[1] TECHNICAL FIELD

[2] The disclosure relates to a tightening system with a tension control mechanism.

[3] BACKGROUND

[4] There are a variety tightening or closure systems that employ a lace or cable based reel for tightening an article, such as orthopedic or prosthetic devices. One conventional type of tightening system includes a lace attached to a rotary tightening system which allows for incremental adjustment of the tension of the lace.

[5] While such tightening systems can be effective at tightening an article over a user, they suffer from a number of drawbacks. One of these drawbacks is the inability to prevent over tensioning of the system. As a result, there is a risk that the user may over tighten the system, and cause injury to the user. For instance, in an orthopedic device which requires precise and prescribed tightening to treat an injury, the user must not further aggravate the injury by creating too much pressure over the injury due to excessive tightening of the tightening system. Further, known tightening systems lack the ability to adjust the maximum tension limit of the lace, significantly hindering the functionality of the tightening system in various treatment protocols.

[6] It can be seen from the foregoing there are many needs for improving on the drawbacks of conventional tightening systems. The embodiments of the present disclosure address these aforementioned shortcomings.

[7] SUMMARY

[8] Embodiments of the tightening system provide the ability to automatically release tension in the tightening system when such tension reaches a predetermined level. By automatically limiting or regulating the level of tension in the tightening system, the tightening system can reduce the likelihood that a user will over-tighten the system about an anatomical member of the user. This is advantageous because overtightening can cause pressure on the skin, which can reduce both capillary blood flow to the skin and arterial flow to the anatomical member. Over-tightening can also cause undesirable and/or excessive loads on the user's bones and/or joints. It should be appreciated that the tightening system can prevent over tensioning of the system during initial tensioning and/or in use. [9] It is a goal of the present disclosure to reduce the need of users themselves having to set or monitor safe tension levels within the tightening system. For instance, conventional tightening systems often require users to monitor tension in the tightening system based on how tight the orthopedic or prosthetic device feels on the user's limb. However, many users, especially users with an injured or affected limb, experience irregular sensation. Consequently, such users are at risk of over-tightening or under tightening the tightening system, causing injury to the user. By including a tension control mechanism in the tightening system that automatically releases excess tension, the user can tighten the tightening system without the need of monitoring safe or target tension levels.

[10] It is another goal of the present disclosure to offer the ability to adjust the maximum tension limit of the tightening system. The tightening system of various embodiments offer a practical solution for a user to adjust the maximum tension limit on the fly during use or when initially donning an article including the tensioning system. This advantageously increases the operational functionality of the tightening system in various treatment protocols.

[1 1] In an embodiment, a tightening system includes a housing and a spool situated within the housing. The spool is rotatable about an axis within the housing. An elongate tensioning element is rotatably linked to the spool and a tension control mechanism is operatively connected to the spool. The tension control mechanism is arranged to automatically shift when tension in the tensioning element reaches a predetermined level, which, in turn, releases at least some of the tension in the tensioning element.

[12] In some embodiments, the tightening system includes a sensitivity adjustment dial arranged to selectively adjust an actuating or maximum tension of the tension control mechanism. Thus, a user, clinician, or medical professional can advantageously adjust the actuating tension of the tension control mechanism to customize the tightening system for different users and/or user needs. For instance, a clinician can adjust the actuating tension during the course of treatment where the maximum load may vary.

[13] Additional features and advantages of embodiments of the present disclosure will be set forth in the description that follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary embodiments. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such exemplary embodiments as set forth.

[14] BRIEF DESCRIPTION OF THE DRAWINGS

[15] To further clarify the above and other advantages and features of the present disclosure, a more particular description of the disclosure will be rendered by reference to specific embodiments illustrated in the drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure and are not to be considered limiting of scope, and are not necessarily drawn to scale. The disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[16] Fig. 1 is an isometric view of a knee brace in which the exemplary embodiments of a tightening system may be implemented.

[17] Fig. 2 is an isometric view of circumferential type walking boot (walker) in which the exemplary embodiments of a tightening system may be implemented.

