Orthopedic foot brace and its assembly method

Abstract

An orthotic foot brace for a shoe wearer comprising: a leg holder; a foot brace having a hinge member extending from the rear of the leg along the length of the shoe to join an instep support securable to an instep portion of the shoe, and a heel member engaging a heel portion of the shoe below the hinge member; and a leg brace comprising a plurality of beams extending along the rear of the leg into the shoe, each beam being secured at a first end within a cuff connector of the leg holder and at a second end within a foot brace connector of the foot brace.

Description

Technical Field

[0001] The improvement generally relates to orthopedic devices, and more specifically to devices for dealing with drop foot conditions.

Background Art

[0002] Drop foot or floppy foot (hereinafter referred to as drop foot for simplicity) is a term used to indicate paralysis of the dorsiflexor muscles of the ankle and toes. According to this, the foot cannot be lifted at the ankle, and during walking, the foot tilts towards the ground and rubs against the ground. Dorsiflexion is the movement of lifting the foot, more specifically the instep part of the foot, upward towards the tibia of the lower leg. This is one of many movements that need to occur during a normal walking cycle, and it is particularly important throughout the swing phase of the walking cycle so as not to drag the toes of the foot (more specifically, the toe part of the shoe being used) along the ground.

[0003] To assist or deal with the condition of drop foot, many braces have been proposed, but there is always room for improvement.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The corrective foot brace may have a leg holder attached to the user's lower leg and a foot support member that contacts the user's foot. The leg holder may be interconnected to the foot support member via a leg support member. When a user whose foot exhibits drop foot symptoms enters the swing phase of the walking cycle, due to the posture of the lower leg and the corrective foot brace, a force can be transmitted upward towards the foot through the reference point of the leg holder to the lower leg. The mechanical force transmitted from the lower leg to the foot is provided by the leg support member that mechanically integrates the two parts.

[0005] The leg brace is the elongated portion of the orthopedic foot brace and can contribute to the transmission of mechanical load. While gait can be observed in relation to a single plane corresponding to the user's linear movement, it should be understood that complex multi-directional movements can occur in the lower leg and foot. The leg brace is subjected not only to axial (acting along the longitudinal axis) and flexural (acting perpendicular to the longitudinal axis) forces, but also torsional forces that need to be effectively transmitted between the foot and lower leg. Furthermore, due to the nature of the use of orthopedic foot braces, it may be desirable that the leg brace be able to operate periodically without fatigue failure. Weight, structural resistance, elastic behavior, and other design considerations for the leg brace are also factors to be taken into account. Since the leg brace is the elongated member that forms the majority of the orthopedic foot brace, the design of the leg brace can have a significant impact on the overall design.

[0006] It has been confirmed that providing multiple beams extending along each other between the leg holder and the foot support has resolved at least some of the problems related to the leg support in orthopedic foot braces. In addition to providing flexural and axial resistance to the orthopedic foot brace, it has been confirmed that the multiple beams work together to achieve significantly stronger torsional resistance than they would exhibit individually, offering new options from a performance standpoint (e.g., cost, weight, appearance, structural strength).

[0007] Furthermore, it has been confirmed that having certain elements of the orthopedic foot brace with a higher modulus of elasticity compared to others provides the advantages of improved force transmission efficiency and the ability to flex the foot support between desired elements. It has been confirmed that by making the instep support from a material with a higher modulus of elasticity than the connected foot support, the amount of deflection of the instep support, and therefore the amount of deflection of the foot attached to it, can be reduced. This has been confirmed to improve the efficiency of mechanical force transmission to the foot support. For the leg support, a material with similar mechanical properties can be used alone or in combination with the corresponding material in the instep support. This improves the efficiency of mechanical force transmission to the foot support and promotes flexion of the orthopedic foot brace at the desired position. [Means for solving the problem]

[0008] According to one embodiment, a corrective foot brace is provided for a person who wears shoes, the corrective foot brace comprising: a leg holder having a cuff that can be fixed to the lower leg of the person for use; a foot support having a hinge member that extends from the rear of the lower leg along the length of the shoe and joins an instep support that can be fixed to the instep of the shoe, and a heel member that engages with the heel of the shoe below the hinge member; and a leg support consisting of a plurality of beams that extend from the rear of the lower leg to the shoe, each fixed at a first end in a cuff connector of the leg holder and at a second end in a foot support connector of the foot support.

