Joint for an orthotic brace

Abstract

A hinged joint assembly for interconnection of multiple orthotic devices and establishment of at least two different angular orientations of a first interconnection beam relative to a second interconnection beam. Preferably, the joint assembly provides for adjusting each angular orientation and thereafter locking a particular angular orientation in either a fixed manner, or in a manner for permitting further angular manipulation within locked first and second limits. In some embodiments the two angular orientations are orthogonal to one another. In some embodiments the two locking mechanisms are located in close proximity to one another, with the locking mechanisms of one orientation being located beneath the adjustment mechanism of the other angular orientation.

Description

141259.000189:JVD:25002187v2JOINT FOR AN ORTHOTIC BRACECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 682,105, filed August 12, 2024, incorporated herein by reference.FIELD OF THE INVENTION

[0002] The inventions described here pertain to orthotic braces used for supporting a limb of a person, and in particular for leg braces used to support a limb that is healing after a bone fracture.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] Some of the figures shown herein may include dimensions. Further, the figures shown herein may have been created from scaled drawings, scaled models, or from photographs that are scalable. It is understood that such dimensions, or the relative scaling within a figure, are by way of example, and not to be construed as limiting unless so stated in a claim. Persons of ordinary skill will also recognize that CAD renderings may include lines that pertain to changes in the computer model, and not necessarily to component features.

[0004] FIG. 1 is a front elevational photographic representation of a leg brace according to one embodiment of the present invention.

[0005] FIG. 2A is a side elevational view of a portion of the apparatus of FIG. 1 .

[0006] FIG. 2B is a side elevational view of the apparatus of FIG. 2A, with the hinge rotated relative to the pelvic girdle.

[0007] FIG. 3A is a front and side elevational view of a prior art hinge assembly.125002187.v2141259.000189:JVD:25002187v2

[0008] FIG. 3B is a line drawing of a perspective photographic representation of the priori art apparatus of FIG. 3A turned 90 degrees.

[0009] FIG. 3C is a line drawing of a perspective photographic representation of the prior art apparatus of FIG. 3B turned 90 degrees.

[0010] FIG. 3D is a line drawing of a perspective photographic representation of the prior art apparatus of FIG. 3C turned 90 degrees.

[0011] FIG. 4 is a side and frontal perspective CAD representation of a hinge assembly according to one embodiment of the present invention.

[0012] FIG. 5A is an exploded view of the apparatus of FIG. 4.

[0013] FIG. 5B is a top view looking down of a portion of the apparatus of FIG. 5A, as taken along line 5B-5B.

[0014] FIG. 6A is a side elevational, perspective line drawing of a photographic representation of the partially assembled device of FIG. 5.

[0015] FIG. 6B is a front elevational, line drawing of a photographic representation of the apparatus of FIG. 6A assembled.

[0016] FIG. 7A is a side elevational, line drawing of a perspective photographic representation of the partially assembled device of FIG. 5.

[0017] FIG. 7B is a front elevational, line drawing of a photographic representation of the apparatus of FIG. 7A assembled.

[0018] FIG. 8A is a side elevational line drawing of a combined photographic representation of a prior art hinge assembly shown on top of the hinge assembly of FIG.4, showing the lack of finger space for adjustment of the prior art joint because of interference with the prior art hinge.

[0019] FIG. 8B is a side elevational line drawing of a combined photographic representation of a prior art hinge assembly shown on top of the hinge assembly of FIG.225002187.v2141259.000189:JVD:25002187v24, showing the change in the location of the pivoting access from the prior art design to the inventive design.

[0020] FIG. 9A is a front and side perspective surface representation from a CAD model of a hinge assembly according to another embodiment of the present invention.

[0021] FIG. 9B is a front elevational line drawing of the apparatus of FIG. 9A.

[0022] FIG. 9C is a side elevational CAD representation of the apparatus of FIG. 9B.

[0023] FIG. 10A is a perspective exploded view of a portion of the apparatus of FIG. 9A.

