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WO2017097906A1 - Replacement of the first metatarsophalangeal joint, in particular based on ceramic - Google Patents

Replacement of the first metatarsophalangeal joint, in particular based on ceramic Download PDF

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Publication number
WO2017097906A1
WO2017097906A1 PCT/EP2016/080263 EP2016080263W WO2017097906A1 WO 2017097906 A1 WO2017097906 A1 WO 2017097906A1 EP 2016080263 W EP2016080263 W EP 2016080263W WO 2017097906 A1 WO2017097906 A1 WO 2017097906A1
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WO
WIPO (PCT)
Prior art keywords
natural
metatarsal
implant system
phalangeal
component
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.)
Ceased
Application number
PCT/EP2016/080263
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German (de)
French (fr)
Inventor
Heinrich Wecker
Alfons Kelnberger
Dennis MAIER
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
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Filing date
Publication date
Application filed by Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of WO2017097906A1 publication Critical patent/WO2017097906A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • 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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
    • 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
    • A61F2002/30838—Microstructures
    • 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
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • 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
    • 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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
    • A61F2002/4228—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes for interphalangeal joints, i.e. IP joints
    • 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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
    • A61F2002/4233—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes for metatarso-phalangeal joints, i.e. MTP joints
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203—Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00239—Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00928—Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass

Definitions

  • the invention relates to an implant system for partial or complete replacement of the metatarsophalangeal joint with an artificial metatarsal component for implantation in the metatarsal and / or an artificial phalangeal component for implantation in the natural phalangeal.
  • implant systems based on plastics such. highly cross-linked PE materials or PEEK or silicone are known.
  • Implant systems based on ceramic materials are also known, but they also have some disadvantages. Mainly to mention is the lack of osseointegration of these implant systems and the associated loosening over time, as well as design-induced unphysiological force discharges, which lead to bone loss, which in turn brings a number of disadvantages. These include bone loss due to mechanical overload or shielding of mechanical stress (stress shielding).
  • the invention has for its object to improve an implant system for partial or complete replacement of the metatarsophalangeal joint with an artificial metatarsal component for implantation in the metatarsal and / or an artificial phalangeal component for implantation in the natural phalangeal so that metallic abrasion and resulting adverse effects on the human organism, medical imaging artefacts, aging effects and long-term behavior (fatigue, corrosion, release of metallic ions that may be toxic), allergy-causing effects, and the risk of infection during surgery. Furthermore, the breaking off of structural features of the implant system, for example during installation, should be avoided. Also should the Osseointegration of these implant systems improved and the associated relaxation over time can be avoided.
  • an implant system according to the features of claim 1.
  • the breaking off of structural features of the implant system, for example during installation is avoided.
  • the osseointegration of these implant systems is improved and the associated loosening over time avoided.
  • the ceramic material is preferably a zirconia-reinforced aluminum oxide material with high hardness and flexural strength, which has established itself as a biocompatible material in medical technology, especially for tribological applications in the hip or shoulder.
  • the osseointegrating surface is preferably a coating based on hydroxyapatite, tri calcium phosphate or a bioglass-based coating, whereby the implant system quickly anchors in the bone.
  • the metatarsal component is half shell-shaped and completely made of the ceramic material and has two substantially parallel pins on its inner surface facing the metatarsal in the implanted state (as distal as possible) protrude into the epiphysis of the natural metatarsal. It has been found that by this embodiment, a detachment from the natural bone is avoided and the tribological properties are optimized. This embodiment is particularly suitable for young patients, in which as little as possible of the bone should be changed.
  • this artificial metatarsal component directly articulates with natural phalangeal component.
  • the metatarsal component is semi-shell-shaped and entirely made of the ceramic material and has a shaft on its inner surface facing the natural metatarsal, which in the implanted state projects into the cavity of the natural metatarsal.
  • This is preferably suitable for a total replacement in which the natural metatarsophalangeal joint is completely replaced by an artificial metatarsophalangeal joint.
  • the phalangeal component consists of a module of a ceramic support member and a plastic sliding member.
  • the sliding element made of a plastic absorbs the rotational forces and minimizes or prevents implant loosening.
  • An embodiment of the implant system according to the invention is suitable for a total replacement of the metatarsophalangeal joint.
  • the support member has on its underside facing the natural phalangeal a shaft which protrudes in the implanted state into the cavity of the natural Phalangeals and facing on its natural metatarsal top has a plateau on which the slider is mounted freely movable with its underside.
  • the leadership of the metatarsal component is carried out in a total endoprosthesis preferably on a superstructure of the phalangeal component, ie that the slider on its upper side facing the natural metatarsal has a bulge for freely movable storage of the artificial metatarsal component.
  • at least the parts of the implant system which come into contact with the natural metatarsal and / or the natural phalangeal have a macrostructure of about 300-700 ⁇ .
  • the invention thus relates to a ceramic component for large toe joint replacement with a special design for safe and low-damage implantation and secure and permanent anchoring with excellent tribological, especially low-abrasion properties.
  • the use of bioinertem ceramic starting material makes the invention extremely patient-friendly.
  • the implant according to the invention consists of a ceramic material, preferably oxide ceramic from the class of aluminum oxides or zirconium oxides.
  • the preferred material here is a zirconia-reinforced AI2O3 material with high hardness and flexural strength, the biocompatible has been established especially for tribological applications in the hip or shoulder.
  • the components are molded either as pressed components in the green state or sprayed in large quantities by means of ceramic injection molding. Subsequently, the components are thermally treated, that is sintered, honed, white-burned, and especially the tribological surfaces mechanically aftertreated, for example, ground or polished. Also conceivable is a subsequent coating of the components for bioactivation, which ensures that bone-forming cells adhere well, find cytocompatible conditions and become osteogenically active.
  • Such coatings can be based on common coatings
  • Coatings based on bioglasses It is known to use a shaft for anchoring the implant in the bone (cementable and cement-free).
  • the forces are introduced via the shaft into the bone. This is always done non-physiologically since the natural anatomical force application occurs directly at the joint (via the cartilage into the epiphysis).
  • the bone structure (spongiosa) is not designed for this proximal shifted force application. See Fig.1.
  • the introduction of force should be made as physiological as possible. Therefore, it is suggested that the forces are introduced via two small pins as distally as possible directly into the epiphysis. See Fig. 2.
  • the concrete geometries of the two pins are determined by the anatomical conditions in the human metatarsophalangeal joint. It is recommended a size portfolio.
  • a base plate is used, which is firmly connected to the shaft. See Fig. 3.
  • Fig. 3 shows a hemiprosthesis according to the prior art.
  • the sliding element has a bulge, in which the phalangeal component is mounted freely movable. See Fig. 5.
  • the natural bone-contacting parts of the implant system are provided with a hydrogel coating for hemian use.
  • the primary stability of the metatarsal component and the phalangeal component is achieved via a press-fit.
  • the secondary stability can be achieved via a Direct to Bone technology DtB, which is an osseointegrating surface.
  • the implant system according to the invention is suitable for all toe joints and is preferably used as a big toe joint replacement.
  • FIG. 1 shows a section of a natural foot of a patient. Clearly visible is the natural metatarsal 3, which is associated with the natural phalangeal 5 via the metatarsophalangeal joint 1 is articulated. The metatarsophalangeal joint 1 of the big toe is also known as the metatarsophalangeal joint.
  • FIG. 2 shows the natural metatarsal 3 of the big toe from a natural foot of a patient.
  • FIG. 3 shows this one-piece metatarsal component 2a, which consists entirely of a ceramic.
  • the metatarsal component 2a has a half-shell-shaped design and has two substantially parallel pins 6 on its inner surface facing the metatarsal 3, which pins project into the epiphysis 7 of the natural metatarsal 3 in the implanted state.
  • the ceramic material is a zirconia-reinforced alumina material.
  • the parts of the implant system which come into contact with the natural metatarsal 3 and / or the natural phalangeal 5 have an osseointegrating surface.
  • the osseointegrating surface is a coating based on hydroxyapatite, tri calcium phosphate or a coating based on bioglasses.
  • FIG. 4 shows an artificial phalangeal component 4 according to the invention for implantation in the natural phalangeal 5, see FIGS. 1 or 2.
  • the phalangeal component 4 consists in a modular fashion of a ceramic support element 9 and a sliding element 10 of a plastic.
  • the support member 9 has on its facing the natural phalangeal 5 underside a shaft 1 1, which protrudes in the implanted state in the cavity of the natural Phalangeals 5 and on its facing the natural metatarsal 3 top plateau 12 on which the Sliding element 10 is freely movably mounted with its underside.
  • a bulge 13 is arranged on the sliding element 10, which serves for the freely movable mounting of the artificial metatarsal component 2b.
  • FIG. 5 shows an implant system for complete replacement of the natural one
  • the artificial phalangeal component 4 is identical to the artificial phalangeal component 4 according to FIG.
  • the artificial metatarsal component 2b has a half-shell-shaped design and is made entirely of the ceramic material and has on its inner surface facing the natural metatarsal 3 a shaft 8 which is implanted in the implant
  • Implant system a macrostructure of about 300 - 700 ⁇ on.

