WO2000053126A1 - Implant for fixing an articulated joint - Google Patents

Implant for fixing an articulated joint Download PDF

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Publication number
WO2000053126A1
WO2000053126A1 PCT/EP1999/001549 EP9901549W WO0053126A1 WO 2000053126 A1 WO2000053126 A1 WO 2000053126A1 EP 9901549 W EP9901549 W EP 9901549W WO 0053126 A1 WO0053126 A1 WO 0053126A1
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WO
WIPO (PCT)
Prior art keywords
arms
temperature state
implant according
implant
clip
Prior art date
Application number
PCT/EP1999/001549
Other languages
German (de)
French (fr)
Inventor
Michael Ogon
Theodor Lutze
Charles Wing
Original Assignee
Aesculap Ag & Co. Kg
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 & Co. Kg filed Critical Aesculap Ag & Co. Kg
Priority to PCT/EP1999/001549 priority Critical patent/WO2000053126A1/en
Priority to DE29904271U priority patent/DE29904271U1/en
Publication of WO2000053126A1 publication Critical patent/WO2000053126A1/en

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Classifications

    • 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7064Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

Definitions

  • the invention relates to an implant for fixing the facet joint.
  • CONFIRMATION COPY can be done easily and very effectively.
  • an implant for fixing the facet joint in that it is designed as a U-shaped clamp with a web and with arms projecting laterally from it at its ends, that the clamp consists of a shape-memory material which changes in shape when the temperature rises changes from a martensitic low-temperature state to an austenitic high-temperature state, and that the arms are at a greater distance from one another in the low-temperature state, which is below body temperature, than in the high-temperature state, which is achieved when the clip is heated to body temperature.
  • Such a clamp-shaped implant can be inserted with its arms into the two parts of the facet joint in the low-temperature state, for example by driving it in or after preparing a corresponding insertion hole in the facet joint parts by inserting the arms into these holes, and upon subsequent heating of the clamp Body temperature changes from the martensitic state to the austenitic state, the arms approaching the clamp and thereby pressing the two parts of the facet joint against each other and thus fixing them.
  • the insertion of such a cooled clip can be accomplished simply and quickly, and the subsequent fixing of the two parts of the facet joint by tensioning the joint surfaces against each other takes place automatically by warming up the clip. mer. This results in a simple and very effective method for fixing the facet joint for the surgeon.
  • the transition from the martensitic state to the austenitic state can also take place at a temperature which is above body temperature. Such a transition is then caused by targeted heating of the clip. Due to a hysteresis property of such alloys, there is a return transition from the austenitic state to the martensitic state at a much lower temperature, which is below the body temperature, so that the clamp remains in a tensioned state even when the body temperature is lower than the transition temperature from the martensitic state to austenitic state.
  • this implant can be inserted into the body endoscopically, that is to say through a trocar sleeve. This is not the case when the vertebral bodies are screwed together in the area of the facet joint because of the necessary orientation of screws possible.
  • the arms of the clip are of different lengths, so that a body-appropriate insertion into the facet joint is made possible in this way.
  • the length of one arm is between 8 mm and 12 mm and that of the other arm between 12 mm and 25 mm.
  • the clip can preferably be bent from a round metal.
  • the clip consists of a sheet metal strip, in particular a cold-rolled sheet.
  • the arms can have a distance between 8 mm and 25 mm in the low temperature state, which is reduced to 6 mm to 23 mm in the high temperature state.
  • the arms approach each other by changing the angle between the web and the arms.
  • the arms are approached by an arcuate deformation of the web stretched in the low temperature state; these types of deformation can also be combined if necessary.
  • FIG. 1 a side view of two adjacent vertebral bodies, each shown partially, the facet joint of which is fixed by inserting a clamp;
  • Figure 2 is a sectional view taken along line 2-2 in Figure 1;
  • Figure 3 a clamp for fixing the facet joint in the low temperature state with arms and apart
  • Figure 4 is a perspective view of another preferred embodiment of a clip.
  • FIGS. 1 and 2 show two vertebral bodies 1, 2 arranged side by side, which are held at a distance from one another by an intervertebral disc 3 arranged between them.
  • the intervertebral disc 3 is flexible and allows the adjacent vertebral bodies to tilt towards each other within certain limits, this tilt is guided and limited by facet joints 4 provided on both sides dorsally on the vertebral bodies, which are formed on the vertebral bodies by laterally protruding projections 5.
