Unitary orthotic insert and orthopedic insole

Abstract

The invention provides a unitary orthotic insert for a shoe that comprises a cupped heel portion having a concave upper bearing surface and a midfoot portion having a medial longitudinal arch support with a curvilinear upper bearing surface. The cupped heel portion extends above a most posterior cephalad portion of a calcaneus and is continuously coupled to the midfoot portion.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of the filing date of U.S. Provisional Patent Application Serial No. 60/288,319, filed May 2, 2001.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable.

REFERENCE TO A MICROFICHE APPENDIX

[0003] Not applicable.

TECHNICAL FIELD

[0004] The present invention relates generally to orthopedic devices, and more particularly to an orthotic insert and an orthopedic insole for a shoe to abate and prevent foot and related ailments.

BACKGROUND INFORMATION AND DISCUSSION OF RELATED ART

[0005] Custom orthotics for feet typically contain a relatively rigid, resilient base comprising a heel portion and an arch portion, contoured to fit the plantar or bottom surface of the foot. Orthotic devices may be inserted into footwear to reduce pronation of feet and to provide a therapeutic and corrective effect for foot ailments such as plantar fasciitis, cuboid syndrome and tissue trauma. Custom-made orthotics are generally created from hard plastics by using a mold or extensive measurements of an individual's foot, and modified as needed to provide prescribed corrections by a podiatrist. Unfortunately, custom orthotics typically fit into only one or a few pairs of shoes, and are too expensive for a wide variety of shoes that might be part of a person's wardrobe. Because of the expense, orthotic devices are often used only after serious degradations of a foot problem and severe increase in foot pain. As a foot condition improves, prescribed orthotics may require alterations with less correction or be discarded altogether. Although highly beneficial in correcting early onsets of podiatric conditions, custom orthotics for a child may be considered cost prohibitive, with frequent size alternations needed due to rapid growth of the feet and changing body physiology of the child.

[0006] In contrast to custom orthotics, inexpensive shoe inserts, which often comprise relatively thin layers of foam material, can be removed from shoes so that they may be washed, replaced, or used in other shoes. These inserts may provide some additional comfort, albeit with temporary relief and minimal physiological effect.

[0007] A conventional insole often consists of materials such as elastomeric foam that are covered with and adhesively bonded to leather, natural fabrics or other synthetic materials. The insole may be contoured to conform to the outline of the foot for placement atop the sole of a shoe. The insoles generally have a flat shape cut out of a sheet of material in the shape of the foot, with additional material in the area corresponding to the arch portion of the foot, and more material in the region surrounding the heel of the foot. Many conventional insoles use an impact cushioning layer or space filler made from synthetic polyurethane or polyolefin foam that has compression-deformation characteristics. Thus, when a wearer puts on a shoe having such an insole, the impact cushion layer of the insole is deformed with the weight of the wearer and conforms to the shape of the foot. Over time and with use, these deformations may become permanent, forfeiting the initial comfort and impact-absorbing qualities of the insole.

[0008] While commonly used, conventional insoles are often ineffective in preventing or alleviating pain associated with foot conditions such as plantar fasciitis. The top surface of their contoured foam material are designed to support and cradle the foot, but the foam is intended mainly to cushion the foot and not to provide the necessary support for proper biomechanical functions of the foot, particularly in the rearfoot and arch areas. Non-custom accommodative orthotics tend to be fabricated from a soft material that compresses under loads, so as to be tolerated by a wide variety and shapes of feet. While increasing foot comfort, they are unlikely to provide significant control of foot motion.

[0009] Some over-the-counter insoles provide limited support in the heel and rear foot areas, but do little to prevent excessive foot pronation. Pronation is an inwardly declining complex motion of the calcaneus or heel bone involving a partial collapse of the medial longitudinal arch of the foot. It occurs during ambulation, after an initial heel strike as the weight and movement of the body progresses forward onto the balls of the feet.

[0010] Some recent efforts have been made to correct foot problems with firmer and higher durometer materials added to the arch area and around the heel of the foot. These devices, most of them custom-molded for the foot, are designed to resist pronation and to distribute weight-bearing stresses to areas of the foot that can better tolerate such stresses, thus maximizing comfort and minimizing trauma to the sole of the foot. Such an orthotic device may provide a padded surface that is shaped to conform to the contours of a particular foot. A corrective orthotic may be designed to guide and restrict the motion of joints of the foot in order to improve gait efficiency and to reduce the stresses imposed on lower extremity anatomical structures during walking, running and standing.

[0011] An exemplary and painful foot condition for which orthotic devices are often used is plantar fasciitis. Extended flattening or stretching of the plantar fascia, and secondarily from microscopic tears and tissue irritation resulting from such flattening or stretching primarily cause plantar fasciitis. Its etiology may include a traumatic event or sustained trauma from ambulatory actions, or it may be due to very mild congenital foot malformations such as flat feet or high arches. Plantar fasciitis is an inflammation of the plantar fascia, which encapsulates muscles in the bottom of the foot and supports the arch of the foot by acting as a bowstring that connects the balls of the foot to the heel. The plantar fascia endures tensional forces that are approximately twice the body weight during walking at the moment when the heel of the trailing leg begins to lift off the ground. This moment of maximum tension is increased and intensified suddenly, particularly when there is lack of flexibility in the calf muscles. A percentage increase in body weight causes the same percentage increase in tension in the fascia. Due to the repetitive nature of walking, plantar fasciitis may be a repetitive stress disorder (RSD) not unlike carpal tunnel syndrome and tennis elbow. All three conditions benefit greatly from rest, ice, and periodic stretching, but may also be treated with non-steroidal anti-inflammation pills (NSAIDs), mechanical splints or straps, and as a last resort, surgery. Other biomechanical and other non-surgical methods for treating plantar fasciitis include injecting steroids, limiting heel strikes, and using heel cups, cushioned inserts, shock-absorbing athletic shoes, crepe-soled shoes, aspirin, a short leg walking cast, heat, ultrasonic treatment and custom orthotics. These treatments and their effectiveness remain unpredictable, sometimes requiring years for foot problems to abate.

