Title of Invention	IMPLANTABLE OSTEOSYNTHESIS SET
Abstract	A set of at least two osteosynthesis plates (2g, h) is used for the implantation, anatomical repositioning and inner splinting of bone fragments, in particular following fractures of the distal humerus. The two claimed osteosynthesis plates (2g, h) are provided with bore holes (3a, b, c) arranged or designed in such a way that the bone screws (12) which extend through them are oriented in various directions in space and the bone mass of the splinted bone (1) is thus crossed by bone screws (12) more completely than in the past.

Title of Invention

IMPLANTABLE OSTEOSYNTHESIS SET

Abstract

A set of at least two osteosynthesis plates (2g, h) is used for the implantation, anatomical repositioning and inner splinting of bone fragments, in particular following fractures of the distal humerus. The two claimed osteosynthesis plates (2g, h) are provided with bore holes (3a, b, c) arranged or designed in such a way that the bone screws (12) which extend through them are oriented in various directions in space and the bone mass of the splinted bone (1) is thus crossed by bone screws (12) more completely than in the past.

Full Text	FORM 2 THE PATENT ACT 1970 (39 of 1970) & The Patents Rules, 2003 COMPLETE SPECIFICATION (See section 10 and rule 13) 1. SET OF OSTEOSYNTHESIS PLATES 2. (A) SYNTHES GMBH (B) Switzerland (C) Elimattstrasse 3 CH-4436 Oberdorf Switzerland The following specification particularly describes the invention and the manner in which it is to be performed. 1 The invention relates to an osteosynthesis set comprising at least one first and at least one second osteosynthesis plate having altogether at least four drilled holes for bone screws. Osteosynthesis plates for implantation, anatomical reduction and internal splinting of bone fragments after fractures are widely known. A bone plate for osteosynthesis could be of a general type, which means that the bone plate is not adapted to a certain anatomical position, or it might be of a specific type, which means that the properties of the bone plate have been adapted in order to correspond to a specific type of an anatomical position. For the elbow or distal humerus, various solutions have been offered to date {cf. fig. 1 to 5); 1) System comprising different plates for an osteosynthesis of a type which is not anatomically specific. These plates were produced for arbitrary anatomical circumstances and may therefore also fit on the distal humerus. These bone plates must be shaped during the operation in order to be adapted to the anatomy of their final anatomical destination, in this case to the shape of the distal humerus. 2) Systems of two osteosynthesis plates cooperating on one bone, one of the plates, the medial or the lateral one, having been anatomically pre-shaped in order to fit the medial or the lateral column 2 of the distal humerus. The other plate is of a type which is not anatomically specific and has to be shaped during the operation in order to fit in its position in the distal humerus. 3) Two-plate systems, one of the plates being pre-shaped in order to fit the anatomy of the lateral arch of the distal humerus, and the other plate being pre-shaped in order to fit the medial ridge of the distal humerus, in positions virtually parallel to one another. These plates require no deformations or only a few deformation during the operation. Bone screws which are introduced through one of the plates come into contact at an obtuse angle with the bone screws which were introduced through the other plate, which is referred to as so-called distal locking of the screws. 4) Two-bone plate systems, one of the bone plates being pre-shaped in order to fit the anatomy of the dorsal aspect of the lateral part, and the other bone plate being pre-shaped in order to fit the medial ridge of the distal humerus and the two plates being fixed on the humerus in positions almost perpendicular to one another. These plates require no deformation or limited deformations during the operation. Bone screws which are introduced through one of the plates come into contact at an acute angle with the bone screws which were introduced through the other plate. 5) Two-bone plate systems as under 4); in addition, 3 the plate extends not only distally but also laterally in the most remote distal region of the lateral osteosynthesis plate, said plate having a hole there. Through this hole, a bone screw will come into contact with the bone screws which arrive from the medial plate, at an obtuse angle. In contrast to other methods, such as simply encasing in plaster, screwing with bone screws or bandaging with wires, osteosynthesis plates have the advantage of fixing a plurality of bone fragments and attaching them in a stable manner to the healthy tissue. In principle, all considerations in the production of osteosynthesis plates were based on the object of forming the shape of these osteosynthesis plates for the implantation on the bone so that anatomically correct positioning and fixing of the osteosynthesis plate without the necessity of changes on the bone and with substantial protection of soft tissue are achieved. The osteosynthesis plates therefore should not be bulky and should have various possibilities for fixing (a plurality of drilled holes). With the systems obtainable on the market, there are the following disadvantages. 1) Non-specific pre-shaping of the plates requires complicated bending of the plates, which may lead to a loss of mechanical stability of the plate osteosynthesis. Complicated adaptation of the plates is moreover time-consuming. Since the plates are not optimized for the distal humerus, a 4- lack of bone support and fixing points for the bone screws may result. 2) For stability reasons, a two-plate system was and is preferred for the distal humerus. With a plate which is shaped to fit a specific anatomical point, and a plate which requires adaptation to its position, the advantage of a system comprising two specially pre-shaped plates is, however, not achieved. 3) A disadvantage of a plate system having a parallel plate configuration is that it requires that all bone fragments lie approximately in a planar, relatively flat space between the two osteosynthesis plates or can be contacted there by inserted bone screws. If, however, bone fragments lie slightly outside this relatively narrow, planar space, they cannot be contacted by the known osteosynthesis plates or by the bone screws in the known osteosynthesis plates and held with reduction. Moreover, the inventors observed that the one-row osteosynthesis plate may have only extremely little stability to tilting out of the connecting axial plane of the holes. Accordingly, the possibility of loading the bone provided with the plate may therefore be greatly limited. 4) A right-angled plate arrangement ensures 5 stability to tilting but lacks the possibility for screw engagement at an obtuse angle between the bone screw which was introduced through the lateral plate and between the bone screws which were introduced through the medial plate. For very distally located fractures and for fractures in osteoporotic bone, the lack of the meeting of the screw directions at an obtuse angle, the so-called lack of amalgamation via the distal block, will reduce the retention of the bone plates in the bone and hence the stability of the osteosynthesis. 