WO2018064725A1

WO2018064725A1 - Improvements in or relating to prosthetics

Info

Publication number: WO2018064725A1
Application number: PCT/AU2017/051087
Authority: WO
Inventors: Timothy CHEGE; Anthony PETTERSON; Jess PUTTING
Original assignee: Ajkp Pty Ltd
Priority date: 2016-10-05
Filing date: 2017-10-05
Publication date: 2018-04-12

Abstract

A fairing (21) for a prosthetic limb (22) or other prosthetic body part is disclosed. The fairing (21) has attachment means (33) for adjustably or removably attaching the fairing (21) to a selected location on the prosthetic limb (22) or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing (21) and the prosthetic limb (22) or other prosthetic body part. A prosthesis (20) comprising a prosthetic limb (22) or other prosthetic body part having a fairing (21) is also disclosed.

Description

IMPROVEMENTS IN OR RELATING TO PROSTHETICS Technical Field

[0001 ] The present invention is directed to improvements in or relating to prosthetics, and to prosthetic housings or fairings for covering a prosthetic limb or other prosthetic body part. More particularly the invention is directed to improvements to housings or fairings for prostheses and to the relationship between the prosthetic limb or other prosthetic body part and the housing/fairing.

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] Limb absence or loss is an unfortunate fact of life for many people. It can result from a congenital condition, as an adverse consequence of a disease such as cancer or a bacterial infection, or from accident or misadventure such as an industrial, work or car accident, or war, requiring full or partial amputation of the limb in order to preserve life.

[0004] In a number of such cases, the decision to replace the lost or missing limb with a prosthesis is made with a view to assisting the patient to gain or to recover a degree of mobility or dexterity forfeited as a consequence of the lost or missing limb, and to thereby improve the quality of the patient's life.

[0005] Limb prostheses are designed to mimic or simulate the complex movement characteristics of a normal limb, and particularly those associated with joint movement or articulation such as an elbow, wrist, knee or ankle, but require individual crafting to reflect factors such as each patient's unique build, age and/or degree of physical activity or prowess, and to ensure compatibility with the part of the body to which the prosthesis is to be attached or with which it will interact. [0006] Examples of lower-extremity limb prostheses include trans-femoral prostheses, which replace a leg missing from above the knee, and trans-tibial prostheses, which replace a leg missing from below the knee.

[0007] Examples of upper-extremity limb prostheses include trans-humeral prostheses, which replace an arm missing from above the elbow, and trans-radial prostheses, which replace an arm missing from below the elbow.

[0008] From an aesthetic perspective, prostheses are intended to be primarily functional, and may contain various mechanical, electrical and/or electromechanical components - in their rawest state they do not generally look like a normal human limb or other body part, as there is no natural exoskeleton or cutaneous layer to contain or hide the endoskeleton or inner workings of the prosthesis.

[0009] To observe one in its raw state can be quite confronting to some people, and so as not to offend sensibilities, a wearer will generally cover the prosthesis with an item of clothing. That in itself can create difficulty, as the prosthesis does not have the shape or curvature of a normal limb, leading to the potential for catching of the clothing on part of the prosthesis, and/or giving the appearance of unshapely, unsightly or ill-fitting clothing.

[0010] These factors can compound the psychological and physical difficulty that the patient already faces as a result of limb absence, loss and replacement.

[001 1 ] Various techniques have been developed to improve the cosmetics or aesthetics of prostheses, including housings or fairings attachable to, or integral with the prosthesis, so as to mask the mechanism of the prosthesis and to simulate the appearance of a normal limb. Subject to cost considerations, these can be standardised devices, or they can be custom-made in order to render them more realistic having regard to the wearer's build, and to also personalise them taking into account wearer demographics and social preferences.

[0012] As alluded to in the foregoing discussion, one of the purposes of a prosthetic fairing is to improve the appearance of a prosthesis. Accordingly aesthetic considerations can assume almost as much importance as the functional characteristics of the prosthetic limb or other prosthetic body part itself. The fairing may also offer some protection from external factors to the prosthetic limb or other prosthetic body part to which it attaches.

[0013] Each prosthesis wearer has unique characteristics with regard to the size, shape and type of their prosthesis, and these factors can be taken into account when designing a fairing.

[0014] When such factors are taken into account, the fairing will typically be a customised variation of a standard fairing form.

[0015] In the case of attachable fairings or housings, it has been observed that the method of attachment, and the consequent behavioural characteristics of the housing or fairing, can be restrictive, alienating or discomforting for some users.

[0016] Other problems or disadvantages which may be associated with prior art fairings include: the time consuming need for tools such as screw drivers to secure fairings to prostheses or to secure fairing shells to each other, the use of parts which are not readily removable and replaceable when broken or worn, thereby requiring users to purchase new fairings or shells in their entirety rather than simply replacing broken or worn parts, and unwanted vibration or slippage of fairings when secured to prostheses.

[0017] The present invention aims to provide an alternative approach to housings or fairings for prostheses which is believed to be more suitable to a user's needs.

Summary of Invention

[0018] In the context of the present invention the terms 'fairing', 'housing', 'covering' and 'shell' or 'outer shell' are intended to be interchangeable, and the specification is accordingly to be read as such when one or other of those terms is used separately.

[0019] Also in the context of the present invention, the terms 'prosthesis', 'prosthetic limb', 'prosthetic body part' and 'limb replacement device' may be used interchangeably. Hence the term 'prosthesis' will in some instances refer in this specification to a limb replacement device alone having primarily functional characteristics, but it may also, depending on the context, refer to a composite structure comprising a limb replacement device and a fairing. [0020] The terms 'prosthetic limb' or 'prosthetic body part' as used in the present specification are intended to encompass both lower-extremity replacement devices, including above- and below-knee prosthetic legs and parts thereof, and upper- extremity replacement devices, including above- and below-elbow prosthetic arms and parts thereof.

[0021 ] In one aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for adjustably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0022] A prosthetic limb according to the invention will typically be a prosthetic leg, though other limb and body part replacements are envisaged as being within the scope of the invention.

[0023] In general terms, a below-knee or trans-tibial prosthetic leg typically comprises a central pylon which is often cylindrical in form and made from a rigid material such as a metallic material, a socket to interface with the stump of the lost or missing leg, and a prosthetic foot.

[0024] An above-knee or trans-femoral prosthetic leg will typically be formed by osseointegration between living bone of the upper part of the leg and a biocompatible upper part of the prosthesis such as an implantable pin to thereby anchor the bone to the prosthesis, or a socket in the same manner as trans-tibial prostheses however fitted at the upper part of the leg on the amputee stump. In both cases the prosthesis will generally in addition be composed of a mechanical or electromechanical joint to replicate knee function, a pylon, and a prosthetic foot.

[0025] A fairing according to the invention will typically be a rigid or semi-rigid outer shell, casing or covering, of a predetermined thickness and/or mass, for the prosthetic limb or other prosthetic body part, and shaped so as to substantially conform to the projected external shape of an anterior and/or posterior part of a missing limb or other missing body part of the prosthetic wearer. [0026] The fairing may be constructed from one or more components. A fairing will typically comprise an anterior component and a posterior component. In the case of a leg replacement, the anterior component will typically approximate the shape, form or contour of the front of a normal human leg or part thereof, whilst the posterior component will typically approximate the shape, form or contour of the rear of a normal human leg or part thereof. In the case of an arm replacement, the anterior component will typically approximate the shape, form or contour of the front of a normal human arm or part thereof, whilst the posterior component will typically approximate the shape, form or contour of the rear of a normal human arm or part thereof.

