Patent Grant
10524534
This application is a National Phase filing under 35 U.S.C. § 371 of PCT/AU2014/050242 filed on Sep. 19, 2014. The entire contents of this application are hereby incorporated by reference.
The present invention relates to orthotics for the feet, also known as innersoles, which are generally planar shaped supports that are correctively shaped and which are worn inside shoes functioning to correct defects in the stance of the user or patient.
The traditional methods of making such orthotics involve the taking of a plaster cast of the patient's foot such as set out in U.S. Pat. No. 7,125,509 to the present inventor, which exemplify this art. Once the plaster cast has been made, a replica of the underside of the foot is fabricated and the final plaster orthotic is moulded onto that replica.
In particular, the abovementioned patent describes how the stance of the patient's foot can be corrected whilst the patient is bearing his or her own weight so as to correct inherent defects and thereby ensure that the cast is taken whilst the patient's foot is in the corrected position. This is because the foot alignment is physically manipulated from which position an orthotic for a corrected stance is advantageously provided.
It is also known to create an orthotic mould directly from the patient's foot with the moulding process being conducted whilst the patient is either lying down or sitting down. In either of these two positions no effort is made to correct the stance defects of the patient. Thus the practitioner is required to make an educated guess or apply some other method of determining how the orthotics should be further shaped so as to overcome any stance defects of the patient.
A recently developed method for producing a foot orthotic involves the use of either a pressure sensitive standing platform that typically takes the form of a deformable or pressure-sensitive mat having very many spaced sensors disposed in a two-dimensional array below the surface of or under the mat. With a patient standing on the mat, a map of the pressure exerted by the surface of the foot is provided. This image is then utilised to produce a three-dimensional model purporting to capture the shape of the foot and this image is then manipulated to attempt to account for a preferred shape or pressure map which would be corrective once the foot is bearing weight. This model can then be used to manufacture an orthotic by various means.
Whilst orthotics made by this method may provide some correction to a patient, they can only estimate the necessary corrective function. This is because the orthotic is formed from an image obtained by the patient standing on the mat without re-alignment to a corrected position. As such, the model is not obtained from a foot where force has actually been applied to realign it and place it into a more functional position and change the stresses placed on the foot due to misalignment. The use of 3-D laser scanning in place of pressure sensors has also become known. However, this method suffers the same defect as using pressure sensors. In each case, the apparatus required is relatively expensive.
The genesis of the present invention is a desire to provide a castless stance corrected prosthetic and method of forming same which enables the orthotic to be moulded directly from the patient's foot whilst the stance of the patient is corrected.
According to a first aspect of the invention there is provided a method of forming a castless orthotic for a patient's foot in need thereof, the method comprising the steps of:
According to another aspect of the invention there is provided a foot orthotic support arrangement comprising:
It can therefore be seen that there is advantageously provided a reliable and reproducible method to accurately produce foot orthotics. Further, the apparatus includes foot support elements that have bladders or other actuators integrated to allow ‘remote’ correction of a foot by means, for example, of a simple valve and air pump. The method and apparatus also allow a faster orthotic production process without compromising accuracy of foot correction. Most advantageously, a patient can walk or otherwise be mobile to practically permit corrections to be made consequently.
Preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:
In the preferred embodiment, a support platform 100 for use in making a foot orthotic according to the preferred embodiments is shown in
The standing support platform 100 is provided for a patient to stand on whilst the clinician forms the orthotics 20. Foot foams 1 are supported by fore foot and heel foot supports 300 & 200 as below. The support platform 100 includes a base frame 101 on which horizontal surface 106 is disposed. The frame 101 also supports heel support mechanisms 200 and the surface 106 supports forefoot support mechanisms 300.
The support platform 100 also includes a vertical frame 103 extending a predetermined height above surface 106. At a top end, a handle 104 for patients to grip for stability is provided. Handgrips 105 are disposed on the handle for convenience. Of particular utility, a mirror 107 is mounted across part of the vertical frame 103. This most advantageously allows a practitioner to see the front of a patient's legs when operating from behind the patient and heel supports 200, or from the sides. The alignment of the front of the knee, ankle and foot can clearly be seen by viewing the mirror between the legs.