5) A combination of the right-angled plate configuration and a lateral plate form which permits an acute-angled screw engagement between the lateral bone screw which was introduced through the plate and the medial bone screws which were introduced through the plate is ideal for the stability and the retention, but the anatomy of the .distal humerus must be followed. The distal part of the plate which is laterally extended must not disturb the soft tissue and the function of the elbow. Systems which are on the market and correspond to this description may disadvantageously come to rest in the region of the points of action of the tendons and thus possibly disturb the function of the elbow. Moreover, the known 6 plates for osteosynthesis do not permit sufficient fixing by the distal block on the medial side. It is therefore an object of the invention to improve the known sets so that the osteosynthesis plates firstly have better retention on the bone and secondly a larger number of different bone fragments can be reliably repositioned relative to one another. This should take place in a manner which protects soft tissue. This object is achieved by the use of the features of Claims 1 or 29. The novel formation of the two osteosynthesis plates results in more complete penetration of the bone tissue with bone screws, so that better fixing of the bone fragments can be achieved even with fewer bone screws. Moreover, laterally located bone fragments can also be fixed, and overall substantially more stable and more rotationally rigid splinting is possible. The idea behind the solution according to the invention lies in the particular division of the bone screws which can be fixed in the osteosynthesis plates with respect to different spatial positions thereof in the mounted state. An osteosynthesis plate set according to the invention therefore makes it possible also to reduce more complicated fractures and in addition to transmit greater forces and moments from the beginning. Premature loosening of the osteosynthesis plates according to the invention is therefore prevented. The preferred formation in which the screws provided are 7 angle-stable supports this effect according to the invention. Further developments of the invention are described in the dependent claims. The following features produce the following additional effects: By means of a preferred version having altogether more than four drilled holes, for example altogether eight or ten drilled holes, as known per se, further improvements can be achieved if these drilled holes, viewed in two normal planes one on top of the other, with their bore axes facing the bone, make an acute angle with one another in each case, and there is, within the system, an intraoperative retention while these or others make obtuse angles with other bore axes or these bore axes. In the context of the invention, "make an angle" means not only touching or intersecting bore axes but in particular also bore axes which merely cross, but apparently intersect in the view of intersecting planes. A further improvement of the angle and tilt stability of osteosynthesis plates according to the invention results from the provision of at least two or at least three parallel rows of drilled holes or alternatively at least one row of drilled holes and at least one further drilled hole offset laterally therefrom. The drilled holes preferably lie along two parallel intersecting planes and additionally at least two further parallel intersecting planes normal to the first ones. Thus, the rotational and tilt stability is improved and moreover better utilization of the bone 8 tissue is possible which tissue tends to be stronger in the edge region than in the middle of the humerus. Preferably, the bone screws used according to the invention are not fixed only in the bone but also via a thread or partial thread in the holes of the osteosynthesis plate. This advantageously results in improved angle stability of the mounted osteosynthesis plates and reduces the dynamic load of the bone tissue in which the bone screw is anchored. In addition, this angle-stable design of the osteosynthesis plates according to the invention has the advantage that, even on loosening of one or other bone tissue in the region of one or other bone screw, the other bone screws can guarantee the angle stability of the osteosynthesis plate. By fixing the bone screws in the osteosynthesis plate, the contact pressure of the osteosynthesis plate on the bones is also reduced, which plays a role in helping to avoid pressure-related bone degradation in the tissue region. The embodiments of bone screws and drilled holes known per se can be provided. Methods in which the bone screws are angle-stabilized by an additional pressure screw inserted only into the osteosynthesis plate are in the view of the inventor preferred in that the osteosynthesis plate must have a relatively great thickness for this purpose and the manipulation with the additional, generally very small, flat screws is difficult under surgery conditions. A particular embodiment of a comparatively small further developed osteosynthesis plate according to the 9 invention is that, in its end region, it has a triangular end region when viewed medially. As a result of this shaping, this osteosynthesis plate can be laid into the outermost distal region of the distal humerus without hindering nerves, tendons or the like there. In a further developed form, the holes can also be designed so that bone screws can be screwed in and fixed in an angle-stable manner in any desired angular positions. Three drilled holes of at least one osteosynthesis plate preferably serve also for improving the angle stability, but also for improving the tilt stability, the three drilled holes together forming the apices of a preferably equilateral triangle. A further important, preferred development of osteosynthesis plates lies in the choice of forming at least one of the two osteosynthesis plates, when viewed in the medial direction, in a stem-like manner and with a tab-like part projecting therefrom so that this osteosynthesis plate appears- somewhat like a "P" in medial view. Since, according to the invention, both the stem-like and the tab-like parts carry drilled holes, particularly good angle stability is possible as a result of this design, but also particularly good fixing of a very wide range of bone fragments. In addition, this design permits so-called 90° mounting of the two osteosynthesis plates, in which the planes in which the respective bone screws lie are approximately perpendicular to one another, as proposed by AO. 10 In this embodiment, the bone screw axes of the two osteosynthesis plates intersect at about 90° - compared with the approximately 180° in the case of known systems which protect soft tissue. In the case of a curvature of the tab-like part, the anatomy of the distal humerus is better taken into account and in addition the possibility of using a very wide range of directions in space for the bone screws is facilitated. A combination of the osteosynthesis plates with the p-shaped, tab-like part and of the osteosynthesis plates with the triangular, distal region of the osteosynthesis plate has proved to be optimum. Firstly, little material is required and secondly the angle stability is improved or improved penetration of the bone fragments is possible. The two osteosynthesis plates are preferably mounted in such a way that the longer lateral edge of one osteosynthesis plate faces the tab-free lateral edge of the other osteosynthesis plate, so that the tab is on the radial or lateral side and the longer side of the osteosynthesis plate having the triangular section has a longer posterior edge than the length of the anterior edge. If the holes are formed in a keyhole-like manner, this results in the advantages which have been disclosed in the case of the LCP plate of the Applicant, or, for example, in WO-A-02096309 of the Applicant. Further developments and details of the invention are 11 disclosed in the description of the figures. Description of figures The figures are described in relation to one another and as a whole. Identical reference numerals denote identical components, and reference numerals with different indices indicate functionally identical components. Fig. 1 shows a prior art with non-specific implants; Fig. 2 shows another prior art with a specific and a non-specific plate; Fig. 3 shows another prior art with two specific plates mounted 180° relative to one another; Fig. 4 shows a range of plates from the prior art for osteosynthesis of the distal humerus; Fig. 5 shows a