[0012] Another treatment for plantar fasciitis, as well as other related foot conditions, is the taping of a foot so as to reduce subtalar joint motion and thereby restrict pronation. This may provide immediate pain relief and the reduction of irritation so that a person may better tolerate a brief period of time while customized orthotic devices are shaped and delivered. However, taping requires a considerable investment in time and requires the expertise of an orthopedist, therapist or trainer specifically skilled in the art. Additionally, taping provides relief and therapeutic efficacy for only a few days, as the tape invariably loosens. Taping may impact normal activities, such as bathing or the selection of footwear. Accordingly, it would be desirable to provide an effective orthopedic device without the need for taping or any other time-consuming task.

[0013] Conditions that may benefit from similar orthopedic devices to those used for plantar fasciitis are arthritis, heel bone damage, bone spurs, stress fractures, loss of natural tissue for cushioning under the heel (“fat pad atrophy”), tarsal tunnel syndrome (the foot's version of carpal tunnel syndrome), stress fractures, and tendonitis.

[0014] Many people may benefit from non-custom orthotic devices and not require expensive, individually fabricated orthotic devices. A desirable orthopedic device, which provides an alternative to some custom orthotics prescribed by medical specialists, cooperatively redistributes the normally greater weight-generated forces applied to the inner and more bony regions of the heel outwardly toward the outer and more fleshy regions of the heel. Additionally, it would provide support and stablility to affected areas of the foot and reduce subtalar joint motion without substantially affecting the fit of the shoe into which the devices is placed. The beneficial orthotic device would also have an ability to adjust for variations in gait, foot and shoe size without the need for a custom fit. In this respect, the adaptability of the devices may lower the expense and limit the need for medical assistance in fitting and prescribing the devices.

[0015] Furthermore, podiatrists and other medical practitioners would benefit from being able to provide effective noncustom orthotic inserts for their patients to use in their shoes while they wait the usual several weeks to receive custom-built orthotics. These specialists also would be able to provide a line of shoes with a built-in orthopedic insole that allows the patient to select from immediately available, off-the-shelf shoes offering therapeutic properties.

[0016] A desirable orthotic device is adaptable to many types and sizes of adult and children's shoes, for use as removable inserts or integrated into the insole or secured onto the sole of a shoe. To maximize its potential, only a single or small set of orthotic inserts is required to fit and be useful in a variety of work, sport, dress, and higher-heeled shoes that a person might wear.

[0017] While orthotic devices are generally considered to be therapeutic and restorative, this beneficial foot orthotic could help prevent foot problems caused by pronation, excessive motion of joints, and increased stresses on vulnerable areas of a foot. Additionally, it could become integrally incorporated into well-constructed shoes available to the general public.

[0018] Therefore, an object of this invention is to provide an orthotic insert for a shoe that overcomes the deficiencies and obstacles described above. Another object of this invention is to provide an orthopedic insole that may be built into the inner sole of a specialty shoe. Yet another object of this invention is to provide a method of manufacturing an orthotic insert or orthopedic insole for a shoe that provides preventative and curative properties for a variety of foot ailments.

BRIEF SUMMARY OF THE INVENTION

[0019] One aspect of the invention provides a unitary orthotic insert for a shoe comprising a cupped heel portion having a concave upper bearing surface, and a midfoot portion having a medial longitudinal arch support with a curvilinear upper bearing surface. The cupped heel portion extends above a most posterior cephalad portion of a calcaneus and is continuously coupled to the midfoot portion. The cupped heel portion and the midfoot portion cooperate to invert a subtalor joint of a foot to a position of inversion to lock a midtarsal joint during ambulation of a foot to reduce pronation and provide stabilization.

[0020] The unitary orthotic insert may include a lower bearing surface substantially conforming to an inside surface of a shoe. The unitary orthotic insert may include a texture embossed on the upper bearing surface. The unitary orthotic insert may include an absorptive layer disposed on at least a portion of the upper bearing surface. The unitary orthotic insert may include a forefoot portion having a substantially planar upper bearing surface. The forefoot portion may be continuously coupled to the midfoot portion and may extend from the midfoot portion to a region corresponding with a distal end of the foot. The unitary orthotic insert may include a reinforcing support member built into the unitary orthotic insert.

[0021] Another aspect of the invention is a specialty shoe including a unitary orthopedic insole, wherein the unitary orthopedic insole comprises a cupped heel portion having a concave upper bearing surface that extends above a most posterior cephalad portion of a calcaneus, a midfoot portion with a curvilinear upper bearing surface having a medial longitudinal arch support, and a forefoot portion having a substantially planar upper bearing surface. The unitary orthopedic insole may be integrated into the innersole of the specialty shoe.

[0022] Another aspect of the invention is a method of manufacturing a unitary orthotic insert or orthopedic insole for a shoe.

