HK1218383B - Proprioceptive orthosis for supporting a joint - Google Patents

Description

Proprioceptive orthosis for supporting a joint

Technical Field

The invention relates to a proprioceptive orthosis intended for supporting a joint of the human body. The invention has particular, but not exclusive, application to supporting a joint, such as a knee or elbow, without requiring any fixation of the joint. Such orthoses can be used to prevent chronic pain, or to relieve minor sprains, or even when work continues after an injury.

Background

Proprioceptive orthoses for knees differ from conventional knee supports in the presence of an adjuster, such as a "patellar plate" that supports the patella or a massage plate or guard that massages certain muscles. Such orthoses are described, for example, in patent applications US2006/0041214, US2010/0036303 and US2011/0160631, as well as in utility model application DE 20005663U 1. The orthoses described in these documents comprise a ring-shaped element made of foam, silicone rubber or TPU (thermoplastic polyurethane) to surround and support the patella.

These orthoses have a number of disadvantages. They are thick and particularly heavy, since they are manufactured using knitting machines which make it possible to obtain only knits which are not as thin as knits, i.e. comprising warp and weft yarns. Due to the high weight of the braids, it may be necessary to provide lateral reinforcement to prevent them from collapsing. Due to their greater thickness and the presence of reinforcement, they are uncomfortable under the trousers or even not suitable for wearing under the briefs. When the knees are repeatedly flexed, such as when running, they tend to slide down the thighs and calves, particularly due to their weight. In the utility model application DE 202010015972U 1, anti-slip surfaces are provided in the area of the joint and at the ends of the orthosis to avoid such slipping.

When the knee is bent, the folds inevitably formed in the popliteal region of the back of the knee overlap and may form a thickness of several millimeters, which may cause discomfort or even pain to the user. They often require the use of hook and loop fastening tapes to ensure adequate retention on the thigh and under the knee.

In addition, a well-known method also involves the use of polymer gel-based plates, such as silicone gel or hydrogel-based plates, for skin protection or load distribution. For example, to achieve the load distribution function, one well-known method involves the use of plates made of a relatively stiff silicone gel such as PDMS (polydimethylsiloxane). Patent FR 2712487 describes a silicone gel having properties similar to those of the foot sole, to prevent the appearance of ultra-high pressure pathologies substantially above or below the foot.

Disclosure of Invention

It is desirable to produce a thin orthosis that is particularly capable of relieving joint discomfort while ensuring that the orthosis remains in place. It is also desirable to be able to adjust the force exerted by the orthosis on the skin and underlying tissue, particularly near the joint.

Some embodiments relate to an orthosis comprising a sleeve made of woven elastic fabric and shaped to exert pressure on both sides of a limb and on a joint, and a plate comprising a viscoelastic polymer gel layer secured on the inner surface of the sleeve to directly contact the skin on the joint. According to one embodiment, the plate comprises a layer made of elastic fabric on which the layer of polymer gel is adhered, an annular portion shaped to surround the top of the protruding area of the joint and tabs extending from the outer edge of the annular portion in the axial direction of the sleeve, the plate being adhered to the skin so that, under the pressure exerted by the sleeve, when the sleeve is longitudinally stretched, the plate remains stretched and locally exerts a bearing force towards the centre of the protruding area of the joint to the underlying limb portion and a restoring force along the axis of the limb.

According to one embodiment, the plate is fixed to the sleeve only by the proximal sectors of the annular portion and by the portion comprising the distal sectors of the annular portion and the tabs.

According to one embodiment, the plate is fixed to the sleeve such that the outer edge of the annular portion of the plate remains free.

According to one embodiment, the plate is fixed to the sleeve along an inner edge of the annular portion.

According to one embodiment, the orthosis comprises two side pads comprising a viscoelastic polymeric gel layer and having the shape of a side sector of the plate, the side pads being fixed below the side sector of the plate by an assembly line extending radially with respect to the plate, the side edges of the pads remaining free.

According to one embodiment, said annular portion of said plate has an opening coinciding with a first opening formed in said sleeve, which opening is closed by a sheet material fixed to said sleeve and/or to said plate, said sheet material being made of a woven elastic fabric less than 0.3mm thick.

According to one embodiment, said sleeve comprises a second opening in a region diametrically opposite to said plate, which second opening is closed by a sheet made of woven elastic fabric less than 0.3mm thick.

According to one embodiment, the sheet closing the second opening formed in the sleeve is fixed to the sleeve so as to remain taut (tentue) regardless of the knee flexion.

According to one embodiment, the sleeve comprises adhesive elements along the proximal and distal edges on its surface intended to contact the skin to help hold the sleeve on the limb.

According to one embodiment, the adhesive elements are formed on bands fixed to the proximal and distal edges of the sleeve, said bands being made of the same elastic fabric as the fabric of the sleeve.

