WO1988003781A1 - Osteosynthetic device - Google Patents

Osteosynthetic device Download PDF

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Publication number
WO1988003781A1
WO1988003781A1 PCT/CH1987/000158 CH8700158W WO8803781A1 WO 1988003781 A1 WO1988003781 A1 WO 1988003781A1 CH 8700158 W CH8700158 W CH 8700158W WO 8803781 A1 WO8803781 A1 WO 8803781A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
screw
head
screw holes
osteosynthesis plate
Prior art date
Application number
PCT/CH1987/000158
Other languages
German (de)
French (fr)
Inventor
Joram Raveh
Franz Sutter
Original Assignee
Synthes Ag
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
Priority claimed from CH470786A external-priority patent/CH669105A5/en
Priority claimed from CH35387A external-priority patent/CH672245A5/en
Application filed by Synthes Ag filed Critical Synthes Ag
Publication of WO1988003781A1 publication Critical patent/WO1988003781A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8038Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers the additional component being inserted in the screw head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8047Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers wherein the additional element surrounds the screw head in the plate hole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8605Heads, i.e. proximal ends projecting from bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7059Cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8071Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8695Washers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth

Definitions

  • the invention relates to an osteosynthetic device, in particular an internal fixator, consisting of an osteosynthesis plate with at least two screw holes and bone screws that can be inserted therein.
  • Fixation devices for osteosynthesis have been known for a long time. Most systems, however, do not allow a rigid, functionally stable fixation between the head of the bone screw and the osteosynthesis plate, which often results in bone resorption at the contact surface between the osteosynthesis plate and bone, with subsequent instability and loosening. With other rigid systems, the relative position of the plate and screws cannot be varied.
  • the invention seeks to remedy this.
  • the invention has for its object to combine the advantages of an external fixator with those of the internal plate osteosynthesis and to achieve long-term functionally stable anchoring of the implant, wherein the axial position of the bone screws relative to the osteosynthesis plate can be variable over a wide range.
  • the invention achieves the stated object with a device which has the features of claim 1.
  • the advantages achieved by the invention are essentially to be seen in the fact that, thanks to the device according to the invention, firstly, the stability of the implant increases with the length of time and the load, and secondly, the stability of the osteosynthesis no longer by pressing the plate against the bone, but by rigid fixation of the screw to the plate can be achieved. Additional advantages result from the rotatability of the screw head, which reduces the requirements for the directional accuracy of the holes for the bone screws. An additional advantage results if the bone contact surfaces of the device according to the invention are provided with a bio-inert, porous layer, because then a direct, interface-free bond is formed on the contact surface between the bone and the implant surface.
  • Fig. 1 shows a longitudinal section through an inventive
  • Fig. 2 shows a cross section along the line II-II in Figure 1;
  • FIG. 3 shows a side view of the osteosynthesis plate of the device according to the invention
  • Figure 4 illustrates a top view of the osteosynthesis plate
  • FIG. 5 shows a section parallel to FIG. 2, but at the level of a bone screw
  • FIG. 6 shows the screw head from FIG. 5, with the preferred, continuously decreasing cross section, on an enlarged scale
  • FIG. 7 shows a top view of the screw head from FIG. 6;
  • FIG. 8 shows a cross section through the bio-inert porous surface of the osteosynthesis plate or the hollow bone screw intended for bone contact
  • Figure 9 represents the equilibrium diagram for the binary mixture
  • Figure 10 represents the equilibrium diagram for the binary mixture
  • FIG. 11 shows a perspective view of two devices connected to an osteosynthetic device according to the invention
  • FIG. 12 shows a longitudinal section through the osteosynthesis plate according to FIG. 11;
  • FIG. 13 illustrates a perspective view of the slotted hollow cylinder serving as an insert
  • FIG. 14 shows a cross section analogous to FIG. 5 with a
  • Fig. 16 shows a cross section through an inventive
  • Fig. 17 shows a cross section through an inventive
  • Expansion screw with smooth outer cone shows a partial cross section through a device according to the invention with an additional, non-expandable bone screw
  • FIG. 19 shows the device according to the invention according to FIG. 18, the head of the additional, non-spreadable
  • Bone screw is shown in cross section
  • FIG. 20 shows a partial cross section through a device according to the invention with a slotted ball screw head
  • FIG. 21 shows further details of the expansion screw according to FIG. 20 in cross section
  • Fig. 26 shows a cross section through an inventive
  • FIG. 28 shows a partial cross section through a device according to the invention with a conical plate hole and a spherical-layer-shaped screw head;
  • FIG. 29 shows the device according to the invention according to FIG. 28 with a screw axis inclined with respect to the vertical.
  • FIG. 1 shows various aspects of an internal fixator according to the invention.
  • the bone screws 3, as shown in the second screw hole from the left, are inserted into the screw holes 2 of the osteosynthesis plate 1 with their shaft 9 in screwed in the bone 4.
  • the screw head 7 is provided with longitudinal slots 10 and a bore 25, so that the insert 11, which is designed as an expansion screw with an external thread 14, can be screwed into the bore 25 provided with an internal thread 13 while the screw head 7 is widened.
  • the screwing in is expediently carried out by means of an instrument which engages in the longitudinal slots 12 of the insert 11.
  • the convex lateral surface 18 of the screw head 7 is wedged with the concave drilling wall 8 of the screw hole 2, which results in an extremely rigid connection between the osteosynthesis plate 1 and screw 3.
  • the osteosynthesis plate 1 has essentially no planar surface areas.
  • the profile 17 lying between the screw holes 2 is tapered on all sides and thus allows a simpler deformation of the osteosynthesis plate on the occasion of its adaptation to the bone surface 4.
  • the bending moment is preferably the between the screw holes 2 lying profile 17 smaller or the same size as that of the profile running through the screw holes 2.
  • the concave configuration of the drilling wall 8 can either be realized, as shown in FIGS. 1, 5 and 15, by appropriate shaping of the screw holes 2 or, as shown in FIGS. 13 and 14, by inserting a correspondingly designed hollow cylinder 19 into the cylindrical bore 20 of the osteosynthesis plate 1, the axial insertion of the hollow cylinder 19 being limited and secured by an edge 21 which is oversized in relation to the diameter of the bore 20.
  • the hollow cylinder 19 can either be made of metal, for example titanium, or can also consist of a deformable material, for example a plastic such as polyethylene (HMPE), under the action of the head 7 of the bone screw 3 screwed and spread into the screw hole 2.
  • HMPE polyethylene
  • the outer surface 22 of the hollow cylinder 19, as shown in FIG. 13, has one or more slots 23 in the lower zone adjacent to the bone contact surface 4 and is slightly undersized in diameter compared to the cylindrical bore 20 of the osteosynthesis plate 1.
  • the slots 23 can also be made in the upper zone adjacent to the edge 21.
  • the two parts 4a, 4b are through an osteosynthesis plate 1 connected to each other, which can be screwed with a solid core shaft 9 having bone screws 3 through the screw holes 2 to the bone 4, the pure titanium osteosynthesis plate 1 being bent manually with the usual surgical instruments and adapted to the bone relief 4.
  • the osteosynthesis plate 1 has essentially no planar surface parts and the profile 17 lying between the screw holes 2 is tapered on all sides.
  • the holes in the bone 4 for the bone screws 3 are made in accordance with the usual surgical technique, expediently using a drilling jig.
  • the screw hole 2 has a cross-sectional constriction 5 in the direction of the bone contact surface 4, which is designed as a stop 6 for the bone screw 3 and allows exact axial positioning and securing.
  • the screwing in of the bone screws 3 can take place by means of an instrument which engages in the longitudinal slots 10 and bore 25 of the screw head 7.
  • the conical threaded expansion bolts 11 are screwed in, which have longitudinal slots 12 on the outer, larger end, which serve to receive the screwing instrument (screwdriver).
  • the preferably conical internal thread 13 of the screw head 7 corresponds to the external thread 14 of the insert 11.
  • the osteosynthesis plate 1 can be removed again, the inserts 11 being unscrewed first and then the bone screws 3.
  • an implant in particular a joint endoprosthesis, for example a temporomandibular joint prosthesis, the bone screws 3 and the osteosynthesis plate 1, to which the implant is then connected, remain permanently in the body of the implant
  • the bone screws 3 can be designed as hollow screws in order to promote the ingrowth of bone tissue.
  • Those surfaces of the bone screws 3 which are intended for contact with the bone 4 have a bio-inert, porous layer 16.
  • This porous layer can either consist, as shown in FIG. 8, of titanium or its alloys, which is applied using a plasma spray or similar process, or else be produced by sandblasting, for example with aluminum oxide particles. Electrolytic surface processes or coating with ceramic (apatite) are also suitable means of making the surface bone-friendly.
  • Achieving a porous titanium layer with an adhesive strength of at least 9.5 kp / mm 2 , preferably of at least 12.0 kp / mm 2, has proven to be important for the desired success proven on the preferably metallic substrate.
  • adhesive strengths of at least 20 kp / mm 2 , preferably at least 40 kp / mm 2 can be achieved.
  • a suitable method for achieving such adhesive strengths is the plasma flame method, but other chemical methods are also suitable.
  • the coating of the internal fixator according to the invention with the bio-inert, porous layer can be done, for example, by spraying on titanium powder with a grain size distribution of approximately 0.05-0.1 mm in a gas mixture of nitrogen and hydrogen flowing out under high pressure in an electric arc at a temperature of 15 ' 000 to 20,000 ° C take place.
  • the titanium hydride particles supplied in an inert gas carrier for example argon, reach a speed of about 600 m / s within the 15 to 20 cm long acceleration distance at which they hit the metal surface to be coated and there a 0.01 depending on the duration of the process - Form 0.50 mm, preferably 0.03 - 0.06 mm thick, bio-inert, porous layer.
