DE3876909T2 - Chirurgisch-prosthetisches implantat. - Google Patents
Chirurgisch-prosthetisches implantat.Info
- Publication number
- DE3876909T2 DE3876909T2 DE8888308375T DE3876909T DE3876909T2 DE 3876909 T2 DE3876909 T2 DE 3876909T2 DE 8888308375 T DE8888308375 T DE 8888308375T DE 3876909 T DE3876909 T DE 3876909T DE 3876909 T2 DE3876909 T2 DE 3876909T2
- Authority
- DE
- Germany
- Prior art keywords
- post
- vertebrae
- bone
- tool
- posts
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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- 230000037431 insertion Effects 0.000 claims abstract description 17
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Classifications
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Landscapes
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Description
- Diese Erfindung betrifft die Technik prothetischer Vorrichtungen, die so ausgelegt sind, daß sie querliegend in eine Wirbelsäule an vorbereiteten Stellen der gegenüberliegenden Flächen benachbarter Wirbel eingefügt werden, wobei sie Streben bilden, die in die Wirbel eingebracht sind, um einen normalen Scheibenabstand zwischen den Wirbeln aufrecht zu erhalten. Diese Vorrichtungen sind, wenn sie in die Wirbelsäule eingesetzt werden, in der Form starrer inerter Pfosten, die den Scheibenzwischenraum nebeneinanderliegend überspannen und aufgerauhte Oberflächen haben, welche das Einwachsen von Knochengewebe erleichtern.
- Die Pfosten sind einseitig auf einem Werkzeug angebracht, um das Einfügen zwischen benachbarten Wirbeln zu erleichtern, haben eine Höhe, die den normalen Scheibenabstand wiederherstellen wird, und können das verbleibende Gewebe einer kollabierten geschädigten Scheibe strecken. Bevorzugte Pfosten haben Widerhaken, die in die Wirbel schneiden, Schlitze zum Tragen von Knochentransplantatmaterial, abgeschrägte Vorderenden, die das Einfügen zwischen den Wirbeln erleichtern und sind aus einem strahlendurchlässigen Material gebildet.
- Die Hauptursache von Schmerzen im unteren Rücken rührt von der Ruptur oder Degeneration von lumbalen intervertebralen Scheiben her. Schmerz in den unteren Bereichen des Rückens (Ischias) wird durch Zusammendrücken spinaler Nervenwurzeln durch geschädigte Scheiben zwischen den Wirbeln verursacht, und Schmerz im unteren Rücken wird durch das Kollabieren der Scheibe und die nachteiligen Effekte des Tragens des Hauptteils des Körpergewichtes von einer geschädigten instabilen Wirbelverbindung verursacht. Chirurgische Behandlungen zum Mildern des Ischiasschmerzes und des Schmerzes im unteren Rücken umfassen im allgemeinen die folgenden:
- Dieses Verfahren entfernt den Teil der Scheibe, die den spinalen Nerv zusammendrückt, und ist im allgemeinen erfolgreich beim Lindern des Ischias-Beinschmerzes, aber in mehr als der Hälfte der Fälle gibt es ein Wiederauf treten des Rückenschmerzes. Über eine Zeitdauer verliert die Scheibe wegen der Ruptur nach und nach an Höhe, und dieser Höhenverlust bedingt, daß die hinteren Facettenverbindungen der Wirbel inkorrekt aneinandergefügt sind, was zu arthritischer Änderung in allen Elementen des spinalen Segmentes führt. Wiederkehrendes Zusammendrücken der Nervenwurzel aufgrund knöchernen Eingriffes (spinaler Stenose) entwickelt sich auch. Der fortdauernde und wiederkehrende Rückenschmerz aus dieser Ursache hat eine hautpsächliche Quelle von Schmerz und Behinderung erzeugt.
- Traditionell verhindert Posterior-Verschmelzung, die Knochenwachstum zwischen den knöchernen Schichten erzeugt, oder postero-laterale Verschmelzung zwischen den Querfortsätzen die Bewegung zwischen den benachbarten Wirbeln, ändert jedoch nicht die Tatsache, daß ungefähr 90% des Körpergewichtes über degenerierte Scheiben übertragen werden muß, was Schmerz verursacht. Weiterhin besteht bei nachträglicher Verschmelzung die Tendenz, vermehrtes Knochenwachstum zu verursachen, was zum Zusammendrücken der Nervenwurzel durch spinale Stenose führt.
- Zwischenkörperverschmelzungstechniken, bei denen die weiche Scheibe vollständig exzisiert wird und entweder durch patienteneigenen Knochen (autologen Knochen) oder Knochen aus einer Transplantatbank (homologer Knochen) ersetzt wird, sind im allgemeinen erfolgreich, wenn eine feste Verschmelzung zwischen benachbarten Wirbelkörpern erhalten werden kann. Unglücklicherweise betrug die Erfolgsrate nur etwa 50%.
