AN ORTHOSIS

Technical Field

The present invention relates to an orthosis for supporting a body part. More specifically, the present invention is directed to an orthosis adapted to accommodate a predetermined orientation for a body part relative to a surface.

Background

Orthoses, and other forms of splints or supports, are commonly used for treating and/or preventing a range of medical and surgical conditions, such as, for example, bone fractures, joint deformities, conditions involving weak limb muscular, pressure ulcers or sores, cervical spine injuries, other spinal injuries, and any one of a number of different medical and/or surgical conditions.

Typical orthoses for use in such applications are generally shaped to accommodate the relevant body part. They are often custom made to suit the needs of the particular patient. Generally, they comprise a support with a portion adapted to receive the body part. For example, orthoses made for a limb are generally constructed with a side of the support, substantially opposite the portion adapted to receive the body part, generally have a curved or concave surface. Typically, one or more straps (for example, made from velcro) are used to secure the orthoses to the relevant body part. In some circumstances, it may be desirable to be able to maintain the relevant body part in a predetermined orientation relative to a surface, such as, for example, a bed surface. Indeed, when a patient is lying supine on a bed surface wearing an orthosis, it may be desirable to ensure that when the orthosis is co-operating with the surface, a predetermined orientation for the relevant body part relative to the surface corresponds to a natural resting position for that body part. Some orthoses are heavy or cumbersome and may have included various additional components, for example, a caliper (or leg brace) with custom made orthotic shoe. If the patjent has limited strength in the leg wearing the caliper, it may be difficult for that patient to lie comfortably on, for example, a bed while wearing the caliper, with his/her leg in the natural resting position. It need not, however, be that the orthosis is heavy or that the patient has a weakness for it to be difficult for the patient to maintain the body part relative to the surface in the natural resting position. Indeed, the fact of wearing an orthosis when lying

supine on a bed could make it difficult for anyone to be able to get comfortable, such that the relevant body part is in the natural resting position.

Furthermore, patients who lie down for prolonged periods are particularly prone to developing pressure ulcers on or around the calcaneus and lateral malleolus of the foot. Other examples of patients who are susceptible to developing ulcers include those with diabetes, who may develop diabetic foot ulcers caused by poor circulation. Patients with peripheral vascular disease are also susceptible to developing arterial ulcers.

Pressure ulcers are typically treated by the use of a prothesis or orthosis which supports the patients lower limb in such a way that the portion of the foot affected by the pressure ulcer is suspended above the surface of the bed, for example. Patients wearing such prostheses or orthoses can have difficulty either maintaining their leg in a natural resting position or maintaining their leg in a preferred therapeutic position, wherein, for example, the portion of the limb affected by the pressure ulcer is suspended above the surface of the bed. Other circumstances in which it may be desirable to be able to accommodate the relevant body part in a particular orientation relative to a surface, include those where maintenance of the relevant body part in an appropriate therapeutic orientation would aid in ensuring, for example, that a bone fracture heals in a preferred alignment.

To address the difficulties associated with rendering it possible for the patient to have his/her relevant body part oriented in a preferred position (for example, the natural resting position or a preferred therapeutic position) relative to a surface, numerous systems have been utilised. For example, it is common practice to use one or more pieces or wedges of foam or one or more pillows, or other such supporting means, located in appropriate positions around the orthosis to position the patient's body part. As will be appreciated, this is a rather cumbersome approach, and may require the assistance of a person (other than the person wearing the orthosis) to locate the supporting means appropriately. Furthermore, where supporting means, such as pillows, are used, the weight of the relevant body part and the orthosis may ultimately indent, or deform, the pillows until the desired position for the body part relative to the surface is lost.

Another related issue is the fact that the natural resting position for one body part is unlikely to be the same as the natural resting position for, for example, the same body part on the other side of the patient. In particular, even if the resting positions for both such body parts were the same, being on opposite sides of the body, the resting

positions would likely be the opposite of one another. As would be appreciated by the skilled addressee, this problem is compounded when consideration is given to orientating the relevant body part into a desired therapeutic position, rather than into its natural resting position. In general terms, even if the supporting means, such as pillows or foam pieces or wedges, were used to support the orthosis appropriately such that, for example, a patient's left lower limb was oriented into its natural resting position relative to a surface, those supporting means would need to be readjusted were the orthosis to be moved over to the patient's right lower limb. Put differently, if an orthosis were being worn by a patient on each of his/her lower limbs, each of those orthoses would need to be supported differently by supporting means.

As it can be difficult to orientate or support opposing limbs, in some applications there has been a need for left- and right-handed orthoses to be made. This increases costs of production and ^" also creates problems of the need to keep a reasonable number of sets of orthoses available for use in a hospital, for example.

The present inventors have developed an improved orthosis with the aim to ameliorate some or all of these problems.

Summary of Invention In a first aspect, the present invention provides an orthosis comprising: a support with a portion adapted to receive a body part, and at least two orientation means associated with the support, with at least one orientation means being integral with the support, wherein each orientation means is adapted to cooperate with a surface to accommodate a predetermined orientation for the body part relative to the surface.

In some preferred embodiments, a transverse cross-section of the support is substantially concave, arcuate, or U-shaped. A support having such a cross-section is particularly useful in embodiments of the orthoses adapted to receive a limb of a patient or the neck of the patient. In some preferred embodiments, the support is tapered along its length. In other preferred embodiments, different sections of the support have different respective cross-sectional widths. In one preferred embodiment, wherein the orthosis is made for use on the lower limb of a patient, the cross-sectional width is

relatively larger where the orthosis supports the calf (generally in the region of the gastrocnemius muscle), compared to where it supports the ankle.

In yet still further preferred embodiments, the support varies in cross-sectional shape along its length. In some preferred embodiments, the support is specifically shaped to accommodate a particular body part. In yet still further preferred embodiments, the support is custom-made to suit the particular needs of a patient. In other preferred embodiments, the shape for the support is not particularly limited to a specific shape provided that the support has a portion which is adapted to receive a body part. Some preferred supports are formed from a plastic (ABS - acrylonitrile- butadiene-styrene, for example). Such embodiments are vacuum formed and injection moulded. Particularly preferred embodiments of the support are formed of a PolyCell™ EVA foam. The injection molding process can manufacture the foam and product simultaneously, resulting in a closed-cell, self-skinning product. In one such preferred embodiment the resultant product is durable and chemical resistant. This material, in a preferred embodiment, is also flexible enough that it will allow the support to accommodate various sized body parts. The orthosis can also be made from other closed or open celled foams, rubbers or polystyrene, among a range of other suitable materials. In alternative embodiments the support is inflatable and deflatable. In some such embodiments, each of the orientation means are preferably integral with the support and inflate and/or deflate at or around the same time as the support. In another such embodiment, each of the orientation means can inflate and/or deflate independently of the support. Some preferred embodiments of the support further include at least one hole which provides ventilation to an area of the limb on which the prosthesis is placed. Yet still further preferred embodiments have a plurality of such holes.