  • the coating is expediently carried out in such a way that the resulting pores have a diameter of approximately 30-200 ⁇ m, preferably approximately 40-70 ⁇ m.
  • the chemical composition of the coating is also important for the bio-inert properties.
  • Porous surface layers have proven to be advantageous which, in addition to the base material (titanium, Ti-6Al-4V etc.), have a carbon content of less than 0.5% (preferably less than 0.3%) and a nitrogen content of less than 4% ( preferably less than 3%) and have an oxygen content between 8-10% (all figures are in% by weight).
  • the titanium in the titanium plasma layer is expediently at least in the form of the hexagonally coordinated ⁇ -Ti and the cubically coordinated 6-TiO and 5-TiN, preferably in a proportion of 76-87% by weight of the hexagonally coordinated ⁇ -Ti.
  • the corresponding phases are from the two equilibrium diagrams shown in FIGS. 9 and 10 for the binary alloys O-Ti (FIG. 9; source: THSchofield and AEBacon, J. Inst. Metals, 1955/6. 84.47) and N- Ti (Fig. 10; source: AE Pally et al. Trans.Amer -Soc.Met., 1954, 46, 312).
  • the preferred material titanium alloys, zirconium, Siobium, tantalum or platinum.
  • the osteosynthesis plate 1 can be removed again, the inserts 11 being unscrewed first and then the bone screws 3.
  • the internal fixator according to the invention is used to fix an implant, in particular a joint endoprosthesis, for example a temporomandibular joint prosthesis, the bone screws 3 and that remain Osteosynthesis plate 1 to which the implant then connects continuously in the patient's body.
  • Bio-inert, preferably reinforced plastic materials can also be used as the osteosynthesis plate 1 for the internal fixator according to the invention, for example in the form of deformable, polymerizable composite structures as described in Swiss patent application No. 03 428 / 86-1.
  • the internal fixator according to the invention is particularly suitable in maxillofacial surgery and for the fixation of endogenous prostheses and vertebral plates.
  • osteosynthesis plates with the usual dimensions have proven to be unsuitable.
  • Osteosynthesis plates 1 which have the following dimensions, have proven to be particularly advantageous for these purposes:
  • the screw head 7 of the bone screws 3 to be used is also very small, the two threads 13, 14 are designed to be continuous at least in the upper part facing away from the bone contact surface 4, so that when the insert 11 is screwed in, it expands the head 7 takes place.
  • a shape of the screw head 7 according to FIG. 6 has proven to be particularly expedient.
  • the lateral surface 18 of the head 7 is increasingly convex only in the lower zone adjacent to the bone contact surface 4, while the upper part practically ends in a cylindrical shape.
  • an appropriately designed drilling wall 8 of the very dovetail hole 2 there is an optimal, rigid and functionally stable connection between the osteosynthesis plate 1 and the bone screw 3.
  • FIG. 16 Another variant of the screw head 7 is shown in FIG. 16.
  • the cylindrical screw head 7 fits into the corresponding cylindrical part of the drilling wall 8 of the screw hole 2.
  • the power transmission takes place between the screw head 7 and the axial stop 6 designed as a taper in the bore 2 of the osteosynthesis plate 1.
  • FIGS. 22-24 Further variants of this print run are shown in FIGS. 22-24.
  • the advantage of these variants is the maximum lateral and axial load capacity.
  • the insert 11 is designed as a conical expansion screw with an external thread 14 which fits the internal thread 13 of the screw head 7 provided with longitudinal slots 10.
  • the variant of the screw head 7 shown in FIG. 17 largely corresponds to the embodiment according to FIG. 16 with the exception of the insert 11, which is designed here as a cone with a smooth outer surface 27, which by means of the cylindrical screw attachment 28 with the likewise smooth outer shell 26 of the conical bore 25 in Screw head 7 can be jammed.
  • FIGS. 20 and 21 The variant of a slotted ball screw head 7 shown in FIGS. 20 and 21 has a further significant advantage, which consists in that, in addition to the rigid and releasable connection between the bone screw 3 and the osteosynthesis plate 1, the screw axis 30 is inclined by the angle ⁇ up to 30 ° to the screw hole axis 24 is possible.
  • the spherical bonnet head 7 provided with longitudinal slots 10 can be expanded and rigidly fixed by means of the insert 11 designed as an expanding screw.
  • FIGS. 22 to 25 show variants of the screw hole bores 2 according to the invention with various embodiments of the annular tapered part 6. In FIG.
  • FIG. 22 shows a variant of the embodiment according to FIG. 22, which consists in the step-shaped taper 6 being inclined downwards.
  • FIG. 24 shows a screw hole 2 which is analogous to FIG. 5, but which widens again in the lower part facing the bone.
  • FIG. 25 shows a spherically formed borehole wall 8 which is particularly suitable for ball screw heads 7 according to FIGS. 26 and 27.
  • FIGS. 25 and 27 correspond essentially to the embodiment shown in FIG. 21, but with a screw hole 2 according to FIG. 24 or 25 and an insert 11 designed as a conical screw bolt.
  • the slots 10 of the screw ball head 7 are slotted crosswise and milled so deep that there is sufficient mechanical strength, but the screw ball head 7 can be easily pressed into one of the various screw holes 2 according to FIGS. 22 to 25.
  • an axial deviation of the screw axis of up to 30 ° is possible.
  • a further advantage is the possibility of an inevitable forward and backward movement of the screw-plate connection.
  • FIGS. 25 and 27 correspond essentially to the embodiment shown in FIG. 21, but with a screw hole 2 according to FIG. 24 or 25 and an insert 11 designed as a conical screw bolt.
  • the slots 10 of the screw ball head 7 are slotted crosswise and milled so deep that there is sufficient mechanical strength, but the screw ball head 7 can be easily pressed into one of the various screw holes 2 according to FIGS. 22 to 25.
  • FIG. 27 and 28 shows an osteosynthetic plate 1 with a borehole wall 8 of the hole 2 designed as a cone, the cone angle ⁇ being between 2-6 °, preferably between 3 and 5 ° and being, for example, 4 °.
  • the screw 3 provided for this hole 2 has a head 7 which is essentially designed as a spherical layer with slots 10 and into which an expansion screw 7 can be screwed. Due to the inner shape of the borehole wall 8 and the outer shape of the screw head 7, a deviation of the screw axis 30 by the angle .alpha. Compared to the hole axis 24 is possible with a consistently good mounting, which considerably extends the application range of the device according to the invention.

Abstract

Internal fixing device for osteosynthesis, in which the bone screws (3) are connected in a rigid and functionally stable manner with a pure titanium osteosynthesis plate (1). The walls (8) of the bore holes (2) have a narrower cross-section (5) in at least the lower of the areas which adjoin the bone contact surfaces (4), forming a stop (6) for the head (7) of the bone screw (3). The head (7) of the bone screw (3), provided with longitudinal grooves (10) and a bore (25), is connected with the osteosynthesis plate (1) with optimum rigidity and functional stability by fitting an adjusting screw (11), by means of which the spherical upper surface of the screw head (7) and the wall of the bore (8) permit a measure of axial alignment of the bone screws (3), so that precision requirements imposed on the angle of the bores for the bone screws (3) are less stringent, due to the rotatability of the screw head (7). Those surfaces of the internal fixing destined for contact with the bone (4) are preferably provided with a bio-inert, porous layer (16) to promote growth in the bone. Application of the internal fixing, besides in osteosynthesis proper, in the fixing of implants, particularly of articulatory endoprostheses, for example prostheses of the jaw, hip or vertebrae.

Description

OSTEOSYNTHETISCHE VORRICHTUNG OSTEOSYNTHETIC DEVICE
Die Erfindung bezieht sich auf eine osteosynthetische Vorrichtung, insbesondere einen Fixateur interne, bestehend aus einer Osteosyntheseplatte mit mindestens zwei Schraubenlöchern und darin einsetzbaren Knochenschrauben.The invention relates to an osteosynthetic device, in particular an internal fixator, consisting of an osteosynthesis plate with at least two screw holes and bone screws that can be inserted therein.
Fixationsvorrichtungen für die Osteosynthese sind schon seit langem bekannt. Die meisten Systeme ermöglichen jedoch keine rigide, funktionsstabile Fixation zwischen Kopf der Knochenschraube und Osteosyntheseplatte, was oft eine Knochenresorption an der Kontaktfläche zwischen Osteosyntheseplatte und Knochen zur Folge hat, mit nachfolgender Instabilität und Lockerung. Bei anderen, rigiden Systemen kann die relative Lage von Platte und Schrauben nicht variiert werde.Fixation devices for osteosynthesis have been known for a long time. Most systems, however, do not allow a rigid, functionally stable fixation between the head of the bone screw and the osteosynthesis plate, which often results in bone resorption at the contact surface between the osteosynthesis plate and bone, with subsequent instability and loosening. With other rigid systems, the relative position of the plate and screws cannot be varied.
Hier will die Erfindung Abhilfe schaffen. Der Erfindung liegt die Aufgabe zugrunde, die Vorteile eines Fixateur externe mit denjenigen der internen Plattenosteosynthese zu kombinieren und eine langfristig funktionsstabile Verankerung des Implantats zu erreichen, wobei die axiale Stellung der Knochenschrauben gegenüber der Osteosyntheseplatte in einem grösseren Bereich variabel sein kann.The invention seeks to remedy this. The invention has for its object to combine the advantages of an external fixator with those of the internal plate osteosynthesis and to achieve long-term functionally stable anchoring of the implant, wherein the axial position of the bone screws relative to the osteosynthesis plate can be variable over a wide range.
