US20170224050A1 - Customizable inserts for footwear - Google Patents

Customizable inserts for footwear Download PDF

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Publication number
US20170224050A1
US20170224050A1 US15/424,883 US201715424883A US2017224050A1 US 20170224050 A1 US20170224050 A1 US 20170224050A1 US 201715424883 A US201715424883 A US 201715424883A US 2017224050 A1 US2017224050 A1 US 2017224050A1
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US
United States
Prior art keywords
insert
structural member
intermediate layer
foot
region
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US15/424,883
Inventor
Kegan L. Schouwenburg
Stephen van Beek Faletti
Richard G. Ranky
John D'Agostino
Jacy Krystal Bulaon
Peter Yee
Jeff E. Smith
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Aetrex Worldwide Inc
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Aetrex Worldwide Inc
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Filing date
Publication date
Application filed by Aetrex Worldwide Inc filed Critical Aetrex Worldwide Inc
Priority to US15/424,883 priority Critical patent/US20170224050A1/en
Assigned to Sols Systems Inc. reassignment Sols Systems Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BULAON, JACY KRYSTAL, RANKY, RICHARD G., D'AGOSTINO, JOHN, FALETTI, STEPHEN VAN BEEK, YEE, PETER, SCHOUWENBURG, KEGAN L., SMITH, JEFF E.
Assigned to AETREX WORLDWIDE, INC. reassignment AETREX WORLDWIDE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: Sols Systems Inc.
Publication of US20170224050A1 publication Critical patent/US20170224050A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/141Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form having an anatomical or curved form
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/003Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined characterised by the material
    • A43B17/006Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined characterised by the material multilayered
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/02Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined wedge-like or resilient
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/14Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined made of sponge, rubber, or plastic materials
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/142Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the medial arch, i.e. under the navicular or cuneiform bones
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/1425Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the ball of the foot, i.e. the joint between the first metatarsal and first phalange
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/143Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the lateral arch, i.e. the cuboid bone
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/1435Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the joint between the fifth phalange and the fifth metatarsal bone
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/144Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the heel, i.e. the calcaneus bone
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/1445Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the midfoot, i.e. the second, third or fourth metatarsal
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1475Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the type of support
    • A43B7/1485Recesses or holes, traversing partially or completely the thickness of the pad
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/24Insertions or other supports preventing the foot canting to one side , preventing supination or pronation
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43DMACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
    • A43D1/00Foot or last measuring devices; Measuring devices for shoe parts
    • A43D1/02Foot-measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0111Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the feet or ankles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/14Special medical insertions for shoes for flat-feet, club-feet or the like
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43DMACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
    • A43D2200/00Machines or methods characterised by special features
    • A43D2200/60Computer aided manufacture of footwear, e.g. CAD or CAM
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2210/00Indexing scheme for image generation or computer graphics
    • G06T2210/41Medical

Definitions

  • This disclosure relates to the field of corrective orthotic devices, in particular, to customizable inserts for footwear.
  • An orthotic insert is a type of orthotic device that, when inserted into a shoe and applied to a foot, supports the foot by redistributing ground reaction forces while properly aligning foot joints during motion. Orthotic inserts are typically used to treat biomechanical deformities as well as inflammatory conditions (e.g., plantar fasciitis) in patients.
  • orthotic insert production is generally limited to the machining of hard materials (top down approaches). This also limits the range of characteristics (flexibility, shock absorption, weight, etc.) of the end product. Shapes of the orthotic inserts tend to be mixed and matched from a database, which may result in orthotic inserts that are unique to a particular lab or production facility but not to a particular patient.
  • FIG. 1 illustrates an example of an insert for footwear in accordance with an implementation of the disclosure.
  • FIG. 2A illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2B illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2C illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2D illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 3 illustrates yet another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 4 illustrates an example of an intermediate layer in accordance with an implementation of the present disclosure.
  • FIG. 5 illustrates an example of padding support in accordance with an implementation of the present disclosure.
  • FIG. 6A illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • FIG. 6B illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • FIG. 6C illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • Implementations of the present disclosure provide customizable inserts (a type of orthotic device) for footwear, such as a shoe, boot, workout or running sneaker, tennis shoe, etc.
  • the term “orthotic device”, as used herein, refers to any device worn by or externally applied to an individual that provides neuromuscular support to the individual, provides skeletal support to the individual, and/or provides prophylactic functionality.
  • the term “corrective device”, as used herein, refers to a type of orthotic device that provides a therapeutic benefit to an individual (e.g., who may be referred to herein as a “patient”) when worn by or externally applied by to the individual.
  • the customizable insert as disclosed herein can aid in the biomechanical alignment and support of the patient's body during various activities.
  • the customizable insert includes a structural member (e.g., elastic structural shell) that is three-dimensionally contoured to the individual foot anatomy of the patient.
  • the structural member includes an upper surface and a lower surface opposite the upper surface.
  • the upper surface is shaped to correspond with contours of the patient's foot to provide a balance of comfort, shock-absorption, custom-fitted arch support, heel stabilization, etc.
  • the lower surface is adapted to rest on a substantially planar surface, such as within the insole of a shoe.
  • An intermediate layer (e.g., a foam layer) is attached to the structural member in a mating relationship such that one or more of their surfaces align.
  • This layer is adapted to distribute a determined amount of foot pressure from the user foot with respect to the structural member.
  • the insert further includes a recessed cavity which may or may not define an opening (e.g., cut out) that passes from the first surface to the second surface of the structural member.
  • the recessed cavity is shaped to stabilize a region of the user foot placed within the opening with respect to the structural member.
  • the structural member of the insert can be constructed in several ways.
  • the structural member can be fabricated based on the geometry of the patient's foot.
  • This geometry e.g., three-dimensional model, or “3D model”
  • 3D model can be generated in response to a foot analysis conducted by a system using, for example, an image of the patient's foot as well as other inputs regarding the patient, such as relevant activities, anatomical measurements, personal preferences, etc.
  • U.S. Provisional Patent Application No. 62/292,154 which is incorporated by reference herein, discloses an example of a type of system to produce a geometry based on individual patient information, which can be used in conjunction with the present disclosure.
  • other types of systems may be used to generate the geometry for constructing the structural member of the insert.
  • the customizable insert is designed as an orthotic device having an elastic exoskeleton to rest under the planar surface of a patient's foot to help promote healthy biomechanical function.
  • the structural member or elastic structural shell provides the primary support and shock absorption effects of the insert.
  • the intermediate foam layer blends the comfort and dynamic loading effects of the shell regions against the soft tissue of the patient.
