DE69725932T2 - Menschliche Zwischenwirbel-Prothese - Google Patents
Menschliche Zwischenwirbel-Prothese Download PDFInfo
- Publication number
- DE69725932T2 DE69725932T2 DE69725932T DE69725932T DE69725932T2 DE 69725932 T2 DE69725932 T2 DE 69725932T2 DE 69725932 T DE69725932 T DE 69725932T DE 69725932 T DE69725932 T DE 69725932T DE 69725932 T2 DE69725932 T2 DE 69725932T2
- Authority
- DE
- Germany
- Prior art keywords
- concave
- intervertebral disc
- disc prosthesis
- prosthesis according
- convex
- 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
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2/30742—Bellows or hose-like seals; Sealing membranes
-
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30016—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A61F2002/30108—Shapes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- Y—GENERAL 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
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- Y10S606/91—Polymer
Description
- Die vorliegende Erfindung betrifft allgemein Prothesen für den Humangebrauch und insbesondere Bandscheibenprothesen für die Wirbelsäule. Die Erfindung betrifft auch chirurgische Verfahren für die Vorbereitung eines Patienten für den Empfang einer Bandscheibenprothese und für die Implantation dieser Prothese in die Wirbelsäule des Patienten.
- Bandscheibenvorfall und die häufig daraus resultierenden Symptome, wie unerträgliche Schmerzen, Schwäche, Empfindungsverlust, Inkontinenz und progressive Arthritis, gehören zu den häufigsten zu Behinderungen führenden Prozessen der Menschheit. Wenn sich der Zustand eines Patienten nach einer konservativen Behandlung nicht bessert und wenn es deutliche körperliche Hinweise auf eine Nervenwurzel- oder Rückenmarkskompression gibt und wenn korrelierende Röntgenaufnahmen (d. h. MRT oder CT oder Myelographie) die Erkrankung bestätigen, dann kann die chirurgische Entfernung der vorgefallenen Bandscheibe angezeigt sein. Das Verfahren der Diskektomie umfasst – wie der Name schon andeutet – die einfache Entfernung der Bandscheibe ohne den Versuch, die Fehlfunktion durch Ersatz oder Reparatur zu beheben. In den Vereinigten Staaten wurden 1985 über 250.000 derartige Operationen an der Lendenwirbelsäule und der Halswirbelsäule durchgeführt.
- Statistische Daten weisen darauf hin, dass die aktuellen Operationstechniken wahrscheinlich nur kurzfristig Linderung verschaffen und die progressive Verschlechterung des Zustands des Patienten langfristig nicht verhindern können. Durch bessere präoperative Verfahren und diagnostische Untersuchungen haben sich die langfristigen Behandlungsresultate der Patienten etwas verbessert. Es ist aber deutlich geworden, dass eine weitere Verschlechterung des Zustands des Patienten mit fast an Sicherheit grenzender Wahrscheinlichkeit stattfinden wird, wenn die entfernte Bandscheibe nicht ersetzt oder die Wirbelsäule anderweitig richtig unterstützt wird.
- Mitte der 50er und 60er Jahre machten Cloward und Smith & Robinson anteriore chirurgische Vorgehensweisen an der Halswirbelsäule zur Behandlung der degenerativen Bandscheibenerkrankung an der Halswirbelsäule und damit verwandten Erkrankungen von Wirbeln, Rückenmark und Nervenwurzeln populär; bei diesen Operationen wurde die Bandscheibe nach Fusion der Zwischenwirbel mit einem Knochentransplantat entfernt. Robinson (Robinson, R. A. The Results of Anterior Interbody Fusion of the Cervical Spine, J. Bone Joint Surg. 440A– 1569–1586, 1962) beobachtete, dass nach operativer Fusion eine Reabsorption von Osteophyten (Knochendorn) am durch Fusion verbundenen Segment auftreten kann. Inzwischen ist aber immer deutlich zu Tage getreten, dass nicht fusionierte Wirbelsegmente auf den Ebenen über und unter dem fusionierten Segment als direktes Ergebnis dieser Fusion schneller degenerieren. Daher führen einige Chirurgen nur eine Diskektomie ohne Fusion durch, wobei sie bei einigen Patienten den posterioren Weg vom Nacken aus wählen. Bei Operationen in der Kreuzgegend, in der Diskektomie ohne Fusion als Erstbehandlung der Bandscheibenvorfallsyndrome häufiger ist, ist eine progressive Degeneration in Höhe der Bandscheibenexzision eher die Regel als die Ausnahme. Eine vorzeitige degenerative Bandscheibenerkrankung in der Ebene über und unter der ausgeschnittenen Bandscheibe kann vorkommen und kommt vor.
