Patent Application
20190262164
The present disclosure relates generally to anatomical supports, and more particularly, to a low profile orthopedic ankle support for reducing edema and selectively restricting movement of a user's ankle.
Acute ankle injuries are the most common acute sport trauma, accounting for about fourteen (14) percent of all sports related injuries. Among eighty (80) percent are ligamentous sprains caused by explosive inversion or supination. The etiology of most ankle sprains is due to incorrect foot positioning at landing during activity. The ligamentous structures are exposed to sudden high explosive forces in an extremely short amount of time, resulting in grade 1, 2, or 3 ligamentous injuries and fractures in and about the joint. In short, the offending moments are presented and actuated before our body can compensate.
Ligaments are generally strong elements designed to facilitate proper joint operation by inhibiting a joint from moving in a direction in which the joint is not designed to move. Numerous ligaments and ligament types are associated with various portions of the human anatomy. The ankle joint, for one, is associated with certain well-known ligaments. When an injury occurs such that one or more ligaments are torn, the remaining ligaments are left to bear the resistance resulting from any ankle movement in order to maintain proper operation of the joint while the injury heals. Sprains, strains and other injuries involving ligaments and ankle tissue are painful, can cause considerable swelling and can endure for some time.
A number of orthopedic supports are currently available to assist in healing for people with ankle injuries including sprains, torn ligaments, and the like. For individuals suffering from severe ankle injuries such as those involving multiple ligaments or bone fractures, a cast or walking boot may be suitable. For the majority of individuals whose sprains and strains are less intense in magnitude, other options may be available. These include primarily non-rigid ankle supports that offer greater flexibility. In principle, these more compact and more flexible supports allow the user to move around, e.g., to walk, with the support in place. Many current braces are designed to be worn with a shoe over the brace.
The archetypical support in this category may include a body defined by various materials, such as, in certain commercial supports, a tense, canvas-like material encompassing the entire body or a substantial portion of the body and a lace-up portion or other tightening mechanism. The uniformly-disposed tense material in these supports is designed to tightly encompass the foot to accent venous flow of blood up the leg and thereby reduce swelling (which in turn reduces pain) and, equally importantly, to restrict the unwanted ankle rotation that led to the injury in the first instance.
Because it can take six weeks or longer for ankle injuries of these types to heal, a pivotal consideration of any such ankle support is comfort. An uncomfortable brace will, more often than not, motivate the user to avoid use of the brace as often as instructed. This consequence can lead to longer healing times. Unfortunately, conventional commercial ankle braces typically involve often multiple layers of material stitched together, rendering these available commercial braces unnecessarily thick and unwieldy. The materials used can also be rough to the touch. They also include protrusions running along lateral portions of the brace due to the stitching. These protrusions tend to dig into the sensitive areas of the foot over time, causing added discomfort. The material may also be designed to include a significant amount of tension to enable the support, when worn properly, to reduce edema (swelling) and to restrict ankle and foot movement. The materials used in conventional braces, often stitched together in layers as described above, lack breathability, which can further irritate the skin. Also, the thick, high tension material is included in many conventional braces below the foot. This can be particularly uncomfortable to a user when walking or standing for extended periods of time, particularly with footwear over the brace. Thus, especially for areas below the shoeline, the thickness of these conventional devices can be a significant problem because they cause discomfort that is likely to worsen over the duration of the injury period. All of the aforedescribed problems reduce the overall motivation for the user to wear the support on a consistent basis to allow the ankle to heal in as short a time as possible.
Another problem with existing ankle supports is that, with their presence of high tension fabric disposed substantially over the entire body of the support to support the ankle, even the lowest-profile (thinnest) available commercial braces fail to discriminate in their restrictions to the foot/ankle system on motion. That is, with these conventional braces, foot motion is limited or restricted in all directions. These braces may resemble a bootie with a heel and a toe opening. Substantially the entire surface of the support, including the rear portion encompassing the sole of a user's foot, may be composed of an often thick and/or very tense material that, when donned by a user, offers the user little flexibility to move the user's foot even in directions necessary for the user to comfortably walk forward. In short, the conventional brace not only restricts unwanted rotation of the ankle that caused the injury, but also restricts natural forward and backward movement of the foot that allows a user to comfortably walk.
These and other deficiencies are addressed in the present disclosure.
Several aspects of an ultra-low-profile motion-selective orthopedic ankle support and method for producing same are disclosed.
In an aspect of the disclosure, an orthopedic ankle support includes a non-rigid body and one or more sections of tense material welded along at least portions of one or both sides of the body and configured to inhibit ankle pronation and supination while promoting dorsi and plantar flexion.
In another aspect of the disclosure, an orthopedic ankle support includes a bootie, one or more tension segments welded to the bootie to at least partially enclose a bootie heel region and to extend radially from the bootie heel region along at least one side of the bootie, wherein the one or more tension segments are configured to inhibit rotatory ankle motion while promoting dorsi and plantar flexion.
