Dr. Ignacio Ponseti is an internationally famous physician and surgeon specializing in the treatment and management of a childhood deformity commonly known as a clubfoot. Dr. Ponseti has for many decades promoted the use of a foot and ankle abduction device, or orthosis, which is used to correct and prevent relapses of the clubfoot deformity. These abduction devices typically consist of a linear, rigid bar connected between shoes worn by the child which the bar separates the feet of the child and holds the feet in an outward rotation or abduction. Typically, if the condition is diagnosed early enough, this device is worn full-time for a period of months, but during the period of treatment, the angle of outward rotation is periodically adjusted using rotatable attachments, which may be screwed into a fixed engagement with the ankle and foot brace/orthotic or clipped into engagement with an attachment clip mechanism that itself is affixed to the linear, rigid bar and the ankle and foot orthotic.
The technique for treating clubfoot developed by Dr. Ponseti has become known throughout the world and has been highly successful in treating club feet without the necessity of corrective surgery. Many devices have been designed and used in performing Dr. Ponseti's technique. Some currently used devices that are used to perform Dr. Ponseti's manipulative technique are shown in U.S. Pat. No. 7,267,657, the disclosure of which is hereby incorporated by reference in its entirety. In the '657 patent there are disclosed devices which provide for release of the mounts from the abduction bar and universal mounts that can be attached to any shoe. The devices of the '657 patent and those typically used in Dr. Ponseti's clubfoot correction technique employ a rigid, typically multi component and metal shoe separating bar. The orthosis clip described in the '657 patent, in its typical arrangement, is affixed to the rigid linear bar using a screw or other fastening system that engages at three locations, one in the center and two proximate the circumference of a circular end of the rigid linear bar.
One aspect of the present disclosure includes a quick release member for attachment to a sole of an orthotic shoe having a body to be coupled to an orthotic bar assembly for keeping the feet of a user at a predetermined distance, a pair of wings extending laterally from the body to slide within corresponding overhangs on the bottom of a shoe sole, a locking tab configured to keep the quick release member coupled to the shoe sole by interfacing with a quick release button barrier on the shoe sole, a locating recess in a top potion of the body configured to provide enhanced stability by interfacing with a platform on the shoe sole, and a notch, typically a centering notch, at the front of the body configured to interface with a centering projection on the shoe sole.
Another aspect of the present disclosure includes a sole attachment assembly for attachment to an orthotic bar having a sole to retain a shoe of a user and a quick release member to couple to an orthotic bar. The sole includes a sole body, a release member receiver, a platform on the receiver, guide wings, a centering projection, and a release button barrier spanning between the guide wings. The quick release member includes a release member body, wings extending laterally from the release member body to slide within the guide wings, a locking tab to keep the quick release member coupled to the shoe sole by interfacing with the quick release button barrier, a locating recess in a top potion of the body configured to provide enhanced stability by interfacing with the platform on the sole, and a centering notch at the front of the body configured to interface with the centering projection on the sole.
Yet another aspect of the present disclosure includes a method of attaching a quick release member to a sole for attachment to an orthotic bar to treat clubfoot, typically treating clubfoot using Dr. Ponseti's method of treating clubfoot, including the steps of sliding a pair of wings extending laterally from a body of a quick release member into a space formed by a pair of guide walls on the bottom of a sole, stabilizing the quick release member connection to the sole by interfacing a locating recess on the top of the body of the sole and platform on the bottom of the sole, centering the quick release member relative to the sole by interfacing a centering projection and a centering notch, locking the quick release member to the sole by sliding a locking tab on the quick release member past a release button barrier spanning across the pair of guide walls such that the locking tab is urged into an unlocking position until the locking tab slides past the release button barrier and creates an interference between the locking tab and the release button barrier, and releasing the quick release member from the sole by pushing by hand and without the use of tools the locking tab into a release position such that the locking tab and the release button barrier are no longer in interference with one another and sliding the quick release member out of the sole.
