WO2017041136A1

WO2017041136A1 - Orthopaedic bunion splint

Info

Publication number: WO2017041136A1
Application number: PCT/AU2016/050842
Authority: WO
Inventors: Madeleine Monique Croft
Original assignee: Anodynic Pty Ltd
Priority date: 2015-09-07
Filing date: 2016-09-07
Publication date: 2017-03-16

Abstract

The invention relates to an orthopaedic splint for promoting realignment of at least a malpositioned big toe on a foot, the splint comprising: a lever portion which at a first position comprises a housing that can encircle a big toe on a foot, the housing comprising a rigid portion and an elastic portion, the elastic portion for contacting the inner side of the big toe when in use with the top, underneath, and outer side of the big toe encircled by the rigid portion; the lever portion at a second position comprises an attachment means for securing the splint to the foot; and an elastic fulcrum portion attached to the lever portion between the first and second positions, for contacting the side of the foot adjacent the first metatarsophalangeal joint; wherein in use, the splint functions as a lever about the fulcrum portion with the attachment means secured to the foot inputting a force causing an output counter force applied by the elastic portion on the inner side of the big toe to promote realignment of the big toe.

Description

Orthopaedic Bunion Splint Technical Field

[0001 ] The present invention relates to an orthopaedic splint for promoting realignment of a malpositioned human big toe and surrounding toes, and the relief from symptoms associated with a hallux valgus condition.

Background Art

[0002] The following discussion of the background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.

[0003] Hallux valgus (or hallux abducto valgus) is the malpositioning inward of the first or 'big' toe (the hallux) toward the second toe. In severe cases, the big toe may even cross over the top or underneath the second toe. As the end of the big toe deviates inwards, the medial portion of the first metatarsal head becomes prominent at the base of the toe. The resultant characteristic lump at the location adjacent the first metatarsophalangeal (MTP) joint is commonly referred to as a bunion.

[0004] This condition is understood to stem from a genetically inherited trait where the muscle on the side of the big toe adjacent to the second toe is shorter than the muscle on the outer side of the big toe. The condition may be exacerbated by certain constricting types of footwear. As a result, the big toe is drawn inward out of normal alignment.

[0005] The deviation of the big toe out of normal alignment engenders a domino effect on surrounding toes in a first instance and surrounding foot structures in a second instance. The homeostasis of aspects of the body's systems which relate to or are connected with the foot are gradually affected over time. In this respect, complications of hallux valgus can extend to the skeletal-muscular system leading to multi-articulation sub luxations, inflammations, straining, and loss of balance; while concurrently, the body delivers cramps in a futile effort to return to this homeostasis. The outcome of such complications can result in cramp-affected sleep for the sufferer, fatigue, loss of enjoyment of life, and a sedentary lifestyle which increases risk factors for obesity and cardio vascular disease amongst other diseases.

[0006] A number of devices and treatments including surgery are available which aim to realign the malpositioned big toe. Many of these devices include braces or splints which commonly make use of a rigid structure to brace or splint the big toe, and in some cases surrounding toes, to move the big toe toward a correctly aligned position.

[0007] The inventor identified three distinct but associated problems with the available braces and splints.

[0008] The first problem was that many of these devices rigidly splint the big toe and push or drag the big toe by force towards a normal alignment. This can result in muscles of the big toe 'shutting down' as they are bypassed during rigid splint wear and are not able to constrict or relax as per normal functioning which can cause muscle strain and inflammation, and even initiate muscle atrophy.

[0009] Moreover, these splints rigidly restrain more than just the big toe. In an attempt to reposition the big toe by force, they unwittingly restrain many of the muscular and skeletal structures of the foot, thereby reducing the probability of returning all of the toes to a correct alignment and muscular-skeletal homeostasis in the foot. In a worst case scenario, there can be a loss of blood circulation with long term use of such devices which can raise certain risk factors for users who also suffer from conditions such as diabetes. As a result, braces and splints which cause this issue are commonly found by users to be extremely uncomfortable and even painful due to the force on the bunion itself, and therefore, reluctantly worn or soon abandoned.