- Diese Prozedur rekonstruiert die normalen anatomischen Beziehungen zwischen der knöchernen und der neuralen Struktur und hat viele Vorteile. Das Tragen des Gewichtes über eine feste Knochenverschmelzung, die zwischen Wirbelkörpern hergestellt wird, mildert den mechanischen Schmerz der traditionellen instabilen degenerativen Scheibe und beugt im allgemeinen langdauernd dem Scheibenkollaps oder weiteren degenerativen Änderungen vor. Die vollständige Scheibenexzision beugt dem wiederkehrenden Vorfall derselben degenerierten Scheibe vor.
- Jedoch hat diese PLIF-Prozedur einige ernsthafte Nachteile dadurch, daß sie technisch sehr schwierig ist und daher nicht so erfolgreich oder so weit verwendet wird, wie es sein könnte. Sie bringt große Mengen an Blutverlust in einem kleinen tiefen Loch mit sich, was physiologischen Streb für den Patienten und psychologischen Distreß für den Chirurgen bringt. Weiterhin verlängert die Verwendung von autologem Knochentransplantat aus der patienteneigenen iliakalen Knochenleiste die Operation und erzeugt eine zweite schmerzvolle Operationsstelle. Weil es schwierig ist, eine ausreichend große Menge autogenen Knochens mit ausreichender Stärke zu erhalten, wird im allgemeinen homologer Knochen aus der Bank verwendet.
- Transplantieren von Zwischenkörperknochen schließt die Probleme der Festigkeit und das des Knocheneinfügens ein. Fester Cortexknochen (die äußere Schicht) ist als eine Strebe in der Zwischenkörperposition erforderlich, um das Kollabieren des Scheibenzwischenraumes zu verhindern, während die Heilung eintritt. Der Chirurg hat die unglückliche Anforderung, die erforderlichen Streben mit handgehaltenen Werkzeugen während der Operation zu gestalten, und diese Cortexknochenstreben sind nicht breit genug für die optimale Lastübernahme, und sie verankern sich selbst durch den Heilungsprozeß, der sich sehr langsam über Jahre erstreckt. Weiterhin ist weicher Gitterknochen, der zuverlässiger über zwölf bis achtzehn Monate verheilt, auch für eine traditionelle Zwischenkörperverschmelzung erforderlich.
- In der orthopädischen Chirurgie ist es wohl bekannt, daß transplantierter Knochen durch einen Prozeß einheilt, der "schleichende Substitution" genannt wird, bei dem zuerst Blutgefäße in den transplantierten Knochen wachsen, der transplantierte Knochen reabsorbiert wird und dann neue Knochenzellen entlang der knöchernen Matrix des Transplantates angelegt werden. Während der Zeit, in der die strukturellen Knochentransplantatscheiben reabsorbiert werden, muß Bewegung in den betroffenen Segmenten noch verhindert werden und obwohl ein Stützkorsett oder Gips oftmals verwendet wird, hat sich gezeigt, daß der gesamte Prozeß weniger zuverlässig als erwünscht ist. Homologer Rückenknochen, der "fremder" ist, erfodert eine viel längere Zeit, um zusammenzuwachsen, und hat eine höhere Ausfallrate, die als dreifacher Ausfall wie mit patienteneigenen Knochen geschätzt wird. Tatsächlich ist keine Quelle für Knochen optimal für die Verschmelzungsprozedur.
- Die EP-A-0 042 271 offenbart eine intervertebrale Scheibenprothese mit einem Körper biologisch akzeptablem Materials, der geeignet bemessen und geformt ist, um eine natürliche Scheibe zu ersetzen. In einigen Ausführungsformen ist ein kreisförmiges Gewindeloch vorgesehen, um ein mit Gewinde versehenes Ende eines Halteinstruments zu befestigen, um das Einfügen der Prothese zu erleichtern.
- Gemäß der vorliegenden Erfindung wird eine Prothese zum Einsetzen in querliegende vorbereitete Furchen mit im wesentlichen gleichförmig durchverlaufendem Querschnitt über ihre Länge in gegenüberliegenden Flächen benachbarter Wirbel einer Wirbelsäuel geschaffen, wobei benachbarte Wirbel einen Scheibenabstand zwischen sich haben, wobei die Prothese, wenn sie eingefügt ist, nebeneinanderliegende starre inerte Pfosten mit im wesentlichen gleichförmig durchverlaufendem Querschnitt über ihre Länge aufweist, um Querstreben zu bilden, die auf den Boden der vorbereiteten Furchen aufgelegt sind, und einen gewünschten Scheibenabstand zwischen den benachbarten Wirbeln aufrechterhalten, wobei jeder Pfosten eine Endfläche mit einer werkzeugaufnehmenden Einrichtung hat, die sich innen in dem Pfosten erstreckt, zum festen Anbringen des Pfostens am Ende auf einem Werkzeug mit den Enden aneinander, um das Einfügen des Pfostens in die vorbereiteten Furchen mit den Enden aneinander zu erleichtern, wobei eine Umfangsfläche der Pfosten über im wesentlichen deren gesamte Fläche zum Zusammenschluß mit den vorbereiteten Furchen aufgerauht ist, um das Einwachsen von Knochen vom Wirbel zu erleichtern, wobei jeder Pfosten wenigstens einen durchgehenden Schlitz hat, ausgelegt zum Aufnehmen von Knochentransplantatmaterial.
