EP2816975A1 - Cement-free surface replacement prosthesis for the natural femur head - Google Patents

Cement-free surface replacement prosthesis for the natural femur head

Info

Publication number
EP2816975A1
EP2816975A1 EP13703809.7A EP13703809A EP2816975A1 EP 2816975 A1 EP2816975 A1 EP 2816975A1 EP 13703809 A EP13703809 A EP 13703809A EP 2816975 A1 EP2816975 A1 EP 2816975A1
Authority
EP
European Patent Office
Prior art keywords
replacement prosthesis
thread
surface replacement
osseointegrative
femoral head
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.)
Withdrawn
Application number
EP13703809.7A
Other languages
German (de)
French (fr)
Inventor
Michael Kuntz
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.)
Ceramtec GmbH
Original Assignee
Ceramtec GmbH
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
Application filed by Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of EP2816975A1 publication Critical patent/EP2816975A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3601—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices
    • A61F2/3603—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30028—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A61F2002/30851—Multiple threadings
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A61F2002/30873—Threadings machined on non-cylindrical external surfaces
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue

Definitions

  • the invention relates to a ceramic surface replacement prosthesis for the natural femoral head with an outer spherical surface and an inner receiving space with an inner circumferential surface.
  • Surface replacement prostheses are also called resurfacing head, hip cap or cap prosthesis.
  • the outer surface of the resurfacing prosthesis is spherically shaped and is inserted either directly into the natural pelvis or into an artificial acetabulum, which in turn is anchored in the natural pelvis.
  • Previous ceramic surface replacement prostheses are largely based on known metallic designs and are basically cemented.
  • the inner surface of the inner receiving space is provided with cement pockets and a centering pin.
  • a cementless version of a surface replacement prosthesis would be very advantageous because of the heat generation of the cement.
  • Another advantage would be an embodiment without centering, since the loss of bone tissue by the attributable center hole is smaller.
  • the invention has the object to improve a ceramic surface replacement prosthesis according to the preamble of claim 1 so that no necrosis of the bone tissue is caused during implantation and there is also no loss of internal bone tissue.
  • Internal bone tissue is understood to mean bone tissue that is not visible from the outside, in contrast to external bone tissue, which is visible from the outside and is processed before the surface replacement prosthesis is put on.
  • this object is achieved in that the inner lateral surface is at least partially provided with an osseointegrative coating or is designed osseointegrativ and / or the lateral surface is formed as a self-tapping thread.
  • an osseointegrative surface coating or design of the inner lateral surface By means of an osseointegrative surface coating or design of the inner lateral surface, a firm and durable anchoring of the surface replacement prosthesis on the femoral head is achieved.
  • An osseointegrative design of the lateral surface is, for example, by designing the near-surface area of the lateral surface in the green state of the ceramic surface replacement prosthesis achieved with the aim of a suitable open-pore structure.
  • a coating of the lateral surface in the sintered state of the ceramic surface replacement prosthesis, for example, with structured coverings of titanium alloys is suitable.
  • the surface replacement prosthesis is attached to the femoral head without cement. This applies to all inventive embodiments. It also arranged in all embodiments, no central centering pin in the receiving space.
  • the lateral surface is designed as a self-tapping thread.
  • the attachment is substantially improved, so that can be dispensed with the cementing or centering.
