Patent Description:
Medical braces are typically fit about a limb and tightened to secure the brace about the limb. Conventional tightening for braces often require a user to use both hands in securing the brace about a limb. For example, Velcro® straps and buckles often require the user to grasp the strap or the body of the brace to hold the brace or strap in position while the strap is secured to the brace. Properly fitting such braces may be difficult and/or challenging for patients, especially when the patient is dexterity challenged or the brace is being fit to the arm or hand. <CIT> is the closest prior art document and discloses an article of footwear with an automatic lacing system with a set of straps that can be automatically opened and closed to switch between a loosened and tightened position of the upper. Other relevant prior art is <CIT>, <CIT> and <CIT>.

The present invention relates to a system and a method as set out in the claims.

According to another aspect, a lacing system is provided. The lacing system includes: a tensioning device, a tensioning mechanism that is operated via the tensioning device, and a plurality of tension members that are coupled with the tensioning mechanism and tensionable thereby. The plurality of tension members are arranged longitudinally about an opening of an article and configured to narrow a gap of the opening upon tensioning of the plurality of tension members in order to tighten the article. Operation of the tensioning mechanism effects a simultaneous and repeatable tensioning of each tension member of the plurality of tension members to achieve a relatively uniform tightening of the article.

In some embodiments, at least one tension member of the plurality of tension members is adjustably coupled with the article so that adjustment of the tension member effects tensioning of the respective tension member upon operation of the tensioning mechanism. The at least one tension member of the plurality of tension members may be adjustably coupled with the article via: an adjustable terminating end, a teeter mechanism, a lock mechanism, and/or a buckle. In some embodiments, the article is a brace.

In some embodiments, the tensioning mechanism includes an elongate member that is moveable longitudinally relative to the opening of the article upon operation of the tensioning device. In such embodiments, each tension member may be positioned longitudinally along the elongate member. A proximal end of the elongate member may be coupled with a lace that is tensioned via operation of the tensioning device to move the elongate member longitudinally relative to the opening of the article.

In another embodiment, the tensioning mechanism includes an elongate member that is positioned longitudinally along the opening of the article. In such embodiments, each tension member is positioned longitudinally along the elongate member and the elongate member is configured to rotate about a longitudinal axis upon operation of the tensioning device to effect winding of the plurality of tension members about the elongate member. At least one of the plurality of tension members may be a strap.

The tensioning mechanism is further configured to equalize the tension in each tension member of the plurality of tension members during tensioning of the plurality of tension members. The tensioning mechanism may also be configured to equalize the tension in each tension member of the plurality of tension members subsequent to tensioning of the plurality of tension members. A lace is coupled with the tensioning mechanism and the tensioning device. The lace is tensionable via operation of the tensioning device to effect movement of the tensioning mechanism and thereby tighten the article. The tensioning mechanism includes one or more posts or pulleys about which at least one tension member is slidably positioned so that the at least one tension member is able to adjust and equalize the tension in the at least one tension member. The tensioning mechanism may be configured to pivot to equalize the tension in each tension member. The tensioning mechanism may include a first tension equalizer and a second tension equalizer. The first tension equalizer may effect equalizing the tension between a first and second tension member and the second tension equalizer may effect equalizing the tension between the a third tension member and the first and second tension members. In such embodiments, the first tension equalizer may be a pulley about which the first and second tension members are slidingly positioned and the second tension equalizer may be a pivotable coupling between the third tension member and the first and second tension members.

According to another aspect, a method of configuring an article with a lacing system is provided. The method includes providing a lacing system that includes: a tensioning device, a tensioning mechanism that is operated via the tensioning device, and a plurality of tension members that are coupled with the tensioning mechanism and tensionable thereby. The method also includes coupling the tensioning device with an article and coupling each tension member of the plurality of tension members with the article so that the plurality of tension members are arranged longitudinally about an opening of an article and configured to narrow a gap of the opening upon tensioning of the plurality of tension members in order to tighten the article. The tensioning mechanism is configured so that operation of the tensioning mechanism effects a simultaneous and repeatable tensioning of each tension member of the plurality of tension members to achieve a relatively uniform tightening of the article. The lacing system further includes a lace coupled with the tensioning mechanism and the tensioning device.

In some embodiments, at least one tension member is adjustably coupled with the article so that adjustment of the tension member effects tensioning of the respective tension member upon operation of the tensioning mechanism. The at least one tension member may be adjustably coupled with the article via: an adjustable terminating end, a teeter mechanism, a lock mechanism, and/or a buckle. In some embodiments, the article is a brace.

In one embodiment, the tensioning mechanism is an elongate member that is moveable longitudinally relative to the opening of the article upon operation of the tensioning device. In this embodiment, the method further includes coupling each tension member longitudinally along the elongate member. In another embodiment, the tensioning mechanism is an elongate member that is coupled with the article longitudinally along the opening of the article. In this embodiment, each tension member is coupled longitudinally along the elongate member and the elongate member is configured to rotate about a longitudinal axis upon operation of the tensioning device to effect winding of the plurality of tension members about the elongate member. The tensioning mechanism is further configured to equalize the tension in each tension member of the plurality of tension members during tensioning of the plurality of tension members. The lace is tensionable via operation of the tensioning device to effect movement of the tensioning mechanism. The tensioning mechanism includes one or more posts or pulleys about which at least one tension member is slidably positioned so that the at least one tension member is able to adjust and equalize the tension in the at least one tension member. In this embodiment, the tensioning mechanism may be further configured to equalize the tension in each tension member of the plurality of tension members subsequent to tensioning of the plurality of tension members. In this embodiment, the tensioning mechanism may include a first means of tension equalization and a second means of tension equalization. The first means of tension equalization may effect equalizing the tension between a first and second tension member and the second means of tension equalization may effect equalizing the tension between the a third tension member and the first and second tension members.

The present invention is described in conjunction with the appended figures. The invention is disclosed in <FIG> and <FIG>. All other figures serve as "background examples" which do not form part of the scope of protection of the present invention.

In the appended figures, similar components and/or features may have the same numerical reference label. Further, various components of the same type may be distinguished by following the reference label by a letter that distinguishes among the similar components and/or features. If only the first numerical reference label is used in the specification, the description is applicable to any one of the similar components and/or features having the same first numerical reference label irrespective of the letter suffix.

Embodiments described herein provide various tightening systems and/or closure devices that may be used with various articles includes braces, footwear, hats, gloves, prosthetics, orthotics, or other apparel or devices to open and close the article, such as to allow a user to don and doff the article. In a specific embodiment, the article may be a prosthetic or orthotic device that is worn by the user to support and/or provide a desired therapy to a limb. For convenience in describing the embodiments herein, the tightening systems and/or closure devices will be mainly described as being used with prosthetic devices, although it should be realized that the embodiments are equally applicable to orthotic devices and/or other article.

As described herein, the tightening system means any system, mechanism, or component thereof that is designed to tighten a prosthetic device about an individual's limb. The closure device may be any component of the tightening system that is used to tighten the prosthetic device about the limb. Conventional tightening systems often include various straps (e.g., Velcro straps), vacuum or suction systems, lace, socks or liners for the limb, and the like. For ease in describing the embodiments herein, the tightening system/closure devices will be referred to generally as "tightening systems" or various components thereof, such as lace or tension members, guides for lace or tension members, reel based closure devices or assemblies, and the like.

In some embodiments, conventional tightening systems often include predetermined component locations (e.g., lace or strap locations) that provide relatively standard distributions of pressure regardless of the unique characteristics of the individual (e.g., limb size, limb configuration, and the like). The embodiments described herein provide adjustable and/or customizable tightening system configurations that enhance the closure and/or fit for the prosthetic to meet a variety of user needs. In some embodiments prosthetic closure customization is achieved by integrating removable guides into arrays of guide receiving components, which allows a user to insert and remove guides to create a unique prosthetic tightening configuration that provides customized support and conforms to the user's unique limb characteristics and/or other needs. For example, the embodiments described herein allow users and/or doctors to alter the configuration of the tightening system so as to create a customized prosthetic fit and/or to avoid tensioning or applying pressure to a certain area of the body that may be pressure sensitive. In other embodiments, the customized fit may be used to create void areas in order to "off-load" or reduce the pressure exerted on a certain area, such as, for example, to reduce pressure in a diabetic walker and the like.

In other embodiments, easy adjustment of the prosthetic may be made possible without the need to remove the prosthetic from the user's limb. In some embodiments, the tightening systems described herein can be incorporated into an off-the-shelf prosthetic to add an additional element of adjustability and/or can be implemented with a custom-made prosthetic device.

The tightening systems described herein, or components thereof, offer solutions to many problems associated with conventional tightening systems for prosthetics. In many of the embodiments described herein, tightening systems may be easily adjusted to create custom pressure zones, allowing for customization of fit for comfort and/or therapeutic purposes. Further, the tightening systems described herein can increase the ease and efficiency associated with adjusting a prosthetic device for a proper fit.

