A BRACE FOR MANAGEMENT OF AN ANATOMICAL STRUCTURE; AND APPLICATIONS THEREOF

Disclosed is a brace for management of an injured part of an anatomical structure. The brace comprises a proximal part extending from a proximal joint end towards a proximal free end along a proximal axis. The brace comprises a proximal fixation configured for supporting a proximal anatomical structure. The proximal part at the proximal joint end interacting via a brace joint with a distal part extending from a distal joint end towards an opposite a distal free end along a distal axis. The proximal part and the distal part are operatively connected via the brace joint. Also disclosed is a brace and a method of measuring a threshold injury force on an anatomical structure.

FIELD

The present disclosure relates generally to devices moving and stabilizing parts of a limb across an anatomical joint, to allow immobilisation, instability testing and rehabilitation of anatomic structures after injury.

BACKGROUND

Anatomic joints connect bones in the body and allow movement in the skeletal system. Injury to anatomic joints might involve bony structures, ligaments, muscle tears, tendon ruptures and more. Most injuries are stable and will heal without or with little compromise to the functional whole across the joint. Certain injuries are severe and cause instability across the anatomical joint, requiring: internal or external fixation (either through surgical stabilization or an external cast/brace); reduction (if the anatomic joint has been dislocated and requires realignment; rehabilitation to restore optimal range of motion across the affected joint.

DESCRIPTION

An objective is achieved by a brace for management of an injured part of an anatomical structure. The brace comprises a proximal part extending from a proximal joint end towards a proximal free end along a proximal axis. The brace comprises a proximal fixation configured for supporting a proximal anatomical structure. The proximal part at the proximal joint end interacting via a brace joint with a distal part extending from a distal joint end towards an opposite a distal free end along a distal axis.

The proximal part and the distal part are operatively connected via the brace joint.

The distal part may comprise a distal plate operatively connected to a proximal plate via two distal parallel arms for a displacement of the proximal plate relative to the distal plate, such that the distal plate is displaced along a tilt axis perpendicular to both the proximal axis and the distal axis.

The brace may have a pair of proximal parallel arms connected to and arranged along the proximal part. The proximal parallel arms may be operatively connected to the distal part for a displacement of the distal part relative to the proximal part substantially along the distal axis.

The degree of instability is often negatively correlated to the functional outcome after an injury. Joint instability is not always apparent. When unstable injuries are suspected, the stability of the ligaments and other anatomic structures are tested using joint specific stress-tests, sometimes also referred to as a laxity tests, to assess whether stabilization is indicated. The brace as disclosed improves the stability across an injured joint.

Both joint reduction, external immobilization, stress testing and rehabilitation, is traditionally performed manually. Joint reductions performed in emergency departments across the world are often labour intensive and inadequate. The brace as disclosed mitigates such insensitivity and inadequacies.

Stress tests performed manually are highly subjective with a lack of normative values and standardization, causing a high rate of false positive findings overestimating instability. This can cause unindicated fixation, affecting post injury functional outcome. Manual rehabilitation of range of motion with a qualified physiotherapist is the gold standard. However, many patients receive limited time with their physiotherapists and do not perform exercises correctly and frequently enough to optimize post injury functional outcome. The brace as disclosed is a functional external fixation product allowing independent multi-planar movement and locking, facilitating reduction and immobilization, as well as standardized instability testing and continuous passive range of motion and resistance rehabilitation means in all required planes.

A person skilled in the art will have arranged the brace in relation to a given anatomical structure with a view to managing an injured part, such as an anatomical joint between say an anatomical proximal structure and an anatomical distal structure.

Thus, the distal part of the brace will engage with or be positioned along an anatomical distal structure and the proximal part of the brace will engage with or be positioned along an anatomical proximal structure. Operating the brace will then apply displacements and/or forces to the anatomical structure, e.g. the anatomical joint, which may be injured and in need of management.

In example, the brace may be applied to an ankle between a lower leg and a foot when the ankle is injured and in need of management.

In example, the brace may be applied to a proximal and distal phalangeal bone of a finger, if the interphalangeal joint is injured. As such, a person skilled in the art will appreciate the general principles exemplified in view of an ankle and be able to apply the same structural features to a brace for other anatomical structures.

By applying a 1stactivation means to the proximal parallel arms, the distal part of the brace will move along the distal axis relative to the proximal part.

In example, when operated with a foot fixed to the distal part and an under leg fixed to the proximal part, then all things equal the foot will be displaced and/or forces will be applied to the foot in the dorsal-ventral direction in the sagittal plane, that is back and forth, anterior-posterior.

A person skilled in the art will appreciate that deviations from anatomical references may result depending on the actual configuration according to operational conditions/positions of the brace. As is clear or as will be disclosed, the distal part may be in an angle or displaced by means other structural characteristics of the brace.

The proximal parallel arms provided will provide sufficient strength in forces and displacement as well as precise movements along the distal axis.

The proximal parallel arms will at one end be adjoined towards the proximal free end, which may be the superior direction. At the opposite end of the proximal parallel arms, which may be the inferior direction, the proximal parallel arm will be adjoined to the brace joint.

The arrangement of arms in a pair, e.g. two arms, of proximal parallel arms provides the arms that are shifted or displaced relative to each other along the distal axis.

The arrangement of arms may include more than a pair of arms, e.g. more than two arms. There may be multiple pairs of arms, or multiple or more than a pair of arms, e.g. three arms or four arms.

The ends of an arm may have a pivot joint part, which may be attached to a longitudinal part of the arm, i.e. a shaft of the arm. The arm may be a monotonic structure.

In an aspect there are two pairs of arms, e.g. four arms, each pair arranged in parallel to each other. For example, a first arm and a second arm are arranged parallel to each other and a third and a fourth arm are arranged parallel to each other. Additionally, the first arm and the third arm may be arranged parallel and the second and the fourth arm may be arranged parallel.

The 1stactivation means may be applied to the proximal parallel arms at the pivotal joints towards the proximal end.

The 1stactivation means may be applied to the distal part.

The parallel arms allow a near linear displacement along the distal axis, while providing multi-planar rigidity in the other directions across the injured anatomical structure.

In an aspect the brace joint is configured with locking means for locking the brace joint and placing the proximal part and the distal part in a fixed position relative to each other. In an aspect the brace joint is configured to receive gauge means for gauging a force on and/or a displacement of the proximal part and the distal part relative to each other.