  • the thread is conical or cylindrical.
  • the femoral head usually has to be processed least.
  • the steepness of the thread is essential: After insertion of the femoral head with the surface replacement prosthesis In the acetabulum at the end of the operation, the interface of the surface replacement prosthesis to the femoral head is axially biased by the natural ligament tension and muscle tone.
  • the greater the steepness of the thread the higher the torque required for unintentional release of the connection; such a releasing torque about the axis of symmetry of the surface replacement prosthesis can occur by rotational movements of the leg during movement exercises.
  • Increasing ingrowth of bone tissue into the osseointegrative-shaped interface between femoral head and surface replacement prosthesis increases the fit between elements of the bone tissue ("trabeculae") and the osseointegrative structure, the safety of the interface.
  • the thread should therefore have a pitch greater than 2 mm / rev
  • the thread can be formed more smoothly.
  • the number of threads, the tooth shape and the pitch can be optimized in terms of primary anti-rotation and axial strength within wide limits and are to be produced on conventional CNC machines during the green machining of the ceramic surface replacement prostheses. Even very steep angles up to 90 ° can be carried out, whereby these can be mounted with an impact instrument.
  • cementless surface replacement prostheses according to the invention are shown. 1 shows schematically a section through a natural thigh neck 9 or femoral head 3 with attached inventive surface replacement prosthesis 1 made of a ceramic.
  • the outer surface of the surface replacement prosthesis 1 is spherical and is used either directly in the natural basin or in an artificial pan, which in turn is anchored directly or indirectly in the natural basin.
  • the surface replacement prosthesis 1 has an inner receiving space with an inner circumferential surface 4, with which the surface replacement prosthesis 1 is placed on the femoral head 3.
  • the inner circumferential surface 4 of the receiving space is preferably conical. But it can also, as shown in Figure 1, be crowned.
  • the surface replacement prosthesis 1 is fastened on the femoral head 3 without cement. This applies to all inventive embodiments. There is also no central centering pin arranged in the receiving space.
  • the inner circumferential surface 4 is provided with an osseointegrative coating 6 or is designed osseointegrative.
  • the inner circumferential surface 4 of the receiving space is formed as a self-tapping thread.
  • FIG 2 shows a surface replacement prosthesis 1 according to the invention, in which the lateral surface 4 of the inner receiving space is designed as a truncated cone and provided with a multi-course coarse thread.
  • a 2-course self-tapping thread is shown as an example.
  • the inner lateral surface 4 is provided with an osseointegrative coating 6 in addition to the thread.
  • An osseointegrative coating 6 is also referred to as a direct-to-bone coating.
  • the preparation of the seat during the operation is carried out with a correspondingly shaped milling instrument. After placement of the surface replacement prosthesis 1, this is fixed by a clockwise rotation. To correct the height, the surface replacement prosthesis 1 could be released again by turning to the left and, if necessary, the seat can be milled.
  • FIG. 3 shows a surface replacement prosthesis 1 according to the invention with a conical, self-forming, four-course thread with a pitch s / 4.
  • FIG. 4 shows a section through a surface replacement prosthesis 1 with a common thread 8 and
  • FIG. 5 shows a surface replacement prosthesis 1 with a four-prong thread.
  • FIG. 6 shows a surface replacement prosthesis 1 according to the invention with a cylindrical self-forming 6-thread thread.
  • the pitch of all threads is 1 to 20 mm / rev, preferably 2 to 10 mm / rev, more preferably 3 to 6 mm / rev.
  • the pitch is preferably 1 -2 mm / revolution, 2-4 mm / revolution for a 2-speed thread and 3-6 mm / revolution for a 3-thread.

