Device for ankle mobilisation

Abstract

Ankle mobilisation device (100) comprising: a frame (10, 10', 11, 12, 12', 13, 16) comprising a retention system (13, 16) of a leg of a user of the device (100), configured for preventing and / or reducing movement of the leg (200); a calcaneal support (31', 31", 32, 33, 34, 35, 36", 36", 37) configured for accommodating an ankle of a user, said ankle being provided with a dorsiflexion / plantarflexion axis of rotation (x); means for actuating (21, 22, 23, 24', 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') comprising a motor (25) configured for generating a rotation about an axis of actuation and a coupling (26, 40, 41, 42, 43, 44, 40', 41', 42') placed between the motor (25) and the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37); the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37), in turn, comprising a rigid casing (31', 31") and a deformable filler (32) positioned within the rigid casing (31', 31") and such that it can be shaped to the shape of a user's calcaneus and the coupling (26, 40, 41, 42, 43, 44, 40', 41', 42') having at least one degree of freedom translational in the direction of the axis of actuation, and no degree of freedom in torsion, so as to compensate for misalignments between the axis of actuation and the axis of rotation (x).

Description

[0001] "DEVICE FOR ANKLE MOBILISATION"

[0002] DESCRIPTION

[0003] TECHNICAL FIELD OF THE INVENTION

[0004] The present invention relates to a device for assisted mobilisation and selective functional recovery of the tibiotarsal joint and, hence, the ankle. More particularly, the device of the present invention is intended to speed up the recovery of the functionality of the tibiotarsal joint in subjects undergoing total or partial ankle prosthetic replacement surgery, as well as in subjects who have suffered severe ankle injuries. To this end, the device of the present invention acts only on the tibiotarsal joint without the involvement of the midfoot joint complex, thus improving and speeding up the recovery of lost functionality.

[0005] STATE OF THE ART

[0006] The ankle joint, also known as the tibio-tarsal joint, consists of the distal parts of the tibia and fibula and the talus, which takes its place inside the tibio-peroneal mortise, as well as the concavity formed at the ends of the tibia and fibula. The talus, together with the calcaneus, constitutes the hindfoot area, i.e. the most proximal part of the foot, followed by the midfoot area, which includes the other bones of the tarsal group (navicular, cuboid and the three cuneiform bones), and the forefoot area, which includes the metatarsals and the phalanges of the toes. One of the pathologies that most frequently affect this joint is arthrosis, a degenerative disease due to ageing, trauma and rheumatological pathologies that involves the consumption of the articular cartilage that covers all the bone surfaces, causing stiffness and swelling of the joint, as well as pain and limitation of movement. To date, prosthetic replacement of the ankle joint is one of the most widely used techniques, where possible, for this pathology. Following this surgery, a rehabilitation treatment of functional re- education and passive mobilisation of the ankle joint district by professionals such as physiotherapists and rehabilitation professionals is required. In rehabilitation practice, however, the use of motorised devices capable of mobilising the ankle according to precise protocols is becoming increasingly widespread. The increasing use of such devices finds its motivation in the possible unavailability of specialised therapists and the inevitable operator-dependent variable on the final rehabilitation outcome. In addition, the physiotherapist prefers not to act manually, as he has no measure of the range of motion he determines on the ankle during treatment, and is therefore unable to ensure that the imposed movements are within certain ranges defined by the clinician in the case of post-traumatic rehabilitation, or determined by the mechanics of the implanted prosthesis (e.g. 'Range Of Motion' or ROM) in the case of post-surgical rehabilitation.

[0007] In this context, the rehabilitation of the ankle by means of motorised devices is particularly problematic due to certain peculiar characteristics presented by the tibio- tarsal joint in comparison to the larger joints such as shoulder, elbow, hip and knee. While the latter, in fact, can be considered 'isolated', i.e., relatively distant from other joint complexes, the movements of the foot-ankle complex (e.g., dorsiflexion and plantarflexion) are produced by the biomechanical synergy of the tibio-tarsal joints, subastragalic joints, and the Chopart and Lisfranc joint complexes, all of which are adjacent to the tibioperoneal-astragalic mortise.

