AU2021220618A1

AU2021220618A1 - Molded insole, footwear item, and manufacturing method

Info

Publication number: AU2021220618A1
Application number: AU2021220618A
Authority: AU
Inventors: Cyril CHAIGNEAU; Nicolas MARGAINE
Original assignee: Sigvaris AG
Current assignee: Sigvaris AG
Priority date: 2020-02-11
Filing date: 2021-02-11
Publication date: 2022-08-25
Also published as: FR3106960B1; FR3106960A1; CA3164807A1; EP4072368A1; MX2022009145A; US20230048857A1; WO2021160761A1; BR112022014541A2

Abstract

Molded insole (1), comprising a base (10), an internal lateral arch (20) that is provided to accommodate the arch of the foot and that is raised up relative to the base (10), and at least one hard region (30) that is integrated into the base, having a hardness equal to or greater than that of the base (10), characterized in that the base (10) and the internal lateral arch (20) of the insole (1) constitute a single, one-material part (2).

Description

MOLDED INSOLE, FOOTWEAR ITEM, AND MANUFACTURING METHOD

Technical area

The present invention relates to a molded insole, designed to fight against venous

stasis induced by venous insufficiency in a patient, and thus improve venous return.

The insole is specifically adapted to the morphology of a patient's foot, in particular a

senior patient, suffering from venous insufficiency. It is designed for the uniform

improvement of venous return, regardless of the patient's plantar morphology. It can be

inserted or directly integrated into any type of footwear, such as stockings, tights, socks

or shoes including flip-flops and sandals.

State of the art

Venous insufficiency is characterized by dilation of the veins or deterioration of the

anti-reflux valves. This pathology is common in elderly patients. A reflux sets in and

causes an increase in blood pressure in the veins. The slowing of the velocity of blood

circulation thus leads to the first signs of the disease. The blood that stagnates in a vein

can then cause a breakdown of the vein wall, causing deformation and the appearance

of varicose veins. Among the risk factors linked to this pathology can be cited, for example,

heredity, gender, age, obesity, position at work, pregnancy, menopause, and plantar

dysmorphisms. In a known way, venous return can be improved by wearing insoles with

variations in density.

Document EP 0 971 606 discloses an insole comprising several cushion-shaped

layers configured to improve venous return. These layers are each separated into several plate-shaped fields juxtaposed in the transverse direction with respect to the insole axis.

The layer forming a bump at the internal lateral arch sits on the base of the insole and is

optional.

Document WO 2011/135278 discloses a plastic insole having zones for reducing

pressure, which include orifices having less rigidity. This insole also increases blood flow

and circulation in the foot.

Document WO 2011/017174 Al discloses an insole for improving comfort, in particular

when running and walking. The insole comprises three portions attached to a central

base, namely an external lateral arch, an internal lateral arch and a portion opposite the

heel. The portion opposite the heel has a greater hardness than the base and the external

lateral arch, which, themselves, have a greater hardness than the internal lateral arch.

Each of the elements is manufactured separately then associated with the central base

by conventional gluing techniques, for example.

Disclosure of the invention

The object of the invention is to propose a new insole to fight against venous stasis

induced by venous insufficiency.

To this end, the invention relates to a molded insole, comprising a base, an internal

lateral arch that is provided to accommodate the arch of the foot and that is raised relative

to the base, and at least one hard region that is integrated into the base, having a

hardness equal to or greater than that of the base. This insole is characterized in that the

base and the internal lateral arch constitute a single, mono-material part. The base extends, in practice, over the entire surface of the foot with the exception of the portion occupied by the internal lateral arch.

In addition, and according to another advantageous characteristic, the base is

configured so that its upper surface does not undergo deformations in contact with the

hard regions at the time of its integration after molding. In other words, the upper surface

of the insole is smooth in the sense that it does not have any bumps next to the hard

regions.

In practice, and as will be explained later, the hard regions are integrated into hollow

chambers formed in the thickness of the base and opening onto the underside of said

base. In other words, the lateral arch does not contain an integrated hard region within

the meaning of the invention.

Thus, the insole is simpler and more economical to manufacture, due to the use of a

single material to produce the base and the internal lateral arch of the insole, and the fact

that the base and the internal lateral arch constitute a single part, compared to bi-material

insoles and/or insoles integrating an added arch, as is the case, for example, in document

WO 2011/017174 Al. In addition, the insole according to the invention is designed to

adapt easily to each type of foot, flat, hollow or physiological.

The internal lateral arch is designed to accommodate the arch of the patient's foot.

This configuration promotes venous return by compressing the plantar venous reservoir

when walking, thanks, in particular, to the raised position of the internal lateral arch,

formed projecting from the base.

Preferably, the internal lateral arch has a volume adapted to the volume of the patient's

arch, in particular in the case of dysmorphia.

According to the invention, the thickness of the internal lateral arch corresponds to the

thickness of mono-material constituting said arch. In practice, this thickness decreases

from the center of the insole towards the inside of the insole. In other words, it decreases

substantially from the center of the insole towards its periphery, on the inside of the foot.

The volume of the arch of the foot corresponds to the volume between the upper side

of the insole and the plane extending the lower surface of the base under the internal

lateral arch.

The correct positioning of the volume of the internal lateral arch on the insole is

guaranteed by matching, from the rearmost point of the insole, the geographical location

of an anatomical reference point taken on the arch of the foot with respect to the rear of

the foot. This anatomical reference point is, in practice, the highest elevation point of the

arch of the foot, i.e., corresponding to the maximum hollow formed in the arch of the foot

between the underside of the base and the underside of the arch.

The internal lateral arch is defined by a virtual line corresponding to the maximum

thickness of the insole for each of the vertical cross sections of the insole in the direction

of the width of the insole.

The thickness of the insole increases from the external side of the insole towards the

internal side of the arch to reach its maximum thickness along this virtual line. From this

maximum thickness, the thickness of the insole decreases again from the external side of

the insole towards the internal side of the arch.

The thickness of the insole increases along this virtual line from its 2 extremities to

reach a maximum value near its center. In other words, the insole reaches a maximum

thickness approximately halfway between the 2 ends of the virtual line.

Preferably, the volume and position of the internal lateral arch are determined

according to three parameters: the gender of the patient; the patient's shoe size; and the

morphology of the patient's foot.

