WO1990013265A1 - Osteosynthesis plates - Google Patents

Osteosynthesis plates Download PDF

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Publication number
WO1990013265A1
WO1990013265A1 PCT/EP1990/000639 EP9000639W WO9013265A1 WO 1990013265 A1 WO1990013265 A1 WO 1990013265A1 EP 9000639 W EP9000639 W EP 9000639W WO 9013265 A1 WO9013265 A1 WO 9013265A1
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WO
WIPO (PCT)
Prior art keywords
osteosynthesis plate
osteosynthesis
fibers
openings
plate according
Prior art date
Application number
PCT/EP1990/000639
Other languages
German (de)
French (fr)
Inventor
Erich Wintermantel
Original Assignee
Aesculap 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 Aesculap Ag filed Critical Aesculap Ag
Publication of WO1990013265A1 publication Critical patent/WO1990013265A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L31/126Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing carbon fillers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the invention relates to an osteosynthesis plate with the features that are specified in the preamble of claims 1 and 5 respectively.
  • Osteosynthesis plates are conventionally made of metal in order to be able to absorb the high forces required to hold bone fragments together in a dimensionally stable manner and at the same time to ensure the necessary compatibility with the body tissue. Due to the dimensional stability of these metallic osteosynthesis plates, it is difficult to adapt them to the respective bone shape.
  • osteosynthesis plates from thermoplastic, fiber-reinforced plastic material and to soften these osteosynthesis plates before application to the body fragments by heating, so that the osteosynthesis plates could be molded onto the respective bone contour (DE-OS 32 40 468 ).
  • an osteosynthesis plate of the type described in the preamble of claim 1 this is achieved according to the invention in that fibers oriented in a wave-like manner to and fro between the regions near the edges are arranged on the longitudinal edges of the osteosynthesis plates and parallel to them.
  • the wave-shaped course means that the fibers in the edge region of the push-through openings run at least in regions essentially along the edge of this opening, i.e. the push-through openings are surrounded by the reinforcing fibers over a larger circumferential area.
  • the wavy fibers run back and forth between adjacent push-through openings and that fibers arranged on opposite sides of the push-through openings cross over between adjacent push-through openings. Fiber bundles are thus laid in a wave-like manner and running in opposite directions, with through openings being located in the bulge areas, while the crossover points of these oppositely running fiber bundles are arranged between push through openings.
  • Another preferred embodiment is characterized in that wavy fibers are laid in the middle part of the osteosynthesis plate between the regions near the edge with the same waveform in the longitudinal direction of the osteosynthesis plate, preferably the wavy fibers in the longitudinal direction are uniform over the length of the osteosynthesis plate. This results in a completely uniform occupancy of the central part of the osteosynthesis plate, fibers crossing each other at each point on the osteosynthesis plate. It is therefore readily possible with osteosynthesis plates of this type to subsequently insert the push-through openings into the full material, since the push-through openings are partially surrounded by the reinforcing fibers in every position, so that there is optimal reinforcement in the area around the push-through openings.
  • an osteosynthesis plate with push-through openings for bone screws which is characterized according to the invention by a shape-constant upper plate and an intermediate layer made of thermoplastic material connected to it and arranged on the bone side.
  • the osteosynthesis plate is thus constructed in two layers, an outer cover layer is designed to be dimensionally stable, while a thermoplastic intermediate layer allows the bone plate to be precisely adapted to the bone contour.
  • the upper, dimensionally stable plate can consist, for example, of metal or a fiber-reinforced plastic, while the intermediate layer is made of a biocompatible, thermoplastic, in which reinforcing fibers can also be embedded, for example in the form of randomly arranged synthetic fibers or also in Form of directional continuous fibers.
  • the osteosynthesis plate is designed as an endless material in the longitudinal direction. Before the operation, the surgeon can then cut an osteosynthesis plate of the desired length from this endless material, for example by means of suitable guillotine shears, so that the storage is considerably simplified.
  • the thermoplastic can be a modified methacrylate, preferably a polyethyl methacrylate, which has the property of softening at a temperature which is relatively slightly above body temperature, for example in the order of 50 to 60 ° C. This slight increase in temperature can be achieved reach the bone itself without seriously damaging the adjacent tissue, so that the shape of the osteosythesis plate can be adjusted at the site itself.
  • the reinforcing fibers preferably consist of carbon fibers.
