WO2008154762A1 - Verankerungselement für endoprothesen in röhrenknochen - Google Patents
Verankerungselement für endoprothesen in röhrenknochen Download PDFInfo
- Publication number
- WO2008154762A1 WO2008154762A1 PCT/CH2008/000270 CH2008000270W WO2008154762A1 WO 2008154762 A1 WO2008154762 A1 WO 2008154762A1 CH 2008000270 W CH2008000270 W CH 2008000270W WO 2008154762 A1 WO2008154762 A1 WO 2008154762A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- anchoring
- anchoring element
- prosthesis
- filling
- wires
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/40—Joints for shoulders
- A61F2/4059—Humeral shafts
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
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- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3662—Femoral shafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/32—Joints for the hip
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2002/30199—Three-dimensional shapes
- A61F2002/30289—Three-dimensional shapes helically-coiled
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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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- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30327—The prosthesis having different structural features at different locations within the same prosthesis differing in diameter
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- A61F2/02—Prostheses implantable into the body
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- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
Definitions
- the invention relates to the anchoring of endoprostheses in long bones. It relates to an anchoring element, an endoprosthesis with such an anchoring element and a method for anchoring such endoprosthesis, according to the preambles of the independent claims.
- prosthesis types are known and in use: the shaft prosthesis, the short shaft prosthesis, the cap prosthesis and the pressure disc prosthesis.
- the anchoring of shaft prostheses is carried out by a metal shaft, which is either cemented or cement-free introduced into the medullary cavity.
- a metal shaft which is either cemented or cement-free introduced into the medullary cavity.
- the medullary canal is treated in such a way that the implant can be inserted as firmly as possible.
- the medullary cavity is filled with bone cement in order to anchor the prosthesis in a form-fitting manner. In both cases, the natural elasticity of the bone in the anchoring area is lost and the undesired effect of the bone is lost
- a short stem prosthesis is a cementless hip prosthesis which, compared to a traditional stem prosthesis, has a shortened prosthesis stem by about 2/3.
- the disadvantages of the short-stem prosthesis are stress-shielding and consequent bone atrophy, and the short stem prosthesis often also has fractures at the end of the prosthesis or bone perforation.
- the damaged articular surfaces are milled appropriately, so that the cap can be anchored to the bone in conjunction with a bone cement.
- the mandrel connected to the center of the cap is inserted into the femoral neck and provides additional stability.
- This prosthesis type is only suitable for younger, active patients.
- the anchorage should in particular be inserted bone-friendly, be force-fit or positively inserted, anchor the prosthesis head with primary stability, ensure good conditions for osseointegration, reduce the fracture risk at the end of the prosthesis and be applicable regardless of the bone quality.
- inventive anchoring element as defined in the first claim.
- Another claim defines an endoprosthesis with the inventive anchoring element.
- a method for anchoring the inventive endoprosthesis is given.
- Advantageous embodiments are given in the dependent claims.
- the invention is based on the idea to provide a flexible anchoring element, which has the smallest possible transverse dimensions for introduction into the intended opening in the long bones.
- After the introduction of the anchoring element is expanded by building an internal pressure, so that it clings as possible to the inner walls of the opening.
- the internal pressure creates large radial forces between the anchoring element and the inner walls of the opening, which lead to high static friction. This stiction fixes the anchoring element frictionally in the opening.
- Embodiment is possible in addition to the non-positive a positive connection.
- the anchoring element according to the invention for anchoring an endoprosthesis in a long bone has a flexible sheath connected to a prosthesis head of the endoprosthesis for receiving a filling which presses the sheath outwards against the long bone.
- the sheath includes anchoring wires.
- the filling preferably includes a plurality of solid packing, wherein the volume of a single packing is substantially smaller than the volume enclosed by the casing in the implanted state.
- the filler can z. B. as
- Anchoring balls be executed with the same or different diameters.
- the endoprosthesis according to the invention for use in a long bone has a prosthesis head and an anchoring element connected to the prosthesis head.
- the anchoring element is an anchoring element according to the invention.
- the sheath is introduced without filling into an opening provided in the long bone and filled after insertion with the filling so that it is pressed outwards from the filling against the cortex (bone wall) becomes.
- the anchoring element according to the invention is suitable for use without cement material. Depending on the application, it may be advantageous to additionally fix the anchoring element with a cement material on the tubular bone.
- the anchoring element according to the invention With the anchoring element according to the invention, an excellent and immediate primary stability of the implant is achieved.
- the structure of anchoring wires and anchoring balls that press against the cortex forms the ideal prerequisite for osseointegration.
- the anchoring element according to the invention With the anchoring element according to the invention, the load introduction near the joint center becomes possible. Thus, only a minor remodeling of the bone substance takes place, and there is no loosening of the implant.
- the endoprosthesis according to the invention is bone anatomy-independent and therefore very versatile.
- the anchoring element according to the invention can be executed in various lengths, for example by means of the length of the anchoring wires.
