DE20313512U1 - Implant used for closing gap created in annulus fibrous, designed in shape of flexible plug with rigid holding elements - Google Patents

Implant used for closing gap created in annulus fibrous, designed in shape of flexible plug with rigid holding elements Download PDF

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Publication number
DE20313512U1
DE20313512U1 DE20313512U DE20313512U DE20313512U1 DE 20313512 U1 DE20313512 U1 DE 20313512U1 DE 20313512 U DE20313512 U DE 20313512U DE 20313512 U DE20313512 U DE 20313512U DE 20313512 U1 DE20313512 U1 DE 20313512U1
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DE
Germany
Prior art keywords
implant according
stopper
implant
plug
annulus
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
Application number
DE20313512U
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German (de)
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.)
Aesculap AG
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Aesculap AG
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Filing date
Publication date
Application filed by Aesculap AG filed Critical Aesculap AG
Priority to DE20313512U priority Critical patent/DE20313512U1/en
Publication of DE20313512U1 publication Critical patent/DE20313512U1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
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    • 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
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
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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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    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
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    • 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
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    • A61F2002/009Special surfaces of prostheses, e.g. for improving ingrowth for hindering or preventing attachment of biological tissue
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/30004Material 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
    • A61F2002/30014Material 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 elasticity, stiffness or compressibility
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    • A61F2002/30016Material 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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Abstract

In case of a disk prolapse at the spine a gap is created in the wall of the disk (3), allowing some of the substance of the nucleus to escape, which can be replaced with the patients own cells grown from the substance after two weeks. A rectangular implant (20) made of a flexible material ideally absorbed by the body after some time can be used as a plug (20) closing the gap and kept in position by upper and lower vertical holding elements (21, 22) engaging with grooves (18, 19) located at the surfaces (6, 7) of the adjacent vertebrae (1, 2).

Description

Die Erfindung betrifft ein Implantat zum Verschluß einer Öffnung des Annulus fibrosus in Form eines Stopfens.The invention relates to an implant to close an opening of the Annulus fibrosus in the form of a stopper.

Die menschliche Wirbelsäule, insbesondere die Bandscheiben, sind einem natürlichen Alterungsprozeß unterworfen. Dabei verringert sich der Flüssigkeitsgehalt des gelartigen Kerns der Bandscheibe (Nucleus pulposus). Dadurch verliert die Bandscheibe an Höhe, und der faserartige Ring, der den Nucleus umgibt (Annulus fibrosus), wird immer stärker beansprucht. Es können Risse im Annulus entstehen, durch welche Nucleusmaterial nach außen gedrückt wird. So entstehen zunächst Vorwölbungen (Prolaps), bei denen das Nucleusmaterial noch innerhalb der Bandscheibe bleibt. Ist das Nucleusmaterial vollständig aus dem Annulus ausgetreten, spricht man von einem Sequester. Prolaps und Sequester können Schmerzen von unterschiedlichem Ausmaß hervorrufen, je nachdem wie stark die benachbarten Nervenwurzeln oder der Spinalkanal beeinträchtigt werden.The human spine, especially the Intervertebral discs, are a natural one Subject to aging process. This reduces the liquid content of the gel-like nucleus of the intervertebral disc (nucleus pulposus). Thereby the intervertebral disc loses height, and the fibrous ring that surrounds the nucleus (annulus fibrosus), is getting stronger claimed. It can Cracks develop in the annulus, through which nucleus material is pressed outwards. So initially arise protrusions (Prolapse), in which the nucleus material is still inside the intervertebral disc remains. When the nucleus material has completely exited the annulus, one speaks of a sequester. Prolapse and sequester can be painful of varying degrees, depending on how strong the neighboring nerve roots or the spinal canal be affected.

Bei einer Bandscheibenoperation wird deshalb zunächst alles ausgetretene Nucleusmaterial entfernt. Um sicherzugehen, daß es zu keinem erneuten Bandscheibenvorfall kommt, wird auch ein Teil des noch in der Bandscheibe befindlichen Nucleus entfernt (Nucleotomie). Das dabei entfernte Material kann zur Wiederherstellung oder Regeneration des Nucleus verwendet werden. Es wird nämlich ein Teil des Nucleusmaterials, welches dem Patienten bei der Nucleotomie entnommen wurde, dazu benutzt, um biotechnologisch Zellen neu anzuzüchten. Es wird ein Bandscheibenzelltransplatat aus körpereigenen Zellen hergestellt, welches dem Patienten etwa zwei Wochen nach der Bandscheibenoperation wieder in die Bandscheibe injiziert wird. Die injizierten Zellen siedeln sich wieder an und tragen zu einer Regeneration des noch vorhandenen Nucleus bei.During an intervertebral disc surgery therefore first all leaked nucleus material removed. To make sure it is too If there is no renewed herniated disc, part of the Nucleus still in the intervertebral disc removed (nucleotomy). The removed material can be used to restore or regenerate the Nucleus can be used. Because it becomes part of the nucleus material which was removed from the patient during the nucleotomy used to re-grow cells biotechnologically. It becomes a spinal disc cell transplant from the body's own Cells produced, which the patient about two weeks after the intervertebral disc surgery is injected back into the intervertebral disc. The injected cells resettle and contribute to one Regeneration of the remaining nucleus.

