WO2003099053A1

WO2003099053A1 - Method and application for biomechanical support device

Info

Publication number: WO2003099053A1
Application number: PCT/US2002/016415
Authority: WO
Inventors: Mark Oishi; Donald G. Harrison
Original assignee: Ubertech Products, Inc.
Priority date: 2002-05-21
Filing date: 2002-05-22
Publication date: 2003-12-04
Also published as: AU2002316167A1

Abstract

Structural formations and formulations of a silicon foam, for example, used in high performance shoes, as, for example, mid/sole materials of excellent energy efficiency (measured as a ratio of energy returned/energy absorbed) of 8050D IMEVA of excellent (151 mJ/cm3) shock absorption qualities foreseeably embodied in orthoses, shoes, midsoles, inserts and other molded forms.

Description

(a) Title of the Invention:

"Method and Application of BioMechanical Support Device"

(b) Cross Reference to Related Applications. This is a non-provisional counterpart to U.S. Application Serial No. 60/292,406, filed on May 21, 2001 and entitled Method and Application for BioMechanical Support Device.

(c) Statement Regarding Federally Sponsored Research or Development. (N/A)

(d) Reference to a "Sequence Listing," a table, or a computer program listing appendix submitted on a compact disc (see 37 CFR 1.52(e)(5Y>. (N/A)

(e) Background of the Invention

Background

Silicone rubbers are compositions containing a high molecular weight dimethyl silicone linear polymer. Such materials offer excellent viscoelastic properties capable of providing shock absorption by dissipating the energy invading the body of a foam during locomotion. This is accomplished without "bottoming out" as quickly as other materials used for the same purpose, making them a good substitute for the natural viscoelastic body tissues in the manufacture of orthoses or running shoes. Devices made from silicone can be heated and cooled without drying or cracking. They maintain both their shape and viscoelastic properties over wide ranges of temperature as demonstrated by the invention herein.

Other important characteristics of silicone rubbers include a high degree of chemical inertness, which allows the silicone devices to be soaked in many types of solutions for both cleaning and disinfecting without any loss of function. This chemical inertness also reduces the chance of allergies upon contact with the skin and does not support bacterial growth or odor. A variety of both heel and full foot prefabricated silicone orthoses are currently known. Although they differ somewhat in appearance, they are all designed primarily for both shock attenuation and weight dispersion. For example, a shoe pad can be made to cushion in the heel using a silicone pad. Foam pads can compress too much and loose effectiveness if worn, for instance, for over a half hour. It is a goal of the disclosed materials and formations to be utilized in foot orthoses for improved pressure distribution as well as high performance running shoes.

A cost effective, energy efficient and optimal weight in silicone foam for molding in various applications is another goal of the disclosed invention. Silicone though, if not formed or formulated well, can demonstrate poor shock absorption, in for example, running shoes. The disadvantages of using known silicone include high cost, weight and compression (Energy absorbed per volume). To achieve cost effective and optimal weights in silicone foams, fillers or foaming agents are sometimes added.

Examples of potential usage of the disclosed silicon includes insoles, shoes, orthopedics devices, which achieve, for example, reduce shearing of various design formation. It is a goal of the invention to be utilized in viscoelastic full insoles as an insert made of silicone to achieve significant pressure redistribution under the foot as well as gait correction, as well as other foreseeable structures such as a midsole.

One foreseeable utilization of the disclosed inventions is a silicone which is, for example, usable in a high performance running shoe. Athletes wear running shoes to protect against injury by cushioning impact and aiding joint alignment. A runner lands on the hind heel, rocks forward through his or her instep and then presses off from the forepart of the foot. The heel strike, with its associated impact forces, is considered by certain research the most treacherous phase of the gait cycle. Midstance, with its threat of overpronation, has also receiving considerable attention in shoe research and design. Peter Cavenaugh in the text The Running Shoe Book has shown that running biomechanics are more complex and idiosyncratic than previously suspected. To better generate distribution of forces is a goal of the disclosed invention utilizing foam and formed structures, achieving relieved pain and weight distribution. Serious runners count on their shoes to improve their performance as well For a running shoe, the foam can be utilized to improve gait, for example, with improved biomechanics and in various designs. A shoe can be designed from the disclosed foam for a shoe, for example, with increased soft-tissue vibrations, and other modifications to decrease the soft-tissue vibrations by modifying such varying aspects of foam density, foam formulations as well as other aspects of the foam's structural formation such as nobs, sponge pads, grooves, ridges, barrels, etc. and achievement of the disclosed and recited invention. Reducing impact and alignment in running injuries and athletic performance is a goal for an embodiment of the foam disclosed utilized in a shoe or athletic device. A goal of the disclosed foam is to utilize the disclosed material, implemented as a shoe which is, for example, utilized for controlling roll in a high performance shoe.