[0023] The aforementioned, and other features and advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0024] The following drawings are shown with left feet, left unitary inserts and insoles, and left shoes, and it should be understood that the right foot, inserts or shoes are substantially mirror images of the left side. It should also be understood that the use of the word shoe, in the context of this document, is intended to be synonymous with nearly all articles of footwear, including but not limited to boots, sandals, open-toe shoes and closed-toe shoes. Further characteristics and advantages of the invention will become apparent from the following detailed descriptions of particular but not exclusive embodiments, illustrated by way of non-limitative examples in the accompanying drawings, wherein:

[0025] FIG. 1 illustrates a side view and a top view of a human foot;

[0026] FIG. 2 illustrates a perspective view of a unitary orthotic insert, in accordance with the current invention;

[0027] FIG. 3 illustrates a top view of a unitary orthotic insert, in accordance with the current invention;

[0028] FIG. 4 illustrates a side view of a unitary orthotic insert, in accordance with the current invention;

[0029] FIG. 5 illustrates a perspective view of a two-thirds or partial length unitary orthotic insert extending from the heel to the balls of a foot, in accordance with the current invention;

[0030] FIG. 6 illustrates a top view of a two-thirds or partial length unitary orthotic insert extending from the heel to the balls of a foot, in accordance with the current invention;

[0031] FIG. 7 illustrates a cross-sectional view of a unitary orthotic insert with an absorptive layer on an upper surface, in accordance with the current invention;

[0032] FIG. 8 illustrates a perspective view of an inside of a unitary orthotic insert, in accordance with the current invention;

[0033] FIG. 9 illustrates a perspective view of a shoe with a full-length unitary orthopedic insole, in accordance with the current invention;

[0034] FIG. 10 illustrates a perspective view of a shoe having a unitary orthopedic insole of partial or two-thirds length, in accordance with the current invention;

[0035] FIG. 11 illustrates a side view of a boot with a full-length unitary orthopedic insole, in accordance with the current invention; and

[0036] FIG. 12 illustrates a flow diagram of a method of manufacturing a unitary orthotic insert or unitary orthopedic insole, in accordance with the current invention.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The unitary orthotic shoe insert and orthopedic insole of the present invention may benefit the fitness of the foot by reducing subtalar joint motion, limiting the stretching of the plantar fascia and stabilizing the heel of the foot while walking or running. The present invention may assist in inverting the subtalar joint to a position of inversion and simultaneously, plantar-flexing the first ray to lock the midtarsal joint during ambulation. Thus, the present invention reduces excessive pronation, a condition that often leads to foot injury. The therapeutic device is capable of relieving foot pain and biomechanically correcting or alleviating misaligned conditions in a foot. The insert may help prevent or provide relief from common foot problems such as heel spurs, arch pain, metatarsalgia (ball-of-foot pain), bunions, hammertoe, arthritis, neuromas, diabetes foot, plantar fasciitis, cuboid syndrome, tendonitis, stress fractures, shin splints, and other ailments of the foot, leg, and lower back. Diabetics, for example, may be more susceptible to foot disease such as ulcers or sores caused by infection and minor injuries that may be avoided or corrected by use of an effective insert. Although the invention may serve as an aid in the recovery from a foot ailment, the invention may also serve to prevent the onset or reoccurrence of various foot problems and athletic injuries.

[0038] The insert includes a high-rise heel cup portion that absorbs shock during heel strikes, while providing support to the proximal, distal and posterior of the calcaneus. The insert includes a midfoot portion that cooperates with the heel portion to stabilize and support the foot while preventing excessive pronation, and provides a therapeutic characteristic for a podiatric condition.

[0039] The deep heel cup portion of the present invention wraps around the heel of the foot and extends above a most posterior cephalad portion of a calcaneus, which is the area above the posterior portion of the heel bone proximal to the Achilles tendon. The midfoot portion of the insert is continuously coupled to the cupped heel portion. The midfoot portion includes a curvilinear upper bearing surface and a medial longitudinal arch support to aid in the support of the medial longitudinal arch of the foot. The upper surface of the midfoot portion may include a minor arch to support the lateral longitudinal arch near the outside of the foot, and a minor arch to support the transverse arch perpendicular to the medial longitudinal arch and the lateral longitudinal arch of the foot. The midfoot portion extends from the heel cup towards the heads or anterior ends of the metatarsal bones.

[0040] The single piece or unitary orthotic insert may also include a forefoot portion that is a generally flat or planar section continuously coupled to the midfoot portion, and contoured around the perimeter to correspond with the sides and distal end of a person's foot.

[0041] The cupped heel portion and the midfoot portion coordinate to help realign the rearfoot to avoid overpronation and reduce stress on the Achilles tendon. Excessive pronation renders the gait of a walker or runner less efficient, and is a source of lower extremity pathologies, including muscle tiredness and inflammation, foot and knee joint pain, tendonitis, ligament strain, and even neurological damage. With the full-length insert or insole, the forefoot portion may cushion and reduce stress on the balls and phalangeal area of the foot.

[0042] The present invention may be a removable insert for a shoe or may be an insole integrated into the innersole of a shoe. The actual dimensions of a unitary orthotic insole and insole, in accordance with the present invention, will vary depending on the size of the foot, the intended use of the shoe, and other factors. The net result of various embodiments of the present invention is a unitary orthotic insert that controls pronation, supports the foot, and produces a more stable platform on which and in which the foot ambulates.

[0043] FIG. 1 illustrates a side view and a top view of a human foot at 100. The toes of a human foot are formed by fourteen phalanges. Starting from the inside of the foot, each toe has distal phalanges 102, 104, 106, 108 and 110, middle phalanges 114, 116, 118 and 120, and proximal phalanges 122, 124, 126, 128 and 130. The first phalange or big toe lacks a middle phalange. The forefoot comprises the phalanges and the heads or anterior end of the metatarsals.

[0044] The midfoot includes five metatarsals 132, 134, 136, 138 and 140. First metatarsal 132, which is the shortest and thickest of the metatarsal bones, bears the most weight and plays the most important role in propulsion. First metatarsal 132 also provides attachment for several tendons. The more stable second metatarsal 134, third metatarsal 136, and fourth metatarsal 138 are well protected with only minor tendon attachments, and thus are not subjected to strong to pulling forces.

[0045] The midfoot also includes five of seven tarsal bones: navicular, cuboid, and cuneiform bones. The distal row contains three cuneiforms 142, 144 and 146 and a cuboid 148. The midfoot includes five tarsometatarsal joints, which are among multiple joints within the midfoot itself. Proximally, cuneiforms 142, 144 and 146 articulate with a navicular 150.