In another aspect of the disclosure, an orthopedic ankle support includes a non-rigid body having an open heel region, the body including an anchor segment, and at least one tension segment connected to the anchor segment and extending across at least a portion of at least one side of the body, wherein the at least one tension segment is welded to the body and configured to provide directional support for selectively stabilizing the ankle.
In another aspect of the disclosure, an orthopedic ankle support includes a non-rigid body having an open heel region, the body including at least one tension segment extending across at least a portion of at least one side of the body, wherein the at least one tension segment is welded to the body and configured to provide directional support for selectively stabilizing the ankle.
In another aspect of the disclosure, an orthopedic ankle support includes a non-rigid body having an open heel region, the body including two or more pieces of material welded together to form a bootie, wherein at least one welded region of the bootie is oriented to provide directional support to selectively stabilize the ankle, and wherein the at least one welded region comprises sufficient tensile strength to provide the directional support.
In another aspect of the disclosure, a method for making an orthopedic ankle support includes welding together two or more pieces of material to form a bootie; and orienting at least one welded region of the bootie to provide directional support to selectively stabilize the ankle, wherein the oriented at least one welded region comprises tensile strength sufficient to provide the directional support.
In another aspect of the disclosure, an orthopedic ankle support includes a non-rigid body having open toe and heel regions, the body including an attachment portion along opposing edges of the body at a front of the foot; an anchor segment extending along at least a portion of one or both of (i) an area proximate the open heel region and (ii) a sole region; at least one tension segment extending from the anchor segment to the attachment portion on at least one side of the body; wherein one or both of the anchor and tension segments are welded to the body and configured to provide directional tension to inhibit rotatory ankle motion while promoting dorsi and plantar flexion.
In another aspect of the disclosure, a method for producing an orthopedic ankle support comprising a non-rigid body configured to provide directional support for selectively stabilizing the ankle, aligning flat tension sections with a fabric body to produce a stack of aligned materials, the aligned materials of the stack being aligned directly or via a substrate material configured to facilitate thermal fusion, applying heat and pressure only to predetermined portions of the stack, including the flat tension sections, to weld the predetermined portion leaving the remaining stack portions unwelded, and shaping the resulting stack to form the ankle support.
It is understood that other aspects will become readily apparent to those skilled in the art from the following detailed description, wherein it is shown and described only exemplary configurations of an orthopedic ankle support by way of illustration. As will be realized, the present disclosure includes other and different aspects and its several details are capable of modification in various other respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not as restrictive.
Various aspects of the present invention are illustrated by way of example, and not by way of limitation, in the accompanying drawings, wherein:
Various aspects of an orthopedic ankle support will now be presented. However, as those skilled in the art will readily appreciate, these aspects may be extended to other anatomical supports without departing from the spirit and scope of the present disclosure. The detailed description set forth below in connection with the appended drawings is intended to provide a description of various exemplary embodiments of techniques for an orthopedic ankle support and is not intended to represent the only embodiments in which the invention may be practiced. The term “exemplary” used throughout this disclosure means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments presented in this disclosure. The detailed description includes specific details for the purpose of providing a thorough and complete disclosure that fully conveys the scope of the invention to those skilled in the art. However, the invention may be practiced without these specific details. In some instances, well-known structures and components may be shown in block diagram form, or omitted entirely, in order to avoid obscuring the various concepts presented throughout this disclosure. The various aspects of the present disclosure illustrated in the drawings may not be drawn to scale. Rather, the dimensions of the various features may be expanded or reduced for clarity. In addition, some of the drawings may be simplified for clarity. Thus, the drawings may not depict all of the components of a given apparatus or method.
In accordance with various aspects of the present disclosure, a welded orthopedic ankle support is provided. Instead of employing conventional stitching techniques, the materials that constitute the non-rigid body of the ankle support may be welded or thermally fused together to produce an ultra-low profile support. The welding of the various materials together enables otherwise intrusive seams and stitching lines to be substantially eliminated or reduced, which categories of items have caused substantial prior discomfort. This is in contrast to prior art solutions which are typically unnecessarily thick because they rely exclusively on stitching techniques to combine different regions of materials. Where multiple layers of material are used on the support, the problem is exacerbated because the profile of the support is simply further increased using these conventional solutions. In addition to excessively restricting movement of the foot/ankle system, higher profile supports render it difficult, if not impossible, to don ordinary footwear over the support.
In contrast, because the support materials are welded instead of sewn, the body of the ankle support has a naturally low profile with a compact volume that tends to be much smaller than existing solutions. Thermal fusion via welding produces an overall compression of the constituent materials. Further, using welding to assemble constituent parts of the body, it is generally easier for a designer to accurately design and achieve predictable and continuous properties over specific areas or regions of the ankle support. This is in part due to the fact that the belt behaves as a unitary segment with gradual changes in properties over different areas of the support, rather than as a collection of individual materials with substantially different properties and different degrees of directional freedom. Welding the materials causes the materials to become permanently affixed together across all welded regions, in contrast to the conventional approaches that rely purely on stitching or lamination.
