Source: https://patents.google.com/patent/EP1827271A2/en
Timestamp: 2019-08-21 21:12:20
Document Index: 468319500

Matched Legal Cases: ['art 21', 'art 22', 'art 23', 'art 23', 'art 22', 'art 23', 'art 22', 'art 23', 'art 21', 'art 3', 'art 3', 'art.\n56']

EP1827271A2 - Bone fixing device - Google Patents
EP1827271A2
EP1827271A2 EP20050815861 EP05815861A EP1827271A2 EP 1827271 A2 EP1827271 A2 EP 1827271A2 EP 20050815861 EP20050815861 EP 20050815861 EP 05815861 A EP05815861 A EP 05815861A EP 1827271 A2 EP1827271 A2 EP 1827271A2
EP20050815861
EP1827271B1 (en
Hans Ulrich Stäubli
2004-12-23 Priority to CH21432004 priority Critical
2005-12-22 Application filed by Hans Ulrich Stäubli filed Critical Hans Ulrich Stäubli
2007-09-05 Publication of EP1827271A2 publication Critical patent/EP1827271A2/en
2009-12-02 Publication of EP1827271B1 publication Critical patent/EP1827271B1/en
Disclosed is a bone fixing device comprising an intramedullary nail (1) with a distal end part (2), a proximal end part (3), a center line (4), and a bore (5) that extends perpendicular to the center line (4) in the proximal end part (3) and is provided with a bore axis (6). The inventive bone fixing device further comprises a bone plate (10) with a top face (11), a bottom face (12) that is to be in contact with the bone, a continuous, central opening (13) which is located in the central portion of the bone plate (10) and connects the top face (11) to the bottom face (12), and several plate holes (14) that are also continuous and are disposed peripherally around the central opening (13). At least one clamping area (7) that faces the nail is embodied on the proximal end part (3) of the intramedullary nail (1) while the bone plate (10) is provided with a clamping area (16) which faces the plate and corresponds to the clamping area (7) facing the nail such that the two corresponding clamping areas (7, 16) can be displaced towards each other in the non-clamped state while being attached to each other in the clamped state.
The bone fixation device
The invention relates to a bone fixation device according to the preamble of claim 1.
The inventive bone fixation device is described below specifically for use on the tibia.
For performing a high tibial osteotomy, several techniques are known: In general, so-called lateral zuklappende be distinguished from the medial tibial osteotomies drop down. In the English language is spoken by "high tibial osteotomy lateral closing wedge" and "medial opening wedge". In French, it is called "osteotomy tibia d'ouverture du internal" or "d'addition internal". In addition to these classic Osteotomieformen also Halbschaftosteotomien be with
Reverse stretch insert, dome-shaped osteotomies and different forms of Tuberositasosteotomien performed.
For fixation of the lateral tibial zuklappenden of the art according to the state-T or L
Plates called reconstruction plates, gable plates, link plates and curved handle
Half-pipe plates TomoFix tiles and external fixation in different variants applied
Aaron Hofmann of Salt Lake City Utah beschieb an inclined cutting jig and a L-shaped plate for fixation of the lateral high tibial osteotomy zuklappenden under the name of "
Natural-Knee High Tibial Osteotomy Family System ".
For fixation of the medial tibial drop down different systems are used:
The "bone plate system for opening wedge proximal tibial osteotomy" according to US 5,620,448. The "bone plate system for proximal tibial osteotomy" according to US 5,749,875.
Lobenhoffer et de Simoni et Alex Staubli described in. "Open-Wedge High Tibial Osteotomy With Rigid
. Plate Fixation "Techniques in Knee Surgery 1 (2): 93-105, 2002, a bone plate for the
Stabilization of the medial tibial drop down is applied to the anteromedial tibial surface of the proximal tibia.
Rab published in 1988, the upwardly inclined tibial osteotomy in children with Blount's disease. "Oblique tibial osteotomy for Blount's disease", J. Pediatr Orthop 8:.. 715-720 1988.
Sanouillier Jean Louis and Rosa Thierry from France published an elongated proximal T-shaped osteotomy plate configured with interchangeable wedges ( "wedges") to the inner support of the medial tibial drop-down according to FR 2,785,518.
Leone James et al. published under US Patent US 6,767,351 a T-shaped plate system with multi-directional fixation pins.
For fixation of the medial drop down corrective and external fixators are applied.
Ito et al. In 2001 an improved locking nail for intramedullary fixation in osteoporotic bone published J Orthop Trauma 2001; 15: 192-196
To endomedullary fixing of Tibiaschaft- and proximal tibia fractures in adults, "The bundle nailing" was described in 1961 by KH Hackenthal, Berlin, Gottingen in a monograph More intramedullary nail techniques. The classic tibial nailing in the art for Kiintscher, conventional, drilled tibial intramedullary nailing, the different variants of the static and dynamic locking nailing according to Grosse / Kempf as well as recommended by Zimmer GmbH (formerly Sulzer Medica, Centerpulse) and the elastic nailing means Prevost- Metesiau- or Nancy nails in children. characteristic of this nailing techniques in usually a tibial transligamentärer access by longitudinal splitting of the ligament patellae under deportation of Hoffa 'rule fat body with residual symptoms in the neck area of the extensor mechanism of the tuberosity, heterotopic ossification and shrinkage of the patellar ligament with subsequent painful Pa Tella infera or Patelia Baja (depression of the kneecap) and flexor and extensor failure of the knee joint. Rarely is a Sudeck 'dystrophy see the patella or the trochlea femoris shrinkage of Hoffa'schen fat body or the patellar ligament as a complication.
Typically, the endomedullary load carrier comprising a dorsal convex in the sagittal plane
having curvature in the proximal part of the Tibiamarknagels, inserted through an access to transligamentären tibia above the tibial tuberosity. To lock a plurality of proximal, middle and distal locking fixation means are known.
In German Auslegeschrift DE 2459257 a disc-shaped flattened distal nail is shown, characterized in that a plurality of nail ends come to lie one above the other.
In German Patent DE 7519604 an intramedullary nail describes the end of the rest of the round nail shape is different for the purpose of introducing forces and torques. In EP 00669048 a resilient femoral medullary nail has been disclosed, for receiving a convex, T-shaped designed fixation means which is provided with round receiving holes with an elongated, cylindrical, half the nail miteinbeziehenden upper end of the nail, which is designed concave.
From EP-B 1024762 LEU ET AL. is an endomedullary intramedullary nail is known having a plate-like top which can be rotated about an approximately perpendicular to the nail axis rotational axis in an arbitrary position on a base plate resting on the bone and fixed by means of fixation elements. The coaxially arranged to the nail top is therefore also arranged endomedullary and can therefore only be rotated coaxially to the medullary nail about the common axis. Also missing in the apparatus of LEU ET AL. one resting on the bone bone plate.
From US 5,603,715 KESSLER a device with a hollow intramedullary nail is known, which has at its proximal end a lying orthogonally to the nail axis sprocket. The apparatus further comprises a bone plate with a perpendicularly arranged on the plate sleeve, whose free end has a corresponding to the nail sprocket. By means of a connecting screw, which is conducted through the sleeve into the hollow medullary nail, the bone plate in a rotationally arbitrary position can be fixed to the nail. A disadvantage of this device is the limitation of the rotatability coaxial to the nail longitudinal axis such that the bone plate is in the region of the joint and hinders its function. Furthermore it is disadvantageous that this known panel is shown proximal humerus placed on the soft tissue that is to say on the Rotatorenmanchette, with the risk of the consequent restriction of movement of the shoulder joint so supplied with consecutive shoulder stiffness. A device having a hollow medullary nail, which is designed in a straight line in the middle part and rigidly constructed can be practically distal forth not in the close medullary cavity of a bone marrow cavity with narrow as that of the humerus bone to insert illustrated. For this reason, elastic intramedullary nails are small diameter of flexible titanium alloy used for the supply of humeral shaft fractures (Prevost Nancy or nails).
The invention aims to provide a remedy. The invention has for its object to provide a bone fixation device with which both the bone and the soft tissue structures are less affected.
The invention achieves this object with a bone fixation apparatus having the features of claim 1, as well as an implant having the features of claim 41st
The advantages achieved by the invention are to be seen essentially in the fact that due to the inventive bone fixation apparatus comprising: (a) a extraartikuiäre and extraligamentäre placement ie outside and sub-ligamentous under the ligamentum but patellae not through the patellar ligament therethrough) of the implant is possible that patellar to protect the extensor mechanism and in particular of the ligament and the tibial tuberosity leads; b) the knee joint and in particular the tibia can be operated more easily in bending position, which the Fragmentreposition and implantation of the fixation device significantly simplifies and protects the soft tissue; c) exerted no substantial translational forces and rotational moments on the upper, middle and lower boundaries of the endomedullary medullary canal portions of the tibia; d) are spared of the bone normally covering soft tissue and in particular the stretching apparatus including patellar ligament and Hoffa'schem fat body is substantially in the implantation / explant and the fixation; e) a knee flexion up to 110 ° as well as cleavage of the ligamentum patellae can be avoided. f) correction capabilities of the relative positions of the set by the endomedullary and extramedullary fixation means bone fragment positions of the mutually displaceable main bone fragments are in a defined extent possible against each other; g) reached bone fragment corrections are held against each other can be fixed firmly in the corrected position until bony healing and to again made-up Knochendurchbau; h) subsequent post-corrections if necessary be achieved by simple manipulations; i) neurovascular complications are avoided; j) the periosteal bone fracture healing is spared in the diaphyseal meta-shaft region of the bone; k) an eccentrically located opposite the central medullary wide soft tissue gently
Bone support is reached; I) a plurality of bone fixation means of the bone fixation device is a versatile
Fixing the epi-meta-diaphyseal bone area guarantees; m) with respect to the EP-B1 024 762 LEU ET AL. no soft tissue interference results by a centrally axially aligned nail head portion; and n) any injury to the extensor mechanism results and thus the dreaded Patellatiefstand is avoided.