  • the intervertebral disc 3 is normally removed and replaced by a spacer, this is not shown in the drawing.
  • the arms 8 and 9 are of unequal length, for example the length of the web can be 16 mm, the length of the short arm 10 mm and the length of the long arm 18 mm.
  • the two arms 8 and 9 are tapered at their ends.
  • the bracket consists of a shape memory alloy, for example a nickel-titanium alloy, to which other metals can be added, for example vanadium.
  • shape memory alloys have the property that, when the temperature rises, they change from a martensitic state to an austenitic state and thereby change their shape, namely reversibly.
  • the material properties are chosen so that the transition temperature is slightly above normal body temperature, i.e. above 37 ° C. A cooled clip is thus in the martensitic low-temperature state, a transition to the austenitic high-temperature state only takes place when the clip is heated to a temperature which is above body temperature.
  • Such heating is carried out by targeted heating, for example by a hot air stream, by exposure to a hot liquid or by a special electric heater.
  • targeted heating for example by a hot air stream, by exposure to a hot liquid or by a special electric heater.
  • This has the advantage that the surgeon attaches the bracket Can use body temperature in the body without a transition from the martensitic to the austenitic state. This transition can only be brought about by targeted heating when the clip is in the correct position. Even when it cools down to body temperature, the shape memory alloy remains in the austenitic high-temperature state, since the hysteresis properties of such alloys mean that the re-transformation temperature is significantly below body temperature.
  • the clamp 6 To insert the clamp 6, it is brought to the side of the facet joint 4 with the tapered ends of the two arms 8 and 9 such that one of the two arms 8 or 9 can be inserted into an extension 5 of a vertebral body 1 or 2 , either by driving in, or by inserting it into prefabricated bores.
  • the insertion takes place after pre-cooling of the clamp 6, i.e. during insertion, the clamp 6 is in the martensitic low-temperature state, the arms 8 and 9 are thus at a large distance from one another. This can be done, for example, in that the clip is present, as shown in FIG. 3, with an elongated web 7 and arms 8 and 9 running parallel to one another.
  • the arms 8, 9 of the clamp 6 are preferably placed in such a way that the short arm 9 is driven into the lower articular process of the upper vertebral body, the longer arm 8, however, into the pedicle entry point of the lower vertebral body.
  • the lower articular process of the upper vertebral body is usually thicker det as the medial adjoining vertebral arch, and therefore care must be taken that the shorter arm 9 is not inserted too far medially, that is to say it is placed securely in the lower articular process. It is entirely possible that, deviating from the illustration in FIG. 1, the plane of the clamp is inclined with respect to the longitudinal axis of the spine.
  • the clamp 6 After insertion, the clamp 6 is heated and thereby goes into the austenitic high temperature state, a deformation taking place in such a way that the arms 8 and 9 are brought closer to one another.
  • This can be done in that the arms 8 and 9 are angled more strongly in the area of the connection between the arms 8 and 9 and the web 7 and thus pivot against one another, it is also possible that with this deformation the elongated web 7 into a curved one Configuration passes, this also leads to an approach of the two arms 8 and 9.
  • both deformations can also be present at the same time.
  • the arms 8 and 9 are thus brought closer to one another when the clamp is heated, and in the process they tension the two parts of the facet joint 4 against one another, the two facet joints between the two vertebral bodies are thereby fixed.
  • FIG. 4 A further preferred exemplary embodiment of a clamp 6 is shown in FIG. 4, parts which correspond to one another have the same reference symbols.
  • the clip 6 In contrast to the clip of Figure 3, which is bent from a round material, the clip 6 consists of Figure 4 from a flat strip, for example from a cold-rolled sheet, so that the arms 8 and 9 are strip or plate-shaped.
  • the arms 8, 9 taper to a point; in contrast to the exemplary embodiment in FIGS. 1 to 3, the shorter arm 9 is split into two parallel individual arms 10, 11 which lie next to one another.

Abstract

The invention relates to an implant for fixing an articulated joint. To simplify the use of said implant, the inventive device provides that it is designed as a U-shaped clip comprising a bar and arms which extend laterally at the ends of said bar, whereby the clip consists of a shape memory material which changes form with an increase of temperature from a martensitic low temperature state into an austenitic high temperature state, and there is a greater distance between the arms in the low temperature state, which lies below body temperature, than in the high temperature state, which is reached when the clip is heated to body temperature.

