The invention relates to an orthosis with an upper part and a lower part, which are coupled to each other via a first joint device in such a way as to be pivotable about a pivot axis, wherein devices for receiving a body part or a limb or for securing the orthosis to a body part or a limb are arranged on the upper part and/or the lower part, a system composed of an orthosis and of a functional element, and a method for adapting an orthosis to a patient.
Orthoses are fitted in place on a limb and generally have rails or shells with devices for securing the respective rails or shells to the limb. The rails or shells are connected to each other via a joint device, such that the orthosis can be arranged on the limb in a manner engaging over the joints. By means of an orthosis, movements can be performed, pivot angles about a joint axis can be limited, pivoting movements can be prevented, or an orientation of limbs relative to each other can be assisted or secured. In addition, orthoses can be provided with damper elements in order to damp pivoting movements about the joint axis. The damper devices can be provided with a controller, such that modified damping in the flexion direction or extension direction can be made available, depending on loads, pivot angles or sensor data.
There is the possibility of assigning an energy store to the upper part and the lower part, such that, by pretensioning of a spring or of an elastomeric element or of a hydraulic or pneumatic energy store, a resistance to a pivoting movement for example is made available in a first direction and is increased, wherein the opposite movement is assisted by relaxation of the energy store. End stops for setting the respective pivot angles can be formed adjustably in the joint devices, and a damper for avoiding an undamped impact in an end stop can likewise be provided.
In addition, there are orthoses with active drives in which a displacement of the upper part relative to the lower part about the pivot axis is actively effected, for example, via an electric motor. The orthoses can engage over only one joint, for example the knee joint or the ankle joint, although it is likewise possible that the orthosis engages over several joints, for example the knee joint and the ankle joint, or also the hip joint, the knee joint and the ankle joint. In an orthosis that engages over several natural joints, the proximal component is the upper part, and the distal component is the lower part. In a knee-ankle orthosis, a lower-leg rail is therefore the lower part, as regards the part engaging over the knee, since the lower-leg rail is arranged distally with respect to a thigh rail. With respect to a foot rail or foot shell, the lower-leg rail is then an upper part, while the foot rail or foot shell, which is connected to the lower-leg rail via an orthosis ankle joint, forms the lower part.
In highly loaded orthoses, for example in knee-ankle-foot orthoses, which are known by the abbreviation KAFO, joints are provided bilaterally in the knee region in order to configure an orthosis. A joint device is arranged both on the medial side and also on the lateral side of the knee joint, said joint devices each having a thigh rail and a lower-leg rail, which are connected to each other. Problems posed by a bilateral arrangement of rails on a leg include the difficulty in adapting to different leg circumferences, the interference caused by the medial joint device, which can collide with the unaffected leg, and complicated adaptation, particularly in trial set-ups.
The object of the present invention is therefore to make available an orthosis, a system composed of an orthosis and of a functional element, and a method, which do not have the disadvantages of the prior art. According to the invention, this object is achieved by an orthosis having the features disclosed herein, and by a system and a method having the features disclosed herein. Advantageous embodiments and developments of the invention are also set forth in the description and the figures.