[0009] In another embodiment, a corrective foot brace is provided for a person who wears shoes, the corrective foot brace comprising: a leg holder having a cuff that can be fixed to the lower leg of the person for use; a foot support having a hinge member extending from the rear of the lower leg along the length of the shoe and a heel member that engages with the heel portion of the shoe below the hinge member; an instep support that can be fixed to the instep portion of the shoe and joins the foot support to the side of the shoe; and a leg support extending along the length of the lower leg and joining the leg holder to the foot support, wherein the modulus of elasticity of the material of the instep support is at least twice that of the material of the foot support.

[0010] A method is provided for assembling an orthopedic foot brace comprising: a leg holder having a cuff; a foot support having a hinge member extending from the rear of the leg along the length of the shoe and joining to an instep support, and a heel member that can engage with the shoe; and a plurality of beams connecting the leg holder to the foot support, the method comprising: inserting a first beam end of a beam into a path of one of the cuff connector and foot support connectors; tightening a fastener corresponding to the path accommodating the first beam end and abutting against the surface of the beam to lock the beam in place within the path; repeating the insertion and tightening steps for at least one subsequent beam; and for each of the beams, inserting a second beam end into another of the cuff connector and foot support connectors; and tightening a fastener corresponding to the path accommodating the second beam end and abutting against the surface of the beam to lock the beam in place within the path.

[0011] In this specification, the terms anterior, posterior, plantar, dorsal, proximal, distal, central, and lateral refer to the location of elements, referencing anatomical atlases centered on the human torso. Therefore, distal refers to the region relatively farther from the torso, compared to other regions considered proximal, which are relatively close to the torso. Anterior generally refers to the space facing the torso in the direction a person typically walks. Posterior generally refers to the space facing the anatomical back of a person. Therefore, the anterior portion of a leg is, for example, the approximate portion facing the direction of movement, while the posterior portion faces the opposite direction of movement. If a hypothetical midline cuts the body in half longitudinally, each leg lies on opposite sides of the midline. Therefore, the central portion of something refers to the part closest to or extending roughly toward the midline. Lateral portions, on the other hand, refer to the part furthest from or extending roughly away from the midline. This should not be confused with the side (one or both) of an object or body.

[0012] In light of the nature of the corrective foot brace of this application, anatomical reference terms may be used to indicate the relative positions of elements on the device. These terms are understood in relation to an anatomical atlas of a hypothetical user whose leg is engaged within the corrective foot brace. As will be clarified below, the corrective foot brace of this application may be used on one or both of the user's feet, which are mirror images of each other along the midline. Therefore, the terms are not to be interpreted restrictively in any sense, but are used solely for the purpose of clarifying relative positions.

[0013] Further features of this improvement, and their combinations, will be understood by those skilled in the art by reading the following disclosure.

[0014] The diagram is shown below. [Brief explanation of the drawing]

[0015] [Figure 1] This is a front perspective view of an example of an orthopedic foot brace. [Figure 2] This is a side view of another example of an orthopedic foot brace attached to the user's legs and feet. [Figure 3A] Figure 2 shows a rear perspective view of the corrective foot brace, which is not attached to the user's legs and feet. [Figure 3B] This is a cross-sectional view along line 3B-3B in Figure 3A. [Figure 3C] Figure 3B is a cross-sectional view of another embodiment of the beam. [Figure 4A] This is an enlarged perspective view of section 4A-4A in Figure 3A. [Figure 4B] This is a cross-sectional view along line 4B-4B in Figure 4A. [Figure 4C] This is a partial top view of a support member for the beam, along its cross-section. [Figure 5] This is a bottom perspective view of an example of an orthopedic foot brace without beams and leg supports. [Figure 6] This flowchart shows the steps for assembling an exemplary orthopedic foot brace. [Figure 7]Partial side view of an exemplary corrective foot brace that is evenly loaded on the side and central sides and flexes under load. [Figure 8] Partial front view of an exemplary corrective foot brace that is loaded on either the side or the central side and flexes under load.

Best Mode for Carrying Out the Invention

[0016] FIG. 1 shows an example of a corrective foot brace 10. The foot brace 10 includes a leg holder 12 having a cuff 14 that is operable to be attached to the user's lower leg (see FIG. 2). In the present embodiment, the leg holder 12 has a pad 18 that extends along the surface of the cuff 14 that houses the user's lower leg 16, and further has a band 20 that extends from a first side surface of the cuff 14 to the opposite side surface of the cuff 14. In this specific case, the band 20 is hooked on the first side of the cuff 14, extends across the front portion of the lower leg 16, and is configured to be fastened by a hook-and-loop fastener system. For example, the fastening means can be of the type known as Velcro®. In that case, one of a hook or loop portion is provided on the band 20 and the other one is provided on the cuff 14. This enables, for example, fixing the lower leg 16 to the pad 18.

