorgänge. Außerdem unterscheiden sich die biomechanischen Eigenschaften der .Implantate und der Knochen. Weiterhin ist die Verträglichkeit derartiger Implantate vielfach nicht gegeben, so daß zum einen Keimbesiedlungen auftreten können, zum anderen allergische Reaktionen ausgelöst werden können. Zusätzlich können bei derartigen, für längere Zeiten im Körper des Patienten zu verbleibenden Implantaten Korrosionsvorgänge auftreten, die aus medizinischer Sicht unerwünscht oder bedenklich sind.According to the prior art, metallic elements are inserted for the supply of load-bearing bone areas, for example made of titanium alloys or composite materials. Such plates or implants, however, form a foreign body that does not control the formation of new bones in a controlled manner. In particular, in the contact area between such implants and the bone there are uncontrollable remodeling processes. In addition, the biomechanical properties of the implants and the bones differ. Furthermore, the compatibility of such implants is often not given, so that on the one hand germ colonization can occur and on the other hand allergic reactions can be triggered. In addition, such implants that remain in the patient's body for long periods of time can cause corrosion processes that are undesirable or questionable from a medical point of view.
Es ist weiterhin üblich, Knochenstücke aus dem Skelett des Patienten als Transplantate einzusetzen. Dies ist jedoch stets mit einem erheblichen Aufwand verbunden und vielfach nicht oder nur bedingt möglich.It is also common to use pieces of bone from the patient's skeleton as grafts. However, this is always associated with considerable effort and is often not possible or only possible to a limited extent.
Der Erfindung liegt die Aufgabe zugrunde, eine Knochenimplantatvorrichtung und ein Verfahren zu deren Herstellung zu schaffen, welche bei einfachem Aufbau und einfacher, sicherer Anwendbarkeit die Generierung von Knochen mittels Knochenersatzmaterialien in lasttragenden Knochenabschnitten ermöglicht . Erfindungsgemäß wird die Aufgabe durch die Merkmale des Hauptanspruchs bzw. des Anspruchs 22 gelöst, die jeweiligen Unteransprüche zeigen weitere vorteilhafte Ausgestaltungen der Erfindung.The invention has for its object to provide a bone implant device and a method for its production, which allows the generation of bone by means of bone replacement materials in load-bearing bone sections with a simple structure and simple, safe applicability. According to the invention, the object is achieved by the features of the main claim and of claim 22, the respective subclaims show further advantageous embodiments of the invention.
Erfindungsgemäß ist somit eine Knochenimplantatvorrichtung vorgesehen, welche einen ersten und einen zweiten Flansch aufweist, welche jeweils lösbar an einem Knochenbereich, angrenzend an einen fehlenden oder defekten Knochenbereich, befestigbar sind. Weiterhin sind erfindungsgemäß mehrere Stabelemente vorgesehen, welche selektiv lösbar mit den Flanschen verbunden sind.According to the invention, a bone implant device is thus provided which has a first and a second flange, each of which can be releasably attached to a bone area, adjacent to a missing or defective bone area. Furthermore, several rod elements are provided according to the invention, which are selectively detachably connected to the flanges.
Die erfindungsgemäße Vorrichtung zeichnet sich durch eine Reihe erheblicher Vorteile aus. Durch die Flansche und die Stabelemente wird eine Trägerstruktur geschaffen, welche sämtliche biomechanischen Anforderungen erfüllen kann. Die Trägerstruktur ist in der Lage, die auftretenden Kräfte und Momente zwischen den beiden Knochenbereichen aufzunehmen und zu übertragen. Somit bildet diese Trägerstruktur der erfindungsgemäßen Knochenimplantatvorrichtung ein stabiles Stützgerüst, welches zum einen die Knochengenerierung ermöglicht und zum anderen dem Patienten gestattet, den Knochenbereich während der Heilungsphase zu belasten. In den zwischen den Flanschen und den Stabelementen gebildeten Innenraum kann Knochenersatzmaterial eingebracht werden, welches das Wachstum von neuen Knochen ermöglicht. Dabei wird dieser Generierungseffekt nicht durch auftretende Belastungen gestört, da die Vorrichtung die entsprechenden Kräfte und/oder Momente auf immt. Durch die selektive Lösbarkeit der einzelnen Stabelemente ist es unter Verwendung der erfindungsgemäßen Vorrichtung möglich, mit zunehmender Festigkeit des neu gebildeten Knochens die lasttragende Trägerstruktur der erfindungsgemäßen Vorrichtung unter Erhalt der biomechanischen Anforderungen schrittweise zu reduzieren. Es können somit in zeitlichen Abstanden einzelne Stabelemente entfernt werden. Hierdurch wird die Belastung des sich neu bildenden Knochens schrittweise erhöht. Es ist bekannt, daß sich Knochen bei fehlender Belastung nicht oder nur ungenügend bildet. Durch die erfindungsgemaße Vorrichtung ist es somit möglich, angepaßt an den Neubildungsvorgang schrittweise zunehmende Belastungen aufzubringen.The device according to the invention is distinguished by a number of considerable advantages. The flanges and the rod elements create a support structure that can meet all biomechanical requirements. The support structure is able to absorb and transmit the forces and moments that occur between the two bone areas. This support structure of the bone implant device according to the invention thus forms a stable support structure which, on the one hand, enables bone generation and, on the other hand, allows the patient to strain the bone area during the healing phase. Bone replacement material can be introduced into the interior formed between the flanges and the rod elements, which enables the growth of new bones. This generation effect is not disturbed by occurring loads, since the device absorbs the corresponding forces and / or moments. The selective releasability of the individual rod elements makes it possible, using the device according to the invention, to gradually increase the load-bearing support structure of the device according to the invention with increasing strength of the newly formed bone while maintaining the biomechanical requirements to reduce. Individual bar elements can thus be removed at intervals. This gradually increases the load on the newly formed bone. It is known that bone does not form or only insufficiently in the absence of stress. The device according to the invention thus makes it possible to apply incrementally increasing loads adapted to the new formation process.