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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)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to an implant system for the partial or complete replacement of the metatarsophalangeal joint (1), with an artificial metatarsal component (2a, 2b) for implantation in the metatarsal bone (3) and/or an artificial phalangeal component (4) for implantation in the natural phalangeal bone (5). For the partial or complete replacement of the metatarsophalangeal joint (1), it is proposed that the parts of the implant system coming into contact with the natural metatarsal bone (3) and/or with the natural phalangeal bone (5) are made of a ceramic material, in particular an oxide ceramic from the class of aluminium oxides or zirconium oxides, and the parts of the implant system coming into contact with the natural metatarsal bone (3) and/or with the natural phalangeal bone (5) have an osseointegrating surface.

Description

Großzehengrundgelenksersatz, insbesondere auf keramischer Basis  Big toe joint replacement, especially on a ceramic basis

Die Erfindung betrifft ein Implantatsystem zum teilweisen oder vollständigen Ersatz des Metatarsophalangeal Gelenks mit einer künstlichen Metatarsal-Komponente zur Implantation in den Metatarsal und/oder einer künstlichen Phalangeal-Komponete zur Implantation in den natürlichen Phalangeal. The invention relates to an implant system for partial or complete replacement of the metatarsophalangeal joint with an artificial metatarsal component for implantation in the metatarsal and / or an artificial phalangeal component for implantation in the natural phalangeal.

Es sind eine Vielzahl von Implantatsystemen auf Basis nicht-keramischer Werkstoffe (Metall, Polymer, Silikon) bekannt, die jedoch ganz spezifische Nachteile aufweisen. There are a variety of implant systems based on non-ceramic materials (metal, polymer, silicone) are known, but have very specific disadvantages.