It is a goal of the disclosed invention to, for example, be utilized by manufacturers to vary foam structure placement as well as formation, varying material qualities and strategically place holes ridges, nobs and grooves in a foam crafted form utilization in, for example, a running shoe. The disclosed foam can be utilized in a shoe to provide greater stability and alignment, for example, controlling pronation, by using varying density of formation and formulation in, for example, midsoles in an attempt to deal with pronation. Example designs of the disclosed material could foreseeably include a midsole thinned, thickened and rounded toward the outside edges of a shoe. For example, in one embodied utilization of the foam varying structures of the foam can be utilized in shoes promoting a preferred alignment, to feel great and improve performance; preventing irritation and exhaustion for the runner or walker.

Another foreseeable implementation of the foam embodied herein is for reinforcements in shoe models according to parameters such as degree of cushioning, dynamic alignment and shape, attuned to varying biomechanical analyses characterizing according to a consumer's running style of varying factors such as pressure and compression, varying cushioning and stability features to accommodate different body weights, running as well as walking surfaces and patterns of ground contact.

The foam disclosed herein can be used for an array of choices, formations and functionalities preventing suffering in the protective forms of orthotic devices, for example for therapeutic footwear for people with diabetes, as well as other orthoses.

(f) Brief Summary of the Invention

As noted and recited amongst various embodiments, an example formulation and structural formation of a silicon foam is disclosed which achieves criteria, for example, when utilized in high performance shoes, as for example, as mid-sole materials of excellent energy efficiency (energy returned/energy absorbed) of known 8050D IMENA of excellent (151 mJ/cm3) shock absorption qualities. The disclosed formation can also foreseeably be embodied in orthoses, shoes, midsoles, inserts and other molded forms.

The structural formations of silicone in various forms and formulations of excellent "energy efficiency and consistency" has several advantages for use in, for example, an orthotic support device which is customizable, or sports wear such as high performance running shoes midsole. Example structural embodiments comprise the silicone foam, for example, as supplied by GE Silicones of the following criteria: a foam silicone as a 10 to 1 mix with liquid injection molded silicon, mixed to form a catalyst, which is cured by adding heat to 10 parts of A to 1 part B. RTF 762 Silicone foam or known RTN 615 Silicone at 10% (for example known RTN 615 GE Silicone) to process a pure foam silicon, inconsistencies make it difficult to mold from shot to shot. Adding, RTV as silicone at 10% makes, a mold more controllable.

It is a goal of the present invention to achieve consistency structural formation from foam

(% change in average stiffness from a 10th to 1000th impact) with the lower the value, the better. An embodiment example of a sole formation such as a mid-sole which comprises a foam of a consistency of 15% or less, with EVA foams which are typically around 10% of the original value.

Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, varying embodiments of the present invention are disclosed.

Figure 1 Brief Descriptions of the Several Views of the Drawings

Figure 1

Example tolerances are shown, for variations of structural forms of the sponge. Other variations of the present invention are foreseeable.

Figure 1 A is a top view of a sponge with holes cut vertically through the body.

1 Al For example a radius 2mm radius curvature.

1 A2 is a Holes all 3mm diameter, for example.

Figure IB is a side view of a sponge

IB 1 is a radius 2mm, typical on 2 corners rounding.

1B2 as shown in a sectional view of cylinder formed by holes in sponge.

1B3 with a dimension of 6mm from holes diameter to hole diameter.