The locking means may be a bolt-screw arrangement. The locking means may include recesses, or pins blocking the turn of blocking means. The locking means may include complementary faces being tightened together and optimally being secured. The gauge means may be a Newton-meter. The gauge means may be a torque wrench argument. The torque wrench may be integrated or applied separately. The gauge means may be a torque wrench or digital torque-meter. Such wrench may be applied to a bolt.

In an aspect, the gauge may be a spring element inserted into the brace to gauge the displacement. In an aspect there may be a scale to measure the displacement. The spring may be a linear spring.

The locking means and/or the gauge means may apply to the 1stactivation and/or any one or more of the following 2nd-6thactivations. Likewise, scales as required, i.e. linear scales and/or angular scales may be arranged as required.

In an aspect, the proximal part supports a proximal free end fixation configured for supporting an adjacent anatomical structure. The proximal part may support a proximal guide being configured for a displacement of the distal part relative to the proximal free end fixation along the proximal axis. The displacement may be achieved by a 2ndactivation means.

Such activation results in a displacement of the proximal fixation. Consequently, when applied on an adjacent anatomical structure, e.g. an upper leg relative to a foot, the displacement is in a cranial-caudal direction.

Often severe injuries across anatomic structures are impacted by the force of the trauma, requiring distraction in a cranial-caudal direction.

The locking means may be as disclosed. The gauge means may be as disclosed.

In an aspect, the brace joint is configured to rotate the distal part in a plane spanned by the proximal axis and the distal axis. The rotation of the distal part may be relative to the proximal part, e.g. such that an angle between the distal part and the proximal part increases or decreases.

The rotation may be applied by a 3rdactivation means.

The rotation may be substantially a flexion or extension, e.g. causing a flexion or extension in a joint of the anatomical structure, or rotation in an associated sagittal plane.

When reducing dislocated anatomical joints, rotation is essential to align. Furthermore, many stress tests involve external and internal rotation of the distal part relative to the proximal part across an injured joint, testing potentially unstable anatomic structures. A rotational range of motion is the motion across the large joints such as the knee, hip, ankle, wrist and elbow and a main focus of rehabilitation.

The locking means may be as disclosed. The gauge means may be as disclosed.

In an aspect, the distal part comprises a distal plate operatively connected to a proximal plate via a pair of distal parallel arms for a displacement of the proximal plate relative to the distal plate.

By applying a 4thactivation means, the result is a displacement of the distal part in a medial-lateral direction. The distal part may be displaced in a medial-lateral direction relative to the proximal part.

The distal part may comprise a first plate arranged towards the proximal end, which plate is a proximal plate, and a second plate arranged opposite towards the distal end, which plate is a distal plate. The two plates are interconnected by a set of, e.g. two, distal parallel arms. The distal plate is connected to the brace joint. As such, operation of the brace joint results in operation of the distal plate and consequently the operation of the distal parallel arms will result in the proximal plate being displaced relative to the brace joint, the distal plate and the proximal part. Alternatively, the distal plate and the proximal plate may be interconnected by one arm.

In an aspect the proximal plate is a proximal side of an outer box containing an inner box that has a proximal side towards the proximal side of the outer box. The distal plate may be a side of the inner box. The outer box and inner box are operatively connected by the distal parallel arms. The inner box is connected to the brace joint. As such operation of the brace joint results in operation of the inner box and consequently the operation of the distal parallel arms will result in the outer box and thus the proximal plate being displaced relative to the brace joint, the inner box and the proximal part.

The main effect of the 4thactivation means is alignment medial and lateral dislocation of the distal part relative to the proximal part, but is also used in instability stress tests when assessing medial or lateral instability.

The locking means may be as disclosed. The gauge means may be as disclosed.

In an aspect, the brace joint is configured to rotate the distal part substantially about the proximal axis. The rotation of the distal part may be relative to the proximal part. The rotation of the distal part may be relative to the proximal part.

By applying a 5thactivation means to the brace joint or the distal part, the rotation is substantially about the cranial-caudal axis i.e. in a transverse plane.

The locking means may be as disclosed. The gauge means may be as disclosed.

In an aspect the brace joint is configured to rotate the distal part about the distal axis. The rotation of the distal part may be relative to the proximal part.

By applying a 6thactivation means to the brace joint or the distal part, the rotation is substantially about the dorsal-ventral axis.

The locking means may be as disclosed. The gauge means may be as disclosed.

The above-mentioned means for displacement and rotation may be applied alone, in combination or all together.

Each provides a precise and/or repeatable displacement or rotation which allows for improved and consistent management of an anatomical structure. In example an ankle may be managed within specific limits.

In a special aspect, all activations 1st-6thare implemented and the brace will displace/rotate in a total of six-degrees of freedom. The displacement/rotation may be as a route wherein the order of activation is a part. Thereby the brace allows for a wide range of managements, including complex managements.

In an example the brace is configured for management of an injured, unstable ankle.

The proximal part is attached to the lower leg and above the knee. The distal part is attached to the foot in a rigid interphase using a fastener, such as an adjustable casing and straps.

Reduction: If the injury requires reduction, posterior or anterior ankle displacement can be addressed by activating the 1stactivation means, impaction and shortening can be addressed by activation the 2nd activation means and the ankle injury can be distracted. The ankle can be placed into neutral or dorsal flexion by activating the 3rdactivation means. If residual medial gapping is apparent, the lateral translation can be addressed by activating the 4thactivation means. Unstable ankle injuries tend to be externally rotated, and through activating the 5thactivation means internal rotation can be applied. Lastly, the ankle can tilt when grossly unstable which can be addressed with the 6thactivation means. The 4thactivation facilitates enhanced reduction treatment of a joint, to reposition the distal anatomical structure medially or laterally relative to the proximal anatomical structure, especially in reduction treatment of for example an ankle fracture or dislocation, which typically happens in medially or laterally.

Immobilization: All positions can be locked independently when the position is judged to be correct. If further reduction is necessary, each activation means can be unlocked and activated again independently. The device can as such immobilize severely unstable injuries until surgery if the skin interphase does not harm the skin. In a different setting, a moldable cast sock is applied under the device, and is chemically activated and hardened after reduction, allowing the device to be removed, with the cast and thus the ankle remaining in the correct position. The device is constructed from a radiolucent material allowing both reduction and instability testing to be performed under continuous radiography (referred to as fluoroscopy), which allows visualization of mainly bony structures within the ankle joint.