Landscapes

  • 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

The invention relates to a ceramic surface replacement prosthesis (1) for the natural femur head (3), comprising an outer spherical surface (5) and an inner receiving space (7) with an inner lateral surface (4). The aim of the invention is to prevent necrosis of the bone tissue as a result of the implantation process, thus also preventing a loss of inner bone tissue. According to the invention, this is achieved in that the inner lateral surface (4) is provided with an osseointegrative coating (6) or is designed in an osseointegrative manner at least in some areas, and/or the lateral surface (4) is designed as a self-forming thread (8).

Description

Zementfreie Oberflächenersatzprothese für den natürlichen Femurkopf  Cement-free surface replacement prosthesis for the natural femoral head
Die Erfindung betrifft eine keramische Oberflächenersatzprothese für den natürlichen Femurkopf mit einer äußeren kugelförmigen Oberfläche und einem inneren Aufnahmeraum mit einer inneren Mantelfläche. The invention relates to a ceramic surface replacement prosthesis for the natural femoral head with an outer spherical surface and an inner receiving space with an inner circumferential surface.
Oberflächenersatzprothesen werden auch Resurfacing Kopf, Hüftkappe oder Kappenprothese genannt. Surface replacement prostheses are also called resurfacing head, hip cap or cap prosthesis.
Bei Verschleiß des natürlichen Femurkopfes bzw. Hüftgelenkkopfes (Caput femoris) ist es nach dem Stand der Technik bekannt, eine Oberflächenersatzprothese aus Metall oder Keramik auf den Femurkopf aufzusetzen und mit Knochenzement zu verankern. Die Oberflächenersatzprothese ersetzt nur den Gelenkknorpel des Femurkopfes und wird angewendet, wenn der Femur-Knochen unter dem Gelenkknorpel in Form oder Struktur nicht wesentlich geschädigt ist. When wear of the natural femoral head or femoral head (caput femoris), it is known in the prior art to set up a surface replacement prosthesis made of metal or ceramic on the femoral head and anchored with bone cement. The surface replacement prosthesis replaces only the articular cartilage of the femoral head and is used when the femur bone under the articular cartilage is not substantially damaged in shape or structure.
Die äußere Oberfläche der Oberflächenersatzprothese ist kugelförmig ausgebildet und wird entweder direkt in das natürliche Becken oder in eine künstliche Pfanne eingesetzt, die wiederum im natürlichen Becken verankert wird. The outer surface of the resurfacing prosthesis is spherically shaped and is inserted either directly into the natural pelvis or into an artificial acetabulum, which in turn is anchored in the natural pelvis.
Bisherige keramische Oberflächenersatzprothesen sind weitgehend angelehnt an bekannte metallische Designs und werden grundsätzlich einzementiert. Die innere Mantelfläche des inneren Aufnahmeraums ist mit Zementtaschen und einem Zentrierstift versehen. Previous ceramic surface replacement prostheses are largely based on known metallic designs and are basically cemented. The inner surface of the inner receiving space is provided with cement pockets and a centering pin.
Wegen der exothermen Reaktion bei der Härtung der verwendeten Zemente besteht die Gefahr einer thermischen Schädigung und Nekrotisierung des Knochengewebes. Eine zementfreie Version einer Oberflächenersatzprothese wäre sehr vorteilhaft wegen der entfallenden Wärmeentwicklung des Zements. Because of the exothermic reaction in the curing of the cements used, there is a risk of thermal damage and necrosis of the bone tissue. A cementless version of a surface replacement prosthesis would be very advantageous because of the heat generation of the cement.
Ein weiterer Vorteil wäre eine Ausführung ohne Zentrierstift, da der Verlust an Knochengewebe durch die entfallende Zentrierbohrung geringer ausfällt. Another advantage would be an embodiment without centering, since the loss of bone tissue by the attributable center hole is smaller.
