Method for the reproducible production of defined bone fractures.

专利摘要:
The invention relates to a method for the reproducible production of defined bone fractures with accompanying soft-tissue injuries in preparations comprising bones and soft tissues, in particular in human preparations. In the method, a defined force impulse is exerted on the fixed preparation (106) and the change in the length of the preparation (106) along the force rector is limited to a maximum of 80 mm. The preparations produced by the method according to the invention, in particular human preparations, can be used for the training, education and training of medical personnel, for the development and validation of medical devices, implants and prostheses, for accident analyzes and reports.
公开号:CH713083B1
申请号:CH00370/18
申请日:2016-07-29
公开日:2019-09-13
发明作者:Holz Robert；Ebinger Marc
申请人:Rimasys Gmbh；
IPC主号:

专利说明:

CH 713 083 B1
The invention relates to a method for the reproducible generation of defined bone fractures with accompanying soft tissue injuries in preparations, in particular in human preparations. Devices for using the method and the preparations produced with the aid of the method, in particular human preparations, which are characterized by a defined bone fracture with accompanying soft tissue injuries are described. The preparations produced by the method according to the invention, in particular human preparations, can be used for the training, education and further training of medical personnel, for the development and validation of medical devices, implants and prostheses, for accident analyzes and expert reports.
In surgical training and further education, there are certified courses in which practical surgery is practiced, with artificial bones or intact, undamaged human preparations serving as "exercise patients" in the practical parts. As a result, there is a large discrepancy between the situation in the training courses and the reality in the operating room. Most of the surgical methods can therefore only be discussed theoretically.
[0003] Artificial bones do not have the same biomechanical properties as human bones. This means that e.g. Screws offer a completely different hold in artificial bones compared to human bones. The different bone qualities of patients also play an important role in everyday clinical practice for the type of care. The choice of implants to be used depends to a large extent on the genetic and age-related bone quality and the inhomogeneous structure of the bone itself. Artificial bones cannot adequately represent these differences. For this reason, handling different medical technology products, such as osteosynthesis materials, screws and implants, or working processes such as drilling and milling with the help of artificial bones, cannot be practiced sufficiently. Another disadvantage is that the soft parts (skin, subcutaneous tissue, muscles, etc.) have not been taken into account in previous courses. It is operated on the "bare" bone and the handling of the soft tissues, which is crucial for the postoperative result, cannot be taught with this method.
Therefore, training and further education courses are offered, in which the practical parts of the human preparation are carried out. Surgery can be carried out on human specimens with a preserved soft tissue covering, but the bones and surrounding soft tissues are intact. Osteosynthesis materials can only be attached to the intact bone. This is trivial for advanced doctors. For this reason, the claim of this further training can be regarded as inadequate. So far there are no specimens with realistic bone fractures, i.e. Bone fractures with accompanying soft tissue injuries, as they occur in real accidents. A realistic education and training with realistic bone fractures and realistic soft tissue injuries is currently not possible.
In practice, attempts are made to compensate for the problem of non-existing bone fracture in human preparations by direct, invasive force acting on the preparation. Bone fractures are created by the participants themselves using tools such as a saw, chisel, hammer or surgical instruments on human preparations. A high amount of energy must be applied to the preparation. Current practice leads to collateral damage to the specimen and poor quality of both the bone fractures generated as a result and the soft tissues surrounding the bone. Through this direct force application, the target area can usually be controlled with certainty under sight, but the direction of the force applied does not match the line of action in a real accident mechanism. Due to the direct application of force, the soft tissue jacket is opened and the soft tissues surrounding the bones are damaged massively and unrealistic. The bone fractures that arise in this way therefore do not correspond to those in real bone fractures caused by indirect force. In particular, they differ in terms of their geometry and the nature of the bone fragments involved from the typical fracture patterns that arise in a real accident. In addition, no typical accompanying ligament injuries (on capsules, ligaments and tendons) are generated. The manual application of force with tools from non-standardized heights and angles leads to different results on the specimen and is not standardized. The individuality of the preparations in morphology and geometry is not taken into account.
The other methods known in the prior art are simple physical experiments in which high energies are conducted into preparations. The questions were always concerned with how an injury occurs or how preparations react when they are exposed to a possible injury mechanism in a practical experiment.
Amis, A. and Miller, J. (1995) Injury Voi. 26, No. 3: 163-168 examined the development of elbow fractures on 40 specimens in which the bone was surrounded by subcutaneous soft tissue. The bone was dissected free at one end, poured into polymethacrylate bone cement, attached to a mass of 60 kg and hung horizontally on two rods. The mass of 60 kg should simulate the inertial properties of the human torso. The injuries in the specimen were generated by means of a deflectable pendulum with a mass of 20 kg, which struck the specimen from various deflections. The prepared humeral shaft was fixed using an angle-adjustable device in such a way that the flexion and extension movement of the elbow joint was in the plane of movement of the pendulum. Force shock tests were carried out with different elbow flexion and forearm rotation. The location of the initial contact of the pendulum with the specimen could not be specified exactly, so that both forearm bones were loaded simultaneously or only one initially. With a hit rate of 37.5%
In CH 713 083 B1, a distal radius fracture was created with flexion angles from 0 to 80 degrees and force surges from 0.3 to 6.1 kN. An ulna fracture was produced with a hit rate of 32.5% at flexion angles from 60 to 135 degrees and force surges from 2.1 to 6.8 kN.
McGinley, J. et al. (2003), The Journal of Bone and Joint Surgery: 2403-2409 positioned human specimens in a vertical position with respect to a gravitationally accelerated mass of 27 kg, which was dropped onto the clamped specimens from a height of 90 cm. After the impact, the mass was braked by two springs to prevent the specimens from being crushed. With a given forearm rotation of 2, 4, 6 and 8 degrees (5 +/- 2.6 degrees), a proximal radial fracture with accompanying distal ulna fracture was generated in the clamped specimens. With a given forearm rotation of 40, 41, 42, 45, 50 and 53 degrees (44.4 +/- 5.2 degrees) an isolated radius head fracture was generated and Essex-Lopresti fractures with a given forearm rotation of 51, 54, 58, 90, 108 and 110 degrees (70 +/- 25.2 degrees). A proximal radial fracture with accompanying distal ulna fracture was found in 4 of 20 specimens (i.e. hit rate 20%), the isolated radial head fracture in 7 of 20 specimens (ie hit rate 35%) and an Essex-Lopresti fracture in 9 of 20 specimens (ie hit rate 45%). In the studies by McGinley et al. the soft parts of the forearm were left untouched, but the hand was completely separated from the arm. A realistic fall on the outstretched arm could therefore not be shown. It was not checked whether the fractures generated correspond to those of reality. A specification about deformation or compression of the specimens by the device used was not given.
McGinley, J. et al. (2006), Skeletal Radiol. 35: 275-281 examine the injury patterns of IOM (interosseous membrane) in human preparations.
[0010] In Delye, H. et al. (2007), Journal of Neurotrauma 24: 1576-1586, skull fractures were created on skull preparations without a soft tissue coat using a mechanical pendulum with a mass of 14.3 kg and a pendulum length of 128 cm.
Fitzpatrick, Μ. et al. (2012), J. Orthop Trauma, Voi. 0, No. 0: 1-6 examined specimens without soft tissue sheath, which were twisted, clamped in a machine and compressed. The force was used to test the failure limits of biological material and did not simulate a real accident. Defined fractures were not created.
Masouros, S. et al. (2013), Annals of Biomedical Engineering, DOI: 10.1007 / s10439-013-0814-6 examined the effects of an explosion on the lower extremity. For this purpose, specimens were fixed in two different positions (standing and sitting position), with the shoe foot attached to the cover of a printing cylinder. Gas was pumped into the cylinder until the pressure inside the cylinder was so great that the lid was accelerated upwards against the preparation. Various injuries were randomly generated in this study, but fractures that were not specifically defined were produced.
Henderson, K. et al. (2013), “Biomechanical Response of the Lower Leg under High Rate Loading” IRCOBI Conference 2013 also examined the lower extremities in preparations without a soft tissue jacket. The specimens are clamped in a device and dropped onto the specimens from a height of 1 to 2.3 m, weighing 38.5 to 61.2 kg, and the fractures produced are examined.
Robert Holz (2013) (master thesis "The Mechanism of Essex-Lopresti: Investigation of Tissue Failure Using a Newly Developed Simulator") used a gravity-accelerated falling body simulator to examine the biomechanics and injury order of the Essex-Lopresti fracture. For this purpose, the human preparations were freed, i.e. Skin and subcutaneous tissue including the muscles removed and the arms except for the IOM (interosseous membrane) and the joint capsules around the elbows and wrists. Holz describes the alignment and clamping of the preparation in the simulator, the optical analysis of the fracture generation and the determination of the horizontal and vertical as well as the relative movement of the segments during fracture generation. The Essex-Lopresti fracture was from wood in 4 out of 30 cases, i.e. with a hit rate of 13.3%, can be produced in preparations without a soft tissue jacket.
Marc Ebinger (2013) (master thesis "Design and evaluation of a novel simulator for high-speed injuries of the human forearm") discloses a drop test bench for generating axial shock loads. Piezoelectric force sensors were used to record the force curve. The kinematics were recorded using three high-speed cameras. The test rig was used to generate and analyze Essex-Lopresti, Monteggia and Galeazzi injuries in human specimens without a soft tissue coating. Ebinger recommends designing adapters for further work to standardize the fixation of the specimens so that sources of error by the operator are minimized.
Dieter Fink (2013) (master thesis «Concept and creation of a software package for synchronization, data acquisition and measurement signal display to simulate the Essex-Lopresti») discloses the selection of suitable measurement technology and methods of evaluating the measurement results to clarify and validate the sequence of injuries during the development an Essex Lopresti on human preparations.
Wegmann, K. et al. (2014), Acta Orthopaedica, 85 (2): 177-180 investigated the development of an Essex Lopresti on human preparations without a soft tissue coat. For this purpose, the freely prepared bones were marked and
CH 713 083 B1 with a device with gravitationally accelerated falling body bone fractures. The course of the injury was analyzed with high-speed cameras.
Deborah R. Marth (2002) (dissertation "Biomechanics of the shoulder in lateral impact") examined the injuries on twelve whole-body corpses in a car accident when a side impact occurred. The corpse specimens were placed on a chair, tied, and the head raised using a pulley system to allow the human specimen to stand upright. Accelerometers were attached to the specimen at different anatomical corners, with no bone preload. The side impact was carried out using a pneumatic machine in the form of a cylinder (23.4 kg). The center of the cylinder was centered on the acromion visible from the side. The preparations were divided into two groups. One group (n = 6) received the blast at a speed of 4.47 m / s (group A), the other (n = 6) at 6.71 m / s (group B). X-rays were taken for evaluation and autopsies were performed. In Group A, the most common injuries were broken ribs. In group B, 5 out of 6 specimens had either a clavicular fracture (exact location is not mentioned) or an acromion fracture and at least 4 broken ribs. With a cylinder speed of 5.7 m / s, an impact force of 2916 N and a deformation stiffness between Acromion and the T1 vertebra of 23%, the probability of a serious shoulder injury (AIS 2+) was 50%. Critical comments on the study design were made regarding the accuracy of the power surge in combination with the different anthropometric characteristics and soft tissue masses of the test specimens. Marth noticed that the stroke was not always the same, which is why the specimens exposed to the simulated accident scenario showed accidental injuries.
[0019] The bone fractures generated in the prior art are random products. No methods are known with which defined bone fractures can be created in a targeted manner.
[0020] Bone fractures can be divided into defined fracture classes. The defined bone fractures are the same in terms of their location and their fracture pattern or, if one takes into account the individual anatomical deviations in the accident victims, very similar. The defined bone fractures are also the same or very similar with regard to the accompanying soft tissue injuries in individual accident victims.
For the development of better implants, prostheses, osteosynthesis materials and the better training of medical personnel, preparations with realistic bone fractures are required. Doctors, especially surgeons, must have a certain number of operations in order to obtain their qualifications and to be able to perform operations independently. This costs a lot of time and potentially harms the patient himself by "practicing on the patient". Doctors use certified advanced training courses in which surgical care on human specimens is practiced. So far there are no courses with realistic bone fractures on the preparations.
[0022] Human preparations are body donations. For ethical reasons, there is a need for methods with which defined, realistic bone fractures with a high hit rate can be generated in the preparations. Methods with which bone fractures are randomly generated with a low probability are not suitable for commercial use for ethical reasons.
There is therefore a great need for methods with which defined bone fractures can be produced in a targeted and reproducible manner in human preparations. There is also a great need for the human preparations produced with the aid of the processes and their use for training and further education and for the medical technology industry.
[0024] These tasks are solved by the methods, preparations and devices according to the invention.
The invention relates to a method for generating at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106, characterized in that a defined force shock is exerted on the fixed preparation 106 and the change in the length of the preparation 106 along the force vector to a maximum 80 mm is limited. The change in the length of the preparation 106 is preferably limited to a maximum of 80 mm by setting a defined compression to which the preparation 106 is exposed when the force is applied. The defined bone fracture can be generated in the preparation 106 by the method according to the invention by means of a force shock resulting from a kinetic energy of 5 to 500 joules.
The invention relates to a method for generating at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 as defined in claim 1. The method preferably comprises:
a) fixation of a preparation 106;
b) setting a defined mass and positioning of the defined mass with a holding mechanism 114, 214;
c) setting a defined speed at which the defined mass impacts the preparation 106;
d) setting a defined compression to which the preparation 106 is exposed upon impact of the defined mass when the holding mechanism 114, 214 is released;
CH 713 083 B1
e) setting a defined damping to which the preparation 106 is exposed upon impact of the defined mass when the holding mechanism 114, 214 is released;
f) triggering the holding mechanism 114, 214 to accelerate the defined mass in the direction of the preparation 106;
g) removing the fixation of the preparation 106;
the steps a) to e) can be carried out in a variable order and the setting of a defined damping is optional. The change in the length of the preparation 106 along the force vector is limited to a maximum of 80 mm. This can be achieved by setting a defined compression.
The inventive method leads to the reproducible generation of a defined bone fracture with accompanying soft tissue injuries in a preparation 106 with a probability of at least 50%, preferably at least 55%, 60%, 65%, 70%, 75%, 80%, 85% , 90%, 95%.
In the method, the change in the length of the preparation 106 is limited along the force vector. The reduction in the length of the preparation 106 is preferably at most 80 mm, for example preferably at most 65 mm, particularly preferably at most 52 mm or less. The maximum compression of the preparation is 80 mm, preferably a maximum of 65 mm, particularly preferably a maximum of 52 mm. The defined compression that the preparation experiences when the mass impacts is a maximum of 80 mm, preferably 1 mm to 60 mm, particularly preferably 2 mm to 55 mm.
In a particular embodiment of the method, the force shock is dampened on impact with the preparation. In another embodiment of the method, the impact on the preparation is undamped. In a preferred embodiment of the method, the force shock is exerted by the impact of a defined mass moving in the direction of the specimen at a defined speed. The method according to the invention can be carried out by means of a device 100, 200 according to FIG. 1 or 2. The defined speed in method step d) can be set by using a device 100, 200 by means of a defined head. The defined compression and the defined damping can be set with means for setting the defined damping in the event of an impact 110, 210.
The defined bone fracture can be selected, for example, from shaft fracture of the phalanges, shaft fracture of the metacarpal, radius fracture, distal radius fracture, distal radius fracture extension, distal radius fracture flexion, distal radius fracture die-punch fracture, chapoid fracture, chaperoid fracture, distal radius fracture, chaperoid fracture Terrible Triad, olecranon fracture, Monteggia fracture, Monteggia Iike lésion, Galeazzi fracture, Capitulumfraktur, humerus, distal humerus, proximal humerus, clavicularer shaft fracture, lateral clavicle fracture, medial clavicle fracture, femur fracture, distal femoral fracture, proximal femur fracture, tibial plateau fracture, proximal tibial plateau fracture, distal tibial plateau fracture, talus fracture , Pilon fracture, Calcaneus fracture, Maleoli fracture, Navicular fracture, Patella fracture, Metatarsale fracture, Scapula fracture, Arm fracture, Hand fracture, Ankle fracture, Vertebral fracture, Rib fracture, Sacral fracture structure, foot fracture, metatarsal fracture, hip fracture, luxation fracture.
[0031] The preparation can be a human preparation or an animal preparation. The preparation can be a formalin-fixed preparation, a thiel-fixed preparation or a thawed preparation.
The defined mass has a weight of at least 1 kg, preferably a maximum weight of 72 kg, particularly preferably a weight of 5 kg to 33 kg or 4 kg to 40 kg. The defined mass is positioned in the axial direction, preferably in the vertical direction, with respect to the preparation. The defined mass can be set, for example, by a mass 112 and one or more additional weights 113.
The defined speed of the defined mass on impact with the preparation is at least 0.5 m / s, preferably at least 3 m / s to 10 m / s, particularly preferably 5 m / s to 6 m / s. The defined fall height is, for example, 10 cm to 150 cm, preferably 20 cm to 120 cm.
The defined bone fracture can be generated in the preparation 106 by the method according to the invention by a force shock resulting from a kinetic energy of 5 to 500 joules, preferably 15 to 300 joules. The force that is exerted on the preparation when the defined mass impacts is preferably at least 50 N, preferably at most 34 kN. The kinetic energies generated are, for example, 15-450 joules, preferably 120 to 250 joules (see Table 2).
The defined damping with which the defined mass is braked upon impact with the preparation can be set, for example, with at least one shock absorber, preferably at least one hydraulic shock absorber. The impact can be undamped (defined damping equals zero) or a defined damping can be set (defined damping greater than 0). The defined damping, which is set by means of one or more means for setting the defined damping 110, 210, for example shock absorbers, is, for example, a maximum of 50 mm, preferably from 0 mm to 40 mm, particularly preferably from 5 mm to 25 mm or 37 mm ,
Defined bone fractures are bone fractures that occur in real accidents on the bones. Defined bone fractures are known to the person skilled in the art, for example from the AO classification (Maurice E. Müller: The Compre
CH 713 083 B1 hensive Classification of Fractures of Long Bones in: Μ. E. Müller u. a. (Ed.): Manual of Internai Fixation. 3rd Edition. P. 118 ff.Springer-Verlag, Berlin / Heidelberg / New York / Tokyo 1991, ISBN 3-540-52523-8), orthopedics and trauma surgery essentials (Steffen Ruchholtz, Dieter Christian Wirtz), intensive course for further education (2nd, complete revised and expanded edition, 1155 illustrations, paperback, Thieme Georg Verlag, November 2012 - cardboard - 770 pages), orthopedics and trauma surgery, specialist knowledge according to the new regulations for further training ((2011) 2nd edition, Scharf, HannsPeter; Rüter, Axel; Pohlemann, Tim; Marzi, Ingo; Kohn, Dieter; Günther, Klaus-Peter).
Methods according to the invention for generating fragment fractures (only one fracture gap), piece fractures (up to three additional fragments) and debris fractures (more than three additional fragments) are included. Defined bone fractures include shaft fractures (diaphyseal fractures), fractures close to the joints (metaphyseal fractures) and joint fractures (fractures involving the joint surface and dislocation fractures).
[0038] According to the invention, the defined bone fracture is reproducibly generated using the method. This means that a defined bone fracture is selected and is generated with the method according to the invention with a certain probability, that is to say with a certain hit rate. Reproducible means that the defined bone fracture is generated with a probability of at least 50%, preferably at least 60%, 70%, 80%, 85%, 90%, 95% or more. The method according to the invention enables for the first time the foreseeable generation of defined bone fractures in preparations (no coincidence). This enables ethically justifiable production of human preparations with defined bone fractures for commercial use. The reproducibility also leads to a significant cost reduction in all areas in which these preparations are required, since fewer rejects are produced.