According to one embodiment, the strip of the adhesive element fixed to the proximal edge of the sleeve comprises two strips fixed together, the two strips having different lengths to adapt to the shape of the limb.

According to one embodiment, the thickness of the sleeve is less than 0.5mm and the thickness of the plate is less than 1 mm.

Some embodiments also relate to a method of manufacturing an orthosis, the method comprising the steps of: forming a sleeve from a woven elastic fabric, the sleeve being capable of exerting pressure on both sides of a limb and on a joint; forming a plate comprising a viscoelastic polymer gel layer, a layer of elastic fabric adhered to the polymer gel layer, an annular portion shaped to surround a top of the joint in a flexed position, and a tab extending from an outer edge of the annular portion; and fixing the plate on the inner surface of the sleeve to directly contact the skin on the joint, the tab being oriented in a distal direction of the sleeve, the plate being adhered to the skin such that under pressure applied by the sleeve, when the sleeve is longitudinally stretched, the plate remains stretched and locally applies a pulling force to the skin parallel to the surface of the skin towards the centre of the annular portion.

According to one embodiment, the plate is fixed to the sleeve by means of sutures, so that the side portions of the outer edge of the annular portion remain free.

According to one embodiment, the manufacturing method comprises the step of fixing, by means of an assembly line extending radially with respect to the plate, a pad under the lateral portions of the annular portion of the plate, the lateral edges of the pad remaining free, the pad comprising a viscoelastic polymeric gel layer and having the shape of the lateral sectors of the plate.

According to one embodiment, the manufacturing method comprises the step of fixing a sheet of woven elastic fabric having a thickness of less than 0.3mm to close the opening of the annular portion of the plate.

According to one embodiment, the manufacturing method comprises a step of forming an opening in the sleeve opposite the plate, and a step of fixing a sheet of woven elastic fabric having a thickness of less than 0.3mm to close the opening formed in the sleeve.

According to one embodiment, the sheet closing the second opening formed in the sleeve is fixed to the sleeve so as to remain taut regardless of the bending of the knee.

According to one embodiment, the manufacturing method comprises a step of moulding the plate, the mould forming spikes on the surface of the tab intended to come into contact with the skin, so as to increase the adhesion of the tab to the skin.

According to one embodiment, the manufacturing method comprises the step of fixing a band made of elastic fabric along the proximal and distal edges of the sleeve, said band comprising adhesive elements to help hold the sleeve on the limb.

Drawings

Some examples of embodiments of the invention will be described below, in conjunction with, but not limited to, the accompanying drawings, in which:

figure 1 is a front view of a knee orthosis according to one embodiment,

figure 2 is a front view of the orthosis of figure 1 placed on a right lower limb,

figure 3 is a rear view of an orthosis according to one embodiment,

figure 4 is a rear view of the orthosis of figure 1 placed on a right lower limb,

figures 5A, 5B show in sagittal section the bones of the right lower limb (ilium, femur, patella, tibia) with the knee extended and bent through 90 respectively,

figure 5C shows figures 5A and 5B stacked together,

figures 6A and 6B show the polymer gel sheet of the orthosis in two configurations depending on whether the knee is straight or curved respectively,

figure 7 shows a cross-section of the right knee,

figures 8A, 8B are schematic illustrations of transverse and longitudinal sections of an orthosis according to some embodiments along planes AA 'and BB' shown in figure 1,

figures 9A, 9B are schematic illustrations of transverse and longitudinal sections of an orthosis according to other embodiments along the planes AA 'and BB' shown in figure 1,

figure 10 shows a plate made of polymer gel according to another embodiment,

fig. 11A, 11B and 11C are schematic illustrations of transverse and longitudinal sections along the planes AA 'and BB' shown in fig. 1 and of the inner surface of an orthosis according to other embodiments.

Detailed Description

Fig. 1 and 2 illustrate a knee orthosis 10 according to one embodiment, and fig. 2 illustrates the orthosis installed on a right lower limb. Fig. 1 shows the orthosis in a medial-lateral configuration, the visible side being the side intended to contact the skin. The orthosis 10 comprises an elastic sleeve 14 and a plate 11, the plate 11 comprising a layer made of a viscoelastic polymer gel and being fixed on that side of the sleeve 14 intended to contact the skin. The sleeve 14 is shaped to exert pressure on the thigh, knee and lower leg. To this end, the sleeve 14 has a cylindrical shape with a variable diameter in the longitudinal direction of the sleeve, which is adapted to the diameter of the thigh base, knee and calf top in order to obtain the desired pressure at these different parts of the lower limb.

