FR3061852A1 - METHOD OF MANUFACTURING A SLEEVE FOR A PROSTHESIS OR ORTHESIS AND CORRESPONDING TOOL - Google Patents

Abstract

The invention relates to a method for manufacturing a sleeve for prosthesis or orthosis provided with a shell (6) from a sleeve blank (1), the shell defining a hollow intended to fit into the shape of a stump. or a member and the sleeve blank consisting of a prefabricated hollow element made of thermoformable material. The process comprises the following steps: (a) heating the preform (1) until softening, (b) inserting the softened preform into the hollow of the shell (6), (c) adapts the shape of the blank (1) to the shape of the shell (6) by introducing a fluid inside the blank (1) under conditions adapted to press an outer face of the blank (1) against an inner face of the shell (6), (d) is allowed to cool the blank (1), (e) is removed from the shell (6) the blank (1) cooled which is the desired sleeve.

Description

Holder (s):

PROTEOR Simplified joint-stock company.

O Extension request (s):

® Agent (s): CABINET FEDIT LORIOT.

FR 3,061,852 - A1 (54) METHOD FOR MANUFACTURING A CORRESPONDING SLEEVE.

@) The invention relates to a method of manufacturing a sleeve for prosthesis or orthosis provided with a shell (6) from a sleeve blank (1), the shell defining a hollow intended to follow the shape of a stump or a member and the sleeve blank consisting of a prefabricated hollow element made of thermoformable material. The process includes the following steps:

(a) the blank is heated (1) until it softens, (b) the softened blank is inserted inside the hollow of the shell (6), (c) the shape of the blank is adapted (1) to the shape of the shell (6) by introducing a fluid inside the blank (1) under conditions suitable for pressing an external face of the blank (1) against an internal face of the shell (6), (d) the blank (1) is allowed to cool, (e) the cooled blank (1) which constitutes the desired sleeve is removed from the shell (6).

FOR A PROSTHESIS OR ORTHESIS AND TOOL

METHOD FOR MANUFACTURING A SLEEVE FOR A PROSTHESIS OR ORTHESIS AND CORRESPONDING TOOL.

TECHNICAL AREA

The invention relates to a method of manufacturing a sleeve for a prosthesis or orthosis and a tool for implementing the method.

STATE OF THE ART

Prostheses intended to replace a limb have a part called "socket" which comes to fit on the patient's stump. In some cases related to pathology or amputation, an external prosthesis needs an interface between the stump and its socket. This interface, called a sleeve, protects the stump from stresses arising from the fitting of the prosthesis or from its use. This problem can also be encountered for orthotics, devices which compensate for an absent or deficient function, the interface of which is called "padding".

The sleeves were first made from exact measurements of the stump or limb and using various materials such as rubber, leather, silicone gel, polyurethane gel, using various methods such as molding, countermolding, gluing, injection. However, these techniques required specific know-how and a relatively long manufacturing time.

In order to reduce this manufacturing time, the applicant has developed a manufacturing process in which a sleeve blank made of thermoformable material is used to make the sleeve. This process is described in document FR2799953. It consists in placing the sleeve blank previously softened on the stump / member or on a reproduction thereof in order to adapt the shape of the sleeve blank to that of the stump / member or its reproduction.

In general, a reproduction of the stump / limb is used for this shaping. However, it may happen that a reproduction of the stump / limb is not available because it is lost or non-existent. This is for example the case when the socket of the prosthesis is directly produced from digital data: scan or photograph of the limb, 3D reconstruction on computer; the manufacturing process can be additive manufacturing (three-dimensional printing). When such a reproduction is not available, it can be long and costly to reproduce the stump / limb only for the production of the sleeve.

There is therefore a need to produce a prosthesis or orthosis sleeve which can be easily and quickly manufactured, at low cost.

