Wrist brace

Abstract

The invention relates to an orthosis adapted to be worn on a human forearm and hand for immobilizing the wrist joint, comprising a stiff body, wherein the stiff body comprises (i) a metacarpal section, a. having a ring-shaped or ring-segment-shaped thumb holding section adapted to receive the thumb of the human hand, b. having a palmar section adapted to be brought into engagement with the palm of the human hand, and c. having an ulnar section adapted to wrap around the human hand from the volar to the dorsal side, (ii) an elongated middle section adapted to be brought into engagement with the human forearm, and, optionally, wrist, on their medial or lateral side, and (iii) a forearm section adapted to wrap around the human forearm from its ventral to its dorsal side; wherein the ulnar section comprises a hinge section comprising at least one film hinge. The invention also relates to a method for the production of the orthosis.

Description

[0001] Wrist Brace

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to an orthosis adapted to be worn on a human forearm and hand for immobilizing the wrist joint as well as to a method for production of the orthosis.

[0004] BACKGROUND

[0005] Orthoses of this type are used to immobilize the wrist joint of a subject which suffers from a painful condition of the wrist or hand. The painful condition or injury can be caused by frequent, sustained repetitive motion of the hand or an acute accident. To allow the wrist to heal, it is desirable to reliably stabilize the joint in all directions of movement.

[0006] Known orthoses usually provide an extensive covering of the forearm and at least the palm of the hand for this purpose. The extensive covering has the disadvantage that it is very difficult to keep the body part clean. The patient can usually only wash the forearm when the orthosis is removed. However, during that time in which the orthosis is removed, the injured wrist is not stabilized. To promote the healing process, the orthosis should be worn as consistently as possible. Removal of the device should be avoided.

[0007] Further negative effects resulting from a long wearing time for common orthoses include itching and odour development. The aforementioned negative effects are enhanced by the textile portions of some orthoses which soil quite rapidly. These textile portions require regular, thorough washes and subsequent air drying during which the patient cannot wear the orthosis and is very limited in his or her daily activities.

[0008] Extensive coverage of the forearm and hand additionally blocks access to the affected wrist area that may be needed by a physician. In prior art orthoses, the physician can, therefore only examine the wrist, e.g. inspect surgical sites on the wrist, after the orthosis is removed. Each removal exposes the wrist to unwanted, detrimental movements.

[0009] Moreover, donning an orthosis on a forearm and removing it may be difficult for a user and may also be painful. In particular, creating a wide opening on the orthosis that makes it easy for a user to don or remove the orthosis is difficult to achieve if the orthosis at the same timeshall provide a secure fastening of the orthosis and a secure fixation of the orthosis on a user’s hand and forearm. In addition, it is desirable that the orthosis is adaptable to the size of a user’s hand and / or forearm.

[0010] There is, thus, a need in the art for improved wrist orthoses which provide a good level of stabilization, but allow for an improved hygiene, improved healing and better access to the wrist region. At the same time, donning and removing of the wrist brace should cause as little pain and / or frustration as possible. The orthosis should also be broadly applicable for users.

[0011] SUMMARY

[0012] This problem is solved by the orthosis as described in the appended claims.

[0013] The present invention makes use of a specific hinge section comprising at least one film hinge, which improves donning and removing the orthosis. The orthosis may comprise a washable, reversibly plastically deformable material that stabilizes the wrist in particular on the ulnar or radial side of the forearm and wrist. In particular, the orthosis may be designed to allow easy access for a physician to the dorsal and ventral side of forearm and wrist.

[0014] In a first aspect, the invention, hence, relates to an orthosis adapted to be worn on a human forearm and hand for immobilizing the wrist joint, comprising a stiff body, wherein the stiff body comprises

[0015] (i) a metacarpal section,

[0016] a. having a ring-shaped or ring-segment-shaped thumb holding section adapted to receive the thumb of the human hand,

[0017] b. having a palmar section adapted to be brought into engagement with the palm of the human hand, and

[0018] c. having an ulnar section adapted to wrap around the human hand from the hand’s volar to the hand’s dorsal side,

[0019] (ii) an elongated middle section adapted to be brought into engagement with the human forearm, and, optionally, wrist, on their ulnar (medial) or radial (lateral) sides, and(iii) a forearm section adapted to wrap around the human forearm from its ventral to its dorsal side,

[0020] wherein the ulnar section comprises a hinge section comprising at least one film hinge.

[0021] The orthosis of the invention is adapted to be worn on a human forearm and hand for stabilizing the wrist joint. This means that the orthosis has an elongated shape that runs along the forearm, wrist and hand of the wearer. The shape of the orthosis is anatomically adapted to fit to these body parts. The shape of the inner side of the orthosis can be shape-complementary to parts of the surface of the hand, wrist and forearm, in particular to parts of the metacarpal region of the hand, such as the palm of the hand, the ulnar (medial) or radial (lateral) side of the wrist and forearm and parts of the proximal end region of the forearm. The “inner side” of the orthosis is the side which faces the surface of the wearer’s body when the orthosis is worn. The inner side can reside directly, i.e. can be adapted to reside directly, on the surface of hand, wrist and forearm, preferably at least 50%, at least 75% or at least 95% of the surface of the inner side. In other words, from 50% to 100% of the surface area of the inner side can be adapted to reside directly on the surface of the hand, wrist and forearm of the wearer, from 60% to 100%, from 70% to 100%, from 75% to 100%, from 80% to 100%, from 85% to 100%, from 90% to 100%, or from 95% to 100%.

[0022] An important element of the orthosis is the hinge section comprising at least one film hinge. A film hinge may also be considered a flexure bearing. A film hinge is a single part in which two rigid structures are joined by a thin area. The thin area may be on one side of the part or on both sides of the part. Both the bending angle and the durability of the film hinge depend on the thickness and / or the size of the thin area. While a large thin area allows for high bendability, it may be less durable and also less comfortable to wear than a smaller thinarea. Film hinges may be combined. For example, a series of film hinges with a small thin area may be combined in a hinge section. This may increase durability and / or flexibility. Moreover, such a series of film hinges with a small thin area may improve wearing comfort.

[0023] Due to its special hinge section comprising at least on film hinge, the orthosis can be bent open very far thereby allowing for easy donning and doffing (removing) of the orthosis. At the same time, the hinge section adapts flexibly yet tightly to a user’s hand when closed improving the fixation of the hand as well as comfort to wear. In this way, the orthosis can be donned or removed causing very little pain if at all and a user’s hand and forearm can be securely fixated by the orthosis. Moreover, the hinge section comprising at least one film hinge allows for an easy adaptability of the orthosis to a user’s hand.As explained above, the hinge section may comprise more than one, in particular several film hinges. The presence of more than one film hinge in the hinge section allows for a small thin area for each individual film hinge, increasing wearing comfort and durability for a good flexibility. The individual film hinges are separated from each other by an area that is not thin (a rib). If the distance between two individual film hinges is small, the area that is not thin has the appearance of a rib. According to an embodiment, the hinge section comprises at least two, preferably at least three, more preferably at least four, film hinges, in particular comprising a rib in between. In other words, the hinge section can comprise film hinges alternating with ribs. The hinge section can comprise e.g. 1 to 10, 2 to 9, 3 to 8, 4 to 7 film hinges, preferably comprising a rib in between, i.e. between adjacent film hinges. In a particular embodiment, the hinge section comprises 5 film hinges, preferably comprising a rib between adjacent film hinges. In another embodiment, the hinge section comprises 6 film hinges, preferably comprising a rib between adjacent film hinges.