On this basis, the morphology parameter of the patient's foot defines three

possibilities: flat, hollow or physiological foot.

The insoles differ from each other for these 3 types of morphology by their maximum

thickness at approximately halfway between the 2 ends of the virtual line defining the

internal lateral arch.

As mentioned before, this thickness subsequently decreases:

- towards the inside of the insole depending on the volume of the arch of the

foot, to reach, in practice, a value of less than 2 mm, for example of the

order of 1.5 ±0.3 mm,

- towards the outside of the insole to reach, in practice, a value of at least 3

mm, preferably around 3.5 ±0.3 mm.

According to the invention, the maximum thickness of the insole is 5.6 ±0.2 mm for a

flat foot, 8.4 ±0.4 mm for a hollow foot and 8.8 ±0.2 mm for a physiological foot.

Preferably, the internal lateral arch has a curved lower surface forming a hollow with

respect to the lower plane of the base, and a curved upper surface forming a projection

with respect to the upper plane of the base.

Similarly, and in practice, the lower surface of the internal lateral arch has a greater

slope than the upper surface of the arch.

In the embodiment where the hardness of the hard regions is greater than that of the

base, the base may have a hardness between 22 and 50 on the Shore A scale depending

on its thickness. The hardness of elastomers may be measured according to ISO 868

/ DIN 53505 / ASTM 2240 standards. The base may have a density between 120 and 465

kg/m3 depending on its thickness.

In practice, and always in this embodiment, the hard regions may have a hardness

between 53 and 58 on the Shore A scale, preferably 55 on the Shore A scale. The hard

regions may have a density between 494 and 690 kg/m 3, preferably between 570 and 610

kg/m 3 , for example 590 kg/m 3 .

For example, the hard regions may be made of 95% polyurethane and 5% carbon

foam, while the part formed by the base and the internal lateral arch may be made of

100% polyurethane foam.

More generally, the insole may be made of all types of polymers or natural materials,

pure or as a mixture, containing or not containing fillers or additives providing additional

properties of the anti-odor type.

The insole may include a top layer covering the base and the internal lateral arch. This

upper layer constitutes an accommodating surface for the foot resting on the insole, as

well as a protective element. It thus makes it possible to avoid direct contact between the

insole and the arch of the patient's foot and to improve comfort and hygiene when wearing

the insole. This layer is made of flexible material, for example made from a composition

of 90% microfiber polyamide and 10% polyurethane.

The applicant found that particularly advantageous results were obtained in terms of

venous return when the hardness of the insole, in the parts of the base without a hard

region, measured on the upper side of the insole and over its entire thickness, was

between 30 and 56 on the Shore A scale depending on the thickness of the insole, and

that the hardness of the insole, in the parts of the base incorporating the hard regions,

measured under the same conditions, was between 65 and 77 on the Shore A scale

depending on the thickness of the insole.

Thus, the invention also relates to a molded insole, comprising a base and an internal

lateral arch provided to accommodate the arch of the foot, raised relative to the base, the

base integrating hard regions. This insole is characterized in that the base and the internal

lateral arch of the insole constitute a single mono-material part, advantageously covered

with an upper layer over its entire surface, and in that:

- the hardness of the insole, in the parts of the base without hard regions,

measured on the upper side and over its entire thickness, is between 30

and 56 on the Shore A scale depending on the thickness,

- the hardness of the insole, in the parts of the base incorporating hard

regions, measured on the upper side and over its entire thickness, is

between 65 and 77 on the Shore A scale depending on the thickness.

The hardness of elastomers may be measured according to ISO 868 / DIN 53505/

ASTM 2240 standards.

According to the invention, the hardness may vary from one point to another on the

surface of the insole within the ranges mentioned above.

In the present application, the limits of each density or hardness value range are

included in the range.

According to the invention, the hard regions are formed by inserts integrated into the

base. In practice, the base has chambers in which the hard regions are inserted. Thus,

the insole has a smooth surface, i.e., an upper surface containing no localized extra

thickness next to the hard regions. This makes it possible not to modify the proprioception

sensations of the foot.

Preferably, the hard regions are laid out in the open air under the base. In other words,

the hard regions are not covered by an additional layer of material. This reduces the time

and cost of manufacturing the insole. Similarly, and still according to the invention, the

hard regions are flush with the lower surface of the base and are, therefore, not projecting

from the lower surface of the base.

As mentioned above, the results on venous return are even more convincing in the

hardness ranges mentioned above and measured on the upper side of the insole.

A person skilled in the art will be able to determine the nature of the materials of the

base and the hard regions to be implemented, as well as the compressive force to be applied to the base at the time of molding, in order to obtain the hardness within the ranges described.

The present invention also relates to a footwear item, for example stockings, tights,

socks or shoes including flip flops and sandals, comprising an insole as defined above.

The insole may constitute a distinct element of the footwear item, i.e., the insole may

be placed at the bottom of the footwear item to wear it. Alternatively, the insole may be

directly integrated into the footwear item. This allows relatively varied uses of the insole.

The insole may be adapted for a flat, hollow or physiological foot. Within the meaning

of the invention:

- a flat foot corresponds to a CSI strictly greater than 0.4;

- a hollow foot corresponds to a CSI strictly less than 0.3;

- a physiological foot corresponds to a CSI between 0.3 and 0.4.

The CSI is the Chippaux Smirak Index, representing the ratio between the minimum

width of the footprint at the arch of the foot (DC length) and the maximum width of the

footprint at the metatarsals (AB length), as shown in Fig. 10.

The index is defined by the formula: CSI = (DC) / (AB) x 100.

The invention also relates to a manufacturing method of an insole as mentioned

above. The process includes the following steps:

a) a step of forming at least one hard region having a hardness equal to or greater

than that of the base; b) a step of cutting, from a mono-material strip, with or without an upper layer laminated on its surface, a preform to the dimensions of the mold corresponding to the insole; c) a step of molding the preform, as a part comprising the base and the internal lateral arch formed projecting from the base, to the desired size of the insole; d) a step of assembling the part comprising the base and the lateral arch once removed from the mold; and hard regions; and e) a finishing step to obtain the insole.