Description

IMPLANTAT ZUR FESTLEGUNG DES FACETTENGELENKES IMPLANT FOR DETERMINING THE FACET JOINT
Die Erfindung betrifft ein Implantat zur Festlegung des Facettengelenkes.The invention relates to an implant for fixing the facet joint.
Bei Schäden an der Wirbelsäule ist es häufig notwendig, benachbarte Wirbelkörper durch eine Knochenfusion miteinander zu verbinden. Dies kann dadurch erfolgen, daß anstelle der entfernten Bandscheibe ein Distanzkörper zwischen benachbarte Wirbelkörper eingesetzt wird, insbesondere ein Distanzkörper, der von Knochenmaterial durchwachsen werden kann. Obwohl eine derartige Fixierung in vielen Fällen ausreicht, ist es in anderen Fällen wünschenswert, auch im dorsalen Teil der Wirbelsäule zusätzlich noch eine Verbindung der benachbarten Wirbelkörper vorzunehmen, und zwar im Bereich des Facettengelenkes, in dem die benachbarten Wirbelkörper aneinander anliegen. Eine Verbindung in diesem Bereich führt zu einer zusätzlichen Stabilisierung der benachbarten Wirbelkörper und fördert dadurch die vollständige Fusion dieser Wirbelkörper.If the spine is damaged, it is often necessary to join neighboring vertebral bodies by means of a bone fusion. This can be done by inserting a spacer between adjacent vertebral bodies instead of the removed intervertebral disc, in particular a spacer that can be grown through by bone material. Although such a fixation is sufficient in many cases, it is desirable in other cases to additionally connect the adjacent vertebral bodies also in the dorsal part of the spine, in the region of the facet joint in which the adjacent vertebral bodies abut one another. A connection in this area leads to an additional stabilization of the neighboring vertebral bodies and thereby promotes the complete fusion of these vertebral bodies.
Es ist bekannt, das Facettengelenk dadurch festzulegen, daß Knochenschrauben durch die beiden Teile des Facettengelenkes hindurchgeschraubt werden, so daß die Gelenkflächen dadurch relativ zueinander fixiert werden. Dies ist jedoch kompliziert und erfordert einen erheblichen Zeitaufwand.It is known to fix the facet joint by screwing bone screws through the two parts of the facet joint so that the joint surfaces are thereby fixed relative to one another. However, this is complicated and requires a considerable amount of time.
Es ist Aufgabe der Erfindung, ein Implantat anzugeben, mit dem eine solche Verbindung des Facettengelenkes inIt is an object of the invention to provide an implant with which such a connection of the facet joint in
BESTATIGUNGSKOPIE einfacher Weise und sehr effektiv vorgenommen werden kann.CONFIRMATION COPY can be done easily and very effectively.
Diese Aufgabe wird bei einem Implantat zur Festlegung des Facettengelenkes erfindungsgemäß dadurch gelöst, daß es als U-förmige Klammer ausgebildet ist mit einem Steg und mit an dessen Enden seitlich von ihm abstehenden Armen, daß die Klammer aus einem Formgedachtnismaterial besteht, welches bei Temperaturerhöhung unter Formänderung von einem martensitischen Tieftemperaturzustand in einen austenitischen Hochtemperaturzustand übergeht, und daß die Arme im Tieftemperaturzustand, der unter Körpertemperatur liegt, einen größeren Abstand voneinander aufweisen als im Hochtemperaturzustand, der beim Erwärmen der Klammer auf Körpertemperatur erreicht wird.This object is achieved according to the invention in an implant for fixing the facet joint in that it is designed as a U-shaped clamp with a web and with arms projecting laterally from it at its ends, that the clamp consists of a shape-memory material which changes in shape when the temperature rises changes from a martensitic low-temperature state to an austenitic high-temperature state, and that the arms are at a greater distance from one another in the low-temperature state, which is below body temperature, than in the high-temperature state, which is achieved when the clip is heated to body temperature.