Allerdings ergibt sich dadurch ein Problem, daß der Annulus nicht mehr intakt ist, durch die bei der Nucleotomie erzeugte Öffnung und durch Risse im Annulus können die injizierten Zellen wieder entweichen und absterben, noch bevor sie anwachsen konnten.However, this results in a Problem that the Annulus is no longer intact due to the opening and nucleotomy through cracks in the annulus the injected cells escape and die even before they could grow.

Es ist bekannt, Öffnungen im Annulus durch Einsetzen von Annulusverschlüssen zu verschließen ( WO 01/10316 A1 ; WO 99/04720 ; WO 02/080821 ; WO 01/28464 ). In der Mehrzahl der Fälle stützt sich dabei der verwendete Verschlußkörper direkt am Annulusgewebe ab und ist mit diesem vernäht, verklebt oder in anderer Weise verbunden. Da das Annulusgewebe ein sehr flexibles Gewebe ist, ist auch der Verschluß den Bewegungen des Annulus ausgesetzt, und es besteht die Gefahr, daß dieser Verschluß sich unbeabsichtigt löst. In Ausnahmefällen wird der Verschlußkörper auch an den benachbarten Wirbelkörpern festgelegt, es handelt sich dann aber ausschließlich um netzartige oder membranartige Verschlüsse, die nach Art einer Folie die Annulusöffnung verschließen sollen. Dabei ist eine sichere Abdichtung nicht gewährleistet.It is known to close openings in the annulus by inserting annulus closures ( WO 01/10316 A1 ; WO 99/04720 ; WO 02/080821 ; WO 01/28464 ). In the majority of cases, the closure body used is supported directly on the annulus tissue and is sewn, glued or connected in some other way. Since the annulus tissue is a very flexible tissue, the closure is also subject to the movements of the annulus and there is a risk that this closure will unintentionally detach. In exceptional cases, the closure body is also attached to the adjacent vertebral bodies, but then these are exclusively mesh-like or membrane-like closures which are intended to close the annulus opening like a film. A secure seal is not guaranteed.

Es ist Aufgabe der Erfindung, ein gattungsgemäßes Implantat so auszubilden, daß einerseits eine sichere Festlegung des Implantates sichergestellt ist und andererseits ein zuverlässiger Verschluß der Annulusöffnung, wobei die Beweglichkeit des Annulus erhalten bleiben soll.It is an object of the invention generic implant to train so that on the one hand secure fixation of the implant is ensured and on the other hand a reliable Closure of the Annulusöffnung, the mobility of the annulus should be preserved.

Diese Aufgabe wird bei einem Implantat der eingangs beschriebenen Art erfindungsgemäß dadurch gelöst, daß der Stopfen an seiner Oberseite und an seiner Unterseite formstabile Verankerungselemente für die Endplatten benachbarter Wirbelkörper und im Bereich zwischen Oberseite und Unterseite eine verformbare Struktur aufweist.This task is done with an implant of the type described in the invention solved in that the stopper Anchoring elements of stable shape on the top and bottom for the End plates of adjacent vertebral bodies and a deformable area between the top and bottom Has structure.

Es wird also ein Implantat in Form eines Stopfens verwendet, welcher in die Öffnung des Annulus eingesetzt wird und welcher im wesentlichen eine verformbare Struktur aufweist, so daß er sich an die Struktur des Annulus anpaßt und sich insbesondere im Abdichtungsbereich am Rand der zu verschließenden Öffnung dicht an das Annulusgewebe anlegt, während er andererseits die freie Beweglichkeit des Annulusgewebes nicht beeinträchtigt. Andererseits läßt sich dieser verformbare Stopfen durch die formstabilen Verankerungselemente an der Oberseite und an der Unterseite des Stopfens an den Endplatten der benachbarten Wirbelkörper festlegen, so daß die Wirbelkörper die Positionierung des Stopfens gewährleisten, so daß dieser durch die Bewegung des Annulus nicht aus seiner Position entfernt wird.So it becomes an implant in shape of a stopper, which is inserted into the opening of the annulus and which essentially has a deformable structure, so he adapts to the structure of the annulus and especially in the Sealing area at the edge of the opening to be closed tightly against the annulus tissue, while on the other hand, he does not see the free mobility of the annulus tissue impaired. On the other hand, this deformable plug through the dimensionally stable anchoring elements on the top and bottom of the plug on the end plates of the neighboring vertebrae set so that the vertebra ensure the positioning of the plug so that it not removed from its position by the movement of the annulus becomes.

Die formstabilen Verankerungselemente können beispielsweise dadurch gebildet werden, daß gemäß einer bevorzugten Ausführungsform die Oberseite und/oder die Unterseite formstabiler sind als der zwischen Oberseite und Unterseite liegende Bereich des Stopfens. In diesem Falle wirken die Oberseite und die Unterseite als Verankerungselemente und bilden Anlageflächen, die an den Endplatten anliegen und dadurch den Stopfen in seiner Lage fixieren.The dimensionally stable anchoring elements can, for example are formed in that according to a preferred embodiment the top and / or bottom are more dimensionally stable than that area of the stopper between the top and bottom. In this case, the top and the bottom act as anchoring elements and form contact areas, which rest on the end plates and thereby the plug in its Fix position.