- the anatomy of long bones is irrelevant to an anchoring element according to the invention because the sheath adapts to the cortex. Extensions or bends on the bone have an advantageous effect on the stability, because this increases the potential contact surface between the sheath and the bone.
- the surgical technique for the implantation of an endoprosthesis according to the invention is safe and reproducible.
- the operation is bone-friendly and offers opportunities for retreat.
- the operation requires only a few standardized instruments.
- the endoprosthesis according to the invention can also be implanted cemented. In this case, bone cement is added before and / or during the filling of the filling, or the cement is introduced without filling in the medullary cavity, so that the shell assumes the function of a reinforcement.
- FIG. 1 shows a first embodiment of a humeral prosthesis according to the invention in the implanted state (a) in a side view and (b) in a frontal view.
- FIG. 2 shows the humeral prosthesis of FIG. 1 before the implantation (a) in a side view, (b) in a longitudinal section, (c) in a perspective view and (d) in a perspective, partially longitudinally cutaway view,
- FIG. 3 shows a second embodiment of a humeral prosthesis according to the invention before implantation (a) in a side view and (b) in a longitudinal section.
- Figures 4 and 5 show interior views of parts of two ⁇ us Installationsformen the inventive anchoring element.
- FIG. 6 shows a femoral prosthesis (a) according to the invention in a side view and (b) in a partial exploded view.
- FIG. 1 illustrates the invention using a cementless implanted distal humeral prosthesis with wire anchoring in the implanted state.
- a tubular bone is indicated by dashed lines.
- FIG. 2 shows the same embodiment of the humeral prosthesis according to the invention prior to implantation.
- the endoprosthesis according to the invention comprises an anchoring element 1 and a prosthesis head 2 connected to the anchoring element 1 as a connecting link between the anchoring element 1 and a joint counterpart (not shown).
- the anchoring element 1 has a flexible sheath connected to the prosthesis head 2 for receiving a filling which pushes the sheath outwards against the long bone.
- the flexible sheath of the anchoring element 1 consists of a plurality of anchoring wires Ia, which are releasably fixed in the prosthetic head 2.
- the anchoring wires Ia are preferably made of a biocompatible metal. They may be round, square or knurled in cross-section or have any other cross-sectional shape. The surgeon can choose the optimal length of anchoring due to several given wire lengths. The lengths of a primary or a revision prosthesis differ significantly.
- the fixation of the anchoring wires Ia takes place by a wedge-shaped (cone-shaped) Prosthesis head inner part 2a is pressed against the anchoring wires Ia and ultimately against a prosthetic head outer part 2b.
- the inner shape of the prosthetic head outer part 2b corresponds to the wedge shape (conical shape) of the prosthetic head inner part 2a.
- the ends of the anchoring wires Ia facing away from the prosthesis head 2 are held together by a prosthesis end part 3.
- at least two anchoring wires Ia are entwined in the prosthesis end part 3. All other anchoring wires Ia are either guided in the prosthesis end part 3, form a loop without touching the prosthesis end part 3 or are located loosely in the medullary canal without touching the prosthesis end part 3.
- the prosthesis end part 3 has bores for guiding anchoring wires 1a and / or means for entangling at least two anchoring wires 1a.
- the cavity within the anchoring wires Ia, between the prosthetic head 2 and the prosthesis end part 3, is filled with anchoring balls 4 during the operation. This is preferably done via the center bore in the prosthetic head inner part 2a.
- a pressure screw 5 in the prosthetic head inner part 2a serves to press in the anchoring balls 4 and the closure of the medullary canal on the joint side.
- the pressure screw 5 is releasably fixed in the prosthetic head inner part 2 a.
- Two security screws 6 are, for example.
- the prosthesis end part 3 forms the conclusion of Wire anchoring and prevents the anchoring balls 4 continue to penetrate into the open medullary canal.
- the wire shell of the anchoring element 1 expands, and there is a strong stiction between the anchor and the cortex. This leads to an excellent and immediate primary stability of the implant.
- the anchoring balls 4 may be made of a biocompatible metal with hardened and / or polished surfaces.
- the anchoring balls 4 may be loose balls of the same or different diameters or ball chains consisting of at least two interconnected balls. For the sake of simplicity we will only speak of anchoring balls 4 below.
- the prosthesis head 2 and the prosthesis end part 3 differ substantially between the different prostheses.
- Anchoring balls 4 is the ideal prerequisite for osseointegration and thus secondary stability of the implant. This additionally reinforces the long bones in the region of the anchoring element 1. Self-tapping anchoring ribs on the prosthetic head 2 and / or
- Cortex screws 10 which fix the prosthesis head 2 to the bone provide for improved primary stability.