SUMMARY OF THE INVENTION

To this end, there is provided a method of manufacturing a sleeve for prosthesis or orthosis having a shell from a sleeve blank, the shell defining a hollow intended to follow the shape of a stump or a member. and the sleeve blank being made up of a hollow prefabricated element made of a thermoformable material, preferably flexible, comprising a closed end, in particular of rounded shape, and another end, notably opposite, open.

According to the invention, the method comprises the following stages:

(a) the sleeve blank is heated until it softens, (b) the softened sleeve blank is inserted inside the hollow defined by the shell, (c) the shape of the sleeve blank in the shape of the shell by introducing a fluid inside the sleeve blank under conditions suitable for pressing an external face of the sleeve blank against an internal face of the shell, (d ) the sleeve blank is allowed to cool, its external face being held in abutment against the internal face of the shell by the fluid introduced inside the sleeve blank, (e) the blank is removed from the shell of cooled sleeve which constitutes the desired sleeve.

The method according to the present invention thus makes it possible to manufacture a sleeve directly from a prosthesis or orthosis shell, so that it is not necessary to obtain a reproduction of the stump or of the patient's limb. This allows a sleeve to be made simply and quickly. The previously mentioned shell forms a socket intended to be fitted onto a stump in the case of a prosthesis or a shell which conforms to the shape of the deficient member in the case of an orthosis.

The method according to the invention is suitable in particular for the manufacture of sleeves for prostheses or orthoses whose shell is made of thermoformed plastic material, reinforced or not with fibers, such as vegetable fibers, carbon fibers, glass fibers or similar, or any other material withstanding the temperature to which the sleeve blank must be heated to be softened.

The invention also relates to a tool for implementing the method according to the invention, in particular of step (c) of this method. This tool comprises a closure element intended to close, in particular in a sealed manner, an open end of a sleeve blank consisting of a hollow prefabricated element made of a thermoformable material, in particular flexible, having a closed end, in particular of rounded shape. , and another end, notably opposite, open. This obturation element notably comprises a plate of predetermined dimensions having a through hole for the introduction of a fluid inside the sleeve. This orifice is capable of being connected to a device for introducing fluid.

In particular, the dimensions of the plate are chosen so that the plate is adapted to be placed inside the sleeve blank on the side of its open end and to close the latter.

Advantageously, the plate extends substantially perpendicular to a longitudinal direction of the sleeve blank when it closes the latter.

The fluid introduction device may include a fluid supply circuit, equipped with an element shaped to move the fluid inside the circuit, such as a pump, a compressor or the like. This fluid introduction device can be part of the tool of the present invention.

Advantageously, the plate can comprise a rod mounted perpendicular or substantially perpendicular to the plate and extending over a predetermined length on one side of the plate intended to be on the side of an internal face of the sleeve blank. This rod, the distant end of the plate may have a rounded shape and / or be made of a flexible material, can also be slidably mounted relative to the plate, which can allow easy adjustment of its length. A seal between the plate and the rod can then seal between the two parts.

Advantageously, the closure element may comprise a sealed pocket formed of an extensible material and closed, in particular in a sealed manner, by the plate of the closure element, the orifice of the closure element being in fluid communication with the inside of the pocket. This arrangement avoids direct contact between the sleeve blank and the fluid as explained in detail below.

DETAILED DESCRIPTION OF THE INVENTION

In step (a), the sleeve blank is heated until it softens. The heating conditions, such as the temperature and the duration of the heating, will be adapted to the material constituting the sleeve blank and sufficient to obtain a softening allowing the material to be shaped.

The sleeve blank may, for example, be made of a polyolefin foam, ethylene vinyl acetate (EVA) or any other thermoformable material which can be used industrially for such an application. This blank may also consist of a mixture of two or more thermoformable materials. The thermoformable material used is preferably “flexible”, namely flexible; in other words, it can be folded and folded easily without being broken or damaged.

For example, the temperature used to obtain softening can vary from 120 ° C to 200 ° C, for a heating time of 2 to 20 minutes.

During step (b), the softened sleeve blank is inserted inside the recess defined by the shell. In particular, the sleeve blank is inserted through its closed end, so that it is placed inside the recess and the open end of the sleeve blank remains accessible.

