WO1988003781A1 - Osteosynthetic device - Google Patents

Osteosynthetic device

Info

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
Grant status
Application
Patent type
Prior art keywords
bone
characterized
preferably
screw
device according
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

Links

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
    • A61B17/86Threaded wires, pins or screws; 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
    • A61B17/86Threaded wires, pins or screws; 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 and/or bone-contacting surfaces, e.g. coating for improving bone ingrowth

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

osteosynthesis DEVICE

The invention relates to an osteosynthesis device, in particular an internal fixator consisting of an osteosynthesis plate with at least two screw holes and can be inserted therein bone screws.

Fixation devices for osteosynthesis have been known for a long time. However, most systems do not allow rigid, functionally stable fixation between the head of the bone screw and the osteosynthesis plate, which often has a bone at the contact surface between the osteosynthesis plate and bone resulted with subsequent instability and loosening. In others, rigid systems, the relative position of the plate and screws can not will vary.

The invention aims to provide a remedy. The invention has for its object to combine the advantages of an external fixator with those of the internal plate fixation and to achieve a long-term functionally stable anchoring of the implant, wherein the axial position of the bone screw relative to the osteosynthesis plate in a wider range can be variable.

The invention solves the problem with a device having the features of claim 1. The advantages achieved by the invention are to be seen essentially in the fact that due to the inventive device, firstly, the stability of the implant with the investment period and the load increases and secondly the stability of the fixation is no longer by the pressing of the plate to the bone, but by the rigid fixation of the screw can be achieved to the plate. Additional advantages arise because of the rotatability of the screw head, which reduces the demands on the directional accuracy of the holes for bone screws. An additional advantage is obtained if the bone contact areas of the inventive device are provided with a bio-inert, porous layer, because then formed on the contact surface between the bone and the implant surface, a direct, release layer-free bond.

Exemplary embodiments of the invention, which also illustrate the principle of operation, are shown in the drawings and will be described in more detail below.

Fig. 1 shows a longitudinal section through an inventive

Internal fixator group;

Fig. 2 represents a cross section along the line II-II in Figure 1;

Fig. 3 represents a side elevation view of the osteosynthesis plate of the inventive device;

Fig. 4 illustrates a top view of the osteosynthesis plate;

Fig. 5 illustrates a plane parallel to figure 2 section, but at the height of a bone screw is; Fig. 6 shows the screw head in Figure 5, with the preferred continuously decreasing cross-section, on an enlarged scale;

Fig. 7 illustrates a top view of the screw head of Figure 6;

Fig. 8 shows a cross section through the particular for the Knoσhenkontakt bioinert porous surface of the osteosynthesis plate, or the bone screw is hollow;

Fig. 9 represents the equilibrium diagram for the binary mixture

O-Ti represents;

Fig. 10 illustrates the equilibrium diagram for the binary mixture

N-Ti is.

Fig. 11 illustrates a perspective view of two with an inventive apparatus connected osteosynthetisehen

Parts of a lower jaw group;

Figure 12 shows a longitudinal section through the osteosynthesis plate according to figure 11 represents;

Fig. 13 is presented a perspective view of serving as an insert, slotted hollow cylinder;

Fig. 14 shows a cross section analogous to FIG 5 illustrates a

Hollow cylinder according to Figure 13;

Fig. 15 illustrates a cross-section similar to Figure 5 is without

Hohlzyl Indian according to Figure 13;

Fig. 16 shows a cross section through an inventive

Device with a cylindrical screw head, and a

Expansion screw with a conical external thread group;

Fig. 17 shows a cross section through an inventive

Device with a cylindrical screw head, and a

Expansion screw with a smooth outer cone group; Fig. 18 illustrates a partial cross section through an inventive apparatus with an additional, non-expandable bone screw;

Fig. 19 illustrates the inventive device according to FIG. 18 illustrates, where, not expandable, the head of the additional

Bone screw is shown in cross section;

Fig. 20 illustrates a partial cross section through an inventive device with a slotted ball screw head group;

Fig. 21 shows further details of the expansion screw according to FIG 20 in cross section.