  • FIG. 1 shows a side view of an osteosynthesis plate adapted to the bone contour
  • Fig. 2. a plan view of a first exemplary embodiment of an osteosynthesis plate as shown in FIG. 1;
  • FIG. 3 shows a view similar to FIG. 2 in another embodiment of an osteosynthesis plate
  • FIG. 4 shows a view similar to FIG. 1 of a two-layer osteosynthesis plate with a thermoplastic intermediate layer for adaptation to the bone contour.
  • both bone fragments 1 and 2 are connected to one another via an osteosynthesis or bone slat 4 crossing the fracture line 3, which m their
  • Contour is adapted to the outer contour of the bone fragments 1 and 2 in a form-fitting manner.
  • the osteosynthesis plate 4 is fixed to the bone fragments 1 and 2 by bone screws 5, which push through openings in the osteosynthesis plate 4 and are screwed into the bone fragments 1 and 2.
  • the osteosynthesis plate 4 is elongated and strip-shaped and consists of a thermoplastic material, e.g. from a modified methacrylate, in particular a polyethyl methacrylate. This material is set so that it is at body temperature, e.g. is dimensionally stable at 40 ° C, while it becomes soft and deformable at a temperature above this temperature, for example in the range of approximately 50 ° C, so that the osteosynthesis plate can be adapted to the bone contour when this temperature is reached.
  • a thermoplastic material e.g. from a modified methacrylate, in particular a polyethyl methacrylate. This material is set so that it is at body temperature, e.g. is dimensionally stable at 40 ° C, while it becomes soft and deformable at a temperature above this temperature, for example in the range of approximately 50 ° C, so that the osteosynthesis plate can be adapted to the bone contour when this temperature is reached.
  • fibers 6 are embedded in the thermoplastic material, which are designed as continuous fibers. In the areas adjacent to the longitudinal edges 7, these fibers 6 run parallel to the longitudinal wheels 7 and extend over the entire length of the osteosynthesis plate, while in the central area 8 between the longitudinal edges 7 in the embodiment shown in FIG. 2, wavy fibers are laid, the different distances
  • the fibers themselves are also laid in a wave shape in the area between the longitudinal edges 7, but in this case they are not guided through common crossing points, but all fibers show the same wave profile, the waves formed by the different fibers in the longitudinal direction of the Osteosynthesis ⁇ plate 4 are shifted against each other, in the embodiment of FIG. 3 . _ in such a way that a uniform fiber covering is created in the area between the longitudinal edges 7.
  • the push-through opening 10 at any point in the middle part of the osteosynthesis plate 4, for example also by subsequent drilling, each push-through opening being surrounded on the circumferential side in the same way by fibers which reinforce the edge regions of the push-through openings.
  • the osteosynthesis plates 4 are preferably made of endios material so that the surgeon can cut the bone plate with the desired length from the endless material when fitting a bone plate, for example using suitable guillotine shears.
  • the osteosynthesis plate 14 is formed in two layers, namely it comprises a dimensionally stable, upper plate 11 and an intermediate layer 12 connected therewith and made of thermoplastic plastic material.
  • the upper plate 11 can, for example, be made of metal or a dimensionally stable plastic exist, which can also be reinforced with fibers 13.
  • the plastic material then used is designed so that it cannot be deformed at the softening temperatures of the intermediate layers, for example it can be a thermosetting plastic material or a thermoplastic material with a much higher softening temperature.
  • the fiber reinforcement of the outer plate 11 can be designed in a similar manner as has been explained with reference to FIGS. 2 and 3 above.
  • the intermediate layer 12 is formed from a thermoplastic material which can be softened at a temperature which is just above the body temperature, for example at a temperature around 50 ° C. As in the exemplary embodiment in FIGS. 1 to 3, the material used can be a modified methacrylate.
  • thermoplastic plastic material of the intermediate layer is heated to adapt this two-layer osteosynthesis plate to the contour of the bone fragments 1 and 2, so that when the bone plate is placed on the bone fragments, the then deformable plastic material of the intermediate layer fits positively on the outer contour of the fragments, while the upper plate 11 this adaptation remains dimensionally stable.
  • the two-layer osteosynthesis plate described can also be produced as an endless material and then cut off to the desired length by the surgeon.

Abstract

To enhance the strength of a thermoplastic osteosynthesis plate (4) provided with screw holes (10), fibres (6) are arranged on the longitudinal edges (7) of the osteosynthesis plate (4) parallel to the latter and undulating fibres (6) run back and forth between the regions near the edges. The osteosynthesis plate (14) can also have a dimensionally stable upper plate (11) connected to a thermoplastic intermediate layer (12) arranged on the side nearer the bone.