[0010] The second problem is that many such braces and splints do not provide any freedom of movement of the splinted big toe in any direction other than the direction the big toe is being forced towards. The restriction of movement for the big toe and often for the surrounding toes can cause significant discomfort for the wearer and also results in cramping throughout the foot. In addition, sustained forced stretching in the one direction can cause tight muscles of the toe leading to muscle strain and injury and reduced blood supply and inflammation. This can result in discontinuation of treatment with the device to alleviate these issues further aggravating the hallux valgus.

[001 1 ] The third problem is that the rigidity of the braces and splints and the forces they apply to skin, as well as the constant contact over a large portion or all of the big toe, can quickly irritate the skin, causing redness, rash, and discomfort, and affect the growth of the toenail. Those persons more prone to issues with their skin can have greater reactions from long term irritation and inflammation. This reduces the user's ability or desire to use such a device for sufficient time for any beneficial realignment to occur and/or for the device to have any therapeutic effect. Pressure on the nail of the big toe and/or other toes, can lead to painful thickening of the nail and in turn, the user needs the assistance of a podiatrist to trim such nails. This, in turn limits the style of footwear that can be used.

[0012] The inventor identified that the configuration of available braces and splints generally caused at least one or more of these three problems when used by a subject during treatment for hallux valgus.

[0013] Other available treatments include spreading or spacer devices which are usually in the form of a wedge positioned in the space between the big toe and the second toe. The aim of such devices is to force the big toe towards a position of normal alignment. The problem with using such spacer devices is that the other toes are required to provide support while the big toe is forced towards a normal alignment position. However, rather than hold their position and assist the realignment of the big toe, the other toes which are supported by smaller muscles are more likely to be forced out of their own natural alignment during this process defeating the purpose of these devices.

[0014] An aim of the present invention was therefore to overcome substantially, or at least provide a useful alternative to, the above-mentioned problems associated with the prior art. Summary of the Invention

[0015] The present invention provides an orthopaedic splint for promoting realignment of at least a malpositioned big toe on a foot, the splint comprising : a lever portion which at a first position comprises a housing that can encircle a big toe on a foot, the housing comprising a rigid portion and an elastic portion, the elastic portion for contacting the inner side of the big toe when in use with the top, underneath, and outer side of the big toe encircled by the rigid portion; the lever portion at a second position comprises an attachment means for securing the splint to the foot; and an elastic fulcrum portion attached to the lever portion between the first and second positions, for contacting the side of the foot adjacent to the first metatarsophalangeal joint; wherein in use, the splint functions as a lever about the fulcrum portion with the attachment means secured to the foot inputting a force causing an output counter force applied by the elastic portion on the inner side of the big toe to promote realignment of the big toe.

[0016] The lever portion of the splint is preferably rigid or comprises a rigid frame or portion of a frame. The housing preferably encircles the big toe in a ring-like structure that is preferably open at both ends. Within this structure, the top, underneath, and outer side of the big toe is preferably encircled by the rigid portion of the housing. More preferably, the rigid portion forms a substantially C-shaped structure.

[0017] For the purpose of describing the invention, the Outer side' of the big toe refers to the side of the big toe on the inner or medial side of the foot, and the 'inner side' of the big toe refers to the side of the big toe adjacent to the second toe. The 'underneath' of the big toe refers to the bottom of the toe, that is, the part of the toe that normally contacts the ground when walking or standing. The rigid portion may be constructed from a variety of rigid, semi-rigid, stiff or relatively stiff materials known in the art which can substantially maintain their shape under the normal conditions and forces that could be experienced during use of the splint. Preferably, the rigid portion is constructed from a relatively stiff plastic or resin such as what could be prepared in a mould or 3D printed.

[0018] The elastic portion of the housing can preferably be adjusted. More preferably, the elastic portion can be loosened to decrease, or tightened to increase, the elastic force applied by the elastic portion on the inner side of the big toe.