Each heel support 200 is mounted on independent pillars 108. The pillars 108 are able to be independently moved vertically by means of a threaded adjustment rod (not illustrated) and can be moved towards or away from each other to suit the width and angle of the patient's stance. This is achieved by means of a winding screw to which at least one of the pillars 108 is threadedly engaged. Handle 116 is disposed on the side of the platform 100. Rotation of the handle 116 causes corresponding movement of the pillars toward or away from each other. It will be appreciated that the vertical height adjustment of the pillars 108 is preferred and not essential.
Turning now to
This causes corresponding movement of the heel supporting surface 201. This is engaged with a slot 110 in an upper face of each pillar 108 by means of a curved rib 206. A lower centre projection 207 is also preferably provided. A gear 208 having a plurality of teeth 209 is disposed at the boundary of the supporting surface 201 and the curved rib 206. An outer support 302 is used to support the inside of a foot as required.
In use, the knob 205 is rotated and this causes corresponding rotation of the heel support surface 201 perpendicular to the longitudinal axis of the foot. Not only does the heel support 201 rotate, the engagement with the slot 110 allows it to translate along the slot 110 correspondingly.
Referring now to
This rolling effect is provided by arm 303 extending from the platform 301 and being threadedly engaged with adjustment rod 309. A nut 308 is hingedly mounted to a threaded shaft 304. The nut 307 allows the platform 301 to roll along curved bearing surface 307 importantly without moving the platform 301 away from the shaft 304. This is ‘anchored’ by support foot 305 when under the weight of a patient's foot.
In practice it is found that the desired angle of inward tilt of the surface 301 is between 12° to 18° and most preferably 15°. It will be appreciated that the surfaces 301 need not be able to rotate or tilt, or may be able to rotate outwardly if desired.
It will be appreciated that the patient's stance can be further adjusted by use of a rear foot adjustment curve and/or further adjusting the patient's stance by use of a forefoot adjustment curve. The rear foot and forefoot curves can be those as disclosed in US 2012/015972A1 or labeled 14 and 14′ in
In this embodiment, a piece of plastic 5 in the form of 2 mm natural polypropylene or similar extends from the heel support 200 to the front support 300 to support the foot foam 1 in place between the heel & front supports 200 & 300 and this acts as support surface 2 for the foot foams 1. The plastic 5 is to support apparatus used to correct the stance of the patient under the load of the patient. The plastic support 5 assists in preventing the foot foams 1 from deforming or collapsing under the weight of the patient.
It will be appreciated plastic 5 is of no utility in other preferred embodiments such as where using a flat horizontal support surface 6 (as best shown in
Other preferred embodiments shown in the remaining Figs are similar to
In contrast,
It will be appreciated that in the embodiment of
Each bladder hinges about a front end 9 thereof disposed towards the centre of the foot and the rear end 10 under or protruding from the side of the foot. One bladder 7 is disposed substantially underneath the cuboid on the outside lateral edge of the foot and the other bladder 8 on the inside is disposed substantially underneath the medial longitudinal arch.