- the second embodiment according to Figure 3 is similar to the first embodiment of Figures 1 and 2. Analogous elements are denoted by the same reference numerals as in Figures 1 and 2 and will not be explained here. The main difference is that the
- Anchoring wires Ia are twisted together before implantation. Thanks to the twist, the anchoring element 1 is particularly compact and slim, which facilitates implantation. During or after the implantation, the twist is released, whereby the wire sheath of the anchoring element 1 expands. The expansion is supported and reinforced by the filling with the anchoring balls 4.
- Anchoring wires 1 partially connected by brackets 7.
- the anchoring wires Ia are partially intertwined.
- the brackets 7 and the partial interweaving of the anchoring wires Ia provide a desired, preferably uniform distribution of the anchoring wires Ia along the circumference of the anchoring element 1. They give the anchoring element 1 increased stability and prevent the anchoring wires Ia at certain points along the Amount accumulate while other bodies are provided with only a few or no anchoring wires Ia.
- the femoral prosthesis includes a femoral plate 9. This presses in the implanted state on the bone surface at the distal femoral neck of the proximal femur, thus forming the conclusion of the
- the femur plate 9 presses against the prosthetic head inner part 2a.
- Three locking screws 6 prevent the prosthetic head inner part 2 a from being loosened by being screwed through the femoral plate 9 into the prosthetic head outer part 2 b.
- At least one cortical screw 10 connects the femur plate 9 to the femur. The cortical screws 10 contribute significantly to the primary stability of the prosthetic head 2.
- the sheath of the anchoring element 1 is constructed in the embodiment of Figure 6 from two layers of anchoring wires Ia, which are divided and / or guided by a connecting element 8.
- the invention is not limited to the embodiments discussed above.
- the discussed embodiments may be combined with each other.
- a shell for the inventive anchoring element 1 also other flexible structures such as fabric, braids, nets or films come into question.
- the filling may consist of a substantially homogeneous material, or a combination of homogeneous material and solid packings. LIST OF REFERENCE NUMBERS
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Das Verankerungselement (1) zur Verankerung einer Endoprothese in einem Röhrenknochen weist eine mit einem Prothesenkopf (2) der Endoprothese verbundene flexible Hülle auf, die bspw. aus Verankerungsdrähten (1a) besteht. Die Hülle dient zur Aufnahme einer Füllung, die bspw. aus Verankerungskugeln (4) besteht. Durch das Hineinpressen der Verankerungskugeln (4) dehnt sich die Hülle aus, und es entsteht eine grosse Haftreibung zwischen dem Verankerungselement (1) und dem Röhrenknochen. Dies führt zu einer hervorragenden und sofortigen Primärstabilität des Implantats.
Description
VERÄNKERUNGSELEMENT FÜR ENDOPROTHESEN IN RÖHRENKNOCHEN
FACHGEBIET
Die Erfindung bezieht sich auf die Verankerung von Endoprothesen in Röhrenknochen. Sie betrifft ein Verankerungselement, eine Endoprothese mit einem derartigen Verankerungselement und ein Verfahren zur Verankerung einer derartigen Endoprothese, gemäss den Oberbegriffen der unabhängigen Patentansprüche.
STAND DER TECHNIK
Um den Stand der Technik zu beschreiben, betrachten wir die Verankerungstechnik von proximalen Femurprothesen. Folgende Prothesentypen sind bekannt und im Einsatz: die Schaftprothese, die Kurzschaftprothese, die Kappenprothese und die Druckscheibenprothese.
Die Verankerung von Schaftprothesen erfolgt durch einem Metallschaft, welcher entweder zementiert oder zementfrei in den Markraum eingebracht wird. Bei der zementfreien Insertion wird der Markraum so bearbeitet, dass das Implantat möglichst kraftschlüssig eingebracht werden kann. Bei der zementierten Schaftprothese wird der Markraum mit Knochenzement aufgefüllt, um die Prothese formschlüssig zu verankern. In beiden Fällen geht dadurch die natürliche Elastizität des Knochens im Bereich der Verankerung verloren, und der unerwünschte Effekt des
„stress shielding" (Lastabschirmung) kommt zum tragen. Die Belastungsabschirmung des Knochengewebes im Bereich der Verankerung und der daraus resultierende Knochenabbau
führen zu Lockerungen des Implantats. Im Weiteren wirken sich die Belastungen des Implantats verstärkt auf das Prothesenende aus. Dadurch wird das Frakturrisko am Prothesenende deutlich erhöht.
Bei einer Kurzschaftprothese handelt es sich um eine zementfreie Hüftprothese, die im Vergleich zu einer klassischen Schaftprothese einen um ca. 2/3 verkürzten Prothesenschaft aufweist. Die Nachteile der Kurzschaftprothese liegen wie bei der Schaftprothese im „stress-shielding" und der daraus folgenden Knochenatrophie. Auch bei der Kurzschaftprothese kommt es oftmals zu Frakturen am Prothesenende oder zur Knochenperforation .