Advantageously, step c) of molding the preform is carried out by compressing a mono

material part of constant thickness, hardness and density in a mold, the mold being in

shapes intended to configure the base so that its upper surface does not undergo

deformations in contact with hard regions.

According to a particular embodiment, step c) may first comprise a step of laminating

a strip corresponding to the upper layer over the entire surface of the mono-material strip.

According to a particular embodiment, the finishing step e) may consist in cutting out

the outline of the pre-insole in order to obtain the insole in its final state.

Alternatively, the insole may be manufactured by other techniques, for example by 3D

printing.

The insole may receive design elements by screen printing, pad printing, transfer, or

any other technique (for adding a logo, marking areas, various style effects).

The insoles may be mass-produced, including different sizes and different

morphologies (flat foot, hollow foot or physiological foot), depending on the gender of the

patient. Alternatively, the insoles may be custom-made, depending on the morphology of

the patient's foot.

Description of the figures

The invention will be better understood on reading the following description, given

solely by way of non-limiting example and made with reference to the appended drawings

in which:

Fig. 1 is a schematic top view of a molded insole according to the invention according

to the arrow I of Fig. 3.

Fig. 2 is a schematic view from below of the insole of Fig. 1 according to the arrow II

of Fig. 3.

Fig. 3 is a lateral view of the insole of Figs. 1 and 2 from the periphery of the internal

lateral arch, on the internal side of the foot.

Fig. 4 is a front view of the insole, according to the arrow IV in Fig. 1.

Fig. 5 is a rear view of the insole, according to the arrow V in Fig. 1.

Figs. 6, 7 and 8 are sections of the insole seen from below in Fig. 2, along the axes

VI, VII and VIII respectively.

Fig. 9 is a perspective view from the front and top of a pair of insoles according to the

invention, with the insole on the right in real view, and the insole on the left in conceptual

view, with elevation lines shown on the arch, and hard regions shown in dotted lines on

the base.

Fig. 10 is a schematic representation of the underside of a right foot, illustrating the

Chippaux Smirak Index (CSI).

Detailed description

Figs. 1 to 10 show a molded insole (1) designed to fight against venous stasis induced

by venous insufficiency in a patient.

The insole (1) comprises a base (10), an internal lateral arch (20) raised relative to the

base (10), four hard regions (30 (31, 32, 33, 34)) having a hardness greater than that of

the base (10), and a top layer(40).

According to the invention, the base (10) and the internal lateral arch (20) of the insole

constitute a single, mono-material part (2). Thus, the insole (1) is simple and economical

to manufacture, due to the use of a single material to make the base (10) and the internal

lateral arch (20) of the insole (1).

The base (10) is substantially planar.

The internal lateral arch (20) constitutes a portion of the insole (1), provided to

accommodate the arch of the patient's foot. This configuration promotes venous return,

thanks, in particular, to the raised position of the internal lateral arch (20), formed

projecting from the upper side of the base (10). The internal lateral arch (20) has a curved

shape so as to match the shape of the arch of the patient's foot.

As shown in Fig. 1 in particular, the internal lateral arch (20) is defined by a virtual line

connecting the periphery of the insole, on the internal side of the foot, in front of the heel

to the periphery of the insole, on the internal side of the foot, near the base of the

metatarsus in the longitudinal direction, this virtual line passing near the center of the

insole in the transverse direction.

According to the invention, the insole reaches a maximum thickness approximately

halfway between the 2 ends of the virtual line defining the lateral arch designated "MAX"

in Fig. 1.

internal side of the arch to reach its maximum thickness along the virtual line. From this

maximum thickness, the thickness of the insole decreases again.

The internal lateral arch is defined by this virtual line corresponding to the maximum

thickness of the insole for each of the vertical cross sections of the insole, in the direction

of the width of the insole. These values are designated MAX1, MAX', MAX2, MAX2' etc.

and gradually increase to the MAX value.

The arch (20) has a curved lower surface (21) forming a hollow with respect to the

lower plane (P11) of the base (10). The arch (20) has a curved top surface (22) projecting

from the top plane (P12) of the base (10). The lowersurface (21) has a steeper slope than

the upper surface (22) of the arch (20). This allows the insole to match the morphology of

the arch of the foot.

In practice, the plantar venous reservoir is positioned in the lateral plantar veins

located deep at the arch of the foot.

By following the shape of the arch of the foot, the internal lateral arch (20) acts as a

"pump" for the deep activation of the lateral plantar veins.

This action is particularly useful in case of dysmorphism of the patient, characterized

by a deformation of the arch of the foot leading to poor functioning of the plantar pump

linked to the anatomical modifications. The insole (1) then allows to correct this problem.

The hard regions (30) are spaced apart along a longitudinal direction of the insole (1).

These hard regions (30) correspond to the foot support points: sole of the foot (central

zone of the foot), metatarsus (forefoot), heel and tarsus (rearfoot). The specific location

of the hard regions (30) allows to distribute in a homogeneous manner the weight of the

body while in a standing position from these points subject to strong stresses over the

entire surface located under the foot. Moreover, the hard regions (30) constitute a

reinforced protection of these sensitive points.

The hard regions (30) are auxiliary activators for improving venous return. Due to their

location, and their hardness equal to or greater than that of the base (10), the hard regions

(30) act at the surface of the soles of the feet to create a "2nd pump" effect, as a

complement to the "1st pump" effect created by the internal lateral arch (20) acting in

depth to activate the lateral plantar veins.

This effect is reinforced by the fact that the base is configured so that its upper surface

does not undergo deformations in contact with the hard regions at the time of manufacture

of the insole, as will be seen later. Therefore, the surface of the insole is smooth.

More particularly, the hard regions (30) may be formed by inserts (31, 32, 33, 34)

integrated into chambers provided in the base (10). This integration may be done, for

example, by laminating the inserts (31-34) on the base (10).

The inserts (31-34) act as reinforcements, arranged on the underside of the insole (1)

and corresponding to the bearing points of the patient's foot on the insole.

The inserts (31-34) have different geometric shapes, corresponding to the surface of

the patient's bearing points:

- the insert (31) is located at the forefoot, below the phalanges,

- the insert (32) is located in the central zone of the foot,

- the insert (33) is located in a zone close to the heel, between the central zone and

the heel,

- the insert (34) is located under the heel.

