DE102011087899B4 - Gelenkscaffold - Google Patents

Gelenkscaffold

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Publication number
DE102011087899B4
DE102011087899B4 DE201110087899 DE102011087899A DE102011087899B4 DE 102011087899 B4 DE102011087899 B4 DE 102011087899B4 DE 201110087899 DE201110087899 DE 201110087899 DE 102011087899 A DE102011087899 A DE 102011087899A DE 102011087899 B4 DE102011087899 B4 DE 102011087899B4
Authority
DE
Grant status
Grant
Patent type
Prior art keywords
gelenkscaffold
according
convex
endokultivierung
joint
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.)
Active
Application number
DE201110087899
Other languages
German (de)
Other versions
DE102011087899A1 (en )
Inventor
Patrick Warnke
Hermann Seitz
Sebastian Spath
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.)
Universitaet Rostock
Universitatsklinikum Schleswig-Holstein (UKSH)
Original Assignee
Universitaet Rostock
Universitatsklinikum Schleswig-Holstein (UKSH)
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Grant date

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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials 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
    • A61L27/38Materials 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
    • A61L27/3804Materials 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
    • A61L27/3817Cartilage-forming cells, e.g. pre-chondrocytes
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    • A61L27/38Materials 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
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00293Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/24Materials or treatment for tissue regeneration for joint reconstruction

Abstract

Gelenkscaffold, dessen Form und Größe patientenindividuell angepasst ist, aus einem bioresorbierbaren Material besteht und mit Hilfe einer Endokultivierung biologisiert ist, dadurch gekennzeichnet, dass zwei sich gegenüberliegende Hälften mit einer konkaven (5) und einer konvexen (4) zueinander gerichteten Fläche versehen sind, die durch einen dazwischenliegenden Gelenkspalt (2) beabstandet sind, wobei zum Zeitpunkt der Endokultivierung eine feste Verbindung zwischen konkaver (5) und konvexer (4) Seite besteht, und dass beide Hälften jeweils einen großen Zentralkanal (3) und interkonnektierende komplexe Kanalnetzwerke (7) aufweisen. Gelenkscaffold, whose shape and size is adapted to the individual patient, consists of a bioresorbable material and is biologized using a Endokultivierung, characterized in that two opposing halves each having a concave (5) and a convex (4) facing surface are provided, which by an intermediate joint gap (2) are spaced apart, whereby a firm connection between the concave (5) and convex (4) side, there is at the time of Endokultivierung, and that both halves each have a large central channel (3) have and interconnecting complex channel networks (7) ,

Description

  • Die Erfindung beschreibt einen resorbierbaren, patientenindividuellen Gelenkersatz (Gelenkscaffold). The invention describes a resorbable, patient-specific arthroplasty (Gelenkscaffold).
  • Stand der Technik State of the art
  • Die Therapie von Gelenkdefekten stellt ein schwieriges Problem in der Orthopädie sowie der Unfall- und Wiederherstellenden Chirurgie dar. Hervorgerufen durch Trauma, Fehlbildungen, Verschleißerscheinungen (Arthrose), Arthritis (insbesondere Rheuma) oder nach Tumoroperationen ist häufig der Einsatz von Gelenkprothesen notwendig. The therapy of articular defects presents a difficult problem in orthopedic and trauma and reconstructive surgery is. Caused by trauma, birth defects, wear and tear (osteoarthritis), arthritis (especially rheumatoid) or after tumor operations is often the use of joint prostheses necessary. Dabei kommen bisher Prothesen unter anderem zum Beispiel als Knie-, Hüft- bzw. Fingergelenkersatz in unterschiedlicher Ausführung zum Einsatz, welche die Wiederherstellung der Gelenkfunktion zum Ziel haben. Here, so far prostheses are, inter alia, for example as a knee, hip or finger joint replacement in different embodiments are used, which have the recovery of joint function to the destination. Diese bestehen aus nicht resorbierbaren, körperfremden Materialien wie z. These consist of non-resorbable, exogenous materials such. B. Titan, verbleiben also als Dauerimplantat im Körper. As titanium, that remain as a permanent implant in the body. Diese Ersatzgelenke können Bestandteile aus Keramik und Kunststoff aufweisen. These replacement joints may comprise components made of ceramic and plastic. Durch die mechanische Belastung kommt es zu Verschleißerscheinungen am Gelenk und im Kontakt zum umgebenden Knochengewebe, was Folgeoperationen und damit zusätzliche Belastungen für den Patienten zur Folge hat. By the mechanical load leads to wear and tear on the joint and in contact with the surrounding bone tissue, resulting in follow-up operations and additional cost to the patient. Insbesondere die begrenzte Haltbarkeit der Verankerung von Hüftendoprothesen und die damit verbundene Notwendigkeit von Revisionsoperationen stellt ein sehr großes Problem dar. Dauerimplantate