WO1988001488A1

WO1988001488A1 - External fixation apparatus

Info

Publication number: WO1988001488A1
Application number: PCT/EP1987/000486
Authority: WO
Inventors: Wolfgang Herzberg
Original assignee: Wolfgang Herzberg
Priority date: 1986-08-26
Filing date: 1987-08-26
Publication date: 1988-03-10
Also published as: DK224488A; DK224488D0; ATE62122T1; HUT50275A; FI893009A0; FI893009A; FI104616B; HU205706B

Abstract

The external apparatus for fixing bone fragments consists of a tube-shaped portion, of which the internal space is filled with glass fibre. The fixing tube is secured by means of nails or screws (12) to the bone fragments to be fixed, whereby a rapid hardening material is introduced into the closed tube system after completion of assembly. After setting, a plastic-glass fibre composite is obtained which has excellent strength properties and is ideally suited for use as an external fixation apparatus.

Description

External fixator.

The invention relates to an external fixator consisting of at least one flexible tubular part, which is arranged outside the patient opposite the bone fragments to be fixed and which is connected to wires, nails or screws fastened in the different bone fragments, the tubular part filled with a hardenable material after which Harden the material with the wires, nails or screws to form a solid frame that holds the bone fragments together in a desired position to grow together.

External fixators are used for orthopedic fixation and for holding together bone fragments. With an external fixator, broken bones are fixed in their mutual position so that healing can take place in the correct position. For this purpose, bone nails are inserted into or through the bone, preferably with a thread, e.g. Schanz screws or bridge bars, inserted and at their ends protruding from the body by at least one rod-shaped element, e.g. a slide rod or a guide rod, interconnected. This connection is made by clamping elements, or the like as clamping pieces, joint pieces and possibly as a ball joint, as a coupling or handle pieces. are trained. In this way, a frame construction can be formed with which the bone parts are firmly fixed and held.

Known tensioning elements consist of non-oxidizing steel. When applying the fixator and tensioning the rods, the entire frame structure is relatively loose, shaky and displaceable since the rods to be held against one another must be loosened in the clamping elements in order to bring them into the correct position. That's not how a fixator is created Can be performed by a single person, but additional assistants are required who have to hold the joints and double joints and the frame until after tensioning and finally fixing and fixing can be carried out. To make this work easier, separate clamping devices can be used. Since steel has a very high coefficient of elasticity and a smooth surface, it is not possible to achieve only a weak clamping by tightening a clamping screw; Because of the high coefficient of elasticity, even a slight turn of a locking screw causes a very high change in the clamping pressure. When adjusting the fixator, the rods, bone nails or screws can only lie loosely in the clamping elements. Added to this is the fact that the parts and elements used for the fixator interfere with X-rays due to their material selection. In addition, the manufacturing costs for fixators trained in this way are very high.

The use of metal components is predominant, from which the fixator is assembled by the surgeon depending on individual requirements. Components made of metal-free materials are also used to obtain X-ray transparency for the fixators. Thus, DE-A-27 45 504 describes a device for immobilizing and / or supporting limbs of humans and animals, which has opposing pairs and has at least one bone screw or one bone nail each connecting parts, which have clamping elements with connecting or threaded rods related, known. The connecting parts, the clamping elements and the connecting rods as well as the integrated turnbuckles consist of fiber-reinforced thermoplastic materials. Furthermore, from DE-A-31 41 909 an orthopedic fracture fixation device with at least one elongate part lying outside the patient, which is known or similar with bone pins. connected in the different fragments of the broken bone, the elongated part and the pins forming a solid frame which holds the fragments in the desired position to grow together. The elongated portion outside of the patient, which is attached with bone pins with the different pieces of broken bone, comprises an elongate support of flexible shape filled with a curable material which is in the support in an inactive, fluid state.

Fixators who use preformed and solid components are very costly to produce the required kits. A certain kit has only limited applicability to certain fractures, which results in the storage and storage of an extensive range of the individual components. Threaded components show signs of wear after repeated use. If metallic materials are used, the radiological control of fracture healing may be considerably impeded. With each patient being cared for, part of the kit is blocked for weeks, which makes it necessary to expand the stock of the individual components. The unreliable and the passing patient does not return to the primary care hospital. The components used do not return to the hospital, which leads to a high loss of components. The rigid building systems also force to varying degrees the arrangement of bone fragments in accordance with the coordinates and external fixator. In order to achieve a good surgical result under these constraints, it is not uncommon for a high degree of experience as well as spatial and planning imagination to be required.

In the case of external fixators made of flexible components that are hardened to a rigid system, a tube filled with liquid plastic is used, which, however, can only be pushed over the free ends after the nails have been fixed to the bone. In reverse, the nail tips would carry an infection (such a tube cannot be sterilized) as well as monomeric plastic into the organism. This requirement requires a parallel arrangement of the nails, which comes close to the constraints that the rigid system imposes on the surgeon. A fixation in more than one level what. A mechanical hose should not always be used for mechanical reasons. In various dimensions, only a small breaking strength with low elasticity. This results in the need for large cross sections of the supporting fixator tube, without the guarantee that the fixator will not break due to a peak load. In addition, mixing the plastic components in an already filled hose has several disadvantages. The risk of incomplete mixing with the result that soft and more easily bendable tube sections are obtained after the end of the operation is relatively large. A lack of mixing also increases the proportion of remaining, possibly toxic, monomers in the fixator. The best possible mixing is only possible in a soft, easy-to-push-in carrier hose. The consequence of this is that a plastic cross-section that is as constant as possible is not guaranteed, in particular not when the fixator tube has numerous turns is misplaced. Mixing the components that make up the hardenable material with the tube already filled practically always results in plastic escaping from the nail perforation openings and thus in an incalculable loss of substance and stability. The following problems arise when curing by adding heat or radiation: Only surface coatings can be polymerized with radiation. A completely filled hose can hardly be polymerized with radiation.