Fig. 22-25 show various cross-sections through the screw holes of devices according to the invention;

Fig. 26 shows a cross section through an inventive

Device with a slotted screw head in a ball

Screw hole in accordance with FIG. 24;

Fig. 27 shows a cross section through an inventive

Device with a slotted screw head in a ball

Screw hole in accordance with FIG. 25;

Fig. 28 illustrates a partial cross section through an inventive device with a conical plate hole and a ball-layered screw head;

Fig. 29 shows the inventive device according to FIG. 28 illustrates a relation to the vertical inclined screw axis.

1 shows various aspects of a fixation device according to the invention are shown internal. In the bolt holes 2 of the osteosynthesis plate 1, the bone screws 3, as shown in the second screw hole of left, screwed by its shank 9 in the bone. 4 The screw head 7 is shown in Figures 6 and 7 with longitudinal slots 10 and provided a bore 25, so that the as expander configured with an external thread 14 insert 11 can be screwed in the provided with an internal thread 13 of hole 25 by expansion of the screw head. 7 The screwing is conveniently effected by means of an engaging into the longitudinal slots 12 of the insert 11 instrument. Here, the convex lateral surface 18 of the screw head 7 with the concave wall of the bore 8 of the screw hole 2, whereby a very rigid connection between the osteosynthesis plate 1 and the screw 3 results in wedged. Since the bore diameter d of the bolt holes 2 in the lower bone contact surface 4 adjacent zone decreases continuously results in a cross-sectional constriction 5 serving as an axial stop 6 for the head 7 of the bone screw. 3 Owing to the spherical design of the wall of the bore 8 and the lateral surface 18 of the screw head can assume a variable position within certain limits in the screw hole. 2 In the second screw hole from the right in Figure 1, such a case is shown in which the screw axis with respect to the screw is inclined Iochachse 24th

As the figures 2 to 4 show, the osteosynthesis plate 1 substantially no planar surface parts on. The lying between the bolt holes 2 profile 17 on all sides is tapered and thus allows for easier deformation of the osteosynthesis plate on the occasion of its adaptation to the bone surface 4. Preferably, the bending moment of the lying between the bolt holes 2 profile 17 is smaller or the same size as that of through the bolt holes 2 extending profile.

The concave configuration of the wall of the bore 8 can either, as shown in Figures 1, 5 and 15 can be realized by appropriate shaping of the bolt holes 2 or, as shown in Figures 13 and 14, by insertion of an appropriately configured hollow cylinder 19 into the cylindrical bore 20 of the osteosynthesis plate 1, wherein the axial insertion of the hollow cylinder is limited by a comparison with the diameter of the bore 20 the oversized edge of 21 19 and secured.

The hollow cylinder 19 may (HMPE), made either of metal, for example titanium or of a, under the effect of which is screwed into the screw hole 2 and verspreizten head 7 of the bone screw 3, deformable material, for example a plastic such as polyethylene. The circumferential surface 22 of the hollow cylinder 19 has, as shown in Figure 13, 4 adjacent zone in the bottom of the bone-contacting surface one or more slots 23 and is slightly undersized diameter than the cylindrical bore 20 of the osteosynthesis plate. 1 However, the slots 23 can also be mounted in the upper edge 21 of the adjacent zone. The actual surgical technique will be explained with reference to FIG. 11 In Figure 11, a lower jaw 4 is shown, from which a piece had to be due to a tumor resected. In this case, the lower jaw 4b was separated into two parts 4a,. The two parts 4a, 4b are connected by an osteosynthesis plate 1 together, which is provided with a solid core shaft 9 having bone screws 3 through the Sσhraubenlöcher 2 with the bone 4 can be screwed, with the existing pure titanium osteosynthesis plate 1 is bent manually with the usual surgical instruments and to the bone relief can be adapted. 4 The osteosynthesis plate 1 has substantially no planar surface parts and the profile 17 lies between the bolt holes 2 is tapered on all sides. The attachment of the holes in the bone for the bone screws 4 3 takes place according to the conventional surgical techniques, conveniently using a jig. As is apparent from Figure 12, the Schraubenloσh 2 in the direction of the bone-contacting surface 4 is a cross-sectional constriction 5 which is designed as a stop 6 for the bone screw 3, and an exact axial positioning and securing allowed.