- Die Pfosten können viele verschiedene Formen und Umfangskonfigurationen haben.
- Die bevorzugten Pfosten sind an einem ihrer Enden mit einem innen mit Gewinde versehenen axialen Loch versehen und können Flügel oder radiale Schlitze haben, die strahlenartig von diesem Loch in der Endfläche ausgehen, so daß ein Einsetzwerkzeug in das Loch geschraubt werden kann und eine Muffe des Einsetzwerkzeuges in die Schlitzausnehmung eingepaßt werden kann. Beispielsweise kann ein zylindrischer Pfosten, mit den Enden aneinander auf dem Werkzeug getragen, an vorbereiteten Stellen der benachbarten Wirbel eingefügt werden, und wenn er genau positioniert ist, kann die Muffe drehfest gehalten und das Werkzeug von dem Pfosten abgeschraubt werden ohne den Pfosten zu verschieben. Der radiale Schlitz wird nicht gebraucht, wenn Pfosten und Stellen so geformt sind, daß sie Rotation verhindern.
- Die Stellen werden bevorzugt mit einem von einem Bohrschutz umgebenen Bohrer mit vorstehenden Zähnen gebildet, die in die hinteren Enden benachbarter Wirbel eingebettet sind, um den Bohrer zum Ausbilden von Kanälen in den gegenüberliegenden Flächen benachbarter Wirbel korrekt zu positionieren. Die Kanäle sind ausreichend breit und lang, um harten Cortexknochen zu umfassen, erstrecken sich jedoch bevorzugt nicht vollständig durch die vordere Seite der Wirbel. Umgekehrt, wenn der Bohrer von der vorderen Position der Wirbel eingeführt wird, wird die Bohrtätigkeit kurz vor der hinteren Seite beendet.
- Die Pfosten können aus einem inerten starren Metall hergestellt sein, wie rostfeier Stahl, Kobalt-Chrom-Molydtän- Legierungen, Titan oder dergleichen. Die Pfosten können mit aufgerauhten Oberflächen versehen sein, welche Gruben, Zinken, Borsten, Noppen oder dergleichen Unregelmäßigkeiten zum Verankern des Knocheneinwuchses bilden. Diese aufgerauhten Oberflächen können Teil des Pfostenkörpers sein oder ein Überzug auf dem Körper, wie ein Polymerharz. Borsten- oder Zinkenoberflächen können starr oder flexibel und, wenn gewünscht, so ausgebildet sein, daß das Einfügen erleichert und dem Zurückziehen widerstanden wird.
- Bevorzugte aufgerauhte Oberflächen umfassen gerändelte Flächen, mit Gruben versehene Flächen, mit Widerhaken versehene Flächen, mit Borsten versehen Flächen und mit Gewinde versehene Flächen, die in die vorbereiteten Stellen eingreifen.
- In einer bevorzugten Ausführungsform sind die aufgerauhten Oberflächen Widerhaken oder Noppen, die strahlenartig von dem Pfostenumfang oder den Seiten ausgehen. Die Widerhaken können in der Richtung des Einfügens des Pfostens defomierbar sein, um das Einfügen in die vorbereitete Stelle zu erleichtern. Die Widerhaken und Noppen können bei versuchten Zurückziehen des Pfostens in die vorbereiteten Stellen greifen.
- Die aufgerauhten Oberflächen können auf der Peripherie eines Kunststoffmaterialüberzugs auf dem Pfosten sein.
- Der Pfosten ist bevorzugt aus einem strahlendurchlässigen Material gebildet.
- Der Pfosten hat bevorzugt eine Länge, die größer ist als seine Höhe, und eine Breite, die geringer ist als seine Höhe.
- In einer Ausführungsform hat der Pfosten wenigstens einen durchgehenden Schlitz, der dazu ausgelegt ist, mit Knochentransplantatmaterial gefüllt zu werden.
- Bevorzugt hat der geschlitzte Pfosten einen vertikalen Schlitz in Längsrichtung und einen horizontalen Schlitz in Querrichtung, der den vertikalen Schlitz durchschneidet, um das Knochentransplantatmaterial aufzunehmen.
- In einer bevorzugten Ausführungsform hat der Pfosten unzählige sich radial erstreckende Noppen, deren Oberflächen durch Rillen getrennt sind. Die Noppen haben bevorzugt Vorderflächen eingeschlossen
- In einer Ausführungsform hat der Pfosten eine abgeschrägte Vorderfläche und eine rückwärtige Fläche mit einer werkzeugaufnehmenden Ausnehmung.
- Ein bevorzugt angebrachtes Gewindeloch in der Endfläche des Pfostens bestimmt weniger als eine Hälfte der Länge des Pfostens und hat einen Durchmesser geringer als 1/3 des Durchmessers des Pfostens. Bevorzugt geht ein Flügel oder Schlitz strahlenartig diametral von dem Loch in der Endfläche des Pfostens aus, endet jedoch innerhalb des Außenumfangs des Pfostens.