  • the intermediate foam layer can be pre-tensioned or compressed depending on the differences in surface topology and contribute to how foot pressure is redistributed during different activities, such as walking, working, running, climbing, etc.
  • the present disclosure relates to an orthotic device as described herein.
  • numerous details are set forth. It will be apparent, however, to one skilled in the art, that the present disclosure may be practiced without these specific details.
  • well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present disclosure.
  • numerous details are set forth. It will be apparent, however, to one of ordinary skill in the art having the benefit of this disclosure, that the present disclosure may be practiced without these specific details.
  • well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present disclosure.
  • FIG. 1 illustrates an example of an insert 100 for footwear in accordance with an implementation of the disclosure.
  • the insert 100 comprises a support or structural member 101 that has a particular shape to fit within a base of footwear, such as a shoe.
  • the structural member 101 is biomechanically designed to support regions of the patient's foot and absorb different kinds of impact shock.
  • the structural member 101 of the insert 100 extends along a longitudinal direction between opposite regions, e.g., a forefoot or front region 103 and a rear or heel region 105 .
  • the forefoot region 103 of the insert 100 may continue as a flat layer underneath the forefoot of the patient, or may terminate medial-laterally at the anterior arch just prior to the metatarsal heads of a foot (i.e., long bones of the foot).
  • the structural member 101 includes an upper surface 102 that faces towards a patient's foot, and a lower surface 104 that is opposite the upper surface 102 facing away from the patient's foot. As such, the lower surface 104 faces and engages an inner portion of the patient's footwear during use of the insert 100 by the patient.
  • the structural member 101 may be made of a various types of material.
  • these materials may be comprised of, but not limited to, various kinds of fiber nylons, gypsum or rubber-like materials, or other types of materials.
  • the material between the upper surface 102 and lower surface 104 of the insert 100 can be solid or nearly hollow to vary or customize the elastic profile of the structural member 101 in a linear or nonlinear manner.
  • the interior and exterior heel contours of the structural member 101 may work in balance to expand when loaded enough to maintain a close fit with the shoe (by applying appropriate shear friction) as well as the patient (by applying comfortable and low level compression of the heel).
  • the intermediate foam layer (not shown) that can be adhered to the structural member 101 may be compressed or expanded by this heel shape in a manner custom to the heel anatomy of the patient. This may help increase or decrease the insert's control-contact at the heel region 105 .
  • the insert 100 may be constructed using various techniques based on a foot analysis of the patient. By analyzing the patient's foot, a 3D model for constructing the insert may be individualized for each patient's particular needs. In some implementations, this 3D model may be fabricated using a type of additive or subtractive fabrication system. Additive or subtractive systems, as referred to herein, refers to a machine that can build or fabricate a kind of device or real-world 3D objects by adding or subtracting successive layers of a material (e.g., fiber nylon, powdered nylon, etc.) under the control of a computing device. These objects can be of almost any shape or geometry, and are produced from a 3D model or other electronic data source. Alternatively, the inserts can be constructed based on the 3D model using traditional manufacturing techniques know in the art.
  • Additive or subtractive systems refers to a machine that can build or fabricate a kind of device or real-world 3D objects by adding or subtracting successive layers of a material (e.g., fiber
  • Contours 108 of the insert 100 are shaped in view of the individual contours of the patient's foot.
  • the 3D model for constructing the insert 100 as discussed above may be based on contour data and other information with regards to a patient's foot.
  • the contours 108 are formed in a manner to take on the particular shape based on this 3D model.
  • the contours 108 are customized in view of the 3D model in order to provide a level of therapeutic and/or performance benefit for the patient.
  • the contour 108 of the insert 100 may be customized to alleviate a particular foot ailment associated with the patient or to enhance a patient's stride performance by enhancing the amount of energy return and/or absorption provided by the insert 100 .
  • the heel region 105 of the insert 100 provides medial-lateral stability during heel strike of the patient's gait while also absorbing some impact loads and offloading the plantar fascia (e.g., a flat band of tissue that connects the heel bone to the toes of a foot).
  • the insert 100 consists of a roughly semi-circular contour around the sides and posterior of the heel region 105 , with a slope contoured to hold the heel.
  • An arch region 107 of the insert 100 comprises a structure for the medial and lateral aspects of the arch to support during static and dynamic conditions. This is intended to prevent the arch of the patient foot from collapsing when standing or walking.
  • the medial and lateral aspects of the arch region are designed for independent mechanical function, but may not be connected by a material interface with the foot or with a nonfunctional aesthetic design of the insert 100 . Rather, they are connected through the heel via matching contours and support the foot as gait progresses from heel strike to mid-stance.
  • the heel region 105 and the arch region 107 of the insert 100 promote a loading profile concentrated at the midline of the foot.
  • the medial aspect is designed such that the peak of the profile curve rests underneath the navicular bone found in the foot and prevents pronation.
  • the lateral aspect has a peak and curvature designed to hold the foot and prevent over supination during gait.
  • FIG. 2A-2C illustrates another example of an insert 200 for footwear in accordance with an implementation of the present disclosure.
  • the insert 200 (which may be compared to insert 100 of FIG. 1 ) includes an upper surface 202 and a lower surface 204 opposite the upper surface 202 .
  • the upper surface 202 of the insert 200 is shaped to correspond with contours of a user foot and the lower surface 204 is shaped to rest on an inner portion of footwear, such as a shoe.
  • the insert 200 is shown in a particular arrangement, it should be appreciated that the insert 200 may be arranged in different configurations and/or include different components than what is shown.
  • the insert 200 includes as recessed cavity 210 .
  • insert 200 may include multiple recessed cavities based on the needs of the patient.
  • the recessed cavity 210 defines an opening 215 (e.g., cut out) that passes through the insert 200 .
  • the opening 215 may pass from the upper surface 202 of the insert to the lower surface 204 .
  • the opening 215 in the insert 200 may be formed in several ways. In some implementations, the opening may be formed during construction of the insert 200 . In alternative implementations, the opening may be created after an initial body of the insert 200 is constructed. For example, the opening 215 may be cut out of the body of the insert 200 . Still further, other techniques know in the art may be used to create the opening 215 of the recessed cavity 210 .
  • the recessed cavity 210 is arranged near the heel region 205 of the insert 200 .
  • the recessed cavity 210 is surrounded on all sides by material of the insert 200 .
  • the opening 215 comprises a teardrop shaped cutout underneath the heel. This shape is designed to offload the plantar fascia insertion at the calcaneus by supporting and slightly raising the foot regions around it.