Ein solches klammerförmiges Implantat kann im Tieftemperaturzustand mit seinen Armen in die beiden Teile des Facettengelenkes eingeführt werden, beispielsweise durch Einschlagen oder nach einer Vorbereitung einer entsprechenden Einsteckbohrung in den Facettengelenk- teilen durch Einschieben der Arme in diese Bohrungen, und bei dem nachfolgenden Erwärmen der Klammer auf Körpertemperatur geht diese vom martensitischen Zustand in den austenitischen Zustand über, wobei sich die Arme der Klammer dabei annähern und dadurch die beiden Teile des Facettengelenkes gegeneinander drücken und so fixieren. Das Einsetzen einer derartigen abgekühlten Klammer ist einfach und schnell zu bewerkstelligen, und die anschließende Fixierung der beiden Teile des Facettengelenkes durch Gegeneinanderspannen der Gelenkflächen erfolgt selbsttätig durch das Aufwärmen der Klam- mer. Damit ergibt sich für den Operateur eine einfache und sehr effektive Methode zur Fixierung des Facettengelenkes.Such a clamp-shaped implant can be inserted with its arms into the two parts of the facet joint in the low-temperature state, for example by driving it in or after preparing a corresponding insertion hole in the facet joint parts by inserting the arms into these holes, and upon subsequent heating of the clamp Body temperature changes from the martensitic state to the austenitic state, the arms approaching the clamp and thereby pressing the two parts of the facet joint against each other and thus fixing them. The insertion of such a cooled clip can be accomplished simply and quickly, and the subsequent fixing of the two parts of the facet joint by tensioning the joint surfaces against each other takes place automatically by warming up the clip. mer. This results in a simple and very effective method for fixing the facet joint for the surgeon.
Der Übergang vom martensitischen Zustand in den austenitischen Zustand kann auch bei einer Temperatur erfolgen, die oberhalb der Körpertemperatur liegt. Ein solcher Übergang wird dann durch gezielte Erwärmung der Klammer hervorgerufen. Aufgrund einer Hystereseeigenschaft derartiger Legierungen erfolgt ein Rückübergang vom austenitischen Zustand in den martensitischen Zustand bei einer wesentlich tieferen Temperatur, die unterhalb der Körpertemperatur liegt, so daß die Klammer auch dann in gespanntem Zustand verbleibt, wenn die Körpertemperatur niedriger ist als die Übergangstemperatur vom martensitischen Zustand zum austenitischen Zustand.The transition from the martensitic state to the austenitic state can also take place at a temperature which is above body temperature. Such a transition is then caused by targeted heating of the clip. Due to a hysteresis property of such alloys, there is a return transition from the austenitic state to the martensitic state at a much lower temperature, which is below the body temperature, so that the clamp remains in a tensioned state even when the body temperature is lower than the transition temperature from the martensitic state to austenitic state.
Ein weiterer wesentlicher Vorteil des beschriebenen Implantats liegt darin, daß dieses Implantat endosko- pisch, das heißt durch eine Trokarhülse hindurch in den Körper eingesetzt werden kann, dies ist bei Verschrau- bung der Wirbelkörper im Bereich des Facettengelenks wegen der dabei notwendigen Orientierung von Schrauben nicht möglich.Another important advantage of the implant described is that this implant can be inserted into the body endoscopically, that is to say through a trocar sleeve. This is not the case when the vertebral bodies are screwed together in the area of the facet joint because of the necessary orientation of screws possible.
Besonders vorteilhaft ist es, wenn die Arme der Klammer unterschiedlich lang sind, so daß auf diese Weise ein körpergerechtes Einsetzen in das Facettengelenk ermöglicht wird. Beispielsweise kann vorgesehen sein, daß die Länge des einen Armes zwischen 8 mm und 12 mm liegt und die des anderen Armes zwischen 12 mm und 25 mm.It is particularly advantageous if the arms of the clip are of different lengths, so that a body-appropriate insertion into the facet joint is made possible in this way. For example, it can be provided that the length of one arm is between 8 mm and 12 mm and that of the other arm between 12 mm and 25 mm.
Die Klammer kann vorzugsweise aus einem Rundmetall gebogen sein.The clip can preferably be bent from a round metal.
Bei einer anderen Ausführungsform besteht die Klammer aus einem Blechstreifen, insbesondere aus einem kaltgewalzten Blech.In another embodiment, the clip consists of a sheet metal strip, in particular a cold-rolled sheet.
Es ist günstig, wenn die Arme spitz auslaufende Enden aufweisen, dies unterstützt das Eintreiben der Klammer in die beiden Teile des Facettengelenkes.It is advantageous if the arms have tapered ends, this supports driving the clip into the two parts of the facet joint.