Es ist günstig, wenn das Implantat aus resorbierbarem Material besteht, so daß sich der Stopfen nach einiger Zeit auflöst. Sobald die implantierten Zellkulturen angewachsen sind, verschließen sie den Annulus wieder, so daß dann der Stopfen durch körpereigenes Gewebe ersetzt werden kann.It is beneficial if the implant is made resorbable material, so that the plug after some Dissolves time. As soon as the implanted cell cultures have grown, they close the annulus again, so that then the plug through the body's own Tissue can be replaced.

Der Stopfen kann insbesondere aus einem porösen Material bestehen, die Porengröße kann beispielsweise zwischen 150 μm und 200 μm liegen. Es ist dadurch möglich, Zellkulturen auch in den Stopfen zu injizieren, so daß diese auch in diesem Bereich anwachsen und die Öffnung beschleunigt verschließen.The plug can be made in particular a porous Material exist, for example, the pore size between 150 μm and 200 μm lie. This makes it possible Inject cell cultures also into the stopper so that this also grow in this area and close the opening faster.

Besonders vorteilhaft ist es, wenn die Oberseite und die Unterseite mindestens einen in die Endplatte des benachbarten Wirbelkörpers einsetzbaren Vorsprung tragen. Diese Vorsprünge können in das Material der benachbarten Wirbelkörper eingreifen und fixieren dadurch den Stopfen in der gewünschten Lage. Beispielsweise ist es möglich, im Wirbelkörper entsprechende Vertiefungen auszuarbeiten, in die diese Vorsprünge eingreifen.It is particularly advantageous if the upper side and the lower side carry at least one projection which can be inserted into the end plate of the adjacent vertebral body. These projections can engage in the material of the adjacent vertebrae and thereby fix the plug in the desired position. For example, it is possible to work out corresponding depressions in the vertebral body in which these projections engage.

Günstig ist es, wenn mehrere Vorsprünge in einer Linie nebeneinander liegen, diese Vorsprünge können dann beispielsweise in eine linienförmige Vertiefung der Endplatte eingreifen.Cheap it is when there are multiple protrusions next to each other in a line, these projections can then for example in a linear depression engage the end plate.

Bei einer anderen Ausführungsform ist vorgesehen, daß der Vorsprung eine Längsrippe ist.In another embodiment it is envisaged that the Protrusion a longitudinal rib is.

Dabei ist es vorteilhaft, wenn die Linie der Vorsprünge bzw. die Längsrichtung der Längsrippe parallel zur Einschubrichtung des Stopfens verläuft. Man kann auf diese Weise den Stopfen in die Öffnung einschieben, und gleichzeitig greifen die in einer Linie hintereinander angeordneten Vorsprünge oder die entsprechend ausgerichtete Längsrippe in eine in Vorschubrichtung verlaufende Rinne im Wirbelkörper ein, die vor dem Einsetzen in den Wirbelkörper eingearbeitet wird. Man erhält auf diese Weise eine sehr sichere Festlegung des Stopfens.It is advantageous if the Line of protrusions or the longitudinal direction parallel to the longitudinal rib to the direction of insertion of the plug. You can do that the plug into the opening insert, and at the same time they grip in a line arranged projections or the correspondingly aligned longitudinal rib into a groove in the vertebral body running in the direction of advance, which is worked into the vertebral body before insertion. you receives in this way a very secure fixing of the plug.

Eine zusätzliche Fixierung des Stopfens kann man dadurch erreichen, daß der Vorsprung eine Zahnung aufweist.An additional fixation of the plug can one can achieve that the Projection has a toothing.

Insbesondere bei größeren Stopfen ist es günstig, wenn quer zur Einschubrichtung des Stopfens nebeneinander mehrere Vorsprünge angeordnet sind, so daß eine besonders homogene Festlegung des Stopfens in den benachbarten Wirbelkörpern erfolgen kann.Especially with larger plugs is it convenient if several crosswise to the direction of insertion of the stopper projections are arranged so that a the plug in the adjacent vertebral bodies is particularly homogeneous can.

Dabei ist es vorteilhaft, wenn die Vorsprünge gegenüber der Seitenfläche des Stopfens zurückgesetzt sind, so daß die seitlich überstehenden Teile des Stopfens sich optimal an das Gewebe des Annulus anpassen können, da dieses Gewebe flexibel und gegebenenfalls elastisch ausgebildet ist.It is advantageous if the Lead over the side surface of the stopper are so that the protruding laterally Parts of the stopper adapt optimally to the tissue of the annulus can, because this fabric is flexible and possibly elastic is.

Bei einer bevorzugten Ausführungsform ist vorgesehen, daß der Stopfen die Form eines Würfels oder Quaders hat, es sind aber auch andere Formen des Stopfens möglich, beispielsweise können Stopfen in Zylinderform verwendet werden, deren Längsachse parallel zur Einschubrichtung verläuft.In a preferred embodiment it is envisaged that the Plug the shape of a cube or Cuboid has, but other forms of tamping are possible, for example can Plugs are used in cylindrical form, their longitudinal axis runs parallel to the direction of insertion.

Bei einer besonders bevorzugten Ausführungsform ist der Stopfen mit einer Membran abgedeckt, die ebenfalls aus resorbierbarem Material besteht, dies dichtet den Stopfen nach außen zusätzlich ab, so daß in ihn injizierte Zellen sicher im Stopfen verbleiben.In a particularly preferred embodiment the stopper is covered with a membrane, which is also made of absorbable Material exists, this additionally seals the plug to the outside, so that in cells injected remain safely in the stopper.