It will be noted in particular that the dimensions of the sleeve blank are preferably adapted to the dimensions of the shell of the prosthesis or of the orthosis. One can for example provide several sleeve blanks of different dimensions, a sleeve blank of predetermined dimensions then being chosen so that its dimensions are adapted to the dimensions of the shell of the desired application.

In some cases, the shell may have a non-continuous lateral face, for example comprising an opening or notch. This is for example the case of a tibial prosthesis with a popliteal counter-support. In order to prevent the sleeve blank from being deformed significantly at this opening or notch, it may be preferable to temporarily close the latter, for example by means of a possibly deformable but non-extensible material, such as leather, a thin plastic plate, adhesive tape, or any other suitable material. This temporary closure can be carried out before step (b).

During step (c), the shape of the sleeve blank is adapted to the shape of the shell.

To this end, a fluid is introduced inside the sleeve blank under conditions suitable for pressing an external face of the sleeve blank against an internal face of the shell. The fluid is notably introduced through the open end of the sleeve blank.

Different fluids can be used to achieve this shaping. The fluid used can also be hot when it is introduced so as not to cool the sleeve blank too quickly. The temperature of the fluid can then be close to or identical to the temperature used during the heating step.

A pressurized gaseous fluid can be used, for example air. For example, the pressure can be from 1 to 5 bars, preferably from 2 to 4 bars. Any other pressure suitable for obtaining the support of the sleeve blank against the shell can nevertheless be applied.

Alternatively, a liquid can be used. Optionally, this liquid may be hot when it is introduced. The liquid used is then preferably a liquid having a boiling point above this temperature.

In another variant, it is possible to use as fluid solid particles capable of flowing, such as balls, sand or solid particles having characteristics similar to sand in terms of flowability, etc.

Preferably, a pressurized gaseous fluid will be used.

The conditions of implementation of step (c) are in particular adapted so that the major part of the external face of the sleeve blank is pressed against the internal face of the shell. In order to improve this plating and consequently the shaping of the sleeve blank, provision may be made for the implementation of an additional step prior to step (c), in particular before or after step (a ) or after step (b).

During this additional step, the open end of the sleeve blank is closed, in particular in a sealed manner, by means of a closure element. The closure element is further provided with a hole for the introduction of the fluid inside the sleeve blank.

Advantageously, the closure element can seal the sleeve blank, in particular when the fluid used in step (c) is gaseous.

Advantageously, the orifice is suitable for the introduction of a gaseous fluid under pressure.

This sealing element may for example comprise a plate of predetermined dimensions, in particular capable of closing the sleeve blank on the side of its open end, for example of dimensions adapted to be placed inside the sleeve blank of the side of this open end. Thus, the periphery of the plate can match the internal face of the blank to which it is fixed, this plate extending perpendicular or substantially perpendicular to a longitudinal axis of the sleeve blank. This plate is also pierced with the hole for the introduction of the fluid, which can be connected to a device for introducing the fluid.

In a particular embodiment, the closure element used during this additional step may comprise a sealed pocket formed of an extensible material and closed, in particular in a sealed manner, by the closure element, the orifice the closure element being in fluid communication with the interior of the pocket. The closure element is then mounted on the sleeve blank so that the pocket is located inside of it.

It is thus understood that during step (c), the fluid is introduced inside this pocket and fills it which causes its expansion and the support of the external face of the sleeve blank on the inner side of the hull. This can improve the adaptation of the shape of the sleeve blank to the shell.

The dimensions of the pocket are preferably adapted to the dimensions of the sleeve blank, for better shaping of the latter.

The pocket is preferably made of a material which withstands the temperature to which the sleeve blank is heated. It can for example be an elastomeric material having a high elasticity, in particular greater than 125%, such as silicone.

The use of a closure element with such a pocket makes it possible to avoid direct contact of the fluid with the sleeve blank, thus possibly protecting the latter depending on the nature of the fluid used. In addition, the pocket is reusable.