Unlike the conventional medial tibial osteotomies drop down a medial soft tissue access at the level of the tibial head is unnecessary. The pes tendon, the medial collateral ligament and the posterior oblique ligament are spared, nerve damage of Ramus infrapatellaris the saphenous nerve is avoided. The typical increase of the Dorsalneigung the tibial head in the sagittal plane ( "Increased posterior slope"), and the possible Patellatiefstand as we observed in the intraligamental Aufklapposteotomie eliminated. A medial soft tissue access can be avoided.
Unlike the lateral tibial osteotomies zuklappenden the replacement of the anterolateral muscles of the anterolateral shin edge is unnecessary. The fibula does not require an osteotomy. Damage possibility of the peroneal nerve, which runs below the fibular head, is absent; compartment syndrome of the anterolateral muscle compartment of the tibia is very unlikely. The typical inclination of the so-called joint line of the knee joint in the frontal plane, as we observe this after lateral Zuklapposteotomie, omitted, as is the insufficiency of the lateral capsular ligament (arcuate complex).
This allows a corresponding correction of the axis, the lateral displacement and the length of the tibia and stabilizes the fracture of the tibia and Osteotomiefragmente axis meet and torsion, and bending stable, after the correction thereof, secure until bony healing. Prerequisite for this is an adequately produced, biomechanically viable and stable angle fixable, material proved endosteal, endomedulläres basic implant consisting of appropriate upper, middle, and lower parts and a matching instrument and Positionierungsset. The endosteal fixation elements of the upper parts, the intermediate connecting member, the distal, endomedullary fixation element and the tibia transfixierenden fixation elements vary designed anatomically scaled according to the external and internal shape of the tibial concerned and follow the outer geometry and internal architecture of the tibia and its corresponding, inner medullary cavities configuration.
The intermediate intermediate element is in turn designed by means of guarding against twisting mechanism and by means of a suitable fine toothing system, preferably as a trunnion, pivot plates equivalent, with the lower endomedullary fixing means (endomedullary load carrier EMKT) connected in the sense that an axis correction, a lateral shift of typically from 0 mm up to half the shaft width and a length correction of 0 - 3 cm. The distal adapted to the inner shape of the medullary canal of the tibia, endomedullary fixation element can be, after the correction, angle, torsional, and connect the axis stable at the proximal endosteal fixation elements. The, the fracture and Osteotomiezonen bridging implantable construct consisting of endosteal proximal fixation elements, intermediate-link system and distal, fixed endomedullary fixation elements, forms a stable functional unit to the formal bony healing of the fracture of the tibia / tibial osteotomy. The proximal fixation elements are fixed endosteal in the internal architecture of the proximal medial, central and lateral tibial substantially. The thereon adapted, intermediate fixation element is trimmed with small bumps, protrusions from the underlying periosteum and follows with its fit the outer geometry of the tibial plateau while respecting the intact untreated approach geometry and the substance of the approach of the stretching apparatus (patellar ligament) of the tibia at the tibial tubercle as well as the approach geometry the iliotibial tract tubercle of Gerdy. The intermediate fixation element can be sunk also partly or wholly in the tibial anterior ago. The intermediate connecting member is in turn connected to the distal, endomedullary force carrier, preferably designed as verdrehsicherbarer mechanism, typically a three-dimensional fine-toothed pivot / turntable concept, which guarantees the stable anchoring of the fixing elements. Another connection option is designed as a hinge concept.
The distal anchor is carried out by means of special transosseous connecting and / or locking fixing means, which are optionally supplemented by elastic integrated in the base graft and introduced fixing nails. The orthopedic / trauma, endosteal, endomedullary basic implant enables in conjunction with customized tools and the matching positioning system, a biomechanical adequate fixation of the fracture and Osteotomiefragmente a soft tissue sparing, mini invasive approach. To further protect the soft tissue is a specially-adapted, endomedulläres osteotomy system application, the cited by the destruction of the periosteum conventionally from the outside which avoids vibrating blades and thus the periosteal bone healing is useful. The Assemblage and Desassemblage of endosteal, endomedullary basic implant are simply designed. The resulting bone defects are left open after the soft tissue gentle removal of orthopedic / traumatological basic implant or completely filled with suitable bone replacement materials. The bone fixation device expediently comprises a compression apparatus, by means of which the nail-side and plate-side clamping surface are pressed against one another. The compression apparatus typically includes an internal thread in the bore of the intramedullary nail and can be passed through the central Öffnung_der bone plate and screw into the internal thread of the clamping screw bore.
In a particular embodiment of the intramedullary nail has two nail-side clamping surfaces. This embodiment makes it possible to fix the proximal portion of the intramedullary nail, either below or above the bone plate, in particular, the two nail-side clamping surfaces may be arranged substantially asymmetrically eccentric to the central line.
In another embodiment, the nail-side clamping surface is flat and defines a plane B2 that with by the central line and extending parallel to the plane B2
Diameter d of the intramedullary nail plane defined B1 has an angle alpha of 0 ° to 30 °, preferably 10 ° to 20 °.
Alternatively, an orthogonal plane to the bore axis B2 can with by the central line and parallel to the plane B2 extending diameter d of the intramedullary nail (1) a defined plane B1
have angles alpha from 0 ° to 30 °, preferably of 10 ° to 20 °.
In another alternative, an orthogonal to the bore axis plane B2 B1 may extend parallel to a plane defined by the center line and parallel to the plane B2 extending diameter d of the intramedullary nail level.
In a particular embodiment, the nail-side clamping surface is located in the region of the bore of the intramedullary nail.
The plate-side clamping surface may be formed either only on the underside or only on the upper side of the bone plate, or be formed on both the underside and at the top.
In another variant, the plate-side clamping surface may be formed in the interior of the bone plate and extending substantially parallel to its top and bottom. In this embodiment the nail-side clamping surface is inserted into the U-shaped bone plate, and there - sandwiched by the bone plate - after jamming. The U-shaped bone plate can be provided in the interior of U with one or two clamping surfaces; the same applies also to the intramedullary nail, which may have one or two clamping surfaces also, so that can face two pairs of clamping surfaces in this embodiment, which improves the clamping surface and the clamping action.
In a particular embodiment, the plate-side clamping surface may be formed in the region of the opening of the bone plate. The central line, the nail-side clamping surface at an average angle of 1 ° - 20 °, preferably cut of 2 ° -10 °.
In a further embodiment, the proximal end portion of the intramedullary nail may be formed as a separate, modular component.
In another embodiment, an intermediate piece may be arranged from a plastically deformable material between the mutually corresponding clamping surfaces. This can be prevented "corrision fretting" called.
The intramedullary nail may be curved asymmetrical, multi-planar in a particular embodiment. Due to the multi-planar, asymmetric curvature, the intramedullary nail can easily bring in this embodiment with a slightly bent knee in the medullary cavity and into the medullary canal.
The mutually corresponding clamping surfaces of the intramedullary nail and the bone plate may each be formed planar or spherical or cylindrical. The shape congruent fixation surfaces allow this mutual correction within the meaning of the six degrees of freedom (6DOF = six degrees of freedom), ie the three axes of rotation: flexion / extension, abduction / adduction, internal rotation / external rotation and the three translation levels: Anterior Translation / posterioreTranslation , Medial translation / lateral translation, as well as in the compression level / Distraktionsebene; this in a desired degree but at the same time with a certain limitation.
The clamping surfaces have advantageously have a three-dimensional structure, preferably in the form of serrations. This allows relative_Winke! Shifts and relative translations between the nail and bone plate and a mutual form-locking and force-locking fixation according carried angular displacements and translations in a desired position, for example by means of a clamping screw. The teeth may for example be in the form of rounded windings, pyramid tips or multilayered polygons formed of. Furthermore, the tooth surface can be cured, coated and / or anodically funkenanodisiert (in particular by anodic Funkenanodisiering II) be. The tooth surface may be designed in other concave or convex and / or with corresponding multi-planar surfaces and formed wölbungskongruent.
The distal end of the intramedullary nail may be advantageously parabol symmetrically rounded. The intramedullary nail may have at least nine other plane-parallel arranged longitudinal grooves, in order to achieve a rotational stabilization.
