WO2026013032A1 - Hand orthosis - Google Patents

Abstract

The invention relates to a hand orthosis having a hand liner (100) with a thumb receiving portion (110) which, when the liner is worn, surrounds the proximal phalanx of the thumb and the thumb saddle joint; wherein the hand liner (100) has metacarpal regions (120, 130) which, when the liner is worn, at least partially cover the metacarpus on both the dorsal and palmar sides of the hand; wherein the hand liner (100) has an opening (140) and is designed so that it can be opened up, and wherein a dimensionally stable main body (10) is positioned on the outside of the hand liner (100).

Description

Hand orthosis

The invention relates to a hand orthosis with a hand liner having a thumb receptacle which, when applied, encompasses the proximal phalanx of the thumb and the carpometacarpal joint of the thumb, wherein the hand liner, when applied, has metacarpal areas that at least partially cover the dorsal and palmar aspects of the metacarpals. The hand orthosis is, in particular, designed as a modular hand orthosis and allows the configuration of complex hand orthosis systems.

Patients with pathologically increased muscle tone, for example due to a stroke or other damage to the central and/or peripheral nervous system, may suffer from impairments in hand motor skills. The fingers may not be able to achieve their full range of motion due to the damage; for example, there is the so-called swan neck deformity, in which full extension of the fingers is not possible and flexion is restricted. The thumb may also be restricted in terms of its position and positional mobility relative to the other fingers.

Furthermore, people affected by a stroke or, for example, plexus palsy are often unable to move the hand on the affected side purposefully; in most cases, grasping and holding objects is difficult. This has various causes depending on the specific condition. In cases of pathologically increased muscle tone, the fingers of the affected hand are, in most cases but not exclusively, forced into a flexed position from which patients are unable to open the hand, or can only do so with the support of the healthy hand or with the assistance of someone nearby. In plexus palsy, there is an avulsion and/or damage to the nerves that supply the brachial plexus. protrude from the cervical vertebrae, leading to an inability or impairment of voluntary control of the fingers of the affected hand.

From WO 2022/043843 A1, a hand orthosis in the form of an exoskeleton is known, comprising a support that can be attached to the wrist or hand and has a section that can be positioned near a metacarpophalangeal (MCP) joint. An elongated motion unit is attached to the support and has a plurality of adjacent, movable links positioned along a longitudinal axis. A compliant layer extends through the motion unit along its longitudinal axis, as does a first cable located within a first recess and connected to the motion unit. A second cable is arranged within a second recess and connected to the motion unit. At least one finger receptacle for holding two fingers is attached to the motion unit. Movement of the two cables produces a corresponding extension or flexion.

US Patent 2020/0375687 A1 discloses a supportive exoskeleton comprising a glove and a platform positioned radially adjacent to the index finger via a fastening strip in the region of the metacarpophalangeal joint. A three-segment splint is articulated to the platform. The individual segments are coupled to each other by means of struts such that flexion of the metacarpophalangeal joint results in flexion of the medial and distal interphalangeal joints. A tab for securing the finger is located on the distal segment. A corresponding design is provided for the thumb. Actuators for motorized repositioning of the splints are located on both the platform and the thumb.

Hard-shell hand orthoses are difficult to adjust to the individual hand. The thumb socket and the flat base of the orthosis form a rigid unit, making it difficult to put on. Soft, glove-like orthoses are of limited use for patients with increased muscle tone, especially when the hand is flexed due to pathologically increased muscle tone or in cases of... Limited motor skills due to plexus paresis make application difficult.

German patent DE 202023 107 556 U1 relates to an elastically deformable correction and/or stabilization strip for immobilizing, relieving, and/or correcting a human thumb at the base or carpometacarpal joint. The strip comprises a loop section that rests against the inner side of the thumb and/or at least partially encircles the thumb, extending from the inner side of the thumb below the base joint. Two strip ends or sections are attached to the loop section, with a shorter section extending into or ending at the base joint. A longer section continues to the wrist, wraps around the wrist at least partially, and rests against the inner side of the wrist or the forearm under tension, thus holding the thumb in a relieved and/or corrected position. The stabilization strip is inherently stable and is under tension when applied.

The object of the present invention is to provide a hand orthosis that is adaptable to the respective impairment and easy to apply.

This problem is solved by a hand orthosis with the features of the main claim. Advantageous embodiments and further developments of the invention are disclosed in the dependent claims, the description, and the figures.

The hand orthosis with a hand liner featuring a thumb receptacle that, when applied, encompasses the proximal phalanx of the thumb and the carpometacarpal joint of the thumb, and wherein the hand liner, when applied, has metacarpal areas that at least partially cover the dorsal and palmar surfaces of the hand, is characterized in that the hand liner has an opening and is designed to be hinged, and that at least one dimensionally stable base body is arranged on the outside of the hand liner. The hand liner, which may also be multi-part, with the individual parts being attached to one another or permanently fixed to one another, is advantageously made of a flexible material to adapt individually to the hand's shape. The shape of the hand can be adjusted to fit the individual hand. The thumb holder fixes the thumb in a predetermined position or at least ensures that the thumb is held in a preferred position or that movement from the preferred position to another position is resisted. This achieves at least a semi-stable fixation of the thumb in the desired position, for example, in an opposition position. If, for example, the thumb holder is designed as a separate component of the hand orthosis, it is manufactured independently and connected to the rest of the flexible hand liner. The connection can be made using hook-and-loop fasteners, clips, plug-in connections, magnetic connections, or similar methods. A modular design has the advantage that the individual components of the hand liner can be applied sequentially. The thumb holder can first be applied over the thumb, the carpometacarpal joint, and the proximal phalanx. The rest of the hand liner is then connected to the metacarpal sections, which at least partially cover the metacarpals dorsally and palmarly. The connection is advantageously made with fasteners that allow for repeated detachment.