- Eine Wirbelsäulenoperation umfasst gelegentlich die Fusion der Wirbelsäulensegmente. Zusätzlich zu den Problemen, die durch den Bandscheibenvorfall entstanden sind, können auch traumatische, maligne, infektiöse und degenerative Syndrome der Wirbelsäule durch Fusion behandelt werden. Andere Verfahren können Knochentransplantate und belastungsfähige Metallstangen, Haken, Platten und Schrauben umfassen, die an die Anatomie des Patienten angehängt werden; häufig sind sie starr intern fixiert. Keine dieser Optionen sorgt dafür, dass die fast normale Funktionsfähigkeit des Patienten wiederhergestellt wird. Diese Verfahren können zwar ein Problem kurzfristig lösen, aber sie können auch längerfristige Probleme verursachen.
- Es wurden bereits mehrere Versuche durchgeführt, einige der oben beschriebenen Probleme zu lösen, indem ein Patient mit Bandscheibenprothesen oder künstlichen Bandscheiben der einen oder anderen Art versorgt wird. Steffee, US-Patent 5.031.437, beschreibt beispielsweise eine Bandscheibenprothese mit einer oberen und einer unteren festen, flachen Platte und einem flachen Elastomerkern zwischen den Platten. Frey et al., US-Patente 4.917.704 und 4.955.908, offenbaren Zwischenwirbelprothesen, aber die Prothesen werden als feste Körper beschrieben.
- Die US-Patente 4.911.718 und 5.171.281 offenbaren nachgiebige Bandscheibenabstandshalter, wobei aber keine Verbindungs- oder Halteebenen oder ähnliche Elemente vorgeschlagen werden und die gesamte Einheit nicht abgedichtet ist. DE-22 63842A zeigt eine Prothese mit den Merkmalen des Oberbegriffs von Anspruch 1.
- Das primäre Ziel der vorliegenden Erfindung ist es, eine Bandscheibenprothese bereitzustellen, die in der Wirbelsäule eines Patienten über lange Zeit hinweg wirksam ist und nicht zur Degeneration oder Schädigung benachbarter natürlicher Bandscheibenteile führt.
- Ein weiteres Ziel ist die Bereitstellung einer Bandscheibenprothese, für die keine Stifte oder anderen üblichen mechanischen Scharnierelemente notwendig sind, die aber dennoch die natürliche Bewegung der Prothesenteile und der umliegenden natürlichen Anatomie gestattet.
- Ein verwandtes Ziel ist die Bereitstellung eines neuen Operationsverfahrens für eine Bandscheibenprothese, das die postoperative Rekonvaleszenzzeit verkürzt und postoperative Degeneration von Bandscheiben, Wirbelkörpern und Wirbelsäule verhindert.
- Ein damit zusammenhängendes Ziel ist die Bereitstellung einer Prothese, die die Anheftung von Knochen an den Außenflächen der Prothese und das Anwachsen darauf fördert.
- Ein weiteres Ziel ist die Bereitstellung einer Wirbelprothese, deren Teile nicht onkogen sind.
- Ein weiteres Ziel ist die Bereitstellung einer Bandscheibenprothese mit einem nachgiebigen Element zur Absorption von Stößen und anderen Kräften, die auf die Wirbelsäule aufgebracht werden.
- Ein weiteres Ziel ist die Bereitstellung einer hochwirksamen Wirbelprothese, die mehrere Bandscheibenprothesen und ein oder mehrere prothetische Wirbelkörper enthält. Ein verwandtes Ziel ist die Bereitstellung dieser Elemente in einer vormontierten Anordnung zur Implantation in einen Patienten.
- Zur Erreichung dieser Ziele stellt die Erfindung eine Prothese wie in Anspruch 1 definiert bereit. Wenn medizinische Überlegungen es angezeigt erscheinen lassen, können mehrere Bandscheibenprothesen mit einem oder mehreren prothetischen Wirbelkörpern in einer Gesamtanordnung kombiniert werden.
- Zur Implantation dieser Prothesenanordnung werden Informationen eingeholt über Größe, Form und Art der beschädigten natürlichen Bandscheiben des Patienten. Wenn ein oder mehrere Wirbelkörper des Patienten ersetzt werden müssen, werden auch Informationen über diese Körper eingeholt. Anschließend werden ein oder mehrere Prothesenbandscheibeneinheiten und dazwischenliegende prothetische Wirbelkörpereinheiten konstruiert und entsprechend den eingeholten Informationen vormontiert. Schließlich wird die fertige angepasste Anordnung aus Bandscheibenprothese und Wirbelkörperprothese in die Wirbelsäule des Patienten implantiert.