[18] Fig. 3 is an isometric view of a tightening system according to an embodiment.

[19] Fig. 4 is an exploded view of the tightening system shown in Fig. 3.

[20] Fig. 5 is an isometric view of a dial according to an embodiment.

[21] Fig. 6 is an isometric view of a spool according to an embodiment.

[22] Fig. 7 is an isometric view of a dial and tensioning element according to an embodiment.

[23] Fig. 8 is an exploded view of a tightening system according to another embodiment.

[24] Fig. 9 is a partial detailed view of the dial and the spool shown in Fig. 8.

[25] DETAILED DESCRIPTION

[26] A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements. [27] For further ease of understanding the exemplary embodiments as disclosed herein, a description of a few terms is necessary. As used herein, the term "dorsal" has its ordinary meaning and refers to the top surfaces of the foot, ankle and foreleg or shin. As used herein, the term "plantar" has its ordinary meaning and refers to a bottom surface, such as the bottom of a foot. As used herein, the term "proximal" has its ordinary meaning and refers to a location that is closer to the heart than another location. Likewise, the term "distal" has its ordinary meaning and refers to a location that is further from the heart than another location. The term "posterior" also has its ordinary meaning and refers to a location that is behind or to the rear of another location. Lastly, the term "anterior" has its ordinary meaning and refers to a location that is ahead of or to the front of another location.

[28] The terms "rigid," "flexible," and "resilient" may be used herein to distinguish characteristics of portions of certain features of the orthopedic device. The term "rigid" is intended to denote that an element of the device is generally devoid of flexibility. Within the context of support members or shells that are "rigid," it is intended to indicate that they do not lose their overall shape when force is applied, and in fact they may break if bent with sufficient force.

[29] On the other hand, the term "flexible" is intended to denote that features are capable of repeated bending such that the features may be bent into retained shapes or the features do not retain a general shape, but continuously deform when force is applied. The term "resilient" is used to qualify such flexible features as generally returning to an initial general shape without permanent deformation. As for the term "semi-rigid," this term is used to denote properties of members that provide support and are free-standing; however such members may have some degree of flexibility or resiliency.

[30] The exemplary embodiments of a tightening system can be used in various articles, including, but not limited to, configurations of knee braces, wrist braces, ankle braces, cervical collars, elbow braces, walking boots, orthopedic shoes, postsurgical shoes, prosthetic devices, footwear, athletic gear, prosthetic sockets, traction devices, or any other suitable article.

[31] For example, exemplary embodiments of a tightening system can be implemented with a knee brace 11, as shown in Fig. 1. An exemplary knee brace 1 1 includes a shell 13 connected to a frame 15. In this exemplary device 11, a tightening system 17 is secured on the shell 13. The tightening system 17 can be arranged to draw the shell 13 toward a limb of a user by tensioning an elongate tensioning element 19, such as a cable or lace, wound by the tightening system 17 and connected to the frame 15. It will be appreciated that the tightening system 17 can be secured to the frame, a strap, or any other suitable component of the knee brace 1 1.

[32] Further, exemplary embodiments of a tightening system can be implemented with a walker 21, as shown in Fig 2. The walker 21 can include a base shell 23 and a dorsal shell 25, such that the lower leg is generally fully enclosed and supported by the walker 21. An outsole 29 can be provided along the distal planar surface of the walker 21. The dorsal shell 25 can be moveable away from and towards the base shell 23 in order to open and close the walker 21. A tightening system 27 can be secured to the walker 21 that utilizes an elongate tensioning element, such as a cable or lace, to simultaneously and incrementally tighten the components of the walker 21 around the lower leg.