The hand liner as a whole has an opening that allows it to be unfolded. Advantageously, this opening extends across the entire proximal-distal dimension of the hand liner. For example, the opening is located dorsally or ulnarly from the carpal bones to the metacarpophalangeal joints, allowing the hand liner to be unfolded in the dorsal metacarpal region. If the opening is located on the outer edge of the hand or ulnarly, unfolding or bending the hand liner allows the two metacarpal sections to be folded away from each other. Increasing the distance between the metacarpal sections makes it easier to apply the hand liner, particularly to insert the thumb into the thumb pocket and then position the metacarpal sections over the respective areas of the hand. To stabilize the hand orthosis, at least one dimensionally stable base is arranged on the outside of the hand liner. This base increases the structural rigidity of the hand orthosis and can limit or prevent deformation or displacement of the individual hand components relative to each other. The natural hand is a complex structure with a multitude of degrees of freedom, the mobility of which in relation to each other is particularly important. This must also be taken into account when applying a hand orthosis. Individual areas of the natural hand influence each other's mobility and function, so a modular orthosis design offers advantages in terms of ease of application. The rigid base alone, even with some residual hand function, can provide sufficient support for the patient. The rigid base, which has greater stiffness than the hand liner, at least in the metacarpal areas, is designed, for example, as a brace or plate that rests against the outer surface of the metacarpal area. In one configuration, the base(s) are attached to the hand liner by positive locking, friction locking, and/or force locking. In another configuration, they also feature positive locking, friction locking, and/or force locking fastening elements on their outer surface for additional components of the hand orthosis.

As an alternative to the previously described ulnar or dorsal positioning of the opening, it can also be radial, resulting in a widening in the radial orthosis area or in the thumb area. The hand is then inserted ulnarly into a connecting area between the metacarpal sections, and the radial opening is closed by placing the metacarpal sections, which are permanently or detachably connected to the thumb socket, together or overlapping. Regardless of where the opening is located in the hand liner, which facilitates or enables hand insertion, the metacarpal sections are attached to the thumb socket, or, in the case of a split thumb socket, the thumb socket components are attached to the metacarpal sections. The attachment can be detachable, particularly repeatedly detachable, without damaging the components, or permanent, for example, through appropriate joining or bonding techniques. Alternatively, the thumb socket is formed as a single unit with the metacarpal sections. The flexible and/or multi-part design of the hand liner facilitates the donning process, which can be difficult for patients with strokes or brachial plexus palsy.

The base body features attachment points for at least one functional module, allowing the hand orthosis to be easily adapted to the user's individual needs. These attachment points make it possible to position the functional modules as desired. to be arranged on the base body or base bodies. The fastening points are designed, for example, as elongated holes, bores, projections, recesses, hook-and-loop fasteners, magnets, or the like, in order to allow the functional module(s) to be variably attached to the base body. The attachment is preferably reversible, without having to destroy the individual components. This is achieved, for example, via hook-and-loop fasteners, clip fasteners, screws, hooks, or other positive-locking, force-locking, and/or friction-locking connections of the respective functional module to the base body.

In one embodiment, the base body is arranged as a planar, dimensionally stable component on the outside of the liner, for example dorsally, palmarly, or both dorsally and palmarly, with a connecting area that is advantageously ulnar in design, but in another embodiment can also be radial, for example, between the thumb and index finger. Several base bodies can also be arranged dorsally and/or palmarly and coupled to each other via the hand liner.

In one embodiment, a closure is arranged in the opening area at the metacarpal sections, allowing the opening to be closed so that the hand liner can be applied and advantageously completely encircle the metacarpals. In another variant, the metacarpal sections are designed to overlap each other when applied. These overlapping metacarpal sections can be equipped with closure devices, such as hook-and-loop fasteners, snaps, buckles, tabs, magnets, or similar, and/or adhesive surfaces that reinforce or maintain the overlapping of the sections.

In one embodiment, the base body is designed such that, when applied, it covers the opening, so that the combination of the base body and hand liner results in a completely closed, glove-like liner with dimensionally stable areas. The closure can also be achieved by the base body itself. For example, the base body can be attached to corresponding hook-and-loop fastener components on opposite sides via a hook-and-loop fastener. The hand liner is closed off by the overlapping areas of the midhand. This results in a modular hand orthosis that completely surrounds the hand, at least in the midhand area.

The base body also includes a closure in one embodiment, particularly if it is designed in a clamp-like or ring-like manner with an open cross-section, so that greater stability for the base body can be provided by the closure.