- Ein bevorzuger Polymerüberzug zum Bilden der aufgerauhten Oberfläche ist Nylon, ein Polyolefin, ein Vinyl oder ein ähnliches Harz, das in der Umgebung des Implantates resistent gegen Abbau ist.
- Die vorliegende Erfindung stellt nun auch rechtwinklige Wirbelprothesen-Implantatpfosten oder -blöcke zur Verfügung, die in rechtwinklig querliegende oder senkrechte Kanäle oder Nuten eingepaßt sind, welche in benachbarte Flächen von Wirbelkörpern geschnitten sind, mit Höhen, die das verbleibende Kreisringgewebe, der dazwischenliegenden Scheiben, die noch die Wirbel verbinden, strecken. Rechteckige oder quadratische Blöcke oder Pfosten mit ebenen Seiten sind vorgesehen, um in diese querliegenden rechtwinkligen Kanäle oder Schlitze eingepaßt zu werden, und haben schräg verlaufende oder abgeschrägte Vorderenden, die leicht in die offenen Enden der Querschlitze eingefügt werden, um die Wirbel auseinanderzuspreizen, so daß die Deck- und Bodenflächen jedes Blockes oder Pfostens fest auf dem Boden in dem Schlitz aufliegen, wobei die gestreckten Scheibengewebe bewirken, daß die Wirbel die Pfosten greifen. Diese Pfosten werden seitlich oder quer zur Wirbelsäule in die Schlitze eingefügt, während sie auf dem Ende eines Einsetzwerkzeuges angebracht sind, haben aufgerauhte Oberflächen, um den Knocheneinwuchs zu erleichtern, und können auch vertikale oder horizontale durchgehende Schlitze oder sich schneidende vertikale und horizontale Schlitze haben, gefüllt mit Knochentransplantatmaterial, wie Knochenstreifen, die von der iliakalen Knochenleiste des Beckens exzisiert sind. Dieses Implantatmaterial schafft einen Block lebenden Knochens, der ganz um den Implantatpfosten herum und durch ihn hindurch in den Wirbel des Knochens wächst.
- Auch gemäß dieser Erfindung können die Blöcke oder Pfosten, anstatt daß sie aus einem inerten Metall hergestellt sind, aus einem strahlendurchlässigen Material hergestellt sein, wie einen Kunststoff vom Typ Nylon, Polycarbonat, Polypropylen, Polyacetal, Polyethylen und Polysulfon, bevorzugt beladen mit Glas- oder Kohlefasern. Diese Kunststoffe können formgespritzt sein, sind leichtgewichtig, haben eine große lastaufnehmende Stärke und schaffen eine verbesserte Sichtbarmachung der Knochenheilung mit Hilfe von Röntgenstrahlen. Faserverstärkte Kunststoffe, zusammengesetzt aus solchen Materialien, beladen mit Glas- oder Kohlefasern, sind auch wünschenswert. Ein bevorzugtes Material ist ein Polyäther- Sulfonharz, beladen mit Glas- und Kohlefasern. Geeignete Kohlefaser-Verbundwerkstoffe werden unter dem Handelsnamen "VICTREX P.E.S." vertrieben, was Polyäthersulfon, beladen mit Kohlefasern, ist. Geeignete Mischungen sind "4101 G.L.- 30", ein Füllmittel mit 30% Glasfaser, und "450 C.A.-30", ein Füllmittel mit 30% Kohlefaser. Diese Materialien werden von ICI Industries, Wilmington, Delaware, geliefert. Kohle- Kohlefaserkunststoffe des Typs, der von Fiber-Rite Corporation, Winona, Minnesota, verkauft wird, sind nützlich.
- Die Erfindung wird nun weiter beispielhaft mit Bezug auf die beigefügten Zeichnungen beschrieben, in denen:
- Fig. 1 eine Seitenaufrißansicht des unteren Abschnittes einer menschlichen Wirbelsäule ist, mit weggebrochenen Teilen und im Schnitt gezeigt, um die prothetischen Implantate dieser Erfindung darzustellen, die zwischen einigen der untern Wirbel eingefügt sind, um die Wirbel anstelle der menschlichen Scheibe dazwischen zu stützen, die teilweise exzisiert worden ist, um geschädigtes und eingeklemmtes Gewebe zu entfernen;
- Fig. 2 eine Aufrißansicht von hinten eines Bereiches der Figur 1 entlang der Linie XIII-XIII der Figur 1 ist;
- Fig. 3 eine Querschnittsansicht mit Teilen im Aufriß und im Schnitt weggebrochen, entlang der Linie XIV-XIV der Figur 2 ist;
- Fig. 4 eine vergrößerte fragmentarische Seitenaufrißansicht ist, mit weggebrochenen Teilen und im vertikalen Schnitt gezeigt, die die Art darstellt, in der ein Test- oder Medpfosten oder -block dieser Erfindung in Position in den querliegenden rechteckigen Schlitzen benachbarter Wirbel eingefügt ist, um das verbleibende zwischenliegende Scheibengewebe, das mit diesen Wirbeln verbunden ist, zu strecken, und um die Stellen zum Aufnehmen eines Dauerimplantates genauer Größe auszumessen;
- Fig. 5 eine Draufsicht einer Wirbelscheibe ist, wobei die innere Pulpa entfernt ist und wobei das Scheibengewebe teilweise exzisiert ist, um Spalte oder Schlitze zu bilden, die mit in den Wirbel geschnittenen Kanälen ausgerichtet sind, um durchgehende Pfosten aufzunehmen;
- Fig. 6 eine perspektivische Ansicht eines glattflächigen Test- oder Meßpfostens oder -blocks zur Verwendung wie in Fig. 4 gezeigt ist;
- Fig. 7 eine perspektivische Ansicht einer bevorzugten Form eines Dauerimplantatspfostens oder -blocks dieser Erfindung ist;
- Fig. 8 eine vertikale Längsschnittansicht des Pfostens aus Fig. 7 entlang der Linie XIX-XIX aus Fig. 7 ist.