Description

B E S C H R E I B U N G DESCRIPTION
OsteosyntheseplattenOsteosynthesis plates
Die Erfindung betrifft eine Osteosyntheseplatte mit den Merkmalen, die im Oberbegriff der Patentansprüche 1, bzw, 5 angegeben sind.The invention relates to an osteosynthesis plate with the features that are specified in the preamble of claims 1 and 5 respectively.
Osteosyntheseplatten werden herkömmlich aus Metall ge¬ fertigt, um die hohen, zum Zusammenhalten von Knochen¬ fragmenten notwendigen Kräfte formstabil aufnehmen zu können und gleichzeitig die notwendige Kompatibilität mit dem Körpergewebe zu gewährleisten. Aufgrund der Formstabilität dieser metallischen Osteosyntheseplatten ist es schwierig, diese an die jeweilige Knochenform anzupassen.Osteosynthesis plates are conventionally made of metal in order to be able to absorb the high forces required to hold bone fragments together in a dimensionally stable manner and at the same time to ensure the necessary compatibility with the body tissue. Due to the dimensional stability of these metallic osteosynthesis plates, it is difficult to adapt them to the respective bone shape.
Es ist bereits bekannt, Osteosyntheseplatten aus thermo¬ plastischem, faserverstärktem Kunststoffmaterial herzu¬ stellen und diese Osteosyntheseplatten vor dem Anlegen an die Körperfragmente durch Erwärmung zu erweichen, so daß die Osteosyntheseplatten an die jeweilige Knochen¬ kontur angeformt werden könnten (DE-OS 32 40 468) .It is already known to manufacture osteosynthesis plates from thermoplastic, fiber-reinforced plastic material and to soften these osteosynthesis plates before application to the body fragments by heating, so that the osteosynthesis plates could be molded onto the respective bone contour (DE-OS 32 40 468 ).
Es ist Aufgabe der Erfindung, Osteosyntheseplatten der eingangs beschriebenen Art so auszugestalten, daß sie A -It is an object of the invention to design osteosynthesis plates of the type described above in such a way that they A -
trotz der Verwendung von Kunststoffmaterial die notwendigen Festigkeitseigenschaften zeigen.show the necessary strength properties despite the use of plastic material.
Dies wird bei einer Osteosyntheseplatte der im Oberbegriff des Patentanspruches 1 beschriebenen Art erfindungsgemäß dadurch gelöst, daß an den Längsrändern der Osteosynthese¬ platten parallel zu diesen orientierte Fasern und zwischen den randnahen Bereichen wellenförmig hin- und herverlaufende Fasern angeordnet sind.In an osteosynthesis plate of the type described in the preamble of claim 1, this is achieved according to the invention in that fibers oriented in a wave-like manner to and fro between the regions near the edges are arranged on the longitudinal edges of the osteosynthesis plates and parallel to them.
Ein solcher Verlauf der Verstärkungsfasern hat sich als be¬ sonders günstig herausgestellt, insbesondere wird durch den wellenförmigen Verlauf erreicht, daß die Fasern im Randbe¬ reich der Durchstecköffnungen zumindest bereichsweise im wesentlichen längs der Kante dieser Öffnung verlaufen, d.h. die Durchstecköffnungen werden von den Verstärkungsfasern über einen größeren Umfangsbereich umgeben.Such a course of the reinforcing fibers has been found to be particularly favorable; in particular, the wave-shaped course means that the fibers in the edge region of the push-through openings run at least in regions essentially along the edge of this opening, i.e. the push-through openings are surrounded by the reinforcing fibers over a larger circumferential area.
Bei einer ersten bevorzugten Ausführungsform ist dabei vor¬ gesehen, daß die wellenförmig verlegten Fasern zwischen be¬ nachbarten Durchstecköffnungen hin- und herlaufen und daß sich auf gegenüberliegenden Seiten der Durchstecköffnungen angeordnete Fasern zwischen benachbarten Durchstecköffnungen überkreuzen. Es werden also Faserbündel wellenförmig und gegensinnig verlaufend verlegt, wobei sich in den Ausbauchungε- bereichen Durchstecköffnungen befinden, während die Über¬ kreuzungspunkte dieser gegenläufig verlaufenden Faserbündel zwischen Durckstecköffnungen angeordnet sind. In a first preferred embodiment, it is provided that the wavy fibers run back and forth between adjacent push-through openings and that fibers arranged on opposite sides of the push-through openings cross over between adjacent push-through openings. Fiber bundles are thus laid in a wave-like manner and running in opposite directions, with through openings being located in the bulge areas, while the crossover points of these oppositely running fiber bundles are arranged between push through openings.