As seen in Figure 7, the screwing of the bone screw 3 can be effected by means of an engaging into the longitudinal slots 10 and bore 25 of the screw head 7 instrument. After the osteosynthesis plate has been screwed 1 having a sufficient number of bolts 3 to the bone 4, the screwing of the conical threaded expansion pin 11 having on the outer, larger end of longitudinal slots 12, for receiving the Eindrehinstrumentes (screwdriver) are effected. The preferably conical internal thread 13 of the screw head 7 corresponds to the external thread 14 of the insert 11. By screwing the inserts 11 are spread apart and clamping is carried out of the longitudinally slotted screw head 7 against the inner wall 8 of the screw hole 2 which results in a very rigid connection between the osteosynthesis plate 1 and screw 3 is obtained.

After fixation the osteosynthesis plate 1 can be removed again, wherein first, the inserts are screwed out 11 and then the bone screws. 3

In the use of the inventive internal fixator for

Fixing an implant, particularly a joint endoprosthesis, such as a temporomandibular joint prosthesis remain the bone screws 3 and the osteosynthesis plate 1, to which is then followed by the implant, permanently in the body of

Patients.

The bone screws 3 may be used for long-term implants, such as shown in Figure 14 and 15 may be formed as a hollow screw 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, comprise a bio-inert, porous layer sixteenth This porous layer may be either as shown in Figure 8, are made of titanium or alloys thereof, which is applied by a plasma spray or similar methods or by sand blasting, for example, alumina particles can be produced. And electrolytic surface treatment or the coating with ceramic (apatite) are to be designed suitable means the surface of bone-friendly.

As important for the desired success has the achievement of a titanium porous layer with an adhesive strength of at least 9.5 kgf / mm 2, preferably of at least proved to 12.0 kgf / mm 2 on the preferably metallic substrate. With the latest methods may even adhesive strengths of at least 20 kgf / mm 2, preferably made of at least 40 kgf / mm 2. A suitable method for achieving such a bond strengths is the plasma flame method, but other chemical methods are suitable.

The coating of the inventive internal fixation with the bioinert porous layer may, for example, by spraying of titanium powder having a particle size distribution of about 0,05 - 0,1 mm in a flowing high pressure gas mixture of nitrogen and hydrogen in an electric arc at a temperature of 15 ' carried 000 to 20,000 ° C. In this method, supplied in an inert gas carrier, for example argon Titanhydridpartikel reach within the 15 to 20 cm long acceleration section, a speed of about 600 m / s with which they impinge on the metal to be coated surface, where, depending on the duration of the operation, a 0.01 - 0.50 mm, preferably 0.03 - 0.06mm thick, bioinert, form porous layer.

Conveniently, the coating is carried out such that the resulting pores have a diameter of about 30-200 μ, preferably about 40 - 70 μ have.

The various internal needed depending on the use of the inventive fixator variations in coating quality can be obtained by controlling the process parameters, but a plasma enthalpy of about 20 million joules / kg should be maintained. For the bio-inert properties of the coating and their chemical composition is important. An advantageous such porous surface layers have been found which, in addition to the base material (titanium, Ti-6Al-4V, etc.) has a carbon content of less than 0.5% (preferably less than 0.3%), a nitrogen content of less than 4% ( preferably less than 3%) and an oxygen content between 8 - 10% have (all figures are in wt%)..

The titanium in the titanium plasma layer is conveniently effected at least in the form of hexagonal coordinated α-Ti and the cubic coordinated 6-TiO and 5-TiN before, preferably with a proportion of 76 - by weight 87% of hexagonal coordinated α-Ti.. The respective phases of the two equilibrium diagrams illustrated 9 and 10 for the binary alloys Ti-O in the figures (Fig 9; Source: THSchofield and AEBacon, J .Inst Metals, 1955/6 84.47...) (And N-Ti Figure 10. source:... Pally AE et al Trans.Amer -Soc.Met, 1954, 46, 312) can be seen. Instead of the preferred material described in Example (titanium) may also be used other bioinert materials such as titanium alloys, zirconium, Siob, tantalum or platinum.