further prior art with two specific plates 90° to one another and a distal, laterally directed part, showing an obtuse angle of the screws projecting from the 90° plate relative to the screws of the other plate; fixing of the angular position of the screws is not envisaged; Fig. 6 shows a schematic diagram of the set of osteosynthesis plates 2g,h according to the invention in the positioned state; 12 Fig. 7 shows a schematic diagram of another set of osteosynthesis plates 2g,i according to the invention in the positioned state; Fig. 8 shows a schematic diagram of the osteosynthesis plate 2g according to Fig. 6 and 7 in plan view; Fig. 9 shows a schematic diagram of the osteosynthesis plate 2h according to Fig. 6 in plan view; Fig. 10 shows a schematic diagram of the osteosynthesis plates 2i according to Fig. 7 in plan view; Fig. 11 shows a schematic diagram of the osteosynthesis plates 2g,h in the positioned state, rotated somewhat in comparison with Fig. 6; Fig. 12 shows a schematic diagram of the osteosynthesis plates 2g,i in the positioned state, rotated somewhat in comparison with Fig. 7; Fig. 13 shows a schematic diagram of a single osteosynthesis plate 2g from the set in the positioned state, the osteosynthesis plate 2g having a triangular end region 7; Fig. 14 shows a schematic diagram of a single 13 osteosynthesis plate 2h from the set in the positioned state, the osteosynthesis plate 2h having a tab-like part 4 and being curved in a spoon-like manner at the end region; Fig. 15 shows a schematic diagram of a single osteosynthesis plate 2i from the set in the positioned state, the plate having a spoonlike end region; Fig. 16 shows a medial plate with trochlea support and flexible extension, for adaptation to bones, intraoperatively; Fig. 17 shows a dorsal view of a plate system comprising medial (without trochlea support) and lateral plate (with flange), right arm; Fig. 18 shows a frontal view of a system according to Fig. 17 and Fig. 19 shows a caudal view of a system according to Fig. 17. Fig. 1-5 show the solutions available today on the market. Fig. 3-5 show the latest solutions on the market: the prior art according to Acumed and Zimmer, while Fig. 6, 7, 11 and 12 show osteosynthesis plate sets 2g,h,i according to the invention in the positioned state. Fig. 8-9 show two different osteosynthesis plates 2g,h of a set according to the invention, and Fig. 10 shows 14 a variant 2i of the design according to Fig. 9 without a tab. Fig. 6 and 7 show various hole shapes 3a,b,c in the osteosynthesis plates 2h and 2i, and Fig.6, 7 and 11, 12 show the preferred position of the osteosynthesis plates 2g,h,i on the bone 1. As is evident from the diagrams in Fig. 6 and 11 drilled holes 3a,b,c lie along axes which intersect approximately at right angles with comparable axes of the drilled holes 3a,b,c of the respective other osteosynthesis plate 2h,g. In addition, further holes 3b which, owing to the tab-like curvature of the flange 4 are not parallel to the axes of the other holes 3a,b,c of the same osteosynthesis plate 2h are present in the region of the tab-like part 4. In the conceptual view of a set mounted according to the invention and having bone screws 12 according to Fig. 17-19, it is evident that these now no longer come to rest only before a narrow, planar region but penetrate the bone space in a very wide range of directions in space at acute and oblique angles relative to one another and are thus most suitable for reducing and for splinting differently positioned bone fragments. Fig. 8-10 and, in rudimentary form, Fig. 6-7 and 11-12 schematically show, in the region of the osteosynthesis plates 2g,h which are free of drilled holes, finger tip-like undercuts 8 which, as shown, are only thinner material parts or are completely eliminated (milled out) regions. These undercuts 8 serve for reducing disturbances of the plate on the bone by minimizing the 15 contact between bone and plate there. In addition the weight of the plate is reduced thereby. The different shapes of the drilled holes 3a,b,c known per se, such as slot-like holes 3a, keyhole-like combination holes 3c and round holes 3b, are also evident, at least some of the holes 3a,b,c according to the invention having an internal thread which cooperates with the bone screws 12 in an angle-stabilizing manner. Fig. 13-15 each show an osteosynthesis plate 2g,h,i according to the invention in the positioned state, Fig. 13 showing an osteosynthesis plate 2g having a triangular end region 7, Fig. 14 showing an osteosynthesis plate 2h having a tab-like part 4, which is curved and has a spoon-like end region and Fig. 15 showing an osteosynthesis plate 2i which has a spoonlike end region. 16 List of reference numerals 1 Bone 2g First osteosynthesis plate 2h Second osteosynthesis plate 2i Third osteosynthesis plate 2k Fourth osteosynthesis plate 3a Slot-like hole 3b Round hole 3c Locking-compression combination hole 3d Round hole 4 Tab-like part, flange 5 Stem-like part 6a Triangle 6b Triangle 7 Triangular end region 8 Undercuts 9 Central axis 10 Joint axis 11 Narrowed extension 12 Bone screw 17 We Claim:- 1. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) , in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles. 2. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) designed to be different from the first and having altogether at least four holes (3a,b,c) passing through the plate 18 surface for bone screws (12) which, in the implanted state, point in a plurality of directions in space, characterized in that the two osteosynthesis plates (2g,h,i) and/or the holes (3a,b,c) thereof are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles. 3. Implantable osteosynthesis set for the splinting and screwing of a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) designed to be different from the first and having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which, in the implanted state, point in a plurality of directions in space, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes (3a,b,c) thereof are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws 19 (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles. 4. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10), in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that at least one of the holes (3a,b,c) in one of the two osteosynthesis plates 20 (2g,h,i) and at least one threaded bore in this hole (3a,b,c) or the bone screw (12) intended therefor are formed in such a way they permit angle-stable anchoring in the bone (1) by virtue of the fact that the bone screws (12) which can be inserted into the threaded bore have a head thread for locking with the threaded bore. 5. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10), in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that at least one of the two osteosynthesis plates (2g,h) has an end region (7) which is triangular in plan view. 21 6. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) , in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that .at least three holes (3b) in at least one osteosynthesis plate (2g,h) form the apices of a - preferably equilateral - triangle (6b,a). 7. Osteosynthesis set according to any of Claims 1 to 3, 5 or 6 characterized in that at least one of the holes (3a,b,c) in one of the two osteosynthesis plates (2g,h,i) and at least one threaded bore in this hole (3a,b,c) or the bone screw (12) intended therefor are formed in such a way that they permit angle-stable 22 anchoring in the bone (1) by virtue of the fact that the bone screws (12) which can be inserted into the threaded bore have a head thread for locking with the threaded bore. 8. Osteosynthesis set according to Claim 7, characterized in that the angle of the angle-stable anchoring in at least one hole (3a,b,c) is selectable by virtue of the fact that no rigid thread is predetermined in the hole (3a,b,c) or at least two rigid threads differing from one another are predetermined. 