Erfindungsgemaß ist es besonders gunstig, wenn der jeweilige Flansch passend zu dem jeweils mit dem Flansch zu verbindenden Knochenbereich ausgebildet ist. Im Rahmen des erfindungsgemäßen Herstellungsverfahrens für die Implantatvorrichtung ist somit in einem ersten Herstellungsschπtt vorgesehen, daß die beiden mit den Flanschen zu verbindenden Knochenbereiche dreidimensional vermessen werden. Dies erfolgt bevorzugterweise mittels eines Tomographieverfahrens . Nach Feststellung der genauen Form und Große der Knochenbereiche ist es dann möglich, den Flansch exakt passend herzustellen, beispielsweise mittels eines Umform- oder Gießverfahrens oder spanendem Formgebungsverfahren oder mittels Verfahren, die aus dem rapid prototyping bekannt sind.According to the invention, it is particularly expedient if the respective flange is designed to match the bone region to be connected to the flange. In the context of the manufacturing method according to the invention for the implant device, it is therefore provided in a first manufacturing step that the two bone areas to be connected to the flanges are measured three-dimensionally. This is preferably done using a tomography method. After the exact shape and size of the bone areas have been determined, it is then possible to produce the flange in a precisely fitting manner, for example by means of a shaping or casting process or machining shaping process or by processes which are known from rapid prototyping.
Der Flansch kann erfindungsgemaß einstuckig oder mehrstuckig ausgebildet werden. Bei einer mehrstuckigen Ausbildung kann er zur Befestigung an den Knochenbereichen entsprechend zusammengesetzt werden. Bei einer einstuckigen Ausbildung kann der Flansch beispielsweise einen U-formigen Querschnitt aufweisen oder mit zumindest einem Ξchwachungsbereich versehen sein. Form und Gestalt des Flansches sind bevorzugterweise so zu wählen, daß dieser wahrend einer Operation einfach und sicher auf den Knochenbereich aufgeschoben oder aufgesetzt werden kann und daß es in einfacher Weise möglich ist, nach der Neubildung des Knochens den Flansch zu entfernen. Bei einer mehrstuckigen Ausgestaltung des Flansches können die einzelnen Bereiche entnommen werden, bei einer einstückigen Ausgestaltung kann der Flansch aufgebogen oder aufgebrochen werden.According to the invention, the flange can be formed in one piece or in several pieces. In the case of a multi-piece design, it can be assembled appropriately for attachment to the bone areas. In the case of a one-piece design, the flange can have, for example, a U-shaped cross section or can be provided with at least one monitoring area. The shape and shape of the flange should preferably be chosen so that it can be easily and securely pushed or placed onto the bone area during an operation and that it is possible in a simple manner to remove the flange after the new bone has formed. With a multi-piece design of the flange, the individual Areas are removed, in a one-piece design, the flange can be bent or broken open.
Um die erfindungsgemäße Vorrichtung auch in räumlich beengten Bereichen einsetzen zu können und um die Anbringung der Flansche zu vereinfachen, kann es günstig sein, wenn diese im Bereich der Lagerung der Stabelemente einen verdickten Querschnitt aufweisen und im übrigen mit einem relativ dünnen Querschnitt versehen ist. Weiterhin kann es günstig sein, den Flansch nicht flächig an den Knochenbereich anzulegen, sondern einzelne Kontaktbereiche oder Anlagebereiche auszubilden. Hierdurch wird verhindert, daß ein Kochen ungleichmäßig belastet wird und sich der Knochen im Bereich des Flansches zurückbildet .In order to be able to use the device according to the invention even in confined spaces and to simplify the attachment of the flanges, it can be advantageous if these have a thickened cross section in the area of the bearing of the rod elements and are otherwise provided with a relatively thin cross section. Furthermore, it may be advantageous not to place the flange flat against the bone area, but rather to form individual contact areas or contact areas. This prevents cooking from being loaded unevenly and the bone regressing in the area of the flange.