[0046] A talus 152 and a calcaneus 154 make up the rear or hind portion of the foot. Calcaneus 154 is the largest tarsal bone, and forms the heel. Talus 152 rests on top of it, and forms the pivot for the ankle.

[0047] Toe movements take place at joints that are capable of motion in two directions: plantar flexion and dorsiflexion, as well as abduction and adduction. The remainder of the foot has two movements, inversion and eversion, to which joints of the hindfoot and midfoot contribute. These complex movements are combined ordinarily with ankle movements and movements of the fibula and tibia.

[0048] Two primary functions of the foot are weight bearing and propulsion, both requiring stability and flexibility. The bones and intervening joints of the foot give flexibility while multiple bones form an arch to support the weight of the body.

[0049] The three arches of the foot are the medial longitudinal arch, lateral longitudinal arch, and transverse arch. The inner or medial longitudinal, the highest of the arches, comprises calcaneus 154, talus 152, navicular 150, cuneiforms 142, 144 and 146, and first three metatarsals 132, 134 and 136. The outer or lateral longitudinal arch, which is lower and flatter than the medial arch, comprises calcaneus 154, talus 152, cuboid 148, and fifth metatarsal 140. At times, fourth metatarsal 138 is included in the lateral arch. The generally hemispherical arc of the transverse arch comprises cuneiforms 142, 144 and 146, cuboid 148, and the bases of metatarsals 132, 134, 136, 138 and 140. The arches of the foot are maintained by the shapes of the bones and ligaments, and supported by muscles and tendons. The lateral arch, medial arch and transverse arch aid the foot in supporting and distributing the weight of a person. During a heel strike, for example, the force on the heel region may exceed three times the normal weight of the body.

[0050] When walking, body weight is first placed on the heel, then forward to the ball of the foot. As body weight is applied to the foot, the arches flatten out slightly to absorb the added pressure, spreading out the force and strain across the bones of the foot evenly. As the foot is lifted before taking another step, the arch springs back into its arched position.

[0051] The foot has two primary motions: supination and pronation. Supination is a combination of inward rotation at the ankle, adduction of the hindfoot, inversion of the forefoot, and medial arch elevation. Supination occurs when a heel comes off the ground. Subtalar joint supination involves three simultaneous planes of motion: adduction, inversion, and plantarflexion. As the foot supinates, lateral structures tighten. Continued supination and adduction force may rupture portions of lateral collateral ligaments or avulse these ligaments from their bony attachment sites on the distal fibula, resulting in an ankle sprain.

[0052] Subtalar joint pronation involves three simultaneous planes of motion: abduction of a forefoot, eversion of a hindfoot, and dorsiflexion. Because of the close contiguity of the joints involved, pronation is accompanied by eversion of the heel and internal rotation of the leg and hip. In simple terms, pronation is a motion that occurs when the foot lands on the outside edge and the inner arch collapses as far as it can to absorb shock.

[0053] Overpronation, the maximum range of motion between pronation and supination, is often cited as a cause of leg and foot problems among runners and a contributor to knee, hip and back pain. While pronation is a normal part of a person's gait, it is understood that excessive pronation may be the source of many lower extremity pathologies, including muscle tiredness and inflammation, foot and knee joint pain, tendonitis, ligament strain, and even neurological damage. Excessive pronation may render the gait less efficient since time and effort is wasted in pronating and supinating.

[0054] FIG. 2 illustrates a perspective view of a unitary orthotic insert, in accordance with the present invention at 200. A unitary orthotic insert 210 for a shoe may include a cupped heel portion 250 having a concave upper bearing surface 252 and an upwardly concave shape for engaging the heel of a foot, and an upwardly arched midfoot portion 230 having a medial longitudinal arch support with a curvilinear upper bearing surface 232 for engaging an arch portion of the foot.

[0055] Unitary orthotic insert 210 has midfoot portion 230 formed continuously with cupped heel portion 250 and forefoot portion 220. Midfoot portion 230 extends from cupped heel portion 250 to an opposite end corresponding to the anterior ends of the metatarsal bones, and from the inner or medial portion to the outer or lateral side of the foot.

[0056] Cupped heel portion 250 extends above a posterior portion of a calcaneus or heel bone and be continuously coupled to midfoot portion 230. Frontal extremities of cupped heel portion 250 may be positioned somewhat more forwardly on the medial side than on the lateral side. Cupped heel portion 250 deforms to conform to the shape of the heel and to provide medial, posterior and lateral support to the calcaneus. A posterior surface of cupped heel portion 250 may engage the heel above the heel bone close to the Achilles tendon. A medial surface and a lateral surface of cupped heel portion 250 may engage the heel bone below the ankle malleolus. The upper edge of cupped heel portion 250 may extend along an arcuate path in a generally descending manner from the Achilles tendon to midfoot portion 230. Upper bearing surface 252 of cupped heel portion 250 and upper bearing surface 232 of midfoot portion 230 may be continuously curvilinear, adapted to follow the contours of the plantar surface of the foot. A raised arch area in midfoot portion 230 provides support for the arches of the foot without collapsing under body weight. Upper bearing surface 252 of cupped heel portion 250 and upper bearing surface 232 of midfoot portion 230 are contoured to engage the plantar surface of a foot. Lower bearing surface 254 of cupped heel portion 250 and lower bearing surface 234 of midfoot portion 230 may be shaped to substantially conform to an inside surface of a shoe. Similarly, lower bearing surface 254 of cupped heel portion 250 and lower bearing surface 234 of midfoot portion 230 may be shaped to substantially conform to an inside surface of the sole of a shoe when built into or integrated with the innersole of a shoe.