In the orthosis according to the invention with an upper part and a lower part, which are coupled to each other via a first joint device in such a way as to be pivotable about a pivot axis, wherein devices for receiving a body part or a limb or for securing the orthosis to a body part or a limb are arranged on the upper part and/or the lower part, provision is made that an upper support element is secured to the upper part on one side, in particular laterally, and a lower support element is secured to the lower part on one side, in particular laterally, which support elements are connected to each other via a second joint device in such a way as to be pivotable about the pivot axis, wherein a bearing plate having at least one fastening device for securing the second joint device is fastened to or formed on the upper part and/or the lower part. By the arrangement of the two support elements on one side, in particular laterally on the upper part and the lower part, if appropriate also on rail parts or components which are arranged or formed on the upper part and lower part, the torsional moments and the moments arising in the orthosis are better taken up in a frontal plane. The functionality of the orthosis is not limited here, since the second joint device, which connects the upper and lower support element pivotably to each other, permits a pivoting movement about a common pivot axis of the two joint devices. The pivot axes of the joint devices are coaxial, wherein the pivot axis preferably runs coaxially with respect to the natural joint axis or a compromise joint axis, so as to permit a movement of the natural limb that is impeded as little as possible. The second joint device in particular can have a virtual joint axis, and it is therefore only necessary that the upper and lower support element are able to pivot about a common pivot axis with the upper part and lower part. A bearing plate is fastened to or formed on the upper part and/or the lower part and has at least one fastening device to which the second joint device can be secured. By way of the bearing plate and the fastening device, it is possible to fasten different joint devices to the upper part and/or the lower part, without having to make adjustments to the second joint device, in particular the upper support element and the lower support element. In this way, the modular set-up of the orthosis can be facilitated, and, in particular, a selection can be made from a multiplicity of different second joint devices in order, for example, to carry out an assembly for test purposes. Particularly if several fastening devices are arranged or formed at different locations on the bearing plate, the assembly of different second joint devices is made easier. It is no longer necessary to secure the upper and lower support element directly on the upper part or the lower part, and instead the securing can be done substantially independently of the configuration of the upper part and/or the lower part. The fastening devices can be arranged displaceably on the bearing plate. The adaptability to different second joint devices can be increased by displaceable fastening devices, for example screw inserts, bolts, lockable slide guides or the like. The bearing plate as such does not have to be flat; it can likewise have a curvature. Bearing plates can be arranged both on the upper part and also on the lower part; alternatively, a bearing plate is arranged either on the upper part or on the lower part and serves to secure the second joint device. In the case where there is just one bearing plate, the respective other support element, which is not secured to the bearing plate, is secured to the upper part or the lower part respectively. The bearing plate is an adapter which is arranged on the first joint device and via which the fastening of the second joint device can take place or is made easier.
On account of the arrangement of the additional support elements on one side, in particular laterally with respect to the upper part and the lower part, and on account of the resulting arrangement of the upper part and lower part on one side, in particular laterally, alongside the natural limb, the opposite region of the limb, in particular the medial region, is free, in particular when the orthosis is used as an orthosis of a lower extremity, such that a slim configuration is achieved, and, in the case of a lateral arrangement, no collisions of orthosis components with the contralateral side or the torso can occur. If both limbs are fitted with such a laterally arranged orthosis, in particular the lower limbs, more space for swing-through of the lower limb is present on the medial side, which increases the wearing comfort.
The orthosis can have devices for receiving a body part or a limb or fastening devices for fastening the orthosis to a body part or a limb. Orthoses are often secured to the orthosis user by a strap system or a combination of a shell receptacle with a strap system. The fact that the double joint device and therefore the rails or the shells extending from the joint device along the limb are arranged on one side, in particular only laterally, facilitates the adaptation of the orthosis to different limb circumferences, with the result that such an orthosis can be used very effectively as a test orthosis, on which the final set-up of the individual components can be arranged or changed around for optimal patient care.
In a development of the invention, provision is made that the first joint device and the second joint device are arranged laterally and spaced apart from each other. By virtue of the joint devices being spaced apart from each other, a circumferential frame structure is obtained via which torsional moments can be better taken up along the longitudinal extent of the orthosis. Similarly, in the case of a relatively wide configuration, the moments in the frontal plane can be better taken up by virtue of a spacing between the two joint devices, resulting in a more stable configuration of the orthosis, even when the joint devices are arranged only laterally on a limb.
The support elements can be secured to each other releasably and connected to each other via the second joint device, so as to be able to more easily exchange the individual components. Thus, different upper support elements can be releasably connectable to just one lower support element, such that different geometries, dimensions or connections can be made available in the upper support element and can be easily changed if this proves necessary for the adaptation to the particular patient. Thus, with a base orthosis and different upper and lower support elements that are able to be combined with one another, it is possible to make available a large number of individually adaptable orthoses.
Fastening devices for the releasable fastening of rails or devices for receiving a body part or a limb can be formed or arranged on the upper part and the lower part. The fastening devices are preferably what are known as rail boxes, or receptacles for rails, which are secured in the upper part with form-fit engagement, for example by screws or by similar releasable form-fit elements. It is thus possible for different rails or devices for receiving a body part or a limb, for example shells, foot supports or the like, to be variably fastened to the upper part or lower part in order to achieve simple adaptation to the requirements of the users.