The distal end of the intramedullary nail may be cleaved in the other lengthwise. This training serves to avoid stress concentration at the end of the nail due to the transligamentären access and consecutive Fettköpervernarbung. The bone plate may have a concave curved bottom. This results in an optimal adaptation to the bone surface.
The bone plate may also have a convex, curved upper surface. This allows a simple manufacture of the curved panel from a flat plate.
In a further embodiment, the bottom and / or top side may be formed spherically curved, which also results in ease of manufacture.
In a particular embodiment, the underside of the bone plate has a groove with a the plate-side clamp surface-forming groove bottom, a first and a second side wall. The groove has, between the first and the second side wall to a minimum width b which, so that the nail-side clamping surface is an at least partially receiving the proximal end portion of the intramedullary nail in the nail-side Klemmfläche_gestattet to the plate-side clamp surface to the plant. The groove allows for a lateral limitation of the movement of the medullary pin relative to the bone plate during implantation, which is an aid in assembling the implant for the surgeon. The proximal end of the nail of the intramedullary nail in the nail-side clamping surface advantageously, B> b to a width. The advantage of this embodiment is based on the fact that the lateral displacement can be selected by choosing the appropriate components.
In a further embodiment, the bone fixation device comprises at least one having a longitudinal axis bone fixation element (25). The at least one bone fixation element may advantageously be arranged such that the projections of its longitudinal axis in the X 1 Z plane, the X, Y plane and in the Y, Z plane of a three-dimensional coordinate system with the axes x, y, z relative to the x-axis (in the x, Y plane), to the z axis (in the x, Z plane) and the z-axis (in the Y, Z plane) enclose an angle between 0 ° and 60 °, wherein the z-axis coaxial with the Zentrailinie (4) runs of the intramedullary nail (1) in the region of the nail-side clamping surface (7) and the x-axis orthogonal to the z-axis and extending coaxially to the parallel to the plane (2) diameter D of the intramedullary nail (1).
In an intramedullary nail having a curved center line of the z-axis can be formed with the axis of rotation forming the bore axis (6) by the tangent to the central line (4) in the intersection point of the central line (4).
The surface of the components of the bone fixation device, in particular of the medullary nail, the bone plate and of any bone fixation elements may be funkenanodisiert (preferably by anodic Funkenanodisierung II) This achieves an increase in the mechanical strength as well as a microbicidal effect. The surface of the components can also be a - preferably containing silver ions - be provided microbicidal coating. As already mentioned, the intramedullary nail may be formed asymmetrically. Here, the intramedullary nail may have a second curvature in a first (frontal or latero-medial) plane and a erste_Krümmung in a, direction perpendicular to the first plane, second (sagittal or anterior-posterior) plane.
The bone fixation device may additionally one or more of the following components: a shock-screw, a train-screw, a compression screw, a setscrew, comprise as bone fixation elements.
The intramedullary nail may also have a continuous cannulation.
In a further embodiment, the bone fixation elements are formed as elastic medullary space wires.
The bone fixation elements may include sleeves which in recordings
Bone plate are pressed and their central holes allow the implementation of bone screws.
In a further embodiment, the bone fixation device is formed as an implant for endosteal and endomedullary fixation of bone, especially tibial fractures, tibial osteotomies, tibial plateau fractures or tibial osteotomies and thereby comprises
A) at least one top part (23) which is anchored in the epiphyseal, metaphyseal and / or diaphyseal region of a bone;
B) at least one lower part (21) which, in epiphyseal metaphyseal and / or diaphyseal region of a bone can be anchored; and
C) at least one middle part (22) which is suitable for connecting the at least one upper part (23) with the at least one lower part (21) and in the epiphyseal, metaphyseal and / or diaphyseal region of a bone can be anchored.
The upper part, at least one, preferably comprise a plurality of bone fixation elements. The upper part can also comprise at least a lateral bone fixation element (L), at least one central bone fixation element (Z) and at least a medial bone fixation element (M) include. The at least one bone fixation element may comprise a sleeve (26) having a central bore and a feasible through the central bore bone screw.
The at least one bone fixation element may include a bone screw.
The upper endosteal lateral fixing device (L) in the lateral tibial plateau can be followed with respect to the orthogonal alignment in the sagittal and coronal plane of the individual shin configuration and suitably from ventral inlet region of the endosteal lateral (L) fixation means, in an axis deviation in the axial plane in the sense of sector proper position, an angle alpha relative to have anteroposterior zero orientation of 0 to 25 degrees to the central and from 0 to 25 degrees to the lateral, preferably designed as an angle alpha from 0 to 5 degrees to the central and lateral back.
The upper endosteal lateral fixing device (L) with respect to the sagittal inclination of the tibial plateau and in relation to the anteroposterior axis of orientation may be in the sagittal plane in a suitable position sector, an angle aeta from 0 to 25 degrees to the cranial, and at an angle aeta from 0 to 45 degrees be designed to caudal, 0 to 25 degrees to be in relation to the sagittal axis of the bore of the endomedullary force the carrier in a sagittal angle theta from 0 to 110 degrees, preferably designed with a sufficient distance from mindestem 1 mm to the immediately subchondral, tibial to 3 mm regions of the medial and lateral femoro-tibial joint, and the compartment of the joint area of ​​the proximal tibio-Fibulargelenkes and the Area intercondilaris anterior and posterior Area intercondilaris the Schienbeinkopfepiphyse.
The upper, lateral endosteal fixation means (L) with at least one upper epi-, meta-, diaphyseal lateral (L), center (Z), medial (M) fixing means of the upper part, the upper part with at least an average epi-, meta-, diaphyseal middle part and the middle part having at least a lower diaphyseal endosteal, exostalen, endomedullary fixing part of the base may be configured connected in a suitable manner.
The upper, endosteal, lateral fixing device (L) with at least one endosteal, lateral (L), center (Z), medial (M) endosteal, exostalen and endomedullary fixing means can be stably connected in a suitable manner, regardless of whether axis, lengths - and angle corrections have been made.
The upper endosteal lateral (L), center (Z), medial (M), epi-, metaphyseal endosteal fixation means can with at least a distal endomedullary, exomedullär, endosteal, exosteal mounted fixation means (lower part of the orthopedic, traumatological base implant) in a suitable way axis-, adjustable in length, and its angle-stable manner.
The upper, at least one, endosteal lateral epi-metaphyseal fixing means (L) can in a suitable manner with a typically similarly configured central (Z) and medial (M) epi-, meta-, diaphyseal endosteal fixation means to be connected, the endomedullary central fixation means in Referring designed to anteroposterior orientation or zero axis in the axial plane than at an angle beta of 0 to 25 degrees to the center than at an angle beta from 0 to 45 degrees to the lateral, in the sagittal plane with respect to the anteroposterior zero axis as an angle deviation aeta designed from 0 to 25 degrees in cranial direction and an angular deviation aeta from 0 to 25 degrees in caudal direction. The endosteal, lateral fixing device (L) and the endosteal central fixation means (Z) for the lateral (L), or designed fixation means for the central (Z), can be connected to at least one endosteal medial (M) fixing means, endosteal, medial fixation means (M) with respect to a generally 45 degree oriented obliquely to the anteroposterior axis of the tibia zero axis at an angle gamma of 0- 45 degrees anterior to an angle gamma of 0- 45 degrees to the dorsal designed in the sagittal plane with respect to an anteroposterior zero axis as an angle deviation aeta from 0 to 25 degrees in cranial direction and as one. Aeta angular deviation of 0 to 25 degrees in caudal direction designed.
The endosteal lateral (L) and the endosteal central (Z) fixation element can be designed for the lateral (L), and for the central (Z) endosteal fixation element; the medial endosteal fixation means (M) with respect to a zero axis oriented ventrodorsal delta can be configured from 0 to 75 degrees to the ventral limit sector with an angle delta central of 0 to 20 degrees to the sector boundary and an angle.
The endosteal fixation elements whose zero axes medial epsilon an angle of at least two central and medial least two, or at least two lateral and medial least two oriented depending anterior paraligamentary introduced endosteal more or less in the anteroposterior direction fixing means, lateral forming an angle zeta be designed.
The central (Z) and medial (M) endosteal, epi-, meta-, diaphyären fixation means may be adapted by means of a suitable device with at least one central, intermediate (I) and at least one lower diaphyseal endostalen- endomedullary fixing part.
The intermediate fixation devices can, designed as central part, between the individual endosteal lateral (L), endosteal central (Z) and endosteal medial (M) fixation elements of the upper part and the endomedullary fixing parts of the lower part (the distal, endomedullary power carrier) against each other typically in a angle of 0 to 30 degrees angled be stably connected, adapted to each other to each side of 0 mm, to about half the width of tibial shaft slidably displaceable in length by 0 cm to 3 cm, and after the correction in an ideal position.