[0027] An advantage of constructing the fairing from more than one component relates to the ease of fitting the fairing to the prosthetic limb or other prosthetic body part, as it is generally impractical or otherwise physically impossible to slip a rigid structure over the end of a prosthetic limb and locate it. It is more practical to firstly fit one of the fairing components to the prosthetic limb or other prosthetic body part, and to then fit the other of the components to the prosthetic limb or other prosthetic body part.

[0028] The two components may in some embodiments be releasably hinged to one another, or be secured together by distal and/or proximal seams, or be secured together by fixing or attachment such as by screws or the like, or they may in situ simply closely abut one another, as is presently preferred.

[0029] Determining the projected external shape of an anterior or posterior part of a missing limb or other missing body part of a prosthetic wearer may take any suitable form. Typically it will involve an inspection of the intact limb if available, capturing the intact limb data (such as side and front profiles of the intact limb) by photography/photogrammetry and/or by 3D scanning, capturing prosthesis data using similar methods to obtain key parameters, and using the data obtained from photographic/photogrammetric analysis or 3D scanning of the prosthesis from one or more angles to convert that data to a 3D model/surface.

[0030] Once the 3D model/surface has been generated, the parameters of the fairing design can be, or are set, and the fairing shape can be produced. [0031 ] The shape of the fairing inner surface profile will typically be produced using the side and front profiles of the intact limb as a visual reference. A shape is thereby created that is an apt representation of the intact limb fitted to match matters such as the size and intricacies of the wearer's anatomical profile.

[0032] Horizontal cross-sections of a typical human limb can also be used to create a shape profile for the inner surface of the fairing. This outcome can be adjusted to ensure that there is no physiognomic clash with the prosthesis hardware, and that the shape marries in closely with the wearer's prosthesis socket at the top of the prosthesis and the foot shell at the bottom of the prosthesis. The 3D model/scan may be used as a visual guide in order to achieve this outcome.

[0033] When the work on the fairing's inner surface profile has been completed, the fairing is then typically allocated a thickness to accord with the overall fairing design.

[0034] The fairing may be constructed from any suitable material, although rigid plastics material(s) are presently preferred. The construction may be undertaken using any suitable means, such as by hot moulding, pressing, extrusion, or by 3D printing.

[0035] The projected external shape of an anterior or posterior part of a missing limb is typically generated from an inspection of the intact limb (where one such limb exists and is available for inspection). Due to the general symmetry of the human body, the projected external shape of the missing limb will typically be a mirror image of the intact limb.

[0036] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for adjustably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0037] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0038] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0039] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having a plurality of surfaces, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said plurality of surfaces by complementary attachment means carried by the fairing and the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0040] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having a plurality of surfaces, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said plurality of surfaces by complementary attachment means carried by the fairing and the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0041 ] As indicated above, the form of attachment selected will allow for a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, such as rotational movement about a horizontal and/or vertical axis, or a compressive movement of the fairing relative to the prosthetic limb or other prosthetic body part.

[0042] Permitting a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part is thought to allow for appropriate adjustable or removable attachment, fitting, fixing, securing, location or positioning of the fairing during an attachment, fitting, fixing, securing, locating or positioning phase, having regard to the structure of the prosthetic limb or other prosthetic body part and/or the wearer's anatomical and/or physical structure.

[0043] The allowable or permissible degree of movement may be during or post- attachment.

[0044] The present invention is thought to differ from the prior art, which has been observed to be restrictive in adapting to prosthesis adjustments that may be required from time to time, whether during or post-attachment, fitting, fixing, securing, locating or positioning of the fairing to or on the prosthetic limb or other prosthetic body part, or removing it therefrom.

[0045] The attachment means according to the present invention may take any suitable form, one of its purposes being to provide, in use, a strong, durable attachment between the fairing and the prosthetic limb whilst allowing for the abovementioned relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0046] In one embodiment of the invention the attachment means comprises at least one mounting assembly. The mounting assembly may take any suitable form. It may for example form part of one or both of anterior or posterior components of a fairing outer shell.

[0047] The mounting assembly may be interposed between anterior and posterior components of a fairing outer shell. The mounting assembly will preferably be such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0048] In a preferred embodiment the fairing and the prosthetic limb or other prosthetic body part carry complementary attachment means in the form of a mounting assembly having at least two components, one of which is a mounting component and the other of which is a securing component. [0049] A mounting component according to the invention will typically comprise a mounting member cooperable with the securing component. In one embodiment the mounting component is associated with or carried by the fairing. The mounting component will typically extend inwardly from an inner surface of the fairing, and may be integral with the fairing. The mounting component may include at least one inner face. The inner face may define a substantially continuous, inwardly extending surface. The inwardly extending surface may be downwardly extending. It may be upwardly extending. It may be conical or part-conical in form. It may comprise a cone or part-cone. The cone or part-cone may be concave or convex.

[0050] The inner face may in one typical embodiment be concave in shape and downwardly extending, or convex in shape and upwardly extending, or a combination thereof. The mounting component may in a preferred embodiment include a first inwardly, downwardly extending surface and a second inwardly, upwardly extending surface comprising, of themselves, a mounting member, or terminating in a mounting member. In one embodiment the inwardly extending surface comprises an arm.

[0051 ] The inner face of the mounting component may include a mounting member. The mounting member will typically project inwardly from the inner face of the mounting component. The mounting member may be in the form of a bracket or other similar mount. The mounting member may be apertured or recessed to receive a complementary member of the securing component.

[0052] In an embodiment where the fairing comprises an outer shell having an anterior component and a posterior component, each component may carry on its inner face at least one part-cone, the components when brought together forming at least one substantially continuous inner cone constituting one component (such as a mounting component) of the attachment means. The formation of a substantially continuous inner cone(s) is thought to aid the overall structural integrity of the fairing.

[0053] A securing component according to the invention will typically comprise a collar having a securing member cooperable with the mounting component. The collar will, in this embodiment, typically surround part of, and be secured to, the prosthetic limb or other prosthetic body part, such as the pylon of a prosthetic leg. [0054] The mounting member may in one embodiment comprise a socket of a ball- and-socket joint, with the securing component comprising the ball of the ball-and- socket joint, or vice versa.

[0055] Other mounting component-securing component arrangements are envisaged within the scope of the invention.

[0056] Attachment means according to the invention may, in one embodiment, comprise or include a damping or cushioning material. The damping or cushioning material may in one embodiment include a compressive or compressible material, such as a rubber material.

[0057] The attachment means may, in another embodiment, comprise or include a compressive or compressible material, such as a rubber material.

[0058] In an embodiment where the attachment means includes a damping, cushioning or compressive/compressible material, the damping or compressive/compressible material will typically be interposed between mounting and securing components of the attachment means.

