DE69916280T2 - Zwischenwirbel-allotransplantat-distanzstück - Google Patents

Zwischenwirbel-allotransplantat-distanzstück

Info

Publication number
DE69916280T2
DE69916280T2 DE1999616280 DE69916280T DE69916280T2 DE 69916280 T2 DE69916280 T2 DE 69916280T2 DE 1999616280 DE1999616280 DE 1999616280 DE 69916280 T DE69916280 T DE 69916280T DE 69916280 T2 DE69916280 T2 DE 69916280T2
Authority
DE
Germany
Prior art keywords
implant
characterized
implant according
upper
part
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 - Fee Related
Application number
DE1999616280
Other languages
English (en)
Other versions
DE69916280D1 (de
Inventor
Hansjuerg Emch
David Paul
Beat Schenk
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes GmbH
Original Assignee
AO Technologies 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
Priority to US9520998P priority Critical
Priority to US95209P priority
Priority to WOPCT/EP99/05008 priority
Priority to EP9905008 priority
Application filed by AO Technologies AG filed Critical AO Technologies AG
Priority to PCT/EP1999/005541 priority patent/WO2000007527A1/en
Priority to US09/814,214 priority patent/US7087082B2/en
Application granted granted Critical
Publication of DE69916280D1 publication Critical patent/DE69916280D1/de
Publication of DE69916280T2 publication Critical patent/DE69916280T2/de
Anticipated expiration legal-status Critical
Application status is Expired - Fee Related legal-status Critical

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/006Pressing and sintering powders, granules or fibres
    • 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
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • 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
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    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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    • 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
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    • A61F2/30721Accessories
    • A61F2/30724Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
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    • 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
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    • AHUMAN NECESSITIES
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    • 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
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    • A61F2/3094Designing or manufacturing processes
    • AHUMAN NECESSITIES
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    • 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
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    • A61F2/3094Designing or manufacturing processes
    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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    • A61F2/442Intervertebral or spinal discs, e.g. resilient
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    • 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
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    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
    • 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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • AHUMAN NECESSITIES
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    • 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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • AHUMAN NECESSITIES
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    • 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
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    • A61F2/28Bones
    • A61F2002/2817Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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    • A61F2002/30057The prosthesis made from materials having different values of a given property at different locations within the same prosthesis made from both cortical and cancellous adjacent parts
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    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
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    • B29L2031/3005Body finishings
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/924Material characteristic
    • Y10S623/925Natural

Description

  • Die vorliegende Erfindung beinhaltet ein homologes Implantat nach der Definition in Anspruch 1. Insbesondere bezieht sie sich auf ein allogenes Bandscheibenimplantat, das in Form und Größe zu den Endplatten der Wirbelkörper passt.
  • Eine Reihe von Erkrankungen wie Kompression der Rückenmark-Nervenwurzeln, Bandscheibendegeneration und Spondylolisthesis können zu starkem Lendenschmerz führen, der chirurgisch durch Wirbelkörperfusion reduziert werden kann. Bei dorsaler interkorporeller Spondylodese (PLIF = posterior lumbar interbody fusion) werden zwei benachbarte Wirbelkörper miteinander verschmolzen, indem die betroffene Bandscheibe entfernt und ein Implantat eingesetzt wird, das das Knochenwachstum zwischen den beiden Wirbelkörpern ermöglicht, wodurch die durch das Entfernen der Bandscheibe entstandenen Lücke geschlossen wird.
  • Für die dorsale interkorporeller Spondylodese wurde mit unterschiedlichem Erfolg eine Reihe von Materialien eingesetzt. Aktuell verwendete Implantate sind zum Beispiel Titan-Käfige mit Gewinde und homologe Implantate, wobei erstere den Nachteil haben, dass für deren Insertion die Wirbelplatten angebohrt und geschnitten werden müssen. Weiterhin ist unbekannt, wie groß die Gefahr des Kollabierens bei Langzeitgebrauch ist. Da Titan für die Kernspintomographie ungeeignet ist, ist die Beurteilung einer Fusion problematisch. Außerdem ist die Restauration einer Lordose, also die Wiederherstellung der natürlichen Wirbelsäulenkrümmung bei Verwendung eines zylindrischen Titan-Cages sehr schwierig.
