FR3141330A1 - PROSTHETIC SOCKET DESIGNED TO ADAPT IN PARTICULAR TO A VARIATION IN VOLUME OF AN AMPUTE LIMB - Google Patents

Abstract

The invention relates to a prosthetic socket (1) capable of accommodating a stump of said amputated limb and capable of adapting to variations in volume of said amputated limb and/or of said stump, comprising an internal layer (2) made at least partially of elastomeric material , in the shape of a sock, covered at least partially with a rigid structure (3), comprising at least two masts (32, 33) as well as a shell (30) for receiving said stump. The internal layer (2) comprises at least one cutout (4, 5) which extends in said longitudinal direction (L) of the socket, having two longitudinal lips (21, 22) made at least partially of elastomeric material, which extend on either side of said at least one cutout (4, 5) and which overlap at least partially one on the other. Figure for abstract: [Fig. 1]

Description

PROSTHETIC SOCKET DESIGNED TO ADAPT IN PARTICULAR TO A VARIATION IN VOLUME OF AN AMPUTE LIMB FIELD OF INVENTION

A prosthetic socket is designed to accommodate a change in volume or a change in shape of an amputated limb, said socket being designed to accommodate a stump.

Amputees, whoever they may be, would like to regain the sensation of their lost limb, with good proprioception and as few constraints as possible.

By “proprioception” we will understand all the nervous information transmitted to the brain, in particular through the skin, allowing the regulation of posture and body movements.

STATE OF THE ART

We know of sockets which attach to an amputated limb, accommodating a stump, and which are associated with an articulated device, or not; make it possible to extend the amputated limb, the device aiming to replace the missing limb part: document FR 3 011 176 describes an example of a socket which comprises an internal layer of silicone (which is an elastomeric material) covered at least partially by a rigid structure, the whole being fitted in an external layer of silicone.

The internal silicone layer provides a certain comfort for the patient: the layer being soft and elastic, it adapts to the movement of the limb accommodated in the socket.

Unfortunately, this flexibility is not sufficient and does not allow the socket to be adapted to a variation in the volume of the limb over a long period: for example, after an operation, the shape and size of the stump will vary over a period of time. year or more, depending on whether the patient presents a disorganization of the lymphatic and vascular system or not, whether or not he exercises the muscles of the amputated limb, etc.

It is therefore necessary to redo the unsuitable socket in the case of suction. If the patient has a standard prefabricated sleeve on the skin, he can put a cap between the sleeve and the socket to compensate for the loss of volume (which reduces proprioception by 50%).

PRESENTATION OF THE INVENTION

There is therefore a need to have a socket whose internal diameter can adapt to variations in size of the limb accommodated.

To this end, the invention relates to a prosthetic socket for an amputated limb, capable of accommodating a stump of said amputated limb and capable of adapting to variations in volume of said amputated limb and/or of said stump, said socket extending in a longitudinal direction and comprising an internal layer made at least partially of elastomeric material, in the form of a sock, capable of wrapping said stump and at least partially said amputated limb, said internal layer being covered at least partially with a rigid structure, said rigid structure comprising at least two masts which extend in a direction parallel or substantially parallel to said longitudinal direction, as well as a shell for receiving said stump, said shell being connected to one end of each of said at least two masts.

The socket according to the invention is remarkable in that said internal layer comprises at least one cutout which extends in said longitudinal direction, or substantially in the longitudinal direction from a free edge of said layer into said receiving shell, the internal layer having two longitudinal lips made at least partially of elastomeric material, which extend on either side of said at least one cutout and which overlap at least partially one on the other along a contact surface which extends in a direction parallel to a tangential direction of said internal layer or in a direction inclined relative to said tangential direction.

The superposition of the lips makes it possible to separate them from each other and to enlarge or narrow the opening of the inner layer more or less: thus, the inner layer can adapt to variations in volume. In addition, the production of the internal layer in elastomeric material ensures adhesion of the lips together, which allows the internal layer to be maintained in position on the skin of the supported member.