Die Erfindung löst die gestellte Aufgabe mit einer Vorrichtung, welche die Merkmale des Anspruchs 1 aufweist. Die durch die Erfindung erreichten Vorteile sind im wesentlichen darin zu sehen, dass dank der erfindungsgemässen Vorrichtung erstens die Stabilität des Implantats mit der Liegedauer und der Belastung zunimmt und zweitens die Stabilität der Osteosynthese nicht mehr durch das Andrücken der Platte an den Knochen, sondern durch die rigide Fixation der Schraube an die Platte erzielt werden kann. Zusätzliche Vorteile ergeben sich wegen der Rotierbarkeit des Schraubenkopfes, was die Anforderungen an die Richtungsgenauigkeit der Bohrungen für die Knochenschrauben herabsetzt. Ein zusätzlicher Vorteil ergibt sich, wenn die Knochenkontaktflächen der erfindungsgemässen Vorrichtung mit einer bioinerten, porösen Schicht versehen sind, weil sich dann an der Kontaktfläche zwischen Knochen und Implantatoberfläche ein direkter, trennschichtfreier Verbund ausbildet.The invention achieves the stated object with a device which has the features of claim 1. The advantages achieved by the invention are essentially to be seen in the fact that, thanks to the device according to the invention, firstly, the stability of the implant increases with the length of time and the load, and secondly, the stability of the osteosynthesis no longer by pressing the plate against the bone, but by rigid fixation of the screw to the plate can be achieved. Additional advantages result from the rotatability of the screw head, which reduces the requirements for the directional accuracy of the holes for the bone screws. An additional advantage results if the bone contact surfaces of the device according to the invention are provided with a bio-inert, porous layer, because then a direct, interface-free bond is formed on the contact surface between the bone and the implant surface.
Ausführungsbeispiele der Erfindung, welche zugleich das Funktionsprinzip erläutern, sind in den Zeichnungen dargestellt und werden im folgenden näher beschrieben.Embodiments of the invention, which also explain the functional principle, are shown in the drawings and are described in more detail below.
Fig. 1 stellt einen Längsschnitt durch einen erfindungsgemässenFig. 1 shows a longitudinal section through an inventive
Fixateur interne dar;Internal fixator;
Fig. 2 stellt einen Querschnitt längs der Linie II-II in Figur 1 dar;Fig. 2 shows a cross section along the line II-II in Figure 1;
Fig. 3 stellt einen Seitenriss der Osteosyntheseplatte der erfindungsgemässen Vorrichtung dar;3 shows a side view of the osteosynthesis plate of the device according to the invention;
Fig. 4 stellt eine Aufsicht auf die Osteosyntheseplatte dar;Figure 4 illustrates a top view of the osteosynthesis plate;
Fig. 5 stellt einen zu Figur 2 parallelen Schnitt, jedoch auf der Höhe einer Knochenschraube dar; Fig. 6 zeigt den Schraubenkopf aus Figur 5, mit dem bevorzugten, kontinuierlich abnehmenden Querschnitt, in vergrössertem Massstab;5 shows a section parallel to FIG. 2, but at the level of a bone screw; FIG. 6 shows the screw head from FIG. 5, with the preferred, continuously decreasing cross section, on an enlarged scale;
Fig. 7 stellt eine Aufsicht auf den Schraubenkopf aus Figur 6 dar;FIG. 7 shows a top view of the screw head from FIG. 6;
Fig. 8 stellt einen Querschnitt durch die für den Knoσhenkontakt bestimmte bioinerte poröse Oberfläche der Osteosyntheseplatte, bzw. der Knochenhohlschraube dar;8 shows a cross section through the bio-inert porous surface of the osteosynthesis plate or the hollow bone screw intended for bone contact;
Fig. 9 stellt das Gleichgewichtsdiagramm für das binäre GemischFigure 9 represents the equilibrium diagram for the binary mixture
O-Ti dar;O-Ti;
Fig. 10 stellt das Gleichgewichtsdiagramm für das binäre GemischFigure 10 represents the equilibrium diagram for the binary mixture
N-Ti dar.Represents N-Ti.
Fig. 11 stellt eine perspektivische Ansicht von zwei mit einer erfindungsgemässen osteosynthetisehen Vorrichtung verbundenen11 shows a perspective view of two devices connected to an osteosynthetic device according to the invention
Teilen eines Unterkiefers dar;Parts of a lower jaw;
Figur 12 stellt einen Längsschnitt durch die Osteosyntheseplatte gemäss Figur 11 dar;FIG. 12 shows a longitudinal section through the osteosynthesis plate according to FIG. 11;
Fig. 13 stellte eine perspektivische Ansicht des als Einsatz dienenden, geschlitzten Hohlzylinders dar;13 illustrates a perspective view of the slotted hollow cylinder serving as an insert;
Fig. 14 stellt einen Querschnitt analog zu Figur 5 dar mit einem14 shows a cross section analogous to FIG. 5 with a
Hohlzylinder gemäss Figur 13;Hollow cylinder according to Figure 13;
Fig. 15 stellt einen Querschnitt analog zu Figur 5 dar ohne15 shows a cross section analogous to FIG. 5 without
Hohlzyl Inder gemäss Figur 13;Hohlzyl Indians according to Figure 13;
Fig. 16 stellt einen Querschnitt durch eine erfindungsgemässeFig. 16 shows a cross section through an inventive
Vorrichtung mit einem zylindrischen Schraubenkopf und einerDevice with a cylindrical screw head and a
Spreizschraube mit konischem Aussengewinde dar;Expansion screw with conical external thread;
Fig. 17 stellt einen Querschnitt durch eine erfindungsgemässeFig. 17 shows a cross section through an inventive
Vorrichtung mit einem zylindrischen Schraubenkopf und einerDevice with a cylindrical screw head and a
Spreizschraube mit glattem Aussenkonus dar; Fig. 18 stellt einen teilweisen Querschnitt durch eine erfindungsgemässe Vorrichtung mit einer zusätzlichen, nicht spreizbaren Knochenschraube dar;Expansion screw with smooth outer cone; 18 shows a partial cross section through a device according to the invention with an additional, non-expandable bone screw;
Fig. 19 stellt die erfindungsgemässe Vorrichtung gemäss Fig. 18 dar, wobei der Kopf der zusätzlichen, nicht spreizbarenFIG. 19 shows the device according to the invention according to FIG. 18, the head of the additional, non-spreadable
Knochenschraube im Querschnitt dargestellt ist;Bone screw is shown in cross section;
Fig. 20 stellt einen teilweisen Querschnitt durch eine erfindungsgemässe Vorrichtung mit einem geschlitzten Kugelschraubenkopf dar;20 shows a partial cross section through a device according to the invention with a slotted ball screw head;
Fig. 21 zeigt weitere Details der Spreizschraube gemäss Fig. 20 im Querschnitt;FIG. 21 shows further details of the expansion screw according to FIG. 20 in cross section;
Fig. 22 - 25 zeigen diverse Querschnitte durch Schraubenlöcher von Vorrichtungen gemäss der Erfindung;22-25 show various cross sections through screw holes of devices according to the invention;
Fig. 26 zeigt einen Querschnitt durch eine erfindungsgemässeFig. 26 shows a cross section through an inventive
Vorrichtung mit einem geschlitzten Kugelschraubenkopf in einemDevice with a slotted ball screw head in one
Schraubenloch gemäss Fig. 24;24 according to FIG. 24;
Fig. 27 zeigt einen Querschnitt durch eine erfindungsgemässe27 shows a cross section through a device according to the invention
Vorrichtung mit einem geschlitzten Kugelschraubenkopf in einemDevice with a slotted ball screw head in one
Schraubenloch gemäss Fig. 25;Screw hole according to FIG. 25;
Fig. 28 stellt einen teilweisen Querschnitt durch eine erfindungsgemässe Vorrichtung mit einem konischen Plattenloch und einem kugelschichtförmigen Schraubenkopf dar;28 shows a partial cross section through a device according to the invention with a conical plate hole and a spherical-layer-shaped screw head;
Fig. 29 stellt die erfindungsgemässe Vorrichtung gemäss Fig. 28 dar mit einer gegenüber der Vertikalen geneigten Schraubenachse.FIG. 29 shows the device according to the invention according to FIG. 28 with a screw axis inclined with respect to the vertical.