Instability testing of the ankle: Activating the 1stactivation means through a standardized torque-meter will test the anatomical structures securing anterior/posterior stability, mainly the syndesmosis, the posterior malleolus, the talar dome and ligaments. Activating the 4thactivation means with a known force will test the lateral anatomical structures, which are the most common to sustain injury in ankle trauma. Externally rotating the foot through the 5thactivation means with a known force will test the syndesmosis, a ligamentous structure between the fibula and tibia, the two bones constituting the lower leg, and a pivotal anatomical structure securing stability of the ankle joint. Activating the 6thactivation means will further test the lateral and medial anatomical structures.

Rehabilitation: By locking all undesired movements, the ankle can be specifically activated in the desired plane, either by the patient's own force in active motion or passively through a motor moving the joint in continuous passive motion, applying force to the 1st-6thactivation means. If more or all directional movements are desired, the activation means can be unlocked accordingly. A desired resistance can be applied to each activation means individually. Range of motion, force and resistance can be measured and tracked over time by the patient, therapist or a specific mobile/computer application.

In an aspect the brace is made of carbon fiber, plastic material and/or other material in order to be radiolucent to radiography. Continuous radiography (referred to as fluoroscopy) is often used in the emergency department or in the operating theater to visualize mainly bony structures and secure correct alignment during reduction. Thus, it is important for the brace to allow full radiographical visualization of the affected anatomical structure.

An objective may be achieved by a brace for injuring an anatomical structure of a human cadaver. Such brace for injuring an anatomical structure of a human cadaver may be denoted a trauma brace. The brace as disclosed herein may be used for injuring an anatomical structure of a human cadaver. Hence, the disclosed brace may be a trauma brace. The brace for injuring an anatomical structure may be a more rigid or stiff version of the brace as disclosed.

Structural elements may be changed to stronger materials or stiffer materials. Materials may be selected according to elastic modulus, E, a starting point.

In example, peek carbon peek50maybe be changed to aluminum. Peek carbon50may be changed to stainless steel. Carbon fiber may be changed to stainless steel. Aluminum may be changed to carbon fiber.

In example, peek carbon components can be changed to aluminum or stainless steel with an estimated stiffness increase from 30% to 270%, respectively.

Carbon fiber components can be changed to stainless steel with an estimated stiffness increase of 54%.

Knowing typical forces needed to provide an injury to a joint, or anatomical structure of a give type, the above material characteristics provide a starting point to select the proper and required strength:

As a starting point for a brace for inducing a trauma on an ankle, substantial multi-planar forces need to be applied to the anatomical structures within the ankle and the brace will be a stainless steel construct to allow maximal rigidity.

A person skilled in the art will appreciate that a brace for a finger is different in size and may be different with respect to material compared to a brace for an ankle. Using the above guidelines and principles a person skilled in the art will be able to device a brace for a finger, a wrist, an elbow, a knee etc.

A person skilled in the art will appreciate the need for a fastener, such as one or more straps or alike, to fixation of the anatomical structure to the brace. The fasteners may be attached to the proximal free end fixation or the proximal fixation. Fasteners may also be attached to the distal part, such as to the distal plate.

The brace may be arranged on a support, which may be a plate or a table.

An objective may be achieved by a method for measuring a threshold injury force on an anatomical structure of a human cadaver. The method may comprise one or more acts as follows.

There is an act of providing a human cadaver having an anatomical structure.

There is an act of arranging a brace about an anatomical structure.

There is an act of applying one or more forces to the anatomical structure by use of the brace until a point of injury of an anatomical structure.

There is an act of measuring the one or more forces and/or displacements, or both, until and/or at the point of injury.

Thereby is achieved a way of tabulating forces, displacements leading to an injury.

The methodology will provide standardized tabulation.

In an aspect the brace is as disclosed herein. The brace may be implemented with one, more or all of the 1stto 6thactivation means applied to the respective parts of the brace.

In example, a certain torque, T, is needed to break, i.e. injure, an ankle.

The required torque will depend on the species and in the case of a human, the person being man, a woman, a child, and the individual size.

A handle, here of a length from the point of activation on the brace to the point of applying a force may be applied the activation means. The handle may be chosen according to the following appliance of a weight m for a number of lengths1. For l=50 cm; m=10 kg then: T=50 Nm. For l=50 cm; m=20 kg then: T=100 Nm. For l=50 cm; m=30 kg then: T=150 Nm. For l=50 cm; m=40 kg then: T=200 Nm. The handle may be configured to be removably attached.

To break an ankle, a brace may be configured with following displacement, including rotations, ranges.

The brace may be configured for 1stactivation resulting in a displacement or transition of +/−50 mm in the dorsal-ventral direction, or posterior-anterior direction.

The brace may be configured for 2ndactivation resulting in a displacement or transition of +/−50 mm in the cranial-caudal direction, i.e. along the proximal axis.

The brace may be configured for 3rdactivation resulting in a rotation or flex, dorsal flex, in the sagittal plane of +/−90 degrees.

The brace may be configured for 4thactivation resulting in a displacement or transition of +/−15 mm in medial-lateral direction.

The brace may be configured for 5thactivation resulting in a rotation about the proximal axis, i.e. the cranial-caudal axis, which may substantially be in the transverse plane, of about +/−90 degrees.

The brace may be configured for 6thactivation resulting in a rotation about the distal axis, i.e. substantially a supination or pronation, of +/−90 degrees.

The brace may be configured with a scale display and/or means to record readings of the actual displacement.

A brace may be configured different ranges of rotational angles or linear displacements.

For one or more of the displacement or rotations, the brace may be configured with a scale display and/or means to record readings of the actual displacement/rotation.

In an aspect, the route of displacements and rotations may be recorded. There may be a 1stroute comprising a 1stactivation of 10 mm, a 2ndactivation of −5 mm, and a 6thactivation of +20 degrees. There may be a 2ndroute with a different order of the same activations, just as an example.

In an aspect the brace is implemented with all six activation means. Thus, the brace will be able to tabulate all possible (six degrees of freedom) displacements and/or rotations.

In example, the brace may be used as follows: One by one torque wrenches are turned to a position just before the ankle is damaged. The positions are kept manually.

All torque wrenches are at the same time forced towards a maximum until the ankle breaks.