Die Arme können im Tieftemperaturzustand einen Abstand zwischen 8 mm und 25 mm aufweisen, der im Hochtemperaturzustand reduziert ist auf 6 mm bis 23 mm.The arms can have a distance between 8 mm and 25 mm in the low temperature state, which is reduced to 6 mm to 23 mm in the high temperature state.
Bei einem ersten bevorzugten Ausführungsbeispiel ist vorgesehen, daß die Annäherung der Arme durch Veränderung des Winkels zwischen Steg und Armen erfolgt.In a first preferred embodiment it is provided that the arms approach each other by changing the angle between the web and the arms.
Es ist aber auch möglich, daß gemäß einer anderen bevorzugten Ausführungsform die Annäherung der Arme durch eine bogenförmige Verformung des im Tieftemperaturzustand gestreckten Steges erfolgt; diese Verformungsarten können gegebenenfalls auch kombiniert werden.However, it is also possible that, according to another preferred embodiment, the arms are approached by an arcuate deformation of the web stretched in the low temperature state; these types of deformation can also be combined if necessary.
Die nachfolgende Beschreibung einer bevorzugten Ausfüh- rungsform der Erfindung dient im Zusammenhang mit der Zeichnung der näheren Erläuterung. Es zeigen: Figur 1: eine Seitenansicht von zwei jeweils teilweise dargestellten benachbarten Wirbelkörpern, deren Facettengelenk durch Einsetzen einer Klammer fixiert ist;The following description of a preferred embodiment of the invention serves in conjunction with the drawing for a more detailed explanation. Show it: FIG. 1: a side view of two adjacent vertebral bodies, each shown partially, the facet joint of which is fixed by inserting a clamp;
Figur 2: eine Schnittansicht längs Linie 2-2 in Figur 1;Figure 2 is a sectional view taken along line 2-2 in Figure 1;
Figur 3: eine Klammer zur Fixierung des Facettengelenkes im Tieftemperaturzustand mit voneinander entfernten Armen undFigure 3: a clamp for fixing the facet joint in the low temperature state with arms and apart
Figur 4: eine perspektivische Ansicht eines weiteren bevorzugten Ausführungsbeispiels einer Klammer.Figure 4 is a perspective view of another preferred embodiment of a clip.
In den Figuren 1 und 2 erkennt man zwei nebeneinander angeordnete Wirbelkörper 1, 2, die durch eine zwischen ihnen angeordnete Bandscheibe 3 im Abstand zueinander gehalten werden. Die Bandscheibe 3 ist flexibel und ermöglicht in gewissen Grenzen eine Verkippung der benachbarten Wirbelkörper gegeneinander, diese Verkippung wird geführt und begrenzt durch beidseitig dorsal an den Wirbelkörpern vorgesehene Facettengelenke 4, die durch seitlich abstehende Fortsätze 5 an den Wirbelkörpern ausgebildet werden.FIGS. 1 and 2 show two vertebral bodies 1, 2 arranged side by side, which are held at a distance from one another by an intervertebral disc 3 arranged between them. The intervertebral disc 3 is flexible and allows the adjacent vertebral bodies to tilt towards each other within certain limits, this tilt is guided and limited by facet joints 4 provided on both sides dorsally on the vertebral bodies, which are formed on the vertebral bodies by laterally protruding projections 5.
Zur Fusion von zwei benachbarten Wirbelkörpern 1 und 2 wird normalerweise die Bandscheibe 3 entnommen und durch einen Distanzkörper ersetzt, dies ist in der Zeichnung nicht dargestellt. Außerdem ist es günstig, die Bewegungsmöglichkeit der benachbarten Wirbelkörper 1 und 2 dadurch zusätzlich einzuschränken, daß die Fortsätze 5 im Bereich der Facettengelenke 4 relativ zueinander fixiert werden.For the fusion of two adjacent vertebral bodies 1 and 2, the intervertebral disc 3 is normally removed and replaced by a spacer, this is not shown in the drawing. In addition, it is beneficial to be able to move the neighboring vertebrae 1 and 2 additionally restrict that the extensions 5 are fixed relative to each other in the area of the facet joints 4.
Dies erfolgt im vorliegenden Fall durch ein Implantat in Form einer Klammer 6, die einen Steg 7 und quer davon abstehende, parallele, in einer Ebene liegende Arme 8, 9 aufweist (Figur 3). Die Arme 8 und 9 sind dabei ungleich lang, beispielsweise kann die Länge des Steges 16 mm betragen, die Länge des kurzen Armes 10 mm und die Länge des langen Armes 18 mm. Die beiden Arme 8 und 9 sind an ihren Enden zugespitzt.In the present case, this is done by means of an implant in the form of a clamp 6, which has a web 7 and parallel arms 8, 9 projecting transversely therefrom and lying in one plane (FIG. 3). The arms 8 and 9 are of unequal length, for example the length of the web can be 16 mm, the length of the short arm 10 mm and the length of the long arm 18 mm. The two arms 8 and 9 are tapered at their ends.
