WO2019180577A1

WO2019180577A1 - Method for making a custom-made podiatry orthosis integrated into an improved sock

Info

Publication number: WO2019180577A1
Application number: PCT/IB2019/052167
Authority: WO
Inventors: Pagliari DIEGO; Pagliari ENRICA ALESSANDRA
Original assignee: Eurocostruzioni S.N.C. Di Pagliari Romano & C.
Priority date: 2018-03-19
Filing date: 2019-03-18
Publication date: 2019-09-26
Also published as: EP3768200A1; IT201800003720A1

Abstract

A method is provided for the realization of a custom-made podiatry orthosis (191) integrated into a sock (150, 170, 190) or leggings comprising the steps of identifying at least one area (121) in a foot (120) or limb of a user on which the orthosis is intended to be placed (191 ), cutting from a sheet of adhesive material (130) at least a portion of adhesive material (131, 151, 171, 180) of the same shape as the area (121), cutting from a polymer gel sheet (141) at least a portion of polymer gel (140, 161, 172) of the same shape as the portion of adhesive material (131, 151, 171, 180), arranging the portion of said adhesive material (131, 151, 171, 180) in adhesion with the sock (150, 170, 190) or leggings such that, when the sock (150) or leggings are on the foot (120) or limb, the portion of adhesive material (131, 151, 171, 180) is arranged in an area (152) superposing the area (121), arranging the polymer gel portion (140, 161, 172) on a template, inserting the template inside the sock (150, 170, 190) or leggings so as to superpose the adhesive material portion (131, 151, 171, 180) with the polymer gel portion (140, 161, 172), removing the adhesive material portion (131, 151, 171, 180) from the sock (150, 170, 190) or leggings, thermobonding the polymer gel portion (140, 161, 172) on the sock (150, 170, 190) or leggings by heating it to temperatures between 80°C and 200°C and subjecting it to pressure with pressures between 3 bar and 10 bar at least at said zone (152).

Description

DESCRIPTION

METHOD FOR MAKING A CUSTOM-MADE PODIATRY ORTHOSIS INTEGRATED INTO AN IMPROVED SOCK

The present invention relates to a method for making a custom-made podiatry orthosis integrated into an improved sock of the type specified in the preamble of the first claim.

In particular, the invention and relative method find their main application as a custom-made medical device, more precisely as a podiatry orthosis. However, applications are also possible in the fields of amateur and/or competitive sports activities, in addition to the more common uses in which the characteristics of comfort and fit are improved. The use of the podiatry orthosis may be intended for a child or elderly person, in a healthy or diseased foot, such as diabetic or with pathological and painful deformities such as bunions, hammer toes or so forth.

In the field of clothing, garments ensuring adequate protection and satisfactory comfort to the foot, and more generally to the lower limbs, are known of. Adequate protection from low temperatures, good breathability to ensure proper respiration of the skin, and some characteristics which do not alter the peripheral venous circulation of blood and the biomechanics of walking or running are thus required. Precisely these last two aspects are the subject of research, insofar as with appropriate technical improvements it is possible to create socks with technical inventions such as to transform these garments into custom-made medical devices for the patient, namely actual Orthoses with specific characteristics for the multiple problems of the foot. These improvements, however, can also be aimed at improving the of the walking dynamics of a limb not affected by disease and at offering adequate protection against rubbing/ compression during occupational and sports activities. In the state of the art, accessories made of soft material are available on the market that are worn individually on the toes or part of the foot (therefore under the sock); it should be noted, however, that this particular solution detracts space from between the toes, increasing sweating, the likelihood of developing callous phenomena and the presence of bacterial and fungal infections. These solutions, well known in the podiatry field, are made through the making of foot casts. A further disadvantage of these solutions is the im practicality of use for elderly people with poor musculoskeletal mobility. At the sock level instead, the protections mostly consist of soft reinforcements of variable thickness sewn into the fabric, including in specific material different from that of the sock itself, or suitable materials injected hot during the manufacturing process of the sock itself through the use of moulds. In the first case, the seams secure and block the portion of material added to the sock, also making pocket-shaped housings in which such materials are placed. There are also inventions that exclusively concern the soles of the foot called orthopaedic insoles. The insoles are placed inside the footwear, more precisely above the inner sole. There are multiple insoles on the market depending on their function, or generic insoles to improve comfort during walking or running, or specific insoles tailored to certain diseases related to posture, walking or other specific medical conditions of the foot. The two categories of protections listed above (insoles and padded socks) perform their function independently of each other and have some undesirable or certainly improvable characteristics, respectively. Padded socks, for example, generally have additional seams that do not add to comfort when worn. On the other hand, when made with injection moulds, it is impossible for a podiatrist to create specific socks for each patient because the injection process can only be replicated in an industrial and non-outpatient setting. Insoles are devices that are added to the sole of a shoe, creating a series of layers of material between the foot and the inner sole that often do not act in perfect synergy with each other. It is well known in fact that any type of shock-absorber or protective and/or corrective element (particularly an Orthosis) must be positioned to the exact millimetre in the area to be treated; any small change in the position of such device in the footwear nullifies its effect (or even makes it detrimental). Note that it is preferable to buy as many insoles as the footwear owned. Furthermore, in the case of needing to insert these portions of shock-absorber material or protections and/or Orthoses in the upper areas of the foot, this operation is complicated by the impossibility of effectively fixing these devices in the footwear, with increased problems of positioning and stability of the same.