Bei der Kappenprothese werden die geschädigten Gelenkflächen passgerecht zugefräst, so dass die Kappe in Verbindung mit einem Knochenzement auf dem Knochen verankert werden kann. Der mit dem Zentrum der Kappe verbundene Dorn wird in den Schenkelhals eingeführt und sorgt für zusätzliche Stabilität. Dieser Prothesentyp eignet sich ausschliesslich für jüngere, aktive Patienten.
Bei der Druckscheibenprothese erfolgt die Verankerung durch einen Schraubbolzen, der durch den Oberschenkelhals geführt wird und die proximale Druckscheibe mit einer lateral am Femur anliegenden Druckplatte verspannt. Dieser Prothesentyp ist wie die Kappenprothese auf eine gute Knochenqualität des proximalen Femurs angewiesen.
DARSTELLUNG DER ERFINDUNG
Es ist daher eine Aufgabe der vorliegenden Erfindung, eine Verankerung für Endoprothesen in Röhrenknochen zu schaffen, welche die oben erwähnten Nachteile nicht aufweist. Die Verankerung soll insbesondere knochenschonend inseriert werden, kraft- oder formschlüssig inseriert werden, den Prothesenkopf primärstabil verankern, gute Bedingungen für die Osseointegration gewährleisten, das Frakturrisiko am Prothesenende vermindern und unabhängig von der Knochenqualität anwendbar sein.
Diese und andere Aufgaben werden durch das erfindungsgemässe Verankerungselement, wie es im ersten Patentanspruch definiert ist, gelöst. Ein weiterer Patentanspruch definiert eine Endoprothese mit dem erfindungsgemässen Verankerungselement . Ferner wird auch ein Verfahren zur Verankerung der erfindungsgemässen Endprothese angegeben. Vorteilhafte Ausführungsformen sind in den abhängigen Patentansprüchen angegeben.
Die Erfindung beruht auf der Idee, ein flexibles Verankerungselement zu schaffen, welches zur Einführung in die vorgesehene Öffnung im Röhrenknochen möglichst kleine Querdimensionen hat. Nach der Einführung wird das Verankerungselement durch Aufbau eines Innendrucks ausgeweitet, so dass es sich möglichst an die Innenwände der Öffnung anschmiegt. Durch den Innendruck entstehen grosse Radialkräfte zwischen dem Verankerungselement und den Innenwänden der Öffnung, die zu einer hohen Haftreibung führen. Diese Haftreibung fixiert das Verankerungselement kraftschlüssig in der Öffnung. Je nach
Ausführungsform ist zusätzlich zur kraftschlüssigen eine formschlüssige Verbindung möglich.
Somit weist das erfindungsgemässe Verankerungselement zur Verankerung einer Endoprothese in einem Röhrenknochen eine mit einem Prothesenkopf der Endoprothese verbundene flexible Hülle zur Aufnahme einer die Hülle nach aussen, gegen den Röhrenknochen drückenden Füllung auf.
In einer bevorzugten Ausführungsform beinhaltet die Hülle Verankerungsdrähte. Die Füllung beinhaltet vorzugsweise eine Vielzahl von festen Füllkörpern, wobei das Volumen eines einzelnen Füllkörpers wesentlich kleiner ist als das von der Hülle umschlossene Volumen im implantierten Zustand. Die Füllkörper können z. B. als
Verankerungskugeln mit gleichen oder unterschiedlichen Durchmessern ausgeführt sein.
Die erfindungsgemässe Endoprothese zum Einsatz in einem Röhrenknochen, weist einen Prothesenkopf und einen mit dem Prothesenkopf verbundenes Verankerungselement auf. Das Verankerungselement ist ein erfindungsgemässes Verankerungselement .
Gemäss dem erfindungsgemässen Verfahren zur Verankerung einer erfindungsgemässen Endoprothese in einem Röhrenknochen wird die Hülle ohne Füllung in eine dafür vorgesehene Öffnung im Röhrenknochen eingeführt und nach der Einführung mit der Füllung gefüllt, so dass sie von der Füllung nach aussen, gegen die Kortikalis (Knochenwand) gedrückt wird.
Das erfindungsgemässe Verankerungselement ist zum Einsatz ohne Zementmaterial geeignet. Je nach Anwendung kann es aber vorteilhaft sein, das Verankerungselement zusätzlich mit einem Zementmaterial am Röhrenknochen zu fixieren.
Mit dem erfindungsgemässen Verankerungselement wird eine hervorragende und sofortige Primärstabilität des Implantats erreicht. Die Struktur aus Verankerungsdrähten und Verankerungskugeln, welche an die Kortikalis drücken, bildet die ideale Voraussetzung für die Osseointegration. Mit dem erfindungsgemässen Verankerungselement wird die Lasteinleitung nahe dem Gelenkzentrum möglich. Somit findet nur ein geringfügiger Umbau der Knochensubstanz statt, und es gibt keine Lockerung des Implantats. Die erfindungsgemässe Endoprothese ist knochenanatomieunabhängig und dadurch sehr -vielseitig einsetzbar. Das erfindungsgemässe Verankerungselement ist in verschiedenen Längen ausführbar, bspw. mittels der Länge der Verankerungsdrähte.