IR radiation is said to penetrate the tube system, which is close to the skin level - 2 to 5 cm - but not to warm the skin itself. Protecting the patient from UV radiation is easier than when using IR radiation, but comprehensive illumination of the tube system must be achieved with both types of radiation. This . has to be carried out simultaneously with X-ray illumination and the surgeon's repositioning maneuver, an overall arrangement which may be technically difficult to carry out. In the case of a photosensitive plastic, which is protected by an opaque film, drilling the tube with fixing nails may already trigger curing. A final bone reduction is held by the surgeon for about 5 minutes. The fixator must be cured during this time. Longer curing times increase the X-ray exposure and harbor the risk of a rather poor reduction result due to the fatigue of the surgeon.

The invention solves the problem of creating an external fixator according to the type mentioned, with which simple handling without forced working planes with the possibility of making position corrections to the fixation tube before curing of the filling compound is possible without displacements of aligned bone fragments occurring , so that even complicated bone fractures, ie a large number of broken bones pieces, can be held in the correct position until the filling compound has hardened, whereby universal applicability is guaranteed and limited storage with a small range of components of the external fixator is possible. In addition, there should be X-ray transparency and great stability and elasticity even with small cross sections. Furthermore, it is an object of the invention to provide an external part for a fixator, which part can also be used as a casting mold for the plastic to be hardened and whose tubular body forms an intimate bond with the hardened plastic.

This object is achieved by the features characterized in claim 1.

Through the use of a tubular part in a fixator external from a plastic leek with a retracted glass fiber tube or from a glass fiber reinforced plastic or from a plastic-embedded glass fiber fabric, all the disadvantages given in the known fixator are eliminated. A tubular part designed in this way is filled with quick-curing synthetic resin after assembly, so that a rigid, external holder is obtained from a flexible, easy-to-use material, which is also permeable to X-rays, which is very inexpensive and universally applicable when using different tube thicknesses and glass fiber fillings is so that any desired strength is obtained. Using the external fixator as a disposable article avoids the wear problem. Through the use of a plastic / glass fiber composite at an external fixator, a material is being used for the first time that enables the surgeon to have a system for orthopedic fixation and for holding together bone fragments with which the requirements placed on an external fixator can be met be fulfilled. In particular, by using a glass-fiber-filled spiral tube, a fixator tube is obtained that can be easily deformed and bent into different planes when the fixator is being set up, without cross-section changes in the kinks, which is due on the one hand to the inherent stability of the fixator tube and on the other hand that a fiberglass tube is drawn into the plastic tube.

It is precisely this dimensional stability during the shaping and laying of the fixator tube that guarantees an unimpeded flow of the flowable plastic material that is injected into the outside of the fixator tube after the components have been mixed. The fixator tube then "mixes" woven glass fibers with the synthetic resin and creates a plastic-glass fiber composite. The glass fibers anchored in the material of the fixator tube or those drawn into the pure plastic tube. Glass fiber fabric hose increases the tensile strength of the tubular part, which is preferably designed as a spiral hose and can be easily bent and thus laid due to this configuration. Due to the high breaking strength, hoses with small cross sections can also be used. Even when the preferably quick-hardening synthetic resin composition is injected, it is not possible for plastic to emerge from the nail perforation openings in the walls of the fixator tube, since the openings formed by inserting the fixing nails or screws into the wall of the fixator tube in the passage area of the fixing nail close automatically, the latter automatically closing Closing is supported by the glass fibers worked into the tube material, the glass fiber filling or by the drawn-in glass fiber fabric tube, which represent a type of locking device, it being advantageous if very leek-shaped parts are used that consist of a very tight-meshed glass fiber fabric embedded in a plastic or of a very tight-meshed glass fiber fabric tube. This means that very thin-walled tubing can also be used.

According to a further feature of the invention, the external fixator consists of a single tubular part made of a glass fiber fabric hose drawn into a synthetic material leek or of a glass fiber reinforced plastic or of a glass fiber fabric embedded in a plastic, this tubular part in different planes and Directions over the bone fragments and connected to the bone fragments by means of the wires, nails or screws. The two free ends of this very fine part are connected to one another via a preferably Y- or T-shaped connecting piece, which is provided with a closable filling opening for the hardenable material. In this way it is possible to break fragments of broken bones, e.g. to fix the finger bones with a single seh leek-shaped part using wires, nails or screws, without the need for an elaborate frame. After introducing the tendon-hardening synthetic resin into the leek-shaped part and after hardening the synthetic resin, a solid, inherently rigid system is obtained, so that a good healing process is achieved.

Furthermore, there is the possibility of assembling several tubular parts to form a frame, all of the tubular parts being connected to one another in such a way that the interiors of all of the tubular parts are connected to one another, the tube system thus formed having at least one closable filler opening for which has curable material. In addition, there is also the possibility of combining several tubular parts of the tube system in groups, with the each tube system formed has at least one closable fill opening for the curable material.

In this way it is possible to optimally adapt such an external holding device to the different requirements, different types of connecting pieces being used. Then two-dimensional connectors are used as 90 ° or 180 ° bent connectors as well as T, Y and cross connectors. No connecting pieces should preferably be incorporated into tube sections spanning the fracture, since these could possibly become weak points of stability.

To ensure adequate power transmission from the hose system to the fixing nails or screws, it is included in the. Larger nail or screw cross-sections and, at the same time, greater force, for example in the case of fractures of the lower extremity, are no longer sufficient, the nails or .See rob simply to drill through the tube, especially since bending and sinking is no longer possible due to the larger nail cross-section. The nail or the screw must rather be anchored to the hose system by a fixing element, such a fixing element having to perform the following tasks:

It must be attached to any position on the hose, it must be able to hold the nail or screw rotationally stable, it should be anchored in the glass fiber plastic of the hose in order to distribute the frictional connection, it should be as universal as possible for different people

Nail or screw cross-sections can be used, the element must be X-ray transparent.