In example, the brace may be used as follows: One by one the torque wrenches are turned to a position just before the ankle is damaged. The positions are locked by mechanical systems. Then one chosen torque wrench is forced towards a maximum until the ankle breaks.

DETAILED DESCRIPTION

FIG. 1illustrates a brace100, an anatomical structure90and degrees of freedom of the anatomical structure90.

The anatomical structure90has a proximal anatomical structure91, a distal anatomical structure93, an anatomical joint92interconnecting the proximal anatomical structure91and the distal anatomical structure93.

The proximal anatomical structure91is further connected to an adjacent anatomical structure94distal to the distal anatomical structure93.

The movement of the distal anatomical structure93relative to the proximal anatomical structure91is controlled by the anatomical joint92.

The brace100has a proximal part200extending from a proximal joint end202towards a proximal free end204along a proximal axis10.

The proximal part200comprises a proximal fixation210, which is configured for supporting the proximal anatomical structure91.

The proximal part200comprises a proximal free end fixation230, which is configured for supporting the adjacent anatomical structure94.

The brace100comprises a distal part400extending from a distal joint end402towards an opposite a distal free end404along a distal axis20.

The distal part400is adapted for supporting the distal anatomical structure93.

The brace100comprises a brace joint300. The proximal part200at the proximal joint end202interacts via the brace joint300with the distal part400at the distal joint end402.

The distal axis20has a dorsal end22in the direction of the distal joint end402and a ventral end24opposite to the dorsal end22. The distal axis20may also be called dorsal-ventral axis20.

The proximal axis10has a distal end14in a direction of the proximal joint end202and a proximal end12opposite to the distal end14and in the direction of the proximal free end204. The proximal axis10may also be called cranial-caudal axis10. The proximal axis10and the distal axis20define a sagittal plane50.

A tilt axis30is perpendicular to both the proximal axis10and the distal axis20and intersects the distal joint end402. The part of the tilt axis30intersecting the distal joint end402is a medial33and the ends of the tilt axis30are respectively a left lateral end32and a right lateral end34. The tilt axis30may also be called medial-lateral axis30. The tilt axis30and the distal axis20define a transverse plane70. The tilt axis30and the proximal axis10define a coronal plane60.

The brace100comprises a pair of proximal parallel arms220. The pair of proximal parallel arms220are connected to and arranged along the proximal part200and operatively connected to the distal part400for a displacement of the distal part400relative to the proximal part200substantially along the distal axis20. This may be performed by a 1stactivation means10.

The proximal part200comprises a proximal guide240, which is configured for a displacement of the distal part400relative to the proximal free end fixation230along the proximal axis10. This may be performed by a 2ndactivation means102. The displacement is a cranial-caudal displacement.

The brace joint300is configured to rotate the distal part400in the sagittal plane50spanned by the proximal axis10and the distal axis20.

The distal part400comprises means for displacement of the distal anatomical structure93parallel to the tilt axis30. Thereby, the distal anatomical structure93can be displaced towards the left lateral end32or the right lateral end34.

The brace joint300is configured to rotate the distal part400substantially about the proximal axis10in the transverse plane70. The brace joint300is configured to rotate the distal part400about the distal axis20.

Thereby the brace100is able to control six degrees of freedom of the anatomical structure90.

In this specific embodiment, the anatomical structure90is a leg96, the proximal anatomical structure91is a lower leg98, the distal anatomical structure93is a foot95, the anatomical joint92is an ankle99and the adjacent anatomical structure94is an upper leg97.

The ankle99is able to move in the previously described six degrees of freedom and thus to be able to treat a broken ankle99, it may be necessary to control all six degrees of freedom of the broken ankle to give a proper support of the entire leg96.

The brace100and the anatomical structure90have all the same features as the brace100and the anatomical structure90shown in theFIG. 1. The brace100is likewise able to displace and rotate the anatomical structure90in and around the axis10,20,30and planes50,60,70.

The brace100comprises a pair of proximal parallel arms220. The pair of proximal parallel arms220are connected to and arranged along the proximal part200and operatively connected to the distal part400for a displacement of the distal part400relative to the proximal part200substantially along the distal axis20. This may be performed by a 1stactivation means101.

The displacement of the distal part400along the distal axis20is controlled by a 1stactivation means101. The 1stactivation means101will cause, if activated, the distal part and thus the distal anatomical structure93,95to be displaced towards either the dorsal end22or the ventral end24.

The anatomical joint92,99enables the distal anatomical structure93,95to be displaced towards either the dorsal end22or the ventral end24. Since a torque wrench is the 1stactivation means101, the applied force on the anatomical structure90,96along the distal axis20can be controlled precisely and thus the movement of the anatomical joint92,99can be controlled precisely.

The proximal part200comprises a proximal guide240, which is configured for a displacement of the distal part400relative to the proximal free end fixation230along the proximal axis10. This may be performed by a 2ndactivation means102. The displacement is a cranial-caudal displacement.

The displacement of the distal part400along the proximal axis is controlled by a 2ndactivation means102. The 2ndactivation means102will cause, if activated, the proximal guide240to displace the distal part400relative to the proximal free end fixation230.

The proximal guide240comprises a linear rack gear242capable of displacing the proximal free end fixation230along the proximal axis10thereby changing the distance between the distal part400and the proximal free end fixation230.

The 2ndactivation means102being operatively connected to the linear rack gear242.

The displacement of the distal part400relative to the proximal free end fixation230will cause the distal anatomical structure93,95to be displaced relative to the adjacent anatomical structure94,97.

The anatomical joint92,99enables the distal anatomical structure93,95to be displaced relative to the adjacent anatomical structure94,97along the proximal axis10.

Since a torque wrench is the 2ndactivation means102, the applied force on the anatomical structure90,96along the proximal axis10can be controlled precisely and thus the movement of the anatomical joint92,99can be controlled precisely.

The brace joint300is configured to rotate the distal part400in the sagittal plane50spanned by the proximal axis10and the distal axis20. The rotation of the distal part400in the sagittal plane50is operatively controlled by a 3rdactivation means103.

The rotation of the distal part400in the sagittal plane50causes the distal anatomical structure93to either rotate towards the proximal anatomical structure91,98or rotate away from the proximal anatomical structure91,98.

The anatomical joint92,99enables the distal anatomical structure93,95to rotate, in the sagittal plane50, towards and away from the proximal anatomical structure91,98.

