WO2008040408A1 - Élément d'augmentation pour implants osseux - Google Patents

Élément d'augmentation pour implants osseux Download PDF

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Publication number
WO2008040408A1
WO2008040408A1 PCT/EP2007/006753 EP2007006753W WO2008040408A1 WO 2008040408 A1 WO2008040408 A1 WO 2008040408A1 EP 2007006753 W EP2007006753 W EP 2007006753W WO 2008040408 A1 WO2008040408 A1 WO 2008040408A1
Authority
WO
WIPO (PCT)
Prior art keywords
augmentation component
augmentation
bone
cavities
implant
Prior art date
Application number
PCT/EP2007/006753
Other languages
German (de)
English (en)
Inventor
Wilhelm Blömer
Richard Zeller
Jens Schneider
Jens Beger
Patricia Graf
Original Assignee
Aesculap Ag & Co. Kg
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 Aesculap Ag & Co. Kg filed Critical Aesculap Ag & Co. Kg
Publication of WO2008040408A1 publication Critical patent/WO2008040408A1/fr

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    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

Definitions

  • the invention relates to an augmentation component for bone implants, in particular for femur or tibial implants, with a metallic, porous structure and with at least one opening for a fastening element which fixes the augmentation component to the bone implant.
  • augmentation components can have a wide variety of shapes, for example in the form of plates, wedges, cylinders, etc., and they can have openings through which fastening means, for example screws, reach through which fixes these augmentation components to the corresponding implants.
  • fastening means for example screws
  • bone replacement materials of biological or synthetic origin are also used to fill in bony defects.
  • materials of biological origin the poor availability of disadvantage, also with autologous implants, the additional burden on the patient by removing bone material from another part of the body. Therefore, increasingly synthetic, ceramic or metallic bone substitute materials are used, which have a porous structure (company prospectus The actipore.PLF system of Biorthex, Inc., 2002).
  • the strength in the load-bearing area of the bone is often insufficient, and in the case of the metallic porous augmentation components there is the problem that, with sufficient strength, the size of the pores is small, since a relatively large wall thickness is necessary to ensure mechanical stability to ensure. There is therefore very little volume available for ingrowth of the bone.
  • the augmentation component is composed of a three-dimensional framework of interconnected webs forming interconnected cavities with a size between 0.5 mm and 6 mm.
  • the webs may for example have a thickness between 0.2 mm and 2.5 mm.
  • the relative density of the augmentation component can be between 0.05 and 0.5.
  • relative density is meant the density of the cellular material divided by the density of the solid from which the webs are made.
  • the augmentation component consists of a biocompatible metallic material, for example titanium, a titanium alloy or a cobalt alloy.
  • the webs are provided with a coating, for example with a resorbable calcium phosphate layer that stimulates bone growth.
  • the size of the cavities within the augmentation component may be the same, but in a preferred embodiment it is contemplated that the size of the cavities will vary within the augmentation component.
  • cavities of different sizes can be uniformly distributed over the entire volume of the augmentation component, but it is also possible for the size of the cavities to change from one area of the augmentation component to another area of the augmentation component.
  • This makes it possible, in particular, to vary the mechanical properties of the augmentation component over its volume, for example to adapt the mechanical properties to the mechanical properties of the adjacent bone material. By means of this adaptation, it is possible to prevent the adjacent bone material from being damaged by osteolysis due to excessive strength of the augmentation component.
  • the size of the cavities can thereby change gradually or even suddenly in the transition from one area to another area.
  • the augmentation component has no cavities in the region of the opening, but is made compact. In the region of the opening, which serves to fix the augmentation component to an implant, for example by a screw passing through the opening, this results in a particularly high strength of the augmentation device. tion component, which leads to a secure and unchangeable fixing of the augmentation component on the implant.
  • the augmentation component corresponds in its outer dimensions to the outer dimensions of the bone implant on which it is held by the fastening element.
  • the augmentation component forms a continuation of the implant parts into the respective bone defect.
  • a lattice-like structure, as used in the described augmentation component, can be easily machined on its outer surfaces in any shape, so that the augmentation component can be adapted not only to the outer dimensions of the bone implant, but also to the exact structure of the bone defect to be filled ,
  • the augmentation component can be plate-shaped as a support for a tibial plateau of a tibial implant.
  • the invention also relates to a bone implant, in particular a femoral or tibial implant, which is connected to an augmentation component of the type described above.
  • FIG. 1 shows a schematic view of a tibial implant with a plate-shaped augmentation component prior to assembly and placement on a tibial plateau;
  • FIG. 2 shows a cross-sectional view of the augmentation component of FIG. 1 in the direction of the arrow 2 in FIG. 1 and FIG
  • FIG. 3 shows an enlarged detailed view of the three-dimensional lattice structure of the augmentation component of FIG. 2 in region A of FIG. 2.
  • tibial implant 1 which is placed on the tibial plateau 2 of a correspondingly resected tibia 3. It is understood, however, that the invention also applies to other bone implants that are placed on bone to bridge bone defects, particularly in joint prostheses in the area of the knee joint or hip joint. Also, in bone replacement implants, which are used to bridge defects of the femur or tibia, the invention may find application.