As described in greater detail below, in some embodiments, the tightening system may include a reel based closure device or system, which may include a reel assembly, lace, and one or more lace guides that tighten the prosthetic device via tensioning of the lace via the reel assembly. The use of a reel based tensioning system may significantly increase the customization of the prosthetic device by allowing the prosthetic to be more tailored or custom fit to a patient. For example, the lace of the system may be easily wound around custom placed/positioned, custom designed, and/or custom fit lace guides that are coupled with the prosthetic device in order to create a customized and/or unique lace path about the medical brace. The lace path may be tailored or customized to the patient to provide increased and/or decreased zonal tensioning and/or pressure about the patient's limb that promotes optimal fit and minimizes potential pressure issues. As used herein, zonal tensioning means differentially tightening one or more specific areas or "zones" of the prosthetic device with the tightening system. Zonal tensioning may be preferred when increased pressure is desired in one or more areas/zones and/or decreased pressure is desired in one or more zones. The tightening systems described herein allows the user to control the zonal tensioning applied to the prosthetic device as desired.

The reel assembly of the lacing system may be operated to quickly and conveniently tension the lace and thereby tighten the prosthetic device about the unique or customized lace path so as to apply zonal pressure as desired to the patient's limb. In some embodiments, snap-in or easily coupled lace guides may be utilized to form or create the unique or customized lace path about the prosthetic device. As such, customization of the prosthetic device, which may be an off-the-shelf prosthetic/component or a specially designed prosthetic/component, is relatively straightforward and easy, and/or development and production of such prosthetic/components is relatively straightforward and easy. These advantages are not provided by conventional prosthetic tightening systems.

For convenience in describing the embodiments, the disclosure generally describes the tightening system using a reel based closure device or tensioning system. However, it should be realized that any tightening system or mechanism may be used to tighten the prosthetic device and that the disclosure is not limited to only the tightening system embodiments disclosed herein. For example, the tightening system may include or utilize various pull cords, pull straps, strap members, lace locks or clamps, and the like, or any combination thereof, to tighten the prosthetic device.

<FIG> (which do not form part of the scope of protection) provide a general description of a tightening system that utilizes a reel based tensioning system and components thereof. <FIG> provide an overview of general reel based systems. It should be realized, however, that the reel based system described in <FIG> is only a general overview and that modifications may be made to the reel based system or components thereof in the various embodiments described herein.

Referring to <FIG>, illustrated is a background example of an orthopedic brace <NUM>. The orthopedic brace <NUM> generally comprises a knee brace that is tightened around a wearer's leg such that the knee brace substantially surrounds and protects the wearer's knee. Brace <NUM> may be tightened using a lacing configuration comprising two reel based tensioning systems 22a, 22b. The orthopedic brace of the illustrated embodiment is particularly concerned with relieving and/or supporting the knee joint. Although this illustrated embodiment shows the reel based tensioning systems applied to a knee braces, it is to be understood that the principles discussed herein are readily applicable to any of a variety of orthopedic braces, including ankle braces, wrist braces, foot braces, elbow braces and many other types of orthopedic braces well known to those of skill in the art.

In some background examples the configuration of tightening system comprises two distinct reel based tensioning systems 22a, 22b (hereinafter reel based systems). In some embodiments, each reel based system <NUM> includes a lace or cable <NUM> that is threaded through portions of the orthopedic brace and attached at opposite ends to a tightening mechanism <NUM> or reel assembly (hereinafter reel assembly <NUM>), which includes a control such as a lever, crank or knob that can be manipulated to retract the lace <NUM>. The reel assembly <NUM> may include a mechanism of release, such as a button or lever, for disengaging the reel assembly <NUM>, to permit the lace <NUM> to be withdrawn freely. In other embodiments, the reel assembly <NUM> may be pulled upward to allow an internal spool to spin and the lace to be pulled freely. In yet another embodiment, the reel assembly <NUM> may be unwound (e.g., counterclockwise) to release the spool and allow the lace to be pulled, or to unwind the lace. As shown in <FIG>, the lace <NUM> may be threaded in a crossing pattern along a generally forward-facing portion of the brace <NUM>, between two generally parallel rows of side retaining members or straps <NUM>. In another embodiment, the lace <NUM> may be threaded or run laterally across the brace <NUM>. The straps <NUM> may consist of a strip of material attached to the brace <NUM> so as to define a space in which guides <NUM> are positioned. The lace <NUM> slides through the guides <NUM> during tightening and untightening of the lace <NUM>. A more thorough description of the brace <NUM> and reel based systems, 22a & 22b, is provided in<CIT>.

The orthopedic brace <NUM> shown in <FIG> is constructed to fit a wearer's leg. The upper cuff <NUM> is formed to fit the wearer's thigh and curves around the thigh, generally conforming to the wearer's musculature. The lower cuff <NUM> is similar in construction to the upper cuff <NUM>, and is formed to fit and curve around the wearer's calf. In some embodiments, the upper and lower cuffs <NUM>, <NUM> are formed from a relatively lightweight, breathable material. In some embodiments, the cuffs <NUM>, <NUM> are manufactured from a cloth, fabric, or foam-like material, or a thermoformable or non-thermoformable plastic material as would be well-known to those skilled in the art.

As shown, each of the cuffs <NUM>, <NUM> are generally formed from a single piece of material that is wrapped around itself, forming two ends <NUM>, <NUM> that are drawn towards each other and, in fact, may overlap. Although the ends <NUM>, <NUM> are shown in an overlapping position, it should be understood that these ends might also be sized to be separated by some distance when the orthopedic brace <NUM> is tightened. Generally, the lace <NUM> may be tensioned to draw the ends <NUM>, <NUM> past each other and thereby tighten the orthopedic brace <NUM> about the wearer's limbs. As is readily understood in the art, the two ends <NUM>, <NUM> of brace <NUM> are designed to be open and fit about a patient's leg. The two ends <NUM>, <NUM> are then positioned over the leg and brace <NUM> is tightened as described above.

<FIG> and <FIG> illustrate another brace <NUM> being fit over a wearer's leg <NUM>. Brace <NUM> includes a reel based system (e.g., 122a and 122b) that is described in more detail in <CIT>. Brace <NUM> also includes a rough adjustment feature that permits further opening of the brace <NUM> to facilitate attachment of the brace <NUM> to a wearer's leg <NUM>, while still providing the reel assembly/tightening mechanism <NUM> for final tightening. The rough adjustment feature may be variable length retaining members <NUM> that allow brace <NUM> to fit a wider variety of wearer's legs. In one embodiment, the variable length retaining member <NUM> includes adjustable straps. In other embodiments, a panel <NUM> that includes one or more components of the reel based system (e.g., reel assembly, lace, guides, and the like) may be used. The panel <NUM> may be coupled with a reel assembly <NUM> to provide gross or macro adjustment of the brace <NUM> and/or tightening of the brace about a limb. In some embodiments, retaining members <NUM> are configured to be releasably engaged with guides <NUM> positioned opposite the reel assembly <NUM> and/or attached to the panel <NUM>.

The engagement may be by way of a quick release mechanism <NUM>, such as those described in <CIT>, (<CIT>, entitled "Coupling Members for Closure Devices and Methods,". In other embodiments, Fastex® buckles (shown), Velcro® or other similar mechanisms known to those of skill in the art may be used. As shown in greater detail in <FIG>, each quick release mechanism <NUM> may include a female component 142a and a male component 142b that are coupled over the wearer's leg <NUM> to allow brace <NUM> to be donned and doffed. Exemplary embodiments of male and female components, 142b and 142a, are described in the <CIT> (<CIT>). In some embodiments, the female component 142a may be attached to the guide <NUM> while the male component 142b is attached to the retaining member, though the arrangement of components may be switched as needed. The opposite end of the retaining member <NUM> may be attached to the brace such that tension in the lacing system <NUM> causes tension on the retaining member <NUM> when the quick released mechanism <NUM> is engaged, thereby compressing the cuffs around the wearer's limb.

Reel based system <NUM> may include additional gross adjustment features in combination with the quick release mechanism <NUM> to provide a rough or gross adjustment of the closing pressure of the brace <NUM> prior to use of the reel assembly <NUM>. For example, the reel based system <NUM> may include ladder locks (e.g., Fastex Slider®) which allow the retaining members <NUM> to be lengthened or shortened as needed. Though shown with two retaining members <NUM>, as with the other embodiments disclosed herein in some embodiments, the number of retaining members <NUM> may vary. In some embodiments, three, four, five, six or more retaining members <NUM> may be desirable.

<FIG> shows one embodiment of the brace <NUM> in a partially open configuration. The quick release mechanism <NUM> have been disconnected leaving the guides <NUM> attached to the brace and releasing one end of the retaining member <NUM>. To remove the brace <NUM>, the user may open the cuffs <NUM>, <NUM> and slide the brace from the user's leg <NUM>. Prior to releasing the quick release mechanism <NUM>, the user may release tension in the reel based system <NUM> by releasing the reel assembly <NUM>, for example, by pulling outwards on the knobs <NUM>. Alternatively, the user may release the reel assembly <NUM> after releasing the quick release mechanism <NUM> to facilitate reattachment of the brace <NUM> by providing additional slack in the system without adjusting the retaining members <NUM> themselves.

As shown in <FIG> (which do not form part of the scope of protection), one advantage of using the above described brace <NUM> and/or <NUM> is the increased ability of the brace <NUM> to fit a conical shape or an adjusting shape, such as a leg <NUM>, arm, or any other body part of the individual. The ability of the brace <NUM> to fit a conical shape is provided by the reel based system <NUM>. As the brace <NUM> is fit about a conical shape (e.g., the leg <NUM>) and the lace <NUM> is tensioned/wound via the reel assembly <NUM>, an upper portion 23a of the brace <NUM> contacts the conically shaped object. As the lace <NUM> is further tensioned, the lace <NUM> causes the brace to adjust until the lower portion 23b of the brace <NUM> also contacts the conically shaped object (e.g., the leg <NUM>). Additional tensioning of the lace <NUM> will result in an approximately equal tensioning throughout the lace <NUM> and equal tightening of the brace, which provides a relative even pressure on the conically shaped object. As such, the brace <NUM> fits well on a conical shape.

