MXPA00006590A - Improved procedure for the confection of insoles for correcting feet deformities and its product - Google Patents

Abstract

It is presented a novel procedure for the confection of orthotics products for the treatment of the biomechanical alterations of the lower extremities and feet affections and deformities, disposed in a series of stages and finally resulting in an orthotic insole for feet. This procedure has the characteristic that said insole is moulded with the required orthotic correction directly to the patient's feet and employing cheap materials. The steps of this invention are as follows:a first step, consisting in the elaboration of an orthotic pattern, starting from a paper inner sole with the patient's footprint;a second step, which consists in the preparation of the orthotic insole transferring the footstep to a resin of a thermoformable plastic, placing the resin inside a furnace in order to soften it;a third step, consisting in preparing the patient's feet for receiving the chosen thermoformable laminated resin;a fourth step, which consists in placing the thermoformable resin previously softened in the furnace over a heat-insulating sock, where it is intercalated a paper film between the sock and the softened resin in order to avoid that the resin get stick to the sock, then all the elements are wrapped in a plastic bag and it is sealed with some neoprene straps with a fastener such as a clasp or Velcro;a fifth step, consisting in polishing and lining the insole at the orthopedic workshop where depending on the specific case some discharges are incorporated to the product. The action field of the present invention subscribes to the orthotic inventions for the treatment of the biomechanical alterations of the lower extremities and feet affections and deformities.

Description

IMPROVED PROCEDURE FOR MAKING TEMPLATES FOR THE CORRECTION OF FOOT DEFORMITIES AND THEIR PRODUCT TECHNICAL FIELD OF THE INVENTION A novel procedure is presented for the preparation of orthotics indicated in the treatment of the alterations of the biomechanics of the lower extremities and of the affections and deformities of the feet, arranged by a series of stages giving as final result an orthotic insole for the foot . This procedure has the characteristic that said template is molded directly on the foot of the patient with the required orthotic correction and using very low cost materials. In this way, the resulting orthotic template will be far superior to the known procedures, both in time for its preparation and for the materials used, which have a very low value compared to those used by other systems. In addition, this orthotic template has the flexibility to be able to correct slightly the orthotic insole after its completion, or to vary according to the results obtained in the patient. The orthotic template used is made and molded on the foot of the patient consists of a plastic resin, laminated, which after its molding remains with sufficient strength to finish in the laboratory where it proceeds to the polishing and finishing operations to stabilize the orthotic insole.

Consequently, the field of action of the present invention subscribes to orthotic inventions for the treatment of alterations in the biomechanics of the lower extremities and of the affections and deformities of the feet.

OBJECTIVES OF THE INVENTION As indicated in the field of action of the invention, the main purpose of the present invention is to correct the alterations, affections and deformities of the feet, as long as this is possible through the use of templates.

Therefore, it is an objective of the present invention to have a method for making an orthotic insole which is molded directly on the foot of the patient, with which it is certain that the correction to be made will correspond exclusively to the patient's own alteration or deformity and in no way will it be a correction established comparatively to specific computed patterns. It is another goal of the present invention to have a prepared orthotic insole, which allows subsequent corrections for the perfect adjustment of the same on the patient. It is another unique feature of this invention, that during the manufacturing process of the orthotic insole no polluting powders are produced, since the plastic resin as well as all the materials involved do not produce it. It is another mission of the present invention, to have an orthotic insole endowed with elasticity and flexibility, with which the patient will not have any discomfort for daily use. In another intention of the present invention, the use of innocuous materials throughout the process of making the orthotic insole, in addition to the plastic resin used has an allergenic characteristic. Finally, the proposed method is completely hygienic, as the materials do not come into contact with the patient and the bags used are disposable, in addition to the fact that the plastic bags have a recyclable character so they are not contaminants.