As shown in Figs. 6 and 8, in particular, the base (10) comprises cavities or chambers

for accommodating the inserts (31-34). The thickness of the base (10) is reduced in these

cavities. This thickness is such that the upper surface of the base does not undergo

deformations in contact with hard regions during manufacture, which contributes to the

improvement of venous return. In practice, the hard regions (30) are flush with the lower

surface of the base (10). This makes it possible to have contact at all points between the

underside of the insole and the shoe.

The internal lateral arch (20) of each insole (1) is designed according to the gender,

size and morphology of the patient's foot (flat foot, hollow foot or physiological foot).

Advantageously, the internal lateral arch (20) is designed with a volume specifically

adapted to the volume of the patient's arch of the foot, in particular in the event of

dysmorphia. This volume may be determined by acquisition by 3D scanner. The volume

of the internal lateral arch (20) is then the 3D shape of the arch of the foot. The correct

positioning of the volume of the internal lateral arch (20) on the insole (1) is guaranteed by matching, from the rearmost point of the insole (1), the geographical location of an anatomical reference point taken on the arch of the foot in relation to the rear of the foot.

Preferably, this anatomical reference point is the point of highest altitude of the arch of

the foot, i.e., corresponding to the maximum hollow formed in the arch of the foot.

Figs. 6, 7 and 8 show cross sections of the insole at different locations:

- The cross section VI is made close to the heel,

- The cross section VII is made in the rear middle part of the insole,

- The cross section VIII is made in the front middle part of the insole.

As the cross section VI shows, the insole (1) has a constant thickness at the heel, in

practice of the order of 3.5 mm, then gradually increases near the virtual line, appearing

in a solid line, then reaches the virtual line at the MAX1 value greater than 3.5 mm. The

thickness of the lateral arch then decreases towards the inside of the insole.

The cross section VII corresponds to the section of the insole with the maximum

thickness. It is designated MAX.

The cross section VIII corresponds to a section of the insole with a constant thickness

across its width, which means that this section does not contain the internal lateral arch.

The thickness of the insole is constant here, in practice approximately 3.5 mm over its

entire width.

As already stated, the insoles are different depending on the morphology of the

patient's foot. What changes from one insole to another is essentially the MAX maximum

thickness that said insole may reach, in practice 5.6 ±0.2 mm for a flat foot, 8.4 ±0.4 mm

for a hollow foot and 8.8 ±0.2 mm for a physiological foot.

The insole (1) preferably comprises an upper layer (40), covering the mono-material

part (2), to improve the comfort and hygiene of the insole (1). The upper layer (40)

constitutes an accommodating surface for the foot resting on the insole (1).

To mass-produce a range of insoles (1), one mold is available per gender and per size

(for example, 36 to 41 for women; 39 to 45 for men), and per type of arch (flat, hollow or

physiological).

Clinical trials were carried out to test the insole (1) according to the invention as to its

effectiveness on improving venous return.

The insoles (1) tested comprise a base (10) of 100% polyurethane foam, with a

hardness of 22-50 on the Shore A scale depending on its thickness, as well as hard

regions (30) composed of a foam consisting of 95% polyurethane and 5% carbon, with a

hardness of 56 on the Shore A scale.

In the parts free of hard regions measured on the upper side and over its entire

thickness, the insoles have a hardness of between 30 and 56 on the Shore A scale

depending on the thickness.

In the parts incorporating hard regions measured on the upper side and over its entire

thickness, the base of the insoles has a hardness of between 65 and 77 on the Shore A

scale depending on the thickness.

The hardness of the elastomers was measured according to ISO 868 / DIN 53505/

ASTM 2240 standards.

On the upper side, in contact with the foot, the insole is covered with an upper layer

(40) composed of 90% polyamide microfiber and 10% polyurethane.

First, the effect of wearing a pair of molded insoles (1) on the velocity of venous return

was compared to the effect obtained when not wearing these insoles (1). Also, the effect

of wearing a pair of insoles (1) on postural stability in a standing position (eyes closed and

eyes open) was compared to the effect obtained when not wearing these insoles.

A population of 75 subjects was divided into 3 groups of 25, depending on the type of

foot: hollow, flat or physiological).

The tests were carried out to study four criteria:

1- Evaluation and comparison of the evolution of the maximum velocity of the venous

flow at the popliteal vein (called PV: Peak Velocity) between morning and evening, after

wearing insoles (1) for one day and one day without wearing insoles (1).

2- Evaluation and comparison of the evolution of the maximum velocity of the venous

flow at the popliteal vein, averaged over a window of time (called TAPV: Time Average

Peak Velocity) between morning and evening, after wearing insoles (1) for one day and

one day without wearing insoles (1).

3 - Evaluation and comparison of the evolution of the average velocity of the venous

flow over the entire section of the popliteal vein, averaged over a time window (called

TAMV: Time Average Mean Velocity) between morning and evening, after wearing insoles

(1) for one day and one day without wearing insoles (1).

4 - Evaluation and comparison of the evolution of postural stability between morning and

evening, in a standing position (eyes closed and eyes open) after wearing insoles (1) for

one day and one day without wearing insoles (1), by analyzing:

- the length traveled by the center of pressure (COP) over 30 seconds of

recording,

- the area of the ellipse in mm2

. For the first three criteria presented above, the study shows that wearing an insole (1)

leads to a clear improvement in venous return with wearing an insole (1) between morning

and evening, and a clear improvement of venous return at fixed time (e.g., evening).

In the tables below, the results obtained are expressed in percentages and show an

average improvement of 49.9% for the 75 subjects, broken down into 55.95% for the flat

foot group, 44.96% for the hollow foot group; 48.76% for the physiological foot group.

Table 1 below corresponds to the control test (without insole). Subjects 1 to 25 have

flat feet, subjects 26 to 50 have hollow feet, and subjects 51 to 75 have physiological feet.

[Table 1]

CONTROL (WITHOUT INSOLE)

Morning Evening

Evol Evol T Sub Evol ution of ution of ype ject No. P T T P T T ution of TAPV TAMV of V APV AMV V APV AMV PV(%) (%) (%) feet (cm/s (cm/s (cm/s (cm/s (cm/s (cm/s

) ) ) ) ) )

3. 3. 1. 4. 3. 1. 2.56 -

1 95 42 15 05 28 14 % 4.15% 1.04%

1 10 3. 1 12 6. - 16.5 71,0

2 7.79 .56 65 6.42 .31 25 7.70% 7% 3%

1 5. 1. 9. 4. 1.