1B4 with a dimension of 50mm at the base.

1B5 shows a 7mm dimension distance from cylinder center to edge of sponge wall.

Figure 1C is a front view of a sponge.

ICI is a cutaway sectional view of a rounded corner through the sponge.

1C2 shows a radius of 2mm, typical on 2 corners, for example.

1C3 A 6mm distance is shown from a cylinder center to cylinder center.

1C4 shows 7mm distance from cylinder center to edge of sponge wall.

1C5 shows 50mm diameter of the test sponge.

1C6 shows 15mm height of an example sponge. Figure 2

Figure 2 A is a top view of a sponge with slots.

2A1 shows a radius 2mm, rounding of corners.

2A2 shows 10 slots, 3mm wide, with typical slot shown in 2A2.

2A3 shows a radius 1.5mm, typical on 20 ends of slots, for example.

2A4 for the 10 slots, 17mm length is shown.

Figure 2B is a side view of a sponge.

2B1 shows a radius 2mm, typical for rounding corners.

2B2 shows a 7mm distance from a cylinder center to a sponge wall is shown.

2B3 shows a 9mm distance from a cylinder radius to a cylinder radius is shown.

2B4 shows a 50mm length is shown for a sponge wall length.

Figure 2C is a front view of a sponge.

2C1 shows a radius of 2mm, typical rounding of an example sponge slab.

2C2 shows a 5mm spacing from slot gap to sponge wall.

2C3 shows a 6mm wall forward from sponge slot to sponge slot.

2C4 shows a 15mm height of a sponge.

2C5 shows a 50mm wall gauge.

Figure 3

Figure 3 A is a top view of a sponge with nobs.

3A1 shows 16 domes of 8mm diameter, 3A1 a typical dome for example R2 TYP 4X radius 2mm, typical on 4 corners

Figure 3B is a side view of a sponge.

3B1 shows from nob centerlines, 12mm distance between nobs.

3B2 shows a 2mm radius, typical on rounding of corners of the sponge.

3B3 shows a 7mm distance of a nob center to a sponge wall.

3B4 shows a 8mm height of a nob from sponge wall flat.

3B5 shows a 50mm length of a sponge, for example.

Figure 3C is a front view of a sponge formed with nobs of 8mm.

3C1 shows a centerline to centerline, 12mm distance from nob to nob.

3C2 shows a 4mm radius, typical on 16 domes, as shown for example by the dome nobs. 3C3 shows a 2mm radius rounding of corners of a wall.

3C4 shows a 7mm distance from nob center to sponge wall.

3C5 shows a 50mm length of a sponge.

3C6 shows a height of the wall.

3C7 shows a cutaway view through a sponge

Figure 4

Figure 4A is a top view of the sponge with ribs.

4A1 shows a 2mm radius, typical on 4 corners rounding for example

Figure 4B a side view of a sponge with ribs.

4B1 shows a 2mm radius, typical on 2 corners rounding of a sponge edge.

4B2 shows a 8mm height of a rib.

4B3 shows a 50mm length of a sponge.

Figure 4C is a front view of a sponge with ribs

4C1 shows a 4mm radius top, typical on 4 ribs, as shown in one example rib.

4C2 shows a 2mm radius, typical on 2 corner rounding of a sponge wall.

4C3 shows a 3 centerlines, 12mm distance from rib center to rib center.

4C4 shows a 7mm distance to the sponge wall edge from edge rib center.

4C5 shows a 50mm length of a sponge.

4C6 shows a 15mm height of the sponge.

Figure 5 Figure 5 A is a top view of a sponge with nobs.

5A1 shows 9 nobs of 16mm diameter, with 5A1 showing a typical nob 16mm of diameter. 5A2 shows a 2mm radius typical rounding on 4 corners of the sponge. Figure 5B is a side view of a sponge with nobs 5B1 shows a 9mm distance from nob center to wall edge. 5B2 shows a 16mm distance from nob center to nob center. 5B3 shows a 8mm height of a nob. Figure 5C is a view of the sponge with nobs. 5C1 show a cutaway of the sponge.

