One-handed closure system for orthopedic devices

Abstract

Orthopaedic aid (1) with a closure system comprising a stationary part (26) and a movable part, which in combination are placed circularly around a human body part and serve to fix or fasten the orthopaedic aid (1) to a body part, wherein the closure system comprises at least one mechanically latching closure (25) which comprises at least two components (26, 27), wherein one component (26) forms the stationary part of the closure system and a further component (27) is fastened to the movable part, characterized in that the components (26, 27) have a magnetically acting centering, and in that the component (27) fastened to the movable part is freely movable in at least one direction, independently of the operation of the movable part.

Description

[0001] The invention is defined by the claims and belongs to the category of orthopedic aids, particularly specifically supporting bandages and orthoses. Such aids are typically secured to the corresponding body part in the intended position of use by straps or similar flexible fastening systems. Systems are known in which simple straps are guided in a circle around the corresponding body part and are fastened either to themselves or to other components using, for example, buckles, snap fasteners, hook-and-loop fasteners, or snap fasteners, etc. In order to achieve higher fastening forces with reduced force exerted by the user, single or multiple deflections are often provided.In the latter case, for example, a strap, originating from a rigid or semi-flexible clamp-like part that at least partially encloses the body part of the orthosis wearer, is guided in a circular manner from one end of the clamp-like part around the body part, pulled through a loop provided at the other end of the clamp-like part, and folded back using a hook-and-loop fastener system, either onto itself or again onto the clamp-like part on the side opposite the loop. Other known systems use pin buckles or snap fasteners, which are known and available in a wide variety of designs.

[0002] All known systems have the disadvantage that the user must either thread the fastening strap through a guide loop or, in the case of snap fasteners, actively bring the two corresponding parts into a specific, precise position relative to each other and create the locking action using force. Many users of supports and orthoses have lost certain bodily functions. For example, hemiplegia, often spastic, is a common complication after a stroke. For this group of users, it is often difficult or even impossible to properly close a required orthopedic aid for optimal function without outside assistance while retaining their remaining mobility, especially with only one hand.

[0003] Locking mechanisms are known from the transportation and sports sectors whose components close automatically upon approach through the effect of magnetic force. Examples of these are publications DE 20 2005 021 283 U1, DE 10 2004 015 873 B4, DE 10 2008 019 063 B4, or DE 20 2010 044 144 B3. These systems are used, among other things, as holders for certain objects in transport containers, as closures for bags and suitcases, or as closure systems for sports items, such as snowboard helmets. The use of similar magneto-mechanical closure systems for orthopedic aids is unknown to date.

[0004] Further prior art is described in the documents US 7 785 283 B1, DE 202 10 137 U1, WO 2008 / 025 905 A2 and US 2012 / 0 117 764 A1.

[0005] When using the above-mentioned magnetomechanical closure systems in conjunction with flexible closure elements such as straps, the known systems are typically gripped at the component attached to the strap and guided by hand to the corresponding counterpart. This means that the possible self-finding property of the generic closure system is not utilized, since one component is restricted in its degrees of freedom by the user's hand. This is not relevant for the known applications mentioned above, since in bags, for example, the components can be geometrically arranged on two articulated parts of the bag, such as the bag body and the closure flap, in such a way that the closure components are brought together in the correct position almost automatically.When used on harnesses, such as the sports helmets mentioned above, the potential for self-discovery of the components of the closure is not particularly relevant, since the user group typically has no physical limitations and is able to operate the closure without any problems.

[0006] In contrast, when using generic closures in the orthopaedic aid sector, it is desirable that the closure can be closed without visual contact using only one hand.

[0007] It is therefore an object of the invention to provide a closure system which uses the known magnetomechanical closure elements in such a way that the above-mentioned requirements, namely to ensure one-handed operation in the absence of visual contact, are met.

[0008] The object of the invention is achieved according to the embodiments of claim 1. Particular embodiments are shown in the subclaims.

[0009] The invention is described in more detail below using the example of a lower leg-foot orthosis. The example of the use of the invention in connection with lower leg-foot orthoses was chosen because it is particularly market-relevant. Of course, this does not limit the use of the invention to the group of orthoses mentioned as examples. Rather, the use of the invention can also be applied in a similar sense and in a generic way to other orthopedic aids, in particular to orthoses and supports, but also to prosthetic products.

