DE102008042401A1 - Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells - Google Patents
Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells Download PDFInfo
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- DE102008042401A1 DE102008042401A1 DE102008042401A DE102008042401A DE102008042401A1 DE 102008042401 A1 DE102008042401 A1 DE 102008042401A1 DE 102008042401 A DE102008042401 A DE 102008042401A DE 102008042401 A DE102008042401 A DE 102008042401A DE 102008042401 A1 DE102008042401 A1 DE 102008042401A1
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- matrix layer
- disc implant
- implant according
- carrier component
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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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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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
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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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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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Abstract
Description
Die Erfindung betrifft ein künstliches Bandscheibenimplantat sowie ein Verfahren zum Herstellen eines solchen gemäß des ersten bzw. elften Patentanspruchs.The The invention relates to an artificial disc implant and a method of manufacturing such according to first or eleventh claim.
Bandscheiben sind knorpelähnliche Verbindungselemente, die zwischen jedem Wirbel einer Wirbelsäule eines Menschen oder eines Wirbeltieres angeordnet und mit diesen verwachsen sind. Sie bestehen aus einen äußeren Faserring (Anulus Fibrosus) und einer inneren Gallertkern (Nucleus Pulposus). Bandscheiben sind im Gegensatz zu den Wirbeln elastisch und bewirken damit die Beweglichkeit der Wirbelsäule. Sie übernehmen damit neben der Aufnahme von Körpergewicht auch die Funktion von Biegelementen.Band washers are cartilage-like fasteners that intervene any vertebra of a spine of a human or a human Vertebrate arranged and fused with these. They persist from an outer fiber ring (Anulus Fibrosus) and an inner nucleus (nucleus pulposus). Intervertebral discs are in contrast to the vertebrae elastic and thus cause the mobility of the Spine. They take over next to the recording body weight also the function of bending elements.
Bei einem sog. Bandscheibenvorfall kommt es meist in Folge einer Überlastung zu einer Beschädigung oder Zerstörung einer Bandscheibe, insbesondere des äußeren Faserrings. Ist die Bandscheibe danach nicht mehr reparabel, ist sie, sofern man eine künstliche lokale Versteifung vermeiden möchte, durch ein Bandscheibenimplantat zu ersetzen.at A so-called herniated disc usually occurs as a result of overloading damage or destruction of an intervertebral disc, in particular the outer fiber ring. Is the disc After that it is not repairable anymore, it is, if you have an artificial one to avoid local stiffening, through an intervertebral disc implant to replace.
Bekannte Bandscheibenimplantate sind Biegeelemente, die anstelle der Bandscheiben zwischen zwei Wirbel eingesetzt werden und mit diesen fest verbunden werden.Known Disc implants are bending elements that replace the discs be inserted between two vertebrae and firmly connected with these become.
Beispielhaft
offenbart die
Die vorgenannten Bandscheibenimplantate sind jedoch nicht nur aufwendig und komplex in ihrem Aufbau, sondern erfordern zur Verankerung oftmals auch signifikante Eingriffe in die benachbarten Gewebebereiche oder Knochen.The However, the aforementioned disc implants are not only expensive and complex in their construction, but also often require anchoring significant interference with adjacent tissue areas or bones.
Alternativ sind Bandscheibenimplantate bekannt, die aus einem biokompatiblen oder bioresorbierbaren Material bestehen, die eine Matrix für das Neuwachstum von Zwischenwirbel-Fibrocyten bilden und nach Bildung dieser sich zurückbilden.alternative Disc implants are known that consist of a biocompatible or bioresorbable material consisting of a matrix for Form the new growth of intervertebral fibrocytes and after formation they regress.
Beispielsweise
offenbart
Resorbierbare Trägermaterialien zeichnen sich zwar durch eine einfache Handhabbarkeit bei der Implantation aus, weisen aber oftmals nur eine ungenügende mechanische Stabilität auf und neigen daher bei länger andauernder oder wiederkehrender Belastung zu plastischer Verformung.absorbable Carrier materials are characterized by a simple Handling during implantation, but often have only an insufficient mechanical stability and are therefore prone to prolonged or recurrent loading to plastic deformation.