5C2 shows a 4mm radius for nob head.

5C3 shows a 9mm distance from a nob center to a sponge wall.

5C4 shows a 16mm distance from a nob center to nob center for example.

5C5 shows a 50mm length of a sponge pad

5C6 shows a 15mm height of a sponge pad

FIGURE 6 Figure 6 shows a sponge with ribs. In all cases these examples were tested to help develop an appropriate structure that will collapse easier under load, (i.e; improve energy absorbed per volume).

6A1 shows a 2mm radius, rounding of sponge wall edges, typical on 4 comers.

6B2 shows a 2mm radius, rounding of sponge wall edges, typical on 4 comers.

6B3 shows a 50mm length sponge.

6C shows a side view of a sponge with ribs

6C5 shows a radius of 4mm for one of 4 example ribs.

6C1 shows a 7 mm length from rib to wall.

6C2 shows 11 mm height of a sponge.

6C3 shows a 4 mm cone base of a rib.

6C4 shows a 50 mm length of a sponge.

Figure 7 Figure 7 is a structure utilized for the heel portion of a shoe mid-sole. 7A1 3.000 inches length of a sponge is shown. 7A2 2.500 inches from comer rod center to comer rod center. 7A3 .630 inches from rod to rod center. 7A4 .630 inches from rod to rod center. 7B1 .295 inches of a wall height of a sponge is shown 7B2 .610 inches of a platform wall to rod top height is shown 7C1 shows a gauge of 1.969 inches from a rod to rod to rod. 7C2 show a gauge of 1.220 inches for a rod height. Figure 8

Figure 8, achieves a structure for use in a shoe mid-sole. The "opposed" dome to dome structure helps the foam collapse, or act as a spring to allow the energy absorbed per volume value to increase. This is an achievement over solid silicone foam.

Figure 8, for example, shows Figure 8 A a sponge with geometric barrels.

The barrels are in a stmcture that allows the material to collapse, thus reducing the amount of energy need to compress the MIDSOLE. Empty space is filled with compressed dome stmcture, absorbing shock.

8A1 is a length of a sponge slab with geometric rods of 3.00 inches,

8A2 is a length of 2.5 inches center comer to center comer radius.

8A3 is a .630 inches measurement from barrel to barrel center. 8A4 is a .630 inches measurement from barrel to barrel center. 8B1 is a .610 inches measurement of barrel to midwall. 8B2 is a .295 inches measurement of midwall to barrel top. 8C1 is a 1.969 inch length measurement of a sponge. 8C2 is a 1.220 inch height measurement of a sponge.

Figure 9 Figure 9 shows a silicone foam base with barrel structures molded into the base for example midsole, heal portion, exemplary.

Figure 9 shows a sponge with barrels and the significance of the stractural forms for instance as a midsole just the heal portion?

Detailed Description of the Preferred Embodiments

It is a goal of the disclosed foam formed as at least one of several stmctural formations for shock absorption implemented in one embodiment as a lightweight material and formed within running shoes. The battle between cushioning and stability occurs m. & d esigners efforts, to reduce the weight of running shoes, because stability components tend to be heavy. A goal achieved by the disclosed silicone foam and the disclosed stractural formations is of a shoe of a lighter weight, without making a high performance shoe which is too flexible while accomplishing excellent shock absorption.

In one embodiment, the disclosed shoe can be utilized as a solution to shoe designers' constant battle to get a shoe with an adequate amount of both shock absorption and stability. A trade-off occurs between at least two aims: shock-absorbing materials such as trapped gas, silicone gel and foam polymers cushion the impact of pounding feet, which can, if not designed well, result in running injuries. Yet too much cushioning compromises a shoe's ability to stabilize the alignment and movement of the joints in the legs and feet. Resulting for example in Achilles tendonitis from the popularity of soft heels in running shoes. When a heel gets too soft, the foot sinks into it and torques, and it is possible to have more Achilles tendonitis flare-ups.