[0024] The hinge section preferably has a proximal side and a distal side. The proximal side in particular faces a user’s hand when the orthosis is in use, i.e. it is the skin-facing side of the hinge section. The distal side in particular faces away from a user’s hand. The proximal side and the distal side are in particular opposite to each other. As explained above, a film hinge is a single part in which two rigid structures are joined by a thin area. The thin area of a film hinge may be achieved by a groove on one side of the hinge section, for example on its proximal side. The thin area of a film hinge may also be achieved by a groove on one side of the hinge section, for example on its proximal side, and one groove on the other side of the hinge section, for example on its distal side. The two grooves may be substantially opposite to each other. The two grooves may be directly opposite to each other. As long as two grooves on opposite sides act as one film hinge, these two grooves are considered to be substantially opposite to each other forming a film hinge. Accordingly, each film hinge in the hinge section may be formed by one groove or by two grooves that are substantially, in particular directly, opposite to each other. Film hinges formed by one groove and by two grooves can be combined in a hinge section. A film hinge formed by two grooves opposite to each other has a greater flexibility in different directions. According to an embodiment, each film hinge is formed by two grooves substantially, in particular directly, opposite to each other on a proximal side and a distal side of the hinge section.

[0025] The good fit of the orthosis is in particular also ensured by its ability to be plastically deformed and, thus, be adapted to the specific morphology of the individual wearer. The orthosis is, in other words, particularly adaptable to the specific morphology of a wearer by plastic deformation, more particularly by reversible plastic deformation. These properties and thehigh stability of the orthosis are preferably ensured by the stiff body comprised in the orthosis. The stiff body preferably comprises an exostructure enclosing an elongated core. Suitable materials for exostructure and core are described elsewhere herein. In one embodiment, the stiff body consists of exostructure and core.

[0026] In particular, the elongated core is reversibly plastically deformable. A plastic deformation is caused by an applied force and - contrary to an elastic deformation - not undone simply by removing the force. The medical personnel donning the orthosis can, hence, bend the stiff body into the desired shape to adapt it to the individual patient’s hand. The plastic deformation is, moreover, preferably reversible so that the orthosis can be adapted in case the initial fit has to be corrected. The term “plastic deformation” as used herein does, hence, not include a breaking of the stiff body. The bending of the core and stiff body which can be performed by the medical personnel is usually only a minor adaptation of the already existing basic shape of the stiff body which is established by the components of the stiff body described above (metacarpal section, middle section and forearm section), for example a slight bending of the stiff body in the palmar section to bring the surface of the inner side of the stiff body closer to the palm of the hand of the wearer.

[0027] According to an embodiment, the exostructure of the stiff body surrounds the plastically deformable core. The core is, in other words, embedded in the exostructure. Like the core, the exostructure can also be plastically deformable, but this is merely one alternative embodiment. In other embodiments, the exostructure is elastic, i.e. comprises or consists of an elastic material. The elastic material is adapted to ensure that the exostructure will deform as well when the core is being bent into the desired shape.

[0028] It is preferred that the exostructure covers 50% or more of the surface of the core, 60% or more, 70% or more, 80% or more, 90% or more, 95% or more, such as 100%. In other words, the exostructure covers from 50% to 100% of the surface of the core, 60% to 100%, 70% to 100%, 80% to 100%, 90% to 100%, or 95% to 100%. While the core will in most cases be entirely or substantially be covered by the exostructure, this may be influenced, e.g., by the method of production that is chosen for producing the stiff body. Uncovered sections of the core are, therefore, acceptable. Exemplary methods of production are described elsewhere herein.

[0029] The stiff body comprises (i) a metacarpal section, (ii) an elongated middle section and (iii) a forearm section. The sections are arranged in the orthosis in the aforementioned order and are, preferably, directly adjacent to each other. In other words, the metacarpal section ispreferably directly adjacent to the middle section and the middle section is directly adjacent to the forearm section. In one embodiment, the stiff body consists of the metacarpal section, the elongated middle section and the forearm section. The stiff body is in particular a one-piece construction. According to an embodiment, the exostructure is continuous in the stiff body, in particular the aforementioned metacarpal section, elongated middle section and forearm section. In this embodiment, the exostructure is, thus, continuous from the ulnar section, the palmar section, the thumb holding section, the elongated middle section to the forearm section. This means that there are no gaps in the exostructure between the aforementioned sections. It will be understood that this does not exclude smaller productionbased holes in the exostructure as long as the exostructure connects the aforementioned sections. The ulnar section’s and thumb holding section’s parts of the exostructure are not directly connected.

[0030] The term “stiff’ means that the stiff body resists deformation by forces that are applied to the orthosis during normal use by the wearer, i.e. when the orthosis in worn (donned). Thereby, the orthosis is able to keep the wrist joint in position. At the same time, the term “stiff” does not exclude that the stiff body can be bent, in particular plastically deformed as described above, when higher than normal forces are applied to the stiff body and that the hinge section can be bent during donning and doffing. It is, in fact, an advantageous property of the orthosis of the invention that it can be bent by the medical personnel donning the orthosis to adapt it to the hand and forearm of the wearer.

[0031] The orthosis comprises (i) a metacarpal section which is designed to wrap at least partially around the hand in its metacarpal region. The metacarpal section can be formed by at least one elongated element and at least partially encloses the metacarpal in a plane which, in the normal anatomical position of the hand and forearm, is essentially perpendicular to the longitudinal axis of the forearm. The metacarpal section is designed in such a way that it can be brought into engagement with a human hand by placing it at least partially around the back of the hand and in particular the palm of the hand below the metacarpal joints of the index finger, middle finger, ring finger and little finger and above the wrist so that it extends around the metacarpus in the circumferential direction and subsequently rests completely or partially against the palm and partially encompasses the metacarpal.

[0032] Preferably, the metacarpal section does not extend distally beyond the metacarpal region of the hand when the orthosis is worn. This improves mobility of the fingers of the wearer. The largest part of the metacarpal section will usually be designed to rest on the volar side of the hand of the wearer. The metacarpal section runs around one or both edges of the hand andlies completely or partially on one or both edges of the hand. It extends in the circumferential direction of the metacarpal over the entire palm of the hand or at least part of the palm, preferably the entire palm. It can lie completely or partially against the palm of the hand in order to provide a structure for immobilizing the flexion direction and the extension direction, i.e. preventing flexion and extension movements, and to prevent supination and pronation of the hand.

[0033] As a result of this configuration of the metacarpal section, the contact surfaces on the hand are advantageously arranged in the area of the metacarpal and at a distance from the wrist in the direction of the fingers when the brace is applied. The “contact surfaces” are in this context the surfaces of the stiff body, in particular the metacarpal region, e.g. the palmar region, which are in direct contact with the skin of the wearer, e.g. the skin of the hand of the wearer, i.e. which are adapted to be in direct contact with the skin of the wearer. Thus, the wrist is advantageously not covered on its volar and dorsal surface, so that these areas remain freely accessible to a sufficient extent and that no additional stress or pressure is exerted on a potential wound located in the region of the wrist.

[0034] Moreover, while the metacarpal section is in particular wrapped around one or both sides of the hand, in particular the radial and ulnar sides, it will usually not extend over the entire width of the hand on its dorsal side (back of the hand). The metacarpal section can, for example, extend (i.e. be adapted to extend) over 100% of the circumference of the volar side of the metacarpal region of the hand, i.e. the palm, in radial to ulnar direction, and extend (i.e. be adapted to extend) over 0% to 50%, preferably 0% to 25%, of the circumference of the dorsal side of the metacarpal region of the hand, in radial to ulnar direction. There is, thus, a section of the dorsal side which is not covered by the metacarpal section or other parts of the stiff body. The coverage on the volar side of the hand provides a sufficient stability of the orthosis while the gap(s) on the dorsal side ensure good accessibility and easy cleaning of the hand. The gap(s) on the dorsal side can be closed by removable, flexible closure devices as described elsewhere herein.