  • Allotransplantate sind Knochenstücke aus einem langen Knochen eines Spenders. Dem Knochen wird ein Querschnitt entnommen, der mit bekannten Techniken verarbeitet wird, so dass er bis zur Implantation erhalten bleibt und die Gefahr von anschließenden Immunreaktionen möglichst gering ist. Zum Beispiel wird in US-Patent Nr. 4,678,470 eine Methode zur Verarbeitung von Knochentransplantatmaterial beschrieben, bei der Glutaraldehyd verwendet wird, um ein nicht antigenes, biokompatibles Material herzustellen. Allotransplantate haben mechanische Eigenschaften, die vergleichbar mit der Abschirmung sind, die bei Metallimplantaten auftreten. Außerdem sind sie für die Kernspintomographie geeignet, so dass eine Fusion präziser festgestellt werden kann, und die Knochenbildung wird gefördert. Obwohl das Allotransplantat die Knochenbildung fördert und damit die biologische Verbindung zwischen Allotransplantat und Wirbel und langfristige mechanische Stabilität ermöglicht, fehlen ursprüngliche und kurzzeitige mechanische Stabilität der Grenzfläche zwischen Transplantat und Wirbeln, was sich daran zeigt, dass das Transplantat nach der Implantation abgestoßen werden kann.
  • Zurzeit kommerziell erhältliche Allotransplantate sind normale Knochenschnitte, die nicht speziell für die Anwendung bei dorsaler interkorporeller Spondylodese hergestellt wurden. Daher erfolgt die Fusion der Wirbelkörper nicht in einer anatomisch optimalen Position. Zwar ist der Arzt in der Lage, während der Operation Form und Größe des Transplantats in geringem Maß an die Wirbelsäulenanatomie des Patienten anzupassen, aber aufgrund der Natur des Transplantats sind größere Änderungen nicht möglich. Jedoch selbst dann, wenn dies der Fall wäre, wären die Ärzte häufig damit überfordert, manuelle Anpassungen vorzunehmen. Die meisten PLIF-Implantate, sowohl Cages als auch Allotransplantate, sind in verschiedenen Größen erhältlich, und die Breite hängt von der Höhe des Implantats ab. Zum Beispiel entspricht die Höhe eines zylindrischen Cages weitgehend der Implantathöhe. Zwar mögen bei derartigen Implantaten mitunter größere Höhen klinisch indiziert sein, aber eine größere Breite ist nicht erwünscht, weil diese erfordern würde, dass ein größerer Teil der Fovea entfernt wird, was wiederum die Stabilität beeinträchtigen und die Retraktion der Nervenwurzeln würde, wobei letzteres zu einer temporären oder Dauerschädigung der Nerven führen könnte.
  • Aus US-A-5 514 180 HEGGENESS et al. ist eine Intervertebralprothese bekannt, die wie ein einfacher Zylinder geformt ist und gekrümmte Seitenwände und glatte obere und untere Oberflächen hat, damit sie zwischen die Oberflächen benachbarter Wirbel passt. Dieses bekannte Implantat weist möglicherweise Allotransplantat-Anteile auf, ohne dass aber die Besonderheiten eines derartigen Ausführungsbeispiels angeführt werden.
  • Wie oben beschrieben, besteht ein Bedarf an einem verbesserten Implantat zur Fusion von Wirbeln.
  • Die hier beschriebene Erfindung löst das gestellte Problem mit einem Implantat, das die in Anspruch 1. hat. Weitere vorteilhafte Ausführungsbeispiele der Erfindung sind in den Unter-Ansprüchen beschrieben.
  • Die hier dargestellte Erfindung beinhaltet ein allogenes, intervertebrales Implantat, welches bei der Fusion von Wirbelkörpern anwendbar ist. In einem Ausführungsbeispiel besteht das Implantat aus einem allogenen Knochenstück, das in Form und Größe zu einem Teil der Endplatten der Wirbelkörper passt; und hat ein keilförmiges Profil und mehrere Zähne auf der oberen und der unteren Oberfläche. Die obere und die untere Oberfläche können flach oder gekrümmt sein, um sich der Form der Endplatten anzupassen. Das Implantat hat auf mindestens einer Seite einen Kanal, welcher ein chirurgisches Instrument aufnehmen kann. Dieser Kanal verläuft in anteriorer Richtung, um eine Reihe verschiedener chirurgischer Techniken zu ermöglichen. Es ist möglich, die anteriore, posteriore, posterior-laterale oder laterale Seitenwand mit einer Gewindebohrung zu versehen, um ein Einführungswerkzeug mit Gewinde aufzunehmen.
  • In einem anderen Ausführungsbeispiel hat das Implantat einen interioren Hohlraum zur Aufnahme eines osteokunduktiven Materials, welches zur Förderung des Wachstums von neuem Knochenmaterial geeignet ist.
  • In einem weiteren Ausführungsbeispiel besteht das Implantat aus zwei Hälften: das Oberteil hat eine obere Verbindungsoberfläche während das Unterteil eine untere Verbindungsoberfläche aufweist. Die obere Verbindungsoberfläche ist passend zur unteren Verbindungsoberfläche, wenn beide Teile miteinander verbunden werden. Oberteil und Unterteil haben Öffnungen, die so ausgerichtet sind, dass sie einen Stift aufnehmen können, der beide Teile fest miteinander verbindet. Der Stift kann aus allogenem Knochenmaterial bestehen.