[0010] Particularly after a stroke, but also due to other neurological diseases or injuries, there is often a partial or complete loss of the ability to actively lift the foot, i.e. to achieve dorsiflexion of the ankle. Those affected are therefore unable to lift the tips of their feet during the swing phase of walking and have to compensate for the lengthened leg during the swing phase of the step cycle by increasing flexion of the knee and hip joints. This is not only strenuous for the affected person but also leads to a very unnatural gait. In addition, those affected often get their tips caught on small bumps in the ground, which can lead to stumbling or even falling. Many affected people also have spastic paralysis symptoms, which further exacerbate the above-mentioned problem.In addition to the aforementioned stroke, other central neurological deficits can be caused by other causes, such as traumatic brain injury, cervical tumors, and others. Peripheral causes include injuries, particularly to the peroneal nerve, herniated discs, narrowing of the nerve root exit between the vertebrae, damage due to infectious diseases, or other degenerative diseases.

[0011] Common aids, especially supports and orthoses, aim to mechanically hold the affected foot in a raised (dorsiflexed) position using external forces. There are lower leg-foot supports that support the remaining function of the foot via corrective straps in cases of foot drop. In cases of complete loss of the ability to actively lift the foot, orthoses with predominantly rigid elements, joints, and / or spring-like components in various designs are generally used in a conventional manner.

[0012] The invention is described in more detail below using an exemplary embodiment of such a lower leg-foot orthosis. All orthoses have in common that, in order to transmit the desired forces, the device must be attached to the affected leg using clamps and straps. It is desirable and crucial for proper function that there is as little relative movement as possible between the limb and the orthosis when in use. This means that it is essential to securely fasten the fastening elements and pull any straps tight. With prior art designs, the affected person must firstly find the closure without visual contact and secondly securely close it with one hand and then, if necessary, pull the closure tight. In particular, closing under tension is almost impossible with the known systems using only one hand, which is a major disadvantage of the prior art.

[0013] When constructing a comparable orthosis with the features of this invention, the affected person merely needs to bring the free end of the fastening strap on the device provided for this purpose close to the stationary component of the closure. The two closure components are equipped in such a way that when the two parts approach each other, they are mutually attracted by a magnetic force. The magnetic force is preferably generated by permanent magnets. It is irrelevant whether this is a magnet in each part of the closure or whether only one component contains a magnet and the corresponding other component is provided with a ferromagnetic material, such as a sheet iron. It goes without saying that when two magnets are used, they must be aligned to one another in such a way that the desired attractive effect is achieved.The innovations of this invention make it easy to guide a fastening strap on an orthopedic device under tension to the closure until it automatically engages. According to the teachings of the invention, this is achieved by allowing the fastening component attached to a strap to retain at least one degree of freedom even when the strap is guided into the closed position under tension with one hand.

[0014] The invention is described in more detail below using sketches as an example of a dynamic foot lifting orthosis.

[0015] They show: Fig. 1: A preferred embodiment of a foot lifting orthosis with the features of this invention on the leg of an orthosis wearer with the lower strap and upper strap closed, immediately before the strap fastening is closed. Fig. 2: The orthosis made of Fig. 1 without representation of the leg with closed fastening straps Fig. 3: The orthosis according to Fig. 2 seen from above Fig. 4: An enlarged view of the closure according to the invention using the example of an orthosis according to Fig. 2 - 3 in non-closed position. Fig. 5: Orthosis according to Fig. 2 - 4 with stylized representation of the closure process according to the invention. Fig. 6: Another embodiment of a closure component on a belt with the features of this invention.

[0016] Before the special features of the invention are explained with reference to the figures, the function of the foot lifting orthosis shown as an example is briefly explained in general for easier understanding: The structural components of the dynamic orthosis (1) shown are made in one piece from a