Davon ausgehend liegt die Aufgabe der Erfindung darin, ein Bandscheibenimplantat vorzuschlagen, das sich durch eine mechanische Langzeitstabilität sowie einer unkomplizierten Handhabung auszeichnet. Ferner liegt die Aufgabe auch darin, ein Verfahren zur Herstellung des Bandscheibenimplantats vorzuschlagen.From that Based on the object of the invention is an intervertebral disc implant to propose that by a mechanical long-term stability and uncomplicated handling. Further lies the task also therein, a method for producing the disc implant propose.
Die Aufgabe wird mit einem Bandscheibenimplantat und einem Verfahren mit den Merkmalen des Anspruch 1 bzw. 12 gelöst. Unteransprüche geben vorteilhafte Ausführungsformen wieder.The Task is with an intervertebral disc implant and a procedure with the features of claim 1 or 12 solved. under claims give advantageous embodiments again.
Das Bandscheibenimplantat umfasst im Wesentlichen zwei Komponenten, eine Trägerkomponente sowie einen Kern, der ganz oder teilweise mit einer Matrixschicht beschichtet ist. Die Trägerkomponente weist vorzugsweise eine Perforierung oder Durchbrüche aufweist oder wird aus einen Netzgewebe gebildet. Damit ist sie von Zellkulturen gut durchdringbar und in deren Volumen gut integrierbar. Sie umgibt vorzugsweise ganz oder teilweise den Kern und die Matrixschicht und weist dabei eine vorzugsweise die Form einer natürlichen Bandscheibe auf.The Disc implant essentially comprises two components, a carrier component and a core, in whole or in part coated with a matrix layer. The carrier component preferably has a perforation or openings or is made of a netting. This is her cell culture good penetrable and well integrable in their volume. It surrounds preferably completely or partially the core and the matrix layer and has a preferably the shape of a natural Intervertebral disc.
Der Kern dient der elastischen Verformbarkeit des Bandscheibenimplantats und besteht vorzugsweise aus einem elastischen Formkörper. Er nimmt als Kraftbrücke zwischen jeweils zwei benachbarten Wirbeln die zwischen zwei Wirbeln auftretenden Kräfte auf. Vorzugsweise besteht der Kern aus einem Voll- oder Hohlkörper aus einem elastischen biokompatiblen Material wie z. B. Silikonkautschuk.Of the Core serves the elastic deformability of the disc implant and preferably consists of an elastic molded body. He takes as a power bridge between each two adjacent Whirl up the forces between two vertebrae. Preferably, the core consists of a solid or hollow body made of an elastic biocompatible material such. B. silicone rubber.
Ist der Kern als Hohlkörper gebildet, weist dieser eine oder mehrere mit einem Fluid oder mehrerer Fluide gefüllte Kavitäten auf. Vorzugsweise sind die Fluide nicht toxisch und biologisch resorbierbar, sodass sie bei einer Beschädigung des Kerns mit einem Auslaufen der Fluide aus den Kavitäten möglichst keine Schäden auslösen und im Körper biologisch abgebaut werden können. Gasförmige Fluide sind kompressibel und bewirken eine Einstellung der elastischen Eigenschaften, bereiten aber bei einer Beschädigung mit einem Austreten von Gas in den Körper besondere Probleme. Flüssige oder pastöse Fluide (z. B. Gele oder Salzlösungen) verursachen diese Probleme nicht. Sie begrenzen ein Zusammendrücken der Bandscheibenprothese zwar insgesamt, lassen aber in vorteilhafter Weise auch größere Anpassungen der Prothese zwischen zwei Wirbeln beim Einsetzen und bei Relativbewegungen, insbesondere Kippungen zu. Eine Prothese ist somit ohne größere individuelle Formgebung implantierbar. Lokal auftretende Belastungssenken und -spitzen sind durch lokale Nachgiebigkeiten aufgrund der Flüssigkeitsbewegung ausgleichbar.If the core is formed as a hollow body, it has one or more cavities filled with one or more fluids. Preferably, the fluids are non-toxic and bioabsorbable, so that they can cause damage to the core with leakage of the fluids from the cavities as possible damage and biodegrades in the body. Gaseous fluids are compressible and cause an adjustment of the elastic properties, but cause special problems in the event of damage with the escape of gas into the body. Liquid or pasty fluids (eg gels or saline solutions) do not cause these problems. Although they limit compression of the intervertebral disc prosthesis, overall, but allow advantageously greater adjustments of the prosthesis between two vertebrae during insertion and relative movements, in particular tilting. A prosthesis is thus implantable without major individual shaping. Locally occurring stress sinks and tips can be compensated by local compliances due to the fluid movement.