3 0.71 27 67 65 75 51 9.90% 9.86% 9,52%

5. 4. 2. 5. 4. 1. 0.33 -

4 41 35 05 43 32 98 % 0.76% 3,46%

3. 2. 0. 3. 2. 0. - 0.07 4,27

87 74 88 86 74 92 0.08% %

% 1 12 4. 1 9. 4. - -

6 5.71 .57 88 5.61 77 08 0.64% 22.27% 16,34%

7. 5. 2. 7. 5. 1. - -

7 74 63 29 67 40 97 0.87% 4.14% 13,85%

3. 3. 1. 3. 2. 1. - - 0,19

8 84 04 04 82 98 05 0.36% 1.81%

% 5. 4. 2. 7. 6. 2. 32.5 28.9 16,4

9 75 83 23 62 22 59 2% 4% 8%

1 8. 1. 1 8. 1. 1.43 3.63 0,38

0.32 34 59 0.47 64 60 % % %

1 15 6. 1 15 6. - 0.53

11 8.09 .09 34 8.06 .17 30 0.17% % 0,63%

1 10 3. 1 9. 2. - -

12 3.46 .63 10 1.33 49 91 15.82% 10.67% 6,19%

5. 4. 1. 4. 4. 1. - -

13 29 51 70 96 07 63 6.26% 9.74% 3,60%

1 8. 3. 1 8. 2. 2.56 -

14 0.28 31 29 0.47 38 71 % 4.15% 1,04%

1 12 5. 1 14 6. 11.1 13.2 7,55

15 7.60 .45 71 9.56 .10 14 4% 5%

% 1 8. 3. 1 10 4. 10.5 18.0 7,25

16 2.20 95 74 3.49 .57 01 7% 4%

% 1 16 6. 1 12 4. - -

17 9.37 .29 70 6.66 .19 78 13.99% 25.17% 28,71%

9. 7. 1. 8. 5. 1. - -

18 65 56 93 05 49 56 16.57% 27.33% 19,35%

5. 4. 1. 7. 5. 1. 40.4 39.3

19 10 13 47 16 75 45 0% 7% 1,30%

2 17 8. 2 16 7. - -

20 6.44 .73 33 3.47 .20 95 11.23% 8.63% 4,64%

1 12 4. 1 11 4. 0.63 -

21 4.23 .10 49 4.32 .95 12 % 1.24% 8,05%

1 10 4. 1 9. 2. - -

22 1.95 .25 36 1.85 33 99 0.84% 8.94% 31,54%

6. 5. 1. 1 10 3. 86.3 109. 85,7

23 70 07 92 2.48 .64 57 5% 74% 1%

1 8. 1. 1 8. 2. 0.36 0.25 43,5

24 1.17 01 87 1.21 03 68 % % 7%

1 10 4. 2 12 5. 24.7 20.0 19,0

25 6.59 .00 97 0.69 .00 92 1% 7% 4%

Ave 1 8. 3. 1 8. 3. 5.13 4.66 3,59

rage 1.33 47 25 1.53 55 27 % % %

7. 6. 2. 6. 5. 1. - -

26 15 03 04 11 00 79 14.58% 17.10% 12,40%

5. 3. 1. 5. 4. 1. - 6.36 0,65

27 30 78 84 24 02 86 1.09% %

% 3. 2. 1. 3. 3. 1. 8.55 14.1 9,26

28 32 63 12 61 00 23 % 0%

% 1 7. 3. 8. 6. 2. - -

29 0.59 82 45 17 36 98 22.89% 18.67% 13,62%

5. 4. 2. 5. 4. 2. 1.75 1.00 0,00

30 67 82 42 77 87 42 % %

% 4. 4. 1. 4. 3. 1. 0.59 -

31 94 01 40 97 99 40 % 0.37% 0,21%

5. 4. 1. 5. 4. 1. 0.23 0.50

32 61 64 78 62 66 77 % % 0,56%

9. 8. 2. 1 8. 2. 1.94 5.92

33 81 40 69 0.00 90 66 % % 0,89%

1 11 4. 1 10 4. - -

34 3.48 .99 77 2.19 .93 38 9.57% 8.83% 8,24%

4. 3. 1. 4. 3. 1. - -

35 64 46 21 59 34 19 1.06% 3.38% 1,32%

3. 2. 0. 3. 2. 0. 0.03 0.42

36 84 62 95 84 63 95 % % 0,21%

5. 3. 1. 6. 4. 1. 15.6 11.1 6,19 U 37 68 99 52 57 43 61 8% 1% %

-i 7. 5. 1. 8. 5. 1. 0.16 0.43 0,06

38 98 58 74 00 61 74 % % %

9. 7. 2. 8. 6. 2. - -

39 94 89 71 16 44 24 17.89% 18.38% 17,62%

6. 4. 1. 6. 5. 1. 3.44 5.41 4,59

40 05 75 59 25 01 66 % %

% 8. 7. 1. 8. 7. 2. 1.82 2.40 9,18

41 75 45 94 91 63 12 % %

% 8. 5. 1. 8. 5. 1. 2.05 2.84

42 57 77 85 74 94 80 % % 2,97%

1 11 4. 1 12 4. - 2.70 0,52

43 6.98 .84 24 5.48 .16 26 8.83% %

% 9. 7. 1. 9. 7. 1. 0.47 1.27 2,69