The bladders can be made to allow a medial longitudinal arch (MLA) or cuboid support 11 & 12 (shown in
In preferred embodiments, supports 11 & 12 are as shown in
It will be appreciated that in some preferred embodiments, the MLA and cuboid supports 11 & 12 can be formed as part of the respective bladder 7 & 8 such that the upper face 13 of the bladders 7 & 8 are shaped to perform the function of the MLA and cuboid supports 11 & 12. It will be appreciated that either bladder 7 & 8 can be replaced with an equivalent device capable of moving the foot foam 1 supporting the cuboid or MLA in a like manner. Such devices include a linear actuator or screw device movable upwardly from the platform (or floor if not platform is used), or a mechanical lever such as a hinged MLA or cuboid support, or can be hydraulic, pneumatic, electrically powered or simply manually movable such as by supports shown in
It will be understood in the case of MLA and cuboid supports 11 & 12 being integrally formed with the support surface 13 of a bladder 7 or 8 then the handle portion 14 (seen at 7B, 7C, 8A and 8B in
Referring now to
In this embodiment, the use of the support surfaces 200 and 300 as in
Once the foot has been moved into the corrected position, and noting this is regardless of the type of platform 106 or 6 used for example, the MLA and cuboid supports 11 & 12 (in
It will be appreciated that in preferred embodiments, a thin preferably plastic sheet layer, for example 0.6 mm thick Promeg®, is disposed under the foam foot supports 1. This is to assist in sliding either the MLA and Cuboid supports or a bladder or similar relocatable device can be slid under the foams 1 without unnecessary resistance.
In the process of providing an orthotic for a patient when they are in a corrected stance, orthotics 20 (such as in
A fabric or other sheet material layer 24 is added over the underside of the full length or three-quarter length thermoplastic material to cover the whole of the full or three-quarter thermoplastic material at the bottom or lower face. The full-length or three-quarter thermoplastic upper material 22 is about 1.4 mm thick and the three-quarter length lower material 23 is about 1.2 mm thick. In the preferred embodiment, the commercially available product CAMBRELLE® lining material forms the bottom or lower layer 24, details of which can be found at http://www.cambrelle.com/Products/. These layers are glued together to form a single piece blank orthotic.
The blank orthotic 20 is placed in an oven at approximately 100° C. for 4 min 30 sec to soften the thermoplastic materials 21 & 22. Other heating methods can be employed as desired, such as microwave ovens or heat guns, for example. The heated blank orthotic 20 is removed from the oven, and has a top foam or cushion layer 21 added. Any preferred material such as leather, vinyl, ethyl vinyl acetate (EVA) and neoprene can be used. This is preferably pre-glued on one side or with the use of a double sided tape. The top layer, in addition to desirably providing a long wearing surface also protects the foot from the heated blank orthotic 20.
It will be appreciated that the template 20 can alternatively be supplied with the top covers already applied requiring that the orthotic heated only from beneath.
The patient is stood on the foot foams 1 where they lift either their left or right foot and the heated blank orthotic 20 is placed onto the foot foam 1 with the top foam or cushion layer 21 added. The heated blank orthotic is then smoothed into the contours of the foot foam 1 to reduce or eliminate any creases forming in the heated blank orthotic 20 as it cools under the load of a foot.
The lifted foot is then guided by the hands of the practitioner and placed back on the heated template 20 on the appropriate foot foam 1 so the foot is on top of the heated blank orthotic 20 on the foot foam 1. This is then wrapped about the sole of the foot by means of a wrap 15, which had been placed in advance between the foam 1 and the template 20, to conform the heated orthotic template 20 to the foot. This is shown in
The wrap 15 is positioned on top of the foot foam 1 before the template is placed in position. That is, the template sits on top of the wrap.
In another embodiment, the wrap 15 can be integrally formed with the foot foam 1 but it must be remembered then that the foam 1 would need to be moved with the foot and orthotic 20 into the Windlass position (as below) for the orthotic 20 to be allowed to set.
The foot wrap 15 can be integrally formed as part of the foot foam supports 1, or could be a separate element that is simply wrapped around the foot and the heated orthotic template 20. The wrap 15 is composed of any type of elasticised or stretchable fabric or mesh. The wrap 15 may be secured by means of Velcro or buttons or studs, ties or the like.
Once the heated blank orthotic 20 is wrapped around the foot of the patient, the cuboid support 12 is disposed on the outside of the foot or the foot is placed over a cuboid bladder 7 or the like when such devices are used.