  • the tibial implant 1 comprises a plate-shaped tibial plateau 4 with a shaft 5 protruding vertically downwards.
  • On the tibial plateau 4 joint components are placed in a conventional manner and not shown in the drawing, take over the function of the meniscus, for example, a Gelenk laketeil of ultra high molecular weight polyethylene (UHWM-PE) on which then the Condyle one at the femur Supported femur implant, which is also not shown in the drawing.
  • UHWM-PE ultra high molecular weight polyethylene
  • a plate-shaped augmentation component 7 is arranged, which serves to bridge a bone defect between the underside of the tibial plateau 4 and the top of the tibial plateau 2 and the one hand flat on the underside of the tibial plateau 4 and on the other hand flat at the top of the tibia is applied.
  • the augmentation component 7 has a central opening 8, through which the shaft 5 protrudes, and two through openings 9, 10, through which screws 11, 12 are inserted, which can be screwed into the tibial plateau 2 and thereby the augmentation component 7 firmly and permanently connect with the tibial plateau 4, for example by clamping the augmentation component 7 between the tibial plateau 4 and the tibial plateau 2.
  • the outer contour of the augmentation component 7 is adapted to the outer contour of the tibial plateau 4, that is to say the outer contour of the augmentation component 7 follows the outer contour of the tibial plateau 4 so that the augmentation component 7 does not protrude laterally beyond the tibial plateau 4, but the space between the tibial plateau 4 and the tibia 3 completely filled out.
  • the height of the augmentation component 7 depends on the size of the bone defect and can be chosen differently so that the tibial plateau 4 of the tibial implant 1 assumes the desired position relative to the tibia 3.
  • different thickness augmentation components 7 are available.
  • the augmentation component 7 consists of a metallic material, for example of titanium or a titanium alloy, in particular Ti6AI4V, or a cobalt alloy.
  • It is composed of a plurality of webs 13, which are connected to each other so that a three-dimensional lattice structure is formed with adjacent cavities 14, which communicate with each other.
  • the webs can have a diameter between 0.2 mm and 2.5 mm, their length is dimensioned so that the size of the cavities formed by them is between 0.5 mm and 6 mm. It is possible that the webs are all the same size and arranged regularly, so that there is a uniform distribution of cavities of the same size on the volume of the augmentation, but the webs 13 may also be arranged differently long and irregular, so that the size of the Cavities varies. This variation can be made so that different sized cavities are distributed uniformly over the entire volume of the augmentation component 7, but it is also possible that the size of the cavities from one area of the augmentation component 7 changed to another, either gradually or possibly also leaps and bounds , As a result, an adaptation of the strength properties can be achieved.
  • webs 13 are provided of equal length and in a regular arrangement.
  • the webs form individual trusses 15, in each of which the same length of webs 13 alternately connected by 120 ° inclined to adjacent webs. In a traverse so the webs run alternately at an angle of 30 ° up and down.
  • a plurality of such trusses 15 are arranged parallel to each other.
  • Below this first level extending in a lower plane in the same way trusses perpendicular to the traverses of the top level, in such a way that their highest points in each case coincide with the lowest points of the traverses in the overlying level. In this area, the perpendicular to each other trusses are connected.
  • Such a very complicated structure gives the augmentation component a high strength and nevertheless allows a complete intergrowth with bone material, so that the bone augmentation augmented component consists for the most part of bone material, for example, the proportion of bone material is on the order of 50% to 95%. while the metallic material of the augmentation component is only 5% to 50%.
  • Such complex lattice structures can be built up in layers, for example, using an electron beam melting method in which metal powder is deposited in layers in a layer by means of a controlled electron beam. becomes molten, at which the lattice structure passes through the respective plane.
  • the layered structure also makes it possible to produce very complicated progressions of the webs in the three-dimensional structure, and the shaped body produced in this way can also already be adapted to the outer contour of the implant.
  • the augmentation component 7 in the illustrated embodiment has cavities in the entire region, it can be provided that in the edge region 16 of the openings 9, 10 no cavities are provided, but a compact design. As a result, a particularly high strength is achieved in the region of the openings 9, 10, so that the screws 11, 12 passing through the openings 9, 10 can securely and permanently fix the augmentation component 7 on the tibial implant 1.
  • a structural unit of an implant is obtained, in which a layered implant upper part is formed, which is formed from the compact tibial plateau 4 on the one hand and the lattice-shaped framework the augmentation component 7 on the other.
  • This unit can be handled by the surgeon like a tibial implant with a tibial plateau 4 of greater strength, and he also has the ability to make an adjustment of the thickness of the upper part of the implant by connecting the tibial plateau 4 with augmentation 7 different thickness.
  • the described complex three-dimensional lattice structure gives the augmentation component 7 such a high mechanical strength that all loads can be transferred from the tibial plateau 4 via the augmentation component 7 to the tibia 3, even if no bone has yet grown.
  • the lattice structure of the augmentation component 7 can be designed such that its mechanical strength corresponds to the strength of the incorporated bone substance, so that with regard to the mechanical properties a homogeneous Structure arises.