[0017] It should be understood that the characteristics of the leg holder 12 can be changed without departing from the present disclosure. For example, the band 20 can utilize another fastening means to hold the lower leg 16 in place. In another embodiment, the pad 18 can be changed or omitted without departing from the present disclosure.

[0018] Referring further to FIG. 1, the corrective foot brace 10 further includes a foot support member 22 configured to contact the user's foot directly or indirectly via the shoe 24 (see FIG. 2). In the present embodiment, the foot support member 22 extends substantially downwardly from a single vertex. Two hinge members 26a, 26b extend downwardly and forwardly from the vertex until they finally reach the joints 28, namely 28a, 28b. The joints 28a, 28b form connection portions with the heel member 30. The heel member 30 extends downwardly from the joints 28a, 28b and returns rearwardly, under the hinge members 26a, 26b, in the direction of the heel portion 32 of the shoe 24 (shown in FIG. 2). Two proximal portions 34 of the heel member 30 extend from each of the joints 28a, 28b and converge at the distal portion 36. Thereby, a loop is formed between the two joints 28a, 28b. The joints 28a, 28b have openings for accommodating, among other things, the proximal portions of the arms 38a, 38b of the dorsal support 40. The dorsal support 40 extends forwardly from the joints 28a, 28b of the foot support member 22 while forming an arcuate shape between the two arms 38a, 38b and connecting between the two joints 28a, 28b.

[0019] The foot support member 22 and the leg holder 12 are joined by a leg support member 42. In this specific embodiment, the leg support member 42 has a pair of beams 44a, 44b. The beams 44a, 44b each have a first end engaging with the leg holder 12 and a second end engaging with the foot support member 22. The first and second ends of the beams 44a, 44b may be the same in the present embodiment.

[0020] As perhaps best illustrated in Figure 2, the orthopedic foot brace 10 engages with the user's lower leg 16 and shoe 24, with the cuff 14 of the leg holder 12 configured to abut against the rear portion of the leg 16, while the band 20 wraps around the front portion of the leg 16. Referring to Figures 4A and 4B, and as further detailed below, the cuff 14 has a cuff connector 46 that accommodates the first ends 48 of beams 44a, 44b. The beams 44a, 44b extend along the rear portion of the lower leg 16, somewhat parallel to the longitudinal axis A of the leg, and away from the cuff connector 46 downward. As perhaps best illustrated in Figure 3A, the orthopedic foot brace has two beams that are spaced laterally apart from each other and extend parallel to the axis C of the foot brace, which is substantially parallel to the axis A of the lower leg when the foot brace is in use.

[0021] Returning to Figure 2, the beam extends from the cuff connector 46 until it reaches the foot support 22. The second end of the beam engages with the foot support 22 via foot support connectors 50a, 50b integrated with the vertex 52 in this embodiment. The foot support connectors 50a, 50b are located directly above the vertex 52 and behind the leg 16. The vertex 52, also located behind the leg and foot, branches to form two hinge members 26a, 26b. These hinge members 26a, 26b extend downward from the vertex 52 and forward along the longitudinal axis B of the shoe 24, and further along the side of the shoe 24. Thus, when the shoe 24 engages with the orthopedic foot brace, the hinge members 26a and 26b are kept adjacent to the side and general shape of the shoe 24, perhaps best shown in Figure 2, and further form a curved portion corresponding to the angular difference between the lower leg axis A and the longitudinal axis B of the shoe 24.

[0022] The hinge members 26a and 26b each terminate at joints 28a and 28b along the sides of the shoe 24, approximately midway along the length of the shoe 24. The upper support member 40 engages with the joints 28a and 28b on each side, forming extensions to the hinge members 26a and 26b. From its connection at the joints 28a and 28b, the upper support member 40 extends along the longitudinal axis B of the shoe into the upper portion 54 of the shoe 24, and extends across the back portion 56 of the shoe 24. The back portion 56 of the shoe 24 is fixed to the upper support member 40 using a connector 58.