Additionally, the ankle support according to the present disclosure tends to avoid sharp gradients in property transitions of materials in regions where those gradients are unnecessary. This benefit is due to the ability of thermal welding to integrate the fused materials together. This gradual transition of material properties, rather than sharp gradients in unnecessary regions of the support produced by conventional means, generally results in a body that has less discontinuities that are less noticeable to the user when the ankle support is worn. This, combined with a more compact and lower profile that makes it easier to don footwear over the support, results in an ankle support that is far more likely to be worn by a user as recommended by a specialist.
In accordance with other aspects of the present disclosure, the non-rigid bodies of the ankle support, that were traditionally adorned across most or all regions with uniform layers of high tension material to restrict foot and ankle movement, have been modified using concepts of anchors and tension segments to adopt a unique approach that combines efficacy in healing with comfort to the user. In an embodiment, the use of anchors and tension segments involves removing still further material and creating a still lower profile. The approach according to these aspects is premised on the inventors' recognition that certain major ligaments that govern action of the ankle joint terminate/originate in the calcaneus region of the foot/ankle system, or terminate/originate in a region proximate the calcaneus region. With this recognition, an ankle support as disclosed herein can be designed such that, in lieu of uniform regions of high tension, selectively shaped and oriented sections of a low-profile, tense material such as TPU can be used to effectively emulate action of these ligaments. In some embodiments, these high tension segments may originate in an area proximate the heel region and may extend across one or both sides of the foot/ankle system. For example, in an embodiment, an “anchor segment” of a low-profile, tense material may partially or wholly surround or otherwise encircle the open heel region of the non-rigid body. In alternative or additional configurations, the anchor segment may extend underneath a user's foot, e.g., under the sole or a portion thereof.
As shown further below, the emulation of the ligaments need not be direct such that the orientation of the applicable segments visibly correspond to the user's ligament anatomy. Rather, depending on the design and desired objectives, the emulation may be indirect. In this fashion, the restrictive segments of the ankle support need not directly resemble the orientation of corresponding ligaments, but in function, may operate as if they were substitutions for the ligaments. These embodiments are discussed further below.
The tension segments may be attached to the anchor segments and may run directionally or extend radially across one or both sides of the ankle/foot system to provide selective restriction of motion to the ankle/foot system. For example, in many instances of ankle injury it is desirable to avoid supination or pronation of the ankle to further exacerbate the injury. The anchor segment and tension segment(s) extending therefrom may be oriented and shaped to restrict supination or pronation of the foot or ankle. At the same time, and in contrast to conventional braces, the placement of the segments may be made to avoid interfering with normal forward and backward motion of the foot, i.e., dorsal and plantar flexion. The tension segments may effectively “substitute” for the ligaments in function while the ligaments heal.
In some embodiments, additional or alternative segments may be employed that do not necessarily originate at an anchor section proximate the heel or sole, but may instead extend laterally across the ankle/foot system. In these cases, the tension segments may extend indirectly from an anchor segment surrounding the open heel region via the use of the branching or fanning out of segments. In other cases, the tension segments can be oriented in a manner such that they are independent of the anchor section and can still perform their intended functions of inhibiting unwanted supination and pronation of the ankle. In still other embodiments, one or more tension segments may originate at an anchor section and extend across a region of the body to an attachment portion. An attachment portion may include an area on the body that is used to tighten and secure the body. In an embodiment, an attachment portion includes regions at respective, opposing ends of the body that use eyelets and laces, hook and loop, or other mechanisms to connect and secure the body to the foot/ankle system. In some embodiments, the attachment portions include thicker material to support the tightening of this portion of the body and also to receive tension segments from the sides of the body.
The anchor function may, but need not, be performed by discrete segments of material. Instead for example, the anchor segments may be implemented by the use of additional welding, stitching or binding of the support (e.g., proximate the heel or sole region) that provides the tension segment with a durable anchor.
The tension and/or anchor segments may be described for purposes of convenience and clarity as discrete segments of material. However, in practice, these segments may constitute any number of discrete pieces or sections of material. For example, while two tension segments may be apparent on a side of the body, the two tension segments may in practice be part of the same piece of material that was appropriately cut and shaped before the welding process. Similarly, the tension and anchor segments may in practice constitute a single integrated piece or section of material, or more than one piece or section of material. The anchor and tension segments may also, in some embodiments, use more than one layer of materials, or may use a composite material.
Some embodiments combine the benefits of welding with the selective use of the tension segments to produce an ultra-low-profile ankle support that may provide superior properties of comfort and efficacy in healing. Using an appropriate thermal fusion techniques as described below, different layers of material having different functions or objectives may be welded together to form an integrated, non-rigid body that performs these objectives at a minimum of thickness and with few, if any, interior seam lines or protrusions that the user may notice with tactile senses on the ankle and foot, and that may otherwise result in discomfort to the user. The discomfort in this event may significantly worsen over longer periods of time and particularly if a shoe or footwear is worn in conjunction with the support. The support of the present disclosure addresses these shortcomings, as shown in the non-exhaustive examples below.