What is therefore needed is to design a shock-absorber device equipped with appropriate technical solutions that can also act as a medical orthosis in podiatry, therefore not made with industrial processes but by replicable procedures in the outpatient setting and with different characteristics from one patient to the next in relation to the different diseases. Such invention must be able to adhere perfectly to the foot to be treated, must be perfectly stable once positioned and must not promote sweating or any type of fungal/bacterial infection. It should also not hamper venous and arterial blood circulation and should not be perceived as an additional device to the normal clothing of said lower limbs. In order to make such a custom- made invention and define a relative manufacturing method, the priority of the method filed in IT Patent Application No. 102017000090825 by the present Inventor is claimed, which reveals the technique for permanently welding a sheet of polymer gel already solidified to any medium of synthetic or natural material. The technical purpose and specified aims are achieved by a method for making a podiatry orthosis integrated into an improved sock as claimed in the appended Claim 1 .

Preferred technical embodiments are described in the dependent claims.

The characteristics and advantages of the invention are clearly evident from the following detailed description of preferred embodiments thereof, with reference to the accompanying drawings, in which:

Fig. 1 shows a sock of the prior art.

Fig. 2 shows a sock with polymer gel areas applied.

Fig. 3 shows the calf area of the sock with the polymer gel attached.

Fig. 4 shows a particular processing of the polymer gel in the calf area.

Fig. 5 shows from above, a sock with polymer gel plates applied in the containment area of the calf.

Fig. 6 shows embossed machining of the polymer gel.

Fig. 7 shows embossed machining and a perforation on a polymer gel surface.

Fig. 8 shows a regular perforation of the polymer gel sheet.

Fig. 9 shows a portion of polymer gel attached in the sole of a sock.

Fig. 10 shows leggings with polymer gel areas inserted according to the idea of the invention.

Fig. 11 shows a polymer gel sheet in which a pocket has been made by longitudinal cutting suitable to contain a sensor type device or other active and/or passive electronic device.

Fig. 12 shows an area of the foot to be treated.

Fig. 13 shows a portion of suitably trimmed adhesive.

Fig. 14 shows a portion of suitably trimmed polymer gel. Fig. 15 shows a sock in which the adhesive is applied.

Fig. 16 shows a template in which the trimmed polymer gel portion is positioned. Fig. 17 shows the template inserted into the sock and the method for aligning the polymer gel to the position of the adhesive attached to the sock.

Fig. 18 shows the detachment of the adhesive from the sock containing the template.

Flerein, the measures, values, shapes and geometric references (such as perpendicularity and parallelism), when used with words like "about" or other similar terms such as "approximately" or "substantially", are to be understood as except for measurement errors or inaccuracies due to production and/or manufacturing errors and, above all, except for a slight divergence from the value, measure, shape or geometric reference which it is associated with. . For example, said terms, if associated with a value, preferably indicate a divergence of not more than 10% of said value.

