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US-12616272-B2 - Gait modification apparatuses, systems and methods

US12616272B2US 12616272 B2US12616272 B2US 12616272B2US-12616272-B2

Abstract

The disclosure provides gait modification or treatment apparatus, systems and methods that are appropriate for everyday life, have a significant mechanical effect, and provide a mechanism for tracking the compliance and performance of the patient to allow for individualized management of a gait modification prescription or treatment plan or sequence. Gait modification/treatment apparatus, systems and methods utilizing substantially rectilinear projections in the hindfoot and the forefoot are disclosed. Gait modification/treatment apparatus, systems and methods utilizing a projection that defines an engagement surface extending from the hindfoot to the forefoot are also disclosed. Gait modification/treatment apparatus, systems and methods utilizing a non-linear guide rail extending from the hindfoot to the forefoot are also disclosed. Further, gait modification/treatment apparatus, systems and methods utilizing an array of discrete pegs of differing stiffness/compression that provide load instability at least in the hindfoot and the forefoot are disclosed.

Inventors

  • John Dougall
  • Frank Foley
  • Scott Greenberg

Assignees

  • SCIENTIFIC MOTION TECHNOLOGIES INC.

Dates

Publication Date
20260505
Application Date
20210423

Claims (20)

  1. 1 . A gait modification apparatus, comprising: a sculpted sole configured for use on an underside of a shoe, the sculpted sole comprising a plantar projection that projects downwardly from the underside of the shoe, the plantar projection comprising a bottom side that comprises: a planar ground engagement surface that extends from a hindfoot portion of the sculpted sole to into a forefoot portion of the sculpted sole; and a plurality of upwardly inclined relief surfaces that extend upwardly as the plurality of upwardly inclined relief surfaces extend contiguously from end edges of the planar ground engagement surface toward a periphery of the sculpted sole, the plurality of upwardly inclined relief surfaces comprising: a posterior relief surface portion extending upwardly from a rear edge end of the planar ground engagement surface as the posterior relief surface portion extends rearwardly from the rear edge end toward a rear portion of the periphery of the sculpted sole; a medial relief surface portion extending upwardly from an inner side edge end of the planar ground engagement surface as the medial relief surface portion extends from the inner side edge end toward an inner side portion of the periphery of the sculpted sole; a planar lateral relief surface that is inclined upwardly and forwardly as the planar lateral relief surface extends from a first portion of a front edge end of the planar ground engagement surface toward an outer front portion of the periphery of the sculpted sole; and a planar anterior relief surface that is inclined upwardly and forwardly as the planar anterior relief surface extends from a second portion of the front edge end of the planar ground engagement surface toward an inner front portion of the periphery of the sculpted sole.
  2. 2 . A gait modification system, comprising: the gait modification apparatus of claim 1 ; and at least one sensor configured to monitor physical activity of a patient utilizing the gait modification apparatus to determine a gait modification prescription plan.
  3. 3 . A method of modifying a gait of a patient, comprising: coupling the gait modification apparatus of claim 1 to a plantar underside of the shoe of the patient such that the sculpted sole forms a plantar side of the shoe.
  4. 4 . The method of claim 3 , further comprising associating at least one sensor with the patient, wherein the sensor is configured to monitor physical activity of the patient.
  5. 5 . The method of claim 3 , further comprising determining a gait modification prescription plan of differing gait modification apparatuses based on monitored activity of the patient.
  6. 6 . The method of claim 5 , further comprising replacing or modifying the gait modification apparatus according to the determined gait modification prescription plan.
  7. 7 . The gait modification apparatus of claim 1 , further comprising a shoe, and wherein the sculpted sole is coupled to the shoe and forms a bottom side of the shoe.
  8. 8 . The gait modification apparatus of claim 7 , wherein the sculpted sole is removably coupled to an underside of the shoe.
  9. 9 . The gait modification apparatus of claim 7 , wherein the sculpted sole is fixedly coupled to an underside of the shoe.
  10. 10 . The gait modification apparatus of claim 1 , wherein the sculpted sole further comprises a top side opposite the bottom side of the plantar projection, the top side being configured to couple with the underside of the shoe.
  11. 11 . The gait modification apparatus of claim 1 , wherein the planar ground engagement surface extends in an inner side to outer side direction as it extends from the hindfoot portion of the sculpted sole into the forefoot portion of the sculpted sole.
  12. 12 . The gait modification apparatus of claim 1 , wherein the planar ground engagement surface extends to an outer side portion of the periphery of the plantar projection.
  13. 13 . The gait modification apparatus of claim 1 , wherein the planar ground engagement surface extends to an inner side portion of the periphery of the plantar projection.
  14. 14 . The gait modification apparatus of claim 1 , wherein the planar ground engagement surface is the lowest surface portion of the bottom side of the plantar projection.
  15. 15 . The gait modification apparatus of claim 1 , wherein at least a portion of the inner side edge end of the planar ground engagement surface extends arcuately inwardly as it extends forwardly.