Eine andere bevorzugte Ausführungsform ist dadurch gekenn¬ zeichnet, daß wellenförmig verlegte Fasern im mittleren Teil der Osteosyntheseplatte zwischen den randnahen Bereichen mit gleicher Wellenform in Längsrichtung der Osteosyntheseplatte gegeneinander versetzt verlegt sind, vorzugsweise sind dabei die wellenförmig verlegten Fasern in Längsrichtung gleich¬ mäßig über die Länge der Osteosyntheseplatte verteilt. Damit ergibt sich eine vollständig gleichmäßige Belegung des mitt¬ leren Teils der Osteosyntheseplatte, wobei an jeder Stelle der Osteosyntheseplatte sich überkreuzende Fasern vorgesehen sind. Es ist daher bei Osteosyntheseplatten dieser Art ohne weiteres möglich, die Durchstecköffnungen nachträglich in das volle Material einzubringen, da die Durchstecköffnungen in jeder Position von den Verstärkungsfasern partiell umgeben werden, so daß sich im Bereich um die Durchstecköffnungen herum eine optimale Verstärkung ergibt.Another preferred embodiment is characterized in that wavy fibers are laid in the middle part of the osteosynthesis plate between the regions near the edge with the same waveform in the longitudinal direction of the osteosynthesis plate, preferably the wavy fibers in the longitudinal direction are uniform over the length of the osteosynthesis plate. This results in a completely uniform occupancy of the central part of the osteosynthesis plate, fibers crossing each other at each point on the osteosynthesis plate. It is therefore readily possible with osteosynthesis plates of this type to subsequently insert the push-through openings into the full material, since the push-through openings are partially surrounded by the reinforcing fibers in every position, so that there is optimal reinforcement in the area around the push-through openings.
Die vorstehende Aufgabe wird auch durch eine Osteosynthese¬ platte mit Durchstecköffnungen für Knochenschrauben gelöst, die erfindungsgemäß gekennzeichnet ist durch eine formkonstante, obere Platte und eine mit dieser verbundene, knochenseitig angeordnete Zwischenlage aus thermoplastischem Kunststoff¬ material. Bei dieser Ausgestaltung ist die Osteosynthese¬ platte also zweilagig aufgebaut, eine äußere Decklage ist formstabil ausgebildet, während eine thermoplastische Zwischen¬ lage eine genaue Anpassung der Knochenplatte an die Knochen¬ kontur erlaubt. - Δ -The above object is also achieved by an osteosynthesis plate with push-through openings for bone screws, which is characterized according to the invention by a shape-constant upper plate and an intermediate layer made of thermoplastic material connected to it and arranged on the bone side. In this embodiment, the osteosynthesis plate is thus constructed in two layers, an outer cover layer is designed to be dimensionally stable, while a thermoplastic intermediate layer allows the bone plate to be precisely adapted to the bone contour. - Δ -
Die obere, formstabile Platte kann beispielsweise aus Metall oder aus einem faserverstärkten Kunststoff bestehen, während die Zwischenlage aus einem biokompatibleπ, thermoplastischen Kunststoff ausgebildet ist, in dem ebenfalls Verstärkungs¬ fasern eingebettet sein können, beispielsweise auch in Form von regellos angeordneten Kunstfasern oder aber auch in Form von gerichtet eingebrachten Endlosfasern.The upper, dimensionally stable plate can consist, for example, of metal or a fiber-reinforced plastic, while the intermediate layer is made of a biocompatible, thermoplastic, in which reinforcing fibers can also be embedded, for example in the form of randomly arranged synthetic fibers or also in Form of directional continuous fibers.
In allen Fällen ist es günstig, wenn die Osteosyntheseplatte in Längsrichtung als Endlosmaterial ausgebildet ist. Der Operateur kann dann vor der Operation von diesem Endlos¬ material eine Osteosyntheseplatte der gewünschten Länge abschneiden, beispielsweise mittels einer geeigneten Schlag¬ schere, so daß die Lagerhaltung wesentlich vereinfacht wird.In all cases, it is advantageous if the osteosynthesis plate is designed as an endless material in the longitudinal direction. Before the operation, the surgeon can then cut an osteosynthesis plate of the desired length from this endless material, for example by means of suitable guillotine shears, so that the storage is considerably simplified.
