Wrist brace

Abstract

The present invention relates to a brace configured to be worn on the forearm and hand of a human being to stabilize the wrist joint, and comprises a rigid body having an exoskeleton surrounding an elongated core. [Solution] The rigid body 12 comprises a metacarpal section 18 having (i) a ring-shaped or ring-segment-shaped thumb-holding section 20 configured to receive the thumb of a human hand, a palm section 22 configured to engage with the palm of a human hand, and an ulnar section 24 configured to wrap around the human hand from the palm side to the dorsal side; (ii) an elongated intermediate section 26 configured to engage with the medial or lateral side of a human forearm; and (iii) a forearm section 28 configured to wrap around the human forearm from the ventral side to the dorsal side.

Description

Technical Field

[0001] The present disclosure relates to a device configured to be worn on a human forearm and hand to immobilize the wrist joint, as well as a method for manufacturing the device.

Background Art

[0002] This type of device is used to immobilize the wrist joint of a subject suffering from a condition associated with wrist or hand pain. The painful condition or injury can be caused by frequent repetitive movements of the hand or an acute accident. To recover the wrist, it is desirable to securely stabilize the joint in all directions of movement.

[0003] Known devices typically cover the forearm and at least the palm of the hand extensively for this purpose. The extensive coverage has the drawback that it is very difficult to keep the body part clean. Patients can usually only wash their forearms when the device is removed. However, during the time the device is removed, the injured wrist is unstable. To facilitate the recovery process, the device should be worn as consistently as possible. Removal of the device should be avoided.

[0004] Further adverse effects resulting from long wearing times of common devices include itching and odor generation. The aforementioned adverse effects are exacerbated by some fabric parts of the device that get dirty rather quickly. These fabric parts require regular and thorough washing and subsequent air drying, during which time the patient cannot wear the device and is very restricted in daily activities.

[0005] The extensive coverage of the forearm and hand further blocks access to the affected wrist area that a physician may need. Thus, with prior art devices, a physician can only examine the wrist after the device is removed, for example, inspect the surgical site of the wrist. Each removal exposes the wrist to undesirable harmful movements.

[0006] Therefore, in this field, there is a need for improved wrist orthoses that provide the same level of stabilization but allow for improved hygiene, improved recovery methods, and better access to the wrist area. [Overview of the project]

[0007] This problem is solved by an orthotic device as described in the attached claims.

[0008] The present invention uses a washable and reversibly plastically deformable material to stabilize the wrist, particularly on the ulnar or radial side of the forearm and wrist. This allows the dorsal and ventral sides of the forearm and wrist to remain accessible to a physician.

[0009] Therefore, in a first aspect, the present invention relates to a device configured to be worn on the forearm and hand of a human for fixing the wrist joint, comprising a rigid body having an exoskeleton surrounding an elongated core, the rigid body being (i) A metacarpal section, a. A ring-shaped or ring-segment-shaped thumb-holding section configured to receive the thumb of a human hand, b. A palmar section configured to engage with the palm of a human hand, c. A metacarpal section having an ulnar section configured to enclose the human hand from the palm side to the back side of the hand, (ii) A slender intermediate section configured to engage with the human forearm and optionally the wrist, on the ulnar (medial) or radial (lateral) side of the human forearm, (iii) A forearm section configured to enclose the human forearm from the ventral side to the dorsal side, Regarding orthotic devices.

[0010] The orthosis of the present invention is configured to be worn on the human forearm and hand to stabilize the wrist joint. This means that the orthosis has an elongated shape that extends along the wearer's forearm, wrist, and hand. The shape of the orthosis is anatomically configured to fit these body parts. The internal shape of the orthosis may be complementary in shape to the surface of the hand, wrist, and forearm, particularly to the metacarpal region of the hand, such as the palm, the ulnar (medial) or radial (lateral) side of the wrist and forearm, and the proximal end region of the forearm. The “medial” side of the orthosis is the side that faces the surface of the wearer's body when the orthosis is worn. The medial side may be directly present, i.e., it may be configured to be directly present on the surface of the hand, wrist, and forearm, preferably at least 50%, at least 75%, or at least 95% of the medial surface. In other words, 50% to 100% of the inner surface area can be configured to be directly present on the surface of the wearer's hand, wrist, and forearm, at a rate of 60% to 100%, 70% to 100%, 75% to 100%, 80% to 100%, 85% to 100%, 90% to 100%, or 95% to 100%.

[0011] The good fit of the orthosis is ensured by its ability to be plastically deformed and thus configured to the specific morphology of the individual wearer. In other words, the orthosis is adaptable to the wearer's specific morphology by plastic deformation, particularly by reversible plastic deformation. These properties and high stability of the orthosis are ensured by a rigid body provided in the orthosis, which has an exoskeleton surrounding an elongated core. Suitable materials for the exoskeleton and core are described elsewhere in this specification. In one embodiment, the rigid body consists of an exoskeleton and a core.

[0012] In particular, the elongated core is reversibly plastically deformable. Plastic deformation is caused by an applied force and, in contrast to elastic deformation, does not return to its original state simply by removing the force. Therefore, healthcare professionals performing orthotic fitting can bend the rigid body to the desired shape to fit it to the individual patient's hand. Furthermore, the plastic deformation is preferably reversible, and as a result, the orthosis may be configured if the initial fit needs to be modified. Therefore, the term “plastic deformation” as used herein does not include the fracture of the rigid body. The bending of the core and rigid body that healthcare professionals can perform is usually a slight adjustment of the existing basic shape of the rigid body established by the components of the rigid body described above (metacarpal section, intermediate section, and forearm section), for example, a slight bending of the rigid body in the palmar section to bring the inner surface of the rigid body closer to the wearer’s palm.

[0013] The rigid exoskeleton surrounds a plastically deformable core. In other words, the core is embedded within the exoskeleton. Like the core, the exoskeleton may also be plastically deformable, but this is merely one alternative embodiment. In other embodiments, the exoskeleton is elastic, i.e., it contains or consists of an elastic material. The elastic material is configured to ensure that the exoskeleton deforms similarly when the core is bent into a desired shape.