  • In einem weiteren Ausführungsbeispiel hat die mediale Seitenwand des Implantats eine bogenförmige Kante, so dass bei der Implantation eines ersten und eines zweiten, dem ersten gegenüberliegenden Implantates die bogenförmigen Kanten einen zylindrischen Hohlraum bilden.
  • Die hier beschriebene Erfindung umfasst auch ein separates Distanzstück, das zusammen mit einem beliebigen Ausführungsbeispiel des Implantats verwendet werden kann. In einem Ausführungsbeispiel besteht das Distanzstück aus einem allogenen Knochenstück, dessen Größe und Form zu einem Teil der Wirbelkörper-Endplatte passt und hat ein keilförmiges Profil mit im wesentlichen glatten Oberflächen auf der Ober- und der Unterseite. Die sich schneidenden Bereiche zwischen den Oberflächen auf der Ober- und der Unterseite und wenigstens einer lateralen Seite haben gekrümmte Oberflächen, um die Implantation des Distanzstücks zu erleichtern. Daher ist es möglich, das Distanzstück durch eine Öffnung auf einer Seite des Rückenmarkkanals zu implantieren und mit einem chirurgischen Instrument auf die kontralaterale Seite zu bewegen.
  • Die Erfindung und weitere Ausführungsbeispiele dieser Erfindung werden im Detail erklärt und mit entsprechenden, teilweise als Schema angelegten Abbildungen illustriert.
  • Liste der Abbildungen
  • 1 zeigt eine Draufsicht auf ein erstes Ausführungsbeispiel des Implantats nach der hier beschriebenen Erfindung;
  • 2 zeigt eine Seitenansicht des in 1 dargestellten Implantats;
  • 3 zeigt eine Rückansicht des in 1 dargestellten Implantats.
  • 4 zeigt eine Draufsicht auf ein zweites Ausführungsbeispiel des Implantats.
  • 5 zeigt eine Seitenansicht des in 4 dargestellten Implantats.
  • 6 zeigt eine Draufsicht auf ein drittes Ausführungsbeispiel des Implantats.
  • 7 zeigt eine Seitenansicht des in 6 dargestellten Implantats.
  • 8A zeigt eine Draufsicht auf die obere Verbindungsoberfläche eines Oberteils des in 6 dargestellten Implantats.
  • 8B zeigt eine Draufsicht auf die untere Verbindungsoberfläche eines Unterteils des in 6 dargestellten Implantats.
  • 9 zeigt eine perspektivische Ansicht eines vierten Ausführungsbeispiels des Implantats.
  • 10A zeigt eine Seitenansicht eines Ausführungsbeispiels der Zähne auf dem Implantat.
  • 10B zeigt eine Seitenansicht eines zweiten Ausführungsbeispiels der Zähne auf dem Implantat.
  • 11 zeigt eine Seitenansicht eines Ausführungsbeispiels des Implantats, ähnlich wie das Ausführungsbeispiel in den 68.
  • 12 zeigt eine Draufsicht auf einen Wirbelknochen, die charakteristisch für Hals-, Brust- und Lendenwirbelsäule ist.
  • 13 zeigt eine Seitenansicht aufeinander folgender, ausgerichteter Wirbelknochen, wie sie in Hals-, Brust- und Lendenwirbelsäule auftreten.
  • 14 zeigt eine Rückansicht einer Folge von Wirbelkörpern.
  • 15 zeigt eine Endansicht eines weiteren Ausführungsbeispiels des Implantats.
  • 1 zeigt eine Draufsicht auf ein erstes Ausführungsbeispiel des intervertebralen Allotransplantat-Distanzstücks oder Implantates 10 nach der hier beschriebenen Erfindung. Das Implantat 10 passt nach Größe und Form zu einem Teil der Wirbelkörper-Endplatten, zwischen die das Implantat 10 implantiert wird. Da das Implantat 10 ein Allotransplantat ist, fördert es die Bildung neuen Knochengewebes, mit dem die beiden Wirbelkörper miteinander fusioniert werden. Zwar dürfte das Implantat 10 vorwiegend im Bereich der Lendenwirbelsäule angewendet werden, es kann aber so gestaltet werden, dass es für praktisch jeden Bereich der Wirbelsäule geeignet ist. Das Implantat 10 hat mehrere Zähne 12 auf der oberen und unteren Oberfläche 14; 16, die das Implantat 10 und die Endplatten mechanisch verzahnen. Die Zähne 12 bewirken diese Verzahnung durch Penetrierung in die Endplatten. Die bereits zu Anfang vorhandene mechanische Stabilität durch die Wirkung der Zähne 12 senkt das Risiko der postoperativen Abstoßung des Implantates 10. Die Zähne 12 können eine pyramidenähnliche Form haben (10A). Vorzugsweise beträgt der Winkel, der von der Spitze zur Basis gebildet wird, etwa 60°. Stattdessen können die Zähne 12 eine Sägezahnform haben, wobei die Sägezähne in die anterior-posteriore Richtung weisen (10B).