Der thermoplastische Kunststoff kann ein modifiziertes Methacrylat sein, vorzugsweise ein Polyethylmethacrylat, welches die Eigenschaft hat, bei einer Temperatur zu er¬ weichen, die relativ geringfügig über der Körpertemperatur liegt, beispielsweise in der Größenordnung von 50 bis 60CC. Diese geringe Temperaturerhöhung läßt sich am Knochen selbst erreichen, ohne daß das anliegende Gewebe ernsthaft geschädigt wird, so daß die Anpassung der Form der Osteosytheseplatte am Anlageort selbst erfolgen kann.The thermoplastic can be a modified methacrylate, preferably a polyethyl methacrylate, which has the property of softening at a temperature which is relatively slightly above body temperature, for example in the order of 50 to 60 ° C. This slight increase in temperature can be achieved reach the bone itself without seriously damaging the adjacent tissue, so that the shape of the osteosythesis plate can be adjusted at the site itself.
Die Verstärkungsfasern bestehen vorzugsweise aus Kohlenstoff- fasern. The reinforcing fibers preferably consist of carbon fibers.
Die nachfolgende Beschreibung bevorzugter Ausführungsformen der Erfindung dient im Zusammenhang mit der Zeichnung der näheren Erläuterung. Es zeigt:The following description of preferred embodiments of the invention serves in conjunction with the drawing for a more detailed explanation. It shows:
Fig. 1 eine Seitenansicht einer an die Knochenkontur angepaßten Osteosyntheseplatte;1 shows a side view of an osteosynthesis plate adapted to the bone contour;
Fig. 2 . eine Draufsicht auf ein erstes Ausführungs¬ beispiel einer Osteosyntheseplatte gemäß der Darstellung der Fig. 1 ;Fig. 2. a plan view of a first exemplary embodiment of an osteosynthesis plate as shown in FIG. 1;
Fig. 3 eine Ansicht ähnlich der Fig. 2 bei einem anderen Ausführungsbeispiel einer Osteo¬ syntheseplatte;3 shows a view similar to FIG. 2 in another embodiment of an osteosynthesis plate;
Fig. 4 eine Ansicht ähnlich der Fig. 1 einer zwei- lagig ausgebildeten Osteosyntheseplatte mit einer thermoplastischen Zwischenlage zur Anpassung an die Knochenkontur.4 shows a view similar to FIG. 1 of a two-layer osteosynthesis plate with a thermoplastic intermediate layer for adaptation to the bone contour.
In Fig. 1 sind- zwei Knochenfragmente 1 und 2 dargestellt, die längs einer Bruchlinie 3 voneinander getrennt sind und so angeordnet sind, daß sie längs der Bruchlinie 3 zusammen¬ heilen können. Zu diesem Zweck sind beide Knochenfragmente 1 und 2 über eine die Bruchlinie 3 überquerende Osteosvnthese- oder Knochenolatte 4 miteinander verbunden, die m ihrer 1 shows two bone fragments 1 and 2, which are separated from one another along a fracture line 3 and are arranged such that they can heal together along the fracture line 3. For this purpose, both bone fragments 1 and 2 are connected to one another via an osteosynthesis or bone slat 4 crossing the fracture line 3, which m their
Kontur an die Außenkontur der Knochenfragmente 1 und 2 form¬ schlüssig angepaßt ist. Die Osreosyntheseplatte 4 ist an den Knochenfragmenten 1 und 2 durch Knochenschrauben 5 festgelegt, welche Durchstecköffnungen in der Osteosyntheseplatte 4 durch¬ setzen und in die Knochenfragmente 1 und 2 eingeschraubt sind.Contour is adapted to the outer contour of the bone fragments 1 and 2 in a form-fitting manner. The osteosynthesis plate 4 is fixed to the bone fragments 1 and 2 by bone screws 5, which push through openings in the osteosynthesis plate 4 and are screwed into the bone fragments 1 and 2.