The cuboid support 12 is then pushed upwardly by the practitioner until resistance is felt and preferably more force is applied until the foot starts to move, raising the lateral arch cuboid area of the foot via vertical, translation and/or rotational forces until the foot either is moved into a neutral position or cannot be moved any further towards neutral position or has reached its end range of motion. It will be appreciated that in the case of a patient with a pronated foot, the movement of the cuboid curve will be modest relative to the extent of movement created by use of the MLA curve.
The medial longitudinal arch support 11 is then disposed under the arch of the foot or the foot is placed over a MLA bladder 8 or the like (eg support 11 and 12) when such devices are used and this is pushed upwardly by the practitioner until resistance is felt and preferably more force is applied until the foot starts to move, raising the arch via vertical, translation and rotational forces until the foot either is moved into a neutral position or cannot be moved any further towards neutral position or has reached its end range of motion.
As noted above, the patient may instead be standing on a bladder 8 and this is simply pumped up or otherwise moved to have the same effect.
Optionally, the practitioner may ask the patient to roll their ankle, inwardly or outwardly as required, thereby assisting in the movement of the foot via the cuboid curve 11 or MLA curve 12 to its optimal corrected position.
In the case where a bladder 7 & 8 or the like device is not being used, once the MLA and cuboid supports 11 & 12 are moved into position a wedge or other supporting/packing material (not illustrated) is inserted under the cuboid and the arch to maintain the foot in a corrected position and stop the areas corrected by supports 11 & 12 from moving. The supports 11 & 12 are maintained between the packing material and foam 1 retaining the orthotic 20 in the corrected position.
When the arch and cuboid of the foot have been adjusted so the foot is in a more neutral position, the rear foot alignment curve 201 may be adjusted to correct any misalignment through the calcaneus (heel) with the same principles applying in the correction process. Further, the width of the patient's stance may be narrowed to approximately hip width by adjusting actuator 116 shown in
With the foot in the corrected position, the patient then lifts one of their heels (
At this stage, all of the exposed underside material of the orthotic 20, proximal to the metatarsals through the midfoot and heel areas, is cooled down by applying a cool temperature source. This is most preferably an aerosol freeze spray such as commonly used by athletes such as VITALIC® Instant Ice Sports Spray (see https://www.airssential.com.au/productdetails.aspx?prdid=37), or CRC® or AEROSOLVE® brand aerosol can freeze sprays. These work by the evaporation of butane or propane, for example.
Saturation of the wrap may be required to ensure sufficient cooling of the orthotic through the midfoot.
Any alternate preferred means can be used such as cooled or frozen gel pack, and the foot wrap 15 may include a pouch or pocket (not illustrated) to allow insertion of a gel pack. Such cooling means may be integrated into the foot foam supports 1 or the support surfaces 2. For example, leaving channels in the foot foams 1 terminating at the surface and that are connectable to a freeze spray or cooling source so that the cooling is done from below by an integral source.
The foot is then raised to clear the foot foam 1. The foot wrap 15 is then released. It will be appreciated that in some Figs the orthotic 20, orthotic top cover 21 and foot wrap 15 are omitted in order to clearly illustrate the position of the foot.
The foot wrap 15 is preferably perforated such as 2 mm thick neoprene formed from an elastic woven material. This is to allow air or other cooling materials (gas or even liquid) to freely pass through it to more efficiently cool the formed orthotic 20.
At this stage, the orthotic 20 is removed to a freezer or otherwise cooled to well below the softening point but can be slightly reshaped if desired before completely cooling. An orthotic 20 of the preferred embodiment is shown in
The orthotic 20 can advantageously be later re-heated in specific areas to deflect or re-shape the orthotic 20 as desired.
After an orthotic for a patient standing in a corrected stance is formed, a region about the arch on the bottom of the cooled orthotic may be ‘stiffened’ or ‘stabilised’ so as to resist downward forces applied by the foot onto the orthotic. This is preferably done by attaching a suitably dimensioned volume of foam, ethyl vinyl acetate or other material (an example is shown at element 25 in
Referring to
Turning to
Particularly, bladder 8D is intended to be located proximal to the metatarsals. This bladder is intended to create “a dome effect” and provide a convex bulge in the orthotic so as to provide additional support to this area of the plantar surface of the foot. It can be seen that the foot foam 1 sits on support surface 6 having the valve mechanism 19 and bladders 7 & 8 integrated therewith. Further, it can be seen that rear foot curve 14 is employed together with fore foot curve 14′.