In other preferred embodiments, the support further includes at least one reinforcement means for reinforcing the rigidity of the support. In some such embodiments, the reinforcement means is integral with the support and in other embodiments, it is connected to or secured to the support.

The reinforcement means of preferred embodiments is a thickened portion formed from a substantially rigid material. The reinforcement means may extend around

a perimeter of the support proximal an edge of the perimeter. In alternative embodiments, the reinforcement means may cover a portion of the support which is different to the portion adapted to receive the body part. The reinforcement means may also take the form of a strip or strips running along a longitudinal axis of the support and/or running along a horizontal axis of the support.

In alternative embodiments, there are a plurality of such reinforcement means, and in some embodiments, the reinforcement means form a cross-hatched pattern on a surface of the support. It will be appreciated by persons skilled in the. art that provided the reinforcement means are capable of enhancing or increasing the rigidity of the support, there is no particular limitation on the shape of the reinforcement means or on the manner in which the reinforcement means are located on the support, or on the material from which the reinforcement means are formed.

In one preferred embodiment, for example, the reinforcement means are provided by one or more of the orientation means. In such embodiments, the or more of the orientation means may have the dual function of providing reinforcement to the support and the ability to cooperate with a surface to accommodate a predetermined orientation for a body part relative to a surface.

A portion of the support is adapted to receive a body part. In preferred embodiments, the portion has an arcuate, concave or U-shaped cross-section. In alternative embodiments, the portion is substantially planar. In yet still further preferred embodiments, the portion is specifically moulded to accommodate the particular shape of the body part for which it will be used. Some preferred embodiments disclose that the portion is custom-made.

A surface of the portion of preferred embodiments is substantially smooth. In alternative embodiments, a surface of the portion is corrugated, or has multiple undulations in a horizontal plane, or in a vertical plane, or in both horizontal and vertical planes. In alternative embodiments, the surface of the portion is rough.

Some preferred embodiments of the orthosis further include a liner element for lining the portion of the support adapted to receive a body part. In such embodiments, the liner element is preferably shaped, or adapted to be shaped, to accommodate the shape of the portion or the body part. This liner element provides a further support for the relevant body part. Preferred liner elements can be formed of foam, sheep skin, synthetics, wool, cotton, leather, vinyl, or another material suitable to act as a liner element. In some preferred embodiments, the line element is disposable. A preferred

embodiment of a disposable liner element is formed of a therapeutic open-celled foam. The liner element is preferably further covered in a material, cloth or cotton sleeve. In some preferred embodiments, the liner element is attached to the support by, for example, elastic straps, toggles that engage with the support, a sock or stocking that encompasses all components (including the leg), velcro, or any other appropriate means of attaching the liner element to the support.

The orthosis of the present invention can be used on a range of body parts. In preferred embodiments the orthosis is adapted to be used on a limb of the body, and in particularly preferred embodiments it is adapted to be used on a lower limb of the body. The orthosis can, however, be used to support the cervical spine or another part of the spine. In appropriate forms, the orthosis can be used to support the wrists or ankles.

At least two orientation means are associated with the support, with at least one orientation means being integral with the support.

In some embodiments, there are a plurality of orientation means associated with the support. In a preferred embodiment, there are two orientation means associated with the support. In such embodiments, a first orientation means is integral with the support and a second orientation means can be integral with, connected to, affixed to, aligned with, resting against, or abutting, the support. Other forms of association of the orientation means with the support are also contemplated by the invention. In some embodiments, the second orientation means and/or any additional orientation means is connected to the support by means of, for example, a pivot defined by a slot in the support and a corresponding pivot arm attached to the orientation means. Such embodiments provide for the option to move or adjust the position of the second or other additional orientation means, in order to facilitate orientating the relevant body part relative to the surface into the desired position. In another embodiment, the second or other additional orientation means are connected to the support by means of, for example, a friction fitted sleeve defined by a groove in the support and a correspondingly shaped locking element connected to the orientation means, the locking element slidably engaging with the groove. A plurality of other means for connecting the second or other additional orientation means are also contemplated by the invention.

In further preferred embodiments, the second and/or additional orientation means are connected to the support with velcro straps, plastic snap fittings, interlocking

plugs, alignment pins, locking bars, adhesive tape, or any other mechanism that connects the orientation means to the support.

In some preferred embodiments, at least two orientation means are connected to one another. In some embodiments, there are more than two orientation means connected to one another. Other preferred and alternative embodiments provide that at least two orientation means are integral with one another.

Orientation means of preferred embodiments have at least one area which is adapted to cooperate with a surface, such as, the surface of a bed. In some preferred embodiments, the area is substantially planar. In others, the area has curves. In alternative embodiments, the area is formed into a particular shape which facilities its cooperation with a specific surface. For example, if the surface with which the orientation means is adapted to cooperate is a portion of the body of a patient, then the area of the orientation means may be specifically shaped to facilitate cooperation of the orientation means with that portion of the body of the patient. In preferred embodiments, there is an angle between respective axes of each orientation means. In a particularly preferred embodiment, at least two orientation means are integral with the support, and the area of each orientation means is substantially planar. The angle between respective axes of each orientation means is determined, in such preferred embodiments, by reference to the angle formed between the two substantially planar areas. Preferably, the angle is obtuse. More preferably, the angle is between about 110° and about 160°, and more preferably still the angle is about 140°. Other angles between the respective axes the orientation means are also contemplated by the invention.