The socket according to the invention may also include the following characteristics, taken separately or in combination:

- the two internal lips have two complementary shapes which assemble with one another along said cutout,

- the internal layer has a regular internal layer thickness and the two lips superimposed on each other together have a superposition thickness which is equal or substantially equal to the internal layer thickness. In this way, the superposition of the lips does not create an excess bulge which would be bothersome for the patient,

- the cutout is positioned against at least one of said two masts of said rigid structure,

- the socket comprises at least one flexible tension band, which extends at least partially around said internal layer,

- said at least one flexible tension strip is made of material comprising polyamide and covers at least partially at least one of said two mats,

- said at least one flexible tension band is associated with an adjustment device, ensuring the tightening or loosening of said flexible tension band around said internal layer,

- said adjustment device is fixed on said rigid structure,

- said device comprises a cable connected on the one hand to one end of the flexible tension band and on the other hand to an adjustment wheel of the adjustment device ensuring traction or release of said cable, said wheel being manually operable,

- in the case where the socket is designed to accommodate a patient's thigh (for example), it may have an anteroexternal socket part, which is positioned on an anteroexternal face of the patient's thigh, one of the two said masts erected in said anteroexternal part of said socket and the other of said two masts erected on the internal layer diametrically opposite to a central axis of said internal layer, to be positioned under the ischium or substantially under the ischium of a patient when the patient wears said socket.

PRESENTATION OF FIGURES

Other advantages and characteristics of the invention will appear on examination of the detailed description of a mode of implementation in no way limiting, and of the appended drawings, in which:

is a rear and slightly left profile view of a socket according to the invention illustrated in perspective,

is a side view and slightly in right profile of the socket of the illustrated in perspective,

is a front view of a socket conforming to a variant embodiment of a socket conforming to the invention,

is a sectional view of an internal layer of the socket,

is a sectional view of an internal layer of the socket, illustrating a first cutout and a first method of covering the lips of the internal layer, on either side of the cutout,

is another example of a sectional view of an internal layer of the socket, illustrating a second cutout and a second method of covering the lips of the internal layer, on either side of the cutout, and

is a perspective and exploded view of an adjustment device, allowing manual adjustment of the tension of a band maintaining position around the internal layer of the socket.

MODE OF REALIZATION

There illustrates a socket 1 which is designed to receive a right thigh and the stump of a right thigh amputated at the level above the knee.

The socket 1 is illustrated seen from behind (arrow A), the left part (arrow G) of the socket 1 being positioned under the ischium of a person, and the right part (arrow D) of the socket 'socket corresponding to the socket part which is positioned on the outside of the thigh.

The socket has an internal socket layer 2, made of Silicone (elastomeric material) which is slipped around the stump and positioned around the thigh. It should be understood that the internal layer of the socket could be made of an elastomeric material other than silicone, without departing from the scope of the invention.

The internal layer 2 of Silicone is in the form of a sock which is positioned against the patient's skin (skin of the stump and amputated limb).

The internal layer 2 has a substantially constant thickness, so that there is no excess thickness which could be the source of discomfort or embarrassment to the patient.

Around the internal layer 2, the socket includes a rigid structure 3.

The rigid structure includes an end shell 30 (also called an apple picker by prosthetists) which has an internal cavity of shape substantially complementary to that of the stump to accommodate it.

This internal cavity can be made as follows:

First, a cast is formed on the skin of the stump to obtain a negative of the shape of the stump and part of the thigh.

Then, a plaster is poured into the mold, in order to have a life-size replica of the stump and thigh.

After correction of the plaster: Silicone is then molded over the replica.

Finally, the carbon shell is laminated, that is, resin is formed with carbon around the replica to obtain the shell.

The end shell 30 is also designed to allow a device to be attached to replace the missing limb.

This device has not been shown to simplify reading of the figures. In the context of our example, it may be an articulated device, simulating a knee, and a lower part of a leg carrying an articulated foot at its end.