Since a torque wrench is the 3rdactivation means103, the applied torque on the distal anatomical structure93,95in the sagittal plane50can be controlled precisely, and thus the movement of the anatomical joint92,99can be controlled precisely.

The distal part400comprises 4thactivation means104for displacement of the distal anatomical structure93,95parallel to the tilt axis30. Thereby, the distal anatomical structure93,95can be displaced towards the left lateral end32or the right lateral end34.

The anatomical joint92,99enables the distal anatomical structure93,95to be displaced along the tilt axis30towards the left lateral end32and the right lateral end34.

Since a torque wrench is the 4thactivation means104, then the applied force on the distal anatomical structure93,95along the tilt axis30can be controlled precisely and thus the movement of the anatomical joint92,99can be controlled precisely.

The brace joint300is configured to rotate the distal part400substantially about the proximal axis10in the transverse plane70. The brace joint300comprises a 5thactivation means105for controlling the rotation of the distal part400in the transverse plane70about the proximal axis10. The anatomical joint92,99enables the distal anatomical structure93,95to be rotated about the proximal axis10in the transverse plane70.

Since a torque wrench is the 5thactivation means105, the applied torque on the distal anatomical structure93,95about the proximal axis10in the transverse plane50can be controlled precisely and thus the movement of the anatomical joint92,99can be controlled precisely.

The brace joint300is configured to rotate the distal part400about the distal axis20. The brace joint300comprises a 6thactivation means106for controlling the rotation of the distal part400about the distal axis20. The anatomical joint92,99enables the distal anatomical structure93,95to be rotated about the distal axis20.

Since a torque wrench is the 6thactivation means106, then the applied torque on the distal anatomical structure93,95about the distal axis20can be controlled precisely and thus the movement of the anatomical joint92,99can be controlled precisely.

FIG. 3illustrates braces100, each brace capable of rotating or displacing an anatomical structure90in a different direction.

FIG. 3Iillustrates a brace100capable of displacing a distal anatomical structure93along a distal axis20.

The brace100comprises a proximal part200interacting via a brace joint300with a distal part400extending along the distal axis and being adapted for supporting the distal anatomical structure93, wherein a pair of proximal parallel arms220are connected to and arranged along the proximal part200and operatively connected to the distal part400for a displacement of the distal part400relative to the proximal part200substantially along the distal axis20.

The brace100comprises 1stactivation means101for controlling the displacement along the distal axis20. The 1stactivation means101may be a handle or a torque wrench.

The skilled person would know that the brace100could be a brace100only capable of displacing the distal anatomical structure93along the distal axis20or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means except the means for displacing the distal anatomical structure93along the distal axis20are locked in place.

The skilled person would know that when a foot95is the distal anatomical structure93, then the distal axis20would be equivalent to the dorsal-ventral axis10.

FIG. 3IIillustrates a brace100capable of displacing a distal anatomical structure93along a proximal axis10relative to an adjacent anatomical structure94.

The brace100comprises a proximal part200extending along the proximal axis and interacting via a brace joint300with a distal part400for supporting the distal anatomical structure93.

The proximal part200further comprises a proximal free end fixation230for supporting the adjacent anatomical structure94and a proximal guide240for displacement of the proximal free end fixation230along the proximal axis10relative to the distal part400.

The brace100comprises 2ndactivation means101for controlling the displacement along the proximal axis10, thereby the distal anatomical structure93can be displaced relative to the adjacent anatomical structure94.

The 2ndactivation means102may be a handle or a torque wrench.

The skilled person would know that the brace100could be a brace100only capable of displacing the distal anatomical structure93relative to the adjacent anatomical structure94along the proximal direction10or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means, except the means for displacing the distal anatomical structure93relative to the adjacent anatomical structure94along the proximal direction10, are locked in place.

The skilled person would know that when a foot95is the distal anatomical structure93and an upper leg97is the adjacent anatomical structure94, then the proximal axis20would be equivalent to the cranial-caudal axis20.

FIG.3III illustrates a brace100capable of rotating a distal anatomical structure93in a sagittal plane50defined by a distal axis20and a proximal axis10.

The brace100comprises a brace joint300and a distal part400extending along the distal axis20and being adapted for supporting a distal anatomical structure93. The brace joint300is configured to rotate the distal part400in the sagittal plane50, thereby enabling the brace100to rotate a distal anatomical structure93in the sagittal plane50.

The brace joint300comprises 3rdactivations means103for controlling the rotation of the distal part400in the sagittal plane50. The 3rdactivation means103may be a handle or a torque wrench.

The skilled person would know that the brace100could be a brace100only capable of rotating the distal anatomical structure93in the sagittal plane50defined by the distal axis20and the proximal axis10or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means except the means for rotating the distal anatomical structure93in the sagittal plane50defined by the distal axis20and the proximal axis10are locked in place.

FIG. 3IVillustrates a brace100capable of displacing a distal anatomical structure93along the tilt axis30between a medial33and a left lateral end32or a right lateral end34.

The brace100comprises a distal part400having means for displacing a distal plate410along the tilt axis30, thereby enabling the brace100to displace a distal anatomical structure93along the tilt axis30between the medial33and the left lateral end32or the right lateral end34.

The brace joint300comprises 4thactivations means104for controlling the displacement of the distal part400along the tilt axis30. The 4thactivation means104may be a handle or a torque wrench.

The means for displacing the distal plate410are shown in greater detail in subsequent figures e.g.FIGS. 7 and 10.

The skilled person would know that the brace100could be a brace100only capable of displacing the distal anatomical structure93along the tilt axis30between the medial33and the left lateral end32or the right lateral end34or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means, except the means for displacing the distal anatomical structure93along the tilt axis30between the medial33and the left lateral end32or the right lateral end34, are locked in place.

The skilled person would know that when a foot95is the distal anatomical structure93, the tilt axis30would be equivalent to the medial-lateral axis30.

FIG. 3Villustrates a brace100capable of rotating a distal anatomical structure93around a proximal axis10in a transverse plane70.

The brace100comprises a brace joint300being configured by a 5thactivation means105to rotate a distal part400substantially about the proximal axis10in the transverse plane70. Thereby, the brace100is enabled to rotate a distal anatomical structure93about the proximal axis10in the transverse plane70.

The 5thactivations means105controls the rotation of the distal part400about the proximal axis10in the transverse plane70. The 5thactivation means105may be a handle or a torque wrench.