A fixation element made of two shell-shaped, the tubular part fulfills all these requirements surrounding parts that complement each other to form a tubular component, each shell-shaped part having at least on two opposite sides of shell-shaped sections, which complement two aligned fastening sockets and serve to receive a screw or a nail, the shell-shaped sections on their Wear an external thread on the outer wall to receive a union nut that spans a crimp ring. In addition to screws with a thread that extends over the entire length of the screw shaft, it is also possible to use screws that have a thread on the drilled-in section, while the rest of the shaft is smooth. Even if the thread is continuously formed on the screw shaft, the handling of these screws is as if there was no thread. The application of the jaw-like shell-shaped parts of the fixing element takes place after. Drilling in the nails or screws.

According to a further embodiment of the invention, the fixing element consists of a tube which is guided through two opposing and mutually aligned openings in the wall of the tubular part and is provided with an external thread and which receives a nail or a screw in its interior, the threaded tube on both sides is led out with a section from the tubular part and carries on its sections in the area of the ends of each of which a coupling nut engaging in the external thread of the threaded pipe, which nut is provided at the end of each section of the threaded pipe, on the outer wall surface of the nail or screw arranged in the threaded pipe to engage when tightening the crimp ring that can be brought in, with the threaded tube on its section facing the bone fragment, a thread-bearing, on the external thread-mounted coupling clip with in the wall of the tubular part engaging pin, mandrel or the like. and on its other section a thread-free union clamp with the pin, mandrel or the like engaging in the wall of the tubular part. carries, the thread-free union clip is held on the threaded tube by means of a nut.

These two differently designed fixing elements adapt to the different nail or screw cross-sections by using appropriate crimp rings and thus meet the requirements placed on the fixing element.

Advantageous embodiments of the invention are characterized in the subclaims.

In the following the subject matter of the invention is explained in the drawings. It shows

1 shows, in a diagrammatic view, an external fixator, consisting of a plurality of tubular parts connected to one another and attached to two bone fragments.

2 is a diagrammatic view of a fixator consisting of an end part connected to one another and secured by means of Kirschner wires to two bone fragments,

3 partly in view, partly in a vertical section, a Kirschner wire externally attached to a section of a tubular part of the fixator,

4 is a perspective view of a fixing element,

5 shows a partial cross section through the fixing element in FIG. 4, 6 partly in view, partly in a vertical section, a further embodiment of the fixing element,

7 is a horizontal section along line VII-VII in Fig. 6th

8 shows a longitudinal section through a perforator for introducing the threaded tube into the fixing element according to FIG. 6,

9 is a diagrammatic view of a tensioning element,

10 is a plan view of the clamping element in the direction of its longitudinal axis,

11 shows a longitudinal section through half of the tensioning element according to FIG. 9,

12 is an enlarged vertical section of a portion of a very fine h-shaped part made of a tubular body made of plastic with a glass fiber fabric tube drawn into the tubular body,

13 shows an enlarged, vertical section of a section of a tubular part made of a tubular body made of plastic with a plurality of glass fiber fabric tubes drawn in in layers,

Fig. 14 in an enlarged, vertical section a portion of a seh leekformi gene part from a Seh leek body made of a plastic with a retracted into the Seh leek body glass fiber fabric tube, wherein in the interior of the tubular part hardened plastic is arranged. 15 in an enlarged, vertical section, a section of a tubular part made of a spiral tubular body filled with a glass fiber fabric,

16 is a vertical section along line XVI-XVI in FIG. 15,

17 is an enlarged vertical section of a section of a tubular part made of a plastic tube body with glass fibers embedded in it

18 shows an enlarged, vertical section of a section of a tubular part made of a tubular body made of a plastic with a glass fiber fabric incorporated therein.

The external fexateur shown in FIGS. 1 and 2 is designated by 10. This external fixator 10 consists of a tubular part 11 or 211 in the form of a tube system 20 made up of several individual, interconnected tube sections, the two ends of which are interconnected (FIG. 2). This tubular one

Part 11 or 211 forms the fixator tube; his

Wall is labeled 111 and 211a. The attachment of the tubular part 11 or 211 to two with

Bone fractures designated K1 and K2 are carried out by means of

Wires, nails or screws 12.

The tubular part 211 consists of a tubular body 212 made of a flexible plastic having a certain elasticity. This hose body 212 is filled with glass fibers or other mineral fibers. This glass fiber filling takes the form of a hose or stocking 215 made of a glass fiber fabric and drawn into the interior of the hose body 212 (FIG. 12). According to FIG. 13, several can also individual fiberglass hoses 215,216,217 have been drawn into the interior of the tube body 212, so that, seen in cross section, there are several layers of fiberglass fabrics. According to a further embodiment according to FIGS. 15 and 16, so many glass fiber fabric tubes are drawn into the interior of the tube body 212 that the interior of the tube body 212 is completely filled with glass fibers. It is also possible to use a glass fiber fabric mat instead of glass fiber fabric hoses, which is folded or rolled into the interior of the Seh Lauehkörper 212. When using multiple fiberglass hoses, all hoses can be of the same thickness; however, different strengths can also be used.

According to a further embodiment according to FIGS. 17 and 18, the tubular part 11 consists of a glass fiber reinforced plastic or of a glass fiber fabric embedded in a plastic. The tubular part 11 then comprises a tubular body 115 made of a flexible plastic having a certain elasticity, into which glass fibers 116 are incorporated for reinforcement, it being advantageous if glass fibers emerge from the inner wall 115a or at least lie in the surface of the inner wall 115a in order to be able to enter into an intimate, firm bond as a kind of adhesion promoter with the plastic hardened in the interior of the leek body 115.