In one embodiment, the hand liner includes at least one reinforcement, insert, or sleeve for stabilizing the thumb's metacarpophalangeal joint when worn, and/or a fastening element. The insert, sleeve, or similar reinforcement improves gripping function by providing a more stable support for the other fingers. The reinforcement, in the desired shape, allows for adjustment of the thumb's position relative to the rest of the hand. The reinforcement can be attached to or integrated into the hand liner. The reinforcement can be replaceable, just as the base body can be replaceable and detachable. For this purpose, the corresponding fastening elements are designed for force-fit, form-fit, and/or friction-fit attachment to the hand liner and the reinforcement. The fastening element(s), if several are arranged on the hand liner, serve in particular to secure the dimensionally stable base body and other components or functional modules of the hand orthosis, such as supports, covers, actuator mounts, power transmission components, or deflection devices.

Preferably, the thumb grip is held fixed in the opposition position, which increases reliability during gripping movements.

In one embodiment, the thumb receptacle is designed to be flexible or adjustable, for example via a solid body joint, a recess or the like, in order to allow flexibility or adjustability of the thumb receptacle relative to the rest of the hand. The base body is manufactured in one configuration from a fiber-reinforced plastic or is produced using an additive manufacturing process; optionally, fiber-reinforced plastics are also processed in the additive manufacturing process. Additive manufacturing processes are particularly well suited for the production of customized components based on previously obtained data or models. The data can be acquired, for example, non-contact or contact-based, using appropriate optical or tactile measuring machines.

The thumb socket is designed to be rigid in flexion, although a certain degree of flexibility is both unavoidable and intended in hand orthoses due to the usual manufacturing processes, materials used, and material thicknesses. To achieve and adjust flexibility in specific areas of the thumb socket, recesses are provided dorsally and/or palmarly in a joint area of the thumb socket, either as an alternative or supplement.

In one version, the handliner is molded from a model or a natural hand, or it is individually manufactured using an additive manufacturing process based on a scan. The model itself can be a plaster cast or produced using an additive manufacturing process; the scan can also be made from the model. In one design, the handliner has proximal and distal sections that extend beyond the metacarpal area, respectively. With a proximal extension, the handliner stretches across the metacarpal area into the wrist region and, if necessary, into the forearm. With a distal extension, the metacarpophalangeal joints of the fingers with three phalanges—index, middle, ring, and little fingers—are at least partially covered. One design initially incorporates a finger with three phalanges completely within the handliner, for example, to attach functional modules to the corresponding finger and position a handliner between the finger and the functional module.

In one embodiment, the base body features fastening elements for attaching a forearm splint and/or a functional module. The functional module can influence finger movement, for example, guiding, braking, activating, or modulating finger movements via actuators. and/or block. The position of the midhand relative to the forearm splint and forearm can be influenced and guided via a forearm splint. In one embodiment, the forearm splint has at least one joint that is coupled or can be coupled to actuators or passive resistance devices and/or locking elements to enable, control, influence, or prevent displacement of the hand relative to the forearm. The fastening elements can be, for example, slots, hooks, projections, recesses, positive locking elements, and the like, arranged dorsally, medially, and/or ulnarly. This provides a variety of fastening options for different components to the base body.

At least one functional module is detachably attached to the base body in a specific configuration, allowing different functional modules with varying properties and movement control capabilities to be attached to the hand orthosis's base body as needed. In particular, attachment via fastening elements simplifies the application process. First, the at least partially flexible hand liner is placed over the thumb and part of the metacarpal and, if necessary, fastened. Then, the base body, made of a rigid, particularly dimensionally stable material, is attached to the outside of the hand liner and secured to it. This securing is achieved, for example, using positive locking elements, force-locking elements, and/or friction-locking elements, or a combination of one or more of these elements. Finally, the corresponding functional modules, such as powered finger supports, are attached to the base body of the hand orthosis, thus completing the modular hand orthosis.

The functional modules may include actuators and/or coupling devices with finger grips and/or a thumb holder, or be connected to such an actuator. The actuators may be motor drives, manual drives, or energy storage devices. Resistance devices against displacement are also considered actuators within the meaning of this application. The handliner is designed in a flexible and/or elastic material or has elastic material sections, particularly in the area of the metacarpals, to ensure easy adaptability to the patient's natural hand.

Exemplary embodiments of the invention are explained in more detail below with reference to the figures. Reference numerals denote identical components. For clarity, not all reference numerals are shown in all figures. The figures show:

Figure 1 - a hand orthosis in a perspective view;

Figure 2 - a variant of a hand orthosis with attached base body;

Figure 3 - a detailed view of the hand orthosis according to Figure 2;

Figure 4 - two views of a hand orthosis according to Figures 2 and 3 during and after the application of the base body;

Figure 5 - a variant of the hand orthosis according to Figure 2;

Figure 6 - a schematic representation of the dressing process;

Figure 7 - a flowchart of the connection process when attaching a functional module to the base body;

Figure 8 - Variants of a handliner with different openings;

Figure 9 - Variants of a handliner with different base bodies and fastening elements;

Figure 10 - Variants of a handliner;

Figure 11 - a bottom view of a hand orthosis with functional elements;