In Figur 1 sind verschiedene Aspekte eines erfindungsgemässen Fixateur interne dargestellt. In die Schraubenlöcher 2 der Osteosyntheseplatte 1 werden die Knochenschrauben 3 , wie im zweiten Schraubenloch von links gezeigt, mit ihrem Schaft 9 in den Knochen 4 eingeschraubt. Der Schraubenkopf 7 ist wie in Figur 6 und 7 dargestellt mit Längsschlitzen 10 und einer Bohrung 25 versehen, so dass der als Spreizschraube mit einem Aussengewinde 14 ausgestaltete Einsatz 11 in die mit einem Innengewinde 13 versehene Bohrung 25 unter AufWeitung des Schraubenkopfes 7 eingeschraubt werden kann. Das Einschrauben erfolgt zweckmässigerweise mittels eines in die Längsschlitze 12 des Einsatzes 11 eingreifenden Instrumentes. Dabei verkeilt sich die konvexe Mantelfläche 18 des Schraubenkopfes 7 mit der konkav ausgebildeten Bohrwandung 8 des Schraubenloches 2 , wodurch sich eine äusserst rigide Verbindung zwischen Osteosyntheseplatte 1 und Schraube 3 ergibt. Da der Bohrungsdurchmesser d der Schraubenlöcher 2 in der unteren der Knochenkontaktfläche 4 benachbarten Zone kontinuierlich abnimmt ergibt sich eine Querschnittsverengung 5 die als axialer Anschlag 6 für den Kopf 7 der Knochenschraube 3 dient. Bedingt durch die sphärische Ausgestaltung der Bohrwandung 8 und der Mantelfläche 18 kann der Schraubenkopf innerhalb gewisser Grenzen im Schraubenloch 2 eine variable Stellung einnehmen. Im zweiten Schraubenloch von rechts in Figur 1 ist ein solcher Fall dargestellt, bei dem die Schraubenachse gegenüber der Schrauben- Iochachse 24 geneigt ist.FIG. 1 shows various aspects of an internal fixator according to the invention. The bone screws 3, as shown in the second screw hole from the left, are inserted into the screw holes 2 of the osteosynthesis plate 1 with their shaft 9 in screwed in the bone 4. 6 and 7, the screw head 7 is provided with longitudinal slots 10 and a bore 25, so that the insert 11, which is designed as an expansion screw with an external thread 14, can be screwed into the bore 25 provided with an internal thread 13 while the screw head 7 is widened. The screwing in is expediently carried out by means of an instrument which engages in the longitudinal slots 12 of the insert 11. The convex lateral surface 18 of the screw head 7 is wedged with the concave drilling wall 8 of the screw hole 2, which results in an extremely rigid connection between the osteosynthesis plate 1 and screw 3. Since the bore diameter d of the screw holes 2 continuously decreases in the lower zone adjacent to the bone contact surface 4, a cross-sectional constriction 5 results which serves as an axial stop 6 for the head 7 of the bone screw 3. Due to the spherical configuration of the drilling wall 8 and the lateral surface 18, the screw head can assume a variable position within the screw hole 2 within certain limits. Such a case is shown in the second screw hole from the right in FIG. 1, in which the screw axis is inclined with respect to the screw yoke axis 24.
Wie die Figuren 2 bis 4 zeigen, weist die Osteosyntheseplatte 1 im wesentlichen keine planaren Oberflächenpartien auf. Das zwischen den Schraubenlöchern 2 liegende Profil 17 ist allseitig verjüngt und erlaubt damit eine einfachere Deformation der Osteosyntheseplatte anlässlich deren Anpassung an die Knochenoberfläche 4. Vorzugsweise ist dabei das Biegemoment des zwischen den Schraubenlöchern 2 liegenden Profils 17 kleiner oder gleich gross wie dasjenige des durch die Schraubenlöcher 2 verlaufenden Profils.As FIGS. 2 to 4 show, the osteosynthesis plate 1 has essentially no planar surface areas. The profile 17 lying between the screw holes 2 is tapered on all sides and thus allows a simpler deformation of the osteosynthesis plate on the occasion of its adaptation to the bone surface 4. The bending moment is preferably the between the screw holes 2 lying profile 17 smaller or the same size as that of the profile running through the screw holes 2.
Die konkave Ausgestaltung der Bohrwandung 8 kann entweder, wie in den Figuren 1, 5 und 15 dargestellt, durch entsprechende Ausformung der Schraubenlöcher 2 realisiert werden oder auch, wie in Figuren 13 und 14 dargestellt, durch Einschub eines entsprechend ausgestalteten Hohlzylinders 19 in die zylindrische Bohrung 20 der Osteosyntheseplatte 1 , wobei der axiale Einschub des Hohlzylinders 19 durch einen gegenüber dem Durchmesser der Bohrung 20 überdimensionierten Rand 21 begrenzt und gesichert ist.The concave configuration of the drilling wall 8 can either be realized, as shown in FIGS. 1, 5 and 15, by appropriate shaping of the screw holes 2 or, as shown in FIGS. 13 and 14, by inserting a correspondingly designed hollow cylinder 19 into the cylindrical bore 20 of the osteosynthesis plate 1, the axial insertion of the hollow cylinder 19 being limited and secured by an edge 21 which is oversized in relation to the diameter of the bore 20.
Die Hohlzylinder 19 können entweder aus Metall, z.B. Titan bestehen oder auch aus einem, unter der Wirkung des in das Schraubenloch 2 eingeschraubten und verspreizten Kopfes 7 der Knochenschraube 3, deformierbaren Material, z.B. einem Kunststoff wie Polyaethylen (HMPE), bestehen. Die Mantelfläche 22 der Hohlzylinder 19 weist, wie in Figur 13 dargestellt, in der unteren der Knochenkontaktfläche 4 benachbarten Zone einen oder mehrere Schlitze 23 auf und ist im Durchmesser gegenüber der zylindrischen Bohrung 20 der Osteosyntheseplatte 1 leicht unterdimensioniert. Die Schlitze 23 können aber auch in der oberen, dem Rand 21 benachbarten Zone angebracht sein. Die eigentliche Operationstechnik soll nun anhand der Figur 11 erläutert werden. In Figur 11 ist ein Unterkiefer 4 dargestellt, aus dem wegen eines Tumors ein Stück reseziert werden musste. Dabei wurde der Unterkiefer in zwei Teile 4a, 4b getrennt. Die beiden Teile 4a,4b sind durch eine Osteosyntheseplatte 1 miteinander verbunden, welche mit einen Vollkernschaft 9 aufweisenden Knochenschrauben 3 durch die Sσhraubenlöcher 2 mit dem Knochen 4 verschraubbar ist, wobei die aus Reintitan bestehende Osteosyntheseplatte 1 mit den üblichen chirurgischen Instrumenten manuell gebogen und an das Knochenrelief 4 adaptiert werden kann. Die Osteosyntheseplatte 1 weist im wesentlichen keine planaren Oberflächenpartien auf und das zwischen den Schraubenlöchern 2 liegende Profil 17 ist allseitig verjüngt. Die Anbringung der Bohrungen im Knochen 4 für die Knochenschrauben 3 erfolgt gemäss der üblichen Operationstechnik, zweckmässigerweise unter Verwendung einer Bohrlehre. Wie aus Figur 12 ersichtlich ist, weist das Schraubenloσh 2 in Richtung der Knochenkontaktfläche 4 eine Querschnittsverengung 5 auf, welche als Anschlag 6 für die Knochenschraube 3 ausgebildet ist und eine exakte axiale Positionierung und Sicherung erlaubt.The hollow cylinder 19 can either be made of metal, for example titanium, or can also consist of a deformable material, for example a plastic such as polyethylene (HMPE), under the action of the head 7 of the bone screw 3 screwed and spread into the screw hole 2. The outer surface 22 of the hollow cylinder 19, as shown in FIG. 13, has one or more slots 23 in the lower zone adjacent to the bone contact surface 4 and is slightly undersized in diameter compared to the cylindrical bore 20 of the osteosynthesis plate 1. The slots 23 can also be made in the upper zone adjacent to the edge 21. The actual surgical technique will now be explained with reference to FIG. 11. FIG. 11 shows a lower jaw 4 from which a piece had to be resected due to a tumor. The lower jaw was separated into two parts 4a, 4b. The two parts 4a, 4b are through an osteosynthesis plate 1 connected to each other, which can be screwed with a solid core shaft 9 having bone screws 3 through the screw holes 2 to the bone 4, the pure titanium osteosynthesis plate 1 being bent manually with the usual surgical instruments and adapted to the bone relief 4. The osteosynthesis plate 1 has essentially no planar surface parts and the profile 17 lying between the screw holes 2 is tapered on all sides. The holes in the bone 4 for the bone screws 3 are made in accordance with the usual surgical technique, expediently using a drilling jig. As can be seen from FIG. 12, the screw hole 2 has a cross-sectional constriction 5 in the direction of the bone contact surface 4, which is designed as a stop 6 for the bone screw 3 and allows exact axial positioning and securing.
Wie aus Figur 7 ersichtlich kann das Eindrehen der Knochenschrauben 3 mittels eines in die Längsschlitze 10 und Bohrung 25 des Schraubenkopfes 7 eingreifenden Instrumentes erfolgen. Nachdem die Osteosyntheseplatte 1 mit einer genügenden Anzahl Schrauben 3 an den Knochen 4 festgeschraubt worden ist, erfolgt das Einschrauben der konischen Gewinde-Spreizbolzen 11 , welche am äusseren, grösseren Ende Längsschlitze 12 aufweisen, welche zur Aufnahme des Eindrehinstrumentes (Schraubenzieher) dienen. Das vorzugsweise konische Innengewinde 13 des Schraubenkopfs 7 entspricht dabei dem Aussengewinde 14 des Einsatzes 11. Durch das Einschrauben der Einsätze 11 erfolgt eine Aufspreizung und Verklemmung des längsgeschlitzten Schraubenkopfes 7 gegen die Innenwandung 8 des Schraubenlochs 2 wodurch sich eine äusserst rigide Verbindung zwischen Osteosyntheseplatte 1 und Schraube 3 ergibt.As can be seen from FIG. 7, the screwing in of the bone screws 3 can take place by means of an instrument which engages in the longitudinal slots 10 and bore 25 of the screw head 7. After the osteosynthesis plate 1 has been screwed onto the bone 4 with a sufficient number of screws 3, the conical threaded expansion bolts 11 are screwed in, which have longitudinal slots 12 on the outer, larger end, which serve to receive the screwing instrument (screwdriver). The preferably conical internal thread 13 of the screw head 7 corresponds to the external thread 14 of the insert 11. By screwing in the inserts 11, the longitudinally slotted screw head 7 spreads and jams against the Inner wall 8 of the screw hole 2, resulting in an extremely rigid connection between the osteosynthesis plate 1 and screw 3.