[0057] Unitary orthotic insert 210 may act simultaneously on the calcaneus and subtalar of the foot. Cupped heel portion 250 may help to stabilize and control the motion of the foot, keeping the heel in its natural state and preventing it from excessively pronating or rolling inward during walking and running, thereby properly aligning the foot and providing better shock absorption and stress distribution.

[0058] Cupped heel portion 250 and midfoot portion 230 may cooperate to provide a therapeutic characteristic for a podiatric condition, which may include plantar fasciitis or another medical condition such as cuboid syndrome, a neuroma, hammertoe, a bunion, a pronation condition, tendonitis, or a foot ailment. Other podiatric conditions may include fat pad atrophy, heel spurs, metatarsalgia, diabetic foot, hyperkeratosis, Morton's neuroma, plantar pain from arthritis or peak shock load, sore heels, sore knees, shin splints, Sever's disease, calcaneal apophysitis, bursitis, achilles tendonitis, and elongated metatarsals.

[0059] Forefoot portion 220 extends from the forward end of midfoot portion 230 to the end of forefoot portion 220 corresponding to the metatarsal heads of a wearer's foot, and from a medial side to a lateral side of the foot. Forefoot portion 220 may have a relatively thin, substantially planar upper bearing surface. Forefoot portion 220 is continuously coupled to midfoot portion 230 and extends from the front of midfoot portion 230 to a region corresponding with the distal end of the foot while comfortably encompassing the bottoms of the toes. Forefoot portion 120 may reduce stress on the balls of the foot, and aid in distributing ambulatory stresses into the front portion of the foot.

[0060] Unitary orthotic insert 210 may be relatively thick in cupped heel portion 250 under and around the heel of the foot, and relatively thin and flexible near its upper and lateral edges. Unitary orthotic insert 210 may be relatively thick at the arched regions of midfoot portion 230, particularly in the region under the medial longitudinal arch of the foot, and relatively thin near the sides. Unitary orthotic insert 210 may be relatively thin and generally flat or planar in forefoot portion 220. The thickness and dimensions of various portions or unitary orthotic insert 210 may be selected to provide suitable support and stability while thin where possible to maintain low weight and to allow comfortable incursion of a foot into a shoe fitted with the orthotic insert or insole. The size of the insert may be selected to accommodate a number of shoe sizes for men or women. The dimensions of the insert may be selected to fit snugly into a children's shoe or one of a variety of adult specialty shoes. Unitary orthotic insert 210 may have a seamless surface, or may have ribs, contours or cavities to retain the structural stability while remaining lightweight.

[0061] Material comprising unitary orthotic insert 210 provides dynamic control as well as static balance. The lower layer of unitary orthotic insert 210 is made from a flexible material that can cushion and absorb the shock from heel strike on unitary orthotic insert 210. Unitary orthotic insert 210 may be formed from a substantially flexible, resiliently compressible cushioning material having an upper surface for engaging a plantar surface of a foot and a bottom surface for engaging a sole of a shoe. Unitary orthotic insert 210 may be comprised of a semi-rigid, injection moldable material. The durometer value of the flexible material may extend from a value less than 20 to a value in excess of 70. The flexible material may include a neoprene rubber, a silicone rubber, an elastomer, a polymeric material, a urethane, polyethylene teraphthalate, a viscoelastic polymer, a silicone gel, and combinations thereof.

[0062] The flexible and shock-absorbing polymeric material may be a lightweight and durable thermoplastic such as polyethylene or cross-linked ethylene vinyl acetate foam, cross-linked polyethylene, poly(ethylene-vinyl acetate), polyvinyl chloride, an acrylic, synthetic and natural latex rubbers, block polymer elastomers, thermoplastic elastomers, polystyrene, ethylenepropolene rubbers, silicone elastomers, polystyrene, polyurea or polyurethane, a polyurethane foam, an elastomeric foam, a non-foam elastomer, and combinations thereof.

[0063] The flexible material may comprise a gripping characteristic to allow the shoe insert to firmly engage a heel and midfoot. Unitary orthotic insert 210 may have a texture embossed on the upper bearing surface to improve the gripping characteristic.

[0064] The material used in the orthotic system of the present invention may be a compression-resistant, deformable material that provides shock attenuation and support for the foot without use of rigid materials such as posting frequently used in custom orthotic devices. The absence of such rigid materials allows the orthotic device to be used with a greater variety of shoes.

[0065] In alternative configurations, reinforcing support members may be built into the unitary orthotic insert. For example, a rim region of harder material may surround the base of the cupped heel portion. Reinforcing support members may be built into the cupped heel portion of the insert to provide additional support of the calcaneus, using, for example, semi-circular rods of high strength, resilient material extending around the back and sides of the heel, or upwards from the base of the cupped heel portion towards the ankle. Regions of soft, gel-like material may be incorporated into select regions of the insert, such as directly underneath the fat pad of the foot where heels may bruise and bone spurs may occur.

[0066] FIG. 3 illustrates a top view of a unitary orthotic insert, in accordance with the present invention at 300. In this embodiment, unitary orthotic insert 310 is configured with a midfoot portion 330 and a cupped heel portion 350 as a single unit, closed about the heel, extending from molleolar height, proximally, and extending in a contoured fashion distally to the plantar proximal contact surface. The single-piece insert maintains a subtalor joint in an inverted position, and locks the midtarsal joint during ambulation of the foot. Flexible cupped heel portion 350 may include relieved or cutout areas. Cupped heel portion 350 may be continuously joined to midfoot portion 330 to support the calcaneus and permit limited freedom of movement of the heel relative to the midfoot portion. Cupped heel portion 350, which includes a lower surface extending longitudinally and continuously under midfoot portion 330, is adapted to surround the heel and adjacent portions of a foot. A reinforcing support member may be built into cupped heel portion 350 to provide additional support of the sides, back and bottom portions of the heel, yet retain a cushioning, impact absorbing characteristic under particularly sensitive portions of the heel or foot.