The device can be fixed at the bottom 31 of the shell 30.

Two masts 32 and 33 are made integral with the edge of the shell 30 and extend substantially on either side of the internal layer 2 in the form of a sock, from the bottom of the internal layer 2 going towards the top of the layer internal sock-shaped.

The mast 32 is made to be positioned under the patient's ischium, that is to say substantially on the inside of his thigh, a little towards the rear of the thigh (if we considered that the section of the socket represented a clock, the position of mast 32 would be between 7 o'clock and 8 o'clock).

The mast 33 is made to be positioned on the outside of the thigh, slightly to the right (anteroexternal face of the thigh), substantially towards the front of the thigh (if we consider once again that the section of the socket represented a clock, the position of mast 32 would be around 2 o'clock).

The positioning of the masts 32 and 33 allows that the back of the patient's thigh, which is in the sock-shaped internal layer 2, is not covered with any rigid material.

This allows the patient to have significant comfort when sitting because the back of their thigh only rests on the internal silicone layer: it does not rest on a mast.

The masts 32 and 33 each extend in the direction L (or substantially in the direction L) along which the socket 1 extends, that is to say in the longitudinal direction of the amputated limb which will be accommodated in the 'socket.

It should be understood that the longitudinal direction is not necessarily an axis parallel to the axis of the socket: it could be inclined without departing from the scope of the invention. The longitudinal axis is an axis which starts from a point of the shell 30 towards a point of the opening of the internal layer 2.

According to the invention, the sock-shaped internal layer 2 has a cutout 4, which extends from the opening 20 of the internal layer (the opening 20 being the opening through which the amputated limb is introduced into the internal layer) up to the level of the shell 30 which covers the internal layer 2, following the longitudinal direction L of the socket.

More precisely, the cutout 4 extends below the edge 34 of the hull 30, the edge 34 being the edge which delimits the upper free end of the hull 30 and from which the masts 32 and 33 extend towards the high.

Even more precisely, the cutout 4 extends to the level of the change in curvature of the internal cavity of the shell 30, but it does not continue to the bottom of the cavity.

The cutout 4 has the function of allowing adjustment of the internal layer 2 around the amputated limb. In this way, socket 1 adapts to the perimeter of the limb accommodated in internal layer 2.

Figures 4, 5 and 6 illustrate the cutout 4 made in the thickness of the internal layer 2.

The inner layer 2 is shown in section view on the , which shows that the cutout 4 was not made radially: the cutout 4 is made in an inclined direction Di with respect to a tangent direction Dt to the surface of the internal layer 2: said cutout forms an inclined plane 40 with respect to tangent direction Dt, which defines a contact plane between two edges of layer 2.

The edges together form two lips 21 and 22 which overlap when the internal layer is positioned around the amputated limb, along the contact plane 40.

The adhesion of the silicone is such that the two lips 21 and 22 can hardly slide over each other following the contact plane. Thus, the internal layer 2 is held around the member thanks to the superposition of the lips 21 and 22 one on the other.

If the cut had been made transversely (that is to say perpendicular to a tangential plane), the contact plane between the lips 21 and 22 would be transverse (perpendicular to the tangential plane) and the lips 21 and 22 would not be maintained not together alone: in fact, the spreading force which occurs when the amputated limb has grown, for example, is oriented in a direction tangent to the limb (therefore tangent to the wall of the internal layer 2). The two lips then tend to move away from each other tangentially. If the cut were made transversely, there would be no resistance to the spacing of the lips 21 and 22 which would not cause them to slide over each other: the lips would move away from each other without resistance.

The plane 40 along which the lips 21 and 22 are positioned on top of each other makes it possible to create this resistance since the silicone ensures adhesion of the two lips along a plane which is close to the tangential direction and along which the two lips tend to be spaced apart from each other, the contact plane 40 thus creating a force opposite to the force of spacing of the internal layer following the cutout 4 (see ).