Receptacles for a damper, a drive, a control device and/or a sensor can be arranged or formed on the upper support element and the lower support element, so as to be able to expand the functionality of the orthosis via the support elements. The upper and lower support element serves as a carrier for further components, for example damper devices or drives, in order to influence the pivoting movement of the orthosis. Purely passive add-on components such as damper devices or springs can be mounted on the orthosis via the support elements, such that the support elements are used as module carriers. The damper device can be adjustable, in particular with an adjustability based on sensor data, for which purpose an adjusting mechanism with a controller has to be present inside the damper device, so as to permit an adjustment of the damping on the basis of sensor data. A drive, in particular a motorized drive or an actuator driven by a pump, can likewise be fastened to the orthosis via the upper and lower support element, such that a movement of the limb is assisted or indeed made possible via a motorized drive. The motorized drive can at the same time be used as a damper. The support elements have suitable receptacles for the components that are to be inserted, which can be screwed onto the support elements or can be coupled thereto in some other way so as to transmit force, in particular with form-fit engagement, in particular spring stores, extension assists, enabling and locking devices, actuators, energy stores, pumps, motors, dampers, control devices and/or sensors.
The support elements are preferably fastened releasably to the upper part and the lower part via the bearing plate, so as to ensure easy exchangeability of the support elements. On account of the lateral arrangement both of the upper support element and of the lower support element, an exchange can easily take place, even with the orthosis fitted, in order to facilitate adaptation to the particular user.
The bearing plate itself can preferably be fastened exchangeably on the upper part or lower part, so as to be able to mount different bearing plates, which can have different fastening devices or which have fastening devices at different locations or in different arrangements.
The upper and/or lower support element can be designed to be adjustable in terms of angle to the pivot axis, such that tilting is possible in the frontal plane in an extended position of the orthosis. This tilting does not adversely affect the coaxial nature of the pivot axes and may be necessary in order to permit optimized adaptation to the particular conditions of use.
The orthosis is preferably designed as a unilateral orthosis of a lower extremity, in particular as a cross-knee orthosis, a knee-ankle-foot orthosis, a hip-knee-ankle-foot orthosis or an ankle-foot orthosis, since orthoses of the lower extremity have to take up and transmit comparatively high forces and moments, which can be taken up effectively via the second joint device. For this purpose, it is advantageous if the support elements are secured to the upper part and the lower part to transmit force and moment. In particular, the support elements are screwed onto the upper part and the lower part, if appropriate inserted into preformed projections or recesses, in order to ensure a fixed relationship and therefore a transmission of force and moment. The support elements can be made from metal or a fiber-reinforced plastic, in order to ensure sufficient strength and stability for transmitting the forces and moments acting in the orthosis.
In a development of the invention, at least one of the support elements is designed as a functional element, or such a functional element is fastened to at least one support element. The functional element can be designed as a drive, damper, brake, locking device, transducer and/or energy store. The drive can be an electromotive drive or hydraulic drive, wherein the hydraulic drive can be coupled to a pump and/or an energy store, for example a mechanical or pneumatic spring. A hydraulic volume can be subjected to pressure via the drive or the energy store in order to move a piston, for example a linear piston or a pivot piston, so as to move one orthosis component relative to the other orthosis component. It is thereby possible to pivot an upper part of the joint device relative to the lower part in order to bring about or at least assist a flexion and/or extension. It is additionally possible to configure the functional element as a damper device, in particular as a hydraulic damper in which the pivoting movement in the extension direction and/or flexion direction can be influenced by the change of a hydraulic resistance. A brake or an adjustable limit stop can likewise be formed as functional element or can be part of the functional element. In addition, the functional element can be designed as or have a transducer, in order to detect motion data and/or load data of the upper part, the lower part or further components of the orthosis or of an orthosis system. The transducers can be configured as force sensors, angle sensors, travel sensors, moment sensors or position sensors. In addition, the transducers can receive motion data such as accelerations or speeds, in order to implement these via a control device for changing resistances or settings on a functional element, for example a damper device or a drive. Depending on values detected via the transducers, the orthosis can then be controlled in order to be able to permit settings adapted to the user or to the particular movement or movement situation. An energy store as functional element is configured in particular as a spring, such that, for example, kinetic energy can be converted to deformation energy during braking of a movement and stored and, at a later point, released again in a controlled manner. This dispenses with the conversion of kinetic energy to electrical energy and with the storage of electrical energy in an accumulator. Besides an integral configuration of the support element as functional element, it is possible that such a functional element is fastened to the at least one support element in order not only to guide the limb but also to be able to analyze and/or influence the particular movement.