aus Titan werden vom Patienten zudem häufig dauerhaft als Fremdkörper empfunden. In particular, the limited shelf life of the anchorage of hip implants and the associated need for revision surgery is a very big problem. Permanent titanium implants are also often permanently perceived by the patient as a foreign body. Ein weiteres Problem besteht darin, dass bislang nur standardisierte Ersatzgelenke auf dem Markt angeboten werden. Another problem is that so far only standardized replacement joints offered on the market. Dadurch ist die individuelle Berücksichtigung des Patienten hinsichtlich der Anatomie und Verfassung des Knochengerüsts bei der Wahl eines geeigneten Implantats häufig nur unzureichend möglich. Thus, the individual consideration to the patient's anatomy and constitution of the skeleton in the choice of a suitable implant is often insufficiently possible. Bei den bisher überwiegend eingesetzten Implantaten aus Titan- oder Kobalt-Chrom-Legierungen wird aufgrund der fehlenden Porosität der Materialien bisher auf eine vorhergehende Kultivierung der Gelenke mit körpereigenen Zellen verzichtet. In the hitherto predominantly used implants made of titanium or cobalt-chromium alloys due to the lack of porosity of the materials is previously dispensed to a previous cultivation of the joints with the body's own cells. Damit muss eine unzureichende Integration des Gelenks in den Organismus in Kauf genommen werden. Thus a lack of integration of the joint in the body must be taken into account. Komplette Gelenke aus resorbierbaren Materialien sind derzeit am Markt nicht erhältlich. Complete joints of resorbable materials are not currently available on the market.
  • Es sind allerdings Knochenersatz- wie auch Knorpelersatzmaterialien bekannt, welche aus Keramik oder Polymer bestehen und vollständig resorbierbar sind. There are, however, bone replacement as well as cartilage replacement materials known which are made of ceramic or polymer and are fully absorbable. So wird in Thus, in WO 01/17 463 A1 WO 17/01 463 A1 ein resorbierbares Scaffold offenbart, welches für den Ersatz beschädigter Knorpel in einem Gelenk, wie etwa ein Kniegelenk dienen soll. a resorbable scaffold is disclosed, which is intended to serve in a joint such as a knee joint for the replacement of damaged cartilage. Das Scaffold beinhaltet ein Netzwerk von nicht-starren ”Abtrennungen”, die effektiv einen großen Defekt in kleinere Fächer unterteilen. The scaffold includes a network of non-rigid "separations" which effectively divide a large defect into smaller compartments. Jedes Fach hat eine Fläche von in der Regel weniger als 1 Quadratzentimeter. Each compartment has an area of ​​usually less than 1 square centimeter. Dies erlaubt es, Chondrozytenzellen zur Regeneration von Knorpel zu implantieren. This makes it possible to implant chondrocyte cells to regenerate cartilage. Die Abtrennungen können aus einem langsam resorbierbaren Material hergestellt werden, so dass sie allmählich resorbiert werden bis der regenerierte Knorpel wieder in der Lage ist, ohne weitere Unterstützung zu funktionieren. The enclosures can be made of a slowly resorbable material so that they are gradually absorbed by the regenerated cartilage again is able to function without further assistance.
  • Die Patentanmeldung The patent application US 2008/0 195 211 A1 US 2008/0 195 211 A1 beinhaltet ein Verfahren für Bandscheiben-Reparatur- und Gelenk-Reparatur-Scaffolds. includes a method for disc repair and joint repair scaffolds. Diese werden mit Hilfe von Magnetresonanz-Bildern oder kombiniert Magnetresonanz- und Computertomographie-Aufnahmen als Vorlage für entweder ein intervertebrales Scaffold oder ein Knorpel-Knochen-Scaffold mit Fixierung auf den darunter liegenden Knochen erstellt. They are using magnetic resonance images or combined magnetic resonance and computed tomography images created as a template for either an intervertebral scaffold or an osteochondral scaffold with fixation on the underlying bone. Das Bandscheiben- Scaffold beinhaltet einen äußeren Ring mit den gewünschten Strukturen und eine zentrale Nukleus Region, die entweder eine Mikrostruktur oder ein Hydrogel enthaltenen kann. The intervertebral disc includes an outer ring scaffold having the desired structures, and a central nucleus region capable contained a microstructure or a hydrogel, either. Es sind außerdem Befestigungslaschen für die Fixierung am Knochen vorgesehen. There are also fixing lugs provided for fixation to the bone. Mit diesem Verfahren können keine Gelenkfunktionen realisiert werden. With this method, no joint functions can be realized.
  • Darstellung der Erfindung Summary of the Invention
  • Die Aufgabe der Erfindung ist es, einen resorbierbaren, patientenindividuellen, biologisierten Gelenkersatz bereit zu stellen, der einfach hergestellt werden kann und nach der Transplantation in die Defektregion die Aufgabe eines natürlichen Gelenks übernimmt. The object of the invention is to provide a resorbable, patient-specific, biologised joint replacement ready, which can be manufactured easily and after transplantation into the damaged region assumes the role of a natural joint.