9. Osteosynthesis set according to any of Claims 1 to 7, characterized in that each of the two osteosynthesis plates (2g,h,i) has at least one hole (3a,b,c), preferably at least two or three holes (3a,b,c), having a threaded bore for angle-stable anchoring in the bone. 10. Osteosynthesis set according to Claim 7 or 8, the threaded bore being oriented about one thread axis in each case, characterized in that at least 4 threaded bores are formed with their thread so that the angle between thread axis and plate surface or between thread axis and all tangents to the plate surface with common point of intersection at the thread axis is not equal to 90°. 11. Osteosynthesis set according to any of the preceding Claims, characterized in that at least two of the holes (3a,b,c) or at least two of the threaded bores have diameters differing from one another. 23 12. Osteosynthesis set according to any of the preceding Claims, comprising bone screws (12) which have a thread for the bone and a head thread, characterized in that the ratio of the diameter of the thread to that of the head thread is as small as possible so that the diameter of the threaded bore is only insignificantly larger than the diameter of the thread for the bone. 13. Set according to any of the preceding Claims, characterized in that more than four holes (3a,b,c) altogether are provided, and in that the four different directions in space make in each case an acute angle with the joint axis (10) , the angle being measured in each case in an observation plane parallel to the joint axis (10), so that directions in space which intersect but also cross the joint axis (10) are included therein. 14. Set according to any of the preceding Claims, characterized in that, in each osteosynthesis plate (2g,h) the holes(3a,b,c) lie along two parallel planes of intersection and additionally at least two further planes of intersection which are normal to the parallel ones, through each osteosynthesis plate (2g,h). 15. Set according to Claim 8, characterized in that the holes (3a,b,c) lie in at least three parallel planes of intersection and at least two planes of intersection normal thereto through each osteosynthesis plate (2g,h). 24 16. Set according to any of Claims 1 to 6, characterized in that at least one hole (3a,b,c) has a threaded bore or partly threaded bore which is formed for the cooperation with a thread on a bone screw (12) intended therefore. 17. Set according to Claim 15, characterized in that the bone screw (12) intended therefor has a threaded head, the thread of which is compatible with the threaded bore or partly threaded bore in the hole (3a,b,c). 18. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has an end region (7) which is triangular in plan view. 19. Set according to any of the preceding Claims, characterized in that at least three holes (3b) in at least one osteosynthesis plate (2g,h) form the apices of a - preferably equilateral - triangle (6b,a). 20. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has, in plan view, a stemlike part (5) and a tab-like part (4) projecting therefrom (p-shaped) , both the stem-like part (5) and the tab-like part (4) carrying holes (3a,b,c). 21. Set according to Claim 19, characterized in that the tab-like part (4) is curved. 22. Set according to any of the preceding Claims, 25 characterized in that the distal region of at least one of the two osteosynthesis plates is curved in spoonlike manner. 23. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has a thickness in the range of 1.7-2.7 mm, preferably 1.8-2.5 mm. 24. Set according to any of the preceding Claims, characterized in that the stem-like part (5) of at least one osteosynthesis plate (2g,h) is curved at least in a partial region, viewed in the direction of its central axis (9). 25. Set according to any of the preceding Claims, characterized in that at least one of the osteosynthesis plates (2g,h) has, at least in a partial region, a curvature running transversely to its central axis (9) , preferably having a radius of curvature in the range from 18 to 22 mm. 26. Set according to any of the preceding Claims, characterized in that at .least one of the two osteosynthesis plates (2g,h) has, over its total length, a curvature running transversely to the central axis (9) - preferably having different radii of curvature. 27. Set according to any of the preceding Claims, characterized in that, in at least one osteosynthesis plate (2g,h) , at least two holes (3a,b,c) lie in two planes which are approximately parallel to one another 26 and are at an angle different from 90° to the surface or a tangent to the surface of the osteosynthesis plates (2g,h) in the area of intersection with each plane. 28. Set according to any of the preceding Claims, characterized in that one osteosynthesis plate (2h) has the p-shaped, tab-like part (4) and the other osteosynthesis plate (2g) has the triangular end region (7). 29. Set according to any of the preceding Claims, characterized in that the two osteosynthesis plates (2g,h) having the triangular end region (7) or having the tab-like part (4) lie relative to one another in the position of use so that the longer lateral edge of one osteosynthesis plate (2g,h) faces the tab-free lateral edge of the other osteosynthesis plate (2h,g). 30. Set according to any of the preceding Claims, characterized in that at least one hole has a keyhole shape (3c). 31. Set according to any of the preceding Claims, characterized in that the thickness and/or width of at least one osteosynthesis plate (2g,h) in the hole-free region of this osteosynthesis plate (2g,h) is smaller than in the region of the holes (3a,b,c). 32. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has, at its end facing the joint axis (10), a narrowed extension (11) which has at 27 least one hole (3d) for a bone screw (12) and can be bent around the bone. 33. Set according to Claim 32, characterized in that the extension (11) comprises a plurality of holes (3d), the extension (11) being narrower between the regions with the holes (3d) than in the region of the holes (3a,b,c), so that bending for adaptation to the bone is possible also in the plane of the plate. 34. Set comprising at least two osteosynthesis plates (2g,h) and bone screws (12) for the osteosynthesis of a distal humerus with a joint axis (10) characterized by the combination of the following features: both osteosynthesis plates (2g,h) have an elongated extension along one - optionally curved - longitudinal axis each; both osteosynthesis plates (2g,h) each lie, in the implanted state, in a plane which is at least approximately perpendicular to the other plane; both osteosynthesis plates (2g,h) each have at least two holes (3a,b,c) which are arranged or formed • so that their axes have different directions in space; the bone screws (12) inserted in the implanted state into these holes (3a,b,c) intersect or cross the joint axis (10) at least almost parallel in the implanted state; at least one of the two osteosynthesis plates (2g,h) has at least one hole (3a,b,c) which is arranged or formed so that its axis or a bone screw (12) inserted therein intersects 28 or crosses the joint axis at least almost at right angles in the implanted state. 35. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region as claimed substantially as herein described with forgoing description and figures. Dated this 21st day of April 2006. Dr. Rajeshkumar H. Acharya Advocate & Patent Agent For and on Behalf of Applicant Abstract Set comprising at’ least two osteosynthesis plates (2g,h) for implantation, anatomical reduction and internal splinting of bone fragments, in particular after fractures of the distal humerus. The two osteosynthesis plates (2g,h) according to the invention are provided with drilled holes (3a,b,c) which are arranged or formed so that the bone screws (12) passing through them come to rest in different directions in space, so that bone screws (12) can pass more completely than in the past through the bone space of the splinted bone (1). (Fig. 11)