In addition, where used terms such as "first", "second", "upper", "lower", "main" and "secondary" do not necessarily refer to an order, a priority relationship or relative position, but may simply be used to more clearly distinguish different components from each other.

The measurements and data presented herein are to be considered, unless otherwise indicated, as made in Standard International Atmospheres ICAO (ISO

2533: 1975).

The podiatry application of the invention, i.e. the application as an orthosis, is now described.

The invention is based on the use of a soft, elastic material, preferably with high shock-absorber power, zero shape memory and non-toxic which is identified in the category of gel-polymer materials. Such a substance, preferably gel, e.g. SEBS, is available in sheets of various sizes and thicknesses. Once the area of a user's foot intended to be covered or relieved, as necessary, with an orthosis, has been identified, and once the aforementioned sheets have been appropriately cut out according to the required shape, they are fixed in certain defined areas of a sock [Fig1 (10)], or leggings [Fig1 (1 1 )]. The identification step may include, for example, drawing, or rather contouring, the shape of the area of interest on the user's skin. The fixation of the sheets is possible thanks to the specific processes for adhesion between already solidified polymer gel and sock: this is a process already filed by this Inventor in the Italian application IT n.102017000090825 of which priority is claimed, and which reveals an innovative physical processing of the polymer gel material (when already solidified and available in sheets of various sizes and thicknesses) and of the medium to which it must adhere. The process of patent application IT No. 102017000090825 therefore excludes the process of stitching or of the bag typical of the prior art to fix the polymer gel to the sock. It also excludes the casting of the liquid polymer gel into a mould, allowing simplified processing on the sock according to the idea of the invention and, more importantly, making it possible to replicate such processing in an outpatient podiatry setting. The surface area of the polymer gel made to adhere to the surface of the sock is determined by the type of performance and protection desired for said sock. For posture correction and an improvement of walking or running, therefore for general applications, such polymer gel portions [Fig9 (91 )] are inserted in a single shape on the sock sole [Fig9 (90)] or in separate shapes [Fig2 (21 )(22)]. In this application it may be noted how the positions of the polymer gel areas are similar to those of an insole for footwear. Likewise, protections may coexist, in addition, in the upper heel area [Fig2 (20)], above the toes [Fig2 (24)] and on the instep of the foot [Fig2 (23)], or even lateral protections [Fig2 (25) (26) (27)] etc. According to the idea of the invention the positioning of these polymer gel areas remains particularly stable because the sock is worn on the limb and the polymer gel is welded to the sock itself. In this way there are no slipping phenomena and incorrect positioning of these protective areas on the surface of the foot. More specific and innovative, however, is the application of the inventive idea to the making of a podiatry orthosis, an idea that allows the podiatrist to achieve objectives and performance of a higher level than that obtained so far in the prior art. The sock, to which the podiatrist bonds the polymer gel surfaces for such medical application, is that of the patient; the area on which he works is created by the specific needs of the patient's disease after careful study, and without the need to add surfaces or layers of containing materials to the polymer gel. The stability of the Orthosis thus obtained is excellent because it is closely linked to that of the sock worn. In addition, the patient can freely change the type of footwear at will while maintaining the same benefits, as guaranteed by the modified sock according to the idea of the invention and not by an additional device to the footwear, such as an insole. The measuring of the shape of the Orthosis, as can be seen from the description below regarding the method, does not require casting and the use of invasive materials or complex procedures. Thanks to its characteristics of non-toxicity, the polymer gel can remain in contact with the skin without causing damage, so it is possible to minimize any disadvantage resulting from the use of shock-absorber materials contained in containment envelopes.

Other applications of the invention will now be described.