[0014] The exoskeleton preferably covers 50%, 60%, 70%, 80%, 90%, or 95% or more of the core surface, for example, 100%. In other words, the exoskeleton covers 50% to 100%, 60% to 100%, 70% to 100%, 80% to 100%, 90% to 100%, or 95% to 100% of the core surface. In most cases, the core will be completely or substantially covered by the exoskeleton, which may be influenced, for example, by the manufacturing method chosen to produce the rigid body. Thus, uncovered sections of the core are acceptable. Exemplary manufacturing methods are described elsewhere in this specification.

[0015] The rigid body comprises (i) a metacarpal section, (ii) an elongated intermediate section, and (iii) a forearm section. The sections are arranged in the orthosis in the aforementioned order and preferably directly adjacent to one another. In other words, the metacarpal section is preferably directly adjacent to the intermediate section, and the intermediate section is preferably directly adjacent to the forearm section. In one embodiment, the rigid body consists of the metacarpal section, the elongated intermediate section, and the forearm section. The rigid body is a single, integrated structure. The exoskeleton is continuous with the rigid body, particularly in the aforementioned metacarpal section, the elongated intermediate section, and the forearm section. Thus, the exoskeleton is continuous from the ulnar section, palmar section, thumb-holding section, and elongated intermediate section to the forearm section. This means there are no gaps in the exoskeleton between the aforementioned sections. This will be understood as not excluding holes based on smaller fabrications within the exoskeleton, insofar as the exoskeleton connects the aforementioned sections. The ulnar section portion and the thumb-holding section portion of the exoskeleton are not directly connected.

[0016] The term "rigid" means that the rigid body resists deformation caused by forces applied to the orthosis during normal use by the wearer. This allows the orthosis to maintain the wrist joint in place. At the same time, the term "rigid" does not exclude the fact that the rigid body may be bent and, in particular, plastically deformed as described above when a force greater than normal is applied to the rigid body. In fact, the fact that the orthosis may be bent by the medical professional performing the orthosis fitting, and that the orthosis is configured on the wearer's hand and forearm, is an advantageous property of the orthosis of the present invention.

[0017] The orthosis comprises (i) a metacarpal section within the metacarpal region of the orthosis, designed to at least partially enclose the hand. The metacarpal section may be formed by at least one elongated element and, in the normal anatomical position of the hand and forearm, at least partially enclose the metacarpals in a plane that is essentially perpendicular to the longitudinal axis of the forearm. The metacarpal section is designed to be able to engage with the human hand by at least partially around the back of the hand, and in particular by being positioned in the palm of the hand below the metacarpal joints of the index, middle, ring, and little fingers and above the wrist, thereby the metacarpal section extending circumferentially around the metacarpals and subsequently fully or partially resting on the palm, partially enclosing the metacarpals.

[0018] Preferably, the metacarpal section does not extend distally beyond the metacarpal region of the hand when the orthosis is fitted. This improves the mobility of the wearer's fingers. The largest portion of the metacarpal section is typically designed to rest on the palmar side of the wearer's hand. The metacarpal section extends around one or both edges of the hand and lies entirely or partially on one or both edges of the hand. The metacarpal section extends circumferentially across the entire palm or at least a portion of the palm, preferably the entire palm, in the metacarpal direction. The metacarpal section may fully or partially abut the palm to provide a structure for fixing curvature and extension, i.e., preventing curvature and extension movements, and to prevent supination and pronation of the hand.

[0019] As a result of this configuration of the metacarpal section, the contact surface on the hand is preferably located within the metacarpal area and away from the wrist in the direction of the fingers when the brace is applied. In this context, “contact surface” refers to the surface of the rigid body, particularly the metacarpal region, e.g., the palmar region, that is in direct contact with the wearer’s skin, e.g., the skin of the wearer’s hand, i.e., configured to be in direct contact with the wearer’s skin. Thus, the wrist is preferably not covered by the palmar and dorsal surfaces of the wrist, thereby leaving these areas freely accessible to a sufficient extent and preventing additional stress or pressure on potential wounds located in the wrist region.

[0020] Furthermore, the metacarpal section may enclose one or both sides of the hand, particularly the radial and ulnar sides, but will not typically extend across the entire width of the hand on the dorsal side (back of the hand). The metacarpal section may extend (i.e., be configured to extend) 100% of the palmar circumference of the metacarpal region of the hand, i.e., across the palm in the radial-ulnar direction, and 0% to 50%, preferably 0% to 25%, of the dorsal circumference of the metacarpal region of the hand in the radial-ulnar direction (i.e., be configured to extend). Thus, there is a dorsal section that is not covered by the metacarpal section or other parts of the rigid body. The coverage on the palmar side of the hand provides sufficient stability of the orthosis, while the gap on the dorsal side ensures good access to the hand and easy cleaning. The dorsal gap may be closed by a removable flexible fastener, as described elsewhere in this specification.

[0021] The metacarpal section has (a) a ring-shaped or ring-segmented thumb-retaining section configured to receive the thumb of a human hand. The thumb-retaining section has a ring-shaped or ring-segmented opening configured to receive the thumb. Overall, the thumb-retaining section is designed so that when the metacarpal section is engaged with the hand, the thumb extends through the ring-shaped or ring-segmented thumb-retaining section, i.e., through the ring-shaped opening defined by the thumb-retaining section, and then the thumb-retaining section extends over at least a portion of the circumference of the thumb, so as to fit against the thumb of the hand, so as to fully or at least partially enclose the circumference of the thumb.

[0022] Furthermore, the thumb-holding section can wrap around the radial side of the hand. This ensures that the wrist brace remains stable on the hand even when the fastener is not closed.

[0023] The purpose of the brace is to stabilize the wrist, not specifically the thumb, and therefore it typically does not extend along the thumb itself. The thumb can maintain its mobility, at least at the interphalangeal joint. The brace is not designed to cover this joint.