Die Stabelemente weisen erfindungsgemäß bevorzugterweise einen kreisrunden Querschnitt auf, es ist jedoch möglich, die Stabelemente oval oder in anderer Weise zu dimensionieren. Die Stabelemente können entweder in Form von geraden Stäben ausgebildet sein, es ist jedoch auch möglich, diese wendeiförmig auszubilden. Die Form der Stäbe richtet sich zum einen nach den zu übertragenden Kräften, zum anderen nach den örtlichen Gegebenheiten und der Möglichkeit, die Stäbe in einzelnen Operationsschritten nacheinander zu entfernen.According to the invention, the bar elements preferably have a circular cross section, but it is possible to dimension the bar elements oval or in some other way. The bar elements can either be in the form of straight bars, but it is also possible to make them helical. The shape of the rods depends on the one hand on the forces to be transferred, on the other hand on the local conditions and the possibility of removing the rods one after the other in individual surgical steps.
Um die Montage zu erleichtern und um ein späteres selektives Entnehmen der Stabelemente so einfach wie möglich zu gestalten, ist es günstig, wenn der erste Flansch Festlager für die Stabelemente aufweist. Es ist somit möglich, die Stabelemente an dem ersten Flansch vorzumontieren. Der zweite Flansch ist bevorzugterweise mit Lagern ausgerüstet, die ein axiales Spiel der Stabelemente ermöglichen, so daß diese entsprechend aufgeschoben oder aufgesteckt werden können. Es versteht sich, daß hierbei geeignete Fixiermittel vorgesehen sind, um die Enden der Stabelemente auch mit dem zweiten Flansch fest zu verbinden.In order to facilitate assembly and to make later selective removal of the rod elements as simple as possible, it is advantageous if the first flange has fixed bearings for the rod elements. It is thus possible to pre-assemble the rod elements on the first flange. The second flange is preferably equipped with bearings that allow axial play of the rod elements, so that they can be pushed on or plugged on accordingly. It is understood that suitable fixing means are provided around the ends of the rod elements also to be firmly connected to the second flange.
Im Rahmen der Erfindung ergeben sich vielfältige Möglichkeiten, die Flansche mit den Knochenbereichen zu verbinden. So können beispielsweise Mittel zum Verschrauben vorgesehen sein. Es ist möglich, durch Ausnehmungen der Flansche Schrauben in den Knochenbereich einzubringen. Die Flansche können jedoch auch mittels durchgehender Schrauben fixiert werden. Weiterhin besteht erfindungsgemäß die Möglichkeit, die Flansche mit den Knochenbereichen zu verkleben. Da die Flansche sehr exakt passend zu der Dimensionierung der Knochenbereiche hergestellt werden, ist es auch möglich, diese auf die Knochenbereiche aufzuschieben und zu verklemmen. Eine weitere Möglichkeit besteht darin, die Flansche aus einer Memory-Legierung zu fertigen, die sich nach der Montage, beispielsweise durch Wärmeeinwirkung, exakt an die Knochenbereiche anlegt.Within the scope of the invention, there are various possibilities for connecting the flanges to the bone areas. For example, means for screwing can be provided. It is possible to insert screws into the bone area through recesses in the flanges. However, the flanges can also be fixed using continuous screws. Furthermore, according to the invention, there is the possibility of gluing the flanges to the bone areas. Since the flanges are manufactured very precisely to the dimensions of the bone areas, it is also possible to push them onto the bone areas and clamp them. Another possibility is to manufacture the flanges from a memory alloy which, after assembly, for example by heat, fits exactly on the bone areas.
In den durch die Stabelemente und die Flansche gebildeten Innenraum wird erfindungsgemäß Knochenersatzmaterial eingebracht. Um dieses während des Generierungsvorganges des Knochen zu halten und um diesem eine definierte Form vorzugeben, ist es besonders vorteilhaft, wenn in dem Innenraum Haltemittel für die Knochenersatzmaterialien angeordnet sind. Diese können folienartig, netzartig, granulatartig, gelartig und/oder gitterartig ausgebildet sein. Besonders vorteilhaft ist es, wenn die Haltemittel aus biodegradierbarem Material gefertigt sind. Es ist dann nicht erforderlich, die Haltemittel wieder zu entfernen.According to the invention, bone replacement material is introduced into the interior formed by the rod elements and the flanges. In order to hold the bone during the generation process and to give it a defined shape, it is particularly advantageous if holding means for the bone replacement materials are arranged in the interior. These can be film-like, net-like, granular, gel-like and / or grid-like. It is particularly advantageous if the holding means are made from biodegradable material. It is then not necessary to remove the holding means again.
