Description

The present invention refers, in general, to an orthopedic medical device. More particularly, the present invention refers to an orthopedic medical device for a universal use in fixed or mobile orthopedic guardians as well as in the therapy of foot pathologies.

As is known, in the use of fixed or mobile orthopedic guardians in general, and in particular prostheses, orthopedic corsets, knee-guards, orthopedic knitted correctors, collars, wristbands, helmets and the like, pathologies of orthopedic type are possible.

In the treatment of said pathologies as well as in the therapy of foot pathologies it is possible to use orthopedic guardians, plantar soles or other similar devices which are subjected to modifications or simple wear and tear in the long run.

Owing to alterations such as a formation of decubitus zones or compression zones, or yielding in the articulations or in the loading points of the foot, said orthopedic guardians or plantar soles are no more tolerated by the patient or user because the patient or user feels so sharp pains (plantalgies) that are unbearable.

In order to solve said problem, the patient or user has to substitute the used orthopedic guardian or plantar sole repeatedly by a new device.

Thus, there is the need of intervening effectively and rapidly in order to predispose a different orthesis anatomy without substituting or destroying the orthopedic guardian or medical podotherapic device already predisposed or worn by the patient or user.

An object of the invention is to remove the above-mentioned inconveniences and still others through an orthopedic medical device that ensures a wide possibility of varying, reconstructing or, in any case, modifying the orthesis anatomy of an orthopedic guardian, a medical podotherapic device or the like, also with an immediate or gradual intervention according to the evolution of the therapy in course and without interruptions in the treatment.

Another object of the invention is to provide a medical orthopedic device ensuring an optimal adaptability of an orthesis anatomy obtainable also for subsequent approximations, according to the specific requirements of each single case, in decubitus and compression zones causing pain or in zones that need to be isolated and protected.

Another object of the invention is to provide a medical orthopedic device that is washable and/or sterilizable and/or replaceable and is capable of ensuring the maintenance of hygienic conditions in each intervention area or otherwise positionable in order to be adapted to a changed condition of the area to be protected.

All the above-mentioned objects and still others are reached according to the invention through an orthopedic medical device which comprises an orthesis structure which has at least one external wall to be anchored to a face or wall of an orthopedic guardian adapted to directly or indirectly contact an area of a body limb or bodypart to be protected.

In the medical orthopedic device according to the present invention, the orthesis structure comprises, preferably, at least one external wall which is anchored removably to the face of the orthopedic guardian.

Preferably, the at least one external wall comprises a layer of grasping or graspable material which grasps or is grasped to said face of the orthopedic guardian which comprises a graspable or grasping material, respectively.

According to a preferred embodiment, the external wall comprises removable male or female engaging means which cooperate with removable female or male engaging means, respectively, which are provided on the face of the orthopedic guardian.

Advantageously, the orthopedic medical device is at least partially configured as an orthesis map with removable zonal islands and ortheses for the formation of anatomical discharges and/or inserts.

According to a preferred embodiment, the orthesis structure comprises a layered structure consisting of at least one supporting layer and at least one diecut layer defined by removable islands or zones.

According to this last embodiment, preferably said supporting layer comprises a diecut layer and a covering element in a graspable material, joined to each other. In particular, said diecut layer comprises:

- a grasping layer turned toward the graspable material of the diecut layer for a removable fixing;

- a layer of soft or rigid or semirigid material,

- a covering layer.

Said diecut layer and said covering element are jointed to each other in correspondence of the peripheral edge of the hollow punch.

Typically, the orthesis structure is in a rigid or semi-rigid or elastically yielding material.

The layers of grasping material, soft, rigid or semirigid material and covering material are bound or coupled together.