44 23 54 75 27 64 80 % %

% 3 26 10 3 28 10 10.6 7.10

45 0.14 .91 .80 3.36 .82 .31 8% % 4,56%

8. 6. 2. 8. 6. 3. - 0.56 4,84

46 40 62 89 09 66 03 3.75% %

% 1 14 3. 1 14 3. - 1.14 3,37

47 8.84 .09 83 8.55 .25 96 1.54% % %

9. 7. 2. 9. 7. 2. - -

48 96 62 31 84 50 25 1.19% 1.56% 2,47%

1 8. 3. 1 14 4. 55.4 60.1 19,1

49 1.93 98 37 8.55 .39 01 9% 9% 6%

4. 3. 1. 4. 3. 1. - -

50 37 57 61 25 10 39 2.70% 13.15% 13.15%

Ave 9. 7. 2. 9. 7. 2. 0.71 1.68

rage 25 31 63 36 49 59 % % 0.71%

2 11 5. 2 11 5. - -

51 0.98 .65 954 0.12 .33 238 4.10% 2.76% 12.03%

2 20 8. 2 20 5. 0.00 -

52 4.85 .61 71 4.85 .44 85 % 0.82% 32.79%

8. 4. 1. 8. 4. 1. - -

53 73 82 93 37 68 88 4.15% 2.92% 2.60%

8. 6. 1. 8. 6. 1. - -

54 66 93 80 46 42 56 2.40% 7.44% 13.64%

1 11 3. 1 11 4. 2.14 3.65 19.9

55 3.53 .08 60 3.82 .49 31 % % 4%

2 22 9. 2 22 9. - - 2.50

56 8.02 .69 07 7.93 .40 30 0.32% 1.28%

% 8. 7. 2. 7. 5. 2. - -

57 56 13 32 19 62 01 16.04% 21.19% 13.45%

7. 6. 2. 7. 5. 2. - -

58 99 06 57 67 52 22 4.03% 8.92% 13.60%

9. 7. 2. 8. 6. 2. - -

59 51 20 89 64 81 71 9.12% 5.47% 6.19%

8. 6. 2. 8. 6. 2. - - Lu Lu 60 54 75 89 47 47 89 0.73% 4.16% 0.03%

1 7. 3. 1 7. 3. 1.14 - 35 0.26 41 10 % 1.96% 7.66% 61 0.15 56

7. 5. 2. 7. 5. 2. 2.80 9.03 3.61 I 62 42 46 11 62 96 18 % % %

7. 5. 2. 6. 5. 1. - -

63 04 94 51 16 17 99 12.49% 13.00% 20.82%

1 10 4. 1 10 4. 1.02 5.77 1.41

64 7.59 .21 04 7.77 .79 10 % %

% 6. 5. 1. 9. 7. 2. 34.9 51.2 74.7

93 16 43 36 81 49 9% 7% 0%

6. 4. 2. 6. 4. 1. 0.78 -

66 03 96 01 08 92 79 % 0.93% 11.12%

1 9. 4. 1 8. 4. - -

67 5.50 45 34 4.38 91 27 7.23% 5.67% 1.66%

6. 5. 1. 6. 5. 1. - - 0.57

68 80 73 92 60 64 93 2.88% 1.48%

% 1 10 3. 1 10 3. - -

69 2.41 .34 25 2.12 .07 12 2.34% 2.61% 4.00%

1 11 3. 1 11 3. - -

4.25 .82 25 3.77 .20 11 3.37% 5.21% 4.25%

3. 3. 1. 4. 3. 1. 12.1 7.18 22.6

71 81 05 07 28 27 32 2% % 7%

5. 4. 1. 4. 3. 1. - -

72 42 30 50 92 95 36 9.28% 8.21% 8.90%

4 39 16 3 31 16 - -

73 3.94 .72 .43 7.19 .05 .01 15.36% 21.83% 2.56%

7. 6. 2. 7. 6. 1. 10.0 0.53

74 24 04 01 96 08 82 2% % 9.39%

1 12 4. 1 12 4. - - 0.42

5.57 .25 08 5.40 .03 10 1.09% 1.80% %

Ave 1 9. 3. 1 9. 3. -

rage 2.78 88 80 2.38 42 63 7.23% 5.67% 1.66%

1 8. 3. 1 8. 3. 1.55 1.58 0.44 AVERAGE 1.12 55 23 1.09 49 16 % %

% Table 2 below corresponds to the test with an insole according to the invention: The

subjects are the same as for Table 1. Subjects 1 to 25 have flat feet, subjects 26 to 50

have hollow feet, and subjects 51 to 75 have physiological feet.

[Table 2]

INSOLE ACCORDING TO THE INVENTION

Morning Evening Ty Ev Evol Evol Subj P T T P T T pe of olution ution of ution of ect No. V APV AMV V APV AMV feet of PV TAPV TAMV (cm/ (cm/ (cm/ (cm/ (cm/ (cm/ (%) (%) (%) s) s) s) s) s) s)

