JP6984830B2 - Customized orthopedic insoles and how to make them - Google Patents

Description

Background of the invention

The present invention relates to orthopedic insoles for shoes and methods for quickly and efficiently customizing the insoles for a particular user.

A peculiar structure in which a person's foot can be very flexible or very stiff as the person walks according to the mechanism of fixation and release within the skeleton and joints of the person's foot. Is.

This mechanism does not work properly when the skeletons and joints of a person's feet and ankles are abnormally aligned. In the presence of such abnormal alignments, the muscles at the more ends are required to work more strongly to control the alignment between the skeleton and the joints. As a result, these muscles fatigue faster. Once the muscles are tired, the person will experience pain and discomfort because these muscles can no longer compensate for the abnormal alignment of the feet and ankles.

There have been many advances in prior art that address the anomalous alignment of the foot and ankle. In addition to invasive surgical procedures, shoe insoles have been developed. These insoles are placed between the sole or aspect of a person's foot and the shoe. Custom sole shoe-inserts support the skeleton and joints to maintain normal alignment and feet so that a person can walk stronger, more stable and more comfortable. Redistributes the pressure exerted by a person's weight on the appearance of the sole of the foot.

Typical methods in the prior art are required by the patient's specific needs as determined by the plaster cast of the person's or patient's foot and then by the podiatrist in charge. Is to manufacture a customized insole based on a plaster mold with any correction. This type of procedure is expensive and requires considerable time, sometimes weekly units, between the initial plaster mold and the final product.

Therefore, the patient must tolerate the pain of improper alignment until the insole satisfies the nursing foot sick doctor. In addition, due to the cost, patients generally cannot afford additional insoles and typically use the same insoles when wearing other shoes.

More recent prior art has attempted to address the cost and time related issues of making custom insoles. U.S. Pat. No. 7,017,218 issued to Nguyen describes how to make a custom insole using water injected through a syringe in the reaction of a woven polyurethane casting material. is doing.

U.S. Pat. No. 7,017,218

As used herein, terms such as patient, user, wearer, and person are interchangeable and have the same meaning.

An object of the present invention is as follows.
1. 1. Once a customized shape is obtained, providing a way to quickly make a customized insole for shoes using a layer of intermediate material that can be permanently cured,
2. 2. To provide an insole for the patient's unique needs and requirements,
3. 3. Providing insoles that are not expensive to manufacture and, as a result, allow the user to afford other insoles for other shoes that the user wears, and
4. No supervision of a foot sick doctor is required, and the insoles can be customized by the user at the time and place of the user's choice.

The present invention is a method of making a customized insole having a top layer, a moldable middle layer, and a molded bottom layer.

The materials that make up the top and bottom layers are required to be perforated to provide the necessary passages for moisture to contact the layers of material so that they cure upon contact with moisture. .. The material selected can be a flexible plastic that is perforated and covered with a cloth material.

The top layer is for foot cushions. It can be made of various thicknesses and of any kind of material such as leather used in the footwear industry, or any synthetic material. Perforation of the top layer is desirable. However, non-perforated materials are acceptable as long as the bottom layer is sufficiently perforated.

The moldable intermediate layer is thick enough to be able to contoured the adjacent sole aspect area of the user's foot. Immediately after contact with an accelerator, such as water, this intermediate layer cures permanently. Intermediate layers can be made from various types of chemicals or compounds that are materials such as potting compounds, epoxies, glass fibers and the like. Glass fiber is a preferred material because it is strong, hard to break, and easily activated by water or ambient moisture. In the glass fiber layer, the insole is pressed against the foot and the appearance of the sole of the foot is pressed against it. After the mixture (such as fiberglass resin) that cures is cured after contact with a reaction accelerator (such as water produced by the ambient conditions in the wearer's foot or shoes), this shape is Become permanent. For this reason, custom inserts must remain raw in an airtight, moisture-free package.

The perforated bottom layer to be molded can be made from various types of materials such as plastic, leather, or foam. The through-holes can be a plurality of small holes with a diameter of 1-3 mm in the center of the bottom layer to be molded, or a row of relatively large through-holes with a diameter of 10-15 mm, or a combination of both. An alternative to plastic materials is any hygroscopic material with fine perforations. The bottom layer can be made into a very high arch shape that fits even the highest arch of a person's foot. As the wearer walks, the appearance of the soles of the wearer's feet is orthoticsically remembered. Once the middle layer has hardened, it permanently maintains the shape of the wearer's foot. The shape of the insole is individualized to fit the shape of the foot deformity by additional padding to a certain area of the foot, and then during the molding process or by simply walking for a sufficient period of time. You can readjust the foot in one direction.

The moldable bottom layer provides upward pressure as the moldable intermediate layer is sandwiched under the pressure between the bottom layer to be molded and the foot. The bottom layer to be molded can be made of various types of materials such as foam, elastic bandages, vacuum suction, plastic and the like. Plastic is the preferred material because it is flexible and takes up much less volume in the shoe. This bottom layer is well perforated to allow moisture to be absorbed into the moldable intermediate layer. The bottom layer to be molded covers the bottom of the foot from the heel, preferably with respect to the area under the ball of the foot. Inside this layer is a cavity constructed to fit a moldable intermediate layer. Around the cavity there is a narrow edge for attachment to the perimeter of the top cover.

Since the intermediate layer can be made of various materials, the curing agent or reaction accelerator utilized depends on the material constituting the intermediate layer. The preferred material used is a polyurethane cast material as disclosed in US Pat. No. 4,433,680 issued to Yoon and further improved in US Pat. No. 6,007,505 issued to Grim et al. The improvement under Grim et al. Is the addition of hydroxypropylmethyl-cellulose (HPMC), which prevents urethane from becoming viscous when in contact with water. The material produced by Grim et al. Is sealed in a package and is flexible if maintained in the package or immediately removed. The material cures more slowly in ambient conditions without the addition of water, but contact with water accelerates the process of curing.