[0024] FIG. 10B is a bottom perspective exploded view of a CAD surface representation of the apparatus of FIG. 9A.

[0025] FIG. 11 is a side perspective CAD surface representation of a portion of the apparatus of FIG. 9C.325002187.v2141259.000189:JVD:25002187v2ELEMENT NUMBERING

[0026] The following is a list of element numbers used with all of the embodiments, and at least one noun used to describe that element. The “X” for all of these numbers is removed or replaced with a number (0 or greater) in the text and drawings of this application. Consistent with statements made elsewhere in this specification, these various 2-digit element numbers are used among multiple embodiments, and aspects of a particular element stated for one embodiment can be applied to the same element number in a different embodiment, except as shown and described differently, and as would be understood by a person of ordinary skill in the art. It is understood that none of the embodiments disclosed herein are limited to these nouns, and these element numbers can further include other words that would be understood by a person of ordinary skill reading and reviewing this disclosure in its entirety.425002187.v2141259.000189:JVD:25002187v2525002187.v2141259.000189:JVD:25002187v2625002187.v2141259.000189:JVD:25002187v2DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS

[0027] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. At least one embodiment of the present invention will be described and shown, and this application may show and / or describe other embodiments of the present invention, and further permits the reasonable and logical inference of still other embodiments as would be understood by persons of ordinary skill in the art.

[0028] It is understood that any reference to “the invention” is a reference to an embodiment of a family of inventions, with no single embodiment including an apparatus, process, or composition that should be included in all embodiments, unless otherwise stated. Further, although there may be discussion with regards to “advantages” provided by some embodiments of the present invention, it is understood that yet other embodiments may not include those same advantages, or may include yet different advantages. Any advantages described herein are not to be construed as limiting to any of the claims. The usage of words indicating preference, such as “various embodiments” or “preferably,” refers to features and aspects that are present in at least one embodiment, but which are optional for some embodiments, it therefore being understood that use of the word “preferably” implies the term “optional.”.

[0029] The use of an N-series prefix for an element number (NYY.YY) refers to an element that is the same as the non-prefixed element (YY.YY), except as shown and described. As an example, an element 1020.1 would be the same as element 20.1 ,725002187.v2141259.000189:JVD:25002187v2 except for those different features of element 1020.1 shown and described. Further, common elements and common features of related elements may be drawn in the same manner in different figures, and / or use the same symbology in different figures. As such, it is not necessary to describe the features of 1020.1 and 20.1 that are the same, since these common features are apparent to a person of ordinary skill in the related field of technology. Further, it is understood that some features 1020.1 and 20.1 may be backward compatible, such that a feature of a later discussed embodiment (NYY.YY) may include features compatible with other various embodiments that were discussed earlier (MYY.YY), as would be understood by those of ordinary skill in the art.

[0030] This document may use different words to describe the same element number, or to refer to an element number in a specific family of features (NYY.YY). It is understood that such multiple, different words are not intended to provide a redefinition of any language herein. It is understood that such words demonstrate that the particular feature can be considered in various linguistical ways, such ways not necessarily being additive or exclusive.

[0031] FIGS. 1 and 2 show various views of an orthotic brace 10 according to one embodiment of the present invention. In some embodiments, brace 10 includes a pelvic girdle 12 that is interconnected by a hip hinge assembly 20 to an upper and lower leg brace that is adapted and configured for support of the upper leg, lower leg, and foot. However, the present invention further contemplates those inventions in which the orthotic brace is useful for any portion of any limb of a user, including leg braces that do not include a pelvic connection, and arm orthotic braces of any type. In some embodiments, the inventions described herein pertain to the interconnection of two body parts in which the body parts are interconnected with a joint. For the leg brace 10 shown in FIGS. 1 and 2, it is appreciated that the hinge 20 provides restraint to the hip joint of the user, preferably limiting motion of the upper leg to the hip in a first pivoting direction,825002187.v2141259.000189:JVD:25002187v2 and preferably permitting pivoting motion in a second pivoting direction that is different than the first pivoting direction. In some embodiments, the first and second pivoting directions are orthogonal to one another.