A known breakthrough in strong, lightweight material occurred decades ago, when nylon replaced leather and canvas uppers and the known foam polymer called ethylene vinyl acetate (EVA) supplanted rubber in the midsole and heel. EVA is a known closed-cell foam in the midsole of many athletic, trail running and hiking shoes. EVA is used for its cushioning qualities since it is lighter and softer than the other known major midsole ingredient - polyurethane. Progress in weight reduction has consisted of removing unnecessary material — strategically carving out the surplus EVA in perforated midsole designs.

Shoe manufacturers (for example) straggle to strike the right balance between cushioning and stability. An achievement of the disclosed invention is to reduce impact forces and running injuries. Impact exercises such as basketball, gymnastics and running can damage joints. An achievement of one embodiment of utilizing the disclosed foam formations is for prevention of degenerative joint diseases such as osteoarthritis. The cushioning provided by the disclosed silicon foam and structures of the invention can be utilized to reduce the frequency or type of running injuries due to the excellent shock absorbing qualities of the disclosed invention's "sponginess" and structural formations to redistribute impact forces.

Known stability features such as stiffer soles, racing stripes and arch supports are meant to steady the foot within the shoe and guide its contact with the ground. Yet a shoe that, for example, is too rigid won't protect against impact and can restrict the complex series of motions that make up a normal gait cycle. A goal of one embodiment of the present invention is to provide for example, a silicone foam formed as structural form as for use in a running shoe with a built in support such as a silicone foam midsole to prevent excess pronation, or inward rolling of the foot, as, for example, the runner's weight shifts from heel to toe.

Yet some amount of pronation is natural and even necessary in normal walking and ranning. Yet a dual-density midsole design for example, may lead to an increase in the frequency of iliotibial-band friction syndrome, a condition in which a band of connective tissue running down the outside of the thigh rabs painfully against a bony protrasion near the knee. If a shoe is designed poorly in dual density technology normal pronators may roll far onto the outer edges of their feet - a motion called supination that is also part of normal ranning but that can be harmful in excess. Oversupination stretches the illiotibial band and causes the long bone of the thigh to twist inward, increasing the friction between the band and the bony knob. The disclosed foam and structures foreseeably achieves a desired balance and shock absorption.

It is possible for the disclosed silicon foam to be utilized for reduced vibrations generation when a heel strikes the ground, as well. The disclosed foam can be utilized for cushioning of ranning shoes which can amplify or damp soft-tissue resonance by shifting impact frequencies toward or away from a walker's soft/firm vibration frequency, aspects which can be controlled by changing the disclosed foam's formulation, stractural formation_^ density, as well as other aspects.

As a configurable variety of structural formations, one preferred foam utilized is RTF 762 and RTV 615 silicone with a high performance criteria of RTV 615 silicone @ 10% silicone

used.

For RTF 762 silicone foam, and RTV 615 silicone @ 10%, these example choices of silicon foam yield a foam product that has a density of about 29-lbsJcu.ft. All manner of structural formations are possible due to the excellent stock absorption, resistance to shearing, as well as other aspects of the disclosed foam.

The content of 762 silicone foam is as follows:

DATA FOR MATERIAL = 80025

The Data, for example, for 762 Silicone Foam is of the following criteria: **** MAPTIS NONMETALLIC SELECTION LIST DATA FOR MTRL CODE: 80025 **** 01-APR-02

MTRL CODE: 80025

USE TYPE: INSULATION FOAM FLAME RETARD ANT DESIGNATION: RTF 762 COMPOSITION: SILICONE RUBBER

GENERIC ID: FJDPXX MFG SERVICE TEMPS IN AIR - MIN: MAX:

MANUFACTURER: GENERAL ELECTRIC DIVISION: SILICONE PRODUCTS

FLAMMABILITY DATA

BURN PROP

NHB/ CUR PCT +/ PRESS +/ SAMPLE S CHM SMP THICK +/ LENGTH T RATE K DFS SUBSTR SUBSTRATE

TYPE TEST NR NR R OXY - psia - TMP f V VOL NR inch - inch B in/sec 10 BJP THK in MATERIAL