[0024] The metacarpal section further comprises (b) a palmar section configured to engage with the palm of a human hand. In a preferred embodiment, the palmar section extends onto the palm substantially perpendicular to the longitudinal axis of the joints of the forearm and wrist. This configuration of the palmar section, when placed, is preferably located within the metacarpal region and away from the wrist in the direction of the fingers. The wrist is thus preferably not covered and remains freely accessible to a physician if necessary. The palmar section may be positioned, for example, in the palm below the metacarpophalangeal joints of the index, middle, ring, and little fingers.

[0025] On the side opposite to the thumb holding section of the metacarpal section, the ulnar section is provided in the metacarpal section. The ulnar section is configured to wrap around the human hand from the palmar side to the dorsal side on the ulnar side of the hand, that is, on the bone side of the fifth metacarpal bone. For this purpose, the ulnar section is curved and may have a semi-circular or semi-elliptical cross-section. The ulnar section forms one end of the metacarpal section of the device and may leave most of the back of the hand free, whereby these parts of the back of the hand are not covered by a part of the rigid body. As described elsewhere in this specification, the ulnar section may be connected to the thumb holding section by a fastener extending over the back of the hand.

[0026] The metacarpal section has a first end formed by a thumb holding section that comprises one of the two longitudinal ends of an elongate element in the longitudinal direction of the metacarpal section, and a second end 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 rigid body may consist of the thumb holding section, the palmar section, and the ulnar section.

[0027] In addition to the metacarpal section, the rigid body also comprises (ii) an elongate intermediate section configured to engage the human forearm and wrist on the ulnar or radial side of the human forearm, or configured to engage the human forearm on the ulnar or radial side of the forearm. Usually, the intermediate section will extend, that is, be configured to extend from the forearm into the wrist region. However, in some cases, the wrist may be covered by the thumb section of the device. In these cases, the elongate intermediate region is configured to engage the human forearm. In most other cases, the intermediate section is configured to engage the human forearm and wrist.

[0028] In the context of the present invention, this stabilization by means of a rigid body on one side of the wrist and forearm has been found to provide sufficient fixation to promote wrist recovery. It is not necessary to provide stabilization sections on both the ulnar and radial sides. Thus, the elongated intermediate section is preferably arranged on one side of the forearm and wrist, i.e., configured to be arranged on one side of the forearm and wrist, and the opposite side of the wrist and forearm is freely accessible, i.e., not covered by any part of the rigid body. In a particular embodiment, the intermediate section is configured to be arranged on the radial side of the forearm and wrist. Thus, the intermediate section may be directly adjacent to the thumb holding section of the metacarpal section. In these embodiments, the intermediate section will not be adjacent to the ulnar section of the metacarpal section. The ulnar section is preferably not directly connected to the part that extends to the forearm when the appliance is worn. In this way, the ulnar side as well as parts of the dorsal and ventral sides are freely accessible, ensuring good ventilation of the skin and accessibility for medical personnel.

[0029] The intermediate section may be configured to cover 50%, 45%, 40%, 35%, 30%, 25%, 20%, or 15% or less of the outer circumference of each wrist and / or forearm section (preferably within each wrist and forearm section spanning the entire length of the intermediate section, where the intermediate section is located). In other words, this means that only 50%, 45%, 40%, 35%, 30%, 25%, 20%, or 15% or less of the surface of the wrist and / or forearm is covered by the intermediate section within the limb section where the intermediate section is located. For example, the intermediate section may be configured to cover 5% to 50%, 10% to 50%, 5% to 45%, 10% to 45%, 5% to 40%, 10% to 40%, 5% to 35%, 10% to 35%, 5% to 30%, 10% to 30%, 5% to 25%, 10% to 25%, 5% to 20%, 10% to 20%, 5% to 15%, or 10% to 15% of the circumference of the human wrist and / or forearm. This ensures access to the palmar and dorsal sides of the wrist and forearm, particularly the center of the palmar and dorsal sides of the wrist and forearm. In this context, “center” refers to the area extending along the palmar longitudinal axis or the dorsal longitudinal axis. In a particular embodiment, the intermediate section is configured to cover 50% or less of the circumference of the human wrist and / or forearm. In another embodiment, the intermediate section is configured to cover each human wrist and / or forearm by 25% or less of the circumference of each wrist and / or forearm. In other words, the intermediate section may be configured to cover each human wrist and / or forearm by 2% to 50%, 3% to 40%, 4% to 30%, or 5% to 25% of the circumference of each wrist and / or forearm.

[0030] The shape of the intermediate section is configured to match the shape of the wearer's forearm. The intermediate section of the orthosis may have the form of a curved wall of a partial cylinder, for example, a semi-cylindrical shape. The inside of the cylinder forms the inside of the intermediate section configured to be present on the wearer's skin. Thus, the cross-section of the intermediate section has the shape of a partial circle or partial ellipse. The partial circle or partial ellipse has a central angle of 5° or more, 10° or more, or 15° or more. At the same time, it is preferable that the central angle of the partial circle or partial ellipse is 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 ellipse is 5° to 180°, for example, 10° to 100°.

[0031] To stabilize the wrist most efficiently, the intermediate section may extend along a substantial portion of the forearm. For example, the intermediate section may be long enough to ensure that the proximal end of the brace is positioned as close to the elbow as possible without interfering with elbow joint movement. The lengths of the intermediate and forearm sections together may be configured to extend along 50%, 60%, 70%, 75%, 80%, 85%, or 90% of the wearer's forearm, with 60% being preferred and 70% being particularly preferred. In other words, the lengths of the intermediate and forearm sections together may be configured to extend along 50% to about 100%, 60% to about 100%, 70% to about 100%, 75% to about 100%, 80% to about 100%, 85% to about 100%, or 90% to about 100% of the wearer's forearm.