  • Wie in den 2 und 3 dargestellt, hat eine erste laterale Seitenwand 18 einen Kanal 20 und eine zweite laterale Seitenwand 22 hat ebenfalls einen Kanal 20. Die Form der Kanäle 20 ist dazu bestimmt, ein chirurgisches Instrument sowie eine Einführungshilfe für die Implantation des Implantates 10 aufnehmen zu können. Wenn die Einführungshilfe mit einem Arm mit Gewinde ausgestattet ist, kann das Implantat 10 mit einer Gewindebohrung 24 versehen werden. In 2 ist der Kanal 20 so dargestellt, dass er sich nur über einen Teil der ersten lateralen Seitenwand 18 erstreckt. Das Ausführungsbeispiel in 5 zeigt jedoch, dass der Kanal 20 sich auch über die gesamte Länge der ersten lateralen Seitenwand 18 erstrecken kann. In 3 sind auf der ersten und der zweiten lateralen Seitenwand 18; 22 angeordnete Kanäle 20 dargestellt. Es ist zu betonen, dass das Implantat 10 ebenso ohne Kanäle oder nur mit Kanälen auf einer lateralen Seitenwand gestaltet sein kann, wie im Ausführungsbeispiel in 9 dargestellt ist.
  • Die Abmessungen des Implantates 10 können an die anatomischen Gegebenheiten einzelner Patienten angepasst werden. Im typischen Fall hat das Implantat 10 eine Breite von 6–15 mm (in medio-lateraler Richtung), eine Länge von 15–30 mm (in antero-posteriorer Richtung) und eine Höhe von 4–30 mm (maximale Höhe in superior-inferiorer Richtung). Die Größe des Implantates 10 ermöglicht dessen Implantation sowohl mit konventionellem offenen chirurgischen Techniken als auch mit minimal invasiven Techniken wie laparoskopischer Chirurgie. Weiterhin ist es möglich, da ja die Breite in einem eingeschränkten Bereich gehalten wird und nicht notwendigerweise mit der Höhe des Implantats zunimmt, höhere Implantate zu verwenden, ohne dass diese breiter sein müssen. Daher können die Entfernung der Fovea und die Retraktion der Nervenwurzeln auf ein Minimum reduziert werden.
  • Damit die Wirbelsäule nach Entfernung des betroffenen Wirbelkörpers wieder ihre natürliche Krümmung annehmen kann, hat das Implantat 10 ein keilförmiges Profil. Wie in 2 dargestellt, beruht die Keilform auf einem allmählichen Nachlassen der Höhe der anterioren Seitenwand 22 zu einer posterioren Seitenwand 28. Die anatomische Bezeichnung der natürlichen Wirbelsäulenkrümmung der Lendenwirbelsäule lautet Lordose. Wenn das Implantat 10 im Bereich der Lendenwirbelsäule verwendet werden soll, muss der Winkel, der von dem Keil gebildet wird, zwischen 4,2° und 15° liegen, so dass die Keilform der Lordoseform ähnlich ist und somit die Anatomie der Lendenwirbelsäule imitiert.
  • Um das Einsetzen des Implantates 10 zu erleichtern, geht die anteriore Seitenwand 26 in die superioren und inferioren Oberflächen 14; 16 mit gerundeten Kanten 30 über. Die gerundeten Kanten 30 ermöglichen es, das Implantat 10 zwischen die Endplatten gleiten zu lassen und dabei deren unvermeidliche Distraktion möglichst gering zu halten.
  • Obwohl das Implantat 10 typischerweise aus einem festen Knochenstück gefertigt ist, kann es einen ausgehöhlten Innenraum haben. Dieser Innenraum kann mit Knochenspänen oder anderem osteokunduktivem Material gefüllt werden, um die Osteogenese noch weiter zu fördern.