[0008] Because of this synergy, it becomes complex to be able to mobilise the tibiotarsal joint without also mobilising all the other joints involved in the movements of the foot and, consequently, it becomes difficult to carry out a selective recovery of this joint. If the movement is dispersed, in fact, over several joint planes, the effective mobilisation of the ankle is reduced and, therefore, the effectiveness of the treatment.

[0009] The documents US9603768, KR10-2019-0092918, CN109498367, RU2658760, in particular, describe devices designed to rotate the foot with respect to the tibia by means of a rotary motor with a rigid transmission, possibly considering the possibility of making the axis of actuation coincide with that of the ankle joint by means of an additional motor (CN109498367). Also documents CN105476819, CN108542703, CN107803820, while considering the movement of the axis of the joint, do not take into account the compensatory motions of the midfoot. In all the cases mentioned, and in general for all the devices of the known art of which we are aware, since there is no restriction on the mobilisation of the hindfoot and midfoot, several joints are mobilised in addition to that of the ankle, making the latter joint absorb only part of the imposed ROM. This makes it effectively impossible to accurately assess the range of motion imparted to the ankle during the rehabilitation session, as well as to assess the actual state of the ankle in terms of ROM recovered during the rehabilitation period, making the effectiveness of the treatment itself doubtful.

[0010] OBIECTS AND SUMMARY OF THE INVENTION

[0011] The object of the present invention is, therefore, to provide an ankle mobilisation device that allows the joint to be mobilised selectively by excluding the other joints of the foot from movement, thereby improving the effectiveness of rehabilitation treatment.

[0012] This object is achieved by a device comprising:

[0013] - a frame;

[0014] - a calcaneal support configured for accommodating a user's ankle, said ankle being equipped with a dorsiflexion / plantarflexion axis of rotation;

[0015] - a retention system of a leg of the user of the device, configured for preventing and / or reducing leg movement;

[0016] - means for actuating comprising a motor and a coupling configured for coupling the motor with the calcaneal support.

[0017] The coupling is provided with at least one translational degree of freedom in the direction of the actuation axis and no degree of freedom in torsion, so as to compensate for misalignments between the actuation axis and the axis of rotation (x). The coupling also has a further two translational degrees of freedom in the transverse directions and two rotational degrees of freedom in flexion.

[0018] Calcaneal support, on the other hand, comprises: a rigid casing; and a deformable filler positioned within the rigid casing and such that it can be conformed to the shape of a user's calcaneus.

[0019] The joint, whereby the motor rotates only the calcaneal support and thus only the ankle joint, may be an elastic joint or a homokinetic joint. Both can absorb any misalignment between the axis of the motor and that of the ankle joint. Making the two axes 'rigidly' coincide would be complex, and possibly harmful, because of the difficulty in identifying the axis of instantaneous rotation of the ankle joint, which in any case does not remain fixed during its movement. The elastic joint, as well as the homokinetic joint, if appropriately chosen, allow, therefore, to compensate for this difference, guaranteeing the transmission of the drive torque to the ankle joint, without forcing it into incorrect movements, limiting losses and thus improving the effectiveness of the treatment.

[0020] The particular structure of the calcaneal support, which, as mentioned above, is divided into a rigid outer part and a deformable inner filler that can be customised to the patient, makes it possible to compensate for the differences in shape between the foot and the rigid outer part, thus allowing it to grip and adhere solely to this part of the foot (calcaneus) so as to be integral with it and transmit movement directly to it, without loss of torque, which in turn is transmitted by the joint.

[0021] A second object of the present invention is to ensure the safety of the mobilisation treatment. This object is achieved by the present invention due to the presence of the elastic joint, as well as the homokinetic joint, since any misalignment, poorly or uncompensated, between the axis of the actuation system and the axis of the ankle joint could pose a risk to safety.

[0022] A third object of the present invention is, then, to ensure stability in the grip of the calcaneus. This third object is achieved by means of the particular conformation of the calcaneal support itself, since this adheres to the calcaneus thanks to the deformable filler which compensates for the differences between the rigid external part and the foot.

[0023] A fourth object of the present invention is, then, to provide a device for ankle mobilisation which provides a high degree of comfort. This object is achieved by the present invention thanks to the presence, in the calcaneal support, of the deformable filler, which, being soft and customisable to the patient's foot, constitutes an extremely comfortable interface with the limb.