Nachteile metallischer Werkstoffe für ein Metatarsophalangeal Gelenk, speziell für ein Großzehen Metatarsophalangeal Gelenk sind beispielsweise: Disadvantages of metallic materials for a metatarsophalangeal joint, especially for a metatarsophalangeal joint, are for example:

• Metallischer Abrieb und daraus resultierende negative Auswirkungen auf den menschlichen Organismus • Metallic abrasion and the resulting negative effects on the human organism

• Artefakte in der Bildgebung bei der medizinischen Diagnostik • Artifacts in imaging in medical diagnostics

• Alterungseffekte und Langzeitverhalten (Ermüdung, Korrosion, Freisetzung von metallischen Ionen, die toxisch wirken können) • aging effects and long-term behavior (fatigue, corrosion, release of metallic ions that can be toxic)

• Allergieauslösende Effekte • Allergy-causing effects

Als generelles Problem stellt sich mehr und mehr ein zunehmendes Infektionsrisko während der Operation heraus, was mit keramischen Bauteilen reduziert werden kann. Auch Implantatsysteme basierend auf Kunststoffen, wie z.B. hochvernetzte PE- Werkstoffe oder PEEK oder Silikon sind bekannt. As a general problem, more and more an increasing infection risk arises during the operation, which can be reduced with ceramic components. Also implant systems based on plastics, such. highly cross-linked PE materials or PEEK or silicone are known.

Nachteile bei den Kunststoffen sind z.B. • Unzureichende mechanische Eigenschaften wie z.B. das Abbrechen von strukturellen Merkmalen des Bauteils beispielsweise beim Einbau. Dies kann negative Auswirkungen auf den menschlichen Organismus haben Disadvantages of the plastics are eg • Insufficient mechanical properties, such as breaking off structural features of the component during installation, for example. This can have negative effects on the human organism

• Mangelnde Darstellbarkeit bei den gängigen Bildgebungsverfahren (MRI, Röntgen). Dadurch bedingt Einsatz von metallischen Markern. • Lack of representability in common imaging procedures (MRI, X-ray). This requires the use of metallic markers.

• Alterungseffekte und Langzeitverhalten, insbesondere Ermüdung des Materials • Aging effects and long-term behavior, especially fatigue of the material

Es sind auch Implantatsysteme auf keramischer Werkstoffbasis bekannt, jedoch weisen diese ebenfalls einige Nachteile auf. Hauptsächlich zu nennen ist die mangelhafte Osseointegration dieser Implantatsysteme und die damit verbundene Lockerung über die Zeit, sowie konstruktionsbedingt unphysiologische Krafteinleitungen, die zu Knochenverlust führen, was wiederum eine Reihe von Nachteilen mit sich bringt. Zu nennen sind hier Knochenabbau aufgrund mechanischer Überlastung oder Abschirmung von mechanischer Belastung (stress shielding). Implant systems based on ceramic materials are also known, but they also have some disadvantages. Mainly to mention is the lack of osseointegration of these implant systems and the associated loosening over time, as well as design-induced unphysiological force discharges, which lead to bone loss, which in turn brings a number of disadvantages. These include bone loss due to mechanical overload or shielding of mechanical stress (stress shielding).

Der Erfindung liegt die Aufgabe zugrunde, ein Implantatsystem zum teilweisen oder vollständigen Ersatz des Metatarsophalangeal Gelenks mit einer künstlichen Metatarsal-Komponente zur Implantation in den Metatarsal und/oder einer künstlichen Phalangeal-Komponete zur Implantation in den natürlichen Phalangeal so zu verbessern, dass metallischer Abrieb und daraus resultierende negative Auswirkungen auf den menschlichen Organismus, Artefakte in der Bildgebung bei der medizinischen Diagnostik, Alterungseffekte und Langzeitverhalten (Ermüdung, Korrosion, Freisetzung von metallischen Ionen, die toxisch wirken können), allergieauslösende Effekte und das Infektionsrisko während der Operation vermindert sind. Ferner soll das Abbrechen von strukturellen Merkmalen des Implantatsystems beispielsweise beim Einbau vermieden werden. Auch soll die Osseointegration dieser Implantatsysteme verbessert und die damit verbundene Lockerung über die Zeit vermieden werden. The invention has for its object to improve an implant system for partial or complete replacement of the metatarsophalangeal joint with an artificial metatarsal component for implantation in the metatarsal and / or an artificial phalangeal component for implantation in the natural phalangeal so that metallic abrasion and resulting adverse effects on the human organism, medical imaging artefacts, aging effects and long-term behavior (fatigue, corrosion, release of metallic ions that may be toxic), allergy-causing effects, and the risk of infection during surgery. Furthermore, the breaking off of structural features of the implant system, for example during installation, should be avoided. Also should the Osseointegration of these implant systems improved and the associated relaxation over time can be avoided.