In some embodiments, at least one orientation means has a hollow portion. The hollow portion may be useful for reducing the volume, and therefore, weight of the orthosis. ^l

The hollow portion can also be adapted to receive a correspondingly shaped orientation member, which in preferred embodiments provides a further means of orientating the body part relative to the surface (over and above the orientation provided by the orientation means themselves). In some preferred embodiments, the orientation member assists in preventing the support from rotating when, for example, in contact with the surface. In other preferred embodiments, the orientation member is used, for example, to immobilise or inhibit movement of a patient's leg during, for example, hip and/or knee surgery. The orientation member of preferred embodiments can be

manufactured in varying thicknesses, providing different support heights under, for example, the knee.

It will be appreciated by persons skilled in the art that the orientation member is an additional component of some of the preferred embodiments of the orthosis of the present invention.

In such embodiments, the area of the orientation means that is adapted to cooperate with the surface of, for example, a bed, is provided by a rim extending around a perimeter of the hollow portion. In some preferred embodiments, a shape of the rim is substantially oval. In other preferred embodiments, the shape of the rim is a quadrant of a circle, a circle, a square, a triangle, a trapezium, a trapezium with at least one curved side, or any other shape that would achieve the objective of providing for cooperation with the surface. Indeed, there is no particular limitation on the shape of the rim.

In some embodiments, the orientation means span a portion of the length of the orthosis. In other embodiments, the orientation means span a portion of the width of the orthosis. In yet still further preferred embodiments, the orientation means span substantially the entire length of the orthosis, or substantially the entire width of the orthosis, or both.

In some preferred embodiments, the orientation means are beatable on either side of a longitudinal axis of the support. In the same and in other preferred embodiments, the orientation means are locatable on, or about, a side of the support which is substantially opposite the portion adapted to receive the body part.

In preferred embodiments, the orientation means which is integral with the support is formed of the same or different material as the support. In yet still further preferred embodiments, the second and/or other additional orientation means can be formed of the same or a different material. For example, such orientation means can be injection moulded or formed of plastics, cut or moulded of alternate rubber and/or foam compounds, formed of polystyrene, formed of an inflatable material, or of cardboard or fabric, among a range of other suitable materials.

In yet still further preferred embodiments, the orthosis is substantially symmetrical about a longitudinal axis of the support.

A cross-section of some preferred embodiments of the orthosis is such that the portion adapted to receive a body part is substantially U-shaped, and the orientation means are locatable on the side of the support which is substantially opposite the

portion adapted to receive the body part. In such embodiments, a cross-section of the side of the support substantially opposite the portion adapted to receive the body part, substantially corresponds to the shape created by four consecutive sides of a hexagon with the two parallel sides preferably representing a cross-section of two side sections of the support, and the two other sides (in between the two parallel sides) of these four consecutive sides of the hexagon shape, representing a cross-section of the respective areas of the orientation means that are adapted to cooperate with the surface.

The orientation means are adapted to cooperate with the surface to accommodate a predetermined orientation for the body part relative to the surface. The orientation means can cooperate with the surface in any suitable manner. Examples include, but are not limited to, aligning with the surface, abutting the surface, resting on the surface, lying on the surface, or affixing to the surface. Other forms of cooperation of the orientation means with the surface are also contemplated by the invention.

In a preferred embodiment, the predetermined orientation substantially corresponds to a natural resting position for the body part. As would be appreciated by those skilled in the art, the natural resting position will vary for each body part, and is likely to vary amongst patients. In very general terms, however, for a large number of people, the resting positions for each body part may be similar. For example, typically, when a person is lying supine on a relatively flat surface in the generally horizontal plane, the lower limbs tend to supinate, evert, or externally rotate when in their respective natural resting positions. This is one reason why, for example, patients who lie down for prolonged periods are at higher risk of developing pressure ulcers in the general region of the calcaneus, more specifically on the posterior end lateral aspects of the calcaneus, and or of the lateral malleolus. Preferred embodiments of the orthosis for use in circumstances where it may be desirable to accommodate the natural resting position for, for example, the lower limb relative to the surface of, for example, a bed, include at least two orientation means each with its own area which is adapted to cooperate with the surface. In such preferred embodiments, this area of the orientation means is substantially planar in each case and there is an obtuse angle between the respective axes of the planar areas.

As explained above, the side of the orthosis with which the orientation means are associated generally has a cross-sectional shape corresponding to four consecutive sides of a hexagon. In such embodiments, two consecutive sides of the hexagon shape respectively correspond with respective cross-sectional views of the planar areas of

each orientation means. The meeting point of an edge of each orientation means corresponds, in this preferred embodiment, with a centre of the orthosis. In effect, preferred embodiments of the orthosis according to this configuration pivot about the fulcrum created by the meeting of the edges of the planar areas. In such embodiments, the orthosis can freely rotate about the fulcrum (when resting on the surface of, for example a bed) such that at least one orientation means can cooperate with the surface. In other words, the orthosis of such embodiments with two orientation means (configured as just described) can cause pronation or supination of, for example, the lower limb. As supination generally corresponds with the resting position for the lower limb, the orthosis can generally rest with the orientation means cooperating with the surface of, for example, the bed, such that the lower limb is supinated, everted or externally rotated into its resting position.

In other preferred embodiments, there is a curved, planar, or other shaped portion between the orientation means. In such embodiments, rather than pivoting about a fulcrum created between the orientation means, the orthosis may be moved in a different manner between the orientation means. For example, where the portion between the orientation means is curved, the orthosis may be moved or rotated by causing the curved portion to rotate on the relevant surface. As would be appreciated by persons skilled in the art, in such embodiments there is no specific limitation on the shape of that portion.

It would be appreciated by persons skilled in the art that the more orientation means that are associated with the support for the orthosis, the more orientations for the relevant body part relative to the surface that can be accommodated using the orthosis.

In other preferred embodiments, the predetermined orientation substantially corresponds to a preferred therapeutic position for the body part. As has been previously explained, there are a plurality of circumstances in which it may be desirable to be able to orientate a particular body part relative to a surface, including, for example, those associated with assisting a bone fracture to heal in a preferred alignment.

Such embodiments of the orthosis are preferably facilitated by having the second (and/or any one or more other additional) orientation means connected to the support in a manner that allows relative movement of the second (and/or any one or more other additional) orientation means with respect to the support. For such embodiments, the second (and/or any one or more other additional) orientation means are moved and

preferably locked into a position that enables the orthosis to accommodate the preferred therapeutic position for the relevant body part relative to the surface.