Figure 12 - a flowchart of the process of creating a functional element; Figure 13 - a hand orthosis with functional element and forearm splint;

Figure 14 - the hand orthosis according to Figure 13 in a different view;

Figures 15 to 18 - a variant of the hand orthosis;

Figure 19 - a variant of the handliner;

Figure 20 - a variant of Figure 19

Figure 21 - a variant of the hand orthosis with fastening element;

Figure 22 - a handliner made using an additive manufacturing process;

Figure 23 - a variant of Figure 22;

Figure 24 - a variant with a handliner and fastening elements;

Figure 25 - a hand orthosis with a partially attached functional module;

Figure 26 - a hand orthosis with a fully attached functional module;

Figure 27 - a variant of Figure 24; as well as

Figure 28 - a variant of Figure 27.

Figure 1 shows a perspective view of a hand orthosis with a hand liner 100 made of a flexible material. The flexible material can be elastic or stretchable; alternatively or additionally, elastic and/or stretchable material sections are formed or incorporated into the hand liner 100. The hand liner 100 can be made of multiple parts; in the illustrated embodiment, the hand liner 100 is made of a single piece and has a thumb receptacle 110 that completely surrounds the base of the thumb and the proximal phalanx when the orthosis is in place. In this embodiment The thumb is completely enclosed by the thumb recess 110 of the hand liner. The hand liner 100 is thus designed as a flexible glove in the thumb area, with a metacarpal area extending from the thumb recess 110 towards the edge of the hand or in an ulnar direction. The dorsal metacarpal area 120 is visible, while a palmar metacarpal area 130 is only indicated. The metacarpal areas 120 and 130 extend proximally to approximately the carpus (wrist) and distally not over the entire length of the fingers, but only to just beyond the respective metacarpophalangeal joints of the four three-phalangeal fingers.

On the outer surface of the hand liner 100, a base body 10 made of a dimensionally stable, essentially planar material is arranged. In the illustrated embodiment, the base body 10 is designed as a brace and extends from the metacarpal bone of the index finger ulnarly across the dorsal side to the metacarpal bone on the palmar side. A space is formed in the dorsal base body section 12 and the palmar base body section 13. Due to its dimensional stability, the base body 10, as a brace, can be bent open in the area of the ulnar connection. Not shown is an opening in the hand liner 100, which is formed in the area of the edge of the hand or ulnar side and extends over the entire proximal-distal length of the metacarpal regions 120, 130. To apply the hand orthosis, the hand liner 100 is first applied. The thumb is inserted into the thumb recess 110, and the proximal metacarpal section 120 is placed over the back of the hand, while the palmar metacarpal section 130 is positioned on the palm side. A connecting element or closure can be arranged or formed at the junction between the two metacarpal sections 120 and 130 to keep them in position. The clip-like base body 10 is then slid over the hand liner 100. If necessary, the base body 10 is bent open to facilitate application, so that the dorsal base body section 12 is bent away from the palmar base body section 13. Once correctly positioned, the base body 10 returns to its original position due to its elastic design or shape stability and rests against the outside of the hand liner 100. This flexibility, and preferably individual adjustment, makes the hand liner significantly easier for users to apply. as a complete hand orthosis. At the same time, after application, it ensures a pre-positioning of the hand and fingers, which facilitates the further application of the main body and any additional functional elements and finger attachments.

Fastening elements such as hook-and-loop fasteners or adhesive surfaces can be arranged on the outer surface of the handliner 100 and on the inner surface of the base body 10 facing the handliner 100 to secure the position of the base body 10 on the handliner 100. Additionally or alternatively, the free area in the radial region on the index finger side can be closed with a fastener, thus exerting an increased clamping force on the handliner 100.

In the illustrated embodiment, a functional element 20 is attached to a fastening element 17 on the dimensionally stable base body 10, which is, for example, made of a fiber-reinforced composite material and/or manufactured using an additive manufacturing process. The fastening element 17 enables a positive-locking and repeatedly releasable attachment of the functional element 20 to the base body 10. The functional element 20 is designed as a finger guide and has a coupling device 40 that guides a finger receptacle 30 in which two fingers are held. The coupling device 40 is designed as a four-link mechanism that, upon flexion about the metacarpophalangeal (MCP) joint of the finger, causes flexion about the proximal interphalangeal (PIP) joint of the finger. Other functional elements 20 can be attached to the base body 10 as needed. Fastening elements 17 can be arranged or formed at other locations on the outside of the base body 10, for example dorsally or ulnarly, in order to attach any functional elements to it for influencing the movement of the fingers.