The endosteal epi-, meta-, diaphyseal fixation means can of pipes, parts of pipes, cylinders, parts of cylinders, tubes, parts of sleeves, bars, parts of rods, slabs, parts of slabs, plates, parts of plates, nails, consist bolts, screws, staves, elastic nails, T and U-profiles, polygonal elements and locking bolt, locking nails, locking screws, bendable screws, bolts or other fixation devices. In a preferred embodiment guide sleeves and fixed therein rod-shaped elements in the upper region of the tibia can with an intermediate fixing means (I), preferably designed as a base plate and be fixed by preferably bent designed endomedullary (D) fixation elements in the upper, middle and distal portion of the Tibia ,
The intermediate fixation means (I) connected to the meta, dia- the endosteal epi-metaphyseal fixing means epiphyseal, can connect endomedullary fixing agent is selected from, the external and internal architecture of the tibial und_dessen surface and adapted from the adjacent soft tissue elements consist, preferably as support plates with mutual gearing, as a pivot-rotation plate members as a ball and socket elements, a fork-tenon elements, as a hinge devices as a pivot plate - are designed trunnion elements, as a ball-bar elements.
The intermediate fixation means, the central part, as a bone plate or base plate (BP) designed, which is typically directed against the front surface of the tibial head with elevations and projections against the bone out, can be supported at a distance of 0.1 mm to 4 mm and in a suitable , the tibialis anterior limit up to a maximum lateral (outer) edge of the tibial head laterally and above the tibial tuberosity, patellae behind and adjacent to the ligament and its recognition zone in the central tibial region (apophysis) across to the medial rounded tibial surface cover, and engage around, and as the base fixation plate for the appropriate endosteal, endomedullary fixing means may be designed.
The base plate may be one third (usually 1-33%), two thirds of ((usually 34-66%) or more than two thirds of usually 67-100% in the ventral region of the tibial be recessed, with respect to the center of the tibial tuberosity in a radius of 5 mm arranged 30 mm, at least 0.1 mm distance to the patellar ligament comprising approach, be designed.
The base plate may cover the paraligamentären lateral and medial surfaces of the tibia and the central patellar ligament under the lying front tibial surface and allow the insertion of at least one paraligamentary introduced anterior endosteal fixation element technically.
The base plate may also comprise a directly integrated in the base plate, endosteal fixed in the upper lateral (L), center (Z) or media (M) area of ​​the tibial part of fixation means.
The endomedullary fixation element can be fixed in a further embodiment verdrehsicherbar around a central fixation mechanism, wherein the fixing elements of the base plate are designed as slit-shaped openings for receiving the upper and lower fixation of the endomedullary power transmitter in the base plate. The base plate and the endomedullary fixation part can be designed as a fine-toothed pivot turntable mechanisms, which the stable fixation of the endomedullary force support to the base plate ensure independent of a possibly necessary correction of the fragment position (see Figures 6A, 6B, 6C, 6D, 6E).
The upper lateral (L) 1 center (Z) and medial (M) epi-meta diaphyseal fixation means may suitably according to the required displacement against each other, be designed stable angle to each other and offset to ensure connectable.
The lower endomedullary fixation means can in a suitable manner with the intermediate
Fixing means of the base plate to be fixedly connected, preferably as a sector of a sphere designed congruent with a second ball sector element connected in the sense that angle adjustments are possible, and kept fixed by means of suitable fixation mode.
The endomedullary fixation means, the endomedullary load carrier (EMKT) to stabilize
Tibial fractures, designed tibial osteotomies, proximally, at least one integrated in the EMKT
provide support plate, for paraiigamentären, retroligamentären endosteal fixation suitably designed.
The endomedullary lower fixation means may be arranged endomedullary against the distal main fragment by suitable fixation means, endosteal, and transosseous exosteal fixation in its course.
The endomedullary load carrier (EMFK) may be suitably connected to the distal and proximal tibial main fragment by means of suitable fixation devices, and after the relative position change of the tibial main fragments against each other again in a suitable manner angle, be designed rotationally and part load stability.
The inventive bone fixation device is particularly suitable for performing a method for endosteal and endomedullary fixation of bone, especially tibial fractures, tibial osteotomies, tibial plateau fractures or tibial osteotomies, being generated in at least three different levels of the bone to be treated targeted bone weakening the plastic formability of the bone. Bone weakening can be created by drilling or sawing. Simultaneously with the bone weakening autologous bone structured material can be obtained.
FIG. 1a is a schematic perspective view of an embodiment of the inventive bone fixation apparatus;
Figure 1b is a schematic representation of the corresponding to the clamping surfaces levels. Figure 2 is a perspective view of an embodiment of the inventive implant for fixation of bone.
Figure 3 is a perspective view of another embodiment of the inventive implant for fixation of bone.
4A is a schematic representation of an embodiment of the inventive bone plate.
FIG. 4B is a schematic representation of a further embodiment of the inventive bone plate;
Fig. 4C is a schematic representation of still another embodiment of the inventive bone plate;
5A - 5E are schematic illustrations of the fixation sectors of endosteal fixation elements in the axial plane of the tibial head.
Figure 6 is a schematic illustration of the fixation sectors of endosteal fixation elements in the sagittal plane.
7A - 7E are schematic perspective views of different embodiments of the fixation mechanism between the bone plate and the intramedullary nail of the inventive bone fixation device. and
Fig. 8 is an exploded view of another embodiment of the inventive implant.
In Fig. 1a, an embodiment of the bone fixation device including an intramedullary nail 1 of a bone plate 10 and a compression mechanism 9 for fixing the bone plate 10 to the intramedullary nail 1. The intramedullary nail 1 comprises a distal end portion 2, a proximal end portion 3, a central line 4 and in the proximal end portion 3 perpendicular to the central line 4 extends, as a bearing suitable for an axis of rotation bore 5 with the bore axis 6. the bone plate 10 has an upper surface 11 and an intended for bone contact underside 12 and includes a housed in the central part of the bone plate 10, the upper side 11 with the bottom 12 connecting, through central opening 13 and a plurality of peripherally around the central opening 13 is arranged, also continuous plate holes fourteenth
Further, at the proximal end 3 of the intramedullary nail 1 is a nail-side clamping surface 7 is formed, and the bone plate 10 has a corresponding to the nail-side clamping face 7 plate-side clamping surface 16, with the two mutually corresponding clamping surfaces 7,16 in the unclamped state, that against each other when dissolved compression device 9 are slidably and rotatably and are fixed in the clamped state against each other. In the embodiment shown in FIG. 1 embodiment, the clamping surfaces 7,16 are formed planar. The nail-side clamping surface 7 is located in the region of the bore 5 while the plate-side clamping surface is defined by the underside 12 of the sixteenth
The two mutually corresponding clamping surfaces are 7.16 by means of a through central opening 13 and the bore 5 which can be passed clamping screw 15 clamped against each other, wherein the clamping screw 20 is anchored in the bone or in the bore by means of a threaded connection. The clamping surfaces 7,16 have a three-dimensional structure on a respective gears.
The planar, nail-side clamping surface 7 lies in a plane B2, which is orthogonal to the bore axis 6 (Fig. 1 b). a second plane and parallel to the plane B2 extending diameter d of the intramedullary nail 1 spanned B1 - Further, through the center line 4 - with a curved central line 4 by the tangent at the point of intersection with the bore axis. 6 Depending on the embodiment of the nail-side and plate-side clamp surface 7, 16 the two planes intersect B1; B2 and include an angle alpha, or the two planes B1, B2 are parallel or coincide. In the embodiment shown in Fig. 1a embodiment, the two planes B1 and B2 are parallel and are at a distance a from one another.
Further, 1 is a three-dimensional coordinate system is shown in Fig. B shown, the z-axis is coaxial to the center line 4 (Fig. 1 a) of the intramedullary nail 1 in the region of the nail-side clamp surface 7, respectively, in an intramedullary nail 1 with a curved central line 4 tangent formed by the intersection point Central line 4 runs with the axis of rotation forming the bore axis. 6 The x-axis is orthogonal to the z-axis and coaxially to the plane B2 parallel to running diameter d of the intramedullary nail. 1
The system shown in FIG. 2 for endosteal and endomedullary fixation of bone comprising an orthopedic / traumatology basic implant 20 in the subsequent OTGI called, which is embodied as a intramedullary nail 1 lower part 21, a as a bone plate 10 or the base plate (BP) formed center part 22, and a from a plurality of bone fixation elements 25 existing upper part 23 includes. In the illustrated embodiment, three bone fixation elements 25 are provided, / which the first lateral (L), the second central (Z) and the third medial (M) is arranged.
The bone fixation elements 25 are arranged such that the projections of their longitudinal axes 24 L; 24 Z and 24 M in the X, Z plane, the X, Y plane and in the Y, Z plane (Fig. 1 b) to the x-axis relative (in the X, Y plane), for z axis (in the X, Z plane) and the z-axis (in the Y, Z plane) are arranged at an angle.
The intramedullary nail 1 and the bone plate 10 are (to the outer shape and the innnere architecture of the upper shin part adapted to the so-called epiphysis, metaphysis apophysis and diaphysis of the proximal tibia and to the endomedullary form (Mark-dimensional shape) of the tibia and follow in scaled version the inner and outer shape of the tibia intact leaving the patellar ligament 42, the anterolateral muscle compartment, the distal neck pes tendon for stable endosteal, exostalen, endomedullary fixation of tibial plateau fractures, tibial fractures, tibial osteotomies, tibial osteotomies.