  • In 4 ist eine Draufsicht auf ein zweites Ausführungsbeispiel eines Implantats 40 nach der hier beschriebenen Erfindung dargestellt. Die Struktur des Implantates 40 ist weitgehend identisch oder vergleichbar mit der Struktur des Implantates 10. Daher wird die Beschreibung der gleichen Teile nicht für erforderlich erachtet. Die superioren und inferioren Oberflächen 14; 16 des Implantates 40 sind flach und eben ausgebildet. Wie am besten aus 5 hervorgeht, sind die die superioren und inferioren Oberflächen 14; 16 des Implantates 40 gekrümmt und haben noch ein keilförmiges Profil. Die superioren und inferioren Oberflächen 14; 16 des Implantates 40 sind Spiegelbilder der Topographie der Wirbelkörper-Endplatten. Daher passen die gekrümmten Oberflächen zu den Konturen der Endplatten.
  • 6 zeigt eine Draufsicht auf ein drittes Ausführungsbeispiel eines Implantats 50 nach der hier beschriebenen Erfindung. Die Strukturier des Implantates 50 ist weitgehend identisch oder vergleichbar mit der Struktur der Implantate 10 und 40. Daher wird die Beschreibung der gleichen Teile nicht für erforderlich erachtet. Wie am besten aus 7 hervorgeht, besteht das Implantat 50 aus einem Oberteil 52, das mit einem Unterteil 54 verbunden ist. Da es unter Umständen schwierig ist, einen einzelnen Knochenbereich finden, aus dem das Implantat 50 hergestellt werden kann, ermöglicht die Herstellung des Implantates 50 aus zwei Stücken, nämlich dem Oberteil 52 und dem Unterteil 54 die Verwendung kleinerer allogener Knochenbereiche. Eine obere Verbindungsoberfläche 56 und eine untere Verbindungsoberfläche 58 definieren die Grenzfläche zwischen Oberteil 52 und Unterteil 54. Wie in den 8A und 8B dargestellt, haben die obere Verbindungsoberfläche 56 und die untere Verbindungsoberfläche 58 Leisten 60, die zu den Einkerbungen 62 passen, so dass das Oberteil 52 und das Unterteil 54 miteinander verzahnt werden können. Vorzugsweise werden die Leisten 60 und die Einkerbungen 62 so hergestellt, dass die obere Verbindungsoberfläche 56 und die untere Verbindungsoberfläche 58 erst in einer Richtung und anschließend um 90° versetzt gefräst werden.
  • Ein Stift 64, der durch die ausgerichteten Löcher 66 in Oberteil 52 und Unterteil 54 geführt wird, hält diese beiden Teile zusammen. Der Stift 64 kann grundsätzlich aus jedem beliebigen biokompatiblen Material hergestellt werden, besteht aber vorzugsweise aus allogenem Knochenmaterial. Die Zahl und Orientierung der Stifte 64 kann variiert werden.
  • 11 zeigt ein Ausführungsbeispiel eines Implantats 80, das ähnlich wie das Implantat 50 aus mehreren Teilen besteht. Die Struktur des Implantates 80 ist weitgehend identisch oder vergleichbar mit der Struktur der Implantate 10, 40 und 50. Daher wird die Beschreibung der gleichen Teile nicht für erforderlich erachtet. Das Implantat 80 besteht aus einem Oberteil 82, einem Mittelteil 84 und einem Unterteil 86. Wie auch bei dem Implantat 80 passen die Oberflächen der einzelnen Teile zueinander und können sich mit Hilfe von Leisten und Einkerbungen ineinander verzahnt werden. Einer oder vorzugsweise mehrere Stifte halten Oberteil 82, Mittelteil 84 und Unterteil 86 zusammen.
  • 9 zeigt eine perspektivische Ansicht eines vierten Ausführungsbeispiels eines ersten Implantats 70 nach der hier beschriebenen Erfindung. Zusätzlich ist ein zweites Implantat 70' dargestellt, das dem ersten Implantat 70 weitgehend entspricht. Die Struktur der Implantate 70 und 70' ist weitgehend identisch oder vergleichbar mit der Strukturierung der Implantate 10, 40 und 50 Daher wird die Beschreibung der gleichen Teile nicht für erforderlich erachtet. Die lateralen Seitenwände 18 des ersten und zweiten Implantats 70; 70' haben bogenförmige (C-förmige) Kanten. Werden ein erstes und ein zweites Implantat 70; 70' so nebeneinander gelegt, dass die lateralen Seitenwände 18 einander gegenüberliegen, entsteht ein zylindrischer Hohlraum 72. Werden ein erstes und ein zweites Implantat 70; 70' gemeinsam implantiert, kann dieser zylindrische Hohlraum 72 mit osteokunduktivem Material gefüllt werden, um die Osteogenese noch weiter zu fördern. Das erste und das zweite Implantat 70; 70' können mit Verschlussstiften 74 ausgestattet sein, welche in die Vertiefungen 76 einrasten, um die gegenseitige räumliche Lage des ersten und des zweiten Implantates 70; 70' aufrecht zu erhalten.