  • Die Lösung der Aufgabe erfolgt durch ein Gelenkscaffold bestehend aus einem bioresorbierbaren Material, welches dadurch gekennzeichnet ist, dass zwei sich gegenüberliegende Hälften mit einer konkaven und einer konvexen zueinander gerichteten Fläche versehen sind, die durch einen dazwischenliegenden Gelenkspalt beabstandet sind, und dass beide Hälften jeweils einen großen Zentralkanal und interkonnektierende komplexe Kanalnetzwerke aufweisen, wobei die Form und die Größe des Gelenkscaffolds direkt aus Computertomographie-Daten eines Patienten individuell an den Defekt angepasst, über ein generatives Fertigungsverfahren patientenindividuell hergestellt und mit Hilfe einer Endokultivierung biologisiert werden. The object is achieved by a Gelenkscaffold consisting of a bioresorbable material, which is characterized in that two opposing halves are provided with a concave and a convex mutually facing surface which are spaced apart by an intermediate joint space, and that both halves each have a have large central channel and interconnecting complex channel networks, wherein the shape and size of the Gelenkscaffolds adapted directly from computer tomography data of an individual patient to the defect, are prepared individually for each patient by a generative manufacturing method and by means of a biologized Endokultivierung.
  • Die konkave und die konvexe Seite des Gelenkscaffolds sind während der Kultivierung durch Pins fest verbunden, welche zur Aktivierung der Gelenkfunktion gelöst werden. The concave and the convex side of Gelenkscaffolds are firmly connected during the cultivation by pins, which are solved to enable the joint function.
  • Der Gelenkscaffold besteht aus synthetischen Rohstoffen. The Gelenkscaffold composed of synthetic raw materials. Das bioresorbierbare Material ist Keramik, Polymer oder ein Kompositmaterial. The bioresorbable material is ceramics, polymer or a composite material.
  • In einer Ausführungsform besteht das bioresorbierbare Material aus Calciumphosphat, insbesondere Hydroxylapatit, Tricalciumphosphate oder biphasischen Calciumphosphaten. In one embodiment, the bioabsorbable material is selected from calcium phosphate, in particular hydroxyapatite, tricalcium phosphate or biphasic calcium phosphates. Das Kompositmaterial besteht aus Calciumphosphaten und Biopolymeren. The composite material consists of calcium phosphates and biopolymers.
  • In einer weiteren Ausführung werden in den Zentralkanal biologische Strukturen oder zusätzliche Matrizes und Materialien eingebracht. In another embodiment, in the central channel biological structures or additional matrices and materials are introduced. Dies können unter Anderem Gefäße, Nerven, Markräume, Gels und/oder weitere Substanzen, Zytokine, Wachstumsfaktoren, Hormone, antibakterielle Substanzen oder Chemotherapeutika sein. These can be vessels, nerves, marrow spaces, gels and / or other substances, cytokines, growth factors, hormones, antibacterial agents or chemotherapeutic agents, among others.
  • In den Gelenkspalt wird nach einer weiteren Ausführung ein Hydrogel mit Knorpelzellen oder Stammzellen eingebracht. Into the joint space, a hydrogel with cartilage cells or stem cells is introduced according to another embodiment.
  • Die Knochen- und Knorpelbildung im Gelenkscaffold wird durch mechanische oder elektromagnetischen Stimulierung in vivo unterstützt. The bone and cartilage formation in Gelenkscaffold is supported by mechanical or electromagnetic stimulation in vivo.