Nach erfolgter Osteosynthese kann die Osteosyntheseplatte 1 wieder entfernt werden, wobei zuerst die Einsätze 11 herausgeschraubt werden und danach die Knochenschrauben 3.After osteosynthesis has taken place, the osteosynthesis plate 1 can be removed again, the inserts 11 being unscrewed first and then the bone screws 3.
Bei der Verwendung des erfindungsgemässen Fixateur interne zurWhen using the internal fixator according to the invention for
Fixierung eines Implantates, insbesondere einer Gelenkendoprothese, beispielsweise einer Kiefergelenkprothese verbleiben die Knochenschrauben 3 und die Osteosyntheseplatte 1, an die sich dann das Implantat anschliesst, dauernd im Körper desFixation of an implant, in particular a joint endoprosthesis, for example a temporomandibular joint prosthesis, the bone screws 3 and the osteosynthesis plate 1, to which the implant is then connected, remain permanently in the body of the
Patienten.Patient.
Die Knochenschrauben 3 können für Langzeit-Implantate, wie in Figur 14 und 15 dargestellt, als Hohlschrauben ausgebildet sein um das Einwachsen von Knochengewebe zu fördern. Diejenigen Oberflächen der Knochenschrauben 3, welche für den Kontakt mit dem Knochen 4 bestimmt sind, weisen eine bioinerte, poröse Schicht 16 auf. Diese poröse Schicht kann entweder , wie in Figur 8 gezeigt, aus Titan oder dessen Legierungen bestehen, welche mit einem Plasmaspray- oder ähnlichen Verfahren aufgebracht wird oder auch durch Sandstrahlung, beispielsweise mit Aluminiumoxidpartikel, erzeugt werden. Auch elektrolytische Oberflächenverfahren oder die Beschichtung mit Keramik (Apatit) sind geeignete Mittel die Oberfläche knochenfreundlich zu gestalten.For long-term implants, as shown in FIGS. 14 and 15, the bone screws 3 can be designed as hollow screws in order to promote the ingrowth of bone tissue. Those surfaces of the bone screws 3 which are intended for contact with the bone 4 have a bio-inert, porous layer 16. This porous layer can either consist, as shown in FIG. 8, of titanium or its alloys, which is applied using a plasma spray or similar process, or else be produced by sandblasting, for example with aluminum oxide particles. Electrolytic surface processes or coating with ceramic (apatite) are also suitable means of making the surface bone-friendly.
Als wichtig für den angestrebten Erfolg hat sich die Erzielung einer porösen Titanschicht mit einer Haftfestigkeit von mindestens 9,5 kp/mm2, vorzugsweise von mindestens 12,0 kp/mm2 auf dem vorzugsweise metallischen Substrat erwiesen. Mit neuesten Verfahren können sogar Haftfestigkeiten von mindestens 20 kp/mm2, vorzugsweise von mindestens 40 kp/mm2 erzielt werden. Ein geeignetes Verfahren zur Erzielung solcher Haftfestigkeiten ist das Plasmaflamm-Verfahren, doch sind auch andere chemische Verfahren geeignet.Achieving a porous titanium layer with an adhesive strength of at least 9.5 kp / mm 2 , preferably of at least 12.0 kp / mm 2, has proven to be important for the desired success proven on the preferably metallic substrate. With the latest methods, adhesive strengths of at least 20 kp / mm 2 , preferably at least 40 kp / mm 2, can be achieved. A suitable method for achieving such adhesive strengths is the plasma flame method, but other chemical methods are also suitable.
Die Beschichtung des erfindungsgemässen Fixateur interne mit der bioinerten, porösen Schicht kann beispielsweise durch Aufsprühen von Titanpulver einer Korngrössenverteilung von etwa 0,05 - 0,1 mm in einem unter hohem Druck ausströmenden Gasgemisch aus Stickstoff und Wasserstoff im elektrischen Bogen bei einer Temperatur von 15'000 bis 20'000 °C erfolgen. Bei diesem Verfahren erreichen die in einem inerten Gasträger, beispielsweise Argon zugeführten Titanhydridpartikel innerhalb der 15 bis 20 cm langen Beschleunigungsstrecke eine Geschwindigkeit von etwa 600 m/s mit der sie auf die zu beschichtende Metalloberfläche auftreffen und dort je nach Dauer des Vorgangs eine 0,01 - 0,50 mm, vorzugsweise 0,03 - 0.06 mm dicke, bioinerte, poröse Schicht bilden.The coating of the internal fixator according to the invention with the bio-inert, porous layer can be done, for example, by spraying on titanium powder with a grain size distribution of approximately 0.05-0.1 mm in a gas mixture of nitrogen and hydrogen flowing out under high pressure in an electric arc at a temperature of 15 ' 000 to 20,000 ° C take place. In this process, the titanium hydride particles supplied in an inert gas carrier, for example argon, reach a speed of about 600 m / s within the 15 to 20 cm long acceleration distance at which they hit the metal surface to be coated and there a 0.01 depending on the duration of the process - Form 0.50 mm, preferably 0.03 - 0.06 mm thick, bio-inert, porous layer.
Zweckmässigerweise erfolgt die Beschichtung derart, dass die entstehenden Poren einen Durchmesser von etwa 30 - 200 μ, vorzugsweise von etwa 40 - 70 μ aufweisen.The coating is expediently carried out in such a way that the resulting pores have a diameter of approximately 30-200 μm, preferably approximately 40-70 μm.
Die verschiedenen je nach Verwendungszweck des erfindungsgemässen Fixateur interne benötigten Variationen der Beschichtungsqualität können durch Regelung der Verfahrensparameter erzielt werden, wobei jedoch eine Plasmaenthalpie von über 20 Millionen Joule/kg beibehalten werden sollte. Für die bioinerten Eigenschaften der Beschichtung ist auch deren chemische Zusammensetzung von Bedeutung. Als vorteilhaft haben sich solche porösen Oberflächenschichten erwiesen, welche neben dem Grundmaterial (Titan, Ti-6Al-4V u.a.) einen Kohlenstoffgehalt von weniger als 0,5 % (vorzugsweise weniger als 0,3%), einen Stickstoffgehalt von weniger als 4 % (vorzugsweise weniger als 3%) und einen Sauerstoffgehalt zwischen 8 - 10 % aufweisen (alle Angaben verstehen sich in Gew. %).The various variations in coating quality that are required internally, depending on the intended use of the fixator according to the invention, can be achieved by regulating the process parameters, although a plasma enthalpy of over 20 million joules / kg should be maintained. The chemical composition of the coating is also important for the bio-inert properties. Porous surface layers have proven to be advantageous which, in addition to the base material (titanium, Ti-6Al-4V etc.), have a carbon content of less than 0.5% (preferably less than 0.3%) and a nitrogen content of less than 4% ( preferably less than 3%) and have an oxygen content between 8-10% (all figures are in% by weight).
Das Titan in der Titanplasmaschicht liegt zweckmässigerweise mindestens in Form des hexagonal koordinierten α-Ti und des kubisch koordinierten 6-TiO und 5-TiN vor, vorzugsweise mit einem Anteil von 76 - 87 Gew.% des hexagonal koordinierten α-Ti. Die entsprechenden Phasen sind aus den beiden in den Figuren 9 und 10 dargestellten Gleichgewichtsdiagrammen für die binären Legierungen O-Ti (Fig. 9; Quelle: T.H.Schofield und A.E.Bacon, J .Inst. Metals, 1955/6. 84.47) und N-Ti (Fig. 10; Quelle: A.E. Pally et al. Trans.Amer -Soc.Met., 1954, 46, 312) ersichtlich. Statt des im Beispiel angegebenen bevorzugten Materials (Titan) können auch andere bioinerte Materialien verwendet werden, wie beispielsweise Titanlegierungen, Zirkon, Siob, Tantal oder Platin.The titanium in the titanium plasma layer is expediently at least in the form of the hexagonally coordinated α-Ti and the cubically coordinated 6-TiO and 5-TiN, preferably in a proportion of 76-87% by weight of the hexagonally coordinated α-Ti. The corresponding phases are from the two equilibrium diagrams shown in FIGS. 9 and 10 for the binary alloys O-Ti (FIG. 9; source: THSchofield and AEBacon, J. Inst. Metals, 1955/6. 84.47) and N- Ti (Fig. 10; source: AE Pally et al. Trans.Amer -Soc.Met., 1954, 46, 312). Instead of the preferred material (titanium) specified in the example, other bio-inert materials can also be used, such as titanium alloys, zirconium, Siobium, tantalum or platinum.
Für Applikationen bei denen es auf die vollständige Entfernbarkeit der Knochenschrauben 3 ankommt ist es auch möglich diese als Vollkernschrauben auszubilden und mindestens diejenigen Oberflächen der Knochenschrauben 3, welche für den Kontakt mit dem Knochen 4 bestimmt sind, glatt zu polieren. Nach erfolgter Osteosynthese kann die Osteosyntheseplatte 1 wieder entfernt werden, wobei zuerst die Einsätze 11 herausgeschraubt werden und danach die Knochenschrauben 3. Bei der Verwendung des erfindungsgemässen Fixateur interne zur Fixierung eines Implantates, insbesondere einer Gelenkendoprothese, beispielsweise einer Kiefergelenkprothese, verbleiben die Knochenschrauben 3 und die Osteosyntheseplatte 1 an die sich dann das Implantat anschliesst dauernd im Körper des Patienten.For applications in which the complete removability of the bone screws 3 is important, it is also possible to design them as solid core screws and to smoothly polish at least those surfaces of the bone screws 3 which are intended for contact with the bone 4. After the osteosynthesis has been carried out, the osteosynthesis plate 1 can be removed again, the inserts 11 being unscrewed first and then the bone screws 3. When the internal fixator according to the invention is used to fix an implant, in particular a joint endoprosthesis, for example a temporomandibular joint prosthesis, the bone screws 3 and that remain Osteosynthesis plate 1 to which the implant then connects continuously in the patient's body.