The skilled person would know that the brace100could be a brace100only capable of rotating the distal anatomical structure93around the proximal axis10in the transverse plane70or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means except the means for rotating the distal anatomical structure93around the proximal axis10in the transverse plane70are locked in place.

The skilled person would know that when a foot95is the distal anatomical structure93, then the proximal axis10would be equivalent to the cranial-caudal axis10and the transverse plane70would be spanned by the dorsal-ventral axis20and the medial-lateral axis30.

FIG. 3VIillustrates a brace100capable of rotating a distal anatomical structure93about a distal axis20.

The brace100comprises a brace joint300being configured by a 6thactivation means106to rotate a distal part400substantially about the distal axis20, thereby enabling the brace100to rotate a distal anatomical structure93about the distal axis20. The 6thactivation means106may be a handle or a torque wrench.

The skilled person would know that the brace100could be a brace100only capable of rotating the distal anatomical structure93about the distal axis20or a brace100capable of rotating or displacing the anatomical structure90in different directions, but where all means except the means for rotating the distal anatomical structure93about the distal axis20are locked in place.

The skilled person would know that when a foot95is the distal anatomical structure93, the distal axis20would be equivalent to the dorsal-ventral axis20.

FIG. 2discloses a brace100comprising the 1st-6thactivation means101,102,103,104105and106. The resulting brace100is able to control the six rotations or displacements of a anatomical structure90at the cost of the brace100becoming more complicated.

The purpose of the brace100is to treat an anatomical joint92interconnecting a proximal anatomical structure91and the anatomical distal structure93. Depending on the trauma of the anatomical joint92, there may not be needed more than a single displacement or a single rotation for the brace100to be able to treat the anatomical joint92, thus the brace100may only have the 1stactivation means101disclosed inFIG. 3I.

However, it may be necessary to use a brace100having the 2nd, 4thand 6thactivation means102,104,106if the trauma of the anatomical joint92is more complicated.

Thus, a brace100capable of treating a trauma of an anatomical joint92may have any combination of features disclosed inFIGS. 3I-3VI.

The figure shows two different embodiments (A, B) of the 1stactivation means101.FIG. 4AandFIG. 4Bboth show a part of the brace100as shown at the top ofFIG. 4.

FIG. 4Adiscloses an anatomical structure90with a proximal anatomical structure91connected to a distal anatomical structure93via an anatomical joint92.

The brace100comprises a proximal part200with a proximal fixation210for supporting the anatomical structure90and two pairs of proximal parallel arms220interacting via a brace joint300to a distal part400supporting the distal anatomical structure93.

The two pairs of proximal parallel arms220increase the stability of the brace100significantly. The two pairs of proximal parallel arms220enable displacement of the distal part400and thus the distal anatomical structure93substantially along a distal axis20.

The displacement along the distal axis20is controlled by the 1stactivation means101positioned in an arm of the pairs of proximal parallel arms220. The 1stactivation means101connected to a handle120, where a rotation of the handle120causes a biasing force, which displaces the distal part400supporting the distal anatomical structure93substantially along the distal axis20.

In the embodiment ofFIG. 4A, the handle120is a female socket for interacting with a torque wrench or the like.FIG. 4Bdiscloses an anatomical structure90with a proximal anatomical structure91connected to a distal anatomical structure93via an anatomical joint92. The embodiment inFIG. 4Bdiffers only fromFIG. 4Aby having a different type of handle120adapted to be manually rotatable by hand.

The brace100at the top ofFIG. 5supports an anatomical structure90with a proximal anatomical structure91connected to a distal anatomical structure93via an anatomical joint92. The circle at the brace100is shown in close-up.

The close-up discloses a proximal part200having a proximal upper body206with at least a pair of proximal parallel arms220for interaction with a distal part400via a brace joint300.

The proximal upper body206has a through-going proximal channel207being substantially parallel to a proximal axis10.

The proximal part200further comprises a proximal guide240. The proximal guide240comprises a slider body244having an upper slider body245and a lower slider body244, the proximal guide240with a rod248extending between the upper and lower slider body245,246.

The rod248being positioned in the proximal channel207such that the slider body244can only be displaced along the proximal axis10.

The proximal upper body206and the slider body244have combined a linear rack gear249, where the gear is positioned in the proximal upper body206facing a side of the slider body244between the upper and lower slider body245,246, which side of the slider body244being threaded for interacting with the gear.

The linear rack gear249is the 2ndactivation means102, because the rotation of the rack gear249will cause the slider body244to be displaced along the proximal axis10. Thereby the distal plate400will be displaced relative to the slider body244. The linear rack gear249may be activated by a handle120, which could be a torque wrench.

FIG. 6illustrates part of a proximal part200comprising an upper body206, a lower body208, and two pairs of parallel arms220extending between the upper body206and the lower body208.

Thereby, the lower body208can be displaced relative to the upper body206substantially along a distal axis20.

The lower body208is the proximal joint end202and will translate the displacement relative to the upper body207through a brace joint300(not shown) to a distal part400(not shown).

The displacement can be controlled through the 1stactivation means101.

The upper body208comprises a trough going proximal channel207for a not shown rod248and not shown gear. The gear is part of 2ndactivation means102, shown in more detail inFIG. 5.

FIG. 7illustrates a brace joint300connected to a distal part400via a ball joint310being a 3rd, 5th and 6thactivation means103,105and106.

The distal part400comprises a distal plate410connected to a proximal plate420, which proximal plate420is connected to the ball joint310.

A distal anatomical structure93with an anatomical joint92is positioned on the distal plate410. In this specific example the distal anatomical structure93is foot95and the anatomical joint92is an ankle99.

Although not shown there are means for securing the distal anatomical structure93,95to the distal plate400such that the displacement or rotation of the distal plate410is transferred to the distal anatomical structure93,95and thus the anatomical joint92.

The distal part400has a distal joint end402and a distal free end402. A distal axis20is defined in the direction from the distal joint end402to the distal free end402.

A proximal axis10disclosed in the figure, a not shown proximal part200would extend along the proximal axis10when the distal part400and the brace joint300is part of a brace100according to the disclosure.

A tilt axis30is extending through the ball joint310while being perpendicular to both the distal axis20and the proximal axis10.