There is also the possibility of incorporating a glass fiber fabric 118 into the plastic instead of glass fibers incorporated into the plastic of the tube body 115, with the glass fiber fabric or an incorporated glass fiber mat also lying in the surface of the inner wall of the visual body 115 in this embodiment (FIG 18). In addition to glass fibers, synthetic materials can also be used in art. of the tubular Part 11 mineral fibers or threads can be incorporated, which includes all fibers that are made from inorganic raw materials. However, the use of glass fibers and threads, which can also be incorporated into the plastic material of the tubular part 11 in the form of fabrics or mats or in the form of a glass fiber fabric tube drawn into the plastic tube body, is particularly advantageous. It is particularly advantageous to use glass fiber-reinforced thermoplastics which are equipped with short glass fibers of less than 1 mm or with glass fibers up to about 3 mm in length, although glass fibers of greater length can also be used. ABS, polyamides, PC, PE can be used as glass fiber reinforced thermoplastics. POM, PP, PS, PVC, S AN, PETP, PBT P, whereby essentially those plastics or thermoplastics are used which are suitable for producing the tubular parts 11 for the external fixator 10 and also Mn connection with the skin have good skin tolerance. Sheet structures made of glass silk rovings, glass threads, glass fibers or glass fiber nonwovens can be used as the glass fiber fabric. The glass fiber fabrics can have a wide variety of weave types. For example, two-shaft, twill and satin weaves can be used; however, all other types of suitable weaves can also be used for the production of the glass fiber fabric.

To produce the external fixator 10, the tubular part 11 or the tubular part 211, which is filled with glass fibers, is filled with a curable material after the bone fracture has been applied and fixed. In particular, those plastics are used that are fast-curing, since only the use of fast-curing plastics ensures that the fixed bone fragments retain their predetermined position after hardening. The short curing time also gives the surgeon the opportunity given to keep the aligned bone fragments in the aligned position without the operator experiencing fatigue, which can lead to an incorrect positional arrangement of the bone fragments. Rapidly curable material is preferably used, although light can also be used to shorten the hardening time if a corresponding hardenable material is used. The tendon-hardening plastic is prepared outside the fixator tube by mixing the two components (hardener and synthetic material) and then injected into the fixator tube. It is advantageous if the hose body 212 consists of a transparent or crystal-clear plastic and if the plastic mass to be entered is colored. When this colored plastic mass is entered, the distribution of the plastic mass in the interior of the tube body can then be observed and monitored to determine whether all sections of the sight leek body 212 are filled with plastic mass.

Instead of the tubular parts 11 used in the exemplary embodiments below in the embodiments shown in FIGS. 17 and 18, tubular parts 211 can also be used which have the structure shown in FIGS. 12, 13, 15 and 16 and described above.

In the exemplary embodiment shown in FIG. 2, the ﬁ xex external 1 0 consists of a hose-shaped part 11, the two ends 11a, 11b of which are brought together in a connecting piece 16 which is provided with a closable filler opening 14. The introduction of the pourable or flowable plastic material in the interior of the tubular part 11 takes place in the direction of the arrow X. The tubular part 11 is connected to the two bone fragments K1, K2 by means of Kirschner wires 30, ie the tubular part 11 is connected to the two bone fractures K1 by means of these Kirschner wires , K2 attached, in such a way that the tubular part 11 comes to lie at a short distance above the two bone fragments. If several bone fragments are to be fixed, then this tubular part 11 is guided over these bone fragments in different planes and directions, in which case the fastening of the tubular part 11 with the individual bone fragments also takes place via Kirschner wires 30 or other suitable wires or pins, in which case the Kirschner wires on the one hand engage in the individual bone fracture pieces and are connected at their other ends to that section of the tubular part 11 which faces the bone fragment to be fixed. Since the tubular part 11 in the embodiment shown in FIG. 2 is only arranged above and on one side of the bone fragments, the Kirschner wires 30 are only fastened on one side in the individual bone fragments. The sections of the Kirschner wires passed through the bone fragments are then not connected with their free ends to a corresponding tubular part 11, but here too there is the possibility of using two tubular parts 11, one of which is a tubular part 11 above the one to be fixed Bone fragments and the other tubular part 11 come to lie below the bone fragments to be fixed, so that the two tubular parts 11 are then connected to one another while simultaneously passing the Kirschner wires 30 through the bone fragments. The arrangement of the tubular part 11 above the bone fragments K1, K2 to be fixed can be such that the Kirschner wires 30 all are inserted into the bone fragments in the same direction. As shown in FIG. 2, the tubular part 11 can, however, be arranged such that, for example, two Kirschner wires 30 are passed in a vertical direction through the section 11c of the tubular part 11, while the other section 11d of the tubular part 11 is bent towards the section 11c that the Kirschner wires 30 passed through this hose section 11d come to lie transversely to the longitudinal direction of the Kirschner wires passed through section 11c of the tubular part 11. For such an arrangement and assignment of the two sections 11c, 11d of the tubular part 11, the connecting piece 16 used can then have a corresponding shape. In this embodiment as well, the tubular part 11 consists of a glass-fiber-filled plastic or of a glass-fiber fabric embedded in a plastic, the tubular part 11 also being able to be designed as a spiral tube. The tubular part 11 can be attached to the bone fragments K1, K2 with Kirschner wires 30, but also with wires, nails or screws of a different design.

In order to anchor the Kirschner wires 30 to the tubular part 11 in a rotationally stable manner, the free end of each Kirschner wire 30 is bent into a U-shape by approximately 180. This bent wire end is designated 30a (Fig. 3). The freeie end 30b of the bent wire section 30a can be beveled or tapered, so that effortless insertion and insertion into the wall 111 of the tubular part 11 is possible.