Sowohl die Flansche als auch die Stabelemente können beispielsweise aus biokompatiblen Titanlegierungen hergestellt werden. Es ergeben sich jedoch auch eine Vielzahl von anderen Material-Zusammensetzungen. Die erfindungsgemäße Knochenimplantatvorrichtung wird somit passend zu dem neu zu bildenden Knochen und den an den defekten Bereich angrenzenden Knochenbereichen hergestellt. Die Dimensionierung der Flansche erfolgt bevorzugterweise mittels eines 3D-Verfahrens, um ein exaktes Passen der Flansche zu gewährleisten. Zahl, Anordnung und Größe der Stabelemente wird aufgrund der auftretenden Belastungen bestimmt. Weiterhin wird erfindungsgemäß die Reihenfolge der schrittweise zu entfernenden Stabelemente bestimmt, um während der Generierung des defekten Knochens jeweils eine ausreichende, das Knochenwachstum fördernde Belastung aufbringen zu können. Nach vollständiger Generierung des Knochens wird die erfindungsgemäße Vorrichtung restlich entfernt. Es verbleiben somit keine störenden oder negativen Implantate im Körper des Patienten. Durch die erfindungsgemäße Knochenimplantatvorrichtung ist es möglich, die Knochenersatzmaterialien während des Generierungs- vorganges in der gewünschten Form zu halten.Both the flanges and the rod elements can, for example, be made from biocompatible titanium alloys. However, there are also a variety of other material compositions. The bone implant device according to the invention is thus manufactured to match the bone to be newly formed and the bone areas adjacent to the defective area. The flanges are preferably dimensioned using a 3D method in order to ensure an exact fit of the flanges. The number, arrangement and size of the bar elements are determined based on the loads that occur. Furthermore, according to the invention, the sequence of the rod elements to be removed step by step is determined in order to be able to apply a sufficient load which promotes bone growth during the generation of the defective bone. After the bone has been completely generated, the device according to the invention is removed. There are therefore no disruptive or negative implants remaining in the patient's body. The bone implant device according to the invention makes it possible to keep the bone replacement materials in the desired shape during the generation process.
Als besonders günstig erweist es sich, wenn zur Dimensionierung der Flansche und der Stabelemente die zu übertragenden Kräfte und Momente mittels eines Verfahrens der Finiten- elemente ermittelt werden. Die Knochenimplantatvorrichtung kann dann die auftretenden Druckkräfte, Zugkräfte, Torsionskräfte und Scherkräfte übertragen.It proves to be particularly favorable if, for dimensioning the flanges and the rod elements, the forces and moments to be transmitted are determined using a method of the finite elements. The bone implant device can then transmit the compressive forces, tensile forces, torsional forces and shear forces that occur.
Zusätzlich zu den durch eine gezielte Dimensionierung der erfindungsgemäßen Knochenimplantatvorrichtung auftretenden Mikrobewegungen in dem sich generierenden Knochen kann es günstig sein, elektrische oder elektromechanische Felder zur Verbesserung des Knochenwachstums aufzubringen.In addition to the micro-movements occurring in the bone that is generated due to the targeted dimensioning of the bone implant device according to the invention, it can be expedient to apply electrical or electromechanical fields to improve the bone growth.
Erfindungsgemäß ist es in einer Weiterbildung der Erfindung auch möglich, einzelne Stabelemente aus metallischen Werkstof- fen herzustellen, wahrend andere Stabelemente aus resorbierbaren Materialien, beispielsweise Polylactiden gefertigt sein können. Letztere Variante ist dann vorteilhaft, wenn sich aus operativen Gründen bei der Entfernung einzelner Stabelemente besondere Schwierigkeiten ergeben konnten. Zusätzlich können die resorbierbaren Stabelemente als zusätzliche Stutzung der Knochenersatzmaterialien dienen, ohne daß diese Stabelemente anschließend operativ entfernt werden müssen.According to the invention, in a further development of the invention, it is also possible to use individual rod elements made of metallic materials. fen manufacture, while other rod elements can be made of resorbable materials, such as polylactides. The latter variant is advantageous if, for operational reasons, special difficulties could arise when removing individual rod elements. In addition, the resorbable rod elements can serve as additional support for the bone replacement materials, without these rod elements subsequently having to be surgically removed.
Als Knochenersatzmaterialien können beispielsweise Kalzium- hydroxylapatitzement oder phasenreine Beta- oder Alpha- Tπkalziumphosphatkeramiken zum Einsatz kommen.Calcium hydroxyapatite cement or phase-pure beta or alpha-calcium calcium phosphate ceramics can be used as bone replacement materials.
Gunstig kann es auch sein, die einzelnen Elemente der erfin- dungsgemaßen Knochenimplantatvorrichtung mit einer Ober- flachenbeschichtung zu versehen, um eine Keimbesiedelung und/oder ein Anwachsen von Weichteilen zu vermeiden.It can also be expedient to provide the individual elements of the bone implant device according to the invention with a surface coating in order to avoid germ colonization and / or growth of soft parts.