BACKGROUND OF THE INVENTION The present technological development has been the result of many tests carried out previously, coming to propose the proposed procedure as well as the orthotic template which today is made known through this document. As is known, the weight of a person is supported on the feet, intermittently relieving the weight of the ligaments and transferring it to the muscles as the person changes position, being accompanied by bipedalism by the help of the knee and the light flexion of the other. The foot is composed of more than thirty bones which intervene in the movement and also, presents an arch, which corresponds to the arched shape of the foot and depending on the bone configuration and the effects of the ligaments on it. Clinical experience indicates muscular insufficiency and ligaments as the most common cause of valgus flat feet and cavo valgus feet, in which the bones lengthen and eventually alter their configuration. For the correction of the alterations and deformities of the feet, the specialist should be consulted, who after the clinical assessment will resort to a surgical treatment or if its correction is made by means of an orthotic template. This work refers to the second case, that is, to the making of an orthotic template. As a background of the present invention we have that orthotic insole, made of a metal with a bow designed and covered with a skin film, constructed in series according to established patterns, in such a way that, once the characteristics of the patient are detected , the template is simply selected and the patient is forced to use it. Unfortunately, said invention in practice it was observed that it does not correct appropriately the deformations of the foot, this because each foot differs substantially varying the pattern, besides that the patient sometimes requires some additional templates and, finally the use of the template on the part of the patient is not regular because it causes discomfort when walking, with which, many times the user chooses not to use the template further aggravating his deformity. A second known method employed is the use of orthopedic shoes, performing the correction of shoes by means of heels which elevate certain areas or sections of the shoe and force the patient to step on it in a different way. This procedure, which is very useful in infants, has the disadvantage of requiring some of these additional implements, which must be used permanently even when the patient is in rest position as in sleep. While good results are obtained with the use of this method, these are seen in the long term, although sometimes shoes and artifacts are painful because they have to use the implements throughout the day. A third procedure consists in having a model of the patient's foot. This is achieved by manufacturing a mold which we call positive of the patient and is achieved by two substantially similar methods: the first, by the use of a foam, on which the patient must tread to have a footprint or negative and, the second, by obtaining a negative mold based on plaster bandages (plaster). Referring to the foams, it has been seen that they are not an adequate system, mainly because the patient does not have the necessary knowledge to know how to step on the foams correcting their alteration and because the professional has few possibilities to make the necessary corrections. The other procedure is to say, from plaster bandages, it requires fast-setting bandages to obtain the negative. Once the negative is achieved in either case, we proceed to remove the positive also from plaster and mold over this the thermoformable material that has been chosen for the manufacture of orthotics. Now, the positive comes from taking a negative and has the disadvantage of requiring an excellent impression, which if not taken accurately, the result will be wrong. This leads to the estimation that it is often necessary to take more than one negative mold with the obvious elevation of material and the cost having to be absorbed by the patient. Another disadvantage is that the positive is often accompanied by wrinkles and roughness due to imperfections of the setting so the laboratory when designing the orthotic template should first polish and adjust the positive to subsequently mold a metal or plastic material chosen for the preparation of the orthotic It will be understood how the procedure is very cumbersome because of the multitude of steps to follow, requires a lot of supervision to minimize errors and the use of various materials which have an impact on the final cost.

The drawbacks described above can be remedied by using the procedure proposed by this work, which has the characteristic of making an orthotic insole that is molded with the correction required for the patient, taking the positive directly from the patient's foot and using materials from very low cost In this way, the resulting orthotic template will be far superior to the known procedures, both for the time of its preparation and for the materials used because they have a very low value compared to those used by other systems.