[0032] The intermediate section of the orthosis may be longer than the metacarpal section and / or forearm section when measured parallel to the longitudinal axis of the orthosis. For example, the intermediate section may be 100% or more of the length of the metacarpal section, e.g., 125%, 150%, 175%, or 200% or more. In other words, the intermediate section may be 100% to 300% of the length of the metacarpal section, or 125% to 300%, 175% to 300%, 200% to 300%, 125% to 250%, 150% to 250%, 175% to 250%, or 200% to 250% of the length of the metacarpal section. Similarly, the intermediate section may be 125% or more of the length of the forearm section, e.g., 150%, 175%, or 200% or more. In other words, the intermediate section may have a length of 125% to 300% of the length of the forearm section, for example, 150% to 300%, 175% to 300%, 200% to 300%, 125% to 250%, 150% to 250%, 175% to 250%, or 200% to 250%. The lengths of the sections referred to herein are measured parallel to the longitudinal axis of the orthosis.

[0033] The intermediate section may have a length of, for example, 7.5 cm or more, or 10 cm or more. In other words, the intermediate section may have a length of 7.5 cm to 20 cm, or 10 cm to 18 cm. It should be understood that the absolute length will depend on the actual size of the orthosis, which is individually selected to fit a particular patient.

[0034] The rigid body, particularly the metacarpal section and / or intermediate section of the rigid body, is configured to establish a hand position suitable for contracture prevention. An appropriate wrist angle may be, for example, 20°–30° of dorsal extension. Therefore, the rigid body, for example, the metacarpal section and / or intermediate section of the rigid body, is configured to establish a 20°–30° dorsal extension angle at the wearer's wrist. This angle is particularly useful for wrist stabilization and recovery. As mentioned above, the appropriate angle can be ensured by manual plastic deformation of the orthosis. It can also be predetermined in the orthosis.

[0035] Finally, the rigid body includes a forearm section configured to at least partially enclose the human forearm from the ventral to the dorsal side. The forearm section encloses the proximal forearm in a direction essentially perpendicular to the longitudinal axis of the rigid body, i.e., the circumferential direction. The forearm section also forms the proximal end of the orthosis. By lying completely or partially enclosing the wearer's forearm, the forearm section provides at least one support for stabilizing wrist flexion, extension, supination, and pronation. Thus, the orthosis is suitable for reducing or preventing wrist flexion, extension, supination, and / or pronation movements, and it is preferable to prevent these movements. The lengths of the intermediate section and forearm section as supports effectively ensure stabilization against these movements. For this purpose, the forearm section is configured to approach the elbow without preventing elbow joint movement when properly fitted. In particular, wrist supination and pronation movements are effectively prevented by this combination of the elongated intermediate section and forearm section.

[0036] In a direction perpendicular to the longitudinal axis of the rigid body, the forearm section is wider than the elongated intermediate section. The forearm section may be configured to cover, for example, 15% to 90%, preferably 25% to 90%, of the outer circumference of a human forearm (within the proximal forearm section where the forearm section is located, preferably within the section extending the entire length of the forearm section). In other words, the forearm section may be configured to cover 15% or more, 25% or more, 35% or more, 45% or more, or 50% or more, of the outer circumference of a human forearm. This means that on the section of the limb (arm) where the forearm section is located, 15% to 90%, preferably 25% to 90%, of the surface of the forearm is covered by the forearm section.

[0037] To achieve this objective, the shape of the forearm section is configured to match the shape of the wearer's forearm. The forearm section of the orthosis has the form of a partial cylinder, for example, a semi-cylindrical curved wall. The inside of the cylinder forms the inside of the forearm section configured to be located on the wearer's skin. Therefore, the cross-section of the forearm section has the shape of a partial circle or ellipse. The central angle of the partial circle or ellipse is 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, with 135° or more being preferable. On the other hand, the central angle of the partial circle or partial ellipse is preferably 300° or less, 280° or less, 260° or less, 240° or less, 220° or less, or 200° or less. In certain embodiments, the central angle of a partial circle or partial ellipse is between 100° and 260°, for example, between 135° and 225°.

[0038] To improve the ability to clean the skin of the hand, wrist, and forearm, and thereby enhance wearing comfort, the metacarpal section and / or forearm section may have openings. These are openings in other larger areas of the material, in addition to the openings created by the ring-shaped or ring-segmented thumb-retaining section. These additional openings are preferably closed on all four sides and can therefore be considered windows to the skin. The openings may have rectangular, circular, oval, elliptical, or irregular shapes with rounded edges. The opening in the metacarpal section is assumed to be located within the ulnar section. Together with the ulnar section, the opening may enclose the ulnar lateral edge of the hand. Therefore, the opening will be on the ulnar side of the orthosis. Also, in the forearm section, the opening may be in the part of the forearm section that encloses the wearer's forearm. This opening will typically be on the radial side of the orthosis.

[0039] The orthotic device of the present invention may preferably be configured to the specific hand shape of the wearer, thereby improving the efficiency and comfort of the device and reducing the need for numerous different size versions of the device. Adjustment of the orthotic device is achieved by plastic deformation of the rigid body and corresponding adjustment of the fasteners described elsewhere in this specification. Thus, the rigid body, in particular the core of the rigid body, may be reversibly plastically deformable as described above. The term plastic deformation as used herein does not refer to irreversible destruction of the product, and therefore the plastic deformation is reversible. Instead, the reversibility of the plastic deformation ensures that further adjustments, such as finer corrections, can still be performed even after the initial adjustment has been made by a medical professional. The rigid body can also be bent back to its originally manufactured form.

[0040] The rigid body, particularly the core of the rigid body, may be plastically deformable at room temperature, i.e., 20°C to 25°C. This minimizes the need for additional equipment and the number of steps involved in the fitting process. Alternatively, the rigid body may be plastically deformable at higher temperatures, such as 28°C or above, 30°C or above, 35°C or above, or 40°C or above. Preferably, the temperature at which the rigid body can be reversibly plastically deformed by a medical professional is low enough to be comfortable for a human patient, for example, 55°C or below, 50°C or below, or 45°C or below. The core that can be reversibly plastically deformed at room temperature is a metal or metal alloy core, such as an aluminum or aluminum alloy core.