01-UPW W20488-A I 25.7 .3 14.4 .3 99 .1530 .008 3.70 NNN

W20488-B A 30.3 .3 10.2 .3 99 .1530 .008 5.30 NSS

W26675-A C 30.3 3 10.2 .3 99 .4930 .02 12.00 T 1.091 SNS

W19964-B 1 1 30.3 .3 10.2 .3 99 .8400 .04 .30 0 NNN

W19964-C 3 1 30.3 .3 10.2 .3 99 .8400 .04 .50 NNN

01-U-C W21642-A 2 30.3 .3 10.2 .3 99 1.1200 .08 4.60 T LNS

01-UPW W19964-A A 30.3 .3 10.2.3 99 1.6300 .08 .90 SNN

TST

NHB TYP TEST NR T DESCRIPTION/REMARK

01 UPW W19964-A R AN ADDITIONAL FLAME FRONT WAS OBSERVED. IT PROPAGATED OVER THE ENTIRE SAMPLE LENGTH ALONG 1 EDGE.

01 UPW W19964-B R AN ADDITIONAL FLAME FRONT WAS OBSERVED ON BOTH SAMPLES. SAMPLE 1 PROPAGATED 3.8" AND SAMPLE 2

PROPAGATED 1.3". 01 UPW W19964-C R AN ADDITONAL FLAME FRONT WAS OBSERVED ON BOTH SAMPLES. SAMPLE 1 FLAME PROPAGATED 1.1" AND SAMPLE 2

FLAME PROGATED 12" LONG 1 EDGE AND ACROSS THE TOP. 01 U-C W21642-A R THE CONVEX SIDE WAS DESIGNATED SIDE A; THE CONCAVE SIDE WAS DESIGNATED SIDE B. 01 U-C THE SAMPLE WAS MOUNTED IN A MANNER THAT PRODUCED THE LONGEST SAMPLE LENGTH.

TOXICITY DATA

CHAMBER SHUTTLE S ISSA RUSSIAN

CUR SMP GT VOLUME SHUTTLE ML WGT S ISSA ML WGT R RUSSIAN ML WGT TEST NR NR grams liters R ZT100 lbs R ZT100 Ibs R ZT100 lbs

W20488-D 20.289 4.3 K .031 1615.05 K .0171 2931.04 H .6663 75.0467

W19964-D 21.604 4.3 K .0945 529.179 K .0521 960.367 A 3.5061 14.2608

W26675-B 21.848 4.3 K .2359 211.92 K .13 384.598 A 3.331 15.0104

TOXICITY DATA

CHAMBER S

CUR SMP WGT VOLUME SHUTTLE SHUTTLE S ISSA ISSA R RUSSIAN RUSSIAN TEST NR NR grams liters R SUM #UNITS R SUM T #UNITS R SUM #UNITS

W21583-B 2 18.449 4.3 A .0005 909.953 A .0003 1651.92 A .0004 1283.18

TEST NR T DESCRIPTION/REMARK

W19964-D R THE SAMPLE MATERIAL WAS CURED BY THE MANUFACTURER PRIOR TO RECEIPT AT WSTF, NO ADDITIONAL CURE WAS

CONDUCTED AT WSTF.

ODOR DATA - NHB TEST 6

CUR SMP WGT PCT PRESS TEMP SUBSTR TEST NR NR R grams OXY psia f ODOR THK in SUBSTRATE MTRL

W20488-C A 20.084 25.9 11.8 120 1.2 W21583-A 2 A 19.014 25.9 11.9 120 .2

THERMAL VACUUM STABILITY DATA • NHB TEST TVS

CUR TEMP TIME RML TML SUBSTR

TEST NR NR R PRESS torr C hr TML CVCM WVR - RML THK in SUBSTRATE MATERIAL

I628-B C 1.0E-06 125 24 1.18 0.32 1.14 0.04

W26675-C C 3.0E-06 125 24 1.445 0.47 .01 1.44

W19964-E C 5.0E-06 125 24 1.36 0.40 .02 1.34

G17886 C 9.0E-05 125 24 .78 0.41 0 0.78

CURE DATA

TIME TEMP PRESS NR PH BLEND Q hr f psia CURE NOTE

1 1 48 250 02.0E-06 TORR. THIS MATERIAL HAD BEEN PREVIOUSLY CURED BY

THE MANUFACTURER. THIS WAS AN ADDITIONAL CURE.