Yet another aspect of the present disclosure includes a method of attaching a quick release member to a sole for attachment to an orthotic bar to treat clubfoot including the steps of sliding a pair of guide walls on the bottom of a sole over a pair of wings extending laterally from a body of a quick release member, stabilizing the quick release member connection to the sole by interfacing a locating recess on the top of the body of the sole and platform on the bottom of the sole, centering the quick release member relative to the sole by interfacing a centering projection and a centering notch, locking the sole to the quick release member by sliding a release button barrier spanning across the pair of guide walls past a locking tab on the quick release member such that the locking tab is urged into an unlocking position until the release button barrier slides past the locking tab and creates an interference between the locking tab and the release button barrier, and releasing the quick release member from the sole by pushing by hand and without the use of tools the locking tab into a release position such that the locking tab and the release button barrier are no longer in interference with one another and sliding the sole away from the quick release member.
Another aspect of the present disclosure is generally directed to a quick release member for attachment to a sole of an orthotic shoe and an orthotic bar that includes: a main body adapted to be coupled to an orthotic bar assembly the main body having a top surface and a bottom surface, orthotic bar facing surface; an orthotic shoe clip portion that engages an orthotic shoe in use wherein the orthotic shoe clip portion has a first wing and a second wing that each extend laterally away from the main body and connect with a locking tab base portion that extends between a distal end of the first wing and a distal end of the second wing; a locking tab spaced between the first wing and the second wing and engaged with the locking tab base portion and the locking tab is biased at an angle such that it is not in the same plane as a plane defined by the first wing and the second wing; and at least one notch within the locking tab base portion.
These and other aspects, objects, and features of the present disclosure will be understood and appreciated by those skilled in the art upon studying the following specification, claims, and appended drawings.
In the drawings:
For purposes of description herein, the terms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,” “horizontal,” and derivatives thereof shall relate to the disclosure as oriented in
Now referring to the drawings wherein like numerals refer to like matter throughout, and more specifically referring to
Insole 106 is typically secured to sole 104 by glue and may be supplemented, if necessary, providing an insole side protuberance 162 to extend through a sole side hole 142 in sole 104. While one insole side protuberance is shown it should be appreciated that a plurality of spaced apart and/or differently shaped protuberances may be used and mated with corresponding side holes. Similarly, insole heel protuberance 164 extends through sole heel hole 144 and thereby holds insole 106 stable with respect to sole 104. Again, while one insole heel protuberance is shown multiple protuberances with the same or different shapes could be used and engaged with the sole heel holes. Insole 106 is also shown having an insole heel right viewing hole 166, which is located near the heel of the insole 106, so that it can readily be seen that a child's foot is in contact with the insole 106. In a preferred embodiment, the insole heel right viewing hole 166 is a pair of holes on opposite sides of the heel or is a single hole which spans to both sides of the heel. In either embodiment, it would be possible to view the placement of the child's foot with respect to the insole 106 from a vantage point on either side of the heel.
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The quick release member 700 is typically attached to a bar using a fastener, typically a threaded fastener such as a screw or bolt, more typically a medical grade screw or bolt, through a single connection hole 1016. Each connection hole typically includes a threaded metal sleeve positioned within the aperture 1016 that typically engages a screw through the quick release member 700 and into the threaded receiving aperture. The threaded metal sleeve(s) are typically integrally formed into the bar. The female threaded metal sleeve positioned within the aperture is typically formed by molding the bar 1000 around the metal threaded screw receiving aperture 1016. Each single connection hole 1016 is typically positioned co-centric with a plurality of ribs 1014 that extend around a majority or the entirety of an aperture 1016 of the bar 1000 and extend upward from the top surface of the bar such that the ribs create ridges and valleys. These ribs 1014 may be used to adjust the angle of the quick release member and thereby the angle of the shoes when engaged with the quick release member during treatment. The ribs 1014 may engage corresponding ridges 1751 on the bottom surface of the quick release member to further retain the quick release member more securely in the correct treatment position and be easily adjustable across a range of positions.