Die durch die erfindungsgemaße Knochenimplantatvorrichtung gebildete Tragerstruktur kann im Rahmen der Erfindung in einfachster Weise an die jeweiligen operativen Gegebenheiten angepaßt werden. Insbesondere Form und Anordnung der Stabelemente sind in weitem Bereich variabel. Durch die wendelartige Ausgestaltung der Stabelemente ist es beispielsweise möglich, diese um 180° versetzt mit ihren Enden am jeweiligen Flansch zu befestigen. Es ist somit zur Entfernung der Stabelemente nicht erforderlich, direkten Zugriff auf den rückwärtigen Teil des Knochens zu nehmen. Dies kann insbesondere bei der Behandlung von Kieferknochen vorteilhaft sein, um den Patienten nicht unnötig zu belasten.The support structure formed by the bone implant device according to the invention can be adapted in the simplest manner to the respective operative conditions within the scope of the invention. In particular, the shape and arrangement of the bar elements can be varied over a wide range. Due to the helical design of the rod elements, it is possible, for example, to attach them with their ends offset by 180 ° to the respective flange. It is therefore not necessary to have direct access to the rear part of the bone to remove the rod elements. This can be particularly advantageous in the treatment of jawbones, in order not to burden the patient unnecessarily.
Im folgenden wird die Erfindung anhand eines Ausfuhrungs- beispiels in Verbindung mit der Zeichnung beschrieben. Dabei zeigt : Fig. 1 eine vereinfachte, perspektivische Ansicht einer erfindungsgemäßen Knochenimplantatvorrichtung zur Verbindung zweier Knochenbereiche,The invention is described below using an exemplary embodiment in conjunction with the drawing. It shows: 1 shows a simplified, perspective view of a bone implant device according to the invention for connecting two bone areas,
Fig. 2 eine vereinfachte Darstellung der erfindungsgemäßen Knochenimplantatvorrichtung in Zuordnung zu einem durch Finiteelemente dargestellten Unterkiefer,2 shows a simplified illustration of the bone implant device according to the invention in association with a lower jaw represented by finite elements,
Fig. 3 eine Schnittansicht längs der Linie III-III von Fig. 2,3 is a sectional view taken along the line III-III of FIG. 2,
Fig. 4 eine Schnittansicht längs der Linie IV-IV von Fig. 2, undFig. 4 is a sectional view taken along the line IV-IV of Fig. 2, and
Fig. 5 eine Schnittansicht längs der Linie V-V von Fig. 2.5 is a sectional view taken along line V-V of FIG. 2nd
Die Fig. 1 und 2 zeigen jeweils einen ersten Flansch 1 sowie einen zweiten Flansch 2, die auf einen ersten Knochenbereich 3 bzw. einen zweiten Knochenbereich 4 aufgesetzt sind. Wie sich aus den Schnittansichten der Fig. 3 und 4 ergibt, kann die Befestigung der Flansche 1 und 2 mittels schematisch dargestellter Schrauben 11 erfolgen.1 and 2 each show a first flange 1 and a second flange 2, which are placed on a first bone area 3 and a second bone area 4, respectively. As can be seen from the sectional views of FIGS. 3 and 4, the flanges 1 and 2 can be fastened by means of schematically illustrated screws 11.
Die beiden Flansche 1 und 2 sind mittels einer Vielzahl von Stabelementen 5 verbunden. Der erste Flansch 1 weist Lagerungen 7 auf, die in Form von Ausnehmungen oder Bohrungen ausgebildet sein können. Es ist somit möglich, die Stabelemente 5 mittels eines Preßsitzes in den ersten Flansch 1 einzubringen. Alternativ ist auch eine Verschraubung möglich. Es versteht sich, daß im Rahmen der Erfindung weitere andere Befestigungsarten gewählt werden können. Das andere Ende der Stabelemente 5 ist an dem zweiten Flansch 2 befestigt. Hierfür weist dieser ebenfalls entsprechende Lagerungen 7 auf.The two flanges 1 and 2 are connected by means of a multiplicity of rod elements 5. The first flange 1 has bearings 7 which can be in the form of recesses or bores. It is thus possible to insert the rod elements 5 into the first flange 1 by means of a press fit. Alternatively, a screw connection is also possible. It is understood that further other types of fastening can be selected within the scope of the invention. The other end of the rod elements 5 is attached to the second flange 2. For this purpose, this also has corresponding bearings 7.
Wie sich aus der Darstellung der Fig. 3 und 4 ergibt, können die Flansche eine U-formige Form aufweisen. Um ein Entfernen der Flansche 1, 2 zu vereinfachen, ist es möglich, einen Schwachungsbereich 6 vorzusehen, welcher ein Aufbiegen der Flansche ermöglicht.As can be seen from the illustration in FIGS. 3 and 4, the flanges can have a U-shaped shape. In order to simplify removal of the flanges 1, 2, it is possible to provide a weakening area 6 which enables the flanges to bend open.
