FR3085114A1 - DEVICE FOR SELECTING AN ORTHESIS - Google Patents

Abstract

Method for selecting a model for an article intended to be put on a limb of a person, said method comprising the following steps: 1) fixing a sample (14) of a reference article on a frame, l the sample being tensioned so as to simulate a tension in a "threaded position" in which the reference article is threaded on said member, the tensioned sample having second and first faces (191,192) opposite; 2) positioning of the first face (191) in front of said member and observation, preferably by the person, of the second face (192); 3) evaluation, preferably by the person, of the appearance of the sample thus observed and, according to said evaluation, selection of the model of the reference article or repeated in step 1) with a sample of another reference item from another model.

Description

DEVICE FOR SELECTING AN ORTHESIS

Technical area

The present invention relates to a method for selecting an elastic venous compression orthosis, or CVE, hereinafter "orthosis", indicated in the event of venous insufficiency of a lower limb of a patient. The invention also relates to a selection device which can be implemented in a method according to the invention.

State of the art

Elastic venous compression orthotics, formerly known as compression stockings or socks, are textile medical devices producing a therapeutic effect by compression of the lower limbs, as opposed to support stockings (or stockings support or anti-fatigue stockings) and low fashion, which are not medical devices for therapeutic purposes.

Elastic venous compression orthotics are designed to produce a therapeutic effect by compressing the lower limb over a greater or lesser extent, usually with a declining compression profile upward from the ankle.

The effectiveness of a treatment using an orthosis is directly linked to compliance with the medical prescription by the patient. In the absence of good compliance, the disease can worsen, which entails an additional risk for the patient, but also costs for the Social Security or the bodies financing the care.

Poor adherence to treatment also makes clinical studies more difficult.

There is therefore an ongoing need for solutions to improve compliance.

An object of the invention is to respond, at least partially, to this need.

Summary of the invention

The invention provides a method of selecting a model for an article intended to be put on a limb of a person, said method comprising the following steps:

1) fixing of a sample of a reference article on a frame, the sample being tensioned so as to simulate a tension in a "threaded position" in which the reference article is threaded on said member, the sample live with second and first opposite sides;

2) positioning of the first face in front of said member and observation, preferably by the person, of the second face;

3) evaluation, preferably by the person, of the appearance of the sample thus observed and, according to said evaluation, selection of the model of the reference article or repeated in step 1) with a sample of another reference item from another model.

Such a process advantageously makes it possible to select a product quickly and without having to put it on.

The invention provides in particular a method of selecting a model for an elastic venous compression orthosis intended to be put on a lower limb of a patient, said method comprising the following steps:

1) fixing a sample of a reference orthosis to a frame, the sample being tensioned so as to simulate a tension in a "threaded position" in which the reference orthosis is threaded on said lower limb, the live sample having second and first opposite sides;

2) positioning of the first face in front of said lower limb and observation, by the patient, of the second face;

3) evaluation by the patient of the appearance of the sample thus observed and, as a function of said evaluation, selection of the model of the reference orthosis or repeated in step 1) with a sample from another reference orthosis of another model.

As will be seen in more detail in the following description, the inventors have found that, until the present invention, the patient passed his hand inside the orthosis to stretch it and thus have an idea of its appearance in the threaded position. This selection process, however, led to disappointments. The inventors have in fact noticed that this process does not allow precise simulation, in particular because the color of the hand is not always the same as that of a lower limb and that the applied voltage is very variable depending on the size of the patient's hand. This problem is all the more critical since the orthosis is highly elastic and can therefore change significantly in appearance when it is put on.

The method according to the invention leads to a much more realistic simulation and therefore advantageously limits the risk of disappointment. Compliance is improved.