[0023] In this embodiment, the foot support 22 is shown to have two hinge members 26a, 26b that extend along each side of the shoe 24 and engage with corresponding arms 38a, 38b of the instep support 40, respectively. However, it should be understood that the orthopedic foot brace 10 can be modified without departing from the present disclosure. For example, in another embodiment, there may be only one arm to the instep support that connects to one of the joints on the side of the shoe. In such an embodiment, the instep support extends from the engaged joint and terminates with a connector. In yet another embodiment, the foot support has hinge members on only one side of the shoe, which may be the central side or side of a given shoe, and the instep support extends along the same side.

[0024] Referring further to Figure 2, the foot support 22 further has a heel member 30 which is integrated with the foot support 22 via joints 28a and 28b. The heel member 30 has a proximal portion 60 which extends downward toward the sole portion 62 of the shoe 24, then backward beneath the hinge members 26a and 26b, laterally along the shoe 24, toward the heel portion 32 and toward the vicinity of the sole portion 62. Similar to Figure 1, the heel member 30 extends from the joint 28a on the first side surface around the heel portion 30 and terminates at the other joint 28b on the opposite side surface.

[0025] Perhaps best illustrated in Figure 2, the heel member 30 follows the heel portion 32 and contributes to the mechanical movement that can be transmitted between the foot and the orthopedic foot brace 10.

[0026] It should be understood that the heel member 30 may be modified, replaced, or omitted without departing from this disclosure. For example, in another embodiment, the heel member may extend from only one of the sides and terminate at the heel portion. In yet another embodiment, the heel member may extend from the apex of the foot support toward the heel member, extending over one or both sides of the shoe near the sole portion of the shoe. In yet another embodiment, the heel member may extend across the dorsal portion of the shoe between two joints present on the side of the shoe and be completely replaced by a strap that provides support corresponding to an orthopedic foot brace. In yet another embodiment, the entire heel member may be omitted.

[0027] Referring now to Figure 3A, the corrective foot brace 10 of Figure 2 is shown in unused condition. It should be noted that the corrective foot brace 10 has two parts that extend substantially along corresponding two separate longitudinal axes. The leg support 42 extends along axis C which is substantially parallel to axis A of the lower leg 16 when in use, and the instep support 40 extends along axis B which corresponds to the longitudinal axis of the shoe 24. Unlike the active use state shown in Figure 2, in Figure 3A, an acute angle, i.e., a stationary angle α of less than 90°, is formed. This angle can be a variety of values ​​depending on the model and customer needs. However, when in use, the angle between axis C and axis B is configured to change according to the gait of the observed walking cycle, perhaps best shown in Figure 2. As will be described in more detail later, in this example, the foot support 22, in particular the hinge members 26a and 26b, are preferably made of a material with a lower modulus of elasticity than the leg support and instep support, and which undergo the greatest elastic deformation when in use.

[0028] Referring further to Figure 3A, in this embodiment, beams 44a and 44b have a set of flat surfaces extending along the length of the beams. The beams have an elliptical, or in other words, a "racetrack" type cross-sectional shape, as perhaps best shown in Figure 3B, which shows the cross-section of the pair of beams along line 3B-3B in Figure 3A. The flat surfaces 60a and 60b of beams 44a and 44b face each other circumferentially, such that parallel surfaces are formed, separated by the curved surfaces on each side.

[0029] In the specific embodiment shown in Figure 3B, beams 44a and 44b are solid. Beams 44a and 44b can be considered to have an outer diameter 62 corresponding to a curved surface. The beams further have a beam thickness 64, a beam width 66, a flat surface width 68 smaller than the beam width 66 due to the presence of a curved surface, and a beam spacing 70 between beams 44a and 44b. Depending on the embodiment, the exact size and dimensions of beams 44a and 44b can be defined by any combination of these measurements.

[0030] It should be understood that the exact structure and dimensions of beams 44a and 44b may be modified without departing from this disclosure. For example, Figure 3C shows another embodiment of beams 44a and 44b which may be used with the foot brace 10 of Figure 3A. In this embodiment, beams 44a and 44b are very similar to the beams of Figure 3B, except that they are hollow rather than solid. The wall thickness 72 of the perimeter walls of beams 44a and 44b defines the internal cavity.

[0031] It should be understood that different mechanical properties can be achieved by changing the structural values ​​of the beams, whether they are solid as shown in Figure 3B or hollow as shown in Figure 3C. Variables that can be changed to achieve the desired mechanical properties may include, for example, beam thickness, beam width, outer diameter, and flat surface width. Furthermore, it should be understood that different mechanical properties can also be achieved by adjusting the beam spacing. As perhaps best shown in Figure 3A, beams 44a and 44b connect the leg holders 12 to the leg supports along axis C. These are subjected to axial and flexural stresses, as well as torsional stresses. The beam spacing 70 can be selected to provide the desired torsional strength of the assemblies forming the leg supports 42. Further, as will be discussed later, in this embodiment, the non-circular cross-section of the beams at the cuff connectors 46 and leg connectors 50a and 50b further provides a means to prevent resulting slippage between the beams and connectors. This contributes to ensuring that the structure formed by the beams and connectors acts as a single unit when subjected to torsion.