Zum Verschrauben der Flansche mit den Knochenbereichen 3, 4 kann es vorteilhaft sein, Spannelemente oder Zangen zu verwenden.To screw the flanges to the bone areas 3, 4, it can be advantageous to use clamping elements or pliers.
Wie sich aus der Schnittansicht der Fig. 5 ergibt, ist in den durch die Stabelemente 5 gebildeten Innenraum Knochenersatz- material 10 eingelegt, welches durch Haltemittel 9 gehalten wird. Diese Haltemittel können beispielsweise in Form einer Folie ausgebildet sein.As can be seen from the sectional view in FIG. 5, bone replacement material 10, which is held by holding means 9, is inserted into the interior formed by the rod elements 5. These holding means can be designed, for example, in the form of a film.
Die Fig. 4 zeigt weiterhin, daß der Flansch unterschiedliche Dicken-Bereiche aufweisen kann. Bei dem in Fig. 4 gezeigten Ausfuhrungsbeispiel sind Anlagebereiche 8 vorgesehen, die gegen den Knochenbereich 4 anliegen, so daß sich der Flansch nicht über seine gesamte Innenflache gegen den Knochenbereich 4 abstutzt.4 further shows that the flange can have different thickness ranges. In the exemplary embodiment shown in FIG. 4, contact areas 8 are provided which bear against the bone area 4, so that the flange is not braced against the bone area 4 over its entire inner surface.
Die Flansche und die Stabelemente können erfindungsgemaß so vormontiert werden, daß ein Flansch mit den Stabelementen kraftschlussig verbunden wird und am anderen Ende der Stabelemente axial um einen bestimmten Bereich verschiebbar zum leichteren Aufschieben an den Knochenenden ausgebildet ist. Diese Enden der Stabelemente sind so gestaltet, daß nach dem Einbringen der erfindungsgemaßen Vorrichtung durch Axialver- schieben eine kraftschlüssige Verbindung mit dem anderen Flansch erreicht wird. Sofern es der Belastungsfall zuläßt, werden die Stabenden im inneren Bereich, d.h. in dem der Körperoberfläche abgewandten Bereich mit dem jeweiligen Flansch nicht oder nur teilweise kraftschlüssig verbunden, um ein leichteres Entfernen dieser Stabelemente zu ermöglichen. Hierfür können die Stabelemente, wie erläutert, entweder geradlinig und einander gegenüberliegend oder um bis zu 180° versetzt angeordnet werden.According to the invention, the flanges and the rod elements can be preassembled in such a way that a flange is non-positively connected to the rod elements and is axially displaceable at the other end of the rod elements by a certain range for easier sliding on the bone ends. These ends of the rod elements are designed such that after the device according to the invention has been introduced by means of axial push a positive connection with the other flange is reached. If the load permits, the rod ends in the inner region, that is to say in the region facing away from the body surface, are not or only partially non-positively connected to the respective flange in order to make it easier to remove these rod elements. For this purpose, as explained, the bar elements can be arranged either in a straight line and opposite one another or offset by up to 180 °.
Bei dem oben beschriebenen Ausführungsbeispiel, insbesondere in Hinblick auf Fig. 2 wurde der Einsatz der Erfindung an einem Unterkiefer-Knochen beschrieben. Die Erfindung ist jedoch nicht auf die Mund-, Kiefer- und Gesichtschirurgie beschränkt, vielmehr ist eine Anwendung auch an anderen Bereichen des menschlichen oder tierischen Skeletts möglich, beispielsweise bei Hand- oder Fingerknochen, im Bereich des Knochenbeines oder ähnlichem.In the exemplary embodiment described above, in particular with reference to FIG. 2, the use of the invention on a lower jaw bone has been described. However, the invention is not limited to oral, maxillofacial and facial surgery, rather it can also be used in other areas of the human or animal skeleton, for example in the case of hand or finger bones, in the area of the bone bone or the like.
Die Erfindung ist nicht auf das gezeigte Ausführungsbeispiel beschränkt, vielmehr ergeben sich im Rahmen der Erfindung vielfältige Abwandlungs- und Modifikationsmöglichkeiten. The invention is not limited to the exemplary embodiment shown, but there are many possible modifications and modifications within the scope of the invention.

Claims

Ansprüche Expectations
1. Knochenimplantatvorrichtung zur Gewebegenerierung mittels Knochenersatzmaterialien, mit einem ersten (1) und einem zweiten (2) Flansch, welche jeweils lösbar an einem Knochenbereich (3, 4) befestigbar sind, sowie mit mehreren selektiv lösbar mit den Flanschen (1, 2) verbundenen Stabelementen (5) .1. Bone implant device for tissue generation using bone substitute materials, with a first (1) and a second (2) flange, each of which can be detachably attached to a bone area (3, 4), and with several selectively detachably connected to the flanges (1, 2) Bar elements (5).