The plate 11 comprises an annular portion 11a and a tab 11b extending from the outer edge of the annular portion. In fig. 2, the plate is fixed to the inner surface of the sleeve 14 so that the annular portion and the tabs are in direct contact with the skin. The plate 11 is fixed in position in the sleeve 14 so that the annular portion 11a can surround the patella and the tabs 11b can overlie the anterior tibial tuberosity (fig. 2). The tab 11b thus extends in the distal direction of the sleeve 14. The annular portion 11a has an opening 12 and a width between the inner and outer edges (of the annular portion) of between 2 and 4cm, the opening 12 having a dimension slightly smaller than that of the patella. The tab 11b has a size slightly larger than the size of the tibial tuberosity. It should be noted that in this configuration, although the anterior tibial tuberosity is not centered about the longitudinal axis of the thigh passing through the center of the patella, it may not be necessary to produce different orthoses for the right and left knees. The thickness of the plate 11 on the thigh, knee and calf may be less than 0.5mm, for example between 0.35mm and 0.45 mm. The sleeve 14 is shaped so as to apply a pressure that conforms to the norm of the force.

The plate 11 is secured to the sleeve 14 by an assembly line, such as a suture. In the example of fig. 1, 2 and 6A, the panels 11 are fixed by means of assembly lines 13a, 13b, 13 c. The assembly line 13a is formed along a proximal portion of the outer edge of the annular portion 11a on about 1/4 circumferences thereof. The end of the assembly line 13a may be connected to the inner edge of the annular portion, but this is not essential. The assembly line 13b is formed along the entire inner edge of the ring portion 11 a. The assembly line 13c is formed on about 1/4 circumferences of the annular portion 11a along a distal end portion of the outer edge of the plate 11 including the edge of the tab 11 b. The end of the assembly line 13c may be connected to the inner edge of the annular portion, but this is not essential. In other words, the assembly lines 13a and 13c divide the plate, starting from the annular portion, into four sectors 12a to 12d (fig. 6A), namely a fixed proximal sector 12a, a fixed distal sector 12d comprising the tabs 11b and two lateral sectors 12b, 12c that are not fixed along the outer edge, each sector extending over about 1/4 circumferences of the annular portion 11 a. The assembly lines 13a, 13c are manufactured along the entire edges of the proximal and distal sectors 12a, 12 d. The outer edges of the side sectors 12b, 12c thus remain free. It should be noted that the assembly line 13b, which fixes the inner edge of the annular portion 11a to the sleeve, serves only to avoid forming any gaps and may therefore be omitted entirely or partly by leaving portions on the proximal and distal sectors 12a, 12 d.

Instead of being fixed by an assembly line, the proximal and distal sectors 12a, 12d of the plate 11 may be fixed to the sleeve 14 by a layer of adhesive, the side sectors 12b, 12c not being adhered to the sleeve 14.

The sleeve 14 may be made of a woven elastic fabric, such as an elastic polyamide fabric, in two perpendicular directions along the warp and weft of the fabric. Thus, the fabric forming the sleeve (along the fabric warp and weft) may have a maximum stretch of between 80% and 110%, for example equal to 95%, and an elastic modulus at 40% of between 5N and 7N, for example equal to 6N. The thickness of the fabric forming the sleeve may be less than 0.5mm, for example between 0.3mm and 0.45 mm. According to one embodiment, the sleeve 14 may be made to cover the thigh over a length of 18cm to 28cm (within ± 10%) from the axis of the patella.

The assembly lines 13a, 13b, 13c may be made of suture thread. The assembly line 13b may be formed by overlooking.

The plate 11 adheres to the skin such that under the pressure applied by the sleeve 14, when the sleeve is longitudinally stretched, the plate remains stretched and locally applies a pulling force to the skin parallel to the surface of the skin towards the centre of the annular portion. The opening 12 can be closed with a piece of thin textile which can be fixed to the orthosis by means of an assembly line 13b or another assembly line along the inner edge of the loop portion 11 a.

According to one embodiment, the polymeric gel layer of the plate 11 is formed by a silicone gel obtained by at least partial polymerization of a mixture of silicone oils, for example polydimethylsiloxane oil. Such a mixture makes it possible to obtain a plurality of silicone gels having different characteristics (in particular in terms of hardness and viscosity) depending on the respective proportions of the silicone oils forming the mixture, these proportions defining the degree of polymerization of the mixture. Therefore, by adjusting these ratios, a viscoelastic gel having greater or lesser hardness and viscosity can be obtained. Since the plate will be subjected to high mechanical stresses, the hardness of the plate can be adjusted by taking into account the elasticity and wear resistance requirements.