Similarly, the brace <NUM> is able to adjust to changes in the shape of the object, such as changes in the shape of a leg <NUM> (or other body part) due to flexing and/or relaxing of the muscle. For example, as leg <NUM> is flexed and assumes a more cylindrical shape, the lace <NUM> is able to slide within, or relative to, the guides <NUM> so that a bottom portion 23b of the brace opens or widens as a top portion 23a contracts or shrinks. Conventional braces typically do not adjust in this manner and as such, when a patient flexes their leg <NUM> (or other body part), the brace <NUM> is typically forced to move or migrate about the body part, such as downward against the knee or ankle. In the embodiments described herein, because the lace <NUM> is able to slide relative to the brace <NUM> and guides <NUM>, and the brace <NUM> is able to adjust to changes in shape, the fit or hold of the brace about the body part is increased and migration of the brace <NUM> is limited or eliminated.

Referring now to <FIG> (which do not form part of the scope of protection), illustrated is a tightening system coupled with prosthetic shells of various shape. For example, in <FIG> a prosthetic <NUM> is a single canopy shell where a single tube shaped prosthetic element encircles a user's limb. An outer edge <NUM> of the shell <NUM> can extend and be slidably positioned over an inner edge <NUM> of the shell <NUM> to secure a user's limb within the shell <NUM>. A reel based tensioning system <NUM> can be used to adjust the tightness or fit of the prosthetic shell <NUM> about the limb and/or to secure the prosthetic shell <NUM> to the limb. In <FIG>, a prosthetic shell <NUM> can include a hinged portion <NUM> that is coupled with a main body portion <NUM>. For example, hinged portion <NUM> can include a hinge element <NUM> that may be positioned near a middle portion of the prosthetic shell <NUM>. An upper portion of the hinged portion <NUM> can be separate from the main body portion <NUM> of shell <NUM>, and can pivot relative thereto via hinge element <NUM>. The upper portion of hinged portion <NUM> may be coupled with a reel based tensioning system <NUM> that is configured to control pivoting of the hinged portion <NUM>. The reel based tensioning system <NUM> can be loosened to pivot the hinged portion <NUM> away from main body portion <NUM>, which allows for insertion and/or removal of a limb into the prosthetic shell <NUM>. The reel based tensioning system <NUM> can also be tightened to create a secure fit of the prosthetic shell <NUM> about the limb. In <FIG>, a double canopy prosthetic shell <NUM> can be used. Double canopy shell <NUM> can include a three-piece shell arrangement in which two side segments <NUM> and <NUM> are slidably positioned over a fixed back segment <NUM>. One of the two side segments, <NUM> or <NUM>, can be slidable positioned in front of the other side segment, <NUM> or <NUM>. The two side segments, <NUM> and <NUM>, can be adjusted using a reel based tensioning system <NUM> to constrict the three prosthetic shell segments (<NUM>, <NUM>, and <NUM>) about the user's limb and thereby ensure a proper fit. Reel based tensioning system <NUM> can be loosened to radially open the three-segment shell <NUM> to allow insertion and/or removal of a limb into the prosthetic shell <NUM>. The reel based tensioning system <NUM> can also be tightened to constrict the three-segment shell <NUM> about the limb. In <FIG>, a two-segment clamshell construction may be used to form a prosthetic shell <NUM>. The two-segments <NUM> and <NUM> of the prosthetic shell <NUM> may be pivotally coupled at a base <NUM> of the prosthetic shell <NUM> to allow the first segment <NUM> to be pivoted relative to the second segment <NUM>. In this configuration, the first segment <NUM> can be pivoted away from the second segment <NUM> by loosening the reel based tensioning system <NUM> and thereby allow for insertion or removal of a limb into the prosthetic shell <NUM>. Similarly, the first segment <NUM> can be pivoted closer to the second segment <NUM> by tightening the reel based tensioning system <NUM> to constrict or tighten the prosthetic shell <NUM> about a user's limb. The lace of the reel based tensioning system <NUM> can span an open portion of the first segment <NUM> and second segment <NUM> to couple the two segments together. The use of the reel based tensioning systems on prosthetic and/or orthotic devices can not only ensure a proper fit, but can also ensure that adjustments of tightness, fit, and/or comfort can easily be made throughout the day by tightening or loosening the lace.

In some background examples, a reel assembly may utilize spools that can store multiple laces. These reel assemblies may allow multiple zones or areas of a brace to be differentially adjusted using a single reel assembly. For example, <FIG> shows a three-tiered spool <NUM> that may be used to differentially tension three laces with a single reel assembly <NUM>. The reel assembly <NUM> is able to tension or loosen all of the laces 704a, 704b, and 704c simultaneously. In some embodiments, a proximal end of each of the three laces 704a, 704b, and 704c can terminate at or near the reel assembly <NUM> while a distal end of each lace 704a, 704b, and 704c terminates on the prosthetic shell <NUM>, preferably on the same side. In some embodiments, the lace termination ends can be varied to vary the length of lace available for tensioning a respective zone and thereby create differential tension in one or more zones of the prosthetic shell <NUM>. Various embodiments of reel based tensioning systems that may be used to create zonal pressure and/or vary lace ends are described in <CIT> (<CIT>, entitled "Devices and Methods for Adjusting the Fit of Footwear,".

<FIG> (which do not form part of the scope of protection) illustrate various background examples of using a lace or tension member to close and tighten a brace. For example, <FIG> shows a reel assembly <NUM> that creates a pressure zone along a longitudinal opening of a prosthetic shell <NUM>. In some embodiments, a second reel assembly can also be coupled with the shell <NUM> and operable to tension a zone of the shell. In some embodiments, the second reel assembly may be placed on the shell <NUM> opposite the first reel assembly <NUM>, such as on a back of the shell <NUM>. The second reel assembly can create a pressure zone along a separate portion of the shell <NUM>, for example, along a collar <NUM> of the shell <NUM> to compress the top portion or region of the shell <NUM> about the limb. The second reel assembly can be positioned in line with a lace <NUM>, or away from the lace <NUM>. In embodiments wherein the second reel assembly is positioned away from the lace <NUM>, a displaceable guide may be used to tension the lace <NUM> as the second reel assembly <NUM> is operated. The displaceable guide may be pulled toward the second reel assembly <NUM> to tension the lace <NUM>. Alternatively, a single reel assembly may be used to adjust the collar portion of shell <NUM> and the longitudinal opening of the shell <NUM>. <FIG> illustrates a background example in which a reel assembly <NUM> is coupled with a lace <NUM> that wraps circumferentially around the brace. The lace <NUM> is tensionable to squeeze or constrict the top portion of the brace about a user's limb. <FIG> illustrate background examples in which distal ends of a lace <NUM> may be attached to the brace. In <FIG>, the distal end of the lace <NUM> may be fixedly attached with the brace <NUM>. In this background example, tensioning of the lace <NUM> effects squeezing or closure of the collar portion <NUM> of the brace <NUM> about the user's limb. In <FIG>, the distal end <NUM> of the lace <NUM> is adjustably coupled with the brace <NUM>. In this embodiment, the distal end <NUM> may be pulled through a lace guide <NUM> to effect an initial closer of the collar portion <NUM> of the brace <NUM> about the limb. The distal end <NUM> may then be crimped or locked in position so that further tensioning of the lace <NUM> via a tensioning mechanism further tightens the collar portion <NUM> of the brace <NUM> about the limb. In this manner, the lace <NUM> can be used to perform a macro or gross adjustment of the brace <NUM> about the limb.

In some background examples (which do not form part of the scope of protection), padded members may be used to create pressure points within a brace. The padded members can be included to focus pressure, distribute pressure, and/or create a more comfortable fit for the user. Padded members may be created from foam, gel, or other spongy and/or flexible materials. For example, in <FIG>, padded members can be included to create one or more pressure zones for reel based tensioning systems <NUM> and <NUM>. A shell <NUM> can include a pressure zone along a longitudinal opening of the shell <NUM>. Shell <NUM> can also include a second pressure positioned near or along a collar <NUM> of the shell <NUM>. The collar pressure zone <NUM> includes one or more padded members <NUM>, which are radially displaceable through windows positioned circumferentially around the shell's collar <NUM>. In some embodiments, the padded members <NUM> may be positioned at approximately equal intervals around the prosthetic <NUM>, or at other locations that would ensure a proper and/or comfortable fit for the user. As lace <NUM> is tensioned, the padded members <NUM> are displaced radially inward through the windows to reduce the volume of the prosthetic against the user's limb and thereby increase the pressure against the limb. In other embodiments, the padded member <NUM> may press against a resilient material or diaphragm that in turn presses against the user's limb.

In some background examples (which do not form part of the scope of protection), customized lace paths may be created on a prosthetic by utilizing the appropriate lace guides. For example, <FIG> shows a single canopy shell <NUM> having multiple rivet holes <NUM>. Guides having rivets or pegs can be inserted into the rivet holes <NUM> to create a desired lace path that produces a desired pressure or prosthetic tightening arrangement. Any guide that can be riveted or snapped into the rivet holes <NUM> can be used. For example, a guide <NUM> can be used to direct segments of a lace <NUM> in different directions along the shell <NUM>. Various riveted guides can be used to create different radii to alter the tension that is applied at a specific portion of the shell <NUM> and can be selected to reduce friction within a lace system.