In another particular embodiment, which can be combined with the previous one, the closure element used during the additional step may have a rod extending substantially along a longitudinal axis from the sleeve blank to the inside of it. This rod is long enough for a distant end of the closure element, in particular of its plate, to bear against the closed end of the sleeve blank and hold it against a bottom of the shell when the sleeve blank is inside the shell. This also makes it possible to promote uniform support of the sleeve blank against the shell, in particular at the level of the closed end of the sleeve blank.

In order to avoid deterioration of the blank, the end of the rod may have a rounded shape and / or be made of a flexible material.

Optionally, the rod can be hollow and serve for the introduction of the fluid. It can then be pierced at its side wall and / or its end.

After step (c), the sleeve blank is allowed to cool during step (d), in particular for a sufficient time to obtain stabilization of the material constituting the blank, in other words to reach a temperature below from which it cannot be shaped.

In step (e), the cooled sleeve blank which constitutes the desired sleeve can then be removed from the shell. Before or after this step (e), it is possible, if necessary, to adjust the shape of the sleeve by cutting out the unnecessary parts (for example at the popliteal abutment). Note that this cutting step is preferably carried out after removing the sealing element which possibly closed the sleeve blank. This cutting can be carried out using a simple pair of scissors or any other cutting tool adapted according to the material.

BRIEF DESCRIPTION OF THE FIGURES

The invention is now described with reference to the accompanying non-limiting drawings, in which:

Figures la to ld schematically represent the steps of a method of producing a sleeve according to the present invention, implemented by means of a closure element according to a particular embodiment;

FIG. 2 schematically represents a closure element usable in the present invention according to another embodiment;

Figure 3 schematically shows a shell of a tibial prosthesis;

FIGS. 4a to 4c schematically represent the steps of a method for producing a sleeve according to the present invention, implemented by means of a closure element according to another particular embodiment.

DETAILED DESCRIPTION OF THE FIGURES

In the figures, the same elements are designated by the same references.

An example of a manufacturing process according to the invention is described with reference to Figures la-ld.

Figure la shows a sleeve blank 1, consisting of a hollow prefabricated element of a flexible thermoformable material, here of substantially conical or cylindrical shape, having a closed end 2, here of rounded shape, and an opposite open end 3. L the sleeve blank 1 thus has an external face 4 and an internal face 5.

In Figure le, there is also a shell 6. This shell 6 is similar to that shown in Figure 3, here a socket for a tibial prosthesis. It thus defines a recess 7 intended to be fitted onto a stump. The shell 6 also has an external face 8 and an internal face 9.

In Figures la-ld, there is also a closure element 10 which comes to close the open end 3 of the sleeve blank 1. This closure element 10 is provided with an orifice 11 for the introduction of the fluid inside the sleeve blank 1. The orifice 11 may be a simple orifice as shown in FIG. la, or define a portion of pipe, as shown in fig. lb.

This orifice 11 can for example be connected to a fluid introduction device 12, shown schematically in fig. the. The latter here comprises a fluid supply circuit 13 connected to a reservoir or a source of fluid 14, the circuit 13 being equipped with an element 15 shaped to move the fluid inside the circuit, such as a pump , a compressor or other.

In the present example, the closure element 10 has a plate 16, here flat, of predetermined dimensions, adapted to be disposed inside the sleeve blank 1, on the side of its open end 3, in order to close this one. The dimensions of the plate are thus adapted to the sleeve blank. These dimensions can thus be slightly smaller than the dimensions of the open end 3, in which case the sleeve blank can be held against the periphery of the plate 16 by a clamping element (strip or other) or be slightly larger than the dimensions of the open end 3, in which case the plate is forcibly inserted inside the sleeve blank. This plate 16 is pierced with the orifice 11 and perpendicular, or substantially perpendicular, to a longitudinal direction X of the sleeve blank 1 when it closes the latter (fig. Lb).