For applications which require the complete removability of the bone screws 3, it is also possible to form it as a solid core screws and to polish at least those surfaces of the bone screws 3 which are intended for contact with the bone 4 smooth. After fixation the osteosynthesis plate 1 can be removed again, wherein first the inserts 11 are screwed out and then the bone screws 3. Internal In the use of the inventive fixation device for the fixation of an implant, in particular a joint prosthesis such as a temporomandibular joint prosthesis remain the bone screws 3 and the osteosynthesis plate 1 to which then connects the implant permanently in the body of the patient.

As osteosynthesis plate 1 for the fixator according to the invention are also internal bioinert, preferably reinforced plastic materials used, for example in the form of deformable polymerizable composite structures as they are 428 / 86-1 described in the Swiss patent application no. 03. The inventive internal fixator is particularly useful in maxillofacial surgery and for fixing of Endogelenkprothesen and vertebral disks. For the attachment of the present invention, internal fixation in the central face, cheekbone and the calotte (Neurosurgery), and for facial corrections to osteosynthesis plates have been found with standard dimensions to be unsuitable. Be particularly advantageous for these purposes osteosynthesis plates 1 have been found which have the following dimensions:

- in the direction of the axis 24 of the screw holes 2 an extension 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 bolt holes 2 from 0.9 to 1.6 mm, preferably from 1.1 - 1.4 mm. Since these small dimensions (mini-plates) of the screw head 7 to be used bone screws 3 is also very small, the two threads 13,14 at least in the top, facing away from the bone contact surface 4 part are formed continuously so that immediately upon screwing the insert 11 a bracer is carried out of the head. 7

In particular, in this mini-plates, but also in normal-sized plates, a shape of the screw head has been found to 7 according to Figure 6 to be particularly practical. The mantle surface 18 of the head 7 is designed increasingly convex only in the bottom of the bone contact surface 4 adjacent zone, whereas the upper part practically terminates in a cylindrical shape. Together with a correspondingly configured bore wall 8 of the Sehraubenlochs 2 gives optimum sicheine, rigid and functionally stable connection between the osteosynthesis plate 1 and bone screw. 3

A further variant of the bolt head 7 is shown in FIG sixteenth The cylindrically shaped screw head 7 fit into the corresponding cylindrical section of the bore wall 8 of the screw hole 2. The power transmission is made between the screw head 7 and designed as a tapering axial stop 6 in the bore 2 of the osteosynthesis plate 1 instead. Other variants of this print run are shown in Figures 22 - represented the 24th The advantage of these variants is the maxiamalen lateral and axial load.

The insert 11 is formed as a conical expansion screw with an external thread 14 which matches the internal thread 13 of the screw head 7 provided with longitudinal slots 10th The variant of the screw head 7 shown in Figure 17 largely corresponds to the embodiment according to Figure 16 with the exception of the insert 11, which is designed here as a cone with a smooth lateral surface 27, which in the means of the cylindrical helical extension 28 with the likewise smooth casing fold 26 of the conical bore 25 screw head 7 can be clamped.

As shown in Figures 18 and 19 it is also possible, in the screw hole 2 of an inventive osteosynthesis plate 1, and in Fig 22 - 24 variants shown from introducing regular or so-called standard bone screws. 3. Although no bracer normal screw head held 29 it is thus possible to mount, for example, additional bone fragments.