<FIG> (which do not form part of the scope of protection) illustrate teeter mechanisms that may be incorporated into or coupled with a prosthetic shell to allow differential tensioning or tightening of different areas or zones of the prosthetic shell. As used herein, a teeter mechanism refers to any device that is capable of increasing the lace length in one zone of a prosthetic device while decreasing the lace length in another zone of the prosthetic device. The teeter mechanisms may include a reel assembly that allows the lace to be pulled through, or otherwise moved, relative to the reel assembly and then locked in position. In this manner, the lace length in multiple zones may be adjusted by the use of a teeter mechanism. As shown in <FIG>, by using a teeter mechanism <NUM>, a user can adjust the pressure applied by a prosthetic shell <NUM> in multiple zones by pulling a portion of the lace <NUM> to one side of a reel <NUM> or the other and locking the lace <NUM> in position relative to the teeter mechanism <NUM>. The lace <NUM> may be locked in position by rotating a knob of the teeter mechanism <NUM> or otherwise operating a lock or locking mechanism. In this manner, when the lace <NUM> is tensioned via a reel assembly, the pressure within each zone on either side of the teeter mechanism <NUM> is varied. In some embodiments, the reel assembly may be the same device as the teeter mechanism. For example, the teeter mechanism <NUM> may include a lumen that allows the lace <NUM> to be pulled through the teeter mechanism. The teeter mechanism <NUM> may then be operated as described above (e.g., rotating a knob) to tension the lace <NUM> and thereby tighten the brace about a user's limb. As shown in <FIG>, the teeter mechanism <NUM> may be used to vary the pressure within an upper zone and lower zone of the prosthetic device, and thereby vary the pressure applied to the limb in the upper and lower regions of the prosthetic device respectively. Various embodiments of teeter mechanisms are further described in <CIT> (<CIT>).

In some instances it may be desired to use a lacing system to simultaneously tension multiple tension members or laces. In such background examples (which do not form part of the scope of protection), the lacing system may include a tensioning device, a tensioning mechanism that is operated via the tensioning device, and a plurality of tension members or laces that are coupled with the tensioning mechanism and tensionable thereby. The plurality of tension members may be arranged longitudinally about an opening of an article and configured to narrow a gap of the opening upon tensioning of the plurality of tension members in order to tighten an article, such as a prosthetic or orthotic brace as described herein. In such embodiments, operation of the tensioning mechanism effects a simultaneous and repeatable tensioning of each tension member to achieve a relatively uniform tightening of the article. As used herein, the term simultaneous tensioning means that the each of the tension members is tensioned at roughly the same time and is not depending on tensioning a proximal portion of the tension member. For example, in conventional systems where a single or a few tension members or laces are employed in tightening an article, the distal portions of the tension member are not tensioned until the proximal portions of the tension member are tensioned. Given the frictional loses that are experienced in conventional systems, the distal portions of the tension member may not fully tension until the tension member shifts about the article and/or within one or more lace guides. As a result, the distal portions of the article that are tensioned via the distal portions of the tension member may not immediately tighten in relation to the proximal portions.

As also used herein, the term repeatable tensioning means that the tensioning of each tension member may be roughly equivalent each time the tensioning device is operated. Stated differently, each tension member may be configured to tighten an article at a given or desired rate in relation to the other tension members. Afterwards, each subsequent operation of the tensioning device may effect tightening of the article at the given or desired rate. The use of conventional systems, where the distal portion of the tension member is tensioned only after tensioning of the proximal portion, does not result in repeatable tensioning or tightening of an article. For example, due to frictional and other loses, the proximal portion of the article typically tightens before the distal portion of the article. The tightness of the article then may equalize or normalize over time as the tension member shift about the article and/or within one or more lace guides. As such, the tensioning or tightening of the tension member and article varies. In contrast, by using the embodiments described herein, the tensioning of each tension member and corresponding tightening of the article is repeatable and relatively uniform in relation to conventional systems.

In some background examples (which do not form part of the scope of protection), one or more of the plurality of tension members is adjustably coupled with the article. For example, the distal end of the tension member may be moved or repositioned about the article, which results in a different lace tension being produced in the tension member. Adjustment of the tension member in this manner may be used to achieve a different or differential tensioning of the respective tension member upon operation of the tensioning mechanism. The tension members may be adjustably coupled with the article via: an adjustable terminating end, a teeter mechanism, a lock mechanism, a buckle, and the like.

<FIG> and <FIG> illustrate embodiments of lacing systems that may be used to simultaneously tension multiple tension members or laces. <FIG> illustrate embodiments of elongate members or tension bars (hereinafter tension bars) that may be used to tension a plurality of laces relatively uniformly. In <FIG>, a tension bar <NUM> is coupled with a reel based tensioning system <NUM> as well as with multiple transverse laces <NUM> that span a compression gap <NUM> of a prosthetic shell <NUM>. As the reel based tensioning system <NUM> is tightened, the tension bar <NUM> displaces longitudinally upward from a first position in which the laces are relatively loose, to a second position in which the laces are tensioned. Displacing the tension bar <NUM> to the second position may consist of pulling the tension bar <NUM> upward and towards the reel based tensioning system <NUM>. In some embodiments, the transverse laces <NUM> that span the compression gap <NUM> may contact and slide about posts <NUM> as the tension bar <NUM> is pulled toward the reel assembly <NUM>. The posts <NUM> may control the radius of curvature of the laces <NUM> and direct the closure force inward and/or across the gap <NUM> as the tension bar <NUM> tensions the transverse laces <NUM>. As the tension bar <NUM> tensions the transverse laces <NUM>, the transverse laces <NUM> pull the opposing sides of the compression gap <NUM> inward to compress the prosthetic device about the limb. In some embodiments, rollers, bearings, or other components may be used instead of posts <NUM> to direct the transverse laces <NUM>.

As shown in <FIG>, the transverse laces <NUM> are slidingly disposed within or about guides <NUM> on opposing sides of the compression gap <NUM>. A single transverse lace <NUM> is coupled with the tension bar <NUM> at two distinct longitudinal positions. The lace <NUM> is able to slide within a guide <NUM> between the two distinct longitudinal positions. In this manner, the tension within the multiple laces is dynamically equalized or balanced. By using guides <NUM> of different lengths, the relative amount of pressure applied to the limb at different positions of the shell <NUM> can be controlled. Since the laces <NUM> are able to slide within the guides <NUM> and thereby adjust, the lace tension in this embodiment may be equalized or balanced to a greater degree than other embodiments.

<FIG> and <FIG> illustrate an embodiment of a prosthetic shell <NUM> using a tension bar <NUM> as previously described to create a uniform compression along a compression zone of the shell <NUM>. In the illustrated embodiment, a reel based tensioning system <NUM> is coupled with the tension bar <NUM> and is operable to tension a plurality of laces <NUM> that span a compression gap <NUM> of the shell <NUM>. The laces <NUM> are attached on opposing ends with the prosthetic shell <NUM> and span the gap <NUM>. A middle portion of the laces <NUM> contact posts <NUM> and <NUM> as described above to direct the closure force laterally across the gap <NUM> and thereby pull opposing sides of the gap <NUM> towards one another. In this manner, the shell <NUM> may be constricted or compressed against the limb of the individual to secure the shell <NUM> to the limb. In some embodiments, the reel based tensioning system <NUM> directly pulls or tensions the tension bar <NUM>. In other embodiments, pulleys <NUM> or other components may be used to direct the force applied by the reel assembly <NUM> to the tension bar <NUM>. By selecting the appropriate pulley <NUM>, or pulley system, the force applied to the tension bar <NUM> can be enhanced to achieve a desired compression characteristic. Unlike the embodiment of <FIG>, the lace <NUM> of <FIG> and <FIG> is not disposed within guides that route the lace between two positions of the tension bar <NUM>. Rather, each individual lace segment <NUM> is attached at opposing ends with the shell <NUM> and disposed across the gap <NUM> so that the lace <NUM> is roughly orthogonal to the gap <NUM>.

Referring now to <FIG> and <FIG>, illustrated are other embodiments of tensioning mechanism that may be used to tension a plurality of laces relatively uniformly. Specifically, <FIG> and <FIG> illustrate an embodiment of a reel based tensioning system that may be used to ensure an equal lace tension is achieved in a plurality of tension members or laces that cross an opening or compression gap <NUM> on an article, such as a prosthetic shell <NUM>. The tensioning mechanism is configured to equalize the tension in each lace during tensioning of the laces. In some embodiments, the tensioning mechanism may also be configured to equalize the tension in each lace subsequent to tensioning of the laces. In other embodiments, the tension of the lace may be locked or set using a lock mechanism (e.g., cam, clamp, ferrule, and the like) after an initial tensioning of the laces so that further tensioning of the laces effects a differential tensioning of the laces. As illustrated in <FIG> and <FIG>, a pair of laces, 2202a and 2202b, span the compression gap <NUM> with each lace, 2202a and 2202b, being coupled with a tension or stabilization component <NUM> (hereinafter stabilization component <NUM>) that equalizes the tension in each lace, 2202a and 2202b. Specifically, a first lace 2202a extends from a first side of the prosthetic shell <NUM>, across gap <NUM>, around a first post <NUM> attached to the prosthetic shell <NUM>, around a first shaft or pulley <NUM> of the stabilization component <NUM>, around a second post <NUM>, and back across gap <NUM> to a termination point on the first side of the prosthetic shell <NUM>. Unequal tension in either side of the first lace 2202a will result in the first lace 2202a sliding around the first pulley <NUM> until the tension in the first lace 2202a is roughly equalized. In this manner, the first pulley <NUM> functions as a first tension equalizer to equalize the tension between a first and second portion of the first lace 2202a. The first and second portions of the first lace 2202a function essentially as first and second laces or tension members, since each portion of the lace tightens a different portion of the article or brace.