Preferably, in step 1), to switch on the sample, the following steps are carried out:

A) introduction of a first part of the frame into the reference orthosis, said first frame part being shaped so that said introduction stretches said reference orthosis in the region of the first frame part;

B) fixing a second part of the frame to the first part of the frame, by sandwiching a portion of the reference orthosis, so as to constitute the frame and to immobilize said portion on the frame;

C) cutting the reference orthosis around the frame so as to constitute said sample, or according to the following steps:

a) fixing the sample on a first frame part, flat, so as to close a first opening of said first frame part;

b) bringing a second part of the frame closer to the first part of the frame to a fixing position authorizing the fixing in step c), the frame parts being configured so that said bringing together causes an elastic deformation of the 'sample and, consequently, a tension in the sample;

c) fixing of the second frame part on the first frame part, so as to immobilize the sample, or, the frame being of variable geometry, according to the following steps:

a ') fixing of the sample on the frame in a first geometry, flat so as to close an opening of the frame;

b ') deformation of the frame to a second geometry, so as to tension the sample.

Preferably, in step b), the second frame part is brought closer to the first frame part until a stop position, that is to say to a position beyond which the approximation cannot continue.

Preferably, in step bj, the frame is deformed to a stop position, that is to say to a position beyond which the deformation cannot continue.

The invention also relates to a device for selecting an article intended to be threaded on a limb of a person, and in particular a dbrthesis model of elastic venous compression intended to be threaded on a lower limb of a patient, the device comprising:

- a frame delimiting an opening;

- a sample of a reference article, and in particular of a reference orthosis, stretched through the opening of the frame so as to simulate a tension in a threaded position in which the reference article, and in particular the 'reference orthosis, is threaded on said member.

A device according to the invention can in particular be used for the implementation of a selection process according to the invention.

A device according to the invention can also include one or more of the following optional characteristics:

- The sample is supported, preferably substantially continuously, on an edge defined by an axial end of the frame, the axial end being defined along an axis perpendicular to the opening of the frame;

the frame comprises first and second frame parts fitted one on the other, preferably one in the other, preferably clipped one on the other, and clamping the sample;

the sample exerts an action tending to dislodge said first and second frame parts; in other words the sample is arranged so as to oppose, by its elastic deformation, the fitting, the fitting thus causing the sample to be tensioned;

the frame has a width of less than 15 mm;

the frame has the general shape of a ring, preferably of constant width;

the frame has a peripheral chute shaped to receive a portion of the sample extending outside the frame.

The invention also relates to a kit comprising several devices according to the invention, the samples of the various devices being extracted from reference articles, in particular reference orthoses, of different models. This kit advantageously makes it possible to quickly test several color renditions.

Brief description of the figures

Other characteristics and advantages of the invention will become apparent on reading the detailed description which follows, and on examining the appended drawing in which

- Figures 1 and 2 schematically show a device in a preferred embodiment of the invention in disassembled and assembled positions, respectively;

- Figures 3a and 3b illustrate the assembly of a device according to the invention, in one embodiment of the invention;

- Figures 4a to 4c illustrate a power-up of a sample, in a preferred embodiment of the invention;

- Figure 5 schematically shows a device in another preferred embodiment of the invention, during assembly.

Definitions

A product model, in particular an orthosis model, designates products, in particular orthoses respectively, of a particular type, for example having a particular structure or intended for a particular treatment.

- Unless otherwise indicated, "comprising", "comprising", "having", "including" or their variations correspond to a non-exclusive inclusion.

detailed description

Orthosis

An orthosis, of generally tubular shape, conventionally comprises a foot part 2 enveloping the foot and a leg part comprising an ankle part 4 enveloping the ankle and a calf part 6 enveloping the calf (FIG. 4a).

The orthosis extends to a level below the knee in the case where the orthosis is a knee-high sock (or hock).

The configuration in the form of a sock is not limiting, and the orthosis can also be produced in the form of a lower thigh, extended by a compressive thigh portion. The orthosis can also be produced in the form of a pantyhose, and / or devoid of foot portion (stockings or pantyhose of the open foot type).

The pressure profile exerted by an orthosis is usually decreasing upwards from the ankle.

The orthoses are distributed according to the ASQUAL standard in four textile classes, from class I (13 to 20 hPa ~ 10 to 15 mmHg at the ankle) to class IV (> 48 hPa ~> 36 mmHg at the ankle).