[33] Referring now to Figs. 3-7, a first exemplary embodiment of a tightening system comprises a tightening system 100 including at least one tensioning element 102 (shown in Fig. 7), a base 104, a spool 106 (shown in Fig. 4), and a dial 108. The spool 106 can be situated within the base 104 such that the spool 106 (shown in Fig. 4) is rotatable about an axis A-A (shown in Fig. 3) relative to the base 104. The tensioning element 102 can be rotatably linked to the spool 106. The tensioning element 102 (best seen in Fig. 7) may be formed from any type of line, cord, strap, rope, string, wire, cable or other suitable element. Further, the tightening system 100 may include one, two, three, four, or any other suitable number of tensioning elements.

[34] When the spool 106 rotates in a tightening direction, the tensioning element 102 is drawn into the base 104 and is wound around the spool 106. As the tensioning element 102 is wound around the spool 106, tension in the tensioning element 102 increases, causing the system 100 to tighten. When the spool 106 rotates in a loosening direction, the tensioning element 102 unwinds from the spool 106 and at least a part of the tensioning element 102 exits the base 104. As the tensioning element 102 (shown in Fig. 7) unwinds from the spool 106, tension in the tensioning element 102 decreases, loosening the system 100. The spool 106 can include a first engagement surface 126 (shown in Fig. 5) described in more detail below.

[35] The dial 108 can be attached to the base 104 such that the dial 108 can rotate about the axis A-A relative to the base 104. The dial 108 can include a second engagement surface 134 (shown in Fig. 6) arranged to mate with the first engagement surface 126 of the spool 106. This arrangement can couple the dial 108 to the spool 106 so that the tension in the tensioning element 102 can be manually controlled by twisting the dial 108. For instance, rotation of the dial 108 in the tightening direction can cause the spool 106 to rotate in the tightening direction, increasing tension in the tensioning element 102. Rotation of the dial 108 in the loosening direction can cause the spool 106 to rotate in the loosening direction, decreasing tension in the tensioning element 102.

[36] The system 100 includes a tension control mechanism 110 configured to automatically release tension in the tensioning element 102 when the tension in the tensioning element 102 reaches a predetermined level. For instance, the tension control mechanism 110 can enable the engagement surfaces of the spool 106 and the dial 108 to be engaged or disengaged in response to the presence of a predetermined level of tension (e.g., a maximum tension level) in the tensioning element 102. When tension in the tensioning element 102 reaches the predetermined level, the tension control mechanism 1 10 can automatically move or shift to disengage the first engagement surface 126 of the spool 106 from the second engagement surface 134 of the dial 108. This allows the spool 106 to spin in the loosening direction, which, in turn, releases excess or at least part of the tension in the tensioning element 102. When the tension in the tensioning element 102 drops back below the predetermined level, the tension control mechanism 1 10 can function to automatically reengage the engagement surfaces 126, 134 of the spool 106 and the dial 108.

[37] Because the tension control mechanism 110 can automatically limit or regulate the level of tension in the tensioning element 102, the tension control mechanism 1 10 advantageously can reduce the likelihood that a user will over-tighten the tightening system 100 as found in the prior art. This is important because over-tightening can cause pressure on the skin, which can reduce both capillary blood flow to the skin and arterial flow to the anatomical member. Over-tightening can also cause undesirable and/or excessive loads on the user's bones and/or joints. Thus, by limiting or automatically regulating the level of tension in the tensioning element 102, the tension control mechanism 1 10 eliminates or reduces the likelihood of over-tightening that can harm the user. It will be appreciated that the tension control mechanism 110 can prevent over tensioning of the system 100 during initial tensioning and in use.

[38] The tension control mechanism 110 can reduce the need for users themselves to set or monitor safe tension levels within the tightening system 100. For instance, conventional tightening systems often require users to monitor tension in the tightening system based on how tight the orthopedic device feels on the user's limb. However, many users, especially users with an injured limb, experience irregular sensation in the user's injured limb. Consequently, such users are at risk of overtightening or under tightening the tightening system 100, causing injury to the user. By including the tension control mechanism 110 in the tightening system 100, the user can tighten the tightening system 100 without the need of monitoring safe or target tension levels. It should be appreciated that many variations of the tension control mechanism 110 having different shapes and sizes can be used for automatically limiting or regulating the tension level in the tensioning element 102. Although such variations may differ in form, they perform substantially similar functions.