Als Osteosyntheseplatte 1 für den erfindungsgemässen Fixateur interne sind auch bioinerte, vorzugsweise verstärkte Kunststoffmaterialien verwendbar, beispielsweise in Form von verformbaren, polymerisierbaren Kompositstrukturen wie sie in der Schweizer Patentanmeldung Nr. 03 428/86-1 beschrieben sind. Der erfindungsgemässe Fixateur interne eignet sich insbesondere in der Kieferchirurgie und für die Fixation von Endogelenkprothesen und Wirbelplatten. Für die Anbringung des erfindungsgemässen Fixateur interne im Mittelgesicht, am Jochbein und der Kalotte (Neurochirurgie), sowie für Gesichtskorrekturen haben sich Osteosyntheseplatten mit den üblichen Dimensionen als ungeeignet erwiesen. Als besonders vorteilhaft für diese Zwecke haben sich Osteosyntheseplatten 1 erwiesen, welche folgende Dimensionen aufweisen:Bio-inert, preferably reinforced plastic materials can also be used as the osteosynthesis plate 1 for the internal fixator according to the invention, for example in the form of deformable, polymerizable composite structures as described in Swiss patent application No. 03 428 / 86-1. The internal fixator according to the invention is particularly suitable in maxillofacial surgery and for the fixation of endogenous prostheses and vertebral plates. For the attachment of the internal fixator according to the invention in the middle face, on the cheekbone and the calotte (neurosurgery), as well as for facial corrections, osteosynthesis plates with the usual dimensions have proven to be unsuitable. Osteosynthesis plates 1, which have the following dimensions, have proven to be particularly advantageous for these purposes:
- in Richtung der Achse 24 der Schraubenlöcher 2 eine Ausdehnung von mindestens 1,1 mm, vorzugsweise mindestens 1,5 mm; - eine Breite von 4 - 7 mm, vorzugsweise von 5 - 6 mm ; und- In the direction of the axis 24 of the screw holes 2, an expansion of at least 1.1 mm, preferably at least 1.5 mm; - A width of 4-7 mm, preferably 5-6 mm; and
- einen Durchmesser der Schraubenlöcher 2 von 0,9 - 1,6 mm, vorzugsweise von 1,1 - 1,4 mm. Da bei diesen kleinen Dimensionen (Miniplatten) der Schraubenkopf 7 der zu verwendenden Knochenschrauben 3 ebenfalls sehr klein ist, sind die beiden Gewinde 13,14 mindestens im oberen, von der Knochenkontaktfläche 4 abgewandten Teil durchgehend ausgebildet, damit unmittelbar beim Einschrauben des Einsatzes 11 eine Verspreizung des Kopfes 7 erfolgt.- A diameter of the screw holes 2 of 0.9-1.6 mm, preferably 1.1-1.4 mm. Since with these small dimensions (mini plates) the screw head 7 of the bone screws 3 to be used is also very small, the two threads 13, 14 are designed to be continuous at least in the upper part facing away from the bone contact surface 4, so that when the insert 11 is screwed in, it expands the head 7 takes place.
Insbesondere bei diesen Miniplatten, aber auch bei normal dimensionierten Platten hat sich eine Form des Schraubenkopfes 7 gemäss Figur 6 als besonders zweckmässig erwiesen. Dabei ist die Mantelfläche 18 des Kopfes 7 nur in der unteren, der Knochenkontaktfläche 4 benachbarten Zone, zunehmend konvex ausgestaltet, währenddem der obere Teil praktisch in eine zylindrische Form ausläuft. Zusammen mit einer entsprechend ausgestalteten Bohrwandung 8 des Sehraubenlochs 2 ergibt sicheine optimale, rigide und funktionsstabile Verbindung zwischen Osteosyntheseplatte 1 und Knochenschraube 3.In the case of these mini plates in particular, but also in the case of plates of normal dimensions, a shape of the screw head 7 according to FIG. 6 has proven to be particularly expedient. The lateral surface 18 of the head 7 is increasingly convex only in the lower zone adjacent to the bone contact surface 4, while the upper part practically ends in a cylindrical shape. Together with an appropriately designed drilling wall 8 of the very dovetail hole 2, there is an optimal, rigid and functionally stable connection between the osteosynthesis plate 1 and the bone screw 3.
Eine weitere Variante des Schraubenkopfes 7 ist in Figur 16 dargestellt. Der zylindrisch ausgebildete Schraubenkopf 7 passt in die entsprechende zylindrische Partie der Bohrwandung 8 des Schraubenlochs 2. Die Kraftübertragung findet dabei zwischen dem Schraubenkopf 7 und dem als Verjüngung ausgebildeten axialen Anschlag 6 in der Bohrung 2 der Osteosyntheseplatte 1 statt. Weitere Varianten dieser Druckauflage sind in den Figuren 22 - 24 dargestellt. Der Vorteil dieser Varianten liegt in der maxiamalen seitlichen und axialen Belastbarkeit.Another variant of the screw head 7 is shown in FIG. 16. The cylindrical screw head 7 fits into the corresponding cylindrical part of the drilling wall 8 of the screw hole 2. The power transmission takes place between the screw head 7 and the axial stop 6 designed as a taper in the bore 2 of the osteosynthesis plate 1. Further variants of this print run are shown in FIGS. 22-24. The advantage of these variants is the maximum lateral and axial load capacity.
Der Einsatz 11 ist als konische Spreizschraube mit einem Aussengewinde 14 ausgebildet, welches zum Innengewinde 13 des mit Längsschlitzen 10 versehenen Schraubenkopfs 7 passt. Die in Figur 17 dargestellte Variante des Schraubenkopfs 7 entspricht weitgehend der Ausführung gemäss Figur 16 mit Ausnahme des Einsatzes 11, der hier als Konus mit glatter Mantelfläche 27 ausgebildet ist, welcher mittels des zylindrischen Schraubenansatzes 28 mit der ebenfalls glatten Mantelfache 26 der konischen Bohrung 25 im Schraubenkopf 7 verklemmt werden kann.The insert 11 is designed as a conical expansion screw with an external thread 14 which fits the internal thread 13 of the screw head 7 provided with longitudinal slots 10. The variant of the screw head 7 shown in FIG. 17 largely corresponds to the embodiment according to FIG. 16 with the exception of the insert 11, which is designed here as a cone with a smooth outer surface 27, which by means of the cylindrical screw attachment 28 with the likewise smooth outer shell 26 of the conical bore 25 in Screw head 7 can be jammed.
Wie in den Figuren 18 und 19 dargestellt ist es auch möglich, in das Schraubenloch 2 einer erfindungsgemässen Osteosyntheseplatte 1 , bzw. den in Fig. 22 - 24 gezeigten Varianten davon, reguläre oder sogenannte Standard-Knochenschrauben 3 einzuführen. Obwohl hier keine Verspreizung des normalen Schraubenkopfs 29 stattfindet ist es damit möglich beispielsweise zusätzliche Knochenfragmente zu befestigen.As shown in FIGS. 18 and 19, it is also possible to insert regular or so-called standard bone screws 3 into the screw hole 2 of an osteosynthesis plate 1 according to the invention, or the variants thereof shown in FIGS. 22-24. Although there is no spreading of the normal screw head 29 here, it is possible, for example, to attach additional bone fragments.
Die in den Figuren 20 und 21 dargestellte Variante eines geschlitzten Kugelschraubenkopfes 7 hat einen weiteren wesentlichen Vorteil, der darin besteht, dass neben der rigiden und wieder lösbaren Verbindung zwischen Knochenschraube 3 und Osteosyntheseplatte 1, eine Neigung der Schraubenachse 30 um den Winkel α bis zu 30° zur Schraubenlochachse 24 möglich ist. In jeder Position der Schraube 3 innerhalb des ca. 60° betragenden Kegels 24,30 kann der mit Längsschlitzen 10 versehene Kugelsehraubenkopf 7 mittels der als Spreizschraube ausgebildeten Einsatzes 11 verspreizt und rigide fixiert werden. Die Figuren 22 bis 25 zeigen erfindungsgemässe Varianten der Schraubenlochbohrungen 2 mit diversen Ausführungsformen der ringförmigen Verjüngspartie 6. In Figur 22 besteht diese in einem treppenförmigen Absatz 31 der sich an den zylindrische Teil der Bohrungswand 8 anschliesst; gegen die Knochenkontaktflache hin erweitert sich dann die Bohrung 2 wieder. Figur 23 zeigt eine Variante der Ausführung gemäss Figur 22, die darin besteht, dass die stufenförmige Verjüngung 6 nach unten geneigt ist. In Figur 24 ist eine zu Figur 5 analoge Schraubenlochbohrung 2 dargestellt, welche sich jedoch im unteren dem Knochen zugewandten Teil wieder erweitert. Schliesslich ist in Figur 25 eine sphärisch ausgebildete Bohrlochwandung 8 dargestellt, welche sich insbesondere für Kugelschraubenköpfe 7 gemäss Figuren 26 und 27 eignet.The variant of a slotted ball screw head 7 shown in FIGS. 20 and 21 has a further significant advantage, which consists in that, in addition to the rigid and releasable connection between the bone screw 3 and the osteosynthesis plate 1, the screw axis 30 is inclined by the angle α up to 30 ° to the screw hole axis 24 is possible. In any position of the screw 3 within the approximately 24 ° cone 24, 30, the spherical bonnet head 7 provided with longitudinal slots 10 can be expanded and rigidly fixed by means of the insert 11 designed as an expanding screw. FIGS. 22 to 25 show variants of the screw hole bores 2 according to the invention with various embodiments of the annular tapered part 6. In FIG. 22, this consists of a step-shaped shoulder 31 which adjoins the cylindrical part of the bore wall 8; then bore 2 widens again against the bone contact surface. FIG. 23 shows a variant of the embodiment according to FIG. 22, which consists in the step-shaped taper 6 being inclined downwards. FIG. 24 shows a screw hole 2 which is analogous to FIG. 5, but which widens again in the lower part facing the bone. Finally, FIG. 25 shows a spherically formed borehole wall 8 which is particularly suitable for ball screw heads 7 according to FIGS. 26 and 27.
