AU5156900A - Customizable orthotic with resilient, dynamic support and simplified adjustable foot cushioning and support shoe insert - Google Patents

Description

WO 00/70984 PCT/US00/14178 CUSTOMIZABLE ORTHOTIC WITH RESILIENT, DYNAMIC SUPPORT AND SIMPLIFIED ADJUSTABLE FOOT CUSHIONING AND SUPPORT SHOE INSERT 5 CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Applications No. 60/135,300 filed 21 May 1999, and No. 60/159,842 filed 15 October 1999. REFERENCE REGARDING FEDERAL SPONSORSHIP 10 Not Applicable REFERENCE TO MICROFICHE APPENDIX Not Applicable 15 BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to insoles for shoes and, in particular, to customizable orthotics with resilient, dynamic support and simplified adjustable foot cushioning and support. 20 2. Description of Related Art and Other Considerations Inasmuch as the present invention relates to concepts which are based upon those described in related Kellerman patents 5,154,682, 5,799,414 and 6,000,147 and in Kellerman patent application Serial No. 09/118,401 and 25 which constitute improvements and other advances in the art over these patents and patent application, the concepts described and illustrated therein are incorporated in this application entirely as if set forth in haec verba. Orthotics or shoe inserts, also called insoles, make standing, walking, running and sports activities more comfortable for individuals who suffer 30 discomfort resulting from various foot, joint, leg, hip, back and other problems and injuries. Some of these problems may be congenital, caused by overuse, improper shoes, sports, workplace injury or other causes.

WO 00/70984 PCT/US00/14178 2 Traditionally custom-made orthotics fitted by a foot care professional have been used to care for these problems and have had some success in correction but generally very limited success in alleviating discomfort. In addition, these orthotics are very expensive and are not easily adjustable. The 5 above-noted Kellerman U.S. Patents 5,154,682 and 5,799,414 describe adjustable orthotic devices, generally comprising a foot-contacting layer, with various cushion pads adjustably adhering to the underside. Such devices require the user to engage in "mirror thinking" in which the underside of the insole, where the pads are to be adjusted, is the mirror image of the user's 10 foot. Additionally, such prior art units may employ a hook-and-loop fastening or attachment system, such as marketed under the trademark Velcro® (trademark of Velcro USA Inc.) and described, for example, as prior art in U.S. Patent 5,953,797 and similar literature. Such a hook-and-loop fastening or 15 attachment system tends to be somewhat harder than the soft cushion pads that are designed for comfort. Thus, when the user steps on the foot-contacting surface, which deforms downwards around the pad profiles, the edges of the pads, where the Velcro® hook member is present, may be harder and the user may feel this as a hard protrusion and experience 20 discomfort on the underside of his/her feet. Furthermore, friction between the rough foot-bed of the shoe and the loop member surface of both the insole and pads tends to wear down the loop member surface over time. In addition, the loop member surface tends to become soiled from the particulate dirt that typically accumulates at the bottom of the wearer's shoes. 25 SUMMARY OF THE INVENTION These and other problems are successfully addressed and overcome by the present invention in which an orthotic of differing components is disposed to be inserted into a shoe and onto its footbed. In general, the orthotic 30 comprises a top section, a pad section and, if desired, a bottom section. The top section has a surface which is disposed to contact a user's foot. The pad WO 00/70984 PCT/US00/14178 3 section is disposed to rest directly on the footbed or through the intermediary of a bottom section on the footbed. The pad section includes at least one pad positioned between the top section and bottom section or between the top section and the flatbed of the shoe. A hook-and-loop fastening system includes 5 one or more hook members and loop members that releasably secure the pad or pads to at least one of the top section, the bottom section and releasable attachment material that is secured to the footbed. Hook members are formed from a sufficiently thin sheet stock to provide molding capability and freedom from the feel of hard edges; a thickness of less than 0.03 inched (0.08 cm) has 10 been found to work well. The top section is formed from a component whose material is of a compressible resilient material, such as that marketed under the trademark Poron® (trademark of the Rogers Corporation) and, if desired, a conformable non-compressible component of a material such as HDPE (high density 15 polyethylene). In the absence of the conformable non-compressible component, the hook member or the loop member is directly adhered to the compressible resilient material enabled, in particular, by the use of thin hook and-loop fastening system members. In addition, in one embodiment, the hook material serves the dual function both of being an element of the hook-and-loop 20 fastening system and of acting as the conformable, non-compressible component. For enhanced mobility, cushioning and impact absorption, a layer of a resin foam material, such as marketed under the mark Evazote® (trademark of BXL Plastics, Ltd.) may be added as a further component to the Poron® 25 component. The Evazote® material causes enhanced cushioning and molding. Other cushioning materials may be used for other purposes to alter the energy absorption or returning characteristics of the insole. The conformable, non compressible materials help the wearer experience more continuous contouring sensations, as opposed to experiencing the sensation of individual underlying 30 cushioning elements, i.e., to avoid any uncomfortably uneven feeling. These WO 00/70984 PCT/US00/14178 4 additional resin foam materials can also add a firmer supporting and molding capability. The pads of the pad section are configured variously in combinations of cushioning material and hook and loop members in both two-section and 5 three-section orthotic assemblies. Such combinations include a loop member cushioning material combination, a hook member-cushioning material combination, a loop member-cushioning material-loop member combination, a loop member-cushioning material-hook member combination and a hook member-cushioning material-hook member combination. The reason for the 10 extra hook and loop members to enable additional cushions to be added to the assembly, such as to raise the heel or arch portions for obtaining resilience, molding contour and various heights. The bottom section is configured to provide a plurality of different functions. The hook member alone can function as a conformable non 15 compressible component for fastening to the top section to protect the orthotic assembly for dirt and wear. A separate conformable nonr-compressible component is fastened to the top section by either hook or loop members. To provide a stiffening capability to the assembly, a hook member alone, or a vinyl component with a hook or a loop member, are used. Such a stiffening 20 capability prevents the assembly from bunching up and facilitates the insertion of the assembly into a shoe. A gripping material, such as latex and neoprene alone, can be adhered to the orthotic assembly solely for gripping purposes. When additional cushioning is desired, such compressible resilient material as Poron® and latex and neoprene gripping material can be added to any of the 25 stiffening elements. The conformable non-compressible component may be provided with perforations, slits or round or rectangular cutouts that provide aeration, wicking for passage of perspiration, and comfort. The shoe footbed may be recessed to form a cavity into which the 30 orthotic is placed, to provide the shoe with a slim-line fashionable appearance.