Erfindungsgemäß wird diese Aufgabe durch ein Implantatsystem nach den Merkmalen des Anspruchs 1 gelöst. Dadurch, dass die mit dem natürlichen Metatarsal und/oder dem natürlichen Phalangeal in Verbindung tretenden Teile des Implantatsystems aus einem keramischen Material, insbesondere einer Oxidkeramik aus der Klasse der Aluminiumoxide oder Zirkonoxide bestehen und die mit dem natürlichen Metatarsal und/oder dem natürlichen Phalangeal in Verbindung tretenden Teile des Implantatsystems eine osseointegrierende Oberfläche aufweisen ist metallischer Abrieb und daraus resultierende negative Auswirkungen auf den menschlichen Organismus, Artefakte in der Bildgebung bei der medizinischen Diagnostik, Alterungseffekte und Langzeitverhalten (Ermüdung, Korrosion, Freisetzung von metallischen Ionen, die toxisch wirken können), allergieauslösende Effekte und das Infektionsrisko während der Operation vermindert. Ferner ist das Abbrechen von strukturellen Merkmalen des Implantatsystems beispielsweise beim Einbau vermieden. Auch ist die Osseointegration dieser Implantatsysteme verbessert und die damit verbundene Lockerung über die Zeit vermieden. According to the invention, this object is achieved by an implant system according to the features of claim 1. By virtue of the fact that the parts of the implant system which come into contact with the natural metatarsal and / or the natural phalangeal consist of a ceramic material, in particular an oxide ceramic of the class of aluminum oxides or zirconium oxides, and which communicate with the natural metatarsal and / or the natural phalangeal Parts of the implant system which have an osseointegrating surface are metallic abrasion and the resulting negative effects on the human organism, medical imaging artefacts, aging effects and long-term behavior (fatigue, corrosion, release of metallic ions which may be toxic), allergenic Effects and the infection risk during surgery diminished. Furthermore, the breaking off of structural features of the implant system, for example during installation, is avoided. Also, the osseointegration of these implant systems is improved and the associated loosening over time avoided.

Bevorzugt ist das keramische Material ein zirkonoxidverstärkter Aluminiumoxid Werkstoff mit hoher Härte und Biegefestigkeit, der sich als biokompatibler Werkstoff in der Medizintechnik, speziell für tribologische Anwendungen in der Hüfte oder Schulter etabliert hat. The ceramic material is preferably a zirconia-reinforced aluminum oxide material with high hardness and flexural strength, which has established itself as a biocompatible material in medical technology, especially for tribological applications in the hip or shoulder.

Die osseointegrierende Oberfläche ist bevorzugt eine Beschichtung basierend auf Hydroxylapatit, Tri Calcium Phosphat oder eine Beschichtung auf der Basis von Biogläsern, wodurch das Implantatsystem schnell im Knochen verankert. In einer erfindungsgemäßen Ausgestaltung besteht die Metatarsal-Komponente halbschalenförmig und vollständig aus dem keramischen Material und weist auf ihrer zum Metatarsal gewandten Innenfläche zwei im wesentlichen parallele Stifte auf, die im implantierten Zustand (so distal wie möglich) in die Epiphyse des natürlichen Metatarsals ragen. Es hat sich gezeigt, dass durch diese Ausgestaltung ein Ablösen vom natürlichen Knochen vermieden ist und die tribologischen Eigenschaften optimiert sind. Diese Ausgestaltung eignet sich besonders für junge Patienten, bei denen so wenig wie möglich der Knochen verändert werden soll. Vorteilhaft artikuliert diese künstliche Metatarsal-Komponente direkt mit atürlichen Phalangeal- Komponete. The osseointegrating surface is preferably a coating based on hydroxyapatite, tri calcium phosphate or a bioglass-based coating, whereby the implant system quickly anchors in the bone. In one embodiment according to the invention, the metatarsal component is half shell-shaped and completely made of the ceramic material and has two substantially parallel pins on its inner surface facing the metatarsal in the implanted state (as distal as possible) protrude into the epiphysis of the natural metatarsal. It has been found that by this embodiment, a detachment from the natural bone is avoided and the tribological properties are optimized. This embodiment is particularly suitable for young patients, in which as little as possible of the bone should be changed. Advantageously, this artificial metatarsal component directly articulates with natural phalangeal component.

Alternativ besteht die Metatarsal-Komponete halbschalenformig und vollständig aus dem keramischen Material und weist auf ihrer zum natürlichen Metatarsal gewandten Innenfläche einen Schaft auf, der im implantierten Zustand in den Hohlraum des natürlichen Metatarsals ragt. Dies eignet sich bevorzugt für einen Totalersatz, bei dem das natürliche Metatarsophalangeal Gelenk vollständig durch ein künstliches Metatarsophalangeal Gelenk ersetzt wird. Alternatively, the metatarsal component is semi-shell-shaped and entirely made of the ceramic material and has a shaft on its inner surface facing the natural metatarsal, which in the implanted state projects into the cavity of the natural metatarsal. This is preferably suitable for a total replacement in which the natural metatarsophalangeal joint is completely replaced by an artificial metatarsophalangeal joint.

Vorteilhafterweise besteht die Phalangeal-Komponete modulartig aus einem Tragelement aus der Keramik und einem Gleitelement aus einem Kunststoff. Durch das Gleitelement aus einem Kunststoff werden die Rotationskräfte absorbiert und wird eine Implantatlockerung minimiert bzw. verhindert. Advantageously, the phalangeal component consists of a module of a ceramic support member and a plastic sliding member. The sliding element made of a plastic absorbs the rotational forces and minimizes or prevents implant loosening.