[0059] Non-exhaustive examples of attachment means suitable in the practice of the invention include a ball-and-socket joint defined by complementary components carried by the fairing and the prosthetic limb or other prosthetic body part, a clamping mechanism to clamp the fairing and the prosthetic limb or other prosthetic body part to each other, an adhesive connection between those parts, screwing and/or riveting the fairing and the prosthetic limb or other prosthetic body part to each other, forming a snap-fit or interference-fit connection between complementary components of the fairing and the prosthetic limb or other prosthetic body part, fastening the fairing and the prosthetic limb or other prosthetic body part together by magnetism, forming a threaded connection between the fairing and the prosthetic limb or other prosthetic body part, and an over-centring latch mechanism.

[0060] A surface of a fairing according to the invention will typically be an inner or an outer surface. In a preferred embodiment the fairing comprises inner and outer surfaces. [0061 ] The outer surface of the fairing will typically be capable of bearing a pattern or ornamentation, either intrinsically applied to it during manufacture or applied to it post-manufacture. The pattern or ornament may be designed in consultation with the wearer so as to complement or accord with a wearer's individual tastes or preferences. The pattern or ornament will typically include a paint or its equivalent.

[0062] The outer surface may be apertured, recessed or otherwise configured to enable attachment means such as a screw or rivet to be passed from or through the outer surface of the fairing towards the prosthetic limb or other prosthetic body part so as to secure the fairing to the prosthetic limb or other prosthetic body part.

[0063] The inner surface of the fairing will typically be capable of carrying attachment means or a component thereof so as to secure the fairing to the prosthetic limb or other prosthetic body part.

[0064] Typically the attachment means will comprise primary and secondary attachment components in order to facilitate securing of the fairing to the prosthetic limb or other prosthetic body part. The primary attachment component will typically be the strong, durable attachment means described above, whilst the secondary attachment component will typically comprise a less constrained form of fixing relative to the primary attachment component.

[0065] Non-exhaustive examples of secondary attachment components include one or more straps, hook and loop fasteners, and banding, adapted to wrap around part of the prosthetic limb or other prosthetic body part, such as a limb socket. The strap(s) may be flexible, elastic or inelastic, and will typically be formed from textile cloth, rope, leather, plastic and/or metal. Alternatives to these arrangements include padding with compressive or compressible materials such as foam or rubber, and suspending offset via grub screws or other mechanical adjustable fixing means which may interface with part of the prosthetic limb or other prosthetic body part, such as a limb socket.

[0066] A selected location on the prosthetic limb or other prosthetic body part according to the invention will, in the case of a trans-tibial prosthetic leg, typically be on the pylon of the prosthetic leg. The precise location will typically be dictated by the construction of the prosthesis and by the patient's anatomy, and so as to avoid patient discomfort.

[0067] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing comprising anterior and posterior components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, and at least one mounting assembly interposed between the anterior and posterior components, the mounting assembly being such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, whereby to allow appropriate positioning of the fairing during an attachment or adjustment phase having regard to the structure of the prosthetic limb or other prosthetic body part and/or the wearer's anatomical and/or physical structure.

[0068] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing comprising anterior and posterior components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, and at least one mounting assembly interposed between the anterior and posterior components, the mounting assembly being such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, whereby to allow appropriate positioning of the fairing during an attachment or adjustment phase having regard to the structure of the prosthetic limb or other prosthetic body part and/or the wearer's anatomical and/or physical structure.

[0069] In one particularly preferred aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having an inner surface and an outer surface, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said surfaces by complementary attachment means comprising a mounting component and a securing component cooperable with the mounting component, the attachment being such as to secure the fairing to the prosthetic limb or other prosthetic body part but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0070] In another particularly preferred aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having an inner surface and an outer surface, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said surfaces by complementary attachment means comprising a mounting component and a securing component cooperable with the mounting component, the attachment being such as to secure the fairing to the prosthetic limb or other prosthetic body part but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0071 ] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment means being capable of manipulation by the application of finger pressure and without the need for intervention of a tool or other locating device.

[0072] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment means being capable of manipulation by the application of finger pressure and without the need for intervention of a tool or other locating device.

[0073] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment means being capable of manipulation by the application of finger pressure and without the need for intervention of a tool or other locating device, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part. [0074] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment means being capable of manipulation by the application of finger pressure and without the need for intervention of a tool or other locating device the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0075] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part .

[0076] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part by manual manipulation, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0077] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part without the intervention of a tool or other fixing device, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part .

[0078] In another suitable aspect, the invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part without the intervention of a tool or other fixing device, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

[0079] In another particular aspect, the invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing comprising anterior and posterior components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, and at least one mounting assembly interposed between the anterior and posterior components, the mounting assembly being such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, the fairing further comprising tool-free engagement members cooperatively disposed on the anterior and posterior components for releasably engaging the components by hand.

[0080] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing comprising anterior and posterior components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, and at least one mounting assembly interposed between the anterior and posterior components, the mounting assembly being such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, the fairing further comprising tool-free engagement members cooperatively disposed on the anterior and posterior components for releasably engaging the components by hand.

[0081 ] The term 'tool-free' as used herein is intended to encompass arrangements whereby an external tool or other fixing device is not required to enable a fairing to be removably or releasably attached to a prosthetic limb, such as a pylon, or other prosthetic body part.

[0082] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, the fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

[0083] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part by manual manipulation or without the intervention of a tool or other fixing, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, the fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

[0084] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation.

[0085] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part by manual manipulation.

[0086] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part without the intervention of a tool or other fixing device.

[0087] In another particular aspect, the invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part without the intervention of a tool or other fixing device. [0088] The attachment means may comprise or form a ball and socket joint. The ball and socket joint may allow relative rotational movement. The range of relative rotational movement available may be up to about thirty degrees. In a particular form, the range of rotation available is less than about twenty degrees. In another particular form, the range of rotation available is about fifteen degrees or less. In another particular form, the range of rotation available is about twelve degrees or less. The ball and socket joint may have one, two or three degrees of freedom. In a particular form, the ball and socket joint has three degrees of freedom.

[0089] The attachment means may comprise a fastening member. The fastening member may comprise the socket of the ball and socket joint. In a particular form, the fastening member is adapted to enclose, or close around, a portion of the prosthetic limb or other prosthetic body part. Thus, the attachment means may be adjustable by hand between a closed configuration wherein the fastener encloses, or is closed around, a portion of the prosthetic limb or other prosthetic body part, and an open configuration wherein the fastener does not enclose, or is opened away from, the portion of the prosthetic limb or other prosthetic body part. The fastening member may comprise a buckle. The fastening member may comprise a band. The fastening member or band may comprise a series of independently adjustable linkages.

[0090] The attachment means may comprise a collar adapted to at least partly surround a portion of the prosthetic limb or other body part. The collar may be an open collar defining a gap between its ends. The fastening member may be adapted to close around the gap. The collar may comprise the ball of the ball and socket joint. In an alternative embodiment, the portion of the prosthetic lib or other body part forms the ball of the ball and socket joint, with the socket being formed by the fastening member.

[0091 ] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing comprising first and second components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, at least one mounting assembly interposed between the first and second components, and engagement means for hand or tool-free engagement and release of the first and second components. The first and second components may be anterior and posterior components respectively.

[0092] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing comprising first and second components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, at least one mounting assembly interposed between the first and second components, and engagement means for hand or tool-free engagement and release of the first and second components. The first and second components may be anterior and posterior components respectively.