[0032] It should be understood that the exact dimensions, internal structure, and surface structure of the beam may be modified without departing from this disclosure. For example, in another embodiment, the beam has only a single flat surface. In yet another embodiment, curved surfaces may be omitted. In yet another embodiment, the flat surface of the beam may extend only from the beam end for a portion of the beam's length (Figure 4B), with the remainder of the beam's length being circular or elliptical.

[0033] The beam may be made of any material deemed suitable for the application of the foot brace. In this particular embodiment, the beam is made of carbon fiber-finished graphite. In a particular embodiment, the beam may be dimensional to achieve, for example, a bending beam modulus of about 1.5 GPa at room temperature. In another embodiment, the beam is made of a material with mechanical properties corresponding to those of the upper brace, which will be described in more detail later. In yet another embodiment, the beam is made of the same material as the upper brace.

[0034] Returning to Figure 3A, in this embodiment, the two flat surfaces 60a and 60b of beams 44a and 44b are oriented such that one flat surface faces the rear portion of the lower leg during use, and the opposite flat surface faces the opposite side of the lower leg. This has the advantage of providing convenient flat surfaces that ensure secure engagement of the fasteners, while minimizing the possibility of the user's leg rubbing against the beam, as will be described in more detail later.

[0035] Beams 44a and 44b connect the leg holder 12 to the leg support 22 via cuff connectors 46 and leg support connectors 50a and 50b, respectively. Now, let us focus on Figure 4A, which is an enlarged view of the cross section 4A-4A of the orthopedic leg brace 10 shown in Figure 3A. The cuff connector 46 accommodates and engages with the respective ends 48 of beams 44a and 44b. Beams 44a and 44b are housed within the cuff connector 46 via corresponding path openings that lead to their respective paths 74. Each path has a cross-sectional shape and size that matches the cross-sectional shape and size of beams 44a and 44b. This ensures that the beam bodies are securely housed while minimizing movement.

[0036] As described above, in this embodiment, the flat surfaces 60b of beams 44a and 44b face away from the rear portion of the user's leg. The cuff connector has a fastener opening 76 configured to house a corresponding fastener 78 inside. As perhaps best shown in Figure 4B, which shows a cross-sectional view of the cuff connector 46 and the beams 44a and 44b housed inside it along line 4B-4B in Figure 4A, the fastener opening 76 communicates with the path 74 and is aligned with the flat surfaces 60b of beams 44a and 44b. Thus, when the fastener 78 is housed in the fastener opening 76, the tip of the fastener 78 abuts flat against the flat surface 60b of beam 44a, allowing beam 44a to press against the opposing surface 80. The fasteners 78, in cooperation with the strong interlocking of beams 44a and 44b with their respective paths 74 due to their non-circular shapes, can prevent the beams 44a and 44b from rotating within their respective paths 74.

[0037] In this way, the cuff connector 46 efficiently transmits force to the beam. This ensures that the load is evenly distributed along the surface of the beam end housed within the cuff connector path, while preventing relative rotation between the beam and the cuff connector. The structure of this cuff connector path, combined with the beam structure and means for holding the beam in place by friction, allows the cuff and beam to work together to efficiently transmit axial, bending, and torsional forces.

[0038] Perhaps best illustrated in Figure 4C, the leg support connectors that accommodate the opposite end of the beam have a similar structure and operating mode in this embodiment, but differ in that, unlike the cuff connector 46 which faces away from the leg, the fastening openings 80 of the leg support connectors 50a and 50b face towards the leg.

[0039] In this specific example, the fastener is a headless fastener whose entire body can be housed within the fastener opening of the cuff connector and the foot support connector. This prevents the fastener from having a head that could rub against the user's leg or snag on clothing, for example. It should be understood that other fastening means may be used without departing from this disclosure. For example, although the above embodiments disclose a single fastener for each of the cuff connector and the foot support connector, it may be desirable to have two fasteners for each connector. In another embodiment, for both the foot support connector and the cuff connector, there is a fastener opening and corresponding fastener facing the posterior portion of the user's lower leg, and a fastener opening and corresponding fastener facing the opposite side of the posterior portion of the user's lower leg. This effectively provides two fasteners for engaging the beam with each connector of the orthopedic foot brace. In yet another embodiment, the fastener is configured to extend through a beam housed within the connector. In yet another embodiment, the beam may be bonded to or integrally manufactured with the cuff connector and / or the foot support connector.