The accompanying soft tissue injuries generated by the method according to the invention are characteristic of the respective defined bone fracture and are therefore realistic. Open and closed bone fractures are included. In a preferred embodiment of the method, defined bone fractures with a closed soft tissue jacket are generated. The accompanying soft tissue injuries characteristic of the respective defined bone fractures are known to the person skilled in the art, for example from Tscherne H., Yesterday H.-J .: Pathophysiology and classification of soft tissue injuries associated with fractures. In: Fractures with soft tissue injuries. Tscherne H., Götzen L .: Berlin; Springer Verlag (1984), pp. 1-9.
The preparations produced with the aid of the method according to the invention are also described.
A bone-fractured preparation, in particular human preparation, with at least one defined bone fracture and accompanying soft tissue injuries is described, obtainable by the method according to the invention or produced by the method according to the invention. Preparations with defined bone fractures and accompanying soft tissue injuries have so far not been able to be created artificially. So far, these injuries have only occurred in real accidents involving living people. Corresponding preparations can be produced for the first time using the method according to the invention.
A bone-fractured preparation, in particular human preparation, with at least one defined bone fracture with accompanying soft tissue injuries is described. The preparation preferably includes a bone fracture with accompanying soft tissue injuries selected from shaft fracture of the phalanges, shaft fracture of the metacarpal, radius fracture, distal radius fracture, distal radius fracture extension, distal radius fracture flexion, distal radius fracture die fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture, fracture radius fracture , olecranon fracture, Monteggia fracture, monteggia-Iike lésion, Galeazzi fracture, Capitulumfraktur, humerus, the distal humerus, proximal humerus, clavicularer shaft fracture, lateral clavicle fracture, medial clavicle fracture, fracture of the femur, distal femur fracture, a proximal femur fracture, tibial plateau, the proximal tibial plateau fracture, distal tibial plateau, talus fracture, pilon fracture , Calcaneus fracture, maleoli fracture, navicular fracture, patella fracture, metatarsal fracture, scapula fracture, arm fracture, hand fracture, ankle fracture, vertebral fracture , Rib fracture, sacrum fracture, foot fracture, metatarsal fracture, hip fracture, dislocation fracture.
[0043] According to the invention, a soft tissue covering is understood to mean all of the body's own tissue that surrounds the bone of a preparation. The biological tissue that surrounds the bone is more elastic, more malleable (softer) than the bone. The term “soft tissue coat” includes the main groups: muscles, ligaments, tendons, joint capsules, nerves, skin and vessels. Other components are fascia, connective tissue, periosteum, bursa. These biological structures have different functions and morphology and therefore show different mechanical properties. Due to these different properties, these structures react differently to injury mechanisms. In real accidents, there is therefore different damage to the different tissues. This tissue-specific damage in a bone fracture is therefore also called "typical" or "accompanying soft tissue injuries".
[0044] The preparation is preferably characterized in that the soft tissue jacket is closed. Alternatively, the preparation is characterized in that the soft tissue jacket is open. With the method according to the invention, preparations with defined bone fractures can be produced in which the soft parts have injuries. In addition, specimens with defined bone fractures can be created with the soft tissue covering open. These are openings that can arise when pointed or sharp-edged bone fragments penetrate the soft tissues and ultimately the skin. It is clearly recognizable that the openings in the skin and the penetration of the soft parts take place from the inside out. This is due to the shapes and shape of the openings
CH 713 083 B1 as well as the damaged tissues underneath. These bone fractures can thus be clearly distinguished from those in which the soft tissues are damaged from the outside in.
[0045] Particular embodiments of the invention relate to processes for their production in detail.
Method, characterized in that the defined bone fracture is a shaft fracture of the phalanges and the defined compression of the preparation 106 is set to 2 to 8 mm and the defined damping to 0 to 5 mm. Preparation comprising a shaft fracture of the phalanges with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a shaft fracture of the metacarpal and the defined compression of the preparation 106 is set to 6 to 14 mm and the defined damping to 0 to 9 mm. Preparation comprising a shaft fracture of the metacarpal with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal radius fracture and the defined compression of the preparation 106 is set to 20 to 36 mm and the defined damping to 6 to 17 mm. Preparation comprising a distal radius fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal radius fracture extension of the classification 23 A2, 23 C1-C3 (dorsal) according to AO and the defined compression of the preparation 106 to 22 to 30 mm and the defined damping to 6 to 14 mm is set. Preparation comprising a distal radius fracture extension of the classification 23 A2, 23 C1-C3 (dorsal) according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal radius fracture of the classification 23 A2 (palmar) according to AO and the defined compression of the preparation 106 is set to 25 to 35 mm and the defined damping to 5 to 17 mm. Preparation comprising a distal radius fracture of classification 23 A2 (palmar) according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal radius fracture / die-punch fracture of the classification 23 C1-C2 according to AO and the defined compression of the preparation 106 to 22 to 31 mm and the defined damping to 9 to 15 mm is set. Preparation comprising a distal radius fracture die punch fracture of classification 23 C1-C2 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a radius fracture / chauffeur fracture of the classification 23 B1 according to AO and the defined compression of the preparation 106 is set to 20 to 28 mm and the defined damping to 6 to 14 mm. Preparation comprising a radius fracture chauffeur fracture of classification 23 B1 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a scaphoid fracture 72 A2, B2-B3 according to AO and the defined compression of the preparation 106 is set to 24 to 32 mm and the defined damping to 10 to 17 mm. Preparation comprising a shaft fracture of the scaphoid fracture 72 A2, B2-B3 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a radial head fracture 21 B2 according to AO and the defined compression of the preparation 106 is set to 21 to 29 mm and the defined damping to 9 to 15 mm. Preparation comprising a radius head fracture 21 B2 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a coronoid fracture and the defined compression of the preparation 106 is set to 20 to 33 mm and the defined damping to 8 to 16 mm. Preparation comprising a coronoid fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a Terrible Triad and the defined compression of the preparation 106 is set to 24 to 38 mm and the defined damping to 10 to 18 mm. Preparation comprising a Terrible Triad with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is an olecranon fracture and the defined compression of the preparation 106 is set to 4 to 17 mm and the defined damping to 0 to 9 mm. Preparation comprising an olecranon fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a Monteggia fracture and the defined compression of the preparation 106 is set to 28 to 46 mm and the defined damping to 10 to 17 mm. Preparation comprising a Monteggia fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
CH 713 083 B1 Method, characterized in that the defined bone fracture is a Monteggia-Iike lesion and the defined compression of the preparation 106 is set to 30 to 46 mm and the defined damping to 9 to 21 mm. Preparation comprising a Monteggia-Iike lesion with accompanying soft tissue injuries, obtainable by the method according to the invention.
The method, characterized in that the defined bone fracture is a galactic fracture and the defined compression of the preparation 106 is set to 24 to 39 mm and the defined damping to 6 to 17 mm. Preparation comprising a galactic fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a capillary fracture and the defined compression of the preparation 106 is set to 14 to 22 mm and the defined damping to 6 to 13 mm. Preparation comprising a capillary fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a humeral fracture and the defined compression of the preparation 106 is set to 26 to 44 mm and the defined damping to 0 to 16 mm. Preparation comprising a humerus fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal humeral fracture and the defined compression of the preparation 106 is set to 26 to 37 mm and the defined damping to 0 to 15 mm. Preparation comprising a distal humeral fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a clavicular shaft fracture and the defined compression of the preparation 106 is set to 4 to 12 mm and the defined damping to 0 to 6 mm. Preparation comprising a clavicular shaft fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a lateral clavicle fracture and the defined compression of the preparation 106 is set to 5 to 14 mm and the defined damping to 0 to 7 mm. Preparation comprising a lateral clavicle fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a proximal humeral fracture 11 B1, B3, C1-C3 according to AO and the defined compression of the preparation 106 is set to 29 to 44 mm and the defined damping to obis 16 mm. Preparation comprising a proximal humeral fracture 11 B1, B3, C1-C3 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal femur fracture and the defined compression of the preparation 106 is set to 31 to 49 mm and the defined damping to 0 to 37 mm. Preparation comprising a distal femur fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a tibia head fracture and the defined compression of the preparation 106 is set to 35 to 47 mm and the defined damping to 10 to 13 mm. Preparation comprising a tibia head fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a talus fracture and the defined compression of the preparation 106 is set to 26 to 48 mm and the defined damping to 0 to 22 mm. Preparation comprising a talus fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a pilon fracture and the defined compression of the preparation 106 is set to 30 to 51 mm and the defined damping to 0 to 25 mm. Preparation comprising a pilon fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a calcaneus fracture and the defined compression of the preparation 106 is set to 25 to 43 mm and the defined damping to 0 to 18 mm. Preparation comprising a calcaneus fracture with accompanying soft tissue injuries, obtainable by the method according to the invention.
Method, characterized in that the defined bone fracture is a distal radius fracture 23 B3 according to AO and the defined compression of the preparation 106 is set to 25 to 36 mm and the defined damping to 10 to 16 mm. Preparation comprising a distal radius fracture 23 B3 according to AO with accompanying soft tissue injuries, obtainable by the method according to the invention.
When carrying out the method, the preparation for fixation is poured in, clamped or clamped at one or more points, preferably at the proximal and distal ends. Before fixation, the specimen can be aligned in a defined geometry.
CH 713 083 B1 In a preferred embodiment, the method for producing at least one defined bone fracture with accompanying soft tissue injuries is carried out in a preparation 106 using a device 100, 200. The device 100, 200 comprises
i. at least one guide column 118, 218, ii. at one end of the guide column 118, 218 a base plate 101, 201, ili. a traverse 109, 209 with punch 111.211, iv. if necessary, at least one means for adjusting the damping upon impact of the defined mass 110, 210,
v. at least one clamping plate for fixing the preparation 107, 207, vi. a mass 112, 212 and possibly additional weight 113, 213 for setting a defined mass, vii. at least one further traverse 115, 215 with at least one triggerable holding mechanism 114, 214 for positioning the defined mass.
The traverse 109, 209, 409 can be adjustable in height or not adjustable in height.
The device 100, 500, 600 can comprise means for testing, for example one or more cameras 528 and / or one or more force sensors 103, 503, in order to continuously increase the reproducibility (the probability) that a defined bone fracture will be generated improve and / or better understand the processes of the various events during the stress. A device 100, 500, 600, which comprises means for testing, can be used to determine one or more parameters selected from the parameters determining the defined mass, the defined direction, the defined speed of the defined mass, the defined geometry of the preparation 106, the defined Compression of the preparation 106, the defined damping upon impact of the defined mass. The procedure for determining defined parameters is described below and can be used by a person skilled in the art to determine the defined parameters in order to generate further defined bone fractures in preparations in an analogous manner.
In a particular embodiment, the device 200 can be dismantled and is therefore more portable. As a result, for example, preparations can be produced on site immediately before each use. This is desirable because the preparations with defined bone fractures and accompanying soft tissue injuries require special storage conditions, which is avoided by making them immediately before use. The subject matter of the invention is a device 200 for carrying out the method according to the invention, which can be dismantled into a drive module 229, 329 and an expansion module 230, 430 for transporting the device.
Described is a drive module 329, 229 for a device 200 for the reproducible generation of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 comprising or consisting of
i. at least one guide column 218, 318, ii. a mass 212, 312 and possibly additional weight 213, 313 for setting a defined mass, ili. at least one traverse 215, 315 with at least one triggerable holding mechanism 214, 314 for positioning the defined mass, iv. optionally a cover 227, 327, characterized in that the drive module does not comprise any means for fixing the preparation 106.
A build-up module 430, 230 for a device 200 for the reproducible generation of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 is described, characterized in that the build-up module 430, 230 does not comprise a defined mass. A build-up module 430, 230 is described for a device 200 for the reproducible production of at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 comprising or consisting of
i. At least one support column 219, 419, ii. a base plate 201, 401 at one end of the support column,
CH 713 083 B1 iii. Means for fixing the preparation 402, iv. at least one traverse 209, 409 with punch stamp 211.411,
v. optionally at least one means for setting the defined damping 210 upon impact of the defined mass and vi. at least one clamping plate 202, 402 for fixing the preparation 106, vii. optionally a panel 227, 427, characterized in that the add-on module 430, 230 does not include a defined mass.
The device 100, 200 should always be specially secured to avoid injuries to persons who use the device 100, 200 for the method. Such a special securing comprises, for example, specially secured holding mechanisms for the defined mass and a cladding 227. The subject matter of the invention is a device 100, 200, 500 or drive module 329, 229 comprising an at least double-secured holding mechanism 214, 314 for positioning the defined mass. Device 100, 200, drive module 329, 229 and / or add-on module 430, 230 comprising at least one cladding 227, 327, 427.
The use of the device 100, 200, 300, 400, 500, 600 for determining one or more parameters selected from the parameters determining the defined mass, the defined direction, the defined speed of the defined mass, the defined geometry of the Preparation 106, the defined compression of preparation 106, the defined damping upon impact of the defined mass. The invention relates to the use of the device 100, 300, 300, 400, 500, 600 for carrying out the method according to the invention. The invention relates to the use of the device 100, 200, 300, 400, 500, 600 to generate a defined bone fracture with accompanying soft tissue injuries in a preparation 106, 506, preferably for the reproducible generation of the defined bone fracture with a probability of at least 50%.
Preparation 106 denotes a dead animal body or part of a dead human body, for example a severed body part (e.g. arm, foot, knee) or part of a dead animal body. The preparation 106 can be frozen. The thawing process is initiated 15 to 24 hours before the bone fracture generation procedure, depending on the objective and anatomical region. For this purpose, the preparation 106 is removed from the cooling (at minus 20 degrees Celsius), the packaging material is removed and stored at room temperature (20 to 22 degrees Celsius). Processing is possible at temperatures from 10 degrees Celsius to 25 degrees Celsius, preferably 15 degrees Celsius to 23 degrees Celsius. A formalin or thiel-fixed preparation 106 can be processed directly without major preparation. The donors of the preparations generally have an age of 78 to 86 years, but the donors can also be older or younger at the time of the donation of the preparations. In a particular embodiment of the method, the preparation 106 comes from a donor with an age of more than 60 years, 70 to 90 years, preferably 78 to 86 years. In a special embodiment of the invention, the preparation 106 according to the invention, which comprises the defined bone fracture with accompanying soft tissue injuries, has an age of more than 60 years, preferably from 70 to 90 years, particularly preferably from 78 to 86 years.
The preparation 106 can be a whole-body preparation or a body part or a defined anatomical region. The preparation 106 can comprise at least one anatomical region selected from the anatomical regions hand and 1 to 5 fingers, wrist, elbow, shoulder, knee, ankle, foot and 1 to 5 toes, hips, pelvis, spine, thorax, ribs. The preparation 106 can comprise at least one joint affected by the force, preferably 1 to 3 joints affected by the force. The joint or the joints can have a joint position in the defined geometry, selected from the neutral position, bent or stretched, rotated, varus or valgus position.
The force is preferably introduced into the preparation not directly, but indirectly, for example via a punch 111, 211, 511 by means of a device 100, 200, 500. The indirect application of force enables the preparation 106, 506 to be fixed exactly. The interface between device 100, 500 and preparation 106, 506 should establish a flush frictional connection, for example by pouring the ends of preparation 106, 506 with a cold-curing polymer such as epoxy resin in a mold 105, 505 and screwing the mold 105, 505 to the device 100, 500.
The specimen 106 can be clamped proximally and / or distally in a defined geometry. The specimen can be rotated through at least one of the clamps by a defined angle and fixed in this defined geometry. The defined geometry of the preparation 106 in relation to the defined force shock when carrying out the method corresponds to the joint position and the joint angles of a person or an animal in relation to the force shock acting in a real accident. The defined geometry of the preparation 106 can easily be determined, for example, by analyzing the course of the accident, for example using documents, images, video recordings and / or eyewitness reports. One or more adapters can be used to fix the preparation 106 in the defined geometry when carrying out the method for producing a defined bone fracture with accompanying soft tissue injuries.
CH 713 083 B1 In one embodiment of the method, a piece of bone is freely prepared at the proximal and distal end of the preparation 106 before the preparation 106 is fixed and poured into a mold 105, 505 in a defined geometry with a hardening material and then fixed at the proximal and distal end in a device 100, 500 with a clamping plate 107, 507 and / or at least one means for fixing the preparation 102, 502. In another embodiment of the method, a piece of bone is freely prepared at the proximal or distal end of the preparation 106 and fixed in a defined geometry with a hardening material into a mold 105, 505 and then at the proximal or distal end before the fixation of the preparation 106 a device 100, 500 with a clamping plate 107, 507 or at least one means for fixing the preparation 102, 502.
According to the invention, the fixation of the preparation 106 is also referred to as clamping the preparation 106.
Each person, e.g. the casualty, and each preparation 106 has three axes of movement (sagital, transverse and longitudinal axes), which in turn span the three body planes (sagital, transverse and frontal planes) (internal coordinate system). The same applies to the room (outer coordinate system), e.g. the device 100. When the preparation 106 is fixed in a defined geometry, the internal coordinate system of the preparation predetermined by the desired joint position of the preparation 106 in the event of an accident is synchronized with the outer coordinate system specified by the device 100, 200, 500. When using a device 100, 200, 500, the outer coordinate system is not variable, but is predefined by the device 100, 200, 500. The inner coordinate system of the preparation 106 is flexible and it is adapted to the outer coordinate system of the device 100, 200, 500 in such a way that when the method according to the invention is carried out, the joint position and possibly the joint angle in the preparation 106 are readjusted, which in the event of an accident occur real conditions that generate defined bone fracture. As a result, the method according to the invention simulates the realistic generation of the defined bone fracture in a preparation 106, 506. Therefore, with the method according to the invention, no random products are generated, but rather specifically selected previously defined bone fractures with the real accompanying soft tissue injuries.
The fixation of the preparation 106 in the defined geometry adjusts the joint position of the real course of the accident in relation to the direction of force acting. The selected clamping of the preparation 106 in the device 100, 200 during the implementation of the method results from the theoretical preparatory work in stages 1 and 2 (see description below) when determining the parameters for a new defined bone fracture. Since the method according to the invention is intended to simulate a real trauma or accident, the preparation 106 is clamped in the device 100, 200 in a defined geometry, which result from accident analyzes. The angle settings of the joints can be made, for example, using a goniometer. Since in the device 100, 200 the impulse transmission takes place through the punch 111, 211, the desired geometry of the joint or joints in the preparation 106 must be able to be represented in relation to the punch 111, 211. This means that a preparation 106 is fixed in a defined geometry to the punch 111, 211 of the device 100, 200. The mechanism of action of a device 100, 200 for generating the defined bone fracture in the preparation 106 is always the same. For example, by means of a gravitationally accelerated, defined mass, which impacts the preparation 106 with a defined kinetic energy from the vertical direction and results in a defined force impact on the preparation 106.
In order to align the preparation 106 in the defined geometry, adapters and molds 105 such as e.g. Pouring devices, foam mats, bandages, tension belts, cold-curing polymers, clips, elbows and other aids are used. As a result, the clamping options for the preparation 106 in the device 100, 200 are very variable and any conceivable defined bone fracture can be produced in this way.