Der Erfindung liegt die Aufgabe zugrunde, eine keramische Oberflächenersatzprothese nach dem Oberbegriff des Anspruchs 1 so zu verbessern, dass beim Implantieren keine Nekrotisierung des Knochengewebes verursacht wird und es außerdem zu keinem Verlust an innerem Knochengewebe kommt. Mit innerem Knochengewebe wird das nicht von außen sichtbare Knochengewebe verstanden im Gegensatz zum äußeren Knochengewebe, welches von außen sichtbar ist und vor dem Aufsetzen der Oberflächenersatzprothese bearbeitet wird. The invention has the object to improve a ceramic surface replacement prosthesis according to the preamble of claim 1 so that no necrosis of the bone tissue is caused during implantation and there is also no loss of internal bone tissue. Internal bone tissue is understood to mean bone tissue that is not visible from the outside, in contrast to external bone tissue, which is visible from the outside and is processed before the surface replacement prosthesis is put on.
Erfindungsgemäß wird diese Aufgabe dadurch gelöst, dass die innere Mantelfläche zumindest bereichsweise mit einer osseointegrativen Beschichtung versehen ist oder osseointegrativ ausgestaltet ist und/oder die Mantelfläche als selbstformendes Gewinde ausgebildet ist. According to the invention, this object is achieved in that the inner lateral surface is at least partially provided with an osseointegrative coating or is designed osseointegrativ and / or the lateral surface is formed as a self-tapping thread.
Eine osseointegrative Oberflächenbeschichtung ist beschrieben in B. Theelke, Mi. Kuntz, M. Zipperle, S. Eichhorn, T. Boxleitner, T. Pandorf, R. Burgkart, "Development of osseointegrative ceramic coatings based on ZPTA - mechanical characterization and influence on the Substrate", Bioceramics 1 , 2010, S. 1 -4. An osseointegrative surface coating is described in B. Theelke, Mi. Kuntz, M. Zipperle, S. Eichhorn, T. Boxleitner, T. Pandorf, R. Burgkart, "Development of osseointegrative ceramic coatings based on ZPTA - mechanical characterization and influence on the Substrates ", Bioceramics 1, 2010, pp. 1-4.
Durch eine osseointegrative Oberflächenbeschichtung bzw. Ausgestaltung der inneren Mantelfläche wird eine feste und haltbare Verankerung der Oberflächenersatzprothese auf dem Femurkopf erreicht. Eine osseointegrative Ausgestaltung der Mantelfläche wird zum Beispiel durch Gestaltung des oberflächennahen Bereichs der Mantelfläche im Grünzustand der keramischen Oberflachenersatzprothese mit dem Ziel einer geeigneten offenporigen Struktur erzielt. Auch eine Beschichtung der Mantelfläche im gesinterten Zustand der keramischen Oberflächenersatzprothese, zum Beispiel mit strukturierten Belägen aus Titanlegierungen ist geeignet. By means of an osseointegrative surface coating or design of the inner lateral surface, a firm and durable anchoring of the surface replacement prosthesis on the femoral head is achieved. An osseointegrative design of the lateral surface is, for example, by designing the near-surface area of the lateral surface in the green state of the ceramic surface replacement prosthesis achieved with the aim of a suitable open-pore structure. A coating of the lateral surface in the sintered state of the ceramic surface replacement prosthesis, for example, with structured coverings of titanium alloys is suitable.
Ein extrem wichtiges Merkmal der Erfindung, ist, dass die Oberflächenersatzprothese ohne Zement auf dem Femurkopf befestigt ist. Dies gilt für alle erfinderischen Ausgestaltungen. Es auch in allen Ausgestaltungen auch kein mittiger Zentrierstift im Aufnahmeraum angeordnet. An extremely important feature of the invention is that the surface replacement prosthesis is attached to the femoral head without cement. This applies to all inventive embodiments. It also arranged in all embodiments, no central centering pin in the receiving space.
Alternativ oder in Kombination zur osseointegrativen Beschichtung oder osseointegrativen Ausgestaltung ist die Mantelfläche als selbstformendes Gewinde ausgebildet. Hierdurch ist die Befestigung wesentlich verbessert, so dass auf das Einzementieren oder den Zentrierstift verzichtet werden kann. Alternatively or in combination with the osseointegrative coating or osseointegrative embodiment, the lateral surface is designed as a self-tapping thread. As a result, the attachment is substantially improved, so that can be dispensed with the cementing or centering.
Das Gewinde ist konisch oder zylinderförmig ausgebildet ist. Beim konischen The thread is conical or cylindrical. When conical
Gewinde muss der Femurkopf in der Regel am wenigsten bearbeitet werden. Thread, the femoral head usually has to be processed least.