Die Osteosyntheseplatte 4 ist länglich und streifenför ig ausgebildet und besteht aus einem thermoplastischen Kunst¬ stoffmaterial, z.B. aus einem modifizierten Methacrylat, insbesondere einem Polyethylmethacrylat. Dieses Material ist so eingestellt, daß es bei Körpertemperatur, also z.B-. bei 40° C formstabil ist, während es bei einer Temperatur oberhalb dieser Temperatur, also beispielsweise im Bereich um eta 50° C weich und verformbar wird, so daß die Osteo- sytheseplatte bei Erreichen dieser Temperatur an die Knochenkontur angepaßt werden kann.The osteosynthesis plate 4 is elongated and strip-shaped and consists of a thermoplastic material, e.g. from a modified methacrylate, in particular a polyethyl methacrylate. This material is set so that it is at body temperature, e.g. is dimensionally stable at 40 ° C, while it becomes soft and deformable at a temperature above this temperature, for example in the range of approximately 50 ° C, so that the osteosynthesis plate can be adapted to the bone contour when this temperature is reached.
Zur Erhöhung der Festigkeit der Osteosyntheseplatte 4 sind in das thermoplastische Kunststoffmaterial Fasern 6 ein¬ gebettet, die als Endlosfasern ausgebildet sind. In den den Längsrändern 7 benachbarten Bereichen verlaufen diese Fasern 6 parallel zu den Längsräπdern 7 und erstrecken sich über die gesamte Länge der Osteosyntheseplatte, während in dem mittleren Bereich 8 zwischen den Längsrändern 7 bei dem in Fig. 2 dargestellten Ausführungsbeispiel wellenförmig verlaufende Fasern verlegt sind, die unterschiedlich weit To increase the strength of the osteosynthesis plate 4, fibers 6 are embedded in the thermoplastic material, which are designed as continuous fibers. In the areas adjacent to the longitudinal edges 7, these fibers 6 run parallel to the longitudinal wheels 7 and extend over the entire length of the osteosynthesis plate, while in the central area 8 between the longitudinal edges 7 in the embodiment shown in FIG. 2, wavy fibers are laid, the different distances
und nach unterschiedlichen Seiten ausgebaucht sind und die sich in gemeinsamen Kreuzungspunkten 8 überschneiden. Es ergeben sich dadurch zwischen den Kreuzungspunkten 8 i den Ausbauchungsbereichen 9 Gebiete, in denen Durchstecköffnun en so angeordnet sein können, daß sie beidseitig von den Aus¬ bauchungen der Fasern 6 umschlossen werden (Fig. 2) . Eine solche Anordnung führt zu einer besonders zuverlässigen Ver¬ stärkung im Randbereich der Durchstecköffnungen und gibt der gesamten Osteosyntheseplatte 4 die zum dauerhaften Zu¬ sammenhalten der Knochenfragmente 1 und 2 notwendige Festig¬ keit.and are bulged on different sides and which overlap at common crossing points 8. This results in areas between the crossing points 8 and the bulging areas 9 in which push-through openings can be arranged such that they are enclosed on both sides by the bulges of the fibers 6 (FIG. 2). Such an arrangement leads to a particularly reliable reinforcement in the edge region of the push-through openings and gives the entire osteosynthesis plate 4 the strength necessary for the permanent holding together of the bone fragments 1 and 2.
Bei einem abgewandelten Ausführungsbeispiel gemäß Fig. 3 sind die Fasern selbst im Bereich zwischen den Längsrändern 7 auch wellenförmig verlegt, jedoch in diesem Falle nicht durch gemeinsame Kreuzungspunkte geführt, sondern alle Fasern zeigen denselben Wellenverlauf, wobei die durch die verschiedenen Fasern gebildeten Wellen in Längsrichtung der Osteosynthese¬ platte 4 gegeneinander verschoben sind, bei dem Ausführungs- beispiel der Fig. 3._ so, daß eine gleichmäßige Faserbelegung im Bereich zwischen den Längsrändern 7 entsteht. Bei dieser Anordnung ist es möglich, die Durchstecköffnung 10 an be¬ liebiger Stelle im mittleren Teil der Osteosyntheseplatte 4 anzuordnen, beispielsweise auch durch nachträgliches Bohren, wobei jede Durchstecköffnung in gleicher Weise umfangseitig von Fasern umschlossen wird, die Randbereiche der Durch¬ stecköffnungen verstärken. In a modified embodiment according to FIG. 3, the fibers themselves are also laid in a wave shape in the area between the longitudinal edges 7, but in this case they are not guided through common crossing points, but all fibers show the same wave profile, the waves formed by the different fibers in the longitudinal direction of the Osteosynthesis¬ plate 4 are shifted against each other, in the embodiment of FIG. 3 . _ in such a way that a uniform fiber covering is created in the area between the longitudinal edges 7. With this arrangement, it is possible to arrange the push-through opening 10 at any point in the middle part of the osteosynthesis plate 4, for example also by subsequent drilling, each push-through opening being surrounded on the circumferential side in the same way by fibers which reinforce the edge regions of the push-through openings.