- Viele andere Typen rauher oder unregelmäßiger Oberflächen können für die Vorrichtungen dieser Erfindung vorgesehen sein, einschließlich poröser Metallüberzüge, hergestellt aus Metallkugeln und -wülsten, die auf einem festen Metallsubstrat aufgesintert sind, wie weiter in dem vorgenannten Patent Nr. 4,743,256 offenbart.
- Die prothetischen Implantate sind in den Zeichnungen gezeigt, wie sie in nebeneinanderliegender paralleler Anordnung angebracht sind, wobei sie ein Paar von Streben bilden, die den Scheibenzwischenraum aufrechterhalten, wobei sie gut auf dem harten Cortexknochen sitzen, um die Last zu tragen. Diese Implantate haben Oberflächen, die den schnellen Knocheneinwuchs erleichtern, welcher die Implantate innerhalb einer relativ kurzen Wachstumsperiode mit den benachbarten Wirbeln verschmelzen wird.
- In den Fig. 1 bis 3 bezeichnet die Bezugsziffer 100 im allgemeinen den unteren Abschnitt einer menschlichen Wirbelsäule mit benachbarten Wirbeln, die auf prothetischen Implantatblöcken oder -pfosten 111 dieser Erfindung getragen werden.
- Fig. 4 zeigt die Art, in der benachbarte Wirbel auseinandergespreizt werden, um kollabiertes zwischenliegendes Scheibengewebe zu strecken, wenn ein Med- oder Testblock dieser Erfindung seitlich in querliegende rechteckige Schlitze benachbarter Wirbel eingefügt wird.
- In Fig. 1 zeigt die Wirbelsäule 100 die fünf unteren Wirbel mit den Nummern 1 bis 5. Die benachbarten Wirbel Nr. 2 und 3 und die benachbarten Wirbel Nr. 3 und 4 sind getrennt durch und getragen auf den prothetischen Implantatblöcken oder -pfosten 111 dieser Erfindung. Die Wirbel Nr. 1 und 2 und die Wirbel Nr. 4 und 5 sind so dargestellt, daß sie auf gesunden oder ungeschädigten menschlichen Scheiben 112 getragen sind und durch diese getrennt sind, wobei ein normaler Scheibenabstand 113 zwischen den benachbarten Wirbeln aufrechterhalten wird.
- Geschädigte Teile der natürlichen menschlichen Scheiben 112 sind von den Wirbeln Nr. 2 und 3 und Nr. 3 und 4 exzisiert worden, wobei die Scheibenabstände 114 durch die Implantatblöcke oder -pfosten 111 aufrechterhalten worden sind. Es ist bevorzugt, so viel wie möglich von dem gesunden Kreisringgewebe der Scheiben 112 zwischen den Wirbeln zu behalten, so daß das verbleibende Scheibengewebe 112a wenigstens teilweise die Implantate umgeben wird und durch diese Implantate unter Spannung gehalten werden wird. Jedoch kann es sein, daß einige der verbleibenden Kreisringscheibengewebe entfernt werden müssen, um Raum für die Implantatpfosten 111 zu öffnen.
- Die gegenüberliegenden Flächen benachbarter Wirbel haben ausgerichtete rechteckige Kanäle oder Rillen 115 mit ebenen Seiten, die darin quer zur Achse der Säule 100 eingeschnitten worden sind, um zuerst Testblöcke oder -pfosten dieser Erfindung zum Bestimmen der genauen Größen für die Dauerimplantate 111 genau aufzunehmen. Diese Querkanäle 115 sind ausreichend weit und tief, um den zentralen weichen Gitterknochen zu überspannen und den harten Cortexknochen der benachbarten Wirbel zu umfassen. Das ungeschädigte menschliche Scheibengewebe 112a, das zwischen den Wirbeln verbleibt, wird auch geschitten oder beschnitten, um die Implantate 111 auf zunehmen, so daß so viel gesundes Kreisringfasergewebe wie verfügbar ist die Implantate umgeben wird.
- Die bevorzugten rechteckigen Kanäle 115 mit ebenen Seiten haben blinde Enden 116, an die die Implantate 111 anstoßen.