[0041] Plastic deformability can be achieved, for example, by using one of the core materials described elsewhere in this specification. Alternatively or additionally, the rigid body, exoskeleton, and / or core structure may be designed to allow or support plastic deformation. The rigid body, exoskeleton, and / or core may have, for example, a deformable grid structure.

[0042] The adjustment of the rigid body to the wearer's hand can be achieved, for example, using metal or thermoplastic materials. Thus, the rigid body, core, and / or exoskeleton, particularly the core, may include or consist of metal and / or thermoplastic materials. In the case of thermoplastic materials, the adjustment of the orthosis to a particular wearer is achieved by applying heat to the thermoplastic material to conform the rigid body to the wearer's hand, wrist, and forearm, and then cooling the material. As mentioned above, the required temperature is preferably low enough to be comfortable for the wearer. However, it is also possible to gradually remove the orthosis from the body surface and then adapt it. In these cases, the temperature required for deformation can be higher.

[0043] In certain embodiments, the core may consist of or include one or more metals or metal alloys. Metals and metal alloys are particularly well suited for use in a rigid body that can be plastically deformed. The metals or metal alloys may be selected from the group consisting of aluminum, iron, and alloys thereof such as steel. In a particularly preferred embodiment, the core is an aluminum core, i.e., a core made from an aluminum alloy.

[0044] In further embodiments, the core may consist of one or more thermoplastic materials, particularly one or more low-temperature thermoplastic materials. The low-temperature thermoplastic materials are characterized by a deformation temperature below 100°C (212°F), for example, between 40°C and 100°C. Suitable materials are known in the art and are commercially available. They can be plastically deformed after or during heating, for example, at a temperature of about 70°C, such as in a water bath.

[0045] The core may be inelastic at lower temperatures, specifically 20-30°C, for example, below room temperature. At these temperatures, the core is also resistant to tension and bending.

[0046] The core may have, for example, a cylindrical, elliptical, oblong, rectangular, or irregular cross-section. Preferably, the core has a cross-section with a width greater than its height, for example, an oblong, elliptical, or rectangular cross-section. Compared to a core with a cross-section having equal width and height, the bending and stabilizing properties are improved. The core may be positioned within the orthosis such that one of the cross-sectional sides of the core with the longer width faces inward towards the orthosis.

[0047] The core may extend from the metacarpal section through the intermediate section into the forearm section. The core does not need to be present in all areas of the exoskeleton, but it is preferable that it be present in the metacarpal, intermediate, and forearm sections. For example, certain areas of the metacarpal region, such as parts of the ulnar and thumb-holding sections, do not need to have a core. However, it is beneficial that at least a portion of the thumb-holding section and at least a portion of the palmar section have a core and exoskeleton. The core can be a single-piece or multi-piece design, and it is preferable that the core be formed as a single integrated component.

[0048] Depending on the material used for the core, the core may be manufactured by a method selected from, for example, (i) dye cutting of a metal blank and subsequent bending of the core, and (ii) dye cutting of a thermoplastic core and subsequent thermoforming of the core.

[0049] Similar to the core, the exoskeleton may contain different materials. Since the exoskeleton material is not the primary stabilizer, it may be more elastic. They may be more flexible at room temperature. The exoskeleton material will be selected based on its ability to provide sufficient wearing comfort while simultaneously facilitating easy cleaning of the rigid body at room temperature (approximately 20°C to 40°C). At these temperatures, the exoskeleton material may be elastic. Therefore, the exoskeleton will have a closed surface structure that does not absorb water, i.e., a liquid-tight surface. Furthermore, the exoskeleton material will have good biocompatibility, medium resistance, sweat resistance, alcohol resistance, disinfectant resistance, and be waterproof.

[0050] The exoskeleton may include or consist of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic rubber (TPR), silicone, and mixtures thereof. In a preferred embodiment, the exoskeleton includes or consists of TPU. In one embodiment of the present invention, the orthosis comprises a rigid body having an aluminum core and a TPU exoskeleton.

[0051] The rigid body can be manufactured by various methods known in the art. For example, the rigid body can be manufactured by a method selected from the group consisting of two-component injection molding such as two-component plastic injection molding, multi-component plastic injection molding, metal core overmolding or general plastic overmolding, and metal mesh overmolding, with metal overmolding methods such as metal core blank overmolding being particularly preferred.

[0052] To secure the orthosis on a human hand, the orthosis may comprise one or more fasteners in addition to a rigid body. The orthosis may include, for example, one, two, three, four, five, six, or seven fasteners, preferably two, more preferably three. For example, one or two, preferably two, of the fasteners may be attached to the metacarpal section. One or two, preferably one, of the fasteners may be attached to the forearm section. It will be understood that the rigid body may have corresponding attachment points, such as openings, to which the fasteners can be secured.

[0053] The fastener may have, for example, one or more flexible or elastic bands that surround the hand, wrist, or forearm when installed, together with the metacarpal section, the intermediate section, and / or the forearm section, with the bands extending at least partially over the back of the hand, the wrist, and the forearm, respectively. For example, the orthosis may have first, second, and third fasteners (e.g., bands) that extend at least partially over the back of the hand, the wrist, and the forearm, respectively. The first, second, and third fasteners (e.g., bands) may be fixable within the attachment points of the metacarpal section, the metacarpal section and the intermediate section, and the forearm section, respectively.

[0054] The fastener may have one or more first fixing sections, which are positioned and configured such that, when the orthosis is installed, the fixing sections can be positioned and securely fastened on the metacarpal section and / or forearm section, in each case extending over the back of the hand, wrist, and / or forearm, and forming at least part of a section of the orthosis that, together with the metacarpal section and forearm section of the rigid body, respectively, encircles the hand and forearm. Thus, the orthosis can be easily and reliably held or securely fastened on the hand and / or forearm by the first fixing section or a plurality of first fixing sections, either by itself or together with further sections of the fastener. The fastener may also have one or more first fixing sections, which are positioned and configured such that, when the orthosis is installed, the fixing sections can be positioned and securely fastened on the metacarpal section, the intermediate section, and / or forearm section, such that in each case the fixing section extends over the back of the hand, the wrist, and / or forearm, and together with the metacarpal section, the intermediate section, and the forearm section of the rigid body, they form at least part of a section of the orthosis that encircles the hand, wrist, and / or forearm.