In the system according to the invention, composed of an orthosis as described above and of a multiplicity of different functional elements, for example different drives, different dampers, brake devices, transducers and/or springs, provision is made that these different functional elements can be secured to the same fastening devices via at least one bearing plate on the upper part and/or lower part. Besides different functional elements that perform different functions from one another, variants of functional elements with identical functions can also be mounted, tested and adapted. By way of the fastening devices on the bearing plate, the different functional elements can be easily exchanged, such that it is possible, by virtue of the modular configuration of the functional elements and the standardized arrangement and orientation of the fastening devices of the functional elements to the fastening devices on the bearing plate, to achieve easy exchangeability and therefore easy adaptability to the particular patient or to the particular purpose of use. The functional elements can be selected depending on the patient, on the purpose of use and/or on other peripheral conditions of treatment and can be adapted to a standardized orthosis. The functional elements then allow the orthosis to be tailored individually and adapted to the particular user. For this purpose, provision is made that on each functional element that is part of the system, fastening devices or fastening elements are arranged or formed which are positioned on the bearing plate for the upper part and/or lower part in a manner corresponding to the fastening devices or receiving devices provided for the purpose. For example, if a functional element configured as a passive hydraulic damper is replaced by a functional element configured as a hydraulic drive, it is possible for a passive orthosis to be made an active orthosis, by which movements can be initiated, executed or assisted. Instead of a functional element that influences the movement of the orthosis, it is likewise possible to arrange what is purely a detection unit by which motion data are detected, for example in order to be able to document progress in healing or to document the course of a physical limitation.
In a development of the system according to the invention, provision is made that all of the functional elements have fastening elements which are arranged corresponding to fastening devices for the fastening elements for securing to the upper part and/or the lower part via the bearing plate. The corresponding arrangement of the fastening elements to the receiving devices for the fastening elements permits in particular the arrangement of at least one spacer element between the actual orthosis and the functional element in order to ensure that the individual adaptability to the respective patient is ensured. For example, in the case of lower extremities, genu valgum may require a different spacing of a functional element from an upper part or lower part than in the case of genu varum, such that spacer elements can be arranged between the upper part and/or lower part or the bearing plate and the functional element, particularly if the functional element has to have a special orientation or has to be oriented specifically in relation to another component.
The functional element in the system is preferably secured releasably to the bearing plate and, if appropriate, to the upper part and the lower part, in order to facilitate adaptability to the particular purpose of use or to the particular patient. The upper support element and the lower support element can be assembled to form a module, thereby permitting a modular set-up and therefore easy exchange and easy adaptability.
In the method for adapting an orthosis, of the kind described above, to a patient, wherein the orthosis is fastened to a body part or limb via devices for receiving or for securing a body part or a limb, provision is made that, after a first joint device has been selected from a multiplicity of different first joint devices and this first joint device has been connected to devices for receiving or for securing a body part of a limb, a second joint device is selected from a multiplicity of different second joint devices, and then an upper and lower support element, which are connected to each other via the selected second joint device, are connected to the upper part and the lower part of the first joint device, such that, based on a selection of different joints or joint devices and a respective permutation of the joint devices, it is possible to provide a considerable variation of different orthosis types and to adapt them to the particular patient. The modular set-up of the individual components, in particular of the first joint devices and of the second joint devices, permits easy exchange thereof. In a development of the invention, provision is made that the joint device suitable for the patient is first of all selected from a multiplicity of first joint devices and is equipped with the rails and fastening devices. After selection of a first joint device that is considered to be the most suitable one, a multiplicity of second joint devices can be secured to the first joint device via the support elements and can be tested out or exchanged, thus allowing the orthosis to be tailored individually or adapted to the particular patient, to the purpose of use or to a variable state of a patient. For the main joint, that is to say the first joint device, loads are taken up in particular in the medial-lateral direction, whereas loads in the anterior-posterior direction are taken up and led off via the second joint device. The main joint is configured in particular as a free running joint, while the second joint device can be equipped in particular with functional elements such as drives, dampers, transducers, enabling or locking devices, extension assists, springs and/or other energy stores.