[39] The construction of the tightening system 100 will now be discussed in greater detail in connection with Figs. 4-7. As noted above, the tightening system 100 can include the base 104, the spool 106, and the dial 108. The base 104 can include a housing 112 and a mounting flange 114. The housing 1 12 can include a plurality of housing teeth 116, which can extend radially inwardly. The housing 1 12 can also include one or more tension element holes 1 18 adapted for allowing the tensioning element 102 to enter and/or exit the housing 1 12. It should be appreciated that many variations of the base 104 having different shapes and/or sizes can be used. The housing 1 12 and the mounting flange 1 14 can comprise a single member or a plurality of members coupled together.

[40] The spool 106 can be situated within the housing 1 12 such that the spool 106 is rotatable about the axis A-A relative to the housing 112. The spool 106 can define a cylindrical winding surface 120 extending circumferentially between a pair of annular flanges 122. The tensioning element 102 can be rotatably linked to the spool 106 such that when the spool 106 is rotated in the tightening direction, the tensioning element 102 is drawn into the housing 112 and is wound around the winding surface 120. When the spool 106 rotates in the loosening direction the tensioning element 102 unwinds from the winding surface 120 and exits the housing 1 12 via the tension element holes 118. While the winding surface 120 is describes as being cylindrical, the winding surface 120 can be elliptical, triangular, or may have any other suitable shape.

[41] As best seen in Figs. 5 and 6, the dial 108 can be attached to the housing 1 12 via a fastener 124 such that the dial 108 can rotate about the axis A-A with respect to the housing 112. The dial 108 includes a first engagement surface 126 comprising a wavy profile with a first plurality of waves 128. The first engagement surface 126 can be located on the lower surface of the dial 108.

[42] Optionally, the dial 108 can also include one or more pawls 130 which can be biased radially outward so as to mate with the housing teeth 116. The pawls 130 and the housing teeth 116 can be configured so that the housing teeth 116 can displace the pawls 130 radially inwardly when the dial 108 is rotated in the tightening and/or loosening directions, thereby allowing the dial 108 to incrementally rotate in the tightening and loosening directions. The radially outer surface of the dial 108 can include a grip portion 132 configured to help a user grip the dial 108 while manipulating the dial 108.

[43] The spool 106 can define a second engagement surface 134 mutually opposed the first engagement surface 126. The second engagement surface 134 can be located on the upper surface of the spool 106 and can form a wavy profile with a second plurality of waves 136. The second waves 136 of the second engagement surface 134 are configured to mate with the first waves 128 of the first engagement surface 126 to couple the dial 108 to the spool 106 such that rotation of the dial 108 in the tightening direction causes the spool 106 to also rotate in the tightening direction. Rotation of the dial 108 in the loosening direction can also cause the spool 106 to rotate in the loosening direction.

[44] Thus, the dial 108 can be rotated in the tightening direction, causing the spool 106 to rotate in the tightening direction, which, in turn, causes the tensioning element 102 to be drawn into the housing 1 12. As the tensioning element 102 is drawn into the housing 1 12, the tension level in the tensioning element 102 increases and the system 100 tightens. The dial 108 can be rotated in the loosening direction, causing the spool 106 to rotate in the loosening direction, which, in turn, causes the tension level in the tensioning element 102 to decrease. The waves of the first and second engagement surfaces can be configured such that any torque transfer between the dial 108 and the spool 106 creates a downward displacement force or in other words pushes the spool 106 away from the dial 108.

[45] Referring again to Fig. 4, the tightening system 100 can include a bushing 140 and/or washer 142 in between components to help properly align, space, and/or fasten the individual components of the tightening system 100. The bushing 140 and/or washer 142 can also help reduce friction between moving parts in the tightening system 100.

[46] In the illustrated embodiment, the tension control mechanism 1 10 can comprise a resilient member 138 situated under the spool 106. The resilient member 138 can comprise a conical spring or a Belleville washer. As seen, the resilient member 138 can be arranged such that a diameter of the resilient member 138 tapers toward the base 102.