Die Anatomie von Röhrenknochen ist für ein erfindungsgemässes Verankerungselement irrelevant, weil sich die Hülle an der Kortikalis anpasst. Ausweitungen oder Krümmungen am Knochen wirken sich für die Stabilität vorteilhaft aus, weil sich dadurch die potenzielle Kontaktfläche zwischen der Hülle und dem Knochen vergrössert .
Die Operationstechnik für die Implantation einer erfindungsgemässen Endoprothese ist sicher und reproduzierbar. Die Operation ist knochenschonend und bietet Rückzugsmöglichkeiten. Für die Operation werden nur wenige standardisierte Instrumente benötigt.
Die erfindungsgemässe Endoprothese kann auch zementiert implantiert werden. Dabei wird vor und/oder während des Einfüllens der Füllung Knochenzement beigemischt, oder der Zement wird ohne Füllung in den Markraum eingebracht, so dass die Hülle die Funktion einer Armierung übernimmt.
AUFZÄHLUNG DER ZEICHNUNGEN
Nachfolgend werden Ausführungsbeispiele der Erfindung anhand von Zeichnungen schematisch erläutert.
Figur 1 zeigt eine erste Ausführungsform einer erfindungsgemässen Humerusprothese im implantierten Zustand (a) in einer Seitenansicht und (b) in einer Frontalansicht .
Figur 2 zeigt die Humerusprothese von Fig. 1 vor der Implantation (a) in einer Seitenansicht, (b) in einem Längsschnitt, (c) in einer perspektivischen Ansicht und (d) in einer perspektivischen, teilweise längs aufgeschnittenen Ansicht,
Figur 3 zeigt eine zweite Ausführungsform einer erfindungsgemässen Humerusprothese vor der Implantation (a) in einer Seitenansicht und (b) in einem Längsschnitt .
Figuren 4 und 5 zeigen Innenansichten von Teilen zweier Äusführungsformen des erfindungsgemässen Verankerungselementes .
Figur 6 zeigt eine erfindungsgemässe Femurprothese (a) in einer Seitenansicht
und (b) in einer teilweisen Explosionsansicht .
AUSFÜHRUNG DER ERFINDUNG
Figur 1 veranschaulicht die Erfindung anhand einer zementfrei implantierten distalen Humerusprothese mit Drahtverankerung im implantierten Zustand. Ein Röhrenknochen ist gestrichelt angedeutet. Figur 2 zeigt dieselbe Ausführungsform der erfindungsgemässen Humerusprothese vor der Implantation. Die erfindungsgemässe Endoprothese beinhaltet ein Verankerungselement 1 und einen mit dem Verankerungselement 1 verbundenen Prothesenkopf 2 als Verbindungsglied zwischen dem Verankerungselement 1 und einem (nicht dargestellten) Gelenkgegenstück. Das Verankerungselement 1 weist eine mit dem Prothesenkopf 2 verbundene flexible Hülle zur Aufnahme einer die Hülle nach aussen, gegen den Röhrenknochen drückenden Füllung auf.
In der Ausführungsform von Figur 1 besteht die flexible Hülle des Verankerungselementes 1 aus einer Vielzahl von Verankerungsdrähten Ia, die im Prothesenkopf 2 lösbar fixiert sind. Die Verankerungsdrähte Ia sind vorzugsweise aus einem biokompatiblen Metall hergestellt. Sie können im Querschnitt rund, eckig gewalzt oder gerändelt sein oder eine beliebige andere Querschnittform aufweisen. Der Operateur kann die optimale Länge der Verankerung aufgrund mehrerer vorgegebener Drahtlängen wählen. Die Längen einer Primär- bzw. einer Revisionsprothese unterscheiden sich wesentlich. Die Fixierung der Verankerungsdrähte Ia erfolgt, indem ein keilförmiger (konusförmiger)
Prothesenkopfinnenteil 2a gegen die Verankerungsdrähte Ia und letztlich gegen einen Prothesenkopfaussenteil 2b gepresst wird. Die Innenform des Prothesenkopfaussenteils 2b entspricht dabei der Keilform (Konusform) des Prothesenkopfinnenteils 2a.
Die vom Prothesenkopf 2 abgewandten Enden der Verankerungsdrähte Ia werden von einem Prothesenendteil 3 zusammengehalten. Im Ausführungsbeispiel von Figur 1 sind mindestens zwei Verankerungsdrähte Ia im Prothesenendteil 3 verschlungen. Alle weiteren Verankerungsdrähte Ia sind entweder im Prothesenendteil 3 geführt, bilden eine Schlaufe ohne den Prothesenendteil 3 zu berühren oder befinden sich lose im Markraum ohne den Prothesenendteil 3 zu berühren. Dementsprechend weist der Prothesenendteil 3 Bohrungen zur Führung von Verankerungsdrähten Ia und/oder Mittel für das Verschlingen von mindestens zwei Verankerungsdrähten Ia auf.