The orthopedic support of the present disclosure is configured to inhibit ankle pronation and supination while promoting dorsi and plantar flexion. It should be noted that like any support, there will be some restriction on flexion at some point. In hyperflexion of the foot/ankle system, for example, there is a point where dorsi and plantar flexion is restricted in whole or in part. Thus, for purposes of this disclosure, when referring to the support permitting dorsi and plantar flexion, implicit in this and similar language are those cases where such flexion is minimally or marginally inhibited by virtue of wearing the support, and those cases of hyperflexion where dorsi and plantar flexion become inhibited.
The orthopedic support of the present disclosure is further configured, as noted above, to inhibit ankle pronation and supination. In addition to pronation and supination, there are also inversion and eversion events that occur and that are associated with the foot ankle/system. Injuries often occur as a combination of supination/pronation with inversion and/or eversion. Thus, for purposes of this disclosure, when referring to the support inhibiting or restricting ankle pronation or supination, implicit in this and similar language is the inhibition or restriction of inversion or eversion, alone or in combination with supination or pronation. Consequently, when the support is said to inhibit supination and pronation for purposes of this disclosure, it is also inhibiting inversion and eversion and therefore avoiding sustaining or exacerbating injuries associated with any of these events, whether alone or in combination. It is also noted that, for purposes of this disclosure, the reference to providing directional or tensile support to the ankle is synonymous with the identified selective restriction of the foot/ankle system to certain permissible movements (dorsi and plantar flexion) that do not inhibit healing, as discussed above.
Body 102 includes flexible fabric regions 126a, 126b, and 126c. In an embodiment, regions 126a-c are porous and stretchable, enabling breathability and allowing for comfort. Regions 126a-c may be made very thin or may be relatively thin but also may include some padding for comfort. In a further embodiment, regions 126a-c constitute 3-D spacer mesh or a similar mesh material, although other materials may be equally suitable depending on the configuration of the support 100. The number and shape of regions 126a-c may also vary depending on the configuration, and three regions are shown by way of example only. Regions 126a-c may be included on one or both sides of the body 102.
Body 102 further includes sections 114. Although obscured from view in these figures, sections 114 may be present on both sides. In an exemplary embodiment, section 114 constitutes a porous, breathable fabric, similar to regions 126a-c. In another exemplary embodiment, sections 114 include a fastening material and are used as fasteners for a conventional figure eight structure, as shown further below. In the context of a fastener, sections 114 may include UBL or a similar material. In other embodiments not using a figure eight structure, sections 114 may be composed of a soft, breathable fabric as noted above. Alternatively, body 102 may be built shorter which may eliminate the necessity of a portion, or the entirety, of region 114.
While in the example of
Shown bordering heel opening 122 is anchor tension segment 108. In an embodiment, anchor tension segment may at least partially surround heel opening 122. In another embodiment, anchor tension segment 108 may completely encircle heel opening 122. In still other embodiments, anchor tension segment 108 need not border heel opening 122 and may only be proximate heel opening 122 such that anchor tension segment 108 is not at the edge of the heel opening 122. Anchor tension segment 108 may additionally or alternatively reside below the foot. In the embodiment shown, anchor tension segment 108 encircles heel opening 122 (via region 116, discussed below). Anchor tension segment 108 may in some embodiments extend across a portion of the user's sole region to constitute anchor segment 110. The shape and orientation of anchor segment 108 and/or segment 110 may vary significantly from support to support without departing from the scope of the present disclosure.
Referring back to
In an alternative exemplary embodiment, anchor segment 108 is effected by stitching, binding or welding in lieu of the use of a discrete segment of material. For example, in this alternative embodiment, tension segment 112b may extend from a region proximate heel opening 122 radially upward along the side of the support, as shown. Instead of (or in addition to) anchor segment 108, tension segment 112b may be stitched, welded, or bound near heel opening 122 to provide the anchor function.
As is evident from the illustrations of
Body 102 further includes posterior region 116 of the support 100. In an exemplary embodiment, posterior region 116 is composed of a tense, supporting material such as TPU. The TPU or other material included in posterior region 116 may generally be thicker than the materials included in the above-referenced tension segments, primarily because the majority or entirety of posterior region 116 is above the shoeline and thus the added thickness should not result in discomfort to the user. In alternative exemplary embodiments, posterior region 116 is made significantly smaller or even eliminated. In the embodiment shown, posterior region 116 is used to provide support to the anchor tension segment and other portions of the body 102. The relative thickness of posterior region 116 also provides added strength and durability to the support 100, supports the posterior region of the user's foot, and assists in stabilizing the user's ankle along with the anchor and tension segments such that unwanted rotatory ankle motion is prevented.