The variant of a slotted ball screw head 7 shown in Figures 20 and 21 has a further important advantage consists in that, besides the rigid and releasable connection between the bone screw 3 and osteosynthesis plate 1, a tilt of the screw axis 30 by the angle α of up to 30 ° is possible for the screw hole axis 24th In each position of the bolt 3 within the 60 ° cone amount ends 24,30, provided with longitudinal slots 10 Kugelsehraubenkopf 7 can be braced by means of the expansion screw formed as insert 11 and are fixed rigidly. Figures 22 to 25 show variants according to the invention the screw hole bores 2 with various embodiments of the annular Verjüngspartie 6. In Figure 22, this consists of a step-shaped shoulder 31 which adjoins the cylindrical portion of the bore wall 8; against the bone contact surface towards the bore 2 then expands again. Figure 23 shows a variant of the embodiment according to Figure 22, which consists in that the stepped taper 6 is inclined downwards. 24 shows a view analogous to Figure 5 screw hole bore 2 is shown which, however, widens again at the bottom side facing the bone portion. Finally, a spherically shaped borehole wall 8 is shown in Figure 25, which is in accordance with particular for ball screw heads 7 Figures 26 and 27 is suitable.

Dia in the figures variants shown 25 and 27 substantially correspond to the embodiment shown in Figure 21, but with a screw hole 2 as shown in FIG 24, or 25 and a formed as a conical bolt insert 11. The slots 10 of the screw spherical head 7 are cross-slotted and so deep milled, that although a sufficient mechanical strength is present, the ball screw head 7, however, in one of the various screw holes can be 22 to 25 pressing easily intercepted 2 according to FIGS. In this embodiment also, an axial deviation of the screw axis is up to 30 ° are possible in addition to a rigid anchor. As additional advantage the possibility of an inevitable forward and backward movement of the screw-plate connection is to be considered. The variant shown in Figures 27 and 28 shows an osteosynthesis plate 1 having an opening formed as a conical borehole wall 8 of the hole 2, the cone angle β between 2-6 °, is preferably between 3 and 5 ° and is for example 4 °. The intended for this hole 2 screw 3 includes a head 7 is substantially designed as a spherical segment with slots 10 into which an expansion screw 7 is screwed. Due to the internal shape of the borehole wall 8 and the outer shape of the bolt head 7 is a deviation of the screw axis 30 α with respect to the hole axis 24 possible around the angle while maintaining good support, which considerably extends the application range of the inventive device.