2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß der Flansch (1, 2) passend zu dem mit dem Flansch (1, 2) zu verbindenden Knochenbereich (3, 4) ausgebildet ist.2. Device according to claim 1, characterized in that the flange (1, 2) is designed to match the bone region (3, 4) to be connected to the flange (1, 2).
3. Vorrichtung nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß der Flansch (1, 2) mehrstückig ausgebildet ist.3. Apparatus according to claim 1 or 2, characterized in that the flange (1, 2) is constructed in several pieces.
4. Vorrichtung nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, daß der Flansch (1, 2) einstückig ausgebildet und mit zumindest einem Schwächungsbereich (6) versehen ist.4. Device according to one of claims 1 or 2, characterized in that the flange (1, 2) is integrally formed and is provided with at least one weakened area (6).
5. Vorrichtung nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, daß der Flansch (1, 2) einstückig ausgebildet ist und einen im wesentlichen U-förmigen Querschnitt aufweist.5. Device according to one of claims 1 or 2, characterized in that the flange (1, 2) is integrally formed and has a substantially U-shaped cross section.
6. Vorrichtung nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß der Flansch (1, 2) im Bereich der Lagerung (7) der Stabelemente (5) einen verdickten Querschnitt aufweist.6. Device according to one of claims 1 to 5, characterized in that the flange (1, 2) in the region of the bearing (7) of the rod elements (5) has a thickened cross section.
7. Vorrichtung nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß der Flansch (1, 2) mit mehreren Anla- gebereichen (8) zur Anlage an den Knochenbereich (3, 4; versehen ist.7. Device according to one of claims 1 to 6, characterized in that the flange (1, 2) with several Anla- areas (8) for bearing against the bone area (3, 4; is provided.
8. Vorrichtung nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß das Stabelement (5) einen kreisrunden oder ovalen Querschnitt aufweist.8. Device according to one of claims 1 to 7, characterized in that the rod element (5) has a circular or oval cross section.
9. Vorrichtung nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß das Stabelement (5) gerade ausgebildet ist.9. Device according to one of claims 1 to 8, characterized in that the rod element (5) is straight.
10. Vorrichtung nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß das Stabelement (5) gewendelt ausgebildet ist.10. Device according to one of claims 1 to 8, characterized in that the rod element (5) is designed helically.
11. Vorrichtung nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß der erste Flansch (1) Festlager (7) für die Stabelemente (5) aufweist und daß der zweite Flansch (2) mit Lagern (7) mit axialem Spiel und Fixiermitteln für die Stabelemente (5) versehen ist.11. Device according to one of claims 1 to 10, characterized in that the first flange (1) has fixed bearings (7) for the rod elements (5) and that the second flange (2) with bearings (7) with axial play and fixing means is provided for the rod elements (5).
12. Vorrichtung nach Anspruch 11, dadurch gekennzeichnet, daß der erste Flansch (1) mit den Stabelementen (5) vormontierbar ist.12. The apparatus according to claim 11, characterized in that the first flange (1) with the rod elements (5) can be preassembled.
13. Vorrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, daß der Flansch (1, 2) mit Mitteln zum Verschrauben mit den Knochenbereichen (3, 4) versehen ist.13. Device according to one of claims 1 to 12, characterized in that the flange (1, 2) is provided with means for screwing to the bone areas (3, 4).
14. Vorrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, daß der Flansch (1, 2) mit Mitteln zum Verkleben mit den Knochenbereichen (3, 4) versehen ist.14. Device according to one of claims 1 to 12, characterized in that the flange (1, 2) is provided with means for gluing to the bone areas (3, 4).
15. Vorrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, daß der Flansch (1, 2) mit Mitteln zum Verklemmen mit den Knochenbereichen versehen ist.15. The device according to one of claims 1 to 12, characterized characterized in that the flange (1, 2) is provided with means for clamping with the bone areas.
16. Vorrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, daß der Flansch (1, 2) zum Fixieren an den Knochenbereichen (3, 4) aus einer Memory-Legierung gefertigt ist.16. Device according to one of claims 1 to 12, characterized in that the flange (1, 2) for fixing to the bone areas (3, 4) is made of a memory alloy.
17. Vorrichtung nach einem der Ansprüche 1 bis 16, dadurch gekennzeichnet, daß der Flansch (1, 2) als Gußteil oder Umformteil ausgebildet ist.17. Device according to one of claims 1 to 16, characterized in that the flange (1, 2) is designed as a cast part or shaped part.
18. Vorrichtung nach einem der Ansprüche 1 bis 17, dadurch gekennzeichnet, daß in dem durch die Stabelemente (5) gebildeten Innenraum folienartige, netzartige, granulatartige, gelartige und/oder gitterartige Haltemittel (9) für Knochenersatzmaterialien (10) angeordnet sind.18. Device according to one of claims 1 to 17, characterized in that in the interior formed by the rod elements (5) foil-like, net-like, granular, gel-like and / or grid-like holding means (9) for bone substitute materials (10) are arranged.