Dia in den Figuren 25 und 27 dargestellten Varianten entsprechen im wesentlichen der in Figur 21 gezeigten Ausführungsform, jedoch mit einer Schraubenlochbohrung 2 gemäss Figur 24, bzw. 25 und einem als Konusschraubenbolzen ausgebildeten Einsatz 11. Die Schlitze 10 des Schraubenkugelkopfes 7 sind dabei kreuzweise geschlitzt und so tief gefräst, dass zwar eine genügende mechanische Festigkeit vorhanden ist, der Schraubenkugelkopf 7 sich jedoch ohne Mühe in eine der verschiedenen Schraubenlochbohrungen 2 gemäss Figuren 22 bis 25 einpressen lässt. Auch bei diesen Varianten ist nebst einer rigiden Verankerung eine axiale Abweichung der Schraubenachse bis zu 30° möglich. Als weiterer zusätzlicher Vorteil ist die Möglichkeit einer zwangsläufigen Vor- und Rückwärtsbewegung der Schrauben-Plattenverbindung anzusehen. Die in den Figuren 27 und 28 dargestellte Variante zeigt eine osteosynthetische Platte 1 mit einer als Konus ausgebildeten Bohrlochwandung 8 des Loches 2, wobei der Konuswinkel β zwischen 2-6°, vorzugsweise zwischen 3 und 5° liegt und beispielsweise 4° beträgt. Die für dieses Loch 2 vorgesehene Schraube 3 weist einen im wesentlichen als Kugelschicht mit Schlitzen 10 ausgebildeten Kopf 7 auf, in den eine Spreizschraube 7 einschraubbar ist. Bedingt durch die Innenform der Bohrlochwandung 8 und der Aussenform des Schraubenkopfes 7 ist eine Abweichung der Schraubenachse 30 um den Winkel α gegenüber der Lochachse 24 bei gleichbleibend guter Halterung möglich, was die Applikationsbreite der erfindungsgemässen Vorrichtung wesentlich erweitert. The variants shown in FIGS. 25 and 27 correspond essentially to the embodiment shown in FIG. 21, but with a screw hole 2 according to FIG. 24 or 25 and an insert 11 designed as a conical screw bolt. The slots 10 of the screw ball head 7 are slotted crosswise and milled so deep that there is sufficient mechanical strength, but the screw ball head 7 can be easily pressed into one of the various screw holes 2 according to FIGS. 22 to 25. With these variants, in addition to rigid anchoring, an axial deviation of the screw axis of up to 30 ° is possible. A further advantage is the possibility of an inevitable forward and backward movement of the screw-plate connection. The variant shown in FIGS. 27 and 28 shows an osteosynthetic plate 1 with a borehole wall 8 of the hole 2 designed as a cone, the cone angle β being between 2-6 °, preferably between 3 and 5 ° and being, for example, 4 °. The screw 3 provided for this hole 2 has a head 7 which is essentially designed as a spherical layer with slots 10 and into which an expansion screw 7 can be screwed. Due to the inner shape of the borehole wall 8 and the outer shape of the screw head 7, a deviation of the screw axis 30 by the angle .alpha. Compared to the hole axis 24 is possible with a consistently good mounting, which considerably extends the application range of the device according to the invention.

Claims

Patentansprüche Claims
1. Osteosynthetische Vorrichtung, insbesondere Fixateur interne bestehend aus einer Osteosyntheseplatte (1) mit mindestens zwei Schraubenlöchern (2) und darin einsetzbaren Knochenschrauben (3), dadurch gekennzeichnet dass die Schraubenlöcher (2) mindestens in der unteren der Knochenkontaktfläche (4) benachbarten Zone eine Querschnittsverengung (5) aufweisen und dass mindestens zwei Knochenschrauben (3) einen spreizbaren Schraubenkopf (7) aufweisen, der gegen die Innenwandung (8) der Schraubenlöcher (2) verklemmbar ist, so dass durch die Verspreizung eine starre Verbindung zwischen Knochenschrauben (3) und Osteosyntheseplatte (1) realisierbar ist.1. osteosynthetic device, in particular internal fixator, consisting of an osteosynthesis plate (1) with at least two screw holes (2) and bone screws (3) that can be inserted therein, characterized in that the screw holes (2) are at least in the lower zone adjacent to the bone contact surface (4) Have cross-sectional constriction (5) and that at least two bone screws (3) have an expandable screw head (7) that can be clamped against the inner wall (8) of the screw holes (2), so that a rigid connection between the bone screws (3) and Osteosynthesis plate (1) can be realized.
2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet dass die Bohrwandung (8) der Schraubenlöcher (2) mindestens in der unteren der Knochenkontaktfläche (4) benachbarten Zone eine konkave Oberfläche und der Kopf (7) der Knochenschrauben (3) eine konvexe, auf die konkave Oberfläche (8) abgestimmte Mantelfläche (18) aufweist.2. Device according to claim 1, characterized in that the drilling wall (8) of the screw holes (2) at least in the lower zone adjacent to the bone contact surface (4) has a concave surface and the head (7) of the bone screws (3) has a convex surface on which has concave surface (8) coordinated lateral surface (18).
3. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet dass die Querschnittsverengung (5) als Anschlag (6) für den Kopf (7) der Knochenschraube (3) ausgebildet ist, vorzugsweise in Form einer Abstufung. 3. Device according to claim 1, characterized in that the cross-sectional constriction (5) is designed as a stop (6) for the head (7) of the bone screw (3), preferably in the form of a step.
4. Vorrichtung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass diejenigen Oberflächen der Osteosyntheseplatte (1), welche für den Kontakt mit dem Knochen (4) bestimmt sind, eine bioinerte, poröse Schicht (16) aufweisen, welche vorzugsweise aus Titan oder dessen Legierungen besteht.4. Device according to one of claims 1 to 3, characterized in that those surfaces of the osteosynthesis plate (1) which are intended for contact with the bone (4) have a bio-inert, porous layer (16), which is preferably made of titanium or its alloys.
5. Vorrichtung nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die Knochenschrauben (3) als Hohlschrauben ausgebildet sind und mindestens diejenigen Oberflächen der Knochenschrauben (3), welche für den Kontakt mit dem Knochen (4) bestimmt sind, eine bioinerte, poröse Schicht (16) aufweisen, welche vorzugsweise aus Titan oder dessen Legierungen besteht.5. Device according to one of claims 1 to 4, characterized in that the bone screws (3) are designed as hollow screws and at least those surfaces of the bone screws (3) which are intended for contact with the bone (4) are bio-inert, have porous layer (16), which preferably consists of titanium or its alloys.
6. Vorrichtung nach Anspruch 4 oder 5, dadurch gekennzeichnet, dass die vorzugsweise aus Titan bestehende Schicht (15) eine Haftfestigkeit auf dem vorzugsweise aus Titan bestehenden Substrat (15) von mindestens 9,5 kp/mm2, vorzugsweise von mindestens 12,0 kp/mm2 aufweist.6. The device as claimed in claim 4 or 5, characterized in that the layer (15) which is preferably made of titanium has an adhesive strength on the substrate which is preferably made of titanium (15) of at least 9.5 kg / mm 2 , preferably of at least 12.0 kp / mm 2 .
7. Vorrichtung nach Anspruch 6, dadurch gekennzeichnet, dass die vorzugsweise aus Titan bestehende Schicht (16) eine Haftfestigkeit auf dem vorzugsweise aus Titan bestehenden Substrat (15) von mindestens 20 kp/mm2, vorzugsweise von mindestens 40 kp/mm2 aufweist. 7. The device according to claim 6, characterized in that the preferably titanium layer (16) has an adhesive strength on the preferably titanium substrate (15) of at least 20 kp / mm 2 , preferably of at least 40 kp / mm 2 .
8. Vorrichtung nach einem der Ansprüche 4 bis 7, dadurch gekennzeichnet, dass das Titan in der Schicht (16) mindestens in Form des hexagonal koordinierten α-Ti und des kubisch koordinierten 6-TiO und 5-TiN vorliegt, vorzugsweise mit einem Anteil von 76 - 87 Gew.% des hexagonal koordinierten α-Ti.8. Device according to one of claims 4 to 7, characterized in that the titanium in the layer (16) is at least in the form of the hexagonally coordinated α-Ti and the cubically coordinated 6-TiO and 5-TiN, preferably in a proportion of 76-87% by weight of the hexagonally coordinated α-Ti.
9. Vorrichtung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Knochenschrauben (3) als Vollkernschrauben ausgebildet sind und mindestens diejenigen Oberflächen der Knochenschrauben (3), welche für den Kontakt mit dem Knochen (4) bestimmt sind, glatt poliert sind.9. Device according to one of claims 1 to 3, characterized in that the bone screws (3) are designed as solid core screws and at least those surfaces of the bone screws (3) which are intended for contact with the bone (4) are polished smooth .