Günstig ist es dabei, wenn die Membran langsamer resorbierbar ist als der Stopfen.Cheap it is when the membrane is more slowly absorbable than the Plug.

Weiterhin kann vorgesehen sein, daß der Stopfen an seiner Außenseite mit einem Anti-Adhäsionsmittel versehen ist, um in diesem Bereich die Bildung von Narbengewebe zu vermeiden.Furthermore, it can be provided that the stopper on its outside with an anti-adhesive is provided to the formation of scar tissue in this area to avoid.

Es ist vorteilhaft, wenn das Implantat Teil eines Satzes von Stopfen mit unterschiedlicher Höhe und/oder Breite ist, so daß der Operateur während der Operation aus diesem Satz einen Stopfen der geeigneten Abmessungen auswählen kann und dadurch eine optimale Abdichtung der Öffnung des Annulus fibrosus erreicht.It is advantageous if the implant Part of a set of plugs of different heights and / or Width is so that the Surgeon during the Operation from this set a stopper of the appropriate dimensions choose can and thus an optimal seal of the opening of the annulus fibrosus reached.

Die nachfolgende Beschreibung bevorzugter Ausführungsformen der Erfindung dient im Zusammenhang mit der Zeichnung der näheren Erläuterung. Es zeigen:The following description of preferred embodiments the invention serves in conjunction with the drawing for a more detailed explanation. Show it:

1a: eine schematische Draufsicht auf den zwischen zwei Wirbelkörpern angeordneten Annulus fibrosus mit einem eingesetzten Implantat zum Verschluß einer Öffnung in diesem; 1a : a schematic plan view of the annulus fibrosus arranged between two vertebral bodies with an inserted implant for closing an opening in it;

1b: eine Seitenansicht auf die Wirbelkörper der 1; 1b : a side view of the vertebrae of the 1 ;

2: eine perspektivische Ansicht des Implantates der 1a und 1b mit geänderten Abmessungen; 2 : a perspective view of the implant of the 1a and 1b with changed dimensions;

3: ein abgewandeltes Ausführungsbeispiel eines Implantates mit mehreren Stegen zur Verankerung in den benachbarten Wirbelkörpern; 3 : a modified embodiment of an implant with several webs for anchoring in the adjacent vertebral bodies;

4: eine schematische Ansicht eines Wirbelkörpers und eines Annulus fibrosus mit einem Bandscheibenvorfall; 4 : a schematic view of a vertebral body and an annulus fibrosus with a herniated disc;

5: eine Darstellung ähnlich 4 beim Eröffnen des Annulus fibrosus und beim Entfernen von überschüssigem Nucleusgewebe; 5 : a representation similar 4 when opening the annulus fibrosus and removing excess nucleus tissue;

6: eine Ansicht ähnlich 1 beim Einsetzen eines Probeimplantats in die Annulusöffnung; 6 : a view similar 1 when inserting a trial implant into the annulus opening;

7: eine Ansicht ähnlich 6 beim Einsetzen eines Meißels zur Vorbereitung der Endplatten des benachbarten Wirbelkörpers; 7 : a view similar 6 when inserting a chisel to prepare the end plates of the adjacent vertebral body;

8: eine Ansicht ähnlich 1 beim Einsetzen eines Implantates zum Verschluß des Annulus; 8th : a view similar 1 when inserting an implant to close the annulus;

9: eine Ansicht ähnlich 4 mit eingesetztem Implantat und 9 : a view similar 4 with inserted implant and

10: eine Ansicht ähnlich 9 beim Injizieren von Zellmaterial in das Implantat und in den Nucleus. 10 : a view similar 9 when injecting cellular material into the implant and into the nucleus.

Wie aus der Zeichnung, insbesondere aus den 1a, 1b und 4 deutlich wird, ist zwischen zwei Wirbelkörpern 1, 2 eine Bandscheibe 3 angeordnet, die aus dem zentralen Nucleus 4 und dem sie umgebenden Annulus fibrosus 5 besteht. In der Darstellung der 4 ist der obere Wirbelkörper 1 der besseren Sichtbarkeit wegen weggelassen, es versteht sich aber, daß dieser obere Wirbelkörper 1 mit seiner unteren Endplatte 6 ebenso wie der untere Wirbelkörper 2 mit seiner oberen Endplatte 7 flächig an der Bandscheibe 3 anliegt.As from the drawing, especially from the 1a . 1b and 4 is clear is between two vertebral bodies 1 . 2 an intervertebral disc 3 arranged that from the central nucleus 4 and the surrounding annulus fibrosus 5 consists. In the representation of the 4 is the upper vertebral body 1 omitted for better visibility, but it goes without saying that this upper vertebral body 1 with its lower end plate 6 just like the lower vertebra 2 with its top end plate 7 flat on the intervertebral disc 3 is applied.

In 4 ist schematisch dargestellt, daß durch eine Öffnung 8 im Annulus fibrosus, die beispielsweise die Form eines Risses haben kann, Nucleusmaterial 9 aus dem Nucleus 4 nach außen austritt, dieses austretende Material kann auf benachbarte Nervenwurzeln drücken und Schmerzen verursachen.In 4 is shown schematically that through an opening 8th in the annulus fibrosus, which may have the shape of a crack, for example, nucleus material 9 from the nucleus 4 leaks outwards, this leaking material can press on neighboring nerve roots and cause pain.