Die Trägerkomponente dient insbesondere der zusätzlichen radialen Versteifung und Formstabilisierung des Kerns gegen ein Ausweichen des Kerns aus dem Spalt zwischen den beiden benachbarten Wirbeln. Sie besteht aus einem biokompatiblen und nicht resorbierbaren Material mit einer ausgeprägten elastischen Nachgiebigkeit, vorzugsweise einem Metall wie Titan oder einer Legierung wie einer Formgedächtnislegierung, z. B. Nitinol. Die Trägerkomponente ist je nach geforderter Steifigkeit vorzugsweise als vergleichsweise elastisch nachgiebiges Drahtgitter oder einem vergleichsweise steifen Blechring mit Durchbrüchen oder offener Porosität gestaltet. Eine plasmachemische Beschichtung der Trägerkomponente mit einfachen organischen Molekülen wie Allylamin (dünne, kunststoffartige Schicht) fördert in vorteilhafter Weise eine schnelle und stabile Anbindung der Zellkulturen und damit eine besonders belastbare Einbindung der Trägerkomponente in die Zellkultur.The Carrier component is used in particular the additional radial stiffening and shape stabilization of the core against a Dodging the nucleus from the gap between the two adjacent vertebrae. It consists of a biocompatible and non-absorbable material with a pronounced elastic compliance, preferably a metal such as titanium or an alloy such as a shape memory alloy, z. Nitinol. The carrier component is as required Stiffness preferably as a comparatively resilient elastic Wire mesh or a comparatively stiff metal ring with openings or open porosity. A plasmachemical Coating of the carrier component with simple organic Molecules like allylamine (thin, plastic-like Layer) advantageously promotes rapid and stable connection of the cell cultures and thus a particularly robust integration the carrier component in the cell culture.
Die Matrixschicht auf dem Kern dient der Anbindung von Gewebezellen an den Kern. Für eine gute Anbindung weist die vorzugsweise biokompatiblen elastomeren Matrixschicht eine bevorzugt offene Porosität auf, die vor Einsetzen der Bandscheibenprothese im Rahmen einer in vitro Zellkultivierung mit Gewebezellen, vorzugsweise Knorpelzellen angefüllt und verschlossen wird. Bei der Zellkultivierung erfolgt nicht nur das Bewachsen der Matrixschicht, sondern auch ein Einwachsen der Trägerkomponente mit den Gewebezellen, wobei die Trägerkomponente dem Implantat eine zusätzliche Stützwirkung verleiht.The Matrix layer on the core serves to connect tissue cells to the core. For a good connection, preferably biocompatible elastomeric matrix layer has a preferably open porosity on, before inserting the disc prosthesis in the context of a in vitro cell culture with tissue cells, preferably cartilage cells filled and closed. In cell cultivation Not only the growth of the matrix layer occurs, but also ingrowth of the carrier component with the tissue cells, wherein the carrier component the implant an additional Lends supporting effect.