Foam mats or other aids with similar properties can be used to protect the skin of the fractured preparation 106. Foam mats protect the biological structures in preparation 106, for example the wrist area, by passively increasing the area of the force transmission. This prevents the preparation 106 from fracturing below the targeted position.
One or more adapters can be used to align and fix (fix) the preparation 106, which support the alignment and fixation in the defined geometry. For an expert, the geometry of the adapter results from the joint position and the joint angles in the underlying real accident.
For example, groups of accident scenarios can be combined and technical adaptations made for the action mechanism on which this group is based, or adapters can be developed in order to enable the specimens to be optimally clamped in the device 100, 200. For example, the adapter 04 can be used to generate different classes of distal radius fractures. The construction of the respective adapter is based on the orientation of the anatomical structures of the bones in the preparation 106 during a real accident, on the movement of the anatomical region which comprises the bone in question, during the accident and on the mode of operation of the device 100, 200.
The following adapters can be used to clamp or fix a preparation 106 in the defined geometry:
CH 713 083 B1 Adapter 01 has the shape of a shell and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
Adapter 02 (hemisphere) has a spherical surface. The adapter 02 can be supported on the base plate 101, 201 of the device 100, 200. For example, one hand can be moved from the neutral position on the round surface of the adapter 02.
Adapter 03 has the shape of a truncated cone. It can be supported on the base plate 101, 201 of the device 100, 200. The hand can be moved laterally on the inclined surface of the adapter 03 until it has a radial abduction from the neutral position.
Adapter 04 is modeled on a handle or a bicycle handlebar. Adapter 04 can be supported on the base plate 101, 201 of the device 100, 200.
Adapter 05 has an inclined surface with an angle of 15 degrees and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
[0100] Adapters 06 and 07 have the shape of a pin, one end of the pin being rounded and the adapter 06 having an area of approximately 3 cm ² and the adapter 07 having an area of 5 cm ² . The pin is vertical, with the rounded side to the preparation 106 under the punch 111, 211. The end of the adapter 06 or 07 is placed centrally above the desired fracture site. Foam mats can be applied between the surface of the adapter and the preparation 106. The foam mats can have different degrees of hardness and on the one hand prevent the adapter 06 or 07 from slipping off the targeted fracture site, and on the other hand they passively increase the area of the force transmission.
Adapter 08 has an inclined surface with an angle of 30 degrees and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
Adapter 09 has an inclined surface with an angle of 45 degrees and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
The adapter 10 has an inclined surface with an angle of 60 degrees and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
Adapter 11 (double finger table) and adapter 12 (triple finger table) are used for clamping fingers. In the vertical position, the wrist is held in the neutral position and the phalanges of the finger members in question are inserted into the adapter 11 or 12. The self-weight of the punch 111, 211 holds the preparation 106 in the desired defined geometry in this clamping. The adapter 11 or 12 is supported flat on the base plate 101, 201 of the device 100, 200 and can be moved on the base plate 101, 201. With the inserted phalanges, the hand cannot be moved sideways or only out of the neutral position if it does not stand stiffly under the weight of the punch 111, 211, but rather dodges.
Adapter 13 is a humerus box for embedding the humerus and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry.
Adapter 14 is a height-adjustable clavicle frame for fixing the clavicle and can be fixed at various points in the device 100, 200 in order to align a preparation 106 in the defined geometry. The medial end of the clavicle can be fixed in a clamping ring on the adapter 14.
Adapter 15 is an angle plate with which an angle of 90 to 130 degrees can be specified in the preparation 106.
Adapter 16 (sandpit) is a form that can be filled with sand and on which the preparation 106 can be supported. On the bottom of the adapter 16, 106 foam mats can be applied under the supported preparation. The adapter 16 can be filled with quartz sand and screwed onto the base plate 101, 201 of the device 100, 200. The filling quantity of the adapter 16 can vary depending on the defined bone fracture and the preparation 106 used.
Adapter 17 (Knieflexkammer) is based on the model of an inverted vice. This means that adapter 17 applies parallel clamping from two sides to the selected preparation 106. The specimen 106 is thus fixed in a stable manner. The adapter 17 can be screwed to the punch 111, 211. The force shock upon impact of the defined mass on the punch 111, 211 is thereby passed on directly to the preparation 106. The adapter 17 has a shaft joint, by means of which the surface that presses on the preparation 106 can be adjusted. As a result, the force application point can be controlled precisely for the defined bone fracture in the joint.
Adapter 18 (Monteggia clamp) is used for clamping e.g. of the Unteram. The adapter can be fixed on the base plate 101, 201 or at a point on the preparation 106.
In an analogous manner, further adapters can be developed if the defined geometry of the preparation 106 and / or the device 100, 200 so require. Suitable adapters and other aids are known to the person skilled in the art.
In one embodiment of the method, the preparation 106 or a specific anatomical structure in the preparation 106 is fixed centrally under the force application point, for example the punch 111, 111. This will ge
CH 713 083 B1 ensures that the kinetic energy in the right place of the preparation results in the power surge and leads to the defined bone fracture and the accompanying soft tissue injuries. In another embodiment of the method, the preparation 106 is fixed decentrally under the force application point, for example the punch 111, 111, in order to generate the defined bone fracture. The fixation of the preparation 106 can differ according to a defined bone fracture and the anatomical region of the preparation 106. In this case, the preparation 106 is fixed in such a way that it remains fixed during the force shock. The specimen 106 can move during the power surge, but should preferably not deflect or slip. For this reason, in a preferred embodiment of the invention, at least one end of the bone is prepared on the preparation 106 and fixed in a mold 105, for example with a casting resin. In another embodiment of the invention, both ends of the preparation 106 are fixed in a mold 105, for example cast in, for fixation. The mold or molds 105 are fixed in the device 100, 200, for example by means for fixing the preparation 102, e.g. an adjustable slide or a clamping plate 107. If one end of the preparation 106 is not poured in, it is preferably “clamped”. There are two ways to do this: a) the end is clamped between at least two metal jaws - like a vice, e.g. with adapter 17, or b) the end is placed vertically or at a 90 degree angle below the force application point, for example the punch 111, 211, so that the preparation 106 is held in position by its own weight and by the weight of the punch 111, 211 ,
In the methods described below for generating defined bone fractures in preparations 106, 506, a device 100, 200, 300 is used together with 400, 500. A gravitationally accelerated mass is used as the defined mass, which exerts a force shock in the vertical direction on the specimens. The defined speed is therefore set in the device 100, 200, 400, 500 by means of a height from which the defined mass falls on the preparation 106. The defined compression and the defined damping are adjusted 110, 210, 510 by the means for adjusting the damping in the event of an impact. For this purpose, shock absorbers are preferably used in the device 100, 200, 300, 400, 500. When using shock absorbers, the setting is then made over a distance (travel path). The defined damping is then also set as a stretch by the damped portion of the compression.
[0114] A method for generating at least one defined bone fracture with accompanying soft tissue injuries in a preparation 106 using a device 100, 200 comprising the steps
a) selection of a defined bone fracture;
b) selection of a preparation 106;
c) setting a defined mass and positioning the defined mass in a defined direction with respect to the preparation 106 by means of a holding mechanism 114, 214;
d) Aligning the preparation 106 in a defined geometry with respect to the direction from which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is released, with the aid of means for fixing the preparation 101, 102;
e) setting a defined speed at which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is released;
f) setting a defined compression to which the preparation 106 is exposed upon impact of the defined mass when the holding mechanism 114, 214 is released;
g) setting a defined damping with which the defined mass is braked upon impact on the preparation 106 when the holding mechanism 114, 214 is released;
h) triggering of the holding mechanism 114, 214 to accelerate the defined mass in a defined direction onto the preparation 106;
i) removing the means for fixing the preparation 102;
wherein steps b) to g) can be carried out in a variable order.
[0115] The following examples illustrate the method and the preparations 106.
Method for producing a shaft fracture of the phalanges IV (78 A2, B2, C2 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a shaft fracture of the phalanges IV is selected, b) a preparation 106 comprising or consisting of the hand and forearm is selected, c) a defined mass of 5.2 to 9.8 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass points to the Specimen 106 impacts when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 1, e) the defined speed is set to 29 to 46 cm by means of a drop height, f) the defined compression is set to 2 to 8 mm,
CH 713 083 B1
g) the defined damping as the damped component of the compression is set to 0 to 5 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation 106 comprising a shaft fracture of the phalanges IV (78 A2, B2, C2 according to AO), obtainable by the above method for producing a shaft fracture of the phalanges IV (78 A2, B2, C2 according to AO) in a preparation 106 ,
Method for producing a shaft fracture of the metacarpal IV (77 A2, B2, C2 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a shaft fracture of the metacarpal IV is selected, b) a preparation 106 comprising or consisting of hand and forearm is selected, c) a defined mass of 7 to 11.2 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass is directed onto the preparation 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 2, e) the defined speed is set to 35 to 52 cm by means of a drop height, f) the defined compression is set to 6 to 14 mm, g) the defined damping is set to 0 to 9 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered t, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation comprising a shaft fracture of the metacarpal IV (77 A2, B2, C2 according to AO), obtainable by the above method for producing a shaft fracture of the metacarpal IV (77 A2, B2, C2 according to AO) in one preparation 106th
Method for producing a distal radius fracture of the classification 23 A2, 23 C1-C3 (dorsal) according to AO in a preparation 106 with a device 100, 200, characterized in that a) a distal radius fracture of the classification 23 A2, 23 C1 -C3 (dorsal) is selected according to AO, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 16.8 to 19.3 kg is set, d) preparation 106 in a defined geometry in relation to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 3, e) the defined speed is set to 76 to 102 cm by means of the fall height, f) the defined compression is set to 22 to 30 mm, g) the defined damping as a damped portion of the defined compression to 6 to 14 mm is set, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a distal radius fracture of the classification 23 A2, 23 C1-C3 (dorsal) according to AO, obtainable by the above method for producing a distal radius fracture of the classification 23 A2, 23 C1-C3 (dorsal) according to AO in a preparation 106.
Method for producing a distal radius fracture of classification 23 A2 (palmar) according to AO in a preparation 106 with a device 100, 200, characterized in that a) a distal radius fracture of classification 23 A2 (palmar) according to AO is selected, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 16.8 to 20.5 kg is set, d) the preparation 106 in a defined geometry in relation to the direction which impinges the defined mass on the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 4, e) the defined speed by means of a drop height of 82 to 102 cm is set, f) the defined compression is set to 25 to 35 mm, g) the defined damping is set as the damped portion of the defined compression to 5 to 17 mm If the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a distal radius fracture of the classification 23 A2 (palmar) according to AO, obtainable by the above method for producing a distal radius fracture of the classification 23 A2 (palmar) according to AO in a preparation 106.
Method for producing a distal radius fracture / die-punch fracture of the classification 23 C1-C2 according to AO in a preparation 106 with a device 100, 200, characterized in that a) a distal radius fracture / die-punch fracture of the classification ( conditionally) 23 C1-C2 is selected according to AO, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 17 to 23.1 kg is set, d) preparation 106 in one defined geometry in relation to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 5, e) Defined speed is set to 90 to 110 cm by means of drop height, f) The defined compression is set to 22 to 31 mm, g) The defined damping as a damped part of the defined sta is set to 9 to 15 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a distal radius fracture / die-punch fracture of the classification 23 C1-C2 according to AO, obtainable by the above method for producing a distal radius fracture / die-punch fracture of the classification 23 C1-C2 according to AO in a preparation 106.
Method for generating a distal radius fracture / chauffeur fracture of classification 23 B1 according to AO in a preparation 106 with a device 100, 200, characterized in that a) a distal radius fracture / chauffeur fracture of classification 23 B1 according to AO is selected, b) a preparation 106 comprising or consisting of the hand, forearm and upper arm is selected, c) a defined mass of 16.6 to 18.3 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass impinges on the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 6, e) the defined speed is set to 80 to 93 cm by means of a drop height
CH 713 083 B1, f) the defined compression is set to 20 to 28 mm, g) the defined damping as the damped component of the defined compression is set to 6 to 14 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100. The invention relates to a preparation 106 comprising a distal radius fracture / chauffeur fracture of the classification 23 B1 according to AO, obtainable by the above method for producing a distal radius fracture / chauffeur fracture of the classification 23 B1 according to AO in a preparation 106.
Method for generating a scaphoid fracture 72 A2, B2-B3 according to AO in a preparation 106 with a device 100, 200, characterized in that a) a scaphoid fracture 72 A2, B2-B3 according to AO is selected, b) comprising a preparation 106 or consisting of hand and forearm is selected, c) a defined mass of 16.8 to 19.5 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass is directed onto the preparation 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 7, e) the defined speed is set to 75 to 88 cm by means of a drop height, f) the defined compression is set to 24 to 32 mm, g) the defined damping is set to 10 to 17 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the Preparation 106 is removed from the device 100. The invention relates to a preparation comprising a scaphoid fracture 72 A2, B2-B3 according to AO, obtainable by the above method for producing a scaphoid fracture 72 A2, B2-B3 according to AO in a preparation 106.
Method for generating a radius head fracture 21 B2 according to AO or type l-III according to Mason (Br J Surg. 1954 Sep; 42 (172): 123-32. Some observations on fractures of the head of the radius with a review of one hundred cases. MASON ML) in a preparation 106 with a device 100, 200, characterized in that a) a radius head fracture 21 B2 according to AO or type l-III according to Mason is selected, b) a preparation 106 comprising or consisting of hand , Forearm and upper arm is selected, c) a defined mass of 18.3 to 21.5 kg is set, d) the preparation 106 in a defined geometry in relation to the direction from which the defined mass impacts the preparation 106, if the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 8, e) the defined speed is set to 75 to 88 cm by means of a drop height, f) the defined compression is set to 2 1 to 29 mm is set, g) the defined damping is set to 9 to 15 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100. The invention relates to a preparation 106 comprising a radius head fracture 21 B2 according to AO or type l-III according to Mason, obtainable by the above method for producing a radius head fracture 21 B2 according to AO or type l-III according to Mason in a preparation 106.
Process for producing a coronoid fracture (21 B1 according to AO or type III-Regan & Morrey (Regan W., Morrey BF Fractures of the coronoid process of the ulna. J Bone Joint Surg [Am] 1989; 71-A: 1348-54)), conditioned in a preparation 106 with a device 100, 200, characterized in that a) a coronoid fracture (21 B1 according to AO or type l-III Regan & Morrey) is selected, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 18.2 to 22.8 kg is set, d) the preparation 106 in a defined geometry in relation to the direction from which the defined mass is applied to the preparation 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 9, e) the defined speed is set to 75 to 86 cm by means of a drop height, f) the defined one Compression to 20 to 33 mm is set, g) the defined damping is set to 8 to 16 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100. The invention relates to a preparation 106 comprising a coronoid fracture (21 B1 according to AO or type III-Regan & Morrey), obtainable by the above method for producing a coronoid fracture (21 B1 according to AO or type III-Regan & Morrey) in one Preparation 106.
Method for producing a Terrible Triad (21 C1 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a Terrible Triad (21 C1 according to AO) is selected, b) a preparation 106 comprising or consisting is selected from the hand, forearm and upper arm, c) a defined mass of 18.9 to 26.8 kg is set, d) the preparation 106 in a defined geometry in relation to the direction from which the defined mass onto the preparation 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 10, e) the defined speed is set to 85 to WO cm by means of a drop height, f) the defined compression 24 to 38 mm is set, g) the defined damping is set to 10 to 18 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the P device 106 is removed from the device 100. The invention relates to a preparation 106 comprising a Terrible Triad (21 C1 to AO), obtainable by the above method for producing a Terrible Triad (21 C1 to AO) in a preparation 106.
Method for generating an olecranon fracture (21 B1, C1 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) an olecranon fracture (21 B1, C1 according to AO) is selected, b) a preparation 106 comprising or consisting of the hand, forearm and upper arm is selected, c) a defined mass of 17.1 to 20 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass points to the Specimen 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 11, e) the defined speed is set to 61 to 79 cm by means of a drop height, f) the defined compression set to 4 to 17 mm
CH 713 083 B1, g) the defined damping is set to 0 to 9 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100. The invention relates to a preparation 106 comprising an olecranon fracture (21 B1, C1 according to AO), obtainable by the above method for producing an olecranon fracture (21 B1, C1 according to AO) in a preparation 106.
[0127] Method for producing a Monteggia fracture (21 A1, B1 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a Monteggia fracture (21 A1, B1 according to AO) is selected, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 16.8 to 17.9 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass strikes the specimen 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in example 12, e) the defined speed is set to 72 to 88 cm by means of a drop height, f ) the defined compression is set to 28 to 46 mm, g) the defined damping as the damped portion of the defined compression is set to 10 to 17 mm, h) the holding mechanism 114, 214 is triggered i) the preparation 106 is removed from the device 100. The invention relates to a preparation 106 comprising a Monteggia fracture (21 A1, B1 according to AO), obtainable by the above method for producing a Monteggia fracture (conditionally 21 A1, B1 according to AO) in a preparation 106.
[0128] Method for generating a Monteggia-Iike lésion (for example 21 B3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a Monteggia-Iike lésion (for example 21 B3 according to AO) is selected, b) a preparation 106 comprising or consisting of the hand, forearm and upper arm is selected, c) a defined mass of 16.8 to 18.4 kg is set, d) the preparation 106 in a defined geometry with respect to the direction which impinges the defined mass on the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 13, e) the defined speed by means of a drop height of 75 to 92 cm is set, f) the defined compression is set to 30 to 46 mm, g) the defined damping is set as a damped portion of the defined compression to 9 to 21 mm, h) the hold mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation 106 comprising a Monteggia-Iike lésion (for example 21 B3 according to AO), obtainable by the above method for producing a Monteggia-Iike lésion (for example
B3 according to AO) in a preparation 106.
[0129] Method for generating a galactic fracture (for example 22 A3, B3, C1-C3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a galactic fracture (for example 22 A3, B3, C1-C3 according to AO), b) a preparation 106 comprising or consisting of the hand, forearm and upper arm is selected, c) a defined mass of 18.5 to 22.6 kg is set, d) the preparation 106 in a defined geometry in Regarding the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, it is aligned with the aid of means for fixing the specimen 102, for example as described in Example 14, e) using the defined speed Fall height is set to 95 to 107 cm, f) the defined compression is set to 24 to 39 mm, g) the defined damping is set to 6 to 17 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a galactic fracture (for example 22 A3, B3, C1-C3 according to AO), obtainable by the above method for producing a galactic fracture (for example
A3, B3, C1-C3 according to AO) in a preparation 106.