There illustrates yet another cutting embodiment.

The cutout bears the reference 5 on the and the lips of the internal layer 2 have the same references 21 and 22 as in Figures 4 and 5.

The cutout 5 has a V shape, so that the lips 21 and 22 have complementary shapes which assemble (male and female shapes).

The V shape of the cutout allows the lips 21 and 22 to be positioned one on top of the other along two inclined planes 50 and 51 relative to a tangential direction of the layer at the level of the covering of the lips.

The force necessary to detach the two lips 21 and 22 from each other of the cutout 5 is even greater than that necessary to detach the lips 21 and 22 from the cutout 4 shown in Figures 4 and 5.

The cutting embodiment 5 is thus used to make a socket for an active patient, the cutting embodiment 4 being used for example for a less active patient.

The cutout could also have a shape other than those illustrated in Figures 5 and 6: for example, the cutout could be made with a transverse part, contiguous to a radial part, itself contiguous to a transverse part. It could also be achieved by an inclined homeland, contiguous to a radial part, itself contiguous to another inclined part.

These embodiments have not been shown but the invention also includes these examples of embodiments.

To ensure that the lips 21 and 22 of the cutout 4 (or the cutout 5) are held in position, it is planned to position the cutout under a mast of the rigid structure 3, for example against the mast 33 of the socket which is positioned on the outer side of the front thigh, as shown in .

The mast 33 thus exerts pressure on the two superimposed lips 21 and 22, which further increases the resistance to opening of the internal layer.

It should be understood that the cutout could be positioned inside the rigid structure against the other mast 32, without departing from the scope of the invention.

It is also advantageously provided that the two lips superimposed one on the other 21 and 22 together have a superposition thickness E which is equal or substantially equal to the thickness of the internal layer: this makes it possible not to create bulges for the mast 33, the bulges (or the variation in thickness of the internal layer) which can create discomfort or pain for the patient: The lips together form a thickness of the internal layer - these are not two layers which overlap by forming a double thickness, but two parts of one and the same thickness which overlap.

We note in Figures 1 to 3 that the socket also includes tension bands which at least partially surround the internal layer 2, or even the masts 32 and 33.

Tension bands can be of two types: they can be semi-rigid (soft resin) or flexible (nylon bands).

The tension bands 6 shown in the embodiment of Figures 1 and 2 are substantially semi-rigid and associated with a tension adjustment device 7 shown in , thanks to a cable 8 which the device 7 includes:

Cable 8 can be linked by one of its ends to one end 60 of strip 6, as shown in Figures 1 and 2.

The cable 8 can pass through a through gallery made in the masts 32 and 33.

The device 7 for adjusting the tension of the cable is fixed on one of the masts 32 or 33 (therefore on the rigid structure). Preferably, it is fixed on the mast 33 which is more easily accessible for the patient and which will not create any discomfort in the crotch area.

The device 7 includes a manually operable wheel 70, which makes it possible to tighten the cable 8 more or less depending on whether the wheel is rotated in one direction or another.

One of the ends of the cable 8 can be equipped with a pin 80 capable of being inserted into a housing 81 of a domino 82 which is inserted into a rail 71 of the device 7. The two ends of the cable are fixed . The cable length is adjusted by actuating the wheel 70, which makes it possible to tighten the cable 8 more or less and to pull on the band 6 to hold the internal layer 2 in a tight position against the skin of the patient's amputated limb.

The strip 6 could also be attached by its end directly to the domino 82 (embodiment not illustrated), without departing from the scope of the invention.

A variant embodiment is also illustrated in : in the context of this variant, the retaining strips 6 go around the internal layer 2 / masts 32, 33 assembly.

As part of this embodiment, the shell 30 is equipped with a vacuum valve 35.

The vacuum valve 35 allows air to be sucked inside the socket, to create a suction phenomenon and thus hold the socket against the skin of the patient's amputated limb.