The intramedullary nail 1 and the bone plate 10 typically come behind (posteriorly), and are below the patellar ligament (subligamentär). By subligamentous position of the bone plate 10 or base plate and the intramedullary nail 1, the ligamentum patellae 42 and the body fat Hoffa spared, a secondary Patellatiefstand as in transligamentären access can thus be avoided with a high probability.
The embodiment of the implant 20 shown in Fig. 2 shows an orthopedic, traumatology Gmndimplantat (OTGI) consisting of upper, middle, and lower portions 23,22,21 and is characterized in that the upper part 23 consists of a plurality of endosteal fixation elements 25, which comprise here a lateral (L), central (Z) and medial (M) endosteal fixation element 25, the center part 22, also Intermedär part called, consists of an anatomically correct, adapted to the soft tissues of bone plate 10 or base plate with plate holes 14 is provided as a pick-up devices 28 for endosteal fixation elements 25, as additional receiving devices 29 for additional fixation elements, for example, bone screws and are provided as recesses 30 for the soft tissue adaptation. Further, the bone plate 10 includes a plate-side Klemmfiäche 16, that here a suitably designed, finely textured surface, which is preferably designed as a fine-toothed fixation device and in a nail-side clamping face 7 engages forming reciprocally designed fixation device so that the plate-side clamp surface 16 and the nail-side clamping surface 7 are rotatively connected positively to each other. The fixation device latter is preferably-angle connected to the upper part of the curved endomedullary power transmitter, respectively, the intramedullary nail 1, wherein said fixation devices, that the nail-side clamping surface 7 and the plate-side clamp surface 16 preferably has a with the bore axis 6 (perpendicular to the drawing plane) coinciding axis of rotation, at an angle alpha of 65 ° - 115 °, preferably 90 °, respectively, to the shaft axis center line 4 of the endomedullary power transmitter is configured relative to each other are rotatably and angularly stable fixed.
The implant 20 (OTGI) typically shows endosteal localized proximal fixation members 25 are formed as upper part 23 and the retro- and paraligamentary located bone plate 10 or base plate which is mainly exosteal fixed, are connected.
The middle part, the base plate is, in turn, with an endomedullary force carrier, or intramedullary nail 1 as connected in a suitable manner, it is possible so that relative axis corrections lateral positional deviations and lateral displacements as well as optionally angle adjustments between the proximal and distal fracture and osteotome ie fragments are. A preferably as fine toothed pivot / turn table is laid out fixation mechanism 8 (see. Fig. 1) allows the correction facility, and guarantees the stability after the correction to the bone consolidation. The distance between the bone surface to the lateral, cranial and medial border of the tibial tuberosity is deliberately chosen to allow a certain displacement of the bone plate 10 relative to the tibial tubercle.
In Fig. 3, another embodiment of the bone plate 10 or base plate (2) of the implant 20 (OTGI) is shown. The bone plate 10, the middle part 22, which the endosteal proximal lateral (L), center (Z) and medial (M) fixing elements 25 of the upper part 23 to the distal sub-part 21, the endomedullary load carrier, that the intramedullary nail 1-angle via fine-toothed fixation mechanism 8 combines.
. As shown in Figure 3 follows the near bone shape of the bone plate 10 or base plate of the outer contour of the anterolateral tibial head 61. The bone plate 10 or base plate preferably covers the ventral surface of the anterolateral tibial head 61 in a radius of 5 - 30 mm, from the center 62 of the tuberosity tibia 47, the attachment of the patellar ligament 42, measured from to the lateral tibial plateau boundary 63 where the approach area of ​​the fascia of the anterolateral muscle 64 of the tibia is located. this potential placement area of ​​the base plate laterally against the top by the tubercle of Gerdy 65 limited (tibial approach area of ​​the iliotibial tract). Against the upward direction, the placement area of ​​the base plate is coronarium by the ligament, meniscus anterior horn 66 and the Hoffa'schen fat body mediai bottom by the approach of the pes tendons 67, down through the proximal boundary of the tibial tuberosity 47 medially through the medial collateral ligament 68 and ventrally through the patellar ligament limited 42nd The integrated into the base plate, fine toothed fixation mechanism 8 is preferably designed flat, configured with a a zur_Bohrungsachse 6 coaxial rotating device 69 which allows a relative displacement of the interlocking fine-toothed fixation devices of bone plate 10 or base plate and of the endomedullary force carrier, or intramedullary nail 1 and on the required correction ensures stable angle in a suitable manner.
FIG. 4A - 4C show one embodiment of bone plate 10 or the base plate. The bone plate 10 is substantially free of the direct soft tissue areas approaches the proximal epiphyses, metaphysis of the tibia head 41 and is located behind the patellar ligament 42 is left intact covered. The bone plate 10 engages around the lateral approach gently 44, cranial 45 and medial 46 limiting the bony projection 43 of the patellar ligament 42 to the tibial tuberosity of a certain distance to the same einhaltend.
The contour of the bone plate 10 substantially follows the approach geometry of the tibial tuberosity 47 and is preferably attached to the lateral 44 and 45 limit the cranial tibial tuberosity 47 with receiving openings for the fixation of the proximal endosteal fixation elements designed (Fig. 3A).
The bone plate 10 is configured in a further embodiment such that it is substantially the lateral 44, cranial 45 and medial 46 limiting the tibial tuberosity 47 engages, so that the endosteal fixation elements 25 preferably paraligamentary, that is, the patellar ligament
42 gently introduced (FIG. 4B).
The bone plate 10 is designed in another embodiment so that the endosteal
Fixation elements 25 are suitably mounted near the periphery and a central opening 13 is arranged in the central area of ​​the bone plate 10, so that the bone plate 10 is configured in a suitable manner for slidable fixation mechanism 8 (Fig. 4C).
In Fig. 4C, the ligamentum patellae 42, under which the bone plate 10 is positioned, in the drawing as a proximal 51 and distal 52 shown severed.
In Fig. 5A - 5E, the fixation sectors of endosteal fixation elements 25 (Fig. 1) shown in the axial plane: The endosteal lateral (L), center (Z), medial (M) cranial or caudal located endosteal fixation elements 25 are preferably as Sleeve rod elements, insertable for example, as in the plate holes 14 (Fig. 1) sleeves with pins which are carried out by the central holes, designed and are essentially anterior introduced posteriorly in the axial plane.
The lateral endosteal fixation element (L) is introduced in the subchondral region of the lateral femorotibial the compartment that measured from the ventral entry site from, in comparison with the orthogonal alignment in the antero-posterior direction of the neutral position 70 from a position sector at an angle alpha defined by plus or minus 25 degrees from the center 71 by laterally 72 towards, preferably with a deviation of plus or minus 5 degrees (Fig. 5A).
The central endosteal fixation element (Z) is subchondral introduced in the more central region of the lateral femorotibalen the compartment in a suitable manner in ventrodorsal direction with respect to the zero position the axis 73 with a possible positional deviation of an angle beta to a central position 71 by 20 degrees and laterally 72 of 35 degree corresponding to (Fig. 5B).
The medial endosteal fixation element (M) is preferably subligamentär of anterolateral forth in comparison to an angle from the anterolateral oriented to posteromedial zero axis 80 with an angular deviation gamma of 35 degrees to the anterior 74 and 45 degrees to the dorsal-central 75 in the subchondral region the medial femorotibial the compartment is introduced (FIG. 5C).
In a further embodiment the medial endosteal fixation element (M) from ventral paraligamentary forth incorporated in the subchondral region of the medial femorotibial the compartment so that from the ventro-posterior aligned zero position 76, an angular deviation delta of 45 degrees medially 77 up to 20 degrees is defined by the center 71, preferably plus or minus 5 degrees (Fig. 5D).
In a further embodiment at least two endosteal lateral (L) and two endosteal medial (M) fixing elements each of ventral lateral, and anterior medial paraligamentary preferably in the antero-posterior direction subchondral so incorporated that, in relation to ventrodorsal aligned medial zero axis 78 an angular deviation epsilon of 30 degrees in the medial direction 77 or 25 to central 71 is preferably defined by 0 degrees with a deviation of 5 degrees in any direction and with respect to ventrodorsal aligned lateral zero axis 79 an angular deviation zeta of 30 degrees to the lateral 72 and 30 degrees are preferably defined by the center 71 of 0 degree with a deviation of each 5 degrees (Fig. 5E).