  • Die Vorteile der Erfindung ergeben sich für den Patienten aus der Kombination eines neuartigen Gelenkscaffolds und einer innovativen Kultivierungstechnik. The advantages of the invention will become apparent to the patient from the combination of a novel and innovative Gelenkscaffolds cultivation technique. Der Patientendefekt kann vor der Behandlung mit Hilfe von Computertomographie-Daten passgenau rekonstruiert werden. The patient defect can be reconstructed accurately with the help of computer tomography data prior to treatment. Der individuell gestaltete Gelenkscaffold kann mit Hilfe des gewonnenen Datensatzes mittels generativer Fertigungsverfahren direkt entworfen und hergestellt werden und besitzt somit eine hohe Passgenauigkeit. The individually designed Gelenkscaffold can be directly designed and with the help of the data set obtained by means of additive manufacturing process produced and thus has a precision fit. Durch den Einsatz eines generativen Fertigungsverfahrens zur Herstellung des Gelenkscaffolds, wie z. The use of a generative manufacturing method for manufacturing the Gelenkscaffolds such. B. 3D-Drucken, Fused Deposition Modeling, Selective Laser Sintering oder Stereolithographie ist es zudem möglich, komplexe Kanalstrukturen in das Innere des Gelenks einzubringen. As 3D printing, fused deposition modeling, selective laser sintering or stereo lithography, it is also possible to introduce complex channel structures inside the joint. So ist es möglich, den Gelenkscaffold mit einem komplexen Kanalsystem für das gerichtete Einwachsen von Hart- und verschiedenen Weichgeweben (z. B. Nerven, Gefäße, Periost, Muskel-, Sehnengewebe etc.) zu versehen. Thus, it is possible to provide the Gelenkscaffold with a complex channel system for the directed ingrowth of hard and various soft tissues (eg. B. nerves, vessels, periosteum, muscle, tendon tissue, etc.). In der Mitte verläuft ein großer Zentralkanal und versorgt die Gelenkflächen während der Kultivierung optimal. In the middle of a large central channel extends, and provides the joint surfaces during the cultivation optimal. Die vorhergehende Endokultivierung ermöglicht eine optimale Biologisierung des Scaffolds und damit eine gute Integration an der Defektstelle des Patienten. The previous Endokultivierung allows optimum biologisation of scaffolds and good integration at the defect site of the patient. Weiterhin wird durch die Verwendung von resorbierbarem Material der Knochenumbauprozess angeregt. Furthermore, it is stimulated by the use of resorbable material of the bone remodeling process. Der Gelenkscaffold wird im Zuge dieses Prozesses abgebaut und durch humanen Knochen ersetzt. The Gelenkscaffold is degraded in the course of this process and replaced with human bones. Der Patient wird am Ende der Behandlung ein neues, funktionierendes, humanes Gelenk besitzen. The patient is at the end of the treatment have a new, functioning, human joint.
  • Mit diesem neuartigen Gelenkersatz kann der Ansicht und dem Anspruch, den menschlichen Knochen und Knorpel als Idealstandard bei der Rekonstruktion von Knochen- und Gelenkdefekten anzusehen, Rechnung getragen werden. With this new joint replacement of the opinion and the desire to look at the human bone and cartilage as Ideal Standard in the reconstruction of bone and joint defects can be accommodated. Durch den Einsatz der Endokultivierung kann der eigene Körper als idealer „Bioreaktor” für die Kultivierung ausgenutzt werden. By using the Endokultivierung own body can be used as an ideal "bioreactor" for cultivation. Die verwendeten Materialien in Kombination mit dem Herstellungsverfahren ermöglichen erstmals den Aufbau neuer humaner individualisierter Gelenkstrukturen. The materials used in combination with the production process the first time enable the creation of new human individualized joint structures. Der Erfolg hängt dabei vor allem von einer guten Integration in den Organismus ab, welche durch den völlig neuen Ansatz der Endokultivierung erreicht wird. Success depends above all on a good integration into the organism, which is achieved by the all-new approach to Endokultivierung.
  • Ausführung der Erfindung Embodiment of the invention
  • Die Erfindung wird anhand von Zeichnungen näher erläutert. The invention will be explained in more detail with reference to drawings. Hierzu zeigt this is shown
  • 1a 1a , b den erfindungsgemäßen Gelenkscaffold und B the Gelenkscaffold and inventive
  • 2 2 einen Schnitt durch den 3D-gedruckten Gelenkscaffold. a section through the 3D printed Gelenkscaffold.
  • Der Gelenkscaffold the Gelenkscaffold 1 1 ähnelt in der Grundform einem natürlichen Gelenk oder Ersatzgelenk und besteht aus einer konvexen is similar in its basic form a natural hinge or joint replacement, and consists of a convex 4 4 ( ( 1a 1a ) und konkaven ) And concave 5 5 ( ( 1b 1b ) Seite mit dazwischenliegendem Gelenkspalt ) Side with intermediate joint space 2 2 . , In der Figur wird der Einfachheit halber der Gelenkscaffold In the figure for simplicity of Gelenkscaffold is 1 1 zylinderförmig dargestellt. represented cylindrical. In der Praxis wird patientenindividuell die konkrete Form des Gelenks nachgebildet. In practice, the concrete form of the joint is simulated patient individually.
  • Der Gelenkscaffold the Gelenkscaffold 1 1 verfügt über einen großen Zentralkanal has a large central channel 3 3 , welcher eine gute Nährstoffversorgung der Zellen im Scaffold und im Gelenkspalt während der Kultivierungsphase ermöglicht. Which allows a good nutrient supply to the cells in the scaffold and in the joint space during the cultivation phase. Der Zentralkanal The central channel 3 3 erlaubt im Weiteren Manipulationen im Scaffold-Zentrum zu verschiedenen Zeitpunkten oder die Integration weiterer biologischer Strukturen, wie z. allowed in addition manipulations in the scaffold center at different times, or the integration of other biological structures, such. B. Gefäße, Nerven, Markräume. B. vessels, nerves, marrow spaces. Der Zentralkanal The central channel 3 3 kann mit zusätzlichen Matrizes und Materialien, wie z. can with additional matrices and materials such. B. Gels, beladen werden. As gels, are loaded. In diese können weitere Substanzen, Zytokine, Wachstumsfaktoren oder Chemotherapeutika eingebracht werden, um das Ergebnis der Kultivierung zu steuern und zu verbessern. In these other substances, cytokines, growth factors or chemotherapeutic agents can be introduced to control the result of the cultivation and improve.