[0024] Last but not least, object of the present invention is to improve the accuracy of ankle recovery monitoring. This object is achieved by the present device, thanks to the possibility of exclusively mobilising the tibio-tarsal joint without the involvement of the midfoot and forefoot. In this way, it becomes possible to more accurately measure the actual ROM imposed on the ankle and, thus, monitor functional recovery with greater accuracy.

[0025] These and further features of the present invention will be made clearer by reading the following detailed description, relating to some preferred embodiments of the present invention, to be considered by way of a non-limiting example of the more general concepts claimed.

[0026] BRIEF DESCRIPTION OF THE DRAWING

[0027] The following description refers to the accompanying drawings, in which:

[0028] - Figure 1 is a perspective view of a device according to the present invention together with a schematic representation of the limb whose ankle is to be mobilised;

[0029] - Figure 2 is a perspective view of a detail of the device of the present invention consisting of the frame;

[0030] - Figure 3a is a perspective view of a detail of a first embodiment of a device according to the present invention consisting of the means for actuating;

[0031] - Figure 3b is a cross-section of a detail of a first embodiment of a device according to the present invention consisting of the means of actuating;

[0032] - Figure 3c is a perspective view of a detail of a first embodiment of a device according to the present invention consisting of the joint and the means for rigidly transmitting motion from the joint to the calcaneal support;

[0033] - Figure 4a is a perspective view of a detail of a second embodiment of a device according to the present invention consisting of the joint and the means for rigidly transmitting motion from the joint to the calcaneal support;

[0034] - Figure 4b is a front view of a detail of a second embodiment according to the present invention consisting of the joint and the means for rigidly transmitting motion from the joint to the calcaneal support;

[0035] - Figure 5 is a perspective view of a detail of the present invention relating to calcaneal support;

[0036] - Figure 6 is a perspective view of a detail of a first embodiment of the present invention together with a schematic representation of the foot whose ankle is to be mobilised, said detail being relative to the assembly comprising the calcaneal support from the joint as well as the means for rigidly transmitting motion from the joint to the calcaneal support;

[0037] - Figure 7 is an exploded view of the joint of a first embodiment of the device according to the present invention, together with a schematic representation of the foot whose ankle is to be mobilised, the foot being positioned in the calcaneal support;

[0038] - Figure 8 is an exploded view of the joint of a second embodiment of the device according to the present invention, together with a schematic representation of the foot whose ankle is to be mobilised, the foot being positioned in the calcaneal support; and

[0039] - Figure 9 is an exploded view of a detail of a first embodiment of the present invention together with a schematic representation of the foot whose ankle is to be mobilised, said detail relating to the assembly comprising the calcaneal support from the joint, as well as the means for rigidly transmitting motion from the joint to the calcaneal support.

[0040] DETAILED DESCRIPTION OF THE INVENTION

[0041] With reference to Figures 1, 2, 3a, 3b, 3c, 5, 6, 7 and 9, a first embodiment of the device (100) of the present invention comprises:

[0042] - a frame (10, 10', 11, 12, 12', 13, 16) comprising a retention system (13, and / or reducing movement of the leg (200);

[0043] - a calcaneal support (31', 31", 32, 33, 34, 35, 36", 37) configured for accommodating a user's ankle, said ankle being provided with an axis of rotation (x) of dorsiflexion / plantarflexion;

[0044] - means for actuating (21, 22, 23, 24', 25, 26) comprising a motor (25) configured for generating a rotation about an actuation axis and an elastic joint (26) placed between the motor (25) and the calcaneal support (31', 31", 32, 33, 34, 35, 36", 37);

[0045] - coupling / uncoupling means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 25, 26) to the frame (10, 10', 11, 12, 12', 13, 16); and

[0046] - means for fixing the leg (200) to the frame (10, 10', 11, 12, 12', 13, 16) consisting of Velcro® strips.

[0047] The frame (10, 10', 11, 12', 13, 16), in turn, comprises:

[0048] - a base (11) which may comprise the electronic components necessary for the operation and control of the device (100);

[0049] - a first pair of rods (10, 10') tiltable in relation to the base (11);

[0050] - a second pair of rods (12, 12') configured for adjusting the height of the support structure (13), the rods (12, 12') of said second pair being hinged to the rods (10, 10') of the first pair and the base (11) comprising a guide (11, 11') for each rod (12, 12') of the second pair, each guide (11, 11') being configured for sliding one end of a rod (12, 12') of the second pair.