In respect of
This is most advantageous as it allows the patient to actually walk once the heated orthotics are in place and initial corrections made. The practitioner can then observe any mis-alignment and make further adjustments accordingly. For example, the practitioner can sit behind the patient whilst they are walking or running on a treadmill such as shown in
Referring to
Whilst the above preferred embodiments principally describe the use of orthotic 20 formed from two or more thermoplastic material layers 22 and 23 that may both be three-quarter length or one full-length and the other three-quarter length, this can be replaced by a single layer thermoplastic material having a graduated or differential thickness to replicate the response provided by thermoplastic material layers 22 and 23. In such an embodiment, the thickness is graduated from thickest at the heel to thinnest at the toe end, or it could change at specific intervals to compensate for increased loads or forces from particular areas of the foot when in use.
It will be appreciated that once an orthotic 20 is formed, it can be advantageous to provide some support material 25 to prevent the thermoplastic material deforming over time under load or when the orthotic becomes warmed. The support material is typically a relatively stiff foam that can be adhered to the underside of the orthotic 20 and then ground to an optimal shape to be received in a shoe. It will be appreciated that a gel, expandable foam, epoxy resin or other two-part mixture, or rubber filler, for example, may be employed to serve this purpose.
The foregoing describes only some preferred embodiments of the present invention and modifications, obvious to those skilled in the orthotic arts, can be made thereto without departing from the scope of the present invention.
The term “comprising” (and its grammatical variations) as used herein is used in the inclusive sense of “including” or “having” and not in the exclusive sense of “consisting only of”.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2013903637 | Sep 2013 | AU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/AU2014/050242 | 9/19/2014 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2015/039191 | 3/26/2015 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 3591882 | Pearsall | Jul 1971 | A |
| 3895405 | Edwards | Jul 1975 | A |
| 4133118 | Khalsa | Jan 1979 | A |
| 4296053 | Doerer | Oct 1981 | A |
| 4338734 | Schwartz | Jul 1982 | A |
| 4716662 | Bar | Jan 1988 | A |
| 5123180 | Nannig | Jun 1992 | A |
| 5733647 | Moore, III | Mar 1998 | A |
| 6195917 | Dieckhaus | Mar 2001 | B1 |
| 6210788 | Cuypers | Apr 2001 | B1 |
| 6346210 | Swartz | Feb 2002 | B1 |
| 6560902 | Eschweiler | May 2003 | B1 |
| 7657054 | Phillips | Feb 2010 | B2 |
| 7752773 | McCarron | Jul 2010 | B2 |
| 9565888 | Joseph | Feb 2017 | B2 |
| 20020043005 | Blackburn | Apr 2002 | A1 |
| 20020050080 | Vasyli | May 2002 | A1 |
| 20030009915 | Bacon | Jan 2003 | A1 |
| 20030061735 | Polifroni | Apr 2003 | A1 |
| 20030061736 | Polifroni | Apr 2003 | A1 |
| 20070234592 | Crates | Oct 2007 | A1 |
| 20070277397 | Chen | Dec 2007 | A1 |
| 20070289170 | Avent | Dec 2007 | A1 |
| 20080010856 | Hakkala | Jan 2008 | A1 |
| 20110307081 | McDuff | Dec 2011 | A1 |
| 20120090198 | Stratten | Apr 2012 | A1 |
| 20120204444 | Liu | Aug 2012 | A1 |
| Number | Date | Country |
|---|---|---|
| WO-2007018449 | Feb 2007 | WO |
| WO-2012103521 | Aug 2012 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 20170273397 A1 | Sep 2017 | US |