Die Klammer besteht auf einer Formgedächtnislegierung, beispielsweise aus einer Nickel-Titanlegierung, der noch andere Metalle zugegeben werden können, beispielsweise Vanadium. Diese Formgedächtnislegierungen haben die Eigenschaft, daß sie bei Temperaturerhöhungen aus einem martensitischen Zustand in einen austenitischen Zustand übergehen und dabei ihre Form ändern, und zwar reversibel. Im vorliegenden Fall werden die Materialeigenschaften so gewählt, daß die Übergangstemperatur etwas oberhalb der normalen Körpertemperatur liegt, also oberhalb von 37 °C. Eine abgekühlte Klammer befindet sich somit im martensitischen Tieftemperaturzustand, ein Übergang in den austenitischen Hochtemperaturzustand erfolgt erst bei einer Erwärmung der Klammer auf eine Temperatur, die oberhalb Körpertemperatur liegt. Eine solche Erwärmung wird die durch gezielte Erwärmung vorgenommen, beispielsweise durch einen Heißluftstrom, durch Beaufschlagung mit einer heißen Flüssigkeit oder durch eine spezielle elektrische Heizung. Die hat den Vorteil, daß der Operateur die Klammer bei Körpertemperatur in den Körper einsetzen kann, ohne daß ein Übergang vom martensitischen in den austenitischen Zustand erfolgt. Erst wenn die Klammer die richtige Position einnimmt, kann durch gezielte Erwärmung dieser Übergang herbeigeführt werden. Auch beim Abkühlen auf Körpertemperatur bleibt die Formgedächtnislegierung in dem austenitischen Hochtemperaturzustand, da die Rück- umwandlungstemperatur aufgrund der Hystereseeigenschaften derartiger Legierungen deutlich unterhalb Körpertemperatur liegt.The bracket consists of a shape memory alloy, for example a nickel-titanium alloy, to which other metals can be added, for example vanadium. These shape memory alloys have the property that, when the temperature rises, they change from a martensitic state to an austenitic state and thereby change their shape, namely reversibly. In the present case, the material properties are chosen so that the transition temperature is slightly above normal body temperature, i.e. above 37 ° C. A cooled clip is thus in the martensitic low-temperature state, a transition to the austenitic high-temperature state only takes place when the clip is heated to a temperature which is above body temperature. Such heating is carried out by targeted heating, for example by a hot air stream, by exposure to a hot liquid or by a special electric heater. This has the advantage that the surgeon attaches the bracket Can use body temperature in the body without a transition from the martensitic to the austenitic state. This transition can only be brought about by targeted heating when the clip is in the correct position. Even when it cools down to body temperature, the shape memory alloy remains in the austenitic high-temperature state, since the hysteresis properties of such alloys mean that the re-transformation temperature is significantly below body temperature.
Zum Einsetzen der Klammer 6 wird diese mit den spitz zulaufenden Enden der beiden Arme 8 und 9 so seitlich an das Facettengelenk 4 herangebracht, daß jeweils einer der beiden Arme 8 bzw. 9 in jeweils einen Fortsatz 5 eines Wirbelkörpers 1 bzw. 2 eingeführt werden kann, sei es durch Einschlagen, sei es durch Einstecken in vorgefertigte Bohrungen. Das Einführen erfolgt dabei nach Vorkühlung der Klammer 6, d.h. während des Einsetzens befindet sich die Klammer 6 im martensitischen Tieftemperaturzustand, die Arme 8 und 9 weisen dabei also einen großen Abstand voneinander auf. Dies kann beispielsweise dadurch erfolgen, daß die Klammer entsprechend der Darstellung der Figur 3 mit einem gestreckten Steg 7 und parallel zueinander verlaufenden Armen 8 und 9 vorliegt.To insert the clamp 6, it is brought to the side of the facet joint 4 with the tapered ends of the two arms 8 and 9 such that one of the two arms 8 or 9 can be inserted into an extension 5 of a vertebral body 1 or 2 , either by driving in, or by inserting it into prefabricated bores. The insertion takes place after pre-cooling of the clamp 6, i.e. during insertion, the clamp 6 is in the martensitic low-temperature state, the arms 8 and 9 are thus at a large distance from one another. This can be done, for example, in that the clip is present, as shown in FIG. 3, with an elongated web 7 and arms 8 and 9 running parallel to one another.