- Weitere Ziele und Vorteile der Erfindung werden beim Lesen der folgenden detaillierten Beschreibung unter Bezugnahme auf die Zeichnungen offensichtlich. In den Zeichnungen beziehen sich gleiche Bezugsziffern auf ähnliche Teile.
- Kurze Beschreibung der Zeichnungen
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1 ist eine vertikale Teilansicht eines Teils einer menschlichen Wirbelsäule, in der eine neue, die vorliegende Erfindung verkörpernde Bandscheibenprothese installiert ist; -
2 ist eine Teilseitenansicht ähnlich1 , die die Elemente der Wirbelsäule eines Patienten zeigt und in der eine neue, die vorliegende Erfindung verkörpernde Bandscheibenprothese installiert ist; -
3 ist eine Schnittansicht im Wesentlichen in der Ebene der Linie 3-3 in1 ; -
4 ist eine aufgebrochene Ansicht der neuen Bandscheibenprothese; -
5 ist eine vertikale Teilansicht der Wirbelsäule eines Patienten ähnlich1 , die aber eine Reihe von neuen Bandscheibenprotheseneinheiten zeigt, die in der Wirbelsäule installiert und miteinander verbunden sind; -
6 ist eine Teilschnittansicht der Wirbelsäule eines Patienten ähnlich3 entlang Linie 6-6 in5 , die aber einen natürlichen oberen Wirbelkörper und eine obere Bandscheibenprothese, einen benachbarten prothetischen Wirbelkörper, eine zweite oder untere Bandscheibenprothese und einen zweiten oder unteren natürlichen Wirbelkörper zeigt; -
7 ist eine Schnittansicht im Wesentlichen in der Ebene der Linie 7-7 in6 ; -
8 ist eine Teilseitenansicht der Anordnung aus6 ; und -
9 ist eine vertikale Teilansicht ähnlich1 eines Teils einer menschlichen Wirbelsäule, in der eine abgewandelte Form der neuen Bandscheibenprothese installiert ist, wobei die abgewandelte Form ein prothetisches Längsband enthält; -
10 ist eine Schnittansicht im Wesentlichen in der Ebene von Linie 10-10 in9 ; -
11 ist eine Draufsicht auf ein Haltemittel zur Verwendung mit einer Bandscheibenprothese; -
12 ist eine Schnittansicht im Wesentlichen in der Ebene von Linie 12-12 in11 ; -
13 ist eine Seitenansicht einer Bandscheibenprothese mit einer Kerbe zur Aufnahme des Haltemittels; und -
14 ist eine Querschnittsansicht des Haltemittels im Gebrauch. - Detaillierte Beschreibung
- Die Erfindung wird zwar in Verbindung mit einer bevorzugten Ausführungsform und einem bevorzugten Verfahren beschrieben, aber es versteht sich, dass die Erfindung damit nicht auf diese Ausführungsform oder dieses Verfahren beschränkt werden soll. Im Gegenteil ist beabsichtigt, dass alle Alternativen, Modifikationen und Äquivalente im Geist und Schutzumfang der Erfindung, wie in den anhängenden Ansprüchen definiert, enthalten sind.