It is not, however, necessary that in order to use the orthosis in circumstances where it is desirable to orientate the relevant body part in a preferred therapeutic position relative to the surface, the second (and/or any one or more other additional) orientation means are moveable with respect to the support. Indeed, appropriately formed embodiments of the orthosis with both or more than two orientation means integral with the support could be used in this application. ^•

In some preferred embodiments, the orthosis is used to immobilise or inhibit movement of the leg of a patient during, for example, knee and/or hip surgery. In some such embodiments, the preferred therapeutic position substantially corresponds with a substantially immobilised position of the leg.

In other preferred embodiments, the orthosis is used, for example, to immobilise the neck of a patient who is suspected of, or at risk of, having sustained a cervical spine injury.

Some preferred embodiments of the orthosis are configured so as to accommodate, for example, treating and/or preventing pressure ulcers on the ankle or heel of a patient. Some such preferred embodiments include a further surface extending from an end of the support, wherein the further surface diverges from a longitudinal axis of the support. In some such preferred embodiments, the further surface is moulded into the portion of the support adapted to receive the body part. In other such embodiments, the further surface is provided by at least one of the orientation means. In other embodiments, the further surface is an additional component of the invention and is unrelated to any of the orientation means or the portion of the support adapted to receive the body part. In some embodiments, for example, the further surface is provided by a flared or splayed section of the support at the appropriate location. Other means by which the further surface is provided are also contemplated by the invention.

In such embodiments, the further surface diverges from the longitudinal axis of the support such that a portion of the body part adjacent that further surface is relieved from pressure.

In circumstances where the orthosis is being used to aid in the treatment and/or prevention of pressure ulcers on the ankle or heel, the further surface extends from the support proximal the end of the support which would be located closest to the ankle

when the orthosis is being worn by the patient. In such embodiments, an edge of the further surface rests firmly, for example, on the bed, and the patients' ankle (including the calcaneus and lateral malleolus) are suspended above the bed and the orthosis.

It would be appreciated by persons skilled in the art that the addition of such a further surface may be useful in other circumstances, and the above description is provided merely to illustrate an example in which the further surface would be of particular use.

In yet still further preferred embodiments, the orthosis additionally includes components to aid in making the patient comfortable whilst wearing the orthosis. For example, in one preferred embodiment, the orthosis further includes an anti- hyperextension means to aid in preventing, for example, a patients lower limb from hyper-extending as a result of an extension pressure (exceeding that which the patient ordinarily experiences when his/her leg is naturally fully extended) caused by the orthosis raising the patients foot above the surface. Some preferred anti-hyperextension means are substantially a rectangular prism and may follow a contour of an outer surface of the support. In embodiments of the orthosis adapted for use on the distal end of the patients lower limb, the anti- hyperextension means is preferably located proximal an end of the support which generally sits on the patients lower limb in the region of the popliteal fossa. Alternative embodiments of the anti-hyperextension means are not limited by a particular shape provided that the anti-hyperextension means is capable of performing its function as described above. The anti-hyperextension means may be integral with, connected to, or secured to the support. In some preferred embodiments, the anti- hyperextension means is provided by at least one of the orientation means. It may also be desirable in certain circumstances to be able to secure an additional object to the support, such as, for example, a frame for preventing bed sheets from coming into contact with an area of the body part. Accordingly, yet still further preferred embodiments provide object receiving means connected to or integral with the support. While the object receiving means are preferably adapted to receive a frame- like structure, the object receiving means can be adapted to receive any object which it may be desirable to bring into association with the orthosis, for example, an orthotic shoe.

In some such preferred embodiments, the object receiving means are integral with the support and are defined by one or more slots within the support at preferred

locations. The slots are preferably adapted to receive a part of the relevant object, for example, a frame supporting arm connected to an appropriately formed frame.

In alternative embodiments, the object receiving means are provided by a threaded aperture for receiving, for example, screws adapted to secure the object to the orthosis. Other mechanisms for securing the object to the orthosis are contemplated by the invention. For example, the object could be secured or connected to the orthosis with velcro, elastic straps, friction fitting, or threaded pins.

Although the orthosis of the present invention can be worn by the patient simply by being placed on or against the relevant body part, it may be desirable in certain circumstances to be able to secure the orthosis to the relevant body part. Some preferred embodiments provide at least one fitting strap adapted to secure the orthosis to the relevant body part. Other embodiments provide a plurality of such straps. In a particularly preferred embodiment, there are two fitting straps, each located proximal a respective end of the orthosis. Fitting straps are preferably formed of velcro. However, anything capable of securing the orthosis to the relevant body part can be used. For example, stockings, compression stockings, bandages or elastic tube socks.

A beneficial feature of the orthosis of the present invention, and particularly a preferred form which is symmetrical about a longitudinal axis, is that it can be used on either side of the patient's body, for example, on either leg or on either arm. As would be appreciated by those skilled in the art, in circumstances where one preferred function for the orthosis is to orientate a particular body part with respect to a surface, such as a bed, such that the body part remains in the resting position, the same orthosis can be used on either side of the body. In particular, if the orthosis is worn, for example, on the left lower limb, then one of the orientation means would cooperate with the surface of the bed to enable the left lower limb to remain supinated, everted or externally rotated (into the natural resting position). Similarly, if the same orthosis were worn on the right lower limb, the other orientation means would cooperate with the bed surface to ensure that that limb remains in the supinated, everted position or externally rotated. This is a particular advantage of some preferred embodiments of the present invention.

In addition, it is to be noted that the orthosis of the present invention can be worn even when the patient is not near, against, or on a particular surface. Indeed, when the orthosis is being used on the lower limb, it is still possible for the patient to ambulate. When the patient is ambulating, the orthosis can remain attached to the relevant body

part, and then when the patient comes into association with a particular surface, such as by lying down on a bed, the orientation means will act to cooperate with the bed surface to accommodate orientation of the relevant body part relative to the surface into either the natural resting position, a preferred therapeutic position, or some other desirable position.

In circumstances where the orthosis is being worn on the lower limb, the orthosis can also be used for additional purposes. For example, patients often dig their heels into, for example, a bed surface in order to shift their body toward the top of the bed. For a patient with a pressure sore on the calcaneus for example, it would not be appropriate to undertake this physical activity. Accordingly, when such a patient is wearing an orthosis of the present invention, they can use a distal end of the orthosis to dig into the bed (instead of the calcaneus or heel) and still achieve the objective of shifting their body toward the top of the bed.