[0035] The metacarpal section has (a) a ring-shaped or ring-segment-shaped thumb holding section adapted to receive the thumb of the human hand. The thumb holding section comprises a ring- or ring-segment-shaped opening adapted for receiving the thumb. Overall, the thumb holding section is designed in such a manner that, when the metacarpal section is brought into engagement with the hand, said thumb holding section can be placed against the thumb of the hand such that the thumb extends through the ring-shaped or ring-segment-shaped thumb holding section, i.e. through the ring opening defined by the thumb holdingsection, and that the thumb holding section then extends over at least part of the circumference of the thumb and entirely or at least partially surrounds the latter.

[0036] The thumb-holding section can, furthermore, wrap around the radial side of the hand. Thereby, the stability of the wrist brace is stably held on the hand even when the closure devices are not closed.

[0037] As the purpose of the orthosis is a stabilization of the wrist and not a stabilization of the thumb in particular, it will usually not extend along the thumb itself. The thumb can retain its movability at least in the interphalangeal joint. The orthosis is not adapted to cover this joint.

[0038] The metacarpal section has additionally (b) a palmar section adapted to be brought into engagement with the palm of the human hand. In a preferred embodiment, the palmar section extends over the palm substantially perpendicularly to the joint longitudinal axis of the forearm and hand. By means of this configuration of the palmar section, the latter, when placed on, is advantageously arranged in the region of the metacarpus and is at a distance from the wrist in the direction of the fingers. Therefore, the wrist is advantageously not covered and remains freely accessible for a physician if needed. The palmar section can, for example, be arranged in the palm of the hand below the metacarpophalangeal joints of an index finger, middle finger, ring finger and small finger.

[0039] On the opposite side of the palmar section from the thumb holding section, the metacarpal section comprises an ulnar section. The ulnar section is adapted to wrap around the human hand from the volar to the dorsal side, specifically on the ulnar side of the hand, i.e. the side of the fifth metacarpal bone. For this purpose, the ulnar section is curved and can have a cross-section of a semi-circle or semi-ellipse. The ulnar section can form one end of the metacarpal section of the orthosis and leave large parts of the back of the hand free, so that these parts of the back of the hand are not covered by a part of the stiff body. As will be described elsewhere herein, the ulnar section can be connected to the thumb holding section by means of closure devices which stretch over the back of the hand.

[0040] In its longitudinal direction, the metacarpal section has a first end which is formed by the thumb holding section which comprises one of the two longitudinal ends of the elongated element, and a second end which is formed by the ulnar section. The thumb holding section is preferably directly adjacent to the palmar section and / or the palmar section is directly adjacent to the ulnar section. The metacarpal section of the stiff body can consist of thumb holding section, palmar section and the ulnar section.In addition to the metacarpal section, the stiff body also comprises (ii) an elongated middle section adapted to be brought into engagement with the human forearm and wrist on their ulnar or radial sides, or with the human forearm on its ulnar or radial side. Usually, the middle section will extend, i.e. will be adapted to extend, from the forearm into the wrist region. It may, in some cases, however, also be possible that the wrist is covered by the thumb section of the orthosis. In these cases, the elongated middle region is adapted to be brought into engagement with the human forearm. In most other cases the middle section will be adapted to be brought into engagement with the human forearm as well as the wrist.

[0041] It has been found in the context of the invention that this stabilization on one side of the wrist and forearm with the stiff body provides sufficient immobilization to promote healing of the wrist. It is not necessary to provide a stabilizing section on both, the ulnar and the radial side. The elongated middle section is, therefore, preferably arranged on one side of the forearm and wrist, i.e. adapted to be arranged on one side of the forearm and wrist, while the opposite side of wrist and forearm is freely accessible, i.e. not covered by any parts of the stiff body. In certain embodiments, the middle section is adapted to be arranged on the radial side of the forearm and wrist. The middle section can, thus, be directly adjacent to the thumb holding section of the metacarpal section. In these embodiments, the middle section will not be adjacent to the ulnar section of the metacarpal section. The ulnar section is preferably not directly connected to a section that extends to the forearm when the orthosis is worn. That way, the ulnar side and parts of the dorsal and ventral sides are freely accessible ensuring good ventilation of the skin and accessibility for medical personnel.

[0042] The middle section can be adapted to cover the wrist and / or forearm of a human on 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, or 15% or less of their respective circumferences (in the section of the wrist and forearm, respectively, in which the middle section is located; preferably over the entire length of the middle section). This means, in other words, that only 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, or 15% or less, of the surface of the wrist and / or forearm are covered by the middle section in the section of the limb on which the middle section is located. For example, the middle section can be adapted to cover the wrist and / or forearm of a human on from 5% to 50%, from 10% to 50%, from 5% to 45%, from 10% to 45%, from 5% to 40%, from 10% to 40%, from 5% to 35%, from 10% to 35%, from 5% to 30%, from 10% to 30%, from 5% to 25%, from 10% to 25%, from 5% to 20%, from 10% to 20%, from 5% to 15%, or from 10% to 15%, of their respective circumferences. Thereby, access to volar and dorsal surfaces of the wrist and forearm are ensured, in particular to the middle of the volar and dorsal sides of the wrist and forearm. The “middle”in this context is the area which extends along the longitudinal axis of the volar side or the longitudinal axis of the dorsal side. In one particular embodiment, the middle section is adapted to cover the wrist and / or forearm of a human on 50% or less of their respective circumferences. In another embodiment, the middle section is adapted to cover the wrist and / or forearm of a human on 25% or less of their respective circumferences. The middle section can, in other words, be adapted to cover the wrist and / or forearm of a human on 2% to 50%, 3% to 40%, 4% to 30% or 5% to 25% of their respective circumferences.

[0043] The shape of the middle section is adapted to the shape of the forearm of a human wearer. The middle section of the orthosis can have the form of the curved walls of a partial cylinder, e.g. a half-cylinder. The inner side of said cylinder forms the inner side of the middle section that is adapted to reside on the wearer’s skin. A cross section of the middle section, thus, has the shape of a partial circle or partial oval. The partial circle or partial oval has a central angle of 5° or more, 10° or more, or 15° or more. At the same time, the central angle of the partial circle or partial oval is preferably 180° or less, 135° or less, 100° or less, or 90° or less. In certain embodiments, the central angle of the partial circle or partial oval is from 5° to 180°, such as from 10° to 100°.

[0044] To most efficiently stabilize the wrist, the middle section can extend along a considerable portion of the forearm. For example, the middle section can be long enough to ensure that the proximal end of the orthosis is located as close as possible to the elbow without interfering with the movement of the elbow joint. The length of middle and forearm sections together may be adapted to extend along 50% or more, 60% or more, 70% or more, 75% or more, 80% or more, 85% or more, or 90% or more of a forearm of a human wearer, wherein 60% or more is preferred, and 70% or more is particularly preferred. In other words, the length of middle and forearm sections together may be adapted to extend along from 50% to about 100%, from 60% to about 100%, from 70% to about 100%, from 75% to about 100%, from 80% to about 100%, from 85% to about 100%, or from 90% to about 100% of a forearm of a human wearer.

[0045] The middle section of the orthosis can be longer than the metacarpal section and / or the forearm section when measured parallel to the longitudinal axis of the orthosis. For example, the middle section can have a length that is 100% or more of the length of the metacarpal section, such as 125% or more, 150% or more, 175% or more, or 200% or more. In other words, the middle section can have a length that is from 100% to 300% or the length of the metacarpal section, such as from 125% to 300%, from 175% to 300%, from 200% to 300%, from 125% to 250%, from 150% to 250%, from 175% to 250%, from 200% to 250%.Similarly, the middle section can have a length that is 125% or more of the length of the forearm section, such as 150% or more, 175% or more, or 200% or more. In other words, the middle section can have a length that is from 125% to 300% of the length of the forearm section, such as from 150% to 300%, from 175% to 300%, from 200% to 300%, from 125% to 250%, from 150% to 250%, from 175% to 250%, from 200% to 250%. The lengths of the sections mentioned herein are measured parallel to the longitudinal axis of the orthosis.