In the embodiment of an external fixator 10 shown in FIG. 1, a frame 20 is created from a number of individual connected Lauchfö rmi ger parts 11, in which the two bone fragments K1, K2 are clamped and fixed by means of nails, screws, pins or wires 12. This frame 20 is formed from three longitudinal spars 21, 22, 23, of which each longitudinal spar, for example, consists of two interconnected sections. These three longitudinal spars 21, 22, 23 are connected via semicircular arches 24, 25 in the region of their free ends, these semicircular arches 24, 25 also each consisting of two sections of circular arc shape and connected to one another. The longitudinal spars 21, 22, 23, the semicircular arches 24, 25 and also the individual sections from which the longitudinal spars and the semicircular arches are formed are connected to one another via connecting pieces 26, these connecting pieces 26 as well as the connecting piece 16 in the External fixator shown in Fig. 2 are tubular. These connecting pieces 26 are designed as T-pieces or angle pieces. If two spar sections are connected to one another, the connecting piece is merely tubular. It is essential that all tubular 'parts which are joined to the frame 20 by means of the connecting pieces 26 are connected to one another via these connecting pieces 26 in such a way that a freely accessible interior is created. A closable filling opening (not shown in the drawing) is provided for introducing the hardenable material into the interior of this frame 20 from the various tubular parts 11. However, there is also the possibility of providing a plurality of filling openings, which should then preferably be connected to a single filling device via corresponding connecting lines, so that a uniform introduction of the curable material is ensured in order to achieve that, in particular when it comes to resin-hardening plastics, then almost at the same time 20 plastic is inserted and contained in all interior sections of the frame. In the embodiment shown in Fig. 1, the frame 20 is formed from the tubular parts 11 such that nails, screws or wires 12 can be arranged running in the vertical direction, these pins 12 running in the vertical direction and held in the longitudinal spar 23 only are embedded in the bone fragments, while the pins or nails 12 passed through the longitudinal spars 21, 22 lying in one plane are passed through the bone fragments K1, K2. However, there is also the possibility of designing the frame 20 such that the two bone fragments K1, K2 to be fixed are then surrounded on all sides by the frame 20, so that the nails, pins or screws 12 passed through the bone fragments each end into the frame on both sides 20 longitudinal spars forming are arranged. There is also the possibility of grouping together several tubular parts 11 of the frame 20, ie of the tube system thus formed, the tube system formed by each group having at least one closable filler opening for the hardenable material. Filling with curable material can be carried out simultaneously or in quick succession in all of the individual Seh leek systems.

The fracture gap formed between the two bone fragments K1, K2 is indicated in FIGS. 1 and 2 at BS.

For anchoring the nails or screws on the hose system consisting of the tubular parts 11, a fixing element 40 is provided, which has the configuration shown in FIGS. 4 and 5. This Fixing element 40 consists of two approximately semicircular-shaped scha lenf örmi gene parts 41, 42, which complement one another to form a tubular component 43, this tubular component 43 having a diameter which corresponds approximately to the outer diameter of the tubular part 11. In addition to tubular parts 11 with a circular cross section, tubular parts with an oval cross section can also be used. The two, the tubular component 43 forming bowl-shaped parts 41, 42 of the fixing element 40 are designed according to the external shape of the tubular part 11 used.

Each shell-shaped part 41 or 42 of the fixing element 40 has sections 44, 45 and 46, 47 formed on two opposite sides and formed in a shell-like manner, which complement each other to form two aligned connecting pieces 48, 49 and which hold a screw or a nail 12 serve. The shell-shaped sections 44, 45 and 46, 47 carry on their outer wall an external thread 50, onto which a union nut 51 is screwed (FIGS. 4 and 5). A nail, pin or screw 12 is held and fastened using a crimp ring 55 which is encompassed by the union nut 51 screwed onto the external thread of the fastening stubs 48 and 49, respectively. The arrangement of the crimp ring 55 is such that the crimp ring 55 rests on the free end of the fastening cross-section 48 or 49, which has a circular cross section, so that the screwed-on union nut 51 engages over the crimp ring 55. When the union nut 51 is tightened, the crimp ring is compressed in the direction of the arrow X1, with the result that it lies against the outer wall surface of the nail 12 at the same time, with the formation of a pressing pressure, so that the nail 12 is firmly fixed in the fastening element 50 is held. The wall 111 of the tubular part 11 arranged in the fixing element 40 has corresponding openings in the extension of the two fastening sockets 48, 49 which can be formed before the nail 12 is inserted. However, since the tubular part consists of a glass fiber reinforced plastic or of a glass fiber fabric embedded in a plastic with a certain resilience, the material of the tubular part 11 expands when the nail 12 is pressed in such that the nail 12, effortlessly through the wall 111 of the tubular TeiLes 11 can be pushed through, so that nails with larger diameters can be easily attached in this way. The attachment pieces 48, 49 of the fixing element 40 are adapted in terms of their diameter to the diameters that the nails or screws used have. The fact that the crimp rings 55 used on the mounting sockets 48, 49 develop a sufficient pressing force when tightening the union nuts 51, there is also the possibility of holding nails and screws securely in the mounting sockets 48, 49 if the nails or screws used 12 relative to the Inner diameter of the fastening piece 48, 49 have a smaller diameter. The attachment pieces 48, 49 are of the same design and also have the same cross-sectional areas and diameters.

In order to fix the tubular part 11 arranged in the fixing element 40, the shell-shaped parts 41, 42, which form the tubular component 43, have fixing pins, spikes or the like on their inner wall surface. 52, which are pressed into the wall 111 of the tubular part 11 when the fixing element 40 is applied. The number of these fixation pins, mandrels or the like. 52 can be any. It is also sufficient if there are two mutually opposite fixing pins 52 in the area of the two ends of the fixing element 40 are provided (Fig. 4 and 5).