Being able to provide an orthosis that is capable of being used on either opposing limb is a real advantage. A hospital, for example, need only purchase the universal orthosis for use on either limb. There is no issue of having to locate a 'left' or 'right' orthosis for a particular application as is often the case with existing orthoses.

In a second aspect, the present invention provides a sleeve assembly adapted to secure an orthosis according to the first aspect of the invention to a body part. In preferred embodiments, the sleeve assembly comprises an orthosis receiving segment and a body part receiving segment. Preferably, the two segments are separated by at least one sheet of material. In other embodiments, the sleeve assembly further includes one or more additional segments for receiving other objects, such as, for example, a soft or comfortable underlay or overlay, or a soft piece of material that can be interposed between, for example, the orthosis receiving segment and the body part receiving segment. In one such embodiment, the liner element can be received by one of the additional segments.

The orthosis receiving segment of some preferred embodiments is open at both ends, and of other preferred embodiments, is closed at one end. In the latter preferred embodiments, although the orthosis can be slidably inserted into the open end of the orthosis receiving segment, it is inhibited from being inserted through the other end or exiting beyond this closed end.

In another preferred embodiment a portion of the orthosis receiving segment has an aperture through which at least one orientation means can pass. In such

embodiments, although the orthosis is received by the orthosis receiving segment, at least a portion of at least one of the orientation means may not be covered by material.

In yet another preferred embodiment, the orthosis receiving segment is comprised of an elastic material in the shape of a substantially oval shaped or circular shaped wall. The elastic material of this embodiment can be stretched over the orthosis in a similar manner to which a shower cap is stretched over a head.

In further preferred embodiments of the sleeve assembly, the body part receiving segment is opened at both ends, and in other preferred embodiments, it is closed at one end. Some embodiments of the sleeve assembly provide that the orthosis receiving segment is specifically shaped so as to receive an orthosis of a particular embodiment. In other preferred embodiments, at least the orthosis receiving segment of the sleeve assembly is formed of a substantially elastic material.

In yet still further preferred embodiments at least a substantial portion of the entire sleeve assembly is preferably formed of material such as cotton and/or a combination of cotton and an elastic material. Other materials are also contemplated by the invention for this purpose.

In a third aspect, the present invention provides an orthosis comprising: a support with a portion adapted to receive a body part, and at least two orientation means integral with the support, with each orientation means locatable on either side of a longitudinal axis of the support and each being adapted to cooperate with a surface to accommodate a predetermined orientation for the body part relative to the surface.

In a fourth aspect, the present invention provides an orthosis according to the first aspect of the present invention in operable association with a sleeve assembly of the second aspect of the present invention.

The present invention also provides methods of treating and/or preventing various diseases or disorders using an orthosis of the present invention.

In a fifth aspect, the present invention provides a method of treating and/or preventing a disease or disorder, the treatment and/or prevention of which responds to accommodating a predetermined orientation for a body part relative to a surface, the method comprising: placing an orthosis according to the first or third aspects of the present invention

on the relevant body part; and manipulating the orthosis such that at least one orientation means is cooperating with the surface to accommodate the predetermined orientation for the body part relative to the surface. In preferred embodiments, the method is used in the treatment and/or prevention of pressure ulcers, more preferably pressure ulcers on the calcaneus and/or lateral malleolus of a patient. In other preferred embodiments, the method of the fifth aspect is used in the treatment and/or prevention of joint deformities.

In yet still further preferred embodiments, the present invention is used in the treatment of bone fractures.

As would be appreciated by persons skilled in the art, an orthosis of the present invention could be used in a range of additional methods of treatment and/or prevention of a wide variety of diseases or disorders.

In a sixth aspect, the present invention provides a method for supporting a body part comprising: placing an orthosis according to the first or third aspects of the present invention on the body part; and manipulating the orthosis such that at least one orientation means is cooperating with a surface. 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 element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed in Australia before the priority date of each claim of this specification.

In order that the present invention may be more clearly understood, preferred embodiments will be described with reference to the following drawings and examples.

Brief Description of the Drawings

Preferred embodiments of the invention will now be further explained and illustrated by reference to the accompanying drawings in which:

Figure 1 is a side view of a preferred embodiment of the orthosis of the present invention.

Figure 2 is a top view of a preferred embodiment of the orthosis of the present invention.

Figure 3 is a bottom view of a preferred embodiment of the orthosis of the present invention. Figure 4 is a rear view of a preferred embodiment of the orthosis of the present invention.

Figure 5 is a front view of a preferred embodiment of the orthosis of the present invention.

Figure 6 is a rear view and a front view of a preferred embodiment of the orthosis of the present invention resting on a surface.

Figure 7 is a rear view and a front view of a preferred embodiment of the orthosis of the present invention resting on a surface, illustrating the preferred manner in which at least one of the orientation means cooperate with the surface to accommodate a predetermined orientation for the body part relative to the surface. Figure 8 is a rear view and front view of view of a preferred embodiment of the orthosis of Figure 7, illustrating how another orientation means cooperates with the surface to accommodate a different predetermined orientation for the body part relative to the surface.

Figure 9 is a top perspective view of a preferred embodiment of the orthosis of the present invention.

Figure 10 is a bottom perspective view of a preferred embodiment of the orthosis of the present invention.

Figure 11 is a top perspective view of a preferred embodiment of the orthosis of the present invention, illustrating a preferred embodiment of a liner element about to be connected or secured to the orthosis.

Figure 12 is a side view of a preferred embodiment of the orthosis being used on a patient's lower limb.

Figure 13 is the side view of Figure 12 with parts of the orthosis shown in dotted line, illustrating those parts of the patient's lower limb which are cancelled from view by the orthosis in Figure 12.

Figure 14 is a side view of an orthosis of another preferred embodiment of the invention.

Figure 15 is a bottom view of the orthosis depicted in Figure 14.

Figure 16 is a rear view of an orthosis of a preferred embodiment, illustrating an alternative form of orientation means.

Figure 17 is a side view of an orthosis of a preferred embodiment, illustrating a preferred mechanism through which the second and/or additional orientation means is moveable relative to the support.

Figure 18 is a top perspective view of the orthosis of Figure 17.

Figures 19A, B, C illustrate an alternative embodiment of the orthosis of the present invention which is inflatable and deflatable. Figure 19A illustrates the orthosis in a deflated state, Figure 19B illustrates one preferred location for the air inlet of the orthosis and, the orthosis in an inflated state, and Figure 19C illustrates a further alternative embodiment of the orthosis in an inflated state.