[0032] FIGS. 2A and 2B show further aspects of the orthotic brace 10. In FIG. 2A it can be seen that a hip hinge assembly 20 is interconnected with a plurality of fasteners to the pelvic girdle 12 by a first preferably rigid proximal beam 22, and connected to an upper leg support with a plurality of fasteners by a preferably rigid distal beam 26. FIG. 2A shows the hip hinge assembly 20 in substantial vertical alignment.

[0033] FIG. 2B shows a configuration of hip hinge assembly 20 in which the distal portion of the hinge assembly (including the distal connection beam 26 and the distal portion of hinge assembly 20) has been rotated or pivoted about flexion / extension axis 32a relative to the proximal beam 22 and the proximal portion of the hinge assembly. As will be discussed further later, the proximal and distal hinge members, 34 and 38 respectively, can further be pivoted relative to each other about a abduction / adduction axis 32b. The proximal and distal hinge members can also be rotated relative to each other about the flexion / extension axis 32a. In one embodiment, the degree of rotation about flexion axis 32a is preferably limited in its range by an adjustable locking mechanism. Further, in yet other embodiments, the rotation of the proximal and distal sections of brace 10 is preferably locked in place after the predetermined angle 32b is established.

[0034] FIGS. 3 show four different views of a prior art hinge assembly. The designation “PA” or “P” after an element number refers to prior art.

[0035] FIGS. 4 and 5 show an outer view and exploded view, respectively, of a hinge joint assembly 20 according to one embodiment of the present invention. Referring to FIG. 4, it can be seen that assembly 20 includes proximal and distal attachment beams 22 and 24, respectively, these beams being attached to one another by a proximal925002187.v2141259.000189:JVD:25002187v2 hinge member 34 and a distal hinge member 38 coupled to beam 26. It can be seen in FIGS. 4 and 5 that each beam includes one or more elongated slots for connection to pelvic girdle 12 or thigh fitting 14, respectively. Each beam 22 and 26 further include one or more holes for attachment of the beam by fasteners to the hinge members 34 and 38, respectively.

[0036] The hinge assembly 20 permits pivoting of the proximal and distal hinge members along axis 32a. The proximal and distal hinge members are further pivotal about an axis 32b that is, in some embodiments, perpendicular to axis 32a.

[0037] FIGS. 4 and 5 further show an adjustable locking mechanism 40 that is located between the underside of housing 30, and the top side of hinge member 34. The adjustable locking mechanism 40 includes an outer disk 42, an inner disk 44, a projection 34c located on proximal hinge member 34, and a locking member 48 supported between the underside of housing 30 and hinge member 34. The projection 34c and projection 48a reside within the respective semicircular slots of disks 42 and 44, respectively, and places limits on the rotation of disk 42 relative to disk 44.. A hinge pin 31a extends through the slot 31 b of housing 30, the central apertures of each of the outer disk 42 and inner disk 44, the central aperture of hinge member 34, and through an aperture in the distal end of proximal beam 22. A fastener is threadably coupled to hinge pin 31a. When the fastener is loose, the disks 42 and 44 can be rotated relative to one another. This relative rotation and adjustment of the relative positions can be accomplished with projections 43 and 45 that are adapted and configured to be pushed by the fingertip of a user.

[0038] Referring to FIG. 5B, a portion of the apparatus of FIG. 5A is shown with some of the apparatus being presented in a semi-transparent view. In some embodiments, apparatus 20 includes a locking mechanism comprising a locking set screw 49 that threadably couples to housing 30. Set screw 49 includes a reduced diameter section1025002187.v2141259.000189:JVD:25002187v249a and a larger diameter distal end 49b. As shown in FIG. 5B, the reduced diameter section 49a of set screw 49 is captured in an intermediate open section of lock 48 after assembly. When set screw 49 is tightened, the distal end 49c pushes against and slides lock 48 toward the assembly of disks 42 and 44. When tightened sufficiently, the projections 48a come into contact with the serrations 42b and 44b, respectively, of disks 42 and 44, thereby locking the angular orientation of the disks relative to housing 30.