In FIG. 6, the fixation sectors of endosteal fixation elements are shown in the sagittal plane: The endosteal lateral (L), center (Z) and medial (M) fixation elements 25 (not shown) are subchondral substantially in the sagittal plane, parallel to the individual aligned Dorsalneigung the medial and lateral tibial plateau 101 and form with respect to the sagittal oriented anteroposterior zero axis 102 an angle deviation aeta of 25 degrees in cranial 103 and 45 degree caudal 104. Preferably, the angle theta in an angle theta from 0 to 90 degrees plus minus 5 degrees to the nail-side clamping surface 7 ( "fixation mechanism") of the localized under the patellar ligament, endomedullary force support, ie designed of the intramedullary nail. 1
In FIGS. 7A, 7B, 7C, 7D, 7E appropriate fixation mechanisms between the base plate (BP) on the one hand and the force endomedullärem carrier (EMKT) are shown on the other hand:
Finely structured surface fixation mechanism embodiment plate-shaped designed (Fig.
7A):
In this embodiment, the reciprocal fixation mechanism is preferably configured in a plate shape 8, such that the feinstrukurierte in suitably fixation surface of the bone plate 10 or
Base plate with the similarly structured surface of the fixation force endomedullary carrier, or
Intramedullary nail 1 to the mutual angle stable fixation by means of a compression mechanism 9 when
intervenes under pressure bringing the fixation surfaces.
Fine toothed fixation mechanism embodiment convex-concave designed (Fig. 7B): In this embodiment, the fixation mechanism of the surface of the bone plate 10 and base plate is fine-meshed and formed with a ventral preferably convexly curved plate-side clamping surface 16 adapted for stable fixation with fine toothings 140 in the reciprocal posteriorly concavely designed, fine-toothed nail-side clamping face 7 engage on the lower surface 150 of the intramedullary nail 1, and endomedullary force wearer.
Fine toothed fixation mechanism embodiment flat-laid out flat (Figure 7C.): In this fixation variant, the fixation mechanism of the top bone plate 10 'and the bottom bone plate 10 adapted "fine pitch, and preferably designed to anterior flat formed for stable fixation, which in the reciprocal posteriorly and ventral feinverzahnt engage flat-out fixation mechanism 8 of the intramedullary nail 1 and endomedullary force medium: fine-toothed, displaceable fixation mechanism negative pressure bringing the interlocking, fine-toothed surfaces by centrally designed compression apparatus. 9
Fig. 7D shows an intramedullary nail 1 and a bone plate 10 having a sleeve-shaped extension 110 for performing an endosteal bone fixation element 25 through the central opening 13. Further, the nail-side and plate-side clamping surface 7; curved 16, wherein the nail-side clamping surface is curved convexly 7 and the plate-side clamping face 16 corresponding concave.
Fig. 7E shows an embodiment in which an intramedullary nail 1 with a fork-shaped trained proximal end portion 3 and a between the two forks 120; comprises 121 arranged bone plate tenth The compression device 9 for fixing the bone plate 10 to the intramedullary nail 1 comprises here substantially a clamping screw 15, which is carried out through the hole 5 in the second fork arm 121 of the intramedullary nail 1 and the central opening 13 in the bone plate 10 and in a corresponding internal thread 130 in the first fork prong 120 is fixed.
Fig. 8 shows an embodiment of the bone fixation device 20 having a spherically curved bone plate 10. The bone plate 10 includes at the bottom 12 is a groove 91 having a width B, the groove bottom forming the clamping plate side surface 16. For this purpose, the groove 91 is formed such that the groove bottom is a flat surface. The bottom of the groove can be formed depending on the requirements on only a portion of the groove length flat. The nail-side clamping surface 7 of the intramedullary nail 1 has a width b <B, so that the intramedullary nail-side clamping face 7 is displaceable relative to the plate-side clamp surface sixteenth Further, the bone plate 10 includes a continuous from the top 11 to the bottom 12, central opening 13 which is adapted to receive the screw shank 92 of a clamping screw 15 °. The bore 5 in the intramedullary nail 1 is provided with an internal thread 93, so that the clamping screw 15, the hole 5 can be screwed. The clamping screw 15 forms together with the internal thread formed by the threaded connection 93, the compression device 9 for the jamming of the nail-side and plate-side clamping surfaces 7,16.
A possible surgical technique for the inventive bone fixation device is described in order to bring out their function better. The surgical technique is described using the example of a tibia.
1. incision lateral to the patellar ligament, which has the advantage that the stretching apparatus is not destroyed.
2. placing a core hole in the anteroposterior direction mainly parallel to the individual inclination of the tibial plateau in the sagittal plane. The bore axis 6 corresponds to the same 10. The localization takes place outside of the soft tissue approaches the central to the medial part of the lateral tibial plateau in the vicinity of the former growth plate line (proximal Tibiaepiphysenlinie) to the posterior cortex of the subsequent axis of rotation between the intramedullary nail 1 and the bone plate.
3. Removal and retention of the bone cylinder thus formed.
4. application of an incomplete horizontal bone weakening, starting from the core bore and laterally above the proximal joint Tibiofibular-localized with sufficient distance to the subchondral bone plate of the lateral tibial plateau.
5. Implementation of an incomplete undercutting of the tibial tuberosity, which remains substantially connected to the lateral column of the tibia.
6. An outgoing from the first Kembohrung second core bore which is directed substantially toward marrow cavity.
7. Removal and retention of the bone cylinder thus obtained.
8. A Zentrierbohrhülse is introduced in the second core bore such that the inclined plane of the targeted bone weakening and the inclination thereof with respect to the longitudinal axis of the tibia - can be fixed - preferably under fluoroscopic control.
9. incision in the postero-medial tibial rounding.
10. Abscheiben the periosteum over a short distance.
11. Run the cutting tools to match to the core drilling.
12. Create a bone opening or incomplete bone gap in the range predetermined by the bone attenuations levels.
13, control of the mechanical axis, defined as a connecting line between the femoral head and the upper ankle joint center, in such a way that the knee joint intersecting force vector is shifted from the damaged Kniegelenkskompartiment in the non or less damaged by Kniegelenkskompartiment progredientes spreading of the bone parts.
14. After successful verification of the course of new mechanical axis fixation of the relative position of the splayed bone parts against each other to secure bone consolidation by means of the inventive bone fixation device.
With respect to the method steps 2 and 8 carried out it is preferably under the control of the position and orientation of the first core bore by means of imager Fluoronavigation, landmarke specific, computer-assisted technologies.
Other variants of the bone weakening consist in a Z-shaped bone weakening for a right side tibia and in an inverted Z-shaped bone weakening for a left side tibia.
1. bone fixation device
A) (an intramedullary nail 1) extending to a distal end portion (2), a proximal end portion (3), a central line (4) and one (in the proximal end part 3) perpendicular to the central line (4) the bore (5) with the bore axis ( 6); as
B) a bone plate (10) having a top (11), a designed for bone contact bottom face (12), (in the central part of the bone plate 10) is accommodated, the upper side (11) connecting with the bottom (12), continuous, arranged central opening (13) and a plurality of peripherally around the central opening (13), also continuous plate holes (14), characterized in that
(C) (at the proximal end part 3) of the intramedullary nail 1) is formed at least one nail-side clamping surface (7); and
D) the bone plate (10) at least one (for the nail-side clamping surface 7) corresponding plate-side clamping surface (16); so that
E) the two mutually corresponding clamping surfaces (7,16) are mutually displaceable in the unclamped state, and are fixed in the clamped state against each other.
2. The bone fixation device according to claim 1, characterized in that the bone fixation device comprises a compression device (9), by means of which the nail-side and plate-side clamping surface (7,16) are pressed against one another.
3. The bone fixation device according to claim 2, characterized in that the compression device (9) has an internal thread (92) in the bore (5) and through the central opening (13) can be passed and in the internal thread (92) of the bore (5) screwable clamping screw (15).
4. The bone fixation device according to one of claims 1 to 3, characterized in that the intramedullary nail (1) has two nail-side clamping surfaces (7).
5. The bone fixation device according to claim 4, characterized in that the two nail-side clamping surfaces (7) are arranged substantially asymmetrically eccentric to the central line (4).
6. The bone fixation device according to any one of claims 1 to 5, characterized in that the nail-side clamping surface (7) is planar, and a plane B2 defines which d with by the central line (4) and parallel to the plane B2 running diameter of the nail (1) defined plane B1 has an angle alpha of 0 ° to 30 °, preferably 10 ° to 20 °.
7. The bone fixation device according to any one of claims 1 to 5, characterized in that the bore axis (6) orthogonal plane B2 with by the central line (4) and parallel to the plane B2 extending diameter d of the intramedullary nail (1) defined plane B1 a having angle alpha from 0 ° to 30 °, preferably of 10 ° to 20 °.
8. The bone fixation device according to any one of claims 1 to 5, characterized in that the bore axis (6) orthogonal plane B2 parallel to a through Zentralünie (4) and parallel to the plane B2 extending diameter d of the intramedullary nail (1) defined plane B1 runs.
9. The bone fixation device according to any one of claims 1 to 8, characterized in that the nail-side clamping surface (7) in the region of the bore (5) is located.
10. The bone fixation device according to any one of claims 1 to 9, characterized in that the plate-side clamping surface (16) on the underside (12) of the bone plate (10) is formed.
11. The bone fixation device according to any one of claims 1 to 9, characterized in that the plate-side clamping surface (16) at the top (11) of the bone plate (10) is formed.