[47] The resilient member 138 can move between an original position and a release position. In the original position, the resilient member 138 can have a shape with at least a part of the upper surface of the resilient member 138 engaging the lower surface of the spool 106. This arrangement can exert an opposing force on the spool 106 that counters the downward displacement force on the spool 106 when torque is transferred between the dial 108 and the spool 106. It will be appreciated that the resilient member 138 can have a generally convex shape, a generally concave shape, a u-shape, or any other suitable shape. In other embodiments, the resilient member 138 can comprise a wave washer or wave spring formed in an irregular shape. A variety of suitable materials, including different metals, elastomeric materials, plastics, rubbers, and/or resins, may produce the resilient member 138.

[48] The opposing force from the resilient member 138 can bias the spool 106 toward the dial 108 to maintain the first engagement surface 126 of the dial 108 engaged with the second engagement surface 134 of the spool 106. The resilient member 138 can use at least in part its material properties (e.g., elasticity) and its preloaded shape to generate the opposing force against the spool 108. In the release position, the resilient member 138 is compressed or has a more flattened shape so that the spool 106 can move axially away from the dial 108, allowing the engagement surfaces to disengage.

[49] As noted above, the downward displacement force can be generated by torque transfer between the dial 108 and the spool 106. The torque transfer can result from twisting of the dial 108 and/or spool 106 and/or tension in the tensioning element 102. The level of tension in the tensioning element 102 can thus correspond to the magnitude of the downward displacement force. For instance, a greater level of tension in the tensioning element 102 can cause a greater downward displacement force on the spool 106.

[50] When the downward displacement force on the spool 106 exceeds the opposing force of the resilient member 138 on the spool 106, the downward displacement force can cause the resilient member 138 to automatically move or flex from the original position to the release position. In the release position, the second engagement surface 134 of the spool 106 can disengage from the first engagement surface 126 of the dial 108. This can allow the spool 106 to spin in the loosening direction, which, in turn, releases excess or at least part of the tension in the tensioning element 102. When the downward displacement force exerted on the spool 106 is less than the opposing force from the resilient member 138, the resilient member 138 can naturally and/or automatically return to the original position such that the engagement surfaces reengage.

[51] The point at which the tension level of the tensioning element triggers or moves the resilient member 138 to the release position is called the actuating tension. It will be appreciated that the actuating tension can be selected or set in any suitable manner. For instance, the actuating tension can be selected or set by utilizing a resilient member 138 having specific material properties and/or a specific preloaded shape. The actuating tension can be selected or set by utilizing a plurality of resilient members 138. The actuating tension can be set by selectively preloading of the resilient member 138.

[52] In an embodiment, the actuating tension can be adjustable. For instance, the actuating tension can be adjusted by customizing the system 100 with one or more resilient members 138 having specific characteristics and/or adjusting the preload on the resilient member 138. Thus, a user, clinician, or medical professional can advantageously adjust the actuating tension to customize the tightening system 100 for different users and/or user needs. In other embodiments, the actuating tension can be selected or set by a clinician or medical professional to correspond to a safe or proper tightness of the tightening system 100.

[53] As previously discussed, the actuating tension can be selected or set to automatically limit or regulate a maximum tension level in the tensioning element 102. This advantageously reduces the likelihood that a user will over-tighten the tightening system 100. This is important because over-tightening can cause pressure on the skin, which can reduce both capillary blood flow to the skin and arterial flow to the anatomical member. Over-tightening can also cause undesirable and/or excessive loads on the user's anatomical limb. Thus, by limiting or automatically regulating the level of tension in the tensioning element 102, the tension control mechanism 110 eliminates or reduces the likelihood of over-tightening that can harm the user. The tension control mechanism 1 10 also can reduce the need for users themselves to set or monitor safe tension levels within the tightening system 100.