Es hat sich überraschend gezeigt, dass die Steigung des Gewindes einen It has surprisingly been found that the pitch of the thread a
wesentlichen Einfluss auf die Verankerung der Oberflächenersatzprothese auf dem Femurkopf ausübt. Die Steilheit des Gewindes ist nötig, damit keine Lockerung der Oberflächenersatzprothese auf dem Femurkopf auftritt. Je größer die Steigung ist, desto größere Kräfte sind erforderlich, um die Oberflächenersatzprothese auf dem Femurkopf zu drehen. Andersherum ausgedrückt: Liegt, bei festsitzender significant influence on the anchoring of the surface replacement prosthesis on the femoral head. The steepness of the thread is necessary so that no loosening of the surface replacement prosthesis occurs on the femoral head. The larger the pitch, the greater the forces required to turn the surface replacement prosthesis on the femoral head. Expressed the other way around: Lie, when stuck
Oberflächenersatzprothese, das durch Reibungskräfte auf die Surface replacement prosthesis caused by frictional forces on the
Oberflächenersatzprothese wirkende Drehmoment unterhalb des Drehmoments, mit der die Oberflächenersatzprothese mit ihrem Gewinde auf dem Femurkopf verdrehbar ist, bleibt die Oberflachenersatzprothese fest auf dem Femurkopf verankert. Die Steilheit des Gewindes ist daher ein wichtiges erfindungsgemäßes Merkmal. Surface replacement prosthesis acting torque below the torque, with the surface replacement prosthesis with its thread on the femoral head is rotatable, the surface replacement prosthesis remains firmly anchored on the femoral head. The steepness of the thread is therefore an important feature of the invention.
Es hat sich gezeigt, dass für die Primärfixierung der Oberflächenersatzprothese unmittelbar nach der Operation, speziell für die Sicherheit gegen das Lösen der Fixierung durch eine ungewollte Linksdrehung der Oberflächenersatzprothese, die Steilheit des Gewindes von wesentlicher Bedeutung ist: Nach dem Einsetzen des Oberschen kelkopfes mit der Oberflächenersatzprothese in die Hüftpfanne zum Ende der Operation wird durch die natürliche Bandspannung und den Muskeltonus die Schnittstelle der Oberflächenersatzprothese zum Oberschenkelkopf axial unter Vorspannung gesetzt. Je größer die Steilheit des Gewindes ist, desto höher ist das notwendige Drehmoment zum ungewollten Lösen der Verbindung; ein solches lösendes Drehmoment um die Symmetrieachse der Oberflächenersatzprothese kann durch Drehbewegungen des Beins bei Bewegungsübungen auftreten. Mit It has been shown that for the primary fixation of the surface replacement prosthesis immediately after the operation, especially for the security against the release of the fixation by an unwanted left rotation of the surface replacement prosthesis, the steepness of the thread is essential: After insertion of the femoral head with the surface replacement prosthesis In the acetabulum at the end of the operation, the interface of the surface replacement prosthesis to the femoral head is axially biased by the natural ligament tension and muscle tone. The greater the steepness of the thread, the higher the torque required for unintentional release of the connection; such a releasing torque about the axis of symmetry of the surface replacement prosthesis can occur by rotational movements of the leg during movement exercises. With
zunehmendem Einwachsen von Knochengewebe in die osseointegrativ gestaltete Grenzfläche zwischen Oberschenkelkopf und Oberflächenersatzprothese vergrößert der Formschluss zwischen Elementen des Knochengewebes („Knochenbälkchen") und der osseointegrativen Struktur die Sicherheit der Schnittstelle. Increasing ingrowth of bone tissue into the osseointegrative-shaped interface between femoral head and surface replacement prosthesis increases the fit between elements of the bone tissue ("trabeculae") and the osseointegrative structure, the safety of the interface.
Das Gewinde sollte daher mit einer Steigung größer als 2 mm/Umdrehung The thread should therefore have a pitch greater than 2 mm / rev
ausgebildet sein. Schon besser ist eine Steigung größer als 4 mm/Umdrehung. Die besten Ergebnisse wurden mit einer Steigung größer als 6 mm/Umdrehung erzielt. be educated. Even better is a pitch greater than 4 mm / turn. The best results were achieved with a pitch greater than 6 mm / rev.
Auch kann das Gewinde mehrgängig ausgebildet sein. Also, the thread can be formed more smoothly.