Figure 2 shows an alternative embodiment of a hand orthosis, in which a hand liner 100 is also shown, extending distally beyond the metacarpophalangeal joints and proximally to the wrist. The base body 10, made of fiber composite material, is designed as a brace and extends with its dorsal base body section 12 from the metacarpal bone of the index finger ulnarly around the edge of the hand into the palmar region. There, an opening 140 in the hand liner 100 is covered, and the The dorsal metacarpal area 120 is connected to the palmar metacarpal area 130. The palmar metacarpal area 130 and the dorsal metacarpal area 120 can also be designed to overlap each other when applied and be held in position by the base body 10. In the area of the finger receptacle 110, an additional reinforcing element 160 is arranged, which reinforces the flexible and, if necessary, elastic hand liner 100 in this area. This ensures that the thumb metacarpophalangeal joint and the thumb carpometacarpal joint are fixed in their respective positions, particularly in an opposition grip, so that, for example, objects can be held more easily. To increase the flexibility and effectiveness of the thumb receptacle 110, recesses 112 are formed in the hand liner 100 in the joint areas. The reinforcement element 160 is manufactured separately and is either permanently arranged on the handliner 100, designed as an integral part of the handliner 100, or can be detachably fixed to the handliner 100 via appropriate fastening elements in a form-fitting, force-fitting and/or friction-fitting manner.

Figure 3 shows a detailed view of the hand orthosis according to Figure 2, in which the palmar metacarpal area 130 is shown more clearly, as are the palmar and dorsal recesses 112 in the thumb joint area. The reinforcement 160 extends to the end of the thumb and has a thumb receptacle 32 to securely hold and support the entire thumb.

Figure 4 shows two representations of the hand orthosis according to Figures 2 and 3. In the left representation, the hand liner 100 is already in place. The palmar metacarpal section 120 extends to the metacarpophalangeal joints and the wrist and is formed integrally with the thumb socket 110. A closure 150 in the form of a climbing fastener is shown in the ulnar region of the hand liner 100. This closure closes the opening 140 (not shown) in the ulnar region of the hand liner 100. The base body 10, with its palmar base body section 13 and dorsal base body section 12, is shaped to resemble the natural hand and is designed as a unilaterally open brace. The open end of the brace is slid radially over the edge of the hand to slide the base body 10 onto the hand liner 100. and to be fixed to the hand. The applied state can be seen in the right-hand illustration of Figure 4. The dorsal base body section 12 transitions ulnarly into the palmar base body section 13 and covers the ulnar opening 140. The hand orthosis thus produced from hand liner 100 and base body 10 completely surrounds the hand, at least in the metacarpal region and in the area of the proximal thumb phalanx and the thumb metacarpophalangeal joint, whereby the application is simplified due to the modular design.

Figure 5 shows a variant of the base body in its applied state. The basic structure of the orthosis corresponds to that of Figures 2 to 4. Instead of a brace-like, essentially smooth design of the base body 10, it is equipped on the dorsal side with fastening elements 17 in the form of elongated holes, reinforcements with bores and threads, slidably mounted locking devices, and receptacles for further functional elements. In addition, a closure device is provided radially, so that the opening in the radial area of the metacarpal is closed.

Figure 6 illustrates the application process of a hand orthosis from left to right. First, the thumb is inserted into the thumb receptacle 110 of the hand liner 100. Patients with increased muscle tone or plexus paresis sometimes have difficulty maintaining full control over thumb function and mobility. Therefore, it is necessary to be able to connect the individual hand components to the hand orthosis separately and sequentially. This allows the user to initially concentrate fully on attaching the thumb receptacle 110 to the thumb of the affected hand and, if necessary, extending or holding joints in their respective positions. The dorsal metacarpal section 120 is placed dorsally over the back of the hand, while the palmar metacarpal section 130 is placed along the palm. The second figure from the left shows how the dorsal metacarpal section 120 is placed over the back of the hand and how the opening 140 between the two metacarpal sections 120 and 130 closes. The middle illustration in Figure 6 shows how the orientation of the two metacarpal areas 120, 130 relative to each other is fixed in the applied state by means of a fastener 150, here also a hook and loop fastener. Thus, in the state of The fourth figure from the left shows a glove-like hand liner 100 without finger coverings, featuring three phalanges and a thumb receptacle 110 that fixes the thumb's position relative to the metacarpal areas. The hand liner 100 is essentially closed. To further complete the hand orthosis, the base body 10, as shown in Figure 4, is slid onto the hand liner 100 from ulnar to radial direction. The fully assembled hand orthosis is shown in the right-hand illustration.

Figure 7 shows the attachment of a functional element 20 to a hand orthosis or to a base body 10 according to Figure 5. A fastening element 17 in the form of a clip closure, click closure, or clamp closure is shown on the dorsal component of the base body 10. In the illustrated embodiment, the functional module 20 is a finger splint that can be used to keep the ring and middle fingers extended. For this purpose, distal finger supports 30 are formed on the functional module 20, which are connected to the proximal end of the functional module 20 via a coupling device 40. After applying the hand liner 100 and the base body 10, the functional module 20 is, for example, slid onto the patient's fingers, which are severely curved due to increased muscle tone; for this purpose, the functional module is inserted between the fingers, which are then levered open and extended. During this movement, the proximal end of the functional module 20 on the dorsal side of the base body 10 is coupled to the locking device on the fastening element 17 and fixed there in the desired position. Other functional modules can, of course, be coupled in the same or a corresponding manner.