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1 –3 zeigen insbesondere einen Teil einer menschlichen Wirbelsäule10 . Die gezeigte Wirbelsäule10 wurde einer operativen Diskektomie unterworfen. Zur Verhinderung einer Degeneration oder Schädigung der natürlichen Wirbelkörper12 und14 und ihrer jeweiligen Facettengelenke wird erfindungsgemäß eine Bandscheibenprothese18 zwischen den natürlichen Wirbelkörpern12 und14 befestigt. Hier umfasst diese Bandscheibenprothese18 einen nachgiebigen Bandscheibenkörper20 mit einem relativ steifen ringförmigen äußeren Dichtungsteil22 und einem relativ geschmeidigen mittleren Kernteil24 . Die ringförmige Dichtung22 kann aus einem geeigneten biokompatiblen Elastomer mit einer Härte von ca. 90 Durometer hergestellt werden, und der mittlere Kernteil24 kann aus einem weicheren biokompatiblen elastomeren Polymer mit einer Härte von ca. 30 Durometer bestehen. - Konkav/konvexe Mittel
30 umgeben den nachgiebigen Körper20 , um den nachgiebigen Körper20 zwischen den benachbarten natürlichen Wirbelkörpern12 ,14 in der Wirbelsäule10 eines Patienten zu halten. Dazu umfassen die konkav/konvexen Mittel30 , wie in3 gezeigt, zwei im Allgemeinen L-förmige Stützen32 und34 . Die Stützen32 ,34 weisen jeweils erste konkav/konvexe Schenkel42 ,44 auf, die jeweils eine relativ konstante Querschnittsdicke aufweisen. Jeder Schenkel42 ,44 besitzt eine konvexe Außenfläche52 ,54 zum Eingriff in den benachbarten Knochen der natürlichen Wirbelkörper12 ,14 . Entsprechende konkave Innenflächen62 ,64 in gegenüberliegender Anordnung halten den nachgiebigen Körper20 in seiner gezeigten, Kompressionskräfte absorbierenden Position. Diese Stützen32 und34 können sich prinzipiell voneinander weg bewegen, aber es erfolgt nur eine begrenzte sekundäre Übersetzungs-, Dreh- und Distraktionsbewegung. Jede Stütze32 ,34 hat einen zweiten Flügel oder Schenkel72 ,74 , der sich im Allgemeinen lotrecht zu den ersten Schenkeln42 ,44 erstreckt und an der benachbarten Knochenstruktur fixiert werden kann. Zur Durchführung der unten beschriebenen Aspekte der Erfindung erfolgt diese wirksame Fixierung durch kanülierte Schraubenvorrichtungen82 ,84 , zum Beispiel vom biologisch abbaubaren Typ, der von Zimmer in Largo, Florida, USA, hergestellt wird. Jede Vorrichtung82 ,84 umfasst eine Schraube92 ,94 , und ein Schraubenanker102 ,104 zur gewindeartigen Aufnahme der Schraube erstreckt sich radial in die Knochenstruktur12 ,14 und sitzt in dieser, wie insbesondere in3 gezeigt. - Zur Verhinderung und Vermeidung einer Migration von Flüssigkeiten zwischen der Prothese
18 und benachbarten Teilen der Anatomie ist ein Dichtungselement110 an den Stützen32 ,34 befestigt, das gemäß einem anderen Aspekt der Erfindung den aus der Dichtung22 und dem Kern24 bestehenden nachgiebigen Körper20 umgibt. Hier umfasst das Dichtungselement110 ein flexibles flächenförmiges Material mit zahlreichen Poren. Vorzugsweise weisen die Poren eine Größe im Bereich von ca. 5 Mikrometer bis ca. 60 Mikrometer auf. Ein flexibles, starkes flächenförmiges Polymermaterial, aus dem die Dichtung geformt ist, kann ein Kevlar-artiges Material oder ein Goretex-artiges Material oder ein anderes biokompatibles Material sein, wie z. B. Polyether-, Polyurethanoder Polycarbonat-Urethan-Membranen. Kevlar wird von E. I. DuPont de Nemours Company in Wilmington, Delaware, USA, angeboten und Goretex von W. T. Gore Company in Flagstaff, Phoenix, Arizona, USA. Bekanntes Dichtungsmaterial kann auf das flexible flächenförmige Material aufgebracht werden, damit das flexible flächenförmige Material im Wesentlichen undurchlässig für Flüssigkeiten wird. Eine perfekte wasserdichte Dichtung wird erhalten, wenn die Dichtung110 an den Schenkeln42 ,44 und Zwischenteilen der Schenkel72 ,74 wie in1 –3 gezeigt festgeklebt oder anderweitig befestigt wird. - Bei einer anderen Ausführungsform kann die wasserdichte Dichtung zwischen der Prothese
18 und benachbarten Teilen der Anatomie bereitgestellt werden, indem eine den Umfang jedes Schenkels42 ,44 vollständig umgebende Kerbe402 eingearbeitet wird. Nur eine der Kerben ist in13 gezeigt. Bei dieser Ausführungsform ist das Dichtungselement410 mit einem Wulstrand412 für jede Kerbe versehen. Zusätzlich ist ein Halteband415 für jede Kerbe vorgesehen, um das Dichtungselement410 in den Kerben402 zu halten. Die Haltebänder415 können in Form eines biokompatiblen monofilen Drahts, beispielsweise aus Edelstahl oder Titan, eines synthetischen Polymerkabels oder eines Flechtdrahtkabels vorliegen. Wie in-11 gezeigt, ist jedes Halteband anterior von einer Kräuselhülse420 gekräuselt. Natürlich kann bei Bedarf auch mehr als eine Kräuselhülse verwendet werden. Obwohl in14 eine Dichtungsanordnung aus Kerbe, Wulstrand und Halteband gezeigt ist, versteht sich, dass die Dichtungsanordnung auf dem konkav/konvexen Schenkel der anderen Stütze in Design und Funktion identisch ist. - Im Gebrauch ist das Dichtungselement