[0046] The middle section can, for example, have a length of 7.5 cm or more, or 10 cm or more. In other words, the middle section can have a length of from 7.5 cm to 20 cm, from 10 cm to 18 cm. It will be understood that the absolute length will depend on the actual size of the orthosis which is individually chosen to fit a certain patient.

[0047] The stiff body, in particular its metacarpal section and / or middle sections, are adapted to establish a hand position suitable for contracture prophylaxis. Suitable angles in the wrist can e.g. be 20° to 30° dorsal extension. Accordingly, the stiff body, e.g. its metacarpal and / or its middle section, is adapted to establish an angle of 20° to 30° dorsal extension in the wrist of a wearer. This angle is particularly useful for stabilization and recovery of the wrist. As indicated above, the appropriate angle can be ensured by manual plastic deformation of the orthosis. It can also be preestablished in the orthosis.

[0048] Finally, the stiff body comprises a forearm section adapted to at least partially wrap around the human forearm from its ventral to its dorsal side. It wraps around the proximal forearm in a direction which is essentially perpendicular to the longitudinal axis of the stiff body, namely in a circumferential direction. The forearm section also forms the proximal end of the orthosis. By wrapping around and lying completely or partially against the forearm of the wearer, the forearm section provides at least one bearing for the stabilization of the wrist flexion, wrist extension, supination and pronation. Accordingly, the orthosis is suitable for reducing or preventing flexion, extension, supination and / or pronation movements of the wrist, wherein prevention of these movements is preferred. The length of the middle section and the forearm section as a bearing effectively ensure a stabilization against these movements. For this purpose, the forearm section is adapted to be close to the elbow when worn correctly, without preventing movement in the elbow joint. Particularly the supination and pronation movements of the wrist are effectively prevented by this combination of elongated middle section and forearm section.

[0049] In a direction that is perpendicular to the longitudinal axis of the stiff body, the forearm section is broader than the elongated middle section. The forearm section can, e.g., beadapted to cover the forearm of a human on 15% to 90%, preferably 25% to 90% of its circumference (in the section of the proximal forearm in which the forearm section is located; preferably over the entire length of the forearm section). In other words, the forearm section can be adapted to cover the forearm of a human on 15% or more, 25% or more, 35% or more, 45% or more, 50% or more of its circumference. This means that 15% to 90%, preferably 25% to 90%, of the surface of the forearm is covered by the forearm section in the section of the limb (arm) on which the forearm section is located.

[0050] To achieve this purpose, the shape of the forearm section is adapted to the shape of the forearm of a human wearer. The forearm section of the orthosis in particular has the form of the curved walls of a partial cylinder, e.g. a half-cylinder. The inner side of said cylinder forms the inner side of the forearm section that is adapted to reside on the wearer’s skin. A cross section of the forearm section, thus, has the shape of a partial circle or oval. The partial circle or oval has a central angle of 75° or more, 80° or more, 85° or more, 90° or more, 95° or more, 100° or more, 110° or more, 120° or more, 130° or more, 140° or more, 150° or more, 160° or more, 170° or more, or 180° or more, wherein 135° or more is preferred. At the same time, the central angle of the partial circle or partial oval is preferably 300° or less, 280° or less, 260° or less, 240° or less, 220° or less, 200° or less. In certain embodiments, the central angle of the partial circle or partial oval is from 100° to 260°, such as from 135° to 225°.

[0051] To improve the ability to clean the skin of hand, wrist and forearm and, thereby, the wearing comfort, the metacarpal section and / or the forearm section can comprise an opening. This is an opening in an otherwise larger area of material that is in addition to the opening generated by the ring-shaped or ring-segment shaped thumb-holding section. This / these additional opening(s) is / are preferably closed on all four sides and can, thus, be regarded as a window to the skin. The opening can have a rectangular shape with rounded edges, circle shape, oval shape, ellipsoid shape or irregular shape. An opening in the metacarpal section is envisaged to be located in the ulnar section. Together with the ulnar section, the opening can wrap around the ulnar edge of the hand. The opening will, thus, be on the ulnar side of the orthosis. Also, in the forearm section, the opening can be in the part of the forearm section that wraps around the forearm of the wearer. This opening will usually be on the radial side of the orthosis.

[0052] The orthosis of the invention can advantageously be adapted to the specific hand shape of the wearer, thus, increasing the efficiency of the orthosis, the wearing comfort and reducing the need for a high number of differently sized versions of the orthosis. Adaptation of theorthosis is effected through plastic deformation of the stiff body and corresponding adjustment of the closure devices described elsewhere herein. The stiff body, in particular its core, can, hence, be reversibly plastically deformable as indicated above. The plastic deformation is reversible because the term plastic deformation as used herein does not refer to an irreversible breaking of the product. Instead, the reversibility of the plastic deformation ensures that even after the first adaptation has been carried out by the medical personal, further adaptations, e.g. smaller corrections, can still be performed. The stiff body can also be bent back to its originally manufactured conformation.

[0053] The stiff body, in particular its core, can be plastically deformable at room temperature, i.e.

[0054] 20°C to 25°C. Thereby the need for further equipment and the number of donning steps is minimized. Alternatively, the stiff body can be plastically deformable at higher temperatures, such as 28° C or more, 30°C or more, 35°C or more, 40°C or more. Preferably, the temperature at which the stiff body is reversibly plastically deformable by medical personnel is low enough to be comfortable for a human patient, e.g. 55°C or less, 50°C or less, 45°C or less. Cores which are reversibly plastically deformable at room temperature are, e.g., metal or metal alloy cores, such as an aluminium or aluminium alloy core.

[0055] Plastic deformability can, e.g., be achieved using one of the core materials that are described elsewhere herein. Alternatively or additionally, the structure of the stiff body, the exostructure and / or the core can be designed to allow for or support a plastic deformation. The stiff body, exostructure and / or core may, for example, have a deformable grid structure.

[0056] Adaptation of the stiff body to the hand of a wearer can be, e.g., achieved using a metal or thermoplastic material. Accordingly, the stiff body, core and / or exostructure, in particular the core, can comprise or consist of a metal and / or thermoplastic material. In the case of a thermoplastic material, the adaptation of the orthosis to a particular wearer will then be effected by applying heat to the thermoplastic material, adapting the stiff body to the wearer’s hand, wrist and forearm and subsequent cooling of the material. As mentioned above, it is preferred that the required temperature is low enough to be comfortable for the wearer. However, it is also possible to adapt the orthosis stepwise removed from the surface of the body. In these cases, the required temperature for deformation can be higher.

[0057] In particular embodiments, the core may consist of or comprise one or more metals or metal alloys. Metals and metal alloys are particularly well suited to be used in a plastically deformable stiff body. The metal or metal alloys can be selected from the group consistingof aluminium, iron and alloys thereof, such as steel. In a particularly preferred embodiment, the core is an aluminium core, i.e. a core made from an aluminium alloy.

[0058] In further embodiments, the core may consist of one or more thermoplastic materials, in particular one or more low temperature thermoplastic materials. Low temperature thermoplastic materials are characterized by a deformation temperature lower than 100°C (212° Fahrenheit), e.g. between 40°C and 100°C. Suitable materials are known in the art and commercially available. They can be plastically deformed after or during heating in a water bath or the like, e.g. around temperatures of 70°C.

[0059] The core may be non-elastic at lower temperatures, specifically at temperatures from 20-30°C, such as room temperatures, or below. At these temperatures, the core is, moreover, resistant to tension and to bending.

[0060] The core can, for example, have a cylindrical, ellipsoid, oval, rectangular or irregular cross section. Preferably, the core has a cross-section having a longer width than height, e.g. an oval, ellipsoid or rectangular cross-section. Compared with cores with cross-sections that have equal width and height, the bending and stabilization properties are improved. The core can be arranged in the orthosis such that one of its cross-sectional sides having the longer width is oriented towards the inner side of the orthosis.