3 3 1. 5. 4. 2. 49. 32.7 60,4

1 .99 .22 25 96 28 00 35% 0% 7%

1 1 4. 2 1 7. 27. 58.6 83,1

2 7.64 0.48 03 2.49 6.63 38 49% 8% 8%

1 5 1. 1 6. 1. 14. 13.3 7,09

3 0.73 .52 78 2.25 26 90 17% 3% %

5 4 2. 1 8. 3. 11 93.1 66,2

W 4 .42 .31 06 1.51 33 43 2.11% 8% 8% U |- 3 2 0. 5. 3. 1. 50. 39.7 36,5

U- 5 .88 .73 95 85 81 30 94% 1% 9%

1 1 4. 1 9. 4. 0.5

6 5.71 2.57 91 5.80 72 11 7% 22.69% 16,46%

7 6 2. 1 8. 3. 58. 41.0 36,3

7 .81 .00 31 2.37 47 15 33% 4% 5%

3 3 1. 5. 3. 1. 41. 22.1 33,8

8 .86 .09 03 45 77 38 07% 8% 7%

5 4 2. 1 7. 3. 75. 60.5 51,5

9 .72 .90 24 0.03 86 39 16% 1% 0%

1 8 1. 1 1 2. 45. 46.5 68,6

0.35 .84 62 5.08 2.95 73 76% 4% 8%

1 1 6. 2 2 8. 41. 41.1 41,7

11 8.18 5.19 32 5.70 1.44 96 36% 5% 6%

9 6 3. 1 9. 4. 70. 46.7 48,3

12 .06 .55 18 5.46 61 72 62% 2% 0%

5 4 1. 8. 6. 1. 52. 49.1 14,9

13 .26 .23 65 03 31 89 59% 7% 4%

1 8 3. 1 1 5. 45. 44.6 56,4

14 0.40 .23 32 5.10 1.90 19 16% 6% 3%

1 1 5. 2 2 1 65. 70.9 84,5

7.60 2.37 49 9.20 1.14 0.12 91% 0% 1%

1 7 3. 1 1 5. 51. 92.2 48,9

16 2.26 .54 91 8.63 4.49 83 96% 5% 8%

1 1 6. 2 1 7. 22. 6.56 28,6

17 9.48 6.31 00 3.83 7.38 72 33% % 9%

9 7 1. 1 9. 2. 23. 25.6 46,1

18 .63 .67 94 1.87 64 83 26% 1% 5%

5 4 1. 1 8. 2. 12 107. 57,7

19 .17 .23 47 1.56 78 32 3.51% 49% 2%

2 1 8. 3 2 1 36. 54.6 37,1

20 6.22 7.55 39 5.89 7.14 1.51 88% 4% 5%

1 1 4. 1 1 6. 40. 34.9 37,0

21 3.99 2.12 46 9.62 6.35 11 24% 0% 2%

1 1 3. 1 1 3. 34. 20.3 7,63

22 1.89 0.19 66 5.96 2.26 94 23% 6%

% 6 5 1. 1 1 5. 18 207. 158,

23 .85 .23 97 9.29 6.05 10 1.73% 18% 95%

1 8 1. 1 1 3. 45. 45.8 104,

24 1.38 .09 89 6.56 1.79 86 52% 1% 67%

1 9 5. 3 1 8. 88. 90.0 75,8

25 6.65 .73 06 1.40 8.48 91 59% 1% 5%

Aver 1 8 3. 1 1 4. 55. 52.9 51,0

age 1.17 .27 23 6.60 2.19 79 95% 0% 5%

7 6 2. 1 8. 3. 49. 48.2 50,2

26 .05 .03 02 0.55 93 03 67% 1% 2%

5 3 1. 8. 5. 1. 55. 38.4 1,25

27 .39 .94 75 39 46 78 68% 3% %

3 3 1. 5. 3. 1. 39. 26.5 0,75 Lu Lu U- 28 .78 .01 33 28 81 34 79% 6% %

-J1 8 3. 1 1 5. 52. 58.6 64,3

29 0.78 .68 45 6.43 3.77 67 41% 6% 1%

5 3 1. 6. 3. 1. 28. 10.2

.28 .31 46 77 65 31 17% 8% 10,13%

5 4 1. 6. 4. 1. 19. 13.3 8,22

31 .07 .07 52 06 61 65 33% 1%

% 5 4 1. 7. 6. 2. 33. 32.2 28,5

32 .63 .66 77 50 16 28 29% 3% 7%

1 8 3. 1 1 4. 28. 32.4 34,5

33 0.10 .47 02 3.02 1.22 06 96% 5% 5%

1 1 4. 1 1 5. 40. 31.6 39,7

34 2.39 0.87 21 7.36 4.31 89 11% 5% 7%

4 3 1. 5. 4. 1. 24. 23.2 12,2

.44 .42 18 54 21 33 77% 5% 8%

3 2 0. 5. 3. 0. 32. 30.2 3,27

36 .86 .61 93 13 40 96 92% 0%

% 5 3 1. 8. 5. 2. 50. 46.8 66,8

37 .69 .94 35 56 79 25 50% 9% 6%

8 5 1. 1 8. 2. 49. 51.9 23,7

38 .01 .59 74 1.95 49 15 11% 5% 2%

1 7 2. 1 9. 3. 30. 28.8 27,6

39 0.05 .75 60 3.15 98 32 83% 2% 3%

6 4 1. 9. 7. 2. 54. 56.9 54,7

.09 .83 58 42 57 45 58% 0% 1%

8 7 1. 1 9. 2. 33. 28.8 52,7

41 .71 .44 92 1.61 59 93 30% 2% 1%

8 6 1. 1 9. 2. 62. 53.9 57,9

42 .45 .37 73 3.75 81 73 82% 5% 3%

1 1 3. 2 1 7. 48. 50.4 90,3

43 6.09 2.28 69 3.87 8.47 02 35% 1% 4%

9 7 1. 1 1 2. 61. 67.3 41,0

44 .36 .47 78 5.12 2.50 51 61% 8% 6%

3 2 1 3 3 1 29. 32.8 19,9

45 0.68 6.33 0.35 9.79 4.98 2.41 69% 5% 1%

8 6 3. 1 1 4. 56. 64.9 42,6

46 .51 .80 11 3.34 1.21 43 83% 5% 1%

1 1 3. 3 2 8. 64. 67.1 117,

47 8.61 4.22 92 0.59 3.77 53 37% 6% 71%

1 7 2. 1 1 3. 42. 58.3 52,4

48 0.15 .46 26 4.50 1.81 44 84% 5% 2%

1 9 3. 2 2 7. 11 140. 134,

49 1.87 .04 38 6.05 1.69 93 9.46% 07% 98%

4 3 1. 5. 3. 1. 14. 8.40 10,5

50 .43 .52 57 08 82 74 68% % 6%

Aver 9 7 2. 1 1 3. 44. 44.0 41,0

age .22 .28 54 3.55 0.76 72 96% 9% 5%

2 1 6. 3 1 7. 44. 25.6 19,9 Lu Lu U- 51 1.21 2.84 45 0.6 6.13 736 27% 2% 8%

o 2 2 8. 3 3 1 54. 52.1 49,1

1J 52 4.88 0.60 59 8.49 1.34 2.80 70% 4% 0%

>- 8 4 1. 1 8. 1. 42. 73.9 0,00

53 .413 .79 89 2.02 341 89 87% 9% %

8 7 1. 1 1 2. 56. 52.5 54,6

54 .82 .03 94 3.77 0.73 99 16% 5% 0%

1 1 3. 1 1 5. 47. 46.9 45,6

3.50 1.04 56 9.88 6.22 19 26% 2% 3%

2 2 1 4 3 1 50. 54.0 50,3

56 8.00 2.40 0.14 2.21 4.50 5.25 75% 2% 4%

8 7 2. 1 8. 2. 21. 20.7 25,0

57 .57 .25 34 0.44 76 93 71% 3% 9%

8 5 2. 8. 6. 3. 8.7 14.4 19,3

58 .01 .83 55 71 66 04 2% 0% 4%

9 7 2. 1 1 4. 59. 52.9 52,1

59 .18 .19 85 4.62 0.99 34 26% 1% 4%

8 6 2. 1 1 3. 60. 79.0 38,5

.43 .41 88 3.57 1.48 99 95% 1% 5%

1 7 2. 1 1 5. 87. 88.9 141,

61 0.15 .51 47 8.99 4.18 98 19% 4% 69%

7 5 2. 1 9. 3. 50. 69.1 48,1

62 .58 .51 23 1.42 32 30 64% 9% 8%

7 5 2. 9. 8. 3. 40. 50.8 47,7

63 .05 .77 57 91 71 79 68% 5% 2%

1 1 3. 2 1 5. 44. 55.9 61,7

64 7.58 0.16 40 5.38 5.84 50 37% 8% 1%

9 7 2. 1 1 4. 67. 69.6 56,0

.18 .82 94 5.35 3.26 58 17% 7% 1%

5 5 2. 1 1 2. 94. 98.4 36,1

66 .99 .09 05 1.67 0.10 79 89% 9% 1%

1 9 4. 2 1 6. 44. 38.7 28,7

67 5.68 .50 66 2.60 3.18 00 13% 2% 8%

6 5 1. 9. 7. 2. 42. 33.5 23,2

68 .83 .73 96 77 66 41 95% 8% 3%

1 1 1. 1 1 4. 43. 43.9 140,

69 2.40 0.33 95 7.76 4.87 68 23% 1% 58%

1 1 3. 1 1 4. 36. 29.1 51,4

70 4.32 1.63 17 9.50 5.02 80 17% 5% 2%

3 3 1. 6. 5. 1. 66. 56.5 70,8

71 .87 .29 14 44 14 95 26% 1% 4%