Um diese Verletzung zu beheben, wird in einer Operation das aus der Öffnung 8 austretende Nucleusmaterial 9 entfernt, dies kann beispielsweise mit Hilfe eines zangenförmigen Instrumentes 10 erfolgen, welches das gallertartige Nucleusmaterial 9 abtrennt und auch dazu verwendet werden kann, die Öffnung 8 zu vergrößern bzw. an den Rändern zu glätten (5). Das dabei entfernte Nucleusmaterial 9 kann zur Anzucht einer körpereigenen Zellkultur verwendet werden, auf diese Weise gelingt es, beispielsweise innerhalb von zwei Wochen eine Zellkultur herzustellen, die dann in der nachstehend beschriebenen Weise verwendet werden kann.In order to remedy this injury, the operation turns out of the opening 8th emerging nucleus material 9 removed, this can be done, for example, with the help of a plier-shaped instrument 10 take place, which is the gelatinous nucleus material 9 separates and can also be used to opening 8th to enlarge or smooth around the edges ( 5 ). The nucleus material removed 9 can be used to cultivate an endogenous cell culture, in this way it is possible, for example, to produce a cell culture within two weeks, which can then be used in the manner described below.

In einem weiteren Operationsschritt muß die Öffnung 8 verschlossen werden. Dazu wird zunächst in die Öffnung 8 ein Probeimplantat 11 eingesetzt, welches beispielsweise aus einem körperverträglichen Metall besteht und im Verhältnis zur Größe der Öffnung 8 so gewählt wird, daß beim Einführen des Probeimplantates 11 in die Öffnung 8 diese nicht unnötig vergrößert wird. Das Probeimplantat 11 kann beispielsweise die Form eines relativ schmalen Quaders haben. Das Probeimplantat 11 ist über eine Stange 12 mit einem in der Zeichnung nicht dargestellten Handgriff verbindbar (6) und weist seitliche Vorsprünge 13 auf, die die Einschubtiefe in die Öffnung 8 begrenzen.The opening must be carried out in a further operation 8th be closed. To do this, first go into the opening 8th a trial implant 11 used, which consists for example of a body-compatible metal and in relation to the size of the opening 8th is chosen so that when inserting the trial implant 11 into the opening 8th it is not enlarged unnecessarily. The trial implant 11 can have the shape of a relatively narrow cuboid, for example. The trial implant 11 is over a peg 12 connectable with a handle not shown in the drawing ( 6 ) and has side protrusions 13 on the insertion depth into the opening 8th limit.

An seiner Oberseite und an seiner Unterseite ist in das Probeimplantat 11 eine zur Stange 12 parallele, mittige Nut 14 eingearbeitet, diese bildet eine Führungsnut aus für einen Meißel 15. Dieser Meißel 15 ist am Ende eines rohrförmigen Schaftes 16 gehalten, der nach Abnahme des Handgriffes von der Stange 12 über diese geschoben werden kann (7). Dabei wird der Meißel 15 in der Nut 14 geführt und steht mit seiner Schneide 17 aus dieser hervor. Wird der Meißel 15 längs der Stange 12 vorgetrieben, schneidet er mit seiner Schneide 17 eine Nut 18 in die benachbarte Endplatte 6 des Wirbelkörpers 1, diese Nut verläuft dann parallel zur Nut 14 im Probeimplantat 11.At its top and at its bottom is in the trial implant 11 one to the pole 12 parallel, central groove 14 incorporated, this forms a guide groove for a chisel 15 , That chisel 15 is at the end of a tubular shaft 16 held by the bar after removing the handle 12 can be pushed over this ( 7 ). This will be the chisel 15 in the groove 14 guided and stands with its cutting edge 17 out of this. Becomes the chisel 15 along the bar 12 driven, it cuts with its cutting edge 17 a groove 18 into the adjacent end plate 6 of the vertebral body 1 , this groove then runs parallel to the groove 14 in the trial implant 11 ,

In gleicher Weise kann auf der Unterseite der Bandscheibe 3 vorgegangen werden, auf diese Weise wird dort eine entsprechende Nut 19 in die Endplatte 7 des Wirbelkörpers 2 eingearbeitet.In the same way, on the underside of the intervertebral disc 3 be proceeded in this way there is a corresponding groove 19 into the end plate 7 of the vertebral body 2 incorporated.

Nach Entnahme des Probeimplantates 11 kann in die Öffnung 8. nunmehr ein diese verschließendes Implantat 20 eingesetzt werden, welches in dem in 8 dargestellten Ausführungsbeispiel die Form eines Quaders aufweist, der an seiner Oberseite und an seiner Unterseite mittig verlaufende Stege oder Rippen 21, 22 trägt, die parallel zu den Kanten des Implantates 20 verlaufen. Das Implantat 20 wird mittels eines geeigneten, das Implantat 20 lösbar ergreifenden Einsetzinstrumentes 23 in die Öffnung 8 eingeschoben, die Vorschubrichtung verläuft dabei parallel zur Längsrichtung der Rippen 21, 22, die beim Einschieben in die Nuten 18 bzw. 19 eintreten. Sobald das Implantat 20 vollständig in die Öffnung 8 eingeschoben ist, kann das Einsetzinstrument gelöst und abgenommen werden.After removal of the trial implant 11 can in the opening 8th , now an implant closing this 20 be used, which in the 8th The illustrated embodiment has the shape of a cuboid, the webs or ribs running centrally on its upper side and on its lower side 21 . 22 bears parallel to the edges of the implant 20 run. The implant 20 is by means of a suitable, the implant 20 releasably gripping insertion instrument 23 into the opening 8th inserted, the feed direction runs parallel to the longitudinal direction of the ribs 21 . 22 that when inserted into the grooves 18 respectively. 19 enter. Once the implant 20 completely into the opening 8th is inserted, the insertion instrument can be released and removed.