According to one embodiment, the sleeve 14 comprises anchoring bands 15a, 15b along its proximal and distal edges to hold the sleeve 14 on the thigh and calf to avoid the sleeve 14 sliding down or up along the lower limb. For this purpose, the anchoring strips 15a, 15b comprise elements having a certain adhesion to the skin. The anchoring bands 15a, 15b may be made of a fabric that may be the same as the fabric from which the sleeve 14 is made. The adhesive elements of the strips 15a, 15b may have the form of plates, pads or spikes, for example made of a polymer gel such as silicone gel. The surface density of the adhesive elements is set to avoid any irritation of the skin due to friction and shear forces, which may cause heating. The adhesive elements along the free edge of the strip 15a and/or 15b may be wider than the adhesive elements along the edge of the strip secured to the sleeve 14.

The orthosis can be fitted to the lower limb by pulling the orthosis over the foot and by pulling the upper edge of the sleeve 14 until the plate 11 is in position over the patella. The natural stiffness of the sleeve determines the amount of stretch of the sleeve, which is much lower than the elastic limit of the fabric forming the sleeve. It will be appreciated that when the knee is bent through 90, the amount of stretch in the thigh-covering portion of the sleeve remains below 20% in the region of maximum stretch of the sleeve and below 10% at 4cm from this region towards the strap 15 a. The amount of stretch is much lower than the maximum amount of stretch of the fabric forming the sleeve. Under these conditions, the alternate bending of the knees does not bring any great stress to the retention of the sleeve on the thigh, when walking or running, this retention being ensured by the belt 15 a. Thus, the straps 15a, 15b are sufficient to prevent the orthosis from slipping.

It can be seen that the elastic stress of the fabric of the sleeve 14 is greatest just above the patella and decreases towards the top of the thigh. The sleeve 14 can thus have a sufficient length between the position of the plate 11 and its proximal edge to place the strap 15a in a region of the thigh (lower muscle stretch region) where the elastic stress of the sleeve 14 is low. According to one embodiment, the width of the belt 15a may be greater than the width of the belt 15b, typically twice the width of the belt 15 b. Thus, the band 15a can be made using a plurality of narrower bands. The advantage is obtained that by providing the two bands forming the band 15a with different lengths, it is possible to adapt to the apparent variation in diameter of the thigh in this region. If two sewn-together strips are used to make strip 15a, one of the two strips may have fewer adhesive elements than the other strip forming strip 15a to leave an area for sewing the two strips together free of any adhesive elements.

Fig. 3 and 4 show the back of an orthosis according to one embodiment, and fig. 4 shows the orthosis mounted on a right lower limb. The orthosis comprises an opening 16, which opening 16 is formed substantially opposite the opening of the plate 11 at a position corresponding to the popliteal region or fossa of the knee. The opening 16 is closed by a piece of textile fabric which can be secured to the sleeve 14 by stitching. The fabric sheet closing the opening 16 may be elastic and less than 0.3mm thick. According to one embodiment, the textile sheet material closing the opening 16 is made of the same fabric as the fabric of the opening 12 of the closing plate 11. The fabric sheet closing the opening 16 may also be fixed to the sleeve around the opening 16 so as to remain taut regardless of the bending of the knee, without introducing any false play of the forces. In this way, "invasion" of the popliteal muscle can always be avoided.

Fig. 5A, 5B show the skeleton of the right lower limb and pelvis (ilium 4, femur 1, tibia 3 and patella 2) in sagittal section in a configuration with the knee straightened and the knee bent through approximately 90 °. Fig. 5C shows these two configurations stacked together. Fig. 5A, 5B show the anterior reference points R1, R2, R3 and the posterior reference points R4, R5, R6 on the bone with circles and the tissues (muscles, tendons) L12, L23, L45, L56 connecting these reference points with lines. Points R1 and R4 are located at the proximal position of femur 1. Point R2 is located on the patella 2. Point R5 is located at the distal position of femur 1. Points R3 and R6 are located at a distal position of tibia 3. These figures show that the anterior connection L12 between points R1 and R2 and L23 between points R2 and R3 undergo amounts of tension d1 and d2 (fig. 5C) between the straightened configuration and the flexed configuration of the knee. However, the connection L45 between the points R4 and R5 has the same length in both configurations. The connection L56 between the points R5 and R6 also has the same length in both configurations, but twists in the region of the popliteal fossa in a configuration in which the knee is flexed by about 90 °. Indeed, the action of the joint of the knee between the femur 1 and the tibia 3 causes the rolling and sliding of the femoral condyles above the tibial glenoid and between the femur 1 and the patella 2, by the sliding of the patella 2 in the trochlear carriage of the femur 1. A thin elastic fabric 16 is placed over this particular area of the popliteal fossa to avoid the formation of increased thickness due to the superimposition of folds of the fabric, which tends to cause discomfort or pain when the knee is flexed in a seated or crouched position. Above 1mm thickness, these increased thicknesses may cause irritation or even heating. The provision of a thin fabric 16 is therefore a significant improvement over such orthoses.

Fig. 5A, 5B also show the medial and lateral ligaments 5 tightened when the knee is straightened. During the flexion phase of the knee, the orthosis exerts a force F which helps to support the patella 2 and to stabilize the knee laterally.