Method for producing a capillary fracture (for example 13 B3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a capillary fracture (for example 13 B3 according to AO) is selected, b) comprising a preparation 106 or consisting of hand, forearm and upper arm is selected, c) a defined mass of 20.5 to 24.2 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass points to the Specimen 106 collides when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 15, e) the defined speed is set to 70 to 81 cm by means of a drop height, f) the defined compression is set to 14 to 22 mm, g) the defined damping as a damped portion of the defined compression is set to 6 to 13 mm, h) the holding mechanism s 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation comprising a capillary fracture (for example 13 B3 according to AO) obtainable by the above method for producing a capillary fracture (for example 13 B3 according to AO) in a preparation 106.
A method for producing a distal humeral fracture (for example 13 B1, B2, C1-C3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a distal humeral fracture (for example 13 B1, B2, C1-C3) according to AO) is selected, b) a preparation 106 comprising or consisting of hand, forearm and upper arm is selected, c) a defined mass of 20.2 to 27.2 kg is set, d) preparation 106 in a defined geometry in With respect to the direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, it is aligned with the aid of means for fixing the specimen 102, for example as described in Example 16, e) using the defined speed Fall height is set to 68 to 81 cm, f) the defined compression is set to 26 to 37 mm, g) the defined damping is set as a damped portion of the defined compression to 0 to 15 mm is ht, the holding mechanism 114, 214 is triggered, i) the preparation
CH 713 083 B1
106 is removed from the device 100, 200. The invention relates to a preparation 106 comprising a distal humeral fracture (for example 13 B1, B2, C1-C3 according to AO), obtainable by the above method for producing a distal humeral fracture (for example 13 B1, B2, C1-C3 according to AO) in one Preparation 106.
A method for producing a clavicular shaft fracture (for example type A and B according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a clavicular shaft fracture (for example type A and B according to AO) is selected, b) a preparation 106 comprising or consisting of humerus, scapula, clavicle and sternum approach is selected, c) a defined mass of 12.3 to 16.5 kg is set, d) preparation 106 in a defined geometry with respect to the direction , from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 17, e) the defined speed by means of falling height to 55 to 68 cm is set, f) the defined compression is set to 4 to 12 mm, g) the defined damping as a damped portion of the defined compression to 0 bi s 6 mm is set, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a clavicular shaft fracture (for example types A and B according to AO), obtainable by the above method for producing a clavicular shaft fracture (for example types A and B according to AO) in a preparation 106.
Method for producing a lateral clavicle fracture (for example type I and II according to Neer (Neer CS 2nd (1963) Fracture of the distal clavicle with detachment of the coracoclavicular ligaments in adults. J Trauma 3: 99-110; Neer CS 2nd ( 1968) Fractures of the distal third of the clavicle. Clin Orthop Relat Res 58: 43-50)) in a preparation 106 with a device 100, 200, characterized in that a) a lateral clavicle fracture (for example type I and II according to Neer ) is selected, b) a preparation 106 comprising or consisting of humerus, scapula, clavicle and sternum approach is selected, c) a defined mass of 10.3 to 21.9 kg is set, d) preparation 106 in a defined geometry in The direction from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered is aligned with the aid of means for fixing the specimen 102, for example as described in Example 18 rubbed, e) the defined speed is set to 57 to 76 cm by means of drop height, f) the defined compression is set to 5 to 14 mm, g) the defined damping is set as a damped portion of the defined compression to 0 to 7 mm, h ) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation 106 comprising a clavicle fracture (for example type I and II according to Neer), obtainable by the above method for producing a clavicle fracture (for example type I and II according to Neer) in a preparation 106.
Method for producing a proximal humeral fracture (for example 11 B1, B3, C1-C3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a proximal humeral fracture (for example 11 B1, B3, C1 -C3 according to AO) is selected, b) a preparation 106 comprising or consisting of humerus, scapula, clavicle and sternum approach is selected, c) a defined mass of 19.2 to 28.8 kg is set, d) the preparation 106 in a defined geometry in relation to the direction from which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 19, e) the defined speed is set to a drop height of 65 to 88 cm, f) the defined compression is set to 29 to 40 mm, g) the defined damping as a damped part of the defined compression is set to 0 to 16 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a proximal humeral fracture (for example 11 B1, B3, C1-C3 according to AO), obtainable by the above method for producing a proximal humeral fracture (for example 11 B1, B3, C1-C3 according to AO) in one Preparation 106.
Method for producing a distal femur fracture (for example 33 C1-C3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a femur fracture (for example 33 C1-C3 according to AO) is selected, b ) a preparation 106 comprising or consisting of the foot, lower leg and thigh is selected, c) a defined mass of 26 to 38.7 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the Defined mass impinges on the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 20, e) the defined speed is set to 99 to 116 cm by means of the drop height , f) the defined compression is set to 31 to 49 mm, g) the defined damping as the damped portion of the defined compression is set to 0 to 37 mm, h) the holder echanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a femur fracture (for example 33 C1-C3 according to AO), obtainable by the above method for producing a femur fracture (for example 33 C1-C3 according to AO) in a preparation 106.
[0136] Method for producing a tibial head fracture (for example 41 B1 according to AO), for example a proximal tibial head fracture, in a preparation 106 with a device 100, 200, characterized in that a) a tibial head fracture (for example 41 B1 according to AO), for example one proximal tibia head fracture, is selected, b) a preparation 106 comprising or consisting of the foot, lower leg and thigh is selected, c) a defined mass of 26 to 31 kg is set, d) the preparation 106 in a defined geometry in relation to the Direction from which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is triggered with the aid of means for fixing the
CH 713 083 B1
Preparation 102 is aligned, for example as described in Example 21, e) the defined speed is set to 96 to 112 cm by means of drop height, f) the defined compression is set to 35 to 47 mm, g) the defined damping as a damped portion of the defined Compression is set to 10 to 13 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a tibia head fracture (for example 41 B1 according to AO), for example a proximal tibia head fracture, obtainable by the above method for producing a tibia head fracture (for example 41 B1 according to AO), for example a proximal tibia head fracture, in a preparation 106.
Method for producing a talus fracture (for example type II, type III according to Hawkins (Leland G. Hawkins. J Bone Joint Surg Am, 1970 Jul; 52 (5): 991-1002) in a preparation 106 with a device 100, 200, characterized in that a) a talus fracture (for example type II, type III according to Hawkins) is selected, b) a preparation 106 comprising or consisting of the foot and lower leg is selected, c) a defined mass of 24.8 to 37, 2 kg is set, d) the preparation 106 is aligned in a defined geometry with respect to the direction from which the defined mass impinges on the preparation 106 when the holding mechanism 114, 214 is triggered, with the aid of means for fixing the preparation 102 For example, as described in Example 22, e) the defined speed is set to 68 to 83 cm by means of the drop height, f) the defined compression is set to 26 to 48 mm, g) the defined damping as a damped part l the defined compression is set to 0 to 22 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The invention relates to a preparation 106 comprising a talus fracture (for example type II, type III according to Hawkins), obtainable by the above method for producing a talus fracture (for example type II, type III according to Hawkins) in a preparation 106.
Method for generating a pilon fracture (for example 43 B3-B4, C1-C3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a pilon fracture (for example 43 B3-B4, C1-C3 according to AO) ) is selected, b) a preparation 106 comprising or consisting of the foot and lower leg is selected, c) a defined mass of 24.7 to 38.5 kg is set, d) the preparation 106 in a defined geometry with respect to the direction , from which the defined mass impacts the specimen 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the specimen 102, for example as described in Example 23, e) the defined speed by means of drop height from 100 to 111 cm is set, f) the defined compression is set to 30 to 51 mm, g) the defined damping is set as a damped portion of the defined compression to 0 to 25 mm, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a pilon fracture (for example 43 B3-B4, C1-C3 according to AO), obtainable by the above method for generating pilon fracture (for example 43 B3-B4, C1-C3 according to AO) in a preparation 106.
Methods for generating a calcaneus fracture (for example type 2A, 2C, type 3AB, 3AC according to Sanders (Sanders R. et al. (1993), Operative Treatment in 120 Displaced Intraarticular Calcaneal Fractures. Clin Orthopedics 290 pp. 87-95) in a preparation 106 with a device 100, 200, characterized in that a) a calcaneus fracture (for example type 2A, 2C, type 3AB, 3AC according to Sanders) is selected, b) a preparation 106 comprising or consisting of the foot and lower leg is selected , c) a defined mass of 24.1 to 32.7 kg is set, d) the preparation 106 in a defined geometry with respect to the direction from which the defined mass impacts the preparation 106 when the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, for example as described in Example 24, e) the defined speed is set to 90 to 98 cm by means of a drop height, f) the defined sta is set to 25 to 43 mm, g) the defined damping is set to 0 to 18 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200 becomes. The invention relates to a preparation 106 comprising a calcaneus fracture (for example type 2A, 2C, type 3AB, 3AC according to Sanders), obtainable by the above method for producing a calcaneus fracture (for example type 2A, 2C, type 3AB, 3AC according to Sanders) in one Preparation 106.
Method for producing a distal radius fracture (for example 23 B3 according to AO) in a preparation 106 with a device 100, 200, characterized in that a) a distal radius fracture (for example 23 B3 according to AO) is selected, b) a preparation 106 is selected comprehensively or consisting of hand and forearm, c) a defined mass of 20 to 23 kg is set, d) the preparation 106 in a defined geometry in relation to the direction from which the defined mass impacts the preparation 106, if the holding mechanism 114, 214 is triggered, is aligned with the aid of means for fixing the preparation 102, e) the defined speed is set to 76 to 102 cm by means of a drop height, f) the defined compression is set to 25 to 36 mm, g ) the defined damping is set to 10 to 16 mm as the damped portion of the defined compression, h) the holding mechanism 114, 214 is triggered, i) the preparation 106 is removed from the device 100, 200. The subject matter of the invention is a preparation 106 comprising a distal radius fracture (for example 23 B3 according to AO), obtainable by the above method for producing a distal radius fracture (for example 23 B3 according to AO) in a preparation 106.
[0141] Further bone fractures can be generated in an analogous manner.
When generating the defined fractures with the method according to the invention, the individuality of the preparations (anatomical, geometric, biomechanical) can influence the defined parameters such as the defined mass, the defined speed, the defined compression, the defined damping and the defined Have geometry. For this reason, a range / value range is specified for these parameters. With the options described
CH 713 083 B1 of the clamping or fixing of the preparation in the device 100, 200 and the setting of the technical parameters in the device 100, 200 result in overlaps in related fractures, e.g. distal radius fracture extension and distal radius fracture flexion. This means that e.g. for a distal radius fracture of classification 23 A2 (dorsal) according to AO, the same clamping is necessary as for a distal radius fracture of classification 23 C1-C3 (dorsal) according to AO. Since the different defined bone fractures differ only minimally with regard to the course of the fracture or the force applied in a real accident, the settings on the device 100, 200 for generating the defined bone fractures hardly differ. In these cases, the individuality of the individual preparation 106 which can be recognized by a person skilled in the art when setting the defined parameters and the fixing or clamping of the preparation 106 must be taken into account.
The procedure for adapting the method according to the invention for generating a newly selected defined bone fracture with accompanying soft tissue injuries is described below. Since it is almost impossible to simulate the course of an accident in reality (for example a motorcycle accident) and to use a complete human body as preparation 106 as in reality, the simulation of the reality in the method according to the invention, for example by means of the device 100, 200 apply the necessary forces and speeds to a preparation 106. The device 100, 200 always works according to the same principle. However, the injuries and accidents underlying the defined bone fractures always differ. For each new bone fracture, the preparation 106 is fixed in the device 100, 200 in the defined geometry with respect to the direction from which the defined mass impinges on the preparation 106 when the holding mechanism 114, 214 is triggered, optionally using Adapters that support the fixation in the defined geometry.
[0144] The defined compression of the preparations 106 depends on the anatomical region and the selected bone fracture. The defined compression can be determined by the person skilled in the art depending on the selected defined bone fracture and the preparation 106. The defined damping depends on the anatomical region of the preparation 106 and the selected defined bone fracture. The defined damping can be determined by the person skilled in the art depending on the selected defined bone fracture and the preparation 106. The defined compression and damping prevent the specimen 106 from being excessively stressed and the anatomical structures (e.g. bones and soft tissues) in the specimen 106 from being destroyed in a way that is far from realistic. The defined speed of the defined mass is the speed that the defined mass at the time of the force shock, i.e. should have reached the point in time of the impact of the defined mass on the preparation 106 or when using a device 100, 200 on the impact stamp 111, 211. This depends on the selected defined bone fracture and the forces acting on the underlying course of the accident. The defined speed can be determined by the person skilled in the art depending on the selected defined bone fracture, the defined mass and the preparation 106. In order to optimally adapt the clamping of the specimens and the settings on the device 100, 200 to the circumstances of the respective specimen 106, individual specimens can be examined before the method for generating a defined bone fracture in the specimen 106 is carried out, for example by means of the Taking and assessing X-ray and CT images, carrying out mechanical and / or orthopedic function tests (eg manually) on the joint or joints. Deficits or anatomical peculiarities in individual preparations can be taken into account, such as the weight of preparation 106, the fat content of the soft tissue mass, the length, width and diameter of the bones in question, the joint spacing, the maximum joint angle, the bone quality and degenerative diseases. The degenerative diseases include the formation of osteophytes, joint instabilities, osteoarthritis and, above all, osteoporosis. If a preparation 106 is affected by such restrictions, bone fractures can only be produced to a limited extent or not at all. For example, bone density measurements can be carried out on the preparations. Correspondingly, a slightly different setting of the defined parameters and the defined geometry and clamping on the device 100, 200 are set for the generation of a defined bone fracture in an “old” preparation 106 (eg 90 years, female, low osteoporosis, low restriction of joint mobility) than with a “young” preparation 106 (eg 60 years, male, no further restrictions). The methods and procedures for determining the quality of a preparation 106 are known to the person skilled in the art. In particular, the quality of preparations can be assessed by a specialist even without precise measurement based on age, stature, nutritional habits, gender and the like and taken into account accordingly.
The determination of the defined parameters for a newly selected bone fracture with accompanying soft tissue injuries comprises several steps i.) To xi.), Which can be carried out in succession or side by side and in a variable order (steps iii.) To xi.)).
[0147] The determination of the defined parameters comprises the steps
i. Selection of a new defined bone fracture;
ii. Evaluation of at least one eyewitness report, patient report, image, video or document on the occurrence of the defined bone fracture in at least one accident victim;
CH 713 083 B1 iii. Starting from i.) And ii.) Determining the speed, direction of movement and joint position in the anatomical region in relation to the direction of force acting when the defined bone fracture arises;
iv. Theoretical assumption of the mass of the casualty and calculation of the inertia and direction of movement of the casualty;
v. Assignment of the injury to a fracture class, for example according to the AO trauma register;
vi. Development of at least one theory for the reproducible generation of the defined bone fracture in a preparation 106;
vii. Calculation of the energy range for generating the defined bone fracture in a preparation 106 and definition of the defined mass and the defined speed of the defined mass;
vili. Selection of a defined anatomical region for the preparation 106;
ix. Determination of the axis symmetry of the preparation 106 in relation to the acting force vector upon impact of the defined mass and definition of the defined geometry for the fixation of the preparation 106 in relation to the axially, preferably vertically, guided mass, for example by adapting the internal coordinate system of the preparation 106 the outer coordinate system of a device 100, 200 for simulating a real accident;
x. Calculation of the defined compression to which the preparation 106 may be exposed upon impact of the defined mass;
xi. Calculation of the defined damping upon impact of the defined mass on the preparation 106, the sequence of the steps being variable.
The adjustment of the method according to the invention for the reproducible generation of a new defined bone fracture with accompanying soft tissue injuries is a three-stage process:
In the first stage, a defined bone fracture is selected from the common fracture classifications (eg AO), which is to be generated in preparations and which is used to analyze the course of the injury underlying the defined bone fracture and the physical parameters and the biomechanical parameters are determined (eg searches, databases, German trauma register). The analysis of the development of the bone fracture in real injury processes is carried out, for example, by eyewitness and / or patient reports, the evaluation of images and / or videos. The physical parameters that are determined are the speeds, e.g. the speed at which a body or a person, preferably the casualty, moves, the direction of movement of individual body segments (such as a foot, a lower leg), the mass of such a segment, a body or a person, in particular the mass of the casualty and the resulting energy in the accident. The biomechanical parameters that are determined are the behavior of the biological material in the accident underlying the bone fracture, such as the joint angle of the affected anatomical region (eg the upper extremity), the inertia of the moving body (usually the body of the accident victim), the direction of movement of the body in the accident and the fracture classifications. The joint positions in the case of accidents can be carried out, for example, by analyzing video recordings, literature searches, biomechanical studies on sports technology and sports injuries or ergonomics studies.
In the second stage, a theory on the injury mechanism is developed. This theory is checked using biomechanical calculations and model simulations, e.g. kinematic model calculations to determine speeds, accelerations, positions and joint angles, inverse dynamic calculations of the acting forces and reaction forces as well as the moments acting on the osseous and ligamentous structures of the preparations. The calculated defined parameters, namely the calculated defined mass, the calculated defined direction, the calculated defined speed of the calculated defined mass upon impact, the calculated defined geometry of the specimen 106 in relation to the calculated force shock upon impact, the calculated defined compression of the specimen 106 , the calculated defined damping upon impact are checked by model calculations. Methods of applied biomechanics (e.g. anthropometry, kinematics, dynamics, kinetics), motion analysis, dynamometry and kinemetry are used. These model calculations are known to the person skilled in the art, for example from Georg Kassat, biomechanics for non-biomechanics, Fitness-Contur-Verl., Bünde 1993; David A. Winter, Biomechanics and Motor Control of Human Movement, 4th Ed. Wiley, J, New York, NY 2009; Benno Kummer: biomechanics. Dt. Ärzte-Verl., Cologne 2004.
[0151] A defined bone fracture can of course arise in various ways. According to the invention, the defined bone fracture is generated by the method according to the invention, preferably using a device 100, 200. This means that the data and the results of the calculations from stages one and two are translated to the principle of action of the method according to the invention. The method according to the invention is characterized in that a defined bone fracture has a low load on the preparation 106 and a low one
CH 713 083 B1 equipment expenditure can be generated. This enables the defined bone fracture to be generated more quickly and with a high degree of probability. In a preferred embodiment, the theoretical calculation therefore includes the transfer of the calculated parameters to the generation of the defined bone fracture in a preparation 106 with the aid of a device 100, 200. In the device 100, 200, the defined bone fracture in the preparation 106 becomes one by the force shock gravitationally accelerated mass. By specifying the defined direction from which the defined mass impacts the specimen 106, the defined geometry in which the specimen 106 must be aligned in the device 100, 200 is inevitably defined by the biomechanical parameters.