In the present figure the distal anatomical structure93is a foot95and thus the proximal axis10is equivalent to the cranial-caudal axis10, the distal axis20is equivalent to the dorsal-ventral axis20and the tilt axis30is equivalent to the medial-lateral axis30.

The proximal axis10and the distal axis20span a sagittal plane50. The distal axis20and the tilt axis30span a transverse plane70. The tilt axis30and the proximal axis10span a coronal plane50.

FIG. 8illustrates another embodiment of a brace joint300adapted to be equipped with a 3rd, 5thand 6thactivation means103,105,106.

FIG. 8Adiscloses the brace joint300in full andFIG. 8Bdiscloses a cross section of the brace joint300.FIG. 8Bdiscloses the proximal axis10, the distal axis20, and the tilt axis30.

The brace joint300has a brace pin350, which is to be connected to a distal part400(not shown) by a nut130(not shown). Thereby the not shown nut130will function as the 3rdactivation means103. Thereby the distal part400may be displaced and locked in position, relative to the proximal part, in the plane defined by the proximal axis10and the distal axis20, e.g. the distal part400may be rotated around the tilt axis30, e.g. relative to the proximal part.

The brace joint300comprises a brace jacket320encompassing a brace inner body330, where the brace inner body330rotational displaceable in the brace jacket320. For example, the brace jacket320surrounds or encloses at least part of the brace inner body330.

The brace jacket320has near the brace pin350a first U-shaped end completely surrounding a first end of the brace inner body330and distal to the first U-shaped end a second U-shaped end completely surrounding a part of the brace inner body330. The second U-shaped end having an aperture, e.g. an end opening (370), through which a second end, e.g. an inner body pin (380), of the brace inner body330extends.

A nut130engages with a threaded part of the second end, e.g. the inner body pin (380), of the brace inner body330and when tightened a friction force between the nut130and the brace jacket320will prevent rotation around the distal axis20between the brace inner body330and the brace jacket320. For example, the nut130may be turned into a tightened position and a loosened position. In the tightened position the nut130abuts the brace jacket320, such that there is no room for movement between the nut130and the brace jacket320keeping the brace inner body330from rotating relative to the brace jacket320. The nut130may be turned into a loosened position. In the loosened position the brace inner body330is free to rotate around the distal axis20relative to the brace jacket320. Thereby the nut130is the 6thactivation means106.

The brace jacket320further comprises two brace jacket arms322, but only one is shown. The brace jacket arms322connect the U-shaped ends of the brace jacket320while exposing two surfaces of the brace inner body330. The brace jacket320comprises one or more, such as two, mid openings360, e.g. formed by the U-shaped ends and the two brace jacket arms322. The mid openings360allows access to the brace inner body330. The brace inner body330has a brace channel340going through the brace inner body330from the one surface to the other surface. The brace channel340enable a not shown distal part400to be rotated relative to a not shown proximal part200around the proximal axis10. Part of the proximal part200may extend through the brace channel340. For example, the proximal part200may comprise a pin configured to extend through the brace channel340. When the proximal part200extends through the brace channel340the rotation of the brace inner body330relative to the brace jacket320is restricted by the interaction between the proximal part200and the mid openings360and/or brace jacket arms322.

Depending on the overall design one or two nuts on one or both sides of the brace channel340, respectively, will be the 5thactivation means105.

Thereby, the brace joint300is adapted to be equipped with a 3rd, 5thand 6thactivation means.

FIG. 9illustrates further embodiments of a brace joint300adapted to be equipped with a 3rd, 5thand 6thactivation means103,105,106.

FIG. 9Adiscloses a section of a brace100near the brace joint300. The brace joint300is connected to a proximal part200with proximal parallel arms220, and a distal part400.FIG. 9Afurther discloses the proximal axis10, the distal axis20, and the tilt axis30.

The brace joint300comprises a nut130III at the connection between the brace joint300and the distal part400. The distal part400becomes pivotal in the plane defined by the proximal axis10and the distal axis20, i.e. the sagittal plane, when the nut130III is loosened. The distal part400becomes locked in the sagittal plane when the nut130III is tightened. Thus, the nut130III is 3rdActivation means103.

The brace joint300comprises a nut130V controlling the connection between the brace joint300and the proximal part200. The loosening of the nut130V enabled the distal part400to be rotationally displaced relative to the proximal part200around the proximal axis10. The tightening of the nut130VI locks the distal part400in a specific position. Thus, the nut130V is 5thactivation means105.

The brace joint300is in two parts300I,300II at least partially relative to each other. The brace joint300comprises a nut130VI controlling the friction between the two parts300I,300II. The second part300II of the brace joint300is connected to the distal part400, while the first part300I of the brace joint300is connected to the proximal part200.

The loosening of nut130VI will enable the two parts300I,300II to rotate relative to each other, thereby the distal part400is rotated relative to the proximal part200around the distal axis. The tightening of nut130VI will lock the position of the two parts300I,300II relative to each other, thereby the distal part400is locked to the proximal part200in a position relative to the distal axis. Thus, the nut130VI is 6thactivation means106.

FIG. 9B-9Cdiscloses two brace joints300, which both are adapted to be equipped with a 3rd, 5thand 6thactivation means103,105,106. Both embodiments inFIG. 9B-9Ccan replace the brace joint300inFIG. 9A.

The skilled person would be able to design other brace joints300, which are adapted to be equipped with a 3rd, 5thand 6thactivation means103,105,106.

FIGS. 10A-Ddisclose the same distal part400with different parts visible, whereFIG. 10Adiscloses a double see-through view of the distal part400,FIG. 10Bdiscloses the distal part400without a distal plate410,FIG. 10Cdiscloses the distal part without the proximal plate420, andFIG. 10ddiscloses the distal part400from a bottom view.

A ball joint310of a brace joint300is connected to the distal plate400. The functions of the ball joint310are described the description ofFIG. 7. The position of the ball joint310can be locked using a handle1201. Alternatively, the brace joint300ofFIGS. 8-9may replace the ball joint310.

The distal part400comprises a distal joint end402near the ball joint310and an opposite distal free end404.

The distal part400comprises a distal plate410for positioning of a distal anatomical structure93(not shown) such as a foot95(not shown), a proximal plate420connected to the ball joint310, and a pair of distal parallel arms430, e.g. two arms430, interconnecting the proximal plate420with the distal plate410.

The pair of distal parallel arms430having a distal parallel arms joint end432connected to the distal plate410near the distal joint end402through a bore in the proximal plate420, and a distal parallel arms free end434connected to proximal plate420near the distal free end404.