[0039] In some embodiments, a Belleville washer 41 is preferably located between the bottom screw (as shown in FIG. 5A) and the bottom surface of beam 22. The Belleville washer 41 assists in preventing an overtightening of the screw into hinge pin 31a. In clearance created by the Belleville washer, the proximal and distal beams 22 and 26, respectively, are free to rotate or pivot about axis 32a while being worn by the user.

[0040] FIG. 5 further illustrates the interconnection of proximal hinge member 34 and distal hinge member 38. Hinge member 34 includes a distally extending flange 34d. Distal hinge member 38 includes a proximally extending flange 38c. Each of these flanges include lockable, opposing mating faces 34f and 38f, respsectively, such that when the flanges are tightened with fasteners 29, the hinge member 34 and 38 can no longer pivot relative to one another.

[0041] Referring to FIGs. 5, 6A, and 6C, it can be seen that flange 34d include a pocket having both hexagonal and circular counterbores. The hexagonal counterbore is useful for retaining a hexagonal fastener in a fixed location. The circular counterbore is useful for receiving the head of the screw fastener 29. Preferably, hinge member 38 includes a similar set of hexagonal and circular counterbores. In one embodiment, the fastener used to connect flanges 34d and 38c can be inserted into either of the flanges, and the hex nut fastener can be inserted into the other of the flanges. Prior to use of leg brace 10, the medical practitioner will adjust the relative angle of the proximal and distal beams 22 and 26 by loosening the fasteners 29, and placing the beams in the1125002187.v2141259.000189:JVD:25002187v2 predetermined angle relative to rotational axis 32b. When tightened, the beams retain this fixed, predetermined angular relationship.

[0042] FIGS. 6 and 7 show one aspect of hinge assembly 20 that uses the combination circular / hex counterbores in both flanges 34d and 38c. Referring to FIG. 6A, the hex / circular counterbore of flange 38c can be seen. In FIG. 6B, the assembly of FIG. 6A is shown with the head of the screw arranged to mate with the circular counterbore 38c, and the hex fastener arranged to fit within the hexagonal counterbore of flange 34d. In FIG. 7A it can be seen that flange 34a includes the combined hex / circular counterbores. In FIG. 7B, the assembly of FIG. 7A is shown with fasteners 29 inserted, such that the head of fastener 29 will be received within the pocket 34a of hinge member 34, and the hexagonal nut will be located within the hexagonal recess of pocket 38a.

[0043] Comparing FIGS. 6B and 7B, it can be seen that the fastener head to hex nut orientation is reversed between the two images. In this way, the orientation of fasteners 29 can be switched based on whether the brace 10 is being used on the left side of the body or the right side of the body. Preferably, the fasteners 29 are oriented such that the screw head is accessible from outside of the limb. By improving the access to the fasteners, less time is spent to don the brace, and less movement of the patient is required while donning the brace.

[0044] FIG. 8A shows the prior art locking mechanism 40PA arranged over top of the locking mechanism 40 of leg brace 10. In each case, the locking mechanisms are shown aligned using the rotational axis 32a. It can be seen that the prior art configuration shows the flange 34dPA to be located distally of projections 43PA and 45PA. The prior art configuration provides very limited space between the projection 45PA and flange 34dPA, such that a person cannot use a finger to move the outer disk1225002187.v2141259.000189:JVD:25002187v242PA or inner disk 44PA, for example when a readjustment of the angular travel about axis 32a needs to be changed. Instead, a tool may be required for this readjustment.

[0045] However, as can be seen in the bottom half of FIG. 8A, the flange 34d of leg brace 10 is located underneath the projections of the outer and inner disk. The bottom of FIG. 8A shows that the some embodiments of the inventive hinge described herein provide clear access of the projections 43 to the fingers of the user. The hinge assembly 20 relocates the axis 32b both down, under, and away from the adjustable locking mechanism 40. The finger projections of mechanism 40 are clear of the obstruction that can be seen in the prior art configuration.