[0061] The core can extend from the metacarpal section, through the middle section and into the forearm section. The core may not be present in all areas of the orthosis and / or the exostructure. If the core is present, it is preferred that it is comprised in metacarpal section, middle section and the forearm section. For example, certain areas of the metacarpal region do not need to comprise the core, such as the ulnar section and parts of the thumb holding section. It is, however, advantageous if at least parts of the thumb holding section and at least parts of the palmar section comprise core as well as exostructure. The core can be a single-piece design or a multi-piece design, wherein forming the core as one piece is preferred.

[0062] Depending on the material to be used in the core, the core can be manufactured e.g. by a method selected from the group of (i) dye cutting of metal blanc and subsequent bending of the core and (ii) dye cutting of the thermoplastic core and subsequent thermoforming of the core.

[0063] Similar to the core, the exostructure can comprise different materials. The materials of the exostructure can be more elastic than the materials of the core. They can be more flexibleat room temperature than the materials of the core. The materials of the exostructure will be in particular selected for their ability to provide sufficient wearing comfort and at the same time facilitate an easy cleaning of the stiff body at room to body temperature (~20°C to ~40°C). At these temperatures, the material of the exostructure can be elastic. The exostructure preferably has a closed surface structure that does not soak up water, i.e. a fluid-tight surface. The material of the exostructure preferably also has a good bio (skin) compatibility, media resistance, sweat resistance, alcohol resistance, disinfectant resistance and will be waterproof.

[0064] The exostructure can comprise or consist of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic rubber (TPR), silicone and mixtures thereof. In a preferred embodiment, the exostructure comprises or consist of TPU. In one embodiment of the invention, the orthosis comprises a stiff body having an aluminium core and a TPU exostructure.

[0065] The stiff body can be manufactured by various methods known in the art. For example, the stiff body can be manufactured by a method selected from the group consisting of 2-component injection moulding, such as 2-component plastic injection moulding; multicomponent plastic injection moulding; metal core overmoulding or plastic overmoulding in general and metal mesh overmoulding, wherein the method of metal core overmoulding, such as metal core blank overmoulding, is particularly preferred.

[0066] For fastening the orthosis on the human hand, the orthosis may comprise in addition to the stiff body one or more closure devices. The orthosis can, e.g. comprise 1, 2, 3, 4, 5, 6, or 7 closure devices, preferably two, more preferably three. For example, one or two of the closure devices may be attached to the metacarpal section, preferably two. One or two of the closure devices may be attached to the forearm section, preferably one. It will be understood that the stiff body can comprise corresponding attachment points (attachment sites), such as openings in which the closure devices can be fastened.

[0067] The closure devices can have, for example, one or more flexible or elastic bands which, together with the metacarpal section, middle section and / or the forearm section, when placed on, surround the hand, wrist or the forearm, wherein the bands at least partially run over the back of the hand, wrist and around the forearm, respectively. For example, the orthosis can have a first, second and third closure device (e.g. band) which run at least partially over the back of the hand, wrist and around the forearm, respectively. The first, second and third closure device (e.g. band) can be securable in attachment points(attachment sites) in the metacarpal section, the metacarpal section and the middle section, and the forearm section, respectively. Alternatively, the first, second and third closure device (e.g. band) can be securable in attachment sites in the metacarpal section, the metacarpal section, and the forearm section, respectively. In other words, the first and second closure device may be adapted to secure (tighten) the orthosis in the metacarpal section and / or the third closure device may be adapted to secure (tighten) the orthosis in the forearm section.

[0068] The closure device has one or more first fastening sections which are arranged and configured in such a manner that, when the orthosis is placed on, said fastening sections can be arranged and secured on the metacarpal section and / or the forearm section in such a manner that said fastening sections in each case run over the back of the hand and forearm, respectively, and together with the metacarpal section and the forearm section, respectively, of the stiff body, forms at least a part of a section of the orthosis, which section annularly surrounds the hand and forearm, respectively. The orthosis can thereby be simply and securely held or secured on the hand and / or forearm by the first fastening section or the first fastening sections — either by themselves or together with further sections of the closure device. The closure device can also have one or more first fastening sections which are arranged and configured in such a manner that, when the orthosis is placed on, said fastening sections can be arranged and secured on the metacarpal section, the middle section and / or the forearm section in such a manner that said fastening sections in each case run over the back of the hand, wrist and / or forearm, respectively, and together with the metacarpal section, the middle section and the forearm section, respectively, of the stiff body, forms at least a part of a section of the orthosis, which section annularly surrounds the hand, wrist and / or forearm, respectively.

[0069] This closure device or at least the first fastening sections or at least one of the first fastening sections can either be provided as separate components which can be completely detached from the metacarpal section and the forearm section or the rest of the orthosis and can be connected again thereto for fastening purposes, or as components which are fastened permanently to the aforementioned sections. In the latter case, it can be provided in particular that the relevant first fastening sections are in each case permanently fastened at one point and, after arrangement such that they run over the back of the hand or forearm, can be fastened releasably for securing at another point.

[0070] First fastening sections of this type can be formed in an advantageous manner, for example, by a respective flexible and / or elastic band. For the releasable connection to the metacarpal section or forearm section, the bands can in each case have touch and close elements whichcan interact with corresponding, suitably arranged, different touch and close elements on the bands themselves or on the metacarpal or forearm section or on another part of the orthosis. In this regard, one or more openings, through which one or more of the bands can be guided in each case, can be provided at the first end or on a section connected to the latter. After passing through, each band can be fastened, for example, to itself, for example with the aid of the abovementioned touch and close elements, thus, in each case producing a loop section which runs through one of the openings.

[0071] The first fastening section of the closure devices connected to the metacarpal section can, e.g. be connected to the thumb holding section of the metacarpal section. Alternatively, they can be connected to the ulnar section. One closure device preferably runs over the back of the hand connecting an area of the thumb holding section that is distal of the base of the thumb with the ulnar section. An alternative or additional closure device preferably runs over the back of the hand connecting an area of the thumb holding section that is proximal of the base of the thumb with the ulnar section. An alternative or additional closure device preferably runs over the back of the hand and wrist, thereby connecting an area of the ulnar section with the middle section. An alternative or additional closure device preferably runs over the forearm on a side that is opposite to a side of the forearm on which the stiff body is located, connecting one end of the forearm section with another end of the forearm section. Thereby, the latter closure device together with the forearm section of the stiff body encircles the forearm.

[0072] The attachment sites for attaching a first closure device, such as a band, to the stiff body can be located in an area of the thumb holding section that is distal of the base of the thumb and in the ulnar section. The attachment sites for attaching a second closure device, such as a band, to the stiff body can be located in an area of the thumb holding section that is proximal of the base of the thumb and in the ulnar section. Alternatively, the attachment sites for attaching a second closure device, such as a band, to the stiff body can be located in an area of the thumb holding section that is proximal of the base of the thumb and in the middle region. The attachment sites for attaching a third closure device, such as a band, to the stiff body can be located at two opposite ends of the forearm section.

[0073] According to an embodiment, the ulnar section comprises an attachment section comprising at least one attachment site. As described above, the attachment sites are used for attaching closure devices. The attachment section preferably comprises at least two attachment sites. With two attachment sites, the ulnar section can be securely fastened using closure devices such as bands to the thumb holding section, thereby contributing to secure fastening of auser’s hand. The first and second closure devices can, thus, be adapted to fasten the ulnar section to the thumb holding section, in particular to a dorsal end region of the thumb holding section. Accordingly, the thumb holding section can also comprise two attachment sites in a dorsal end region.