  • Eine feste Verbindung von konvexer A fixed connection of convex 4 4 und konkaver and concave 5 5 Seite kann während der Kultivierung durch Pins Side can during cultivation by pins 6 6 erreicht werden. be achieved. Diese Pins these pins 6 6 müssen zur späteren Aktivierung der Gelenkfunktion gelöst werden. must be solved for later activation of joint function. Das kann noch am Ort der Kultivierung oder später bei der Implantation am gewünschten Ort erfolgen. This can be done even at the place of cultivation or later during implantation at the desired location. Im Gelenkspalt In the joint space 2 2 befindet sich zum Beispiel ein Hydrogel mit Knorpelzellen oder auch Stammzellen. is, for example, a hydrogel with cartilage cells or stem cells. Die Zellen dienen der Bildung von Knorpel im Gelenkspalt The cells used in the formation of cartilage in the joint space 2 2 im Verlauf der Endokultivierung oder im weiteren Einheilverlauf. in the course of Endokultivierung or other Einheilverlauf.
  • Der Gelenkscaffold the Gelenkscaffold 1 1 wird über ein generatives Fertigungsverfahren hergestellt und kann somit direkt am PC aus Computertomographie-Daten des Patienten individuell an den Defekt angepasst werden. is established through a generative production processes and thus can be individually adjusted via PC from computer tomography data of the patient to the defect. Verfahrensbedingt ist man in der Formgebung nicht limitiert und kann daher sehr komplexe Kanalnetzwerke Due process is not limited in shape and therefore can be very complex channel networks 7 7 in das Gelenk integrieren, was eine vorhergehende Kultivierung sehr effizient macht. integrate into the joint, making a previous cultivation very efficiently. Zur Verbesserung der Kultivierungsergebnisse kann eine einleitende Vor-Biologisierung in vitro erfolgen. To improve the cultivation results an introductory pre-biologisation in vitro can be performed. Die eigentliche Kultivierung erfolgt in vivo mittels der Technik einer Endokultivierung oder vergleichbaren Verfahren. The actual cultivation is carried out in vivo by means of the technique of Endokultivierung or comparable procedures. Bei der Endokultivierung wird heterotoper Knochen mit den Methoden des Tissue Engineerings in vivo beispielsweise im Musculus latissimus dorsi oder anderen Geweben von Menschen kultiviert. When Endokultivierung heterotopic bone with the methods of tissue engineering in vivo, for example in the latissimus dorsi is cultivated or other tissues of humans. Wird der Gelenkscaffold If the Gelenkscaffold 1 1 nicht direkt am Empfängerort kultiviert, muss er mit gezüchtetem Gewebe anschließend in die Defektregion transplantiert werden. not cultivated directly at the receiver, it must be transplanted into the defect region then cultivated tissue.
  • Um ein neues Gelenk im Körper des Patienten zu züchten, wird ein individuell angepasster Gelenkscaffold In order to breed a new joint in the body of the patient, an individually adapted Gelenkscaffold 1 1 aus resorbierbaren Materialien, wie Keramik oder Polymer (z. B. Calciumphosphate, insbesondere Hydroxylapatit (HA), Tricalciumphosphate (TCP) oder biphasische Calciumphosphatgranulate oder Biopolymeren oder Kompositmaterialien aus Calciumphosphaten und Biopolymeren) unter Einsatz eines generativen Fertigungsverfahrens hergestellt. of resorbable materials, such as ceramic or polymer (eg., calcium phosphates, in particular hydroxyapatite (HA), tricalcium phosphate (TCP) or biphasic calcium phosphate granules or biopolymers or composite materials consisting of calcium phosphates and biopolymers) prepared using a generative manufacturing method. Durch das Verfahren werden komplexe Kanalnetzwerke By the method of complex channel networks are 7 7 in das Gelenkscaffold in the Gelenkscaffold 1 1 engebracht, was eine Kultivierung sehr effektiv macht. narrow introduced, which makes cultivation very effective. Zur Verbesserung der Kultivierungsergebnisse kann eine einleitende Vor-Biologisierung in vitro erfolgen. To improve the cultivation results an introductory pre-biologisation in vitro can be performed. Mittels der Technik der Endokultivierung wird in diesem Scaffold heterotoper Knochen in vivo im