  • the exterior shape of the cavity 210 roughly follows the interior with a wall thickness based off of patient kinetics, but has an edge contoured on the lower surface 204 of the insert 200 . An advantage of this edge is that it stabilizes the heel by widening its base to encourage the heel of the patient to become more aligned with the sagittal plane during the early phases of gait (e.g., a manner of walking).
  • the opening 215 is shown having a particular shape in a certain position on the insert 200 , other shapes and configurations are possible.
  • the recessed cavity 220 is arranged substantially near an arch region 225 of the insert 200 .
  • the recessed cavity 220 here is similarly surrounded on all sides by material of the insert 200 .
  • a recessed cavity 230 is arranged along a center region 235 of the insert 200 .
  • the recessed cavity 230 includes an opening in the forward region 203 of the material used to construct the insert 200 .
  • the recessed cavity 230 creates a center channel defining a first panel 207 and a second panel 209 .
  • An interior edge of the center channel created by the recessed cavity 230 encourages offloading of the 2 nd- 3 rd metatarsal bones of a patient's foot.
  • FIG. 3 illustrates yet another example of an insert 300 for footwear in accordance with an implementation of the present disclosure.
  • the insert 300 (which may be compared to insert 100 of FIG. 1 and any one of the configurations of insert 200 of FIGS. 2A-2C respectively) includes an upper surface 302 and a lower surface 304 opposite the upper surface 302 .
  • the upper surface 302 of the insert 300 is shaped to correspond with contours of a user foot and the lower surface 304 is shaped to rest on an inner portion of footwear.
  • the insert 300 is shown in a particular arrangement, it should be appreciated that the insert 300 may be arranged in different configurations and/or include different components than what is shown.
  • the insert 300 includes a recessed cavity 330 (which may be compared to recessed cavity 230 of FIG. 2C ) that defines an opening from upper surface 302 of the insert to a lower surface 304 .
  • the recessed cavity 330 is positioned along a center portion of the insert 300 .
  • the recessed cavity 330 creates a straight narrow channel defining a first panel 310 and a second panel 320 .
  • the first panel 310 and the second panel 320 of the insert 300 are still joined together at a heel region 315 of the insert 300 .
  • each panel on the insert 300 may have a determined length and width.
  • the first panel 310 may have a length of L 1 and a width of W 1 while the second panel 320 may have a length of L 2 and a width of W 2 .
  • the respective lengths and widths of the first panel 310 and second panel 320 may correspond to each other.
  • the lengths and widths may differ.
  • the length L 1 of the first panel 310 may be a shorter or longer than the length L 2 of the second panel 320 and vice-versa.
  • the width W 1 of the first panel 310 may be a wider or narrower than the width W 2 of the second panel 320 , or any combination thereof.
  • an underside topology of the lower surface 304 of insert 300 may be modified to contain certain markings (e.g., 2D or 3D markings), for example, a textured surface of shapes, such as shapes 340 , and grooves, such as grooves 350 , which are slightly embossed or debossed (e.g., on the order of ⁇ 0-3 mm) onto the lower surface 304 in a particular pattern.
  • markings e.g., 2D or 3D markings
  • a textured surface of shapes such as shapes 340
  • grooves such as grooves 350
  • slightly embossed or debossed e.g., on the order of ⁇ 0-3 mm
  • they may provide a certain biomechanical effect or aesthetic impact based on user-specific inputs, such as activity levels, anatomical measurements, or personal preferences.
  • the trajectory (e.g., path) of the patterns along the lower surface 304 of the insert 300 may be along a spline in discrete segments or continuous.
  • the cross-section and configuration of the pattern can impact the gait dynamics of the patient such as: location of flexing of the device, providing mechanical limits on deflection, realignment of center-of-force (COF), improving symmetry of left-right feet pressure distribution, offloading zones with high pressure, absorbing energy during heel strike, assisting with tibial (e.g., pertaining to the largest long bone of the lower leg) progression through mid-stance, or any combination thereof.
  • COF center-of-force
  • an embossed pattern may be added (e.g., ribs) to decrease bending in the medial arch region.
  • a debossed pattern may be added (e.g., grooves) to increase bending along axes perpendicular to the anterior arch.
  • the patterns on the lower surface 304 may also provide feedback regarding the patient's particular use of the insert 300 .
  • the patterns may be designed such that over time the patient's unique wear pattern will provide insight into anatomical and/or physiological parameters of the patient's anatomy.
  • such parameters may include indicators of the unique manner in which the patient loads their feet during gait dynamics, how they apply normal and shear stresses on the underside of the insert 300 and any wear away. These indicators may indicate patterns of walking, such as supination-pronation of the arch or inversion-eversion of the heel.
  • the information regarding the unique wear patterns of the patient may be provided to a system as discussed above. This may be done to adjust the 3D model used to fashion the insert for constructing subsequent inserts.
  • the insert 300 may include a computer-readable identifier 360 , such as a QR (Quick Response) code, that can identify a particular user of the insert.
  • QR Quick Response
  • the patient may take a picture of the lower surface 304 to capture an image of the computer-readable identifier 360 and the wear on the patterns at the bottom of the insert 300 . This picture can be then uploaded to the system for analysis. Thereupon, an updated 3D model can be generated by the system in response to the patient's unique use of the insert 300 .
  • the patterns on the lower surface 304 may serve as an identifier of the particular user. For example, the orientations, sizes, and scale of various shapes that form the pattern may structurally encode an identifier that is associated with the user.
  • FIG. 4 illustrates an example of an intermediate layer 400 according to an implementation of the disclosure, which can be used in conjunction with any one of the inserts of the present disclosure.
  • the intermediate layer 400 may be comprised of a certain type of moldable material having a top portion 402 and a bottom portion 404 opposite the top portion 402 .
  • the intermediate layer 400 may be comprised of a type of foam material of a determined thickness, such as a type of environmentally friendly foam (EFF), or other types of similar materials that provide a sufficient amount shock absorption characteristics when compressed, as well as a sufficient amount of spring back or rebound characteristics after compression.
  • EPF environmentally friendly foam
  • the material of the intermediate layer 400 is formed to provide a 3D contour approximate to the design variety for a particular shoe size and type.
  • a pre-forming process eases adhesion of the intermediate layer 400 to the structural member of the insert by reducing tension in the material from a flat sheet to a 3D contour.
  • the shape of this layer will be modified or otherwise deformed by adhesion to the structural member of the insert. This adhesion may be accomplished using certain techniques, such as compression molding. Due to preforming and adhesion, the intermediate layer 400 becomes deformed at the heel and arch region to match the topology of the insert.
  • a thin layer or top-cover of material may be affixed to the intermediate layer 400 before the pre-forming process.
  • This top-cover may have properties specific to the wearer's needs such as antimicrobial, textured, moisture wicking, or heat wicking.