The plate 16 may also be provided with a rod 17 mounted perpendicular or substantially perpendicular to the plate 16 and extending over a predetermined length on the side of the plate intended to be on the side of the internal face 5 of the blank of sleeve 1. This rod has an end 18 distant from the plate 16 which can have a rounded shape and / or be made of a flexible material, in particular sufficiently flexible so as not to damage the sleeve blank. Optionally, provision can be made to mount this rod 17 slidingly on the plate 16 in order to facilitate the adjustment of its length, a gasket being able to be disposed between the rod 17 and the plate.

16.

The manufacture of the sleeve then takes place in the following manner. The open end 3 of the sleeve blank 1 is closed by means of the closure element 10 described above (fig.la). This closure is preferably sealed in the embodiment described. One can for example keep the sleeve blank 1 tight on the plate 16 by means of a strip. The whole is then heated to a temperature sufficient to soften the sleeve sleeve 1 (fig. Lb). The blank is then placed inside the hollow of the shell 6. Air under pressure is then introduced inside the sleeve blank 1, for example by means of the device 12 previously described, which has the effect of inflating the sleeve blank 1 so that its outer face 4 bears against the inner face 9 of the shell 6 (fig.le). In fig.le, the wall of the sleeve blank 1 is shown in dotted lines before introduction of air and in solid lines after introduction of air, the arrows symbolizing the thrust exerted by the air under pressure. The fluid pressure is maintained so that this support continues until the sleeve blank 1 cools down and stabilizes. The sleeve 20 thus obtained can then be cut to the dimensions of the shell 6, as shown in FIG. Id.

FIG. 2 represents another embodiment of a closure element 10 which differs from that previously described only by the presence of a sealed pocket 19 formed of an extensible material. This pocket 19 is closed by the plate 16 of the closure element 10, preferably in a sealed manner.

Figure 3 shows a shell 6 for a tibial prosthesis. It will be noted that the open end of this shell 6 has a notch 21 (popliteal abutment). This notch 21 is here temporarily closed by a non-extensible material 22, for example a plastic, leather or other strip.

The manufacture of a sleeve using the closure element 10 shown in FIG. 2 is described with reference to Figures 4a-4c.

We start by heating the sleeve blank 1 alone until it softens (fig.4a). Then, it is placed in the cavity of the shell 6; the shutter element 10 shown in FIG. 2 is slid by its open end 3 and the latter is closed with the shutter element 10 (FIG. 4b). Pressurized air is introduced inside the pocket 19 of the closure element 10, which causes it to swell and the external face 4 of the sleeve blank 1 to be pressed onto the internal face 9 of the shell 6. A device 12 similar to that described with reference to FIG. can be used for this purpose. Due to the closing of the notch 21 of the shell 6, a deformation of the pocket 19 and therefore of the sleeve blank 1 is avoided at the notch 21 of the shell 6.

It will be noted that it is also preferable to close this notch 21 in the process described with reference to FIGS. la-ld to prevent swelling of the sleeve blank.

As in the previous process, the fluid pressure is maintained inside the pocket 19 so that it remains inflated until the sleeve blank 1 has cooled and stabilized. We can then disconnect the fluid introduction device 12 and cut the sleeve 20 thus obtained to the dimensions of the shell 6, preferably after having removed the closure element 10, as shown in FIG. 4c.

Whatever the embodiment of the sealing element, it will be noted that the rod 17 can be used to introduce the fluid inside the sleeve blank or the pocket. In this case, it is hollow and its lateral face and / or its distal end 18 can be pierced with one or more holes suitable for the passage of the chosen fluid.

The methods described with reference to the figures use a gaseous fluid. It will nevertheless be understood that the invention is not limited to a particular fluid, provided that it can be easily introduced into the interior of the sleeve blank (or of the pocket) and that it allows it to be pressed down. Ci against the internal face of the shell. It will also be noted that it is possible to introduce the fluid inside the sleeve blank without closing the latter, in particular when the fluid is not gaseous, but the use of an element of obturation makes it possible to improve the adaptation of the shape of the sleeve blank to the shell.