[0051] The height adjustment of the support structure as well as its inclination adjustment by means of the second (12, 12') and first pair (10, 10') of rods, respectively, allow the device (100) to be used in both the lying and sitting positions and enable the patient himself to easily change the configuration of use independently each time he intends to carry out a rehabilitation session, thus ensuring that the device (100) can also be used at home. The retention system (13, 16) is hinged to the frame (10, 10', 11, 12, 12', 13, 16), and comprises: a support structure (13) having a variable inclination by means of a knob (14) positioned at a joint connecting the support structure (13) with a rod of the first pair (10, 10'), and a moving element (16) shaped to wrap around the thigh of the user. Once seated, or lying down, the patient should rest the tibia on the support structure (13), securing it to it by means of the means for fixing the leg (200) to the frame (10, 10', 11, 12, 12', 13, 16), i.e., by means of Velcro® straps not shown in the figures. The use of such bands is important so as not to compromise the effectiveness of the means for actuating (21, 22, 23, 24', 25, 26) and, more generally, of the device (100) which must bring the foot (300) into rotation around the axis (x) of the ankle joint, without the tibia moving, or even tending to rise from the support structure (13). The moving element (16) shaped to wrap around the user's thigh further prevents movement of the tibia and its removal from the support structure (13) during treatment, thus providing greater stability in motion.

[0052] The calcaneal support (31', 31", 32, 33, 34, 35, 36", 37), in turn, comprises:

[0053] - a rigid casing (31', 31") subdivided into two components (31', 31") placed at varying distances depending on the foot size (300) of the user said two components (31', 31") being approachable / removable by means of a screw / screwdriver system (36', 36");

[0054] - a deformable filler (32) coupled to a silicone footbed (33) positioned within the rigid housing (31', 31") and such that it can be conformed to the shape of a user's calcaneus; and

[0055] - Velcro® straps (34) configured for wrapping around the foot (300) dorsally. In addition, pins or pivots can be added in the plantar area to ensure correct alignment between the parts. The rigid casing (31', 31"), moreover, can be designed in such a way that, in the case of anterior prosthesis implantation, a wound in the dorsal area of the foot and anterior area of the ankle is left free. For this object, the anterior flaps of the casing (31', 31") are designed so as not to cover these areas. Rather than having a casing (31', 31") for each new patient, this is made by size and the difference in shape with respect to the foot (300) wearing it is bridged by the deformable filler (32) made, for example, from polyurethane foam, memory foam, or consisting of an inflatable chamber. To increase the adhesion between the parts, as mentioned above, a silicone footbed (33) can also be used. Once the filler (32) has been formed and the two components (3T) and (31") of the rigid casing (3T, 31") have been sufficiently tightened, the Velcro® band (34) can be closed between the loops (38, 38') so that the calcanear support (31', 31", 32, 33, 34, 35, 36', 36", 37) is completely integral with the foot (300). An important advantage associated with the deformable, customised filler (32) concerns its adaptability even when the foot begins to deflate with time after surgery. If differences in shape can no longer be bridged, it will be sufficient to use a new filler (32), rather than a new calcaneal support (31', 31", 32, 33, 34, 35, 36", 37) in its entirety.

[0056] The elastic joint (26) is equipped with at least one degree of freedom translational in the direction of the actuation axis, and no degree of freedom in torsion, so as to compensate for misalignments between the actuation axis and the axis of rotation (x).In addition to the elastic joint (26) and the motor (25), the means for actuating (21, 22, 23, 24', 25, 26) comprise:

[0057] - an engine position adjustment system (22', 24");

[0058] - a first housing (21) configured for accommodating the motor position adjustment system (22, 24', 24");

[0059] - a second housing (23) configured for accommodating the motor (25);

[0060] - means for rigidly transmitting motion (27) to the calcaneal support (31', 31", 32, 33, 34, 35, 36", 37), said means for rigidly transmitting motion (27) being interposed between the joint (26) and the calcaneal support (31', 31", 32, 33, 34, 35, 36", 37) of the foot (300); and

[0061] - a shaft (28) for transmitting motion from the coupling (26) to the means for rigidly transmitting motion (27).