To allow compression of the lower limbs at a high level of pressure providing a therapeutic effect, an orthosis is conventionally produced from a knitted mesh and incorporates, in the leg part, an elastic weft thread, generally made of gimped elastane .

This weft thread, barely visible when the orthosis is relaxed, in the "flat position", can become visible in the threaded position, which modifies the appearance of the orthosis.

The method according to the invention makes it possible to reproduce the aspect in the threaded position, without having to thread the orthosis. Preferably, this method implements a simulation device according to the invention.

Device

Figure 2 shows a device 10 according to the invention in the assembled position.

The device 10 comprises a frame 12 of axis X and a sample 14 of a reference orthosis, fixed, under tension, on the frame.

The frame 12 defines an opening 16. The frame can be closed on itself and have, for example the general shape of a rectangular, square or, preferably annular, frame. The frame 12 then surrounds the opening 16.

Preferably, the opening 16 is delimited by a substantially circular inner edge 17i of the frame. The diameter of the inner edge 17i is preferably greater than 80 mm, preferably greater than 90 mm and / or less than 130 mm, preferably less than 120 mm or 110 mm.

Preferably, the frame is delimited externally by an outer edge 17e which is substantially circular, preferably coaxial with the inner edge 17i. The diameter of the outer edge is preferably greater than 120 mm, preferably greater than 130 mm and / or less than 160 mm, preferably less than 150 mm.

Alternatively, the frame can be opened and present, for example the general shape of a U, an Ω or a V.

At its axial ends, the frame 12 defines first and second axial edges 15i and 15 ₂ , preferably circular, between which a sleeve 21, preferably having the shape of a profile of axis X, extends. Preferably, at least one of the axial edges extends in a plane perpendicular to the axis X.

Preferably, the frame has a handle 18 facilitating the handling of the device.

The frame 12 is preferably made of plastic.

The frame is not substantially deformable under the effect of the tension of the sample. Advantageously, the tension of the sample therefore remains substantially constant.

Preferably, the width / of the upright (s) of the frame 12, or "width of the frame", when the frame is observed along its axis X, is less than 15 mm, 10 mm, 8 mm, preferably 5 mm. Advantageously, the appearance of the sample can thus be easily compared with the appearance of the skin of the patient's lower limb.

Sample 14 is a portion of the reference orthosis, preferably extracted from the part of the reference orthosis for which the patient wishes to have a simulation of the appearance in the threaded position, preferably extracted from the portion of leg.

Preferably, the sample 14 comprises only one layer of the reference orthosis.

The sample 14 extends substantially in the plane of the opening 16 and defines first and second planar faces, 19i and 19 ₂ , respectively.

More specifically, the sample 14 preferably extends in the plane, perpendicular to the axis X, of one of the axial edges of the frame, namely, in FIG. 2, in the plane of the first axial edge 15i. Advantageously, it can thus be brought into contact, substantially flat, with the patient's skin. The quality of the simulation is improved.

The sample 14 can be fixed, under tension, to the frame 12 by any means.

The tension can be unidirectional, that is to say mainly along a tension direction.

It can also be multidirectional. In particular, the sample 14 can be stretched in at least two tension directions perpendicular to each other.

The sample can also be tensioned isotropically, that is to say with substantially the same tension whatever the direction considered in the plane of the sample. Such an isotropic tension can in particular result from the use of a device in which the tension results from the fixing of the sample to the frame. In FIG. 2, the arrows F illustrate different directions of tension when the tension is isotropic, with a circular frame.

Figure 1 shows the device of Figure 2 in the disassembled position.

The frame 12 comprises first and second frame parts 12i and 12 ₂ , respectively, intended to be rigidly fixed to one another in the assembled position, preferably in a non-removable manner, for example with glue, one or several magnets, rivets, one or more screws, one or more clips, preferably by means of clips. The first and second frame parts 12i and 12 ₂ can also be rigidly fixed to one another, in the assembled position, in a removable manner, preferably by complementarity of shapes, preferably by friction after mounting by force.