Menschen kultiviert. Using the technique of Endokultivierung is cultivated in this scaffold of heterotopic bone in vivo in humans. Dabei muss der Ort der Kultivierung nicht mit dem Empfängerort übereinstimmen. Here the place of cultivation does not match the receiver location. Bevorzugt findet die Endokultivierung im M. latissimus dorsi der Menschen statt. Preferably, the Endokultivierung takes place in the latissimus dorsi muscle of the people. Der Prozess der Knochen- und Knorpelbildung sowie der Weichgewebeformation kann durch mechanische (beispielsweise wie in The process of bone and cartilage formation as well as the soft tissue formation may be by mechanical (e.g., as in WO 2010/117 275 A1 WO 2010/117 275 A1 offenbart) oder elektromagnetische Stimulierung in vivo unterstützt werden. disclosed) or electromagnetic stimulation in vivo are supported. Der Gelenkscaffold the Gelenkscaffold 1 1 mit gezüchtetem Gewebe wird anschließend in die Defektregion transplantiert. with cultured tissue is then transplanted into the defect region. Wird der Scaffold gleich am Empfängerort kultiviert, entfällt dieser Schritt. If the scaffold cultured equal at the receiver, this step is omitted. Nach der Implantation erfolgt im Zuge des Knochenumbauprozesses eine Rückbildung des Implantats bei gleichzeitigem Aufbau neuer humaner Knochen mit Gelenkstrukturen. After implantation, a regression of the implant while building new human bone with joint structures takes place as part of the remodeling process.
  • Aus der Gruppe der generativen Fertigungsverfahren eignet sich insbesondere das 3D-Drucken zur Herstellung resorbierbarer Gelenkscaffolds From the group of generative manufacturing processes, in particular, 3D printing is suitable for the production of resorbable Gelenkscaffolds 1 1 aus synthetischen Rohstoffen. of synthetic raw materials. Beim 3D-Druckverfahren handelt es sich um einen pulverbasierten Prozess zur Herstellung von Modellen direkt aus Computerdaten. 3D printing process is a powder-based process for the production of models directly from computer data. Dabei werden dünne Schichten eines Pulvers auf eine Grundplatte aufgebracht, die dann durch gezielte Binderzugabe entsprechend des aktuellen Bauteilquerschnitts verfestigt werden. In this case, thin layers of a powder on a base plate to be applied, which are then solidified through specific addition of binder component according to the current cross-section. Der Binder wird tröpfchenweise mittels eines Druckkopfs aufgetragen. The binder is dropwise applied by a print head. Das Baumaterial besteht aus dem gebundenen Pulver. The building material consists of bound powder. Das lose Pulver übernimmt die Stützfunktion und wird nach dem Prozessende entfernt. The loose powder takes over the supporting function and is removed after the end of the process. Als Ausgangsmaterialien im 3D-Druckprozess werden bevorzugt resorbierbare Calciumphosphate (z. B. Hydroxylapatit, Tricalciumphosphat, biphasische Calciumphosphate) eingesetzt. As starting materials in the 3D printing process preferably absorbable calcium phosphates (eg. As hydroxyapatite, tricalcium phosphate, biphasic calcium phosphates) are used. Diese Materialien haben sich bereits in der plastisch-rekonstruktiven Chirurgie zum Ersatz von Knochenarealen bewährt. These materials have already proven themselves in the plastic reconstructive surgery to replace bone areas. Diese Ausgangsstoffe sind bekannt für ihre gute Biokompatibilität und besitzen eine hohe Osteoinduktivität. These starting materials are known for their good biocompatibility and have high osteoinductive potential.
  • Die im 3D-Druckverfahren hergestellten Rohlinge (Grünteile) werden in einem weiteren Schritt bei einer bevorzugten Temperatur von ca. 1.250°C gesintert. The blanks (green parts) prepared in 3D printing process be sintered in a further step at a preferred temperature of about 1,250 ° C. Dadurch wird eine hohe Endfestigkeit erreicht. This ensures a high final strength is achieved. Zudem werden bei diesem Schritt die beim 3D-Drucken eingesetzten organischen Binderkomponenten vollständig ausgebrannt. In addition, in this step, the organic binder components used for 3D printing are completely burned.