DETAILED DESCRIPTION OF THE INVENTION The method of the present invention begins with a diagnostic step, consisting of review by a specialist. For this, several aspects are carried out, namely: a walking test, a study of the footwear worn by the patient, a barefoot foot exam and a study of the foot in discharge. The examination of the gait consists of the exploration of movement and gait and the use of goniometry (measurement of the range of active and passive joint amplitude), electromyographic, cinematographic and podoborometry systems (instrumented templates) with which it is possible to analyze the static and dynamic pressure on the surface of a collector. For this, a podoscopic corridor is usually used, consisting of a glass corridor to see the sole of the foot and a mirror, placed down the corridor, with a slight inclination to see the movement of the foot when the patient walks. The examination of the footwear used by the patient is very important because there may be correction maybe through the use of other types of shoes. The examination of the foot, turns out to be definitive having to take into account the general aspect and the relation with the rest of the locomotor apparatus. Finally, the study of the foot in discharge, which will have to include the joint and comparative analysis of the feet, the study of the punctual zones, the muscular examination and, the neurological examination and the circulatory examination. Then, we proceed to the assessment and determination of the application of an orthotic template after having obtained the diagnosis and which is described below. Within the orthotic templates to be made, three types are distinguished: those destined to restore the support of the affected metatarsals; those destined to correct the different alterations in the plantar vault; and those where, in addition to the correction of the alteration of the vault, the support of the affected metatarsals must be restructured. However, with slight modifications, the procedure is totally similar. A first step is to make a pattern on paper, which is obtained from a sheet of paper where the patient has left the mark. To do this, the lines that denote the limit to where the template will arrive are first drawn on the sole of the patient's foot, using an indelible ink pen for its writing. Separately, a pattern is drawn from the inside of the shoe, normally worn by the patient and trimmed, placing said pattern inside the shoe. Next, the paper pattern is moistened with alcohol and the patient is asked to put on his shoes again, taking care that the pattern does not run. So the patient is instructed to walk after a few minutes. The alcohol will pass to the foot and download the drawing made on the sole of the foot in the paper similar to a cliché. A second step consists in the preparation of the orthotic template consisting of obtaining again a second pattern on another sheet of paper, tracing only the part that must be corrected, and then drawing the contour of that figure cut out on a plastic resin plate. moldable by heat. These resins come in the form of sheets of a thickness which ranges from 2 to 3 millimeters, and where one face is smooth while the other comes with a layer of fabric with open weft, serving this reinforcement material. Once the contour of the figure drawn on the surface of the laminated plastic resin has been trimmed and placed inside an oven according to the specific temperature of each material in order to soften it, whose temperature ranges between 35 and 120 ° C during a period of time 2 to 3 minutes. When it is desired to have a correction for example of about 5 millimeters, two plates of thermoplastic laminated resin chosen are usually placed, the two plates having to be placed on their smooth faces, that is to say face to face, the faces with fabric facing the Exterior. The heat of the stove will melt the two sheets of thermoformable resin forming a single piece. A third step consists of preparing the patient's feet to receive the thermoplastic laminated resin chosen. To this end, a disposable plastic sock is placed, with which the patient's sock is separated as well as a hygienic mediation between the doctor and the patient so as to isolate perfectly, this being a very simple and inexpensive element. Then a thermoinsulating sock is placed, whose function will be to prevent some damage to the patient's foot by heat. A hose is connected to a vacuum pump inside a sock whose function will be to extract all the air.

A fourth step, consisting in placing the thermo-moldable resin previously softened in the oven and placed on the thermoinsulating sock and so that the resin does not stick to the sock, a paper film is inserted between the sock and the softened resin. All items are wrapped with a plastic bag and the bag is sealed with neoprene straps with a fastener such as snaps or sailboat adhesive film. The vacuum pump will extract all the air and at the same time begin to mold the laminated resin on the foot of the patient, trying to push the resin on the arch. The interstices of air between the foot and the resin are extracted by the vacuum, leaving a template made at the foot of the patient. When a cooling of the molded resin is observed, the belts are removed and the molded insole is removed. This operation lasts a couple of minutes.

The cooling time depending on each type of thermoplastic resin used is 1 to 3 minutes, which allows you to make necessary corrections in each particular case or simply obtain an orthotic in neutral position to ensure the template and if in the opinion of the staff who made the same may place the molded part of a primary way in the patient's shoe and ask him to walk to express their improvement. A fifth step involves the polishing and sheathing of the molded orthotic insole, consisting of sending it to the orthopedic workshop for polishing and lining where, depending on the specific case, the corresponding discharges are incorporated. The manufacture of the orthotic template moldable from the dress of the patient's foot with a sock until the last step, does not go beyond about ten to fifteen minutes, which shows an important saving of time as well as replaced plaster material if compares it with the procedure of obtaining a positive mold from the patient's foot.

In addition, when casting directly on the patient's feet, the orthotic template is exact, unlike the use of a positive one. To obtain orthotics, only disposable socks are needed, which is why it is a clean procedure, thermo-insulating socks and a small vacuum pump. The final finish will be used machinery and usual tool for the manufacture of orthotics.