[0055] The fastener or at least the first fixing section or at least one of the first fixing sections may be provided as a separate component that can be completely detached from the metacarpal section and the forearm section or the rest of the orthosis and reattached to them for fixing purposes, or as a component permanently fixed to the aforementioned sections. In the latter case, in particular, the relevant first fixing section may be provided as one that is permanently fixed at one point in each case, positioned to extend over the back of the hand or forearm, and then releasably fixed at another point for secure fixation.

[0056] This type of first fixation section may be formed in a preferred manner, for example, by each flexible and / or elastic band. For a releaseable connection to a metacarpal section or forearm section, the band may have touch-and-close elements that can interact in each case with different touch-and-close elements appropriately positioned on the band itself or on the metacarpal section or forearm section or on another part of the orthosis. In this regard, one or more openings may be provided on the first end or the section connected to the latter, which can guide one or more of the bands in each case. After passing, each band may be fixed to itself, for example, using the touch-and-close elements described above, and thus create a loop portion that passes through one of the openings in each case.

[0057] The first fixing section of a fastener connected to the metacarpal section may, for example, be connected to the thumb-holding section of the metacarpal section. Alternatively, they may be connected to the ulnar section. One fastener preferably extends over the back of the hand and connects the area of ​​the thumb-holding section distal to the base of the thumb to the ulnar section. An alternative or additional fastener preferably extends over the back of the hand and connects the area of ​​the thumb-holding section proximal to the base of the thumb to the ulnar section. An alternative or additional fastener preferably extends over the back of the hand and wrist, thereby connecting the area of ​​the ulnar section to the intermediate section. An alternative or additional fastener preferably extends over the forearm on the side opposite to the side of the forearm where the rigid body is positioned and connects one end of the forearm section to the other end of the forearm section. Thus, the latter fastener surrounds the forearm together with the forearm section of the rigid body.

[0058] Attachment sites for attaching a first fastener, such as a band, to the rigid body may be located within the thumb-holding section area distal to the base of the thumb and within the ulnar section. Attachment sites for attaching a second fastener, such as a band, to the rigid body may be located within the thumb-holding section area proximal to the base of the thumb and within the ulnar section. Alternatively, attachment sites for attaching a second fastener, such as a band, to the rigid body may be located within the thumb-holding section area proximal to the base of the thumb and within the intermediate area. Attachment sites for attaching a third fastener, such as a band, to the rigid body may be located at both ends of the forearm section. The orthosis of the present invention can preferably be used for the treatment or prevention of injuries or painful conditions of the human wrist. The injury or condition may be acute or chronic. Treatment may include wearing the orthosis for one, two, three weeks, or longer. Furthermore, treatment may include examination and / or surgery of the affected wrist when the brace is fitted to the hand, wrist, and forearm of the wrist.

[0059] In a second aspect, the present invention relates to a method for manufacturing an orthotic device according to the present invention, i.e., an orthotic device as described herein. Any of the processes and materials described herein may be used in the manufacture of an orthotic device by a method selected from the group consisting particularly of two-component (plastic) injection molding, multi-component plastic injection molding, metal core overmolding or general plastic overmolding, and metal mesh overmolding. In a preferred embodiment, the method includes metal core overmolding.

[0060] In a third aspect, the present invention relates to a method for treating or preventing a human wrist injury or painful condition of the human wrist, comprising performing the fitting of the orthosis of the present invention. The injury may be acute or chronic. Treatment may include wearing the orthosis for a period of one, two, three weeks, or longer. Furthermore, treatment may include examination and / or surgery of the affected wrist when the orthosis is fitted to the hand, wrist, and forearm of the wrist. Preferably, the orthosis does not cover the entire dorsal and ventral sides of the wrist, and as a result, no further stress or pressure is applied by the orthosis to a potential wound or surgical site.

[0061] Exemplary embodiments of the present invention are schematically shown in the drawings. [Brief explanation of the drawing]

[0062] [Figure 1] A schematic diagram of the dorsal side of the orthotic device according to the present invention is shown. [Figure 2] Figure 1 shows a schematic diagram of the ventral and palmar views of the orthosis. [Figure 3] A schematic perspective view of the orthotic device shown in Figure 1 is provided. [Figure 4] A schematic second perspective view of the orthotic device shown in Figure 1 is provided. [Figure 5] Figure 1 shows a schematic cross-section of the intermediate section of the orthosis. [Figure 6] A schematic diagram of the dorsal view of another embodiment of the orthotic device according to the present invention is shown. [Figure 7] Figure 6 shows a schematic diagram of the ventral and palmar views of the orthosis. [Figure 8] A schematic perspective view of the orthotic device is shown in Figure 6. [Figure 9] A schematic second perspective view of the orthosis shown in Figure 6 is provided. [Figure 10] A schematic third perspective view of the orthosis shown in Figure 6 is provided. [Figure 11] A schematic diagram of the medial and ulnar sides of the orthosis shown in Figure 6. [Figure 12] A ventral / palmar view of another embodiment of the orthotic device of the present invention, which includes fasteners, is shown. [Figure 13] Figure 12 shows a perspective view of the orthotic device. [Figure 14] Figure 12 shows a dorsal view of the orthosis. [Figure 15] A ventral / palmar view of another embodiment of the orthotic device of the present invention, which includes fasteners, is shown. [Figure 16] Figure 15 shows a perspective view of the orthotic device. [Figure 17] Figure 15 shows a dorsal view of the orthosis. [Figure 18] Figure 15 shows a second perspective view of the orthotic device. [Figure 19] Figure 15 shows a third perspective view of the orthotic device. [Figure 20] Figure 15 shows a dorsal view of the orthosis when applied to the human forearm, wrist, and hand. [Figure 21] Figure 15 shows a perspective view of the orthosis when applied to the human forearm, wrist, and hand. [Modes for carrying out the invention]

[0063] These and other aspects of the present invention will become apparent and clarified by reference to the embodiments described below.