[0074] In the attachment section, the at least two attachment sites are preferably separated by a notch (slit). The notch extends through the stiff body from its inner (proximal, skin-facing) to its outer (distal) side. Separating the attachment sites by a notch allows for separately tightening closure devices attached to the attachment sites at an individual tightness. This further contributes to ensure a secure fastening of a user’s hand. Moreover, it simplifies and increases the comfort when donning the orthosis. Advantageously, after tightening of a first closure device attached to a first attachment site in the attachment region, the second attachment site in the attachment region is raised above the skin of the wearer. The notch is adapted to allow this independent arrangement of the first and second attachment sites in regard to their distance from the skin of the wearer. This simplifies the attachment of a second closure device in the second attachment site. The attachment sites are preferably openings that may have different forms. According to an embodiment, the attachment sites of the attachment section have an oblong shape, for example an oval shape or an ellipsoid shape. An oblong shape is well suited to receive a band as a closure device. The oblong shape comprises different distances, in particular a longest distance. An ellipsoid shape, for example, has a longest distance along the major axis and a shortest distance along the minor axis. Each attachment site having an oblong shape preferably has a main axis defined by its longest distance.

[0075] The notch will be longer than the shortest distance of the openings. For example, the notch can have a length of at least 1.5 times the shortest distance, at least two times or at least three times. For example, the notch can have a length of 5 mm or more, 7.5 mm or more, 10 mm or more. In other words, the notch can have a length of from 5 mm to 50 mm, of from 7.5 mm to 40 mm, such as about 15 mm.

[0076] According to an embodiment, the attachment section comprises at least two attachment sites, wherein the at least two attachment sites have an oblong shape and the notch is oriented at an angle a of from 20° to 70° relative to a longitudinal (main) axis of the proximal attachment site. The proximal attachment site is the one that is closer to a user’s elbow. For example, the angle a can be from 30° to 50°. The longitudinal (main) axis of the attachment site (e.g. opening) is defined by the longest distance of the attachment site. Preferably, the attachment sites have an oblong shape and the main axes of the attachment sites areparallel to each other. The aforementioned arrangement allows for a comfortable donning of the orthosis and a secure fastening of a user’s hand. Each attachment site can be individually connected by a closure device to another attachment site for example at the thumb holding section. By incorporating at least two attachment sites into the attachment section, a secure fastening of the ulnar section is achieved. Separation of the attachment sites by a notch allows for separately tightening closure devices attached to the attachment sites at an individual tightness. By orienting the notch at an angle relative to the main axes of the attachment site, the width of the attachment site can be reduced increasing accessibility to the user’s hand. The two attachment sites can be arranged in an offset manner, i.e. in a manner where all longitudinal axes of a first of the two attachment sites are offset from (thus, parallel and not identical to) the longitudinal axes of a second of the two attachment sites.

[0077] The ulnar section may comprise a volar end and a dorsal end. The volar end is preferably located closer to a user’s palm. The volar end is preferably connected to the palmar section. The dorsal end is preferably opposite the volar end. The dorsal end is preferably located closer to a user’s back of the hand. According to an embodiment, the ulnar section has a volar end and a dorsal end and the attachment section is placed at the dorsal end of the ulnar section. The attachment section can be preferably flexed due to the hinge section. In other words, the attachment section is adapted to be bendable due to the hinge section. The hinge section is preferably located between the dorsal end and the volar end of the ulnar section. In this way, the flexibility and the ease of donning can be increased. In particular, the combination of a hinge section comprising at least one, preferably at least two, more preferably at least four, film hinges with an attachment section comprising at least two attachment sites increases the ease of donning and the fixation of a user’s hand, because the two attachment sites of the attachment section can flex individually when tightening a closure device allowing for comfortable and precise fastening of the orthosis.

[0078] According to an embodiment, the forearm section comprises at least one forearm attachment site. Preferably, the forearm section comprises at least two forearm attachment sites. By connecting the two forearm attachment sites with a closure device, the orthosis may be fixated to a user’s forearm. According to an embodiment, the at least one forearm attachment site comprises a step. The step is adapted to provide distance between a user’s skin and the orthosis. In other words, the step allows distance between a user’s skin and the orthosis at the step. Due to the distance between the user’s skin and the orthosis at the step, the closure device can be more conveniently attached and tightened to the at least one forearm attachment site. This is particularly true for the closure device connecting one endof the forearm section with another end of the forearm section as described above. In certain embodiments, the forearm section comprises two forearm attachment sites, both of which comprise a step.

[0079] The step has the form of a steplike offset. In the location of the step, the attachment site has a greater distance from the longitudinal axis (middle axis) of the orthosis than in adjacent locations of the orthosis.

[0080] As described above, the material of the orthosis, in particular of the exostructure, preferably has a good skin compatibility allowing for good wearing comfort. According to an embodiment, the orthosis comprises a foam pad. The foam pad is arranged on the skinfacing side of the orthosis. With the foam pad, wearing comfort of the orthosis may be further increased. For example, the foam pad can be arranged on the middle section and / or on the forearm section. The foam pad can, e.g. span from the middle to the forearm section. It may be glued or adapted to be glued to the orthosis. The foam pad is fastened to the stiff body e.g. with an adhesive.

[0081] For a particularly good fit, the foam pad can be cut to the desired size for the individual wearer. In a further aspect, the invention, thus concerns a kit comprising an orthosis as described herein and a separate foam pad. The foam pad can be cut to size directly before use and glued to the inner side of the orthosis with a suitable adhesive.

[0082] Preferably, the foam pad comprises a closed-cell foam. Closed-cell foams are advantageous because they do not soak up liquids. Different materials may be used for the foam pad. Advantageously, the foam pad is made from a plastic material, preferably selected from the group consisting of thermoplastic polyurethane, poly(ethylene-vinyl acetate), polyethylene, nitrile butadiene rubber, polymers from ethylene propylene diene monomer (EPDM), and thermoplastic elastomer such as styrene butadiene styrene (SBS), styrene ethylene butadiene styrene (SEBS).

[0083] The orthosis of the invention can advantageously be used in the treatment or prevention of a human wrist injury or painful condition of the human wrist. The injury or condition may be an acute or chronic injury or condition. The treatment may comprise wearing the orthosis for one, two, three or more weeks. Further the treatment may comprise examination of and / or surgery on the affected wrist at a time when the orthosis is worn on the hand, wrist and forearm of said wrist.In a second aspect, the invention relates to a method of the production of an orthosis according to the invention, i.e. an orthosis as described herein. Any of the aforementioned processes and materials can be used in the manufacture of the orthosis, in particular a method selected from the group consisting of 2-component (plastic) injection moulding, multi-component plastic injection moulding, metal core overmoulding or plastic overmoulding in general and metal mesh overmoulding. In a preferred embodiment, the method comprises metal core overmoulding.

[0084] In a third aspect, the invention relates to a method for the treatment or prevention of a human wrist injury or painful condition of the human wrist comprising donning an orthosis of the invention. The injury may be an acute or chronic injury. The treatment may comprise wearing the orthosis for one, two, three or more weeks. Further the treatment may comprise examination of and / or surgery on the affected wrist at a time when the orthosis is worn on the hand, wrist and forearm of said wrist. Advantageously, the orthosis does not cover the dorsal and ventral sides of the wrist in their entirety so that no additional stress or pressure is exerted on a potential wound or surgical site by the orthosis.

[0085] BRIEF DESCRIPTION OF FIGURES

[0086] Exemplary embodiments of the invention are shown schematically in the drawings.