Der Hohlraum innerhalb der Verankerungsdrähte Ia, zwischen dem Prothesenkopf 2 und dem Prothesenendteil 3, wird während der Operation mit Verankerungskugeln 4 aufgefüllt. Dies geschieht vorzugsweise über die Zentrumsbohrung im Prothesenkopfinnenteil 2a. Eine Druckschraube 5 im Prothesenkopfinnenteil 2a dient dem Hineinpressen der- Verankerungskugeln 4 sowie dem Verschluss des Markraums auf der Gelenkseite. Die Druckschraube 5 wird im Prothesenkopfinnenteil 2a lösbar fixiert. Sie kann z. B. aus einer Kobalt-Chrom-Legierung hergestellt sein. Zwei Sicherungsschrauben 6 sind bspw. im
Prothesenkopfaussenteil 2b eingeschraubt und verhindern ein Lösen des Prothesenkopfinnenteils 2a. Das Prothesenendteil 3 bildet den Abschluss der
Drahtverankerung und verhindert, dass die Verankerungskugeln 4 weiter in den offenen Markraum vordringen. Je nach Prothesentyp kann es notwendig sein, vor der Implantation der Endoprothese eine unabhängige Kugel- oder Zementsperre im Markraum zu platzieren.
Durch das Hineinpressen der Verankerungskugeln 4 dehnt sich die Drahthülle des Verankerungselementes 1 aus, und es entsteht eine starke Haftreibung zwischen der Verankerung und der Kortikalis. Dies führt zu einer hervorragenden und sofortigen Primärstabilität des Implantats .
Die Verankerungskugeln 4 können aus einem biokompatiblen Metall mit gehärteten und/oder polierten Oberflächen bestehen. Bei den Verankerungskugeln 4 kann es sich um lose Kugeln mit gleichen oder verschiedenen Durchmessern handeln oder um Kugelketten, die aus mindestens zwei miteinander verbundenen Kugeln bestehen. Der Einfachheit halber werden wir nachstehend nur von Verankerungskugeln 4 sprechen. Der Prothesenkopf 2 und das Prothesenendteil 3 unterscheiden sich wesentlich zwischen den verschiedenen Prothesen.
Die Struktur aus Verankerungsdrähten 1 und
Verankerungskugeln 4 bildet die ideale Voraussetzung für die Osseointegration und somit zur Sekundärstabilität des Implantats. Dies verstärkt den Röhrenknochen im Bereich des Verankerungselementes 1 zusätzlich. Selbstschneidende Verankerungsrippen am Prothesenkopf 2 und/oder
Kortikalisschrauben 10 die den Prothesenkopf 2 am Knochen fixieren sorgen für eine verbesserte Primärstabilität.
Die zweite Ausführungsform gemäss Figur 3 ist der ersten Ausführungsform der Figuren 1 und 2 ähnlich. Analoge Elemente sind mit denselben Bezugszeichen wie in Figuren 1 und 2 bezeichnet und werden hier nicht mehr erläutert. Der Hauptunterschied besteht darin, dass die
Verankerungsdrähte Ia vor der Implantation miteinander verdrillt sind. Dank der Verdrillung ist das Verankerungselement 1 besonders kompakt und schlank, was die Implantation erleichtert. Während oder nach der Implantation wird die Verdrillung gelöst, wodurch sich die Drahthülle des Verankerungselementes 1 ausweitet. Die Ausweitung wird durch das Befüllen mit den Verankerungskugeln 4 unterstützt und verstärkt.
Im Ausführungsbeispiel von Figur 4 sind die
Verankerungsdrähte 1 teilweise durch Klammern 7 miteinander verbunden. Im Ausführungsbeispiel von Figur 5 sind die Verankerungsdrähte Ia teilweise miteinander verflochten. Die Klammern 7 bzw. die teilweise Verflechtung der Verankerungsdrähte Ia sorgen für eine gewünschte, vorzugsweise gleichmässige Verteilung der Verankerungsdrähte Ia entlang des Umfangs des Verankerungselementes 1. Sie verleihen dem Verankerungselement 1 eine erhöhte Stabilität und verhindern, dass sich die Verankerungsdrähte Ia an bestimmten Stellen entlang des Umfangs anhäufen, während andere Stellen mit nur wenigen oder gar keinen Verankerungsdrähte Ia versehen sind.