Front views, the first and second frame parts 12i and 12 ₂ preferably have the general shape of the frame 12 and define first and second openings 16i and 16 ₂ , respectively, which, in the assembled position (Figure 2), are substantially confuse and define the opening 16 of the frame.

Process

In step 1), during assembly of the device, the sample 14 is tensioned, then clamped between the second and first frame parts 12i and 12 ₂ , so as to close the opening 16 (wide arrows in Figure 1). The second and first frame parts 12i and 12 ₂ are rigidly fixed to each other.

After fixing the sample on the frame, the portions of the sample that extend outside the frame can be cut.

Preferably, the frame defines a peripheral chute 22 (FIG. 3b) in which the portions of the sample which extend outside the frame can be stored. These portions are shown in dotted lines in Figure 3b. The device is thus more aesthetic. In addition, advantageously, these portions of the sample no longer interfere with the portion of the sample which extends into the opening of the frame. The simulation of the aspect in the threaded position is improved.

The tension of the sample is preferably adjusted to be, in the assembled position, substantially identical to the tension of the reference orthosis, at the location of the sample, if it was in the threaded position.

Power-up can be manual. For example, an operator can cover the first opening 161 of the first frame part with the sample 14, then, by pulling on each side of the sample 14, turn it on. While maintaining this tension, the operator can then fix the second frame part on the first frame part, so as to tighten and immobilize the sample under tension.

In a preferred embodiment, the first frame part is shaped so that it cannot be introduced into the reference orthosis without deformation and tensioning of the reference orthosis. The tensioning can therefore result from the introduction of the first frame part inside the reference orthosis at rest, that is to say "flat" (Figures 4a and 4b). The operator therefore only needs to introduce the first part of the frame into the reference orthosis to energize this orthosis in the region near the first part of the frame.

Preferably, the assembly of the device comprises the following steps:

A) introduction of the first frame part into the reference orthosis, the first frame part being shaped so that said introduction stretches said reference orthosis in the region of the first frame part;

B) fixing the second part of the frame to the first part of the frame, sandwiching a portion of the reference orthosis, so as to constitute the frame;

C) optionally, cut the reference orthosis around the frame (Figure 4c).

Advantageously, it suffices to modify the dimensions of the frame to modify the tension of the sample fixed in the frame.

Preferably, the dimensions of the first frame part are adapted, as a function of the reference orthosis, to obtain a predetermined sample tension.

The circularity of the outer edge of the first frame part advantageously facilitates its introduction into the reference orthosis.

The circularity of the two inner and outer edges of the first frame part, that is to say the use of a first annular frame part and the amount of which is of constant width, advantageously makes it possible to obtain a tensioning of the identical sample whatever the angular position, around its axis, of the first frame part.

The tensioning can also result, partially or completely, from the fixing of the second frame part on the first frame part.

In particular, the first part of the frame may include attachment means for fixing the sample and the second part of the frame may be shaped to tension the sample fixed on the first part of the frame when it is fixed on the first part. of frame.

The attachment means can be any. In one embodiment, the sample is simply pinched between the two frame parts.

Preferably, the assembly of the device comprises the following steps:

a) fixing the sample on the first frame part, flat so as to close the first opening 161;

b) bringing the second part of the frame and the first part of the frame together, against a reaction exerted elastically by the sample, to a fixing position authorizing the fixing in step c);

c) fixing the first part of the frame to the second part of the frame.

The second part of the frame is preferably configured for, in step b) and until the end of step c), press on the portion of the sample which extends through the first opening. The sample, by deforming elastically, therefore opposes the bringing together of the two frame parts. This opposition thus leads to increasing the tension of this sample.

In one embodiment, the second frame part has a support flange 20, which preferably follows the general outline of the second frame part, and the support of which on the sample fixed on the first part of cadre opposes the fixing of the second frame part on the first frame part.