Die Anzahl der Gewindegänge, die Zahnform und die Steigung können bezüglich primärer Verdrehsicherheit und axialer Festigkeit in weiten Grenzen optimiert werden und sind bei der Grünbearbeitung der keramischen Oberflächenersatzprothesen auf herkömmlichen CNC-Maschinen zu fertigen. Auch sehr steile Winkel bis 90° sind ausführbar, wobei diese mit einem Aufschlaginstrument montiert werden können. The number of threads, the tooth shape and the pitch can be optimized in terms of primary anti-rotation and axial strength within wide limits and are to be produced on conventional CNC machines during the green machining of the ceramic surface replacement prostheses. Even very steep angles up to 90 ° can be carried out, whereby these can be mounted with an impact instrument.
Nachfolgend wird die Erfindung anhand mehrerer Figuren weiter erläutert. In allen Figuren sind erfindungsgemäße zementfreie Oberflächenersatzprothesen dargestellt. Figur 1 zeigt schematisch einen Schnitt durch einen natürlichen Oberschenkelhals 9 bzw. Femurkopf 3 mit aufgesetzter erfinderischer Oberflächenersatzprothese 1 aus einer Keramik. Die äußere Oberfläche der Oberflächenersatzprothese 1 ist kugelförmig ausgebildet und wird entweder direkt in das natürliche Becken oder in eine künstliche Pfanne eingesetzt, die wiederum direkt oder indirekt im natürlichen Becken verankert wird. The invention will be further explained with reference to several figures. In all figures, cementless surface replacement prostheses according to the invention are shown. 1 shows schematically a section through a natural thigh neck 9 or femoral head 3 with attached inventive surface replacement prosthesis 1 made of a ceramic. The outer surface of the surface replacement prosthesis 1 is spherical and is used either directly in the natural basin or in an artificial pan, which in turn is anchored directly or indirectly in the natural basin.
Die Oberflächenersatzprothese 1 weist einen inneren Aufnahmeraum mit einer inneren Mantelfläche 4 auf, mit dem die Oberflächenersatzprothese 1 auf den Femurkopf 3 aufgesetzt ist. Die innere Mantelfläche 4 des Aufnahmeraums ist bevorzugt konisch ausgebildet. Sie kann aber auch, wie in Figur 1 gezeigt, ballig ausgebildet sein. The surface replacement prosthesis 1 has an inner receiving space with an inner circumferential surface 4, with which the surface replacement prosthesis 1 is placed on the femoral head 3. The inner circumferential surface 4 of the receiving space is preferably conical. But it can also, as shown in Figure 1, be crowned.
Erfindungsgemäß ist die Oberflächenersatzprothese 1 ohne Zement auf dem Femurkopf 3 befestigt. Dies gilt für alle erfinderischen Ausgestaltungen. Es ist auch kein mittiger Zentrierstift im Aufnahmeraum angeordnet. According to the invention, the surface replacement prosthesis 1 is fastened on the femoral head 3 without cement. This applies to all inventive embodiments. There is also no central centering pin arranged in the receiving space.
Zur Verankerung der Oberflächenersatzprothese 1 ist die innere Mantelfläche 4 mit einer osseointegrativen Beschichtung 6 versehen oder ist osseointegrativ ausgestaltet. In einer anderen Ausgestaltung der Erfindung ist die innere Mantelfläche 4 des Aufnahmeraums als selbstformendes Gewinde ausgebildet. Diese Ausgestaltungen werden anhand der Figuren 2 bis 6 näher erläutert. Zusätzlich kann auch bei diesen Ausgestaltungen die innere Mantelfläche mit einer osseointegrativen Beschichtung versehen oder osseointegrativ ausgestaltet sein. To anchor the surface replacement prosthesis 1, the inner circumferential surface 4 is provided with an osseointegrative coating 6 or is designed osseointegrative. In another embodiment of the invention, the inner circumferential surface 4 of the receiving space is formed as a self-tapping thread. These embodiments will be explained in more detail with reference to FIGS 2 to 6. In addition, in these embodiments, too, the inner circumferential surface may be provided with an osseointegrative coating or may be osseointegrated.