Eine Ausführungsform des erfindungsgemäße Implantatsystems eignet sich für einen Totalersatz des Metatarsophalangeal Gelenks. Hier weist das Tragelement auf seiner zum natürlichen Phalangeal gewandten Unterseite einen Schaft auf, der im implantierten Zustand in den Hohlraum des natürlichen Phalangeals ragt und auf seiner zum natürlichen Metatarsal gewandten Oberseite ein Plateau aufweist, auf dem das Gleitelement mit seiner Unterseite frei beweglich gelagert ist. Die Führung der Metatarsal-Komponete erfolgt bei einer Totalendoprothese bevorzugt über eine Überbauung der Phalangeal-Komponete, d.h. dass das Gleitelement auf seiner zum natürlichen Metatarsal gewandten Oberseite eine Ausbuchtung aufweist zur frei beweglichen Lagerung der künstlichen Metatarsal-Komponente. ln bevorzugter Ausführungsform weisen zumindest die mit dem natürlichen Metatarsal und/oder dem natürlichen Phalangeal in Verbindung tretenden Teile des Implantatsystems eine Makrostruktur von ca. 300 - 700 μιτι auf. An embodiment of the implant system according to the invention is suitable for a total replacement of the metatarsophalangeal joint. Here, the support member has on its underside facing the natural phalangeal a shaft which protrudes in the implanted state into the cavity of the natural Phalangeals and facing on its natural metatarsal top has a plateau on which the slider is mounted freely movable with its underside. The leadership of the metatarsal component is carried out in a total endoprosthesis preferably on a superstructure of the phalangeal component, ie that the slider on its upper side facing the natural metatarsal has a bulge for freely movable storage of the artificial metatarsal component. In a preferred embodiment, at least the parts of the implant system which come into contact with the natural metatarsal and / or the natural phalangeal have a macrostructure of about 300-700 μιτι.

Die Erfindung betrifft somit ein keramisches Bauteil zum Großzehengrundgelenksersatz mit einer speziellen Ausgestaltung zur sicheren und schädigungsarmen Implantation und sicheren und dauerhaften Verankerung mit hervorragend tribologischen, insbesondere abriebsarmen Eigenschaften. Durch die Verwendung von bioinertem keramischem Ausgangsmaterial ist die Erfindung darüberhinaus extrem patientenverträglich. Das erfindungsgemäße Implantat besteht aus einem keramischen Material, vorzugsweise Oxidkeramik aus der Klasse der Aluminiumoxide oder Zirkonoxide. The invention thus relates to a ceramic component for large toe joint replacement with a special design for safe and low-damage implantation and secure and permanent anchoring with excellent tribological, especially low-abrasion properties. In addition, the use of bioinertem ceramic starting material makes the invention extremely patient-friendly. The implant according to the invention consists of a ceramic material, preferably oxide ceramic from the class of aluminum oxides or zirconium oxides.

Der hier bevorzugte Werkstoff ist ein zirkonoxidverstärkter AI2O3 Werkstoff mit hoher Härte und Biegefestigkeit, der biokompatible ist sich speziell für tribologische Anwendungen in der Hüfte oder Schulter etabliert hat. Die Bauteile werden entweder als Pressbauteile im grünen Zustand geformt oder in großen Stückzahlen mit Hilfe keramischer Spritzgussverfahren gespritzt. Anschließend werden die Bauteile thermisch behandelt, sprich gesintert, gehipt, weissgebrannt, und speziell die tribologischen Oberflächen mechanisch nachbehandelt, beispielsweise geschliffen oder poliert. Denkbar ist auch eine anschließende Beschichtung der Bauteile zur Bioaktivierung, die dafür sorgt, dass knochenbildende Zellen gut anhaften, zytokompatible Bedingungen vorfinden und osteogenetisch aktiv werden. The preferred material here is a zirconia-reinforced AI2O3 material with high hardness and flexural strength, the biocompatible has been established especially for tribological applications in the hip or shoulder. The components are molded either as pressed components in the green state or sprayed in large quantities by means of ceramic injection molding. Subsequently, the components are thermally treated, that is sintered, honed, white-burned, and especially the tribological surfaces mechanically aftertreated, for example, ground or polished. Also conceivable is a subsequent coating of the components for bioactivation, which ensures that bone-forming cells adhere well, find cytocompatible conditions and become osteogenically active.

Solche Beschichtungen können gängige Beschichtungen basierend auf Such coatings can be based on common coatings

Hydroxylapatit oder Tri Calcium Phosphat sein, es eignen sich aber auch Hydroxylapatite or Tri calcium phosphate, but it is also suitable

Beschichtungen auf der Basis von Biogläsern. Es ist bekannt, einen Schaft zur Verankerung des Implantates im Knochen (zementierbar und zementfrei) zu verwenden. Coatings based on bioglasses. It is known to use a shaft for anchoring the implant in the bone (cementable and cement-free).

Hierbei werden die auftretenden Kräfte über den Schaft in den Knochen eingeleitet. Dies erfolgt immer unphysiologisch da die natürliche anatomische Krafteinleitung direkt am Gelenk (über den Knorpel in die Epiphyse) auftritt. Der Knochenaufbau (Spongiosa) ist für diese nach proximal verlagerte Krafteinleitung nicht ausgelegt. Siehe hierzu Fig.1 . Here, the forces are introduced via the shaft into the bone. This is always done non-physiologically since the natural anatomical force application occurs directly at the joint (via the cartilage into the epiphysis). The bone structure (spongiosa) is not designed for this proximal shifted force application. See Fig.1.

Erfindungsgemäß soll die Krafteinleitung so physiologisch wie möglich gestalltet werden. Deshalb wird vorgeschlagen, die Kräfte über zwei kleine Pins so distal wie möglich direkt in die Epiphyse einzuleiten. Siehe hierzu Fig. 2. According to the invention, the introduction of force should be made as physiological as possible. Therefore, it is suggested that the forces are introduced via two small pins as distally as possible directly into the epiphysis. See Fig. 2.

Durch die damit erzeugte physiologische Krafteinleitung gibt es folgende Vorteile: The resulting physiological introduction of force offers the following advantages:

• Knochenabbau aufgrund mechanischer Überlastung oder Abschirmung von mechanischer Belastung (stress shielding) wird minimiert oder sogar vermieden. • Bone degradation due to mechanical overload or shielding from mechanical stress (stress shielding) is minimized or even avoided.