Illustrative embodiments are explained in more detail below with reference to the accompanying figures, in which:
Support elements 110, 120, arranged laterally with respect to the rails 60, are fastened to the orthosis knee joint by the joint device 30. An upper support element 110 is fastened to the upper part 10 and, if appropriate, to the thigh rail 60 so as to transmit moment and force. Correspondingly, a lower support element 120 is fastened to the lower part 20 so as to transmit force and moment, in particular by being screwed on or being secured via form-fit elements. The upper support element 110 is connected pivotably to the lower support element 120 to form a second joint device 130 pivotably, such that, spaced laterally apart from the first joint device 30 between the upper part 10 and the lower part 20, a second, parallel second joint device 130, pivotable coaxially about the pivot axis 40, is formed in the region of the orthosis knee joint. A corresponding configuration can be provided at an orthosis ankle joint or also at an orthosis hip joint.
The two support elements 110, 120 can in particular be fastened releasably to the upper part 10 and lower part 20, in order to permit easy adaptation of a base orthosis to an alternatively configured, laterally arranged second joint device 120.
A receptacle 112 for further components, for example drives, damper devices, control devices, sensors or the like, is provided in the upper support element 110.
The upper part 10 and the lower part 20 are connected to each other about a pivot axis 40 to form a joint device 30. Laterally with respect to the rails (not shown) and to the upper part 10 and lower part 20, two support elements 110, 120 are fastened, in the illustrative embodiment shown screwed, onto the upper part 10 and lower part 20. An upper support element 110 is fastened by screws to the upper part 10 via the bearing plate 200 so as to transmit force and moment. The bearing plate 200 is configured as a separate component and is fastened releasably to the upper part. Correspondingly, a lower support element 120 is fastened to the lower part 20 to transmit force and moment, here with a spacer 90 placed in between. Both support elements 110, 120 are connected pivotably to each other and form a second joint device 130, of which the pivot axis runs coaxially with respect to the pivot axis of the first joint device 30. It is thereby possible that pivoting of the orthosis components about the pivot axis 40 can take place without twisting or jamming.
The two joint devices 30, 130 are arranged laterally and spaced apart from each other, such that a clearance 80 is formed between the joint devices 30, 130. By the doubling of the joint in the region of the rail holders, it is possible, in highly loaded regions of an orthosis, for forces and moments to be effectively taken up and forwarded. The forces occurring in the orthosis are advantageously taken up and forwarded by the frame-like structure in the orthosis joint with the two joint devices 30, 130. The force lines in the longitudinal extent, i.e. from proximal to distal in the extended position, are divided up and run through both the upper part 10 and the lower part 20 with, between these two structural parts, the first joint device 30 and the upper support element 110, the lower support element 120 and, formed therebetween, the second joint device 130. In the region where the support elements 110, 120 are coupled to the upper part 10 and lower part 20, the forces and moments are divided up and brought together, resulting in a closed force train. The laterally arranged joint device 30 thus works as a medial support joint. The distance between the two joint devices 30, 130 corresponds to twice the thickness of the rails. The greater the distance of the joint devices 30, 130 from each other, the more stable the overall orthosis joint, although a very large distance brings disadvantages as regards wearing comfort.
A variant of the invention is shown in
The rear view according to
A third variant of the invention is shown in
The frontal view according to
This basic set-up is identical in the system shown in
In the embodiment according to
In the embodiments according to
Number | Date | Country | Kind |
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10 2017 128 618.7 | Dec 2017 | DE | national |
This application is a continuation of U.S. patent application Ser. No. 15/733,146, filed 28 May 2020, which is a U.S. National Entry and claims priority to PCT International Patent Application No. PCT/EP2018/083134, filed 30 Nov. 2018, and entitled “ORTHESIS, SYSTEM AND METHOD FOR ADAPTING AN ORTHESIS”, which claims priority to Germany Patent Application No. 10 2017 128 618.7 filed 1 Dec. 2017, the entire disclosures of which are incorporated herein by this reference.
Number | Date | Country | |
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Parent | 15733146 | May 2020 | US |
Child | 18905071 | US |