  • the top portion 402 of the intermediate layer 400 faces upward towards the foot of the patient while the bottom portion 404 faces towards the insert.
  • the inserts as described herein such as insert 100 of FIG. 1 , any one of the configurations of insert 200 of FIGS. 2A-2C respectively, or insert 300 of FIG. 3 , can receive the intermediate layer 400 in a mating relationship with respect to an upper surface of the insert.
  • the intermediate layer 400 may be adhered to selected regions of the structural member of the insert. This intermediate layer 400 may be adhered to the using, for example, an epoxy or alternative techniques such as heat treatment or ultrasonic welding.
  • a cutting process may be used to remove excess material so that intermediate layer 400 and insert can fit inside a shoe.
  • FIG. 5 illustrates an example 500 of padding support 501 according to an implementation of the disclosure.
  • the padding support 501 may be comprised of a certain type of material of a determined thickness having a top portion 502 and a bottom portion 504 .
  • the padding support 501 may be comprised of an ethylene-vinyl acetate (EVA) foam or similar material which is soft enough to allow compression of the toes and metatarsal heads during gait but avoid creating new high pressure zones.
  • EVA ethylene-vinyl acetate
  • the padding support 501 may be used as a secondary material to support those regions of the foot during the latter phases of gait.
  • the padding support 501 may comprises a toe-bed reinforcement region underneath the metatarsal heads and forefoot region of the patient's foot.
  • the padding support 501 may include different shapes made up of one or more additional padding components.
  • a top portion 502 of the padding support 501 may be attached or placed under the intermediate layer 400 . While a bottom portion 504 of the padding support 501 faces away from the patient and towards a resting position within the patient's footwear.
  • FIGS. 6A-6C are example side views of an insert 600 in accordance with implementations of the present disclosure.
  • the insert (which can be compared to insert 100 of FIG. 1 , any one of the configurations of insert 200 of FIGS. 2A-2C respectively, or insert 300 of FIG. 3 ) comprises a structural member 601 that includes an upper surface 602 and a lower surface 604 opposite the upper surface 602 .
  • the upper surface 602 of the structural member 601 is shaped to correspond with contours of a user foot and the lower surface 604 is shaped to rest on an inner portion of footwear, such as a shoe.
  • the structural member 601 is shown in a particular arrangement, it should be appreciated that the structural member 601 may be arranged in different configurations and/or include different components than what is shown.
  • the structural member 601 may in itself act as an insert, such as the insert 600 , or may combine with other components to form an insert.
  • steps for attaching the structural member 601 to an intermediate layer 603 (which may be compared to intermediate layer 400 of FIG. 4 ) to form an insert 610 are shown.
  • the intermediate layer 603 is comprised of a type of moldable material of a determined thickness having a top portion 606 and a bottom portion 608 opposite the top portion 606 .
  • the intermediate layer 603 can be placed within a recess of the structural member 601 such that the moldable material of the intermediate layer 603 takes on a shape corresponding to the structural member 601 .
  • a side view of the structural member 601 is shown in a first position.
  • the structural member 601 may be positioned so that the lower surface 604 of the structural member 601 is oriented downwards and facing away from a patient's foot.
  • a side view of the structural member 601 is shown in a second position with respect to the intermediate layer 603 .
  • the structural member 601 is positioned so that the upper surface 602 is oriented towards the bottom portion 608 of the intermediate layer 603 .
  • the structural member 601 and/or the intermediate layer 603 are moved in a certain direction with respect to the second portion shown in FIG. 6B .
  • the structural member 601 and the intermediate layer 603 may be moved in a manner in which the two components are brought together.
  • FIG. 6C a side view of the structural member 601 is shown in a third position with respect to the intermediate layer 603 .
  • the intermediate layer 603 is moved toward an applied onto the structural member 601 , for example, using a type of adhesion.
  • the intermediate layer 603 is placed within a recess of the upper surface 602 of the structural member 601 .
  • This configuration causes portions of the intermediate layer 603 as indicated by arrows 607 to match to the topology, for example, at the heel and arch region of the structural member 601 .
  • a padding support 609 may further be included.
  • the padding support 609 may be similar to the padding support 501 , and may be applied to the intermediate layer 603 . At least a portion of the padding support 609 may contact the structural member 601 .
  • Adhesives may be used, for example, to adhere the padding support 501 to the intermediate layer 603 and, optionally, the structural member 601 .
  • the above-described customizable inserts provides a level of comfort and therapeutic/performance benefits to a patient while performing different activities. This is accomplished, by interfacing at the patient's foot, a pairing of an elastic structural shell (e.g., structural member 601 ) with a soft interface layer (e.g., intermediate layer 603 ).
  • an elastic structural shell e.g., structural member 601
  • a soft interface layer e.g., intermediate layer 603
  • the health benefits provided by the inserts can include improved posture, decreased foot fatigue, and decrease in common aches and pains associated with the patient's feet.
  • X includes A or B is intended to mean any of the natural inclusive permutations. That is, if X includes A; X includes B; or X includes both A and B, then “X includes A or B” is satisfied under any of the foregoing instances.
  • the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form.
  • Reference throughout this specification to “an implementation” or “one implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation.

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Abstract

An insert to be used with footwear is provided. In one implementation, the insert includes a structural member that has a first surface and a second surface opposite the first surface. The first surface is shaped to correspond with contours of a user foot. The second surface is adapted to rest on substantially planar surface. The insert includes a recessed cavity defining an opening from the first surface to the second surface of the structural member. The recessed cavity is shaped to stabilize a region of the user foot placed within the opening. An intermediate layer is attached to the structural member in a mating relationship with respect to the first surface. This foam layer is adapted to distribute a determined amount of foot pressure from the user foot with respect to the structural member.

Description

    CROSS-REFERENCE TO RELATED APPLICATION
  • This application claims the benefit of priority of U.S. Provisional Patent Application No. 62/292,154, filed on Feb. 5, 2016, and of U.S. Provisional Patent Application No. 62/292,144, filed on Feb. 5, 2016, the disclosures of which are hereby incorporated by reference herein in their entireties.
  • TECHNICAL FIELD
  • This disclosure relates to the field of corrective orthotic devices, in particular, to customizable inserts for footwear.
  • BACKGROUND
  • An orthotic insert is a type of orthotic device that, when inserted into a shoe and applied to a foot, supports the foot by redistributing ground reaction forces while properly aligning foot joints during motion. Orthotic inserts are typically used to treat biomechanical deformities as well as inflammatory conditions (e.g., plantar fasciitis) in patients.