According to the idea of the invention it is also possible to use such a material as a substitute for those elastic fibres generally used to prevent the slipping of the sock down the calf (for example in men's socks). Natural or synthetic fabrics in fact tend to slide on the skin unless an elastic band compresses them adequately on the portion of limb they cover; this solution used by the prior art, however, moderately compromises the peripheral circulation of venous and arterial blood, creating annoying skin irritations that manifest with redness and itching on the epidermis, in addition to the circulatory damage mentioned. The polymer gel thus replaces the high compression zones present in the conventional sock [Fig3 (30)] when suitably positioned in the area designated to block the sock on the limb [Fig3 (31 )], a gel that is suitably added to the sock fabric. The shape given to the polymer gel portion may be smooth and continuous [Fig3 (31 )], or divided into multiple small zones of adhesion to the skin [Fig4 (40)] [Fig5 (51 )]. It is also possible to insert polymer gel inserts with an embossed [Fig6 (61 )] [Fig7(71 )] or perforated [Fig7 (72)] [Fig8(81 )] surface and machined in such a way as to increase air circulation and improve the comfort of the sock. It is known that the polymer gel in contact with the skin has a high adhesion that opposes slipping of the sock. For the types of leggings covering the pelvis and buttocks, for example leggings for sports applications [Fig10], the use of polymer gel can increase the comfort and protection offered, for example, in the areas of the buttocks [Fig10(100)], thigh [Fig10(101 )], knee [Fig10(102)], calves [Fig10(103)] or other areas. Such protections, as for the podiatry application, are made to adhere to the fabric in such a way as to create a single body with the said fabric, to the benefit of correct positioning, absence of seams, no need to use injection moulding machines, maximum protection efficiency, fluidity of movements. Socks, tights and leggings made according to the idea of the invention can act as individual passive protective devices. Another aspect of the invention is the possibility of inserting electronic-type sensor devices inside the polymer gel, which by adhering strongly to the sensor body allows its position to be effectively blocked. At the same time, the softness and elasticity characteristics of the polymer gel guarantee a perfect fit of the garment, allowing the user not to perceive the physicality, rigidity and volume of said sensor positioned on the limb. Temperature sensors, pressure sensors, oximeters, accelerometers, gyroscopes, magnetometers and other types of active/passive sensors can therefore be worn with greater comfort for all next-generation applications in the field of preventive medicine, safety and medical research. In Fig.10 a sensor device with RFID antenna [Fig1 1 (1 10)] is placed inside a pocket [Fig1 1 (1 1 1 )] made in the polymer gel by longitudinal cutting made inside the cross-section of said material. The polymer gel in turn provides shock and impact protection to the sensor inserted inside said material, as well as the ability to effectively protect an active type sensor battery, which can also be recharged wirelessly.

The method for making a podiatry orthosis integrated in an improved sock will now be described.

The method according to the idea of the invention for making the device described above consists of six (6) main steps:

1 . The podiatrist identifies one or more areas in the area of the foot [Fig12 (120)] where an Orthosis [Fig12 (121 )], i.e. a section of gel that protects or acts as a relief on the skin, needs to be inserted.

2. A portion [Fig13 (131 )] of said material with an identical shape to that of the area identified by the podiatrist in point (1 ) is cut out from a sheet of adhesive material [Fig13 (130)].

3. After making the patient wear a sock [Fig15 (150)], the adhesive modelled in point (2) [Fig15 (151 )] is made to adhere in the exact position of point (1 ) [Fig15 (152)]. The sock is then removed from the patient's foot.

4. A portion [Fig14 (140)] having an identical shape to that of the sheet of adhesive material in point (2) is then cut out from a polymer gel sheet [Fig14 (141 )].

5. A template in the shape of an insole made of wood, metal or synthetic material [Fig16 (160)] is used on which the polymer gel cutting in point (3) [Fig16 (161 )] is placed. The template [Fig17 (173)] is then inserted inside the patient's sock [Fig17 (170)] by aligning the position of the adhesive attached to the sock [Fig17 (171 )] with the position of the polymer gel cutting [Fig17 (172)]. The adhesive is then removed from the sock [Fig18 (180)]. Preferably, the template is specially designed to reproduce the planar extension of the foot, both the front and the heel, made in 3 sizes to ensure the tension of the sock fibres when inserted, as if the patient's foot were inserted.

6. The sock containing the template and the polymer gel is sent for the thermobonding process. In the thermobonding process, preferably, the sock 150, 170, 190 or leggings on the template are subjected to pressure at least in zone 152 with temperatures between 80°C and 200°C and pressures between 3 bar and 10 bar.