[0062] The motor position adjustment system (22, 24') comprises, in turn, a rod (22) configured for slinding in a first direction, the first direction being lying on a sagittal plane and being parallel to a longitudinal axis of the leg (200) and in a second direction, the second direction being coplanar with the first direction being perpendicular to said longitudinal axis. A first guide (24') configured for sliding the leg (22) in the first direction and a second guide (24') configured for sliding the leg (22) in the second direction are positioned within the first housing (21). The two guides (24', 24"), mounted at 90°, allow continuous adjustment of the motor position in the sagittal plane (yz) by means of two knobs (51, 51'). It thus becomes possible to bring the motor axis (25) as closely aligned as possible with that (x) of the ankle joint. However, the elastic coupling (26) allows the torque to be transmitted even if the motor axis (25) and the axis (x) of the ankle joint are misaligned.

[0063] The means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 24", 25, 26) comprise a seat (15) for coupling / uncoupling (15) by means of a double-T profile component. The same seat (15) is located on both the right and left side, (not visible in the figures), so that a single device can be used for rehabilitative treatment of both the right and left foot, simply by moving the means for actuating (21, 22, 23, 24', 24", 25, 26), in the appropriate side of the frame (10, 10', 11, 12, 12', 13, 16) by positioning the leg (200) relative to the foot (300) to be treated, in the retention system (13, 16).

[0064] The means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 24", 25, 26) further comprise magnets (30) configured for preventing axial sliding of the shaft (28), said magnets (30) being inserted in a special holder (29) and being configured for preventing axial sliding of the shaft (28).

[0065] The means for rigidly transmitting motion (27), can also be coupled to the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37) by means of an interface component (35), provided with a slot (35') which allows the movement of the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37). The component (35) can be housed in one of the two slots on either side of the two parts of the rigid housing, depending on the foot (300) to be treated, adjusted by means of the knob (37) and fixed.

[0066] With reference to Figures 1, 2, 4a, 4b, 3c, 5, 8, a second embodiment of the device of the present invention comprises all the components of the first embodiment of the present invention with the only exception of the elastic joint, which in the second embodiment is replaced by a constant velocity joint (40, 41, 42, 43, 44, 40', 41', 42'). The second embodiment of the device of the present invention therefore comprises:

[0067] - a frame (10, 10', 11, 12, 12', 13, 16) comprising a retention system (13, 16) of a leg of the user of the device (100), configured for preventing and / or reducing movement of the leg (200);

[0068] - a calcaneal support (31', 31", 32, 33, 34, 35, 36", 37) configured for accommodating a user's ankle, said ankle being provided with an axis of rotation (x) of dorsiflexion / plantarflexion;

[0069] - means for actuating (21, 22, 23, 24', 25, 26) comprising a motor (25) configured for generating a rotation about an actuation axis and a constant velocity joint (40, 41, 42, 43, 44, 40', 41', 42') placed between the motor (25) and the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37);

[0070] - means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 25, 26) to the frame (10, 10', 11, 12, 12', 13, 16); and

[0071] - means for fixing the leg (200) to the frame (10, 10', 11, 12, 12', 13, 16) consisting of Velcro® strips.

[0072] The constant-velocity joint (40, 41, 42, 43, 44, 40', 41', 42') comprises, in turn, a first cardan joint (40, 41, 42), a second cardan joint (40', 41', 42') and a prismatic joint (43, 44) interposed between the first (40, 41, 42) and the second cardan joint (40', 41', 42'), the first cardan joint (40, 41, 42) being connected to the engine (25) and the second cardan joint (40', 41', 42') being connected to the means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 25, 26) to the frame (10, 10', 11, 12, 12', 13, 16). If the double cardan joint (40, 41, 42, 40', 41', 42'), similarly to the elastic joint (26) of the first embodiment has the function of absorbing any misalignment between the axis of actuation and the axis of rotation (x) of the ankle, the prismatic joint (43, 44), guaranteeing a translational degree of freedom in the direction of the axis of actuation allows the self-adjustment of the position of the motor with respect to the point of connection, along the axis of the motor itself (25), to the means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 25, 26) to the frame (10, 10', 11, 12, 12', 13, 16). More particularly, the constant velocity joint (40, 41, 42, 43, 44, 40', 41', 42') of the second embodiment of the device of the present invention is structured as described below. After the motor shaft (25) there is a first cardan joint (40, 41, 42) comprising a spider (41) interposed between two forks (40, 42); the second fork (42) is made integral by forced coupling to a telescopic shaft provided with an end stop (43), which transmits motion to the second cardan joint (40', 41', 42'). Similar to the first embodiment, a suitably formed shaft (28) is forced onto the first fork (40') of the second cardan joint (40', 41', 42'). Also keyed to this are the support (29) for the magnet (30) and the means for rigidly transmitting motion (27), by means of form fit coupling, to the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37).