  • Various techniques have been employed to produce orthotic inserts. Many of these techniques, however, are generally slow in acquiring orthotic data, expensive, and are limited in the range of characteristics that they can provide to the resulting orthotic device. Moreover, the resulting orthotic device is implemented as a one-size-fits-all solution that may be far from optimal for some patients.
  • Furthermore, current techniques for orthotic insert production are generally limited to the machining of hard materials (top down approaches). This also limits the range of characteristics (flexibility, shock absorption, weight, etc.) of the end product. Shapes of the orthotic inserts tend to be mixed and matched from a database, which may result in orthotic inserts that are unique to a particular lab or production facility but not to a particular patient.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The present disclosure is illustrated by way of example, and not by way of limitation, and will become apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
  • FIG. 1 illustrates an example of an insert for footwear in accordance with an implementation of the disclosure.
  • FIG. 2A illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2B illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2C illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 2D illustrates another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 3 illustrates yet another example of an insert for footwear in accordance with an implementation of the present disclosure.
  • FIG. 4 illustrates an example of an intermediate layer in accordance with an implementation of the present disclosure.
  • FIG. 5 illustrates an example of padding support in accordance with an implementation of the present disclosure.
  • FIG. 6A illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • FIG. 6B illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • FIG. 6C illustrates an example side view of an insert in accordance with implementations of the present disclosure.
  • DETAILED DESCRIPTION
  • Implementations of the present disclosure provide customizable inserts (a type of orthotic device) for footwear, such as a shoe, boot, workout or running sneaker, tennis shoe, etc. The term “orthotic device”, as used herein, refers to any device worn by or externally applied to an individual that provides neuromuscular support to the individual, provides skeletal support to the individual, and/or provides prophylactic functionality. The term “corrective device”, as used herein, refers to a type of orthotic device that provides a therapeutic benefit to an individual (e.g., who may be referred to herein as a “patient”) when worn by or externally applied by to the individual.
  • The techniques described herein provide an orthotic device with the flexibility to meet various individual needs. For example, the customizable insert as disclosed herein can aid in the biomechanical alignment and support of the patient's body during various activities. In an exemplary implementation, the customizable insert includes a structural member (e.g., elastic structural shell) that is three-dimensionally contoured to the individual foot anatomy of the patient. In some implementations, the structural member includes an upper surface and a lower surface opposite the upper surface. The upper surface is shaped to correspond with contours of the patient's foot to provide a balance of comfort, shock-absorption, custom-fitted arch support, heel stabilization, etc. The lower surface is adapted to rest on a substantially planar surface, such as within the insole of a shoe.
  • An intermediate layer (e.g., a foam layer) is attached to the structural member in a mating relationship such that one or more of their surfaces align. This layer is adapted to distribute a determined amount of foot pressure from the user foot with respect to the structural member. The insert further includes a recessed cavity which may or may not define an opening (e.g., cut out) that passes from the first surface to the second surface of the structural member. The recessed cavity is shaped to stabilize a region of the user foot placed within the opening with respect to the structural member.
  • In accordance with the present disclosure, the structural member of the insert can be constructed in several ways. In some implementations, the structural member can be fabricated based on the geometry of the patient's foot. This geometry (e.g., three-dimensional model, or “3D model”) can be generated in response to a foot analysis conducted by a system using, for example, an image of the patient's foot as well as other inputs regarding the patient, such as relevant activities, anatomical measurements, personal preferences, etc. U.S. Provisional Patent Application No. 62/292,154, which is incorporated by reference herein, discloses an example of a type of system to produce a geometry based on individual patient information, which can be used in conjunction with the present disclosure. Alternatively, other types of systems may be used to generate the geometry for constructing the structural member of the insert.
  • The customizable insert is designed as an orthotic device having an elastic exoskeleton to rest under the planar surface of a patient's foot to help promote healthy biomechanical function. The structural member or elastic structural shell provides the primary support and shock absorption effects of the insert. While the intermediate foam layer blends the comfort and dynamic loading effects of the shell regions against the soft tissue of the patient. When the intermediate foam layer is adhered to the elastic structural shell, it can be pre-tensioned or compressed depending on the differences in surface topology and contribute to how foot pressure is redistributed during different activities, such as walking, working, running, climbing, etc.
  • The present disclosure relates to an orthotic device as described herein. In the following description, numerous details are set forth. It will be apparent, however, to one skilled in the art, that the present disclosure may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present disclosure. In the foregoing description, numerous details are set forth. It will be apparent, however, to one of ordinary skill in the art having the benefit of this disclosure, that the present disclosure may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present disclosure.
  • FIG. 1 illustrates an example of an insert 100 for footwear in accordance with an implementation of the disclosure. The insert 100 comprises a support or structural member 101 that has a particular shape to fit within a base of footwear, such as a shoe. In some implementations, the structural member 101 is biomechanically designed to support regions of the patient's foot and absorb different kinds of impact shock.
  • As shown in FIG. 1, the structural member 101 of the insert 100 extends along a longitudinal direction between opposite regions, e.g., a forefoot or front region 103 and a rear or heel region 105. In some implementations, the forefoot region 103 of the insert 100 may continue as a flat layer underneath the forefoot of the patient, or may terminate medial-laterally at the anterior arch just prior to the metatarsal heads of a foot (i.e., long bones of the foot). In one implementation, the structural member 101 includes an upper surface 102 that faces towards a patient's foot, and a lower surface 104 that is opposite the upper surface 102 facing away from the patient's foot. As such, the lower surface 104 faces and engages an inner portion of the patient's footwear during use of the insert 100 by the patient.
  • The structural member 101 may be made of a various types of material. For example, these materials may be comprised of, but not limited to, various kinds of fiber nylons, gypsum or rubber-like materials, or other types of materials. In some implementations, the material between the upper surface 102 and lower surface 104 of the insert 100 can be solid or nearly hollow to vary or customize the elastic profile of the structural member 101 in a linear or nonlinear manner. For example, a spring constant of the material can be represented as a function of deformation distance k=f(x) [where k=spring constant and x=deformation distance].
  • Depending on the shoe type used with the insert 100 and anatomical heel width of the patient, the interior and exterior heel contours of the structural member 101 may work in balance to expand when loaded enough to maintain a close fit with the shoe (by applying appropriate shear friction) as well as the patient (by applying comfortable and low level compression of the heel). In some implementations, the intermediate foam layer (not shown) that can be adhered to the structural member 101 may be compressed or expanded by this heel shape in a manner custom to the heel anatomy of the patient. This may help increase or decrease the insert's control-contact at the heel region 105.