  • Die Verwendung des Implantats im Sinn der hier beschriebenen Erfindung wird im folgenden unter Bezugnahme auf die 1214 am Beispiel posteriorer lumbaler interkorporeller Spondylese beschrieben. Da das erfindungsgemässe Implantat in Größe und Form zu einem Teil der Endplatten 100 passt, wird eine präoperative Planung zur Größenanpassung empfohlen. Die Höhe des Implantats wird durch Messung benachbarter Bandscheiben 102 mittels einer Queraufnahme bestimmt. Das Implantat muss fest sitzen und genau zwischen die Endplatten passen, wenn das Segment vollständig distrahiert ist. Um eine möglichst große Stabilität der Segmente zu gewährleisten, sollte ein möglichst langes Implantat verwendet werden. Wegen der Veränderlichkeit im Grad der Vergrösserung von Röntgenbildern ergeben die Messungen jedoch nur Schätzwerte.
  • Wenn sich der Patient in Bauchlage auf einem Lendenrahmen befindet, kann die intraoperative Position des Implantats mit einem Röntgengerät bestimmt werden. Von einer Medianlinie aus inzisiert und schneidet der Arzt lateral und bestimmt die Positionen des Dornfortsatzes 104, der Lamina 106, der Dura 108 und der Nervenwurzeln der gewünschten Ebene(n). Es wird eine Laminotomie zum medianen Aspekt der Fovea 110 vorgenommen, und die Dura 108 wird reflektiert, damit eine etwa 13 mm große Öffnung zur Bandscheibe freigelegt wird. Die Bandscheibe 102 wird durch die Öffnung vorgenommen bis auf den anterioren 110 und lateralen 114 Bandscheibenring entfernt. Auch die Oberflächenschichten der gesamten aus Knorpel bestehenden Endplatten 100 werden entfernt, bis blutender Knochen freiliegt. Es ist darauf zu achten, dass nicht zuviel des Knochengewebes entfernt wird, um die anteriore Wirbelsäule nicht zu schwächen. Vor allem, wenn die gesamte Endplatte entfernt wird, kann dies zu Absenkung und Verlust der Segmentstabilität führen.
  • Die Distraktion kann entweder mit einem Distraktor oder einem implantierten Test-Distanzstück vorgenommen werden. Bei der ersten Vorgehensweise müssen die Klingen des Distraktors vollständig eingeführt werden, sodass die Zähne an den Enden der Klingen auf dem Wirbelkörper ruhen. Mit einer Röntgenaufnahme kann überprüft werden, ob die Klingen des Distraktors parallel zu den Endplatten 100 ausgerichtet sind. Bei korrekter Platzierung des Distraktors sind die Griffe in Richtung zum Cranium ausgerichtet, vor allem bei L5-S1. Zum Distrahieren des Innenraums wird der Griff des Distraktors zusammengedrückt. Die Distraktion wird gesichert, indem die Blechmutter am Griff festgedreht wird.
  • Ein Test-Distanzstück der präoperativ festgelegten Größe wird unter leichtem Klemmen in den kontralateralen Bandscheibenraum eingeführt. Der richtige Sitz kann mit Röntgenbildern und Überprüfung mit der Hand hergestellt werden. Unter Verwendung der Schlitze oder der Einführungsöffnung des Implantats wird das gewählte Implantat in den kontralateralen Bandscheibenraum eingeführt. Alternativ ermöglichen die Kanäle auf dem Implantat die Distraktion und Insertion auf derselben Seite. Unabhängig von der Seite, auf der das Implantat eingesetzt wird, muss autogene Spongiosa oder ein Knochenersatz in den anterioren und medialen Aspekt des Bandscheibenraums eingefüllt werden, bevor das zweite Implantat eingesetzt wird. Der Distraktor wird entfernt, und ein zweites Implantat, das dieselbe Höhe wie das erste Implantat hat, wird in den Raum eingesetzt, ebenfalls unter leichtem Klemmen. Nach Möglichkeit bleibt zwischen Implantaten und dem posterioren Rand des Wirbelkörpers ein Abstand von 2–4 mm.