A second lace 2202b likewise extends from the first side of the prosthetic <NUM>, across gap <NUM>, around a third post <NUM> attached to prosthetic shell <NUM>, around a second pulley <NUM> of the stabilization component <NUM>, around a forth post <NUM>, and back across gap <NUM> to a termination point on the first side of the prosthetic shell <NUM>. Unequal tension in either side of the second lace 2202b will result in the second lace 2202b sliding around the second pulley <NUM> until the tension in the second lace 2202b is roughly equalized. In this manner, the second pulley <NUM> functions like the first tension equalizer to equalize the tension between a first and second portion of the second lace 2202b. The first and second portions of the second lace 2202b function essentially as first and second laces or tension members, since each portion of the lace tightens a different portion of the article or brace.

The stabilization component <NUM> is coupled with a reel assembly <NUM> via a third lace <NUM>. As the reel assembly <NUM> is operated (e.g., a knob of the reel assembly <NUM> rotated) the stabilization component <NUM> is pulled toward the reel assembly <NUM> to tension the first lace 2202a and second lace 2202b. The stabilization component <NUM> is pivotably coupled with the third lace <NUM> via a pin or pivot component <NUM> such that unequal tension in the first lace 2202a and the second lace 2202b causes the stabilization component <NUM> to pivot about pin <NUM> until the tension in each lace, 2202a and 2202b, is equalized. In this manner, the stabilization component <NUM> functions as a second tension equalizer to equalize the tension between the first and second portions of the first lace 2202a and the first and second portions of the second lace 2202b. In some embodiments, the stabilization component <NUM> may be housed within a clear housing <NUM> that is coupled with the prosthetic shell <NUM> so that the operation of the stabilization component <NUM> is visible to a user.

As shown in <FIG> and <FIG>, the configuration of the first and second laces, 2202a and 2202b result in a lace pattern that extends parallel across the compression gap <NUM>. The parallel arrangement of the laces, 2202a and 2202b, ensures that the lace tension is directed across the gap to maximize the closure force applied by the laces. Further, the use of multiple laces across the compression gap <NUM> increases the closing power applied by reel assembly <NUM>. <FIG> also illustrates a slight variation of the load balancing reel based tensioning system in that the laces, 2202a and 2202b, or some portion thereof, are slidably positioned within a guide member that is positioned near one end of the prosthetic shell. The use of the guide member allows the laces to be traversed across the gap near the housing <NUM>.

Referring now to <FIG>, illustrated are yet other embodiments of elongate members that may be used to tension a plurality of laces relatively uniformly. Specifically, a torsion bar or flexible tensioning shaft may allow a plurality of laces to be approximately equally tensioned. In some embodiments, the length of the laces may be adjusted to allow the torsion bar to apply zonal tightening of the prosthetic shell. <FIG> illustrate embodiments of an elongate member, torsion bar, or elongate tensioning shaft <NUM> (hereinafter elongate shaft <NUM>) that may be used to tighten a prosthetic shell <NUM>. The elongate shaft <NUM> extends along the prosthetic shell <NUM> and couples with a plurality of tension members that span an opening or gap <NUM> of the prosthetic shell <NUM>. The tension member may be lace <NUM>, straps <NUM>, or a combination thereof as shown in <FIG>. In some embodiments, the lace <NUM> or strap <NUM> length from the elongate shaft <NUM> to a distal termination point may be adjusted so that tensioning of the lace <NUM> or strap <NUM> via the elongate shaft <NUM> provides a custom zonal fit or tightness. To vary the length, the lace or strap ends may be adjusted and terminated, such as by using a buckle <NUM>, clamp, cam, lock, and the like. Additional embodiments of adjusting the lace or strap ends are provided in <CIT> (<CIT>).

In some embodiments, the lace <NUM> or strap <NUM> may be coupled with the elongate shaft <NUM> by inserting an end of the lace <NUM> or strap <NUM> through a slot (not shown) in the elongate shaft <NUM>. The lace <NUM> or strap <NUM> may then be wound on itself via rotation of the elongate shaft <NUM> about a longitudinal axis of the shaft <NUM>. Rotation of the elongate shaft <NUM> is caused via operation of reel assembly <NUM> and/or one or more gear mechanisms <NUM>. In some embodiments, the flexible tensioning shaft <NUM> may run through tubing (not shown) inside or external to the prosthetic shell <NUM>, or may extend along an outer surface of the prosthetic shell <NUM> and be coupled therewith using one or more bearings or locks (not shown).

In some embodiments, the lace <NUM> or strap <NUM> of one or more zones may be set at a desired tension and the elongate shaft <NUM> rotated (e.g., via reel assembly <NUM>) to differentially tighten the zone or zones. If a different tightness in one or more zones is subsequently desired, the coupling of the lace ends may be adjusted (e.g., via buckles <NUM>) so as to shorten or length the lace in the desired zones and thereby achieve differential tightness upon subsequent operation of the reel assembly <NUM>. The lace ends and/or lace length may then be "locked out" so that a desired tension is achieved in the one or more zones.

The buckle <NUM> may be used to determine an initial tension and then subsequently "locked out" so that the lace in individual zones are displaced or wound about the elongate shaft <NUM> by approximately the same amount. For example, the lace <NUM> or strap <NUM> may be initially tensioned and each lace <NUM> or strap <NUM> may be locked in position via buckle <NUM> so that additional operation of the reel assembly <NUM> winds the laces <NUM> or straps <NUM> in each zone about the elongate shaft <NUM> by roughly the same amount.

As shown in <FIG>, an elongate shaft <NUM> may extend along a prosthetic <NUM> to tension a plurality of zones and reduce a gap <NUM>. The lace <NUM> length from the elongate shaft <NUM> to each of the zones may be adjusted so that tensioning of the lace <NUM> via the elongate shaft <NUM> provides a custom fit. The lace ends <NUM> may be adjusted and terminated as described herein, such as by using a slidable lace stop <NUM> configured to fit within a recess of a guide <NUM>. The lace end <NUM> can be pulled through the guide <NUM> and the lace stop <NUM> coupled with the lace to shorten or lengthen the lace between elongate shaft <NUM> and guide <NUM> and thereby initially tension the lace <NUM>. The lace <NUM> may then be wound on itself via the elongate shaft <NUM> and a reel assembly <NUM>. In some embodiments, the elongate shaft <NUM> may run through tubing (not shown) inside or external to the prosthetic <NUM>, or may extend along an outer surface of the prosthetic <NUM> and be coupled therewith using one or more bearings or locks (not shown).

According to one embodiment, a method of configuring an article with a lacing system includes providing a lacing system that includes: a tensioning device, a tensioning mechanism that is operated via the tensioning device, and a plurality of tension members that are coupled with the tensioning mechanism and tensionable thereby. The method also includes coupling the tensioning device with an article and coupling each tension member of the plurality of tension members with the article so that the plurality of tension members are arranged longitudinally about an opening of an article and configured to narrow a gap of the opening upon tensioning of the plurality of tension members in order to tighten the article. As described herein, in such embodiments, the tensioning mechanism is configured so that operation of the tensioning mechanism effects a simultaneous and repeatable tensioning of each tension member of the plurality of tension members to achieve a relatively uniform tightening of the article. The lacing system further includes a lace coupled with the tensioning mechanism and the tensioning device. The tensioning mechanism is further configured to equalize the tension in each tension member of the plurality of tension members during tensioning of the plurality of tension members. The lace is tensionable via operation of the tensioning device to effect movement of the tensioning mechanism. The tensioning mechanism includes one or more posts or pulleys about which at least one tension member is slidably positioned so that the at least one tension member is able to adjust and equalize the tension in the at least one tension member.

One or more of the tension members may be adjustably coupled with the article so that adjustment of the tension member effects tensioning of the respective tension member upon operation of the tensioning mechanism. The one or more tension members may be adjustably coupled with the article via: an adjustable terminating end, a teeter mechanism, a lock mechanism, a buckle, and the like.

In one embodiment, the tensioning mechanism may be an elongate member that is moveable longitudinally relative to the opening of the article upon operation of the tensioning device. In such embodiments the method may further include coupling each tension member of the plurality of tension members longitudinally along the elongate member. In another embodiment, the tensioning mechanism may be an elongate member that is coupled with the article longitudinally along the opening of the article. In such embodiments, each tension member may be coupled longitudinally along the elongate member and the elongate member may be configured to rotate about a longitudinal axis upon operation of the tensioning device to effect winding of the plurality of tension members about the elongate member. In yet another embodiment, the tensioning mechanism may be configured to equalize the tension in each tension member of the plurality of tension members during and/or subsequent to tensioning of the plurality of tension members. In such embodiments, the tensioning mechanism may include a first means of tension equalization (e.g., a pulley and the like) and a second means of tension equalization (e.g., a pivotable stabilization component and the lie). The first means of tension equalization may effect equalizing the tension between a first and second tension member and the second means of tension equalization may effect equalizing the tension between the a third tension member and the first and second tension members.