Other materials that can be used as the intermediate layer are materials made from glass fiber woven fabrics impregnated with a water curable material, as disclosed in US Pat. No. 5,334,442 issued to Okamoto et al. .. The intermediate layer produced by the present invention should not be limited to the materials disclosed herein. Other suitable materials can be used as long as they are suitable for being formed in the appearance of the sole of the user's foot and cured to that shape within a short period of time. It is possible to select an intermediate layer composed of a material that does not cure under ambient conditions without first contact with the activating agent.

The required thickness of the intermediate material layer varies and depends on the shoe size, width, arch, and material context. When the preferred material of polyurethane cast material is used, the thickness of the intermediate layer is typically in the range of 1-15 mm, and most preferably between 3-4 mm.

The insole can be made to be adjacent to the arch of the foot and confined to the normal area around it or to extend over the length of the foot. Preferably, the intermediate formable layer can extend from under the heel to the metatarsal bone, or below the toe area. In addition, the insole can have a heel sheet that can cover around the heel. The top surface of the heel sheet is curved or flattened in the central region to give the user more stability when the user is standing and applying downward pressure. The peripheral edges of the orthotic are softened and softened in the middle to avoid wrinkles from molding along the lateral flanges. Another option is to form a small number of cuts to absorb the wrinkles along the flange.

<Assembly>
The bottom and top layers are preferably adhesive adhesives around them. The middle layer is sandwiched between the top layer and the bottom layer. Generally, the adhesive is selected to maintain all three layers as a single insole. In some situations, sewing or other physical mounting means is needed to ensure that those layers remain in place. The insoles are then stored in airtight, moisture-proof packaging.

<Usage instructions>
Two different methods, namely accelerated processes, or standard processes, can be utilized to supply sufficient amounts of water to cure the moldable intermediate layer.

I) Acceleration process-Curing time is 10-15 minutes A wet sponge, paper towel, or other source of moisture is required to supply the required amount of water into the moldable intermediate layer.
Invert the insole (or brace) so that the perforated bottom layer faces upwards, and apply a wet sponge or paper towel to the bottom of the bottom layer to allow water to flow through the through holes to the moldable insole. Gently press several times. Then place the insole in the shoe and walk for at least 5 minutes or until the moldable insole has hardened.

II) Standard process-curing time is at least 4 hours Place the insole in the shoe and walk for at least 30 minutes. Remove your foot from the shoe and leave the insole in the shoe for the next 4 hours to cure. Alternatively, the insole is worn for several hours until it is completely cured.

It is understood that specific examples of this insole will be manufactured in various sizes, widths, and arch heights so that one can select the appropriate insole that fits within the intended shoe size and width. Must be done. There are several options for using the insoles described here. They can be made as athletic, casual, formal shoes, or removable orthotic devices for shoe built-in parts.

An advantage beyond the disclosure provided by U.S. Pat. No. 7,017,218 issued to Nguyen is that the water injection device can be eliminated and replaced with multiple through-holes through the bottom layer forming the insole, manufactured and especially worn by the wearer. It has significant advantages in the process of personalizing the orthotic device on the foot.

The inventions described in the original claims of the present application are described below.
[1] A step of selecting one insole from a selection of insoles having various sizes, widths, and arch heights.
Here, the insole is
A top surface, a bottom surface, and a molded bottom layer having a plurality of through holes extending from the top surface to the bottom surface.
A moldable intermediate layer made of a material that permanently cures immediately after contact with the reaction accelerator, a top layer having a top surface and a bottom surface, where the perimeter of the top cushion is the molding. A possible intermediate layer is connected to the molded bottom layer such that it is sealed between the top layer and the molded bottom layer, the top layer having a plurality of through holes extending from the top surface to the bottom surface. can be,
Equipped with
A step of exposing the through-holes to a moisture environment so that a sufficient amount of moisture acts as a reaction accelerator to permanently cure the moldable intermediate layer.
A step of inserting the insole and the wearer's foot onto the insole in the wearer's shoes and applying a downward force to the insole.
A step of maintaining a downward force on the insole until the insole is substantially cured.
How to make customized insoles, including.
[2] The method according to [1], wherein the moldable intermediate layer comprises a sufficient amount of polyurethane casting material and hydroxypropylmethyl-cellulose.

Claims (1)

Steps to select one insole from a selection of orthopedic insoles for shoes with various sizes, widths, and arch heights,
Here, the insole is
A molded bottom layer having a top surface, a bottom surface, and a plurality of through holes extending from the top surface to the bottom surface , wherein the through holes are a plurality of small diameters 1-3 mm in the center of the bottom layer to be molded. A row of holes, or a row of relatively large through holes with a diameter of 10-15 mm, or a combination of both.
A moldable intermediate layer composed of a material that permanently cures immediately after contact with the reaction accelerator , wherein the moldable intermediate layer is a sufficient amount of polyurethane cast material and hydroxypropylmethyl-cellulose. Equipped with
A top layer having a top surface and a bottom surface, where the perimeter of the top cushion is connected to the molded bottom layer such that the moldable intermediate layer is sealed between the top layer and the molded bottom layer. The top layer has a plurality of through holes extending from the top surface to the bottom surface.
Equipped with
A step of exposing the through-holes to a moisture environment so that a sufficient amount of moisture acts as a reaction accelerator to permanently cure the moldable intermediate layer.
A step of inserting the insole and the wearer's foot onto the insole in the wearer's shoes and applying a downward force to the insole.
A step of maintaining a downward force on the insole until the intermediate layer is substantially cured.
How to make customized orthopedic insoles for use in shoes, including.