  • According to the present disclosure, the insert 100 may be constructed using various techniques based on a foot analysis of the patient. By analyzing the patient's foot, a 3D model for constructing the insert may be individualized for each patient's particular needs. In some implementations, this 3D model may be fabricated using a type of additive or subtractive fabrication system. Additive or subtractive systems, as referred to herein, refers to a machine that can build or fabricate a kind of device or real-world 3D objects by adding or subtracting successive layers of a material (e.g., fiber nylon, powdered nylon, etc.) under the control of a computing device. These objects can be of almost any shape or geometry, and are produced from a 3D model or other electronic data source. Alternatively, the inserts can be constructed based on the 3D model using traditional manufacturing techniques know in the art.
  • Contours 108 of the insert 100 are shaped in view of the individual contours of the patient's foot. For example, the 3D model for constructing the insert 100 as discussed above may be based on contour data and other information with regards to a patient's foot. When the insert 100 is constructed, the contours 108 are formed in a manner to take on the particular shape based on this 3D model. In some implementations, the contours 108 are customized in view of the 3D model in order to provide a level of therapeutic and/or performance benefit for the patient. For example, the contour 108 of the insert 100 may be customized to alleviate a particular foot ailment associated with the patient or to enhance a patient's stride performance by enhancing the amount of energy return and/or absorption provided by the insert 100.
  • The heel region 105 of the insert 100 provides medial-lateral stability during heel strike of the patient's gait while also absorbing some impact loads and offloading the plantar fascia (e.g., a flat band of tissue that connects the heel bone to the toes of a foot). In this example, the insert 100 consists of a roughly semi-circular contour around the sides and posterior of the heel region 105, with a slope contoured to hold the heel.
  • An arch region 107 of the insert 100 comprises a structure for the medial and lateral aspects of the arch to support during static and dynamic conditions. This is intended to prevent the arch of the patient foot from collapsing when standing or walking. The medial and lateral aspects of the arch region are designed for independent mechanical function, but may not be connected by a material interface with the foot or with a nonfunctional aesthetic design of the insert 100. Rather, they are connected through the heel via matching contours and support the foot as gait progresses from heel strike to mid-stance.
  • The heel region 105 and the arch region 107 of the insert 100 promote a loading profile concentrated at the midline of the foot. The medial aspect is designed such that the peak of the profile curve rests underneath the navicular bone found in the foot and prevents pronation. The lateral aspect has a peak and curvature designed to hold the foot and prevent over supination during gait.
  • FIG. 2A-2C illustrates another example of an insert 200 for footwear in accordance with an implementation of the present disclosure. The insert 200 (which may be compared to insert 100 of FIG. 1) includes an upper surface 202 and a lower surface 204 opposite the upper surface 202. In accordance with the present disclosure, the upper surface 202 of the insert 200 is shaped to correspond with contours of a user foot and the lower surface 204 is shaped to rest on an inner portion of footwear, such as a shoe. Although the insert 200 is shown in a particular arrangement, it should be appreciated that the insert 200 may be arranged in different configurations and/or include different components than what is shown.
  • In FIG. 2A, an example configuration of the insert 200 is shown. In this example, the insert 200 includes as recessed cavity 210. Although for ease of understanding only one recessed cavity is shown per implementation of insert 200, insert 200 may include multiple recessed cavities based on the needs of the patient. In some implementations, the recessed cavity 210 defines an opening 215 (e.g., cut out) that passes through the insert 200. For example, the opening 215 may pass from the upper surface 202 of the insert to the lower surface 204. The opening 215 in the insert 200 may be formed in several ways. In some implementations, the opening may be formed during construction of the insert 200. In alternative implementations, the opening may be created after an initial body of the insert 200 is constructed. For example, the opening 215 may be cut out of the body of the insert 200. Still further, other techniques know in the art may be used to create the opening 215 of the recessed cavity 210.
  • In FIG. 2A, the recessed cavity 210 is arranged near the heel region 205 of the insert 200. As shown, the recessed cavity 210 is surrounded on all sides by material of the insert 200. The opening 215 comprises a teardrop shaped cutout underneath the heel. This shape is designed to offload the plantar fascia insertion at the calcaneus by supporting and slightly raising the foot regions around it. The exterior shape of the cavity 210 roughly follows the interior with a wall thickness based off of patient kinetics, but has an edge contoured on the lower surface 204 of the insert 200. An advantage of this edge is that it stabilizes the heel by widening its base to encourage the heel of the patient to become more aligned with the sagittal plane during the early phases of gait (e.g., a manner of walking).
  • Although in FIG. 2A the opening 215 is shown having a particular shape in a certain position on the insert 200, other shapes and configurations are possible. For example in FIG. 2B, the recessed cavity 220 is arranged substantially near an arch region 225 of the insert 200. As shown, the recessed cavity 220 here is similarly surrounded on all sides by material of the insert 200.
  • Turning to FIG. 2C, a recessed cavity 230 is arranged along a center region 235 of the insert 200. As shown, the recessed cavity 230 includes an opening in the forward region 203 of the material used to construct the insert 200. In this example, the recessed cavity 230 creates a center channel defining a first panel 207 and a second panel 209. An interior edge of the center channel created by the recessed cavity 230 encourages offloading of the 2nd-3rd metatarsal bones of a patient's foot.
  • FIG. 3 illustrates yet another example of an insert 300 for footwear in accordance with an implementation of the present disclosure. The insert 300 (which may be compared to insert 100 of FIG. 1 and any one of the configurations of insert 200 of FIGS. 2A-2C respectively) includes an upper surface 302 and a lower surface 304 opposite the upper surface 302. In accordance with the present disclosure, the upper surface 302 of the insert 300 is shaped to correspond with contours of a user foot and the lower surface 304 is shaped to rest on an inner portion of footwear. Although the insert 300 is shown in a particular arrangement, it should be appreciated that the insert 300 may be arranged in different configurations and/or include different components than what is shown.
  • In this example, the insert 300 includes a recessed cavity 330 (which may be compared to recessed cavity 230 of FIG. 2C) that defines an opening from upper surface 302 of the insert to a lower surface 304. As shown, the recessed cavity 330 is positioned along a center portion of the insert 300. In this example, the recessed cavity 330 creates a straight narrow channel defining a first panel 310 and a second panel 320. In this regard, the first panel 310 and the second panel 320 of the insert 300 are still joined together at a heel region 315 of the insert 300.