In still other embodiments, posterior region 116 is thinner and is not used as a significant means of support, since the anchor and tension segments can be designed to sustain the pressures and forces that will be experienced over time by a mobile user of the support 100. In these embodiments, the support may also be made smaller to exclude a portion or substantially all of posterior region 116. Referring still to
Referring still to
The body 102 further includes an attachment portion 106a. One function of attachment portion 106a is to tighten and secure the support 100 to the user's foot/ankle system. In one embodiment, attachment portion includes thick sections of one or more materials that are durable and that have limited, if any, flexibility. For example, the thick regions of material 106a may include TPU. In the ankle support shown, there are four regions 106a that, along with lace set 106b, constitute the attachment portion. The attachment portion may be located proximate the respective vertical ends of body 102 and may include eyelets through which the laces 106b can be routed.
The attachment portion, while illustrated as a lace-up system such as those used in footwear, need not be so limited, and any suitable mechanism for securing the support 100 to the user's foot may alternatively be used. In other embodiments, the attachment mechanism may instead use a hook and loop closure system, e.g., with a D-ring, for tightening and attaching the body. Clasps or other structures may also be used alternatively or in addition to the eyelets.
The support 100 further includes a tongue 104. In an exemplary embodiment, the tongue 104 includes two portions. First, the tongue 104 includes a thin, stretchable material 104b coupled at its base to an interior portion of body 102. The tongue 104 may further include a thicker, more durable, and less flexible section 104a. The thickness of section 104a may be used, for example, to provide a cushion to a front of the user's foot when laces 106b are tightly bound. The material in portion 104b may, by contrast, be porous, breathable, and thin.
In an embodiment, ends of the tension segments 112a-c opposite anchor segment 108 and extension segment 110 are coupled to the attachment portion. For example, as shown in
Tension segments 112a-c may in other embodiments constitute a single visible segment extending across a side of the body 102. Tension segments 112a-c need not necessarily be coupled to the attachment portion as noted, since alternative orientations may be suitable in other implementations. The structure of body 102 advantageously enables a designer to orient the tension segments in any desirable way to achieve the intended objectives. As noted above, certain ligaments in the ankle extend from the subtalar joint or near that joint. In one embodiment, the support 100 capitalizes on the nature of major ligaments in the ankle extending to or from the calcaneus region or near the talo calcaneal region such that artificial, exoskeletal ligamentis tension segments on the support 100 can effectively emulate the function of the ligaments, regardless of whether the anatomical comparison is immediately visible or apparent. Thus, for example, where an injury involves a torn ligament in the ankle region near the calcaneus, one or more properly-oriented tension segments may act to prevent the ankle joint from improperly supinating or pronating, potentially with inversion or eversion (a function previously performed in part by the torn ligament) but without restricting all movement of the foot and ankle, as is the case with conventional braces.
In some embodiments, tension segments alone may be used without being attached to corresponding anchor segments or without being associated with anchor functions. Instead, in these exemplary embodiments, one or more tension segments may be disposed along one or both sides of the support and oriented or situated in a manner that assists in selectively stabilizing the ankle/foot system as described herein. Further, in other embodiments, tension segments may be coupled, connected or attached to an anchor segment/function underneath the fabric. That is, the connection may not be visible on the outside of the support, but may occur, for example, in connected layers underneath. For instance, the tension segment may disappear under a separate material but may be welded to other layers to cause a connection to the anchor segment.
In another aspect of the disclosure, the welding alone may alter the properties of the fabric to provide tensile strength that may serve the function of the tension segments, or anchor segments, or some combination of both. In an exemplary embodiment, a support may be manufactured by appending two or more pieces of stretchable material together to form the body. The materials may be joined at or near their edges via welding. Then, the resulting welded combination may be shaped to form the body of the support. Notably, in this embodiment, separate tension/anchor segments comprising a discrete material with high tensile strength (e.g., certain types, formulations or thicknesses of TPU or another suitable material) are not needed. Instead, the appropriate tensile strength may be present in the regions where the materials are welded. When oriented in an optimal direction, these regions effectively emulate the functions of the aforedescribed tension and/or anchor segments and provide the same directional support and selective restriction to the user with all the advantages of the low profile (if not providing even a lower profile) and the stretchability of the non-welded regions. The support according to this embodiment advantageously may be composed of fewer materials or one material and may provide an extremely low profile while maintaining the requisite selective stability for the ankle.
As noted above, conventional braces function by providing higher profile material with generally uniform tension across essentially the entirety of the foot/ankle system, and in many cases across the entire support. When tightened or secured onto the foot/ankle system, these supports assist in restricting unwanted rotatory movements of the ankle, but they also restrict natural movement that should not be and need not be restricted in most types of ankle injuries. These conventional braces, which provide tension all over the foot/ankle system, tend to restrict plantar and dorsi flexion as well, for example. That is, conventional braces restrict the natural forward and backward motion of the foot, which restriction is often not necessary for healing of the specific ankle injury, and particularly soft tissue injuries. By contrast, the support as disclosed in
Welding is superior to conventional methods because when a weld is applied to even low tension or flexible material, directional tension will thereon be provided along the lines of the weld. That is to say, the weld produces permanent changes in the material's stretch characteristics. Accordingly, in an embodiment, the function of tension segments may be emulated along given weld regions or borders when applying thermal fusion along those regions/borders.