Figure 20 is a top perspective view of a preferred embodiment of the orthosis of the present invention, illustrating a plurality of holes or apertures passing through the orthosis.

Figure 21 is a top perspective view a preferred embodiment of the orthosis of the present invention, illustrating preferred locations for straps which can be used to secure the orthosis to a body part of the patient.

Figure 22 is a bottom perspective view of an orthosis of an alternative embodiment, illustrating an alternative form of orientation means.

Figure 23 is a bottom perspective view of an orthosis of an alternative embodiment, illustrating an alternative form of orientation means.

Figure 24 is a bottom perspective view of an alternative embodiment of an orthosis of the present invention, illustrating an alternative form of orientation means, along with a corresponding form of an orientation member.

Figure 25 is a rear view of the orthosis of Figure 24, illustrating how the orientation member could be inserted into the hollow portion of the support in different ways.

Figure 26 is a bottom perspective view of an orthosis of a preferred embodiment of the invention being worn on the lower limb of a patient and illustrating an orientation member about to be inserted into the hollow portion in the support.

Figure 27 is a top perspective view of a preferred embodiment of an orthosis of the present invention incorporating object receiving means.

Figure 28 is a perspective view of the orthosis of Figure 27 being worn on a patient's lower limb, illustrating a cage-like structure received into the object receiving means.

Figure 29 is a side view of Figure 27.

Figure 30 is a perspective view of a preferred embodiment of a sleeve assembly of the present invention. In this Figure, various parts of the sleeve assembly are peeled back so as to illustrate a soft piece of material interposed between the peeled back segments.

Figure 31 is a further perspective view of the sleeve assembly depicted in Figure 30, illustrating the orthosis receiving segment and the body part receiving segment.

Figure 32 is an underside perspective view of a sleeve assembly of one preferred embodiment of the invention, illustrating a particular embodiment of the orthosis receiving segment.

Figure 33 is a perspective view of a sleeve assembly of a preferred embodiment, illustrating a particular embodiment of the body part receiving segment.

Figure 34 is a side view of an orthosis of a preferred embodiment being worn on a patient's lower limb, with a sleeve assembly of a preferred embodiment securing the orthosis to the patient's lower limb.

Detailed Description of the Invention

Figures 1-5 illustrate various views of one preferred embodiment of the orthosis 10 of the present invention. In this embodiment, the orthosis 10 comprises a support 20 with a body part receiving portion 30, and at least two orientation means 40 and 50, with at least one orientation means 40 integral with the support 20.

As is well illustrated in figures 4 and 5, preferred embodiments of the support 20 have a substantially U-shaped or arcuate cross-section. In some preferred embodiments, different sections of the support 20 have different respective cross- sectional widths. In the embodiment depicted in figures 1-5, the orthosis is made for use on the lower limb of a patient. In this embodiment, the cross-sectional width is relatively larger at a first end 21 of the support (where the orthosis supports the calf, generally in the region of the gastrocnemius muscle), compared to the cross-sectional width of the support at a second end 22 where it supports the ankle.

The body part receiving portion 30 in the preferred embodiment depicted in many of the figures has a concave or arcuate shape. However, the body part receiving portion 30 can also be planar. Furthermore, the body part receiving portion 30 depicted in many of the figures has a smooth surface.

As is well illustrated in many of the figures, the orthosis 10 of the present invention can be used on a patient's lower limb 70. The preferred embodiment depicted in figures 1-5 and various other figures illustrate that the orthosis 10 has two orientation means 40 and 50 both of which are integral with the support 20. Although the preferred orientation means 40 and 50 depicted in figures 1-5 (and others) illustrate the orientation means 40 and 50 having hollow portions 41 and 51 , not all embodiments of the orientation means have hollow portions. Various preferred and alternative embodiments for the orientation means 40 and 50 are discussed in more detail below with reference to further figures.

The preferred orientation means 40 and 50 depicted well in figure 3 each have a substantially trapezoid shape 42 and 52 with one side of the trapezoid shape 43 and 53 being curved. As is well illustrated in figures 1 and 5, each of the orientation means 40 and 50 have at least one area 44 and 54 which is adapted to cooperate with a surface 60, such as, the surface of a bed. In some preferred embodiments, the area 44 and 54 is formed into a particular shape which facilities its cooperation with a specific surface.

In preferred embodiments, there is an angle between respective axes 45 and 55 of each orientation means 40 and 50. Preferably, the angle between the respective axes 45 and 55 is obtuse. In a particularly preferred embodiment, the angle is between about 110° and about 160°, and more preferably still, the angle is about 140°.

In the preferred embodiment of the orthosis 10 depicted well in figures 1-5, the area 44 and 54 of the orientation means 40 and 50 that is adapted to cooperate with the surface 60 is provided by a rim 46 and 56 extending around the perimeter of the hollow portion 41 and 51. In some embodiments, the orientation means 40 and 50 span a large part of a side of the support which is substantially opposite the body part receiving portion 30. In many of the embodiments depicted in the figures, and in particular figures 1-5, the orientation means 40 and 50 span a portion of the side of the support 20 which is substantially opposite the body part receiving portion 30. The orientation means are preferably locatable on either side of the longitudinal axis of the support 20 in the embodiments depicted in the many of the figures, the orthosis 10 is substantially symmetrical about a longitudinal axis of the support 20, so that as is well illustrated in the rear view of figure 3, the side of the support 20 substantially opposite the body part receiving portion 30 appears substantially symmetrical about the longitudinal axis.

Figures 6, 7 and 8 illustrate respective end views of the orthosis 10 resting on a surface 60. In the embodiments depicted, a cross-section of the side of the support 20 substantially opposite the body part receiving portion 30 substantially corresponds to the shape created by four consecutive sides 71 , 72, 73 and 74 of a hexagon 70 with the two parallel sides 71 and 74 preferably representing a cross-section of two side sections of the support 20, and two other sides 72 and 73 of these four consecutive sides of the hexagon shape 70, representing a cross-section of at least a part of the respective areas 44 and 54 of the orientation means 40 and 50 that are adapted to cooperate with the surface 60. The orientation means 40 and 50 are adapted to cooperate with the surface 60 to accommodate a predetermined, orientation for the body part relative to the surface 60.