[0093] The engagement means may comprise oppositely charged magnets cooperatively disposed on the first and second components. Additionally or alternatively, the engagement means may comprise at least one hook and recess pair cooperatively disposed on the first and second components. The engagement means or components thereof, such as the hook or magnets in one or different embodiments, may be removable and replaceable.

[0094] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing comprising first and second components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, at least one mounting assembly interposed between the first and second components, and engagement means for releasably engaging the first and second components, and contact means for contacting parts of the prosthesis,.

[0095] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing comprising first and second components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, at least one mounting assembly interposed between the first and second components, and engagement means for releasably the engaging first and second components. The first and second components may be anterior and posterior components respectively. [0096] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation or without the intervention of a tool or other fixing device, the fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

[0097] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part by manual manipulation or without the intervention of a tool or other fixing device, the fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

[0098] In another aspect the present invention provides a fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation or without the intervention of a tool or other fixing device, the fairing further having at least one contact member for contacting the prosthetic limb or other prosthetic body part, thereby facilitating the stabilisation of or support for the fairing.

[0099] In another aspect the present invention provides a prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part by manual manipulation or without the intervention of a tool or other fixing device, the fairing further having at least one contact member for contacting the prosthetic limb or other prosthetic body part, thereby facilitating the stabilisation of or support for the fairing. Brief Description of the Drawings

[00100] Notwithstanding any other embodiments that may fall within the scope of the present invention, some embodiments of the present invention will now be described, by way of example only, with reference to the accompanying Figures, in which:

Figure 1 is a front elevation of the general structure of a typical prosthesis comprising a prosthetic limb and a fairing;

Figure 2 is a side elevation of the prosthesis of Figure 1 ;

Figure 3 is a three-quarter perspective view of the prosthesis of Figures 1 and 2;

Figure 4 is a side section view of a fairing having attachment means for a prosthetic limb according to one embodiment of the invention attached to a prosthetic limb;

Figure 5 is a top section view of the structure of Figure 4;

Figure 6 is a side section view of a fairing having attachment means for a prosthetic limb according to another embodiment of the invention;

Figure 7 is a top section view of the structure of Figure 6;

Figure 8 is a side section view of a fairing having attachment means for a prosthetic limb according to another embodiment of the invention;

Figure 9 is a top section view of the structure of Figure 8;

Figure 10 is a side section view of a fairing having attachment means for a prosthetic limb according to another embodiment of the invention;

Figure 1 1 is a top section view of the structure of Figure 10;

Figure 12 is a side section view of a fairing having attachment means for a prosthetic limb as shown in Figure 4, with an alternative form of secondary attachment to the socket of the prosthetic limb; Figure 13 is a top section view of the structure of Figure 12;

Figure 14 is a rear perspective view of a fairing having attachment means in the form of a mounting assembly according to one embodiment of the invention;

Figure 15 is a rear perspective view of a fairing having attachment means in the form of a mounting assembly according to another embodiment of the invention;

Figure 16 is a rear perspective view of a fairing having attachment means in the form of a mounting assembly according to another embodiment of the invention,

Figure 17 is a rear perspective view of a fairing having attachment means in the form of a mounting assembly according to another embodiment of the invention,

Figure 18 is a rear perspective view of an anterior component of a fairing having attachment means in the form of a mounting assembly according to another embodiment of the invention,

Figure 19 is a magnified perspective view of the attachment means of Figure 18 in a closed configuration,

Figure 20 is a magnified perspective view of the attachment means of Figure 18 in an open configuration,

Figure 21 is a magnified exploded perspective view of the attachment means of Figure 18;

Figure 22 is a side section view of the fairing of Figure 18 secured to a below-knee prosthetic limb;

Figure 23 is a top section view of the structure of Figure 22,

Figure 24 is a front section view of the attachment means of Figure 18 secured to a prosthetic limb,

Figure 25 is a front perspective view of an exemplary fairing suitable for application to an above-knee prosthesis,

Figure 26 is a rear perspective view of the fairing of Figure 25, Figure 27 is a rear perspective view of an anterior component of the fairing of Figure 25,

Figure 28 is a front perspective view of a posterior component of the fairing of Figure 25,

Figure 29 in an exploded view of Figure 28, and

Figure 30 is a side section view of the fairing of Figure 25 secured to an above-knee prosthetic limb.

Detailed Description of the Invention

[00101 ] Turning to the drawings, Figures 1 to 3 are schematics showing the general structure of a typical prosthesis 20 comprising, in the embodiment shown for illustrative purposes, a prosthetic limb 22 in the form of a trans-tibial prosthetic leg having a socket 3 for attachment to a leg stump, a pylon 4 (only partly shown) which is usually cylindrical in form and constructed from a rigid material such as a metallic material or from a rigid composite, and a prosthetic foot 1 1 . Prosthetic limb 22 is covered by fairing 21 having an anterior component 1 and a posterior component 2 sitting in close proximity to each other.

[00102] Although not specifically shown, it will be appreciated that the invention described herein is also applicable to other prosthetic body parts including non- exhaustively, trans-femoral prosthetic legs and parts thereof, and trans-humeral and trans-radial prosthetic arms and parts thereof.

[00103] It can be seen that fairing 21 generally assumes the form of the lower part of a normal human leg, the posterior component 2 adopting the shape of the calf region of the leg and anterior component 1 adopting the shape of the shin region of the leg, constituting thereby an outer shell formation.

[00104] Fairing 21 is a rigid structure, and its outer shell formation enables it to be manually positioned around the prosthetic limb 22 and then for anterior component 1 and posterior component 2 to be secured to prosthetic limb 22, thus forming a general shape which mimics that of the lower part of a normal human leg. [00105] Figures 4 and 5 show prosthesis 30 comprising fairing 31 and prosthetic limb 32 having a form of attachment between fairing 31 and prosthetic limb 32 according to one embodiment of the invention.

[00106] Prosthetic limb 32 is in the embodiment shown in the form of a prosthetic leg composed of socket 3 and pylon 4 attached to a lower part of socket 3. Attachment means 33 comprises, in the embodiment shown, a mounting assembly comprising downwardly extending concave part-cone 34a and upwardly extending convex part- cone 34b formed integrally with an inner surface of anterior fairing component 1 and projecting inwardly from the inner surface. Two-component collar 6 in the form of a clamp having components 6a and 6b secured to each other by fixings 6c, 6d such as screws surrounds pylon 4 of prosthetic limb 32, from one component 6a of which extends a projecting member in the form of a ball 7 of a ball-and-socket joint. As mentioned, part-cones 34a and 34b extend from an inner surface of fairing anterior component 1 and terminate in a mount in the form of a socket 35 which engages in a complementary fashion with ball 7 to provide a secure attachment between fairing 31 and prosthetic limb 32. By its spherical nature, ball 7 permits a degree of relative movement between the fairing anterior component 1 and prosthetic limb 32 about vertical and/or horizontal axes.

[00107] Secondary attachment component 5 (minus a strap, banding or similar fastener, not shown) positioned in an upper region of fairing anterior component 1 in the embodiment shown provides a less constrained form of attachment than described immediately above. The strap, banding or similar fastener is adapted to be wrapped around socket 3 or pylon 4. Posterior component 2 is then fixed via screws, magnets, snap-fit, rivets or other fixing means to anterior component 1 so as to facilitate a secondary attachment or fixing arrangement.