[0087] Fig. 1 schematically shows a dorsal view of an orthosis according to the invention;

[0088] Fig. 2 schematically shows a first perspective view of the orthosis of Fig. 1 with closure devices in a closed position;

[0089] Fig. 3 schematically shows a second perspective view of the orthosis of Fig. 1 when applied to a human forearm, wrist and hand with closure devices;

[0090] Fig. 4 schematically shows a third perspective view of the orthosis of Fig. 1 when applied to a human forearm, wrist and hand with closure devices;

[0091] Fig. 5 schematically shows a fourth perspective view of the orthosis of Fig. 1 viewed from the side facing away from a user’s forearm;

[0092] Fig. 6 schematically shows a perspective view from the forearm section along the longitudinal axis of the middle section of the orthosis of Fig. 1 according to the invention as well as a close-up of a step;Fig. 7a schematically shows a cross-section of the middle section of an orthosis according to the invention having an exostructure and a core;

[0093] Fig. 7b schematically shows a cross-section of the middle section of an orthosis according to the invention having an exostructure without a core; and

[0094] Fig. 8 schematically shows a part of the volar section of an orthosis according to the invention showing a close-up of the hinge section.

[0095] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0096] DESCRIPTION OF EMBODIMENTS

[0097] Additional advantages, characteristics, and features of the present invention will become clear from the following detailed description of exemplary embodiments with reference to the attached drawings. However, the invention is not restricted to these exemplary embodiments.

[0098] Figs. 1 , 5 and 6 schematically show an embodiment of an orthosis 10 of the invention which comprises a stiff body 12. In fact, as shown in these figures, the orthosis 10 consists of the stiff body 12. The orthosis 10 does not comprise any closure devices 34, 36, 38 but these can be added at the respective attachment sites 40, 42, 44, 46, 48, 50 for closure devices as illustrated in Figs. 2, 3 and 4.

[0099] Fig. 1 schematically shows a dorsal view, Fig. 2 shows a first perspective view of the orthosis 10 comprising closure devices 34, 36, 38. An inner side of the orthosis 10 with the foam pad 60 is also shown in Fig. 2. Figs. 3 and 4 show an orthosis comprising closure devices donned on a user’s hand, wrist and forearm. Figs. 5 and 6 show different perspective views of the orthosis 10. The orthosis 10 comprises a metacarpal section 18 which is suitable to be worn on the hand of a patient, in particular in the metacarpal region of the hand, specifically the palm and metacarpal side (ulnar and radial) regions of the hand. The metacarpal section 18 consists of a thumb holding section 20, a palmar section 22 and an ulnar section 24.

[0100] The thumb holding section 20 is ring-shaped and has an opening 30 in the middle of this ring shape through which the thumb of the wearer can pass. The distance between the thumb holding section 20 and the ulnar section 24 on the dorsal side of the orthosis 10 is 1 / 3 or less of the width of the orthosis in the metacarpal section 18 as measured perpendicular to the longitudinal axis of the orthosis 10.The palmar section 22 is designed to lie on the surface of the hand in the palm region. It has a long shape that is narrow enough not to interfere with the individual finger movements. Moreover, as can be seen in Fig. 2, it can have a concave shape, curving inwards towards the direction of the inner side of the orthosis, i.e. towards the palm when the orthosis is worn correctly.

[0101] Adjacent to the palmar section 22, the metacarpal section 18 comprises an ulnar section 24 which is designed to wrap around the area of the fifth bone of the metacarpal region from the ventral to the dorsal side of the hand. Ulnar section 24 may comprise an opening (not shown) which makes the orthosis 10 lighter and the skin surface easier to access.

[0102] The orthosis 10 further comprises an elongated middle section 26 which has, in these embodiments, approximately the same length as the metacarpal section 18 and the forearm section 28. The middle section 26 is narrower than the other two sections of the orthosis 10, in circumferential direction, and is designed to extend along the radial side of the wrist and forearm. The middle section 26 covers mainly the radial side but is slightly bent to extend slightly also onto the ventral and dorsal sides of the wrist and arm. It can be seen that not more than 25% of the areas of the ventral and dorsal sides are covered by the ulnar section 24.

[0103] Proximally adjacent to the middle section 26, the orthosis 10 comprises a forearm section 28 which is adapted to extend around the forearm to a greater extent than the middle section 26. It nevertheless also covers and supports the forearm from the radial side. The forearm section 28 comprises an opening 32 which makes the orthosis 10 lighter and the skin surface easier to access.

[0104] The orthosis 10 comprises a number of six attachment sites 40, 42, 44, 46, 48, 50 which have the conformation of oblong shaped holes, in particular substantially rectangular holes, in the stiff body 12, specifically its exostructure 14. Through these attachment sites 40, 42, 44, 46, 48, 50 closure devices can be inserted (not shown in Figs. 1, 5, 6, 7a, 7b and 8) and used for attachment of the orthosis 10 to the hand, wrist and forearm of a wearer. See Figs.

[0105] 2, 3 and 4 for exemplary embodiments which comprise such closure devices.

[0106] The orthosis 10 further comprises a hinge section 27 comprising a total of six film hinges 271. One film hinge 271 is formed by one groove 2711, the other film hinges 271 are formed by two grooves 2711 and 2712 (see Fig. 8) that are on opposite sides, namely the proximal side and the distal side of the hinge section 27. The film hinges 271 are separated from each other by a rib. The grooves 2711 and 2712 in Fig. 8 are directly opposite each other,however, they may also be substantially opposite each other. The orthosis 10 further comprises an attachment section 29. The attachment section 29 comprises two attachment sites 40 and 46. The two attachment sites 40 and 46 are separated by a notch 291. The attachment section 29 can be flexed due to the hinge section 27.

[0107] Figs. 2, 3 and 4 schematically show other embodiments of the orthosis 10 of the invention which comprise a stiff body 12 and closure devices 34, 36 and 38. Fig. 2 shows a perspective view of the orthosis 10 of Fig. 1. Figs. 3 and 4 show a dorsal and a ventral view of the orthosis 10 of Fig. 1 when applied to a human forearm 56, wrist 54 and hand 52. It can be seen that the thumb 58 fits through the opening 30. The thumb 58 is still movable, i.e. the movement of the thumb 58 is not prevented by the orthosis 10. At the same time, the orthosis 10 is able to stabilize the wrist 54 in an angled position. The wrist 54 is substantially immobilized, i.e. movements of the wrist in any direction are prevented.

[0108] Furthermore, the orthoses 10 of Figs. 2, 3 and 4 comprise the closure devices 34, 36 and 38 which have an elongated strap shape. One end region of each closure devices 34, 36 and 38 is fastened to an attachment site 44, 48, 50 each. The closure devices 34, 36 and 38 are polyamide straps. The end regions are welded to form a loop which fastens the closure devices 34, 36 and 38 in the first attachment sites 44, 48, 50. The straps can be passed through the opposite, second attachment sites 40, 46, 42, respectively, and then returned into the direction of the first attachment sites 44, 48, 50. The closure devices 34, 36 and 38 are closed with a Velcro, hook and loop fastening system. The first closure device 34 can be fastened between attachment sites 40, 44 in the ulnar section 24 and the thumb holding section 20. It can be seen that the second closure device 36 can be fastened between attachment sites 46, 48 in the ulnar section 24 and the thumb holding section 20 (Figs. 2 and 3). The third closure device 38 can be fastened between attachment sites 42, 50 on opposite ends of the forearm section 28.

[0109] Fig. 5 shows another perspective view of the orthosis 10 of Fig.1

[0110] Fig. 6 shows a perspective view of the orthosis 10 of Fig. 1 from the forearm section 28 along the longitudinal axis of the middle section 26. The attachment sites 42, 50 at the forearm section 28 each show a step 281 and 282 that allow for a distance between a user’s skin and the orthosis 10 at the step 281. The steps 281 and 282 facilitate introducing and fastening of the closure device 38 into the orthosis 10. Fig. 6 further shows a close-up of the step 282 with attachment site 42. Due to the distance that the steps 281 and 282 ensurebetween the user’s skin and the orthosis 10, the closure device 38 can be fastened more comfortably.