Full Text

FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. SET OF OSTEOSYNTHESIS PLATES
2. (A) SYNTHES GMBH
(B) Switzerland
(C) Elimattstrasse 3
CH-4436 Oberdorf
Switzerland
The following specification particularly describes the invention and the manner in which it is to be performed.
1

The invention relates to an osteosynthesis set comprising at least one first and at least one second osteosynthesis plate having altogether at least four drilled holes for bone screws.
Osteosynthesis plates for implantation, anatomical reduction and internal splinting of bone fragments after fractures are widely known. A bone plate for osteosynthesis could be of a general type, which means that the bone plate is not adapted to a certain anatomical position, or it might be of a specific type, which means that the properties of the bone plate have been adapted in order to correspond to a specific type of an anatomical position. For the elbow or distal humerus, various solutions have been offered to date {cf. fig. 1 to 5);
1) System comprising different plates for an osteosynthesis of a type which is not anatomically specific. These plates were produced for arbitrary anatomical circumstances and may therefore also fit on the distal humerus. These bone plates must be shaped during the operation in order to be adapted to the anatomy of their final anatomical destination, in this case to the shape of the distal humerus.
2) Systems of two osteosynthesis plates cooperating on one bone, one of the plates, the medial or the lateral one, having been anatomically pre-shaped in order to fit the medial or the lateral column
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of the distal humerus. The other plate is of a type which is not anatomically specific and has to be shaped during the operation in order to fit in its position in the distal humerus.
3) Two-plate systems, one of the plates being pre-shaped in order to fit the anatomy of the lateral arch of the distal humerus, and the other plate being pre-shaped in order to fit the medial ridge of the distal humerus, in positions virtually parallel to one another. These plates require no deformations or only a few deformation during the operation. Bone screws which are introduced through one of the plates come into contact at an obtuse angle with the bone screws which were introduced through the other plate, which is referred to as so-called distal locking of the screws.
4) Two-bone plate systems, one of the bone plates being pre-shaped in order to fit the anatomy of the dorsal aspect of the lateral part, and the other bone plate being pre-shaped in order to fit the medial ridge of the distal humerus and the two plates being fixed on the humerus in positions almost perpendicular to one another. These plates require no deformation or limited deformations during the operation. Bone screws which are introduced through one of the plates come into contact at an acute angle with the bone screws which were introduced through the other plate.
5) Two-bone plate systems as under 4); in addition,
3

the plate extends not only distally but also laterally in the most remote distal region of the lateral osteosynthesis plate, said plate having a hole there. Through this hole, a bone screw will come into contact with the bone screws which arrive from the medial plate, at an obtuse angle.
In contrast to other methods, such as simply encasing in plaster, screwing with bone screws or bandaging with wires, osteosynthesis plates have the advantage of fixing a plurality of bone fragments and attaching them in a stable manner to the healthy tissue. In principle, all considerations in the production of osteosynthesis plates were based on the object of forming the shape of these osteosynthesis plates for the implantation on the bone so that anatomically correct positioning and fixing of the osteosynthesis plate without the necessity of changes on the bone and with substantial protection of soft tissue are achieved. The osteosynthesis plates therefore should not be bulky and should have various possibilities for fixing (a plurality of drilled holes).
With the systems obtainable on the market, there are the following disadvantages.
1) Non-specific pre-shaping of the plates requires complicated bending of the plates, which may lead to a loss of mechanical stability of the plate osteosynthesis. Complicated adaptation of the plates is moreover time-consuming. Since the plates are not optimized for the distal humerus, a
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lack of bone support and fixing points for the bone screws may result.
2) For stability reasons, a two-plate system was and is preferred for the distal humerus. With a plate which is shaped to fit a specific anatomical point, and a plate which requires adaptation to its position, the advantage of a system comprising two specially pre-shaped plates is, however, not achieved.
3) A disadvantage of a plate system having a parallel plate configuration is that it requires that all bone fragments lie approximately in a planar, relatively flat space between the two osteosynthesis plates or can be contacted there by inserted bone screws. If, however, bone fragments lie slightly outside this relatively narrow, planar space, they cannot be contacted by the known osteosynthesis plates or by the bone screws in the known osteosynthesis plates and held with reduction. Moreover, the inventors observed that the one-row osteosynthesis plate may have only extremely little stability to tilting out of the connecting axial plane of the holes. Accordingly, the possibility of loading the bone provided with the plate may therefore be greatly limited.
4) A right-angled plate arrangement ensures
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stability to tilting but lacks the possibility for screw engagement at an obtuse angle between the bone screw which was introduced through the lateral plate and between the bone screws which were introduced through the medial plate. For very distally located fractures and for fractures in osteoporotic bone, the lack of the meeting of the screw directions at an obtuse angle, the so-called lack of amalgamation via the distal block, will reduce the retention of the bone plates in the bone and hence the stability of the osteosynthesis.
5) A combination of the right-angled plate configuration and a lateral plate form which permits an acute-angled screw engagement between the lateral bone screw which was introduced through the plate and the medial bone screws which were introduced through the plate is ideal for the stability and the retention, but the anatomy of the .distal humerus must be followed. The distal part of the plate which is laterally extended must not disturb the soft tissue and the function of the elbow. Systems which are on the market and correspond to this description may disadvantageously come to rest in the region of the points of action of the tendons and thus possibly disturb the function of the elbow. Moreover, the known
6

plates for osteosynthesis do not permit sufficient fixing by the distal block on the medial side.
It is therefore an object of the invention to improve the known sets so that the osteosynthesis plates firstly have better retention on the bone and secondly a larger number of different bone fragments can be reliably repositioned relative to one another. This should take place in a manner which protects soft tissue.
This object is achieved by the use of the features of Claims 1 or 29. The novel formation of the two osteosynthesis plates results in more complete penetration of the bone tissue with bone screws, so that better fixing of the bone fragments can be achieved even with fewer bone screws. Moreover, laterally located bone fragments can also be fixed, and overall substantially more stable and more rotationally rigid splinting is possible.
The idea behind the solution according to the invention lies in the particular division of the bone screws which can be fixed in the osteosynthesis plates with respect to different spatial positions thereof in the mounted state. An osteosynthesis plate set according to the invention therefore makes it possible also to reduce more complicated fractures and in addition to transmit greater forces and moments from the beginning. Premature loosening of the osteosynthesis plates according to the invention is therefore prevented. The preferred formation in which the screws provided are
7