12. The bone fixation device according to claim 10 and 11, characterized in that both the upper side (11) and the bottom (12) of the bone plate (10) have a plate-side clamping surface (16).
13. The bone fixation device according to any one of claims 1 to 12, characterized in that the plate-side clamping surface (16) formed in the interior of the bone plate (10) and substantially at their lower and upper sides (11, 12) parallel runs.
14. The bone fixation device according to any one of claims 1 to 13, characterized in that the plate-side clamping surface (16) is formed in the region of the opening (13).
15. The bone fixation device according to any one of claims 1 to 14, characterized in that the central line (4), the nail-side clamping surface (7) at an average angle of 1 ° - 20 ° cuts, preferably from 2 ° -10 °.
16. The bone fixation device according to one of claims 1 to 15, characterized in that the proximal end part (3) of the intramedullary nail (1) formed as a separate, modular component.
17. The bone fixation device according to any one of claims 1 to 16, characterized in that between the mutually corresponding clamping surfaces (7,16) an intermediate piece (30) made of a plastically deformable material.
18. The bone fixation device according to one of claims 1 to 17, characterized in that the intramedullary nail (1) is asymmetric, multiplanar curved.
19. The bone fixation device according to any one of claims 1 to 18, characterized in that the mutually corresponding clamping surfaces (7,16) are formed in each planar or spherical or cylindrical.
20. The bone fixation device according to any one of claims 1 to 19, characterized in that the clamping surfaces (7,16) have a three-dimensional structure, preferably in the form of teeth
21. The bone fixation device according to claim 20, characterized in that the teeth in the form of rounded windings, pyramid tips or multilayered polygons are formed from.
22. The bone fixation device according to one of claims 1 to 21, characterized in that the distal end of the intramedullary nail is parabol rounded symmetrical.
23. The bone fixation device according to one of claims 1 to 22, characterized in that the intramedullary nail (1) has at least nine plane-parallel arranged longitudinal grooves.
24. The bone fixation device according to one of claims 1 to 23, characterized in that the distal end of the intramedullary nail (1) is split lengthwise.
25. The bone fixation device according to one of claims 1 to 24, characterized in that the bone plate (10) has a concave curved bottom face (12).
26. The bone fixation device according to one of claims 1 to 25, characterized in that the bone plate (10) has a convex curved top surface (11).
27. The bone fixation device according to claim 25 or 26, characterized in that the bottom (12) and / or the upper side (11) are spherically curved.
having 28. The bone fixation device according to any one of claims 1 to 27, characterized in that the underside (12) of the bone plate (10) has a groove (91) forming with the plate-side clamp surface (16) of groove bottom, a first and a second side wall, and that groove (15) between the first and the second side wall has a minimum width b, which permits an at least partially receiving the proximal end part (3) of the intramedullary nail (1) in the region of the nail-side clamping surface (7) so that the nail-side clamping surface ( 7) (at the plate-side clamp surface 16) comes to rest.
29. The bone fixation device according to claim 28, characterized in that comprises the proximal end of the nail (3) of the intramedullary nail (1) in the region of the nail-side clamping surface (7) has a width B> b.
30. The bone fixation device according to any one of claims 1 to 29, characterized in that the bone fixation device comprises at least one having a longitudinal axis bone fixation element (25).
31. The bone fixation device according to any one of claims 6, 7 or 8 and 30, characterized in that arranged at least one bone fixation element (25) such that the projections of its longitudinal axis into the X, Z plane, the X, Y plane and in the Y, Z plane of a three-dimensional coordinate system with the axes x, y, z for the x-axis relative (in the x, Y plane), to the z axis (in the x 1 Z plane) and z axis (in the Y, Z plane) enclose an angle between 0 ° and 60 °, with the z-axis coaxial with the central line (4) of the intramedullary nail (1) in the region of the nail-side clamping surface (7) and the x-axis orthogonal to the z-axis and extending coaxially to the parallel to the plane (2) extends diameter d of the intramedullary nail (1).
32. The bone fixation device according to any one of claims 6, 7 or 8 and 30, characterized in that the z-axis - in a medullary nail (1) with a curved central line (4) - by the tangent to the central line (4) at the intersection of the center line (4) is formed with the axis of rotation forming the bore axis (6).
33. The bone fixation device according to any one of claims 1 to 32, characterized in that the surface of their components, in particular of the medullary nail (1), the bone plate (10) as well as any bone fixation elements (25) are funkenanodisiert, preferably by means of anodic Funkenanodisierung II.
34. The bone fixation device according to any one of claims 1 to 33, characterized in that the surface of their components, in particular of the medullary nail (1), the bone plate (10) as well as any bone fixation elements (25) with a - containing preferably silver ions - microbicidal coating is provided.
35. The bone fixation device according to one of claims 1 to 34, characterized in that the intramedullary nail (1) is formed asymmetrically.
36. The bone fixation device according to one of claims 1 to 35, characterized in that the intramedullary nail (1) in a first (frontal or latero-medial) plane of a first curvature, and (in a perpendicular to the first plane standing, second sagittal or antero posterior) plane having a second curvature.
37. The bone fixation device according to one of claims 1 to 36, characterized in that it additionally comprises one or more of the following components: a shock-screw, a train-screw comprises a compression screw a screw as bone fixation elements (25)
38. The bone fixation device according to one of claims 1 to 37, characterized in that the intramedullary nail (1) has a preferably continuous cannulation.
39. The bone fixation device according to any one of claims 1 to 38, characterized in that the bone fixation elements (25) are formed as elastic medullary space wires.
40. The bone fixation device according to any one of claims 1 to 38, characterized in that the bone fixation elements (25) sleeves (26) which are press-fitted into receptacles (28) in the bone plate (10) and whose central bores the implementation of bone screws allow.
41. An implant for endosteal and endomedullary fixation of bones, especially tibia fractures, tibial osteotomies, tibial plateau fractures, or tibial osteotomies comprehensively
42. The implant of claim 41, characterized in that the upper part (23) at least one, preferably a plurality of bone fixation elements (25).
comprises 43. The implant of claim 41 or 42, characterized in that the upper part (23) at least a lateral bone fixation element (L), at least one central bone fixation element (Z) and at least a medial bone fixation element (M).
44. Implant according to one of claims 41 to 43, characterized in that the at least one bone fixation element (25) comprises a sleeve (26) having a central bore and a feasible through the central bore bone screw.
45. Implant according to one of claims 41 to 44, characterized in that the at least one bone fixation element (25) comprises a bone screw (27).
46. ​​Implant according to one of claims 41 to 45, characterized in that the upper endosteal lateral fixing device (L) follows the lateral tibial head with respect to the orthogonal alignment in the sagittal and coronal plane of the individual shin configuration and suitably from ventral inlet region of the endosteal lateral (L ) fixation means, having in axis deviation in the axial plane in the sense of a suitable position of the sector, an angle alpha with respect to the antero-posterior zero position of 0 to 25 degrees to the central and from 0 to 25 degrees to the lateral, preferably as an angle alpha of 0 to designed 5 degrees to the central and lateral back.
47. An implant according to any one of claims 41 to 46, characterized in that the upper, endosteal lateral fixing device (L) aeta with respect to the sagittal inclination of the tibial plateau and in relation to the anteroposterior axis of alignment in the sagittal plane in a suitable position sector, an angle of 0 to 25 degrees in cranial, and at an angle aeta from 0 to 45 degrees is designed caudal, with respect to the sagittal axis of the bore of the endomedulläen force the carrier in a sagittal angle theta from 0 to 110 degrees, preferably configured from 0 to 25 degrees, with a sufficient distance to the immediately subchondral mindestem of 1mm to 3mm, tibia-side portions of the medial and lateral femoro-tibial joints, as well as the compartment of the joint area of ​​the proximal tibio-Fibulargelenkes and the Area intercondilaris anterior and posterior Area intercondilaris the Schienbeinkopfepiphyse.
48. An implant according to any one of claims 41 to 47, characterized in that the upper, lateral endosteal fixation means (L) with at least one upper epi-, meta-, diaphyseal lateral (L), center (Z), medial (M) fixation means of the upper part, that the upper part with at least an average epi-, meta-, diaphyseal central part, and that the central part is designed with at least one lower diaphyseal endosteal, exostalen.endomedullären fixation part of the lower part connected in a suitable manner.
49. An implant according to any one of claims 41 to 48, characterized in that the upper, endosteal, lateral fixing device endosteal (L) with at least one endosteal, lateral (L), center (Z), medial (M), exostalen and endomedullary fixing means is stably connected in a suitable manner, regardless of whether axes, length, and angular adjustments have been made.
50. An implant according to any of claims 41 to 49, characterized in that the upper endosteal lateral (L), center (Z), medial (M), epi-, metaphyseal endosteal fixation means having at least a distal endomedullary, exomedullär, endosteal, exosteal mounted fixation means (lower part of the orthopedic, traumatological base implant) axis in a suitable way, length, and are angularly stable manner.