[0017] Made from high-strength carbon composite material. This type of composite material is known for its high strength and low weight, as well as its elastic stiffness similar to that of corresponding spring steels. The orthosis is typically worn together with a normal low shoe (6) and is fastened to the leg (3) of the wearer using the two fastening straps (7) and (8). Due to the angle of approximately 90° between the foot section (2) and the rod-shaped section (4) with the attached leg shell (5), the foot is held at a predetermined angle of approximately 90° to the lower leg. This roughly corresponds to the angle that a healthy person's foot would form to the lower leg during the swing phase. During heel strike, the orthosis elastically springs slightly into plantar flexion due to the lever between the heel and the vertical section, which means that the foot forms an angle greater than 90° with the lower leg.The spring properties of the material cushion the heel strike. The stored energy is returned to the wearer as the gait cycle progresses, helping them to transition more easily into the stance phase. When the body weight is increasingly shifted forward onto the balls of the feet due to increased forward lean during the stance phase, the orthosis is elastically deformed towards angles smaller than 90°, and the resulting stored energy helps the wearer lift the foot off the ground at the end of the stance phase. During the swing phase, the orthosis springs back to its normal position of approximately 90°, and the foot is held at this angle to the lower leg, which is the main function of the orthosis.

[0018] In the orthosis (1) after Fig. 1 - 5 is a dynamic foot lifting orthosis as it is essentially known.

[0019] In Fig. Figure 1 shows such an orthosis on the leg (3) of an orthosis wearer, together with a shoe (6), in a typical wear position shortly before the upper strap (8) is closed. The orthosis (1) is preferably made of a rigid material with strong spring properties, so that deformation due to external forces, such as those caused by the rolling of the foot during the stance phase of the gait cycle, leads to an elastic deformation. When the foot pushes off the ground at the end of the stance phase, this elastic deformation returns the energy stored in the spring as deformation energy to the orthosis wearer, thus facilitating the foot's lift-off to initiate the swing phase.

[0020] The orthosis (1) consists of a footplate (2), which also has spring properties, a rod-like, vertically arranged part (4) which is integrally connected to the footplate (2) and extends at an angle of approximately 90° to the footplate in the direction of the lower leg (3), and a shin shell (5). Straps (7) and (8) connected to the shell or clamp (5) at the top and bottom serve as closure elements. In the example shown, the straps (7) and (8) are connected to the shell edge (9) on the side facing the middle of the body, i.e. medially. The type and manner of connection is not important for the function according to the invention.The example shown is a hook-and-loop fastener connection, whereby a textile connecting piece (10) made of a hook-and-loop material, for example velour, is pushed through one of the holes (12) provided for this purpose from the outside (13) towards the inside (14) of the shell (5) and fastened to a hook-and-loop surface (not shown) located on the inside (14) in the area of ​​the opening (12). As in . Fig. 3, the connecting piece (10) protrudes from the opening (12) and widens from approximately 15 mm to approximately 50 mm, which has proven to be the preferred width for the two straps (7) and (8). On the wide side of the connecting piece (10) facing away from the shell, there is a deflection loop (11) through which the strap (8) is guided and folded back on itself. The strap is also made of a hook-and-loop material, for example double-sided velour. A double-sided hook tape (not shown) several centimeters long, which is placed behind the deflection loop (11) between the strap and the folded-back end of the strap, forms a firm loop connection around the deflection loop and thus the strap (8) is connected to the shell (5) in a length-adjustable manner via the deflection loop (11) and the connecting piece (10).The straps (7) and (8) are both connected to the medial side of the shell (5) in the manner described above and are guided around the leg (3) of the orthosis wearer. The inventive magnetomechanical closure (25) is provided on the lateral side, i.e., the side facing outward away from the center of the body, and will be described in more detail later.

[0021] The footplate (2) has the shape of a shoe sole and is worn as a sole inside a shoe (6). The rod-shaped part (4) is integrally connected to the footplate and together with it forms the above-mentioned spring. The rod-shaped part (4) originates at the outer edge of the footplate (2) slightly in front (anterior) of the ankle (14) of the wearer's ankle joint at an angle of approximately 90°, i.e., perpendicular to the footplate (2), runs diagonally across the instep of the foot towards the shinbone, and then, after a further bend and twist, follows the ventral course of the shinbone. The rod-shaped part (4) has a width of 15 - 40 mm and a thickness of 3 - 10 mm, depending on the composite material structure and the desired elastic restoring force. As in Fig. 2, the broad side of the rod-shaped part (4) in the area (15) of the connection to the footplate (2) is aligned approximately parallel to the longitudinal extent of the footplate (2). This results in a high flexural rigidity of the orthosis in the flexion and extension directions of the ankle joint and thus also a high torque, which counteracts the plantar flexion of the foot, i.e. the so-called foot drop, in the desired manner. In the further course of the rod-shaped part (4) in area (16), the broad side of the part (4) roughly follows the contour of the human foot and the rod (4) rotates in area (16) by approximately 90° so that the broad side in area (17), i.e. along the tibia, is aligned parallel to the latter.