[0019] The elastic portion may comprise one or more of a variety of elastic materials or elastomers known in the art that can recover their shape after being stretched or deformed. Preferably, the elastic portion comprises an elastic band of rubber wherein 'elastic band' can refer to a flat elastic strap. More preferably, the elastic portion is non-allergenic. In an alternative embodiment, the elastic portion comprises an elastic band of silicone or latex rubber. However, as some people have mild to serious allergies to latex, the elastic may be latex-free and/or synthetic rubber which may include thermal-formed elastomers.

[0020] In order to preserve the characteristics of the muscle of the big toe during use of the splint of the invention, the elastic preferably comprises low tension, low stretch, or 'low-torque' rubber to provide low-torque stretching or tensioning for prolonged durations. This can preferably comprise available resistance bands or 'therapy bands' of rubber and preferably flat rubber. Such resistance bands are used in muscle strength training providing variable and incremental degrees of resistance within the range of human muscle tolerances, and can replicate incremental muscle contractions. The resistance band is beneficial as it provides a low-torque stretch which does not prevent muscle contractions but provides a progressive resistive force benefiting muscle conditioning and strength.

[0021 ] Available resistance bands such as the Thera-Band^® resistance colour bands and equivalent have their output measured in terms of kilograms of force. This output is dependent on how much the band (or tubing) is stretched and is „

6 referred to as "percent elongation". The percent elongation that the elastic is stretched is based on the increase in length from its resting length. Force elongation charts have been created to mathematically predict what the force will be at a specific elongation for each Thera-Band^® colour. Different colours of Thera-Band^® identifies a different thickness of band which produces a different output of force with elongation as shown in the force elongation chart in Figure 1 . The slope of the line for the Yellow band is less then, for example, the slope for the Black band indicating the Black band is stiffer and takes more force to stretch the Black band than the Yellow band for the same elongation. This is achieved since the Blank band is a thicker band of the same rubber than the Yellow band. Using the force elongation chart the force at a specific percentage elongation can be predicted for each Thera-Band^® colour. For example, a 1 .0 m length of Blue Thera-Band^® when stretched to 3.0 m (200% elongation), has approximately 5 Kg of force. Table 1 shows a Thera-Band^® force elongation table (Kg) which can be used to determine force for each Thera-Band^® colour at various elongations.

[0022] Table 1 : Thera-Band^® Force Elongation Table (units: Kg of force)

[0023] Thera-Band® resistance bands and equivalent bands, wherein "equivalent bands" refers to bands having the same or similar composition, weight, and/or force elongation characteristics, were found by the inventor to be able to apply the correct range of forces to have a therapeutic effect when used in the splint of the invention. Thus, elastomers comprising force elongation characteristics substantially equivalent or at least similar to at least one or more of the Yellow, Red, Green, Blue, and Black Thera-Bands^® are preferably used in the splint of the invention according to the force elongation figures in Table 1 . More preferably, elastomers comprising force elongation characteristics substantially equivalent or at least similar to at least one or more of the Green, Blue, and Black Thera-Bands^® are preferably used in the splint of the invention according to the force elongation figures in Table 1 . It is important to note that while these other elastomers may have the same or similar force elongation properties or 'stiffness' as a particular Thera-Band^®, they may be constructed from a thicker or thinner rubber band (or another elastomer) and therefore have a different band 'weight'.

[0024] The smoothness of the rubber is preferably selected to reduce irritation on the skin on the big toe. Preferably the elastic portion is approximately 30 mm to 50 mm wide, and more preferably approximately 40 mm wide. Preferably, the thickness of the rubber is between approximately 0.1 mm to 0.8 mm. More preferably, the thickness of the rubber is between approximately 0.2 mm and 0.4 mm and comprises the force elongation characteristics of the Green, Blue, and Black Thera-Bands^®, respectively.