  • Zur Herstellung patientenindividueller Gelenkscaffolds To manufacture patient-specific Gelenkscaffolds 1 1 werden Patientendaten verwendet, die durch Computertomografie-Aufnahmen gewonnen werden. be used patient data, which are obtained by computer tomography images. Der aus der Computertomografie resultierende zweidimensionale Datensatz wird mit Hilfe einer speziellen Segmentierungssoftware in ein dreidimensionales Oberflächenmodell umgewandelt. The resulting two-dimensional data set from the computer tomography is converted using a special segmentation software in a three-dimensional surface model. Nach der Segmentierung der knöchernen Strukturen werden die Daten in ein weiteres Software-Tool mit CAD-Funktionalität eingeladen. After segmentation of bony structures, the data is loaded into another software tool with CAD functionality. Dort kann z. There z can. B. durch Spiegelung eines gesunden knöchernen Bereichs auf den entsprechenden Defektbereich und anschließender Subtraktion der beiden Bereiche das zu fertigende Implantat berechnet werden. For example, by reflection of a healthy bone region to be produced, the implant will be calculated to the corresponding defect area and subsequent subtraction of the two regions. Zudem eignen sich diese Tools auch zur Konstruktion des Zentralkanals In addition, these tools are also suitable for the central canal construction 3 3 und des komplexen Kanalsystems and the complex channel system 7 7 im Implantat. in the implant. Auf Basis des dreidimensionalen Datensatzes kann das Implantat mit Hilfe des 3D-Druckverfahrens hergestellt werden. Based on the three-dimensional data set, the implant can be made with the help of the 3D printing process.
  • Das Ausführungsbeispiel in The embodiment in 2 2 zeigt einen 3D-gedruckten Gelenkscaffold shows a 3D printed Gelenkscaffold 1 1 aus Hydroxylapatit. of hydroxyapatite. Der Scaffold ist 67 mm lang und hat einen Durchmesser von 24 mm. The scaffold is 67 mm long and has a diameter of 24 mm. Die beiden Gelenkhälften sind beispielsweise durch vier Pins The two joint halves, for example, by four pins 6 6 miteinander verbunden. connected with each other. Bei anderen Gelenkformen kann es notwendig sein, zwei oder beliebig viele Pins In other joint, it may be necessary, two or any number of pins 6 6 anzubringen. to install. Der Zentralkanal The central channel 3 3 besitzt einen symmetrischen Kreuzquerschnitt mit einer Balkenlänge von ca. 8 mm. has a symmetrical cross section with a beam length of about 8 mm. Das komplexe Kanalsystem The complex channel system 7 7 ist für das gerichtete Einwachsen von Knochengewebe und Gefäßen ist als othogonales Kanalnetzwerk mit einem Kanalquerschnitt von ca. 0,5 mm ausgeführt. is for the directed ingrowth of bone tissue and blood vessels is designed as othogonales channel network with a channel cross section of about 0.5 mm.
  • Die Gelenkscaffolds the Gelenkscaffolds 1 1 bieten ein formgebendes Gerüst für heranwachsende Zellen und durch entsprechend behandelte Oberflächen wird eine Stimulation von Zellen erreicht. provide a forming scaffold for growing cells and by appropriately treated surfaces stimulation of cells is achieved. Gelenkscaffolds Gelenkscaffolds 1 1 können aus diversen resorbierbaren Materialien angefertigt werden, wie z. can be made from various absorbable materials such. B. auf Kollagenbasis, Polylactidbasis, wie Biopolymere (Polylactid-co-Glycolid – PLGA, Polycaprolacton – PCL), Polyurethane, Tricalciumphospatbasis und Hydroxylapatitbasis. B. collagen-based polylactide, such as biopolymers (PLGA - PLGA, polycaprolactone - PCL), polyurethanes, Tricalciumphospatbasis and hydroxyl apatite.
  • In zahlreichen Grundlagenuntersuchungen konnten die vorteilhaften biologischen und technischen Eigenschaften der 3D-gedruckten Scaffolds ua für Anwendungen im Bereich der Endokultivierung nachgewiesen werden. In numerous fundamental studies the beneficial biological and technical properties of the 3D printed scaffolds were detected for applications in the field of Endokultivierung among others. Die Vorteile der Endokultivierung wurden in mehreren Studien demonstriert. The advantages of Endokultivierung have been demonstrated in several studies.

Claims (10)

  1. Gelenkscaffold, dessen Form und Größe patientenindividuell angepasst ist, aus einem bioresorbierbaren Material besteht und mit Hilfe einer Endokultivierung biologisiert ist, dadurch gekennzeichnet, dass zwei sich gegenüberliegende Hälften mit einer konkaven ( Gelenkscaffold, whose shape and size is adapted to the individual patient, consists of a bioresorbable material and is biologized using a Endokultivierung, characterized in that two opposing halves having a concave ( 5 5 ) und einer konvexen ( ) And a convex ( 4 4 ) zueinander gerichteten Fläche versehen sind, die durch einen dazwischenliegenden Gelenkspalt ( ) Mutually facing surfaces are provided, which (by an intermediate joint space 2 2 ) beabstandet sind, wobei zum Zeitpunkt der Endokultivierung eine feste Verbindung zwischen konkaver ( ) Are spaced apart, wherein at the time of Endokultivierung a firm connection between concave ( 5 5 ) und konvexer ( ) And convex ( 4 4 ) Seite besteht, und dass beide Hälften jeweils einen großen Zentralkanal ( ) Side, and in that both halves of each of (a large central channel 3 3 ) und interkonnektierende komplexe Kanalnetzwerke ( ) And interconnecting complex channel networks ( 7 7 ) aufweisen. ) respectively.