Further features and details of the invention will be better understood from the following specification which is provided by way of a non-limiting example, as well as from the annexed drawings, wherein:

Fig. 1 is a plan view of a plantar sole bearing an orthesis element according to the invention;

Fig. 2 is a side view of the plantar sole in Fig. 1 ;

Fig. 3 is a view in section in a slightly enlarged scale taken along the trace in Fig. 1 ;

Fig. 4 represents another embodiment of the plantar sole, an orthesis element according to the invention being applied thereon,

Fig. 5 is a view in section and in an enlarged scale taken along the trace V- V in Fig. 4;

Fig. 6 is a perspective view of an orthesis element to be anchored in a removable way to a plantar sole according to the invention;

Fig. 7 represents a plan view of another embodiment of an orthesis structure made of an elastically yielding material to be anchored in a removable way to a plantar sole according to the invention;

Fig. 8 is a view in section taken along the trace VIII-VIII in Fig. 7;

Fig. 9 shows another embodiment of a mobile orthesis element made of a semirigid material;

Fig. 10 represents a view in section taken along he trace X-X in Fig. 9;

Fig. 1 1 is a partial plan view of the calcaneal portion of another embodiment of the plantar sole according to the invention;

Fig. 12 shows a section taken along the trace XII-XII in Fig. 11 ;

Fig. 13 shows a first embodiment of the plantar sole having an orthesis map; Fig. 14 is a view in section and in an enlarged scale taken along the trace XIV-XIV in Fig. 13;

Figures 15, 16 and 17 shows respective embodiments of plantar soles having an orthesis map;

Fig. 18 is a partial view in section and in an enlarged view taken along the trace XVIII-XVIII in Fig. 17;

Fig. 19 shows another embodiment of a plantar sole having an orthesis plan;

Fig. 20 is a view in partial section and in enlarged scale taken along the trace XX-XX in Fig. 19; and

Fig. 21 is a perspective view of a shoe with an internal calcaneal orthesis band according to the invention, provided with one or more corrective buttresses.

With reference to the annexed drawings, reference number 1 denotes a plantar sole 1 on the whole which is formed by a support 2 which consists of one or more layers of a suitable material such as cardboard, leather, plastic material, and in case shaped so as to be adapted to the foot anatomy, as is usual in the shoe manufacture, as well as a covering layer 3 which covers at least its face, which is designed to support the foot of the user, the covering layer 3 being formed, for example, by a fabric, a non-woven fabric, or the like, and is glued to the support 2.

One or more orthesis elements or inserts 4 can be applied to the covering layer 3 and have the desired anatomic configuration. Each orthesis element or insert consists of one or more layers or bodies or globes of a rigid material (which may be formed by or may include metal elements or metallic alloys, for example copper, aluminum, or ferromagnetic components), or a semi-rigid material such as leather, wood, cork, PVC (polyvinylchloride), polypropylene, polyethylene, polyesther, ETV, EVA (ethylvinylacetate), polyvinylacetate, acrylic materials and soft, elastically yielding materials such as rubber, elastomeric cork-rubber plastic materials, polyethylene sponge, rubber sponge with opened cells and/or microcellular rubber sponge, silicone, felts and the like, and at least one external wall applied thereto so as to be applied removably to the face or wall 3 of the plantar sole 1.

If a plurality of orthesis elements or inserts 4 of different orthesis configuration is provided, it is possible to obtain, on a plantar sole, a template or fussbet of whatever shoe (a normal shoe, a sport shoe, an orthopedic shoe), an orthesis configuration which is modifiable according to the need of the user because it is formed by orthesis elements or inserts 4 which are removable and repositionable.

Figures 4 to 6 show a flat plantar sole or sole 5 formed by three layers, namely, a cardboard layer 6 acting as a supporting surface for the user foot, an intermediate layer 7 in a plastic material, for example polyurethane foam, and a covering 8 in a grasping material of any suitable type, for example of self-adhesive type to be applied to the lower face of the sole or plantar sole. One or more orthesis inserts 9 may be applied to the grasping layer 8, in both the calcaneal zone and the zones of the foot sole and foot toes, so as to form a desired orthesis configuration.

For example, each orthesis insert 9 may have a body 10 in elastically yielding material and at least one surface 11 covered by a fabric or other material on which the grasping layer 8 can ensure a secure removable grip.