As shown in FIG. 3a, the sample 14 can be initially fixed flat to an axial end of the first frame part 12i. During assembly, the support flange 20 penetrates inside the first frame part 12i, thereby pushing the sample towards the inside of the first frame part 12i. The sample being moreover immobilized on the first part of the frame 12i, it deforms under the effect of the support of the support rim 20, which increases its tension (FIG. 3b).

In the variant of the embodiment of FIG. 5, the first part of the frame 12i has a trough 22 and the second part of the frame 12 ₂ has a support flange 20 shaped to be able to be introduced into the trough 22. The sample 14 can be initially fixed flat so as to cover the chute 22. During assembly, the support flange 20 penetrates inside the chute thus coming to tension the sample.

Preferably, the first and second frame parts are shaped so that said approximation in step b) is necessary to authorize the fixing in step c).

In one embodiment, the tension of the sample is variable depending on the degree of closeness of the two frame parts from each other. Preferably, it increases when the two frame parts approach each other. Advantageously, the tension can therefore be adjustable.

The reconciliation is preferably guided. For example, the second frame part can be screwed onto the first frame part.

In one embodiment, the fixing in step a) is carried out so that, after fixing on the first frame part, the sample, substantially flat, is not substantially taut. All the tension therefore results from step b), which allows great tension precision, in particular when the bringing together of the two frame parts is limited, for example by a stop. In the position of maximum approximation, the tension of the sample is advantageously predetermined with precision.

Advantageously, the predetermined tension can be obtained by simple fixing of the first and second frame parts to one another, without any particular tool or specific knowledge.

In step 2), holding the frame 12 by the handle 18, the patient positions the sample against the lower limb intended to receive an orthosis, substantially parallel to the lower limb. Preferably, it positions the sample so that the first face 191 of the sample is in contact with its skin.

He can then observe, on the side opposite the lower limb, the second face 19 ₂ of the sample with an appearance close to that which the reference orthosis would have in the threaded position. In particular, the weft threads are visible as they would be in the threaded position, and the color of the skin seen through the sample is that which would be observed in the threaded position.

Advantageously, the thin edge of the frame also allows the patient to simultaneously see the skin, and therefore to simulate the change in appearance at the transition between the reference orthosis in the threaded position and the skin not covered by the reference orthosis. .

In step 3), the patient decides whether the observations made in the previous step suit him or not.

If they agree, he can choose an orthosis of the same model as that of the sample, that is to say of the same model as the reference orthosis, with good assurance of the appearance that this orthosis will in the threaded position.

Otherwise, he can repeat step 1) with a sample from a reference orthosis of another model.

Preferably, the patient has a plurality of devices, each with a sample of a particular model. It therefore suffices for him to present these devices successively in front of his leg to choose the one which provides the aspect which he considers to be optimal.

Of course, the invention is not limited to the embodiments described and shown, provided for illustration purposes only.

In particular, the tensioning can also result, partially or completely, from the deformation of the frame.

In one embodiment, the frame 12 is deformable between first and second geometries, the area of the opening 16 being larger in the second geometry than in the first geometry.

Preferably, the assembly of the device comprises the following steps:

a ') fixing of the sample on the frame in the first geometry, flat so as to close the opening 16, preferably substantially without exerting tension on the sample 14;

b ') deformation of the frame up to the second geometry, so as to tension the sample.

Preferably, the first and second geometries are predefined, which makes it possible, at the end of step b ’), to obtain a predetermined tension. Preferably, the second geometry is a stop position beyond which the frame can no longer be deformed.

In one embodiment, the frame 12 is deformable between the first geometry and a plurality of second geometries, the area of the opening 16 being different in each of said geometries.

The tension can advantageously be adjusted by choosing one of said second geometries.

In addition, other means of adjusting the sample tension are possible.

In one embodiment, the tension is adjustable by means of a member, for example a screw, arranged to move the support flange 20 or to modify a winding of the sample around a drum or to modify the geometry of the frame.

As is now clear, the invention makes it possible to quickly and reliably simulate the appearance of an orthosis in the donned position. The patient can therefore make an informed choice of the model of the orthosis that he should wear. This results in better compliance.