In fig. 4, the opening 16 is substantially rectangular and the upper and lower limits are substantially rectilinear. According to one possible embodiment, the upper portion may be convex in order to follow the cylindrical shape of the thigh, thus avoiding any discomfort present on certain anatomical structures.

Compared to prior art orthoses, which typically have a weight of more than 150g, an orthosis as described above may have a weight of about 50g (within ± 10%).

Fig. 6A, 6B show the plate 11 in an unstretched and stretched configuration (e.g., with the knee straightened and the knee bent when the orthosis is in place on the lower limb), respectively. In the unstretched configuration, the opening 12 of the plate 11 is substantially circular and adapted to the shape of the patella. The tab 11b is an anchoring point on the skin obtained by the combination of the pressure exerted by the sleeve 14 on the tab 11, the adhesion coefficient (spike) of the tab, in particular of the surface of the tab 11b, and of the polymer gel forming the plate. Strap 15a is the anchorage point of sleeve 14 on the thigh and strap 15b is the anchorage point of the sleeve on the calf. During stretching of the sleeve 14, when the knee is bent, a portion of the amount of stretching d1, d2 (fig. 5C) is transmitted to the plate due to its adhesion to the skin, to the anchorage to the sleeve 14 formed by the bands 15a, 15b and to the additional anchorage resulting from the connection of the annular portion 11a of the plate to the patella. This results in a stretching D of the plate 11, in particular of the annular portion 11 a. The amount of stretching D causes elastic deformation of the plate 11, in particular deformation of the opening 12, which opening 12 extends in the longitudinal direction and narrows in the transverse direction. This results in a pulling force parallel to the skin surface exerted by the plate on the skin and on the limb enclosed by the plate. These forces include opposing longitudinal forces F1, F1 'toward the center of the opening 12 and opposing lateral forces F2, F2' also toward the center of the opening 12. The forces F2, F2' support the patella, avoiding its lateral displacement. The forces F1, F1' help to extend the foot step while walking or running. Thus, during walking or running, the looped portion 11a stretches during the active phase of putting the foot on the floor and the body's inertia causing the knee to bend. During the passive phase, in which the foot is no longer resting on the floor and the lower limb is extended forward to take a new step, the annular portion 11a resumes its unstretched configuration and thus transfers the stored elastic energy to the lower leg. Even if the forces F1, F1', F2, F2' are small, they prove that the description of the orthosis is proprioceptive. In fact, the forces F2, F2' are sufficient to provide some support to the patella and relieve joint discomfort while providing the sensation that the joint is supported. As regards the forces F1 and F1', their presence is sensed by the tendon system to which these forces are applied.

Fig. 7 shows a cross section of the right knee and the orthosis surrounding it. It can be seen that the annular portion 11a takes the form of a substantially tapering concave surface surrounding the right, left, lower and upper portions of the patella 2. Fig. 7 also shows, by means of arrows, the forces F3, F3', F4, F4' exerted by the orthosis on the patella 2, these forces being exerted perpendicularly to the surfaces of the sleeve 14 and of the plate 11. The forces F3, F3 'exerted by the sleeve 14 are directed towards the centre of the knee, and the forces F4, F4' exerted by the annular portion of the plate 11 are substantially parallel to the surface of the interface between the patella 2 and the femur 1. The orthosis thus ensures lateral support of the patella, in particular when the knee is straightened or at the beginning of a bending movement, i.e. in a position in which the tissue surrounding the knee is most lightly tensioned.

It should be noted that the plate 11, and in particular the longitudinal extension of the annular portion 11a, is made locally easier to manufacture by the absence of stitching on the outer edges of the lateral sectors 12b, 12c of the annular portion 11 a. It should also be noted that the sleeve 14 may have a greater longitudinal stretch capability than the stretch amount d1+ d2 (fig. 5C) in order to prevent the proximal and/or distal edges of the sleeve from sliding along the thigh or calf.

According to one embodiment, the tab 11B comprises a spike 17 to increase its adherence to the skin (fig. 6A, 6B). These spike portions may be formed, for example, by molding when the plate 11 is manufactured.

Fig. 8A, 8B show the orthosis 10. Fig. 8A, 8B show, inter alia, a panel 11, the panel 11 comprising a layer of polymer gel 11e adhered to a sheet of woven elastic fabric 11d, the sheet of woven elastic fabric 11d covering the entire face of the polymer gel layer but not closing the opening 12 of the loop portion 11 a. The assembly of the polymer gel layer 11e and the fabric sheet 11d forming the panel 11 can thus be sewn to the sleeve 14 by means of the sewing threads 13a, 13b, 13 c. The stitching threads 13a and 13c may be removed and replaced by adhering the fabric sheet 11d (adhered to the polymer gel layer 11 e) to the sleeve 14 by a layer of adhesive interspersed over the proximal and distal annular sectors 12a and 12b (bounded by the stitching threads 13a and 13 c). The fabric sheet 11d may be made of the same fabric as the sleeve 14.