We understand from the preceding description how the invention makes it possible to propose a socket which adapts to an evolution in circumference of the amputated limb of a patient: thanks to the presence of the cutout, judiciously made in a given direction, the layer internal can adapt to a variation in limb circumference, by making the two lips 21 and 22 overlap more or less.

We also understand how the lips are held in position, thanks to the shape of the cutout combined with the silicone (or other elastomeric material) in which the internal layer is made.

We also understand how the lips are also held in position between the patient's skin and the mast behind which they are positioned.

We also understand how the judicious position of the masts allows a patient to rest his amputated limb on a support without discomfort, because the judiciously positioned masts are not found in the rear part of the amputated limb, intended to rest on a support (seat). for a leg socket, table for an arm socket, etc.).

It should be understood that the invention is not limited specifically to the example described above and that it could extend to the implementation of any equivalent means: in particular, the socket could include two cutouts, more than two masts etc.

Claims (10)

Prosthetic socket (1) for an amputated limb, capable of accommodating a stump of said amputated limb and capable of adapting to variations in volume of said amputated limb and/or of said stump, said socket (1) extending in a longitudinal direction (L) and comprising an internal layer (2) made at least partially of elastomeric material, in the form of a sock, capable of wrapping said stump and at least partially said amputated limb, said internal layer (2) being covered at least partially with a rigid structure (3), said rigid structure (3) comprising at least two masts (32, 33) which extend in a direction substantially parallel to said longitudinal direction (L), as well as a shell (30) for receiving said stump, said shell (30) being connected to one end of each of said at least two masts (32, 33), said socket being characterized in that said internal layer (2) comprises at least one cutout (4, 5) which extends substantially in the longitudinal direction (L) from a free edge of said layer (2) into said receiving shell (30), the internal layer (2) having two longitudinal lips (21, 22) made at least partially of elastomeric material , which extend on either side of said at least one cutout (4, 5) and which are at least partially superimposed on one another along a contact surface (40, 50, 51) which 'extends in a direction parallel to a tangential direction (Dt) of said internal layer or in an inclined direction (Di) relative to said tangential direction (Dt). Socket according to claim 1, characterized in that the two internal lips (21, 22) have two complementary shapes which assemble with one another along said cutout (4, 5). Socket according to any one of the preceding claims, characterized in that said internal layer (2) has a regular internal layer thickness (E) and in that the two lips (21, 22) superimposed one on the other together have an overlay thickness which is substantially equal to the internal layer thickness. Socket according to any one of the preceding claims, characterized in that said cutout (4, 5) is positioned against at least one (33) of said two masts (32, 33) of said rigid structure (3). Socket according to any one of the preceding claims, characterized in that it comprises at least one flexible tension band (6), which extends at least partially around said internal layer (2). Socket according to claim 5, characterized in that said at least one flexible tension strip (6) is made of a material comprising polyamide and covers at least partially one at least of said two mats (32, 33). Socket according to any one of claims 5 or 6, characterized in that said at least one flexible tension band (6) is associated with an adjustment device (7), ensuring the tightening or loosening of said flexible tension band (6) around said internal layer (2). Socket according to claim 7, characterized in that said adjustment device (7) is fixed on said rigid structure (3). Socket according to any one of claims 7 or 8, characterized in that said device comprises a cable (8) connected on the one hand to one end of a flexible tension band (6) and on the other hand to a adjustment wheel. adjustment (70) of the adjustment device (7) ensuring traction or release of said cable (8), said wheel (70) being manually operable. Socket according to any one of the preceding claims, designed in particular to accommodate a patient's thigh, characterized in that it has an anteroexternal socket part, which is positioned on an anteroexternal face of the patient's thigh, in that that one (33) of said two masts (32, 33) is erected in said anteroexternal part of said socket (1) and in that the other (32) of said two masts (32, 33) is erected on the internal layer (2) diametrically opposite to a central axis of said internal layer, to be positioned substantially under the ischium of a patient when the patient is wearing said socket (1).