WO 00/70984 PCT/US00/14178 5 Several advantages are derived from this arrangement. Standing, walking, running and sports activities are made more comfortable for individuals who suffer discomfort from various foot, joint, leg, hip, back and other problems and injuries. The orthotics are easily adjustable. Their cost is lower 5 as compared to custom-made orthotics. Pad inserts are quickly and easily positioned and removed by use of a hook-and-loop fastening system. Frictional and soiling problems are significantly reduced. Other aims and advantages, as well as a more complete understanding of the present invention, will appear from the following explanation of 10 exemplary embodiments and the accompanying drawings thereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts an embodiment in generalized form illustrating an adjustable foot comfort system in top planar view in which any of the inventive 15 embodiments may be housed, including an top section in FIG. 1(a) and middle and bottom sections in FIG. 1(b). The middle section includes cushion pads of various shapes, sizes, thicknesses and physical characteristics which are attached, for example and in accordance with one attachment system, by a hook-and-loop fastening system to the bottom section. Other attachments 20 systems are further described and depicted herein. FIG. 2 is an exploded view in cross-section of a portion of a first more specifically depicted embodiment of the present invention comprising a three section insole or orthotic. FIG. 3 shows a variation of a portion of the bottom section employable 25 in the first embodiment depicted in FIG. 2. FIG. 4 is an exploded view in cross-section of a portion of a second embodiment of the present invention comprising a three-section insole or orthotic similar to that shown in FIG. 3. FIG. 5 is an exploded view in cross-section of a portion of a third 30 embodiment of the present invention comprising a two-section insole or orthotic.