[0025] Different thicknesses of rubber may be used in the splint of the invention at different times during treatment. A specific thickness of rubber which a specific force elongation profile, for example, a Green Thera-Band^® or equivalent, may be used at the start of treatment for a subject. Then after, for example, two weeks or more when the muscles of the big toe can withstand a greater force (this importantly also includes the inner muscles of the big toe as well as the support structures involved in foot articulations, and other aspects of the ambulatory system), the existing rubber may be exchanged with a thicker, and/or higher tension rubber such as a Blue Thera-Band^® or equivalent, and so forth throughout the treatment period. In this respect, the invention preferably further comprises two or more different phases of treatment using the splint of the invention for a subject with a hallux valgus deformity (bunion). Preferably, in a first treatment phase, the "conditioning phase", the splint of the invention assists to gradually lengthen the muscles of the inner side of the big toe. This conditioning phase may take a number of days or even weeks. The conditioning phase preferably uses a Green Thera-Band^® or equivalent, followed by Blue Thera-Band^® or equivalent (i.e. elastomers having equivalent or similar force elongation) as the muscles of the big toe lengthen and adjust to the force of the rubber. In a second treatment phase, the "maintenance phase", the device is used by a subject overnight or during rest periods to maintain and continue the benefit already gained from using the device of the invention in realigning the malpositioned big toe. Preferably a Blue or Black Thera-Band^® (or elastomers having equivalent or similar force elongation) is used in the splint of the invention during this maintenance phase.

[0026] The rubber band is preferably of a consistent thickness, but a rubber with gradated thickness and/or elasticity may be used. The thickness of the rubber will be selected according to the stretch or resistance (for example, the force elongation) that a specific rubber will provide and what is suitable for providing therapeutic tensioning with a big toe of a subject.

[0027] The elastic of the elastic portion is preferably of same thickness, tension, material, form, and other characteristics as the elastic of the elastic fulcrum portion to provide substantially equal forces against the inner side of the big toe, and adjacent the MTP joint, respectively.

[0028] In a preferred embodiment, the elastic portion of the housing is secured to the rigid portion of the housing with at least one clip. The elastic portion preferably comprises two ends and each end of the elastic portion is secured, preferably releasably secured, to the rigid portion with a clip. Preferably, the clip can be releasably secured to the rigid portion. The clip also assists to preserve the flatness of the rubber and therefore prevent rolling, or clumping of the rubber.

[0029] The clip preferably comprises at least one slot through which part of the elastic portion can pass or be threaded through. More preferably, the clip comprises two slots adjacent a first clip end for threading the elastic portion through one slot and back on itself through the other slot for tensioning the elastic portion and securing it to the clip. The elastic portion may be tightened by releasing a clip from the rigid portion, feeding a greater part of the elastic portion through the slots in the clip before re-securing the clip to the rigid portion. Conversely, the elastic portion may be loosened by releasing a clip from the rigid portion, reducing the length of the part of the elastic portion that has passed or been threaded through the slots in the clip before re-securing the clip to the rigid portion.

[0030] In a preferred embodiment, the clip is releasably secured to the rigid portion by inserting a second clip end into a groove formed in the rigid portion, and then forcing a flange on the underside of the clip into a slot in the rigid portion. The clip is released from the rigid portion by forcing the flange out of the slot on the rigid portion by lifting the first clip end away from the rigid portion therein enabling the second clip end to be removed from out of the groove. Securing the clip to the rigid portion secures the elastic portion by wedging it between the closed clip and rigid portion.

[0031 ] In a preferred embodiment of the invention, the lever portion comprises a first splint arm and a second splint arm. In one embodiment, the first and second splint arms are attached. In another preferred embodiment, the lever portion comprises a first splint arm and a second splint arm which are both attached to the housing, and/or attached to each other. During use, the first splint arm is preferably located above the foot, substantially in alignment with the bones of the hallux, and close to the top surface of the foot. During use, the second splint arm is preferably located below the foot, substantially in alignment with the bones of the hallux, and close to the underneath surface of the foot. The first and second splint arms preferably comprise substantially planar surfaces and are parallel to each other. The lever portion may be constructed from a variety of rigid or relatively rigid materials known in the art and is preferably constructed from the same material as the rigid portion of the housing. Preferably, the lever portion comprises a relatively rigid plastic or resin.