[0046] Referring to FIG. 8B, it can further be seen that by reorienting the hinge member flanges, as shown in comparison to the location of the prior art flanges, that the pivot axis 32b (identified graphically with a star) can be located substantially closer to rotational axis 32a, in comparison of the axis 32bPA (also identified graphically with a star). By moving the axes 32a and 32b closer together, the user can make more precise adjustments and in less time, especially considering pediatric patients having a smaller frame.

[0047] FIGS. 9, 10, and 11 show various aspects of a hinge assembly 120 according to another embodiment of the present invention. It is understood that an element numbered “1XX” is the same as the element “XX,” except as shown and described differently.

[0048] Referring to FIG. 9, it can be seen that hinge assembly 120 includes proximal and distal beams 122 and 126, respectively. Proximal and distal hinge members 134 and 138 are each pivotal or rotatable relative to one another (when unlocked) along flexion / extension axis 132a. Hinge assembly 120 further includes an adjustable locking mechanism 140, which in some embodiments comprises outer and inner disks 142 and 144, respectively, and a lock 148 that includes a projection 148a which is retained within1325002187.v2141259.000189:JVD:25002187v2 circular slots of the inner and outer disks. Adjustable locking mechanism 140 limits the range of a first angular orientation of beam 122 relative to beam 126.

[0049] One difference between the hinge assemblies 20 and 120 is with regards to the manner in which hinge member 138 permits movement of beam 126 relative to beam 122 in a second angular orientation different than the first angular orientation. Referring to FIG. 9C, it can be seen that hinge member 138 includes a sliding member 138d having a rounded or spherical surface 150a on the underside of sliding member 138d. Surface 150a is in contact with the rounded surface 134e of dome shaped housing 130.

[0050] Referring FIGS. 9, 10, and 11 , it can be seen that a dome shaped housing 130 provides an enclosure for adjustable locking mechanism 140. However, housing 130 further includes a rounded or domed outer shape 133 that provides a sliding contact surface that is complementary in shape to arm 150 that extends proximally from hinge member 138. In some embodiments arm 150 defines within it a slot 152 that is coupled to the top of housing 130 by a fastener that is threadably received within sliding member 148b and which extends through an aperture in housing 130 and also through slot 152 of arm 150.

[0051] As best seen in FIG. 9B, the loosening of this fastener from the guiding projection 148b permits the distal and proximal portions of brace 10 to pivot relatively to one another (i.e. , in and out of the plane of FIG. 9B). When loosened, the user is able to adjust the relative angular relationship of hinge members 134 and 138 to the proper angle, the angular relationship is limited by the capture of guiding projection 148b sliding within slot 152 of arm 150.

[0052] While the inventions have been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only certain embodiments have been1425002187.v2141259.000189:JVD:25002187v2 shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.1525002187.v2

Claims

141259.000189:JVD:25002187v2WHAT IS CLAIMED IS:1 . An orthotic device for support of a limb, comprising: a first proximal band adapted and configured for connection around a limb, said first band including a first beam having a first end; a second distal band adapted and configured for connection around the limb; said second band including a second beam having a second end; a hinge assembly adapted and configured for adjustable interconnection of the angular relationship of the first end relative to the second end about a first axis, said hinge assembly including: a first hinge coupled to one of said first beam or said second beam by an adjustable locking mechanism, said adjustable locking mechanism being adapted and configured to establish a range of angular movement of said first beam relative to said second beam about a second axis that is orthogonal to the first axis, said adjustable locking mechanism including at least one projection adapted and configured to be adjusted with the finger tip of a user, said first hinge including a first flange; and a second hinge coupled to the other of said first beam or said second beam and including a second flange adapted and configured to connect and align with said first flange; wherein the connection of said first flange to said second flange places said first flange and said second flange below the at least one projection of said locking mechanism.1625002187.v2141259.000189:JVD:25002187v22. The device of claim 1 , wherein the first flange has a first mating face that that contacts a second mating face of the second flange, and each of the first mating face and the second mating face include serrations that interlock with each other.