Wie aus der Darstellung der 9 erkennbar ist, verschließt nunmehr das Implantat 20 die Öffnung 8 und stützt sich mit seiner Oberseite an der Endplatte 6 des Wirbelkörpers 1 und mit seiner Unterseite an der Endplatte 7 des Wirbelkörpers 2 ab, die Rippen 21 und 22 greifen in die Nuten 18 bzw. 19 ein und legen dadurch das Implantat 20 in dieser Position fest.As from the representation of the 9 is recognizable, the implant now closes 20 the opening 8th and rests with its top on the end plate 6 of the vertebral body 1 and with its bottom on the end plate 7 of the vertebral body 2 off the ribs 21 and 22 engage in the grooves 18 or 19 and thereby insert the implant 20 stuck in this position.

Das Implantat 20 besteht aus einem resorbierbaren Material und ist porös ausgebildet, die Größe der Poren liegt zwischen 150 und 200 μm. Das Material des stopfenförmigen Implantates 20 ist flexibel und elastisch, so daß es sich optimal an die Kontur der Öffnung 8 anpaßt und auch die Bewegungen des Materials des Annulus fibrosus ohne weiteres mitmacht. Dagegen sind die Rippen 21 und 22 formstabil ausgebildet, also wesentlich härter und nicht in gleicher Weise verformbar oder elastisch wie das übrige Material des Implantates 20. Dadurch ergibt sich im Bereich der Festlegung des Implantates 20 an den benachbarten Wirbelkörpern 1, 2 eine formstabile Verbindung, dazwischen jedoch paßt sich das Material des Implantates 20 an die Beweglichkeit des Materials des Annulus fibrosus an und verschließt die Öffnung 8 zuverlässig.The implant 20 consists of a resorbable material and is porous, the size of the pores is between 150 and 200 μm. The material of the plug-shaped implant 20 is flexible and elastic, so that it optimally conforms to the contour of the opening 8th adapts and also easily follows the movements of the material of the annulus fibrosus. Against are the ribs 21 and 22 dimensionally stable, so much harder and not deformable or elastic in the same way as the rest of the material of the implant 20 , This results in the area of the fixation of the implant 20 on the neighboring vertebral bodies 1 . 2 a dimensionally stable connection, but in between the material of the implant fits 20 to the flexibility of the material of the annulus fibrosus and closes the opening 8th reliable.

Das gesamte Material des Stopfens zwischen den Rippen 21, 22 kann in dieser Weise flexibel oder elastisch ausgebildet sein, es ist aber auch möglich, daß das Material des Stopfens zu den Rippen 21, 22 hin zunehmend fester wird, beispielsweise könnte die Oberseite und die Unterseite des Stopfens in ähnlicher Weise formstabil ausgebildet sein wie die Rippen 21, 22, so daß sie formstabile Anlageflächen an die Endplatten der Wirbelkörper ausbilden. Wichtig ist lediglich, daß das Material des Stopfens im mittleren Bereich flexibel und elastisch ist, um eine Anpassung an die Beweglichkeit des Annulus-fibrosus-Gewebes zu gewährleisten.All the material of the plug between the ribs 21 . 22 can be flexible or elastic in this way, but it is also possible that the material of the plug to the ribs 21 . 22 becomes increasingly firmer, for example the top and bottom of the stopper could be designed to be dimensionally stable in a similar manner to the ribs 21 . 22 , so that they form stable contact surfaces on the end plates of the vertebral bodies. It is only important that the material of the stopper is flexible and elastic in the middle area in order to ensure adaptation to the mobility of the annulus fibrosus tissue.

Wenn die Öffnung 8 im Annulus fibrosus 5 auf diese Weise verschlossen ist, kann man das außerhalb des Körpers angezüchtete Zellmaterial in das Innere der Bandscheibe 3 einfüllen. Dies erfolgt in der Regel etwa zwei Wochen nach der vorstehend beschriebenen Operation. Die Einfüllung kann mit Hilfe einer Injektionsnadel 24 erfolgen (10), die durch das Implantat 20 hindurch in den Innenraum der Bandscheibe 3 eingeführt wird und das Material sowohl in diesen Innenraum als auch in den porösen Bereich des Implantates 20 injiziert. Die injizierten Körperzellen wachsen im Innenraum der Bandscheibe 3 und im Implantat 20 an und verschließen schließlich die Öffnung 8 zuverlässig, so daß die Öffnung auch dann verschlossen bleibt, wenn sich das Implantat 20 allmählich zersetzt und vom Körper resorbiert wird.If the opening 8th in the annulus fibrosus 5 is closed in this way, the cell material grown outside the body can be inside the intervertebral disc 3 Fill. This is usually done about two weeks after the surgery described above. The filling can be done with the help of an injection needle 24 respectively ( 10 ) caused by the implant 20 through into the interior of the intervertebral disc 3 is introduced and the material both in this interior and in the porous area of the implant 20 injected. The injected body cells grow inside the intervertebral disc 3 and in the implant 20 and finally close the opening 8th reliable, so that the opening remains closed even when the implant 20 gradually decomposes and is absorbed by the body.