[0067] FIG. 4 illustrates a cross-sectional view of a unitary orthotic insert, in accordance with the present invention at 400. Unitary orthotic insert 410 may comprise a forefoot portion 420, midfoot portion 430, and cupped heel portion 450 with upper bearing surfaces 422, 432 and 452, and lower bearing surfaces 424, 434 and 454, respectively. Lower bearing surfaces 424, 434 and 454 may be contoured to conform to an inside surface of a shoe and may have some texture, embossed patterns or other indenting or protruding features, although the surfaces generally are flat and continuous with respect to one another.

[0068] The rear part of cupped heel portion 450 opens toward midfoot portion 430, the heel cup being designed and dimensioned for adapting to the calcaneus. Cupped heel portion 450 may be continuously curved. An inner arcuate portion 456 and an outer arcuate portion 458 of cupped heel portion 450 above the calcaneus may be angled forwardly and upwardly and accorded a heel cup angle alpha (&agr;), the heel cup angle alpha being measured by an arc sweeping from the base of the upwardly concave cupped heel portion 450 to the top of inner arcuate portion 456. Alternatively, heel cup angle alpha may be measured by an angle corresponding to a line essentially parallel to lower bearing surface 454 of cupped heel portion 450 and a line essentially tangential to the top of outer arcuate portion 458, with a larger heel cup angle corresponding to a fuller heel cup. The heel cup angle of the currently preferred embodiment may be greater than 60 degrees, and preferably greater than 90 degrees.

[0069] A larger heel cup angle provides more support and stability for the calcaneus, cooperating with midfoot portion 430 to invert the subtalor joint of a foot to a position of inversion while walking or running.

[0070] The medial, posterior, and lateral portions of the heel cup may hold the vertical axis of the calcaneus essentially coaxial with the axis of the leg. The longitudinal axis of the heel cup and midfoot portions are oriented toward the fifth metatarsus of the foot so as to likewise orient the calcaneus. The midfoot portion has a curvilinear upper bearing surface to support the subtalar. The upper surface of the unitary orthotic insert is contoured to engage and cradle the plantar surface of a person's foot, and the bottom surface may be generally flat and planar, or shaped to conform to the inner surface of a shoe.

[0071] The heel cup portion permits limited freedom of movement of the heel relative to the midfoot portion when the insert is worn. The bottom region of the heel cup may be thicker to absorb the primary force of a heel strike. Reinforcement support members may optionally be embedded and secured into the heel cup to provide additional support for the calcaneus. Regions of softer, pliable material or detents may be formed in the bottom region of the heel cup to provide comfort and relief from heel spurs, for example, or atrophy of the fat pad.

[0072] FIG. 5 illustrates a perspective view of a two-thirds or partial length unitary orthotic insert extending from the heel to the balls of a foot, in accordance with the present invention at 500. Partial length unitary orthotic insert 510 includes a cupped heel portion 550 and a midfoot portion 530. Many of the therapeutic and preventative aspects of the full-length unitary orthotic insert are retained in the partial length embodiment. Being shorter, partial length unitary orthotic insert 510 may more readily be inserted into and removed from a user's shoe. Partial length unitary orthotic insert 510 comprises cupped heel portion 550 having a concave upper bearing surface, and a midfoot portion having a medial longitudinal arch support with a curvilinear upper bearing surface. The cupped heel portion extends above the back of the heel bone, and is continuously coupled to the midfoot portion. Midfoot portion 530 extends from cupped heel portion 550 to an opposite end corresponding to the heads or anterior ends of the metatarsal bones. Points near the medial end of midfoot portion 530 may be more forward than points near the lateral end of midfoot portion 530. The front edge of the partial length insert may be straight or curvilinear. The thickness of midfoot portion 530 may diminish to a smooth taper at the front edge. The lower bearing surface of cupped heel portion 550 and midfoot portion 530 are essentially flat or may be shaped to substantially conform to an inside surface of a shoe.

[0073] Cupped heel portion 550 and midfoot portion 530 are formed from a flexible material, such as neoprene rubber or other synthetic or naturally occurring material. A texture may be embossed on the upper or lower bearing surfaces. Ribs, contours or cavities may be formed in partial length unitary orthotic insert 510 to decrease weight while retaining stability. Reinforcing support members may be built into the unitary orthotic insert. Partial length unitary orthotic insert 510 may have an absorptive layer disposed on at least a portion of the upper bearing surface to provide shock absorbing and body moisture absorbing characteristics.

[0074] FIG. 6 illustrates a top view of a two-thirds or partial length unitary orthotic insert 610 extending from the heel to the balls of a foot, in accordance with the present invention at 600. Cupped heel portion 650 and midfoot portion 630 are continuously connected and adapted to form around and engage the heel of a foot and to support the arches. Cupped heel portion 650 comprises an upwardly concave upper bearing surface extending from beneath the heel to a point above the calcaneus, with a tapered, upper edge generally descending from the back of the heel near the Achilles tendon to midfoot portion 630.

[0075] The perimeter of midfoot portion 630 extends from cupped heel portion 650 along the outer contours of the medial longitudinal arch of the foot, traversing laterally underneath the metatarsal bones of the foot, and continuing along the outer contours of the lateral longitudinal arch of the foot to cupped heel portion 650.

[0076] The upper bearing surface of midfoot portion 630 is contoured to support the medial longitudinal arch, the lateral longitudinal arch, and the transverse arch of the foot. The lower surface of midfoot portion 630 and cupped heel portion 650 may be generally flat or shaped to conform to an inside surface of a shoe.