In this embodiment, the orthesis inserts 9 are designed to be arranged in correspondence of the face of the plantar sole or sole 5 which, in use, is beneath so that the orthesis inserts 9 are hidden and can not be seen.

Further orthesis inserts of various anatomic-geometric configuration are shown in Figures 7 to 12. The orthesis insert 12 of Figure 7 and 8 is typically formed, as the orthesis inserts 4 and 9, by a three-layer structure, namely, an upper covering layer 13 in fabric, non-woven fabric, or the like, an intermediate tridimensional layer 14, for example in elastically yielding material, such as rubber, latex, and the like, and a lower layer 15 in a grasping material, said layers being sewn, in case, together along the border of the orthesis insert.

The orthesis insert 16 (Figures 9 and 10) has a parallelepiped configuration and is formed by two layers: for example, on layer in a semirigid or elastically yielding material 14 and the other layer in a gripping material 15.

Figures 11 and 12 show an orthesis insert 17 which is configured so as to grasp and interest the whole peripheral band of the calcaneal zone of a plantar sole or sole 17, and has a cross section which is decreasing from the periphery to the inside, as shown in Figure 12.

Obviously, orthesis inserts showing a structure as described above may be used in various sectors in addition to the podiatric sector, the orthopedic sector and the medico-chirurgical sector, also in the aesthetic sector, sport sector, physiotherapy and rehabilitation sector and in the shoe industry in general.

In the podiatric sector, orthesis inserts according to the invention may be used, for example in connection with all the problems connected to corns, hyperkeratosis, ingrown nails, and also in all those morbid pathologies and non- morbid pathologies in which it is necessary to modify the posture condition of the foot (valgus or varius heel, twisted or supine or prone forefoot) with corrective effect also of anomalies of the lower limbs as concerns the knee or the femoral rotation, as in the case of a gait with toes turned inwards or outwards, in the case of a varius shinbone, valgus or varius knee or femoral antinversion.

Concerning the sole of the foot, targeted corrections are possible with immediate effect on the fore, medial and rear plantalgia. To this end, it is possible to provide map plantar soles or map soles, for example as those that are shown in the Figures 13 to 20.

The structure of a map plantar sole or map sole 20 can be typically that shown in the Figures 13 and 14, in which a multi-layer structure is provided. More precisely, said multi-layer structure comprises a first support layer which, for example, is formed in turn by a leather die-cut 21 and a covering felt layer 22, which are sewn together along the peripheral border of the die-cut or coupled to each other differently, as well as a mapped layer or die-cut layer including three layers, namely a grasping layer 23 tuned toward the covering felt 22 to be fixed to it removably, a layer of soft, rigid or semi-rigid material 24, for example a plastic material, and a covering layer 25, for example a fabric, a felt, and the like.

For purely illustrative, non-restrictive purposes, the mapping as shown in Figure 16 will be described in detail here below, in which the various subdivision areas or islands of the plantar sole are marked with letters of the alphabet.

The islands "g" to "k" are provided to unload or support the metatarsal heads so as to avoid single or multiple metatarsalgia.

In correspondence of the island I (medial arch), it is possible to support or unload the head of the first (g), second (h+m) and third (n+i) metatarsus while in correspondence of the island "o" (lateral forefoot) it is possible to support or unload the third (n+i), the fourth (j) and the fifth (k) metatarsus as well as to correct the effects of the supination and the effects of all the forefoot anomalies that can affect this area of the foot.

The island "r" (medial plantar bend or longitudinal arch) may be corrective, compensative or stimulating for the structure of the plantar arch in all the cases, for example, of abnormal foot, hollow foot and flat foot. The island "r" may be associated to the island "I" for an effective orthesis correction of pathologies of the plantar arch such as yielding, rigidity, hyperextensions and hyperflexions of the first and second ray.