In the third stage, the method according to the invention is carried out on preparations using the calculated defined parameters. In order to deal economically and ethically with the preparations, especially human preparations, which are human body donations, the aim is to achieve a high level of reproducibility when generating the defined bone fracture with accompanying soft tissue injuries. The establishment of the reproducibility includes that the defined parameters lead to the generation of the defined bone fracture with accompanying soft tissue injuries, regardless of the respective individual properties of the preparation 106. This means that a defined bone fracture is generated with a probability (hit rate) of at least 50%, preferably at least 60%. Whether the bone fractures generated correspond to the selected defined bone fractures is checked, for example, with X-rays or CT images, which are checked and examined by experienced accident surgeons and compared with the common fracture classifications (including AO). If the images and later the bone fractures are matched, i.e. realistic, classified, the focus is placed on reproducibility in order to achieve the desired probability (hit rate) of at least 50%, 60%, 70%, 80% or more. A total of 300 simulations are required to reproduce all relevant fractures of an anatomical region (which comprises 1 joint) with a probability (hit rate) of at least 60%. The method according to the invention is preferably carried out on preparations 106, 506 with the devices 100, 200, 500, 600 according to the invention. The biological structures in the preparations 106, 506 are exposed to high-energy impulses and / or shear forces and bending moments, depending on the selected defined bone fracture. The acting force is measured using dynamometry and the movements of the individual segments of the preparation 106 are recorded in a video-based manner. The data collected are analyzed and evaluated. The procedure is, for example, from Dieter Fink (2013) (master thesis: conception and creation of a software package for synchronization, data acquisition and measurement signal display for the simulator of the Essex-Lopresti »), Marc Ebinger (2013) (master thesis« Design and evaluation of a novel simulator for high -speed injuries of the human forearm ”), Robert Holz (2013) (master thesis“ The Mechanism of Essex-Lopresti: Investigation of Tissue Failure Using a Newly Developed Simulator ”). For each defined bone fracture, a separate combination of technical parameters (settings on the device 100, 200) and biomechanical parameters (orientation of the preparation 106 in the defined geometry with respect to the direction, from the defined mass onto the preparation 106 is impacted according to this procedure , and fixation of the preparation 106 in this defined geometry). These parameters are explained in the examples for the generation of various defined bone fractures.
The generation of a defined bone fracture with accompanying soft tissue injuries by the method according to the invention, for example when testing the calculated parameters, establishing the method or using it for reproducible generation, comprises the following steps: if necessary, thawing the preparation 106, if appropriate pouring in the separated stump , Alignment and clamping of the preparation 106 in the device 100, 200, setting the defined parameters, triggering the holding mechanism 114, 214, possibly checking and documenting the results.
Table 1: Reproducible (i.e. with a probability of at least 50% or more in the present case) producible defined bone fractures with accompanying soft tissue injuries in human preparations.
Anatomical region Example No. fracture status Hand / Finger 1 phalanges Reproducible 86%2 metacarpal Reproducible 79% wrist 3 Extension (Smith) Reproducible 90%4 Flexion (Coles) Reproducible 86%5 The-punch Reproducible 69%6 chauffeur Reproducible 75%7 scaphoid Reproducible 60% elbow 8th Radial head Reproducible 79%
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Anatomical region Example No. fracture status9 coronoid Reproducible 90%10 Terrible triad Reproducible 92%11 olecranon Reproducible 94%12 Monteggia Reproducible 60%13 Monteggia-Iike lésion Reproducible 66%14 Galeazzi Reproducible 53%15 capitulum Reproducible 72%16 distal humerus Reproducible 79% shoulder 17 Clavicle shaft Reproducible 70%18 lateral clavicle Reproducible 52%19 proximal humerus Reproducible 76% knee 20 distal femur 21 tibia Reproducible 72% hock 22 talus 23 Pilon Reproducible 62%24 calcaneus Reproducible 61%
Table 2: Examples of defined parameters for generating defined bone fractures (Def. = Defined)
No. Defined bone fracture Classification according to the AO trauma register Def. Mass in kg Def.fall height in cm Defined compression in mm definedDamping in mm Energy in joules 1 Shank fractures of the phalanges l-V 78 A2, B2, C2 5.2 to 9.8 29 to 46 2 to 8 0 to 5 15 to 44 2 Shaft fractures of the metacarpal l-V 77 A2, B2, C2 7 to 11.2 35 to 52 6 to 14 0 to 9 24 to 57 3 distal radius fracture extension 23 A2, 23C1-C3 (dorsal) 16.8 to 19.3 76 to 102 22 to 30 6 to 14 125bis193 4 distalradius fractureinflection 23 A2 (palmar) 16.8 to 20.5 82 to 105 25 to 35 5 to 17 135 to 211 5 distal radius fracture / die-punch fracture 23c1-C2 17 to 23.1 90 to 110 22 to 31 9 to 15 150 to 249 6 distal radius fracture / chauffeur fracture 23 B1 16.6 to 18.3 80 to 93 20 to 28 6 to 14 130 to 167 7 scaphoid fracture 72 A2, B2-B3 16.8 to 19.5 75 to 88 24 to 32 10 to 17 124 to 168
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No. Defined bone fracture Classification according to the AO trauma register Def. Mass in kg Def.fall height in cm Defined compression in mm definedDamping in mm Energy in joules 8th Radial head fracture 21 B2 (type l-lll according to Mason) 18.3 to 21.5 75 to 88 21 to 29 9 to 15 135 to 168 9 Coronoidfraktur 21 B1 (Regan & Morrey type l-lll) 18.2 to 22.8 75 to 86 20 to 33 8 to 16 134 to 192 10 Terrible triad 21 C1 18.9 to 26.8 85 to 100 24 to 38 10 to 18 158 to 289 11 olecranon fracture 21 B1, C1 17.1 to 20 61 to 79 4 to 17 0 to 9 116 to 139 12 Monteggia fracture 21 A1, B1 16.8 to 17.9 72 to 88 28 to 46 10 to 17 119 to 155 13 Monteggialike lésion 21 B3 16.8 to 18.4 75 to 92 30 to 46 9 to 21 124 to 166 14 Galeazzi fracture 22 A3, B3,C1-C3 18.5 to 22.6 95 to 107 24 to 39 6 to 17 172 to 237 15 Capitulumfraktur 13 B3 20.5 to 24.2 70 to 81 14 to 22 6 to 13 141 to 192 16 distal humeral fracture 13 B1, B2,C1-C3 20.2 to 27.2 68 to 81 26 to 37 Obis 15 135 to 216 17 clavicular shaft fracture Type A and B. 12.3 to 16.5 55 to 68 4 to 12 0 to 6 66 to 110 18 lateral clavicle fracture Type I and II according to Neer 10.3 to 21.9 57 to 76 5 to 14 Obis 7 58 to 163 19 proximal humeral fracture 11 B1, B3,C1-C3 19.2 to 28.8 65 to 88 29 to 44 Obis 16 122 to 249 20 distal femur fracture 33C1-C3 26.0 to 38.7 99 to 116 31 to 49 0 to 37 253 to 440 21 tibial plateau fracture 41 B1 26 to 31 96 to 112 35 to 47 10 to 13 245 to 341 22 talus fracture Type II, type III according to Hawkins 24.8 to 37.2 68 to 83 26 to 48 0 to 22 165 to 303 23 pilon fracture 43 B3-B4, C1-C3 24.7 to 38.5 100 to 111 30 to 51 0 to 25 242 to 419 24 Calcaneusfraktur Type 2A, 2C,Type 3AB, 3AC according to Sanders 24.1 to 32.7 90 to 98 25 to 43 Obis 18 213 to 314 25 distal 23 B3 20 to 23 76 to 102 25 to 36 10 to 16 149 to 230
Radius Fracture The defined damping can be zero, that is, the impact is undamped. When generating a capillary fracture, Galeazzi fracture or Monteggia fracture in specimens, the defined damping cannot be set to zero, otherwise the biological structures will be damaged in an uncontrolled manner.
The invention also relates to the use of the method according to the invention for the training or further training of medical personnel, clinics and doctors, in particular from the fields of orthopedics and trauma surgery, in particular surgeons.
Another area of application of the preparations described or the method according to the invention or the commercial device 200 according to the invention are the manufacturers of articles and devices for trauma surgery and orthopedics. This industry includes all manufacturers of implants for the replacement of joints (e.g. artificial hip or knee joints) and for the treatment of fractures (osteosynthesis).
CH 713 083 B1 The preparations described or the method according to the invention or the commercial device 200 are also used in the consumer goods industry (for example the automotive industry, sports equipment manufacturer), in accident research and accident analysis, in disaster protection, in military training and in the preparation of reports ,
Devices 100, 200, 500, drive module 329, 229 in combination with add-on module 430, 230, which are suitable for carrying out the method according to the invention.
Simple variants are known in the prior art, for example from McGinley et al. (2003), Robert Holz (2013) (master thesis «The Mechanism of Essex-Lopresti: Investigation of Tissue Failure Using a Newly Developed Simulator»), Marc Ebinger (2013) (Master Thesis «Design and Evaluation of a Novel Simulator for High-Speed injuries of the human forearm ”) and Dieter Fink (2013) (master thesis“ Concept and creation of a software package for synchronization, data acquisition and measurement signal display for the simulator of the Essex-Lopresti ”).
Building on this, two different devices 100, 200, 500 were developed. A scientific prototype of the device 100, 500 for determining and validating the defined parameters so that the defined bone fracture can be reproducibly generated in a preparation 106. This scientific prototype includes implemented measurement technology, software-controlled synchronization of the measurement technology, solid construction for reliable and valid data acquisition, mechanical security system (electrically supported). At least 2 people are required to operate the device 100, 500.
Second, a device 200, drive module 329, 229 in combination with expansion module 430, 230 for commercial use, characterized in that the device 100, 200 does not comprise any measurement technology (for faster, more effective work), has a lighter modular construction, is transportable and is quick to assemble and disassemble, has at least one electrical safety system that is mechanically supported, and only one person is required for operation.
In contrast to the McGinley et al. The devices 100, 200 can be variably adjusted and are therefore suitable for generating different defined bone fractures. The McGinley et al. had a fixed kinetic energy on impact of 238 J, neglecting air and sliding friction.
The device 100, 200 can be set so that the speed when the defined mass impacts the preparation 106 is 4.2 m / s or more and the energy when it impacts is 240 J or more. The technical parameters that can be set on the device 100, 200 include the defined mass, here the mass of the falling body, which can be set from 11.8 to 62.9 kg, the defined speed, here the height of the falling body, adjustable from 0 to 1100 mm, the defined compression, here the path (travel path) that the preparation 106 is allowed to move in the direction of the acting force, and the defined damping, here the time at which the shock absorbers Remove residual) energy from the system.
Requirements for the mechanics of the device 100, 200: The energy, the speed and the acceleration can be calculated from the parameters of the defined mass, the time required for the impact and the height of the fall. Furthermore, the momentum and, consequently, the kinetic energy and the force can be calculated (theoretically) from the momentum set. The results of such calculations can then in turn be calculated using the calculations that were carried out beforehand to carry out the method for generating a defined bone fracture with accompanying soft tissue injuries (comparative procedure for adapting the method according to the invention for generating a newly selected defined bone fracture with accompanying soft tissue injuries), to compare. They are also used to compare the forces and speeds actually measured while the method is being carried out. The fixation and clamping of the specimens can be adapted to anatomical deviations in the device 100, 200 and is at the same time stable. Adjustment options are taken into account which enable the central positioning of the different preparations under the force application point in the device 100, 200 when carrying out the method. In addition, the proximal and distal clamping of the preparation 106 can be rotated separately in the device 100, 200 in order to predetermine the preparation 106. The device 100, 200 further comprises safety devices which guarantee the safe working on and with the device 100, 200.
The device 500, 600 may include a measurement technique. The deformation of the biological structures and the chronological order of the occurring injuries are important for the analysis of the injury mechanism. An optical method can be used, for example, in order to be able to record this during the execution of the method and then be able to analyze it. However, other high-resolution methods can also be used. An optical method must apply a frequency of 1000 Hz or more in order to be able to take enough evaluable images over the short period of force (<5 ms). In order to be able to make statements about the defined speed, in this case the level of the force acting on the preparations, this is measured directly during the implementation of the method. According to the video analysis, the impact force should be recorded at a frequency of at least 2000 Hz in order to fulfill the Shannon and Nyquist sampling theorem (Harry Nyquist: Certain Topics in Telegraph Transmission Theory. In: Transactions of the American Institute of Electrical Engineers. Voi. 47 , 1928; Michael Unser: Sampling - 50 Years after Shannon. In: Proceedings of thè IEEE. Voi. 88, No. 4, 2000, pp. 569-587).
CH 713 083 B1 [0168] In the device 100, 200, a gravitationally accelerated falling body is used as a defined mass. With the adjustable fall height, the same impact speed can always be exerted on preparations of different lengths. Using the variable mass of the falling body, the calculated force and energy can be generated when the defined mass collides with preparations of different lengths.
In a particular embodiment, the device 100, 200 has a solid base plate 101, 201 with the dimensions 75 mm × 75 mm × 5 mm and a weight of approx. 220 kg, two guide columns permanently embedded therein and two between the guide columns traverses. The device 100, 200 has a height of 280 cm and is surrounded on the outside with a cladding 227 made of aluminum profiles and Makrolon disks. The upper crossmember 115, 215 serves to stabilize the guide columns 118, 218. The vertically stable falling body of the device 100, 200 comprises a mass 112, 212 and one or more additional weights 113, 213 for setting the defined mass. The defined mass is held at the starting height with an electromagnet (Kendrion GmbH, Donaueschingen) and represents the holding mechanism 114, 214 of the device 100, 200. The defined mass glides almost frictionlessly and gravitationally accelerates towards the preparation 106 in the vertical fall The height of the drop body is variable and can be adjusted from 50 to 110 cm using an adjusting rod 117. The mass can also be increased from 11.8 kg (empty weight) to up to 27 kg using additional weights 113, 213. Below this is a traverse 109, 209, which is either adjustable in height or not. A height-adjustable traverse can be adapted to the length of the preparations 106. The traverse 109, 209 is used for the upper clamping (alignment in a defined geometry and fixation) of the specimens 106 and contains an axially guided and friction-free impact punch 111, 211. This transmits the impulse of the falling body to the specimen 106. The traverse 109, 209 may contain one or more force sensors 103, preferably three force sensors 103 (type 9011A Kistler, Winterthur, Switzerland), which measure the force that occurs when the falling body impacts the punch 111, 211 (and thus the specimen 106). In order to be able to catch the falling body during the impact, there is at least one means for damping 110, 210, preferably shock absorbers, preferably two industrial shock absorbers (ACE SCS33-25EU, ACE Stossuffer GmbH, Langenfeld) in the cross member 109, 209. These two shock absorbers can absorb a maximum energy of 310 J over a braking distance of 2.6 mm and are also height-adjustable (65 mm). With this setting option, the impact of the defined mass on the preparation 106 can be damped or undamped.
Below the crossmember 109, 209 is a base plate 101, 201 for lower clamping of the specimens 106. The base plate 101, 201 comprises means for fixing the specimen 106, for example a slide which can be moved in translation on the base plate and, if appropriate, a shape fastened thereon 105, for example a pouring pot. One or more force sensors 103 (e.g. type 9061A, Kistler, Winterthur, Switzerland) can optionally be clamped between the mold 105 and the means for fixing the preparation 106. With the upper and lower clamping possibility, preparations 106 in various defined geometries can be fixed in the device 100, 200 and preferably positioned centrally under the punch 111, 211. As a result, a defined position of the joints, for example pronation or supination, can also be predefined for a preparation 106.
The adjusting rod 117 in the device 100 is used for height adjustment to adjust the drop height. The height adjustment can also be achieved in other ways, for example by means of a cable pull, an electrical cable winch or a plug-in system.
In a preferred embodiment of the device 200, the focus is placed on the economy, robustness and portability of the device 200. Defined bone fractures in preparations for customer orders are preferably reproducibly generated on this device 200. Therefore, this device 200 preferably does not have any measurement technology. As a result, the device 200 can work faster and more effectively. The components are preferably made of steel alloys and no longer made of aluminum in order to enable a longer service life of the material and less wear and tear with longer running times. A commercial device 200 preferably includes at least two modules that can be separated for easy transportation. The preparations 106 are clamped in the lower module 400 (working module). The module 400 is aligned in such a way that all adapters and other aids for clamping the specimens 106 in a defined geometry can be used to align the specimen 106 in the defined geometry. The dimensioning of the work area in all three directions is increased in order to be able to work faster. The upper module 300 (drive module) has been expanded by some components. The reason for this is to increase the economy of the device 200 and to make the work on the device 200 safer. A drop body is magnetically held on two approximately 2 m long, vertical guide columns 218, which when released slides along the guide columns 218 up to the punch 211. The fall height and the defined mass can be adjusted by one person alone. For this purpose, the holding mechanism 214 for the defined mass is controlled in such a way that the holding mechanism 214 is not triggered unintentionally. For example, by programming the electrically controlled holder of two magnets so that they are permanently magnetic, i.e. they hold the weight of the defined mass. Only when these magnets receive the electrical command controlled by a safety lock, do they release the connection to the defined mass (the drop body). A power failure or other technical malfunction cannot therefore interrupt the holding mechanism 214. In addition, the drop body is mechanically secured during work in the working and / or drive module 329, 229, 400 via locking bolts, which are only removed immediately before the fall. The (free) fall of the falling body is triggered by an electrical signal to the magnets. In order to raise the falling body again, a traverse is placed within the drive module 300
CH 713 083 B1
215, 315 lowered along the guide columns 218, 318, which connects to the drop body via the magnet system described above. The assembly is then pulled upwards using a block and tackle 225. The release of the mass 212, 312 can also be triggered via a structurally identical safety switch 226, 326 at the push of a button and cannot be affected by a power failure or another technical malfunction. In addition, the mass 212, 312 is additionally secured by safety bolts which are inserted into the bores 221, 321.
In a further exemplary embodiment of the device 200, this comprises a construction module 430, 230 and a drive module 329, 229. This device 200 is particularly suitable for a commercial application, since the two modules are simply separated, transported and reassembled to form the device 200 can be. The entire device 200 has a height of 315 cm.
The construction module 430, 230 comprises a base plate 401 (e.g. 70 x 82 cm), on which two support columns 419, for example at a distance of 54 cm, are introduced. The support columns 419 have a height of at least 50 cm, preferably 110 cm and carry the crossmember 409 with the integrated punch 411. Various clamping devices or adapters can be attached to the lower side of the punch 411. In the add-on module 430, 230, the crossmember 409 can be adjusted in height or not. The crossmember 409 is preferably not adjustable in height, so that the working height is kept constant and the base plate 401 on which the preparation 106 is stored is adapted to the height of the punch 411. This adjustment is carried out, for example, over tables (e.g. with an area of 40 x 40 cm) with different heights, which can be screwed into the base plate using holes 402. One or more means for adjusting the damping, for example two shock absorbers, are optionally installed in the crossmember 409.
The generation of the power surge in the drive module 329, 229 is based on the same technology as in the device 100. The drive module 329, 229 comprises at least one guide column 318, preferably two e.g. 190 cm long guide columns 318. The guide columns 318 can have bores 321, for example at 3 cm intervals. These holes 321 are used to place the securing bolts and to securely position the defined mass. The mass 312 and at least two further cross members 315 and 324 run on the guide columns 318. The mass 318 has a dead weight of e.g. 18 kg and can be set to a defined mass using additional weights 313, e.g. a defined mass of max. 72 kg.
[0176] The drive module preferably includes safety mechanisms to avoid accidents when carrying out the method according to the invention. The following non-limiting examples of corresponding security mechanisms can be part of the drive module 300 individually or in combination.
At least two holding mechanisms 314, e.g. two docking plates on which permanent magnets can dock on the underside of the cross member 315. The permanent magnets fit on the docking plates of the drop mass.
The traverse 315 is e.g. with a cable pull 225 (e.g. with three pulleys). It serves to safely raise the drop mass again after the procedure has been carried out. Once the magnets have docked onto the drop mass, the drop mass can be lifted with the connected crossbar 315 via the cable pull 225.
At least one pin of an electrical plug signal transmitter and two further docking plates can be located on the top of the cross member 315. If the cross member 315 is raised to below the cross member 324 (there is the suitable inlet for the pin 323), the pin 322 on the cross member 315 connects to the inlet for the pin 323 on the underside of the cross member 324. This creates an electrical connection Lock closed. At the same time, the docking plates of the cross member 315 connect to the permanent magnets of the cross member 324. The cross member 324 and the cross member 315 and the drop mass are thus firmly connected. The crossbeam 324 serves to hold this assembly and to regulate the drop height. The cross member 324 and / or the cross member 315 is held in the guide columns 318 by means of safety bolts. The safety bolts must be removed to adjust the drop height. Below the drop mass, security bolts can also be secured in the bores 321 of the guide column 318.
In order to release the falling mass for carrying out the method, the permanent magnets on the cross member 315 and 324 must be reversed. This is done via an electrical signal. This means that the drop mass is only released by the magnets when current flows. If the device 200 is disconnected from the electrical connection, the drop mass cannot fall down. The electrical signal that triggers the free fall of the mass is generated via a safety switch 226, 326 on the outside of the drive module 300. The safety switch 226, 326 must be released manually using a key and triggered by an additional push of a button. The signaling of the safety switch 226, 326 can only be triggered if the traverse 315 and 324 have properly connected to the drop mass via the plug signal transmitter 322 and 323.