In some preferred embodiments, the meeting point 75 of an edge of each orientation means 40 and 50 corresponds with a centre of the orthosis 10. As is well illustrated in figure 6, such embodiments of the orthosis 10 according to this configuration pivot about the fulcrum 76 created by the meet point 75 of the edges of the planar areas 44 and 54 of the orientation means 40 and 50.

In one preferred embodiment, the predetermined orientation for the body part relative to the surface 60 substantially corresponds to a natural resting position for the body part. For example, when a person is lying supine on a relatively flat surface in the

generally horizontal plane, the lower limbs tend to supinate, evert or externally rotated when in their respective natural resting positions. As figures 7 and 8 illustrate, the preferred configuration for the orthosis 10 depicted in those figures, is well suited to accommodate supination, eversion or externally rotated of both lower limbs. Indeed, a particular advantage of the orthosis 10 of the present invention is that it can be used on either side of the body. Figure 7 illustrates the orthosis 10 wherein one of the orientation means 40 is cooperating with the surface 60 and figure 8 illustrates the orthosis 10, wherein the other orientation means 50 is cooperating with the surface 60. As would be appreciated by persons skilled in the art, the respective positions for the orthosis relative to the surface illustrated in figures 7 and 8, represent two opposed orientations in which, for example, a lower limb wearing the orthosis 10 would be placed or positioned relative to the surface 60. In other words, figures 7 and 8 illustrate embodiments of the invention which could be cooperating with the surface 60 such that a patient wearing an orthosis 10 on each lower limb, could have his/her lower limbs in their respective resting positions relative to the surface 60.

In other preferred embodiments, the predetermined orientation for the body part relative to the surface 60 substantially corresponds to a preferred therapeutic position for the body part. There are a plurality of circumstances in which it may be desirable to be able to orientate a particular body part relative to a surface 60, including, for example, those associated with assisting a bone fracture to heal in a preferred alignment. In some preferred embodiments, the orthosis can be used to immobilise or inhibit the movement of, for example, the leg of a patient during, for example, knee and/or hip surgery.

In a particularly preferred embodiment, the orthosis 10 is configured so as to accommodate treating and/or preventing pressure ulcers on the ankle or heel 80 of a patient.

In some preferred embodiments, the orthosis 10 includes a further surface 90 extending from an end of the support, wherein the further surface 90 diverges from a longitudinal axis of the support 20. As illustrated in figure 9, the further surface 90 of some preferred embodiments is moulded into the body part receiving portion 30. In other embodiments, the further surface 90 is provided by at least one of the orientation means 40 and 50. In yet still further embodiments, the further surface 90 is an additional component of the invention and is unrelated to any of the orientation means 40 or 50 or the body part receiving portion 30.

As illustrated in figure 11 , some preferred embodiments of the orthosis 10 further include a liner element 100 for lining the body part receiving portion 30. In such embodiments, the liner element 100 is preferably shaped, or adapted to be shaped, to accommodate the shape of the body part receiving portion 30 and/or the body part. In some preferred embodiments, the liner element 100 is attached to the support by, for example, elastic straps, or a sock or stocking, or velcro (not shown). In particularly preferred embodiments, the liner element 100 can be received by a sleeve assembly 110. More detail regarding how the liner element 100 is received by the sleeve assembly 110 is provided below where a detailed description is provided of the sleeve assembly 110.

Figures 12 and 13 illustrate preferred embodiments of the orthosis 10 being worn on the lower limb 70 of a patient. As can be seen best in figure 13, a side of the orthosis 150 (shown in dotted line) conceals a side of the patient's lower limb, and in particular, the lateral malleolus 71 of the patient's foot. As explained earlier, in particularly preferred embodiments, the orthosis 10 is used in the treating and/or prevention of pressure ulcers. In such embodiments, although the side of the orthosis 150 conceals the lateral malleolus 71 , the patient's ankle is suspended by the orthosis 10 such that the lateral malleolus 71 and in some cases, the calcaneus 72 is suspended in the air. As the lateral malleolus 71 and calcaneus 72 are two areas particularly prone to the development of pressure ulcers, the orthosis 10 of the present invention is particularly useful in the treatment and/or prevention of such pressure ulcers.

Figures 14 and 15 illustrate another embodiment of the orthosis 10 of the present invention, wherein the orientation means 40 and 50 take a different form. In these embodiments, the orientation means 40 and 50 do not contain a hollow portion 41 and 51 , but rather have a planar area 44 and 54 for cooperating with the surface 60. Figure

16 provides yet another embodiment of the orthosis 10, illustrating yet another different form of the orientation means 40 and 50.

Some preferred embodiments of the orthosis 10 are facilitated by having the second (and/or one or more other additional) orientation means 160 connected to the support 20 in a manner that allows relative movement of such second or other additional orientation means with respect to the support 20. In the embodiments depicted in figures

17 and 18, the second orientation means 160 is connected to the support 20 by means of a pivot defined by a slot 161 in the support 20 and a corresponding pivot arm 162 attached to the orientation means 160. This embodiment provides for the option to

move or adjust the position of the second orientation means 160 in order to facilitate orientating the relevant body part relative to the surface 60 into the desired position.

Figures 19A, B and C illustrate an embodiment of the orthosis 10 which is inflatable and deflatable. As shown in figure 19A, the orthosis 10 of this embodiment can be essentially flat when deflated. A fluid transferring means 170 provides the means through which air or liquid can be transferred into or out of the orthosis 10. Figure 19B is a perspective view of the inflatable orthosis 10 in an inflated state.

Figure 19C illustrates the inflatable orthosis 10 in an inflated state from an underside perspective view. As can been seen, embodiments of the orthosis 10 which are inflatable can incorporate a similar configuration for the orientation means 40 and 50 as illustrated in other preferred embodiments in some of the other figures. In some embodiments of the invention wherein the orthosis 10 is inflatable and deflatable, the orientation means 40 and 50 are preferably integral with the support 20 and inflate and/or deflate at or around the same time as the support 20. As will be appreciated by persons skilled in the art, in certain circumstances it might be desirable for the orthosis 10 to include at least one, and preferably a plurality, of apertures through which air and/or fluid can flow, thereby providing ventilation means for the body part wearing the orthosis. Figure 20 provides an illustration of an orthosis 10 according to one embodiment incorporating a plurality of such apertures 180. Figure 21 illustrates an embodiment of the invention incorporating straps 190 for securing or connecting the orthosis 10 to the relevant body part. Fitting straps 190 are preferably formed of velcro. However, anything capable of securing the orthosis to the relevant body part can be used.