• Dadurch keine Implantatlockerung · Dadurch hohe Langzeitstabilität und diesbezüglich kein Revisionsbedarf • As a result, no implant loosening. · High long-term stability and no need for revision in this regard

• Selbst im Revisionsfall aufgrund anderer Indikation ist immer noch genügend Knochen für eine Alternative, z.B Arthrodese (Versteifung) vorhanden. • Even in the case of revision due to other indications, there is still enough bone for an alternative, for example, arthrodesis (stiffening).

Die konkreten Geometrien der beiden Pins werden bestimmt durch die anatomischen Gegebenheiten im menschlichen Großzehengrundgelenk. Es ist ein Größenportfolio angeraten. The concrete geometries of the two pins are determined by the anatomical conditions in the human metatarsophalangeal joint. It is recommended a size portfolio.

Nach dem Stand der Technik wird eine Basisplatte verwendet, welche fest mit dem Schaft verbunden ist. Siehe hierzu Fig. 3. Dies führt jedoch durch auftretende Rotationskräfte (bei Bewegung in diesem Gelenk) zu einer Lockerung des Implantats. According to the prior art, a base plate is used, which is firmly connected to the shaft. See Fig. 3. However, this leads to a loosening of the implant due to rotational forces (when moving in this joint).

Fig. 3 zeigt eine Hemiprothese nach dem Stand der Technik. Fig. 3 shows a hemiprosthesis according to the prior art.

Über ein zweiteiliges modulares Implantatsystem, welches ein frei bewegliches Gleitelement aufweist, welche die Rotationskräfte absorbiert, wird eine Implantatlockerung minimiert bzw. verhindert. Siehe hierzu Fig. 4. Through a two-part modular implant system, which has a freely movable sliding member which absorbs the rotational forces, implant loosening is minimized or prevented. See Fig. 4.

Die Führung der Metatarsal-Komponente erfolgt bei einer Totalendoprothese über eine Überbauung der Phalangeal-Komponete. Das Gleitelement weist hierzu eine Ausbuchtung auf, in der die Phalangeal-Komponete frei beweglich gelagert ist. Siehe hierzu Fig. 5. The guidance of the metatarsal component takes place in a total endoprosthesis over a superstructure of the phalangeal component. For this purpose, the sliding element has a bulge, in which the phalangeal component is mounted freely movable. See Fig. 5.

Bevorzugt werden die mit dem natürlichen Knochen in Verbindung tretenden Teile des Implantatsystems mit einer Hydrogel Beschichtung für die Hemianwendung versehen. Preferably, the natural bone-contacting parts of the implant system are provided with a hydrogel coating for hemian use.

Die Primärstabilität der Metatarsal-Komponente und der Phalangeal-Komponete wird über ein Press-Fit erzielt. Die Sekundärstabilität kann über eine Direct to Bone Technologie DtB, welche eine osseointegrierende Oberfläche ist, erzielt werden. The primary stability of the metatarsal component and the phalangeal component is achieved via a press-fit. The secondary stability can be achieved via a Direct to Bone technology DtB, which is an osseointegrating surface.

Von ganz entscheidender Bedeutung ist die Gestaltung der Oberfläche hinsichtlich der Makrostruktur (ca. 300 - 700 μιτι) und der Mikrostruktur, die sich durch das Herstellverfahren ergibt. Das erfindungsgemäße Implantatsystem eignet sich für alle Zehengrundgelenke und wird bevorzugt als Großzehengrundgelenksersatz verwendet. Of crucial importance is the design of the surface in terms of the macrostructure (about 300 - 700 μιτι) and the microstructure resulting from the manufacturing process. The implant system according to the invention is suitable for all toe joints and is preferably used as a big toe joint replacement.

Nachfolgend wird die Erfindung anhand von Figuren weiter beschrieben. The invention will be further described with reference to figures.

Figur 1 zeigt einen Ausschnitt aus einem natürlichen Fuß eines Patienten. Deutlich zu sehen ist das natürliche Metatarsal 3, welches mit dem natürlichen Phalangeal 5 über das Metatarsophalangeal Gelenks 1 gelenkig verbunden ist. Das Metatarsophalangeal Gelenk 1 der Großzehe wird auch als Großzehengrundgelenk bezeichnet. FIG. 1 shows a section of a natural foot of a patient. Clearly visible is the natural metatarsal 3, which is associated with the natural phalangeal 5 via the metatarsophalangeal joint 1 is articulated. The metatarsophalangeal joint 1 of the big toe is also known as the metatarsophalangeal joint.

Figur 2 zeigt aus einem natürlichen Fuß eines Patienten das natürliche Metatarsal 3 der Großzehe. Hier ist erfindungsgemäß in die Epiphyse 7 des natürlichen FIG. 2 shows the natural metatarsal 3 of the big toe from a natural foot of a patient. Here is according to the invention in the epiphysis 7 of the natural

Metatarsals 3 eine einteilige künstliche Metatarsal-Komponente 2a implantiert, die mit dem natürlichen Phalangeal 5 gelenkig artikuliert.  Metatarsals 3 implanted a one-piece artificial metatarsal component 2a articulated with the natural phalangeal 5 articulated.