[0022] In the example shown, the rod-shaped part (4) runs in a groove (18) of the leg shell (5) and is screwed to it (19), (20). This means that the rod-shaped part (4) does not protrude on the inside (14) of the shell (5) and pressure points on the leg of the orthosis wearer are avoided. In addition, a pad (35) is provided on the inside (14) of the shell (5), which lines the entire shell (5) or is glued in. In the area of ​​the screw connection, elongated holes (21) and (22) are provided on the leg shell (5), which allow a certain degree of adjustment of the height of the leg shell (5). In order to keep the counterforces on the leg to the aforementioned spring forces as small as possible, the lever arm of the leg shell should be as long as possible. This means that the leg shell should reach as high as possible, below the knee.It goes without saying that the orthosis must be adapted to the wearer's body in such a way that pressure peaks are avoided and sensitive areas, such as the fibula head with the peroneal nerve directly beneath it, are spared. However, this is well known to those skilled in the art, and the anatomical design of the orthosis is not essential for understanding the invention, which is why this topic will not be discussed in detail here.

[0023] The leg shell or cuff (5) has a length of 15 to 40 cm and at least partially encloses the wearer's leg (3). In the example, the leg cuff encompasses approximately 35 - 50% of the lower leg. The two straps (7) and (8) serve to attach the orthosis to the leg of the orthosis wearer. The orthosis is further secured by the shoe (6) in which the orthosis is worn. The two straps (7) and (8) additionally prevent the orthosis from being levered off the shinbone when the heel strikes, thus ensuring that the orthosis is securely attached to the wearer's leg at all times during the walking cycle. The closure elements (25) according to the invention are preferably mounted medially, i.e., on the inside of the leg, since in cases of foot drop due to a central neurological disorder, the entire body is usually affected, and therefore the arm contralateral to the affected side of the leg can better reach the inside of the affected leg.The closure elements (25) according to the invention each consist of a stationary part (26), which is fastened to the leg clamp (5), for example by riveting, and a movable part (27), which is fastened to the two closure straps (7) and (8) - for example also by riveting. The term "stationary" with regard to the part (26) is intended merely to express that the closure component (26) is mounted on the shin shell (5) and cannot - like the counterpart (27) - be freely moved in space within the limits of a strap, for example. It is intended that the component (26) of the closure (25) mounted on the clamp (5) also has a certain degree of freedom, and for example, a limited pivoting movement is possible between the clamp (5) and the closure part (26).

[0024] The fastening of the straps (7) and (8) on the lateral side has already been described above. As can be seen in the illustrations, the straps are guided around the calf of the orthosis wearer at the back (dorsal) and are also connected to the shell (5) on the medial side via the fasteners (25). The special advantages of the inventive design of the closure system are explained below, particularly with reference to Fig. 4 and Fig. 5 described in more detail.

[0025] The donning process of the orthosis according to the invention typically takes place as follows: The orthosis (1) from Fig. 1 is inserted into the shoe (6) and can remain there. The orthosis wearer steps into the shoe like a healthy person and closes it. The vertical part (4) of the orthosis (1) protrudes from the shoe (6) and rests against the lower leg (3) as soon as the latter forms an angle of approximately 90° with the foot. The orthosis wearer grasps one of the two fastening straps (7) or (8) with his hand (23) at the provided grip tab (24) and guides the strap around the back (dorsal) of the leg so that the Fig. 1 on the upper strap. The grip tab (24) is made of a stiff, dimensionally stable material, for example polyamide with a cross-section of approximately 2 mm x 2 mm to 5 mm x 5 mm. The straps are typically already correctly pre-adjusted in length through prior fitting. The grip tab (24) enables the person affected to guide the strap tightly around the leg. The movable part of the fastener (27) finds the corresponding partner (26) on the leg shell (5) due to the magnetic forces and the connection is automatically established by the attractive magnetic force of the two parts (27) and (26) of the respective fastener (25) creating the mechanical connection.