If the fixing element 40 is used in connection with pins, nails or wires 12, then the inner wall surfaces of the two fastening sockets 48, 49 can be smooth. If, on the other hand, screws or pins or nails with threads formed at the ends are used, then it is advantageous if the fastening sockets 48, 49 have an internal thread on their inner wall surfaces, so that additional fastening of the screws 12 is possible. However, since the fastening and mounting are carried out by means of the crimp rings 55, it is not necessary, however, for the fastening sockets 48, 49 to be provided with a thread on their inner wall surface. In the same way, nails, screws or pins 12 can be held with the fixing element 40.

In another embodiment of a fixing element 140 according to FIG. 6, this fixation element consists of a tube 141 provided with an external thread 160, which in its interior receives a nail or a screw 12 for fixation with the bone fragments. This threaded tube 141 is passed through the wall 111 of a tubular part 11. For this purpose, it is advantageous if two openings 113, 113a, which are aligned with one another, are formed in the wall 111 of the tubular part 11.

The threaded tube 141 of the fixing element 140 is then arranged in the tubular part 11 in such a way that the threaded tube 141 projects on both sides with a section 142 or 143 from this tubular part 11. The external thread 160 formed on the outer wall surface of the threaded tube 141 can be over it extend the entire length of the tube 141. However, there is also the option of only in the area of the two ends 142a, 143a of the two threaded pipe sections 142, 143 to provide external threads.

The threaded pipe 141 carries on its sections 142, 143 in the area of their ends 142a, 143a or at its ends a union nut 144 or 145 engaging in the external thread 160 of the threaded pipe 141. Each union nut 144 or 145 overlaps one at the end of each Section 142, 143 of the threaded tube 141 provided, on the outer wall surface of the nail or screw 12 arranged in the threaded tube 141, can be brought into contact with the tightening of the union nut 144 or 145, and pinch ring 146 or 147 (FIG. 6). On the threaded tube 141, the crimp rings 146, 147 are then arranged at the end with the union nuts 144, 145 extending over them. When the union nuts 144, 145 are tightened in the direction of the arrows X2, X3, the crimp rings 146, 147 are pressed together in such a way that they are brought into contact with the nail or the screw 12. The squeeze rings 55 and 146, 147 are made of a suitable, deformable material, such as rubber or plastics, which if possible has no indentations.

Furthermore, the threaded tube 141 carries on its section 143 a thread-carrying sleeve 148 and on its section 142 a thread-free sleeve 150. The thread-holding sleeve 148 is ring-shaped and provided with an internal thread, so that the sleeve 148 on the External thread 160 of the threaded tube 141 can be screwed on. This coupling clip 148 has at least two aligned pins, spikes or the like 149, which point in the direction of the tubular part 11 and engage in the wall 111 of the tubular part 11. So that the cones, thorns or the like. 149 of the union clip 148 engage in the wall 111 of the tubular part 11, the union clip 148 is not screwed onto the external thread 160 of the threaded tube 141, but through Turning the threaded tube 141 about its longitudinal axis, the coupling clamp 148 is brought so far against the wall 111 of the tubular part 11 that the pins, mandrels or the like. 149 engage on the throw clip 148 in the wall 111 of the tubular part 11.

For this reason, the coupling clamp 150 has no thread on the section 142 of the threaded tube 141, but this coupling clamp 150, which is also of annular design, is moved towards the wall 111 of the tubular part 11 by means of a nut 152. For this purpose, the nut 152 is screwed onto the external thread 160 of the threaded tube 141. The coupling clip 150 also has two pins, mandrels or the like which are in alignment with one another. 151, which assume the position shown in FIG. 6 and which, when the coupling clamp 150 is brought up to the wall 111 of the tubular part 11, engage in the wall 111. The two coupling clips 148, 150 are then held on the threaded tube 141 in such a way that their pins, mandrels or the like. 149, 151 are opposite.

This Fixieruήgselement 140 is applied in such a way that the threaded tube 141 is passed through appropriately designed openings in the wall of the tubular part 11. Then the coupling clips 148, 150 are placed on and by turning the threaded tube 141 the thread-carrying he wu rfkla mm he 148 is moved up to the wall of the tubular part 11 so that its pins, mandrels or the like. 149 engage in the wall of the tubular part 11 or are guided through the wall 111, which is possible due to the material used for the tubular part 11, without material subsequently flowing out of these puncture points when the curable material is introduced into these areas or from these Puncture points is pushed out. In the same way, the thread-free coupling clip 150 is placed on the threaded tube 141 and moved by means of the screwed nut 152 to the wall 111 of the tubular part 11, so that the pins, mandrels or the like. 151 of the cap 150 in the same way as the pins, mandrels or the like. 149 engage in the wall 111 of the tubular part 11 (Fig. 6).

The cap 150 is also provided with a rotation brake, in the form of a cam 154 formed or molded on the inner wall surface of the cap 150, which engages in a recess formed at 112 in the outer wall surface of the tubular part 11 (FIG. 7). The rotation brake lies between the coupling clamp 150 and the threaded tube 141, so that rotation stability is generated between the nail and the tubular part 11 after the plastic compound has been filled and hardened.

To insert the threaded tube 141, a perforator 155 is provided, the tip of which is indicated at 156. This perforator is screwed on to insert the threaded tube 141.

For the positioning and fixing of bone fragments, it is often necessary to design the external fixator in such a way that re-tensioning or even tensioning is possible. For this purpose, a tensioning element 60 is provided, which consists of two tubular sections 61, 62, which are closed on the outer wall surfaces and are provided with external threads (FIG. 9). Of the two external threads of the two tubular sections 61, 62, one external thread is designed as a right-hand thread 63 and the other external thread as a left-hand thread 64. Each tubular section 61, 62 has at its outer end 61a, 62a a connecting piece 65 for tubular parts 11. This approach or connecting piece 65th can be formed from the material of the tubular sections 61, 62; however, there is also the possibility of using separate connecting pieces 65, which are also connected to the tubular sections 61, 62 using suitable connecting means, such as screw connections. The outer diameter of this approach or connection piece 65 corresponds to the inner diameter of the tubular parts 11 to be connected.