[00108] Figures 6 and 7 show prosthesis 40 comprising fairing 41 and prosthetic limb 42, and having a form of attachment between fairing 41 and prosthetic limb 42 according to another embodiment of the invention.

[00109] Prosthetic limb 42 is again in the form of a prosthetic leg composed of socket 3 and pylon 4 attached to a lower part of socket 3. Attachment means 43 comprises, in the embodiment shown, a mounting assembly having a two-component collar 6 in the form of a clamp surrounding pylon 4 of prosthetic limb 42 from which extends a mounting member in the form of flexible material 10. Part-cones 44a and 44b extend inwardly from an inner surface of fairing anterior component 1 and terminate in a mount in the form of an integral coupling 8 or mounting bracket which in turn couples a fixing in the form of a screw, pin or rivet 45 and in a complementary fashion with flexible material 8 to provide a secure attachment between fairing 41 and prosthetic limb 42. By its nature, the attachment arrangement of this embodiment permits a degree of relative compressive and rotational movement between the fairing anterior component 1 and prosthetic limb 42.

[001 10] Secondary attachment component 5 (minus a strap, banding or similar fastener, not shown) positioned in an upper region of fairing anterior component 1 is as described above.

[001 1 1 ] Figures 8 and 9 show prosthesis 50 having a form of attachment between fairing 51 and prosthetic limb 52 according to a further embodiment of the invention.

[001 12] Prosthetic limb 52 is also in the form of a prosthetic leg composed of socket 3 and pylon 4 attached to a lower part of socket 3. Attachment means 53 comprises, in the embodiment shown, a mounting assembly interposed between anterior and posterior components 1 , 2 and having an externally spherical collar 12 in the form of a flexible material composed of rubber, cloth, silicone, plastic or equivalent material surrounding pylon 4 of prosthetic limb 52 forming the ball component of a compressible ball-and-socket joint.

[001 13] Part-cones 54a and 54b extend inwardly from an inner surface of fairing anterior component 1 and terminate in a mount in the form of a rigid pad 55a which abuts spherical collar 12, whilst part-cones 54c and 54d extend inwardly from an inner surface of fairing posterior component 2 and terminate in a mount in the form of rigid pad 55b with a spherical inner face forming the socket of a ball-and-socket joint which also engages with spherical collar 12 to provide a secure attachment between fairing 51 and prosthetic limb 52. Pads 55a and 55b are affixed to one another via screws, pins, magnets, rivets, snap-fit, adhesive or other suitable fixing arrangement 13a, 13b. Part-cones 54a, 54b, 54c and 54d when brought together by the bringing together of anterior component 1 and posterior component 2 form a substantially continuous inner cone, which can aid the overall structural integrity of the fairing.

[001 14] By its nature, the attachment arrangement of this embodiment permits a degree of relative compressive and rotational movement between the fairing and the prosthetic limb.

[001 15] Secondary attachment component 5 (minus a strap, banding or similar fastener, not shown) positioned in an upper region of fairing anterior component 1 is again as described above.

[001 16] Figures 10 and 1 1 show prosthesis 60 having a form of attachment between fairing 61 and prosthetic limb 62 according to a further embodiment of the invention.

[001 17] Prosthetic limb 62 is also in the form of a prosthetic leg composed of socket 3 and pylon 4 attached to a lower part of socket 3. Attachment means 63 comprises, in the embodiment shown, a mounting assembly having a collar 14 in the form of a rigid spherical fixing comprising rigid pads 65a, 65b surrounding pylon 4 of prosthetic limb 62 secured by screws, pins, magnets, rivets, snap fit or the like forming the ball component of a ball-and-socket joint. Part-cones 64a and 64b extend inwardly from an inner surface of fairing anterior component 1 and terminate in a mount in the form of rigid internally spherical pad 66a which abuts collar 14. Part-cones 64c and 64d extend inwardly from an inner surface of fairing posterior component 2 and terminate in a securing component in the form of rigid internally spherical pad 66b which also abuts collar 14. Pad 66a is fixed to internally spherical pad 66b by screws, pins, magnets, rivets, snap-fit, adhesive or other suitable fixing arrangement 13 to form the socket of a ball-and-socket joint which engages with the ball that is collar 14 to provide a secure attachment between the fairing and its components and prosthetic limb 62. Part-cones 64a, 64b, 64c and 64d when brought together by the bringing together of anterior component 1 and posterior component 2 form a substantially continuous inner cone, which can aid the overall structural integrity of the fairing. By its nature, the attachment arrangement of this embodiment permits a degree of relative rotational movement between the fairing and the prosthetic limb. [001 18] Secondary attachment component 5 (minus a strap, banding or similar fastener, not shown) positioned in an upper region of fairing anterior component 1 is again as described above.

[001 19] Figures 12 and 13 show an alternative form of secondary attachment of fairing 31 to socket 3. Upper parts of anterior component 1 and posterior component 2 are secured to socket 3 of prosthetic limb 32 by a plurality of circumferentially located grub screws 80, 81 , 82 and 83. The grub screws can be adjusted in an inward or outward direction to give an adjustable yet fixed or flexible positioning of the fairing components 1 ,2 relative to socket 3, thereby providing a less constrained form of attachment as compared to the primary attachment mechanisms described herein.

[00120] Turning to Figure 14, fairing 1 is illustrated having an anterior outer shell and a means of attachment to a prosthetic limb or other prosthetic body part (not shown). It will be appreciated that whilst the embodiment described refers to an anterior outer shell, the description can apply equally to a posterior outer shell having such components.

[00121 ] The means of attachment in this embodiment is in the form of a mounting assembly 100 having a mounting component 101 and a securing component 102. Mounting component 101 in the embodiment shown comprises upper and lower part- cones 101 a, 101 b (only one of which is clearly shown) terminating in mounting bracket 103. Securing component 102 comprises a two-component clamp 104, 105 adapted to surround a prosthetic limb pylon (not shown), the two components 104, 105 being secured to each other by screws, rivets, pins or the like passing through apertures 105 a, 105b. Damping or compressive material 1 15 in the form of a rubber seat is located on an inner face of clamp component 104 to permit a degree of cushioning, or compressive movement of the fairing relative to the prosthetic limb.

[00122] Attachment points 106, 107, 108, 109 are provided to facilitate attachment of anterior component 1 to posterior component 2 (not shown).

[00123] Apertures 1 10, 1 1 1 , 1 12 are capable of receiving secondary attachment means in the form of a strap, band or equivalent which is passed therethrough and then wrapped around the socket or pylon of the prosthetic limb. [00124] Figure 15 shows an alternative means of attachment of fairing 1 in the form of an anterior outer shell to a prosthetic limb or other prosthetic body part (also not shown).

[00125] It will again be appreciated that whilst the embodiment described refers to an anterior outer shell, the description can apply equally to a posterior outer shell having such components.

[00126] The means of attachment in this embodiment is in the form of a mounting assembly 200 intended to be interposed between anterior and posterior fairing components and having a mounting component 201 and a securing component 202. Mounting component 201 in the embodiment shown comprises upper and lower part- cones 201 a, 201 b (only one of which is clearly shown) terminating in recessed mounting bracket 203. Securing component 202 comprises a spherical collar adapted to surround a prosthetic limb pylon (not shown) and nest in mounting bracket 203 to form the ball of a ball-and-socket joint.