In more detail, preferably, the temperatures are between 100°C and 160°C.

For example, the polymer gel portion and the medium, i.e. the sock or leggings on the template, may be arranged in a thermoforming machine at the indicated temperatures for at least 1 minute, preferably for 2 minutes, or a time that is sufficient for the method according to the inventive idea with respect to the type of materials chosen.

In addition, in detail, the pressures are preferably between 5 bar and 7 bar.

Preferably, the pressurization step is directly subsequent to heating, the polymer gel portion and the medium are pressed at the indicated pressures, or at a pressure that is sufficient for the method according to the inventive idea with respect to the type of materials chosen, so as to glue and bond the polymer gel portion to the medium.

Preferably immediately after coming out of the thermoforming machine, the polymer gel portion and the medium are cooled for example by immersing them in water at a temperature of 12°C or less.

Such cooling may take place for at least 30 seconds, more appropriately for 1 minute. Cooling preferably causes a thermal shock, which causes the polymer gel portion to be permanently attached to the sock or leggings. It should be noted that such thermal shock preferably, but not necessarily, results in lowering the temperature of the polymer gel portion by at least 50°C, for example from a temperature of 85° to a temperature of 15°C.

Substantially, preferably, the polymer gel portion 140, 161 , 172 on the sock 150, 170, 190 or leggings is cooled so as to achieve a temperature drop of at least 50°C within 1 minute.

At the end of the thermobonding process, the Orthosis [Fig19 (191 )] made with the polymer gel is perfectly adherent to the sock [Fig19 (190)]. A further advantage is that whatever area of the foot is to be treated (arch, instep, toes or area above the toes, ankle and/or other) the method according to the inventive idea is the same. Some specific applications of the inventive idea will now be described.

Below are the main applications of the Invention according to the idea of the invention:

• Podiatry orthoses of any shape made on a sock medium for specific pathologies of each patient and made in the outpatient facilities of Podiatry professionals. • Sports socks with high absorption factors of compression and rubbing shocks.

• Enhanced comfort socks.

• Polymer gel insoles integrated into the sock.

• Commonly used socks in which the adhesion capacity on the skin of the limb is perfected and improved.

• Ladies’ tights with inserted protections and shock-absorbing elements in the insole area of the foot for enhanced comfort with high heels.

• Protective leggings for sports applications with differentiated pressure absorption zones on buttocks, thighs, knee, calf and foot.

• Socks with biometric, position and physical/chemical parameter sensor devices, integrated into the body of the sock for a better fit.

The method for making a podiatry orthosis integrated into an improved sock according to the invention and the relative orthosis achieves important advantages. The main advantages of the invention are listed below:

• It is possible to create custom-made podiatry orthoses of any shape, including an insole function, with features of comfort and performance better than the prior art, with the function of protecting the areas where mechanical friction with footwear develops due to deformity or pathological conditions triggered by various factors, or having a relief function for overpressurised areas.

• Custom-made medical orthoses can be made directly in laboratories specialised in Podiatry.

• No seams to secure the shock-absorber material shape to the sock.

• No mould injection process to fix the shock-absorber material shape to the sock.

The shock-absorber zones remain perfectly stable in the area of the limb to be treated, without the use of adhesives and mechanical retention systems, thus ensuring the best possible performance and the absolute absence of toxicity of the Invention.

• No need to wear additional devices beyond the normal sock.

· Easy to use even for people with musculoskeletal diseases or vascular diseases, rheumatic diseases or sports patients.

• Reduction of sweating phenomena and onset of bacterial and fungal infections.

• The Orthoses and socks according to the idea of the invention retain the original characteristics of the fabric they are made of, therefore they withstand normal washing cycles and have the same duration of use.

• The Orthoses and socks according to the idea of the invention can accommodate passive and active sensor devices, including small rechargeable batteries, ensuring maximum comfort and the best protection for said sensors and batteries.