A tubular clamping nut 66 is screwed onto the external thread 63, 64 of the two tubular sections 61, 62, the outer wall surface of which is provided with a grip profile. In the exemplary embodiment shown in FIG. 9, the clamping nut 66 is provided with a number of gripping surfaces 66a, which are obtained by a hexagonal cross-sectional configuration of the clamping nut (FIG. 10). This clamping nut 66 has a number of through-holes 67 which are arranged in a row one behind the other, ie lying next to one another, and extend in the longitudinal direction of the clamping nut. These through holes 67 are used to monitor and check the clamping path, so that these through holes 67 have the function of observation windows. Advantageously, sections of the outer wall surface of the two tubular sections 61, 62 of the tensioning element 60 are provided with a different coloring, so that the tensioning path can then be assessed on the basis of the colors to be seen through the through holes 67. In order to achieve a secure fit of the tubular part 11 on the extension or connecting piece 65, these are provided on their outer wall surface with a corrugated or ribbed profile, which is indicated at 68 in FIG. 11. With 69 a ventilation opening is designated. With a tensioning element 60 designed in this way, a component is created with which tensioning of the tubular parts, for example in the frame 20, can be carried out effortlessly, so that in addition to one clamping, the clamping element has bridging and additional fastening properties at the same time. The tubular sections 61, 62 can also be designed as hollow screws, the interiors of which are filled with glass fibers, which is done by cutting back the tube body 212 receiving the glass fiber filling from plastic, so that a section of the pure glass fiber filling or the glass fiber fabric tube is obtained. This section of the glass fiber filling or the glass fiber fabric hose serves to fill the banjo bolt and thus leads to a firm bond between the tensioning element 60 and the fixator tube after pouring out with synthetic resin, which during pouring out into the exposed section of the fiberglass filling which is located in the interior of the banjo bolt flows. Has the formation of the clamping element 60 as a hexagon. at the same time the advantage that the clamping element 60 can be gripped on the outside with correspondingly designed tools and rotated about its longitudinal axis for clamping.

As fixator tubes, i.e. Plastic tubes which are provided on the outside or inside with a glass fiber fabric can also be used as tubular parts 11, these glass fiber fabrics being embedded in the plastic during the production of the tube material from plastics.

When using Kirschner wires 30, it is advantageous to secure these wires 30 by means of cable ties 80 placed around the fixator tube and the wires 30 (FIG. 3). These cable ties prevent the wires 30 from sliding out of their anchoring in the fixator tube before and during the filling of the fixator tube with synthetic resin.

The fixing elements 40, 140 and the tensioning element 60 consist of suitable plastics of large size Strength, in particular breaking strength; however, other suitable materials can also be used.

12 and 13, the tubular part 211 consists of a tubular body 212 made of a flexible plastic. A hose 215 made of a glass fiber fabric is drawn into the interior of the hose body 212 and bears against the inner wall of the hose body 212. If a hose system consisting of a plurality of hose-shaped parts 211 is used, the glass fiber hoses are drawn into the individual hose sections before they are put together and connected to one another. Longer-dimensioned hose bodies 212 with retracted glass fiber fabric leek 215 can also be used and cut to the required lengths for use.

In the. Interior of the hose body. 212, a glass fiber fabric hose 215 can be drawn in (FIG. 12), but also a plurality of glass fiber fabric hoses 215, 216, 216 can be pulled in, forming several layers (FIG. 13). Depending on the requirements, the glass fiber fabric hoses can have different wall thicknesses. A tubular part 211 designed in this way is then filled with the hardenable plastic. The hardened plastic is indicated at 90 in FIG. 14. The advantage is that such a fixator tube can be made sterile before use. The glass fiber fabric tube can also be sterilized before being drawn into the tube body. The tubular part 211 thus has the function of a casting mold. The curable plastic penetrates into the glass fiber fabric of the glass fiber fabric tube after the input into the tube system and flows through the glass fibers, so that after curing there is a firm, intimate bond between the glass fiber fabric and the plastic. The outer tube body made of plastic only has the function of a shark tens and serves for external limitation and can therefore be thin-walled. In this way, a composite material of high stability is obtained. This stability can be set by using a different number of glass fiber fabric hose layers.

15 and 16, the hose body 212 is of spiral design and preferably consists of a transparent or crystal-clear plastic. The interior of the tube body 212 is provided with a glass fiber filling 218, which consists of a wound glass fiber fabric mat or a plurality of glass fiber fabric tubes drawn into one another. This glass fiber filling 218 fills the interior of the hose body 212.

Claims

1. External fixator made of at least one flexible tubular part which is arranged outside the patient opposite the bone fragments to be fixed and which is connected to wires, nails or screws fastened in the different bone fragments, the tubular part filled with a hardenable material after the hardening of the Material with the wires, nails or screws form a solid frame that holds the bone fragments together in a desired position for growing together, characterized in that the tubular part (11, 211) of the external fixator (10) a) consists of a flexible tube body filled with glass fibers (212) made of a plastic or

b) from a glass fiber reinforced plastic or

c) from a glass fiber fabric embedded in a plastic

consists of, after the completion of the assembly in the interior of the closed eye system, a fast-curing plastic, such as a fast curing polyester resin is entered.

External fixator according to claim 1, characterized in that the glass fiber filling of the tube body (212) consists of at least one tube (215) drawn into the tube body (212) or a glass fiber mat wound into a tube.

3. External fixator according to claim 1 or 2, characterized in that the tubular part (11; 211) is designed as a spiral tube and consists of plastics, in particular transparent or crystal-clear plastics.