[0032] The attachment means may comprise a variety of different means for attaching the splint to a foot. Preferably, the attachment means is a brace. More preferably, the brace is releasably secured to the foot of a user. In a preferred embodiment of the invention the brace is releasably secured to the midfoot and comprises a flexible adjustable strap. The brace may comprise a variety of materials known in the art which is used in bracing a foot or another part of the body.

[0033] The brace is preferably connected to the second end of the first and second splint arms and extends transversely to the lever portion comprising the first and second splint arms. The brace preferably comprises two ends and at least one end of the brace is threaded through a slot in a splint arm and folded back on itself wherein the end of the brace is attached to another part of the brace. Preferably, the end of the brace is attached to the other part of the brace using matching Velcro^® portions on the brace.

[0034] In a preferred embodiment, the elastic fulcrum portion comprises at least one layer of an elastic band wherein 'elastic band' also refers to an elastic strap or piece of elastic. Preferably, the elastic fulcrum portion comprises two layers of an elastic band. The elastic fulcrum portion may comprise an elastic band doubled over to form two layers. The types of elastic and characteristics of the elastic of the elastic fulcrum portion may be the same as that of the elastic portion as described herein, or different.

[0035] The elastic fulcrum portion preferably contacts the foot at the location of a bunion adjacent the MTP joint and contacts at least the bunion adjacent the prominent medial portion of the first metatarsal head. Preferably, the elastic fulcrum portion comprises an elastic band of rubber. In another embodiment, the elastic fulcrum portion comprises a silicone band. More preferably, the elastic fulcrum portion is of a non-allergenic material. In a preferred embodiment, the elastic fulcrum portion is attached to the first splint arm and to the second splint arm and contacts the bunion adjacent the MTP joint of a user between the first and second splint arms.

[0036] The invention further provides the use of an orthopaedic splint as herein described for promoting realignment of at least a malpositioned (i.e. incorrectly positioned) big toe on the foot of a subject in need of such treatment. Preferably the subject has hallux valgus. [0037] The benefit of the adjustable brace, elastic portion, and fulcrum portion mean that the splint of the invention is customisable for different size feet. In an alternative embodiment, the housing can be releasably attached to the lever portion and different housings sizes may be selected to attach to the lever portion to accommodate the size of the big toe of the subject.

[0038] The invention also provides a method of treating a subject with at least a malpositioned (i.e. incorrectly positioned) big toe using an orthopaedic splint as herein described. Preferably the subject has hallux valgus.

[0039] As discussed above, the inventor identified that benefits from the use of existing splints and braces was limiting in the treatment of hallux valgus due to the discomfort experienced with use of such devices for long periods of time. This was as a result of: restricted and forced movement of the big toe and other toes, pressure on the bunion, and rashes and other skin and nail conditions which arose due to perspiration and attendant fungus growth from extended contact and the large coverage of skin and nail with the materials of the devices.

[0040] When considered in respect of the first identified problem, the splint of the invention does not rigidly force the big toe towards a position of normal alignment. Instead the elastic provides isotonic tensioning for the big toe as equal inertia between the retraction and resistance capabilities of the elastic are experienced. That is, equal inertia in the constant balance between the toe pulling inward towards the other toes against the constant low-torque tensioning provided by the elastic in the opposite direction, and over time, muscles of the toe yielding in that inertia resulting in the movement back towards a 'normal' alignment.

[0041 ] When considered in respect of the second identified problem, the splint of the invention comprises a housing that encircles the big toe but allows freedom of movement of the big toe in any direction. That is, the housing is large enough that when encircled by the housing, the big toe does not contact opposing internal surfaces of the housing concurrently, providing this freedom of movement of the big toe in various directions within the housing. This enables muscles of the big toe to stretch and release with movement of the toe, even under the constant tension of the elastic (i.e. 'therapeutic tensioning'). The muscles of the big toe can then lengthen naturally over time with the continual releasing and stretching providing incremental increases in the muscle strength from the freedom of movement allowed by the configuration of the housing and elastic. The gradual stretching provided by the splint of the invention prevents the strains that are observed with use of many existing devices due to constantly tightened muscles.