Eine erfindungsgemässe Femurprothese ist in Figur 6 dargestellt. Viele Elemente dieser Femurprothese sind analog zu Elementen der anlässlich der Figuren 1-3 diskutierten Humerusprothesen. Sie werden mit denselben
Bezugszeichen bezeichnet und brauchen hier nicht erneut erläutert zu werden. Die Femurprothese beinhaltet eine Femurplatte 9. Diese drückt im implantierten Zustand auf die Knochenfläche beim entfernten Schenkelhals des proximalen Femurs und bildet so den Abschluss des
Markraums. Ferner drückt die Femurplatte 9 gegen den Prothesenkopfinnenteil 2a. Drei Sicherungsschrauben 6 verhindern, dass sich der Prothesenkopfinnenteil 2a lösen kann, indem sie durch die Femurplatte 9 hindurch in den Prothesenkopfaussenteil 2b geschraubt werden. Mindestens eine Kortikalisschraube 10 verbindet die Femurplatte 9 mit dem Femur. Die Kortikalisschrauben 10 tragen wesentlich zur Primärstabilität des Prothesenkopfs 2 bei.
Die Hülle des Verankerungselementes 1 ist in der Ausführungsform von Figur 6 aus zwei Schichten von Verankerungsdrähten Ia aufgebaut, die von einem Verbindungselement 8, aufgeteilt und/oder geführt werden.
Selbstverständlich beschränkt sich die Erfindung nicht auf die oben diskutierten Ausführungsformen. Die diskutierten Ausführungsformen können miteinander kombiniert werden. Als Hülle für das erfindungsgemässe Verankerungselement 1 kommen auch weitere flexible Gebilde wie Gewebe, Geflechte, Netze oder Folien in Frage. Die Füllung kann alternativ zu den oben diskutierten festen Füllkörpern aus einem im Wesentlichen homogenen Material bestehen, oder eine Kombination von homogenem Material und festen Füllkörpern sein.
BEZUGSZEICHENLISTE
1 Verankerungselement
Ia Verankerungsdrähte
2 Prothesenkopf
2a Prothesenkopfinnenteil
2b Prothesenkopfaussenteil
3 Prothesenendteil
4 Verankerungskugeln
5 Druckschraube β Sicherungsschrauben
7 Klammer
8 Verbindungselement
9 Femurplatte
10 Kortikal!sschrauben
Claims
1. Verankerungselement (1) zur Verankerung einer Endoprothese in einem Röhrenknochen, gekennzeichnet durch eine mit einem Prothesenkopf (2) der Endoprothese verbundene flexible Hülle zur Aufnahme einer die Hülle nach aussen, gegen den Röhrenknochen drückenden Füllung (4) .
2. Verankerungselement (1) nach Anspruch 1, wobei die Hülle Verankerungsdrähte (Ia) beinhaltet.
3. Verankerungselement (1) nach Anspruch 2, dadurch gekennzeichnet, dass Verankerungsdrähte (Ia) im Prothesenkopf (2) lösbar fixiert sind.
4. Verankerungselement (1) nach Anspruch 3, dadurch gekennzeichnet, dass die lösbare Fixation durch ein Zusammenwirken eines Prothesenkopfinnenteils (2a) mit einem Prothesenkopfaussenteil (2b) entsteht, wobei der Prothesenkopfinnenteil (2a) die Verankerungsdrähte (Ia) gegen den Prothesenkopfaussenteil (2b) presst.
5. Verankerungselement (1) nach einem der Ansprüche 2-4, dadurch gekennzeichnet, dass Verankerungsdrähte (Ia) an ihren vom Prothesenkopf (2) abgewandten Enden von einem Prothesenendteil (3) zusammengehalten werden.
6. Verankerungselement (1) nach Anspruch 5, dadurch gekennzeichnet, dass mindestens zwei Verankerungsdrähte (Ia) im Prothesenendteil (3) verschlungen sind.
7. Verankerungselement (1) nach Anspruch 5 oder 6, dadurch gekennzeichnet, dass ein Teil der Verankerungsdrähte (Ia) eine Schlaufe im Markraum bilden, ohne das Prothesenendteil (3) zu berühren.
8. Verankerungselement (1) nach einem der Ansprüche 2-7, dadurch gekennzeichnet, dass die Verankerungsdrähte (Ia) teilweise untereinander verflochten sind.
9. Verankerungselement (1) nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Verankerungsdrähte (Ia) teilweise miteinander unlösbar verbunden sind.
10. Verankerungselement nach einem der Ansprüche 2-9, dadurch gekennzeichnet, dass die Verankerungsdrähte (Ia) verdrillt sind, so dass sich die Hülle beim Lösen der Verdrillung ausweitet.
11. Verankerungselement (1) nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Füllung
(4) eine Vielzahl von festen Füllkörpern beinhaltet, wobei das Volumen eines einzelnen Füllkörpers wesentlich kleiner ist als das von der Hülle umschlossene Volumen im implantierten Zustand.
12. Verankerungselement (1) nach Anspruch 11, dadurch gekennzeichnet, dass die Füllkörper Verankerungskugeln (4) sind.
13. Verankerungselement (1) nach Anspruch 12, dadurch gekennzeichnet, dass mindestens zwei Verankerungskugeln (4) zu einer Kette verbunden sind.