Die Arme 8, 9 der Klammer 6 werden vorzugsweise so plaziert, daß der kurze Arm 9 in den unteren Gelenkfortsatz des oberen Wirbelkörpers eingeschlagen wird, der längere Arm 8 dagegen in den Pedikel-Eintrittspunkt des unteren Wirbelkörpers. Der untere Gelenkfortsatz des oberen Wirbelkörpers ist normalerweise dicker ausgebil- det als der sich medial anschließende Wirbelbogen, und daher ist darauf zu achten, daß der kürzere Arm 9 nicht zu weit medial eingesetzt wird, also sicher im unteren Gelenkfortsatz plaziert wird. Es ist dabei durchaus möglich, daß abweichend von der Darstellung der Figur 1 die Ebene der Klammer gegenüber der Wirbelsäulenlängsachse geneigt ist.The arms 8, 9 of the clamp 6 are preferably placed in such a way that the short arm 9 is driven into the lower articular process of the upper vertebral body, the longer arm 8, however, into the pedicle entry point of the lower vertebral body. The lower articular process of the upper vertebral body is usually thicker det as the medial adjoining vertebral arch, and therefore care must be taken that the shorter arm 9 is not inserted too far medially, that is to say it is placed securely in the lower articular process. It is entirely possible that, deviating from the illustration in FIG. 1, the plane of the clamp is inclined with respect to the longitudinal axis of the spine.
Nach dem Einsetzen wird die Klammer 6 erwärmt und geht dabei in den austenitischen Hochtemperaturzustand über, dabei erfolgt eine Verformung in der Weise, daß die Arme 8 und 9 einander angenähert werden. Dies kann einmal dadurch erfolgen, daß die Arme 8 und 9 im Bereich der Verbindung zwischen den Armen 8 und 9 und dem Steg 7 stärker angewinkelt werden und somit gegeneinander schwenken, es ist auch möglich, daß bei dieser Verformung der gestreckte Steg 7 in eine gebogene Konfiguration übergeht, auch dies führt zu einer Annäherung der beiden Arme 8 und 9. Selbstverständlich können beide Verformungen auch gleichzeitig vorliegen.After insertion, the clamp 6 is heated and thereby goes into the austenitic high temperature state, a deformation taking place in such a way that the arms 8 and 9 are brought closer to one another. This can be done in that the arms 8 and 9 are angled more strongly in the area of the connection between the arms 8 and 9 and the web 7 and thus pivot against one another, it is also possible that with this deformation the elongated web 7 into a curved one Configuration passes, this also leads to an approach of the two arms 8 and 9. Of course, both deformations can also be present at the same time.
Im Ergebnis werden somit die Arme 8 und 9 bei der Erwärmung der Klammer einander angenähert, und dabei spannen sie die beiden Teile des Facettengelenkes 4 gegeneinander, die beiden Facettengelenke zwischen den beiden Wirbelkörpern werden dadurch fixiert.As a result, the arms 8 and 9 are thus brought closer to one another when the clamp is heated, and in the process they tension the two parts of the facet joint 4 against one another, the two facet joints between the two vertebral bodies are thereby fixed.
In Figur 4 ist ein weiteres bevorzugtes Ausführungsbei- spiel einer Klammer 6 dargestellt, einander entsprechende Teile tragen dieselben Bezugszeichen.A further preferred exemplary embodiment of a clamp 6 is shown in FIG. 4, parts which correspond to one another have the same reference symbols.
Im Unterschied zu der Klammer der Figur 3, die aus einem Rundmaterial gebogen ist, besteht die Klammer 6 der Figur 4 aus einem flachen Streifen, beispielsweise aus einem kaltgewalzten Blech, so daß auch die Arme 8 und 9 streifen- oder plattenförmig ausgebildet sind.In contrast to the clip of Figure 3, which is bent from a round material, the clip 6 consists of Figure 4 from a flat strip, for example from a cold-rolled sheet, so that the arms 8 and 9 are strip or plate-shaped.
Auch hier laufen die Arme 8, 9 spitz zu, im Unterschied zu dem Ausführungsbeispiel der Figuren 1 bis 3 ist der kürzere Arm 9 aufgespalten in zwei parallele Einzelarme 10, 11 die nebeneinanderliegen. Außerdem befindet sich im Steg 7 eine Öffnung 12, in die beispielsweise ein Einsetzinstrument eingesetzt werden kann, so daß das Einsetzen der Klammer erleichtert wird. Here, too, the arms 8, 9 taper to a point; in contrast to the exemplary embodiment in FIGS. 1 to 3, the shorter arm 9 is split into two parallel individual arms 10, 11 which lie next to one another. In addition, there is an opening 12 in the web 7 into which, for example, an insertion instrument can be inserted, so that the insertion of the clip is facilitated.