[0040] It should be understood that the cuff connector and foot support connector may be modified without departing from this disclosure. For example, the cross-sectional shape of the beam may be modified to have only a single flat surface. In such alternative embodiments, the cross-sections of the cuff connector and foot support connector paths are applied to correspond to the cross-section of the beam. In that same embodiment, it may be desirable to position the fastener opening and fastener on the same side of the orthopedic foot brace (i.e., either facing the posterior portion of the user's lower leg or the opposite side). This side may correspond to the orientation of the flat surface of the beam.

[0041] Referring further to Figure 5, the joints 18a and 18b of the foot support 22 each have openings 84 capable of accommodating the corresponding arms 38a and 38b of the instep support 40. When the instep support 40 engages with the instep portion of the shoe 24, which may vary in size from user to user, the instep portion of the orthopedic foot brace is configured to be adjustable along the length of the shoe 24. This is achieved by the sliding of the arms 38a and 38b of the instep support 40 within the joints 18a and 18b, thereby allowing the user some degree of adjustment. The instep support 40 can be firmly held in place by using instep support fasteners 86, which can be fixed within corresponding fastener openings formed within the joints 18a and 18b. The instep support fasteners 86 can be loosened to allow longitudinal sliding of the instep support arms 38a and 38b along the length of the shoe, and can be tightened so that the instep support fasteners 86 engage with adjustment recesses 88 provided on the instep support arms 38a and 38b. When the upper support fastener 86 is tightened, it engages with the corresponding recess, locking the upper support 40 in the desired position.

[0042] It should be understood that alternative adjustment and fastening means for the upper support may be provided without departing from the present disclosure. For example, in another embodiment, the arm of the upper support has a hole for accommodating a portion of an upper support fastener for engagement, instead of an adjustment recess. In yet another embodiment, the upper support may be formed without a recess and configured to engage within the joint of the foot support, similar to how a beam engages with a foot support connector or cuff connector. In yet another embodiment, the upper support arm is permanently engaged with the joint of the foot support so as to be unadjustable.

[0043] Now, let's look at Figure 6, a flowchart showing the steps for assembling an exemplary orthopedic foot brace. The different elements of the orthopedic foot brace described above are provided separately, for example, to save space during transport and storage, and can be assembled so that the orthopedic foot brace is provided through the following steps.

[0044] In step AA, the beam engages with the cuff and one of the foot supports by inserting the beam end into the path of one of the foot support connectors. Once the beam is fitted snugly into the given path, it is locked in place by a fastener. In step BB, the fastener corresponding to the path into which the beam end is fitted abuts against the beam and is tightened until it is locked in place. Since the embodiment of the orthopedic foot brace has two beams, steps AA and BB are repeated for the first end of the other beam. This results in two beams with their first ends fitted into connectors.

[0045] It should be understood that each of the two beams may have a first end that engages with the same connector of the orthodontic foot brace (i.e., both connect to a foot support or cuff). However, in another embodiment, each beam may have a first end that engages with a different connector. In other words, the first beam may have its first end engaged with the cuff connector of the cuff, while the first end of the other beam may have its first end engaged with the foot support connector of the foot support, or vice versa.

[0046] Referring further to Figure 6, in step CC, the second beam end of each beam is inserted into the corresponding path of the cuff connector and foot support connector, and then in step DD, it is locked in place by the corresponding fastener.

[0047] In some embodiments, it may be desirable for the instep support to arrive detached from the foot support. In such embodiments, the arms of the instep support are housed within openings present in the joint of the foot support and are to be fastened in place by instep support fasteners at steps EE and FF, respectively.

[0048] Figure 7 shows a partial side view of an exemplary orthopedic foot brace 10 in a state where a load is applied uniformly to the lateral and central sides, causing it to flex under load. Figure 8 shows a partial front view of an orthopedic foot brace with a load applied to the lateral side.

[0049] When in use, the orthopedic foot brace transfers the load from the shoe on the foot of a patient suffering from foot drop to the rest of the brace. To improve efficiency, it is desirable to minimize the amount of unexpected and unnecessary deflection that may occur due to specific elements of the orthopedic foot brace 10. This is particularly true with respect to the instep support 40, which is the main area of ​​force transfer between the shoe 24 and the orthopedic foot brace 10.