The fact that the user is able to flex the foot may enable the user to easily walk. Thus, the comfortable support according to the disclosure may provide the necessary motivation for the user to regularly don the support, which results in faster healing and a quicker path for the user to return to a mobile, productive state.
Edema.
The support 100 and variations described herein further reduce edema more effectively than conventional braces. The ankle is a more susceptible joint than other joints to prolonged injuries because it is located at a distance farthest from the heart. In ankle injuries, blood may amass in the injured area and cause substantial swelling in that area, which leads to pain. Conventional soft braces, which provide tight, often canvas-like materials that address edema through the non-uniform application of pressure against all of the tissue of the foot/ankle system, may cause considerable discomfort. By contrast, the support 100 according to the present disclosure may include regions of porous, stretchable material (e.g., regions 126a-c, lower tongue, etc.) restrained over the selected regions by nearby ligament-like segments, which are much more comfortable. Edema in the support described herein may be reduced by the comparatively even compression of the porous, soft, stretchable material against the tissue. This is in contrast to the uneven and irregular compression of tissue across a significant portion of, or substantially the entire, foot/ankle system, as provided by existing supports. The material in the present support may include spacer mesh or another suitable material with porous and/or stretchable properties, compressing the tissue substantially evenly through the bordering tension segments. The edema is therefore controlled in a manner that avoids causing additional discomfort to the user.
Generally, the heel region as described herein may cover different areas, and is not intended to be limited to a precise region. The heel region may vary from embodiment to embodiment provided it generally surrounds or approximately borders the calcaneus bone at the outer part of the heel. In some regions, therefore, the heel region may be designed to be very small, and the material of the support may encroach on the calcaneus. In other embodiments, the heel region may be designed to be much larger and therefore, for example, the heel opening on the support may take up much less material. In these latter embodiments, the fabric may be more distant from the calcaneus. The heel region for purposes of this disclosure is intended to include all of these embodiments and variations.
In alternative embodiments, the tension segments are designed as part of a wider section of material, rather than one or more strips. For example, in alternative embodiments, tension segments 212a-c may be combined into a single, wider strip or a pair thereof. Generally, the geometry of the tension segments can vary considerably while achieving the same result of selectively restricting motion using a low profile bootie design.
Tension and Anchor Functions.
The segments or structures that in effect, emulate the ligaments to selectively stabilize the ankle may, but need not necessarily, physically resemble the anatomical structure of the ankle ligaments. The examples below show that in some embodiments, more sophisticated, indirect means may be used to emulate the subject ligaments to selectively stabilize the ankle. Thus, staggered patterns of segments or other patterns that do not directly resemble how ligaments are routed may nonetheless effectively perform the functions of emulating major ligaments to achieve the intended objective. For purposes of this disclosure, a very low profile, ultra-comfortable orthopedic support can be achieved by welding together, on one or both sides of the body, one, two or more, or a network of segments (however shaped) to accomplish the directive of addressing the ankle injury at issue.
Referring first to
In addition,
In some alternative embodiments, less higher tension material may be used provided it is sufficient to perform the anchor and tension functions for inhibition of selective motion. Generally, when less area is used for tension and anchoring, more area may instead be provided as soft, breathable fabric, maximizing the user's comfort. Further, while a number of the embodiments discussed above reference segments in the context of rectangular-based shapes, the disclosure is not so limited and the segments may take on any shape desirable for performing the necessary functions. This may include, for example, use of multiple segments that are very thin and thus each have a very small surface area. This may also include one larger segment, and/or oddly shaped segments. Also, as was seen with reference to
In an embodiment, the support 200 is constructed without any stitching under the shoeline. Thus, anchoring is accomplished using solely welding techniques and appropriate materials. As discussed, the absence of stitching may result in an extremely thin support that is both highly effective and palatable to the eyes of an injured user.
Referring still to
The embodiments in
Figure Eight Structures. Figure Eight Structures can be Added to the Orthopedic Ankle Brace in an exemplary embodiment to provide further support and to add a layer of protection to restrict the ankle from sudden or unexpected supination/pronation. To this end,
In an embodiment, the first side 161a includes a hook material that engages with the UBL material on the region 114. In addition, in some situations one side of the figure eight structure may interfere or overlap with the other side, such as at area x where the first side 161a of the figure eight structure terminates. Similarly, on the opposite side of the body 102 (obscured from view) a second side 161b of the figure eight structure may similarly interfere with the first side 161a. To alleviate this problem, the portions of the
Elastomer Specifications.