The invention has been described with reference to a tibial prosthesis. However, it is not limited to this particular type of prosthesis and can be used for any type of prosthesis or orthosis having a shell. In particular, by way of example, it can be used for making sleeves (fillings) for orthoses such as boots for diabetics, plagiocephaly helmets, or the like.

Claims (10)

1. A method of manufacturing a sleeve (20) for prosthesis or orthosis having a shell (6) from a sleeve blank (1), the shell defining a hollow (7) intended to follow the shape of a stump or limb and the sleeve blank consisting of a hollow prefabricated element of a thermoformable material, having a closed end (2) and another open end (3), characterized in that it comprises the steps following: (a) heating the sleeve blank (1) until it softens, (b) inserting the softened sleeve blank (1) inside the hollow (7) defined by the shell (6), (c) adapting the shape of the sleeve blank (1) to the shape of the shell (6) by introducing a fluid inside the sleeve blank (1) under suitable conditions to press an external face of the sleeve blank (1) against an internal face (9) of the shell (6), (d) the sleeve blank (1) is allowed to cool, its external face (4) being held in abutment against the internal face (9) of the shell (6) by the fluid introduced inside the sleeve blank (1), (e) the sleeve blank is removed from the shell (6) (1) cooled which constitutes the desired sleeve (20). 2. The manufacturing method according to claim 1, wherein the fluid used during step (c) is chosen from a gaseous fluid under pressure, a liquid, solid particles capable of flowing. 3. The manufacturing method according to claim 1 or 2, which comprises, prior to step (c) an additional step during which the open end (3) of the sleeve blank (1) is closed by means a closure element (10), this closure element being provided with an orifice (11) for the introduction of the fluid inside the sleeve blank (1). 4. The manufacturing method according to claim 3, wherein the additional step is carried out before the heating step (a), after the heating step (a), or after the step (b) of insertion. 5. Manufacturing process according to any one of claims 3 or 4, in which: the closure element (10) used during the additional step comprises a sealed pocket (19) formed of an extensible material and closed by the closure element (10), the orifice (11) of the closure element (10) being in fluid communication with the interior of the pocket (19), and the closure element (10) is mounted on the sleeve blank (1) so that the pocket (19) is located inside thereof, during step (c), the fluid introduced inside the sleeve blank (1) fills the pocket (19) with obturation element (10) causing expansion of the pocket (19) and the support of the external face (4) of the sleeve blank (1) on the internal face (9) of the shell (6). 6. Manufacturing method according to any one of claims 3 to 5, wherein the closure element (10) used during the additional step has a rod (17) extending substantially along a longitudinal axis ( X) of the sleeve blank (1) inside the latter, this rod (17) being long enough for one end (18) distant from the closure element (10) to bear against the closed end (2) of the sleeve blank (1) and holds the latter against a bottom of the shell when the sleeve blank (1) is inside the shell (6). 7. The manufacturing method according to claim 6, wherein the end (18) of the rod bearing against the closed end (2) of the sleeve blank has a rounded shape and / or is made of a flexible material. 8. Tool for implementing the method according to any one of claims 1 to 7, characterized in that it comprises a closure element (10) intended to close an open end (3) of a blank sleeve (1) consisting of a prefabricated hollow element made of a thermoformable material, comprising a closed end (2) and another open end (3), said closure element (10) comprising a plate (16) of predetermined dimensions 5 having a through hole (11) for the introduction of a fluid, said orifice (11) being able to be connected to a fluid introduction device (12). 9. Tool according to claim 8, characterized in that the plate (16) comprises a rod (18) mounted substantially perpendicular to the plate (16) and extending over a predetermined length on one side of the plate (16 ) intended to be on the side of an internal face (5) of the sleeve blank (1). 15 10. Tool according to claim 8 or 9, characterized in that the closure element (10) comprises a sealed pocket (19) formed of an extensible material and closed by the plate (16) of the element obturation, the orifice (11) of the closure element being in fluid communication with the interior of the pocket (19).