[54] It will be appreciated that the resilient member 138 is exemplary only, as other tension control mechanisms are possible. For instance, the tension control mechanism can comprise at least one coil spring, a torsion spring, a Belleville washer, one or more spring bars, a resiliently compressible member, combinations thereof, or any other suitable member. In other embodiments, the first and second engagement surfaces may include any number of different profiles that permit engagement and disengagement of the first and second engagement surfaces. For instance, the profile may be sinusoidal or serrated. While both engagement surfaces are shown including general the same profile, in other embodiments, the first engagement surface can have a profile that is different from the profile of the second engagement surface. While the engagement surfaces are shown located on the bottom surface of the dial 108 and the upper surface of the spool 106, the engagement surfaces may be located in any suitable location. For example, the first engagement surface may be located on an inner radial surface of the dial 108 and the second engagement surface may be located on an outer radial surface of the spool 106.

[55] Figs. 8 and 9 illustrate an embodiment of a tightening system 200 having a sensitivity adjustment dial 244 capable of adjusting the actuating tension of the tension control mechanism 210 of the system 200. As shown, the adjustment dial 244 can be secured by a fastener 246 to a dial 208. The dial 208 defines a first engagement surface 226 formed as a serrated profile with a first plurality of teeth 228. The adjustment dial 244 can be connected to an upper surface of the dial 208, and the first engagement surface 226 can be located on a lower surface of the dial 208.

[56] A spool 206 defines a generally cylindrical winding surface 220 for receiving at least a portion of the tensioning element 202. The spool 206 can include a second engagement surface 234 located at an upper surface of the spool 206 that is mutually opposed the first engagement surface 226. The second engagement surface 234 can form a serrated profile with a second plurality of teeth 236 configured for meshing or engaging the first plurality of teeth 228. It should be noted that the teeth of the first and second engagement surfaces are neither vertically nor counter-sloped relative to one another. From this arrangement, any torque transfer from the dial 208 to the spool 206 causes the downward displacement force on the spool 206.

[57] Similar to the system 100, the first and second engagement surfaces are not limited to having a serrated profile, but may include any number of different profiles that permit engagement of the first and second engagement surfaces.

[58] A tension control mechanism 210 can comprise the adjustment dial 244, a conical spring 238, and a sensitivity plate 248. The spring 238 can engage a lower surface of the spool 206. A lower surface of the spring 238 can engage the sensitivity plate 248. The spool 206 and sensitivity plate 248 can be rotatably connected to the base 204 along an axis B-B. As seen in Fig. 8, the spring 238 can be arranged such that a diameter of the spring 238 tapers toward the spool 206.

[59] Like the resilient member 138, the spring 238 is movable between an original position, wherein the spring 238 exerts an opposing force on the spool 206 that maintains the engagement surfaces engaged, and a release position, wherein the downward displacement force on the spool 206 compresses the spring 238, causing the engagement surfaces to disengage. This allows the spool 206 to spin in the loosening direction, which, in turn, releases excess or at least part of the tension in the tensioning element 202.

[60] The actuating tension required to compress the spring 238 sufficiently to move the spring 238 from the original position to the release position can depend in part on preloading of the spring 238. By turning the adjustment dial 244 in a specified direction, the sensitivity plate 248 moves either upwardly or downwardly (depending on the direction the adjustment dial 244 is turned) thereby causing more or less preload on the spring 238, and making the actuating tension more or less. Thus, a user, clinician, or medical professional can advantageously adjust the actuating tension to customize the tightening system 200 for different users and/or user needs. For instance, a clinician can adjust the actuating tension during the course of treatment where the maximum load may vary.

[61] It will be appreciated that in other embodiments, the tightening system can include two, three, four, or any other suitable number of resilient members. It should also be appreciated that many variations of the tightening system having different shapes and/or sizes can be used. Although such variations may differ in form, they perform substantially similar functions.

[62] The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting. Additionally, the words "including," "having," and variants thereof (e.g., "includes" and "has") as used herein, including the claims, shall be open ended and have the same meaning as the word "comprising" and variants thereof (e.g., "comprise" and "comprises").