410 um das konkav/konvexe Mittel30 angeordnet. Die Haltebänder415 werden dann neben der jeweiligen Kerbe402 angeordnet und anterior gekräuselt, so dass die Bänder in die Kerben eingepasst werden. Jeder Wulstrand412 verhindert das Herausrutschen des Dichtungselements unter dem Halteband hindurch. Halteband, Kerbe und Wulstrand sorgen somit zusammen für eine wasserdichte Dichtung zur Verhinderung der Migration von Flüssigkeiten zwischen der Prothese18 und den benachbarten Teilen der Anatomie. Zur Fixierung des Dichtungselements am konkav/konvexen Mittel30 kann auch Klebstoff als zusätzliche Hilfe zur perfekten Abdichtung verwendet werden. - Gemäß einem anderen Aspekt der Erfindung bestehen die Stützen
32 ,34 aus einem biokompatiblen Metall, das Chromkobalt oder Titan enthalten kann. Eine Aufrauung der Oberfläche oder ein Titanwulst112 ,114 auf den Außenflächen52 ,54 der Schenkel42 ,44 fördert eine kraftschlüssige Verbindung zwischen benachbartem Knochen und den konvexen Flächen52 ,54 . - Wie in
9 und10 vorgesehen, kann ein prothetisches Längsband250 zwischen den Schrauben92 ,94 angeschlossen werden, um Bewegungen zwischen den Elementen der Wirbelsäule10 in dem Bereich, in dem die Prothese18 implantiert ist, einzuschränken. Dieser Gurt250 kann aus dem oben beschriebenen Kevlar-artigen Material oder dem Goretex-artigen Material hergestellt werden, oder er kann aus einem beliebigen anderen starken biokompatiblen Material bestehen. - Gemäß einem anderen Aspekt der Erfindung können mehrere Bandscheibenprotheseneinheiten mit einem spreizenden Arretierungsanhang, der wie in
5 gezeigt für Stabilität und Fixierung sorgt, in Reihe angeordnet werden. Ganze Abschnitte der Wirbelsäule eines Patienten können durch eine Reihe von miteinander verbundenen prothetischen Wirbelkörpern und Bandscheibenprotheseneinheiten ersetzt werden.6 –8 zeigen eine obere natürliche Wirbelkörpereinheit312 , an der ein oberer Prothesenkörper308 befestigt wurde. An einem unteren natürlichen Wirbelkörper314 ist am oberen Ende eine Bandscheibenprotheseneinheit318 befestigt. Zwischen diesen Bandscheibenprotheseneinheiten308 und318 befindet sich ein prothetischer Wirbelkörper320 . Wie in7 vorgeschlagen muss der prothetische Wirbelkörper320 im Querschnitt nicht unregelmäßig geformt sein; Herstellungsverfahren können, einen kreisförmigen Querschnitt geeignet erscheinen lassen. Wie in6 und8 gezeigt umfasst dieser prothetische Wirbelkörper320 ein Titanelement321 , an dem die vorgeformten oberen und unteren konkav/konvexen Elemente322 ,324 des oberen und des unteren prothetischen Wirbelkörpers befestigt sind. Jedes konkav/konvexe Element322 ,324 ist, wie in7 gezeigt, durch sich durch den Titan-Wirbelkörper321 in einen schaftartigen Vorsprung331 , der sich von jedem konkav/konvexen Element322 ,324 aus erstreckt, erstreckende Senkschrauben330 am prothetischen Wirbelkörper320 befestigt. Ein Loch360 im Körper320 nimmt die schaftartigen Vorsprünge331 der konkav/konvexen Elemente322 und324 auf. Der schaftartige Vorsprung331 der konkav/konvexen Elemente322 und324 wird nur in Verbindung mit einer prothetischen Wirbelkörperimplantatkonstruktion320 verwendet. - Eine Öse
340 ist z. B. durch die Schweißkonstruktionen341 an einem Schenkel342 befestigt, der sich wie in6 und8 gezeigt von einem konkav/konvexen Element322 erstreckt. Ein Anker352 kann in den prothetischen Wirbelkörper320 gedreht und eine Schraube362 in den Anker352 geschraubt werden, um den Schenkel342 starr an einem Schenkel354 zu montieren, der sich von der unteren Bandscheibenprotheseneinheit318 aus erstreckt. - Die obere Bandscheibenprothese
308 , der prothetische Wirbelkörper320 und die untere Bandscheibenprothese318 können vor der Implantation im Körper eines Patienten bei Bedarf montiert und zu einer Einheit miteinander verbunden werden. - Wie ebenfalls in