[0042] When considered in respect of the third identified problem, the splint of the invention minimises at least constant contact to largely just the inner side surface of the big toe and the bunion with non-allergenic elastic or preferably non-allergenic rubber. This is provided by the C-shape of the rigid portion of the housing encircling the top, underneath, and outer side of the big toe, so that the elastic predominantly contacts the inner side surface and does not substantially wrap around the big toe like other devices. Therefore, with contact minimised there is minimal aggravation on the toe where it contacts the elastic and it does not cover the nail and cuticle thereby avoiding associated skin and nail complications such as proliferation of the nail or other related issues.

[0043] Thus, while assisting realignment of a malpositioned big toe, the invention is also extremely comfortable for the user to use for long periods of time while they are resting, delivers a constant but adjustable force on the big toe, provides freedom of movement for the big toe within the splint, and therein provides a therapeutic benefit and a return toward homeostasis of aspects of the body's systems which relate to or are connected with the foot.

Brief Description of Drawings

Figure 1 . Thera-Band^® Force Elongation Chart.

Figure 2. illustration of a perspective view of the preferred embodiment of an orthopaedic splint in accordance with the invention.

Figure 3. illustration of a (A) side, (B) front, and (C) top, view of the

preferred embodiment of an orthopaedic splint in accordance with the invention. ^

Figure 4. photographs of side and top views of the preferred embodiment of an orthopaedic splint in accordance with the invention in use on a foot.

Figure 5. illustration of a perspective view of a preferred embodiment of a clip for connecting to an elastic portion in accordance with the invention.

Description of Preferred Embodiments

[0044] Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in the specification, individually or collectively and any and all combinations or any two or more of the steps or features.

[0045] The present invention is not to be limited in scope by the specific embodiments described herein, which are intended for the purpose of exemplification only. Functionally equivalent products, compositions and methods are clearly within the scope of the invention as described herein.

[0046] Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

[0047] Other definitions for selected terms used herein may be found within the detailed description of the invention and apply throughout. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

[0048] Features of the invention will now be discussed with reference to the following preferred embodiments. [0049] In the preferred embodiment of the orthopaedic splint of the invention as shown in Figures 2 and 3, and in the photographs in Figure 4 of the preferred embodiment in use, a big toe housing 10 is configured to encircle the big toe of a user. The housing 10 comprises a rigid portion 12 of a relatively stiff plastic in a C-shape configuration for surrounding the top, outer side, and underneath of the big toe. An elastic band 14 of rubber between the C-shape ends 16 of the rigid portion 12 is for contacting and applying an elastic force to the inner side of the user's big toe with minimal or no contact to the nail or cuticle of the big toe.

[0050] The non-allergenic, flat, elastic rubber band 14 passes through a slot adjacent each C-shape end 16 and is secured by clips 18 to the outer surface of the rigid portion 12.

[0051 ] As shown in Figure 5, the clips 18 comprise two slots 20 wider than the thickness of the band 14, the slots 20 adjacent a first clip end 22 for threading the band 14 through one slot 20 and back on itself by passing it through the second slot 20 and tensioning the band 14.

[0052] The clips 18 are releasably secured to the rigid portion 12 by inserting a second clip end 24 into a groove formed in the rigid portion 12 that can accommodate the second clip end 24, and then forcing a flange 28 on the underside of the clip 18 into a slot in the rigid portion 12. The clip 18 is released from the rigid portion 12 by forcing the flange 28 out of the slot on the rigid portion 12 by lifting the first clip end 22 away from the rigid portion 12 and releasing the second clip end 24 from out of the groove 26. Closing the clip 18 and securing it to the rigid portion 12 also secures the band 14 by wedging it between the secured clip 18 and rigid portion 12.