[0073] Based on what has been described, the operation of the device in its various embodiments can be summarised as follows:

[0074] - wearing of the calcaneal support (31', 31", 32, 33, 34, 35, 36", 37), in which the silicone footplate (33) and the deformable filler (32) have already been inserted;

[0075] - adjusting of the two components (31') and (31") of the outer rigid casing with the knob (36), making the filler deform and adhere correctly to the foot (300), also in the plantar area;

[0076] - adjusting the position of the interface component (35) by means of the knob (37) in order to align the axis of the actuator system with that of the ankle as far as possible;

[0077] - adjusting height and tilt of the retention system (13, 16) by means of the rods (12, 12') and the knob (14), depending on whether the patient wants to use it in a seated or lying position;

[0078] - connecting of the means for actuating (21, 22, 23, 24', 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') to the frame (10, 10', 11, 12, 12', 13, 16);

[0079] - once the patient is in position, moving the axis of actuation by means of the two knobs (51, 51') on the outside of the housing (21) which contains the first guide (24') configured for sliding the rod (22) in the first direction and the second guide (24") configured for sliding the rod (22) in the second direction, until it coincides with the interface component (35) of the calcaneal support (31'z31", 32, 33, 34, 35, 36", 37);

[0080] - connecting the means for actuating (21, 22, 23, 24', 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') to the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37) by means for rigidly transmitting motion (27) and the interface component (35);

[0081] - fastening the Velcro® band (34) on the calcaneal support (31', 31", 32, 33, 34, 35, 36", 36", 37) and fixing the tibia to the support structure (13);

[0082] - closing of retention system (13, 16) per leg; and

[0083] - switching on the device (100).

[0084] Thanks to the above-described procedure, the device of the present invention can be used for rehabilitation treatments for the functional recovery of the ankle both in the post-operative period (rehabilitation sessions, in fact, start a few days after surgery to prevent the mechanical parts of the prosthesis from stiffening) and after an injury. Moreover, rehabilitation can be either passive or active: in the former case, the mobilisation of the joint takes place according to predefined kinematic patterns in order to increase the range of motion of the ankle joint, possibly up to the maximum allowed by the implanted prosthesis; in the latter case, on the other hand, the patient moves the ankle autonomously and the interaction forces between the parts are measured in order to modulate the exercise itself in accordance with the patient's progress. In fact, if appropriately sensorised by means of encoders and load cells, the device can monitor the mobility of the ankle, measuring the ROM that the patient achieves at each session, and the interaction forces, it can record the rehabilitation sessions performed, and thus allow an appropriate assessment of the clinical state of the ankle (even possibly in the preoperative phase).

Claims

CLAIMS1. Device (100) for ankle mobilisation comprising:- a frame (10, 10', 11, 12, 12', 13, 16);- a retention system (13, 16) of a leg of the user of the device (100), configured for preventing and / or reducing the movements of the leg (200);- a calcaneal support (31', 31", 32, 33, 34, 35, 36", 37) configured for accommodating a user's ankle, said ankle being provided with an axis of rotation (x) of dorsiflexion / plantarflexion;- means for actuating (21, 22, 23, 24', 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') comprising a motor (25) configured for generating a rotation about an actuating axis and a joint (26, 40, 41, 42, 43, 44, 40', 41', 42') placed between the motor (25) and the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37); characterized in that the calcaneal support (31', 31", 32, 33, 34, 35, 36", 36", 37), in turn, comprises: a rigid casing (31', 31"); a deformable filler (32) positioned within the rigid casing (31', 31") and such that it can be conformed to the shape of a user's calcaneus; and in that:- the joint (26, 40, 41, 42, 43, 44, 40', 41', 42') is equipped with at least one degree of freedom translational in the direction of the actuation axis, and no degree of freedom in torsion, so as to compensate for misalignments between the actuation axis and the axis of rotation (x).