angle-stable supports this effect according to the invention.
Further developments of the invention are described in the dependent claims. The following features produce the following additional effects: By means of a preferred version having altogether more than four drilled holes, for example altogether eight or ten drilled holes, as known per se, further improvements can be achieved if these drilled holes, viewed in two normal planes one on top of the other, with their bore axes facing the bone, make an acute angle with one another in each case, and there is, within the system, an intraoperative retention while these or others make obtuse angles with other bore axes or these bore axes.
In the context of the invention, "make an angle" means not only touching or intersecting bore axes but in particular also bore axes which merely cross, but apparently intersect in the view of intersecting planes. A further improvement of the angle and tilt stability of osteosynthesis plates according to the invention results from the provision of at least two or at least three parallel rows of drilled holes or alternatively at least one row of drilled holes and at least one further drilled hole offset laterally therefrom.
The drilled holes preferably lie along two parallel intersecting planes and additionally at least two further parallel intersecting planes normal to the first ones. Thus, the rotational and tilt stability is improved and moreover better utilization of the bone
8

tissue is possible which tissue tends to be stronger in the edge region than in the middle of the humerus.
Preferably, the bone screws used according to the invention are not fixed only in the bone but also via a thread or partial thread in the holes of the osteosynthesis plate. This advantageously results in improved angle stability of the mounted osteosynthesis plates and reduces the dynamic load of the bone tissue in which the bone screw is anchored.
In addition, this angle-stable design of the osteosynthesis plates according to the invention has the advantage that, even on loosening of one or other bone tissue in the region of one or other bone screw, the other bone screws can guarantee the angle stability of the osteosynthesis plate. By fixing the bone screws in the osteosynthesis plate, the contact pressure of the osteosynthesis plate on the bones is also reduced, which plays a role in helping to avoid pressure-related bone degradation in the tissue region. The embodiments of bone screws and drilled holes known per se can be provided.
Methods in which the bone screws are angle-stabilized by an additional pressure screw inserted only into the osteosynthesis plate are in the view of the inventor preferred in that the osteosynthesis plate must have a relatively great thickness for this purpose and the manipulation with the additional, generally very small, flat screws is difficult under surgery conditions. A particular embodiment of a comparatively small further developed osteosynthesis plate according to the
9

invention is that, in its end region, it has a triangular end region when viewed medially. As a result of this shaping, this osteosynthesis plate can be laid into the outermost distal region of the distal humerus without hindering nerves, tendons or the like there.
In a further developed form, the holes can also be designed so that bone screws can be screwed in and fixed in an angle-stable manner in any desired angular positions.
Three drilled holes of at least one osteosynthesis plate preferably serve also for improving the angle stability, but also for improving the tilt stability, the three drilled holes together forming the apices of a preferably equilateral triangle.
A further important, preferred development of osteosynthesis plates lies in the choice of forming at least one of the two osteosynthesis plates, when viewed in the medial direction, in a stem-like manner and with a tab-like part projecting therefrom so that this osteosynthesis plate appears- somewhat like a "P" in medial view. Since, according to the invention, both the stem-like and the tab-like parts carry drilled holes, particularly good angle stability is possible as a result of this design, but also particularly good fixing of a very wide range of bone fragments. In addition, this design permits so-called 90° mounting of the two osteosynthesis plates, in which the planes in which the respective bone screws lie are approximately perpendicular to one another, as proposed by AO.
10

In this embodiment, the bone screw axes of the two osteosynthesis plates intersect at about 90° - compared with the approximately 180° in the case of known systems which protect soft tissue.
In the case of a curvature of the tab-like part, the anatomy of the distal humerus is better taken into account and in addition the possibility of using a very wide range of directions in space for the bone screws is facilitated.
A combination of the osteosynthesis plates with the p-shaped, tab-like part and of the osteosynthesis plates with the triangular, distal region of the osteosynthesis plate has proved to be optimum. Firstly, little material is required and secondly the angle stability is improved or improved penetration of the bone fragments is possible. The two osteosynthesis plates are preferably mounted in such a way that the longer lateral edge of one osteosynthesis plate faces the tab-free lateral edge of the other osteosynthesis plate, so that the tab is on the radial or lateral side and the longer side of the osteosynthesis plate having the triangular section has a longer posterior edge than the length of the anterior edge.
If the holes are formed in a keyhole-like manner, this results in the advantages which have been disclosed in the case of the LCP plate of the Applicant, or, for example, in WO-A-02096309 of the Applicant.
Further developments and details of the invention are
11

disclosed in the description of the figures.
Description of figures
The figures are described in relation to one another and as a whole. Identical reference numerals denote identical components, and reference numerals with different indices indicate functionally identical components.
Fig. 1 shows a prior art with non-specific implants;
Fig. 2 shows another prior art with a specific and a non-specific plate;
Fig. 3 shows another prior art with two specific plates mounted 180° relative to one another;
Fig. 4 shows a range of plates from the prior art for osteosynthesis of the distal humerus;
Fig. 5 shows a further prior art with two specific plates 90° to one another and a distal, laterally directed part, showing an obtuse angle of the screws projecting from the 90° plate relative to the screws of the other plate; fixing of the angular position of the screws is not envisaged;
Fig. 6 shows a schematic diagram of the set of osteosynthesis plates 2g,h according to the invention in the positioned state;
12
Fig. 7 shows a schematic diagram of another set of osteosynthesis plates 2g,i according to the invention in the positioned state;
Fig. 8 shows a schematic diagram of the osteosynthesis plate 2g according to Fig. 6 and 7 in plan view;
Fig. 9 shows a schematic diagram of the osteosynthesis plate 2h according to Fig. 6 in plan view;
Fig. 10 shows a schematic diagram of the osteosynthesis plates 2i according to Fig. 7 in plan view;
Fig. 11 shows a schematic diagram of the osteosynthesis plates 2g,h in the positioned state, rotated somewhat in comparison with Fig. 6;
Fig. 12 shows a schematic diagram of the osteosynthesis plates 2g,i in the positioned state, rotated somewhat in comparison with Fig. 7;
Fig. 13 shows a schematic diagram of a single osteosynthesis plate 2g from the set in the positioned state, the osteosynthesis plate 2g having a triangular end region 7;
Fig. 14 shows a schematic diagram of a single
13