[0050] For clarity, Figures 7 and 8 illustrate loading conditions, applied in a theoretically perfect plane and as a point load on the orthodontic foot brace 10. This is for illustrative purposes only. In either of these conditions, it should be understood that beams 44a and 44b are statically held and capable of providing any necessary reaction forces to the foot support to illustrate the deflection of the instep support 40, such as when the orthodontic foot brace 10 is worn by a user. Furthermore, the orthodontic foot brace in these figures is intended to be used on the user's right foot, so that different lateral elements are identified. Thus, the lateral arm 38a of the instep support is on the left side of Figure 8, and the central arm 38b of the instep support is on the right side of Figure 8.

[0051] In Figure 7, the load is applied downward in the xz plane at the distal portion 88 of the instep support 40. The load is applied so that the flexion is completely distributed between both the lateral arm 38a and the central arm 38b of the instep support 40. Due to the mirror-like structure of the orthopedic foot brace 10 along the plane formed by axes C and B, perhaps best shown in Figure 3A, the instep support 40 flexes evenly on both sides. In Figure 8, the load is applied downward in the yz plane at the point of contact between the lateral arm 38a of the instep support 40 and the foot support 22. This load simulates a moment M along the yz plane acting on the instep support 40, which may occur due to the rotation of the user's foot.

[0052] First, let's look at Figure 7. When the patient lifts their foot, a downward load is applied to the instep support 40, which is engaged with the upper part of the shoe, because the user cannot lift their foot at the ankle. It is desirable that the instep support engages deeply enough with the foot so that a large moment arm is formed from the pivot point. On the other hand, the longer the instep support 40, the greater the deflection of the member under load. For efficiency, it is desirable that the instep support 40 transmits the maximum load to the foot support 22 so that the hinge members 26a and 26b can deflect predictably and as desired. This creates a deflection angle β between the instep support along axis B in the unloaded state and the instep support along axis B' in the loaded state. In this embodiment, the deflection angle β is achieved by the deflection of the foot support 22 due to the load transmission from the instep support 40.

[0053] With this in mind, the instep support 40 and the foot support 22 are made of different materials. The instep support 40 is made of a fiber-reinforced polymer, preferably a glass-reinforced long-chain polyamide resin. It should be understood that any other type of reinforcing polymer may be used without departing from this disclosure. For example, such a reinforcing polymer may have fibers made of different materials, such as glass, carbon, aramid, or basalt, within it. On the other hand, the foot support 22 is made of a thermoplastic elastomer, preferably a thermoplastic polyester elastomer. It should be understood that any other type of thermoplastic elastomer may be used without departing from this disclosure. For example, thermoplastic polyolefin elastomers, thermoplastic vulcanized products, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic polyamides, or unclassified plastic elastomers may also be used.

[0054] In all cases, the material of the instep support 40 provides an elastic modulus at least twice, preferably at least five times, and more preferably at least twelve times higher than the elastic modulus of the material of the foot support. Preferably, the material of the instep support has an elastic modulus of at least 14 GPa, and the material of the foot support has an elastic modulus of 1.5 GPa or less. It should be understood that the mechanical properties of these materials are obtained at room temperature, preferably at room temperature, and the applicable elastic modulus of these materials is the flexural modulus. In this specific embodiment, the material of the instep support is a glass-reinforced long-chain polyamide resin having a flexural modulus of about 14.4 GPa at 23°C. On the other hand, the material of the foot support is a thermoplastic polyester elastomer having a flexural modulus of about 1.12 GPa at 23°C.

[0055] Referring further to Figure 7, for completeness, an exemplary angular deflection of the upper support under load is provided. In this embodiment, when the load on the distal portion of the upper support corresponds to a weight of 2.75 kg (i.e., when the applied force corresponds to approximately 26.97 Newtons), the upper support deflects at an angle from its original resting position along axis B to a loaded position along axis B'. In this example, the angular deflection β of the upper support is 12° or less.

[0056] Next, let us consider Figure 8. During use, the user's foot typically undergoes a rotation known as inward and outward rotation. Supporting this is as important as supporting dorsiflexion of the foot (Figure 7). For efficiency, it is preferable that the maximum load is transmitted from the instep support to the foot support so that the hinge member can deflect predictably and as desired. This is because a lateral angular deflection γ occurs between the axis D passing through the corresponding portions of the lateral and central arms of the instep support in a stationary (unloaded) state and the axis D' of the instep support under lateral load. In this embodiment, the orthodontic foot brace has the materials and modulus of elasticity corresponding to those described in Figure 7. For brevity, these materials and modulus of elasticity will not be repeated.