Figur 3 zeigt diese einteilige Metatarsal-Komponente 2a, die vollständig aus einer Keramik besteht. Die Metatarsal-Komponente 2a ist halbschalenförmig ausgebildet und weist auf ihrer zum Metatarsal 3 gewandten Innenfläche zwei im wesentlichen parallele Stifte 6 auf, die im implantierten Zustand in die Epiphyse 7 des natürlichen Metatarsals 3 ragen. Hierdurch ist die Metatarsal-Komponente 2a dauerhaft und sich nicht lösend mit dem natürlichen Metatarsals 3 verankert. Das keramische Material ist ein zirkonoxidverstärkter Aluminiumoxid Werkstoff. Die mit dem natürlichen Metatarsal 3 und/oder dem natürlichen Phalangeal 5 in Verbindung tretenden Teile des Implantatsystems weisen eine osseointegrierende Oberfläche auf. FIG. 3 shows this one-piece metatarsal component 2a, which consists entirely of a ceramic. The metatarsal component 2a has a half-shell-shaped design and has two substantially parallel pins 6 on its inner surface facing the metatarsal 3, which pins project into the epiphysis 7 of the natural metatarsal 3 in the implanted state. As a result, the metatarsal component 2a is anchored permanently and not in solution with the natural metatarsal 3. The ceramic material is a zirconia-reinforced alumina material. The parts of the implant system which come into contact with the natural metatarsal 3 and / or the natural phalangeal 5 have an osseointegrating surface.

Bevorzugt ist die osseointegrierende Oberfläche eine Beschichtung basierend auf Hydroxylapatit, Tri Calcium Phosphat oder eine Beschichtung auf der Basis von Biogläsern. Figur 4 zeigt eine erfindungsgemäße künstliche Phalangeal-Komponete 4 zur Implantation in den natürlichen Phalangeal 5, siehe Figuren 1 oder 2. In erfindungsgemäßer Ausführungsform besteht die Phalangeal-Komponete 4 modulartig aus einem Tragelement 9 aus der Keramik und einem Gleitelement 10 aus einem Kunststoff. Das Tragelement 9 weist auf seiner zum natürlichen Phalangeal 5 gewandten Unterseite einen Schaft 1 1 auf, der im implantierten Zustand in den Hohlraum des natürlichen Phalangeals 5 ragt und auf seiner zum natürlichen Metatarsal 3 gewandten Oberseite ein Plateau 12 auf, auf dem das Gleitelement 10 mit seiner Unterseite frei beweglich gelagert ist. Auf der zur künstlichen Metatarsal-Komponente 2b gewandten Seite ist auf dem Gleitelement 10 eine Ausbuchtung 13 angeordnet, die zur frei beweglichen Lagerung der künstlichen Metatarsal-Komponente 2b dient. Figur 5 zeigt ein Implantatsystem zum vollständigen Ersatz des natürlichen Preferably, the osseointegrating surface is a coating based on hydroxyapatite, tri calcium phosphate or a coating based on bioglasses. FIG. 4 shows an artificial phalangeal component 4 according to the invention for implantation in the natural phalangeal 5, see FIGS. 1 or 2. In the embodiment according to the invention, the phalangeal component 4 consists in a modular fashion of a ceramic support element 9 and a sliding element 10 of a plastic. The support member 9 has on its facing the natural phalangeal 5 underside a shaft 1 1, which protrudes in the implanted state in the cavity of the natural Phalangeals 5 and on its facing the natural metatarsal 3 top plateau 12 on which the Sliding element 10 is freely movably mounted with its underside. On the side facing the artificial metatarsal component 2b, a bulge 13 is arranged on the sliding element 10, which serves for the freely movable mounting of the artificial metatarsal component 2b. FIG. 5 shows an implant system for complete replacement of the natural one

Metatarsophalangeal Gelenks 1 . Die künstliche Phalangeal-Komponete 4 ist mit der künstliche Phalangeal-Komponete 4 gemäß Figur 4 identisch ausgebildet. Die künstliche Metatarsal-Komponete 2b ist halbschalenförmig ausgebildet und besteht vollständig aus dem keramischen Material und weist auf ihrer zum natürlichen Metatarsal 3 gewandten Innenfläche einen Schaft 8 auf, der im implantierten  Metatarsophalangeal joint 1. The artificial phalangeal component 4 is identical to the artificial phalangeal component 4 according to FIG. The artificial metatarsal component 2b has a half-shell-shaped design and is made entirely of the ceramic material and has on its inner surface facing the natural metatarsal 3 a shaft 8 which is implanted in the implant

Zustand in den Hohlraum des natürlichen Metatarsals 3 ragt. Im implantierten Zustand ist die Halbschale der künstlichen Metatarsal-Komponete 2b in dem frei rotierbaren Gleitelement 10 und dort in der Ausbuchtung 13 gelagert. State into the cavity of the natural metatarsal 3 protrudes. In the implanted state, the half-shell of the artificial metatarsal component 2b is mounted in the freely rotatable sliding element 10 and there in the bulge 13.

In allen Ausführungsformen weisen zumindest die mit dem natürlichen Metatarsal 3 und/oder dem natürlichen Phalangeal 5 in Verbindung tretenden Teile des In all embodiments, at least the parts in contact with the natural metatarsal 3 and / or the natural phalangeal 5 have

Implantatsystems eine Makrostruktur von ca. 300 - 700 μιτι auf. Implant system a macrostructure of about 300 - 700 μιτι on.