[0064] Further advantages, characteristics, and features of the present invention will become apparent from the following detailed description of exemplary embodiments with reference to the accompanying drawings. However, the present invention is not limited to these embodiments.

[0065] Figures 1 to 4 and 6 to 11 schematically illustrate two different embodiments of the orthosis 10 of the present invention, comprising a rigid body 12. In fact, as shown in these figures, the orthosis 10 consists of a rigid body 12. The orthosis 10 does not include fasteners 34, 36, 38, but these can be added to the respective mounting sites 40, 42, 44, 46, 48, 50 for fasteners, as shown in Figures 12 to 14 and 15 to 19, respectively.

[0066] Figures 1 and 6 schematically show the dorsal view, Figures 2 and 7 show the ventral / palmar view, and Figures 3 and 4, as well as Figures 8, 9, and 10, show different perspective views of the orthosis 10. Figure 11 shows the ulnar and medial views of the orthosis 10. The orthosis 10 includes a metacarpal section 18 suitable for fitting to the patient's hand, particularly the metacarpal region of the hand, specifically the palmar and metacarpal (ulnar and radial) regions. The metacarpal section 18 consists of a thumb-holding section 20, a palmar section 22, and an ulnar section 24.

[0067] The thumb-holding section 20 is ring-shaped and has an opening 30 in the center of the ring through which the wearer's thumb can pass. It can be seen that the thumb-holding section 20 in the embodiment shown in Figure 6 extends further back on the hand than the thumb-holding section 20 in the embodiment shown in Figure 1. The distance between the thumb-holding section 20 and the ulnar section 24 in the embodiment shown in Figure 6 is shorter than that in the embodiment shown in Figure 1 when measured on the dorsal side of the orthosis 10. The distance between the thumb-holding section 20 and the ulnar section 24 on the dorsal side of the orthosis 10 is less than or equal to one-third of the width of the orthosis at the metacarpal section 18 when measured perpendicular to the longitudinal axis of the orthosis 10.

[0068] The palmar section 22 is designed to lie on the surface of the hand within the palmar area. The palmar section 22 has a narrow and elongated shape that does not hinder the movement of individual fingers. Furthermore, as shown in Figure 10, the palmar section 22 may have a concave shape that curves inward toward the inside of the orthosis, i.e., inward toward the palm when the orthosis is properly fitted.

[0069] The metacarpal section 18 is adjacent to the palmar section 22 and includes an ulnar section 24 designed to enclose the area of ​​the fifth bone in the metacarpal region from the ventral to the dorsal side of the hand. The ulnar section 24 includes an opening 31 that makes the orthosis 10 lighter and easier to access the skin surface.

[0070] In these embodiments, the orthosis 10 further comprises an elongated intermediate section 26 having approximately the same length as the metacarpal section 18 and the forearm section 28. The intermediate section 26 is narrower in the circumferential direction than the other two sections of the orthosis 10 and is designed to extend along the radial side of the wrist and forearm. The intermediate section 26 mainly covers the radial side but is slightly curved to extend slightly to the ventral and dorsal sides of the wrist and arm. It can be seen that less than 25% of the ventral and dorsal areas are covered by the ulnar section 24.

[0071] The orthosis 10 includes a forearm section 28 that is adjacent to the intermediate section 26 and is configured to extend around a wider area of ​​the forearm than the intermediate section 26. Nevertheless, the forearm section 28 also covers and supports the forearm from the radial side. The forearm section 28 includes an opening 32 that makes the orthosis 10 lighter and more accessible to the skin surface.

[0072] The orthosis 10 comprises a rigid body 12, specifically the exoskeleton of the rigid body 12, with six attachment points 40, 42, 44, 46, 48, and 50 having substantially rectangular holes. Fasteners (not shown) are inserted through these attachment points 40, 42, 44, 46, 48, and 50 and can be used to attach the orthosis 10 to the wearer's hand, wrist, and forearm. For exemplary embodiments with fasteners, please refer to Figures 12 to 14 and Figures 15 to 19.

[0073] Figure 5 schematically shows a cross-section of the intermediate section 26 of the orthosis shown in Figures 1 to 4. It can be seen that the rigid body 12 within the intermediate section 26 consists of an exoskeleton 14 and a core 16 surrounded by the exoskeleton 14. The core 16 is made of an aluminum alloy metal and is ductile. The exoskeleton 14 is overmolded onto the core 16 and is made of thermoplastic polyurethane (TPU). Embodiments shown in Figures 6 to 19 have the same structure of the exoskeleton 14 and core 16 (not shown).

[0074] Figures 12 to 14 and 15 to 19 schematically illustrate other embodiments of the orthosis 10 of the present invention, comprising a rigid body 12 and fasteners 34, 36, and 38. Figures 12 and 15 show ventral / palmar views of the orthosis 10, Figures 13 and 16, 18, and 19 show perspective views of the orthosis 10, and Figures 14 and 17 show dorsal views of the orthosis 10. The rigid body 12 of the orthosis 10 is substantially identical to the rigid body 12 shown in Figures 1 to 4 and Figures 6 to 11, respectively. Therefore, the descriptions of Figures 1 to 4 and Figures 6 to 11, respectively, also apply to Figures 12 to 14 and Figures 15 to 19, respectively.

[0075] Furthermore, the orthosis 10 in Figures 12 to 14 and Figures 15 to 19 comprises fasteners 34, 36, and 38 having an elongated strap shape. One end region of each fastener 34, 36, and 38 is fixed to attachment sites 44, 48, and 50, respectively. The fasteners 34, 36, and 38 are polyamide straps. The end regions are welded to form loops, thereby fixing the fasteners 34, 36, and 38 to the first attachment sites 44, 48, and 50. The straps can be passed through the opposite second attachment sites 40, 46, and 42, respectively, and then returned towards the first attachment sites 44, 48, and 50. The fasteners 34, 36, and 38 are closed with a Velcro® hook-and-loop fastening system. The first fastener 34 can be fixed between attachment sites 40, 44 in the ulnar section 24 and the thumb-retaining section 20. The second fastener 36 can be fixed between attachment points 46, 48 in the ulnar section 24 and the thumb-holding section 20 (Figures 12 to 14), or between attachment points 46, 48 in the ulnar section 24 and the intermediate section 26 (Figures 15 to 19). The third fastener 38 can be fixed between attachment points 42, 50 on both ends of the forearm section 28.