Certain commercially-available orthopedic braces are currently composed of a flexible body material layered together with an elastomer component to improve compression. These elastomers, however, usually have a low Young's modulus or a low modulus (i.e., low stress, high strain) of elasticity. This means when a stress is applied to the elastomer, the resistance force stays relatively constant while the strain value increases before permanent deformation or yield strength maximization. As evidenced by the stress-to-strain curve (see
Referring still to
An ankle blow-out usually occurs as a result of a very quick and explosive motion. The inventors have observed studies that show that explosive inversion or eversion can happen in as low 40 milliseconds, or quicker than the blink of an eye. Meanwhile, the user's reaction to the ankle blow-out is 50 milliseconds, or longer. See, e.g., Daniel T P Fong et al., Understanding Acute Ankle Ligamentous Sprain Injury in Sports, Jul. 30, 2009 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2724472/.). Accordingly, one or more materials may be used that can properly respond to such a fast event, such as the welded materials described above.
In an embodiment, the tension and anchor segments are composed of TPU. However, the disclosure is not so limited, and other materials having similar modulus of elasticity may be used. While the exemplary elastomers used herein include the TPU tension segments as described and configured herein, other materials or composites that, when welded, yield a sufficiently high modulus of elasticity may also be possible. Based on reference test data, elastomers used in exemplary embodiments of the present disclosure may have a combined modulus of elasticity higher than 380 PSI (pounds per square inch) or 2.8 MPa (Megapascals) (ref test data). Elastomers with a low modulus of elasticity, such as “rubber band” like materials, generally have a modulus of elasticity of up to around a maximum of 120 PSI or 800 Pa and as such, are unsuitable for primary use as tension or anchor segments in the embodiments disclosed herein. It should be understood, however, that such materials with a low modulus of elasticity may be appropriately used in other portions of the support, such as the body (including regions 126a-c), the lower portion of tongue 104b, etc. (see
Flexural modulus vs tensile strength may also be properties to consider in determining which materials can be used for the ankle support disclosed herein. Generally, for the ankle support to be comfortable, the materials should be somewhat flexible. This flexibility, which may help conform the support to the user's foot shape and may generate a more uniform compression. In an embodiment, the materials have a relatively low flexural modulus to conform to the user's foot shape but a high tensile strength to prevent the ankle rolling or rotating in tension. In a further exemplary embodiment, the ankle support as disclosed herein takes advantage of the tensile direction to prevent the ankle inversion or eversion. Thus, for example, the anchor and tension network as disclosed herein may include TPU originating from one side of the foot and running along a periphery of the calcaneus to the other side of the foot (e.g., segment 108,
Another property that can affect the elasticity of an elastomer is temperature. Generally elastomers that are thermoset have a lower resistance to temperature. This means that the elastomer at issue may have different properties when the temperature is at the glass transition of the polymer. For example, TPU and similar materials are thermoplastic, and as a result, have a higher resistance to temperature. These types of materials may be more suitable for primary use in the ankle support so that temperature variations will not significantly affect the elasticity of the support. Temperature differences may become significant in a variety of situations. For example, where an ankle support is worn by athletes, temperature can increase dramatically either by means of their activity alone, or by friction against the shoe when the athlete performs when wearing the ankle support along with regular shoes.
Temperature resistance may also be relevant to abrasion of a material. Abrasion of thermoset materials is generally low. More specifically, because of their low temperature resistance, the materials are easy to break down when glass transition of the polymer is reached. To account for abrasion resistance for the ankle support, the temperature resistance can be made higher by selecting materials with a corresponding high temperature resistance.
It is also noteworthy that ankle supports are designed to restrict ankle motion. Viewing the action of the ankle support from an energy conservation perspective, the kinetic energy transfers into elastic potential energy. TPU, which may be used in several regions in various embodiments (e.g., elements/regions 104, 106a, 108, 110, 112a-c, 116, 118, 121,
It will be appreciated that, although TPU may be used in various embodiments, the disclosure is not limited to TPU, and a number of other materials may be equally suitable without departing from the spirit or scope of the disclosure. In addition, while the use of elastomers with specific properties has been discussed, the ankle support as disclosed herein need not be limited to any specific elastomer. Further, although other elastomers may not be suitable for use in certain aspects of the present ankle support, the elastomers may be appropriate for use in other portions of the support or for other purposes. In addition, various composites may be suitable for use in the ankle support that have not been specifically identified. Thus, the previous discussion is not intended to be limiting, but rather is meant to identify properties of materials that may be relevant to various embodiments.
Above the spacer layer, optionally, another layer (not shown) may be included in some exemplary embodiments for providing plastic stirrups to the body. The layer may include, for example, a hot melt board cut to implement a stirrup on each side. After welding, the support may thereupon incorporate stirrups on each side. A pocket may be added to accept another layer. The additional layer can be added internally or externally. The stirrups may essentially provide an added layer of stability and support on each side of the leg. Unlike traditional rigid hard plastic stirrups that are built onto the sides of the support after the support is assembled, which creates additional unnecessary size to the support, the plastic stirrups as disclosed herein are much more compact because they are welded into the body during assembly. The shape of a plastic stirrup layer according to an embodiment is essentially two rectangles connected together by a smaller strip, which may be curved. In other embodiments, the plastic stirrups are omitted.