In some instances it may be desired to tighten an article via one or more pressure inducing components. For example, it may be desirable to fit a brace about a user's limb via one or more pressure components that apply on inward pressure on the limb. The pressure components may be configured to apply the inward radial pressure via changing a volume of the article. For example, a lacing system for tightening an article about a limb may include: a tensioning device that is coupleable with the article, a tension member that is coupled with the tensioning device and tensionable thereby, and a pressure member that is coupleable with the article. The pressure member may be operable with the tension member and moveable between a first position and a second position relative to the article upon tensioning of the tension member. When the pressure member is in the first position, an opening of the article may have a given surface area. When the pressure member is in the second position, the pressure member may displace into the opening of the article to reduce the surface area and thereby apply inward pressure to the limb. In this manner, the pressure member may effect a volume change of the article to fit the article about the limb.

In another background example (which do not form part of the scope of protection), a lacing system for tightening an article about a limb may include a tensioning device that is coupleable with the article, a tension member that is coupled with the tensioning device and tensionable thereby, and a pressure member that is coupleable with the article and positionable so that an inner surface of the pressure member faces radially inward relative to an opening of the article. The pressure member is operable with the tension member to displace radially into the opening of the article upon tensioning of the tension member to reduce the opening of the article and thereby apply pressure to the limb.

<FIG> and <FIG> illustrate background examples (which do not form part of the scope of protection) of pressure members that function to decrease the effective volume of a prosthetic shell and thereby compress a limb. <FIG> illustrates a shell <NUM> having multiple pressure or padded members <NUM>. Pressure or padded members <NUM> (hereinafter padded member <NUM>) are arranged so that an inner surface of the pressure members <NUM> faces an opening of the shell <NUM>. The pressure members can be spaced equidistant from each other as shown in the illustrated embodiment, or can be placed at other intervals as desired to create a desired compression characteristic. A reel based tensioning system <NUM> is coupled to the outside of the shell <NUM>. The reel based tensioning system <NUM> is configured to create radial pressure around the shell <NUM> by reducing a diameter of the shell <NUM> via lace that is positioned around the shell <NUM>. Specifically, the reel based tensioning system <NUM> is configured to reduce a diameter or surface area of the opening of the shell <NUM> that is defined by the inner surfaces of the shell <NUM> and pressure member. As the radial pressure is increased via reduction in the shell's opening diameter, the padded members <NUM> are forced or flexed radially inward. Flex members <NUM> may be coupled with the padded members <NUM> such that when the padded members <NUM> move radially inward, the flex members <NUM> bow inwardly. To achieve flexing of the flex members <NUM>, the flex members <NUM> have opposing ends that are coupled or attached to the shell <NUM> and a middle portion that is unconnected from the shell <NUM>. As the flex members <NUM> bow inward, the volume within the shell <NUM> is decreased and the shell <NUM> is compressed around the user's limb. In some embodiments, opposing ends of the flex member <NUM> may be fixedly or pivotally coupled with adjacent padded members <NUM>. In some embodiments, one of the opposing ends of the flex member s1806 may be slidably coupled with the shell <NUM> while the other end is fixedly coupled with the shell <NUM>. Upon tensioning of the tension member, the slidable opposing end may slide toward the fixed opposing end, which causes the middle portion to flex or bow into the opening of the shell <NUM> thereby reducing the diameter and/or surface area of the opening.

<FIG> illustrates another background example of a shell <NUM> having a flex member <NUM>. In <FIG>, the flex members <NUM> is positioned across an opening or gap of the prosthetic shell <NUM>. A reel based tensioning system <NUM> is configured to reduce or close the opening or gap of the shell <NUM> and thereby cause the flex member <NUM> to flex radially inward to reduce the volume of the shell <NUM>. Closure of the opening or gap may be effected by spanning lace across the opening or gap and tensioning the lace with a reel assembly as described herein. The flex members, <NUM> or <NUM>, may be configured so that an amount of flexing of the middle portion of the flex members corresponds with an amount of tension that is induced in the tension member. Stated differently, the degree to which the flex members flex or bow into the opening of the respective shell may directly correlate with the tension that is induced in the tension member. As such, infinitesimal amounts of pressure may be applied to the limb via the flex or pressure members.

<FIG> illustrates an background example using a flexible panel <NUM> that may be used to decrease a volume of a prosthetic shell. In one embodiment, panel <NUM> includes transverse or lateral slits <NUM> that are arranged roughly orthogonal to the longitudinal length of the panel <NUM>. The panel <NUM> is coupled with a reel based tensioning system <NUM>, such as by inserting a plug or stop member through an aperture of a distal end <NUM> of the panel. The plug or stop member may contact the distal end <NUM> of the panel as the reel based tensioning system <NUM> is tightened and thereby compress the panel <NUM>. The slits <NUM> allow the panel <NUM> to bend or flex upward as the panel <NUM> is compressed. To increase the volume in a shell, a proximal end <NUM> of the panel <NUM> nearest the reel based tensioning system <NUM> can be fixedly secured to the shell. As the reel based tensioning system <NUM> is tightened, the unfixed distal end <NUM> of the panel <NUM> is compressed toward the fixed end <NUM>, which forces the flexible panel <NUM> to bend inward and against a limb positioned within the prosthetic, thereby increasing pressure on the limb.

<FIG> illustrate another background example of a prosthetic shell <NUM> utilizing one or more extendable pressure members or panels <NUM> (hereinafter pressure panels <NUM>). The pressure panels <NUM> may include two or more parallel rails or members <NUM> that are coupled together via multiple connectors <NUM>. The connectors <NUM> may be compliant mechanisms or may be connected to the rails or member <NUM> via hinges. The pressure panels <NUM> are arranged so that an outer member of the panels <NUM> faces an opening of the shell <NUM>. The pressure panels <NUM> create radial pressure on user's limb positioned within the shell <NUM> by reducing a diameter or surface area of the opening of the shell <NUM> that is defined by the inner surface of the shell <NUM> and the outer member of the pressure panels <NUM>. The pressure panels <NUM> reduce the opening's diameter or surface area by the outer member of the pressure panels <NUM> moving radially inward into the opening as described herein below. For example, as shown in <FIG>, the pressure panel <NUM> can be moved between two positions: a collapsed position <NUM> in which the parallel members are folded or lie relatively flat against one another, and an extended position <NUM>, in which the parallel members are offset or displaced away from one another. Displacement of the parallel members increases the volume occupied by the pressure panels <NUM>. Movement of the two parallel members between the collapsed and extended positions is achieved via the connectors <NUM>. Additionally, in the extended position <NUM>, the hinged connectors <NUM> are roughly perpendicular relative to the parallel members <NUM>.

As shown in <FIG>, an inner member <NUM> of the parallel members of each pressure panel <NUM> may be coupled to an inner surface of the shell <NUM>. A lace of a reel based tensioning system <NUM> may be coupled to a proximal end of the outer member <NUM> of the parallel members. As the lace of the reel based tensioning system <NUM> is tensioned, the proximal end of the outer member <NUM> is pulled toward the reel based tensioning system <NUM>, which causes the pressure panels <NUM> to displace into the extended position <NUM>. This increases the volume occupied by the pressure panels <NUM> within the shell <NUM> and causes the outer member <NUM> to press against a limb positioned within the shell <NUM>.

<FIG> illustrate the pressure panels <NUM> being coupled with the reel based tensioning system <NUM> in a variety of ways. For example, a single lace <NUM> may be threaded through the outer member <NUM> such that as the lace <NUM> is tensioned, each pressure panel <NUM> displaces or moves at the same rate. In another embodiment, a first lace <NUM> may be coupled with a proximal end of an outer member <NUM> of a first pressure panel while a second lace is coupled with a distal end of the first pressure panel's outer member and with a proximal end of an inner member of a second pressure panel that is positioned distally of the first pressure panel. The second lace may cause the inner member to move proximally relative to the outer member of the second pressure panel, which causes the pressure panel to radially expand as previously described. In yet another embodiment, the pressure panels <NUM> may each be coupled with a separate lace <NUM> that is in turn coupled with the reel based tensioning system <NUM>. In such an embodiment, the pressure panels <NUM> can be configured to extend at the same rate, or the length of lace <NUM> to one or more of the pressure panels <NUM> can be varied to a vary the rate at which one or more pressure panels extend. The outer and inner members of the pressure panels <NUM> are configured so that an amount of movement of the outer member <NUM> relative to the inner member <NUM> and inward into the opening of the shell <NUM> corresponds with an amount of tension that is induced in the tension member. Stated differently, the degree to which the outer member <NUM> moves relative to the inner member <NUM> and into the opening of the shell <NUM> is directly correlated with the tension that is induced in the tension member. As such, infinitesimal amounts of pressure may be applied to the limb via the pressure panels be tensioning the tension members to a given degree.