14. Verankerungselement (1) nach einem der Ansprüche 11- 13, dadurch gekennzeichnet, dass in einem Prothesenkopfinnenteil (2a) eine Druckschraube (5) für das Hineinpressen der Füllkörper (4) vorgesehen ist.
15. Verankerungselement (1) nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, dass die Hülle und/oder die Füllung (4) aus mindestens einem biokompatiblen Metall hergestellt sind.
16. Endoprothese zum Einsatz in einem Röhrenknochen, mit einem Prothesenkopf (2) und einem mit dem
Prothesenkopf (2) verbundenen Verankerungselement (1) , dadurch gekennzeichnet, dass das Verankerungselement (1) ein Verankerungselement nach einem der vorangehenden Ansprüche ist.
17. Verfahren zur Verankerung einer Endoprothese nach Anspruch 16 in einem Röhrenknochen, dadurch gekennzeichnet, dass die Hülle ohne Füllung in eine dafür vorgesehene Öffnung im Röhrenknochen eingeführt und nach der Einführung mit der Füllung (4) gefüllt wird, so dass sie von der Füllung (4) nach aussen, gegen den Röhrenknochen gedrückt wird.
18. Verfahren nach Anspruch 17, dadurch gekennzeichnet, dass das Verankerungselement (1) zusätzlich mit einem Zementmaterial am Röhrenknochen fixiert wird.
19. Verfahren nach Anspruch 18, dadurch gekennzeichnet, dass das Zementmaterial vor und/oder während des Füllens mit oder ohne Füllung appliziert wird.
20. Verfahren nach einem der Ansprüche 17-19, wobei eine unabhängige Verankerungskugelsperre und/oder Zementsperre inseriert wird, bevor das Verankerungselement (1) in den Röhrenknochen eingebracht wird.
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CH974/07 | 2007-06-18 | ||
CH9742007 | 2007-06-18 |
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WO2008154762A1 true WO2008154762A1 (de) | 2008-12-24 |
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PCT/CH2008/000270 WO2008154762A1 (de) | 2007-06-18 | 2008-06-16 | Verankerungselement für endoprothesen in röhrenknochen |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011005188A1 (en) * | 2009-07-10 | 2011-01-13 | Milux Holding S.A. | Hip joint device |
CH703627A1 (de) * | 2010-08-25 | 2012-02-29 | Arnold Schefer | Ankerhülse. |
WO2023006566A1 (de) * | 2021-07-28 | 2023-02-02 | mechamed GmbH | Fixiermittel für eine prothese |
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DE2305441A1 (de) * | 1973-02-03 | 1974-08-08 | Rosenthal Stemag Tech Keramik | Spannstueckverbindung fuer implantate |
EP0061993A1 (de) * | 1981-04-01 | 1982-10-06 | Mecron Medizinische Produkte Gmbh | Gelenkprothese |
DE3122730A1 (de) * | 1981-06-04 | 1982-12-23 | Karl Fritz 1000 Berlin Reich | Schaft fuer implantat |
US4888024A (en) * | 1985-11-08 | 1989-12-19 | Powlan Roy Y | Prosthetic device and method of fixation within the medullary cavity of bones |
WO1993006787A1 (fr) * | 1990-04-20 | 1993-04-15 | Jean Perisse | Implant dentaire multibloc |
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2008
- 2008-06-16 WO PCT/CH2008/000270 patent/WO2008154762A1/de active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2305441A1 (de) * | 1973-02-03 | 1974-08-08 | Rosenthal Stemag Tech Keramik | Spannstueckverbindung fuer implantate |
EP0061993A1 (de) * | 1981-04-01 | 1982-10-06 | Mecron Medizinische Produkte Gmbh | Gelenkprothese |
DE3122730A1 (de) * | 1981-06-04 | 1982-12-23 | Karl Fritz 1000 Berlin Reich | Schaft fuer implantat |
US4888024A (en) * | 1985-11-08 | 1989-12-19 | Powlan Roy Y | Prosthetic device and method of fixation within the medullary cavity of bones |
WO1993006787A1 (fr) * | 1990-04-20 | 1993-04-15 | Jean Perisse | Implant dentaire multibloc |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011005188A1 (en) * | 2009-07-10 | 2011-01-13 | Milux Holding S.A. | Hip joint device |
AU2010269153B2 (en) * | 2009-07-10 | 2016-03-03 | Implantica Patent Ltd. | Hip joint device |
US9486318B2 (en) | 2009-07-10 | 2016-11-08 | Peter Forsell | Hip joint device |
CH703627A1 (de) * | 2010-08-25 | 2012-02-29 | Arnold Schefer | Ankerhülse. |
WO2012024806A1 (de) * | 2010-08-25 | 2012-03-01 | Arnold Schefer | Ankerhülse |
WO2023006566A1 (de) * | 2021-07-28 | 2023-02-02 | mechamed GmbH | Fixiermittel für eine prothese |
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