The adjustment bar assembly 1000 further includes quick release members 700, which are configured to be inserted into sole attachment receiving groove 606 and quick release push button receiving void 608 of
As the quick release member 700 is inserted into the sole 104, the quick release button barrier 610 interfaces with the quick release button 708 in the following way. The quick release button 708 slides along the quick release button barrier 610, increasingly pushing against its bias until the quick release member 700 reaches substantially its home position within the sole 104. Once the quick release button 708 clears the quick release button barrier 610, the quick release button 708 snaps back into its biased and default position thereby providing interference with the quick release button barrier 610 such that the quick release member cannot be removed from the sole 104 until a user positively pushes to apply force against the quick release button 708 below the quick release button barrier 610, and the quick release member 700 can slide out of the sole 104. Typically, the force used to depress the quick release button sufficient to release it from engagement with the sole of the orthotic shoe is greater than what a child can apply, typically a child that is four years old or less. The force needed to depress the quick release button 708, which may be a “tab” as shown, is typically greater than 16 Newtons, more typically greater than about 25 Newtons, and more typically greater than 35 Newtons. The force may be adjusted, but is typically high enough that a child being treated for clubfoot can not remove the quick release member 700 from engagement with the orthotic footwear without the assistance of someone older, preferably an adult. Surface 714 typically engages an orthotic bar of the present disclosure when in use.
The quick release members 700 may be attached to the adjustment bar 1000 at the connection holes 1016. The quick release members 700 may include a threaded stud, a screw, a bolt, or other fastener that extends through or into the connection hole 1016, and is attached by a nut on the opposite side of the bar 1000. The nut is attached to the end of the stud and tightened until it applies pressure against the bottom side of the bar 1000. It should be noted that the bolt and nut combination may be reversed, i.e. the bolt may be integral with the bar 1000, or the bolt may be a completely separate member from the quick release member 700 and extend through a corresponding hole in the quick release member 700.
In operation, the present devices can be used to carry out the technique of Dr. Ponseti to treat clubfoot according to the process discussed below. A practitioner determines the proper spacing and angle for a user's feet using any method known in the art. The practitioner then attaches one of the quick release members 700 to the bar 1000 by inserting the integrally coupled bolt through the locator hole 1016. A nut is attached on the opposite side of the bar from the quick release member 700, but not tightened. The practitioner then orients the quick release member at the desired angle. The nut is then tightened down. As the bolt is tightened down, the ribs 1014 of the quick release member interfere with the ribs on the bar 1000, preventing rotation of the quick release member 700 with respect to the bar 1000. The practitioner then attaches the second quick release member 700 to the other end of the bar 1000 in the same way.
The practitioner then places the shoes or footwear 100 on the user's feet. Each of the shoes 100 are placed over the quick release members 700 by sliding the quick release main body into sole attachment receiving groove 606 on the footwear 100 and sliding in further until quick release button 708 snaps into a locked position in quick release push button receiving void 608.
It should be noted that the attachment described above may further be accomplished in alternate steps without deviating from the spirit of the disclosure. For instance, the footwear 100 may be attached to the user first and quick release members 700 slid into their respective receiving grooves 606 before attachment to the bar. The practitioner may then insert the bolts of the quick release into the locator holes 42 and tighten down. Further, there may be no bolts at all, but rather a quick-click style attachment or something similar known in the art.
As shown in more detail in
As the quick release member 700 gets closer to its home and locked position, the locating indentation 720 on the quick release member 700 interfaces with a platform 724 on the sole 104, and a centering notch 730 at the front or leading edge (as the quick release member 700 is inserted into the sole) of the quick release member 700 interfaces with a centering projection 732 on the sole. The platform 724 is typically spaced in the recess of the sole and typically integrally formed therein, but could conceivably be engaged as a separate component to the bottom of a footwear/orthotic. While shown as a rounded bump that is generally V-shaped, the platform 724 typically has a centering projection 732 on the end wall of the platform closest to the toe end of the footwear and projecting backward toward the heel of the footwear and toward the opposite end of the platform 724 that receives a portion of the quick release member including the locating wings 722 and the quick release button or tab. The projection can be any shape. There could also be more than one projection as well that are spaced apart from one another but on the end wall. In such instance, the at least one notch 730 would be designed to correspondingly mate with the projection thereon. This provides the quick release member 700 and the sole 104 with more surfaces and planes to interface and interact and substantially reduces the amount of play between the quick release member 700 and the sole 104, providing a more stable position for the user of the device.