Die Erfindung umfasst ferner ein Verfahren zur Herstellung eines Bandscheibenimplantats der vorgenannten Art. Das Verfahren umfasst die vorgenannte Zellkultivierung, ausgehend von einem Bandscheibenimplantat mit Kern, Matrixschicht und Trägerkomponente. Kultiviert wird vorzugsweise ein Knorpelgewebe vorzugsweise ausgehend von körpereigenen Zellen des für die Implantierung vorgesehenen Patienten. Das Verfahren umfasst eine Beimpfung vorzugsweise der Matrixschicht mit Zellen, vorzugsweise autologen Knorpelzellen, die anschließend die Basis für eine Zellkultur darstellen. Im Rahmen der Zellkultivierung erfolgt vorzugsweise ein Ausfüllen der Porosität der Matrixschicht von dieser ausgehend auch als Zellschichten auf der Matrixschicht.The The invention further includes a method of manufacturing an intervertebral disc implant of the aforementioned type. The method comprises the aforementioned cell cultivation, starting from an intervertebral disc implant with core, matrix layer and carrier component. A cartilage tissue is preferably cultivated preferably starting from the body's own cells for the implantation provided patients. The method comprises an inoculation preferably of the matrix layer with cells, preferably autologous cartilage cells, which subsequently formed the basis for represent a cell culture. As part of the cell cultivation takes place preferably filling the porosity of the matrix layer starting from this also as cell layers on the matrix layer.
Während der Bildung der Knorpelzellschicht ist eine ausreichende Versorgung (Ernährung) mit Nährmedium sicherzustellen. Im Rahmen der Erfindung erfolgt dies durch ein wiederkehrendes Be- und Entlastung des Bandscheibenimplantats, womit ein abwechselndes Komprimieren und Expandieren der Porosität der Matrix- und Zellschicht realisiert wird. In Folge dessen kommt es zu einem Stoffaustausch zu den sich bildenden Knorpelzellen in der Porosität, d. h. das Nährmedium wird (ähnlich wie bei einem Schwamm, sog. Schwammprinzip) im entlasteten Zustand in eine sich vergrößernde Porosität eingesaugt, um es bei einen folgenden Zusammendrücken der Porosität wieder auszustoßen.While the formation of the cartilage cell layer is an adequate supply (Nutrition) with nutrient medium. in the Within the scope of the invention, this is done by a recurring and relief of the disc implant, whereby an alternating Compressing and expanding the porosity of the matrix and cell layer is realized. As a result, it comes to a Mass transfer to the forming cartilage cells in the porosity, d. H. the nutrient medium becomes (similar to a sponge, So-called sponge principle) in the unloaded state in a magnifying Porosity sucked it to a subsequent compression of the Expel porosity again.
Ausgebildetes Knorpelgewebe benötigt dagegen keine weitere Nährmediumversorgung und damit keine Gefäße zur Zellversorgung.trained Cartilage tissue, on the other hand, requires no further nutrient medium supply and therefore no vessels for cell supply.
Nach der Bildung der Knorpelzellen ist das Bandscheibenimplantat fertig gestellt und in den Patienten applizierbar. Die aus körpereigenen Zellen des Patienten gezüchtete Knorpelzellschicht beschleunigt eine Integration des Implantats im Patientenkörper und reduziert die Gefahr einer körperinternen Abstoßung.To the formation of cartilage cells, the disc implant is ready placed and applied in the patient. The from the body's own Accelerated cells of the patient grown cartilage cell layer an integration of the implant in the patient's body and reduces the risk of body rejection.
Mögliche Ausführungsbeispiele der Erfindung werden anhand folgender Figuren näher erläutert. Es zeigenPossible Embodiments of the invention will be described with reference to the following Figures explained in more detail. Show it
Alle
in den Figuren gezeigten Bandscheibenimplantate weisen einen Kern
In
- 11
- Kerncore
- 22
- Matrixschichtmatrix layer
- 33
- Trägerkomponentesupport component
- 44
- Zellschichtcell layer
- 1212
- Kavitätcavity
ZITATE ENTHALTEN IN DER BESCHREIBUNGQUOTES INCLUDE IN THE DESCRIPTION
Diese Liste der vom Anmelder aufgeführten Dokumente wurde automatisiert erzeugt und ist ausschließlich zur besseren Information des Lesers aufgenommen. Die Liste ist nicht Bestandteil der deutschen Patent- bzw. Gebrauchsmusteranmeldung. Das DPMA übernimmt keinerlei Haftung für etwaige Fehler oder Auslassungen.This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.