WO 00/70984 PCT/US00/14178 6 FIG. 6 is a cross-sectional view of a portion of a fourth embodiment of the top section of the present invention in which the hook member or portion of the hook-and-loop fastening system is secured directly to the foot-contacting layer, rather than through the intermediary of a supporting material such as 5 comprising high density polyethylene (HDPE). This is enabled by using a very thin hook member. FIG. 7 is a cross-sectional view of a variation of a portion of the fourth embodiment of the top section of the present invention depicted in FIG. 6 in which the loop member or portion of the hook-and-loop fastening system is 10 likewise secured directly to the foot-contacting layer, rather than through the intermediary of a supporting material such as comprising high density polyethylene (HDPE). This is enabled by using a very thin loop member. FIG. 8 shows the use of a portion of a finishing surface, such as of leather or athletic top cover material, secured to the top section for purposes 15 of presenting the orthotic in a fashionable manner. FIGS. 9-12 respectively illustrate a cross-sectional view of a portion of an top section of a fifth embodiment of the present invention, a perforated component part thereof in plan, and detail views of portions of differently configured perforations in one (e.g., the conformable non-compressible 20 component) of the components of the top section. FIGS. 13-15 depict top planar views of three variations actualized as slit areas and differently configured cut outs in one (e.g., the Conformable non compressible component) of the components of the top section. FIGS. 16-19 illustrate another aspect of the present invention in which 25 a cavity is formed in the shoe itself for reception of an orthotic for purposes, for example, of fashionably reducing the shoe size. FIG. 20 shows a further embodiment wherein an top or bottom section may be reduced in length to constitute only the heel and arch sections for use, for example, where height in the front of the shoe is limited. 30 FIG. 21 illustrates another embodiment including the use of cushioning pads secured by a hook-and-loop fastening system directly onto the footbed of WO 00/70984 PCT/US00/14178 7 a shoe, also for such purposes as to enable the shoe size to be reduced for reasons of fashion and to prevent inside slipping against the footbed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 5 Because the preferred fastening or attachment system employed in the present invention is a hook-and-loop system, as a preliminary matter, it will be useful to describe this hook-and-loop system at this point of exposition. Reference is made, for example, to U.S. Patent 5,953,797 and related literature, not only to the specific product as marketed by the proprietor 10 thereof, but also to all relevant literature relating to such hook-and-loop technology. It is to understood that, although specific reference is made to this patent, other systems similar thereto and to competing systems are equally employable in the present invention and, therefore, no conclusion should be inferred that a particular manufacturer's system is critical to the use and 15 working of the present invention. In general, hook-and-loop fasteners comprise two mating components: a hook member that has upstanding, hook-type fastener elements, and a loop member that has a surface that provides fibers or fiber loops with which the hook member elements become engaged. 20 As used herein, a "hook member" means a member having fastener elements whose hooks extend substantially in a given plane. When of molded form, the stems of these elements are significantly broader in the direction of their plane of extent than in the thickness direction at a right angle thereto. Also, while hook fasteners have performed successfully, other types of 25 fasteners, e.g., those having mushroom-like form, may be employed should their configurations provide equivalent success in the present invention. For purposes of the present invention, however, reference to the term "hook member" will be used as a matter of convenience; but its use is not to be construed in any limiting manner. Thus, the term "hook member" is intended 30 to include equivalent elements in all fastening systems, including those having a mushroom-like form.

WO 00/70984 PCT/US00/14178 8 Loop members for hook-and-loop fastening have been formed from knitted, woven and non-woven textiles. A common example of a non-woven textile is known by the term "spun bonded," which is made by spinning fine filaments of plastic resin, e.g., nylon and polypropylene, and distributing them 5 in superposed layers. The fibers are bonded to each other in random orientation, with a fine, low-lying, nappy component of looped and arched fibers exposed at the surface of the fabric. The use of the term "loop member" herein is intended to incorporate the forgoing description and those elements which cooperate to form a fastening system with the "hook member." 10 In the following discussion, it is to be understood that the hook and loop members may be exchanged, one for the other, as desired. Accordingly, with reference to FIG. 1, an adjustable foot comfort system 30 includes an top section 32, a middle section 34 and a bottom section 36 to form an assembly thereof. Any of the inventive embodiments 15 disclosed hereafter may be housed within system 30. Middle section 34 includes cushion pads 38 of various shapes, sizes, thicknesses and physical characteristics which are attached, for example, by a hook-and-loop fastening system to bottom section 36. This and other examples of attachments systems are further described, referenced by indicia and depicted in greater detail in the 20 ensuing description of the several inventive embodiments. Reference is now made to the assembly shown in FIG. 2. A three section insole or orthotic 40 includes a foot-contacting top section 42, a middle section 44 and a bottom section 46. Middle section 44 is composed of one or more cushioning pads 48. Although two pads are depicted, as many pads as 25 are needed are used. Cushion pads 48 are defined by various shapes, sizes, thicknesses and physical characteristics which, in this embodiment, are attached by hook and loop members 50 and 52 to bottom section 46. As illustrated, bottom section 46 has a top component which comprise a loop member but a hook member can also be used and, if so, a loop member would 30 be secured to pads 48. A component 54 of vinyl or any other suitable sheet material is bonded to the underside of this loop member for support thereof.