[0057] Referring further to Figure 8, for completeness, an exemplary lateral angular deflection of the instep support under lateral load is provided. In this embodiment, when the load on the contact point of the lateral arm 38a with the foot support 22 corresponds to a weight of 2.75 kg (i.e., when the applied force corresponds to approximately 26.97 Newtons), the lateral arm 38a deflects at an angle from its original stationary position forming an axis D across the lateral and central arms of the instep support to a loaded position forming axis D'. In this example, the lateral angular deflection γ of the instep support is 14° or less.

[0058] Figures 7 and 8 show two possible load conditions, but it should be understood that the corrective foot brace in use is subjected to complex multidirectional load conditions. However, in any case, according to this embodiment, the load can be efficiently transmitted from the instep support to the foot support, which is the part that accounts for the majority of the deflection. In this example, when a load is applied to the instep support, at least 80% of the deflection that occurs between the lower leg (i.e., axis A parallel to axis C in use) and the instep support (i.e., the pivot of axis B around axis parallel to axis D) is due to the hinge member of the foot support. Preferably, at least 80% of the deflection is due to the hinge member. More preferably, at least 85% of the deflection is due to the hinge member. More preferably, at least 90% of the deflection is due to the hinge member. Even more preferably, at least 95% of the deflection is due to the hinge member. Even more preferably, at least 99% of the deflection is due to the hinge member.

[0059] Similarly, when a load is applied to the instep support, at least 80% of the deflection between the lateral and central arms of the instep support (i.e., the pivot of axis D around an axis parallel to axis B) is due to the hinge members of the foot support. Preferably, at least 80% of the deflection is due to the hinge members. More preferably, at least 85% of the deflection is due to the hinge members. More preferably, at least 90% of the deflection is due to the hinge members. Even more preferably, at least 95% of the deflection is due to the hinge members. Even more preferably, at least 99% of the deflection is due to the hinge members.

[0060] It should be understood that the materials and moduli corresponding to those described in Figures 7 and 8 can be used in the leg supports of orthopedic foot braces to achieve the corresponding mechanical advantages. The examples described above and illustrated are for illustrative purposes only. Many further features and combinations relating to this improvement will be apparent to those skilled in the art. The scope is specified by the attached claims.

Claims

1. It is a corrective foot brace for people who wear shoes, A leg holder having a cuff that can be fixed to the lower leg of the person for use, A leg support extending from the leg holder, A connector that is attached to the back of the shoe when in use, and an upper support having two arms that extend rearward from each of the two ends of the connector, A foot support having two hinge members, each hinge member extending downward and forward from the leg support until it reaches a joint on the corresponding side of the person's foot when in use, the joint forming a structural connection with a heel member, the heel member having two proximal portions extending downward and backward from each of the joints and converging at their distal portions to form a loop between the two joints, the distal portions engaging with the heel portion of the shoe when in use, the joints each having an opening for accommodating the corresponding ends of the arms of the upper support, the upper support extending forward from the joints, forming an arc between the two arms and connecting the two joints, Equipped with, The foot support and the heel member form a part of the same component that extends continuously across the joint between the foot support and the heel member. The aforementioned instep support is made of fiber-reinforced polymer, and is an orthopedic foot brace.

2. It is a corrective foot brace for people who wear shoes, A leg holder having a cuff that can be fixed to the lower leg of the person for use, A leg support extending from the leg holder, A connector that is attached to the back of the shoe when in use, and an upper support having two arms that extend rearward from each of the two ends of the connector, A foot support having two hinge members, each hinge member extending downward and forward from the leg support until it reaches a joint on the corresponding side of the person's foot when in use, the joint forming a structural connection with a heel member, the heel member having two proximal portions extending downward and backward from each of the joints and converging at their distal portions to form a loop between the two joints, the distal portions engaging with the heel portion of the shoe when in use, the joints each having an opening for accommodating the corresponding ends of the arms of the upper support, the upper support extending forward from the joints, forming an arc between the two arms and connecting the two joints, Equipped with, The foot support and the heel member form a part of the same component that extends continuously across the joint between the foot support and the heel member. The aforementioned instep support is made of glass-reinforced long-chain polyamide resin, and is an orthodontic foot brace.

Images