Claims

claims
1. An osteosynthetic device, in particular internal fixator consisting of an osteosynthesis plate (1) with at least two screw holes (2) and can be inserted therein bone screws (3), characterized in that the screw holes (2) at least in the bottom of the bone contact surface (4) adjacent zone a have cross-sectional constriction (5) and that at least two bone screws (3) have a spreadable screw head (7) which is clamped against the inner wall (8) of the screw holes (2), so that a rigid connection between the bone screws through the bracer (3) and osteosynthesis plate (1) can be realized.
2. Device according to claim 1, characterized in that the bore wall (8) of the screw holes (2) at least in the bottom of the bone contact surface (4) adjacent zone has a concave surface and the head (7) of the bone screws (3) has a convex, on the has concave surface (8) tuned lateral surface (18).
3. Device according to claim 1, characterized in that the cross-sectional constriction (5) (7) of the bone screw (3) is provided as a stop (6) for the head is formed, preferably in the form of a gradation.
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), a bio-inert, porous layer (16) which is preferably made of titanium or alloys thereof.
5. Device according to one of claims 1 to 4, characterized in that the bone screws (3) are formed as a hollow screw and at least those surfaces of the bone screws (3) which are intended for contact with the bone (4), a bioinert, porous layer (16) which is preferably made of titanium or its alloys.
6. The device according to claim 4 or 5, characterized in that the, preferably made of titanium layer (15) has an adhesive strength on the, preferably consisting of titanium substrate (15) of at least 9.5 kgf / mm 2, preferably of at least 12.0 kp / mm 2.
7. Apparatus according to claim 6, characterized by at least 20 kgf / mm 2, preferably of at least 40 kgf / mm 2 in that the, preferably made of titanium layer (16) has an adhesive strength on the, preferably consisting of titanium substrate (15).
8. Device according to one of claims 4 to 7, characterized in that the titanium in the layer (16) is present at least in the form of the hexagonal α-coordinated Ti and coordinated cubic 6-TiN TiO and 5, preferably with a proportion of 76 - 87% by weight of the hexagonal α-coordinated Ti..
9. Device according to one of claims 1 to 3, characterized in that the bone screws (3) are designed as solid-core coil and at least those surfaces of the bone screws (3) which are intended for contact with the bone (4), are polished ,
10. Device according to one of claims 1 to 9, characterized in that the Bohrungsdurchiaesser d of the bolt holes (2) at least in the bottom of the bone contact surface (4) adjacent zone continuously, preferably in an increasing degree decreases and the thus formed cross-sectional constriction (5) serves as an axial stop (6) for the head of the bone screw (3).
11. Device according to one of claims 1 to 10, characterized in that a concave surface having bore wall (8) of the screw holes (2) by inserting correspondingly designed hollow cylinder (19) in a preferably cylindrical bores (20) of the osteosynthesis plate realized (1) is, the axial insertion of the hollow cylinder (19), preferably via a comparison with the diameter of the bores
(20} oversized edge (21) is limited and secured.
12. The device according to claim 11, characterized in that the hollow cylinder (19) from a, screwed under the action of the screw hole (2) and verspreizten head (7) of the bone screw (3), deformable material, preferably of a plastic, consist.
13. The apparatus of claim 11 or 12, characterized in that the outer surface (22) of the hollow cylinder (19) in the bottom of the bone contact surface (4) adjacent zone, or the top of the edge (21) adjacent zone, one or more slots ( 23), and preferably in diameter than the cylindrical bore (20) of the osteosynthesis plate (1) is undersized.
14. Device according to one of claims 1 to 13, characterized in that the osteosynthesis plate (1) having substantially no planar surface parts and that between the bolt holes (2) lying profile (17) is preferably tapered sides.
15. Device according to one of claims 1 to 14, characterized in that the bending moment of the between the screw holes (2) lying profile (17) is less than or the same size as that of through the screw holes (2) extending profile.
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 extension 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 from 1.1 - 1.4 mm.
having 17. Device according to one of claims 1 to 16, characterized in that and said head (7) of the bone screws (3) longitudinal slots (10) with an internal thread (13) provided with hole (25) into which an expansion screw ( 11) (with a corresponding external thread 14) can be screwed, wherein the two threads (13,14)) facing away part are continuous at least in the upper (from the Knochenkσntaktfläche. 4
18. Device according to one of claims 1 to 17, characterized in that the bore wall (8) of the screw holes (2) in the direction of the bottom of the bone contact surface (4) facing zone is formed tapered.
19. The apparatus according to claim 18, characterized in that the cone angle ß of the bore wall (8) between 2-6 °, is preferably between 3 and 5 °.
20. Device according to one of claims 1 to 19, characterized in that at least the osteosynthesis plate (1) consists wesentlihhen made of pure titanium, and is preferably dimensioned such that it is adjustable by manual deformation to the bone anatomy with the usual surgical instruments.
21. Device according to one of claims 1 to 20, characterized in that the ratio of macroscopic surface MAO to volume V of the bone part to be anchored to the bone screws (3) MAO / V in the range 1 - 5 mm, preferably 3, 5 to 4.25 mm, and that the ratio of microscopic surface MIO to volume V of the bone part to be anchored to the bone screws (3) MIO / V in the range 15-35 mm, preferably 20-30 mm.
22. Device according to one of claims 1 to 21, characterized in that the bio-inert porous layer of a thickness of 0.01 - 0.50 mm, preferably from 0.03 - having 0.05mm.
23. The method for manufacturing the device according to any one of claims 1 to 22, characterized in that the bio-inert, porous layer (15) is achieved by sandblasting.
24. The method for manufacturing the device according to any 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)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CH470786 1986-11-25
CH4707/86-0 1986-11-25
CH35387 1987-02-02
CH353/87-0 1987-02-02

Publications (1)

Publication Number Publication Date
WO1988003781A1 true true WO1988003781A1 (en) 1988-06-02

Family

ID=25684311

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH1987/000158 WO1988003781A1 (en) 1986-11-25 1987-11-25 Osteosynthetic device

Country Status (3)

Country Link
EP (1) EP0293411A1 (en)
JP (1) JPH02500490A (en)
WO (1) WO1988003781A1 (en)

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JPH02500490A (en) 1990-02-22 application

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