3. The device of claim 1 , wherein the first flange has a first mating face capable of locking contact with a second mating face of the second flange, and the first mating face is rotatable about the first axis relative to the second mating face when not in locking contact.

4. The device of claim 1 , wherein said adjustable locking mechanism includes first disk and a second disk, the first and second disks being in sliding contact with each other in a plane, and the second axis is perpendicular to the plane of sliding contact.

5. The device of claim 1 , wherein said adjustable locking mechanism includes a first disk and a second disk, each of the first and second disks are located between said first hinge and said second hinge, and one of said first disk and second disk include said projection.

6. The device of claim 1 , wherein said adjustable locking mechanism includes a first disk having a first slot and a second disk having a second slot, said one of said first hinge and said second hinge includes a projection that fits within said first slot and said second slot.

7. The device of claim 1 , wherein said first beam is substantially rigid and said second beam is substantially rigid.1725002187.v2141259.000189:JVD:25002187v28. An orthotic device for support of a limb, comprising: a first proximal band adapted and configured for connection around a limb, said first band including a first beam having a first end; a second distal band adapted and configured for connection around the limb; said second band including a second beam having a second end; a hinge assembly adapted and configured for adjustable interconnection of the angular relationship of the first end relative to the second end, said hinge assembly including: a first hinge coupled to one of said first beam or said second beam by an adjustable locking mechanism, said first hinge including a member having a first rounded surface ; and a second hinge coupled to the other of said first beam or said second beam and including an extended arm having a second rounded surface with a rounded shape complementary to the first rounded surface of said member; wherein interconnection of said proximal hinge to said distal hinge includes placing the rounded second surface of said arm in sliding contact with the rounded first surface of said member.

9. The device of claim 8 wherein, the member of said first hinge is a housing, and which further comprises an adjustable locking mechanism located within the housing.

10. The device of claim 9, wherein the first rounded surface comprises an external surface that is at least partly spherical.1825002187.v2141259.000189:JVD:25002187v211 . The device of claim 9, wherein the second rounded surface includes a through slot, said adjustable locking mechanism includes a projection, and the projection is slidable within the slot.

12. The device of claim 8, wherein said second hinge is pivotal about the first rounded surface in two orthogonal directions.

13. An orthotic device for support of a limb, comprising: a first proximal band adapted and configured for connection around a limb, said first band including a first beam having a first end; a second distal band adapted and configured for connection around the limb; said second band including a second beam having a second end; a hinge assembly adapted and configured for adjustable interconnection of the angular relationship of the first end relative to the second end about a first axis; a housing attached to one of said first beam or said second beam, said housing coupled to said hinge assembly about a second axis orthogonal to the first axis; a first disk located between said hinge assembly and said housing, the periphery of said first disk including a plurality of teeth; a movable lock having at least one tooth and located between said housing and said first disk, said lock being movable between first and second positions; wherein movement of said lock to a first position places said at least one tooth between a pair of teeth of said first disk to limit rotation of said first beam relative to said second beam about the second axis, and movement of said lock to the second position moves said at least one tooth away from said first disk to permit rotation of said first beam relative to said second beam about the second axis.1925002187.v2141259.000189:JVD:25002187v214. The device of claim 13, wherein the member of said first hinge is a housing, and which further comprises an adjustable locking mechanism located within the housing.

15. The device of claim 1 , wherein the first rounded surface comprises an external surface that is at least partly spherical.

16. The device of claim 1 , wherein the second rounded surface includes a through slot, said adjustable locking mechanism includes a projection, and the projection is slidable within the slot.

17. The device of claim 13, wherein said second hinge is pivotal about the first rounded surface in two orthogonal directions.2025002187.v2

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