Figure 8 shows various examples of a hand liner 100. In the left-hand illustration, the hand liner 100 is shown according to Figures 2 to 7; the opening 160, located on the ulnar or border of the hand, extends over the entire proximal-distal extent of the hand liner 100. In the second illustration from the left, the hand liner 100, in addition to the opening 140 on the ulnar border of the hand, has two distal extensions from the metacarpal region 120, so that the index and middle fingers of the affected hand are also surrounded by the distal connecting piece on the metacarpal region 120. In the third illustration from the left in Figure 8, the opening 140 is not located ulnarly, but in an area between the metacarpal bones of the little finger and the ring finger, thus rather on the dorsal side of the palmar liner. In the right-hand illustration of Figure 8, the opening is formed on the dorsal metacarpal segment 120 between the middle finger and the ring finger.

Figure 9 shows another variant of the hand orthosis with a hand liner 100 in the applied state. Instead of a single, brace-like base body, several plate-like base bodies can be attached to the hand liner 100 using fastening elements, such as hook-and-loop fasteners 170. The fastening elements 170 on the hand liner serve either to secure base bodies 10 (not shown) or to directly fix functional elements or modules to the hand liner 100. In one embodiment, a base body 10 is secured to the corresponding position on the hand liner 100 via the fastening elements 170. The base body 10 may also have fastening elements 17 on the side facing away from the hand liner 100 to secure functional modules or other components of the hand orthosis. In Figure 9, the fastening elements 170 are predominantly arranged on the dorsal midhand section 120 in the left-hand illustration; these include, for example, connecting elements for various modules, thumb reinforcements, or actuators. In the second illustration from the left, two fastening elements 170 are arranged dorsally. In the third illustration from the left, in addition to a large-area arrangement on the dorsal metacarpal region 120, a fastening element is arranged radially for fixing either a module radially to the index finger or for fixing a thumb support. In the right illustration, two fastening elements are positioned between the index and middle fingers and between the little and ring fingers in the region of the metacarpal bones.

Figure 10 shows further embodiments of the handliner O; in the left illustration, the handliner 100 extends both proximally beyond the wrist into the forearm section and distally beyond the metacarpophalangeal joints on the palmar side over the entire length of the finger, with the dorsal side of the backs of the fingers left free from the distal phalanx to the metacarpophalangeal joint.

In the central illustration of Figure 10, besides the thumb receptacle 110, which completely surrounds the thumb, there is only a distal one on the palmar side. The extension is arranged for the little finger and the ring finger, the opening 140 extends from distal to proximal from the area between the little finger and the ring finger towards the ulnar side of the wrist.

In the right-hand illustration, the distal finger extension of the handliner 100 overlaps the dorsal area of the index and ring fingers; the handliner 100 is provided with the slit-like opening 140 on the ulnar side.

Figure 11 shows a perspective bottom view of a hand orthosis with the hand liner 100, the thumb receptacle 110 which completely surrounds the thumb, and the base body 10, which is fixed to the outside of the semi-flexible hand liner 100. Radially attached to the base body 100 is the functional module 20 with the multi-jointed coupling device 40, the finger receptacles 30, and an actuator (not shown). The finger receptacle 30 secures the index and ring fingers in a clamp. Additionally, another functional module 20 is attached to the hand liner 100 for the little and middle fingers. Palmarly, a fastening element 170 in the form of a pocket or a hook-and-loop fastener is arranged for a finger stiffener, which is, for example, designed as a plate made of a dimensionally stable plastic. The plate is inserted into the fastening element, the fingers are extended and placed under a distal pocket, which is then fixed dorsally to the metacarpal segment 120 at a corresponding attachment point 170, as shown in Figure 9. This results in a modular hand orthosis with the hand liner 100, a first functional element 20 that allows movement of the index and middle fingers, and a second functional element 20 that holds the little and middle fingers in an extended position and prevents flexion around their metacarpophalangeal joints.

The assembly of such a functional module 20, as shown in Figure 11, is schematically illustrated in Figure 12. The functional module 20 is also referred to as a finger glove applicator, in which the functional module with the dimensionally stable plate is first placed on the palmar side of the index and ring fingers, and the fingers are extended. Subsequently, the proximal end of the plate is inserted into a pocket or fastening element 170 on the palmar side of the hand liner 100, and simultaneously the pocket or cap is inserted dorsally. over the index and ring fingers. In the extended position, the proximal end of the pouch, which is equipped with a Velcro fastener, is releasably locked onto the dorsal part of the palm, resulting in the position shown in the right-hand illustration of Figure 12.

Figures 13 and 14 show illustrations of a hand orthosis constructed similarly to Figures 2 to 7. Figure 14 shows this design in a perspective view from the dorsal side. Figure 13 shows that ulnar fastening elements 17 are provided for securing a forearm splint 22 with a forearm support to the base body 10. The fastening elements 17 are, for example, screws or the like, which are screwed into threads within the base body 10. Distally, several holes or an elongated hole are formed within the forearm splint 22, allowing for longitudinal adjustment. A joint is arranged within the forearm splint 22, enabling flexion and extension of the wrist. Figure 14 shows that two functional modules 20 are attached dorsally to fastening points 17 on the dorsal section of the base body 10. The two functional modules 20 have coupling devices 40 for coupling with the finger rests 30, which can also be seen in Figure 13. The functional modules 20 are each arranged between two fingers, once between the index and middle fingers and once between the little and ring fingers, so that the two pairs of fingers can be independently adjusted or fixed via the respective functional module with regard to their mobility, range of motion, and the like. Figure 14 also shows the support of the forearm splint 22 on the forearm.