Figures 21 and 22 illustrate alternative embodiments to the invention with alternative forms for the respective orientation means. In figure 22, the orientation means 200 and 210 have a sloping portion 201 and 211 and an outer ridge portion 202 and 212. The configuration of these orientation means enables objects to be received between the sloping portion 201 and 211 and outer ridge portion 202 and 212, or to receive uneven components of the surface 60 upon which the orthosis 10 is to rest. Figure 23 illustrates a yet still further alternative embodiment of the orthosis 10 of the present invention, providing for a variation of an earlier described embodiment of the orientation means, wherein orientation means 220 and 230 have substantially planar surfaces.

Figures 24, 25 and 26 illustrate various embodiments of the orthosis 10, having orientation means adapted so as to be able to receive an orientation member 240. As can be seen particularly in figures 24 and 25, the orientation member 240 can have a corresponding shape or corresponding shapes which enable it to be received by the orientation means or an appropriately shaped hollow portion in the base or underside of the support 20.

Figure 25, in particular, illustrates how the orientation member 240 could connect to, be received in, or engage with the orientation means in different ways.

Figure 26 is a perspective view illustrating an orientation member 240 about to be connected with the orthosis 10 being worn on the lower limb 70 of a patient. The orientation member 240 has a corresponding shape to the hollow portions 41 and 51 of the orientation means 40 and 50. The orientation member 240 in preferred embodiments, provides a further means of orientating the body relative to the surface 60. In some preferred embodiments, the orientation member 240 assists in preventing the support 20 from rotating when, for example, in contact with the surface 60. In other preferred embodiments, the orientation member 240 is used, for example, to immobilise or inhibit movement of a patient's lower limb 70 during, for example, hip and/or knee surgery.

In certain circumstances, it may also be desirable to secure an additional object to the support 20, such as, for example, a frame-like structure 250 for, for example, preventing bed sheets from coming into contact with an area of the body part. As illustrated in figures 27 to 29, some preferred embodiments of the orthosis 10 include object receiving means 260 connected to or integral with the support 20. Although as particularly illustrated in figures 28 and 29, the object receiving means 260 are preferably adapted to receive a frame-like structure 250, the object receiving means 260 of other preferred embodiments are adapted to receive any object which it may be desirable to bring into association with the orthosis 10, for example, an orthotic shoe.

As is well illustrated in figure 27, the object receiving means 260 of one preferred embodiment comprise a slot 261 formed integrally with the support 20. In embodiments wherein a frame-like structure 250 is to be received by the object receiving means 260, as illustrated in figures 28 and 29, the frame-like structure 250 slidably engages through the slot 261. In the embodiment depicted in figures 28 and 29, the frame-like structure 250 forms a substantially closed "ring" which surrounds the patient's foot.

The present invention also provides a sleeve assembly adapted to secure an orthosis 10 according to the invention to a body part. Figures 30 to 34 illustrate preferred embodiments of the sleeve assembly 110 according to preferred embodiments of the invention. The sleeve assembly 110 of preferred embodiments comprises an orthosis receiving segment and a body part receiving segment 130. Preferably, the two segments 120 and 130 are separated by a separating member. In some preferred embodiments the separating member is a sheet of material. In other embodiments, the sleeve assembly further includes one or more additional segments for receiving other objects, such as, for example, a soft or comforting underlay, inlay or overlay, or a soft piece of material that can be interposed between the orthosis receiving segment 120 and the body part receiving segment 130. The separating member 140 can comprise or receive one or more of those additional segments.

In one embodiment of the sleeve assembly 110, the separating member 140 comprises an additional sleeve for receiving the liner element 100. As is well illustrated in figure 30, the separating member 140 in the form of a sleeve has an upper layer 141 and a lower layer 142 peeled back to illustrate the liner element 100 or a soft or comfortable underlay, inlay, or overlay or soft piece of material, inserted into the separating member 140. In a preferred embodiment, the upper layer 141 and the lower layer 142 as sealed around their perimeters so that the liner element 100 or comfortable underlay, inlay, or overlay or soft piece of material is securely contained in the separating member 140.

The body part receiving segment 130 of one preferred embodiment is best illustrated in figure 33. In this particular embodiment of the sleeve assembly 110, the body part receiving segment 130 is opened at both ends. In other preferred embodiments, however, the body part receiving segment 130 may be closed at one end. In such embodiments, although the body part can be slid into the open end 131 of the body part receiving segment 130, it is inhibited from passing through the other end.

The orthosis receiving segment 120 is best illustrated in various embodiments in figures 31 and 32. The orthosis receiving segment 120 of some preferred embodiments is open at both ends as is well illustrated in figure 31. In another preferred embodiment, a portion of the orthosis receiving segment 120 has an aperture through which at least one orientation means can pass. In such embodiments, although the orthosis 10 is

received by the orthosis receiving segment 120, at least a portion of at least one of the orientation means 40 or 50 may not be covered by material.

In yet another preferred embodiment best illustrated in figure 32, the orthosis receiving segment 120 is comprised of an elastic material in the shape of a substantially oval shape or circular shaped wall 120. The wall is essentially comprised of bunched up elastic material which can be stretched over the orthosis 10 in a similar manner to which a shower cap is stretched over a head.

The illustration in figure 34 shows an orthosis 10 being worn on a lower limb 70 of a patient, having been secured or connected to the lower limb 70 by means of a sleeve assembly 110 of the present invention. As would be appreciated by persons skilled in the art, the embodiment depicted in figure 32 of the orthosis receiving segment 120 has been applied to the orthosis 10 by stretching it over the entire orthosis and the outer rim 122 represents an end of the bunched up material which (before having been stretched over the orthosis 10) comprised the substantially oval shaped wall 121. It would also be appreciated by those skilled in art that the orthosis receiving segment 120 illustrated in figure 34 could also be a variation of the orthosis receiving segment 120 illustrated best in figure 31 and incorporating an aperture through which at least one orientation means 40 or 50 can pass. As is well illustrated in figure 34, in such embodiments, the orthosis 10 is received by the orthosis receiving segment 120 by sliding the orthosis into the orthosis receiving segment 120 and then at least one of the orientation means 40 or 50 is not covered by the material.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.