WO 00/70984 PCT/US00/14178 9 Top section 42 includes a foot-contacting component or portion 56 of a compressible resilient material, such as a material marketed under the trademark Poron® (trademark of the Rogers Corporation). A conformable non compressible component 58 of a material such as HDPE (high density 5 polyethylene) is bonded by a laminating adhesive 60. It is preferred that Poron® component 56 also be sewed around the perimeter of top section 42 approximately 0.25 inches (0.64 cm) from the edge to ensure a durable attachment. As stated above, middle section 44 of the present invention comprises 10 one or more cushion pads 48 generally spaced apart with hook members 50. The pads are made from a compressible soft material, generally formed from the same type Poron® material used in top foot-contacting component 56 of top section 42. Hook members, preferably formed as strips, are secured to the undersides of the pads. Preferably, loop members 50 and Poron® components 15 48 of this section are bonded together with a laminating adhesive. In addition, it is preferred that two to four lines of stitches be sewn across the width of the pads across the areas where the hook members of the hook-and-loop system is attached to ensure a durable attachment. Hook and loop members may be added to both sides of the pads to allow stacking of two or more pads 20 together. Pads 48 may be produced from any number of compressible, generally soft, resilient materials. However, Poron® has been found to work well in the preferred embodiment. The pads generally are die cut from flat sheet material or can be molded or extruded from suitable materials to provide angular slopes 25 and shapes to enhance foot-weight shaping of the top section as described, for example, in above-referenced patent 5,799,414. Bottom section component 54 of vinyl or other material component can have a textured or coated surface on its underside to provide a frictional engagement to prevent bunching up, slippage and the like, as well as to be 30 durable and protective of the more fragile component of loop member 52 bonded to it and, therefore, to mitigate any wear resulting from the often rough WO 00/70984 PCT/US00/14178 10 surface of the shoe foot bed upon which it rests. This bottom component of the bottom section may be glued, sewn, or otherwise attached to the footbed of the shoe. As shown in FIG. 3, bottom section 44 can optionally have a 5 component of compressible material 62, such as Poron® or other compressible material, laminated and bonded or otherwise adhered between the underside of loop member 52 and the top surface of bottom section component 46. The placement of this extra cushioning in the bottom section enables this embodiment or assembly to be well-suited for thicker cushioning, greater 10 impact absorption and/or greater support for uses involving high impact activities, such as differing sports, hard surfaces, long use, and particular foot conditions. In addition, it is preferable to sew the bottom section around its perimeter approximately 0.25 inches (0.64 cm) from the edge in order to ensure a durable attachment. 15 An optional grip-like material, such as a neoprene or latex, may be bonded to the underside of the bottom section to counteract the shear force of the motion of the foot which would otherwise cause the insole assembly to slide away from the footbed of the shoe as the user exerts step force on the insole. 20 Reference is now made to FIG 3(a) which differs from the embodiment of FIG. 3 solely in that no under supporting vinyl component is used. Here, a bottom section 46a consists of a component 62' of different elements, such as comprising a hook member alone, gripping material such as neoprene and latex, and a compressible material such as Poron® and/or Evazote®. As stated 25 above, these elements comprising bottom section 46a a plurality of different functions. The hook member alone functions as a conformable non compressible component for fastening to the top section to protect the orthotic assembly for dirt and wear, as well as a conformable non-compressible component. As a conformable non-compressible component, the hook member 30 provides a stiffening capability to prevent the assembly from bunching up and to facilitate the insertion of the assembly into a shoe. The gripping material, WO 00/70984 PCT/US00/14178 11 e.g., of latex and neoprene, can be adhered to the orthotic assembly solely for gripping purposes or as a conformable non-compressible component. When additional cushioning is desired, such compressible resilient material as Poron® and latex and neoprene gripping material can be added to any of the stiffening 5 elements. The placement of the cushioning in the bottom section enables this embodiment or assembly to be well-suited for thicker cushioning, greater impact absorption and/or greater support for uses involving high impact activities, such as differing sports, hard surfaces, long use, and particular foot conditions. 10 The embodiment depicted in FIG. 4 provides a response to a matter deriving from the arrangement of the attachment means illustrated in FIG. 2, viz., bottom section 44 of FIG. 2 has unused loop member areas, e.g., those designated by indicium 64, not covered by the cushioning pads. The unused bottom section areas, which are not covered by cushion pads, such as in the 15 toe or forefoot areas and adjoining the medial arch pad areas can be employed to attach the bottom section to the upper section. In the FIG. 4 embodiment, the hook and loop members are reordered amongst the three sections designated as top section 42a, middle section 44a and bottom section 46a. The top section includes Poron® and conformable non-compressible 20 components 56a and 58a secured together by an adhesive 60a. In this embodiment, however, a loop member 66 is secured to the underside of the conformable non-compressible components and a hook member 68 is secured to bottom layer 46a. Although both loop and hook members 66 and 68 are each shown as a single piece, either can be formed as a plurality of discrete 25 segments. This results in an attachment of the top section to the bottom section and, thus, to effect a sandwich assembly including the middle pad section. In operation, the foot care professional or end user first inserts insole or orthotic 40 into the user's shoes and then removes and scissor-cuts the 30 edges of the insole, if necessary, to fit it properly in the shoe.