[0053] The clips 18 enable the user to increase the elastic force to the inner side of the big toe by undoing one (or both) of the clips 18 that is securing an end of the band 14, threading more of the end of the band 14 through the slots 20 in the clip 18 therein tightening the band 14, and closing the clip 18 which secures the tightened band 14. It also enables replacement of a spent band 14, for example, which has lost some elasticity or has been damaged or broken. Alternatively, the elastic force may be decreased by undoing one (or both) of the clips 18 and releasing more band 14 through the slots 20 in the clip 18 before re-securing the clip 18 to the rigid portion 12. The clips 18 also assist to maintain the flatness of the band 14.

[0054] The C-shaped rigid portion 12 of the big toe housing 10 is sufficiently larger than the circumference of the user's big toe to enable freedom of movement of the big toe within the big toe housing 10 during use. Allowing movement of the big toe within the big toe housing 10 can assist to reduce cramping of the big toe, surrounding toes and foot, and other parts of the body during use.

[0055] Importantly, the band 14 preferably only contacts the inner side of the big toe and is prevented from constant contact with the nail or cuticle of the big toe which could otherwise induce proliferation of the nail or other related issues with long term use of the splint of the invention.

[0056] The housing 10 is attached to a first end of a relatively rigid top splint arm 32 of a lever portion 30. The top splint arm 32 lies in a substantially transverse plane above the foot approximately in alignment with the bones of the hallux during use. A relatively rigid bottom splint arm 34 of the lever portion 30, in use, lies in a substantially transverse plane underneath the foot approximately in alignment with the bones of the hallux and below the top splint arm 32.

[0057] At a second end, the lever portion 30 which comprises the top splint arm 32 and bottom splint arm 34, connects to a brace in the form of an adjustable strap 40 for releasably securing the orthopaedic splint of the invention to the mid foot of the user. The strap 40 is connected to the second end of the top splint arm 32 and the second end of the bottom splint arm 34 by threading the strap 40 through a slot 42 in each arm and releasably securing an end of the strap 40 back onto itself with matching Velcro^® portions 44. Detaching the matching Velcro^® portions 44 of the strap 40 can allow removal, replacement, or adjustment of the strap 40. ^

[0058] An elastic fulcrum band 60 of a non-allergenic elastic rubber attaches to the top splint arm 32 and the bottom splint arm 34 of the lever portion 30 between the first and second ends. In use, the elastic fulcrum band 60 contacts the bunion of the user in the location of the MTP joint. The position of the top splint arm 32 and the bottom splint arm 34 is approximately in alignment with the bones of the hallux and the tension of the elastic fulcrum band 60 attached between the splint arms means force applied by the elastic fulcrum band 60 on the bunion is spread more evenly and is more comfortable and flexible for a user than a fulcrum portion of rigid material such as plastic, even if covered with cushioning foam or other material.

[0059] The orthopaedic splint of the invention therefore comprises a lever with the elastic fulcrum band 60 forming the fulcrum of the lever. Tightening of the adjustable strap 40 inputs a mechanical force that results in an output (counter) force applied by the elastic band 14 on the inner side of the user's big toe assisting to realign a malpositioned big toe. This output force can be increased or decreased by adjusting the elastic portion 14 of the housing 10 and/or the adjustable strap 40. Force on the bunion by the elastic fulcrum band 60 at the fulcrum of the lever is necessary to assist realignment of a malpositioned big toe without spreading the MTP joint from the surrounding joints which would result in further incorrect anatomy of the foot and associated issues. However, the necessary force on the bunion is spread relatively evenly by use of the elastic rubber fulcrum band 60 which stretches around the bunion making it comfortable for the user irrespective of the force on the bunion.

[0060] In a further embodiment, one or more additional elastic portions may be attached or releasably attached to the rigid portion of the housing, or to one or more extensions attached to the rigid portion of the housing. These are to contact and apply an elastic force to the inner side of one or more other toes of the user in addition to the big toe, the force on the other toes substantially in a direction towards the big toe, to also assist realignment of other toes which are malpositioned.