Both the body and drive modules 329, 229, 400 are surrounded by an opaque panel 227, 327, 427 (e.g. sheet metal paneling). The claddings are, for example, Makrolon disks and / or sheet metal claddings. This prevents a person from reaching into the device 200 and being injured while the method according to the invention is being carried out.
For the validation of the theoretically calculated defined geometry of the preparation 106 in relation to the defined direction from which the defined mass impinges on the preparation 106, for validation of the theoretically calculated defi
A device 500, 600 with measurement technology according to the invention is used in accordance with CH 713 083 B1 compressed compression of the preparation 106 upon impact of the defined mass, for validating the theoretically calculated defined damping upon impact of the defined mass, for validating the theoretically calculated defined velocity of the defined mass. An appropriate measurement technique can be used to improve the hit rate for generating the defined bone fracture. The structure and the evaluation are from Robert Holz (2013) (master thesis "The Mechanism of Essex-Lopresti: Investigation of tissue failure using a newly developed simulator"), Marc Ebinger (2013) (master thesis "Design and évaluation of a novel simulator for high-speed injuries of the human forearm ”) and Dieter Fink (2013) (master thesis“ Design and creation of a software package for synchronization, data acquisition and measurement signal display for the simulator of the Essex-Lopresti ”).
The figures serve to describe devices which can be used according to the invention and which are suitable for carrying out the method according to the invention and for producing the preparations.
1: Device 100 comprising base plate 101, means for fixing specimen 102, force sensor 103, specimen 106, clamping plate 107, ball bearing 108, crossbar 109 with punch 111, means for adjusting damping 110, mass 112 and additional weight 113, holding mechanism 114 , Traverse 115, roof 116, adjusting rod 117, guide column 118.
2: device 200 comprising drive module 229 and extension module 230, base plate 201, clamping plate 207, cross member 209 with punch 211, means for adjusting the damping 210, mass 212, additional weight 213, holding mechanism 214, cross member 215, roof 216, guide column 218, Support column 219, docking plate 220, bore 221, pin for signal generator 222, inlet for pin 223, cross beam 224, pulley 225, safety switch 226, paneling 227.
3: drive module 329 for a device 200 comprising mass 312, additional weight 313, holding mechanism 314, cross member 315, roof 316, guide column 318, docking plate 320, bore 321, pin for signal transmitter 322, inlet for pin 323, cross member 324, safety switch 326 , Panel 327.
4a: assembly module 430 for a device 200 with closed cladding 427.
4b: assembly module 430 for a device 200 with opened cladding 427, base plate 401, means for fixing the specimen 402, clamping plate 407, non-height-adjustable cross member 409 with punch 411.
5: Device 500 for confirming the calculated parameters and for establishing the method according to the invention using the calculated parameters comprising a clamped preparation 506, which is cast in a mold 505 at the proximal and distal end, cameras 528 and force sensors 503. A mold 505 is attached to the means for fixing the preparation 502, the second mold 505 is attached to the clamping plate 507. The device 500 comprises a base plate 501, a height-adjustable traverse 509 with a punch 511, a mass 512 with an additional weight 513, an adjusting rod 517, and guide columns 518.
6: Experimental setup with device 600 for confirming the calculated parameters and for establishing the method according to the invention using the calculated parameters.
The examples below serve to explain the method according to the invention and the human preparations which comprise a defined bone fracture. However, the invention is not limited to the already reproducibly producible preparations with defined bone fractures, but can be applied to further defined bone fractures which can be produced in preparations in an analogous manner, as explained in the description and the examples.
Example 1: Alignment in a defined geometry for the reproducible generation of shaft fractures of the phalanges I-V (78 A2, B2, C2 according to AO).
For a shaft fracture of the phalanges I-V (78 A2, B2, C2 according to AO), a preparation 106 consisting of hand and forearm is used.
In order to align the preparation 106 in the defined geometry, the forearm is placed about 6-10 cm distal to the elbow. At the proximal end of the forearm stump, approx. 5 cm of the soft tissue around the radius and ulna are dissected and the bones are cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The intersections of the radius and ulna are centrally below the force application point. In this vertical position, the wrist is held in the neutral position and the phalanges of the relevant phalanges are inserted in an adapter (11 or 12). The phalanges should stand in a vertical line as an imaginary extension under the radius and ulna. The own weight of the punch 111 holds the preparation 106 in the desired position in this clamping. The adapter (11 or 12) is supported flat on the base plate 101 of the device 100. With the inserted phalanges, the hand should not be moved sideways or only out of the neutral position if it is under the weight of the blow
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Stamp 111 is not stiff, but evades. The direction and the amount by which the adapter with the inserted phalanges are moved on the base plate depends on the preparation.
The following settings are made on the device 100: The defined mass (falling mass) 5.2 to
9.8 kg, the defined speed by means of drop height to 29 to 46 cm, the defined compression to 2 to 8 mm and the defined damping by the damped portion of the defined compression to 0 to 5 mm. The holding mechanism 114 is triggered and a shaft fracture of the phalanges 1-V, 78 A2, B2, C2 according to AO is generated with a probability of 86% in the preparation 106.
Example 2: Alignment in a defined geometry for the reproducible generation of shaft fractures of the metacarpal l-V (77 A2, B2, C2 according to AO).
For a shaft fracture of the metacarpal l-V, (77 A2, B2, C2 according to AO), a preparation 106 consisting of hand and forearm is used.
To align the preparation 106 in the defined geometry, the forearm is placed approximately 6-10 cm distal to the elbow. The preparation 106 is placed flat on a straight plate with the palm facing downwards, the forearm is fixed in the supination position by means of tension belts. In the device 100, an adapter (6 or 7) is attached to the underside of the punch 111. The pin of the adapter is vertical, with the rounded side to the preparation 106 under the punch 111. The end of the adapter is placed centrally above the desired fracture site.
Optionally, one or more foam mats are applied between the surface of the adapter and the preparation 106 (depending on the preparation). On the one hand, the foam mats prevent the adapter from slipping off the targeted fracture site, on the other hand, they passively enlarge the area of the power transmission. With the help of the foam mats, the skin of the fractured preparation 106 remains intact.
The following settings are made on the device 100: The defined mass (falling mass) 7 to
11.2 kg, the defined speed by means of drop height to 35 to 52 cm, the defined compression to 6 to 14 mm and the defined damping by the damped portion of the defined compression to 0 to 9 mm.
The holding mechanism is triggered and a shaft fracture of the metacarpal l-V, 77 A2, B2, C2 according to AO is generated in the preparation 106 with a probability of 79%.
Example 3: Alignment in a defined geometry for the reproducible generation of a distal radius fracture (extension, 23 A2, 23 C1-C3 dorsal to AO).
For a distal radius fracture classified 23 A2,23 C1-C3 (dorsal) according to AO, a preparation 106 consisting of hand, forearm and upper arm is selected.
To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. About 5 cm of the soft tissue is dissected from the humerus stump and the humerus bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 10 to 12 degrees. In this position, the forearm is turned from maximum supination to a pronation of 60 to 70 degrees. The wrist is maximally extended (maximum means preparation-dependent 59-68 degrees) starting from the neutral position and supported on an adapter 4.
The following settings are made on the device 100: The defined mass (falling mass) 16.8 to
19.3 kg, the defined speed by means of drop height to 76 to 102 cm, the defined compression to 22 to 30 mm and the defined damping by the damped portion of the defined compression to 6 to 14 mm.
[0199] The holding mechanism 114 is triggered and the distal radius fracture of the classification 23 A2, 23 C1-C3 (dorsal) according to AO is generated in the preparation 106 with a probability of 90%.
Example 4: Alignment in a defined geometry for the reproducible generation of a distal radius fracture (flexion, 23 A2, palmar according to AO).
A preparation 106 consisting of hand, forearm and upper arm is prepared for a distal radius fracture of classification 23 A2 (palmar) according to AO.
To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. About 5 cm of the soft tissue is dissected from the humerus stump and the humerus bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 10 to 12 degrees. In this position, the forearm is turned from maximum supination to a pronation of 50 to 60 degrees. The wrist is flexed by 45-58 degrees (starting from the neutral position) and supported on a flat surface against the base plate 101 of the device 100.
CH 713 083 B1 The following settings are made on the device 100: the defined mass (falling mass) 16.8 to
20.5 kg, the defined speed by means of fall height to 82 to 102 cm, the defined compression to 25 to 35 mm and the defined damping by the damped portion of the defined compression to 5 to 17 mm. The holding mechanism 114 is triggered and the distal radius fracture of the classification 23 A2 (palmar) according to AO is generated in the preparation 106 with a probability of 86%.
Example 5: Alignment in a defined geometry for the reproducible generation of a distal radius fracture / die-punch fracture (requires 23 C1-C2 according to AO).
For a distal radius fracture / die-punch fracture classified (conditional) 23 C1-C2 according to AO, a preparation 106 consisting of hand, forearm and upper arm is prepared.
To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 0 to 8 degrees. In this position, the forearm is turned from maximum supination to a pronation of 45 to 52 degrees. The wrist is held in the neutral position and supported on an adapter 4 on the base plate 101 of the device 100. The hand encloses the handle of the adapter 4, the phalanges are bent. The hand thus forms a fist which encloses the handle bar and supports it with the phalanges 11-IV against the base plate 101 of the device 100.
The following settings are made on the device 100: The defined mass (falling mass) 17 to
23.1 kg, the defined speed by means of drop height to 90 to 110 cm, the defined compression to 22 to 31 mm and the defined damping by the damped portion of the defined compression to 9 to 15 mm. The holding mechanism 114 is triggered and the distal radius fracture / die-punch fracture of the classification (conditional) 23 C1-C2 according to AO is generated in the preparation 106 with a probability of 69%.
Example 6: Alignment in a defined geometry for the reproducible generation of a distal radius fracture / chauffeur fracture (23 B1 according to AO).
A preparation 106 consisting of a hand, forearm and upper arm is prepared for a distal radius fracture / chauffeur fracture of classification 23 B1 according to the AO.
[0210] To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 0 to 8 degrees. In this position, the forearm is turned from maximum supination to a pronation of 45 to 52 degrees. The wrist is extended 35-43 degrees from the neutral position and supported on an adapter 2, which has a spherical surface, on the base of the device 100. The support point should lie in the transverse plane 3-8 cm (depending on the preparation) in front of the humeral shaft / force application point. The hand should be moved laterally on the round surface of the adapter 2 until it has a radial abduction of 20 degrees (from the neutral position).
The following settings are made on the device 100: The defined mass (falling mass) 16.6 to
18.3 kg, the defined speed by means of fall height to 80 to 93 cm, the defined compression to 20 to 28 mm and the defined damping by the damped portion of the defined compression to 6 to 14 mm. The holding mechanism 114 is triggered and the distal radius fracture / chauffeur fracture (conditional) of the classification 23 B1 according to AO is generated in the preparation 106 with a probability of 75%.
Example 7: Alignment in a defined geometry for the reproducible generation of a scaphoid fracture (72 A2, B2-B3 according to AO).
A preparation 106 consisting of hand and forearm is prepared for a scaphoid fracture 72 A2, B2-B3 according to AO.
[0214] To align the preparation 106 in the defined geometry, the forearm is placed about 6-10 cm distal to the elbow. At the proximal end of the stump of the forearm, approx. 5 cm of the soft tissue around the radius and ulna are dissected and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The intersections of the radius and ulna are centrally below the force application point. In this vertical position, the wrist is extended 35-50 degrees from the neutral position and supported on an adapter 4 on the base plate 101. The support point lies in the transverse plane 0-4 cm behind the cast-in parts of the radius and ulna / force application point. The hand is moved laterally on the cylindrical surface of the adapter 4 until it has a radial abduction of 3-6 degrees (from the neutral position).
CH 713 083 B1 The following settings are made on the device 100: the defined mass (falling mass) 16.8 to
19.5 kg, the defined speed by means of drop height from 75 to 88 cm, the defined compression to 24 to 32 mm and the defined damping by the damped portion of the defined compression to 10 to 17 mm. The holding mechanism 114 is triggered and the scaphoid fracture of the classification 72 A2, B2-B3 according to AO is generated in the preparation 106 with a probability of 60%.
Example 8: Alignment in a defined geometry for the reproducible generation of a radius head fracture (type I-III according to Mason, 21 B2 according to AO).
For a radius head fracture type III-III according to Mason, 21 B2 according to AO, a preparation 106 consisting of hand, forearm and upper arm is prepared.
To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 0 to 8 degrees. In this position, the forearm is turned from neutral to a 45-52 degree pronation. The hand is fixed with bandages in a fist position, the wrist is stiffened in the neutral position. The bandaged portion of the preparation is supported vertically in an adapter 16. If necessary, one or more foam mats are applied to the bottom of the adapter 16 under the supported hand (depending on the preparation). The adapter 16 is filled with quartz sand and screwed onto the base plate 101 of the device 100. The filling quantity of the adapter should be 12-15 cm, calculated from the base plate 101. The support point on the base plate 101 lies in the transverse plane 3-8 cm (depending on the preparation) in front of the humeral shaft / force application point.
[0219] These foam mats protect the biological structures in the wrist area by passively increasing the area of the force transmission. The foam mats prevent the preparation 106 from fracturing below the targeted position.
The following settings are made on the device 100: The defined mass (falling mass) 18.3 to
21.5 kg, the defined speed by means of drop height to 75 to 88 cm, the defined compression to 21 to 29 mm and the defined damping by the damped portion of the defined compression to 9 to 15 mm. The holding mechanism 114 is triggered and the radius head fracture of the type l-III classification according to Mason, 21 B2 according to AO is generated in the preparation 106 with a probability of 79%.
Example 9: Alignment in a defined geometry for the reproducible generation of a coronoid fracture (Regan & Morrey type l-III, 21 B1 according to AO).
For a coronoid fracture Regan & Morrey type l-III, 21 B1 according to AO, a preparation 106 consisting of hand, forearm and upper arm is prepared.
In order to align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected from the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is held at maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) and the forearm is fixed in the neutral position. The hand is fixed with bandages in a fist position, the wrist is stiffened in the neutral position. The bandaged portion of the preparation 106 is supported vertically in an adapter 16. One or more foam mats are optionally applied to the bottom of the adapter 16 under the supported hand (depending on the preparation). The adapter 16 is filled with quartz sand and screwed onto the base plate 101. The filling quantity of the adapter should be 12-15 cm, calculated from the bottom up. The support point on the base plate 101 lies in the transverse plane 3-8 cm (depending on the preparation) in front of the humeral shaft / force application point.
[0224] The foam mats protect the biological structures in the wrist area by passively increasing the area of the force transmission. With the help of these foam mats, the preparation 106 is prevented from fracturing below the targeted position.
The following settings are made on the device 100: The defined mass (falling mass) 18.2 to
22.8 kg, the defined speed by means of drop height to 75 to 86 cm, the defined compression to 20 to 33 mm and the defined damping by the damped portion of the defined compression to 8 to 16 mm. The holding mechanism 114 is triggered and the coronoid fracture of the Regan & Morrey type l-III, 21 B1 according to AO is generated in the preparation 106 with a probability of 90%.
Example 10: Alignment in a defined geometry for the reproducible generation of a Terrible Triad (21 C1 according to AO).
CH 713 083 B1 A preparation 106 consisting of hand, forearm and upper arm is prepared for a Terrible Triad 21 C1 according to AO.
In order to align the preparation 106 in the defined geometry, the upper arm is set down about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) by 0 to 8 degrees. In this position the forearm is turned from the neutral position to a maximum pronation. The hand is fixed with bandages in a fist position, the wrist is stiffened in the neutral position. The bandaged portion of the preparation is supported vertically in an adapter 16. One or more foam mats are applied to the bottom of the adapter 16 under the supported hand (depending on the preparation). The adapter 16 is filled with quartz sand and screwed onto the base plate 101. The filling quantity of the adapter should be 12-15 cm, calculated from the base plate 101. The support point on the base plate 101 lies in the transverse plane 3-8 cm (depending on the preparation) in front of the humeral shaft or force application point.
[0229] These foam mats protect the biological structures in the wrist area by passively increasing the area of the force transmission. With the help of these foam mats, the preparation 106 is prevented from fracturing below the targeted position.
The following settings are made on the device 100: The defined mass (falling mass) 18.9 to
26.8 kg, the defined speed by means of fall height to 85 to WO cm, the defined compression to 24 to 38 mm and the defined damping due to the damped portion of the defined compression to 10 to 18 mm. The holding mechanism 114 is triggered and the terrible triad of classification 21 C1 according to AO is generated in the preparation 106 with a probability of 92%.
Example 11: Alignment in a defined geometry for the reproducible generation of an olecranon fracture (21 B1, C1 according to AO).
A preparation 106 consisting of a hand, forearm and upper arm is prepared for an olecranon fracture 21 B1, C1 according to AO.
To align the preparation 106 in the defined geometry, the humerus is set down about 6-10 cm distal to the humeral head. At the proximal end of the humerus stump, approx. 5 cm of the soft tissue is dissected and the bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 according to the invention to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is flexed by 90 degrees, the olecranon is supported on an adapter 3, which has the shape of a truncated cone, on the base plate 101 of the device 100. The forearm should be kept in the supination position. The support point lies in the transverse plane under the cast humerus.
The following settings are made on the device 100: the defined mass (falling mass) 17.1 to 20 kg, the defined speed by means of falling height to 61 to 79 cm, the defined compression to 4 to 17 mm and the defined damping by dampened portion of the defined compression to 0 to 9 mm. The holding mechanism 114 is triggered and the olecranon fracture of classification 21 B1, C1 according to AO is generated in the preparation 106 with a probability of 94%.
Example 12: Alignment in a defined geometry for the reproducible generation of a Monteggia fracture (21 A1, B1 according to AO).
A preparation 106 consisting of hand, forearm and upper arm is prepared for a Monteggia fracture 21 A1, B1 according to AO.
In order to align the preparation 106 in the defined geometry, the humerus is placed approximately 10-12 cm distal to the humeral head. At the proximal end of the humerus stump, approximately 5 cm of the soft tissue is dissected and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 according to the invention with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The cut surface of the humerus is centrally below the force application point. The preparation 106 thus stands with the ulna / olecranon facing upward in the device 100. An adapter 18 is attached to the clamping plate 107 under the punch 111. The forearm is clamped medially and laterally. The flexion angle of the humeroulnar joint is between 90 and 100 degrees. The support point of the adapter on the ulna is in the transverse plane 4-6 cm in front of the pouring point or 7-9 cm distal to the olecranon tip, on the radius 2-5 cm in front of the pouring point / 5-7 cm distal to the olecranon tip. The forearm is fixed in maximum supination. The following settings are made on the device 100: The defined mass (falling mass) 16.8 to
17.9 kg, the defined speed by means of fall height to 72 to 88 cm, the defined compression to 28 to 46 mm and the defined damping by the damped portion of the defined compression to 10 to 17 mm. The holding mechanism
CH 713 083 B1
114 is triggered and the Monteggia fracture of classification 21 A1, B1 according to AO is generated in preparation 106 with a probability of 60%.
Example 13: Alignment in a defined geometry for the reproducible generation of a Monteggia-Iike lésion (21 B3 according to AO).
For a Monteggia-Iike lesion 21 B3 according to AO, a preparation 106 consisting of hand, forearm and upper arm is prepared.
In order to align the preparation 106 in the defined geometry, the humerus is set down approximately 10-12 cm distal to the humeral head. At the proximal end of the humerus stump, approximately 5 cm of the soft tissue is dissected and the bone is cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The cut surface of the humerus is centrally below the force application point. The preparation 106 thus stands with the ulna / olecranon facing upward in the device 100. An adapter 18 is attached to the clamping plate 107 under the punch 111. The forearm is clamped medially and laterally. The flexion angle of the humeroulnar joint should be between 80 and 95 degrees. The support point of the adapter on the ulna should be 3-5 cm in front of the pouring point, 6-7 cm distal to the olecranon tip, on the radius 2-5 cm in front of the pouring point / 5-7 cm distal to the olecranon tip. The forearm must be fixed in maximum supination.