Claims

PATENTANSPRÜCHE PATENT CLAIMS
Implantat zur Festlegung des Facettengelenkes (4) zwischen zwei benachbarten Wirbelkörpern (1, Implant to fix the facet joint (4) between two adjacent vertebral bodies (1,
2), dadurch gekennzeichnet, daß es als U-förmige Klammer ( 6 ) ausgebildet ist mit einem Steg ( 7 ) und mit an dessen Enden seitlich von ihm abstehenden Armen (8, 9), daß die Klammer (6) aus einem Formgedächtnismetall besteht, welches bei Temperaturerhöhung unter Formänderung von einem martensitischen Tieftemperaturzustand in einen austenitischen Hochtemperaturzustand übergeht, und daß die Arme ( 8, 9 ) im Tieftemperaturzustand, der unter Körpertemperatur liegt, einen größeren Abstand voneinander aufweisen als im Hochtemperaturzustand, der beim Erwärmen der Klammer ( 6 ) auf Körpertemperatur erreicht wird.2), characterized in that it is designed as a U-shaped bracket (6) with a web (7) and with arms (8, 9) projecting laterally from it at its ends, that the bracket (6) consists of a shape memory metal , which changes from a martensitic low-temperature state to an austenitic high-temperature state when the temperature rises and the shape changes, and that the arms (8, 9) are at a greater distance from one another in the low-temperature state, which is below body temperature, than in the high-temperature state, which occurs when the clip (6) is heated. at body temperature is reached.
Implantat nach Anspruch 1, dadurch gekennzeichnet, daß die Arme (8, 9) unterschiedlich lang sind.Implant according to claim 1, characterized in that the arms (8, 9) are of different lengths.
3. Implantat nach Anspruch 2, dadurch gekennzeichnet, daß die Länge des einen Armes ( 8 ) zwischen 8 mm und 12 mm liegt und die des anderen Armes (9) zwischen 12 mm und 25 mm. 3. Implant according to claim 2, characterized in that the length of one arm (8) is between 8 mm and 12 mm and that of the other arm (9) between 12 mm and 25 mm.
4. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Klammer (6) aus einem Rundmetall gebogen ist.4. Implant according to one of the preceding claims, characterized in that the clip (6) is bent from a round metal.
Implantat nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Klammer (6) aus einem bandförmigen Streifen gebogen ist.Implant according to one of claims 1 to 3, characterized in that the clamp (6) is bent from a band-shaped strip.
Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß beide Arme ( 8, 9 ) spitz auslaufende Enden aufweisen.Implant according to one of the preceding claims, characterized in that both arms (8, 9) have pointed ends.
7. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß zumindest einer der beiden Arme (8, 9) durch zwei nebeneinanderliegende Einzelarme (10, 11) gebildet wird.7. Implant according to one of the preceding claims, characterized in that at least one of the two arms (8, 9) by two adjacent individual arms (10, 11) is formed.
8. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Arme ( 8 , 9 ) im Tieftemperaturzustand einen Abstand zwischen 8 mm und 25 mm aufweisen, der im Hochtemperaturzustand reduziert ist auf 6 mm bis 23 mm.8. Implant according to one of the preceding claims, characterized in that the arms (8, 9) have a distance between 8 mm and 25 mm in the low temperature state, which is reduced to 6 mm to 23 mm in the high temperature state.
9. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Annäherung der Arme (8, 9) durch Veränderung des Winkels zwischen Steg (7) und Armen (8, 9) erfolgt. 9. Implant according to one of the preceding claims, characterized in that the arms (8, 9) are approached by changing the angle between the web (7) and arms (8, 9).
0. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Annäherung der Arme (8, 9) durch eine bogenförmige Verformung des im Tieftemperaturzustand gestreckten Steges ( 7 ) erfolgt. 0. Implant according to one of the preceding claims, characterized in that the arms (8, 9) are approached by an arcuate deformation of the web (7) which is stretched in the low-temperature state.
PCT/EP1999/001549 1999-03-10 1999-03-10 Implant for fixing an articulated joint WO2000053126A1 (en)

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DE29904271U DE29904271U1 (en) 1999-03-10 1999-03-10 Implant to fix the facet joint

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PCT/EP1999/001549 WO2000053126A1 (en) 1999-03-10 1999-03-10 Implant for fixing an articulated joint
DE29904271U DE29904271U1 (en) 1999-03-10 1999-03-10 Implant to fix the facet joint

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