  • As shown in FIG. 3, each panel on the insert 300 may have a determined length and width. For example, the first panel 310 may have a length of L1 and a width of W1 while the second panel 320 may have a length of L2 and a width of W2. In some implementations, the respective lengths and widths of the first panel 310 and second panel 320 may correspond to each other. In alternative implementations, the lengths and widths may differ. For example, the length L1 of the first panel 310 may be a shorter or longer than the length L2 of the second panel 320 and vice-versa. Similarly, the width W1 of the first panel 310 may be a wider or narrower than the width W2 of the second panel 320, or any combination thereof.
  • In some implementations, an underside topology of the lower surface 304 of insert 300 may be modified to contain certain markings (e.g., 2D or 3D markings), for example, a textured surface of shapes, such as shapes 340, and grooves, such as grooves 350, which are slightly embossed or debossed (e.g., on the order of ±0-3 mm) onto the lower surface 304 in a particular pattern. Depending on the resolution of the patterns and magnitude of how far these patterns are offset in a direction normal from the surface, they may provide a certain biomechanical effect or aesthetic impact based on user-specific inputs, such as activity levels, anatomical measurements, or personal preferences.
  • The trajectory (e.g., path) of the patterns along the lower surface 304 of the insert 300 may be along a spline in discrete segments or continuous. The cross-section and configuration of the pattern can impact the gait dynamics of the patient such as: location of flexing of the device, providing mechanical limits on deflection, realignment of center-of-force (COF), improving symmetry of left-right feet pressure distribution, offloading zones with high pressure, absorbing energy during heel strike, assisting with tibial (e.g., pertaining to the largest long bone of the lower leg) progression through mid-stance, or any combination thereof. For regions of the insert 300 where it is desired to add rigidity while minimizing material consumption or avoid adding thickness, an embossed pattern may be added (e.g., ribs) to decrease bending in the medial arch region. For other regions of the insert 300 where it is desired to reduce rigidity while maintaining structural integrity, a debossed pattern may be added (e.g., grooves) to increase bending along axes perpendicular to the anterior arch.
  • In some implementations, the patterns on the lower surface 304 may also provide feedback regarding the patient's particular use of the insert 300. For example, the patterns may be designed such that over time the patient's unique wear pattern will provide insight into anatomical and/or physiological parameters of the patient's anatomy. For example, such parameters may include indicators of the unique manner in which the patient loads their feet during gait dynamics, how they apply normal and shear stresses on the underside of the insert 300 and any wear away. These indicators may indicate patterns of walking, such as supination-pronation of the arch or inversion-eversion of the heel.
  • In some implementations, the information regarding the unique wear patterns of the patient may be provided to a system as discussed above. This may be done to adjust the 3D model used to fashion the insert for constructing subsequent inserts. To accomplish this, in some implementations the insert 300 may include a computer-readable identifier 360, such as a QR (Quick Response) code, that can identify a particular user of the insert. In operation, after using the insert for a while, the patient may take a picture of the lower surface 304 to capture an image of the computer-readable identifier 360 and the wear on the patterns at the bottom of the insert 300. This picture can be then uploaded to the system for analysis. Thereupon, an updated 3D model can be generated by the system in response to the patient's unique use of the insert 300. In some implementations, the patterns on the lower surface 304 may serve as an identifier of the particular user. For example, the orientations, sizes, and scale of various shapes that form the pattern may structurally encode an identifier that is associated with the user.
  • FIG. 4 illustrates an example of an intermediate layer 400 according to an implementation of the disclosure, which can be used in conjunction with any one of the inserts of the present disclosure. The intermediate layer 400 may be comprised of a certain type of moldable material having a top portion 402 and a bottom portion 404 opposite the top portion 402. In some implementations, the intermediate layer 400 may be comprised of a type of foam material of a determined thickness, such as a type of environmentally friendly foam (EFF), or other types of similar materials that provide a sufficient amount shock absorption characteristics when compressed, as well as a sufficient amount of spring back or rebound characteristics after compression.
  • The material of the intermediate layer 400 is formed to provide a 3D contour approximate to the design variety for a particular shoe size and type. A pre-forming process eases adhesion of the intermediate layer 400 to the structural member of the insert by reducing tension in the material from a flat sheet to a 3D contour. In some implementations, the shape of this layer will be modified or otherwise deformed by adhesion to the structural member of the insert. This adhesion may be accomplished using certain techniques, such as compression molding. Due to preforming and adhesion, the intermediate layer 400 becomes deformed at the heel and arch region to match the topology of the insert.
  • In some implementations, a thin layer or top-cover of material may be affixed to the intermediate layer 400 before the pre-forming process. This top-cover may have properties specific to the wearer's needs such as antimicrobial, textured, moisture wicking, or heat wicking.
  • In use, the top portion 402 of the intermediate layer 400 faces upward towards the foot of the patient while the bottom portion 404 faces towards the insert. In some implementations, the inserts as described herein, such as insert 100 of FIG. 1, any one of the configurations of insert 200 of FIGS. 2A-2C respectively, or insert 300 of FIG. 3, can receive the intermediate layer 400 in a mating relationship with respect to an upper surface of the insert. For example, the intermediate layer 400 may be adhered to selected regions of the structural member of the insert. This intermediate layer 400 may be adhered to the using, for example, an epoxy or alternative techniques such as heat treatment or ultrasonic welding. In some implementations, a cutting process may be used to remove excess material so that intermediate layer 400 and insert can fit inside a shoe.
  • FIG. 5 illustrates an example 500 of padding support 501 according to an implementation of the disclosure. The padding support 501 may be comprised of a certain type of material of a determined thickness having a top portion 502 and a bottom portion 504. In some implementations, the padding support 501 may be comprised of an ethylene-vinyl acetate (EVA) foam or similar material which is soft enough to allow compression of the toes and metatarsal heads during gait but avoid creating new high pressure zones. In regions of the foot not covered by the insert, the padding support 501 may be used as a secondary material to support those regions of the foot during the latter phases of gait.
  • As shown in FIG. 5, the padding support 501 may comprises a toe-bed reinforcement region underneath the metatarsal heads and forefoot region of the patient's foot. In alternative implementations, the padding support 501 may include different shapes made up of one or more additional padding components. In use, a top portion 502 of the padding support 501 may be attached or placed under the intermediate layer 400. While a bottom portion 504 of the padding support 501 faces away from the patient and towards a resting position within the patient's footwear.
  • FIGS. 6A-6C are example side views of an insert 600 in accordance with implementations of the present disclosure. The insert (which can be compared to insert 100 of FIG. 1, any one of the configurations of insert 200 of FIGS. 2A-2C respectively, or insert 300 of FIG. 3) comprises a structural member 601 that includes an upper surface 602 and a lower surface 604 opposite the upper surface 602. In accordance with the present disclosure, the upper surface 602 of the structural member 601 is shaped to correspond with contours of a user foot and the lower surface 604 is shaped to rest on an inner portion of footwear, such as a shoe. Although the structural member 601 is shown in a particular arrangement, it should be appreciated that the structural member 601 may be arranged in different configurations and/or include different components than what is shown.