51. An implant according to any one of claims 41 to 50, characterized in that the upper, at least one, endosteal lateral epi-metaphyseal fixing means (L) in a suitable epi-type having a typically similarly configured central (Z) and medial (M), meta-.diaphysären endosteal fixation means is connected, the endomedullary central fixation means with respect to an anteroposterior orientation or zero axis in the axial plane than at an angle beta of 0 to 25 degrees to the center than at an angle beta from 0 to 45 degrees to the lateral adapted in the sagittal plane with respect to the anteroposterior zero axis as an angle deviation aeta from 0 to 25 degrees in cranial direction and an angular deviation of 0 to 25 degrees aeta designed in caudal direction.
52. An implant according to any one of claims 41 to 51, characterized in that the endosteal lateral F ixations medium (L) and the endosteal central Fixatiosmittel (Z) according to claim 36 for the lateral (L) and according to claim 41 (for the central Z) designed fixing means, with at least one endosteal medial (M) fixing means are connected, the endosteal medial fixation means (M) with respect to a generally 45 degree oriented obliquely to the anteroposterior axis of the tibia zero axis at an angle gamma of 0 - designed 45 degrees anterior to an angle gamma of 45 degrees 0- posteriorly in the sagittal plane with respect to an anteroposterior zero axis as an angle deviation aeta from 0 to 25 degrees in cranial direction and as one. Aeta angular deviation of 0 to 25 degrees in caudal direction designed.
53. An implant according to any one of claims 41 to 52, characterized in that the endosteal lateral (L) and the endosteal central (Z) Fixation element in accordance with claim 36 for the lateral (L) and in accordance with claim 41 for the central (Z) endosteal fixation element adapted, characterized in that the endosteal medial fixation means an angle delta is configured from 0 to 75 degrees to the ventral sector boundary (M) with respect to a ventrodorsal oriented zero axis delta of 0 to 20 degrees to the central sector boundary and an angle.
54. An implant according to any of claims 41 to 53, characterized in that the endosteal fixation elements of at least two central and medial least two, or at least two lateral and medial least two, each of ventral paraligamentary introduced endosteal more or less in the anteroposterior direction oriented fixing means whose zero medial axes epsilon an angle, lateral forming an angle zeta, is designed.
55. An implant according to claim 41 and claim 48 for the central (Z), and claim 43 for the medial endosteal fixation means (M), characterized in that the central (Z) and medial (M) endosteal, epi-, meta-, diaphyären fixation means are adapted by means of a suitable device with at least one central, intermediate (I) and at least one lower diaphyseal endostalen- endomedullary fixing part.
56. An implant according to any one of claims 41 to 55, characterized in that the intermediate fixing means, designed as a central part, between the individual endosteal lateral (L), endosteal central (Z) and endosteal medial (M) fixation elements of the upper part and the endomedullary fixing parts the lower part (the distal, endomedullary power carrier) against each other typically angled at an angle of 0 to 30 degrees, displaceable towards each side of 0mm to um_halbe tibial stem width to 3cm displaceable in length by 0cm and after correction in an ideal position are stable again connected, adapted to each other.
57. An implant according to any one of claims 41 to 56 characterized in that the endosteal epi-, meta-, diaphyseal fixation means of pipes, parts of pipes, cylinders, parts of cylinders, tubes, parts of sleeves, bars, parts of rods, plates , parts of slabs, plates, parts of plates, nails, bolts, screws, staves, elastic nails, T and U-profiles, polygonal elements and locking bolt, locking nails, locking screws, bendable screws, bolts or other fixation devices consist, preferably are guide sleeves and fixed therein rod-shaped elements in the upper region of the tibia with an intermediate fixing means (I), preferably designed as a base plate and fixed with preferably bent designed endomedullary (D) fixation elements in the upper, middle and distal portion of the tibia.
58. An implant according to any of claims 41 to 57, characterized in that the intermediate fixing means (I) which with the meta-, dia- the endosteal epi-metaphyseal fixing means epiphyseal, endomedullary fixing means connect from, the external and internal architecture of the tibial and its surface, as well as adapted from the adjacent soft tissue elements consist preferably used as supporting plates with mutual gearing, as trunnion rotary plate members as a ball and socket elements, a fork-and-tenon elements, as a hinge devices as a turntable - pivot elements as ball -Stabelemente are designed.
59. An implant according to any of claims 41 to 58, characterized in that the intermediate fixing means, the central part, as a bone plate (10) or base plate (BP) is designed, which is opposite the front surface of the tibial head typically down with elevations and projections against the bone directed is supported at a distance of 0.1 mm to 4 mm and the anterior tibial limit up to a maximum lateral (outer) edge of the tibial head laterally and above the tibial tuberosity suitably patellae behind and adjacent to the ligament and the attachment zone (in the central tibial area is Apophyse) across to the medial rounded tibial surface covered and surrounds and is designed as a base plate for the fixation suitable endosteal, endomedullary fixing means.
60. An implant according to any one of claims 41 to 59 and base plate (BP) according to claim 59, characterized in that the base plate to one-third (usually 1-33%), (two-thirds usually 34-66 %) or more than two thirds (is sunk usually 67-100% in the ventral region of the tibia head, with respect to the center of the tibial tuberosity construed to 30 mm in a radius of 5 mm, at least 0.1 mm distance comprising the patellar ligament approach designed.
61. An implant according to claims 41 and 60 characterized and designed such that the base plate, the paraligamentären lateral and medial surfaces of the tibia and the tibial surface centrally patellae under the ligament underlying, front covers and introducing at least one paraligamentary introduced anterior endosteal fixation elements technically possible.
62. An implant according to claims 41 and 61 characterized in that the base plate adapted, in another embodiment, a directly integrated in the base plate, endosteal fixed in the upper lateral (L), center (Z) or media (M) area of ​​the tibial part of fixation means having.
63. An implant according to claims 41 and 62, characterized in that the endomedullary fixation element is verdrehsicherbar set in a further embodiment to a central fixation mechanism, wherein the fixing elements of the base plate are designed as slot-shaped receiving openings to the upper and lower fixation of the endomedullary power transmitter in the base plate.
64. An implant according to any one of claims 41 to 63, characterized in that the base plate and the endomedullary fixation part, the turntable mechanisms are designed as fine-toothed pivot which ensures the stable fixation of the endomedullary force support to the base plate regardless of any necessary correction of the fragment position.
65. implant base plate (BP) and endomedullary load carrier (EMKT) according to claims 41-64 characterized in that the upper lateral (L), center (Z) and medial (M) epi-meta diaphyseal fixation means in a suitable manner on the required shift relative to each other, designed stable angle and offset to ensure connected to one another.
66. implant base plate and endomedullary load carrier according to any one of claims 41 to 65, characterized in that fixedly connected in a suitable manner with the intermediate fixing means of the base plate, the lower endomedullary fixation means is preferably designed as a sector of a sphere having a second kongruenten_Kugelsektorelement connected in the sense that angle adjustments are possible and are kept fixed by means of suitable fixation mode.
67. implant base plate and endomedullary load carrier according to claim 41 and claims 63,64 and 65, characterized in that the endomedullary fixation means, the endomedullary load carrier (EMKT) for stabilizing tibia fractures, tibial osteotomies arranged proximally at least one integrated in the EMKT support plate providing adapted for paraligamentären, retroligamentären endostalen.Fixation in a suitable manner.
68. Implant and endomedullary load carrier according to claims 41 and 66 characterized in that the fixation means is lower endomedullary endomedullary against the distal main fragment by suitable fixation means, endosteal, exosteal and adapted for fixation in its course transosseous
69. Implant and endomedullary load carrier according to claims 41 and 68 characterized in that the endomedullary load carrier (EMFK) suitably connected to the distal and proximal tibial main fragment by means of suitable fixation devices, and after the relative position change of the tibial main fragments against each other again in a suitable way angle, rotation and is designed in part load stable.
70. means with the aid of the orthopedic / traumatologic implant base (OTGI), the base plate (BP) of the endomedullary curved load carrier (EMKT) and the intermediate parts are produced according to claims 1-69.
71. Instrument set for positioning of the products according to claims 1-70.
72. An apparatus for changing the appropriate position OTGI, the BP and the EMKF according to claims 1-71.
73. A method for endosteal and endomedullary fixation of bone, especially tibial fractures, tibial osteotomies, tibial plateau fractures or tibial osteotomies by means of implants, characterized in that targeted bone weakenings are generated for the plastic formability of the bone in at least three different levels of the bone to be treated.
74. A method according to claim 73, characterized in that the bone weakenings are created by drilling or sawing.
75. The method of claim 73 or 74, characterized in that simultaneously autologous bone structured material is obtained with the bone weakening.
EP20050815861 2004-12-23 2005-12-22 Bone fixing device Active EP1827271B1 (en)
EP1827271A2 true EP1827271A2 (en) 2007-09-05
EP1827271B1 EP1827271B1 (en) 2009-12-02
EP20050815861 Active EP1827271B1 (en) 2004-12-23 2005-12-22 Bone fixing device
See references of WO2006066440A2 *
JP4922184B2 (en) 2012-04-25
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Owner name: STAUBLI, HANS ULRICH