The positioning of the pair of distal parallel arms430, and thus the distal plate410, relative to the proximal plate420, is controlled by 4thactivation means104. The 4thactivation means may be tightened or loosened.

The pair of distal parallel arms430enables the distal plate410to be displaced along a tilt axis30between a medial33position towards either a left lateral end32or a right lateral end34. When the 4thactivation means is loosened the distal parallel arms430are free to displace the distal plate relative to the proximal plate along the tilt axis. When the distal plate has obtained the desired position the 4thactivation means may be tightened to retain the obtained position.

The pair of distal parallel arms430may alternatively be one arm.

FIG. 11Aillustrates an embodiment of the activation means101,103,104,105,106comprising a housing containing a torsion spring110connected to a handle120. The rotation of the handle120will be transferred to the torsion spring110causing a biasing force causing a part of a brace100(not shown) to be displaced or rotated.

FIG. 11Billustrates the medial-lateral displacement mechanism of a distal part400. The distal part400has a distal joint end402and an opposite distal free end404.

The distal part400comprises a distal plate410for placement of an anatomical structure90, a proximal plate420for connection with a not shown brace joint310at the distal joint end402, and a pair of distal parallel arms430interconnecting the proximal plate420with the distal plate410through a bore in the proximal plate420.

The pair of distal parallel arms430are positioned below the proximal plate420and have a distal parallel arms free end434connected to the proximal plate420in the direction of the distal free end404and an opposite distal parallel arms joint end432connected to the distal plate410through the bore in the proximal plate420.

The bore having a size allowing the distal plate410to be displaced relative proximal plate420along a tilt axis30.

FIG. 12illustrates a brace500for measuring a threshold fracture force, e.g. threshold injury force, of a joint, e.g. an ankle, of an anatomical structure90of a human cadaver900. The brace500ofFIG. 12may have the same features as the brace of the previous figures. The method for measuring a threshold fracture force is described in relation toFIG. 13.

FIG. 13illustrates a method1000for measuring a threshold fracture force, e.g. threshold injury force, of an anatomical structure, such as an ankle, of a human cadaver.

The method1000comprises providing1100a human cadaver having an anatomical structure. The anatomical structure may comprise a lower leg, an ankle, and a foot.

The method1000comprises arranging1200a brace, such as the brace as described in relation to the previous figures, about an anatomical structure. The anatomical structure may be fixed to the brace with one or more fasteners. For example, part of the foot may be fixed to a distal part of the brace and the lower leg may be fixed to a proximal part of the brace.

The method1000comprises applying1300one or more forces to the anatomical structure by use of the brace until a point of injury of the anatomical structure. For example, the foot may be rotated relative to the lower leg until the anatomical structure is injured, e.g. in the ankle joint. The force may be applied with a torque wrench and/or a handle. The required torque will depend on the species and in the case of a human, whether the cadaver is a cadaver of a man, a woman, or a child. The required torque also depends on the individual's size.

Applying1300one or more forces may comprise turning the torque wrenches one by one to a position just before the anatomical structure is damaged. This position may be kept manually. Alternatively, the positions are locked by a mechanical system.

All torque wrenches may at the same time be forced towards a maximum until the anatomical structure breaks. Alternatively, one chosen torque wrench may be forced towards a maximum until the anatomical structure breaks.

The method1000comprises measuring1400the one or more forces and/or displacements until and/or at the point of injury. The brace may be configured with a scale display and/or means to record readings of the actual displacement/rotation.

Thereby is achieved a way of tabulating forces and displacements leading to an injury.

Items

1. A brace (100) for management of an injured part of an anatomical structure (90), the brace (100) comprising:a proximal part (200) extending from a proximal joint end (202) towards a proximal free end (204) along a proximal axis (10) and comprising a proximal fixation (210) configured for supporting a proximal anatomical structure (91); the proximal part (200) at the proximal joint end (202) interacting viaa brace joint (300) witha distal part (400) extending from a distal joint end (402) towards an opposite distal free end (404) along a distal axis (20),

whereina pair of proximal parallel arms (220) are connected to and arranged along the proximal part (200) and operatively connected to the distal part (400) for a displacement of the distal part (400) relative to the proximal part (200) substantially along the distal axis (20).

2. The brace (100) according to item 1, wherein the brace joint (300) is configured with locking means for locking the brace joint (300) and placing the proximal part (200) and the distal part (400) in a fixed position relative to each other and the brace joint (300) is configured to receive gauge means for gauging a force on and/or a dis-placement of the proximal part (200) and the distal part (400) relative to each other.

3. The brace (100) according to item 1 or 2, wherein the proximal part (200) supports a proximal free end fixation (230) configured for supporting an adjacent anatomical structure (97); and the proximal part (200) supports a proximal guide (240) being con-figured for a displacement of the distal part (400) relative to the proximal free end fixation (230) along the proximal axis (10).

4. The brace (100) according to one or more preceding items, wherein the brace joint (300) is configured to rotate the distal part (400) in a plane spanned by the proximal axis (10) and the distal axis (20).

5. The brace (100) according to one or more preceding items, wherein the distal part (400) comprises a distal plate (410) operatively connected to a proximal plate (420) via a pair of distal parallel arms (430) for a displacement of the proximal plate (420) relative to the distal plate (430).

6. The brace (100) according to one or more preceding items, wherein the brace joint (300) is configured to rotate the distal part (400) substantially about the proximal axis (10).

7. The brace (100) according to one or more preceding items, wherein the brace joint (300) is configured to rotate the distal part (400) about the distal axis (20).

8. A trauma brace (500) for injuring an anatomical structure (90) of a human cadaver (900), wherein the trauma brace (500) is a rigid version of the brace (100) according to one or more of items 1-7.

9. A method (1000) for measuring a threshold injury force on an anatomical structure (90) of a human cadaver (900), the method (1000) comprising one or more acts of:providing (1100) a human cadaver (900) having an anatomical structure (90),arranging (1200) a trauma brace (500) about an anatomical structure (90),applying (1300) one or more forces to the anatomical structure (90) by use of the trauma brace (500) until a point of injury of the anatomical structure (90), andmeasuring (1400) the one or more forces and/or displacements until and/or at the point of injury.

10. The method (1000) according to item 9, wherein the trauma brace (500) is according to item 8.