Figures 15 to 18 show the components of the multi-part hand orthosis, with Figure 15 showing a detailed view of the handliner 100 with the thumb receptacle 110, the metacarpal sections extending over the palm and back of the hand, and the lateral opening 140. The handliner is made of a flexible, particularly elastic, material, such as silicone or TPU, and essentially conforms to the shape of the natural hand. In the illustrated embodiment, the handliner 100 has no fingers; the distal opening ends in the area of the metacarpophalangeal joints. Figure 16 shows... The dimensionally stable base body 10 is shown, which has a thumb support and extends over the palm and back of the hand. The base body 10 is made of, for example, a thermoset, a fiber-reinforced composite material, or another dimensionally stable material and has a hinged closure 15 on the ulnar side, which can be opened and locked to the base body 10 in a form-fitting manner. The closure 15 completely covers the slot-shaped opening 140 of the hand liner 100 when the orthosis is applied. A fastening element 17 in the form of a plateau with four upward-projecting protrusions is arranged dorsally and serves to fix, align, and/or secure other components to the base body 10. Figure 17 shows the hand orthosis applied with the hand liner 100 and the base body 10 placed over it, with the closure 15 closed over the opening 140. The thumb is held within the thumb receptacle 110 in the base body 10. Figure 18 shows the hand orthosis in its assembled state with hand liner 100 and base body 10 from a different perspective. A functional module 20 is attached to the fastening element 17, to which further components, such as finger grips or the like, can be attached.

Figure 19 shows a variant of the handliner 100 in its applied state. The closure 150 is arranged ulnarly on the handliner 100 to cover the ulnar opening, although the closure 150 does not need to cover the opening 140 over the entire length of the handliner 100. A fastening element 170 is arranged on the upper or dorsal side, which in the illustrated embodiment is designed as a magnetic form-fit element for securing other components. The fastening element 170 penetrates the material of the handliner 100 dorsally and forms a flat contact surface on the side facing the back of the hand to minimize pressure points. The fastening element 170 can extend through the base body (not shown) or serve to secure the base body to the handliner 100.

Figure 20 shows a variant of Figure 19, in which the handliner 100 is applied around the metacarpal area and fixed to the hand by means of an ulnarly arranged closure 150. The fastening element 170 is arranged dorsally in the form of a magnetic positive-locking element, which can be locked to a corresponding counterpart by frictional and/or positive locking. A plateau with four projections is arranged or formed around the positive locking element 170 to prevent twisting and/or tilting of the base body (not shown) and/or a functional element.

Figure 21 shows the orthosis in its applied state with the handliner 100 and the base body 10 made of a carbon fiber material. The fastening element 17 with the magnetic form-locking element 20 and the surrounding plateau with four projections is shown on the dorsal upper surface of the base body 10, to which further functional elements can be fixed in a rotationally secure and form-locking manner.

Figure 22 shows the flexible handliner 100, which was manufactured using an additive manufacturing process such as 3D printing, with a one-piece molded fastening element 170, which is designed similarly to the plateau of Figures 20 and 21. A receptacle for a magnetic form-locking element is formed in the center of the plateau.

Figure 23 shows the embodiment according to Figure 22 in a different representation with an inserted magnetic fastening element 170 in the receptacle centrally within the plateau.

Figure 24 shows a variant of the handliner 100 with the lateral slot or opening 140, in which two upwardly projecting fastening elements 170 are integrally formed in the area of the back of the hand. The fastening elements 170 project upwards from the handliner 100 and form a receiving space between them for a functional element 20. In the rightmost illustration, the functional element 20 is already positioned between the fastening elements 170 and locked to them. In the illustrations to the left of the handliner, it is shown once in a locked position and once in an assembled position. The functional element 20 can, for example, be designed as a click-lock and has two positive locking elements that, depending on the position of an actuating element, either project laterally beyond the edge of a housing or are retracted into it. In the left illustration of the functional element 20, the positive locking elements are extended; in the right illustration, they are located within the housing. In the left-hand illustration, the actuating element is positioned towards the housing, while in the right-hand illustration, it is positioned away from the housing. In the mounted position on the handliner 100, as shown in the far right illustration, the two positive locking elements are extended laterally and positively lock the functional module 20 to the two fastening elements 170. These fastening elements have recesses (not shown) that correspond to the positive locking elements and receive them in the locked position. This ensures secure fixation of the functional module 20 while locking all rotational and translational degrees of freedom.

Figure 25 shows a frontal view of a hand liner 100 with a base body 10 attached. The base body 10 is clamp-shaped and extends partially over the palm and back of the hand to the index finger. Fastening elements 170, in the form of positive-locking or friction-locking elements, are provided on the upper surface of the base body 10. Corresponding fastening elements of a functional module 20 engage with these elements. Figure 25 shows a partially assembled representation of the functional module 20, in which a first fastening element of the functional module has already been positively engaged with a corresponding fastening element 170 on the base body 10.