[0061 ] In a further embodiment, a separate apparatus for housing the big toe, whether comprising an integral or attachable elastic portion, may be attached to the lever portion, or, more preferably, a first and/or a second splint arm to form the splint of the invention. Thus, the separate apparatus may form a replaceable part of the splint of the invention. Benefits of having such a replaceable part may be to have alternative housing sizes, comprise different materials, or to replace the elastic portion if it is not attached to the device via releasable clips, amongst other benefits.

[0062] In another embodiment, the fulcrum portion may comprise an elastic rubber portion within a frame, for example, amongst others, a substantially circular frame. The frame attached to the lever portion, or a portion of the lever portion, or, more preferably, a first and/or a second splint arm to form the splint of the invention. One benefit, amongst others for this embodiment is that it can allow the user to ambulate with the device in use.

Claims

The Claims Defining the Invention are as Follows

1 . An orthopaedic splint for promoting realignment of at least a

malpositioned big toe on a foot, the splint comprising: a lever portion which at a first position comprises a housing that can encircle a big toe on a foot, the housing comprising a rigid portion and an elastic portion, the elastic portion for contacting the inner side of the big toe when in use with the top, underneath, and outer side of the big toe encircled by the rigid portion; the lever portion at a second position comprises an attachment means for securing the splint to the foot; and an elastic fulcrum portion attached to the lever portion between the first and second positions, for contacting the side of the foot adjacent the first metatarsophalangeal joint; wherein in use, the splint functions as a lever about the fulcrum portion with the attachment means secured to the foot inputting a force causing an output counter force applied by the elastic portion on the inner side of the big toe to promote realignment of the big toe.

2. A splint according to claim 1 , wherein the elastic portion can be

adjusted.

3. A splint according to claim 1 or claim 2, wherein the elastic portion can be loosened to decrease, or tightened to increase, the elastic force applied by the elastic portion on the inner side of the big toe.

4. A splint according to any one of the preceding claims, wherein the

elastic portion is secured to the rigid portion of the housing with at least one clip.

5. A splint according to claim 4, wherein the clip can be releasably

secured to the rigid portion.

6. A splint according to claim 5, wherein the elastic portion comprises two ends and each end of the elastic portion is releasably secured to the rigid portion with a clip.

7. A splint according to claim 6, wherein the clip comprises two slots

adjacent a first clip end for threading the elastic portion through one slot and back on itself through the other slot to releasably secure the elastic portion to the clip.

8. A splint according to claim 7, wherein the clip is releasably secured to the rigid portion by inserting a second clip end into a groove formed in the rigid portion, and then forcing a flange on the underside of the clip into a slot in the rigid portion, and wherein the clip is released from the rigid portion by forcing the flange out of the slot on the rigid portion by lifting the first clip end away from the rigid portion and releasing the second clip end from out of the groove.

9. A splint according to any one of the preceding claims, wherein the lever portion comprises a first splint arm and a second splint arm.

10. A splint according to claim 9, wherein the first and second splint arms are attached.

1 1 . A splint according to claim 9 or claim 10, wherein the first and second splint arms are attached to the housing.

12. A splint according to any one of claims 9 to 1 1 , wherein when in use, the first splint arm is located above the foot substantially in alignment with the bones of the hallux, and the second splint arm is located underneath the foot substantially in alignment with the bones of the hallux.

13. A splint according to any one of the preceding claims, wherein the

attachment means is a brace.

14. A splint according to claim 13, wherein the brace can be releasably secured to the midfoot.

15. A splint according to claim 14, wherein the brace comprises an adjustable strap.

16. A splint according to any one of the preceding claims wherein the

elastic fulcrum portion comprises at least one layer of an elastic band.

17. A splint according to any one of claims 9 to 12, wherein the elastic fulcrum portion is attached to the first splint arm and to the second splint arm.

18. Use of a splint according to any one of the preceding claims for

promoting realignment of at least a malpositioned big toe on the foot of a subject.

19. A method of treating a subject using a splint according to any one of claims 1 to 17.