  2. Gelenkscaffold nach Anspruch 1 dadurch gekennzeichnet, dass die feste Verbindung zwischen konkaver ( Gelenkscaffold according to claim 1, characterized in that the fixed connection between the concave ( 5 5 ) und konvexer ( ) And convex ( 4 4 ) Seite des Gelenkscaffolds ( ) Side of the Gelenkscaffolds ( 1 1 ) durch Pins ( ) (By Pins 6 6 ) realisiert ist. ) Is realized.
  3. Gelenkscaffold nach Anspruch 2 dadurch gekennzeichnet, dass zur Aktivierung der Gelenkfunktion die feste Verbindung durch die Pins ( Gelenkscaffold claimed in claim 2, that the fixed connection (to activate the joint function by pins 6 6 ) gelöst wird. ) Is dissolved.
  4. Gelenkscaffold nach Anspruch 1 dadurch gekennzeichnet, dass der Gelenkscaffold ( Gelenkscaffold according to claim 1, characterized in that the Gelenkscaffold ( 1 1 ) aus synthetischen Rohstoffen besteht. ) Is made of synthetic raw materials.
  5. Gelenkscaffold nach einem der Ansprüche 1 bis 4 dadurch gekennzeichnet, dass das bioresorbierbare Material Keramik, Polymer oder ein Kompositmaterial ist. Gelenkscaffold according to one of claims 1 to 4 characterized in that the bioresorbable material is ceramics, polymer or a composite material.
  6. Gelenkscaffold nach Anspruch 5 dadurch gekennzeichnet, dass das bioresorbierbare Material aus Calciumphosphat, insbesondere Hydroxylapatit, Tricalciumphosphaten oder biphasischen Calciumphosphaten besteht. Gelenkscaffold according to claim 5 characterized in that the bioresorbable material of calcium phosphate, especially hydroxylapatite, tricalcium phosphates or biphasic calcium phosphates is.
  7. Gelenkscaffold nach Anspruch 5 dadurch gekennzeichnet, dass das Kompositmaterial aus Calciumphosphaten und Biopolymeren besteht. Gelenkscaffold according to claim 5 characterized in that the composite material of calcium phosphates and biopolymers is.
  8. Gelenkscaffold nach einem der Ansprüche 1 bis 7 dadurch gekennzeichnet, dass der Zentralkanal ( Gelenkscaffold according to one of claims 1 to 7 characterized in that the central channel ( 3 3 ) biologische Strukturen oder zusätzliche Matrizes und Materialien enthält. contains) biological structures or additional matrices and materials.
  9. Gelenkscaffold nach Anspruch 8 dadurch gekennzeichnet, dass der Zentralkanal ( Gelenkscaffold claimed in claim 8, that the central channel ( 3 3 ) Gefäße, Nerven, Markräume, Gels und/oder weitere Substanzen, Zytokine, Wachstumsfaktoren, Hormone, antibakterielle Substanzen oder Chemotherapeutika enthält. contains) vessels, nerves, medullary spaces, gels and / or other substances, cytokines, growth factors, hormones, antibacterial agents or chemotherapeutic agents.
  10. Gelenkscaffold nach einem der Ansprüche 1 bis 9 dadurch gekennzeichnet, dass der Gelenkspalt ( Gelenkscaffold according to one of claims 1 to 9 characterized in that the joint gap ( 2 2 ) ein Hydrogel mit Knorpelzellen oder Stammzellen enthält. ) Contains a hydrogel with cartilage cells or stem cells.
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WO2001017463A1 (en) * 1999-09-10 2001-03-15 Mansmann Kevin A Improved resorbable scaffolds to promote cartilage regeneration
US20080195211A1 (en) * 2006-10-30 2008-08-14 Chia-Ying Lin Engineered Scaffolds for Intervertebral Disc Repair and Regeneration and for Articulating Joint Repair and Regeneration
WO2010117275A1 (en) * 2009-04-09 2010-10-14 Technische Universiteit Delft Mechanical device for tissue regeneration

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US5766253A (en) * 1996-01-16 1998-06-16 Surgical Dynamics, Inc. Spinal fusion device

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Publication number Priority date Publication date Assignee Title
WO2001017463A1 (en) * 1999-09-10 2001-03-15 Mansmann Kevin A Improved resorbable scaffolds to promote cartilage regeneration
US20080195211A1 (en) * 2006-10-30 2008-08-14 Chia-Ying Lin Engineered Scaffolds for Intervertebral Disc Repair and Regeneration and for Articulating Joint Repair and Regeneration
WO2010117275A1 (en) * 2009-04-09 2010-10-14 Technische Universiteit Delft Mechanical device for tissue regeneration

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