  • Wie bereits erwähnt, kann das in der vorliegenden Erfindung beschriebene Implantat mit minimalen invasiven Maßnahmen eingeführt werden. Je nach Verfahren muss nur eine Seite des Rückenmarks zugänglich sein. Dadurch werden Stripping der Muskeln, Bildung von Narbengewebe im Kanal und Retraktion und Berühren der Nervenwurzeln vermieden. Wenn es die klinische Situation erfordert, dass das Implantat bilateral platziert wird, kann die ordnungsgemäße Implantation auf der Seite, die der Inzision gegenüberliegt, problematisch sein. In 15 ist ein angeschrägtes Distanzstück 120 dargestellt, das die Platzierung auf der zur Inzision kontralateralen Seite erleichtert. Allgemein, und soweit nicht anders beschrieben, ist die Konstruktion des Distanzstücks 120 gleich oder ähnlich wie bei den Implantaten 10, 40, 50 und 80. Daher wird die Beschreibung der gleichen Teile nicht für erforderlich erachtet. Die erste laterale Seitenwand 18 geht mit gerundeten Kanten 30 in die oberen und unteren Oberflächen 14; 16 über. Außerdem hat das Distanzstück 120 keine Zähne. Das Fehlen der Zähne und die gerundete Kante 30 ermöglichen, das Distanzstück 20 zwischen die Endplatte und den entleerten Raum (von einem lateralen Bandscheibenring zum anderen) zu schieben. Die erste laterale Seitenwand 18 ist die Seitenwand, die die Bewegung des Distanzstückes unterstützen muss. Sobald das Distanzstück 120 mit einem chirurgischen Instrument zum Vorwärtsbewegen auf der zum einfachen Einschnitt kontralateralen Seite platziert wurde, wird ein Knochentransplantat oder anderes osteokunduktives Material in den Bandscheibenraum gepackt. Zuletzt wird eines der Implantate 10, 40, 50, 70 oder 70' an der zur Inzision proximalen Seite implantiert.
  • Die zur Illustration herangezogenen Ausführungsbeispiele der hier beschriebenen Erfindung gestatten offensichtlich, die oben beschriebenen Ziele zu erreichen. Aber auch zahlreiche Modifikationen und andere Ausführungsbeispiele sind bei entsprechender Erfahrung möglich. Daher wird der breite Rahmen, in dem die hier beschriebene Erfindung anwendbar ist, durch die im folgenden beschriebenen Patentansprüche umrissen.

Claims (26)

  1. Implantat (10, 40, 50, 70, 80), umfassend ein allogenes Knochenstück mit mehreren planaren oder gekrümmten Seitenwänden (18, 22, 26, 28), einer oberen und einer unteren Oberfläche (14; 16), und welches als Implantat zwischen die Oberflächen benachbarter Knochen oder Knochenfragmente einfügbar ist, dadurch gekennzeichnet, dass a) die obere und untere Oberfläche (14; 16) eine dreidimensionale Strukturierung aufweisen, mit welcher sie sich in den Oberflächen benachbarter Knochen oder Knochenfragmente verzahnen können, und dass b) das Implantat (10, 40, 50, 70, 80) mit einem separaten Distanzstück (120) kombiniert wird, welches ein allogenes, in Grösse und Form zu einem Teil einer Endplatte eines Wirbelkörpers passendes Knochenstück umfasst, und ein keilförmiges Profil aufweist, wobei obere und untere Oberfläche (14; 16) des Distanzstücks (120) im wesentlichen glatt sind und die Übergangsbereiche zwischen der oberen und der unteren Oberfläche (14; 16) sowie der anterioren (26) und der lateralen Seitenwand (18,22) des Distanzstücks (120) gekrümmte Kanten (30) aufweisen, um die Implantation des Distanzstücks (120) zu erleichtern.
  2. Ein Implantat nach Anspruch 1, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) ein keilförmiges Profil aufweist.
  3. Ein Implantat nach den Ansprüchen 1 und 2, dadurch gekennzeichnet, dass wenigstens eine Seitenwand (18, 22, 26, 28) einen Kanal (20) zur Aufnahme eines chirurgischen Instruments aufweist.
  4. Ein Implantat nach Anspruch 3, dadurch gekennzeichnet, dass der Kanal (20) in anterior-posteriorer Richtung verläuft.
  5. Ein Implantat nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die dreidimensionale Strukturierung mehrere Zähne (12) umfasst.
  6. Ein Implantat nach Anspruch 5, dadurch gekennzeichnet, dass die Zähne (12) eine pyramidenartige Form haben.
  7. Ein Implantat nach Anspruch 6, dadurch gekennzeichnet, dass die Zähne (12) sägezahnförmig sind.
  8. Ein Implantat nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass wenigstens eine Seitenwand (18, 22, 26, 28) des Implantats (10, 40, 50, 70, 80) wenigstens ein Loch (24) zur Befestigung einer Einführungsinstrumentes aufweist.
  9. Ein Implantat nach Anspruch 8, dadurch gekennzeichnet, dass mindestens ein Loch (24) mit einem Gewinde versehen ist.
  10. Ein Implantat nach Anspruch 9 oder 10, dadurch gekennzeichnet, dass mindestens ein Loch (24) an der anterioren, posterioren, posterior-lateralen oder lateralen Seite vorgesehen ist.
  11. Ein Implantat nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die obere und die untere Oberfläche (14; 16) flach und eben ausgebildet sind.