In some background examples (which do not form part of the scope of protection) pressure applied to a limb by a prosthetic shell may be adjusted by altering a position of a guide. In <FIG>, a second member or guide <NUM> is positioned on a first member or wedge shaped pressure member <NUM>, for example at a distal end of the wedge member <NUM>. As a lace <NUM> is tensioned, the guide <NUM> forces the distal end of the wedge member <NUM> downward towards an outer surface of the shell <NUM>. An inner surface of the wedge member <NUM> is pressed inward and into contact with the limb, or into contact with cushioning or some other component that is positioned adjacent the limb, thereby increasing the pressure of the shell <NUM> about the limb. In some embodiments, the amount of pressure applied to the limb by the wedge member <NUM> may be adjusted by altering the position of the guide <NUM> relative to the wedge member <NUM>. For example, guide <NUM> can be slidably positioned on a track that enables the guide <NUM> to be moved and positioned along the wedge member <NUM>. For example, guide <NUM> can be positioned near a proximal end <NUM> of the wedge member <NUM> to minimize the amount of pressure applied when a lace <NUM> is tensioned, or guide <NUM> can be moved toward a distal end <NUM> of the wedge member <NUM> to increase the amount of pressure applied to the limb upon tensioning of the lace <NUM>. Sliding of the guide <NUM> from the proximal end to the distal end of the wedge member <NUM> causes a greater displacement of the wedge member <NUM> inward into the opening of the shell <NUM>. The greater displacement inward of the wedge member <NUM> is achieved via the wedge shape of the wedge member <NUM>. Positioning the guide <NUM> over the large wedge portion of the wedge member <NUM> forces a greater displacement of the wedge member <NUM> into the opening of the shell <NUM>. The wedge shape of the wedge member <NUM> and the movement of the guide <NUM> along the wedge member <NUM> enables infinitesimal amounts of pressure to be applied to the limb.

In some background examples (which do not form part of the scope of protection), the guide member <NUM> and wedge member <NUM> may be arranged so that an inner surface of the wedge member <NUM> faces an opening of the shell <NUM>. The wedge member <NUM> creates radial pressure on user's limb positioned within the shell <NUM> by reducing a diameter or surface area of the opening of the shell <NUM>. The wedge member <NUM> reduces the opening's diameter or surface area by the inner surface of the wedge member <NUM> moving radially inward into the shell's opening.

In some background examples (which do not form part of the scope of protection), the lace may be coupled with a movable component so that tensioning of the lace (e.g., via a reel based tensioning system) causes the movable component to slide along a track and against a wedge member. In such embodiments, the pressure exerted on the limb via the wedge member may be dynamically adjusted as the lace is tensioned or loosened via reel based tensioning system.

According to one background example (which do not form part of the scope of protection), a method of configuring an article with a lacing system includes providing a lacing system that includes: a tensioning device, a tension member that is coupled with the tensioning device and tensionable thereby, and a pressure member. The method also includes coupling the tensioning device with the article and coupling the pressure member with the article so that an inner surface of the pressure member faces radially inward relative to an opening of the article. The pressure member is operable with the tension member so that the pressure member displaces radially into the opening of the article upon tensioning of the tension member. Displacement of the pressure member into the opening reduces the opening of the article and thereby applies pressure to a limb positioned with the article.

In some background examples (which do not form part of the scope of protection), coupling the pressure member with the article includes coupling opposing ends of the pressure member with the article while a middle portion of the pressure member remains uncoupled from the article. In such embodiments, tensioning of the tension member causes the middle portion of the pressure member to flex radially inward into the opening of the article. In such embodiments, one of the opposing ends of the pressure member may be slidably coupled with the article while the other opposing end is fixedly coupled with the article. In such embodiments, the slidable opposing end may slide towards the fixed opposing end upon tensioning of the tension member.

In another background example (which do not form part of the scope of protection), the pressure member may include a first member and a second member that is moveably coupled with the first member. In such embodiments, tensioning of the tension member may cause the second member to move relative to the first member and radially into the opening of the article. In such embodiments, the pressure member may also include a third member that couples the second member with the first member and effects movement of the second member radially into the opening of the article upon tensioning of the tension member.

In another background example (which do not form part of the scope of protection), coupling the pressure member with the article may include slidably coupling a second member with a first member so that the second member is slidable between a proximal end and a distal end of the first member. In such embodiments, sliding of the second member from the proximal end to the distal end of the first member causes the first member to displace into the opening of the article. In such embodiments, the first member may include a tapered configuration between the proximal and distal ends so that sliding of the second member along the tapered configuration of the first member effects an increased amount of displacement of the first member radially into the opening of the article.

As shown in <FIG>, in some background examples (which do not form part of the scope of protection) it may be desirable to move the location of a reel assembly or tightening mechanism <NUM> relative to the prosthetic shell <NUM>. For example, the tightening mechanism <NUM> may be moved for easier access to the user or to provide the prosthetic shell <NUM> with a desired visual look. In one embodiment, the tightening mechanism <NUM> can be positioned within a pocket of the user's pants. The position of the tightening mechanism <NUM> allows the user to easily access the tightening mechanism <NUM> to tighten or loosen the prosthetic shell <NUM>. Non-compressible tubing <NUM> may extend from the tightening mechanism <NUM> to a tightening component <NUM> that is coupled with the prosthetic shell <NUM> to tension or loosen the reel based tensioning system's lace. In some embodiments, the prosthetic shell <NUM> may include a tensioning mechanism <NUM> that is removably couplable and operable with the tightening component <NUM> to tension or loosen the reel based tensioning system's lace upon actuation of the tightening mechanism <NUM>. In such embodiments, the tightening component <NUM> is removable from the tensioning mechanism <NUM> such that the tightening mechanism <NUM> may be removed when it is not in use. The tightening component <NUM> may include a cylindrical drive mechanism that is placed on top of a reel assembly (i.e., the tensioning mechanism <NUM>). The tensioning mechanism <NUM> may provide the prosthetic shell <NUM> with a relatively low profile appearance that may be visually pleasing to consumers. In some embodiments, the tensioning mechanism <NUM> may be positioned within the prosthetic shell <NUM> and the tightening component <NUM> may include a plug (not shown) that is inserted within the prosthetic shell <NUM> to operate with tightening mechanism <NUM>. The tightening component <NUM> may be removably or nonremovably coupled with the user's pants via stitching, adhesive bonding, snaps, mechanical, fasteners, Velcro®, and the like. In still other embodiments, the tightening mechanism <NUM> may be positioned elsewhere on the user's pants or clothing, such as a belt and the like.

Although the above figures illustrate the prosthetic devices being closed via manual reel based tensioning systems, it should be realized that the manual reel based tensioning systems described in the various embodiments could be replaced with motorized devices that tension the lace and/or tighten the prosthetic about the limb. It some instances it may be beneficial to replace the manual reel based tensioning systems with motorized devices and/or control systems. For example, the motorized devices/control systems may allow for more precise lace tension monitoring, prosthetic pressure monitoring, real time lace tension adjustment, and the like. The motorized devices/control systems may also be programmed to monitor various prosthetic and/or lace tension conditions and to provide various feedback based on the monitored conditions, such as over-tensioning, over pressurization, excess heat, excess wear on the limb, and the like. The activity and/or condition of the limb may also be monitored and provided to user and/or a physician as desired. Audible alarms may be triggered when potential problems are detected. In addition, the motorized devices/control systems may be used for various other purposes.

<FIG> illustrate a background example (which do not form part of the scope of protection) of a motorized tensioning system <NUM> that may be used used to open and close a prosthetic device <NUM>. The tensioning system <NUM> includes a motorized reel assembly <NUM> that includes a stacked spool, which may be similar to that described in <CIT> (<CIT>). Each spool is coupled with a lace and the two laces <NUM> and <NUM> are wound in opposite directions. When the spool winds in a first direction, the spool draws in a first lace <NUM> guided by guides <NUM> and arranged along a first lace path, which closes a gap <NUM> and tightens the prosthetic device <NUM> about a limb. Stated differently, tensioning of the first lace <NUM> draws a proximal side <NUM> of the gap <NUM> toward to a distal side <NUM> of the gap <NUM>. Winding of the spool in the first direction also causes a second lace <NUM> to release or loosen. The second lace <NUM> may be arranged along a second lace path, which in the illustrated embodiment is circumferentially around the prosthetic device's body.

When the spool is wound in a second direction, opposite the first direction, the second lace <NUM> is drawn in or wound around the spool and tightened while the first lace <NUM> is released or loosened. Loosening of the first lace <NUM> allows the gap <NUM> to be opened, which occurs due to tension in the second lace <NUM>. Because the second lace <NUM> is positioned circumferentially around the prosthetic device's body, tension of the second lace <NUM> functions to pry open the gap <NUM> of the prosthetic device <NUM>. The user may then easily remove the prosthetic device <NUM> from about the limb.