- Wie in den Fig. 2 und 3 gezeigt, sind die Implantate 111 in Form eines Paares nebeneinanderliegender rechteckiger Pfosten, die mit den Enden aneinander in die Querkanäle 115 eingefügt sind. Diese Kanäle haben ebene Böden und Seitenwände, um die Deck- und Bodenenden und Seitenflächen der rechteckigen Pfosten gut sitzend zu umschließen. Der weiche gitterartige Knochen der Wirbel ist bei 117 in Fig. 3 dargestellt und ist von dem harten Cortexknochen 118 umgeben. Die Kanäle 115 umfassen Abschnitte dieses harten Cortexknochens, so daß die Implantate 111 den weicheren Gitterknochen überspannen und auf dem harten Cortexknochen 118 ruhen.
- Die Kanäle 115 können mittels eines Stemm-, Schneid- und Meißelwerkzeuges gebildet werden, und in dem Fall, daß Scheibengewebe 112a die Wege für die Pfosten 111 blockiert, kann Gewebe weggeschnitten oder auseinandergespreizt werden, um die Wege zu öffnen.
- Die Implantatpfosten oder -blöcke 111, wie in den Fig. 7 und 8 gezeigt, sind starr, inert, fest, Rechtecke mit ebenen Seiten, höher als breit und länger als hoch. Sie werden im Zusammenwirken mit Test- oder Meßblöcken, wie 119, gezeigt in Fig. 6, verwendet. Diese Blöcke 119 haben ebene, glatte Seiten und Enden mit ebenen Decken und Böden 119a, ebenen Seiten 119a, einer ebenen Vorderendwand 119c und einer ebenen rückwärtigen Endwand 119d. Die Vorderwand 119c ist auf eine verkleinerte rechteckige Nase abgeschrägt, die von abgeschrägten Wänden 119b mit ebenen Seiten und abgerundeten Ecken 119f umgeben ist.
- Die rückwärtige Endwand 119e hat ein blindes axiales Loch 119g mit Innengewinde in der Mitte der Wand.
- Die Meßblöcke 119 haben bei typischen chirurgischen Operationen eine Länge von etwa 25 mm, eine Breite von etwa 11 mm und werden in der Höhe von etwa 13 bis 17 mm variieren, obwohl es deutlich sein sollte, daß diese Parameter weit variieren können und von der Größe der spinalen Säule des Empfängers abhängen können. Die Abschrägungen 119e betragen bevorzugt etwa 30º. Die abgerundeten Ecken 119f der Schrägen beseitigen scharfe Ecken zwischen der Decke, dem Boden und den Seiten der abgeschrägten Flächen.
- Wie in Fig. 4 gezeigt, wird ein Test- oder Meßblock 119 zum Einpassen unter Zwang in die Kanäle 115 ausgewählt, während er auf einem Werkzeug 120 angebracht ist, das in das Loch 119g eingeschraubt ist. Das abgeschrägte Vorderende 119c des Blockes wird durch irgendeinen Abschnitt des Scheibengewebes 112a verlaufen, das die Eingangsmündungen der Kanäle 115 bedeckt, in dem entweder Löcher durch das verbleibende Gewebe geschnitten werden oder in dem die Fasern der Scheibe auseinandergespreizt werden, um die Meßblöcke 119 aufzunehmen.
- Wie in Fig. 5 gezeigt, wird das verbleibende gesunde Scheibengewebe 112a einer Scheibe 112 zwischen den Wirbeln mit eingeschnittenem Kanal beschnitten, um Schlitze 121 zu öffnen, die den Zugang der Meßblöcke 119 zu den Kanälen 115 erlauben. Diese Schlitze passen mit den Kanälen 115 zusammen und können offene Vorderenden 121a und ein blindes rückwärtiges Ende 121b haben. Es ist bevorzugt, den Nucleus pulposus von der geschädigten Scheibe 112 zu entfernen, was ein kreisringförmiges faseriges Gewebe zurückläßt, das die benachbarten Wirbel verbindet und die eingefügten Blöcke umgibt.
- Ein gut passender Meßblock 119 wird durch "Versuch und Irrtum"-Einfügungen in den Wirbel mit eingeschnittenem Kanal ausgewählt. Diese Blöcke sind glattflächig und können entfernt werden, selbst wenn sie fest in die Kanäle 115 passen.
- Wie in Fig. 4 gezeigt, wird ein Meßblock 119, aufgeschraubt auf das Ende eines Einsetzwerkzeuges 120, ausgewählt, so daß er eine Höhe größer als die Höhe zwischen den Böden gegenüberliegender Kanäle 115 hat. Dann, wenn dieser Block durch die offenen Enden der ausgerichteten Kanäle geschoben wird, wird die abgeschrägte Nase 119c die Böden dieser Kanäle eingreifen und sie auseinanderzwingen, wenn der Block in die Kanäle geschoben wird, so daß jegliches Scheibengewebe 112a, das noch die Wirbel verbindet, gestreckt wird. Der Block wird gegen die blinden Enden 116 der Kanäle geschoben, und die Spannung auf den Scheibenfasern wird bestimmt. Wenn ein Block 119 ausreichender Größe, um das Scheibengewebe genau zu belasten und gut in dem Kanal zu sitzen, ausgemacht ist, wird ein Dauerimplantatpfosten 111 einer Größe, die gerade leicht größer ist als der Meßblock, ausgewählt. Ein solcher Dauerpfosten wird dann auf das Ende eines Werkzeuges 120 geschraubt, der Meßblock 119 wird zurückgezogen, und das Dauerimplantat 111 auf dem Werkzeug wird in eine Position in die Kanäle 115 gezwungen.