  12. Ein Implantat nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, dass ein Bereich zwischen der oberen und der unteren Oberfläche (14; 16) und einer anterioren Seite des Implantats als gekrümmte Kante (30) ausgebildet ist, um die Implantation des Implantats zu erleichtern.
  13. Ein Implantat nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, dass es sich um ein intervertebrales Implantat handelt.
  14. Ein Implantat nach Anspruch 13, dadurch gekennzeichnet, dass die obere und die untere Oberflächen (14; 16) gekrümmt sind.
  15. Ein Implantat nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) einen Hohlraum (72) zur Aufnahme eines osteokunduktiven Materials aufweist.
  16. Ein Implantat nach einem der Ansprüche 1 bis 15, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) aus zwei Teilen besteht, einem Oberteil (52) mit einer oberen Verbindungsoberfläche (56) und einem Unterteil (54) mit einer unteren Verbindungsoberfläche (58), wobei die obere Verbindungsfläche (56) und die untere Verbindungsfläche (58) ineinander eingreifen, wenn das Oberteil (52) und das Unterteil (54) miteinander verbunden werden.
  17. Ein Implantat nach Anspruch 16, dadurch gekennzeichnet, dass die obere und die untere Verbindungsoberfläche (56; 58) Leisten (60) und Einkerbungen (62) aufweisen, welche ineinander eingreifen, um das Oberteil und das Unterteil (52; 54) miteinander zu verzahnen.
  18. Ein Implantat nach Anspruch 16 oder 17, dadurch gekennzeichnet, dass ein Stift (64) durch ein Loch (66) im Oberteil (52) und ein Loch (66) im Unterteil (54) eingeführt wird, um das Oberteil (52) und das Unterteil (54) fest miteinander zu verbinden.
  19. Ein Implantat nach Anspruch 19, dadurch gekennzeichnet, dass der Stift (64) aus allogenem Knochenmaterial besteht.
  20. Ein Implantat nach einem der Ansprüche 1 bis 19, dadurch gekennzeichnet, dass es aus zwei Teilen (70; 70') besteht, die beide eine mediale Seitenwand (18) mit einer bogenförmige Kante aufweisen, derart, dass bei einer Implantation der beiden Teile (70; 70') mit einander gegenüberliegenden medialen Seitenwände (18) die bogenförmigen Kanten der medialen Seitenwände (18) der zwei Teile (70; 70') einen zylindrischen Hohlraum (72) bilden.
  21. Ein Implantat nach Anspruch 20, dadurch gekennzeichnet, dass das erste Teil (70') an der medialen Seitenwand (18) einen Verschlussstift (74) aufweist, und das zweite Teil (79) an der medialen Seitenwand (18) eine Öffnung (76) aufweist, welche so konfiguriert und dimensioniert ist, dass sie den Verschlussstift (74) aufnehmen kann, um die räumliche Verbindung zwischen den beiden Teilen (70; 70') aufrecht zu erhalten.
  22. Ein Implantat nach Anspruch 21, dadurch gekennzeichnet, dass der Verschlussstift (74) aus allogenem Knochenmaterial besteht.
  23. Ein Implantat nach einem der Ansprüche 1 bis 22, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) 6–15 mm breit ist.
  24. Ein Implantat nach einem der Ansprüche 1 bis 23, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) 15–30 mm lang ist.
  25. Ein Implantat nach einem der Ansprüche 1 bis 24, dadurch gekennzeichnet, dass das Implantat (10, 40, 50, 70, 80) 4–30 mm hoch ist.
  26. Ein Implantat nach einem der Ansprüche 1 bis 25, dadurch gekennzeichnet, dass Implantat (80) aus mehreren miteinander verbindbaren Teilen (82, 84, 86) besteht, wobei jedes dieser Teile (82, 84, 86) eine Oberfläche hat, welche mit der Oberfläche des benachbarten Teils zusammen passt.
DE1999616280 1998-08-03 1999-07-30 Zwischenwirbel-allotransplantat-distanzstück Expired - Fee Related DE69916280T2 (de)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US9520998P true 1998-08-03 1998-08-03
US95209P 1998-08-03
WOPCT/EP99/05008 1999-07-15
EP9905008 1999-07-15
PCT/EP1999/005541 WO2000007527A1 (en) 1998-08-03 1999-07-30 Intervertebral allograft spacer
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US20080046090A1 (en) 2008-02-21
EP1100417B1 (de) 2004-04-07
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US20050261771A1 (en) 2005-11-24
US7300465B2 (en) 2007-11-27
US7347873B2 (en) 2008-03-25
WO2000007527A1 (en) 2000-02-17
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US20020062153A1 (en) 2002-05-23
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