[0026] The special functions of the invention are explained by Fig. 4 and Fig. 5. The movable closure part (27) is connected in the area (28) by means of a textile loop so that it can rotate about the axis AA. The flexible belt (8) made of textile material is reinforced in the area (29) in such a way that it has a certain stability. In the area (30) below the gripping tab (24), a thinner of the belt is provided, e.g., created by a lockstitch seam or by embossing, so that a pivoting movement about the axis BB is facilitated in the manner of a foil hinge. Due to the width of the belt in the direction of the axis BB, a pivoting movement of the belt perpendicular to the axis B - B is not possible and the above-mentioned reinforcement in the area (29) also prevents a pivoting movement, so that the part of the belt projecting beyond the gripping tab (24) or its loop connection (30) and carrying the component (27) of the closure (25) is in something in the Fig. 4 shown position is stable when the belt - as shown in Fig. 1 - is held on the grip tab (24). The closure component (27), which is made of a non-flexible material and has a slit-like opening for connection to a belt, is connected to the belt (7) via a loop connection (not shown in detail) in such a way that a pivoting movement about the axis AA is possible, but not a pivoting movement in the direction perpendicular to AA. Viewed from the grip tab or its fastening tab (31) in the direction of the closure (27), two hinge-like elements are provided in series, which give the closure component (27) both a rotational and a translational degree of freedom in the direction of the component (26) of the closure (25) fastened to the clamp (5).If the strap is held by the loop (24) and the corresponding movement of the strap brings the closure component (27) closer to the counterpart (26) to the area of ​​mutual magnetic attraction between the two components (26) and (27), the component (27) can move toward the counterpart (26) due to the degrees of freedom described above. The two components (26) and (27) of the closure (25) thus essentially find each other, and the mechanical locking of the closure (25), which is not described in detail here, can take place automatically.

[0027] To further facilitate the desired automatic locking of the closure (25), the closure component (26) is not rigidly connected to the shell (5), but rather a pivoting movement about the axis CC is possible. For this purpose, a loop (33) made of flexible material, in the case shown consisting of hook-and-loop velour, is provided on the part (26) consisting of rigid material. This loop is formed by guiding a band-like part through a slit-shaped opening (not shown) located in the area of ​​the axis CC in the part (26) and connecting it, for example by sewing it, to form a closed loop. In the illustrated embodiment, the band-like part (34) has a width of 10 - 20 mm and a length of 50 - 80 mm.The free end of the part (34) is guided through one of the openings (12) in the shell (5) and is fixed by means of a Velcro surface (not shown) provided on the inner side (14) in such a way that a type of hinge is formed on the CC axis between the loop (33) and the closure component (26), which allows a pivoting movement of the part (26) about the CC axis. Depending on the size of the loop (33) and the possible play between the loop (33) and the clamp (5), a certain translational movement of the component (26) of the closure (25) is also possible. This means that the closure component (26) also essentially has two degrees of freedom.To ensure that the closure part (26) is fixed in the position shown in the illustrations for easier operation, a ferromagnetic component is provided below the closure part, i.e. on the back side not visible in the illustrations, to which the magnet already present in the part (26) can adhere. In the exemplary embodiment shown, a hole (not shown) is provided centrally below the closure component (26), in which a rivet made of ferromagnetic material (also not shown) is set. The rivet head has a similar diameter to that of the magnet built into the component (26), which in the example shown is approximately 5 mm.The material of the rivet and the position are selected such that the magnetic attraction force between the closure component (26) and the rivet is sufficient on the one hand to hold the (26) on the shell (5) for easy operation in the manner shown, but it is still possible that the component (26) can move automatically towards the counterpart (27) as soon as the distance is small enough due to the relatively stronger magnetic forces between the two components (26) and (27).

[0028] In Fig. 5, the top view of the orthosis once again symbolically shows how the movable closure component (27) can move automatically towards the counterpart (26) if the belt is only held by the grip tab (24) while the two closure components (26) and (27) of the closure (25) are brought closer together. The padding in the leg cuff (5) is - unlike the illustrations from Fig. 1 - 4 - in Fig. 5 not shown.