- Ein bevorzugter Dauerimplantatblock oder -pfosten 111 ist in den Fig. 7 und 8 dargestellt. Dieser Pfosten hat etwa dieselben ebenseitigen Abmessungen wie der ausgewählte Meßblock, hat jedoch, vorstehend von diesen ebenen Deck-, Boden- und Seitenwänden, ein Muster aufragender ringförmiger Noppen 122, die eine aufgerauhte Oberfläche schaffen, welche in die Böden und Seitenwände der rechteckigen Kanäle 115 einschneiden und greifen. Diese Noppen werden von ringförmigen Nuten 123 und Längskanälen 123a getrennt, so daß jede Noppe 122 eine ebene vertikale Rückwand 122a, ein Paar ebener vertikaler Seitenwände 122b und eine geneigte Frontfläche 122c haben wird.
- Der Pfosten 111 hat dieselbe verkleinerte Nase 111a, die von denselben abgeschrägten Seitenwänden 111b wie die Nase 119c und der abgeschrägten Seitenwand 119e des Meßblockes 119 umgeben ist. Zusätzlich ist eine vertikale Rückwand 111c dieselbe wie die Rückwand 119d und enthält dasselbe Loch 111d mit Innengewinde wie die Rückwand 119d des Meßblockes 119.
- Weiterhin hat der Implantatpfosten 111 einen durchgehenden vertikalen Schlitz 124, der die Decken und Böden des Pfostens verbindet. Dieser vertikale Schlitz 124 ist rechteckig, hat eine Breite von etwa 1/3 der Breite des Blockes und eine Länge, die sich nahe des vorderen und des rückwärtigen Endes des Pfostens erstreckt.
- Dieser Schlitz 124 wird mittig von einem horizontalen Durchgangsschlitz 125 durchschnitten. Es wird verständlich, daß alternativ der Block 111 nur einen einzigen horizontalen oder vertikalen Schlitz haben kann.
- Die Schlitze 124 und 125 schaffen Hohlräume in dem Block oder Pfosten 111, die mit Streifen von Knochenimplantat 126 gefüllt werden, das bevorzugt von dem Beckenknochen des Empfängers abgenommen wird. Diese Knochenmaterial, das in dem Implantatpfosten 111 untergebracht ist, wird bald aus den Nuten oder Kanälen 124 und 125 in die radialen und longitudinalen Kanäle zwischen den Noppen 122 wachsen, die die Pfosten 111 umgeben, und wird dann in das Knochengewebe der benachbarten Wirbel einwachsen. Der Implantatpfosten wird einfach in die vorbereiteten Stellen 115 von der hinteren Seite des Wirbels mittels der Werkzeuganordnung 120 eingefügt, die ein Gewindeende 119c hat, das mit einem Gewindeloch 111d in eine Endfläche des Pfostens 111 paßt.
- Wenn der Implantatpfosten in seine Sitzposition zwischen den Wirbeln geschoben ist, werden die geneigten Vorderflächen der Noppen 122 die Vorwärtsbewegung des Pfostens zu den blinden Enden 116 der Kanäle 115 fördern, jedoch werden die scharfen Scheitelpunkte der Noppen dem Zurückziehen der Pfosten vorbeugen, da sie in den Wirbelknochen schneiden werden. Wenn daher die Pfosten in genauer Lage sitzen, werden sie sich nicht aus dieser Position verschieben.
- Es ist bevorzugt, daß die Höhe der Pfosten 111 ausreichend sein wird, um eine Spannungslast von etwa 9.1 bis 13.6 kg (etwa 20 bis 30 Pfund) auf dem Scheibengewebe aufrechtzuerhalten. Eine solche Spannungslast zieht nicht nur die Wirbel fest gegen die Pfosten, sondern beschleunigt auch den Knocheneinwuchs.
- Die bevorzugten prothetischen Pfosten oder Blöcke 111 dieser Erfindung erleichtern und vereinfachen nicht nur die operative Prozedur, sondern beschleunigen auch das Miteinanderverschmelzen der Wirbel mit dem Pfosten. Die aufgerauhten Oberflächen, die von den Noppen geschaffen werden, dienen somit einem vielfachen Zweck des Verankerns in den Wirbeln und des Schaffens von Kanälen für Knocheneinwuchs.