[0111] Fig. 7a schematically shows a cross-section of the middle section 26 of an embodiment of an orthosis 10. It can be seen that the stiff body 12 in the middle section 26 consists of an exostructure 14 and a core 16 which is enclosed by the exostructure 14. The core 16 consists of an aluminium alloy metal and is ductile. The exostructure 14 is overmoulded onto the core 16 and consists of thermoplastic polyurethane (TPU). Fig. 7b shows a cross-section of the middle section 26 of an embodiment of an orthosis 10 showing that the stiff body 12 does not comprise a core 16. The stiff body only consists of an exostructure 14 made of thermoplastic polyurethane.

[0112] Fig. 8 shows a detailed view of the hinge section 27 of the volar section 24 comprising six film hinges 271. The film hinges 271 are formed by one groove 2711 or by two grooves 2711, 2712 opposite each other.

[0113] Although the present invention has been described in detail with reference to the exemplary embodiments, it is obvious to those skilled in the art that the invention is not restricted to these exemplary embodiments, but rather that modifications can be made in such a way that individual features are omitted or other combinations of the individual features presented are realized, provided that the scope of protection of the appended claims is not exceeded. The present disclosure includes any and all combinations of the individual features presented.REFERENCE SIGNS LIST

[0114] 10 orthosis

[0115] 12 stiff body

[0116] 14 exostructure

[0117] 16 core

[0118] 18 metacarpal section 20 thumb holding section 22 palmar section

[0119] 24 ulnar section

[0120] 26 middle section

[0121] 27 hinge section

[0122] 28 forearm section

[0123] 29 Attachment section 30 opening

[0124] 31 opening

[0125] 32 opening

[0126] 34 closure device

[0127] 36 closure device

[0128] 38 closure device

[0129] 40 attachment site

[0130] 42 attachment site

[0131] 44 attachment site

[0132] 46 attachment site

[0133] 48 attachment site

[0134] 50 attachment site

[0135] 52 hand

[0136] 54 wrist

[0137] 56 forearm

[0138] 58 thumb

[0139] 271 film hinge

[0140] 27 hinge section

[0141] 2771 groove

[0142] 2772 groove

[0143] 281 step291 notch

[0144] 5

Claims

C l a i m s1. An orthosis (10) adapted to be worn on a human forearm and hand for immobilizing the wrist joint, comprising a stiff body (12) ,wherein the stiff body (12) comprises(i) a metacarpal section (18),a. having a ring-shaped or ring-segment-shaped thumb holding section (20) adapted to receive the thumb of the human hand,b. having a palmar section (22) adapted to be brought into engagement with the palm of the human hand, andc. having an ulnar section (24) adapted to wrap around the human hand from the volar to the dorsal side,(ii) an elongated middle section (26) adapted to be brought into engagement with the human forearm, and, optionally, wrist, on their medial or lateral side, and(iii) a forearm section (28) adapted to wrap around the human forearm from its ventral to its dorsal sidewherein the ulnar section (24) comprises a hinge section (27) comprising at least one film hinge (271).

2. The orthosis (10) according to claim 1, wherein the hinge section (27) comprises at least two, preferably at least three, more preferably at least four, film hinges (271), in particular comprising a rib in between.

3. The orthosis (10) according to any one of claims 1 or 2, wherein each film hinge (271) is formed by two grooves (2711, 2712) substantially, in particular directly, opposite to each other on a proximal side and a distal side of the hinge section (27).

4. The orthosis (10) according to any one of the preceding claims, wherein the ulnar section (24) comprises an attachment section (29) comprising at least one attachment site (40, 46).

5. The orthosis (10) according to claim 4, wherein the attachment section (29) is adapted to be bendable due to the hinge section (27) and / or wherein the ulnar section (24) has a volar end and a dorsal end and the attachment section (29) is placed at the dorsal end of the ulnar section (24).

6. The orthosis (10) according to any one of claims 4 or 5, wherein the attachment section (29) comprises at least two attachment sites (40), (46).

7. The orthosis (10) according to claim 6, wherein the at least two attachment sites (40), (46) are separated by a notch (291).

8. The orthosis (10) according to claim 7, wherein the at least two attachment sites (40), (46) have an oblong shape and the notch (291) is oriented at an angle a of 20° to 70° relative to a longitudinal axis of the proximal attachment site (46).

9. The orthosis (10) according to any one of the preceding claims, wherein the forearm section (28) comprises at least one forearm attachment site (50).

10. The orthosis (10) according to claim 9, wherein the at least one forearm attachment site (50) comprises a step (281), wherein the step (281) is adapted to provide distance between a user’s skin and the orthosis (10) at the step (281).

11. The orthosis (10) according to any one of the preceding claims, wherein the orthosis (10) comprises a foam pad (60), preferably on the skin-facing side of the orthosis, wherein the foam pad (60) is preferably arranged on the middle section (26) and / or on the forearm section (28).

12. The orthosis (10) according to claim 11, wherein the foam pad (60) comprises a closed-cell foam.

13. The orthosis (10) according to any one of the preceding claims, wherein the stiff body (12) has an exostructure (14) enclosing an elongated core (16).

14. The orthosis (10) according to claim 13, wherein the core (16) is reversibly plastically deformable.

15. The orthosis (10) according to any one of claims 13 or 14, wherein the stiff body (12) consists of exostructure (14) and core (16).

16. The orthosis (10) according to any one of the preceding claims, wherein the middle section (26) has a length that is 100% or more of the length of the metacarpal section (18) when measured parallel to the longitudinal axis of the orthosis (10).

17. The orthosis (10) according to any one of the preceding claims, wherein the middle section (26) has a length that is 125% or more of the length of the forearm section (28) when measured parallel to the longitudinal axis of the orthosis (10).

18. The orthosis (10) according to any one of claims 13 to 17, wherein the exostructure (14) is continuous from the ulnar section (24), the palmar section (22), the thumb holding section (20), the elongated middle section (26) to the forearm section (28).

19. The orthosis (10) according to any one of the preceding claims, wherein the middle section (26) is adapted to cover the wrist and / or forearm of a human on 50% or less of their respective circumferences.

20. The orthosis (10) according to any one of the preceding claims, wherein the forearm section (28) is adapted to cover the forearm of a human on 25% to 90% of its circumference.

21. The orthosis (10) according to any one of the preceding claims, wherein the metacarpal section (18) and / or the forearm section (28) comprise an opening (30, 31, 32).

22. The orthosis (10) according to any one of the preceding claims, wherein the ulnar section (24) comprises an opening (31) on the ulnar side of the orthosis (10).

23. The orthosis (10) according to any one of claims 13 to 22, wherein the core (16) consists of or comprises one or more metals or metal alloys and / or thermoplastic materials.

24. The orthosis (10) according to claim 23, wherein the metal or metal alloys are selected from the group consisting of aluminium, iron and alloys thereof, such as steel.

25. The orthosis (10) according to any one of claims 13 to 24, wherein the exostructure (14) comprises or consists of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic rubber (TPR), silicone and mixtures thereof.

26. The orthosis (10) according to any one of the preceding claims, wherein the stiff body (12) is manufactured by a method selected from the group consisting of 2-component (plastic) injection molding, multi-component plastic injection molding, metal core overmolding or plastic overmolding in general and metal mesh overmolding.

27. The orthosis (10) according to any one of claims 13 to 26, wherein the core (16) extends from the metacarpal section (18), through the middle section (26) and into the forearm section (28).

28. The orthosis (10) according to any one of the preceding claims, comprising one or more closure devices (34, 36, 38) for fastening the orthosis (10) on the human hand.

29. The orthosis (10) according to claim 28, wherein one or two of the closure devices are attached to the metacarpal section (18) and / or wherein one of the closure devices is attached to the forearm section (28).

30. The orthosis (10) according to any one of the preceding claims, for use in the treatment or prevention of a human wrist injury or painful condition of the human wrist.

31. Method of the production of an orthosis (10) according to any one of the preceding claims, using a method selected from the group consisting of 2-component (plastic) injection molding, multi-component plastic injection molding, metal core overmolding or plastic overmolding in general and metal mesh overmolding.

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