2 1 28 78 12.4

3 1 48 250 0 4.0E-07 TORR. THIS MATERIAL HAD BEEN PREVIOUSLY CURED BY

THE MANUFACTURER. THIS WAS AN ADDITIONAL CURE. Achieved characteristics of this foam when tested formed as 3 cm X 5 cm slabs are produced are as follows, for example, as a material of a low-density silicone foam, or a higher density Silicone foam. High density and Low Density samples were submitted for comparison testing configured as a 3cm X 5cm X 1.5 cm slab, tested to 1,000 impacts, excellently. Lower density silicone form test results are achieved and discussed below.

The present invention achieves a criterion of an Energy Absorbed per Volume, with preferably the higher the value, the better, utilizable for various forms and formations.

An example embodiment, of a mid-sole foam of desired criteria achieved by the disclosed silicone is of a criterion which can absorb at least (120 mJ/cm ). Soft silicone foams could be almost acceptable (119 mJ/cm³) while hard silicone foams may tend to have poor characteristics (70 mJ/cm³).

An example of 8050D IMEVA (injection molded ethyl vinyl acetate) achieves excellent results (151 mJ/cm³). A goal of the disclosed IMEVA is to provide a midsole, for example, which provides a lightweight cushioning.

It is a goal of the disclosed invention to achieve a criteria of energy efficiency for a silicone foam (with energy returned/energy absorbed): with the higher the value the better in various forms. Threshold criteria include mid-sole foams, of example of energy efficiency of at least 0.60 KPa. This is a ratio of energy absorbed over energy returned KPa measuring stress over strain, amount of force with strain as the amount of deflection and EVA foams range between 0.65-0.75 KPa. It has been determined that soft silicone foams have very good (0.72 KPa) energy efficiency. Hard silicone foams as well are another embodiment of the disclosed invention with very good (0.71 units KPa typically as measurement) energy efficiency. An embodiment of 8050D IMEVA has good (0.66 uni ts KPa) resulE&as well.

The present invention achieves an excellent consistency (% change in average stiffness from 10th to 1000th impact): with the lower the value the better. An embodiment example of a sole such as a mid-sole example comprises a foam of a consistency of 15% or less, with EVA foams which are typically around 10% KPa.

It is an achievement of the disclosed invention of, for example, a soft silicone foam of excellent results at (2.98% KPa). An achievement of a hard silicone foam with excellent (4.5% KPa) results is disclosed as well. An 8050D IMEVA is achieved of good results (9.11%) in one embodiment.

In one embodiment formation of the present silicon foam invention, for example, utilized as a high performance running shoe demonstrates the below properties:

In an example embodiment of a shoe sample with criteria of

Mid-sole weight 4.2 oz

Tread weight 2 oz

Mid-sole density 29 IbsJcu-ft

Currently, an exemplary weight is also achieved as well when the disclosed foam is implemented in formations within a shoe. Cost effectiveness is also achieved by the disclosed invention as well, for example, with the molding of, for example, a shoe bottom, achieving reduced material labor and molding costs.

An exemplary embodiment formation of the foam formed within a high-end performance shoe of excellent Energy Absorbed Per Volume, with the foam disclosed moldable to any form desirable. Weight constraint is primary in considering design. A weight constraint is such that non- formed silicone will not be a sufficient material for needed height reduction.

A goal of the recited invention, that because of issues in consistency when injection molding foam is used, that the foam density should not be altered any further than 5% manufacturing tolerance of variation to achieve a goal amount of Energy Absorbed per Volume. IMEVA has a density of 161bs per cubic foot. Foamed silicon as used by the novel formation and structure is a goal of the disclosed invention.