Die Osteosyntheseplatten 4 werden vorzugsweise aus Endios- material hergestellt, so daß der Chirurg beim Anpassen einer Knochenplatte die Knochenplatte mit der gewünschten Länge von dem Endlosmaterial abschneiden kann, beispielsweise mittel einer geeigneten Schlagschere.The osteosynthesis plates 4 are preferably made of endios material so that the surgeon can cut the bone plate with the desired length from the endless material when fitting a bone plate, for example using suitable guillotine shears.
Bei dem Ausführungsbeispiel der Fig. 4 ist die Osteosynthese¬ platte 14 zweilagig ausgebildet, sie umfaßt nämlich eine form¬ stabile, obere Platte 11 und eine mit dieser verbundene, aus thermoplatischem Kunststoffmaterial bestehende Zwischenlage 12. Die obere Platte 11 kann beispielsweise aus Metall oder einem formstabilen Kunststoff bestehen, der zusätzlich mit Fasern 13 verstärkt sein kann. Das dann verwendete Kunststoffmaterial is so ausgebildet, daß es sich bei den Erweichungstemperaturen de Zwischenlagen nicht verformen läßt, es kann sich beispielsweis um ein duroplastisches Kunststoffmaterial handeln oder ein thermoplastisches Kunststoffmaterial mit einer wesentlich höheren Erweichungstemperatur. Die Faserverstärkung der äußeren Platte 11 kann in ähnlicher Weise ausgebildet sein, wie dies anhand der Fig. 2 und 3 oben erläutert worden ist.In the embodiment of FIG. 4, the osteosynthesis plate 14 is formed in two layers, namely it comprises a dimensionally stable, upper plate 11 and an intermediate layer 12 connected therewith and made of thermoplastic plastic material. The upper plate 11 can, for example, be made of metal or a dimensionally stable plastic exist, which can also be reinforced with fibers 13. The plastic material then used is designed so that it cannot be deformed at the softening temperatures of the intermediate layers, for example it can be a thermosetting plastic material or a thermoplastic material with a much higher softening temperature. The fiber reinforcement of the outer plate 11 can be designed in a similar manner as has been explained with reference to FIGS. 2 and 3 above.
Die Zwischenlage 12 ist aus einem thermoplastischen Kunst¬ stoffmaterial gebildet, welches sich bei einer Temperatur erweichen läßt, die knapp oberhalb der Körpertemperatur liegt, also beispielsweise bei einer Temperatur um 50° c. Wie bei dem Ausführungsbeispiel der Fig. 1 bis 3 kann das dabei verwendete Material ein modifiziertes Methacrylat sein. The intermediate layer 12 is formed from a thermoplastic material which can be softened at a temperature which is just above the body temperature, for example at a temperature around 50 ° C. As in the exemplary embodiment in FIGS. 1 to 3, the material used can be a modified methacrylate.
Das thermoplastische Kunststoffmaterial der Zwischenlage wird zum Anpassen dieser zweilagigen Osteosyntheseplatte an die Kontur der Knochenfragmente 1 und 2 erwärmt, so daß beim Anlegen der Knochenplatte an die Knochenfragmente das dann verformbare Kunststoffmaterial der Zwischenlage formschlüssig an der Außenkontur der Fragmente anliegt, während die obere Platte 11 bei dieser Anpassung formstabil bleibt.The thermoplastic plastic material of the intermediate layer is heated to adapt this two-layer osteosynthesis plate to the contour of the bone fragments 1 and 2, so that when the bone plate is placed on the bone fragments, the then deformable plastic material of the intermediate layer fits positively on the outer contour of the fragments, while the upper plate 11 this adaptation remains dimensionally stable.
Auch die beschriebene zweilagige Osteosyntheseplatte kann als Endlosmaterial hergestellt und dann vom Chirurgen auf die ge¬ wünschte Länge abgeschnitten werden. The two-layer osteosynthesis plate described can also be produced as an endless material and then cut off to the desired length by the surgeon.