6 zu sehen, können sich die ringförmigen Ecken372 ,374 der natürlichen Wirbelkörper313 ,314 unregelmäßig radial nach außen von der benachbarten Bandscheibenprothese308 ,318 erstrecken. Die Ecken382B ,384B des prothetischen Wirbelkörpers320 ragen aber im Allgemeinen nicht signifikant aus den Bandscheibeneinheiten308 ,318 heraus, so dass ein Eingriff der Wirbelkörper mit benachbarten Teilen der natürlichen Anatomie des Patienten und damit einhergehend Abrieb oder andere Schädigung unterdrückt wird. Vorzugsweise ist der prothetische Wirbelkörper320 nicht exakt rechtszylindrisch, sondern eher leicht bikonisch; d. h. der prothetische Wirbelkörper320 besitzt eine Taille390 mit einem Mindestradius R an einem axialen medialen Punkt wie in6 gezeigt. - Gemäß einem anderen Aspekt der Erfindung gestatten neuartige Operationsverfahren die wirksame und dauerhafte Installation des prothetischen Wirbelkörpers
320 und der dazugehörigen Teile. Zunächst besorgt sich der Chirurg oder Medizintechniker Informationen über Größe, Form und Art des/der beschädigten Wirbelkörper/s eines Patienten aus Röntgenaufnahmen, CT- und/oder MRT-Aufnahmen, unter besonderer Beachtung der anterior-posterioren und lateralen Ausdehnungen der Endplatte jedes betroffenen Wirbelkörpers und der vertikalen Höhe des anterioren Aspekts jedes betroffenen Wirbelkörpers und/oder nahe liegenden Wirbelkörpers und der vertikalen Höhe des mittleren Abschnitts der betroffenen und nahe liegenden relativ normalen Bandscheibenzwischenräume. Diese Informationen werden telefonisch, über eine Computer-Datenverbindung oder Dokumententransport zu einem Speziallabor übertragen. Dieses Labor konstruiert eine oder mehrere Prothesenanordnungen der in6 gezeigten Art entsprechend den erhaltenen Informationen und dieser Offenbarung. Jede Anordnung kann einen prothetischen Wirbelkörper321 enthalten, und an jedem Körperende befindet sich eine Bandscheibenprothese308 ,318 . Jede Bandscheibenprotheseneinheit umfasst wiederum konkav/konvexe Elemente30 , den zwischen den konkav/konvexen Elementen gelagerten nachgiebigen Körper20 und die Dichtungseinheit110 , die um die Innenschenkel und den nachgiebigen Körper herum befestigt ist. Anschließend wird die fertige und angepasste Anordnung in die Wirbelsäule10 eines Patienten implantiert. - Wenn die Einheit oder Einheiten in Empfang genommen wurden und der Patient richtig vorbereitet ist, werden die beschädigte(n) natürliche(n) Bandscheibe(n) und der/die Wirbelkörper entfernt und die benachbarten Knochenflächen gefräst oder anderweitig geformt, um konkave Flächen zu erhalten, die die gegenüberliegenden konvexen Flächen
52 ,54 aufnehmen können. Anschließend werden die Bandscheibeneinheiten und der Wirbelkörper in der Wirbelsäule des Patienten installiert. - Zur genauen Lokalisation der konkav/konvexen Flächen in der Wirbelsäule des Patienten werden Löcher
382A ,384A (3 ) präzise lokalisiert und anschließend mit einem Messinstrument, das im evakuierten natürlichen Bandscheibenzwischenraum zentriert ist, angebracht. Diese Löcher werden dann angeschnitten, um Innengewinde darin zu formen. Nach Formung der Gewinde werden die Anker102 ,104 in den jeweiligen Gewindelöchern implantiert, so dass eine imaginäre Plattform mit Referenzpunkten entsteht, die gegenüber der Wirbelsäule des Patienten präzise angeordnet sind. Nach Bildung der Löcher und Implantation der Anker102 ,104 wird eine (nicht gezeigte) Fräslehre für die Knochenfläche an den Ankern102 ,104 befestigt und die gewünschten konkaven Flächen mit der vorbestimmten Form werden unter Verwendung einer ausgewählten vorgegebenen Fräskopf- oder Spitzengröße auf den unteren und oberen Flächen der gegenüberliegenden Wirbelkörper geformt. Anschließend wird die Knochenfräslehre entfernt und die konkav/konvexen Elemente52 ,54 , deren Form mit der Form der gefrästen Flächen112 ,114 identisch ist, werden zwischen die getrennten gefrästen Wirbelkörper12 ,14 geschoben. Das Distraktionsinstrument wird dann entfernt. Die konkav/konvexen Strukturen werden dann mit denselben Ankern102 ,104 am Knochen befestigt, so dass ein stabiler und präziser Passsitz zwischen den Knochenflächen und den konvexen Flächen52 ,54 gewährleistet ist. - Wenn notwendig kann ein beschädigter implantierter Kern und/oder eine entsprechende Dichtung
24 entfernt und ausgetauscht werden. Dies kann erreicht werden, wenn die Dichtung110 verschoben wird, die ringförmige Dichtung24 und der beschädigte Kern22 entfernt und durch neue unbeschädigte Elemente ersetzt werden. Anschließend kann die Dichtung110 durch Zunähen oder Zukleben der getrennten Dichtung wiederhergestellt werden.