The foam disclosed can be molded to various physical structures of various form and function design characteristics. A foam for testing with various structures was molded. An example, stractural foam in one embodiment comprised of a material of a low-density silicone foam configured as tip-tip barrel shapes 3cm X 5cm X 1.50 m which forms a sponge for example for a running shoes midsole tested to 1,000 impacts with the following results: Energy/ Absorbed per volume 122.72 mJ/cm³ (minimum requirement is 120 mJ/cm³, EVA is Typically 145 mJ/cm ) which passed testing successfully.

An Average Modulus = 1232.9 kPa (requirement is 1000 kPa -1300 kPa) - the disclosed foam was successfully achieved.

An instantaneous stiffness of foam was equal to 3x the Average Stiffness (meeting criteria of requirement is <= 3 times average Stiffness value which) a successful achievement.

Energy Efficiency = 0.79 KPa (minimum requirement is > 0.60 KPa, EVA is typically 0.65-0.70 KPa) also passed testing successfully.

A consistency = 2.14% KPa (in one example embodiment, a minimum requirement is < 15% KPa, with an EVA (typically 10% KPa) also was an achieved criteria from testing. Further foreseeable embodiments of the disclosed foam formations comprise αrthotic devices (commonly known as a brace or splint), which is an orthopedic device that is applied externally to the limb or body. The foam can be structurally formed to provide support, protection or replacement of lost physical function.

Ideally there are a large variety of stractural devices available for the disclosed silicone to be formed and formulated depending on the diagnosis and physical needs of the individual. Orthoses are formally named for the body segment or area that they cover or the particular function they provide. Some examples embodiments the foam can be formed to comprise an

AFO - ankle foot orthosis

KAFO - knee ankle foot orthosis

HKAFO - hip knee ankle foot orthosis

RGO - reciprocating gait orthosis

AO - ambulation orthosis

The silicone foam described herein can be custom made or custom formed depending on the criteria of clientele, functioning to protect a user.

Custom made orthoses are made over a cast, in one embodiment, which is, for example, a model of a client's body part. The foam material and formations described herein could be customized to form devices as fabricated by orthotic technicians and fit by orthotists.

A custom fit orthosis is made to measurements and is customized for a particular client. The foam and formations can be custom formed to devices provided in a kit form, for example requiring assembly and customization by a technician and orthotist, in one embodiment. While the invention has been described in connection with a preferred embodim nt, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims. As a material, the silicone foam disclosed has endless possible uses.

Claims

(i) ClaimsWhat is claimed is:

1. A stractural form for a shoe for optimized shock absorption, said form comprising:

silicone foam material having the characteristic of an optimized ratio energy return/energy absorption of greater than .6mJ within a shoe;

at least one of a nob, a slit, an aperture, at least one of several ribs, at least one of several columns, at least one of several slots, at least one of several holes or at least one of several barrels;

wherein said silicone foam material is of a criteria of 8050D IMEVA with (151 mJ/cm³) measurement of said energy absorbed per volume.

2. The structural form of claim 1, further wherein said form is formed within a shoe as an IMEVA midsole; wherein said midsole provides a lightweight cushioning.

3. A shoe stmcture formed as a midsole, said stmcture comprising:

a silicone foam material of optimized energy return/ energy absorption formed within a shoe wherein, said shoe is a ranning shoe of controlled pronation from said structural formation.

4. A stractural form, comprising:

ID a silicone material for formation within an orthotic support of optimized energy return/ energy absorption, wherein said silicone is a silicone foam material formed within as an orthotic structural support device to provide protection of bodily function; wherein said orthotic stractural support device, compπses;

a formation within one of:

an ankle foot orthosis;

a knee ankle foot orthosis;

a hip knee ankle foot orthosis;

a reciprocating gait orthosis; or

an ambulation orthosis.

5. The stractural form of claim 4, where said orthotic structural support device is customizable.

6. The stractural form of claim 5, wherein said orthotic device comprises formation as an orthopedic device that is applied externally to the limb or body, further said device comprising a brace.

7. The stractural form of claim 6, wherein said orthotic device further comprises a splint.

8. A structural formation formed of silicone as a molded shock absorbing viscoelastic full insole molded as an as insert wherein said insole comprises;

said stractural formation to redistribute pressure when worn under the foot; and

at least one of said stractural formations utilized in correcting gait.