[00127] A complementary mounting component (not shown) carried by a posterior fairing component aids in forming the socket of the ball-and-socket joint and in securing the components of the mounting assembly 200 together when the anterior and posterior components are brought into proximity with each other.

[00128] Figure 16 shows another alternative means of attachment of fairing 1 in the form of an anterior outer shell to a prosthetic limb or other prosthetic body part (also not shown).

[00129] It will again be appreciated that whilst the embodiment described refers to an anterior outer shell, the description can apply equally to a posterior outer shell having such components.

[00130] The means of attachment in this embodiment is in the form of a mounting assembly 300 intended to be interposed between anterior and posterior fairing components and having a mounting component 301 and a securing component 302. Mounting component 301 in the embodiment shown comprises upper and lower part- cones 301 a, 301 b (only one of which is clearly shown) terminating in recessed mounting bracket 303. Securing component 302 comprises a collar in the form of a rigid spherical fixing comprising rigid pads surrounding the pylon of a prosthetic limb and secured by screws, pins, magnets, rivets, snap fit or the like, forming the ball component of a ball-and-socket joint.

[00131 ] A complementary mounting component (not shown) carried by a posterior fairing component aids in forming the socket of the ball-and-socket joint and in securing the components of the mounting assembly 300 together when the anterior and posterior components are brought into proximity with each other.

[00132] Figure 17 shows another alternative means of attachment of fairing 1 in the form of an anterior outer shell to a prosthetic limb or other prosthetic body part (also not shown).

[00133] It will again be appreciated that whilst the embodiment described refers to an anterior outer shell, the description can apply equally to a posterior outer shell having such components.

[00134] The means of attachment in this embodiment is in the form of a mounting assembly 400 intended to be interposed between anterior and posterior fairing components and having a mounting component 401 and a securing component 402. Mounting component 401 in the embodiment shown comprises upper part-cone 401 a terminating in mounting member 403. Securing component 402 comprises a two-component clamp 404, 405 adapted to surround a prosthetic limb pylon (not shown), the two components 404, 405 being secured to each other by screws, rivets, pins or the like passing through apertures 405a, 405b. Channels 410, 41 1 positioned on an upper part of the inner surface of fairing 1 are capable of receiving secondary attachment means in the form of a strap, band or equivalent fed therethrough and then wrapped around the socket or pylon of the prosthetic limb. The arrangements of the foregoing embodiments are thought to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, particularly during an attachment or adjustment phase.

[00135] Turning now to Figure 18, there is shown an another exemplary fairing 500 having an anterior component or outer shell 510 and a posterior component or outer shell (570 - shown in Figures 22 and 23). Anterior shell 510 is shown to comprise means of attachment to a prosthetic limb or other prosthetic body part (572 - shown in Figures 22 and 23), means of engagement with a corresponding posterior outer shell, and padding. It will be appreciated that whilst the embodiment described refers to an anterior outer shell, the description can equally apply to a posterior outer shell having such components.

[00136] The padding in this embodiment comprises generally rectangular shaped pads 524, 526 of compressive or compressible material positioned on an upper part of the inner surface of fairing 510. Pads 524, 526 are adapted to form a cushioned interface between anterior shell 510 and prosthesis 572.

[00137] The shell engagement means in this embodiment comprises a pair of upper engagement portions 528 located above the attachment means and a pair of lower engagement portions 530 located beneath the attachment means. Each of the pairs 528, 530 is disposed towards a posterior edge of shell 510.

[00138] Upper engagement portions 528 each comprise a rectangular recess 532 adapted for receipt of corresponding hooks of the posterior shell (not shown), thereby connecting the anterior and posterior shells. It is envisaged in some embodiments that the hooks of a posterior shell will be removable and replaceable.

[00139] Directly beneath its recess 532, each upper engagement portion further comprises a circular magnet adapted for attracting and abbutingly engaging a corresponding opposite polarity magnet (not shown) of the posterior shell 570. Similarly, each lower engagement portion comprises a circular magnet adapted for attracting and abbutingly engaging a corresponding opposite polarity magnet (not shown) of the posterior shell 570.

[00140] In this embodiment, the engagement portions 528, 530 use magnetism, and hook and recess mating, for tool-free engagement of anterior and posterior shells. However, it is envisaged that other means of engagement may be used, such as guide pins, screws, snaps or any other suitable fixings which engage with partner fixings on the opposite shell.

[00141 ] In this embodiment, the means of attachment to a part of the prosthesis are in the form of a mounting assembly 512 having a mounting component 514 and a securing component 516 . [00142] As shown in more detail in Figures 19 to 21 , mounting component 514 comprises upper and lower part-cones 518a, 518b terminating in mounting bracket 520. Defined centrally in upper part cone 518a is a vertically oriented recess 538 which opens into the roof of mounting bracket 520. Similarly, defined centrally in lower part cone 518b is a vertically oriented lower recess 540 which opens into the floor of mounting bracket 520 and vertically aligns with upper recess 540.

[00143] Securing component 516 comprises a ball-and-socket collar fastener which is mounted in bracket 520 and adapted to surround and hold the prosthetic limb pylon 4 (see Figures 22 and 23). Collar fastener comprises a ball portion comprising an open circular collar piece 534 in the form of a flexible material composed of rubber, cloth, silicone, plastic or equivalent material. In this embodiment, the open collar piece 534 defines a gap 576 between its ends posteriorly.

[00144] Open collar piece 534 has a convex outer surface 556 and a flat inner surface 554 for correspondence with a flat tubular shaped pylon 4. A pair of lugs 558 with enlarged heads 559 projects out horizontally from opposite sides of the convex outer surface 556.

[00145] The open collar piece is adapted to at least partially surround and grip a pylon of a prosthetic limb, and forms an inner ball component of a compressible ball- and-socket joint formed by the collar fastener.

[00146] Collar fastener further comprises an adjustable collar member 536 having a concave inner surface 578 which corresponds with the convex outer surface 556 of open collar piece 534. Thus, adjustable collar member 536 acts as an outer socket component of the ball and socket joint.

[00147] Collar member 536 is adjustable between an open configuration, as shown in Figure 20, and a closed configuration, as shown in Figure 19. Thus, the collar member 536 is adapted to close around the rear aspect of open collar piece 534 and gap 576, thereby surrounding the pylon and compressing the collar piece thereagainst (see Figures 22 and 23).

[00148] Collar member 536 comprises a stationary semi-circular mounting piece 542, and a fastening member in the form of first, second and third adjustable linkages 544, 546, 548 which enable opening and closing of the collar member 536. Defined anteriorly in the mounting piece 542 is an internally threaded mounting recess 550 which vertically corresponds with upper and lower recesses 538, 540 of the mounting bracket 520. An externally threaded bolt 521 extends through vertically aligned recesses 538, 550, and optionally 540, thereby securely nesting mounting piece 542 in mounting bracket 520. It is envisaged that other removable fixings may be utilised to secure mounting piece in the mounting bracket. In other versions still, it is envisaged that the mounting piece may be permanently secured to or integrally formed with the mounting bracket or some aspect of the anterior or posterior shell.