The invention is not limited to an application to an elastic venous compression orthosis and extends to any transparent article intended to be worn against the skin of a person. By "transparent" is meant that, in the threaded position in which the article is worn, the color rendering of the article is modified, by transparency, by the person's skin.

All the characteristics of the device or of the method described above and relating to a reference orthosis or orthosis can therefore be generalized to an article or to a reference article, respectively.

The article can be, in particular, a "fashion" tights, stockings or socks, that is to say without therapeutic effect.

Claims (12)

1. Method for selecting a model for an article intended to be donned on a member of a person, said method comprising the following steps: 1) fixing of a sample (14) of a reference article on a frame, the sample being tensioned so as to simulate a tension in a "threaded position" in which the reference article is threaded on said member, the live sample having opposite second and first faces (19i, 19 ₂ ); 2) positioning of the first face (19i) in front of said member and observation, preferably by the person, of the second face (19 ₂ ); 3) evaluation, preferably by the person, of the appearance of the sample thus observed and, according to said evaluation, selection of the model of the reference article or repeated in step 1) with a sample of another reference item from another model. 2. Method according to the preceding claim, in which, in step 1), to energize the sample, the following steps are carried out: A) introduction of a first part of the frame (12 _Ί ) into the reference article, said first part of frame (12i) being shaped so that said introduction tends said reference article in the region of the first part of frame ( 12 _Ί ); B) fixing of a second frame part (12 ₂ ) on the first frame part (12i), by sandwiching a portion of the reference article, so as to constitute the frame and to immobilize said portion on the frame ; C) cutting of the reference article around the frame so as to constitute said sample (14), or according to the following steps: a) fixing the sample (14) on a first frame part (12i), flat, so as to close a first opening of said first frame part; b) bringing a second part of the frame (12 ₂ ) closer to the first part of the frame (12i), to a fixing position authorizing the fixing in step c), the parts of the frame being configured so that said approximation causes elastic deformation of the sample and, consequently, a tension in the sample (14); c) fixing the second frame part (12 ₂ ) to the first frame part (12i), so as to immobilize the sample (14), or according to the following steps: a ') the frame (12) being of variable geometry, fixing the sample (14) on the frame (12) in a first geometry, flat, so as to close an opening of the frame; b ') deformation of the frame to a second geometry, so as to tension the sample. 3. Method according to any one of the preceding claims, in which, in step b), the second frame part (12 ₂ ) is brought closer to the first frame part (12i) up to a stop position, or, in step b '), the frame (12) is deformed to a stop position. 4. Method according to any one of the preceding claims, in which the sample is a sample of a model of elastic venous compression orthosis intended to be put on a lower limb of a patient, and in which the observation in step 2) and the assessment in step 3) are performed by the patient. 5. Device for selecting an article intended to be put on a limb of a person, the device comprising: - a frame (12) defining an opening (16); - a sample (14) of a reference article stretched through the opening of the frame so as to simulate a threaded position in which the article is threaded on said member of the person. 6. Device according to the preceding claim, in which the sample (14) is supported, preferably in a substantially continuous manner, on an edge (15i) defined by an axial end of the frame, the axial end being defined with reference to an axis (X) perpendicular to the opening of the frame (12). 7. Device according to any one of the two preceding claims, in which the frame comprises first and second frame parts fitted one on the other and clamping the sample (14). 8. Device according to the preceding claim, wherein the sample exerts an action tending to dislodge said first and second frame parts. 9. Device according to any one of the four preceding claims, in which the frame (12) has a width (/) of less than 15 mm. 5 10. Device according to any one of the five preceding claims, in which the frame (12) has the general shape of a ring of constant width. 11. Device according to any one of the six preceding claims, in which the frame (12) comprises a peripheral chute (22) shaped to receive a portion of the sample extending outside the frame (12). 10 12. Device according to any one of the seven preceding claims, in which the sample is a sample of an elastic venous compression orthosis model intended to be put on a lower limb of a patient.