Claims (6)
1. Prothese zum Einsetzen in querliegende
vorbereitete Furchen mit im wesentlichen gleichförmig
durchverlaufendem Querschnitt über ihre Länge (115) in
gegenüberliegenden Flächen benachbarter Wirbel (2-3, 2-4)
einer Wirbelsäule, wobei benachbarte Wirbel einen
Scheibenabstand zwischen sich haben, wobei die Prothese,
wenn sie eingefügt ist, nebeneinanderliegende starre
inerte Pfosten mit im wesentlichen gleichförmig
durchverlaufendem Querschnitt über ihre Länge (111)
aufweist, um Querstreben zu bilden, die auf den Boden
der vorbereiteten Furchen aufgelegt sind und einen
gewünschten Scheibenabstand zwischen den benachbarten
Wirbeln aufrechterhalten, wobei jeder Pfosten eine
Endfläche mit einer werkzeugaufnehmenden Einrichtung
(111d) hat, die sich innen in dem Pfosten erstreckt, zum
festen Anbringen des Pfostens am Ende auf einem Werkzeug
(120) mit den Enden aneinander, um das Einfügen des
Pfostens in die vorbereiteten Furchen mit den Enden
aneinander zu erleichtern, wobei eine Umfangsfläche
(122) der Pfosten über im wesentlichen deren gesamte
Fläche zum Zusammenschluß mit den vorbereiteten Furchen
aufgerauht ist, um das Einwachsen von Knochen vom Wirbel
zu erleichtern, wobei jeder Pfosten wenigstens einen
durchgehenden Schlitz (124, 125) hat, ausgelegt zum
Aufnehmen von Knochentransplantatmaterial (126).
2. Prothese nach Anspruch 1, bei der die
aufgerauhten Oberflächen des Pfostens Widerhaken (122)
sind, die von jedem Pfosten strahlenartig ausgehen und
Vorderflächen (122c) haben, die sich auf das
werkzeugaufnehmende Ende des Pfostens zu abschrägen, um
in den Wirbel zu schneiden und ausgedehnte Flächen, die
einwachsenden Knochen aufnehmen, zu schaffen.
3. Prothese nach Anspruch 1 oder 2, bei der die
werkzeugaufnehmende Einrichtung ein innen mit Gewinde
versehenes Loch (111d) in der Endfläche jedes Pfostens
zum Gewindeeingriff mit dem Ende des Werkzeuges ist.
4. Prothese nach Anspruch 3, bei der jeder Pfosten
einen radialen Schlitz in der Endfläche aufweist, der von
dem innen mit Gewinde versehenen Loch strahlenartig
ausgeht.
5. Prothese nach einem der vorangehenden Ansprüche,
bei der jeder der Pfosten strahlendurchlässiges Material
aufweist.
6. Prothese nach einem der vorangehenden Ansprüchen
bei der jeder Pfosten einen Nylon-, Polycarbonat-,
Polypropylen-, Polyacetal- oder Polysulfonkunststoff
aufweist, der mit Glas- oder Carbonfasern gefüllt ist.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US9546187A | 1987-09-11 | 1987-09-11 | |
US07/173,928 US4834757A (en) | 1987-01-22 | 1988-03-28 | Prosthetic implant |
Publications (2)
Publication Number | Publication Date |
---|---|
DE3876909D1 DE3876909D1 (de) | 1993-02-04 |
DE3876909T2 true DE3876909T2 (de) | 1993-04-29 |
Family
ID=26790256
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE8888308375T Expired - Lifetime DE3876909T2 (de) | 1987-09-11 | 1988-09-09 | Chirurgisch-prosthetisches implantat. |
Country Status (8)
Country | Link |
---|---|
US (2) | US4834757A (de) |
EP (1) | EP0307241B1 (de) |
JP (1) | JPH03503133A (de) |
AT (1) | ATE83639T1 (de) |
AU (1) | AU614609B2 (de) |
CA (1) | CA1292596C (de) |
DE (1) | DE3876909T2 (de) |
WO (1) | WO1989009035A1 (de) |
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- 1988-09-08 CA CA000576859A patent/CA1292596C/en not_active Expired - Lifetime
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- 1988-09-09 EP EP88308375A patent/EP0307241B1/de not_active Expired - Lifetime
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1989
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- 1989-03-10 WO PCT/US1989/000905 patent/WO1989009035A1/en unknown
- 1989-03-10 JP JP1503992A patent/JPH03503133A/ja active Granted
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CA1292596C (en) | 1991-12-03 |
ATE83639T1 (de) | 1993-01-15 |
EP0307241B1 (de) | 1992-12-23 |
EP0307241A2 (de) | 1989-03-15 |
DE3876909D1 (de) | 1993-02-04 |
JPH0551304B2 (de) | 1993-08-02 |
US4834757A (en) | 1989-05-30 |
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US4878915A (en) | 1989-11-07 |
AU614609B2 (en) | 1991-09-05 |
WO1989009035A1 (en) | 1989-10-05 |
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Owner name: ACROMED CORP., CLEVELAND, OHIO, US |
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8381 | Inventor (new situation) |
Free format text: BRANTIGAN, JOHN W., OHMAHA, OHIO, US |
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8327 | Change in the person/name/address of the patent owner |
Owner name: DEPUY ACROMED, INC., CLEVELAND, OHIO, US |