WO 00/70984 PCT/US00/14178 12 Next the user or foot care professional selects pads 48 from among various standard pre-cut pad or, if that shape and/or size is not available, to cut a non-standard pad from pad sheet stock and places the pads on the top side of bottom section 46 to create the desired support areas, e.g., for the arch or 5 other foot areas needing support, and/or valleys defined by areas that are partially or completely surrounded by elevated areas. Pressure relief of sensitive areas can be achieved by attaching cushioning material adjacent or surrounding the sensitive area to transfer pressure away from the sensitive area. In such a manner, parts of the foot which need support, or are sensitive 10 or painful due to injury, overuse, anatomical problems, disease or other causes, are shielded from the full impact of the user's weight against the shoe and the step shock of the surface below. The user then inserts the insole with Poron® component 56 of top section 42 side up and steps into the shoe. The user's weight causes the top 15 section to mold around the pads to provide the optimal orthotic shape for the user's foot. In one embodiment, the top section utilizes a component of a conformable, non-compressible material, such as HDPE, which conforms to the underlying shapes of the pads below, flexibly supports and conforms to the unique contours of the foot. 20 As the foot moves and with the pressure of each step, each of these layers modulates and undulates differently due to differing density, thickness, softness, compression and resiliency characteristics. This special combination of material properties creates simultaneous and continuous actions of molding, massaging, cushioning and support, with the ameliorative effect of exercising 25 the foot, and providing pressure relief and flexible dynamic support. When the pads are moved, the top section will be re-molded to the existing underlying shapes of the pads below. The pads may also be optionally stacked one on top of the other or staggered (see FIG. 9 of U.S. Patent 5,799,414), to vary the amount of lift and pressure relief and to topographically 30 adapt the assembly to the contours of the foot, thereby enabling the individual needs of the wearer for his/her best comfort. These end results are achieved WO 00/70984 PCT/US00/14178 13 by attaching the hook member surface at the bottom of one pad to the loop member at the top of another pad below it to achieve a desired topography of the conforming sections above. For stacking purposes, small hook member circles or strips thereof can be used as attachments to stacked or nested pads, 5 and may take the form of double-sided hooks or loops, respectively to fasten facing loop member-loop member and hook member-hook member arrangements. Similar double-sided fastening members are positionable between facing like fastening members on the top and bottom sections. They can be attached within the loop member areas which will then form an 10 attachment to the loop member of the top section. As disclosed in FIG. 5, a two-section orthotic 70 comprises a top or first section 72 and a second pad section 74. Top section 72 includes a Poron® component 76 and an Conformable non-compressible component 78 bonded thereto by an adhesive 80. A hook member 82 is attached to the 15 bottom side of Conformable non-compressible component 78 by bonding, sewing, glueing, etc. Second section 74 includes one or more.pads 84 with a loop member 86 positioned on top of the pads, to enable the pads to be affixed to the hook member on the underside of top section 76. If desired, the two-section orthotic assembly may be converted into a three-section assembly 20 by adding a bottom section comprising a component of vinyl or similar material to top section 70 by an appropriate hook-and-loop system to enclose pads 74 and thus to reduce friction and wear, and to inhibit dirt from entering the shoe foot bed. Further embodiments of the present invention are shown in FIGS. 6 and 25 7, and may be used with either of the above described three-section orthotic or two-section orthotic designs. These assemblies relate to alternative top section configurations, viz., an top section 88 (FIG. 6) and an top section 88 (FIG. 7). Both include top components 92 and 94 of Poron® or like material with good resiliency and shock absorbing properties, which are respectively 30 attached to bottom components respectively configured as a hook member 96 and a loop member 98 by bonding, sewing, gluing, etc., without inclusion of WO 00/70984 PCT/US00/14178 14 an intervening component of non-compressible (HDPE) material between them and their respective Poron® components 92 and 94. In this variation, loop materials having a thickness of less than 0.03 inches (0.08 cm) are used any molding that occurs is instantaneous without residual memory. Nevertheless, 5 the benefits described above of cushioning and massaging remain, due to the conformation of the top cushioning section to the variable hills and valleys created by the underlying cushioned pads with its attendant ability to vary shape, resiliency, cushioning and size of these created hills and valleys. This design is useful for one whose primary foot treatment needs are for the unique 10 combination afforded by the present invention of cushioning, massaging, exercising, pressure relief and soft support capabilities where firmer support is not necessarily needed. In particular, it has been found that, when various shaped pads having a hook or loop members on their top surfaces which are then attached to the 15 bottom surface of the insole, a greatly improved feel of comfort is achieved. The general thickness of the hook member of about 0.024 inches (0.06 cm) is available in other thickness ranges and formed from polyethylene, nylon and other materials. The embodiments illustrated in FIGS. 6 and 7 provide thinner orthotic 20 assemblies for use in low profile footwear. Where fashion or other requirements so dictate, these thinner innersoles, which include an top section 100 having a Poron® component 102 of previously described construction, can further utilize a leather or other decorative component overlayed onto and suitable laminated or otherwise adhered to component 104. The lamination of 25 leather and like, to cover the Poron® component of the top section, is employed for various reasons, such as to create a certain aesthetic appearance or to add a non-slip capability to the insole. For aesthetic purposes, a leather or leather like component may be used in a dress shoe model. To prevent foot slippage, an athletic-type top cover may be added to the top layer for an athletic model 30 to be used for such athletic activities as running and jumping or for wicking away and absorbing perspiration.