Claims

P A T E T A N S P R Ü C H E PATETA CLAIMS
1. Osteosyntheseplatte aus einem thermoplastischen Kunst¬ stoff mit Durchstecköffnungen für Knochenschrauben und mit in den Kunststoff eingebetteten Verstärkungsfasern, dadurch gekennzeichnet, daß an den Längsrändern (7) der Osteosyntheseplatten (4) parallel zu diesen orientierte Fasern (6) und zwischen den randnahen Bereichen wellenförmig hin- und herver¬ laufende Fasern angeordnet sind.1. Osteosynthesis plate made of a thermoplastic Kunst¬ with push-through openings for bone screws and with reinforcing fibers embedded in the plastic, characterized in that on the longitudinal edges (7) of the osteosynthesis plates (4) parallel to these fibers (6) and between the areas close to the edges in a wave shape fibers running to and fro are arranged.
2. Osteosyntheseplatte nach Anspruch 1, dadurch gekennzeichnet, daß die wellenförmig verlegten Fasern zwischen benach¬ barten Durchstecköffnungen (10) hin- und herlaufen und daß sich auf gegenüberliegenden Seiten der Durchsteck¬ öffnungen (10) angeordnete Fasern zwischen benachbarten Durchstecköffnungen (10) überkreuzen.2. Osteosynthesis plate according to claim 1, characterized in that the wavy fibers run back and forth between neighboring openings (10) and that on opposite sides of the openings (10) arranged fibers cross between adjacent openings (10).
3. Osteosyntheseplatte nach Anspruch 1 , dadurch gekennzeichnet, daß wellenförmig verlegte Fasern im mittleren Teil der Osteosyntheseplatte (4) zwischen den randnahen Bereichen mit gleicher Wellenform in Längsrichtung der Osteosynthese¬ platte gegeneinander versetzt verlegt sind. 3. Osteosynthesis plate according to claim 1, characterized in that wavy fibers in the central part of the osteosynthesis plate (4) between the regions near the edge with the same waveform in the longitudinal direction of the Osteosynthese¬ plate are offset against each other.
4. Osteosyntheseplatte nach Anspruch 3, dadurch gekennzeichnet, daß die wellenförmig verlegten Fasern in Längsrichtung gleichmäßig über die Länge der Osteosyntheseplatte (4) verteilt sind.4. osteosynthesis plate according to claim 3, characterized in that the wavy fibers are evenly distributed in the longitudinal direction over the length of the osteosynthesis plate (4).
5. Osteosyntheseplatte mit Durchstecköffnungen für Knochen¬ schrauben, gekennzeichnet durch eine formkonstante, obere Platte (11) und eine mit dieser verbundene, knöchenseitig angeordnete Zwischenlage (12) aus thermoplastischem Kunststoffmaterial.5. osteosynthesis plate with push-through openings for bone screws, characterized by a shape-constant, upper plate (11) and an associated intermediate layer (12) made of thermoplastic material arranged on the bone side.
6. Osteosyntheseplatte nach Anspruch 5, dadurch gekennzeichnet, daß die obere Platte (11) aus Metall besteht.6. Osteosynthesis plate according to claim 5, characterized in that the upper plate (11) consists of metal.
7. Osteosyntheseplatte nach Anspruch 5, dadurch gekennzeichnet, daß die obere Platte (11) aus einem faserverstärkten Kunststoff besteht.7. osteosynthesis plate according to claim 5, characterized in that the upper plate (11) consists of a fiber-reinforced plastic.
8. Osteosyntheseplatte nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Osteosyntheseplatte (4, 14) in Längsrichtung als Endlosmaterial ausgebildet ist. 8. osteosynthesis plate according to one of the preceding claims, characterized in that the osteosynthesis plate (4, 14) is formed in the longitudinal direction as an endless material.
9. Osteosyntheseplatte nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß der thermoplastische Kunststoff ein modi iziertes Methacrylat ist, insbesondere ein Polyethylmethacryla .9. osteosynthesis plate according to one of the preceding claims, characterized in that the thermoplastic is a modi iziert methacrylate, in particular a Polyethylmethacryla.
10. Osteosyntheseplatte nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Verstärkungsfasern (6) Kohlenstofffasern sind. 10. Osteosynthesis plate according to one of the preceding claims, characterized in that the reinforcing fibers (6) are carbon fibers.
PCT/EP1990/000639 1989-04-28 1990-04-20 Osteosynthesis plates WO1990013265A1 (en)

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