Bei dem in den 1 bis 10 dargestellten Ausführungsbeispiel ist das Implantat 20 im wesentlichen würfelförmig oder quaderförmig ausgebildet und trägt an seiner Oberseite und an seiner Unterseite jeweils einen mittig angeordneten Steg.In the in the 1 to 10 The illustrated embodiment is the implant 20 essentially cubic or cuboid and each has a centrally arranged web on its top and bottom.

Bei dem abgewandelten Ausführungsbeispiel der 3 ist das Implantat 20 auch im wesentlichen quaderförmig ausgebildet, jedoch breiter, und dementsprechend sind auf der Oberseite und der Unterseite zwei parallel zueinander verlaufende Rippen 21 bzw. 22 angeordnet, die von den Seitenflächen des Implantates 20 einen Abstand einhalten, so daß im Bereich der Seitenflächen das Implantat aufgrund der nachgiebigen und elastischen Struktur sich optimal an das Gewebe des Annulus fibrosus anpassen kann, während das Implantat 20 durch die parallel verlaufenden Rippen 21, 22 in entsprechenden doppelten Nuten 18, 19 in den Endplatten der Wirbelkörper fixiert wird.In the modified embodiment of the 3 is the implant 20 also essentially cuboid, but wider, and accordingly there are two parallel ribs on the top and bottom 21 respectively. 22 arranged by the side faces of the implant 20 keep a distance so that the implant can adapt optimally to the tissue of the annulus fibrosus in the area of the side surfaces due to the resilient and elastic structure, while the implant 20 through the parallel ribs 21 . 22 in corresponding double grooves 18 . 19 the vertebral body is fixed in the end plates.

Anstelle der Rippen 21, 22 könnten auch mehrere stiftförmige Vorsprünge vorgesehen werden, die in einer Reihe nebeneinander liegen. Außerdem ist es zur besseren Festlegung des Implantates in den Wirbelkörpern möglich, die Rippen oder Vorsprünge mit einer Zahnung zu versehen, die in die Seitenwände der Nuten 18, 19 eingreifen.Instead of the ribs 21 . 22 several pin-shaped projections could also be provided, which lie side by side in a row. In addition, for better fixation of the implant in the vertebral bodies, it is possible to provide the ribs or protrusions with a toothing that fits into the side walls of the grooves 18 . 19 intervention.

An seiner Außenseite kann das Implantat 20 mit einer Membran 25 abgedeckt sein (1b), die dicht ausgebildet ist und das poröse Implantat 20 nach außen hin abdichtet. Auch diese Membran 25 kann aus resorbierbarem Material bestehen, vorzugsweise zersetzt sich dieses Material langsamer als das Material des übrigen Implantates 20 und wird dementsprechend später resorbiert.The implant can be on the outside 20 with a membrane 25 be covered ( 1b ), which is dense and the porous implant 20 seals to the outside. This membrane too 25 can consist of resorbable material, this material preferably decomposes more slowly than the material of the rest of the implant 20 and is accordingly reabsorbed later.

Außerdem kann in diesem Bereich eine in der Zeichnung nicht näher dargestellte Anti-Adhäsionsschicht aufgetragen werden, diese kann beispielsweise aus einem gelatinehaltigen Gel oder Spray bestehen. Dadurch kann eine postoperative Entstehung von Narbengewebe verhindert werden.It can also in this area one not in the drawing anti-adhesion layer shown can be applied, for example, from a gelatin-containing Gel or spray exist. This can result in postoperative development can be prevented by scar tissue.

Claims (17)