The following settings are made on the device 100: The defined mass (falling mass) 16.8 to
18.4 kg, the defined speed by means of drop height to 75 to 92 cm, the defined compression to 30 to 46 mm and the defined damping by the damped portion of the defined compression to 9 to 21 mm. The holding mechanism 114 is triggered and the Monteggia-Iike lésion of the classification 21 B3 according to AO is generated in the preparation 106 with a probability of 66%.
Example 14: Alignment in a defined geometry for the reproducible generation of a galactic fracture (22 A3, B3, C1-C3 according to AO).
A preparation 106 consisting of a hand, forearm and upper arm is prepared for a galactic fracture 22 A3, B3, C1-C3 according to AO.
To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 according to the invention to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The humeroulnar joint is bent from the maximum extension (usually between 176 and 189 degrees, the angle depends on the preparation) 5 to 12 degrees. In this position the forearm is turned from the neutral position to a maximum supination. The wrist is fixed with bandages in an extension position of 80 to 90 degrees and supported vertically in an adapter 16. Various foam mats are applied to the bottom of the adapter 16 under the supported hand (depending on the preparation). These foam mats (there are three different degrees of hardness) protect the biological structures in the wrist area by passively increasing the area of the power transmission. With the help of these mats, the preparation 106 is prevented from fracturing below the targeted position. The adapter 16 is filled with quartz sand and screwed onto the base plate 101 of the device 100. The filling quantity of the adapter should be 6-8 cm from the bottom. The support point on the base plate 101 should lie in the transverse plane 3-8 cm (depending on the preparation) in front of the humerus shaft / force application point.
The following settings are made on the device 100: The defined mass (falling mass) 18.5 to
22.6 kg, the defined speed by means of drop height to 95 to 107 cm, the defined compression to 24 to 39 mm and the defined damping by the damped portion of the defined compression to 6 to 17 mm. The holding mechanism 114 is triggered and the galactic fracture of the classification 22 A3, B3, C1-C3 according to AO is generated in the preparation 106 with a probability of 53%.
Example 15: Alignment in a defined geometry for the reproducible generation of a capillary fracture (13 B3 according to AO).
A preparation 106 consisting of a hand, forearm and upper arm is prepared for a capillary fracture 13 B3 according to AO.
In order to align the preparation 106 in the defined geometry, the humerus is set down approximately 10-12 cm distal to the humeral head. At the proximal end of the humerus stump, approximately 5 cm of the soft tissue around the tibia and fibula is dissected and the bones are cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The cut surface of the humerus is centrally below the force application point. The preparation 106 thus stands with the ulna / olecranon facing upward in the device 100. An adapter 5 or 8 is attached to the clamping plate 107 under the punch 111. The ulna is supported flat against the inclined surface of the adapter 5 or 8. The flexion angle of the humeroulnar joint should be between 90 and 115 degrees. The support point of the olecranon should be in the transverse plane above the pouring point, the forearm should be fixed in maximum supination.
CH 713 083 B1 The following settings are made on the device 100: The defined mass (falling mass) 20.5 to
24.2 kg, the defined speed by means of fall height to 70 to 81 cm, the defined compression to 14 to 22 mm and the defined damping by the damped portion of the defined compression to 6 to 13 mm. The holding mechanism 114 is triggered and the capillary fracture of the classification 13 B3 according to AO is generated in the preparation 106 with a probability of 72%.
Example 16: Alignment in a defined geometry for the reproducible generation of a distal humeral fracture (13 B1, B2, C1-C3 according to AO).
For a distal humeral fracture 13 B1, B2, C1-C3 according to AO, a preparation 106 consisting of hand, forearm and upper arm is prepared.
To align the specimen 106 in the defined geometry, the humerus is placed approximately 16-20 cm distal to the humeral head. At the proximal end of the humerus stump, approx. 5 cm of the soft tissue is dissected and the bone is cast vertically in a mold 105 with cold-curing polymer. The mold 105 is connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The cut surface of the humerus is centrally below the force application point. The preparation 106 thus stands with the ulna / olecranon facing upward in the device 100. An adapter 5, 9 or 10 is attached to the clamping plate 107 under the punch 111. The ulna is supported flat against the inclined surface of the adapter 5, 9 or 10. The flexion angle of the humeroulnar joint should be between 120 and 150 degrees. The support point of the olecranon should be in the transverse plane above the pouring point, the forearm should be fixed in maximum supination.
The following settings are made on the device 100: The defined mass (falling mass) 20.2 to
27.2 kg, the defined speed by means of drop height to 68 to 81 cm, the defined compression to 26 to 37 mm and the defined damping by the damped portion of the defined compression to 0 to 15 mm. The holding mechanism 114 is triggered and the distal humeral fracture of the classification 13 B1, B2, C1-C3 according to AO is generated in the preparation 106 with a probability of 79%.
Example 17: Alignment in a defined geometry for the reproducible generation of a clavicular shaft fracture (type A and B according to AO).
For a clavicular shaft fracture type A and B according to AO, a preparation 106 consisting of humerus, scapula, clavicle and sternum attachment is prepared.
To align the specimen 106 in the defined geometry, the upper arm is placed approximately 10-12 cm distal to the humeral head. Approx. 3 cm of the soft tissue is dissected on the humerus stump. At the scapula, the inferior angulus is separated 7-8 cm below the horizontal, so that the cutting edge runs parallel to the scapular spine. The scapula and the humerus are cast in vertically on their cut edges in an adapter 12 by means of cold-curing polymer about 3 cm deep. The vertical alignment of the scapula on the cutting edge below the spina without tilting sideways must be taken into account. The adapter 12 is then connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. An adapter 3 with the shape of a blunt cone is integrated on the clamping plate 107 below the punch 111. The means for fixing the preparation 102, for example an adjustable slide, is positioned on the base plate 101 in such a way that the targeted (marking) fracture point of the clavicle is centrally located under the force application point / adapter 3. The marking for all clavicular shaft fractures type A and B lies in the transition of the S-shaped oscillation (5-8 cm medial to the sternum approach). The medial end of the clavicle is fixed in a clamping ring on a height-adjustable adapter 14. There is a 5 mm thick foam inside the clamping ring, which allows minimal movement of the clavicle in all directions. The height of the medial end is adjusted to the height of the lateral end / humeral head.
The following settings are made on the device 100: The defined mass (falling mass) 12.3 to
16.5 kg, the defined speed by means of drop height to 55 to 68 cm, the defined compression to 4 to 12 mm and the defined damping by the damped portion of the defined compression to 0 to 6 mm. The holding mechanism 114 is triggered and the clavicular shaft fracture of the type A and B classification according to AO is generated in the preparation 106 with a probability of 70%.
Example 18: Alignment in a defined geometry for the reproducible generation of a lateral clavicle fracture (type I and II according to Neer).
For a lateral clavicle fracture type I and II according to Neer, a preparation 106 consisting of humerus, scapula, clavicle and sternum attachment is prepared.
[0261] To align the preparation 106 in the defined geometry, the upper arm is placed about 10-12 cm distal to the humeral head. Approx. 3 cm of the soft tissue is dissected on the humerus stump. At the scapula, the inferior angulus is separated 7-8 cm below the horizontal, so that the cut edge runs parallel to the scapular spine. The scapula and the humerus are cast in vertically on their cut edges in an adapter 12 by means of cold-curing polymer about 3 cm deep. The vertical alignment of the scapula on the cutting edge below the spina without tilting sideways must be taken into account. The adapter 12 is then in the device 100 with means for
CH 713 083 B1
Fixation of the preparation 102, for example an adjustable slide, connected to the base plate 101. An adapter 2 with a spherical surface is integrated on the clamping plate 107 below the punch 111. The means for fixing the preparation 102, for example the slide, is positioned on the base plate (101) in such a way that the targeted fracture point of the clavicle is located centrally under the force application point / adapter 2. The marking should be in the shoulder triangle (between the clavicle, coracoid process and acromion) for all of the fractures mentioned above. The medial end of the clavicle is fixed in a clamping ring on a height-adjustable adapter 14. There is a 5 mm thick foam inside the clamping ring, which allows minimal movement of the clavicle in all directions. The height of the medial end is adjusted to the height of the lateral end / humeral head.
The following settings are made on the device 100: The defined mass (falling mass) 10.3 to
21.9 kg, the defined speed by means of drop height to 57 to 76 cm, the defined compression to 4 to 14 mm and the defined damping by the damped portion of the defined compression to 0 to 7 mm. The holding mechanism 114 is triggered and the lateral clavicle fracture of the type I and II classification according to Neer is generated in the preparation 106 with a probability of 52%.
Example 19: Alignment in a defined geometry for the reproducible generation of a proximal humeral fracture (11 B1, B3, C1-C3 according to AO).
For a proximal humeral fracture 11 B1, B3, C1-C3 according to AO, a preparation 106 consisting of humerus, scapula, clavicle and sternum attachment is prepared.
[0265] In order to align the preparation 106 in the defined geometry, the upper arm is placed approximately 16-20 cm distal to the humeral head. Approx. 5 cm of the soft tissue is dissected on the humerus stump and the humerus bone is cast vertically in a mold 105 with cold-curing polymer. The scapula is dissected at its medial edge (margo medialis) approx. 3 cm and cast with the medial edge in an adapter 12 with cold-curing polymer approx. 3 cm deep. The vertical alignment of the scapula on the medial edge without tilting to the side must be observed. During the curing of the polymer, the humerus should be held in a 90 degree abduction position to simulate the later position in the device 100. The adapter 12 is then connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The mold 105 is connected in the device 100 according to the invention to the clamping plate 107 on the punch 111. The cut surface of the humerus is centrally below the force application point. The means for fixing the specimen 102, for example the adjustable slide, is positioned on the base plate 101 in such a way that the fixed humerus is at an abduction angle of 85-95 degrees in the socket of the scapula. The humerus should also have an internal rotation of 10-15 degrees to the scapula.
The following settings are made on the device 100: the defined mass (falling mass) 19.2 to 28.8 kg, the defined speed by means of falling height to 65 to 88 cm, the defined compression to 29 to 44 mm and the defined damping due to the damped portion of the defined compression to 0 to 16 mm. The holding mechanism 114 is triggered and the proximal humeral fracture of the classification 11 B1, B3, C1-C3 according to AO is generated in the preparation 106 with a probability of 76%.
Example 20: Alignment in a defined geometry for the reproducible generation of a distal femur fracture (33 C1-C3 according to AO).
For a femur fracture 33 C1-C3 according to AO, a preparation 106 consisting of the foot, lower leg and thigh is clamped.
To align the preparation 106 in the defined geometry, the foot is placed on the base plate 101 of the device 100, the knee joint is bent between 110 degrees and 130 degrees and fixed under the punch 111 with an adapter 17. The adapter 17 is based on the model of an inverted vice. This means that it applies parallel clamping from two sides (lateral and medial) to the selected preparation 106. The specimen 106 is thus fixed in a stable manner. The adapter is screwed to the punch 111. The impulse is therefore passed on directly to the preparation 106. The adapter 17 has a shaft joint, by means of which the surface that presses on the femur can be adjusted. As a result, the force application point can be controlled precisely / fracture-specifically in the joint. The knee should be positioned 4-8 cm in front of the ankle in the transverse plane, the inner angle of the knee should be between 100 degrees and 130 degrees. The tibial rotation should not be affected. The lateral inclination (varus / valgus) should also not be influenced, but should not exceed 5 degrees.
The following settings are made on the device 100: The defined mass (falling mass) 26.0 to
38.7 kg, the defined speed by means of drop height to 99 to 116 cm, the defined compression to 31 to 49 mm and the defined damping by the damped portion of the defined compression to 0 to 37 mm. The holding mechanism 114 is triggered and the distal femur fracture of the classification 33 C1-C3 according to AO is generated in the preparation 106.
Example 21: Alignment in a defined geometry for the reproducible generation of a tibial head fracture (41 B1 according to AO).
For a (proximal) tibial head fracture of classification 41 B1 according to AO, a preparation 106 consisting of the foot, lower leg and thigh is clamped.
CH 713 083 B1 [0273] To align the preparation 106 in the defined geometry, the foot is placed on the base plate 101 of the device 100 and fixed under the punch 111 with an adapter 17. The adapter 17 is based on the model of an inverted vice. This means that it applies parallel clamping from two sides (lateral and medial) to the selected preparation 106. The specimen 106 is thus fixed in a stable manner. The adapter 17 is screwed to the punch 111. The impulse is therefore passed on directly to the preparation 106. The adapter 17 has a shaft joint, by means of which the surface that presses on the femur can be adjusted. As a result, the force application point can be controlled in the joint in a fracture-specific manner. The knee angle should be between 90 degrees and 105 degrees. The knee joint should be positioned 2-4 cm in front of the ankle in the transverse plane, the dorsal extension of the foot should be between 0 degrees and 10 degrees. The tibial rotation should not be affected. The lateral inclination (varus / valgus) should not exceed 0 to 5 degrees.
The following settings are made on the device 100: the defined mass (falling mass) 26 to 31 kg, the defined speed by means of falling height to 96 to 112 cm, the defined compression to 35 to 47 mm and the defined damping by the damped portion the defined compression to 10 to 13 mm. The holding mechanism 114 is triggered and the tibial head fracture of the classification 41 B1 according to AO is generated with a probability of 72% in the preparation 106.
Example 22: Alignment in a defined geometry for the reproducible generation of a talus fracture (type II, type III according to Hawkins).
For a talus fracture type II, type III according to Hawkins, a preparation 106 consisting of the foot and lower leg is clamped.
In order to align the preparation 106 in the defined geometry, the lower leg is set down about 15-20 cm distal to the tibia head. At the proximal end of the stump of the lower leg, approx. 5 cm of the soft tissue around the tibia and fibula is dissected and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 according to the invention to the clamping plate 107 on the punch 111. The cut surfaces of the tibia and fibula are centrally below the force application point. The ball of the foot is placed stably on an adapter 3 and held by means of tension belts, the plantar flexion of the foot should be 10 to 15 degrees. The lateral tilt (inversion and eversion) should not be influenced. The ankle should be 1-3 cm in front of the pouring point in the transverse plane.
The following settings are made on the device 100: The defined mass (falling mass) 24.8 to
37.2 kg, the defined speed by means of drop height to 68 to 83 cm, the defined compression to 26 to 48 mm and the defined damping by the damped portion of the defined compression to 0 to 22 mm. The holding mechanism 114 is triggered and the talus fracture of the Type II, Type III classification according to Hawkins is generated in the preparation 106.
Example 23: Alignment in a defined geometry for the reproducible generation of a pilon fracture (43 B3-B4, C1-C3 according to AO).
For a pilon fracture 43 B3-B4, C1-C3 according to AO, a preparation 106 consisting of the foot and lower leg is clamped.
In order to align the preparation 106 in the defined geometry, the lower leg is set down about 15-20 cm distal to the tibia head. At the proximal end of the stump of the lower leg, approx. 5 cm of the soft tissue around the tibia and fibula is dissected and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 with means for fixing the preparation 102, for example an adjustable slide, on the base plate 101. The cut surfaces of the tibia and fibula are centrally below the force application point. The foot is thus flat with the sole facing upwards against the clamping plate 107 under the punch 111. The ankle should be in the transverse plane above the pouring point, the dorsal extension of the foot should not exceed 5 degrees.
The following settings are made on the device 100: The defined mass (falling mass) 24.7 to
38.5 kg, the defined speed by means of drop height from 100 to 111 cm, the defined compression to 30 to 51 mm and the defined damping by the damped portion of the defined compression to 0 to 25 mm. The holding mechanism 114 is triggered and the pilon fracture of the classification 43 B3-B4, C1-C3 according to AO is generated in the preparation 106 with a probability of 62%.
Example 24: Alignment in a defined geometry for the reproducible generation of a calcaneus fracture (type 2A, 2C, type 3AB, 3AC according to Sanders).
For a calcaneus fracture type 2A, 2C, type 3AB, 3AC according to Sanders, a preparation 106 consisting of foot and lower leg is clamped.
To align the preparation 106 in the defined geometry, the lower leg is set down about 15-20 cm distal to the tibia head. At the proximal end of the stump of the lower leg, approx. 5 cm of the soft tissue around the tibia and fibula is dissected and the bones are cast vertically in a mold 105 using cold-curing polymer. The mold 105 is connected in the device 100 according to the invention to the clamping plate 107 on the punch 111. The cut surfaces of the tibia and fibula are centrally below the force application point. The ankle should therefore
CH 713 083 B1 in the transverse plane under the pouring point. The Calcaneus is placed stably on an adapter 03, the plantar flexion of the foot should not exceed 10 degrees.
The following settings are made on the device 100: The defined mass (falling mass) 24.1 to
32.7 kg, the defined speed by means of drop height to 90 to 98 cm, the defined compression to 25 to 43 mm and the defined damping by the damped portion of the defined compression to 0 to 18 mm. The holding mechanism 114 is triggered and the calcaneus fracture of the type 2A, 2C, type 3AB, 3AC classification according to Sanders is generated in the preparation 106 with a probability of 61%.
Example 25: Exemplary procedure for creating a new defined bone fracture in a preparation 106. It is assumed that the new defined bone fracture is generated in a bicycle accident in which a person with a body size of 165 cm and a Body weight of 50 kg in front on the outstretched arms or hands on the street, the following initial situation prevails:
The fall height is 155 cm and the initial speed is 15 km / h.
[0290] i ^ liilul ^ ί.ίΐί 1 (1)
·> () /.’// / III -III =. n. IG — J + 5 () /, 7 /.().^ 1 - ^. 1.55 /// (3) = 11 () 1 ./(- 1) [0291] The cyclist therefore has almost 1, 2 kilojoules of energy before hitting the ground.
This example shows the dimensions in which the first model calculations move. This is based on examples of bicycle accidents from reality. By using different masses for the casualties and different speeds when the casualty hits the bicycle when falling, an energy range is obtained that can be used to generate the bone factor typical of a bicycle accident (= selected defined bone fracture with accompanying soft tissue injuries). This defined bone fracture, which is typical in a bicycle accident when falling over the handlebars, can be classified according to the AO trauma classification, for example. With the help of the known model calculations, the calculated energy in the event of an impact in the real accident and the biochemical parameters in the accident, e.g. the joint position in the arm or hand of the accident victim upon impact with the road, the parameters, namely the defined mass, the defined direction, the defined speed of the calculated defined mass upon impact, the defined geometry of the preparation 106 in relation to the calculated force shock upon impact calculate or determine the defined compression of the preparation 106, the defined damping upon impact of the defined mass.
The angle settings of the joints are made using a goniometer and documented in all simulations. The settings / pre-tensioning of Varus / Valgus can also be made with tension belts.
Example 26: Validation of the Defined Parameters The specimen 106 is clamped in the defined geometry in the device 100, 500 and the settings (defined mass, defined speed as defined height of the falling mass, defined compression and defined damping) are applied the device 100, 500 made. The force transferred to the specimens by the impulse during the force shock is measured by the three force measuring rings (type 9011A Kistler, Winterthur, Switzerland) or force sensors used in the punch. In order to meet the above-mentioned sampling theorem and to obtain enough measured values over the short duration of the power surge, the signal of the measuring rings was recorded in the tests with the prototype at 100,000 Hz. The force sensors were arranged in the transverse plane as an equilateral triangle. Based on this arrangement and the individually output force values of the three sensors, the force vector can be determined subsequently from the direction vectors and thus the force application point. The force vector should run axially (in the Z direction) through the preparation 106. Another force sensor (type 9061A, Kistler, Winterthur, Switzerland) was installed below the clamped specimen and also scanned at 100,000 Hz. The energy absorbed by the biological tissue can be estimated from the difference between the two force signals.
[0296] Three high-speed cameras 528 (type HCC 1000 (F) BGE, Vosskühler, Alited Vision Technologies GmbH, Stadtroda) are used for optical data acquisition of the sequence of injuries. The image section of the cameras is variable, but is usually set to 1024 x 256 pixels in order to achieve the highest possible recording rate of 1825 fps (frames per second). Due to the rapid application of force, 15 to 20 images result for evaluation from the recorded data sets per preparation 106 and camera. In all experiments, the cameras are optimally aligned with the markings made on the preparation 106 and around the preparation 106 at approximately 120-degree intervals