WO 00/70984 PCT/US00/14178 15 Still another embodiment 116 of the present invention is disclosed in FIGS. 9-12. Assembly 116 includes a component 108, for example of Poron®, to which a perforated Conformable non-compressible component 110 is bonded by an adhesive 112. Component 110 includes a plurality of perforations or 5 openings 114 of different sizes. Such differently sized openings are illustrated in FIGS. 11 and 12 as openings 114a and 114b disposed in their respective components 110 Oa and 110 Ob. In prior art products employing perforated, such perforation has extended entirely to the foot-contacting top surface, rendering the device somewhat uncomfortable for individuals with sensitive feet. In the 10 present invention, however, the perforation is located only in the hook member and conformable non-compressible component. The foot thus contacts only the smooth Poron® component, consequently avoiding such discomfort. By adjusting the number of holes, the size of the holes, and the spacing therebetween, the support, in terms of rigidity, flexibility and compressibility, 15 can be adjusted to meet particular needs. This additional means of adjustability is effected, not by the ultimate user, but by the insole fabricator who can, by the perforation means, provide a range of insole models with grades of light to heavier duty use and variations of foot sense of "just right comfort" with a certain style. 20 Additionally, by restricting the perforation to the Conformable non compressible component, aeration is enabled due in part to the open cell structure of the Poron® material without the discomfort often caused by prior art units whose perforations extend to the foot-contacting surface. The perforations also assist in the wicking away of foot perspiration achieved in the 25 open cell construction of the Poron®, migrating downwards through the perforations. Thus, the bottom side of the Poron® component will be essentially drier than the foot-contacting top side thereof. The variations in component thickness vis-a-vis opening size, as shown in FIGS. 11 and 12, also provide different patterns of perspiration. For walking 30 and standing activity, the Conformable non-compressible component in thickness will range from about 0.01 inches to 0.14 inches (0.03 - 0.36 cm) WO 00/70984 PCT/US00/14178 16 and in open area from about 10% to 30%. For active sports, the Conformable non-compressible component in thickness will range from about 0.015 inches to 0.03 inches (0.04 - 0.08 cm) with a perforation range of about 25% to 50%. Representative hole sizes range from about %/ to 4 inch (0.33 - 0.64 5 cm). The Conformable non-compressible components in the top sections can also be adapted in other manner, as depicted in FIGS. 13-15, for use in other orthotic assemblies. FIG. 13 shows a component 116 with slits or slit areas 118 for increased softness and give. FIG. 14 shows a component 120 with 10 circular or otherwise rounded cutouts 122. FIG. 15 shows a component 124 with rectangular cutouts 126. The round or rectangular cutouts including slits can be used for all embodiments and serve to provide variations in Conformable non-compressible component flexibility and resultant molding to the plantar aspect of the feet. 15 Special styles, which can be machine or hand laminated, can combine the Conformable non-compressible components disclosed in FIGS. 13-15 with other components. e.g., those of Poron®, and with hook and loop members. For example, the loop members can utilize selective area cutouts to provide a softer or firmer resilience, support, shock protection or other characteristics. 20 This will enable the areas beneath the heel and metatarsal bones of the feet to benefit from elliptical and other special cut out or slit shapes. The art of pairing perforations and slits of varying shapes and degree, combined with the ratio of open to closed Conformable non-compressible areas and to the thickness range of the Conformable non-compressible material used, 25 provides a plethora of styles for all footwear needs. The manufacturer using the present invention can provide styles to suit lighter and heavier weight individuals, younger, more active and elderly individuals. People requiring special support after trauma, surgery, or diabetic care can have standard or custom styles. Also, all the above styles are further 30 enhanced by the adjustability feature of the hook and loop member feature of attachment of resilient pads to the insole.