Zitierte PatentliteraturCited patent literature
- - DE 10311477 A1 [0005] - DE 10311477 A1 [0005]
- - DE 102006030124 A1 [0005] - DE 102006030124 A1 [0005]
- - DE 10116412 C1 [0005] - DE 10116412 C1 [0005]
- - DE 69126971 T2 [0008] - DE 69126971 T2 [0008]
Claims (11)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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DE102008042401A DE102008042401A1 (en) | 2008-09-26 | 2008-09-26 | Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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DE102008042401A DE102008042401A1 (en) | 2008-09-26 | 2008-09-26 | Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells |
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DE102008042401A1 true DE102008042401A1 (en) | 2010-04-08 |
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DE102008042401A Withdrawn DE102008042401A1 (en) | 2008-09-26 | 2008-09-26 | Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells |
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DE (1) | DE102008042401A1 (en) |
Cited By (2)
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DE102013005398B3 (en) * | 2013-03-28 | 2014-06-18 | Spontech Spine Intelligence Group Ag | Motion preserving spinal disk prosthesis implanted into intervertebral space between vertebral bodies of human spinal column, has foam core with pores, whose pore size from center of core is decreased continuously toward edges of core |
EP3258978A4 (en) * | 2015-02-16 | 2018-10-31 | CTM@CRC Ltd. | Methods and products for delivering cells |
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DE10116412C1 (en) | 2001-04-02 | 2003-01-16 | Ulrich Gmbh & Co Kg | Implant to be inserted between the vertebral body of the spine |
DE69817600T2 (en) * | 1997-11-14 | 2004-06-24 | Bonetec Corp., Toronto | BIODEGRADABLE POLYMER SUPPORT SCAFFOLDING |
DE10311477A1 (en) | 2003-03-15 | 2004-09-23 | Ulrich Gmbh & Co. Kg | Implant to be inserted between the vertebral body of the spine |
DE69534038T2 (en) * | 1994-05-13 | 2005-12-29 | Kensey Nash Corp. | DEVICE AND METHOD FOR IN-VIVO BREEDING OF DIFFERENT TISSUE CELLS |
US20060064172A1 (en) * | 2000-08-30 | 2006-03-23 | Trieu Hai H | Composite intervertebral disc implants and methods for forming the same |
US7201774B2 (en) * | 1999-10-08 | 2007-04-10 | Ferree Bret A | Artificial intervertebral disc replacements incorporating reinforced wall sections |
DE102006030124A1 (en) | 2006-06-28 | 2008-01-03 | Ulrich Gmbh & Co. Kg | Implant for insertion between two vertebral bodies of the spine |
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DE69126971T2 (en) | 1990-05-07 | 1998-02-12 | Regen Biologics, Inc., San Francisco, Calif. | DISC PROSTHESIS |
DE69534038T2 (en) * | 1994-05-13 | 2005-12-29 | Kensey Nash Corp. | DEVICE AND METHOD FOR IN-VIVO BREEDING OF DIFFERENT TISSUE CELLS |
US5674295A (en) * | 1994-10-17 | 1997-10-07 | Raymedica, Inc. | Prosthetic spinal disc nucleus |
DE69817600T2 (en) * | 1997-11-14 | 2004-06-24 | Bonetec Corp., Toronto | BIODEGRADABLE POLYMER SUPPORT SCAFFOLDING |
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US20060064172A1 (en) * | 2000-08-30 | 2006-03-23 | Trieu Hai H | Composite intervertebral disc implants and methods for forming the same |
DE10116412C1 (en) | 2001-04-02 | 2003-01-16 | Ulrich Gmbh & Co Kg | Implant to be inserted between the vertebral body of the spine |
DE10311477A1 (en) | 2003-03-15 | 2004-09-23 | Ulrich Gmbh & Co. Kg | Implant to be inserted between the vertebral body of the spine |
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DE102013005398B3 (en) * | 2013-03-28 | 2014-06-18 | Spontech Spine Intelligence Group Ag | Motion preserving spinal disk prosthesis implanted into intervertebral space between vertebral bodies of human spinal column, has foam core with pores, whose pore size from center of core is decreased continuously toward edges of core |
EP3258978A4 (en) * | 2015-02-16 | 2018-10-31 | CTM@CRC Ltd. | Methods and products for delivering cells |
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