2. Device (100) according to claim 1, wherein the retention system (13, 16) comprises:- a support structure (13) having a variable inclination; and- a moving element (16) shaped to wrap around a thigh of the user.

3. Device (100) according to claim 1 wherein the joint (26, 40, 41, 42, 43, 44, 40', 41', 42') is an elastic joint (26).

4. Device (100) according to claim 1 wherein the joint (26, 40, 41, 42, 43, 44, 40', 41', 42') is a constant velocity joint (40, 41, 42, 43, 44, 40', 41', 42') comprising a first cardan joint (40, 41, 42), a second cardan joint (40', 41', 42') and a prismatic joint (43, 44) interposed between the first (40, 41, 42) and second cardan joint (40', 41', 42').

5. Device (100) according to any one of the preceding claims in which the rigid casing (31', 31") is divided into two components (31', 31") placed at a variable distance depending on the size of the foot (300) of the user said two components (31', 31") being approachable / removable by means of a screw / mother system (36', 36").

6. Device (100) according to any one of the preceding claims, wherein the frame (10, 10', 11, 12, 12', 13, 16) comprises:- a base (11);- a first pair of rods (10, 10') tiltable with respect to the base (11);- a second pair of rods (12, 12') configured for height adjusting of the support structure (13), the rods (12, 12') of said second pair being hinged to the rods (10, 10') of the first pair and the base (11) comprising a guide (11, 11') for each rod (12, 12') of the second pair, each guide (11, 11') being configured for sliding one end of a rod (12, 12') of the second pair.

7. Device (100) according to any one of the preceding claims, comprising means for coupling / uncoupling (15, 27, 28, 29, 30) of the means for actuating (21, 22, 23, 24', 24", 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') to the frame (10, 10', 11, 12, 12', 13, 16).

8. Device (100) according to any of the preceding claims wherein the means foractuating (21, 22, 23, 24', 25, 26, 40, 41, 42, 43, 44, 40', 41', 42') comprise:- an motor position adjustment system (22', 24");- a first housing (21) configured for accommodating the motor position adjustment system (22, 24', 24");- a second housing (23) configured for accommodating the motor (25) and coupling (26, 40, 41, 42, 43, 44, 40', 41', 42'); and- means for rigidly transmitting motion (27) to the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37), said means for rigidly transmitting motion (27) being interposed between the joint (26, 40, 41, 42, 43, 44, 40', 41', 42') and the calcaneal support (31', 31", 32, 33, 34, 35, 36', 36", 37) of the foot (300); and- a shaft (28) for transmitting motion from the joint (26) to the means for rigidly transmitting motion (27).

9. Device (100) according to any preceding claim, wherein the motor position adjustment system (22, 24', 24') comprises a rod (22) configured for translating in a first direction, the first direction being lying on a sagittal plane and being parallel to a longitudinal axis of the leg (200), and in a second direction, the second direction being coplanar with the first direction and being perpendicular to said longitudinal axis.

10. Device (100) according to any preceding claim wherein a first guide (24') configured for sliding the rod (22) in the first direction and a second guide (24") configured for sliding the rod (22) in the second direction are positioned within the first housing (21).

11. Device (100) according to any one of the preceding claims wherein the means for coupling / uncoupling (15, 27, 28, 29, 30) comprise a seat (15) for coupling / uncoupling by means of a double-T profile component.

12. Device (100) according to any one of the preceding claims wherein the means for coupling / uncoupling (15, 27, 28, 29, 30) comprise magnets (30).

13. Device (100) according to the preceding claim, wherein the magnets (30) are, in addition, configured for preventing axial sliding of the shaft (28).

14. Device (100) according to any one of claims 5 to 13, wherein the calcaneal support (31', 31", 32, 33, 34, 35, 36", 36", 37) comprises:- a silicone footbed (33);- Velcro® straps (34) configured for wrapping around the foot (300) dorsally;- an interface component (35), configured for coupling to the means for rigidly transmitting motion (27), said interface component (35) being provided with a slot (35') allowing displacement of the calcaneal support (31', 31", 32, 33, 34, 35, 36", 36", 37) with respect to the motor (25).

15. Device (100) according to any one of the preceding claims comprising means for attaching the leg (200) to the frame (10, 10', 11, 12, 12', 13, 16) consisting in Velcro® strips.

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