  • The structural member 601 may in itself act as an insert, such as the insert 600, or may combine with other components to form an insert. In these examples, steps for attaching the structural member 601 to an intermediate layer 603 (which may be compared to intermediate layer 400 of FIG. 4) to form an insert 610 are shown. In accordance with the present disclosure, the intermediate layer 603 is comprised of a type of moldable material of a determined thickness having a top portion 606 and a bottom portion 608 opposite the top portion 606. In some implementations, the intermediate layer 603 can be placed within a recess of the structural member 601 such that the moldable material of the intermediate layer 603 takes on a shape corresponding to the structural member 601.
  • In FIG. 6A, a side view of the structural member 601 is shown in a first position. For example, the structural member 601 may be positioned so that the lower surface 604 of the structural member 601 is oriented downwards and facing away from a patient's foot. With regards to FIG. 6B, a side view of the structural member 601 is shown in a second position with respect to the intermediate layer 603. For example, the structural member 601 is positioned so that the upper surface 602 is oriented towards the bottom portion 608 of the intermediate layer 603. At this point, the structural member 601 and/or the intermediate layer 603 are moved in a certain direction with respect to the second portion shown in FIG. 6B. For example, the structural member 601 and the intermediate layer 603 may be moved in a manner in which the two components are brought together.
  • Turning to FIG. 6C, a side view of the structural member 601 is shown in a third position with respect to the intermediate layer 603. In this example, the intermediate layer 603 is moved toward an applied onto the structural member 601, for example, using a type of adhesion. As shown, the intermediate layer 603 is placed within a recess of the upper surface 602 of the structural member 601. This configuration causes portions of the intermediate layer 603 as indicated by arrows 607 to match to the topology, for example, at the heel and arch region of the structural member 601. In some implementations, a padding support 609 may further be included. The padding support 609 may be similar to the padding support 501, and may be applied to the intermediate layer 603. At least a portion of the padding support 609 may contact the structural member 601. Adhesives may be used, for example, to adhere the padding support 501 to the intermediate layer 603 and, optionally, the structural member 601.
  • The above-described customizable inserts provides a level of comfort and therapeutic/performance benefits to a patient while performing different activities. This is accomplished, by interfacing at the patient's foot, a pairing of an elastic structural shell (e.g., structural member 601) with a soft interface layer (e.g., intermediate layer 603). In this regard, the health benefits provided by the inserts can include improved posture, decreased foot fatigue, and decrease in common aches and pains associated with the patient's feet.
  • Whereas many alterations and modifications of the present disclosure will no doubt become apparent to a person of ordinary skill in the art after having read the foregoing description, it is to be understood that any particular implementation shown and described by way of illustration is in no way intended to be considered limiting. The words “example” or “exemplary” are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “example” or “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the words “example” or “exemplary” is intended to present concepts in a concrete fashion. As used in this application, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or”. That is, unless specified otherwise, or clear from context, “X includes A or B” is intended to mean any of the natural inclusive permutations. That is, if X includes A; X includes B; or X includes both A and B, then “X includes A or B” is satisfied under any of the foregoing instances. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form. Reference throughout this specification to “an implementation” or “one implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, the appearances of the phrase “an implementation” or “one implementation” in various places throughout this specification are not necessarily all referring to the same implementation. Moreover, it is noted that the “A-Z” notation used in reference to certain elements of the drawings is not intended to be limiting to a particular number of elements. Thus, “A-Z” is to be construed as having one or more of the element present in a particular implementation.
  • It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other implementations will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims (20)

What is claimed is:
1. An insert for footwear, comprising:
a structural member having a first surface and a second surface opposite the first surface, the first surface is shaped to correspond with contours of a user foot and the second surface is adapted to rest on an at least partially planar surface;
a recessed cavity defining an opening from the first surface to the second surface of the structural member, the recessed cavity is shaped to stabilize a region of the user foot placed within the opening; and
an intermediate layer attached to the structural member in a mating relationship with respect to the first surface, the intermediate layer to distribute a determined amount of foot pressure from the user foot with respect to the structural member.
2. The insert of claim 1, wherein the shape of the first surface of the structural member is patient-matched and is fabricated based on a 3D model of the user foot.
3. The insert of claim 1, wherein the structural member is additively or subtractively fabricated.
4. The insert of claim 1, wherein the recessed cavity is surrounded by material of the structural member.
5. The insert of claim 4, wherein the recessed cavity is positioned at an arch region of the insert.
6. The insert of claim 4, wherein the recessed cavity is positioned at a heel region of the insert.
7. The insert of claim 1, wherein the recessed cavity is positioned along a center region of the insert.
8. The insert of claim 7, wherein the opening creates a center channel that separates the structural member into a first panel and a second panel at a forward region of the insert.
9. The insert of claim 8, wherein the first panel and the second panel are each of lengths that accommodate the user foot.
10. The insert of claim 9, wherein the first panel and the second panel of the structural member are joined together at a heel region of the insert.
11. The insert of claim 1, wherein the intermediate layer is comprised of a foam material.
12. The insert of claim 11, wherein the foam material is adapted to conform to a topology corresponding to contours of the first surface of the insert.
13. The insert of claim 1, wherein the intermediate layer comprises an outline of an insole.
14. The insert of claim 1, further comprising a padding support to be attached to the intermediate layer.
15. The insert of claim 14, wherein the padding support is attached to a toe region of the intermediate layer.
16. The insert of claim 1, wherein the structural member further comprises a computer-readable identifier disposed on the second surface, the computer-readable identifier being associated with an identify a user of the insert.
17. The insert of claim 16, wherein the structural member further comprises a plurality of markings disposed on the second surface.
18. The insert of claim 17, wherein the markings are arranged in a determined pattern.
19. The insert of claim 18, wherein the markings are positioned to adjust an amount of flexibility of material in a region of the structural member.
20. The insert of claim 19, wherein when markings are worn such that a wear pattern is formed thereon, and wherein the wear pattern is predictive of an anatomical parameter of the user of the insert.
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US16/409,064 Active 2037-02-09 US10842220B2 (en) 2016-02-05 2019-05-10 Systems and methods for generating orthotic device models using simulated patient anatomy
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US20210177089A1 (en) 2021-06-17
US10842220B2 (en) 2020-11-24
US10327502B2 (en) 2019-06-25
US11730230B2 (en) 2023-08-22
US20190261733A1 (en) 2019-08-29

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