  16. 16 . The gait modification apparatus of claim 1 , wherein the planar ground engagement surface is oriented normal to the upward-to-downward direction.
  17. 17 . The gait modification apparatus of claim 1 , wherein the posterior relief surface portion extends upwardly and rearwardly from the rear edge end of the planar ground engagement surface to the rear portion of the periphery of the sculpted sole.
  18. 18 . The gait modification apparatus of claim 1 , wherein the posterior relief surface portion comprises a continuous arcuate surface.
  19. 19 . The gait modification apparatus of claim 1 , wherein the posterior relief surface portion comprises a plurality of planar surfaces.
  20. 20 . The gait modification apparatus of claim 1 , wherein the medial relief surface portion extends upwardly and inwardly from the inner side edge end of the planar ground engagement surface to the inner side portion of the periphery of the sculpted sole.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority benefit from International Application No. PCT/US2019/057767 filed on Oct. 24, 2019, entitled “Gait Modification Apparatus, Systems and Methods”, which claims priority benefit of U.S. Provisional Patent Application No. 62/750,482, filed on Oct. 25, 2018, and entitled “Gait Modification Apparatus, Systems and Methods” each of which is incorporated herein by reference in its entirety. TECHNICAL FIELD The present disclosure generally relates to apparatus, systems and methods of gait modification to treat a functional disability and/or pain. More specifically, the present disclosure also relates apparatus, shoe systems and methods of effectuating gait modification by perturbing and biomechanically adjusting the interface of a patient's foot or feet to the ground. The present disclosure also relates to gait monitoring systems that improve compliance and record nature of use information of gait modification apparatus and shoe systems to manage and adjust a gait adjustment prescription over time. BACKGROUND A person's gait is their manner of ambulation or locomotion, involving their total body. Gait speed determines the contribution of each participating body segment. Normal walking speed primarily involves the lower extremities, with the arms and trunk providing stability and balance. The faster the speed, the more the body depends on the upper extremities and trunk for propulsion as well as balance and stability. The legs continue to do the most work as the joints produce greater ranges of motion through greater muscle responses. In the bipedal system, the three major joints of the lower body and pelvis work with each other as muscles and momentum move the body forward. The degree to which the body's center of gravity moves during forward movement defines efficiency. The body's center moves both side to side and up and down during gait. The gait cycle is a repetitive pattern involving steps and strides. A step is one single step, while a stride is a whole gait cycle. Step time is the time from one foot hitting the floor to the other foot hitting the floor. Step width can be described as the mediolateral space between the two feet. The sequence that occurs in a typical gait cycle (i.e., walking) may be summarized as registration and activation of the gait command within the central nervous system, transmission of the gait command to the peripheral nervous system, contraction of muscles, generation of several forces, regulation of joint forces and moments across synovial joints and skeletal segments, and generation of ground reaction forces, for example. The gait cycle is often classified into two main phases: the stance phase and the swing phase. The stance phase typically occupies about 60% of the gait cycle, while the swing phase typically occupies only about 40%. Gait involves a combination of open- and close-chain activities. As shown in FIG. 1, a typical gait cycle comprising two steps is also often classified into six detailed phases: 1) heel strike; 2) foot flat; 3) mid-stance; 4) heel-off; 5) toe-off; and 6) mid-swing. A subsequent gait cycle of a walking person repeats the phases beginning with the next heel strike at the end of the mid-swing phase. As also shown in FIG. 1, a common alternative classification of gait breaks the cycle into eight phases: 1) initial contact; 2) loading response; 3) midstance; 4) terminal stance; 5) pre-swing; 6) initial swing; 7) mid-swing; and 8) late swing Abnormal gait is when a person is unable to walk in the usual way. Many systems of the body, such as strength, coordination, and sensation, work together to allow a person to walk with the “normal” or “typical” gait described above. When one or more of these interacting systems is not working properly or typically, it can result in abnormal gait or a walking abnormality. This may be due to injuries, underlying conditions, or problems with the legs and/or feet. For example, congenital deficit, injury or illness involving one or more lower extremities or the spine or torso can result in the advent of a gait irregularity or abnormality. Anatomically, an irregularity can be the result of injury, atrophy, denervation or impaired innervation of one or more muscles or muscle groups, ligament or tendon injury, joint injury or disease, or pain or stiffness of any kind involving the lower extremities, spine or lower torso, for example. Generally, an irregularity is the manifestation of an asymmetry in the movement or step pattern of the right and left legs. A gait irregularity can include a step duration, step force, or step form difference between the left leg step and the right leg step, for example. An irregularity in the step duration, step force, or step form is commonly referred to as a limp. Elimination or reduction of gait irregularity is often an important part of a therapeutic and/or healing process, such as to treat a functional disability or pain