Abstract

La présente invention concerne un élément d'augmentation (7) destiné à des implants osseux, en particulier à des implants de fémur ou de tibia, comprenant une structure métallique poreuse et présentant une ouverture (8, 9, 10) destinée à un élément de fixation (11, 12) qui sert à fixer l'élément d'augmentation (7) sur l'implant osseux (1). Afin d'une part de garantir la dureté, et d'autre part de permettre une croissance interne optimale de la matière osseuse, l'élément d'augmentation (7) a une ossature tridimensionnelle qui se compose de tiges reliées entre elles qui forment des cavités reliées entre elles ayant une taille comprise entre 0,5 mm et 6 mm. L'invention concerne également un implant osseux (4) qui est relié à un élément d'augmentation (7) de ce type.
PCT/EP2007/006753 2006-09-29 2007-07-31 Élément d'augmentation pour implants osseux WO2008040408A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE202006015416U DE202006015416U1 (de) 2006-09-29 2006-09-29 Augmentationskomponente für Knochenimplantate
DE102006047663A DE102006047663A1 (de) 2006-09-29 2006-09-29 Augmentationskomponente für Knochenimplantate
DE102006047663.8 2006-09-29

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US8920508B2 (en) 2011-12-08 2014-12-30 Cleveland Clinic Foundation Glenoid vault fixation
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US9788957B2 (en) 2012-12-07 2017-10-17 Cleveland Clinic Foundation Glenoid vault fixation
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WO2009022911A2 (fr) * 2007-08-16 2009-02-19 Cam Implants B.V. Prothèse comprenant une surface d'interface osseuse anti-micromouvement, et son procédé de fabrication
FR2932674B1 (fr) 2008-06-20 2011-11-18 Tornier Sa Procede de modelisation d'une surface glenoidienne d'une omoplate, dispositif d'implantation d'un composant glenoidien d'une prothese d'epaule, et procede de fabrication d'un tel compose.
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US11234721B2 (en) 2017-07-11 2022-02-01 Howmedica Osteonics Corp. Guides and instruments for improving accuracy of glenoid implant placement
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