Figur 2 zeigt eine erfindungsgemäße Oberflächenersatzprothese 1 , bei der die Mantelfläche 4 des inneren Aufnahmeraums als Kegelstumpf ausgeführt und mit einem mehrgängigen Steilgewinde versehen ist. In Figur 2 ist als Beispiel ein 2- gängiges selbstformendes Gewinde dargestellt. Die innere Mantelfläche 4 ist zusätzlich zum Gewinde mit einer osseointegrativen Beschichtung 6 versehen. Eine osseointegrative Beschichtung 6 wird auch als Direct-To-Bone-Beschichtung bezeichnet. Die Präparation des Sitzes während der Operation erfolgt mit einem entsprechend geformten Fräsinstrument. Nach dem Aufsetzen der Oberflächenersatzprothese 1 wird diese durch eine Rechtsdrehung fixiert. Zur Korrektur der Höhe könnte die Oberflächenersatzprothese 1 wieder durch Linksdrehung gelöst und der Sitz gegebenenfalls nachgefräst werden.  Figure 2 shows a surface replacement prosthesis 1 according to the invention, in which the lateral surface 4 of the inner receiving space is designed as a truncated cone and provided with a multi-course coarse thread. In Figure 2, a 2-course self-tapping thread is shown as an example. The inner lateral surface 4 is provided with an osseointegrative coating 6 in addition to the thread. An osseointegrative coating 6 is also referred to as a direct-to-bone coating. The preparation of the seat during the operation is carried out with a correspondingly shaped milling instrument. After placement of the surface replacement prosthesis 1, this is fixed by a clockwise rotation. To correct the height, the surface replacement prosthesis 1 could be released again by turning to the left and, if necessary, the seat can be milled.
Wegen der zentrierenden Wirkung des kegelförmigen Sitzes kann auf einen Zentrierstift im Aufnahmeraum verzichtet werden mit dem Vorteil des Gewebeerhalts. Because of the centering effect of the conical seat can be dispensed with a centering pin in the receiving space with the advantage of tissue preservation.
In Figur 2 ist die Steigung (s) des konischen 2-gängigen Gewindes konstant, d.h. der axiale Weg pro ganzer Umdrehung ist konstant. Die Teilung (t), d.h. der Abstand zwischen zwei Gewindespitzen ist hier s/2. In Figure 2, the pitch (s) of the 2-conical conical thread is constant, i. the axial travel per entire revolution is constant. The division (t), i. the distance between two thread crests is s / 2 here.
Figur 3 zeigt eine erfindungsgemäße Oberflächenersatzprothese 1 mit einem konischen selbstformenden 4-gängigen Gewinde mit einer Teilung s/4. Figur 4 zeigt einen Schnitt durch eine Oberflächenersatzprothese 1 mit einenn 2- gängigen Gewinde 8 und Figur 5 eine Oberflächenersatzprothese 1 mit einem 4- gängigen Gewinde. Figur 6 zeigt eine erfindungsgemäße Oberflächenersatzprothese 1 mit einem zylinderförmigen selbstformenden 6-gängigen Gewinde. Hier weist nur der kugelförmige Abschnitt 2 des Aufnahmeraums oberhalb des Gewindes eine osseointegrative Beschichtung 6 auf. Die Steigung aller Gewinde liegt bei 1 bis 20 mm/Umdrehung, bevorzugt bei 2 bis 10 mm/Umdrehung, besonders bevorzugt bei 3 bis 6 mm/Umdrehung. Die Auswahl der Gänge des Gewindes erfolgt in Abhängigkeit von der Steigung und der Gewindeform. So beträgt bei einem 1 -gängigen Gewinde die Steigung bevorzugt 1 -2 mm/Umdrehung, 2-4 mm/Umdrehung bei einem 2-gängigen Gewinde und 3-6 mm/Umdrehung bei einem 3-gängigen Gewinde. FIG. 3 shows a surface replacement prosthesis 1 according to the invention with a conical, self-forming, four-course thread with a pitch s / 4. FIG. 4 shows a section through a surface replacement prosthesis 1 with a common thread 8 and FIG. 5 shows a surface replacement prosthesis 1 with a four-prong thread. FIG. 6 shows a surface replacement prosthesis 1 according to the invention with a cylindrical self-forming 6-thread thread. Here, only the spherical section 2 of the receiving space above the thread has an osseointegrative coating 6. The pitch of all threads is 1 to 20 mm / rev, preferably 2 to 10 mm / rev, more preferably 3 to 6 mm / rev. The selection of the threads of the thread is made depending on the pitch and the thread form. Thus, for a 1-start thread, the pitch is preferably 1 -2 mm / revolution, 2-4 mm / revolution for a 2-speed thread and 3-6 mm / revolution for a 3-thread.
Erläuterung zu den Bezugszeichen: Explanation of the reference numbers:
1 Oberflächenersatzprothese 1 surface replacement prosthesis
2 kugelförmiger Abschnitt des Aufnahmeraums oberhalb des Gewindes 2 spherical section of the receiving space above the thread
3 Femurkopf  3 femoral head
4 Mantelfläche  4 lateral surface
5 kugelförmigen Oberfläche  5 spherical surface
6 osseointegrative Beschichtung  6 osseointegrative coating
7 Aufnahmeraum 7 recording room
8 Gewinde  8 threads
9 Oberschenkelhals  9 thigh neck