The hardness and thickness of the polymer gel layer 11e of the plate 11 can be chosen so as to be able to sew the entire plate 11 adhering to the fabric sheet 11 d. In addition, the spikes of plate 11 may be selected so as to prevent plate 11 from sliding on the skin under the pressure exerted by sleeve 14.

The bands 19, 20 anchoring the proximal and distal edges of the sleeve 14 to the skin may be secured to the proximal and distal edges of the sleeve 14 by sutures 21, 22. The bands 19, 20 have, for example, plates or pads or spikes 15a, 15b or even bands with a greater adhesion to the skin than the sleeve 14. The opening 16 formed in the sleeve, corresponding to the dorsal area of the knee, can be closed by a textile sheet 16', which textile sheet 16' is sewn, for example flat, for example by a seam 23, the sleeve or sheet 16' not being stretched beforehand. The width of the respective straps 19, 20 and the holding action exerted on the thigh or calf can be adapted to the desired holding of the sleeve 14 on the lower limb.

According to one embodiment, the sleeve 14 does not comprise any opening opposite the opening 12 of the plate 11.

According to another embodiment, illustrated in fig. 8A, 8B, the openings 12 of the loop portion 11a are closed by a piece of textile fabric 18, which piece of textile fabric 18 has substantially the same dimensions as the openings 12. The sheet 18 may be sewn flat, with the sleeve 14 or the sheet 18 not previously stretched. The fabric sheet 18 may be fixed, for example, to the inside of the sleeve by the sewing thread 13b or by another sewing thread. The fabric sheet 18 may be elastic and less than 0.25mm thick, for example 0.2mm thick, and have a maximum amount of stretch between 50% and 90%, for example between 60% and 80%, and an elastic modulus at 40% between 1N and 2N. The fabric sheet 18 may be secured to the sleeve 14 so as not to exert any force on its periphery when the sleeve is not taut. When the sleeve 14 is tightened, it may be desirable that the fabric sheet 18 not resist extension of the plate 11 and only exert insignificant force on the patella. The fabric sheet 18 has a low modulus of elasticity so as to prevent the opening 12 from splitting only in certain use cases. The suture may be formed so as to not interfere or interfere in a limited manner with the stretching of the sleeve along its axis. Thus, a form of stitching, such as a loose-seam stitch, may be preferred for securing the fabric sheet 18.

It should be noted that the presence of the fabric sheet 18 may be advantageous for forming the seam 13b or for fixing the seam of the sheet 18 if the fabric sheet 18 is superimposed on the panel 11. In fact, the presence of the sheet 18 can make it possible to prevent any direct contact between the plate 11 and the sewing machine used to create said stitches, thus avoiding the sticking of the plate which causes the orthosis to jam in the sewing machine. It will be appreciated that other means may be used to avoid such clogging, for example the use of a suitable lubricant. It should also be noted that the stitch line 13b may be formed in the form of a simple stitch, which may be removed after the plate 11 is secured to the sleeve 14.

According to another embodiment, shown in fig. 8A, 8B, the sleeve 14 comprises an opening 16 opposite the opening 12 of the plate 11. The thin textile sheet 16' may close the opening 16. The fabric sheet 16' may be made of the same fabric as the sheet 18.

Fig. 9A, 9B illustrate an orthosis according to another embodiment. The orthosis shown in fig. 9A, 9B differs from the orthosis shown in fig. 8A, 8B in that: the fabric sheet 11d, on which the polymer gel layer 11e of the plate 11 is fixed, is not open against the opening 12. The fabric sheet 11d thus closes the opening 12. Therefore, the sheet 18 does not have to be provided. As described above, the assembly of the board 11 and the fabric sheet 11d may be achieved by adhesion. The plate 11 (polymer gel layer 11e and fabric sheet 11d) may then be secured to the sleeve 14 by means of the stitching lines 13a, 13b, 13c or by means of a layer of adhesive spread over the proximal and distal sectors 12a and 12b defined by the stitching lines 13a, 13b, 13 c.

In addition, as shown in FIG. 9A, a fabric sheet 16' may be secured to the inside of the sleeve 14.

Fig. 10 shows a plate 11' according to another embodiment. The plate 11' differs from the plate shown in particular in fig. 6A, 6B in that: it includes a tab 11b' that includes an opening 12e at the location of the anterior tibial tuberosity. Since the anterior tibial tuberosity is not located on the longitudinal axis of the thigh passing through the center of the patella, opening 12e may be slightly offset. As a result, the orthosis will be different for the right and left knee. As mentioned above, the tab 11b' may comprise a spike 17, the spike 17 being arranged to increase the adherence of the tab to the skin in the presence of pressure applied by the sleeve 14. It is also possible to make the opening 12e wider so that it is not necessary to pair the orthosis.