[00149] Right and left oval shaped holes 560 are defined in opposite sides of the mounting piece 542 for receipt therethrough of respective lugs 558 of collar piece 534, thereby engaging mounting piece 542 and collar piece 534 with some play. Further, a grid 564 of diagonal criss-cross configuration is provided on the inner surface of mounting piece 542 and linkage 546 in order to limit slipping and sliding on the open collar piece 534.

[00150] Located at posterior ends of the mounting piece 542 and anterior and/or posterior ends of the linkages 544, 546, 548, are tubular shaped connecting members 562. When aligned one above the other with bolts 566 passing therethrough, the connecting members 562 provide rotatable connections between adjacent first and third linkages and between the mounting piece and adjacent first and second linkages, thereby enabling individual linkage adjustment within the overall opening and closing adjustment of the fastening member / collar member 536.

[00151 ] Third linkage 548 forms a buckle which is adapted to clasp on to lug 568 projecting from the outer surface of second linkage 546, thereby releasably locking the collar fastener in the closed position. As is evident, this locking arrangement is designed for easy fastening and unfastening of the collar fastener by hand, without the use of tools such as a screw driver, thereby enabling easy and efficient application and removal of fairings to and from the prosthesis.

[00152] Figures 22 and 23 illustrate attachment of anterior shell 510 of fairing 500 to a prosthetic limb 572 in the form of a prosthetic leg composed of socket 3 and pylon 4 attached to a lower part of socket 3. As shown, collar piece 534 surrounds roughly the anterior three quarters of pylon 4, and the linkages 544, 546, 548 close behind pylon 4 and collar piece 534, thereby compressing collar piece 534 and securing fairing 500 to prosthetic limb 572. Although the connection itself is not apparent in these figures, anterior shell 510 is also magnetically and hookingly engaged with posterior shell 570 via upper and lower engagement portions 528, 530.

[00153] Referring now to Figure 24, correspondence of concave inner surfaces of the mounting piece 542 and linkage 546 with convex outer surface 556 of open collar piece 534, along with play between lugs 558 and holes 560, permits a degree of relative compressive and rotational movement between the fairing and the prosthetic limb. In this particular example, the ball and socket joint permits rotation of around twelve degrees nominally (as indicated by arrow 574) from true to pylon in all directions, although it is envisaged that different ranges of movement and/or degrees of freedom will be available in alternatives forms.

[00154] Referring now to Figures 25 and 26, there is shown another exemplary fairing, generally designated 600, having first and second corresponding components 610, 612 suitable for attachment to an above-knee prosthesis (662 in Figure 30). Whilst the first and second components 610, 612 are respectively anterior and posterior components in this instance, it is to be appreciated for all described embodiments that other component arrangements may be utilised, such as arrangements instead involving left and right components, or additional components, without departing from the scope of the invention. It is to be further appreciated that description of components of the first or anterior shell may equally apply to components of the second or posterior shell in alternative embodiments, and vice versa.

[00155] Figure 27 shows the anterior component or shell 610 of fairing 600. Anterior component 610 comprises a means of attachment to a prosthetic limb or other prosthetic body part in the form of a mounting assembly 614 having a mounting component 616 and a securing component 618. Mounting assembly 614 shares the same features as mounting assembly 512 of the previous embodiment as described above. [00156] Anterior component 610 further comprises engagement means embodied as a pair of right and left upper tabs 620, and a pair of right and left lower tabs 622, positioned at rear edges of the shell 610. Each tab comprises a recess 624 and magnet 626. In other embodiments it is envisaged that lower tabs 622 may be similar to 530 in figure 18, consisting of magnets only.

[00157] Contact means for stabilising or supporting fairing 600 are provided as various forms of contact members, each having a projecting portion with a contacting portion at an inner end thereof. One form of contact member comprises a kneeling support 628 positioned in the midline towards the top of anterior component 610. Kneeling support 628 comprises a cushioning pad 630 mounted on a bracing member 631 (see also Figure 30) having a series of braces extending inwardly from the inner aspect of anterior component 610. Kneeling support 628 provides structural support to anterior component 610 when the user is kneeling. Further, kneeling support 628 may reduce user discomfort by cushioning weight beared during kneeling, and may help to stabilise anterior component 610 with respect the prosthesis.

[00158] In another form, the contact means comprises a pair of left and right side contacting members 632 located about midway down anterior component 610, towards respective left and right posterior edges. The side contacting members each comprise an inwardly projecting pillar 634 with a cushioned head 636 at the inner end thereof.

[00159] Referring now to Figures 28 and 29, there is shown posterior component 612 of fairing 600. Posterior component 612 is shorter than anterior component 610 and includes a U-shaped recess 650 at its top end to limit blocking or impaction of the prosthesis during end-range knee flexion.

[00160] Posterior component 612 comprises engagement means embodied as a pair of right and left upper tabs 638, and a pair of right and left lower tabs 640, positioned at front edges of the shell 612. Each tab comprises a hook 642 adapted for engagement with the corresponding recess 624 of anterior shell 610 when upper and lower tabs 620, 622 of the anterior shell are aligned with upper and lower tabs 638, 640 of the posterior shell. [00161 ] Each tab 638, 640 further comprises a magnet of opposite polarity to its corresponding magnet 626 in the anterior shell 610 when anterior and posterior shells 610, 612 are aligned. In this embodiment, hooks 642 are fixed within tabs 638, 640 by use of screws 646, thereby making them easily fixed and easily removable. Such an arrangement enables replacement of broken hooks without the need to replace an entire shell or fairing. Magnets 626, 644 are also easily removable and replaceable in this embodiment.

[00162] Posterior component 612 further comprises contact means in the form of a stabilising member 648 having inwardly directed upper and lower part cones 652, 654. Part cones 652, 654 meet anteriorly with an elastic but resilient U-shaped bracket 656, at the front of which is mounted a C-shaped cupping bracket 658. A cushioning pad 660 is adhered to the anterior inner surface of the cupping bracket 658 (shown figure 30), which cushion 660 contacts a rear portion of the prosthesis in use. The stabilising member is adapted to stabilise and limit vibration or rattling of the posterior component 648 with respect to the prosthesis.

[00163] Figure 30 shows fairing 600 in use, secured to an above-knee prosthesis 662. Prosthesis 662 has a socket 664 for attachment to a thigh stump, an upper knee joint portion 666 extending beneath the socket, a lower knee joint portion 668, the upper end of which articulates with the upper knee joint portion 666 to form a knee joint 670, a cylindrical pylon 672 (only partly shown) extending beneath the lower knee joint portion 668, and a prosthetic foot (not shown).