[0077] FIG. 7 illustrates a cross-sectional view of a unitary orthotic insert with an absorptive layer on the upper surface, in accordance with the present invention at 700. The unitary orthotic insert may include an absorptive layer 712 attached to the upper bearing surface of unitary orthotic insert 710. Absorptive layer 712 may comprise a compressible polymeric foam with a nominally thickness of one-sixteenth to one-eighth inch. Absorptive layer 712 may be treated with bacteria and fungus inhibitors to reduce foot odors. Absorptive layer 712 may include a cloth, polymeric, synthetic or natural leather top layer that is fixedly superposed onto the upper surface of absorptive layer 712 so that the compressible layer interposes the top layer and support layer. The top layer may wick moisture from the foot and allows unitary orthotic insert 710 to breathe. Alternatively, the top layer may be attached directly to the upper bearing surface of the insert without an intervening compressible layer.

[0078] FIG. 8 illustrates a perspective view of an inside of a unitary orthotic insert, in accordance with the current invention at 800. The surfaces of the insert may be smooth, or embellished with various patterns and textures. The upper or bottom surfaces of unitary orthotic insert 810 may have a texture characteristic formed on or in the bearing surfaces. Textured surfaces may aid in enhancing the gripping capability of the heel cup to effectively engage the heel and redistribute stresses. Texture surfaces may enhance contact with the foot or the sole of a shoe. Textured surfaces such as deep waffle or honeycomb patterns may enhance shock-absorbing qualities of the insert, or be cosmetic in nature.

[0079] FIG. 9 illustrates a perspective view of a shoe with a full-length unitary orthopedic insole, in accordance with the present invention at 900. The unitary orthopedic insole comprises all of the features and attributes of the unitary orthotic insert, though it may be built into or integrated into the innersole or insole of a shoe and may be non-removable. A unitary orthopedic insole 910 may include a lower bearing surface substantially conforming to an inside surface of a unitary orthopedic insole or sole of a shoe 960, wherein the unitary orthopedic insole comprises a cupped heel portion having a concave upper bearing surface that extends above a posterior portion of the heel bone, a midfoot portion with a curvilinear upper bearing surface having a medial longitudinal arch support, and a forefoot portion having a substantially flat or planar upper bearing surface. Although an athletic shoe is indicated, the unitary orthopedic insole may be built into nearly any article of footwear.

[0080] Shoe 960 is a specialty shoe such as an athletic shoe, a running shoe, a tennis shoe, a cross-trainer shoe, a children's shoe, a work shoe, a dress shoe, a casual shoe, an open-toe shoe, an orthopedic shoe, a sandal, a military shoe, an all-terrain shoe, a diabetic shoe, a maternity shoe, and a boot. In the case of an athletic shoe, soft-sided uppers may be formed of cloth, vinyl, or other flexible materials that yield outwardly under pressure, thereby providing little inward buttressing around the insole. In the case of a boot, the unitary orthopedic insert may be integrated into the insole of a work boot, a military boot, or a fashion boot.

[0081] The perimeter surface of unitary orthopedic insole 910 may be angled to match the inside of the upper where the upper joins the sole of shoe 960. Unitary orthopedic insole 910 may be integrated into a conventional insole that may consist of materials such as synthetic resin foam or elastomer covered with leather, woven fabrics, unwoven fabrics or other materials adhesively bonded thereto. Unitary orthopedic insole 910 may be directly attached to the sole of the shoe.

[0082] FIG. 10 illustrates a side view of a shoe having a unitary orthopedic insole of partial or two-thirds length, in accordance with the present invention at 1000. A unitary orthopedic insole of partial or two-thirds length conforms to the contours of the sole of a wearer's foot during use, having a perimeter that encompasses a foot from the heel to a region near the balls of the foot.

[0083] A shoe 1060 may comprise a unitary orthopedic insole 1010, wherein the unitary orthopedic insole comprises a cupped heel portion having a concave upper bearing surface that extends above a posterior portion of a heel bone and a midfoot portion with a curvilinear upper bearing surface having a medial longitudinal arch support, the cupped heel portion and the midfoot portion extending approximately two-thirds of the length of a foot. Unitary orthopedic insole 1010 may also include a forefoot portion having a substantially flat upper bearing surface. Unitary orthopedic insole 1010 may conform to an inside surface of shoe 1060. The unitary orthopedic insole may be integrated into the innersole of a specialty shoe, or attached directly to the sole of the shoe. The partial length or full length insole may be readily adapted to different shoe sizes and types such as work shoes, sport shoes, shoes with heels and so forth.

[0084] FIG. 11 illustrates a side view of a boot with a full-length unitary orthopedic insole, in accordance with the present invention at 1100. In this embodiment, a boot 1160 may be manufactured to include a unitary orthopedic insole 1110 that has a cupped heel portion, a midfoot portion, and a forefoot portion. The cup-like insole includes a body of elastic material having a bottom surface that has a shape to fit to a bottom member of a boot. As in other embodiments of the present invention, unitary orthopedic insole 1110 may have a flat portion corresponding to the forefoot, a midfoot portion extending from the medial side of the foot to the lateral side of the foot with a generally curvilinear upper bearing surface to support the arches, and a concave side wall portion formed continuously therewith, extending rearwards from the midfoot portion to an area corresponding to the heel of the foot and extending upwardly to engage the medial, posterior and lateral sides of the heel. A partial length unitary orthopedic insole may be built into the boot, comprising the midfoot portion and the cupped heel portion.

[0085] A partial length or full-length unitary orthopedic insole 1110 may be integrated into the innersole of the boot, or attached directly to the inside of the sole of the boot.

[0086] FIG. 12 illustrates a flow diagram of a method of manufacturing a unitary orthotic insert or a unitary orthopedic insole for a shoe, in accordance with the present invention at 1200. Although the method is directed at manufacturing a unitary orthotic insert, it is understood that the method equally applies to the manufacturing of a unitary orthopedic insole.