19. Vorrichtung nach Anspruch 18, dadurch gekennzeichnet, daß die Haltemittel (9) aus biodegradierbarem Material gefertigt sind.19. The apparatus according to claim 18, characterized in that the holding means (9) are made of biodegradable material.
20. Vorrichtung nach einem der Ansprüche 1 bis 19, dadurch gekennzeichnet, daß die Flansche (1, 2) und/oder die Stabelemente (5) mit einer Oberflächenbeschichtung versehen sind.20. Device according to one of claims 1 to 19, characterized in that the flanges (1, 2) and / or the rod elements (5) are provided with a surface coating.
21. Vorrichtung nach Anspruch 20, dadurch gekennzeichnet, daß die Oberflächenbeschichtung Mittel zur Verhinderung einer Keimbesiedelung und/oder eines Anwachsens von Weichteilen umfaßt.21. The apparatus according to claim 20, characterized in that the surface coating comprises means for preventing germ colonization and / or growth of soft parts.
22. Verfahren zur Herstellung einer Knochenimplantatvorrichtung nach einem der Ansprüche 1 bis 21, gekennzeichnet durch folgende Arbeitsschritte:22. A method for producing a bone implant device according to one of claims 1 to 21, characterized through the following steps:
dreidimensionales Vermessen der beiden mit den Flanschen (1, 2) zu verbindenden Knochenbereiche (3, 4), Ermitteln der zwischen den beiden Knochenbereichen (3, 4) zu übertragenden Kräfte und Momente, und Dimensionierung der Flansche (1, 2) und Bestimmung der Zahl, Größe, Form und Anordnung der Stabelemente (5) .three-dimensional measurement of the two bone areas (3, 4) to be connected to the flanges (1, 2), determination of the forces and moments to be transmitted between the two bone areas (3, 4), and dimensioning of the flanges (1, 2) and determination of the Number, size, shape and arrangement of the rod elements (5).
23. Verfahren nach Anspruch 22, gekennzeichnet durch die nachfolgende Bestimmung der Reihenfolge der schrittweise zu entfernenden Stabelemente (5) .23. The method according to claim 22, characterized by the subsequent determination of the order of the rod elements (5) to be removed step by step.
24. Verfahren nach einem der Ansprüche 22 oder 23, dadurch gekennzeichnet, daß das dreidimensionale Vermessen der Knochenbereiche (3, 4) mittels eines Tomographieverfahrens erfolgt.24. The method according to any one of claims 22 or 23, characterized in that the three-dimensional measurement of the bone areas (3, 4) is carried out by means of a tomography method.
25. Verfahren nach einem der Ansprüche 22 bis 24, dadurch gekennzeichnet, daß das Ermitteln der Kräfte und Momente mittels Finiterelementeverfahren erfolgt.25. The method according to any one of claims 22 to 24, characterized in that the forces and moments are determined by means of finite element methods.
26. Verfahren nach einem der Ansprüche 22 bis 25, dadurch gekennzeichnet, daß Größe, Form und Anordnung der Flansche26. The method according to any one of claims 22 to 25, characterized in that the size, shape and arrangement of the flanges
(1, 2) und der Stabelemente (5) im wesentlichen der Form des zu generierenden defekten Knochenbereichs angepaßt werden. (1, 2) and the rod elements (5) are essentially adapted to the shape of the defective bone area to be generated.
PCT/EP2000/002983 1999-04-06 2000-04-04 Bone implant device for generating tissue using bone replacement materials and method for producing said bone implant device WO2000059409A1 (en)

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DE19915395A DE19915395B4 (en) 1999-04-06 1999-04-06 Bone implant device for tissue regeneration using bone replacement materials, and method of making the bone graft device
DE19915395.7 1999-04-06

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CN110891520A (en) * 2017-07-10 2020-03-17 卡尔·莱宾格医疗技术有限责任两合公司 Bone augmentation element and kit of bone augmentation elements with inserted (dental) implants
RU2776875C2 (en) * 2017-07-10 2022-07-28 КАРЛ ЛЯЙБИНГЕР МЕДИЦИНТЕХНИК ГМБХ И Ко. КГ Bio-absorbable bone implant and its manufacturing method
US11517439B2 (en) 2017-07-10 2022-12-06 Karl Leibinger Medizintechnik Gmbh & Co. Kg Bioresorbable bone implant and production method
WO2019011913A1 (en) * 2017-07-10 2019-01-17 Karl Leibinger Medizintechnik Gmbh & Co. Kg Bioresorbable bone implant and production method
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AU2018299928B2 (en) * 2017-07-10 2023-11-16 Karl Leibinger Medizintechnik Gmbh & Co. Kg Bioresorbable bone implant and production method
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