[00164] In applying fairing 600 to prosthesis 662, mounting assembly 614 of anterior component 610 is secured to pylon 672, following which posterior component 612 is aligned with anterior component 610 and magnetically and hookingly engaged. With components engaged, kneeling member 628 contacts prosthetic knee anteriorly, stabilising member 648 contacts prosthetic knee posteriorly, and side contacting members 632 also contact the prosthetic knee, but more towards left and right sides. Thus, fairing 600 is stably and securely attached with prosthesis 662, whilst still permitting a degree of rotational movement about pylon 672. Description of Method for Constructing Fairing

[00165] A presently preferred method for constructing a fairing according to the invention is as follows:

Capturing patient data, prosthesis and intact leg

[00166] The end user or their prosthetist is asked to supply the following information:

(a) Photographs of the intact leg, from the front and from the side, with a tape measure present to provide scale

(b) Photographs of the prosthesis from the front and from the side, with a tape measure present to provide scale

(c) Some key dimensions of the prosthesis and intact limb for reference

(d) One of a 3D scan of the prosthesis or a series of photos of the prosthesis from various angles which can be converted to a 3D model/surface using a 3D graphics software

(e) Any personalised aspects of the fairing that the user requires, such as a desired pattern or ornamentation, the colour of the fairing, and/or the level of fairing flexibility desired, i.e. whether the user prefers a rigid structure or a degree of structural flexibility

(f) 3D scans of the intact leg may be used as part of the data generating process.

3D Design models

[00167] The user has a variety of 3D patterns and colours that it may choose from. Based on their design choices, the personalised/customised fairing will be generated as follows. Importing the captured information

[00168] Using 3D CAD design software, the 3D model/surface of the prosthesis is incorporated into a design file (with or without the front and side profile photos of the intact leg). This sets the design parameters for the fairing.

The Design Process

[00169] CAD design software is now employed so that the internal fixings of the fairing design will interface with the prosthesis. For this the imported data is used as a guide, a model of the key prosthesis parts is generated and those are positioned into the prosthesis assembly and fixed.

[00170] The fairing outer profile (or inner profile in an alternative embodiment) is then shaped using the front and side profiles of the intact leg as a visual reference. In this way a shape is created that is a good representation of the form of the intact leg, best fit to match the size and intricacies of the wearer's anatomical profile.

[00171 ] To make the shape similar to a leg using only the front and side profiles, numerous horizontal cross-sections typical of human leg form, running from the bottom of the foot to the top of the leg, are used.

[00172] This outcome is then adjusted as required to ensure there is no clash with the prosthesis hardware, and so that the top shape marries in closely with the wearer's prosthesis socket at the top, and foot shell at the bottom. This is done by using the 3D model/scan of the prosthesis as a visual guide.

[00173] Once the outer profile is complete (or inner profile in an alternative embodiment), it is then given thickness in accordance with the particular design parameters of the fairing. Manufacture and Finish of the Fairing

[00174] The design file is exported as a 3D printable file and the fairing is 3D printed. Depending on the fairing choice, the print may be in, non-exhaustively, nylon, glass filled nylon, ABS, simulated polypropylene, a bio-compatible photopolymer, or functional or chemical equivalents to any one or more of these.

[00175] The print technology may include Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), Polyjet, or Stereolithography (SLA). The fairing is then subjected to a finishing process that may involve surface preparations such as sanding, brushing, washing, priming, and/or cleaning. Colouring can then be applied, which may include painting, dying, staining, or coating. The fairing may also include finishing such as a clear coat or a matte finish depending on personal taste.

[00176] In view of the foregoing, the present invention is thought to provide a useful advance to the prosthetic art.

Alterations and Modifications to the Embodiments

[00177] Various additions, modifications and substitutions regarding design and construction can be made without departing from the spirit and scope of the invention.

[00178] Modifications and variations such as would be apparent to the skilled addressee are considered to be within the scope of the present invention. The present invention is accordingly not to be limited in scope by any of the specific embodiments described herein as these embodiments are intended for the purpose of exemplification only. Functionally equivalent products, constructions and methods are clearly within the scope of the invention as described herein.

[00179] Reference to positional descriptions, such as lower and upper, are to be taken in context of the embodiments depicted in the figures, and are not to be taken as limiting the invention to the literal interpretation of the term but rather as would be understood by the skilled addressee.

[00180] 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.

Claims

CLAIMS:

1 . A fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for adjustably or removably attaching the fairing to a selected location on the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

2. A fairing for a prosthetic limb or other prosthetic body part, the fairing having a plurality of surfaces, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said plurality of surfaces by complementary attachment means carried by the fairing and the prosthetic limb or other prosthetic body part, the attachment being such as to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

3. A fairing according to claim 2, wherein said plurality of surfaces comprises an inner surface and an outer surface, the fairing being attachable to a selected location on the prosthetic limb or other prosthetic body part by or through at least one of said surfaces by complementary two-component attachment means comprising a mounting component and a securing component cooperable with the mounting component, the attachment being such as to secure the fairing to the prosthetic limb or other prosthetic body part but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part.

4. A fairing for a prosthetic limb or other prosthetic body part, the fairing comprising anterior and posterior components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, and at least one mounting assembly interposed between the anterior and posterior components, the mounting assembly being such as to facilitate attachment of the fairing to the prosthetic limb or other prosthetic body part at a selected location but to permit a degree of relative movement between the fairing and the prosthetic limb or other prosthetic body part, whereby to allow appropriate positioning of the fairing during an attachment or adjustment phase having regard to the structure of the prosthetic limb or other prosthetic body part and/or the wearer's anatomical and/or physical structure.

5. A fairing according to any preceding claim, wherein the attachment means is capable of manual manipulation such as by the application of finger pressure and without the need for intervention of a tool or other fixing or locating device.

6. A fairing according to claim 4 or claim 5, and further comprising tool-free engagement members cooperatively disposed on the anterior and posterior components for releasably engaging the components by hand.

7. A fairing according to any preceding claim, said fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

8. A fairing according to any preceding claim, wherein said relative movement between the fairing and the prosthetic limb or other prosthetic body part comprises rotational movement about a horizontal and/or vertical axis and/or a compressive movement of the fairing relative to the prosthetic limb or other prosthetic body part.

9. A fairing according to any preceding claim, and further including secondary attachment means to facilitate securing of the fairing to the prosthetic limb or other prosthetic body part.

10. A fairing for a prosthetic limb or other prosthetic body part, the fairing comprising first and second components capable in situ of being located in close proximity to each other around the prosthetic limb or other prosthetic body part, at least one mounting assembly interposed between the first and second components, and engagement means for hand or tool-free engagement and release of the first and second components.

1 1 . A fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation, the fairing further having contact means adapted to contact the prosthetic limb or other prosthetic body part so as to limit vibration of the fairing, or structurally support or cushion the fairing when bearing weight thereon.

12. A fairing for a prosthetic limb or other prosthetic body part, the fairing having attachment means comprising for removably attaching the fairing to a selected location on the prosthetic limb or prosthetic body part by manual manipulation, the fairing further having at least one contact member for contacting the prosthetic limb or other prosthetic body part, thereby facilitating the stabilisation of or support for the fairing.

13. A prosthesis comprising a prosthetic limb or other prosthetic body part and a fairing, the fairing being as claimed in any preceding claim.

14. A fairing or prosthesis according to any preceding claim, wherein the prosthetic limb is a prosthetic leg.

15. A fairing or prosthesis according to claim 14, wherein the prosthetic leg comprises a pylon and a socket to interface with the stump of the missing leg.

16. A fairing or prosthesis according to any one of claims 1 to 13, wherein the prosthetic limb is a prosthetic arm.

17. A fairing or prosthesis according to claim 16, wherein the prosthetic arm comprises a pylon and a socket to interface with the stump of the missing arm.