BEST METHOD TO CARRY OUT THE INVENTION.

As an example, consider the case of a person of legal age who has suffered the crushing of the cavity or arch of the foot due to fatigue due to excessive weight. After having assessed the possibility of correcting their deficiency through a template, we proceed to mark on the sole of the foot with an indelible ink pen. Figure two shows the paper pattern and the fingerprint left by the patient. The steps described by the description are continued until an orthotic template is obtained. The orthotic insole will be finished with a lining and an elongation for the discharge of the toes. It should be noted that in the case of a woman who wears high-heeled shoes, only a moldable resin plate can be used, unlike, for example, a person who has the bow expired due to excess weight.

Claims (3)

NOVELTY OF THE INVENTION Having described the invention, it is considered as a novelty and therefore the contents of the following claim clauses are claimed as my property:

1. Improved procedure for the preparation of templates for the correction of foot deformities, which comprises a sequence of process steps and which are previously initiated with a diagnosis by a specialist, consisting of the revision of the feet in order to assess whether the patient needs to correct their somatic deficiency by means of surgery or by means of an orthotic template, following the determination of the application of an orthotic template after having obtained the diagnosis, to proceed to the preparation of the orthotic template characterized by understanding : A first step, consisting of obtaining a paper pattern, of the patient's footprint where the mark of the correction will be left, for which the lines that are drawn on the sole of the patient's foot are drawn denote the limit to where the template will arrive, using an indelible ink pen for its writing, continuing from Separated, you draw a pattern on the inside of the shoe, usually worn by the patient, which is cut and placed inside the shoe, continuing with the wet paper pattern with alcohol and unloading the drawing made on the floor of the foot in the paper similar to a cliché, for which the patient is asked to put on the footwear again, trying that the template does not run. A second step consists in the preparation of the orthotic insole consisting in obtaining the pattern again from the template on a second sheet of paper, tracing the part that should be corrected, drawing the contour of that cut out figure on a resin sheet of a thermoformable plastic, and where they are presented with one side is smooth while the other is corrugated by a layer of fabric with open weft, serving this reinforcement material, made the base of the plate by cutting the contour of the figure drawn on the surface of the laminated resin ter moldable and placing it in an oven according to the specific temperature of each material in order to soften it whose temperature ranges from about 35 to 120 ° C for a period of 2 to 3 minutes. A third step is to prepare the patient's feet to receive the thermo-moldable laminated resin chosen by placing a disposable plastic sock, with which the patient's sock is separated as well as a hygienic mediation between the doctor and the patient so as to isolate perfectly , this being a very simple and inexpensive element, to then place a thermal insulating sock, whose function will be to prevent some damage to the patient's foot by heat and then a hose connected to a vacuum pump inside a sock whose function will be the of extra the all the air; A fourth step, consisting of placing the thermo-moldable resin previously softened in the oven and placed on the thermoinsulating sock and so that the resin does not stick to the sock, a paper film is interspersed between the sock and the softened resin, wrapping all the elements with a plastic bag and the bag is sealed with neoprene straps with a fastener such as snaps or adhesive film with sailboat until a cooling of the molded resin is observed directly on the patient's foot; A fifth step involves the polishing and sheathing of the molded orthotic insole, consisting of sending it to the orthopedic workshop for polishing and lining where, depending on the specific case, the corresponding discharges are incorporated, using the usual machinery and tool in the final finishing. for the manufacture of orthotics.

2. Improved procedure for the preparation of templates for the correction of foot deformities, claimed according to clause one, characterized in that the resins of thermoformable material are presented in the form of sheets of deferent thicknesses for each case and are presented in thicknesses of 2 to 3 millimeters, which makes it possible to make several combinations to give a certain thickness.

3. Improved procedure for the preparation of templates for the correction of foot deformities, claimed according to clause one, characterized in that when it is desired to have a correction of 5 millimeters, two plates of thermoplastic laminated resin chosen are usually placed, having to place the two plates by their smooth faces, leaving therefore the faces with fabric towards the outside, and where the heat of the stove will fuse the two sheets of thermoformable resin forming a single piece.