osteosynthesis plate 2h from the set in the positioned state, the osteosynthesis plate 2h having a tab-like part 4 and being curved in a spoon-like manner at the end region;
Fig. 15 shows a schematic diagram of a single osteosynthesis plate 2i from the set in the positioned state, the plate having a spoonlike end region;
Fig. 16 shows a medial plate with trochlea support and flexible extension, for adaptation to bones, intraoperatively;
Fig. 17 shows a dorsal view of a plate system comprising medial (without trochlea support) and lateral plate (with flange), right arm;
Fig. 18 shows a frontal view of a system according to Fig. 17 and
Fig. 19 shows a caudal view of a system according to Fig. 17.
Fig. 1-5 show the solutions available today on the market. Fig. 3-5 show the latest solutions on the market: the prior art according to Acumed and Zimmer, while Fig. 6, 7, 11 and 12 show osteosynthesis plate sets 2g,h,i according to the invention in the positioned state.
Fig. 8-9 show two different osteosynthesis plates 2g,h of a set according to the invention, and Fig. 10 shows
14
a variant 2i of the design according to Fig. 9 without a tab.
Fig. 6 and 7 show various hole shapes 3a,b,c in the osteosynthesis plates 2h and 2i, and Fig.6, 7 and 11, 12 show the preferred position of the osteosynthesis plates 2g,h,i on the bone 1.
As is evident from the diagrams in Fig. 6 and 11 drilled holes 3a,b,c lie along axes which intersect approximately at right angles with comparable axes of the drilled holes 3a,b,c of the respective other osteosynthesis plate 2h,g. In addition, further holes 3b which, owing to the tab-like curvature of the flange 4 are not parallel to the axes of the other holes 3a,b,c of the same osteosynthesis plate 2h are present in the region of the tab-like part 4. In the conceptual view of a set mounted according to the invention and having bone screws 12 according to Fig. 17-19, it is evident that these now no longer come to rest only before a narrow, planar region but penetrate the bone space in a very wide range of directions in space at acute and oblique angles relative to one another and are thus most suitable for reducing and for splinting differently positioned bone fragments.
Fig. 8-10 and, in rudimentary form, Fig. 6-7 and 11-12 schematically show, in the region of the osteosynthesis plates 2g,h which are free of drilled holes, finger tip-like undercuts 8 which, as shown, are only thinner material parts or are completely eliminated (milled out) regions. These undercuts 8 serve for reducing disturbances of the plate on the bone by minimizing the
15

contact between bone and plate there. In addition the weight of the plate is reduced thereby.
The different shapes of the drilled holes 3a,b,c known per se, such as slot-like holes 3a, keyhole-like combination holes 3c and round holes 3b, are also evident, at least some of the holes 3a,b,c according to the invention having an internal thread which cooperates with the bone screws 12 in an angle-stabilizing manner.
Fig. 13-15 each show an osteosynthesis plate 2g,h,i according to the invention in the positioned state, Fig. 13 showing an osteosynthesis plate 2g having a triangular end region 7, Fig. 14 showing an osteosynthesis plate 2h having a tab-like part 4, which is curved and has a spoon-like end region and Fig. 15 showing an osteosynthesis plate 2i which has a spoonlike end region.
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List of reference numerals
1 Bone
2g First osteosynthesis plate
2h Second osteosynthesis plate
2i Third osteosynthesis plate
2k Fourth osteosynthesis plate
3a Slot-like hole
3b Round hole
3c Locking-compression combination hole
3d Round hole
4 Tab-like part, flange
5 Stem-like part
6a Triangle
6b Triangle
7 Triangular end region
8 Undercuts
9 Central axis
10 Joint axis
11 Narrowed extension
12 Bone screw
17

We Claim:-
1. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) , in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles.
2. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) designed to be different from the first and having altogether at least four holes (3a,b,c) passing through the plate
18

surface for bone screws (12) which, in the implanted state, point in a plurality of directions in space, characterized in that the two osteosynthesis plates (2g,h,i) and/or the holes (3a,b,c) thereof are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles.
3. Implantable osteosynthesis set for the splinting and screwing of a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) designed to be different from the first and having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which, in the implanted state, point in a plurality of directions in space, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes (3a,b,c) thereof are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws
19

(12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles.
4. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10), in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that at least one of the holes (3a,b,c) in one of the two osteosynthesis plates
20

(2g,h,i) and at least one threaded bore in this hole (3a,b,c) or the bone screw (12) intended therefor are formed in such a way they permit angle-stable anchoring in the bone (1) by virtue of the fact that the bone screws (12) which can be inserted into the threaded bore have a head thread for locking with the threaded bore.
5. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10), in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that at least one of the two osteosynthesis plates (2g,h) has an end region (7) which is triangular in plan view.
21
6. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region having at least one joint and one joint axis (10) , in particular for a distal humerus, comprising at least one first and at least one second osteosynthesis plate (2g,h,i) having altogether at least four holes (3a,b,c) passing through the plate surface for bone screws (12) which point in a plurality of directions in the implanted state, characterized in that the two osteosynthesis plates (2g,h or i) and/or the holes thereof (3a,b,c) are formed in such a way that the bone screws (12) inserted in the implanted state or the holes (3a,b,c) point in at least four different directions in space, at least one of the two osteosynthesis plates (2g,h,i) having at least two holes (3a,b,c) for bone screws (12), the bone screws (12) of which, in the implanted state, intersect or cross the joint axis (10) at least almost parallel, and preferably at least one of the two osteosynthesis plates (2g,h,i) having at least one hole (3a,b,c) which is arranged or formed in such a way that its axis or a bone screw (12) inserted therein intersects or crosses the joint axis in the implanted state at least almost at right angles, and in that .at least three holes (3b) in at least one osteosynthesis plate (2g,h) form the apices of a - preferably equilateral - triangle (6b,a).
7. Osteosynthesis set according to any of Claims 1 to 3, 5 or 6 characterized in that at least one of the holes (3a,b,c) in one of the two osteosynthesis plates (2g,h,i) and at least one threaded bore in this hole (3a,b,c) or the bone screw (12) intended therefor are formed in such a way that they permit angle-stable
22