The quick release members may further include a hole 706 within a counterbore, which is a cylindrical flat-bottomed hole that enlarges another coaxial hole. As the practitioner attached the quick release member 700 to the bar 1002 in this embodiment, a fastener such as a screw may be placed within the hole 706 and through the hole 1016 in the bar 1002. A nut may be placed on the bottom side of the bar 1002 and fastened to the screw to tighten the quick release member to the bar 1002 and keep it in place.
Another quick release member is shown in
Another adjustable bar and using a quick release member 1700 or other quick release member as described herein is shown in
The quick clip members 1700 according to this aspect of the present disclosure may engage an intermediate portion 2710, which, in turn, engages a bottom portion 2720. The three components 1700, 2710, and 2720 may be assembled first and the angle of the quick clip member set with respect to the bottom portion 2720 before introducing the bar 2102 into the assembly. The assembly includes a slot 2730 into which the bar 2102 is placed, and a screw is tightened through the center holes of each part, through a hole 2104 of the bar 2102, and into a threaded portion of the bottom portion 2720. The intermediate portion may be a plastic material, but is most typically a thermoplastic elastomer (TPE), which is sometimes referred to as thermoplastic rubber, such that, when the intermediate portion 2710 is an elastomeric material, it provides higher friction and a better grip of the bar 2102 to prevent slippage during use if one wearing the device stands (see right side of assembly shown in
It will be understood by one having ordinary skill in the art that construction of the described disclosure and other components is not limited to any specific material. Other exemplary embodiments of the disclosure disclosed herein may be formed from a wide variety of materials, unless described otherwise herein.
To the extent that the term “includes” or “including” is used in the specification or the claims, it is intended to be inclusive in a manner similar to the term “comprising” as that term is interpreted when employed as a transitional word in a claim. Furthermore, to the extent that the term “or” is employed (e.g., A or B) it is intended to mean “A or B or both.” When the Applicant intends to indicate “only A or B but not both” then the term “only A or B but not both” will be employed. Thus, use of the term “or” herein is the inclusive, and not the exclusive use. Also, to the extent that the terms “in” or “into” are used in the specification or the claims, it is intended to additionally mean “on” or “onto.”
For purposes of this disclosure, the term “coupled” (in all of its forms, couple, coupling, coupled, etc.) generally means the joining of two components (electrical or mechanical) directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two components (electrical or mechanical) and any additional intermediate members being integrally formed as a single unitary body with one another or with the two components. Such joining may be permanent in nature or may be removable or releasable in nature unless otherwise stated.
It is also important to note that the construction and arrangement of the elements of the disclosure as shown in the exemplary embodiments is illustrative only. Although only a few embodiments of the present innovations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of the interfaces may be reversed or otherwise varied, the length or width of the structures and/or members or connector or other elements of the system may be varied, the nature or number of adjustment positions provided between the elements may be varied. It should be noted that the elements and/or assemblies of the system may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present innovations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the desired and other exemplary embodiments without departing from the spirit of the present innovations.
It will be understood that any described processes or steps within described processes may be combined with other disclosed processes or steps to form structures within the scope of the present disclosure. The exemplary structures and processes disclosed herein are for illustrative purposes and are not to be construed as limiting.
It is also to be understood that variations and modifications can be made on the aforementioned structures and methods without departing from the concepts of the present disclosure, and further it is to be understood that such concepts are intended to be covered by the following claims unless these claims by their language expressly state otherwise.
This application is an International Patent Application that claims priority to and incorporates by reference in their entireties each of the following: U.S. Provisional Application No. 63/284,411, filed on Nov. 30, 2021, entitled “UNITARY INJECTION MOLDED BAR FOR CORRECTING CLUBFOOT;” U.S. Provisional Application No. 63/284,413, filed on Nov. 30, 2021, entitled “ORTHOTIC BRACE AND CLIP ATTACHMENT MECHANISM;” and U.S. Provisional Application No. 63/340,204, filed on May 10, 2022, entitled “UNITARY INJECTION MOLDED BAR FOR CORRECTING CLUBFOOT.”
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/051446 | 11/30/2022 | WO |
Number | Date | Country | |
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63340204 | May 2022 | US | |
63284413 | Nov 2021 | US | |
63284411 | Nov 2021 | US |