10. Vorrichtung nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass der Bohrungsdurchiaesser d der Schraubenlöcher (2) mindestens in der unteren der Knochenkontaktfläche (4) benachbarten Zone kontinuierlich, vorzugsweise in zunehmendem Masse, abnimmt und die dadurch ausgebildete Querschnittsverengung (5) als axialer Anschlag (6) für den Kopf der Knochenschraube (3) dient.10. Device according to one of claims 1 to 9, characterized in that the bore diameter d of the screw holes (2) decreases continuously, preferably to an increasing extent, at least in the lower zone adjacent to the bone contact surface (4) and the cross-sectional constriction (5) formed thereby serves as an axial stop (6) for the head of the bone screw (3).
11. Vorrichtung nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die eine konkave Oberfläche aufweisende Bohrwandung (8) der Schraubenlöcher (2) durch Einschub entsprechend ausgestalteter Hohlzylinder (19) in vorzugsweise zylindrische Bohrungen (20) der Osteosyntheseplatte (1) realisiert ist, wobei der axiale Einschub der Hohlzylinder (19) vorzugsweise durch einen gegenüber dem Durchmesser der Bohrungen11. The device according to any one of claims 1 to 10, characterized in that the concave surface drilling wall (8) of the screw holes (2) by inserting appropriately designed hollow cylinder (19) in preferably cylindrical bores (20) of the osteosynthesis plate (1) is, the axial insertion of the hollow cylinder (19) preferably by one compared to the diameter of the bores
(20} überdimensionierten Rand (21) begrenzt und gesichert ist. (20} oversized edge (21) is limited and secured.
12. Vorrichtung nach Anspruch 11, dadurch gekennzeichnet, dass die Hohlzylinder (19) aus einem, unter der Wirkung des in das Schraubenloch (2) eingeschraubten und verspreizten Kopfes (7) der Knochenschraube (3), deformierbaren Material, vorzugsweise aus einem Kunststoff, bestehen.12. The device according to claim 11, characterized in that the hollow cylinder (19) from a, under the action of the screwed into the screw hole (2) and spread head (7) of the bone screw (3), deformable material, preferably made of a plastic, consist.
13. Vorrichtung nach Anspruch 11 oder 12, dadurch gekennzeichnet, dass die Mantelfläche (22) der Hohlzylinder (19) in der unteren der Knochenkontaktfläche (4) benachbarten Zone, oder der oberen dem Rand (21) benachbarten Zone, einen oder mehrere Schlitze (23) aufweist und vorzugsweise im Durchmesser gegenüber der zylindrischen Bohrung (20) der Osteosyntheseplatte (1) unterdimensioniert ist.13. The apparatus of claim 11 or 12, characterized in that the outer surface (22) of the hollow cylinder (19) in the lower zone adjacent to the bone contact surface (4), or the upper zone adjacent to the edge (21), one or more slots ( 23) and is preferably undersized in diameter compared to the cylindrical bore (20) of the osteosynthesis plate (1).
14. Vorrichtung nach einem der Ansprüche 1 bis 13, dadurch gekennzeichnet, dass die Osteosyntheseplatte (1) im wesentlichen keine planaren Oberflächenpartien aufweist und dass das zwischen den Schraubenlöchern (2) liegende Profil (17) vorzugsweise allseitig verjüngt ist.14. Device according to one of claims 1 to 13, characterized in that the osteosynthesis plate (1) has essentially no planar surface portions and that the profile (17) lying between the screw holes (2) is preferably tapered on all sides.
15. Vorrichtung nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, dass das Biegemoment des zwischen den Schraubenlöchern (2) liegenden Profils (17) kleiner oder gleich gross ist wie dasjenige des durch die Schraubenlöcher (2) verlaufenden Profils.15. Device according to one of claims 1 to 14, characterized in that the bending moment of the profile (17) lying between the screw holes (2) is smaller than or equal to that of the profile running through the screw holes (2).
16. Vorrichtung nach einem der Ansprüche 1 bis 15, dadurch gekennzeichnet, dass die Osteosyntheseplatte (1) folgende Dimensionen aufweist: - in Richtung der Achse (24) der Schraubenlöcher (2) eine Ausdehnung von mindestens 1,1 mm, vorzugsweise mindestens 1,5 mm; - eine Breite von 4 - 7 mm, vorzugsweise von 5 - 6 mm ; und - einen Durchmesser der Schraubenlöcher (2) von 0,9 - 1,6 mm, vorzugsweise von 1,1 - 1,4 mm.16. Device according to one of claims 1 to 15, characterized in that the osteosynthesis plate (1) has the following dimensions: - In the direction of the axis (24) of the screw holes (2) an expansion of at least 1.1 mm, preferably at least 1.5 mm; - A width of 4-7 mm, preferably 5-6 mm; and - a diameter of the screw holes (2) of 0.9-1.6 mm, preferably of 1.1-1.4 mm.
17. Vorrichtung nach einem der Ansprüche 1 bis 16, dadurch gekennzeichnet, dass der Kopf (7) der Knochenschrauben (3) Längsschlitze (10) aufweist und eine mit einem Innengewinde (13) versehene Bohrung (25) aufweist, in welche eine Spreizschraube (11) mit entsprechendem Aussengewinde (14) einschraubbar ist, wobei die beiden Gewinde (13,14) mindestens im oberen, von der Knochenkσntaktfläche (4) abgewandten Teil durchgehend ausgebildet sind.17. Device according to one of claims 1 to 16, characterized in that the head (7) of the bone screws (3) has longitudinal slots (10) and has a bore (25) provided with an internal thread (13) into which an expansion screw ( 11) can be screwed in with a corresponding external thread (14), the two threads (13, 14) being formed continuously at least in the upper part facing away from the bone contact surface (4).
18. Vorrichtung nach einem der Ansprüche 1 bis 17, dadurch gekennzeichnet, dass die Bohrwandung (8) der Schraubenlöcher (2) in Richtung der unteren der Knochenkontaktfläche (4) zugewandten Zone konisch verjüngt ausgebildet ist.18. Device according to one of claims 1 to 17, characterized in that the drilling wall (8) of the screw holes (2) is conically tapered in the direction of the lower zone facing the bone contact surface (4).
19. Vorrichtung nach Anspruch 18, dadurch gekennzeichnet, dass der Konuswinkel ß der Bohrwandung (8) zwischen 2-6°, vorzugsweise zwischen 3 und 5° liegt.19. The apparatus according to claim 18, characterized in that the cone angle β of the drilling wall (8) is between 2-6 °, preferably between 3 and 5 °.
20. Vorrichtung nach einem der Ansprüche 1 bis 19, dadurch gekennzeichnet, dass mindestens die Osteosyntheseplatte (1) im wesentlihhen aus Reintitan besteht und vorzugsweise derart dimensioniert ist, dass sie mit den üblichen chirurgischen Instrumenten durch manuelle Deformation an die Knochenanatomie anpassbar ist.20. Device according to one of claims 1 to 19, characterized in that at least the osteosynthesis plate (1) consists essentially of pure titanium and preferably such is dimensioned such that it can be adapted to the bone anatomy by means of manual deformation using the usual surgical instruments.
21. Vorrichtung nach einem der Ansprüche 1 bis 20, dadurch gekennzeichnet, dass das Verhältnis von makroskopischer Oberfläche MAO zu Volumen V des im Knochen zu verankernden Teils der Knochenschrauben (3) MAO/V im Bereich von 1 - 5 mm, vorzugsweise von 3,5 bis 4,25 mm liegt und dass das Verhältnis von mikroskopischer Oberfläche MIO zu Volumen V des im Knochen zu verankernden Teils der Knochenschrauben (3) MIO/V im Bereich von 15 - 35 mm, vorzugsweise von 20 - 30 mm liegt.21. Device according to one of claims 1 to 20, characterized in that the ratio of macroscopic surface MAO to volume V of the part of the bone screws (3) to be anchored in the bone MAO / V in the range of 1-5 mm, preferably of 3, 5 to 4.25 mm and that the ratio of the microscopic surface MIO to the volume V of the part of the bone screws (3) MIO / V to be anchored in the bone is in the range of 15-35 mm, preferably 20-30 mm.
22. Vorrichtung nach einem der Ansprüche 1 bis 21, dadurch gekennzeichnet, dass die bioinerte poröse Schicht eine Dicke von 0,01 - 0,50 mm, vorzugsweise von 0,03 - 0.05 mm aufweist.22. Device according to one of claims 1 to 21, characterized in that the bio-inert porous layer has a thickness of 0.01-0.50 mm, preferably 0.03-0.05 mm.
23. Verfahren zur Herstellung der Vorrichtung nach einem der Ansprüche 1 bis 22, dadurch gekennzeichnet, dass die bioinerte, poröse Schicht (15) durch Sandstrahlen erzielt wird.23. A method for producing the device according to one of claims 1 to 22, characterized in that the bio-inert, porous layer (15) is achieved by sandblasting.
24. Verfahren zur Herstellung der Vorrichtung nach einem der Ansprüche 1 bis 22, dadurch gekennzeichnet, dass die bioinerte, poröse Schicht (16) durch ein Plasmasprayverfahren aufgebracht wird. 24. A method for producing the device according to one of claims 1 to 22, characterized in that the bio-inert, porous layer (16) is applied by a plasma spray process.
PCT/CH1987/000158 1986-11-25 1987-11-25 Osteosynthetic device WO1988003781A1 (en)

Applications Claiming Priority (4)

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CH4707/86-0 1986-11-25
CH470786A CH669105A5 (en) 1986-11-25 1986-11-25 Inner osteosynthesis fastener with bone screws
CH353/87-0 1987-02-02
CH35387A CH672245A5 (en) 1987-02-02 1987-02-02 Inner osteosynthesis fastener with bone screws

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