Implantat zum Verschluß einer Öffnung des Annulus fibrosus in Form eines Stopfens, dadurch gekennzeichnet, daß der Stopfen (20) an seiner Oberseite und an seiner Unterseite formstabile Verankerungselemente (21, 22) für die Endplatten (6, 7) benachbarter Wirbelkörper (1, 2) und im Bereich zwischen Oberseite und Unterseite eine verformbare Struktur aufweistImplant for closing an opening of the annulus fibrosus in the form of a stopper, characterized in that the stopper ( 20 ) dimensionally stable anchoring elements on its top and bottom ( 21 . 22 ) for the end plates ( 6 . 7 ) adjacent vertebral body ( 1 . 2 ) and has a deformable structure in the area between the top and bottom Implantat nach Anspruch 1, dadurch gekennzeichnet, daß die Oberseite und/oder die Unterseite formstabiler sind als die zwischen Oberseite und Unterseite liegenden Bereiche des Stopfens (20).Implant according to claim 1, characterized in that the top and / or the bottom are more dimensionally stable than the areas of the stopper (between the top and bottom) ( 20 ). Implantat nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß es aus resorbierbarem Material besteht.Implant according to claim 1 or 2, characterized in that it consists of resorbable material. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß der Stopfen (20) aus porösem Material besteht.Implant according to one of the preceding claims, characterized in that the stopper ( 20 ) consists of porous material. Implantat nach Anspruch 4, dadurch gekennzeichnet, daß die Porengröße des porösen Materials zwischen 150 μm und 200 μm liegt.Implant according to claim 4, characterized in that the pore size of the porous material between 150 μm and 200 μm. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß die Oberseite und die Unterseite mindestens einen in die Endplatte (6, 7) des benachbarten Wirbelkörpers (1, 2) einsetzbaren Vorsprung (21, 22) trägt.Implant according to one of the preceding claims, characterized in that the upper side and the lower side have at least one in the end plate ( 6 . 7 ) of the neighboring vertebral body ( 1 . 2 ) usable lead ( 21 . 22 ) wearing. Implantat nach Anspruch 6, dadurch gekennzeichnet, daß mehrere Vorsprünge in einer Linie nebeneinander liegen.Implant according to claim 6, characterized in that several projections lie next to each other in a line. Implantat nach Anspruch 6, dadurch gekennzeichnet, daß der Vorsprung eine Längsrippe (21, 22) ist.Implant according to claim 6, characterized in that the projection has a longitudinal rib ( 21 . 22 ) is. Implantat nach einem der Ansprüche 7 oder 8, dadurch gekennzeichnet, daß die Linie der Vorsprünge bzw. die Längsrichtung der Längsrippen (21, 22) parallel zur Einschubrichtung des Stopfens (20) verläuft.Implant according to one of claims 7 or 8, characterized in that the line of the projections or the longitudinal direction of the longitudinal ribs ( 21 . 22 ) parallel to the insertion direction of the plug ( 20 ) runs. Implantat nach einem der Ansprüche 6 bis 9, dadurch gekennzeichnet, daß der Vorsprung (21, 22) eine Zahnung aufweist.Implant according to one of claims 6 to 9, characterized in that the projection ( 21 . 22 ) has teeth. Implantat nach einem der Ansprüche 6 bis 10, dadurch gekennzeichnet, daß quer zur Einschubrichtung des Stopfens (20) nebeneinander mehrere Vorsprünge (21, 22) angeordnet sind.Implant according to one of claims 6 to 10, characterized in that transverse to the direction of insertion of the stopper ( 20 ) several tabs next to each other ( 21 . 22 ) are arranged. Implantat nach Anspruch 11, dadurch gekennzeichnet, daß die Vorsprünge (21, 22) gegenüber der Seitenfläche des Stopfens (20) zurückgesetzt sind.Implant according to claim 11, characterized in that the projections ( 21 . 22 ) opposite the side surface of the plug ( 20 ) are reset. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß der Stopfen (20) die Form eines Würfels oder Quaders hat.Implant according to one of the preceding claims, characterized in that the stopper ( 20 ) has the shape of a cube or cuboid. Implantat nach einem der Ansprüche 3 bis 13, dadurch gekennzeichnet, daß der Stopfen (20) mit einer Membran (25) abgedeckt ist, die ebenfalls aus resorbierbarem Material besteht.Implant according to one of claims 3 to 13, characterized in that the stopper ( 20 ) with a membrane ( 25 ) is covered, which also consists of resorbable material. Implantat nach Anspruch 14, dadurch gekennzeichnet, daß die Membran (25) langsamer resorbierbar ist als der Stopfen (20).Implant according to claim 14, characterized in that the membrane ( 25 ) is more slowly absorbable than the stopper ( 20 ). Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß der Stopfen (20) an seiner Außenseite mit einem Anti-Adhäsionsmittel versehen ist.Implant according to one of the preceding claims, characterized in that the stopper ( 20 ) is provided on the outside with an anti-adhesive. Implantat nach einem der voranstehenden Ansprüche, dadurch gekennzeichnet, daß es Teil eines Satzes von Stopfen (20) mit unterschiedlicher Höhe und/oder Breite ist.Implant according to one of the preceding claims, characterized in that it is part of a set of plugs ( 20 ) with different heights and / or widths.
DE20313512U 2003-08-26 2003-08-26 Implant used for closing gap created in annulus fibrous, designed in shape of flexible plug with rigid holding elements Expired - Lifetime DE20313512U1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006044649A2 (en) * 2004-10-14 2006-04-27 Sdgi Holdings, Inc. Implant system, method, and instrument for augmentation or reconstruction of intervertebral disc
EP2077801A2 (en) * 2006-07-28 2009-07-15 Spinalmotion Inc. Spinal prosthesis with multiple pillar anchors

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006044649A2 (en) * 2004-10-14 2006-04-27 Sdgi Holdings, Inc. Implant system, method, and instrument for augmentation or reconstruction of intervertebral disc
WO2006044649A3 (en) * 2004-10-14 2006-09-21 Sdgi Holdings Inc Implant system, method, and instrument for augmentation or reconstruction of intervertebral disc
US7682393B2 (en) 2004-10-14 2010-03-23 Warsaw Orthopedic, Inc. Implant system, method, and instrument for augmentation or reconstruction of intervertebral disc
EP2077801A2 (en) * 2006-07-28 2009-07-15 Spinalmotion Inc. Spinal prosthesis with multiple pillar anchors
EP2077801A4 (en) * 2006-07-28 2012-01-25 Spinalmotion Inc Spinal prosthesis with multiple pillar anchors

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