5 4 1. 5. 4. 1. 9.8 - 2,18

72 .43 .28 47 96 27 50 2% 0.12%

% 4 4 1 5 4 1 19. 16.2 5,49

73 4.40 0.23 6.02 2.92 6.76 6.90 19% 3%

% 7 5 1. 1 1 3. 79. 86.4 80,7

74 .22 .92 96 2.99 1.04 54 89% 9% 9%

1 1 4. 2 1 8. 46. 47.3 91,6

75 5.66 2.34 19 2.96 8.17 02 62% 0% 1%

Aver 1 1 3. 1 1 5. 48. 50.2 49,6

age 2.89 0.02 81 8.72 4.51 44 79% 9% 4%

1 8 3. 1 1 4. 49. 49.0 47.2 AVERAGE 1.09 .53 20 6.29 2.49 65 90% 9% 5%

Thus, regardless of the type of foot analyzed (hollow/flat/physiological), the study

demonstrates an improvement in hemodynamics obtained by wearing an insole (1)

according to the invention.

Claims

1. A molded insole (1), comprising a base (10), an internal lateral arch (20) that is

provided to accommodate the arch of the foot and that is raised relative to the base (10),

and at least one hard region (30) that is integrated into the base, having a hardness equal

to or greater than that of the base (10), characterized in that the base (10) and the internal

lateral arch (20) of the insole (1) constitute a single, mono-material part (2).

2. The insole (1) according to claim 1, characterized in that the internal lateral arch

(20) has a volume adapted to the volume of the arch of the patient's foot, in particular in

the case of dysmorphism.

3. The insole (1) according to one of the preceding claims, characterized in that the

internal lateral arch (20) has a volume and a position determined according to three

parameters:

- the gender of the patient;

- the patient's shoe size; and

- the morphology of the patient's foot.

4. The insole (1) according to claim 3, characterized in that the morphology parameter

of the patient's foot defines three possibilities: flat, hollow or physiological foot.

5. The insole (1) according to claim 4, characterized in that the maximum thickness of

the insole is 5.6 ±0.2 mm for a flat foot, 8.4 ±0.4 mm for a hollow foot and 8.8 ±0.2 mm

for physiological foot.

6. The insole (1) according to one of the preceding claims, characterized in that the

internal lateral arch (20) has a curved lower surface (21) forming a hollow with respect to

the lower plane (P11) of the base (10) and a curved upper surface (22) projecting from

the upper plane (P12) of the base (10).

7. The insole (1) according to one of the preceding claims, characterized in that the

lower surface of the internal lateral arch has a greater slope than its upper surface.

8. The insole (1) according to one of the preceding claims, characterized in that its

upper surface is smooth.

9. The insole (1) according to one of the preceding claims, characterized in that the

hard regions (30) are integrated into hollow chambers formed in the thickness of the base,

said hard regions opening onto the underside of said base (10).

10. The insole (1) according to one of the preceding claims, characterized in that it

comprises an upper layer (40) covering the mono-material part (2).

11. The insole according to claim 10, characterized in that:

- the hardness of the insole, in the parts of the base without hard regions,

measured on the upper side and over its entire thickness, is between 30 and

56 on the Shore A scale depending on the thickness,

- the hardness of the insole, in the parts of the base incorporating hard regions,

measured on the upper side and over its entire thickness, is between 65 and

77 on the Shore A scale depending on the thickness.

12. A footwear item, for example stockings, tights, socks or shoes including flip flops

and sandals, characterized in that it comprises an insole (1) according to one of the

preceding claims 1 to 11.

13. A manufacturing method of an insole (1) according to any of claims 1 to 11,

comprising the following steps:

than that of the base;

b) a step of cutting from a mono-material strip, with or without an upper layer

laminated on its surface, a preform to the dimensions of the mold corresponding to

the insole;

c) a step of molding the preform in one part comprising the base and the internal

lateral arch, formed projecting from the base, at the insole desired size;

d) a step of assembling the part, including the base and the internal lateral arch once

removed from the mold, and the hard regions; and

e) a finishing step to obtain the insole.

14. A method according to claim 13, characterized in that step c) of molding the

preform is carried out by compressing in a mold a mono-material part of constant

thickness, hardness and density, the mold having shapes intended to configure the base

so that its upper surface does not undergo deformations when in contact with hard

regions.

15. The method according to one of claims 13 or 14, characterized in that step b)

comprises, as a preliminary step, laminating a strip corresponding to the upper layer (40)

over the entire surface of the mono-material strip.

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