A third layer above layer 826 (or above the plastic stirrup layer, where applicable) may include two symmetrically distributed regions 814-1 and 814-2 that correspond respectively to regions 114 (
A fourth layer may include hot melt eyelets for adding thickness and support to the attachment portions 806-1 and 806-2. The attachment portions 801-1 and 806-2 may be constructed to include eyelets, and may add thickness to add further support to this region. It should be noted that because each layer will be incorporated into the final product, in the mold, the eyelets will be included in every layer that intersects with the attachment portion. In an embodiment, the eyelets may be used in some hardware equipment to align the various layers. The resulting attachment portions may include TPU (see below), the welded hot melt eyelets 806-1 and 806-2 for added support, and spacer layer 826.
A fifth layer may include the tension and anchor segments. In this embodiment, the tension and anchor segments are uniformly composed of TPU and represent in principle one piece of material. As discussed with reference to previous embodiments, this need not necessarily be the case, and in some embodiments additional, alternative, or different segments or pieces of TPU or other material may be combined or integrated to form the final product. Moreover, upon welding, the TPU will be integrated with the materials in the other applicable layers such that the properties of this portion of the body will vary gradually over the surface area of the body. Nonetheless, the TPU may provide the necessary tension to stabilize the supination/pronation of the ankle as described. Here again, materials other than TPU may be equally suitable for use in this layer.
A sixth layer may include a segment 828 of posterior TPU to assist in joining the heel portion. In practice, more or less materials and/or layers may be used. In addition, in some embodiments, a single layer may be populated with more than one material, although care in these cases should be taken to ensure that the dimensions and layers align properly.
Thereupon, the mold may be closed to create a closed environment for the aligned layers and to create pressure on the layers, and the welding process may commence. It is anticipated that for purposes of the present disclosure, any number of welding and thermal fusion processes may be used to produce the body. Caution must be taken prior to commencement of the welding, however, to properly configure the layers and welding tool such that the more delicate regions of the body (e.g., the UBL and spacer regions such as 114 and 126a-c (
Welding is a known fabrication process involving the use of heat and pressure on thermoplastics and other materials to integrate layers of materials together. Unlike stitching or other connection means, where the layers remain substantially independent of one another and retain their own chemical properties, welding typically integrates the layers together as one layer with a new set of properties. Where the materials and welding parameters are properly selected, the new set of properties is typically superior to the old set of individual properties of the constituent layers.
Heat is applied to the aligned sections in the mold to integrate the material layers (906). Welding also involves pressure, such that sometimes substantial amounts of pressure are applied to the aligned sections. The application of heat and pressure may be concurrent, in part or in whole, or may be in discrete steps, depending on the welding process employed. Accordingly, a separate step of applying pressure to the aligned sections is identified in
After the welding process, what remains is a unitary body in a flat position. Using an artificial foot/ankle system or other shaping means, the body is curved and shaped into the position of a support. Additional steps may be undertaken in the fabrication process to maintain a permanent curve to the body; these principles will be understood by those skilled in the art upon reviewing this disclosure. A posterior portion (116) can at this point be welded onto respective ends of the curved body to finish the formed body of the support. Thereafter, any additional elements may be added onto the support. For example, the figure eight structures may be stitched (or welded) onto a posterior region of the body as previously discussed. Where the attachment portion is a lace-up configuration, laces may be provided through the eyelets.
While spacer mesh material and other specific materials have been discussed in the context of various embodiments throughout this disclosure, it should again be emphasized that the support as contemplated herein needn't be limited to or require these materials. In other embodiments, materials having similar or superior properties may be substituted for the exemplary materials described while maintaining adherence to the principles of the present disclosure.
Depending on the nature of the injury and the size of the user's foot, numerous different types of supports may be manufactured using the above-described procedures. Custom supports may also be produce to address unique injuries or to meet unique needs, e.g., the needs of an athlete, and to accommodate users with different expected levels of activity, etc. Over time, additional iterations of ideal configurations of the tension segments may become preferred, with one objective to maximize the amount of comfortable fabric layers and potentially minimize the area consumed by the anchor and tension segments.
It is to be understood that the specific order or hierarchy of steps in the methods disclosed is an illustration of exemplary processes. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the methods may be rearranged. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented unless specifically recited therein.
The various aspects of a flexible support presented throughout this disclosure are provided to enable one of ordinary skill in the art to practice the present invention. Various modifications to aspects presented throughout this disclosure will be readily apparent to those skilled in the art, and the concepts disclosed herein may be extended to other flexible supports. Thus, the claims are not intended to be limited to the various aspects of this disclosure, but are to be accorded the full scope consistent with the language of the claims. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.”