[0076] Figures 20 and 21 show dorsal and perspective views, respectively, of the orthosis 10 of Figure 15 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., movement of the thumb 58 is not prevented by the orthosis 10. At the same time, the orthosis 10 can stabilize the wrist 54 in an angled position. The wrist 54 is substantially fixed, i.e., movement of the wrist in any direction is prevented. Figures 20 and 21 show only the orthosis 10 consisting of a rigid body 12, but of course fasteners 34, 36, and 38 can be attached to the rigid body 12 at attachment points 40, 42, 44, 46, 48, and 50 to securely fasten the orthosis 10.

[0077] While the present invention has been described in detail with reference to exemplary embodiments, it will be apparent to those skilled in the art that the present invention is not limited to these exemplary embodiments, and rather, modifications can be made so as not to exceed the scope of protection of the appended claims, that individual features may be omitted or other combinations of the individual features presented may be realized. This disclosure includes all possible combinations of the individual features presented. [Explanation of Symbols]

[0078] 10 Orthotic devices 12 Hard body 14 Exoskeleton 16 cores 18 Metacarpal Sections 20 Thumb holding section 22 Palmar Section 24 Ulnar section 26. Intermediate Section 28 Forearm Section 30 openings 31 Opening 32 openings 34 Fasteners 36 Fasteners 38 Fasteners 40 Mounting location 42 Mounting location 44 Mounting location 46 Mounting location 48 Mounting location 50 Mounting location 52 moves 54 Wrist 56 Forearm 58 Thumb

Claims

1. A brace (10) configured to be worn on the forearm and hand of a person to fix the wrist joint, It comprises a rigid body (12) having an exoskeleton (14) surrounding an elongated core (16), The exoskeleton (14) contains or is made of a thermoplastic material. The aforementioned rigid body (12) (i) Metacarpal section (18), a. A ring-shaped or ring-segment-shaped thumb-holding section (20) configured to receive the thumb of the human hand, b. A palmar section (22) configured to engage with the palm of the human hand, c. The ulnar section (24) is configured to enclose the human hand from the palm side to the dorsal side, A metacarpal section (18) having, (ii) an elongated intermediate section (26) configured to engage with the medial or lateral aspect of the human forearm and optionally the medial or lateral aspect of the wrist, (iii) A forearm section (28) configured to wrap around the human forearm from the ventral side to the dorsal side, Equipped with, The combined length of the elongated intermediate section (26) and the forearm section (28) extends over 70% or more of the wearer's forearm. The orthosis (10) is configured such that the elongated intermediate section (26) is positioned on either the inner or outer side of the forearm and wrist, and the other side of the forearm and wrist is not covered by any part of the rigid body (12).

2. The orthotic device (10) according to claim 1, wherein the core (16) is reversibly plastically deformable.

3. The orthotic device (10) according to claim 1 or 2, wherein the rigid body (12) comprises an exoskeleton (14) and a core (16).

4. The orthosis (10) according to any one of claims 1 to 3, wherein the intermediate section (26) has a length of 100% or more of the length of the metacarpal section (18) when measured parallel to the longitudinal axis of the orthosis (10).

5. The orthosis (10) according to any one of claims 1 to 4, wherein the intermediate section (26) has a length of 125% or more of the length of the forearm section (28) when measured parallel to the longitudinal axis of the orthosis (10).

6. The orthosis (10) according to any one of claims 1 to 5, wherein the exoskeleton (14) is continuous from the ulnar section (24), the palmar section (22), the thumb-holding section (20), the elongated intermediate section (26) to the forearm section (28).

7. The orthosis (10) according to any one of claims 1 to 6, wherein the intermediate section (26) is configured to cover 50% or less of the outer circumference of each of the human wrist and / or forearm.

8. The orthosis (10) according to any one of claims 1 to 7, wherein the forearm section (28) is configured to cover 25% to 90% of the outer circumference of the human forearm.

9. The orthosis (10) according to any one of claims 1 to 8, wherein the metacarpal section (18) and / or the forearm section (28) are provided with openings (30, 31, 32).

10. The orthotic device (10) according to any one of claims 1 to 9, wherein the ulnar section (24) has an opening (31) on the ulnar side of the orthotic device (10).

11. The orthotic device (10) according to any one of claims 1 to 10, wherein the core (16) is made of one or more metals or metal alloys and / or thermoplastic materials, or comprises one or more metals or metal alloys and / or thermoplastic materials.

12. The orthotic device (10) according to claim 11, wherein the metal or metal alloy is selected from the group consisting of aluminum, iron, aluminum alloys, and iron alloys.

13. The orthotic device (10) according to any one of claims 1 to 12, wherein the exoskeleton (14) comprises or consists of thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), thermoplastic rubber (TPR), silicone, and mixtures thereof.

14. The orthosis (10) according to any one of claims 1 to 13, wherein the core (16) extends from the metacarpal section (18) through the intermediate section (26) into the forearm section (28).

15. The orthotic device (10) according to any one of claims 1 to 14, further comprising one or more fasteners (34, 36, 38) for securing the orthotic device (10) to the human hand.

16. The orthosis (10) according to claim 15, wherein one or two of the fasteners are attached to the metacarpal section (18) and / or one of the fasteners is attached to the forearm section (28).

17. A brace (10) according to any one of claims 1 to 16, for use in treating or preventing injuries to the human wrist or painful conditions of the human wrist.

18. A method for manufacturing an orthotic device (10) according to any one of claims 1 to 17, using a method selected from the group consisting of two-component injection molding, multi-component plastic injection molding, metal core overmolding or general plastic overmolding, and metal mesh overmolding.

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