<FIG> shows a plan view of the motorized tensioning device <NUM> and the first and second lace paths. As illustrated, a first lace <NUM> exits the motorized tensioning device <NUM> and is guided (via guides <NUM>) across the gap or opening <NUM> approximately four times. The distal end of the first lace <NUM> then returns to the motorized tensioning device <NUM> and is coupled with an internal spool (not shown) of the motorized tensioning device <NUM>. Because both ends of the first lace <NUM> are coupled with the motorized tensioning device's spool and the lace <NUM> crosses the opening or gap <NUM> four times, the resulting shortening or lengthening of the lace <NUM> upon operation of the motorized tensioning device <NUM> is approximately Δl/<NUM> (i.e., <NUM> lace crossings per <NUM> ends of the lace being tensioned). The second lace <NUM> exits an opposite side of the motorized tensioning device <NUM> and is guided across the distal side <NUM> of the brace <NUM> approximately twice. The distal end of the second lace <NUM> terminates near the opening or gap <NUM>. Because only a single end of the second lace <NUM> is coupled with the motorized tensioning device's spool and the second lace <NUM> crosses the distal side <NUM> twice, the resulting shortening or lengthening of the second lace <NUM> upon operation of the motorized tensioning device <NUM> is also approximately Δl/<NUM> (i.e., <NUM> lace crossings per <NUM> ends of the lace being tensioned). Because the shortening or lengthening of the first lace <NUM> and second lace <NUM> is approximately Δl/<NUM> upon operation of the motorized tensioning device <NUM>, operation of the motorized tensioning device <NUM> in the first direction or the second direction results in an approximately equal amount of the first or second lace being ejected or wound within the motorized tensioning device <NUM>. As such, undue slack is not created in either the first or second lace upon tightening or loosening of the brace from about a user's limb. It should be realized that the lace configurations of <FIG> may vary depending on the desired closure and/or application of the brace and/or for any other reason. Regardless of the lace path used, the first and second lace paths may be configured so that the shortening and lengthening of the first and second laces are approximately equal. Further, the lace paths of a third lace, fourth lace, and the like, may likewise be configured so that shortening and lengthening of all the laces is approximately equal. Such embodiments ensure that undue slack is not created in any lace, which may negatively affect the operation of the motorized tensioning device <NUM> and/or brace closure.

<FIG> illustrates an embodiment in which the brace <NUM> may include a component that compensate for any difference in the shortening or lengthening of different laces due to a lace path. Specifically, a first lace <NUM> exits a motorized tensioning device <NUM> and crosses an opening <NUM> of the brace <NUM> four times. Only a single end of the first lace <NUM> is tensioned via the motorized tensioning device <NUM> so that the resulting shortening/lengthening of the first lace <NUM> upon operation of the motorized tensioning device <NUM> is approximately Δl/<NUM>. A second lace <NUM> exits the motorized tensioning device <NUM> and crosses a distal side of the brace <NUM> twice. A single end of the second lace <NUM> is tensioned via the motorized tensioning device <NUM> so that the resulting shortening/lengthening of the second lace <NUM> upon operation of the motorized tensioning device <NUM> is approximately Δl/<NUM>. The lace paths of <FIG> result in differential shortening/lengthening of the first and second laces, <NUM> and <NUM>. To compensate for the differential shortening/lengthening of the laces, the brace includes a spring component <NUM> that resiliently lengthens and shortens due to the difference in lengthening or shortening of the first and second laces, <NUM> and <NUM>. The spring component <NUM> maintains a nominal level of tension in the first and second laces upon operation of the motorized tensioning device <NUM>. In other embodiments, the spring component <NUM> may be coupled with the first or second lace, <NUM> or <NUM>, instead of being coupled with the brace <NUM>. Although the embodiments of <FIG> are illustrated as employing a motorized tensioning device, in other embodiments a manual device, such as those described previously, may be used to open or close the brace. In such embodiments, the lace configurations described in <FIG> may be employed.

As a general summary of the background examples of <FIG>, a brace, or lacing system for a brace, may include a tensioning device having a first mode of operation and a second mode of operation, a first tension member or lace that is coupled with the tensioning device and tensionable thereby to effect tightening of the brace about the limb, and a second tension member or lace that is coupled with the tensioning device and tensionable thereby to effect opening of the brace from about the limb. The tensioning device may be configured so that: operating the tensioning device in the first mode of operation effects tensioning of the first tension member to close and tighten the brace about the limb and operating the tensioning device in the second mode of operation effects tensioning of the second tension member to loosen and open the brace from about the limb. The tensioning device may also be configured so that: operating the tensioning device in the first mode of operation effects loosening of the second tension member while simultaneously tensioning the first tension member and operating the tensioning device in the second mode of operation effects loosening of the first tension member while simultaneously tensioning the second tension member. The first mode of operation and the second mode of operation of the tensioning device may be effect winding of the spool in opposite directions as previously described.

In some background examples (which do not form part of the scope of protection), the first tension member may be routed about the brace along a first path that is configured to close and tighten the brace upon tensioning of the first tension member, and the second tension member may be routed about the brace along a second path that is configured to open and loosen the brace upon tensioning of the second tension member. In such embodiments, the first path and the second path may be configured so that an amount of displacement of the second tension member about the second path is proportional or equivalent to an amount of displacement of the first tension member about the first path. In some embodiments, the tensioning device may be a reel based closure system having a knob that is rotatable in a first direction and a second direction. In such embodiments, rotation of the knob in the first direction corresponds to the first mode of operation and rotation of the knob in the second direction corresponds to the second mode of operation.

In other background examples (which do not form part of the scope of protection), the tensioning device may be a motorized device having an internal mechanism (e.g., electric motor, spool, etc.) that effects tensioning of the first tension member and simultaneous loosening of the second tension member in the first mode of operation, and that effects tensioning of the second tension member and simultaneous loosening of the first tension member in the second mode of operation. In such embodiments, the brace may further include a control unit that is communicatively coupled with the motorized tensioning device. The control unit may be configured to: receive a first input and communicate a first instruction to the motorized tensioning device to effect operation of the motorized tensioning device in the first mode of operation. The control unit may be further configured to: receive a second input and communicate a second instruction to the motorized tensioning device to effect operation of the motorized tensioning device in the second mode of operation.

According to a background examples (which do not form part of the scope of protection), a method for automatically opening and closing a brace about a limb is provided. The method is used for a brace that includes a tensioning device having a first mode of operation and a second mode of operation. The brace also includes a first tension member or lace that is coupled with the tensioning device and tensionable thereby to effect tightening of the brace about the limb. The method includes operating the tensioning device in the first mode of operation, which effects tensioning of the first tension member to close and tighten the brace about the limb. The method also includes operating the tensioning device in the second mode of operation, which effects loosening of the first tension member and effects opening of the brace from about the limb.

In some background examples (which do not form part of the scope of protection), the brace includes a second tension member or lace that is coupled with the tensioning device and is tensionable thereby to effect opening of the brace from about the limb. In such embodiments, operating the tensioning device in the second mode of operation effects tensioning of the second tension member while loosening the first tension member. The second tension member is coupled with the brace so that tensioning of the second tension member loosens and opens the brace from about the limb. In such embodiments, the first tension member is routed along a first path about the brace that is configured to close and tighten the brace upon tensioning of the first tension member, and the second tension member is routed along a second path about the brace that is configured to open and loosen the brace upon tensioning of the second tension member.

As described above, the first path and the second path of the respective tension members are configured so that an amount of displacement of the second tension member about the second path is proportional or equivalent to an amount of displacement of the first tension member about the first path. In some embodiments, the tensioning device may be a reel based closure system having a knob that is rotatable in a first direction and a second direction. In such embodiments, rotation of the knob in the first direction corresponds to the first mode of operation of the tensioning device and rotation of the knob in the second direction corresponds to the second mode of operation of the tensioning device.

In other background examples (which do not form part of the scope of protection), the tensioning device may be a motorized device having an internal mechanism (e.g., electric motor, spool, etc.) that effects tensioning of the first tension member and simultaneous loosening of the second tension member in the first mode of operation and that effects tensioning of the second tension member and simultaneous loosening of the first tension member in the second mode of operation. In such embodiments, the brace may further include a control unit that is communicatively coupled with the motorized tensioning device and the method may further include: receiving a first input at the control unit, communicating a first instruction from the control unit to the motorized tensioning device, and in response to the first instruction, operating the motorized tensioning device in the first mode of operation to tension the first tension member and close and tighten the brace about the limb. The method may further include: receiving a second input via the control unit, communicating a second instruction from the control unit to the motorized tensioning device, and in response to the second instruction, operating the motorized tensioning device in the second mode of operation to tension the second tension member and open and loosen the brace from about the limb.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included.

As used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a process" includes a plurality of such processes and reference to "the device" includes reference to one or more devices and equivalents thereof known to those skilled in the art, and so forth.

Claim 1:
A lacing system comprising:
a tensioning device (<NUM>, <NUM>);
a tensioning mechanism (<NUM>, <NUM>) that is operated via the tensioning device (<NUM>, <NUM>); and
a plurality of tension members (2202a/b, <NUM>) that are coupled with the tensioning mechanism (<NUM>, <NUM>) and tensionable thereby, the plurality of tension members (2202a/b, <NUM>) being arrangeable longitudinally about an opening of an article (<NUM>, <NUM>) and configured to narrow a gap (<NUM>) of the opening upon tensioning of the plurality of tension members (2202a/b, <NUM>) in order to tighten the article (<NUM>), wherein
the tensioning mechanism (<NUM>, <NUM>) is configured to effect a simultaneous and repeatable tensioning of each tension member of the plurality of tension members (2202a/b, <NUM>); characterized in that
the tensioning mechanism (<NUM>, <NUM>) is further configured to equalize the tension in each tension member of the plurality of tension members (2202a/b, <NUM>) during tensioning of the plurality of tension members (2202a/b, <NUM>);
a lace (<NUM>) is coupled with the tensioning mechanism (<NUM>, <NUM>) and the tensioning device (<NUM>, <NUM>), the lace (<NUM>) being tensionable via operation of the tensioning device (<NUM>, <NUM>) to effect movement of the tensioning mechanism (<NUM>, <NUM>); and
the tensioning mechanism (<NUM>, <NUM>) includes one or more posts or pulleys (<NUM>, <NUM>) about which at least one tension member (2202a, <NUM>) is slidably positioned so that the at least one tension member (2202a, <NUM>) is able to adjust and equalize the tension in the at least one tension member (2202a, <NUM>).