anchoring in the bone (1) by virtue of the fact that the bone screws (12) which can be inserted into the threaded bore have a head thread for locking with the threaded bore.
8. Osteosynthesis set according to Claim 7, characterized in that the angle of the angle-stable anchoring in at least one hole (3a,b,c) is selectable by virtue of the fact that no rigid thread is predetermined in the hole (3a,b,c) or at least two rigid threads differing from one another are predetermined.
9. Osteosynthesis set according to any of Claims 1 to 7, characterized in that each of the two osteosynthesis plates (2g,h,i) has at least one hole (3a,b,c), preferably at least two or three holes (3a,b,c), having a threaded bore for angle-stable anchoring in the bone.
10. Osteosynthesis set according to Claim 7 or 8, the threaded bore being oriented about one thread axis in each case, characterized in that at least 4 threaded bores are formed with their thread so that the angle between thread axis and plate surface or between thread axis and all tangents to the plate surface with common point of intersection at the thread axis is not equal to 90°.
11. Osteosynthesis set according to any of the preceding Claims, characterized in that at least two of the holes (3a,b,c) or at least two of the threaded bores have diameters differing from one another.
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12. Osteosynthesis set according to any of the preceding Claims, comprising bone screws (12) which have a thread for the bone and a head thread, characterized in that the ratio of the diameter of the thread to that of the head thread is as small as possible so that the diameter of the threaded bore is only insignificantly larger than the diameter of the thread for the bone.
13. Set according to any of the preceding Claims, characterized in that more than four holes (3a,b,c) altogether are provided, and in that the four different directions in space make in each case an acute angle with the joint axis (10) , the angle being measured in each case in an observation plane parallel to the joint axis (10), so that directions in space which intersect but also cross the joint axis (10) are included therein.
14. Set according to any of the preceding Claims, characterized in that, in each osteosynthesis plate (2g,h) the holes(3a,b,c) lie along two parallel planes
of intersection and additionally at least two further planes of intersection which are normal to the parallel ones, through each osteosynthesis plate (2g,h).
15. Set according to Claim 8, characterized in that
the holes (3a,b,c) lie in at least three parallel
planes of intersection and at least two planes of
intersection normal thereto through each osteosynthesis
plate (2g,h).
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16. Set according to any of Claims 1 to 6, characterized in that at least one hole (3a,b,c) has a threaded bore or partly threaded bore which is formed for the cooperation with a thread on a bone screw (12) intended therefore.
17. Set according to Claim 15, characterized in that the bone screw (12) intended therefor has a threaded head, the thread of which is compatible with the threaded bore or partly threaded bore in the hole (3a,b,c).
18. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has an end region (7) which is triangular in plan view.
19. Set according to any of the preceding Claims, characterized in that at least three holes (3b) in at least one osteosynthesis plate (2g,h) form the apices of a - preferably equilateral - triangle (6b,a).
20. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has, in plan view, a stemlike part (5) and a tab-like part (4) projecting therefrom (p-shaped) , both the stem-like part (5) and the tab-like part (4) carrying holes (3a,b,c).
21. Set according to Claim 19, characterized in that the tab-like part (4) is curved.
22. Set according to any of the preceding Claims,
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characterized in that the distal region of at least one of the two osteosynthesis plates is curved in spoonlike manner.
23. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has a thickness in the range of 1.7-2.7 mm, preferably 1.8-2.5 mm.
24. Set according to any of the preceding Claims, characterized in that the stem-like part (5) of at least one osteosynthesis plate (2g,h) is curved at least in a partial region, viewed in the direction of its central axis (9).
25. Set according to any of the preceding Claims, characterized in that at least one of the osteosynthesis plates (2g,h) has, at least in a partial region, a curvature running transversely to its central axis (9) , preferably having a radius of curvature in the range from 18 to 22 mm.
26. Set according to any of the preceding Claims, characterized in that at .least one of the two osteosynthesis plates (2g,h) has, over its total length, a curvature running transversely to the central axis (9) - preferably having different radii of curvature.
27. Set according to any of the preceding Claims, characterized in that, in at least one osteosynthesis plate (2g,h) , at least two holes (3a,b,c) lie in two planes which are approximately parallel to one another
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and are at an angle different from 90° to the surface
or a tangent to the surface of the osteosynthesis
plates (2g,h) in the area of intersection with each
plane.
28. Set according to any of the preceding Claims, characterized in that one osteosynthesis plate (2h) has the p-shaped, tab-like part (4) and the other osteosynthesis plate (2g) has the triangular end region (7).
29. Set according to any of the preceding Claims, characterized in that the two osteosynthesis plates (2g,h) having the triangular end region (7) or having the tab-like part (4) lie relative to one another in the position of use so that the longer lateral edge of one osteosynthesis plate (2g,h) faces the tab-free lateral edge of the other osteosynthesis plate (2h,g).
30. Set according to any of the preceding Claims, characterized in that at least one hole has a keyhole shape (3c).
31. Set according to any of the preceding Claims, characterized in that the thickness and/or width of at least one osteosynthesis plate (2g,h) in the hole-free region of this osteosynthesis plate (2g,h) is smaller than in the region of the holes (3a,b,c).
32. Set according to any of the preceding Claims, characterized in that at least one of the two osteosynthesis plates (2g,h) has, at its end facing the joint axis (10), a narrowed extension (11) which has at
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least one hole (3d) for a bone screw (12) and can be bent around the bone.
33. Set according to Claim 32, characterized in that
the extension (11) comprises a plurality of holes (3d),
the extension (11) being narrower between the regions
with the holes (3d) than in the region of the holes
(3a,b,c), so that bending for adaptation to the bone is possible also in the plane of the plate.
34. Set comprising at least two osteosynthesis plates
(2g,h) and bone screws (12) for the osteosynthesis of a
distal humerus with a joint axis (10) characterized by
the combination of the following features:
both osteosynthesis plates (2g,h) have an elongated extension along one - optionally curved - longitudinal axis each;
both osteosynthesis plates (2g,h) each lie, in the implanted state, in a plane which is at least approximately perpendicular to the other plane;
both osteosynthesis plates (2g,h) each have at least two holes (3a,b,c) which are arranged or formed • so that their axes have different directions in space;
the bone screws (12) inserted in the implanted state into these holes (3a,b,c) intersect or cross the joint axis (10) at least almost parallel in the implanted state; at least one of the two osteosynthesis plates (2g,h) has at least one hole (3a,b,c) which is arranged or formed so that its axis or a bone screw (12) inserted therein intersects
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or crosses the joint axis at least almost at right angles in the implanted state.
35. Implantable osteosynthesis set for the splinting and screwing of a bone or bone region as claimed substantially as herein described with forgoing description and figures.

Dated this 21st day of April 2006.

Dr. Rajeshkumar H. Acharya
Advocate & Patent Agent
For and on Behalf of Applicant

Abstract
Set comprising at’ least two osteosynthesis plates (2g,h) for implantation, anatomical reduction and internal splinting of bone fragments, in particular after fractures of the distal humerus. The two osteosynthesis plates (2g,h) according to the invention are provided with drilled holes (3a,b,c) which are arranged or formed so that the bone screws (12) passing through them come to rest in different directions in space, so that bone screws (12) can pass more completely than in the past through the bone space of the splinted bone (1).
(Fig. 11)

IMPLANTABLE OSTEOSYNTHESIS SET

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