Claims

Ansprüche claims 1 . Implantatsystem zum teilweisen oder vollständigen Ersatz des Metatarsophalangeal Gelenks (1 ) mit einer künstlichen Metatarsal- Komponente (2a, 2b) zur Implantation in den Metatarsal (3) und/oder einer künstlichen Phalangeal-Komponete (4) zur Implantation in den natürlichen Phalangeal (5), dadurch gekennzeichnet, dass die mit dem natürlichen Metatarsal (3) und/oder dem natürlichen Phalangeal (5) in Verbindung tretenden Teile des Implantatsystems aus einem keramischen Material, insbesondere einer Oxidkeramik aus der Klasse der Aluminiumoxide oder Zirkonoxide bestehen und die mit dem natürlichen Metatarsal (3) und/oder dem natürlichen Phalangeal (5) in Verbindung tretenden Teile des Implantatsystems eine osseointegrierende Oberfläche aufweisen. 1 . Implant system for partial or complete replacement of the metatarsophalangeal joint (1) with an artificial metatarsal component (2a, 2b) for implantation in the metatarsal (3) and / or an artificial phalangeal component (4) for implantation in the natural phalangeal (5 ), characterized in that the parts of the implant system which come into contact with the natural metatarsal (3) and / or the natural phalangeal (5) consist of a ceramic material, in particular an oxide ceramic of the class of aluminum oxides or zirconium oxides, and those with the natural Metatarsal (3) and / or the natural phalangeal (5) coming into contact parts of the implant system have an osseointegrating surface. 2. Implantatsystem nach Anspruch 1 , dadurch gekennzeichnet, dass das keramische Material ein zirkonoxidverstärkter Aluminiumoxid Werkstoff ist. 2. Implant system according to claim 1, characterized in that the ceramic material is a zirconia-reinforced aluminum oxide material. 3. Implantatsystem nach Anspruch 2, dadurch gekennzeichnet, dass die osseointegrierende Oberfläche eine Beschichtung basierend auf Hydroxylapatit, Tri Calcium Phosphat oder eine Beschichtung auf der Basis von Biogläsern ist. 3. Implant system according to claim 2, characterized in that the osseointegrating surface is a coating based on hydroxyapatite, tri calcium phosphate or a coating based on bioglasses. 4. Implantatsystem nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Metatarsal-Komponente (2a) halbschalenformig und vollständig aus dem keramischen Material besteht und auf ihrer zum Metatarsal (3) gewandten Innenfläche zwei im wesentlichen parallele Stifte (6) aufweist, die im implantierten Zustand in die Epiphyse (7) des natürlichen Metatarsals (3) ragen. 4. Implant system according to one of claims 1 to 3, characterized in that the metatarsal component (2a) halbschalenformig and consists entirely of the ceramic material and on its metatarsal (3) facing inner surface has two substantially parallel pins (6), which in the implanted state protrude into the epiphysis (7) of the natural metatarsal (3). 5. Implantatsystem nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Metatarsal-Komponete (2b) halbschalenförmig und vollständig aus dem keramischen Material besteht und auf ihrer zum natürlichen Metatarsal (3) gewandten Innenfläche einen Schaft (8) aufweist, der im implantierten Zustand in den Hohlraum des natürlichen Metatarsals (3) ragt. 5. Implant system according to one of claims 1 to 3, characterized in that the metatarsal component (2b) is half shell-shaped and completely made of the ceramic material and on its natural metatarsal (3) facing inner surface has a shank (8) in the implanted state in the cavity of the natural metatarsal (3) protrudes. 6. Implantatsystem nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die Phalangeal-Komponete (4) modulartig aus einem Tragelement (9) aus der Keramik und einem Gleitelement (10) aus einem Kunststoff besteht. 6. Implant system according to one of claims 1 to 5, characterized in that the phalangeal component (4) consists of a modular manner of a support member (9) of the ceramic and a sliding element (10) made of a plastic. 7. Implantatsystem nach Anspruch 6, dadurch gekennzeichnet, dass das Tragelement (9) auf seiner zum natürlichen Phalangeal (5) gewandten Unterseite einen Schaft (1 1 ) aufweist, der im implantierten Zustand in den Hohlraum des natürlichen Phalangeals (5) ragt und auf seiner zum natürlichen Metatarsal (3) gewandten Oberseite ein Plateau (12) aufweist, auf dem das Gleitelement (10) mit seiner Unterseite frei beweglich gelagert ist. 7. Implant system according to claim 6, characterized in that the support element (9) on its natural phalangeal (5) facing the bottom has a shank (1 1), which in the implanted state in the cavity of the natural Phalangeals (5) protrudes and on its top facing the natural metatarsal (3) has a plateau (12) on which the sliding element (10) is freely movably mounted with its underside. 8. Implantatsystem nach Anspruch 6 oder 7, dadurch gekennzeichnet, dass das Gleitelement (10) auf seiner zum natürlichen Metatarsal (3) gewandten Oberseite eine Ausbuchtung (13) aufweist zur frei beweglichen Lagerung der künstlichen Metatarsal-Komponente (2a, 2b). 8. Implant system according to claim 6 or 7, characterized in that the sliding element (10) on its natural metatarsal (3) facing the upper side has a bulge (13) for freely movable mounting of the artificial metatarsal component (2a, 2b). 9. Implantatsystem nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass zumindest die mit dem natürlichen Metatarsal (3) und/oder dem natürlichen Phalangeal (5) in Verbindung tretenden Teile des Implantatsystems eine Makrostruktur von ca. 300 - 700 μιτι aufweisen. 9. implant system according to one of claims 1 to 8, characterized in that at least with the natural metatarsal (3) and / or the natural phalangeal (5) in connection parts passing the implant system have a macrostructure of about 300 - 700 μιτι.
PCT/EP2016/080263 2015-12-09 2016-12-08 Replacement of the first metatarsophalangeal joint, in particular based on ceramic Ceased WO2017097906A1 (en)

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