[0087] Insert or insole manufacturing method 1200 begins by providing a unitary orthotic insert mold as seen at block 1210. The mold may have a cavity for a cupped heel portion, a midfoot portion and optionally a forefoot portion. The cupped heel portion may have an upwardly concave upper bearing surface, and the midfoot portion may have a medial longitudinal arch support with a curvilinear upper bearing surface. The forefoot portion may have a substantially flat upper bearing surface with the general outline around the toe or distal end of a foot.

[0088] An injection-molding compound is injected into the unitary orthotic insert mold, as seen at block 1220. The injection-molding compound may include a neoprene rubber, a silicone rubber, an elastomer, a polymeric material, a urethane, polyethylene teraphthalate, a viscoelastic material, a silicone gel, and any combination thereof. The compound may be cured or treated to form the flexible material, as is known in the art. A pre-molded support member may be provided and inserted into the unitary orthotic insert mold prior to injecting the injection-molding compound.

[0089] The unitary orthotic insert is released from the unitary orthotic insert mold, as seen at block 1230. An absorbing material optionally may be attached to at least a portion of the upper bearing surface of the unitary orthotic insert, as sent at block 1240. The unitary orthotic insert optionally may be built into the innersole or onto the sole of a shoe, as seen at block 1250.

[0090] While the embodiments of the invention disclosed herein are presently considered to be preferred, various changes and modifications can be made without departing from the spirit and scope of the invention. The scope of the invention is indicated in the appended claims, and all changes that come within the meaning and range of equivalents are intended to be embraced therein.

Claims

1. A unitary orthotic insert for a shoe comprising:

a cupped heel portion having a concave upper bearing surface; and

a midfoot portion having a medial longitudinal arch support with a curvilinear upper bearing surface; wherein the cupped heel portion extends above a most posterior cephalad portion of a calcaneus and is continuously coupled to the midfoot portion.

2. The unitary orthotic insert of claim 1 wherein the cupped heel portion and the midfoot portion cooperate to invert a subtalor joint of a foot to a position of inversion to lock a midtarsal joint during ambulation of a foot to reduce pronation and provide stabilization.

3. The unitary orthotic insert of claim 1 wherein the concave upper bearing surface of the cupped heel portion comprises a heel cup angle of at least 90 degrees.

4. The unitary orthotic insert of claim 1 wherein the midfoot portion extends from the cupped heel portion to an opposite end corresponding to an anterior end of a metatarsal bone.

5. The unitary orthotic insert of claim 1 wherein the cupped heel portion and the midfoot portion cooperate to provide a therapeutic characteristic for a podiatric condition.

6. The unitary orthotic insert of claim 5 wherein the podiatric condition includes plantar fasciitis.

7. The unitary orthotic insert of claim 5 wherein the podiatric condition is selected from the group consisting of cuboid syndrome, a neuroma, hammertoe, a bunion, a pronation condition, tendonitis, and a foot ailment.

8. The unitary orthotic insert of claim 1 further comprising:

a lower bearing surface substantially conforming to an inside surface of a shoe.

9. The unitary orthotic insert of claim 1 wherein the cupped heel portion and the midfoot portion are formed from a flexible material.

10. The unitary orthotic insert of claim 9 wherein the flexible material is selected from the group consisting of a neoprene rubber, a silicone rubber, an elastomer, a polymeric material, a urethane, polyethylene teraphthalate, a viscoelastic material, a silicone gel, and combinations thereof.

11. The unitary orthotic insert of claim 9 wherein the flexible material comprises a gripping characteristic to provide proximal, posterior and lateral support when engaged with the heel bone.

12. The unitary orthotic insert of claim 1 further comprising:

a texture embossed on the upper bearing surface.

13. The unitary orthotic insert of claim 1 further comprising:

an absorptive layer disposed on at least a portion of the upper bearing surface.

14. The unitary orthotic insert of claim 1 further comprising:

a forefoot portion having a substantially planar upper bearing surface, wherein the forefoot portion is continuously coupled to the midfoot portion and extends from the midfoot portion to a region corresponding with a distal end of the foot.

15. The unitary orthotic insert of claim 1 further comprising:

a reinforcing support member built into the unitary orthotic insert.

16. A specialty shoe comprising a unitary orthopedic insole, wherein the unitary orthopedic insole comprises a cupped heel portion having a concave upper bearing surface that extends above a most posterior cephalad portion of a calcaneus, a midfoot portion with a curvilinear upper bearing surface having a medial longitudinal arch support, and a forefoot portion having a substantially planar upper bearing surface.

17. The specialty shoe of claim 16, wherein the specialty shoe is selected from the group consisting of an athletic shoe, a running shoe, a tennis shoe, a cross-trainer shoe, a children's shoe, a work shoe, a dress shoe, a casual shoe, an open-toe shoe, an orthopedic shoe, a sandal, a military shoe, an all-terrain shoe, a diabetic shoe, a maternity shoe, and a boot.

18. The specialty shoe of claim 16, wherein the unitary orthopedic insole is integrated into the innersole of the specialty shoe.

19. A method of manufacturing a unitary orthotic insert for a shoe comprising:

providing a unitary orthotic insert mold with a cavity for a cupped heel portion having an upper bearing surface, a midfoot portion having a medial longitudinal arch support with a curvilinear upper bearing surface;

injecting an injection-molding compound into the unitary orthotic insert mold; and

releasing the unitary orthotic insert from the unitary orthotic insert mold.

20. The method of claim 19 wherein the injection-molding compound is selected from the group consisting of a neoprene rubber, a silicone rubber, an elastomer, a polymeric material, a urethane, polyethylene teraphthalate, a viscoelastic material, a silicone gel, and combinations thereof.

21. The method of claim 19 further comprising:

providing a pre-molded support member; and

inserting the pre-molded support member into the unitary orthotic insert mold prior to injecting the injection-molding compound.

22. The method of claim 19 further comprising:

attaching an absorptive layer on at least a portion of the upper bearing surface.