权利要求:
Claims (40)
[1]
CH 713 083 B1 set up (Fig. 5). Before and after the practical tests, a calibration is carried out for all cameras. In later image analysis, this serves as a scaling of the aspect ratios of the preparations taken.
claims
1. A method for generating at least one defined bone fracture with accompanying soft tissue injuries in a preparation (106) comprising bones and soft parts, characterized in that a defined force impact is exerted on the fixed preparation (106) and the change in the length of the preparation (106) is along of the force vector is limited to a maximum of 80 mm.
[2]
2. The method according to claim 1, characterized in that the change in the length of the preparation (106) is limited to a maximum of 80 mm by setting a defined compression to which the preparation (106) is exposed when the force is applied.
[3]
3. The method according to claim 2, characterized in that the defined compression is a maximum of 80 mm and that it comprises:
a) fixation of a preparation (106);
b) setting a defined mass and positioning the defined mass with a holding mechanism (114) (214);
c) setting a defined speed at which the defined mass impacts the preparation (106);
d) adjustment of the defined compression to which the preparation (106) is subjected upon impact of the defined mass when the holding mechanism (114) (214) is released;
e) setting a defined damping to which the preparation (106) is exposed upon impact of the defined mass when the holding mechanism (114) (214) is released;
f) triggering the holding mechanism (114) (214) to accelerate the defined mass in the direction of the preparation (106);
g) removing the fixation of the preparation (106);
the steps a) to e) can be carried out in a variable order and the setting of a defined damping is optional.
[4]
4. The method according to claim 3, characterized in that the defined compression is set to 2 to 60 mm.
[5]
5. The method according to any one of claims 3 or 4, characterized in that the defined damping is set to 0 to 50 mm, preferably 5 to 37 mm.
[6]
6. The method according to any one of claims 3 to 5, characterized in that the defined mass is set to 1 to 72 kg, preferably to 4 to 40 kg.
[7]
7. The method according to any one of claims 3 to 6, characterized in that the defined mass is a gravitationally accelerated mass and the defined speed is set by a head.
[8]
8. The method according to claim 7, characterized in that a drop height of 10 to 150 cm, preferably from 20 to 120 cm, is set.
[9]
9. The method according to any one of the preceding claims 2 to 8, characterized in that the soft tissue jacket which surrounds the bones remains closed in the preparation (106) when the defined bone fracture is generated.
[10]
10. The method according to any one of the preceding claims 2 to 9, characterized in that it generates a defined bone fracture, which is selected from shaft fracture of the phalanges, shaft fracture of the metacarpal, radius fracture, distal radius fracture, distal radius fracture extension, distal radius fracture flexion, distal radius fracture / Diepunch fracture, distal radius fracture chauffeur fracture, scaphoid fracture, radius head fracture, coronoid fracture, terrible triad, olecranon fracture, Monteggia fracture, Monteggia equivalent fracture, clavicular fracture, capillary fracture, humeral fracture, distal humeral fracture, humeral fracture distal femur fracture, proximal femur fracture, tibia head fracture, proximal tibia head fracture, distal tibia head fracture, talus fracture, pilon fracture, calcaneus fracture, maleolifracture, navicular fracture, patella fracture, metatarsal fracture, scapular fracture, Arm fracture, hand fracture, ankle fracture, vertebral fracture, rib fracture, sacrum fracture, foot fracture, metatarsal fracture, hip fracture, luxation fracture.
[11]
11. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a shaft fracture of the phalanges and the defined compression of the preparation (106) is set to 2 to 8 mm and the defined damping to 0 to 5 mm.
[12]
12. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a shaft fracture of the metacarpal and the defined compression of the preparation (106) is set to 6 to 14 mm and the defined damping to 0 to 9 mm.
[13]
13. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture and the defined compression of the preparation (106) is set to 20 to 36 mm and the defined damping to 6 to 17 mm.
CH 713 083 B1
[14]
14. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture extension of the classification 23 A2, 23 C1-C3 according to AO and the defined compression of the preparation (106) to 22 to 30 mm and defined damping is set to 6 to 14 mm.
[15]
15. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture of the classification 23 A2 according to AO and the defined compression of the preparation (106) to 25 to 35 mm and the defined damping to 5 to 17 mm is set.
[16]
16. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture / die-punch fracture of the classification 23 C1-C2 according to AO and the defined compression of the preparation (106) to 22 to 31 mm and the defined damping is set to 9 to 15 mm.
[17]
17. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture / chauffeur fracture of the classification 23 B1 according to AO and the defined compression of the preparation (106) to 20 to 28 mm and the defined damping to 6 up to 14 mm.
[18]
18. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a scaphoid fracture and the defined compression of the preparation (106) is set to 24 to 32 mm and the defined damping to 10 to 17 mm.
[19]
19. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a radius head fracture and the defined compression of the preparation (106) is set to 21 to 29 mm and the defined damping to 9 to 15 mm.
[20]
20. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a coronoid fracture and the defined compression of the preparation (106) is set to 20 to 33 mm and the defined damping to 8 to 16 mm.
[21]
21. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a Terrible Triad and the defined compression of the preparation (106) is set to 24 to 38 mm and the defined damping to 10 to 18 mm.
[22]
22. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is an olecranon fracture and the defined compression of the preparation (106) is set to 4 to 17 mm and the defined damping to 0 to 9 mm.
[23]
23. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a Monteggia fracture and the defined compression of the preparation (106) is set to 28 to 46 mm and the defined damping to 10 to 17 mm.
[24]
24. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a Monteggia equivalent injury and the defined compression of the preparation (106) is set to 30 to 46 mm and the defined damping to 9 to 21 mm ,
[25]
25. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a galactic fracture and the defined compression of the preparation (106) is set to 24 to 39 mm and the defined damping to 6 to 17 mm.
[26]
26. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a capillary fracture and the defined compression of the preparation (106) is set to 14 to 22 mm and the defined damping to 6 to 13 mm.
[27]
27. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a humerus fracture and the defined compression of the preparation (106) is set to 26 to 44 mm and the defined damping to 0 to 16 mm.
[28]
28. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal humeral fracture and the defined compression of the preparation (106) is set to 26 to 37 mm and the defined damping to 0 to 15 mm.
[29]
29. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a clavicular shaft fracture and the defined compression of the preparation (106) is set to 4 to 12 mm and the defined damping to 0 to 6 mm.
[30]
30. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a lateral clavicle fracture and the defined compression of the preparation (106) is set to 5 to 14 mm and the defined damping to 0 to 7 mm.
[31]
31. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a proximal humeral fracture 11 B1, B3, C1-C3 according to AO and the defined compression of the preparation (106) to 29 to 44 mm and the defined damping is set to 0 to 16 mm.
CH 713 083 B1
[32]
32. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a distal femur fracture and the defined compression of the preparation (106) is set to 31 to 49 mm and the defined damping to 0 to 37 mm.
[33]
33. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a tibia head fracture and the defined compression of the preparation (106) is set to 35 to 47 mm and the defined damping to 10 to 13 mm.
[34]
34. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a talus fracture and the defined compression of the preparation (106) is set to 26 to 48 mm and the defined damping to 0 to 22 mm.
[35]
35. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a pilon fracture and the defined compression of the preparation (106) is set to 30 to 51 mm and the defined damping to 0 to 25 mm.
[36]
36. The method according to any one of claims 3 to 10, characterized in that the defined bone fracture is a calcaneus fracture and the defined compression of the preparation (106) is set to 25 to 43 mm and the defined damping to 0 to 18 mm.
[37]
37. Method according to one of claims 3 to 10, characterized in that the defined bone fracture is a distal radius fracture 23 B3 according to AO and the defined compression of the preparation (106) is set to 25 to 36 mm and the defined damping to 10 to 16 mm becomes.
[38]
38. The method according to any one of claims 1 to 37, characterized in that the defined bone fracture is generated by a force shock resulting from a kinetic energy of 5 to 500 joules.
[39]
39. The method according to any one of claims 1 to 38, wherein the method is carried out with a device (100) (200) which comprises
i. at least one guide column (118) (218), ii. at one end of the guide column (118) (218) a base plate (101) (201), ili. a traverse (109) (209) with punch (111) (211), iv. if necessary, at least one means for adjusting the damping upon impact of the defined mass (110) (210),
v. at least one clamping plate for fixing the preparation (107) (207), vi. a mass (112) (212) and optionally additional weight (113) (213) for setting a defined mass, vii. at least one further cross member (115) (215) with at least one triggerable holding mechanism (114) (214) for positioning the defined mass.
[40]
40. Use of a device (100) (200) for performing a method according to one of claims 1 to 38, wherein the device (100) (200) comprises
i. at least one guide column (118) (218), ii. at one end of the guide column (118) (218) a base plate (101) (201), ili. a traverse (109) (209) with punch (111) (211), iv. if necessary, at least one means for adjusting the damping upon impact of the defined mass (110) (210)
v. at least one clamping plate for fixing the preparation (107) (207),

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同族专利:

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公开号 | 公开日

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WO2018019390A1|2018-02-01|

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EP3491635A1|2019-06-05|

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AU2016416631A1|2019-03-07|

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DE112016003246B4|2021-09-02|

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US20210012681A1|2021-01-14|

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EP3937157A1|2022-01-12|

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DE112016003246A5|2018-04-12|

引用文献:

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公开号 | 申请日 | 公开日 | 申请人 | 专利标题

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US9607528B2|2012-08-24|2017-03-28|Simquest International, Llc|Combined soft tissue and bone surgical simulator|

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法律状态:

优先权:

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申请号 | 申请日 | 专利标题

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PCT/EP2016/068217|WO2018019390A1|2016-07-29|2016-07-29|Method for reproducible production of defined bone fractures|

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