Fig. 11A, 11B, and 11C illustrate orthoses according to further embodiments. The orthosis shown in fig. 11A, 11B and 11C differs from the orthosis shown in fig. 8A, 8B in that: in addition to the panel 11, it also comprises side pads 31, 31', the pads 31, 31' comprising a viscoelastic polymer gel layer 31a, 31a 'adhered to an elastic textile layer 31b, 31 b'. The gaskets 31, 31' substantially have the shape of the lateral annular sectors 12b, 12c of the plate 11. The gaskets 31, 31' are fixed under the lateral sectors 12b, 12c of the plate 11, on either side of the opening 12 of the annular portion 11 a. Fig. 11B is the same as fig. 8B, with the pads 31, 31' not lying on the longitudinal axis of the plate 11. The gaskets 31, 31' are fixed at their ends to the sleeve 14 by an assembly line extending radially with respect to the plate 11. Thus, the gaskets 31, 31' can be fixed to the sleeve 14 simultaneously with the plate 11, only by the radial portions of the assembly lines 13a and 13c (and not by the central assembly line 13b along the opening 12). The side edges of the pads 31, 31' thus remain free. The gaskets 31, 31' may extend laterally slightly beyond the outer edge of the plate 11.

In fig. 11A, each pad 31, 31 'includes a polymeric gel layer 31A, 31A', which polymeric gel layer 31A, 31A 'is previously adhered to a fabric layer 31b, 31 b'. The pads 31, 31 'are arranged below the plate 11 so that the fabric layers 31b, 31b' are arranged against the fabric layer 11d of the plate 11. Thus, the polymer gel layer of the panel 11 and the polymer gel layer of the pad 31 or 31 'are separated by two fabric layers 11d and 31b or 31 b'. The gasket may be made of the same material as the plate 11 and may have the same thickness as the plate 11.

It should be noted that the fabric layers 31b, 31b 'may be removed so that the two layers 31a, 31a' adhere to the face of the fabric layer 11d not covered by the polymer gel layer 11 e.

On both sides of the plate 11, tucks (or gathered stitches) may be formed on the sleeve 14 below the non-sewn lateral edges of the plate 11, so that the fabric of the sleeve can be deployed at the knee flexion despite the increased thickness formed by the double thickness of the plate, without exerting any excessive pressure associated with the flexion to which the knee is subjected.

The provision of the pads 31, 31' enables the patella to be supported more firmly from the side. Indeed, it may be desirable to provide more relief to the ligaments, particularly when the ligaments are subjected to greater stress, for example when practicing certain sports such as alpine skiing. During such movements, the knee undergoes a lateral action in a more or less curved position, when turning or in order to cushion the unevenness of the ground.

Those skilled in the art will appreciate that the present invention is susceptible to various alternative embodiments and various applications. In particular, the invention applies not only to the joints of the knee, but also to other joints, such as the elbow, the shoulder or even the thumb. The shape and size of the orthosis, in particular the sleeve and the plate, is thus adapted to the configuration of the joint to be supported. Accordingly, these modifications are minor as required to account for the specific characteristics of the joint, and the joint need not comprise a ball and socket joint as would be understood by one skilled in the art. However, regardless of the joint for which the plate is intended, the plate includes a ring portion and a tab extending from an edge of the ring portion. The opening of the ring-shaped part is adapted to the size of the protruding area of the joint to be supported. The tab is arranged to be applied over an area of skin that covers harder tissue than the tissue covered by the annular portion of the plate. The shape of the tab may be adapted to the shape of the tissue on which it is arranged to achieve the best possible anchoring. Thus, the tabs of the plate may have a length from 4cm to 20cm and a width from 2cm to the width of the annular portion. For joints like shoulders, two tabs may be made that extend on either side of the ring portion.

In addition, the support belts 15a, 15b can be completely or partially removed by replacing the sleeve (for the knee) with a garment such as kapri pants or stretch ski pants, which covers the user's pelvis and at least one lower limb that must be supported by the orthosis. The garment can be supported at the ankle by using a tapered shape of the lower leg near the ankle.

Claims (20)

1. Orthosis comprising a sleeve made of a woven elastic fabric and shaped to exert pressure on both sides of a limb and on a joint, and a plate comprising a viscoelastic polymer gel layer,

characterised in that the plate comprises a layer of elastic fabric on which the polymer gel layer is adhered, an annular portion shaped to surround the top of the protruding area of the joint and a tab extending from the outer edge of the annular portion in the axial direction of the sleeve, the polymer gel layer being fixed to the inner surface of the sleeve to directly contact the skin on the joint, the polymer gel layer being adhered to the skin such that, under the effect of the pressure exerted by the sleeve, when the sleeve is longitudinally stretched, the polymer gel layer remains stretched and locally exerts a bearing force towards the centre of the protruding area of the joint to the underlying limb portion and a restoring force along the axis of the limb.