The island "s" (central-lateral zone of the medial plantar arch) is the supporting seat of the base of the fifth metatarsus and can be conveniently unloaded and corrected in case of a pathologic foot or a foot affected in this area by morbid or styloid processes. The island "s" may be advantageously associated to the island "o" for an effective correction of the whole middle-lateral foot by applying suitable orthesis inserts according to the invention.

The island "t" corresponds to the supporting seat of the calcaneal apophysis and can act as a discharge to the calcaneal spine for the treatment of talalgia or heel inflammations and the various pathologies of the heel, while the islands "u" and "v" correspond to areas of the calcaneal contour and allow through the insertion of suitable orthesis elements to compensate the asymmetries of the lower limbs as well as the abnormalities of support caused by a valgus or varius heel, varius shinbone, etc.

The island "p" can act as an unloading area for the medial plantalgia and the supporting seat corresponding to the sinus of the tarsus, or it can be corrected with an orthesis element in case of sprains or dislocations of all the ankle ligaments. The island "p" in association with the island "t" allows, for example, to unload the insertions of the plantar muscles and the aponeurosis in the calcaneal zone.

The island "q" is the separation zone between the middle foot and the forefoot and may be utilized together with the islands "I", "p" and " , or together with the islands "o" and "s", as reinforcement seat by means of orthesis medial or lateral inserts or as unloding seat for medial and lateral orthesis correctives.

The islands "a" to "e" are unloading zones for a respective foot toe, while the island "f may form an unloading zone or a supporting interdiaphyseal zone for any toe anomaly such as olinodattille, hammertoes, deformed toes.

In order to create an unloading zone in a plantar sole or sole 20, it is sufficient to "pull up" (Fig. 15) or remove the corresponding mapping island or remove a portion of layers 24 and 25 from the grasping layer 22, which portion can be, in case, utilized as insert in a neighboring island or elsewhere in the plantar sole or sole. This possibility of transposition of the map island involves that a plantar sole or sole 20 forms a "kit" of orthesis elements at disposal of the operator who can, therefore, intervene rapidly to personalize the plantar sole or sole in order to adapt it to the specific requirements of the anomalies or pathologies of the user.

Naturally, the anchoring means of an orthesis insert may be various. In addition to the grasping fabrics, said means may include the sewing, the closing by means of metal points, the hole-peg coupling 26 (Figures 17 and 18) or the coupling with approaching pegs (type Lego®) or through adhesion by magnetic attraction and others, the particular type of anchoring means being not determinant. However, it is preferable to use anchoring means which allow, if necessary, a removal of the orthesis insert so that it can be replaced with another orthesis element or it can be oriented differently.

The mapping of the orthopedic medical device can be also of the "geometrical" type, with holes, rhombuses, polygonal windows occupied in case by zones incorporating metal elements 31 (Figures 17, 18).

The removability of the orthesis elements according to the present invention forms a particularly advantageous feature because it makes possible to obtain, in a short time, the optimal orthesis configuration for the single user or patient while the optimal orthesis configuration can be often obtained only with successive approximations of conformation of the inserts and positioning or orienting of the inserts.

Besides being applied on plantar soles and insoles, an orthesis element according to the invention can be applied also to the internal wall of the upper or ankle boot of a shoe so that the orthesis element can, for example, take the configuration of a calcaneal medial or lateral buttress 30 (Figure 21 ), or can be applied to the internal front wall of ski boots for the protection of the shinbone.

In the medical field, orthesis elements according to the present invention can be used in decubitus or compression areas creating pain for the patient, and in any case in points where it is necessary to isolate areas to be protected for a rapid rehabilitation of the injured area.

In sports, orthesis elements according to the invention can be arranged inside a helmet, for example for one or more head areas affected by lesions or abnormalities.

In the orthopedic field, orthesis elements according to the invention can constitute modifications in general of orthopedic braces, prostheses, and orthopedic articles.

The thickness and the anatomic-corrective conformation of the various orthesis inserts according to the invention can be the most varied ones according to the specific application to which they are designed.

A technician of the sector can provide other modifications or variants which are to be considered as included in the scope of protection of the present invention.