4. External fixator according to claim 1 to 3, characterized in that the two free ends (11a, 11b) of a tubular part (11; 211) via a preferably Y- or a T-shaped connecting piece (16) are connected to each other, the is provided with a closable fill opening (14) for the curable material.

5. External fixator according to claim 1 to 4, characterized in that the tubular part (11; 211) is guided in different planes and directions over the bone fragments and is connected to the bone fragments by means of the wires, nails or screws.

6. External fixator according to claim 1 to 3, characterized in that a plurality of tubular parts (11; 211) are joined together to form a frame (20), all tubular parts (11; 211; 21,22,23,24, 25) are connected to one another via tubular connecting pieces (16) in such a way that the interiors of all tubular parts (11; 211; 21, 22, 23, 24, 25) are connected to one another, the tube system thus formed having at least one closable filling opening for the hardenable material .

7. External fixator according to claim 6, characterized in that a plurality of tubular parts (11; 211; 21, 22, 23, 24, 25) of the tube system are combined in groups, the one formed by each group Sehlauchsystem has at least one closable fill opening for the curable material.

8. external fixator according to claim 1 to 7, characterized in that when using fixing wires, such as. Kirschner wires (30), each wire is sunk with its free end (30a) after the wire end has been bent by approximately 180 ° into the tubular part (11; 211) and is connected to it in a rotationally stable manner.

9. External fixator according to claim 1 to 7, characterized in that when using fixing screws or nails, these are fastened to the tubular part (11; 211) by means of a fixing element (40; 140).

10. External fixator according to claim 9, characterized in that the fixing element (40) consists of two shell-shaped, the tubular part (11; 211) surrounding parts (41, 42) which complement each other to form a tubular component (43), wherein each shell-shaped part (41; 42) has shell-shaped sections (44,4; 46,47) on at least two opposite sides, which complement each other to form two aligned connecting pieces (48,49) and for receiving a screw or a nail ( 12), the shell-shaped sections (44, 45; 46, 47) carrying an external thread (50) on their outer wall for receiving a union nut (51) which engages around a crimp ring (55) which fits onto the end of the fastening socket (48 ; 49) is attached.

11. External fixator according to claim 8 to 10, characterized in that each shell-shaped part (41; 42) of the fixing element (40) on its inner wall at least two fixing pins, spikes or the like. (52).

12. External fixator according to claim 8, characterized in that the fixing element (140) from a through two opposite and mutually aligned openings (112, 113) in the wall (111) of the tubular part (11) passed, provided with an external thread (160) There is a tube (141) which receives a nail or screw in its interior, the threaded tube (141) being led out on both sides with a section (142, 143) from the tubular part (11) and on its sections (142, 143) in the region of their ends ( 142a, 143a) each carry a union nut (144, 145) which engages in the external thread (160) of the threaded tube (141) and which has a layer provided in the threaded tube at the end of each section (142, 143) of the threaded tube (141)

(141) arranged nail or screw (12) for contact when tightening the union nut (144; 145) bring over crimp ring (146, 147), and that the threaded tube (141) on its section (143) facing the bone fragments (K1, K2) threaded protruding, on the ewg ew in de fitting U e uwu r fklammer (148) with in the wall (111) of the tubular part (11) engaging pin, mandrel or the like. (149) and on its other section

(142) a thread-free union bracket (150) with pins, mandrel or the like engaging in the wall (111) of the tubular part (11; 211). (151) carries, the thread-free union clamp (150) being held on the threaded tube (141) by means of a nut (152) and being connected to the threaded tube (141) in a rotationally stable manner by means of a cam (154).

13. External fixator according to claim 1 to 12, characterized in that each fracture bridging tube section (11; 211) has a tensioning element (60).

14. External fixator according to claim 13, characterized in that the tensioning element (60) consists of one of two on its outer wall surfaces provided with external threads tubular sections (61,62), the two external threads of the two sections (61,62) one external thread as a right-hand thread (63) and the other external thread as a left-hand thread (64) is formed so that each tubular section (61, 62) at its outer end (61a, 62a) with an attachment or connecting piece (65) for tubular parts (11; 211) is provided, and that on the external thread (63,64) of the two tubular sections (61,62) a tubular clamping nut (66) is screwed, which with a grip profile, eg Grip surfaces (66a) and is provided with a number of through holes (67) one behind the other and in the longitudinal direction of the parent nut.

15. External fixator according to claim 14, characterized in that sections of the outer wall surface of the two tubular sections (61, 62) of the tensioning element (60) have different colors.

16. External fixator according to claim 14 and 15, characterized in that in the wall of the tubular sections (61,62) of the clamping element (60) ventilation openings (69) are provided.

17. External fixator according to claim 8, characterized in that the Kirschner wires (30) are held with the tubular part (11; 211) by means of cable ties (90) on the tubular part (11; 211).

18. External fixator according to one of the preceding claims 1 to 16, characterized in that in the case of fixation by wires, nails or pins, the bent and into the wall (111) of the tubular

Part (11; 211) recessed wire ends are secured by cable ties on the tubular part (11; 211).

19. External fixator according to one of the preceding claims 1 to 18, characterized in that in the tube body (212) of the tubular part (211) one or more tubes (215) are drawn from a glass fiber fabric, so that the tube body (212) with the fiberglass tube or the fiberglass tubes (215, 216, 217) and the plastic hardened in the interior of the tubular part (211) forms a composite element.

20. External fixator according to claim 19, characterized in that the glass fiber fabric tubes (215, 216, 216) arranged in the interior of the tube body (212) have the same or different strengths.

21. External fixator according to claim 19 and 20, characterized in that in the interior of the tube body (212) there is a filling (218) of a plurality of glass fiber fabric tubes drawn into one another or of a glass fiber fabric mat wound into a tube.

22. External fixator according to one of the preceding claims 1 to 21, characterized in that the tubular part (11; 211) consists of transparent or crystal-clear plastics and that the curable plastic compound is colored.