In Figure 26, the second fastening element 170 on the base body 10 is also engaged with the corresponding fastening element on the functional module 20. In the illustrated embodiment, both a positive locking and a frictional locking mechanism are used via a magnetic lock. Alternatively, only a positive locking mechanism via the fastening elements or only a frictional locking mechanism via the fastening elements 170 can be used between the base body 10 and the functional module 20. A positive locking connection can be created, for example, by hooking a first fastening element 170 into a corresponding receptacle and pivoting it, followed by positive locking via a click connection. To unlock, the click connection, which in the illustrated embodiment is located on the back of the hand, is released. The functional module 20 is pivoted and then disengaged from the second fastening element 170.

Figure 27 shows a variant of the locking mechanism for a functional module 20 on a liner 100, in which a fastening element 170 is formed on the liner 100 both ulnarly and radially. The fastening element 170 is designed as a receptacle for engaging a projection or bolt of the functional module 20. The ulnar and radial fastening elements 170 on the hand liner 100 have a forward-facing opening into which the corresponding bolts or projections of the functional module 20 are inserted. The functional module 20 is then rotated backward, engaging the third fastening element 170 on the back of the hand. This engagement can be either positive-locking and/or friction-locking, for example, via click elements, a hook-and-loop fastener, a magnet, or a combination thereof.

Figure 28 shows another variant of a functional element 20 with a handliner 170 and fastening elements 170, in which the connection between the functional element 20 and the handliner 100 is made via a sliding connection designed as a dovetail guide. The dovetail-shaped groove is formed on the back of the handliner, while the corresponding longitudinal guide on the functional element 20 is designed as a rail. To connect the functional element 20 and the liner 100, the functional module 20 is inserted into the dovetail guide from the front.

As an alternative to the illustrated embodiment with the attachment of the functional element 20 to a handliner 100, the illustrated fastening elements and locking mechanisms can also be used to secure the base body 10 to the handliner 100. ```

Claims

Patent claims 1. Hand orthosis with a hand liner (100) having a thumb receptacle (110) which, when applied, encompasses the proximal thumb phalanx and the carpometacarpal joint of the thumb, wherein the hand liner (100), when applied, has metacarpal areas (120, 130) that at least partially cover the metacarpals dorsally and palmarly, characterized in that the hand liner (100) has an opening (140) and is designed to be hinged, and that a dimensionally stable base body (10) is arranged on the outside of the hand liner (100). 2. Hand orthosis according to claim 1, characterized in that the opening (140) is arranged ulnarly, radially or dorsally. 3. Hand orthosis according to claim 1 or 2, characterized in that the metacarpal areas (120, 130) are attached to the thumb receptacle (110). 4. Hand orthosis according to one of the preceding claims, characterized in that the hand liner (100) is flexible and/or multi-part. 5. Hand orthosis according to one of the preceding claims, characterized in that attachment points (16) for at least one functional module (20) are arranged or formed on the base body (10). 6. Hand orthosis according to one of the preceding claims, characterized in that a closure (150) is arranged on the metacarpal areas (120, 130) and/or the metacarpal areas (120, 130) overlap each other. 7. Hand orthosis according to one of the preceding claims, characterized in that the base body (10) covers the opening (140). 8. Hand orthosis according to one of the preceding claims, characterized in that the base body (10) has a closure (15). 9. Hand orthosis according to one of the preceding claims, characterized in that the base body (10) is made of a fiber-reinforced plastic and/or is manufactured using an additive manufacturing process. 10. Hand orthosis according to one of the preceding claims, characterized in that the hand liner (100) has at least a reinforcement (160), insert or sleeve for stabilizing the thumb base joint in the applied state and/or a fastening element (170). 11. Hand orthosis according to one of the preceding claims, characterized in that the thumb receptacle (110) is held fixed in opposition position. 12. Hand orthosis according to one of the preceding claims, characterized in that the thumb receptacle (110) is designed to be flexion-rigid and/or has recesses (112) dorsally and/or palmarly in a joint area. 13. Hand orthosis according to one of the preceding claims, characterized in that the hand liner (100) is molded or individually manufactured after a scan using an additive manufacturing process. 14. Hand orthosis according to one of the preceding claims, characterized in that the hand liner (100) in the applied state extends proximal to the metacarpus and/or at least partially covers the metacarpophalangeal joints of the three-jointed fingers. 15. Hand orthosis according to one of the preceding claims, characterized in that the base body (10) has fastening elements (17) for fastening a forearm splint (22) and/or a functional module (20). 16. Hand orthosis according to claim 15, characterized in that the fastening elements (17) are arranged dorsally, medially and/or ulnarly. 17. Hand orthosis according to one of the preceding claims, characterized in that at least one functional module (20) is detachably fixed to the base body (10). 18. Hand orthosis according to claim 17, characterized in that the functional modules (20) have actuators (50) and/or coupling devices (40) with finger receptacles (30) and/or thumb holders (32). 19. Hand orthosis according to one of the preceding claims, characterized in that the base body (10) is attached to the outside of the hand liner (100) by force-fit, friction-fit and/or form-fit. 20. Hand orthosis according to one of the preceding claims, characterized in that the hand liner (100) is made of a flexible and/or elastic material or has elastic material sections. ```