Claims (23)
- Bandscheibenprothese, umfassend einen nachgiebigen Kern (
20 ) und starre konkav/konvexe Elemente (42 ,44 ), die den Kern zumindest teilweise umgeben, wobei die Prothese einen den Kern (20 ) umgebenden ringförmigen Dichtungsring (22 ) enthält, gekennzeichnet durch ein Dichtungselement (110 ) aus flexiblem Material, das an den konkav/konvexen Elementen (42 ,44 ) befestigt ist und den Kern (20 ) und den ringförmigen Dichtungsring (22 ) umgibt. - Bandscheibenprothese nach Anspruch 1, dadurch gekennzeichnet, dass die konkav/konvexen Elemente (
42 ,44 ) jeweils im Allgemeinen Lförmige Stützen (32 ,34 ) aufweisen, wobei jede Stütze einen ersten konkav/konvexen Schenkel (42 ,44 ), der eine konvexe Außenfläche zum Eingriff in benachbarten Knochen aufweist, sowie eine entsprechende konkave Innenfläche zum Halten des Kerns (20 ) hat, wobei jede Stütze ferner einen zweiten Schenkel (72 ,74 ) besitzt, der sich im Allgemeinen lotrecht zum ersten Schenkel erstreckt und an der benachbarten Knochenstruktur befestigt werden kann. - Bandscheibenprothese nach Anspruch 2, gekennzeichnet durch kanülierte Schraubenmittel (
82 ,84 ) zur Verbindung mit den Schenkeln (72 ,74 ) und zur Befestigung in einer allgemein radialen Richtung -in benachbarten, allgemein zylindrischen Knochenwirbeln. - Bandscheibenprothese nach einem der vorhergehenden Ansprüche, gekennzeichnet durch Mittel (
112 ,114 ), die zur Förderung des Knochenwachstums teilweise auf den konkav/konvexen Elementen und der Knochenverbindung mit den konkav/konvexen Elementen an den konkav/konvexen Elementen befestigt sind. - Bandscheibenprothese nach einem der vorhergehenden Ansprüche, gekennzeichnet durch Aufrauung der Außenflächen der konkav/konvexen Elemente zur Förderung des Knochenwachstums teilweise auf den konkav/konvexen Elementen und der Knochenverbindung mit den konkav/konvexen Elementen.
- Bandscheibenprothese nach einem der vorhergehenden Ansprüche, gekennzeichnet durch Mittel (
340 ) zur Verbindung eines der konkav/konvexen Elemente mit einem konkav/konvexen Element einer anderen Bandscheibenprothese, wodurch der Ersatz mehrerer natürlicher Bandscheiben ermöglicht wird. - Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der nachgiebige Kernkörper (
20 ) einen relativ nachgiebigen Zentralkörper (24 ) umfasst und die Dichtung relativ steif ist und den Zentralkörper umgibt, wobei der nachgiebige Kernkörper gut passend in die benachbarten, zusammengehörigen konkaven Flächen der konkav/konvexen Elemente eingreift. - Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die konkav/konvexen Elemente nicht ineinander eingreifen.
- Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass jedes konkav/konvexe Element mit einer Kerbe (
402 ) versehen ist. - Bandscheibenprothese nach Anspruch 9, gekennzeichnet dadurch, dass das Dichtungselement (
410 ) Wulstränder (412 ) umfasst, wobei das Dichtungselement an den konkav/konvexen Elementen befestigt ist und den nachgiebigen Körper umgibt. - Bandscheibenprothese nach Anspruch 10, gekennzeichnet durch Haltemittel (
415 ) zum Halten des Dichtungselements (410 ) gegen die Kerben (402 ), wobei das Haltemittel mit den Wulsträndern und den Kerben zur Bildung einer wasserdichten Dichtung zusammenwirkt. - Bandscheibenprothese nach Anspruch 11, dadurch gekennzeichnet, dass das Haltemittel ein biokompatibler monofiler Metalldraht, ein synthetisches Polymerband oder ein geflochtenes Drahtkabel ist.