Claims

CLAI M S

1. A method for making a custom-made podiatry orthosis (191 ) integrated into a sock (150, 170, 190) or leggings characterized in that it comprises the steps of:

- identifying at least one area (121 ) in a foot (120) or limb of a user on which said orthosis (191 ) is intended to be placed;

- cutting from a sheet of adhesive material (130) at least a portion of adhesive material (131 , 151 , 171 , 180) of the same shape as said area (121 );

- arranging said portion of said adhesive material (131 , 151 , 171 , 180) in adhesion with said sock (150, 170, 190) or leggings such that, when said sock (150, 170, 190) or leggings are on said foot (120) or limb, said portion of said adhesive material (131 , 151 , 171 , 180) is arranged in an area (152) superposed on said area (121 );

- cutting from a polymer gel sheet (141 ) at least a portion of polymer gel (140, 161 ,172) of the same shape as said portion of said adhesive material (131 , 151 , 171 , 180);

- arranging said polymer gel portion (140, 161 , 172) on a template;

- inserting said template in said sock (150, 170, 190) or leggings so as to superpose said portion of adhesive material (131 , 151 , 171 , 180) with said polymer gel portion (140, 161 , 172);

- removing said portion of adhesive material (131 , 151 , 171 , 180) from said sock (150, 170, 190) or leggings;

- thermobonding said polymer gel portion (140, 161 , 172) on said sock (150, 170, 190) or leggings by heating said sock (150, 170, 190) or leggings on said template to temperatures between 80°C and 200°C and subjecting said sock (150, 170, 190) or leggings on said template to a pressure between 3 bar and 10 bar at least at said zone (152).

2. The method according to at least one preceding claim, wherein in said thermobonding step said pressurization is carried out immediately after said heating.

3. The method according to claim 1 , wherein said temperatures are between 100°C and 160°C.

4. The method according to at least one of the preceding claims, wherein said pressures are between 5 bar and 7 bar.

5. The method according to at least one of the preceding claims, wherein said polymer gel portion (140, 161 , 172) on said sock (150, 170, 190) or leggings is cooled so as to achieve a temperature drop of at least 50°C within 1 minute.

6. The method according to at least one preceding claim, wherein said template defines a desired shape between the insole (160, 173) and the limb so as to stretch the fibres of said sock (150, 170, 190) or leggings.

7. The method according to at least one preceding claim, wherein said template comprises any one of wooden, metallic or synthetic material.

8. The method according to at least one preceding claim, comprising a further step of inserting polymer gel inserts into predetermined adhesion zones between the skin of said user and said sock (150, 170, 190) or leggings and surface machining said inserts so as to create embossed surfaces (61 , 71 ) at said adhesion zone so as to increase air circulation inside said sock (150, 170, 190) or leggings.

9. The method according to at least one preceding claim, comprising a further step of inserting polymer gel inserts into predetermined contact zones between the skin of said user and said sock (150, 170, 190) or leggings and surface machining said inserts so as to make perforated surfaces (72, 81 ) at said contact zones so as to increase air circulation inside said sock (150, 170, 190) or leggings.

10. The method according to at least one preceding claim, comprising a further step of notching said polymer gel portion (140, 161 , 172), after said thermobonding step, so as to make a housing and a step of inserting a sensor inside said housing.

11. An improved sock (150, 170, 190) including at least one orthosis (191 ) made using the method in claim 1.

12. The sock (150, 170, 190) according to claim 11 , wherein said area (121 ) corresponds to any one of the metatarsal area (22), the plantar arch, the heel (21 ), the toe area and the area above the toes (24), the instep (23), the ankle (27), the tibia (28) and the lateral area of the phalanges (25, 26) of said foot (120).

13. The sock (150, 170, 190) according to at least one of the claims 10 and 11 , wherein said polymer gel inserts are arranged at one said zone (152) corresponding, when said sock (150, 170, 190) is worn, to one said area (121 ) corresponding to the calf of said user in such a way as to reduce slipping between said sock (150, 170, 190) and the skin of said user.

14. An improved leggings including at least one orthosis (191 ) made using the method in claim 1.

15. The leggings according to claim 14, wherein said area (121 ) corresponds to any one of the areas of the buttocks (100), the thigh (101 ), the knee (102) and the calf.