2. An orthosis according to claim 1, wherein said plate is secured to said sleeve only by proximal sectors of said annular portion and by a portion comprising distal sectors of said annular portion and said tabs.

3. An orthosis according to claim 1, wherein said plate is secured to said sleeve such that an outer edge of said annular portion of said plate remains free.

4. An orthosis according to claim 1, wherein said plate is secured to said sleeve along an inner edge of said annular portion.

5. Orthosis according to one of claims 1 to 4, characterized in that it comprises two side pads comprising a viscoelastic polymer gel layer and having the shape of the side sectors of the plate, said side pads being fixed under the side sectors of the plate by assembly lines extending radially with respect to the plate, the side edges of the side pads remaining free.

6. Orthosis according to one of claims 1 to 4, characterized in that the annular portion of the plate has an opening coinciding with a first opening formed in the sleeve, which opening is closed by a first sheet fixed on the sleeve and/or the plate, the first sheet being made of a woven elastic fabric less than 0.3mm thick.

7. An orthosis according to any of claims 1 to 4, wherein said sleeve comprises a second opening located in a region diametrically opposite said plate along said sleeve, which second opening is closed by a second sheet of woven elastic fabric less than 0.3mm thick.

8. An orthosis according to claim 7, wherein said second sheet is secured to said sleeve so as to remain taut regardless of the flexion of the joint.

9. An orthosis according to any of claims 1 to 4, wherein said sleeve includes adhesive elements along proximal and distal edges on its surface intended to contact the skin to assist in retaining said sleeve on the limb.

10. An orthosis according to claim 9, wherein said adhesive elements are formed on bands secured to the proximal and distal edges of said sleeve, said bands being made of the same elastic fabric as the fabric of said sleeve.

11. An orthosis according to claim 9, wherein the band of the adhesive element secured to the proximal edge of the sleeve comprises two bands secured together, the two bands being of different lengths to accommodate the shape of the limb.

12. An orthosis according to any of claims 1 to 4, wherein said sleeve has a thickness of less than 0.5mm and said plate has a thickness of less than 1 mm.

13. A method of manufacturing an orthosis, comprising the steps of:

forming a sleeve from a woven elastic fabric, said sleeve being capable of exerting pressure on both sides of the limb and on the joint,

forming a panel comprising a viscoelastic polymer gel layer, a layer of elastic fabric adhered to the polymer gel layer, the polymer gel layer comprising an annular portion shaped to surround a top of the joint in a flexed position and a tab extending from an outer edge of the annular portion, and

securing the plate on an inner surface of the sleeve such that the polymer gel layer is able to directly contact skin on the joint when the sleeve is mounted around the joint, the tabs being oriented in a distal direction of the sleeve, the polymer gel layer having an adhesive property capable of adhering to skin, such that under pressure applied by the sleeve, the polymer gel layer remains stretched as the sleeve is longitudinally stretched and locally applies a pulling force to the skin parallel to the surface of the skin towards the center of the annular portion.

14. A method of manufacturing according to claim 13, wherein the plate is secured to the sleeve by a stitch line so that a side portion of the outer edge of the annular portion remains free.

15. The manufacturing method according to claim 14, characterized in that it comprises the step of fixing, by means of an assembly line extending radially with respect to said plate, a pad under the side portions of said annular portion of said plate, the side edges of said pad remaining free, said pad comprising a viscoelastic polymeric gel layer and having the shape of the side sectors of said plate.

16. A method of manufacturing according to any one of claims 13 to 15, characterised in that it comprises the step of fixing a sheet of woven elastic fabric having a thickness of less than 0.3mm to close the opening of said annular portion of said plate.

17. A method of manufacturing as claimed in any one of claims 13 to 15, comprising the steps of forming an opening in the sleeve opposite the plate, and securing a sheet of woven elastic fabric having a thickness of less than 0.3mm to close the opening formed in the sleeve.

18. The method of manufacturing of claim 17, wherein a sheet of material closing the second opening formed in the sleeve is secured to the sleeve so as to remain taut regardless of how the knee is flexed.

19. A method of manufacturing according to any one of claims 13 to 15, including the step of moulding the plate, the mould forming spikes on the surface of the tab intended to contact the skin to increase the adherence of the tab to the skin.

20. A method of manufacture as claimed in any one of claims 13 to 15, including the step of securing a strap of elastic fabric along the proximal and distal edges of the sleeve, the strap including adhesive elements to assist in retaining the sleeve on the limb.