Claims

Patentansprüche claims
1 . Keramische Oberflächenersatzprothese (1 ) für den natürlichen Femurkopf (3) mit einer äußeren kugelförmigen Oberfläche (5) und einem inneren Aufnahmeraum (7) mit einer inneren Mantelfläche (4), dadurch gekennzeichnet, dass die innere Mantelfläche (4) zumindest bereichsweise mit einer osseointegrativen Beschichtung (6) versehen ist oder osseointegrativ ausgestaltet ist und/oder die Mantelfläche (4) als selbstformendes Gewinde (8) ausgebildet ist. 1 . Ceramic surface replacement prosthesis (1) for the natural femoral head (3) with an outer spherical surface (5) and an inner receiving space (7) with an inner lateral surface (4), characterized in that the inner lateral surface (4) at least partially with an osseointegrative Coating (6) is provided or designed osseointegrativ and / or the lateral surface (4) is designed as a self-tapping thread (8).
2. Oberflächenersatzprothese nach Anspruch 1 , dadurch gekennzeichnet, dass das Gewinde (8) konisch oder zylinderförmig ausgebildet ist. 2. Surface replacement prosthesis according to claim 1, characterized in that the thread (8) is conical or cylindrical.
3. Oberflächenersatzprothese nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass das Gewinde (8) mit einer Steigung größer als 2 mm/Umdrehung ausgebildet ist. 3. Surface replacement prosthesis according to claim 1 or 2, characterized in that the thread (8) is formed with a pitch greater than 2 mm / revolution.
4. Oberflächenersatzprothese nach Anspruch 3, dadurch gekennzeichnet, dass das Gewinde (8) mit einer Steigung größer als 4 mm/Umdrehung ausgebildet ist. 4. Surface replacement prosthesis according to claim 3, characterized in that the thread (8) is formed with a pitch greater than 4 mm / revolution.
5. Oberflächenersatzprothese nach Anspruch 4, dadurch gekennzeichnet, dass das Gewinde (8) mit einer Steigung größer als 6 mm/Umdrehung ausgebildet ist. 5. surface replacement prosthesis according to claim 4, characterized in that the thread (8) is formed with a pitch greater than 6 mm / revolution.
6. Oberflächenersatzprothese nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass das Gewinde (8) mehrgängig ausgebildet ist. 6. surface replacement prosthesis according to claim 1 or 2, characterized in that the thread (8) is formed more continuous.
EP13703809.7A 2012-02-24 2013-02-12 Cement-free surface replacement prosthesis for the natural femur head Withdrawn EP2816975A1 (en)

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PCT/EP2013/052753 WO2013127623A1 (en) 2012-02-24 2013-02-12 Cement-free surface replacement prosthesis for the natural femur head

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JP (1) JP2015507985A (en)
KR (1) KR20140133879A (en)
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CA2885160A1 (en) * 2012-09-27 2014-04-03 The General Hospital Corporation Dba Massachusetts General Hospital Femoral heads, mobile inserts, acetabular components, and modular junctions for orthopedic implants and methods of using femoral heads, mobile inserts, acetabular components, and modular junctions for orthopedic implants
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ES2767674T3 (en) * 2016-12-06 2020-06-18 Link Waldemar Gmbh Co Revision prosthetic shaft for a revision joint stent

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AU2013225244A1 (en) 2014-10-02
DE102013202243A1 (en) 2013-08-29

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