WO 00/70984 PCT/US00/14178 17 A further, differently constructed assembled embodiment of the present invention is disclosed in FIGS. 16-19, comprising a specially constructed shoe 130. FIG. 16 depicts a shoe 130 which is provided with a space or cavity 132 in its footbed 134 for an orthotic 136, either by creating an indentation in the 5 footbed into which the orthotic fits, or by surrounding the orthotic with a berm or lip. The berm or lip holds the orthotic and foot in place for sideways support. Additionally, it enables the orthotic to be better adapted for use in dress or other shoes which, for reasons of style, do not or may not have a particularly high toe box. This embodiment is adaptable also for use with any 10 other type of shoe or foot covering, such as sandals, slippers and boots. A shoe thus constructed effects a slim-line appearance. In FIGS. 17 and 18, the cutaway shoe is viewed looking through its toe box in which insole 136 is not flat, as evidenced by protuberance 138. Due to the molding of the lamination with the cushion pads beneath the top Poron® 15 and Conformable non-compressible components and the loop/hook member, the foot plantar irregular aspect shapes around pad shapes. Here, the orthotic is shaped by the weight of the foot. The FIG. 19 embodiment depicts a shoe 130a, similar to that shown in FIG. 16, but without orthotic 138, to provide more toe box height. 20 The assembly of FIG. 20 illustrates an orthotic 140 which shows a further embodiment wherein an top and/or bottom section may be reduced in length to constitute only the heel and arch sections for use, for example, in small shoe interiors where height in the front of the shoe is limited. FIG. 21 illustrates another embodiment where pads are secured to the 25 shoe through an intermediary structure, e.g., a hook member or a loop member. A shoe 142, represented by its footbed 144, has cushioning pads 146 secured by a hook-and-loop fastening system directly to a top section 150, in any convenient manner, such as previously described. This embodiment may be used for such purposes as to enable the shoe size to be reduced for reasons 30 of fashion or to prevent slippage of the foot on the footbed. Pads 146 may be fashioned in any manner so as to provide the necessary support for the foot.

WO 00/70984 PCT/US00/14178 18 Although the invention has been described with respect to particular embodiments thereof, it should be realized that various changes and modifications may be made therein without departing from the spirit and scope of the invention.

Claims (29)

CLAIMS What is Claimed is:

1 . An adjustable orthotic for insertion in footwear having a footbed, comprising: an top section having a surface for contact with a user's foot; a pad section including means defining at least one pad positioned between said top section and the footbed to effect an assembly with said top section; cushioning positioned in at least one of said top section and said pad means for increased comfort of the user's foot; and means for releasably fastening said pad means to at least one of said top section.

2. An adjustable orthotic according to claim 1 in which said pad means is releasably secured to a fastening material which, in turn, is adhered to the footbed.