- Bandscheibenprothese nach Anspruch 12, dadurch gekennzeichnet, dass der biokompatible monofile Metalldraht aus Edelstahl oder Titan besteht.
- Bandscheibenprothese nach einem der Ansprüche 11 bis 13, gekennzeichnet durch ein Kräuselmittel (
420 ) zum Kräuseln des Haltemittels um das Dichtungselement. - Bandscheibenprothese nach Anspruch 3, bei der das kanülierte Schraubenmittel eine Schraube (
82 ,84 ) und einen Schraubenanker (102 ,104 ), der in einer Knochenstruktur sitzen und die Schraube gewindeartig aufnehmen kann, umfasst. - Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Dichtungselement ein flexibles flächenförmiges Material mit zahlreichen Poren enthält, wobei die Poren vorzugsweise eine Größe von ca. 5 Mikrometer bis ca. 60 Mikrometer aufweisen.
- Bandscheibenprothese nach Anspruch 16, gekennzeichnet durch ein Dichtungsmittel, das auf dem flexiblen flächenförmigen Material aufgebracht ist, um das flexible flächenförmige Material gegenüber Fluiden im Wesentlichen undurchlässig zu machen.
- Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die konkav/konvexen Elemente und das Dichtungselement zusammen den nachgiebigen Körper umgeben und eine wasserdichte Dichtung bilden.
- Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die konkav/konvexen Elemente aus einem biokompatiblen Metall bestehen.
- Bandscheibenprothese nach einem der Ansprüche 1 bis 18, dadurch gekennzeichnet, dass die konkav/konvexen Elemente aus einem Titan enthaltenden Metall bestehen.
- Bandscheibenprothese nach einem der Ansprüche 1 bis 18, dadurch gekennzeichnet, dass die konkav/konvexen Elemente aus einem Chromkobalt enthaltenden Metall bestehen.
- Bandscheibenprothese nach Anspruch 4, dadurch gekennzeichnet, dass das Mittel einen Metallwulst zumindest auf einem Teil der Außenflächen der konkav/konvexen Elemente zur Förderung der Verbindung zwischen Knochen und den Außenflächen der konkav/konvexen Elemente aufweist.
- Bandscheibenprothese nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die konkav/konvexen Elemente aus einem nicht-onkogenen Material bestehen.
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Application Number | Priority Date | Filing Date | Title |
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US08/681,230 US5674296A (en) | 1994-11-14 | 1996-07-22 | Human spinal disc prosthesis |
US681230 | 1996-07-22 | ||
CA002202453A CA2202453C (en) | 1996-07-22 | 1997-04-11 | Human spinal disc prosthesis |
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DE69725932D1 DE69725932D1 (de) | 2003-12-11 |
DE69725932T2 true DE69725932T2 (de) | 2004-09-02 |
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DE69725932T Expired - Lifetime DE69725932T2 (de) | 1996-07-22 | 1997-06-06 | Menschliche Zwischenwirbel-Prothese |
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EP (2) | EP0820740B1 (de) |
AT (2) | ATE525982T1 (de) |
CA (1) | CA2202453C (de) |
DE (1) | DE69725932T2 (de) |
ES (1) | ES2210458T3 (de) |
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-
2003
- 2003-11-14 US US10/713,837 patent/US20040098131A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
ATE525982T1 (de) | 2011-10-15 |
CA2202453C (en) | 2006-08-29 |
USRE42480E1 (en) | 2011-06-21 |
ES2210458T3 (es) | 2004-07-01 |
EP1166725A3 (de) | 2002-07-03 |
US5674296A (en) | 1997-10-07 |
US6001130A (en) | 1999-12-14 |
EP1166725B1 (de) | 2011-09-28 |
EP1166725A2 (de) | 2002-01-02 |
US5865846A (en) | 1999-02-02 |
EP0820740B1 (de) | 2003-11-05 |
USRE42576E1 (en) | 2011-07-26 |
CA2202453A1 (en) | 1998-10-11 |
US6156067A (en) | 2000-12-05 |
DE69725932D1 (de) | 2003-12-11 |
US20040098131A1 (en) | 2004-05-20 |
ATE253339T1 (de) | 2003-11-15 |
EP0820740A1 (de) | 1998-01-28 |
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