[0029] In Fig. 6 shows an alternative arrangement of the invention. Only the end region of the belt (7) or (8) with the magneto-mechanical closure is shown. The belt is made of a flexible material, preferably a textile material. Instead of the separate handle loop (24) made of a rigid plastic, which in the other exemplary embodiment is connected to the belt (7) or (8) via a loop (31), the latter in this embodiment is formed by the respective belt itself by appropriate cutting and, if necessary, by assigning a reinforcement by means of a stiffening material. Along the axes A - A or B - B in the area (28) or in the area (30), as described above, suitable measures, e.g.By embossing or perforation, film hinge-like joints are formed, which allow the closure component (27) to pivot freely about the axes AA and BB shown, even when the strap is held and tensioned by hand at the handle loop (24). To prevent twisting or pivoting of the strap area (29), a reinforcement, as described above, is also provided in this area.

[0030] In the exemplary embodiments, the function and advantages of the invention were described using only one of the two fastening straps as an example. Naturally, both straps in the example are equipped with the functions of this invention. It is also possible to combine different embodiments of the invention in a single orthopedic aid.

[0031] It is also emphasized again that the invention is by no means limited to the illustrated embodiments. The invention can be used in a wide variety of orthopedic devices. The materials mentioned are also merely preferred materials for the illustrated application. Naturally, the invention can also be realized using other materials. With a suitable arrangement of joints, it would also be possible, for example, to use clasp-like elements made of a rigid material instead of fastening straps made of a flexible material. Fig. 6, for example, there would have to be smooth-running hinges with the rotation axes AA and BB at least in the area (28) and (39).

Claims

[1] An orthopaedic aid (1) with a closure system comprising a stationary part (26) and a movable part, which in combination are placed circularly around a human body part and serve to fix or fasten the orthopaedic aid (1) to a body part, wherein the closure system comprises at least one mechanically locking closure (25) comprising at least two components (26, 27), wherein one component (26) forms the stationary part of the closure system and a further component (27) is fastened to the movable part, characterized by that the components (26, 27) have a magnetically acting centering, and that the component (27) attached to the movable part is freely movable in at least one direction independently of the operation of the movable part. [2] Orthopaedic aid (1) according to claim 1, characterized bythat a gripping element (24) is provided on the movable part, which is located at a distance from the closure component (27) fastened to the movable part such that the latter can carry out at least one pivoting movement even when the belt (8) is manually tensioned by means of the gripping element (24). [3] Orthopaedic aid (1) according to claim 2, characterized by that the at least one pivoting movement takes place about an axis perpendicular to the longitudinal extent of the movable part. [4] Orthopaedic aid (1) according to claim 3, characterized by that the handle element (24) is spatially fastened in front of a belt end carrying a closure component (27), wherein the handle element is movably fastened to the belt. [5] Orthopaedic aid (1) according to claim 1, characterized by that the locking components (26, 27) automatically lock mechanically when they approach sufficiently. [6] Orthopaedic aid (1) according to claim 1 characterized by that at least one movable part consists of a flexible material. [7] Orthopaedic aid (1) according to claim 6 characterized by that the flexible material is textile, leather or plastic film. [8] Orthopaedic aid (1) according to claim 2 characterized by that the at least one pivoting movement takes place about an axis perpendicular to the longitudinal extent of the movable part. [9] Orthopaedic aid (1) according to claim 2 characterized by that the handle element (24) consists of a substantially rigid material. [10] Orthopaedic aid (1) according to claim 2 characterized by that the handle element (24) is movably attached to the belt. [11] Orthopaedic aid (1) according to claims 2 to 4 characterized bythat the gripping element (24) is spatially fastened in front of the strap end carrying a closure component, but the loop for gripping is provided behind said strap end. [12] Orthopaedic aid (1) according to one of claims 4 to 11 characterized by that the handle loop is made of the same material as the strap. [13] Orthopaedic aid (1) according to claim 1 characterized by that the mobility of the closure component (27) is formed by different bending stiffnesses of the material structure in discrete areas. [14] Orthopaedic aid (1) according to one of the preceding claims, characterized in that the movable part consists of a rigid material and corresponding hinges or joints are provided to generate the necessary mobility.

15. Orthopaedic aid (1) according to one of the preceding claims, characterized in that the stationary component (26) of the closure (25) attached to the orthosis is fastened in such a way that it can make at least one pivoting movement in the direction of the counter-component (27) approaching during closure.

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