3. An adjustable orthotic according to claim 2 in which said pad means is releasably secured to said top section.

4. An adjustable orthotic according to claim 1 in which said footbed comprises means defining a cavity in said shoe, and said top and pad sections are positioned in said cavity means to effect a shoe having a slim-line appearance.

5. An adjustable orthotic according to claim 1 in which said top section includes a first component formed of a compressible resilient material and a second component formed of a deformable material secured to said first component, said second component having perforations extending only to said first component, said perforations performing aeration and comfort functions.

6. An adjustable orthotic according to claim 5 in which said perforations are numbered, sized and spaced from one another to adjust rigidity, flexibility and compressibility characteristics of the assembly.

7. An adjustable orthotic according to claim 1 in which said top section includes a first component formed of a compressible resilient material and a second component formed of a deformable material secured to said first component and having slits and cutouts.

8. An adjustable orthotic according to claim 1 in which said assembly is reduced in length less than the full length of the footbed to cover an equivalent part thereof.

9. An adjustable orthotic according to claim 1 in which said releasably fastening means comprises a hook-and-loop fastening system which includes a hook member and a loop member.

1 0. An adjustable orthotic according to claim 9 in which said pad means is provided with one of said hook and loop members and said top section is provided with the other of said hook and loop members for fastening of said pad means to said top portion.

1 1 . An adjustable orthotic according to claim 9 in which said hook member comprises the top section.

12. An adjustable orthotic according to claim 1 1 in which a compressible resilient component is secured to said hook member.

1 3. An adjustable orthotic according to claim 9 in which said hook member is secured to another conformable non-compressible component which comprises said top section.

14. An adjustable orthotic according to claim 1 3 in which a compressible resilient component is secured to said hook member.

1 5. An adjustable orthotic according to claim 9 in which said hook member comprises said bottom section.

1 6. An adjustable orthotic according to claim 1 5 in which a compressible resilient component is secured to said hook member.

1 7. An adjustable orthotic according to claim 1 5 in which said hook member is secured to another conformable non-compressible component which comprises said bottom section.

1 8. An adjustable orthotic according to claim 1 7 in which a compressible resilient component is secured to said hook member.

1 9. An adjustable orthotic according to claim 1 further including a bottom section positioned adjacent said pad means and disposed to be placed in contact with the footbed, and in which said releasably fastening means: is disposed also to releasably secure said bottom section to at least one of said pad means or said top section, and comprises a hook-and-loop fastening system comprising means defining at least one hook member and one loop member.

20. An adjustable orthotic according to claim 1 9 in which one of said hook and loop member means is secured to said pad means and the other of said hook and loop member means is secured to said bottom section.

21 . An adjustable orthotic according to claim 20 in which said hook and loop member means comprises a further one of said hook and loop members secured to said bottom section to releasably secure said bottom section to said other of said hook and loop means secured to said top section, for providing a sandwich assembly of said top, pad and bottom sections to enclose said pad means therein and thus to reduce friction and wear, and to inhibit dirt from entering said assembly.

22. An adjustable orthotic according to claim 1 in which said top section includes a first component formed of a compressible resilient material and a second component formed of a deformable material secured to said first component, and said releasably fastening means comprises a hook-and-loop fastening system comprising means defining at least one hook member and one loop member secured to said second component.

23. An adjustable orthotic according to claim 1 in which said top section includes a component formed of a compressible resilient material, and said releasably fastening means comprises a hook-and-loop fastening system comprising means defining at least one hook member and one loop member of which a one of said members is secured directly to said second component.

24. An adjustable orthotic according to claim 23 in which said hook and loop members are each selected from respective sheet stock having a thickness of less than 0.03 inches (0.08 cm) to provide a compressible component in said top portion.

25. An adjustable orthotic according to claim 24 in which said hook and loop members are each selected from respective sheet stock having a combined thickness of less than 0.06 inches (0.16 cm) to provide a compressible component in said top portion.

26. An adjustable orthotic according to claim 1 in which said pad means is formed from at least two different compressible resilient materials comprises to effect resiliency, firmness, density and moldability characteristics.

27. An adjustable orthotic according to claim 1 in which a layer of leather or an athletic top cover is positioned atop said top section to provide a fashionable appearance thereto.

28. An adjustable orthotic according to claim 1 in which said pad means comprises a plurality of pads placed one atop the other.

29. An adjustable orthotic according to claim 1 further including a bottom section fastened to said pad section for providing stiffening to said assembly.